Neurology

Medicare beneficiaries in Alabama were more likely to get a prescription for an opioid than in any other state in 2019, based on newly released data.

That year, opioids represented 6.48% of all drug claims for part D enrollees in the state, just ahead of Utah at 6.41%. Idaho, at 6.07%, was the only other state with an opioid prescribing rate over 6%, while Oklahoma came in at an even 6.0%, according to the latest update of the Centers for Medicare & Medicaid Services’ dataset.

The lowest rate in 2019 belonged to New York, where 2.51% of drug claims, including original prescriptions and refills, involved an opioid. Rhode Island was next at 2.87%, followed by New Jersey (3.23%), Massachusetts (3.26%), and North Dakota (3.39%),

Altogether, Medicare part D processed 1.5 billion drug claims in 2019, of which 66.1 million, or 4.41%, involved opioids. Both of the opioid numbers were down from 2018, when opioids represented 4.68% (70.2 million) of the 1.5 billion total claims, and from 2014, when opioids were involved in 5.73% (81,026,831) of the 1.41 billion drug claims, the CMS data show. That works out to 5.77% fewer opioids in 2019, compared with 2014, despite the increase in total volume.

Among the states, Delaware had the largest 5-year decrease, 2.38 percentage points, as its opioid prescribing rate dropped from 6.61% to 4.23% from 2014 to 2019, with Hawaii showing the smallest decline as it slipped 0.41 percentage points from 3.9% to 3.49%, according to the CMS.

In 2019, part D beneficiaries in Vermont were the most likely to receive a long-acting opioid, which accounted for 20.14% of all opioid prescriptions in the state, while Kentucky had the lowest share of prescriptions written for long-acting forms at 6.41%. The national average was 11.02%, dropping from 11.79% in 2018 and 12.75% in 2014, the CMS reported.

rfranki@mdedge.com

Medicare beneficiaries in Alabama were more likely to get a prescription for an opioid than in any other state in 2019, based on newly released data.

That year, opioids represented 6.48% of all drug claims for part D enrollees in the state, just ahead of Utah at 6.41%. Idaho, at 6.07%, was the only other state with an opioid prescribing rate over 6%, while Oklahoma came in at an even 6.0%, according to the latest update of the Centers for Medicare & Medicaid Services’ dataset.

The lowest rate in 2019 belonged to New York, where 2.51% of drug claims, including original prescriptions and refills, involved an opioid. Rhode Island was next at 2.87%, followed by New Jersey (3.23%), Massachusetts (3.26%), and North Dakota (3.39%),

Altogether, Medicare part D processed 1.5 billion drug claims in 2019, of which 66.1 million, or 4.41%, involved opioids. Both of the opioid numbers were down from 2018, when opioids represented 4.68% (70.2 million) of the 1.5 billion total claims, and from 2014, when opioids were involved in 5.73% (81,026,831) of the 1.41 billion drug claims, the CMS data show. That works out to 5.77% fewer opioids in 2019, compared with 2014, despite the increase in total volume.

Among the states, Delaware had the largest 5-year decrease, 2.38 percentage points, as its opioid prescribing rate dropped from 6.61% to 4.23% from 2014 to 2019, with Hawaii showing the smallest decline as it slipped 0.41 percentage points from 3.9% to 3.49%, according to the CMS.

In 2019, part D beneficiaries in Vermont were the most likely to receive a long-acting opioid, which accounted for 20.14% of all opioid prescriptions in the state, while Kentucky had the lowest share of prescriptions written for long-acting forms at 6.41%. The national average was 11.02%, dropping from 11.79% in 2018 and 12.75% in 2014, the CMS reported.

rfranki@mdedge.com

Medicare beneficiaries in Alabama were more likely to get a prescription for an opioid than in any other state in 2019, based on newly released data.

That year, opioids represented 6.48% of all drug claims for part D enrollees in the state, just ahead of Utah at 6.41%. Idaho, at 6.07%, was the only other state with an opioid prescribing rate over 6%, while Oklahoma came in at an even 6.0%, according to the latest update of the Centers for Medicare & Medicaid Services’ dataset.

The lowest rate in 2019 belonged to New York, where 2.51% of drug claims, including original prescriptions and refills, involved an opioid. Rhode Island was next at 2.87%, followed by New Jersey (3.23%), Massachusetts (3.26%), and North Dakota (3.39%),

Altogether, Medicare part D processed 1.5 billion drug claims in 2019, of which 66.1 million, or 4.41%, involved opioids. Both of the opioid numbers were down from 2018, when opioids represented 4.68% (70.2 million) of the 1.5 billion total claims, and from 2014, when opioids were involved in 5.73% (81,026,831) of the 1.41 billion drug claims, the CMS data show. That works out to 5.77% fewer opioids in 2019, compared with 2014, despite the increase in total volume.

Among the states, Delaware had the largest 5-year decrease, 2.38 percentage points, as its opioid prescribing rate dropped from 6.61% to 4.23% from 2014 to 2019, with Hawaii showing the smallest decline as it slipped 0.41 percentage points from 3.9% to 3.49%, according to the CMS.

In 2019, part D beneficiaries in Vermont were the most likely to receive a long-acting opioid, which accounted for 20.14% of all opioid prescriptions in the state, while Kentucky had the lowest share of prescriptions written for long-acting forms at 6.41%. The national average was 11.02%, dropping from 11.79% in 2018 and 12.75% in 2014, the CMS reported.

rfranki@mdedge.com

Adherence to the MIND diet can improve memory and thinking skills of older adults, even in the presence of Alzheimer’s disease pathology, new data from the Rush Memory and Aging Project (MAP) show.

Suprijono Suharjoto/Fotolia

“The MIND diet was associated with better cognitive functions independently of brain pathologies related to Alzheimer’s disease, suggesting that diet may contribute to cognitive resilience, which ultimately indicates that it is never too late for dementia prevention,” lead author Klodian Dhana, MD, PhD, with the Rush Institute of Healthy Aging at Rush University, Chicago, said in an interview.

The study was published online Sept. 14, 2021, in the Journal of Alzheimer’s Disease.
 

Impact on brain pathology

“While previous investigations determined that the MIND diet is associated with a slower cognitive decline, the current study furthered the diet and brain health evidence by assessing the impact of brain pathology in the diet-cognition relationship,” Dr. Dhana said.

The MIND diet was pioneered by the late Martha Clare Morris, ScD, a Rush nutritional epidemiologist, who died in 2020 of cancer at age 64. A hybrid of the Mediterranean and DASH (Dietary Approaches to Stop Hypertension) diets, the MIND diet includes green leafy vegetables, fish, nuts, berries, beans, and whole grains and limits consumption of fried and fast foods, sweets, and pastries.

The current study focused on 569 older adults who died while participating in the MAP study, which began in 1997. Participants in the study were mostly White and were without known dementia. All of the participants agreed to undergo annual clinical evaluations. They also agreed to undergo brain autopsy after death.

Beginning in 2004, participants completed annual food frequency questionnaires, which were used to calculate a MIND diet score based on how often the participants ate specific foods.

The researchers used a series of regression analyses to examine associations of the MIND diet, dementia-related brain pathologies, and global cognition near the time of death. Analyses were adjusted for age, sex, education, apo E4, late-life cognitive activities, and total energy intake.

The results show that a higher MIND diet score was associated with better global cognitive functioning around the time of death (beta, 0.119; P = .003).

Notably, the researchers said, neither the strength nor the significance of association changed markedly when AD pathology and other brain pathologies were included in the model (beta, 0.111; P = .003).

The relationship between better adherence to the MIND diet and better cognition remained significant when the analysis was restricted to individuals without mild cognitive impairment at baseline (beta, 0.121; P = .005) as well as to persons in whom a postmortem diagnosis of AD was made on the basis of NIA-Reagan consensus recommendations (beta, 0.114; P = .023).

The limitations of the study include the reliance on self-reported diet information and a sample made up of mostly White volunteers who agreed to annual evaluations and postmortem organ donation, thus limiting generalizability.

Strengths of the study include the prospective design with annual assessment of cognitive function using standardized tests and collection of the dietary information using validated questionnaires. Also, the neuropathologic evaluations were performed by examiners blinded to clinical data.

“Diet changes can impact cognitive functioning and risk of dementia, for better or worse. There are fairly simple diet and lifestyle changes a person could make that may help to slow cognitive decline with aging and contribute to brain health,” Dr. Dhana said in a news release.
 

Builds resilience

Weighing in on the study, Heather Snyder, PhD, vice president of medical and scientific relations for the Alzheimer’s Association, said this “interesting study sheds light on the impact of nutrition on cognitive function.

“The findings add to the growing literature that lifestyle factors – like access to a heart-healthy diet – may help the brain be more resilient to disease-specific changes,” Snyder said in an interview.

“The Alzheimer’s Association’s US POINTER study is investigating how lifestyle interventions, including nutrition guidance, like the MIND diet, may impact a person’s risk of cognitive decline. An ancillary study of the US POINTER will include brain imaging to investigate how these lifestyle interventions impact the biology of the brain,” Dr. Snyder noted.

The research was supported by the National Institute on Aging of the National Institutes of Health. Dr. Dhana and Dr. Snyder disclosed no relevant financial relationships.

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

Adherence to the MIND diet can improve memory and thinking skills of older adults, even in the presence of Alzheimer’s disease pathology, new data from the Rush Memory and Aging Project (MAP) show.

Suprijono Suharjoto/Fotolia

“The MIND diet was associated with better cognitive functions independently of brain pathologies related to Alzheimer’s disease, suggesting that diet may contribute to cognitive resilience, which ultimately indicates that it is never too late for dementia prevention,” lead author Klodian Dhana, MD, PhD, with the Rush Institute of Healthy Aging at Rush University, Chicago, said in an interview.

The study was published online Sept. 14, 2021, in the Journal of Alzheimer’s Disease.
 

Impact on brain pathology

“While previous investigations determined that the MIND diet is associated with a slower cognitive decline, the current study furthered the diet and brain health evidence by assessing the impact of brain pathology in the diet-cognition relationship,” Dr. Dhana said.

The MIND diet was pioneered by the late Martha Clare Morris, ScD, a Rush nutritional epidemiologist, who died in 2020 of cancer at age 64. A hybrid of the Mediterranean and DASH (Dietary Approaches to Stop Hypertension) diets, the MIND diet includes green leafy vegetables, fish, nuts, berries, beans, and whole grains and limits consumption of fried and fast foods, sweets, and pastries.

The current study focused on 569 older adults who died while participating in the MAP study, which began in 1997. Participants in the study were mostly White and were without known dementia. All of the participants agreed to undergo annual clinical evaluations. They also agreed to undergo brain autopsy after death.

Beginning in 2004, participants completed annual food frequency questionnaires, which were used to calculate a MIND diet score based on how often the participants ate specific foods.

The researchers used a series of regression analyses to examine associations of the MIND diet, dementia-related brain pathologies, and global cognition near the time of death. Analyses were adjusted for age, sex, education, apo E4, late-life cognitive activities, and total energy intake.

The results show that a higher MIND diet score was associated with better global cognitive functioning around the time of death (beta, 0.119; P = .003).

Notably, the researchers said, neither the strength nor the significance of association changed markedly when AD pathology and other brain pathologies were included in the model (beta, 0.111; P = .003).

The relationship between better adherence to the MIND diet and better cognition remained significant when the analysis was restricted to individuals without mild cognitive impairment at baseline (beta, 0.121; P = .005) as well as to persons in whom a postmortem diagnosis of AD was made on the basis of NIA-Reagan consensus recommendations (beta, 0.114; P = .023).

The limitations of the study include the reliance on self-reported diet information and a sample made up of mostly White volunteers who agreed to annual evaluations and postmortem organ donation, thus limiting generalizability.

Strengths of the study include the prospective design with annual assessment of cognitive function using standardized tests and collection of the dietary information using validated questionnaires. Also, the neuropathologic evaluations were performed by examiners blinded to clinical data.

“Diet changes can impact cognitive functioning and risk of dementia, for better or worse. There are fairly simple diet and lifestyle changes a person could make that may help to slow cognitive decline with aging and contribute to brain health,” Dr. Dhana said in a news release.
 

Builds resilience

Weighing in on the study, Heather Snyder, PhD, vice president of medical and scientific relations for the Alzheimer’s Association, said this “interesting study sheds light on the impact of nutrition on cognitive function.

“The findings add to the growing literature that lifestyle factors – like access to a heart-healthy diet – may help the brain be more resilient to disease-specific changes,” Snyder said in an interview.

“The Alzheimer’s Association’s US POINTER study is investigating how lifestyle interventions, including nutrition guidance, like the MIND diet, may impact a person’s risk of cognitive decline. An ancillary study of the US POINTER will include brain imaging to investigate how these lifestyle interventions impact the biology of the brain,” Dr. Snyder noted.

The research was supported by the National Institute on Aging of the National Institutes of Health. Dr. Dhana and Dr. Snyder disclosed no relevant financial relationships.

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

Adherence to the MIND diet can improve memory and thinking skills of older adults, even in the presence of Alzheimer’s disease pathology, new data from the Rush Memory and Aging Project (MAP) show.

Suprijono Suharjoto/Fotolia

“The MIND diet was associated with better cognitive functions independently of brain pathologies related to Alzheimer’s disease, suggesting that diet may contribute to cognitive resilience, which ultimately indicates that it is never too late for dementia prevention,” lead author Klodian Dhana, MD, PhD, with the Rush Institute of Healthy Aging at Rush University, Chicago, said in an interview.

The study was published online Sept. 14, 2021, in the Journal of Alzheimer’s Disease.
 

Impact on brain pathology

“While previous investigations determined that the MIND diet is associated with a slower cognitive decline, the current study furthered the diet and brain health evidence by assessing the impact of brain pathology in the diet-cognition relationship,” Dr. Dhana said.

The MIND diet was pioneered by the late Martha Clare Morris, ScD, a Rush nutritional epidemiologist, who died in 2020 of cancer at age 64. A hybrid of the Mediterranean and DASH (Dietary Approaches to Stop Hypertension) diets, the MIND diet includes green leafy vegetables, fish, nuts, berries, beans, and whole grains and limits consumption of fried and fast foods, sweets, and pastries.

The current study focused on 569 older adults who died while participating in the MAP study, which began in 1997. Participants in the study were mostly White and were without known dementia. All of the participants agreed to undergo annual clinical evaluations. They also agreed to undergo brain autopsy after death.

Beginning in 2004, participants completed annual food frequency questionnaires, which were used to calculate a MIND diet score based on how often the participants ate specific foods.

The researchers used a series of regression analyses to examine associations of the MIND diet, dementia-related brain pathologies, and global cognition near the time of death. Analyses were adjusted for age, sex, education, apo E4, late-life cognitive activities, and total energy intake.

The results show that a higher MIND diet score was associated with better global cognitive functioning around the time of death (beta, 0.119; P = .003).

Notably, the researchers said, neither the strength nor the significance of association changed markedly when AD pathology and other brain pathologies were included in the model (beta, 0.111; P = .003).

The relationship between better adherence to the MIND diet and better cognition remained significant when the analysis was restricted to individuals without mild cognitive impairment at baseline (beta, 0.121; P = .005) as well as to persons in whom a postmortem diagnosis of AD was made on the basis of NIA-Reagan consensus recommendations (beta, 0.114; P = .023).

The limitations of the study include the reliance on self-reported diet information and a sample made up of mostly White volunteers who agreed to annual evaluations and postmortem organ donation, thus limiting generalizability.

Strengths of the study include the prospective design with annual assessment of cognitive function using standardized tests and collection of the dietary information using validated questionnaires. Also, the neuropathologic evaluations were performed by examiners blinded to clinical data.

“Diet changes can impact cognitive functioning and risk of dementia, for better or worse. There are fairly simple diet and lifestyle changes a person could make that may help to slow cognitive decline with aging and contribute to brain health,” Dr. Dhana said in a news release.
 

Builds resilience

Weighing in on the study, Heather Snyder, PhD, vice president of medical and scientific relations for the Alzheimer’s Association, said this “interesting study sheds light on the impact of nutrition on cognitive function.

“The findings add to the growing literature that lifestyle factors – like access to a heart-healthy diet – may help the brain be more resilient to disease-specific changes,” Snyder said in an interview.

“The Alzheimer’s Association’s US POINTER study is investigating how lifestyle interventions, including nutrition guidance, like the MIND diet, may impact a person’s risk of cognitive decline. An ancillary study of the US POINTER will include brain imaging to investigate how these lifestyle interventions impact the biology of the brain,” Dr. Snyder noted.

The research was supported by the National Institute on Aging of the National Institutes of Health. Dr. Dhana and Dr. Snyder disclosed no relevant financial relationships.

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

Women with a history of migraine are more likely to experience severe or very severe hot flashes than women without migraines, according to research presented Sept. 24 at the hybrid annual meeting of the North American Menopause Society. An estimated one in five women experience migraine, and women tend to have greater migraine symptoms and disability, the authors note in their background information. Since migraines are also linked to a higher risk of cardiovascular disease, the authors sought to learn whether migraines were associated with vasomotor symptoms, another cardiovascular risk factor.

“The question in my mind is, can we do better at predicting cardiovascular risk in women because the risk prediction models that we have really don’t work all that well in women because they were designed for use in men,” Stephanie S. Faubion, MD, MBA, Penny and Bill George Director for Mayo Clinic’s Center for Women’s Health said in an interview. “My ultimate goal is to see if we can somehow use big data, artificial intelligence to figure out how to weight some of these female-specific or female-predominant factors to come up with a better model for cardiovascular risk prediction.”

The researchers analyzed cross-sectional data from 3,308 women who participated in the Data Registry on the Experiences of Aging, Menopause and Sexuality (DREAMS) study through Mayo Clinic sites in Rochester, Minn.; Scottsdale, Ariz.; and Jacksonville, Fla.. The women ranged in age from 45 to 60 years old, with an average age of 53, and the vast majority of them were white (95%) and had at least some college (93%). Most were also in a long-term relationship (85%), and a majority were employed (69%) and postmenopausal (67%).

The data, collected between May 2015 and December 2019, included a self-reported history of migraine and questionnaires that included the Menopause Rating Scale of menopause-related symptoms.

The researchers adjusted their findings to account for body mass index (BMI), menopause status, smoking status, depression, anxiety, current use of hormone therapy, and presence of low back pain within the past year. ”The diagnosis of low back pain, another pain disorder, was used to test the specificity of the association of migraine and vasomotor symptoms,” the authors write.

Just over a quarter of the women (27%) reported a history of migraine, and these women’s Menopause Rating Scale scores were an average 1.36 points greater than women without a history of migraines (P < .001). Women with self-reported migraine were also 40% more likely than women without migraines to report severe or very severe flashes versus reporting no hot flashes at all (odds ratio, 1.4; P = .02).

“The odds of reporting more severe hot flashes increased monotonically in women with a history of migraine,” the authors report. “In addition, women with low back pain had higher Menopause Rating Scale scores, but were no more likely to have severe/very severe hot flashes than those without back pain, confirming the specificity of the link between vasomotor symptoms and migraine.”

It’s not clear if migraine or hot flashes are risk factors that add to a woman’s existing cardiovascular risk profile or whether they are simply biomarkers of a shared pathway, Dr Faubion said in an interview. She speculates that the common link between migraine and vasomotor symptoms could be neurovascular dysregulation.

Rachael B. Smith, DO, of the department of ob.gyn. at the University of Arizona, Phoenix, was not involved in the research but found that hypothesis plausible as well.

“Our neurologic and vascular systems are coordinated physiologic processes working together for basic brain and body function,” Dr. Smith said in an interview. Some of the symptoms of migraines and menopause are similar and both are often explained by the dysfunction of these systems. The association between history of migraines and severity of vasomotor symptoms is very likely to be explained by this dysregulation between the neurologic and vascular systems.”

Dr. Smith also pointed out, however, that the largely homogeneous study population, all from the same national clinic system, makes it difficult to know how generalizable these findings are.

The primary clinical implications of these findings are that women’s providers need to be sure they’re asking their patients about migraine history and symptoms.

“The counseling we provide on menopausal symptoms should be better tailored to our patients’ medical history, specifically inquiring about history of migraines and how this may impact their symptoms,” Dr. Smith said.

The research was funded by the National Institutes of Health. Dr. Faubion and Dr. Smith had no disclosures.

Women with a history of migraine are more likely to experience severe or very severe hot flashes than women without migraines, according to research presented Sept. 24 at the hybrid annual meeting of the North American Menopause Society. An estimated one in five women experience migraine, and women tend to have greater migraine symptoms and disability, the authors note in their background information. Since migraines are also linked to a higher risk of cardiovascular disease, the authors sought to learn whether migraines were associated with vasomotor symptoms, another cardiovascular risk factor.

“The question in my mind is, can we do better at predicting cardiovascular risk in women because the risk prediction models that we have really don’t work all that well in women because they were designed for use in men,” Stephanie S. Faubion, MD, MBA, Penny and Bill George Director for Mayo Clinic’s Center for Women’s Health said in an interview. “My ultimate goal is to see if we can somehow use big data, artificial intelligence to figure out how to weight some of these female-specific or female-predominant factors to come up with a better model for cardiovascular risk prediction.”

The researchers analyzed cross-sectional data from 3,308 women who participated in the Data Registry on the Experiences of Aging, Menopause and Sexuality (DREAMS) study through Mayo Clinic sites in Rochester, Minn.; Scottsdale, Ariz.; and Jacksonville, Fla.. The women ranged in age from 45 to 60 years old, with an average age of 53, and the vast majority of them were white (95%) and had at least some college (93%). Most were also in a long-term relationship (85%), and a majority were employed (69%) and postmenopausal (67%).

The data, collected between May 2015 and December 2019, included a self-reported history of migraine and questionnaires that included the Menopause Rating Scale of menopause-related symptoms.

The researchers adjusted their findings to account for body mass index (BMI), menopause status, smoking status, depression, anxiety, current use of hormone therapy, and presence of low back pain within the past year. ”The diagnosis of low back pain, another pain disorder, was used to test the specificity of the association of migraine and vasomotor symptoms,” the authors write.

Just over a quarter of the women (27%) reported a history of migraine, and these women’s Menopause Rating Scale scores were an average 1.36 points greater than women without a history of migraines (P < .001). Women with self-reported migraine were also 40% more likely than women without migraines to report severe or very severe flashes versus reporting no hot flashes at all (odds ratio, 1.4; P = .02).

“The odds of reporting more severe hot flashes increased monotonically in women with a history of migraine,” the authors report. “In addition, women with low back pain had higher Menopause Rating Scale scores, but were no more likely to have severe/very severe hot flashes than those without back pain, confirming the specificity of the link between vasomotor symptoms and migraine.”

It’s not clear if migraine or hot flashes are risk factors that add to a woman’s existing cardiovascular risk profile or whether they are simply biomarkers of a shared pathway, Dr Faubion said in an interview. She speculates that the common link between migraine and vasomotor symptoms could be neurovascular dysregulation.

Rachael B. Smith, DO, of the department of ob.gyn. at the University of Arizona, Phoenix, was not involved in the research but found that hypothesis plausible as well.

“Our neurologic and vascular systems are coordinated physiologic processes working together for basic brain and body function,” Dr. Smith said in an interview. Some of the symptoms of migraines and menopause are similar and both are often explained by the dysfunction of these systems. The association between history of migraines and severity of vasomotor symptoms is very likely to be explained by this dysregulation between the neurologic and vascular systems.”

Dr. Smith also pointed out, however, that the largely homogeneous study population, all from the same national clinic system, makes it difficult to know how generalizable these findings are.

The primary clinical implications of these findings are that women’s providers need to be sure they’re asking their patients about migraine history and symptoms.

“The counseling we provide on menopausal symptoms should be better tailored to our patients’ medical history, specifically inquiring about history of migraines and how this may impact their symptoms,” Dr. Smith said.

The research was funded by the National Institutes of Health. Dr. Faubion and Dr. Smith had no disclosures.

Women with a history of migraine are more likely to experience severe or very severe hot flashes than women without migraines, according to research presented Sept. 24 at the hybrid annual meeting of the North American Menopause Society. An estimated one in five women experience migraine, and women tend to have greater migraine symptoms and disability, the authors note in their background information. Since migraines are also linked to a higher risk of cardiovascular disease, the authors sought to learn whether migraines were associated with vasomotor symptoms, another cardiovascular risk factor.

“The question in my mind is, can we do better at predicting cardiovascular risk in women because the risk prediction models that we have really don’t work all that well in women because they were designed for use in men,” Stephanie S. Faubion, MD, MBA, Penny and Bill George Director for Mayo Clinic’s Center for Women’s Health said in an interview. “My ultimate goal is to see if we can somehow use big data, artificial intelligence to figure out how to weight some of these female-specific or female-predominant factors to come up with a better model for cardiovascular risk prediction.”

The researchers analyzed cross-sectional data from 3,308 women who participated in the Data Registry on the Experiences of Aging, Menopause and Sexuality (DREAMS) study through Mayo Clinic sites in Rochester, Minn.; Scottsdale, Ariz.; and Jacksonville, Fla.. The women ranged in age from 45 to 60 years old, with an average age of 53, and the vast majority of them were white (95%) and had at least some college (93%). Most were also in a long-term relationship (85%), and a majority were employed (69%) and postmenopausal (67%).

The data, collected between May 2015 and December 2019, included a self-reported history of migraine and questionnaires that included the Menopause Rating Scale of menopause-related symptoms.

The researchers adjusted their findings to account for body mass index (BMI), menopause status, smoking status, depression, anxiety, current use of hormone therapy, and presence of low back pain within the past year. ”The diagnosis of low back pain, another pain disorder, was used to test the specificity of the association of migraine and vasomotor symptoms,” the authors write.

Just over a quarter of the women (27%) reported a history of migraine, and these women’s Menopause Rating Scale scores were an average 1.36 points greater than women without a history of migraines (P < .001). Women with self-reported migraine were also 40% more likely than women without migraines to report severe or very severe flashes versus reporting no hot flashes at all (odds ratio, 1.4; P = .02).

“The odds of reporting more severe hot flashes increased monotonically in women with a history of migraine,” the authors report. “In addition, women with low back pain had higher Menopause Rating Scale scores, but were no more likely to have severe/very severe hot flashes than those without back pain, confirming the specificity of the link between vasomotor symptoms and migraine.”

It’s not clear if migraine or hot flashes are risk factors that add to a woman’s existing cardiovascular risk profile or whether they are simply biomarkers of a shared pathway, Dr Faubion said in an interview. She speculates that the common link between migraine and vasomotor symptoms could be neurovascular dysregulation.

Rachael B. Smith, DO, of the department of ob.gyn. at the University of Arizona, Phoenix, was not involved in the research but found that hypothesis plausible as well.

“Our neurologic and vascular systems are coordinated physiologic processes working together for basic brain and body function,” Dr. Smith said in an interview. Some of the symptoms of migraines and menopause are similar and both are often explained by the dysfunction of these systems. The association between history of migraines and severity of vasomotor symptoms is very likely to be explained by this dysregulation between the neurologic and vascular systems.”

Dr. Smith also pointed out, however, that the largely homogeneous study population, all from the same national clinic system, makes it difficult to know how generalizable these findings are.

The primary clinical implications of these findings are that women’s providers need to be sure they’re asking their patients about migraine history and symptoms.

“The counseling we provide on menopausal symptoms should be better tailored to our patients’ medical history, specifically inquiring about history of migraines and how this may impact their symptoms,” Dr. Smith said.

The research was funded by the National Institutes of Health. Dr. Faubion and Dr. Smith had no disclosures.

The Food and Drug Administration has approved atogepant (Qulipta), a novel calcitonin gene-related peptide (CGRP) receptor antagonist, for the prevention of episodic migraine, the manufacturer announced in a release.

The once-daily medication will be available in doses of 10 mg, 30 mg, and 60 mg.

“Qulipta provides a simple oral treatment option specifically developed to prevent migraine attacks and target CGRP, which is believed to be crucially involved in migraine in many patients,” coinvestigator Peter J. Goadsby, MD, PhD, DSc, neurologist and professor at the University of California, Los Angeles, and King’s College London, said in the release.

Approval was based partly on the findings from the phase 3 ADVANCE trial, in which patients with episodic migraine were randomly assigned to receive placebo or a 10-mg, 30-mg, or 60-mg daily dose of atogepant for 12 weeks.

As reported by this news organization, all three doses of atogepant reduced the number of mean monthly migraine days.

With this approval, neurologists will be able to choose from four monoclonal antibodies and two gepants for the preventive treatment of migraine.

“Having another gepant that can also be given preventively is a good idea, because one may be better than the other for a patient,” Alan M. Rapoport, MD, past president of the International Headache Society and founder and director emeritus of the New England Center for Headache, Stamford, Conn., told this news organization.

“Once we have a year or so of experience with atogepant, we’ll have a pretty good idea of which one works better preventively,” said Dr. Rapoport, who was not involved with the research.
 

Practice changing?

In the ADVANCE trial, there was a reduction of 3.69 migraine days with the 10-mg dose, 3.86 days with the 30-mg dose, and 4.2 days with the 60-mg dose. Placebo was associated with a reduction of 2.48 migraine days.

In addition, more than half of patients in each atogepant arm achieved a reduction in mean monthly migraine days of 50% or greater. This outcome occurred in 55.6% of the 10-mg atogepant group, 58.7% of the 30-mg group, and 60.8% of the 60-mg group. Approximately 29% patients who received placebo achieved this outcome.

The data indicated that atogepant has a favorable safety profile. The most common adverse events associated with treatment were constipation, nausea, and upper respiratory tract infection.

Dr. Rapoport, who is also a clinical professor of neurology at UCLA, noted that he was impressed with the efficacy.

“I’m not as impressed with the adverse events, but they’re not serious, and they don’t necessarily last,” he said.

Although being able to prescribe a single drug for acute and preventive treatment may be an advantage, it remains to be seen whether the tolerability and price of atogepant will be barriers for patients, Dr. Rapoport added.

How the approval will affect clinical practice is also unclear, he noted.

“If you’re going to start someone on a preventive, especially if it’s a woman of childbearing potential, you might just consider one of the two gepants. Doctors will decide once they see how they work,” said Dr. Rapoport.
 

Not a ‘breakthrough’ treatment

Also commenting ahead of the approval, Elizabeth W. Loder, MD, vice chair for academic affairs in the department of neurology at Brigham and Women’s Hospital, Boston, noted that the “safety of these CGRP medications in pregnancy is uncertain, and there are theoretical reasons to be concerned about it.”

Unlike injectable CGRP medications, atogepant is eliminated from the body relatively quickly after the patient stops taking it, said Dr. Loder, who is also professor of neurology at Harvard Medical School, Boston. However, atogepant may not otherwise differ greatly from other medications of its type.

“I don’t see a reason to think that one of these oral CGRP medicines is much more effective than another one,” said Dr. Loder.

“In my mind, as a clinician who will be prescribing these for patients, it will be cost and the ease of getting it covered that makes the difference,” she added.

These questions may raise concerns. “Those of us who treat patients who do not have private insurance find it very difficult to get these medications for them, even in situations where they have exhausted other alternatives,” said Dr. Loder.

Patients insured by Medicare or Medicaid “usually have no avenue to get some of these new, expensive treatments,” she said.

The approval of atogepant for acute and preventive treatment shows that the distinction between these indications may be artificial, Dr. Loder noted. The approval “will, I hope, help people think more flexibly about the way in which we use medications.”

It is a positive that atogepant has emerged as another option for preventive therapy, but the treatment cannot be considered a breakthrough, Dr. Loder added. The efficacy of atogepant, like that of other preventive treatments for migraine, is modest.

“It would be so nice if we could find things that were more effective than the treatments we currently have,” said Dr. Loder.

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

The Food and Drug Administration has approved atogepant (Qulipta), a novel calcitonin gene-related peptide (CGRP) receptor antagonist, for the prevention of episodic migraine, the manufacturer announced in a release.

The once-daily medication will be available in doses of 10 mg, 30 mg, and 60 mg.

“Qulipta provides a simple oral treatment option specifically developed to prevent migraine attacks and target CGRP, which is believed to be crucially involved in migraine in many patients,” coinvestigator Peter J. Goadsby, MD, PhD, DSc, neurologist and professor at the University of California, Los Angeles, and King’s College London, said in the release.

Approval was based partly on the findings from the phase 3 ADVANCE trial, in which patients with episodic migraine were randomly assigned to receive placebo or a 10-mg, 30-mg, or 60-mg daily dose of atogepant for 12 weeks.

As reported by this news organization, all three doses of atogepant reduced the number of mean monthly migraine days.

With this approval, neurologists will be able to choose from four monoclonal antibodies and two gepants for the preventive treatment of migraine.

“Having another gepant that can also be given preventively is a good idea, because one may be better than the other for a patient,” Alan M. Rapoport, MD, past president of the International Headache Society and founder and director emeritus of the New England Center for Headache, Stamford, Conn., told this news organization.

“Once we have a year or so of experience with atogepant, we’ll have a pretty good idea of which one works better preventively,” said Dr. Rapoport, who was not involved with the research.
 

Practice changing?

In the ADVANCE trial, there was a reduction of 3.69 migraine days with the 10-mg dose, 3.86 days with the 30-mg dose, and 4.2 days with the 60-mg dose. Placebo was associated with a reduction of 2.48 migraine days.

In addition, more than half of patients in each atogepant arm achieved a reduction in mean monthly migraine days of 50% or greater. This outcome occurred in 55.6% of the 10-mg atogepant group, 58.7% of the 30-mg group, and 60.8% of the 60-mg group. Approximately 29% patients who received placebo achieved this outcome.

The data indicated that atogepant has a favorable safety profile. The most common adverse events associated with treatment were constipation, nausea, and upper respiratory tract infection.

Dr. Rapoport, who is also a clinical professor of neurology at UCLA, noted that he was impressed with the efficacy.

“I’m not as impressed with the adverse events, but they’re not serious, and they don’t necessarily last,” he said.

Although being able to prescribe a single drug for acute and preventive treatment may be an advantage, it remains to be seen whether the tolerability and price of atogepant will be barriers for patients, Dr. Rapoport added.

How the approval will affect clinical practice is also unclear, he noted.

“If you’re going to start someone on a preventive, especially if it’s a woman of childbearing potential, you might just consider one of the two gepants. Doctors will decide once they see how they work,” said Dr. Rapoport.
 

Not a ‘breakthrough’ treatment

Also commenting ahead of the approval, Elizabeth W. Loder, MD, vice chair for academic affairs in the department of neurology at Brigham and Women’s Hospital, Boston, noted that the “safety of these CGRP medications in pregnancy is uncertain, and there are theoretical reasons to be concerned about it.”

Unlike injectable CGRP medications, atogepant is eliminated from the body relatively quickly after the patient stops taking it, said Dr. Loder, who is also professor of neurology at Harvard Medical School, Boston. However, atogepant may not otherwise differ greatly from other medications of its type.

“I don’t see a reason to think that one of these oral CGRP medicines is much more effective than another one,” said Dr. Loder.

“In my mind, as a clinician who will be prescribing these for patients, it will be cost and the ease of getting it covered that makes the difference,” she added.

These questions may raise concerns. “Those of us who treat patients who do not have private insurance find it very difficult to get these medications for them, even in situations where they have exhausted other alternatives,” said Dr. Loder.

Patients insured by Medicare or Medicaid “usually have no avenue to get some of these new, expensive treatments,” she said.

The approval of atogepant for acute and preventive treatment shows that the distinction between these indications may be artificial, Dr. Loder noted. The approval “will, I hope, help people think more flexibly about the way in which we use medications.”

It is a positive that atogepant has emerged as another option for preventive therapy, but the treatment cannot be considered a breakthrough, Dr. Loder added. The efficacy of atogepant, like that of other preventive treatments for migraine, is modest.

“It would be so nice if we could find things that were more effective than the treatments we currently have,” said Dr. Loder.

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

The Food and Drug Administration has approved atogepant (Qulipta), a novel calcitonin gene-related peptide (CGRP) receptor antagonist, for the prevention of episodic migraine, the manufacturer announced in a release.

The once-daily medication will be available in doses of 10 mg, 30 mg, and 60 mg.

“Qulipta provides a simple oral treatment option specifically developed to prevent migraine attacks and target CGRP, which is believed to be crucially involved in migraine in many patients,” coinvestigator Peter J. Goadsby, MD, PhD, DSc, neurologist and professor at the University of California, Los Angeles, and King’s College London, said in the release.

Approval was based partly on the findings from the phase 3 ADVANCE trial, in which patients with episodic migraine were randomly assigned to receive placebo or a 10-mg, 30-mg, or 60-mg daily dose of atogepant for 12 weeks.

As reported by this news organization, all three doses of atogepant reduced the number of mean monthly migraine days.

With this approval, neurologists will be able to choose from four monoclonal antibodies and two gepants for the preventive treatment of migraine.

“Having another gepant that can also be given preventively is a good idea, because one may be better than the other for a patient,” Alan M. Rapoport, MD, past president of the International Headache Society and founder and director emeritus of the New England Center for Headache, Stamford, Conn., told this news organization.

“Once we have a year or so of experience with atogepant, we’ll have a pretty good idea of which one works better preventively,” said Dr. Rapoport, who was not involved with the research.
 

Practice changing?

In the ADVANCE trial, there was a reduction of 3.69 migraine days with the 10-mg dose, 3.86 days with the 30-mg dose, and 4.2 days with the 60-mg dose. Placebo was associated with a reduction of 2.48 migraine days.

In addition, more than half of patients in each atogepant arm achieved a reduction in mean monthly migraine days of 50% or greater. This outcome occurred in 55.6% of the 10-mg atogepant group, 58.7% of the 30-mg group, and 60.8% of the 60-mg group. Approximately 29% patients who received placebo achieved this outcome.

The data indicated that atogepant has a favorable safety profile. The most common adverse events associated with treatment were constipation, nausea, and upper respiratory tract infection.

Dr. Rapoport, who is also a clinical professor of neurology at UCLA, noted that he was impressed with the efficacy.

“I’m not as impressed with the adverse events, but they’re not serious, and they don’t necessarily last,” he said.

Although being able to prescribe a single drug for acute and preventive treatment may be an advantage, it remains to be seen whether the tolerability and price of atogepant will be barriers for patients, Dr. Rapoport added.

How the approval will affect clinical practice is also unclear, he noted.

“If you’re going to start someone on a preventive, especially if it’s a woman of childbearing potential, you might just consider one of the two gepants. Doctors will decide once they see how they work,” said Dr. Rapoport.
 

Not a ‘breakthrough’ treatment

Also commenting ahead of the approval, Elizabeth W. Loder, MD, vice chair for academic affairs in the department of neurology at Brigham and Women’s Hospital, Boston, noted that the “safety of these CGRP medications in pregnancy is uncertain, and there are theoretical reasons to be concerned about it.”

Unlike injectable CGRP medications, atogepant is eliminated from the body relatively quickly after the patient stops taking it, said Dr. Loder, who is also professor of neurology at Harvard Medical School, Boston. However, atogepant may not otherwise differ greatly from other medications of its type.

“I don’t see a reason to think that one of these oral CGRP medicines is much more effective than another one,” said Dr. Loder.

“In my mind, as a clinician who will be prescribing these for patients, it will be cost and the ease of getting it covered that makes the difference,” she added.

These questions may raise concerns. “Those of us who treat patients who do not have private insurance find it very difficult to get these medications for them, even in situations where they have exhausted other alternatives,” said Dr. Loder.

Patients insured by Medicare or Medicaid “usually have no avenue to get some of these new, expensive treatments,” she said.

The approval of atogepant for acute and preventive treatment shows that the distinction between these indications may be artificial, Dr. Loder noted. The approval “will, I hope, help people think more flexibly about the way in which we use medications.”

It is a positive that atogepant has emerged as another option for preventive therapy, but the treatment cannot be considered a breakthrough, Dr. Loder added. The efficacy of atogepant, like that of other preventive treatments for migraine, is modest.

“It would be so nice if we could find things that were more effective than the treatments we currently have,” said Dr. Loder.

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

Apple Watches and iPhones can differentiate between individuals with early, untreated Parkinson’s disease and healthy controls, new research shows. Results from the WATCH-PD study show clear differences in a finger-tapping task in the Parkinson’s disease versus control group. The finger-tapping task also correlated with “traditional measures,” such as the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), investigators reported.

“And then the smartphone and smartwatch also showed differences in gait between groups,” said lead investigator Jamie Adams, MD, University of Rochester, New York.

The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
 

WATCH-PD

The 12-month WATCH-PD study included 132 individuals at 17 Parkinson’s Study Group sites, 82 with Parkinson’s disease and 50 controls.

Participants with Parkinson’s disease were untreated, were no more than 2 years out from diagnosis (mean disease duration, 10.0 ±7.3 months), and were in Hoehn and Yahr stage 1 or 2.

Apple Watches and iPhones were provided to participants, all of whom underwent in-clinic assessments at baseline and at months 1, 3, 6, 9, and 12. The assessments included motor and cognitive tasks using the devices, which contained motion sensors.

The phone also contained an app that could assess verbal, cognitive, and other abilities. Participants wore a set of inertial sensors (APDM Mobility Lab) while performing the MDS-UPDRS Part III motor examination.

In addition, there were biweekly at-home tasks. Questions and tests on the watch assessed symptoms of mood, fatigue, cognition, and falls as well as cognitive performance involving perceptual, verbal, visual spatial, and fine motor abilities. Both the watch and iPhone were used to gauge gait, balance, and tremor.

Ages of the participants were approximately the same in the Parkinson’s disease and control groups (63.3 years vs. 60.2 years, respectively), but male to female ratios differed between the groups. There were more men in the Parkinson’s disease cohort (56% men vs. 44% women) and more women in the control cohort (36% vs. 64%; P =.03).
 

Between-group differences

Results showed that MDS-UPDRS total scores and on all individual parts of the rating scale were significantly better for the control group (lower scores are better), as shown in the following table.

‘Tremendous interest’

Commenting on the findings, Ludy Shih, MD, MMSc, of Boston University, noted that in the future, devices such as the ones used in this study may help clinicians remotely monitor their patients’ Parkinson’s disease conditions and response to therapy.

That would “eliminate some of the transportation barrier for people with Parkinson’s disease,” said Dr. Shih, who was not involved with the research.

The devices can give objective measurements, reducing inter-rater variability in assessment of movements, she noted.

“I think there’s tremendous interest in using digital measures to pick up on subtle disease phenotypes earlier than a clinical diagnosis can be made,” Dr. Shih said.

She also referred to literature “going back a few decades” showing that finger tapping can be used as a pharmacodynamic measure of how well a patient’s dopaminergic medications are working, so the devices may be a way to remotely assess treatment efficacy and decide when it is time to make adjustments.

Dr. Shih said she thinks regulatory agencies are now open “to consider these as part of the totality of evidence that a therapeutic [device] might be working.”

Whether these would need to be professional grade and approved as medical devices or if patients could just buy smartwatches and smartphones to generate useful data is still a question, she said. Already, there are several Parkinson’s apps that the public can download to track symptoms, improve voice, provide exercises, find support groups or research studies, and more.

Dr. Shih predicted that the biweekly at-home tasks, as in the current protocol, could be a burden to some people. If only a segment of the population were willing to comply, it could call into question how generalizable the results were, she added.

“There’s even a prior publication showing that compliance rate really dropped like a rock,” she noted. However, for those people willing to perform the tasks on a regular schedule, the results could be valuable, Dr. Shih said.

Dr. Adams concurred, saying that she had received feedback from some of her study participants that the biweekly tasks were a bit much.

The study was supported by Biogen and Takeda Pharmaceuticals. Dr. Adams receives research support from Biogen. Dr. Shih has disclosed no relevant financial relationships.

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

Apple Watches and iPhones can differentiate between individuals with early, untreated Parkinson’s disease and healthy controls, new research shows. Results from the WATCH-PD study show clear differences in a finger-tapping task in the Parkinson’s disease versus control group. The finger-tapping task also correlated with “traditional measures,” such as the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), investigators reported.

“And then the smartphone and smartwatch also showed differences in gait between groups,” said lead investigator Jamie Adams, MD, University of Rochester, New York.

The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
 

WATCH-PD

The 12-month WATCH-PD study included 132 individuals at 17 Parkinson’s Study Group sites, 82 with Parkinson’s disease and 50 controls.

Participants with Parkinson’s disease were untreated, were no more than 2 years out from diagnosis (mean disease duration, 10.0 ±7.3 months), and were in Hoehn and Yahr stage 1 or 2.

Apple Watches and iPhones were provided to participants, all of whom underwent in-clinic assessments at baseline and at months 1, 3, 6, 9, and 12. The assessments included motor and cognitive tasks using the devices, which contained motion sensors.

The phone also contained an app that could assess verbal, cognitive, and other abilities. Participants wore a set of inertial sensors (APDM Mobility Lab) while performing the MDS-UPDRS Part III motor examination.

In addition, there were biweekly at-home tasks. Questions and tests on the watch assessed symptoms of mood, fatigue, cognition, and falls as well as cognitive performance involving perceptual, verbal, visual spatial, and fine motor abilities. Both the watch and iPhone were used to gauge gait, balance, and tremor.

Ages of the participants were approximately the same in the Parkinson’s disease and control groups (63.3 years vs. 60.2 years, respectively), but male to female ratios differed between the groups. There were more men in the Parkinson’s disease cohort (56% men vs. 44% women) and more women in the control cohort (36% vs. 64%; P =.03).
 

Between-group differences

Results showed that MDS-UPDRS total scores and on all individual parts of the rating scale were significantly better for the control group (lower scores are better), as shown in the following table.

‘Tremendous interest’

Commenting on the findings, Ludy Shih, MD, MMSc, of Boston University, noted that in the future, devices such as the ones used in this study may help clinicians remotely monitor their patients’ Parkinson’s disease conditions and response to therapy.

That would “eliminate some of the transportation barrier for people with Parkinson’s disease,” said Dr. Shih, who was not involved with the research.

The devices can give objective measurements, reducing inter-rater variability in assessment of movements, she noted.

“I think there’s tremendous interest in using digital measures to pick up on subtle disease phenotypes earlier than a clinical diagnosis can be made,” Dr. Shih said.

She also referred to literature “going back a few decades” showing that finger tapping can be used as a pharmacodynamic measure of how well a patient’s dopaminergic medications are working, so the devices may be a way to remotely assess treatment efficacy and decide when it is time to make adjustments.

Dr. Shih said she thinks regulatory agencies are now open “to consider these as part of the totality of evidence that a therapeutic [device] might be working.”

Whether these would need to be professional grade and approved as medical devices or if patients could just buy smartwatches and smartphones to generate useful data is still a question, she said. Already, there are several Parkinson’s apps that the public can download to track symptoms, improve voice, provide exercises, find support groups or research studies, and more.

Dr. Shih predicted that the biweekly at-home tasks, as in the current protocol, could be a burden to some people. If only a segment of the population were willing to comply, it could call into question how generalizable the results were, she added.

“There’s even a prior publication showing that compliance rate really dropped like a rock,” she noted. However, for those people willing to perform the tasks on a regular schedule, the results could be valuable, Dr. Shih said.

Dr. Adams concurred, saying that she had received feedback from some of her study participants that the biweekly tasks were a bit much.

The study was supported by Biogen and Takeda Pharmaceuticals. Dr. Adams receives research support from Biogen. Dr. Shih has disclosed no relevant financial relationships.

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

Apple Watches and iPhones can differentiate between individuals with early, untreated Parkinson’s disease and healthy controls, new research shows. Results from the WATCH-PD study show clear differences in a finger-tapping task in the Parkinson’s disease versus control group. The finger-tapping task also correlated with “traditional measures,” such as the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), investigators reported.

“And then the smartphone and smartwatch also showed differences in gait between groups,” said lead investigator Jamie Adams, MD, University of Rochester, New York.

The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
 

WATCH-PD

The 12-month WATCH-PD study included 132 individuals at 17 Parkinson’s Study Group sites, 82 with Parkinson’s disease and 50 controls.

Participants with Parkinson’s disease were untreated, were no more than 2 years out from diagnosis (mean disease duration, 10.0 ±7.3 months), and were in Hoehn and Yahr stage 1 or 2.

Apple Watches and iPhones were provided to participants, all of whom underwent in-clinic assessments at baseline and at months 1, 3, 6, 9, and 12. The assessments included motor and cognitive tasks using the devices, which contained motion sensors.

The phone also contained an app that could assess verbal, cognitive, and other abilities. Participants wore a set of inertial sensors (APDM Mobility Lab) while performing the MDS-UPDRS Part III motor examination.

In addition, there were biweekly at-home tasks. Questions and tests on the watch assessed symptoms of mood, fatigue, cognition, and falls as well as cognitive performance involving perceptual, verbal, visual spatial, and fine motor abilities. Both the watch and iPhone were used to gauge gait, balance, and tremor.

Ages of the participants were approximately the same in the Parkinson’s disease and control groups (63.3 years vs. 60.2 years, respectively), but male to female ratios differed between the groups. There were more men in the Parkinson’s disease cohort (56% men vs. 44% women) and more women in the control cohort (36% vs. 64%; P =.03).
 

Between-group differences

Results showed that MDS-UPDRS total scores and on all individual parts of the rating scale were significantly better for the control group (lower scores are better), as shown in the following table.

‘Tremendous interest’

Commenting on the findings, Ludy Shih, MD, MMSc, of Boston University, noted that in the future, devices such as the ones used in this study may help clinicians remotely monitor their patients’ Parkinson’s disease conditions and response to therapy.

That would “eliminate some of the transportation barrier for people with Parkinson’s disease,” said Dr. Shih, who was not involved with the research.

The devices can give objective measurements, reducing inter-rater variability in assessment of movements, she noted.

“I think there’s tremendous interest in using digital measures to pick up on subtle disease phenotypes earlier than a clinical diagnosis can be made,” Dr. Shih said.

She also referred to literature “going back a few decades” showing that finger tapping can be used as a pharmacodynamic measure of how well a patient’s dopaminergic medications are working, so the devices may be a way to remotely assess treatment efficacy and decide when it is time to make adjustments.

Dr. Shih said she thinks regulatory agencies are now open “to consider these as part of the totality of evidence that a therapeutic [device] might be working.”

Whether these would need to be professional grade and approved as medical devices or if patients could just buy smartwatches and smartphones to generate useful data is still a question, she said. Already, there are several Parkinson’s apps that the public can download to track symptoms, improve voice, provide exercises, find support groups or research studies, and more.

Dr. Shih predicted that the biweekly at-home tasks, as in the current protocol, could be a burden to some people. If only a segment of the population were willing to comply, it could call into question how generalizable the results were, she added.

“There’s even a prior publication showing that compliance rate really dropped like a rock,” she noted. However, for those people willing to perform the tasks on a regular schedule, the results could be valuable, Dr. Shih said.

Dr. Adams concurred, saying that she had received feedback from some of her study participants that the biweekly tasks were a bit much.

The study was supported by Biogen and Takeda Pharmaceuticals. Dr. Adams receives research support from Biogen. Dr. Shih has disclosed no relevant financial relationships.

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

Study Overview

Objective. To examine differences in care, specifically hospitalization towards the end of life, among nursing home residents with dementia who were Black compared with those who were White.

Design. Population based cohort study in the US. The study included all decedents with Alzheimer’s disease or related dementia (ADRD) who resided in a nursing home from 2014 to 2017. Decedents from nursing homes were identified by death within 1 day of an identified nursing home stay or within 8 days of a hospital transfer from nursing home. Data were obtained from Minimum Data Set 3.0 (MDS) which contains clinical data from all Medicaid or Medicare certified nursing homes, and from the Medicare Beneficiary Summary File (MBSF) and Medicare Provider and Analysis and Review (MedPAR) which contains hospitalization events for all Medicare Beneficiaries. These files were linked to identify nursing home residents with ADRD who were hospitalized at the end of life. ADRD diagnosis was identified from the chronic condition list from the MBSF and from MDS diagnosis list.

Setting and participants. The study included 665 033 residents from 14 595 nursing homes who died during the study period. Resident race was categorized as White or Black based on the MBSF. Severe cognitive impairment was identified using the MDS that categorized residents as severe or not using the Brief Interview for Mental Status and the Cognitive Performance Scale. The mean (SD) age of the study population was 86.7 (9.2) years for White residents and 82.6 (11.1) years for Black residents. Of the participants, 68.8% and 61.2% were female for Black and White residents, respectively. Approximately 23.4% of White and 32.5% of Black residents had severe cognitive impairment. For nursing home characteristics, 71.5% of the 14 595 nursing homes represented were for profit; average bedside was 109.5 (57.0) and occupancy rate was on average 81.2% (14.3%).

Main outcome measures. The study outcome measure was any hospitalization within 30 days prior to death. The outcome was selected as an indicator of quality of care because as older adults living with ADRD experience progressive worsening of cognitive symptoms, at the end of life when dementia is severe, advance care planning and communication with health care proxies and surrogates often result in coordinated care that avoids acute hospitalizations, which are often burdensome to both patient and family and may yield poorer quality of life.

Main results. The study found that approximately 29.5% of White decedents and 40.7% of Black decedents were hospitalized towards the end of life. Nursing homes with a higher proportion of Black residents were more likely to have residents hospitalized towards the end of life with 35% of residents hospitalized in the highest quartile (27% Black) compared with 17% hospitalized for nursing homes in the lowest quartile (0% Black).After adjusting for covariates, Black residents were 7.9% more likely to be hospitalized in the last 30 days of life compared with White residents. Blacks with severe cognitive impairment has elevated risk of hospitalization by 4.9% when compared with White residents. After accounting for nursing home facility–level characteristics, nursing homes with a low proportion of Black residents had a 5.2% higher risk of hospitalizations compared with nursing homes with no Black residents, and nursing homes with a higher percentage of Black residents had a 13.3% higher risk of hospitalization compared with nursing homes with no Black residents.

Conclusion. Race is associated with care disparities in older nursing home residents with dementia. This study suggests that hospitalization towards the end of life as a quality of care marker differs across nursing homes, and nursing homes with a higher proportion of Black residents were more likely to be hospitalized. This suggests that these nursing homes may have fewer resources and delivered poorer quality of care, and that disparities in health systems or institutions contribute to differences in quality of care for this vulnerable group.

Commentary

Disparities of health status, health care, and affordability across race and ethnicity have persisted throughout the past 20 years.¹ There is further evidence to support systemic differences that can contribute to differences in health outcomes.² Although changes in health care policy such as the Affordable Care Act have expanded health care coverage, and instituted changes that aims to improve health care quality and reduce disparities, it is clear that factors contributing to disparities in care are structural and perhaps systemic. The latest evidence comes in this study that examines racial disparities in health care quality in one of the most vulnerable populations—older adults with Alzheimer’s disease and dementia. The finding that Black nursing home residents, when compared with White residents, often has higher risk of hospitalization at the end of life, even among those with severe dementia where better coordinated care, clear goals of care and perhaps instituting palliative care would result in lower rate of hospitalization. The disparities were observed across nursing homes as well, where nursing homes with higher proportion of Black residents appear to have lower quality of care.

These findings are consistent with prior work that has examined differences in Black and White population on uptake of palliative care, discussion, and the documentation of advance care planning.³ Factors that may contribute to these differences include mistrust of the health care system among minorities, and not being connected to adequate health care resources. Family members and surrogate health care decision makers may consider receiving more aggressive care as advocating for better health care for their family members.⁴ These differences may contribute to the differences in hospitalization rates among residents within the same nursing home; however, the differences between nursing homes even after accounting for individual differences may indicate more widespread systemic differences that is associated with race. Policy changes that will address these differences are needed to level these differences so that quality care can be delivered regardless of race.⁵ For this vulnerable population with a terminal illness, approaches to enhance uptake of palliative approaches and care delivery for dementia patients at terminal stage are needed and understanding and targeting factors that contribute to low uptake of these approaches will enhance end of life care. Understanding the differences in resources and systems of care in nursing homes and perhaps how palliative care is integrated in these settings will be important to address care disparities that occurs across nursing homes.

Applications for Clinical Practice

Clinicians who take care of this population of older adults with advanced dementia should be aware of the potential for racial disparities that may lead to differences in the quality of care. The underlying reasons for these differences could be targeted so that older adults in all racial groups may have equal access to quality care including palliative approaches that avoid aggressive care for terminal illnesses across settings that may yield better care and quality of life. Policy makers and health systems leaders need to consider the current realities with racial disparities that policies need to address these differences so that they may not continue to persist in our systems of care.

Financial disclosures: None.

Study Overview

Objective. To examine differences in care, specifically hospitalization towards the end of life, among nursing home residents with dementia who were Black compared with those who were White.

Design. Population based cohort study in the US. The study included all decedents with Alzheimer’s disease or related dementia (ADRD) who resided in a nursing home from 2014 to 2017. Decedents from nursing homes were identified by death within 1 day of an identified nursing home stay or within 8 days of a hospital transfer from nursing home. Data were obtained from Minimum Data Set 3.0 (MDS) which contains clinical data from all Medicaid or Medicare certified nursing homes, and from the Medicare Beneficiary Summary File (MBSF) and Medicare Provider and Analysis and Review (MedPAR) which contains hospitalization events for all Medicare Beneficiaries. These files were linked to identify nursing home residents with ADRD who were hospitalized at the end of life. ADRD diagnosis was identified from the chronic condition list from the MBSF and from MDS diagnosis list.

Setting and participants. The study included 665 033 residents from 14 595 nursing homes who died during the study period. Resident race was categorized as White or Black based on the MBSF. Severe cognitive impairment was identified using the MDS that categorized residents as severe or not using the Brief Interview for Mental Status and the Cognitive Performance Scale. The mean (SD) age of the study population was 86.7 (9.2) years for White residents and 82.6 (11.1) years for Black residents. Of the participants, 68.8% and 61.2% were female for Black and White residents, respectively. Approximately 23.4% of White and 32.5% of Black residents had severe cognitive impairment. For nursing home characteristics, 71.5% of the 14 595 nursing homes represented were for profit; average bedside was 109.5 (57.0) and occupancy rate was on average 81.2% (14.3%).

Main outcome measures. The study outcome measure was any hospitalization within 30 days prior to death. The outcome was selected as an indicator of quality of care because as older adults living with ADRD experience progressive worsening of cognitive symptoms, at the end of life when dementia is severe, advance care planning and communication with health care proxies and surrogates often result in coordinated care that avoids acute hospitalizations, which are often burdensome to both patient and family and may yield poorer quality of life.

Main results. The study found that approximately 29.5% of White decedents and 40.7% of Black decedents were hospitalized towards the end of life. Nursing homes with a higher proportion of Black residents were more likely to have residents hospitalized towards the end of life with 35% of residents hospitalized in the highest quartile (27% Black) compared with 17% hospitalized for nursing homes in the lowest quartile (0% Black).After adjusting for covariates, Black residents were 7.9% more likely to be hospitalized in the last 30 days of life compared with White residents. Blacks with severe cognitive impairment has elevated risk of hospitalization by 4.9% when compared with White residents. After accounting for nursing home facility–level characteristics, nursing homes with a low proportion of Black residents had a 5.2% higher risk of hospitalizations compared with nursing homes with no Black residents, and nursing homes with a higher percentage of Black residents had a 13.3% higher risk of hospitalization compared with nursing homes with no Black residents.

Conclusion. Race is associated with care disparities in older nursing home residents with dementia. This study suggests that hospitalization towards the end of life as a quality of care marker differs across nursing homes, and nursing homes with a higher proportion of Black residents were more likely to be hospitalized. This suggests that these nursing homes may have fewer resources and delivered poorer quality of care, and that disparities in health systems or institutions contribute to differences in quality of care for this vulnerable group.

Commentary

Disparities of health status, health care, and affordability across race and ethnicity have persisted throughout the past 20 years.¹ There is further evidence to support systemic differences that can contribute to differences in health outcomes.² Although changes in health care policy such as the Affordable Care Act have expanded health care coverage, and instituted changes that aims to improve health care quality and reduce disparities, it is clear that factors contributing to disparities in care are structural and perhaps systemic. The latest evidence comes in this study that examines racial disparities in health care quality in one of the most vulnerable populations—older adults with Alzheimer’s disease and dementia. The finding that Black nursing home residents, when compared with White residents, often has higher risk of hospitalization at the end of life, even among those with severe dementia where better coordinated care, clear goals of care and perhaps instituting palliative care would result in lower rate of hospitalization. The disparities were observed across nursing homes as well, where nursing homes with higher proportion of Black residents appear to have lower quality of care.

These findings are consistent with prior work that has examined differences in Black and White population on uptake of palliative care, discussion, and the documentation of advance care planning.³ Factors that may contribute to these differences include mistrust of the health care system among minorities, and not being connected to adequate health care resources. Family members and surrogate health care decision makers may consider receiving more aggressive care as advocating for better health care for their family members.⁴ These differences may contribute to the differences in hospitalization rates among residents within the same nursing home; however, the differences between nursing homes even after accounting for individual differences may indicate more widespread systemic differences that is associated with race. Policy changes that will address these differences are needed to level these differences so that quality care can be delivered regardless of race.⁵ For this vulnerable population with a terminal illness, approaches to enhance uptake of palliative approaches and care delivery for dementia patients at terminal stage are needed and understanding and targeting factors that contribute to low uptake of these approaches will enhance end of life care. Understanding the differences in resources and systems of care in nursing homes and perhaps how palliative care is integrated in these settings will be important to address care disparities that occurs across nursing homes.

Applications for Clinical Practice

Clinicians who take care of this population of older adults with advanced dementia should be aware of the potential for racial disparities that may lead to differences in the quality of care. The underlying reasons for these differences could be targeted so that older adults in all racial groups may have equal access to quality care including palliative approaches that avoid aggressive care for terminal illnesses across settings that may yield better care and quality of life. Policy makers and health systems leaders need to consider the current realities with racial disparities that policies need to address these differences so that they may not continue to persist in our systems of care.

Financial disclosures: None.

Study Overview

Objective. To examine differences in care, specifically hospitalization towards the end of life, among nursing home residents with dementia who were Black compared with those who were White.

Design. Population based cohort study in the US. The study included all decedents with Alzheimer’s disease or related dementia (ADRD) who resided in a nursing home from 2014 to 2017. Decedents from nursing homes were identified by death within 1 day of an identified nursing home stay or within 8 days of a hospital transfer from nursing home. Data were obtained from Minimum Data Set 3.0 (MDS) which contains clinical data from all Medicaid or Medicare certified nursing homes, and from the Medicare Beneficiary Summary File (MBSF) and Medicare Provider and Analysis and Review (MedPAR) which contains hospitalization events for all Medicare Beneficiaries. These files were linked to identify nursing home residents with ADRD who were hospitalized at the end of life. ADRD diagnosis was identified from the chronic condition list from the MBSF and from MDS diagnosis list.

Setting and participants. The study included 665 033 residents from 14 595 nursing homes who died during the study period. Resident race was categorized as White or Black based on the MBSF. Severe cognitive impairment was identified using the MDS that categorized residents as severe or not using the Brief Interview for Mental Status and the Cognitive Performance Scale. The mean (SD) age of the study population was 86.7 (9.2) years for White residents and 82.6 (11.1) years for Black residents. Of the participants, 68.8% and 61.2% were female for Black and White residents, respectively. Approximately 23.4% of White and 32.5% of Black residents had severe cognitive impairment. For nursing home characteristics, 71.5% of the 14 595 nursing homes represented were for profit; average bedside was 109.5 (57.0) and occupancy rate was on average 81.2% (14.3%).

Main outcome measures. The study outcome measure was any hospitalization within 30 days prior to death. The outcome was selected as an indicator of quality of care because as older adults living with ADRD experience progressive worsening of cognitive symptoms, at the end of life when dementia is severe, advance care planning and communication with health care proxies and surrogates often result in coordinated care that avoids acute hospitalizations, which are often burdensome to both patient and family and may yield poorer quality of life.

Main results. The study found that approximately 29.5% of White decedents and 40.7% of Black decedents were hospitalized towards the end of life. Nursing homes with a higher proportion of Black residents were more likely to have residents hospitalized towards the end of life with 35% of residents hospitalized in the highest quartile (27% Black) compared with 17% hospitalized for nursing homes in the lowest quartile (0% Black).After adjusting for covariates, Black residents were 7.9% more likely to be hospitalized in the last 30 days of life compared with White residents. Blacks with severe cognitive impairment has elevated risk of hospitalization by 4.9% when compared with White residents. After accounting for nursing home facility–level characteristics, nursing homes with a low proportion of Black residents had a 5.2% higher risk of hospitalizations compared with nursing homes with no Black residents, and nursing homes with a higher percentage of Black residents had a 13.3% higher risk of hospitalization compared with nursing homes with no Black residents.

Conclusion. Race is associated with care disparities in older nursing home residents with dementia. This study suggests that hospitalization towards the end of life as a quality of care marker differs across nursing homes, and nursing homes with a higher proportion of Black residents were more likely to be hospitalized. This suggests that these nursing homes may have fewer resources and delivered poorer quality of care, and that disparities in health systems or institutions contribute to differences in quality of care for this vulnerable group.

Commentary

Disparities of health status, health care, and affordability across race and ethnicity have persisted throughout the past 20 years.¹ There is further evidence to support systemic differences that can contribute to differences in health outcomes.² Although changes in health care policy such as the Affordable Care Act have expanded health care coverage, and instituted changes that aims to improve health care quality and reduce disparities, it is clear that factors contributing to disparities in care are structural and perhaps systemic. The latest evidence comes in this study that examines racial disparities in health care quality in one of the most vulnerable populations—older adults with Alzheimer’s disease and dementia. The finding that Black nursing home residents, when compared with White residents, often has higher risk of hospitalization at the end of life, even among those with severe dementia where better coordinated care, clear goals of care and perhaps instituting palliative care would result in lower rate of hospitalization. The disparities were observed across nursing homes as well, where nursing homes with higher proportion of Black residents appear to have lower quality of care.

These findings are consistent with prior work that has examined differences in Black and White population on uptake of palliative care, discussion, and the documentation of advance care planning.³ Factors that may contribute to these differences include mistrust of the health care system among minorities, and not being connected to adequate health care resources. Family members and surrogate health care decision makers may consider receiving more aggressive care as advocating for better health care for their family members.⁴ These differences may contribute to the differences in hospitalization rates among residents within the same nursing home; however, the differences between nursing homes even after accounting for individual differences may indicate more widespread systemic differences that is associated with race. Policy changes that will address these differences are needed to level these differences so that quality care can be delivered regardless of race.⁵ For this vulnerable population with a terminal illness, approaches to enhance uptake of palliative approaches and care delivery for dementia patients at terminal stage are needed and understanding and targeting factors that contribute to low uptake of these approaches will enhance end of life care. Understanding the differences in resources and systems of care in nursing homes and perhaps how palliative care is integrated in these settings will be important to address care disparities that occurs across nursing homes.

Applications for Clinical Practice

Clinicians who take care of this population of older adults with advanced dementia should be aware of the potential for racial disparities that may lead to differences in the quality of care. The underlying reasons for these differences could be targeted so that older adults in all racial groups may have equal access to quality care including palliative approaches that avoid aggressive care for terminal illnesses across settings that may yield better care and quality of life. Policy makers and health systems leaders need to consider the current realities with racial disparities that policies need to address these differences so that they may not continue to persist in our systems of care.

Financial disclosures: None.

Social distancing and the shutdown of services like physical and occupational therapy because of COVID-19 have had a profound impact on the mental health of people with Parkinson’s disease, a team of researchers in the Netherlands reported, but they also identified meaningful targets for intervention.

Lisanne Dommershuijsen, MSc, a PhD candidate and researcher in epidemiology at the Erasmus University Medical Center in Rotterdam, the Netherlands, reported on a cross-sectional study of 833 participants with Parkinson’s disease in the PRIME-NL study at the International Congress of Parkinson’s Disease and Movement Disorders. The average age of participants was 70.2 and 38% were women.

“We studied targeted hypothetical interventions on COVID-19 stressors in people with Parkinson’s disease,” Ms. Dommershuijsen said. “This disruption in normal life caused considerable psychological stress in community-dwelling individuals. People with Parkinson’s disease might be especially vulnerable to this stress.

“For instance, because reduced levels of physical activity have worsened symptoms or because people with Parkinson’s often have difficulty with flexible [adaptations] to drastic and rapid changes in daily routines, such as those introduced by the COVID-19 pandemic, previous studies found that COVID-19 worsened depression and anxiety symptoms and reduced quality of life (QOL) in people with Parkinson’s disease,” Ms. Dommershuijsen said.

Hence, the goal of the study was to identify the most vulnerable subgroups in the Parkinson’s population and to suggest potential interventions to ameliorate these impacts, she said.

The study focused on eight different stressors that emerged in the pandemic: access to care, medicine and nursing services; loss of social contact; canceled social events; tension or conflict in the home; inability to perform physical activity or relax; and COVID-19 symptoms. The outcomes of interest were depression, as measured with the Beck Depression Inventory (BDI); anxiety, as measured with the Spielberger State-Trait Anxiety Inventory (STAI); and QOL, with the Parkinson’s Disease Quality of Life Questionnaire. The aggregate resulted in a scale of 0-40, with the mean stressor score in the study being 9.6, Ms. Dommershuijsen said.

The BDI and STAI scores for social stressors – loss of social contacts, social events canceled and tension or conflict at home – exceeded those for the so-called care stressors – problems accessing care, medication or nursing – she said, although all eight stressors yielded higher BDI and STAI scores across the board.
 

Vulnerable subgroups

“When we looked at vulnerable subgroups of people with Parkinson’s disease, we found more pronounced associations between the COVID-19 stress and mental health in women, in highly educated participants, and in participants with advanced Parkinson’s disease,” Ms. Dommershuijsen said. The impact on women and people with advanced disease is explainable, Ms. Dommershuijsen added in an interview; the former because depressive symptoms are more common in women, and the latter because loss of access to care impacts mental wellness.

“The finding that social stressors were more related to anxiety in highly educated people was surprising to us, given that depression in general is more common in people with a lower education,” she said in an interview. “One previous study of the general population suggested this might be related to expectations about available resources, but this findings and the possible explanation warrants further investigation.”

When the study stratified for coping strategies, the COVID-19 stressors had a smaller effect on depressive and anxiety symptoms in Parkinson’s disease patients prone to confrontive coping and planful problem solving, she said. “Whereas, we observed a larger effect of these stressors in people who are prone to using distancing or seeking social support as coping mechanisms,” Ms. Dommershuijsen said.

The researchers also created a model of a hypothetical 50% reduction in COVID-19 stressors among all study participants, but the effect wasn’t clinically relevant, Ms. Dommershuijsen said. However, in people with advanced Parkinson’s disease – that is, with an Movement Disorder Society–Unified Parkinson Disease Rating Scale score above median – the effect was clinically relevant in all outcomes.

The potential interventions the study identified were telemedicine via virtual consultations to alleviate care stressors, and virtual support groups and online classes to address social stressors. “However, a more personalized approach is needed to target tension or conflict at home, which was the most important social stressor influencing depression and anxiety symptoms in our study,” she said. “Social work can play an important role here.”

Asked to comment on the study, Roy Alcalay, MD, professor of neurology at Columbia University Irving Medical Center in New York, said in an interview that the findings align with his research on the impact of COVID-19 and related restrictions on people with Parkinson’s disease.

“The pandemic has affected people in different ways,” he said. “Initially very acutely, people just didn’t have access to doctors. There was also the acute question in movement disorders, but also in other diseases where the people with Parkinson’s disease are going to have the worse outcome when they have COVID-19.” Dr. Alcalay authored two recent papers on the impact of COVID-19 in people with Parkinson’s disease.

“Then we see that, in addition to that question, there’s the question of even if they don’t have COVID-19, just the social distancing and the lack of access to health care, and specifically to physical and occupational therapy and other services, can be quite damaging,” he said.

What’s commendable about the study, he said, was that it just doesn’t highlight the problem. “They’re also highlighting potential solutions, that planful problem solving and coping strategies can be helpful to people.”

Neither Ms. Dommershuijsen nor Dr. Alcalay have any relevant relationships to disclose.

Social distancing and the shutdown of services like physical and occupational therapy because of COVID-19 have had a profound impact on the mental health of people with Parkinson’s disease, a team of researchers in the Netherlands reported, but they also identified meaningful targets for intervention.

Lisanne Dommershuijsen, MSc, a PhD candidate and researcher in epidemiology at the Erasmus University Medical Center in Rotterdam, the Netherlands, reported on a cross-sectional study of 833 participants with Parkinson’s disease in the PRIME-NL study at the International Congress of Parkinson’s Disease and Movement Disorders. The average age of participants was 70.2 and 38% were women.

“We studied targeted hypothetical interventions on COVID-19 stressors in people with Parkinson’s disease,” Ms. Dommershuijsen said. “This disruption in normal life caused considerable psychological stress in community-dwelling individuals. People with Parkinson’s disease might be especially vulnerable to this stress.

“For instance, because reduced levels of physical activity have worsened symptoms or because people with Parkinson’s often have difficulty with flexible [adaptations] to drastic and rapid changes in daily routines, such as those introduced by the COVID-19 pandemic, previous studies found that COVID-19 worsened depression and anxiety symptoms and reduced quality of life (QOL) in people with Parkinson’s disease,” Ms. Dommershuijsen said.

Hence, the goal of the study was to identify the most vulnerable subgroups in the Parkinson’s population and to suggest potential interventions to ameliorate these impacts, she said.

The study focused on eight different stressors that emerged in the pandemic: access to care, medicine and nursing services; loss of social contact; canceled social events; tension or conflict in the home; inability to perform physical activity or relax; and COVID-19 symptoms. The outcomes of interest were depression, as measured with the Beck Depression Inventory (BDI); anxiety, as measured with the Spielberger State-Trait Anxiety Inventory (STAI); and QOL, with the Parkinson’s Disease Quality of Life Questionnaire. The aggregate resulted in a scale of 0-40, with the mean stressor score in the study being 9.6, Ms. Dommershuijsen said.

The BDI and STAI scores for social stressors – loss of social contacts, social events canceled and tension or conflict at home – exceeded those for the so-called care stressors – problems accessing care, medication or nursing – she said, although all eight stressors yielded higher BDI and STAI scores across the board.
 

Vulnerable subgroups

“When we looked at vulnerable subgroups of people with Parkinson’s disease, we found more pronounced associations between the COVID-19 stress and mental health in women, in highly educated participants, and in participants with advanced Parkinson’s disease,” Ms. Dommershuijsen said. The impact on women and people with advanced disease is explainable, Ms. Dommershuijsen added in an interview; the former because depressive symptoms are more common in women, and the latter because loss of access to care impacts mental wellness.

“The finding that social stressors were more related to anxiety in highly educated people was surprising to us, given that depression in general is more common in people with a lower education,” she said in an interview. “One previous study of the general population suggested this might be related to expectations about available resources, but this findings and the possible explanation warrants further investigation.”

When the study stratified for coping strategies, the COVID-19 stressors had a smaller effect on depressive and anxiety symptoms in Parkinson’s disease patients prone to confrontive coping and planful problem solving, she said. “Whereas, we observed a larger effect of these stressors in people who are prone to using distancing or seeking social support as coping mechanisms,” Ms. Dommershuijsen said.

The researchers also created a model of a hypothetical 50% reduction in COVID-19 stressors among all study participants, but the effect wasn’t clinically relevant, Ms. Dommershuijsen said. However, in people with advanced Parkinson’s disease – that is, with an Movement Disorder Society–Unified Parkinson Disease Rating Scale score above median – the effect was clinically relevant in all outcomes.

The potential interventions the study identified were telemedicine via virtual consultations to alleviate care stressors, and virtual support groups and online classes to address social stressors. “However, a more personalized approach is needed to target tension or conflict at home, which was the most important social stressor influencing depression and anxiety symptoms in our study,” she said. “Social work can play an important role here.”

Asked to comment on the study, Roy Alcalay, MD, professor of neurology at Columbia University Irving Medical Center in New York, said in an interview that the findings align with his research on the impact of COVID-19 and related restrictions on people with Parkinson’s disease.

“The pandemic has affected people in different ways,” he said. “Initially very acutely, people just didn’t have access to doctors. There was also the acute question in movement disorders, but also in other diseases where the people with Parkinson’s disease are going to have the worse outcome when they have COVID-19.” Dr. Alcalay authored two recent papers on the impact of COVID-19 in people with Parkinson’s disease.

“Then we see that, in addition to that question, there’s the question of even if they don’t have COVID-19, just the social distancing and the lack of access to health care, and specifically to physical and occupational therapy and other services, can be quite damaging,” he said.

What’s commendable about the study, he said, was that it just doesn’t highlight the problem. “They’re also highlighting potential solutions, that planful problem solving and coping strategies can be helpful to people.”

Neither Ms. Dommershuijsen nor Dr. Alcalay have any relevant relationships to disclose.

Social distancing and the shutdown of services like physical and occupational therapy because of COVID-19 have had a profound impact on the mental health of people with Parkinson’s disease, a team of researchers in the Netherlands reported, but they also identified meaningful targets for intervention.

Lisanne Dommershuijsen, MSc, a PhD candidate and researcher in epidemiology at the Erasmus University Medical Center in Rotterdam, the Netherlands, reported on a cross-sectional study of 833 participants with Parkinson’s disease in the PRIME-NL study at the International Congress of Parkinson’s Disease and Movement Disorders. The average age of participants was 70.2 and 38% were women.

“We studied targeted hypothetical interventions on COVID-19 stressors in people with Parkinson’s disease,” Ms. Dommershuijsen said. “This disruption in normal life caused considerable psychological stress in community-dwelling individuals. People with Parkinson’s disease might be especially vulnerable to this stress.

“For instance, because reduced levels of physical activity have worsened symptoms or because people with Parkinson’s often have difficulty with flexible [adaptations] to drastic and rapid changes in daily routines, such as those introduced by the COVID-19 pandemic, previous studies found that COVID-19 worsened depression and anxiety symptoms and reduced quality of life (QOL) in people with Parkinson’s disease,” Ms. Dommershuijsen said.

Hence, the goal of the study was to identify the most vulnerable subgroups in the Parkinson’s population and to suggest potential interventions to ameliorate these impacts, she said.

The study focused on eight different stressors that emerged in the pandemic: access to care, medicine and nursing services; loss of social contact; canceled social events; tension or conflict in the home; inability to perform physical activity or relax; and COVID-19 symptoms. The outcomes of interest were depression, as measured with the Beck Depression Inventory (BDI); anxiety, as measured with the Spielberger State-Trait Anxiety Inventory (STAI); and QOL, with the Parkinson’s Disease Quality of Life Questionnaire. The aggregate resulted in a scale of 0-40, with the mean stressor score in the study being 9.6, Ms. Dommershuijsen said.

The BDI and STAI scores for social stressors – loss of social contacts, social events canceled and tension or conflict at home – exceeded those for the so-called care stressors – problems accessing care, medication or nursing – she said, although all eight stressors yielded higher BDI and STAI scores across the board.
 

Vulnerable subgroups

“When we looked at vulnerable subgroups of people with Parkinson’s disease, we found more pronounced associations between the COVID-19 stress and mental health in women, in highly educated participants, and in participants with advanced Parkinson’s disease,” Ms. Dommershuijsen said. The impact on women and people with advanced disease is explainable, Ms. Dommershuijsen added in an interview; the former because depressive symptoms are more common in women, and the latter because loss of access to care impacts mental wellness.

“The finding that social stressors were more related to anxiety in highly educated people was surprising to us, given that depression in general is more common in people with a lower education,” she said in an interview. “One previous study of the general population suggested this might be related to expectations about available resources, but this findings and the possible explanation warrants further investigation.”

When the study stratified for coping strategies, the COVID-19 stressors had a smaller effect on depressive and anxiety symptoms in Parkinson’s disease patients prone to confrontive coping and planful problem solving, she said. “Whereas, we observed a larger effect of these stressors in people who are prone to using distancing or seeking social support as coping mechanisms,” Ms. Dommershuijsen said.

The researchers also created a model of a hypothetical 50% reduction in COVID-19 stressors among all study participants, but the effect wasn’t clinically relevant, Ms. Dommershuijsen said. However, in people with advanced Parkinson’s disease – that is, with an Movement Disorder Society–Unified Parkinson Disease Rating Scale score above median – the effect was clinically relevant in all outcomes.

The potential interventions the study identified were telemedicine via virtual consultations to alleviate care stressors, and virtual support groups and online classes to address social stressors. “However, a more personalized approach is needed to target tension or conflict at home, which was the most important social stressor influencing depression and anxiety symptoms in our study,” she said. “Social work can play an important role here.”

Asked to comment on the study, Roy Alcalay, MD, professor of neurology at Columbia University Irving Medical Center in New York, said in an interview that the findings align with his research on the impact of COVID-19 and related restrictions on people with Parkinson’s disease.

“The pandemic has affected people in different ways,” he said. “Initially very acutely, people just didn’t have access to doctors. There was also the acute question in movement disorders, but also in other diseases where the people with Parkinson’s disease are going to have the worse outcome when they have COVID-19.” Dr. Alcalay authored two recent papers on the impact of COVID-19 in people with Parkinson’s disease.

“Then we see that, in addition to that question, there’s the question of even if they don’t have COVID-19, just the social distancing and the lack of access to health care, and specifically to physical and occupational therapy and other services, can be quite damaging,” he said.

What’s commendable about the study, he said, was that it just doesn’t highlight the problem. “They’re also highlighting potential solutions, that planful problem solving and coping strategies can be helpful to people.”

Neither Ms. Dommershuijsen nor Dr. Alcalay have any relevant relationships to disclose.

Traumatic experiences, especially sexual assault, may put women at greater risk for poor brain health.

In the Ms Brain study, middle-aged women with trauma exposure had a greater volume of white matter hyperintensities (WMHs) than those without trauma. In addition, the differences persisted even after adjusting for depressive or post-traumatic stress symptoms. 

WMHs are “an important indicator of small vessel disease in the brain and have been linked to future stroke risk, dementia risk, and mortality,” lead investigator Rebecca Thurston, PhD, from the University of Pittsburgh, told this news organization.

“What I take from this is, really, that sexual assault has implications for women’s health, far beyond exclusively mental health outcomes, but also for their cardiovascular health, as we have shown in other work and for their stroke and dementia risk as we are seeing in the present work,” Dr. Thurston added.

The study was presented at the North American Menopause Society (NAMS) Annual Meeting in Washington, D.C., and has been accepted for publication in the journal Brain Imaging and Behavior.
 

Beyond the usual suspects

As part of the study, 145 women (mean age, 59 years) free of clinical cardiovascular disease, stroke, or dementia provided their medical history, including history of traumatic experiences, depression, and post-traumatic stress disorder and underwent magnetic resonance brain imaging for WMHs.

More than two-thirds (68%) of the women reported at least one trauma, most commonly sexual assault (23%).

In multivariate analysis, women with trauma exposure had greater WMH volume than women without trauma (P = .01), with sexual assault most strongly associated with greater WMH volume (P = .02).

The associations persisted after adjusting for depressive or post-traumatic stress symptoms.

“A history of sexual assault was particularly related to white matter hyperintensities in the parietal lobe, and these kinds of white matter hyperintensities have been linked to Alzheimer’s disease in a fairly pronounced way,” Dr. Thurston said.

“When we think about risk factors for stroke, dementia, we need to think beyond exclusively our usual suspects and also think about women [who experienced] psychological trauma and experienced sexual assault in particular. So ask about it and consider it part of your screening regimen,” she added.
 

‘Burgeoning’ literature

Commenting on the findings, Charles Nemeroff, MD, PhD, professor and chair, department of psychiatry and behavioral sciences, Dell Medical School, University of Texas at Austin, and director of its Institute for Early Life Adversity Research, said the research adds to the “burgeoning literature on the long term neurobiological consequences of trauma and more specifically, sexual abuse, on brain imaging measures.”

“Our group and others reported several years ago that patients with mood disorders, more specifically bipolar disorder and major depression, had higher rates of WMH than matched controls. Those older studies did not control for a history of early life adversity such as childhood maltreatment,” Dr. Nemeroff said.

“In addition to this finding of increased WMH in subjects exposed to trauma is a very large literature documenting other central nervous system (CNS) changes in this population, including cortical thinning in certain brain areas and clearly an emerging finding that different forms of childhood maltreatment are associated with quite distinct structural brain alterations in adulthood,” he noted. 

The study was supported by grants from the National Institutes of Health. Dr. Thurston and Dr. Nemeroff have disclosed no relevant financial relationships.

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

Traumatic experiences, especially sexual assault, may put women at greater risk for poor brain health.

In the Ms Brain study, middle-aged women with trauma exposure had a greater volume of white matter hyperintensities (WMHs) than those without trauma. In addition, the differences persisted even after adjusting for depressive or post-traumatic stress symptoms. 

WMHs are “an important indicator of small vessel disease in the brain and have been linked to future stroke risk, dementia risk, and mortality,” lead investigator Rebecca Thurston, PhD, from the University of Pittsburgh, told this news organization.

“What I take from this is, really, that sexual assault has implications for women’s health, far beyond exclusively mental health outcomes, but also for their cardiovascular health, as we have shown in other work and for their stroke and dementia risk as we are seeing in the present work,” Dr. Thurston added.

The study was presented at the North American Menopause Society (NAMS) Annual Meeting in Washington, D.C., and has been accepted for publication in the journal Brain Imaging and Behavior.
 

Beyond the usual suspects

As part of the study, 145 women (mean age, 59 years) free of clinical cardiovascular disease, stroke, or dementia provided their medical history, including history of traumatic experiences, depression, and post-traumatic stress disorder and underwent magnetic resonance brain imaging for WMHs.

More than two-thirds (68%) of the women reported at least one trauma, most commonly sexual assault (23%).

In multivariate analysis, women with trauma exposure had greater WMH volume than women without trauma (P = .01), with sexual assault most strongly associated with greater WMH volume (P = .02).

The associations persisted after adjusting for depressive or post-traumatic stress symptoms.

“A history of sexual assault was particularly related to white matter hyperintensities in the parietal lobe, and these kinds of white matter hyperintensities have been linked to Alzheimer’s disease in a fairly pronounced way,” Dr. Thurston said.

“When we think about risk factors for stroke, dementia, we need to think beyond exclusively our usual suspects and also think about women [who experienced] psychological trauma and experienced sexual assault in particular. So ask about it and consider it part of your screening regimen,” she added.
 

‘Burgeoning’ literature

Commenting on the findings, Charles Nemeroff, MD, PhD, professor and chair, department of psychiatry and behavioral sciences, Dell Medical School, University of Texas at Austin, and director of its Institute for Early Life Adversity Research, said the research adds to the “burgeoning literature on the long term neurobiological consequences of trauma and more specifically, sexual abuse, on brain imaging measures.”

“Our group and others reported several years ago that patients with mood disorders, more specifically bipolar disorder and major depression, had higher rates of WMH than matched controls. Those older studies did not control for a history of early life adversity such as childhood maltreatment,” Dr. Nemeroff said.

“In addition to this finding of increased WMH in subjects exposed to trauma is a very large literature documenting other central nervous system (CNS) changes in this population, including cortical thinning in certain brain areas and clearly an emerging finding that different forms of childhood maltreatment are associated with quite distinct structural brain alterations in adulthood,” he noted. 

The study was supported by grants from the National Institutes of Health. Dr. Thurston and Dr. Nemeroff have disclosed no relevant financial relationships.

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

Traumatic experiences, especially sexual assault, may put women at greater risk for poor brain health.

In the Ms Brain study, middle-aged women with trauma exposure had a greater volume of white matter hyperintensities (WMHs) than those without trauma. In addition, the differences persisted even after adjusting for depressive or post-traumatic stress symptoms. 

WMHs are “an important indicator of small vessel disease in the brain and have been linked to future stroke risk, dementia risk, and mortality,” lead investigator Rebecca Thurston, PhD, from the University of Pittsburgh, told this news organization.

“What I take from this is, really, that sexual assault has implications for women’s health, far beyond exclusively mental health outcomes, but also for their cardiovascular health, as we have shown in other work and for their stroke and dementia risk as we are seeing in the present work,” Dr. Thurston added.

The study was presented at the North American Menopause Society (NAMS) Annual Meeting in Washington, D.C., and has been accepted for publication in the journal Brain Imaging and Behavior.
 

Beyond the usual suspects

As part of the study, 145 women (mean age, 59 years) free of clinical cardiovascular disease, stroke, or dementia provided their medical history, including history of traumatic experiences, depression, and post-traumatic stress disorder and underwent magnetic resonance brain imaging for WMHs.

More than two-thirds (68%) of the women reported at least one trauma, most commonly sexual assault (23%).

In multivariate analysis, women with trauma exposure had greater WMH volume than women without trauma (P = .01), with sexual assault most strongly associated with greater WMH volume (P = .02).

The associations persisted after adjusting for depressive or post-traumatic stress symptoms.

“A history of sexual assault was particularly related to white matter hyperintensities in the parietal lobe, and these kinds of white matter hyperintensities have been linked to Alzheimer’s disease in a fairly pronounced way,” Dr. Thurston said.

“When we think about risk factors for stroke, dementia, we need to think beyond exclusively our usual suspects and also think about women [who experienced] psychological trauma and experienced sexual assault in particular. So ask about it and consider it part of your screening regimen,” she added.
 

‘Burgeoning’ literature

Commenting on the findings, Charles Nemeroff, MD, PhD, professor and chair, department of psychiatry and behavioral sciences, Dell Medical School, University of Texas at Austin, and director of its Institute for Early Life Adversity Research, said the research adds to the “burgeoning literature on the long term neurobiological consequences of trauma and more specifically, sexual abuse, on brain imaging measures.”

“Our group and others reported several years ago that patients with mood disorders, more specifically bipolar disorder and major depression, had higher rates of WMH than matched controls. Those older studies did not control for a history of early life adversity such as childhood maltreatment,” Dr. Nemeroff said.

“In addition to this finding of increased WMH in subjects exposed to trauma is a very large literature documenting other central nervous system (CNS) changes in this population, including cortical thinning in certain brain areas and clearly an emerging finding that different forms of childhood maltreatment are associated with quite distinct structural brain alterations in adulthood,” he noted. 

The study was supported by grants from the National Institutes of Health. Dr. Thurston and Dr. Nemeroff have disclosed no relevant financial relationships.

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

Pregnant women should use paracetamol/acetaminophen only with a medical indication and at the lowest effective dose for the shortest possible time, according to an international consensus statement published online Sept. 23 in Nature Reviews Endocrinology.

With global rates of use high and risks considered negligible, the expert panel of 13 U.S. and European authors call for focused research into how this analgesic and febrifuge may impair fetal development and lead to adverse outcomes in children. They outline several precautionary measures to be taken in the meantime.

According to first author and epidemiologist Ann Z. Bauer, ScD, a postdoctoral research fellow at the University of Massachusetts in Lowell, and colleagues, this drug is used by an estimated 65% of pregnant women in the United States, and more than 50% worldwide. It is currently the active ingredient in more than 600 prescription and nonprescription medications, including Tylenol, which historically has been deemed safe in all trimesters of pregnancy.

But a growing body of experimental and epidemiological evidence suggests prenatal exposure to paracetamol (N-acetyl-p-aminophenol, or APAP) might alter fetal development and elevate the risks of neurodevelopmental, reproductive and urogenital disorders in both sexes. Exposure in utero has been linked, for example, to potential behavioral problems in children.

The new recommendations are based on a review of experimental animal and cell-based research as well as human epidemiological data published from January 1995 to October 2020. The authors include clinicians, epidemiologists, and scientists specializing in toxicology, endocrinology, reproductive medicine and neurodevelopment.
 

Recommendations

Although the new guidance does not differ markedly from current advice, the authors believe stronger communication and greater awareness of risks are needed. In addition to restricting use of this medication to low doses for short periods when medically necessary, expectant mothers should receive counseling before conception or early in pregnancy. If uncertain about its use, they should consult their physicians or pharmacists.

In other recommendations, the panel said:

• The 2015 FDA Drug Safety Communication recommendations should be updated based on evaluation of all available scientific evidence.
• The European Medicines Agency Pharmacovigilance Risk Assessment Committee should review the most recent epidemiologic and experimental research and issue an updated Drug Safety Communication.
• Obstetric and gynecological associations should update their guidance after reviewing all available research.
• The Acetaminophen Awareness Coalition (“Know Your Dose” Campaign) should add standardized warnings and specifically advise pregnant women to forgo APAP unless it’s medically indicated.
• All sales of APAP-containing medications should be accompanied by recommendations specifically for use in pregnancy. This information should include warning labels on packaging, and if possible, APAP should be sold only in pharmacies (as in France).

Mechanism of action

APAP is an endocrine disruptor (Neuroscientist. 2020 Sep 11. doi: 10.1177/1073858420952046). “Chemicals that disrupt the endocrine system are concerning because they can interfere with the activity of endogenous hormones that are essential for healthy neurological, urogenital, and reproductive development,” researchers wrote.

“The precise mechanism is not clear but its toxicity is thought to be due mainly to hormone disruption,” Dr. Bauer said in an interview.

Moreover, APAP readily crosses the placenta and blood–brain barrier, and changes in APAP metabolism during pregnancy might make women and their fetuses more vulnerable to its toxic effects. For instance, the molar dose fraction of APAP converted to the oxidative metabolite N-acetyl-p-benzoquinone imine increases during pregnancy. In addition to its hepatotoxicity, this poisonous byproduct is thought to be a genotoxin that increases DNA cleavage by acting on the enzyme topoisomerase II.

Asked for her perspective on the statement, Kjersti Aagaard, MD, PhD, a professor of obstetrics and gynecology at Baylor College of Medicine and Texas Children’s Hospital in Houston, called the expert panel’s statement thoughtful and comprehensive, but she urged caution in interpreting the role of acetaminophen.

The challenge in linking any commonly used medication to adverse effects and congenital defects, she said, is “teasing out an association from causation. Given the commonality of the use of acetaminophen with the relative rarity of the outcomes, it is clear that not all cases of exposure result in adverse outcomes.”

As for judicious use, she said, one would be to reduce a high fever, which can cause miscarriage, neural tube defects, and potential heart disease in adulthood. Acetaminophen is the drug of choice in this case since nonsteroidal anti-inflammatory drugs such as ibuprofen are not recommended owing to their known risks to the fetal heart.

Dr. Aagaard emphasized that while acetaminophen use is temporally associated with learning and behavioral problems, and urogenital disorders at birth in male infants such as like hypospadias, so is exposure to multiple environmental chemicals and pollutants, as well as climate change. “It would be a real mistake with real life implications if we associated any congenital disease or disorder with a commonly used medication with known benefits if the true causal link lies elsewhere.”

She said the precautionary statements fall into the time-honored therapeutic principle of first do no harm. “However, the call for research action must be undertaken earnestly and sincerely.”

According to Dr. Bauer, the statement’s essential take-home message is that “physicians should educate themselves and educate women about what we’re learning about the risks of acetaminophen in pregnancy.” Risk can be minimized by using the lowest effective dose for the shortest time and only when medically indicated. “Pregnant women should speak to their physicians about acetaminophen. It’s about empowerment and making smart decisions,” she said.

This study received no specific funding. Coauthor Dr. R.T. Mitchell is supported by a UK Research Institute fellowship.

Pregnant women should use paracetamol/acetaminophen only with a medical indication and at the lowest effective dose for the shortest possible time, according to an international consensus statement published online Sept. 23 in Nature Reviews Endocrinology.

With global rates of use high and risks considered negligible, the expert panel of 13 U.S. and European authors call for focused research into how this analgesic and febrifuge may impair fetal development and lead to adverse outcomes in children. They outline several precautionary measures to be taken in the meantime.

According to first author and epidemiologist Ann Z. Bauer, ScD, a postdoctoral research fellow at the University of Massachusetts in Lowell, and colleagues, this drug is used by an estimated 65% of pregnant women in the United States, and more than 50% worldwide. It is currently the active ingredient in more than 600 prescription and nonprescription medications, including Tylenol, which historically has been deemed safe in all trimesters of pregnancy.

But a growing body of experimental and epidemiological evidence suggests prenatal exposure to paracetamol (N-acetyl-p-aminophenol, or APAP) might alter fetal development and elevate the risks of neurodevelopmental, reproductive and urogenital disorders in both sexes. Exposure in utero has been linked, for example, to potential behavioral problems in children.

The new recommendations are based on a review of experimental animal and cell-based research as well as human epidemiological data published from January 1995 to October 2020. The authors include clinicians, epidemiologists, and scientists specializing in toxicology, endocrinology, reproductive medicine and neurodevelopment.
 

Recommendations

Although the new guidance does not differ markedly from current advice, the authors believe stronger communication and greater awareness of risks are needed. In addition to restricting use of this medication to low doses for short periods when medically necessary, expectant mothers should receive counseling before conception or early in pregnancy. If uncertain about its use, they should consult their physicians or pharmacists.

In other recommendations, the panel said:

• The 2015 FDA Drug Safety Communication recommendations should be updated based on evaluation of all available scientific evidence.
• The European Medicines Agency Pharmacovigilance Risk Assessment Committee should review the most recent epidemiologic and experimental research and issue an updated Drug Safety Communication.
• Obstetric and gynecological associations should update their guidance after reviewing all available research.
• The Acetaminophen Awareness Coalition (“Know Your Dose” Campaign) should add standardized warnings and specifically advise pregnant women to forgo APAP unless it’s medically indicated.
• All sales of APAP-containing medications should be accompanied by recommendations specifically for use in pregnancy. This information should include warning labels on packaging, and if possible, APAP should be sold only in pharmacies (as in France).

Mechanism of action

APAP is an endocrine disruptor (Neuroscientist. 2020 Sep 11. doi: 10.1177/1073858420952046). “Chemicals that disrupt the endocrine system are concerning because they can interfere with the activity of endogenous hormones that are essential for healthy neurological, urogenital, and reproductive development,” researchers wrote.

“The precise mechanism is not clear but its toxicity is thought to be due mainly to hormone disruption,” Dr. Bauer said in an interview.

Moreover, APAP readily crosses the placenta and blood–brain barrier, and changes in APAP metabolism during pregnancy might make women and their fetuses more vulnerable to its toxic effects. For instance, the molar dose fraction of APAP converted to the oxidative metabolite N-acetyl-p-benzoquinone imine increases during pregnancy. In addition to its hepatotoxicity, this poisonous byproduct is thought to be a genotoxin that increases DNA cleavage by acting on the enzyme topoisomerase II.

Asked for her perspective on the statement, Kjersti Aagaard, MD, PhD, a professor of obstetrics and gynecology at Baylor College of Medicine and Texas Children’s Hospital in Houston, called the expert panel’s statement thoughtful and comprehensive, but she urged caution in interpreting the role of acetaminophen.

The challenge in linking any commonly used medication to adverse effects and congenital defects, she said, is “teasing out an association from causation. Given the commonality of the use of acetaminophen with the relative rarity of the outcomes, it is clear that not all cases of exposure result in adverse outcomes.”

As for judicious use, she said, one would be to reduce a high fever, which can cause miscarriage, neural tube defects, and potential heart disease in adulthood. Acetaminophen is the drug of choice in this case since nonsteroidal anti-inflammatory drugs such as ibuprofen are not recommended owing to their known risks to the fetal heart.

Dr. Aagaard emphasized that while acetaminophen use is temporally associated with learning and behavioral problems, and urogenital disorders at birth in male infants such as like hypospadias, so is exposure to multiple environmental chemicals and pollutants, as well as climate change. “It would be a real mistake with real life implications if we associated any congenital disease or disorder with a commonly used medication with known benefits if the true causal link lies elsewhere.”

She said the precautionary statements fall into the time-honored therapeutic principle of first do no harm. “However, the call for research action must be undertaken earnestly and sincerely.”

According to Dr. Bauer, the statement’s essential take-home message is that “physicians should educate themselves and educate women about what we’re learning about the risks of acetaminophen in pregnancy.” Risk can be minimized by using the lowest effective dose for the shortest time and only when medically indicated. “Pregnant women should speak to their physicians about acetaminophen. It’s about empowerment and making smart decisions,” she said.

This study received no specific funding. Coauthor Dr. R.T. Mitchell is supported by a UK Research Institute fellowship.

Pregnant women should use paracetamol/acetaminophen only with a medical indication and at the lowest effective dose for the shortest possible time, according to an international consensus statement published online Sept. 23 in Nature Reviews Endocrinology.

With global rates of use high and risks considered negligible, the expert panel of 13 U.S. and European authors call for focused research into how this analgesic and febrifuge may impair fetal development and lead to adverse outcomes in children. They outline several precautionary measures to be taken in the meantime.

According to first author and epidemiologist Ann Z. Bauer, ScD, a postdoctoral research fellow at the University of Massachusetts in Lowell, and colleagues, this drug is used by an estimated 65% of pregnant women in the United States, and more than 50% worldwide. It is currently the active ingredient in more than 600 prescription and nonprescription medications, including Tylenol, which historically has been deemed safe in all trimesters of pregnancy.

But a growing body of experimental and epidemiological evidence suggests prenatal exposure to paracetamol (N-acetyl-p-aminophenol, or APAP) might alter fetal development and elevate the risks of neurodevelopmental, reproductive and urogenital disorders in both sexes. Exposure in utero has been linked, for example, to potential behavioral problems in children.

The new recommendations are based on a review of experimental animal and cell-based research as well as human epidemiological data published from January 1995 to October 2020. The authors include clinicians, epidemiologists, and scientists specializing in toxicology, endocrinology, reproductive medicine and neurodevelopment.
 

Recommendations

Although the new guidance does not differ markedly from current advice, the authors believe stronger communication and greater awareness of risks are needed. In addition to restricting use of this medication to low doses for short periods when medically necessary, expectant mothers should receive counseling before conception or early in pregnancy. If uncertain about its use, they should consult their physicians or pharmacists.

In other recommendations, the panel said:

• The 2015 FDA Drug Safety Communication recommendations should be updated based on evaluation of all available scientific evidence.
• The European Medicines Agency Pharmacovigilance Risk Assessment Committee should review the most recent epidemiologic and experimental research and issue an updated Drug Safety Communication.
• Obstetric and gynecological associations should update their guidance after reviewing all available research.
• The Acetaminophen Awareness Coalition (“Know Your Dose” Campaign) should add standardized warnings and specifically advise pregnant women to forgo APAP unless it’s medically indicated.
• All sales of APAP-containing medications should be accompanied by recommendations specifically for use in pregnancy. This information should include warning labels on packaging, and if possible, APAP should be sold only in pharmacies (as in France).

Mechanism of action

APAP is an endocrine disruptor (Neuroscientist. 2020 Sep 11. doi: 10.1177/1073858420952046). “Chemicals that disrupt the endocrine system are concerning because they can interfere with the activity of endogenous hormones that are essential for healthy neurological, urogenital, and reproductive development,” researchers wrote.

“The precise mechanism is not clear but its toxicity is thought to be due mainly to hormone disruption,” Dr. Bauer said in an interview.

Moreover, APAP readily crosses the placenta and blood–brain barrier, and changes in APAP metabolism during pregnancy might make women and their fetuses more vulnerable to its toxic effects. For instance, the molar dose fraction of APAP converted to the oxidative metabolite N-acetyl-p-benzoquinone imine increases during pregnancy. In addition to its hepatotoxicity, this poisonous byproduct is thought to be a genotoxin that increases DNA cleavage by acting on the enzyme topoisomerase II.

Asked for her perspective on the statement, Kjersti Aagaard, MD, PhD, a professor of obstetrics and gynecology at Baylor College of Medicine and Texas Children’s Hospital in Houston, called the expert panel’s statement thoughtful and comprehensive, but she urged caution in interpreting the role of acetaminophen.

The challenge in linking any commonly used medication to adverse effects and congenital defects, she said, is “teasing out an association from causation. Given the commonality of the use of acetaminophen with the relative rarity of the outcomes, it is clear that not all cases of exposure result in adverse outcomes.”

As for judicious use, she said, one would be to reduce a high fever, which can cause miscarriage, neural tube defects, and potential heart disease in adulthood. Acetaminophen is the drug of choice in this case since nonsteroidal anti-inflammatory drugs such as ibuprofen are not recommended owing to their known risks to the fetal heart.

Dr. Aagaard emphasized that while acetaminophen use is temporally associated with learning and behavioral problems, and urogenital disorders at birth in male infants such as like hypospadias, so is exposure to multiple environmental chemicals and pollutants, as well as climate change. “It would be a real mistake with real life implications if we associated any congenital disease or disorder with a commonly used medication with known benefits if the true causal link lies elsewhere.”

She said the precautionary statements fall into the time-honored therapeutic principle of first do no harm. “However, the call for research action must be undertaken earnestly and sincerely.”

According to Dr. Bauer, the statement’s essential take-home message is that “physicians should educate themselves and educate women about what we’re learning about the risks of acetaminophen in pregnancy.” Risk can be minimized by using the lowest effective dose for the shortest time and only when medically indicated. “Pregnant women should speak to their physicians about acetaminophen. It’s about empowerment and making smart decisions,” she said.

This study received no specific funding. Coauthor Dr. R.T. Mitchell is supported by a UK Research Institute fellowship.

An unusual surge of new-onset tics in patients with no prior history of these disorders has been tied to the psychological stress associated with the COVID-19 pandemic, new research suggests.

Results from a large, single-center study show several cases of tic-like movements and vocalizations with abrupt onset among older adolescents and adults during the pandemic. None had a previous diagnosis of a tic disorder. Among 10 patients, two were diagnosed with a purely functional movement disorder, four with an organic tic disorder, and four with both.

“Within our movement disorders clinic specifically ... we’ve been seeing an increased number of patients with an almost explosive onset of these tic-like movements and vocalizations later in life than what is typically seen with organic tic disorders and Tourette syndrome, which is typically in school-aged children,” said study investigator Caroline Olvera, MD, Rush University Medical Center, Chicago.

“Abrupt onset of symptoms can be seen in patients with tic disorders, although this is typically quoted as less than 10%, or even 5% is more characteristic of functional neurological disorders in general and also with psychogenic tics,” she added.

The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
 

Anxiety, other psychiatric conditions

Tic disorders typically start in childhood. However, the researchers observed an increase in the number of patients with abrupt onset of tic-like movements and vocalizations later in life, which is more often characteristic of functional neurological disorders.

To examine the profile, associated conditions, and risk factors in this population, the investigators conducted a thorough chart review of patients attending movement disorder clinics between March 2020, when the COVID pandemic was officially declared, and March 2021.

Patients with acute onset of tics were identified using the International Classification of Diseases codes for behavioral tics, tic vocalizations, and Tourette syndrome.

The charts were then narrowed down to patients with no previous diagnosis of these conditions. Most patients were videotaped for assessment by the rest of the movement disorder neurologists in the practice. Since the end of the study inclusion period in March 2021, Dr. Olvera estimates that the clinic experienced a doubling or tripling of the number of similar patients.

In the study cohort of 10 patients, the median age at presentation was 19 years (range, 15-41 years), nine were female, the gender of the other one was unknown, and the duration of tics was 8 weeks (range, 1-24 weeks) by the time they were first seen in the clinic. Four patients reported having COVID infection before tic onset.

All exhibited motor tics and nine had vocal tics. Two were diagnosed with a purely functional neurologic disorder, four with only an organic tic disorder, and four with organic tics with a functional overlay.

“All patients, including those with organic tic disorders, had a history of anxiety and also reported worsening anxiety in the setting of the COVID pandemic,” Dr. Olvera said.

The majority of patients were on a psychotropic medication prior to coming to the clinic, and these were primarily for anxiety and depression. Three patients had a history of suicidality, often very severe and leading to hospitalization, she noted.

“In terms of our conclusions from the project, we feel that this phenotype of acute explosive onset of tic-like movements and vocalizations in this older population of adults, compared with typical organic tic disorders and Tourette syndrome, appears novel to the pandemic,” she said.

She cautioned that functional and organic tics share many characteristics and therefore may be difficult to differentiate.
 

COVID stress

Commenting on the findings, Michele Tagliati, MD, director of the movement disorders program at Cedars-Sinai Medical Center, Los Angeles, said the research highlights how clinicians’ understanding of particular diseases can be challenged during extraordinary events such as COVID-19 and the heightened stress it causes.

“I’m not surprised that these [disorders] might have had a spike during a stressful time as COVID,” he said.

Patients are “really scared and really anxious, they’re afraid to die, and they’re afraid that their life will be over. So they might express their psychological difficulty, their discomfort, with these calls for help that look like tics. But they’re not what we consider physiological or organic things,” he added.

Dr. Tagliati added that he doesn’t believe rapid tic onset in adults is not a complication of the coronavirus infection, but rather a consequence of psychological pressure brought on by the pandemic.

Treating underlying anxiety may be a useful approach, possibly with the support of psychiatrists, which in many cases is enough to relieve the conditions and overcome the symptoms, he noted.

However, at other times, it’s not that simple, he added. Sometimes patients “fall through the cracks between neurology and psychiatry,” Dr. Tagliati said.

Dr. Olvera and Dr. Tagliati have disclosed no relevant financial relationships.

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

An unusual surge of new-onset tics in patients with no prior history of these disorders has been tied to the psychological stress associated with the COVID-19 pandemic, new research suggests.

Results from a large, single-center study show several cases of tic-like movements and vocalizations with abrupt onset among older adolescents and adults during the pandemic. None had a previous diagnosis of a tic disorder. Among 10 patients, two were diagnosed with a purely functional movement disorder, four with an organic tic disorder, and four with both.

“Within our movement disorders clinic specifically ... we’ve been seeing an increased number of patients with an almost explosive onset of these tic-like movements and vocalizations later in life than what is typically seen with organic tic disorders and Tourette syndrome, which is typically in school-aged children,” said study investigator Caroline Olvera, MD, Rush University Medical Center, Chicago.

“Abrupt onset of symptoms can be seen in patients with tic disorders, although this is typically quoted as less than 10%, or even 5% is more characteristic of functional neurological disorders in general and also with psychogenic tics,” she added.

The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
 

Anxiety, other psychiatric conditions

Tic disorders typically start in childhood. However, the researchers observed an increase in the number of patients with abrupt onset of tic-like movements and vocalizations later in life, which is more often characteristic of functional neurological disorders.

To examine the profile, associated conditions, and risk factors in this population, the investigators conducted a thorough chart review of patients attending movement disorder clinics between March 2020, when the COVID pandemic was officially declared, and March 2021.

Patients with acute onset of tics were identified using the International Classification of Diseases codes for behavioral tics, tic vocalizations, and Tourette syndrome.

The charts were then narrowed down to patients with no previous diagnosis of these conditions. Most patients were videotaped for assessment by the rest of the movement disorder neurologists in the practice. Since the end of the study inclusion period in March 2021, Dr. Olvera estimates that the clinic experienced a doubling or tripling of the number of similar patients.

In the study cohort of 10 patients, the median age at presentation was 19 years (range, 15-41 years), nine were female, the gender of the other one was unknown, and the duration of tics was 8 weeks (range, 1-24 weeks) by the time they were first seen in the clinic. Four patients reported having COVID infection before tic onset.

All exhibited motor tics and nine had vocal tics. Two were diagnosed with a purely functional neurologic disorder, four with only an organic tic disorder, and four with organic tics with a functional overlay.

“All patients, including those with organic tic disorders, had a history of anxiety and also reported worsening anxiety in the setting of the COVID pandemic,” Dr. Olvera said.

The majority of patients were on a psychotropic medication prior to coming to the clinic, and these were primarily for anxiety and depression. Three patients had a history of suicidality, often very severe and leading to hospitalization, she noted.

“In terms of our conclusions from the project, we feel that this phenotype of acute explosive onset of tic-like movements and vocalizations in this older population of adults, compared with typical organic tic disorders and Tourette syndrome, appears novel to the pandemic,” she said.

She cautioned that functional and organic tics share many characteristics and therefore may be difficult to differentiate.
 

COVID stress

Commenting on the findings, Michele Tagliati, MD, director of the movement disorders program at Cedars-Sinai Medical Center, Los Angeles, said the research highlights how clinicians’ understanding of particular diseases can be challenged during extraordinary events such as COVID-19 and the heightened stress it causes.

“I’m not surprised that these [disorders] might have had a spike during a stressful time as COVID,” he said.

Patients are “really scared and really anxious, they’re afraid to die, and they’re afraid that their life will be over. So they might express their psychological difficulty, their discomfort, with these calls for help that look like tics. But they’re not what we consider physiological or organic things,” he added.

Dr. Tagliati added that he doesn’t believe rapid tic onset in adults is not a complication of the coronavirus infection, but rather a consequence of psychological pressure brought on by the pandemic.

Treating underlying anxiety may be a useful approach, possibly with the support of psychiatrists, which in many cases is enough to relieve the conditions and overcome the symptoms, he noted.

However, at other times, it’s not that simple, he added. Sometimes patients “fall through the cracks between neurology and psychiatry,” Dr. Tagliati said.

Dr. Olvera and Dr. Tagliati have disclosed no relevant financial relationships.

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

An unusual surge of new-onset tics in patients with no prior history of these disorders has been tied to the psychological stress associated with the COVID-19 pandemic, new research suggests.

Results from a large, single-center study show several cases of tic-like movements and vocalizations with abrupt onset among older adolescents and adults during the pandemic. None had a previous diagnosis of a tic disorder. Among 10 patients, two were diagnosed with a purely functional movement disorder, four with an organic tic disorder, and four with both.

“Within our movement disorders clinic specifically ... we’ve been seeing an increased number of patients with an almost explosive onset of these tic-like movements and vocalizations later in life than what is typically seen with organic tic disorders and Tourette syndrome, which is typically in school-aged children,” said study investigator Caroline Olvera, MD, Rush University Medical Center, Chicago.

“Abrupt onset of symptoms can be seen in patients with tic disorders, although this is typically quoted as less than 10%, or even 5% is more characteristic of functional neurological disorders in general and also with psychogenic tics,” she added.

The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
 

Anxiety, other psychiatric conditions

Tic disorders typically start in childhood. However, the researchers observed an increase in the number of patients with abrupt onset of tic-like movements and vocalizations later in life, which is more often characteristic of functional neurological disorders.

To examine the profile, associated conditions, and risk factors in this population, the investigators conducted a thorough chart review of patients attending movement disorder clinics between March 2020, when the COVID pandemic was officially declared, and March 2021.

Patients with acute onset of tics were identified using the International Classification of Diseases codes for behavioral tics, tic vocalizations, and Tourette syndrome.

The charts were then narrowed down to patients with no previous diagnosis of these conditions. Most patients were videotaped for assessment by the rest of the movement disorder neurologists in the practice. Since the end of the study inclusion period in March 2021, Dr. Olvera estimates that the clinic experienced a doubling or tripling of the number of similar patients.

In the study cohort of 10 patients, the median age at presentation was 19 years (range, 15-41 years), nine were female, the gender of the other one was unknown, and the duration of tics was 8 weeks (range, 1-24 weeks) by the time they were first seen in the clinic. Four patients reported having COVID infection before tic onset.

All exhibited motor tics and nine had vocal tics. Two were diagnosed with a purely functional neurologic disorder, four with only an organic tic disorder, and four with organic tics with a functional overlay.

“All patients, including those with organic tic disorders, had a history of anxiety and also reported worsening anxiety in the setting of the COVID pandemic,” Dr. Olvera said.

The majority of patients were on a psychotropic medication prior to coming to the clinic, and these were primarily for anxiety and depression. Three patients had a history of suicidality, often very severe and leading to hospitalization, she noted.

“In terms of our conclusions from the project, we feel that this phenotype of acute explosive onset of tic-like movements and vocalizations in this older population of adults, compared with typical organic tic disorders and Tourette syndrome, appears novel to the pandemic,” she said.

She cautioned that functional and organic tics share many characteristics and therefore may be difficult to differentiate.
 

COVID stress

Commenting on the findings, Michele Tagliati, MD, director of the movement disorders program at Cedars-Sinai Medical Center, Los Angeles, said the research highlights how clinicians’ understanding of particular diseases can be challenged during extraordinary events such as COVID-19 and the heightened stress it causes.

“I’m not surprised that these [disorders] might have had a spike during a stressful time as COVID,” he said.

Patients are “really scared and really anxious, they’re afraid to die, and they’re afraid that their life will be over. So they might express their psychological difficulty, their discomfort, with these calls for help that look like tics. But they’re not what we consider physiological or organic things,” he added.

Dr. Tagliati added that he doesn’t believe rapid tic onset in adults is not a complication of the coronavirus infection, but rather a consequence of psychological pressure brought on by the pandemic.

Treating underlying anxiety may be a useful approach, possibly with the support of psychiatrists, which in many cases is enough to relieve the conditions and overcome the symptoms, he noted.

However, at other times, it’s not that simple, he added. Sometimes patients “fall through the cracks between neurology and psychiatry,” Dr. Tagliati said.

Dr. Olvera and Dr. Tagliati have disclosed no relevant financial relationships.

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