How to talk with patients in ways that help them feel heard and understood

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A common sentiment shared by patients who are happy with their health care professionals is, “I feel heard and understood.” How do we become those professionals and make sure that we are doing a good job connecting and communicating with our patients?

Dr. Douglas S. Paauw

Here are a few suggestions on how to do this.
 

Practice intent listening

When a patient shares their symptoms with you, show genuine curiosity and concern. Ask clarifying questions. Ask how the symptom or problem is affecting their day-to-day life. Avoid quick, rapid-fire questions back at the patient. Do not accept a patient self-diagnosis.

When a patient with a first-time headache says they are having a migraine headache, for example, ask many clarifying questions to make sure you can make a diagnosis of headache type, then use all the information you have gathered to educate the patient on what you believe they have.

It is easy to jump to treatment, but we always want to make sure we have the diagnosis correct first. By intently listening, it also makes it much easier to tell a patient you do not know what is causing their symptoms, but that you and the patient will be vigilant for any future clues that may lead to a diagnosis.
 

Use terminology that patients understand

Rachael Gotlieb, MD, and colleagues published an excellent study with eye-opening results on common phrases we use as health care providers and how often patients do not understand them.

Only 9% of patients understood what was meant when they were asked if they have been febrile. Only 2% understood what was meant by “I am concerned the patient has an occult infection.” Only 21% understood that “your xray findings were quite impressive” was bad news.

It is easy to avoid these medical language traps, we just have to check our doctor speak. Ask, “Do you have a fever?” Say, “I am concerned you may have an infection that is hard to find.”

Several other terms we use all the time in explaining things to patients that I have found most patients do not understand are the terms bilateral, systemic, and significant. Think carefully as you explain things to patients and check back to have them repeat to you what they think you said.
 

Be comfortable saying you don’t know

Many symptoms in medicine end up not being diagnosable. When a patient shares symptoms that do not fit a pattern of a disease, it is important to share with them why you think it is okay to wait and watch, even if you do not have a diagnosis.

Patients find it comforting that you are so honest with them. Doing this also has the benefit of gaining patients’ trust when you are sure about something, because it tells them you don’t have an answer for everything.
 

Ask your patients what they think is causing their symptoms

This way, you know what their big fear is. You can address what they are worried about, even if it isn’t something you are considering.

Patients are often fearful of a disease a close friend or relative has, so when they get new symptoms, they fear diseases that we might not think of. By knowing what they are fearful of, you can reassure when appropriate.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at dpaauw@uw.edu.

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A common sentiment shared by patients who are happy with their health care professionals is, “I feel heard and understood.” How do we become those professionals and make sure that we are doing a good job connecting and communicating with our patients?

Dr. Douglas S. Paauw

Here are a few suggestions on how to do this.
 

Practice intent listening

When a patient shares their symptoms with you, show genuine curiosity and concern. Ask clarifying questions. Ask how the symptom or problem is affecting their day-to-day life. Avoid quick, rapid-fire questions back at the patient. Do not accept a patient self-diagnosis.

When a patient with a first-time headache says they are having a migraine headache, for example, ask many clarifying questions to make sure you can make a diagnosis of headache type, then use all the information you have gathered to educate the patient on what you believe they have.

It is easy to jump to treatment, but we always want to make sure we have the diagnosis correct first. By intently listening, it also makes it much easier to tell a patient you do not know what is causing their symptoms, but that you and the patient will be vigilant for any future clues that may lead to a diagnosis.
 

Use terminology that patients understand

Rachael Gotlieb, MD, and colleagues published an excellent study with eye-opening results on common phrases we use as health care providers and how often patients do not understand them.

Only 9% of patients understood what was meant when they were asked if they have been febrile. Only 2% understood what was meant by “I am concerned the patient has an occult infection.” Only 21% understood that “your xray findings were quite impressive” was bad news.

It is easy to avoid these medical language traps, we just have to check our doctor speak. Ask, “Do you have a fever?” Say, “I am concerned you may have an infection that is hard to find.”

Several other terms we use all the time in explaining things to patients that I have found most patients do not understand are the terms bilateral, systemic, and significant. Think carefully as you explain things to patients and check back to have them repeat to you what they think you said.
 

Be comfortable saying you don’t know

Many symptoms in medicine end up not being diagnosable. When a patient shares symptoms that do not fit a pattern of a disease, it is important to share with them why you think it is okay to wait and watch, even if you do not have a diagnosis.

Patients find it comforting that you are so honest with them. Doing this also has the benefit of gaining patients’ trust when you are sure about something, because it tells them you don’t have an answer for everything.
 

Ask your patients what they think is causing their symptoms

This way, you know what their big fear is. You can address what they are worried about, even if it isn’t something you are considering.

Patients are often fearful of a disease a close friend or relative has, so when they get new symptoms, they fear diseases that we might not think of. By knowing what they are fearful of, you can reassure when appropriate.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at dpaauw@uw.edu.

A common sentiment shared by patients who are happy with their health care professionals is, “I feel heard and understood.” How do we become those professionals and make sure that we are doing a good job connecting and communicating with our patients?

Dr. Douglas S. Paauw

Here are a few suggestions on how to do this.
 

Practice intent listening

When a patient shares their symptoms with you, show genuine curiosity and concern. Ask clarifying questions. Ask how the symptom or problem is affecting their day-to-day life. Avoid quick, rapid-fire questions back at the patient. Do not accept a patient self-diagnosis.

When a patient with a first-time headache says they are having a migraine headache, for example, ask many clarifying questions to make sure you can make a diagnosis of headache type, then use all the information you have gathered to educate the patient on what you believe they have.

It is easy to jump to treatment, but we always want to make sure we have the diagnosis correct first. By intently listening, it also makes it much easier to tell a patient you do not know what is causing their symptoms, but that you and the patient will be vigilant for any future clues that may lead to a diagnosis.
 

Use terminology that patients understand

Rachael Gotlieb, MD, and colleagues published an excellent study with eye-opening results on common phrases we use as health care providers and how often patients do not understand them.

Only 9% of patients understood what was meant when they were asked if they have been febrile. Only 2% understood what was meant by “I am concerned the patient has an occult infection.” Only 21% understood that “your xray findings were quite impressive” was bad news.

It is easy to avoid these medical language traps, we just have to check our doctor speak. Ask, “Do you have a fever?” Say, “I am concerned you may have an infection that is hard to find.”

Several other terms we use all the time in explaining things to patients that I have found most patients do not understand are the terms bilateral, systemic, and significant. Think carefully as you explain things to patients and check back to have them repeat to you what they think you said.
 

Be comfortable saying you don’t know

Many symptoms in medicine end up not being diagnosable. When a patient shares symptoms that do not fit a pattern of a disease, it is important to share with them why you think it is okay to wait and watch, even if you do not have a diagnosis.

Patients find it comforting that you are so honest with them. Doing this also has the benefit of gaining patients’ trust when you are sure about something, because it tells them you don’t have an answer for everything.
 

Ask your patients what they think is causing their symptoms

This way, you know what their big fear is. You can address what they are worried about, even if it isn’t something you are considering.

Patients are often fearful of a disease a close friend or relative has, so when they get new symptoms, they fear diseases that we might not think of. By knowing what they are fearful of, you can reassure when appropriate.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at dpaauw@uw.edu.

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HRT may prevent Alzheimer’s in high-risk women

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Hormone replacement therapy (HRT) introduced early during the menopausal transition may protect against Alzheimer’s dementia in women carrying the APOE4 gene, new research suggests.

Results from a cohort study of almost 1,200 women showed that use of HRT was associated with higher delayed memory scores and larger entorhinal and hippocampal brain volumes – areas that are affected early by Alzheimer’s disease (AD) pathology.

HRT was also found to be most effective, as seen by larger hippocampal volume, when introduced during early perimenopause.

“Clinicians are very much aware of the susceptibility of women to cognitive disturbances during menopause,” lead author Rasha Saleh, MD, senior research associate, University of East Anglia (England), said in an interview.

“Identifying the at-risk APOE4 women and early HRT introduction can be of benefit. Confirming our findings in a clinical trial would be the next step forward,” Dr. Saleh said.

The findings were published online in Alzheimer’s Research and Therapy.
 

Personalized approaches

Dr. Saleh noted that estrogen receptors are localized in various areas of the brain, including cognition-related areas. Estrogen regulates such things as neuroinflammatory status, glucose utilization, and lipid metabolism.

“The decline of estrogen during menopause can lead to disturbance in these functions, which can accelerate AD-related pathology,” she said.

HRT during the menopausal transition and afterward is “being considered as a strategy to mitigate cognitive decline,” the investigators wrote. Early observational studies have suggested that oral estrogen “may be protective against dementia,” but results of clinical trials have been inconsistent, and some have even shown “harmful effects.”

The current researchers were “interested in the personalized approaches in the prevention of AD,” Dr. Saleh said. Preclinical and pilot data from her group have shown that women with APOE4 have “better cognitive test scores with nutritional and hormonal interventions.”

This led Dr. Saleh to hypothesize that HRT would be of more cognitive benefit for those with versus without APOE4, particularly when introduced early during the menopausal transition.

To investigate this hypothesis, the researchers analyzed baseline data from participants in the European Prevention of Alzheimer’s Dementia (EPAD) cohort. This project was initiated in 2015 with the aim of developing longitudinal models over the entire course of AD prior to dementia clinical diagnosis.

Participants were recruited from 10 European countries. All were required to be at least 50 years old, to have not been diagnosed with dementia at baseline, and to have no medical or psychiatric illness that could potentially exclude them from further research.

The current study included 1,178 women (mean age, 65.1 years), who were divided by genotype into non-APOE4 and APOE4 groups. HRT treatment for current or previous users included estrogen alone or estrogen plus progestogens via oral or transdermal administration routes, and at different doses.

The four tests used to assess cognition were the Mini-Mental State Examination dot counting to evaluate verbal working memory, the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total score, the Four Mountain Test, and the supermarket trolley virtual reality test.

Brain MRI data were collected. The researchers focused on the medial temporal lobe as the “main brain region regulating cognition and memory processing.” This lobe includes the hippocampus, the parahippocampus, the entorhinal cortex, and the amygdala.
 

‘Critical window’

The researchers found a “trend” toward an APOE-HRT interaction (P-interaction = .097) for the total RBANS score. In particular, it was significant for the RBANS delayed memory index, where scores were consistently higher for women with APOE4 who had received HRT, compared with all other groups (P-interaction = .009).

Within-genotype group comparisons showed that HRT users had a higher RBANS total scale score and delayed memory index (P = .045 and P = .002, respectively), but only among APOE4 carriers. Effect size analyses showed a large effect of HRT use on the Four Mountain Test score and the supermarket trolley virtual reality test score (Cohen’s d = 0.988 and 1.2, respectively).

“This large effect was found only in APOE4 carriers,” the investigators noted.

Similarly, a moderate to large effect of HRT on the left entorhinal volume was observed in APOE4 carriers (Cohen’s d = 0.63).

In members of the APOE4 group who received HRT, the left entorhinal and left and right amygdala volumes were larger, compared with both no-APOE4 and non-HRT users (P-interaction = .002, .003, and .005, respectively). Similar trends were observed for the right entorhinal volume (P = .074).

In addition, among HRT users, the left entorhinal volume was larger (P = .03); the right and left anterior cingulate gyrus volumes were smaller (P = .003 and .062, respectively); and the left superior frontal gyrus volume was larger (P = .009) in comparison with women who did not receive HRT, independently of their APOE genotype.

Early use of HRT among APOE4 carriers was associated with larger right and left hippocampal volume (P = .035 and P = .028, respectively) – an association not found in non-APOE4 carriers. The association was also not significant when participants were not stratified by APOE genotype.

“The key important point here is the timing, or the ‘critical window,’ when HRT can be of most benefit,” Dr. Saleh said. “This is most beneficial when introduced early, before the neuropathology becomes irreversible.”

Study limitations include its cross-sectional design, which precludes the establishment of a causal relationship, and the fact that information regarding the type and dose of estrogen was not available for all participants.

HRT is not without risk, Dr. Saleh noted. She recommended that clinicians “carry out various screening tests to make sure that a woman is eligible for HRT and not at risk of hypercoagulability, for instance.”
 

Risk-benefit ratio

In a comment, Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, called the study “exactly the kind of work that needs to be done.”

Dr. Fillit, who was not involved with the current research, is a clinical professor of geriatric medicine, palliative care medicine, and neuroscience at Mount Sinai Hospital, New York.

He compared the process with that of osteoporosis. “We know that if women are treated [with HRT] at the time of the menopause, you can prevent the rapid bone loss that occurs with rapid estrogen loss. But if you wait 5, 10 years out, once the bone loss has occurred, the HRT doesn’t really have any impact on osteoporosis risk because the horse is already out of the barn,” he said.

Although HRT carries risks, “they can clearly be managed; and if it’s proven that estrogen or hormone replacement around the time of the menopause can be protective [against AD], the risk-benefit ratio of HRT could be in favor of treatment,” Dr. Fillit added.

The study was conducted as part of the Medical Research Council NuBrain Consortium. The investigators and Dr. Fillit reported no relevant financial relationships.

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

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Hormone replacement therapy (HRT) introduced early during the menopausal transition may protect against Alzheimer’s dementia in women carrying the APOE4 gene, new research suggests.

Results from a cohort study of almost 1,200 women showed that use of HRT was associated with higher delayed memory scores and larger entorhinal and hippocampal brain volumes – areas that are affected early by Alzheimer’s disease (AD) pathology.

HRT was also found to be most effective, as seen by larger hippocampal volume, when introduced during early perimenopause.

“Clinicians are very much aware of the susceptibility of women to cognitive disturbances during menopause,” lead author Rasha Saleh, MD, senior research associate, University of East Anglia (England), said in an interview.

“Identifying the at-risk APOE4 women and early HRT introduction can be of benefit. Confirming our findings in a clinical trial would be the next step forward,” Dr. Saleh said.

The findings were published online in Alzheimer’s Research and Therapy.
 

Personalized approaches

Dr. Saleh noted that estrogen receptors are localized in various areas of the brain, including cognition-related areas. Estrogen regulates such things as neuroinflammatory status, glucose utilization, and lipid metabolism.

“The decline of estrogen during menopause can lead to disturbance in these functions, which can accelerate AD-related pathology,” she said.

HRT during the menopausal transition and afterward is “being considered as a strategy to mitigate cognitive decline,” the investigators wrote. Early observational studies have suggested that oral estrogen “may be protective against dementia,” but results of clinical trials have been inconsistent, and some have even shown “harmful effects.”

The current researchers were “interested in the personalized approaches in the prevention of AD,” Dr. Saleh said. Preclinical and pilot data from her group have shown that women with APOE4 have “better cognitive test scores with nutritional and hormonal interventions.”

This led Dr. Saleh to hypothesize that HRT would be of more cognitive benefit for those with versus without APOE4, particularly when introduced early during the menopausal transition.

To investigate this hypothesis, the researchers analyzed baseline data from participants in the European Prevention of Alzheimer’s Dementia (EPAD) cohort. This project was initiated in 2015 with the aim of developing longitudinal models over the entire course of AD prior to dementia clinical diagnosis.

Participants were recruited from 10 European countries. All were required to be at least 50 years old, to have not been diagnosed with dementia at baseline, and to have no medical or psychiatric illness that could potentially exclude them from further research.

The current study included 1,178 women (mean age, 65.1 years), who were divided by genotype into non-APOE4 and APOE4 groups. HRT treatment for current or previous users included estrogen alone or estrogen plus progestogens via oral or transdermal administration routes, and at different doses.

The four tests used to assess cognition were the Mini-Mental State Examination dot counting to evaluate verbal working memory, the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total score, the Four Mountain Test, and the supermarket trolley virtual reality test.

Brain MRI data were collected. The researchers focused on the medial temporal lobe as the “main brain region regulating cognition and memory processing.” This lobe includes the hippocampus, the parahippocampus, the entorhinal cortex, and the amygdala.
 

‘Critical window’

The researchers found a “trend” toward an APOE-HRT interaction (P-interaction = .097) for the total RBANS score. In particular, it was significant for the RBANS delayed memory index, where scores were consistently higher for women with APOE4 who had received HRT, compared with all other groups (P-interaction = .009).

Within-genotype group comparisons showed that HRT users had a higher RBANS total scale score and delayed memory index (P = .045 and P = .002, respectively), but only among APOE4 carriers. Effect size analyses showed a large effect of HRT use on the Four Mountain Test score and the supermarket trolley virtual reality test score (Cohen’s d = 0.988 and 1.2, respectively).

“This large effect was found only in APOE4 carriers,” the investigators noted.

Similarly, a moderate to large effect of HRT on the left entorhinal volume was observed in APOE4 carriers (Cohen’s d = 0.63).

In members of the APOE4 group who received HRT, the left entorhinal and left and right amygdala volumes were larger, compared with both no-APOE4 and non-HRT users (P-interaction = .002, .003, and .005, respectively). Similar trends were observed for the right entorhinal volume (P = .074).

In addition, among HRT users, the left entorhinal volume was larger (P = .03); the right and left anterior cingulate gyrus volumes were smaller (P = .003 and .062, respectively); and the left superior frontal gyrus volume was larger (P = .009) in comparison with women who did not receive HRT, independently of their APOE genotype.

Early use of HRT among APOE4 carriers was associated with larger right and left hippocampal volume (P = .035 and P = .028, respectively) – an association not found in non-APOE4 carriers. The association was also not significant when participants were not stratified by APOE genotype.

“The key important point here is the timing, or the ‘critical window,’ when HRT can be of most benefit,” Dr. Saleh said. “This is most beneficial when introduced early, before the neuropathology becomes irreversible.”

Study limitations include its cross-sectional design, which precludes the establishment of a causal relationship, and the fact that information regarding the type and dose of estrogen was not available for all participants.

HRT is not without risk, Dr. Saleh noted. She recommended that clinicians “carry out various screening tests to make sure that a woman is eligible for HRT and not at risk of hypercoagulability, for instance.”
 

Risk-benefit ratio

In a comment, Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, called the study “exactly the kind of work that needs to be done.”

Dr. Fillit, who was not involved with the current research, is a clinical professor of geriatric medicine, palliative care medicine, and neuroscience at Mount Sinai Hospital, New York.

He compared the process with that of osteoporosis. “We know that if women are treated [with HRT] at the time of the menopause, you can prevent the rapid bone loss that occurs with rapid estrogen loss. But if you wait 5, 10 years out, once the bone loss has occurred, the HRT doesn’t really have any impact on osteoporosis risk because the horse is already out of the barn,” he said.

Although HRT carries risks, “they can clearly be managed; and if it’s proven that estrogen or hormone replacement around the time of the menopause can be protective [against AD], the risk-benefit ratio of HRT could be in favor of treatment,” Dr. Fillit added.

The study was conducted as part of the Medical Research Council NuBrain Consortium. The investigators and Dr. Fillit reported no relevant financial relationships.

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

 

Hormone replacement therapy (HRT) introduced early during the menopausal transition may protect against Alzheimer’s dementia in women carrying the APOE4 gene, new research suggests.

Results from a cohort study of almost 1,200 women showed that use of HRT was associated with higher delayed memory scores and larger entorhinal and hippocampal brain volumes – areas that are affected early by Alzheimer’s disease (AD) pathology.

HRT was also found to be most effective, as seen by larger hippocampal volume, when introduced during early perimenopause.

“Clinicians are very much aware of the susceptibility of women to cognitive disturbances during menopause,” lead author Rasha Saleh, MD, senior research associate, University of East Anglia (England), said in an interview.

“Identifying the at-risk APOE4 women and early HRT introduction can be of benefit. Confirming our findings in a clinical trial would be the next step forward,” Dr. Saleh said.

The findings were published online in Alzheimer’s Research and Therapy.
 

Personalized approaches

Dr. Saleh noted that estrogen receptors are localized in various areas of the brain, including cognition-related areas. Estrogen regulates such things as neuroinflammatory status, glucose utilization, and lipid metabolism.

“The decline of estrogen during menopause can lead to disturbance in these functions, which can accelerate AD-related pathology,” she said.

HRT during the menopausal transition and afterward is “being considered as a strategy to mitigate cognitive decline,” the investigators wrote. Early observational studies have suggested that oral estrogen “may be protective against dementia,” but results of clinical trials have been inconsistent, and some have even shown “harmful effects.”

The current researchers were “interested in the personalized approaches in the prevention of AD,” Dr. Saleh said. Preclinical and pilot data from her group have shown that women with APOE4 have “better cognitive test scores with nutritional and hormonal interventions.”

This led Dr. Saleh to hypothesize that HRT would be of more cognitive benefit for those with versus without APOE4, particularly when introduced early during the menopausal transition.

To investigate this hypothesis, the researchers analyzed baseline data from participants in the European Prevention of Alzheimer’s Dementia (EPAD) cohort. This project was initiated in 2015 with the aim of developing longitudinal models over the entire course of AD prior to dementia clinical diagnosis.

Participants were recruited from 10 European countries. All were required to be at least 50 years old, to have not been diagnosed with dementia at baseline, and to have no medical or psychiatric illness that could potentially exclude them from further research.

The current study included 1,178 women (mean age, 65.1 years), who were divided by genotype into non-APOE4 and APOE4 groups. HRT treatment for current or previous users included estrogen alone or estrogen plus progestogens via oral or transdermal administration routes, and at different doses.

The four tests used to assess cognition were the Mini-Mental State Examination dot counting to evaluate verbal working memory, the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total score, the Four Mountain Test, and the supermarket trolley virtual reality test.

Brain MRI data were collected. The researchers focused on the medial temporal lobe as the “main brain region regulating cognition and memory processing.” This lobe includes the hippocampus, the parahippocampus, the entorhinal cortex, and the amygdala.
 

‘Critical window’

The researchers found a “trend” toward an APOE-HRT interaction (P-interaction = .097) for the total RBANS score. In particular, it was significant for the RBANS delayed memory index, where scores were consistently higher for women with APOE4 who had received HRT, compared with all other groups (P-interaction = .009).

Within-genotype group comparisons showed that HRT users had a higher RBANS total scale score and delayed memory index (P = .045 and P = .002, respectively), but only among APOE4 carriers. Effect size analyses showed a large effect of HRT use on the Four Mountain Test score and the supermarket trolley virtual reality test score (Cohen’s d = 0.988 and 1.2, respectively).

“This large effect was found only in APOE4 carriers,” the investigators noted.

Similarly, a moderate to large effect of HRT on the left entorhinal volume was observed in APOE4 carriers (Cohen’s d = 0.63).

In members of the APOE4 group who received HRT, the left entorhinal and left and right amygdala volumes were larger, compared with both no-APOE4 and non-HRT users (P-interaction = .002, .003, and .005, respectively). Similar trends were observed for the right entorhinal volume (P = .074).

In addition, among HRT users, the left entorhinal volume was larger (P = .03); the right and left anterior cingulate gyrus volumes were smaller (P = .003 and .062, respectively); and the left superior frontal gyrus volume was larger (P = .009) in comparison with women who did not receive HRT, independently of their APOE genotype.

Early use of HRT among APOE4 carriers was associated with larger right and left hippocampal volume (P = .035 and P = .028, respectively) – an association not found in non-APOE4 carriers. The association was also not significant when participants were not stratified by APOE genotype.

“The key important point here is the timing, or the ‘critical window,’ when HRT can be of most benefit,” Dr. Saleh said. “This is most beneficial when introduced early, before the neuropathology becomes irreversible.”

Study limitations include its cross-sectional design, which precludes the establishment of a causal relationship, and the fact that information regarding the type and dose of estrogen was not available for all participants.

HRT is not without risk, Dr. Saleh noted. She recommended that clinicians “carry out various screening tests to make sure that a woman is eligible for HRT and not at risk of hypercoagulability, for instance.”
 

Risk-benefit ratio

In a comment, Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, called the study “exactly the kind of work that needs to be done.”

Dr. Fillit, who was not involved with the current research, is a clinical professor of geriatric medicine, palliative care medicine, and neuroscience at Mount Sinai Hospital, New York.

He compared the process with that of osteoporosis. “We know that if women are treated [with HRT] at the time of the menopause, you can prevent the rapid bone loss that occurs with rapid estrogen loss. But if you wait 5, 10 years out, once the bone loss has occurred, the HRT doesn’t really have any impact on osteoporosis risk because the horse is already out of the barn,” he said.

Although HRT carries risks, “they can clearly be managed; and if it’s proven that estrogen or hormone replacement around the time of the menopause can be protective [against AD], the risk-benefit ratio of HRT could be in favor of treatment,” Dr. Fillit added.

The study was conducted as part of the Medical Research Council NuBrain Consortium. The investigators and Dr. Fillit reported no relevant financial relationships.

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

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Possible bivalent vaccine link to strokes in people over 65

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A vaccine database found a possible link between the Pfizer/BioNTech bivalent COVID-19 vaccine and ischemic strokes in people over 65 who got the shot, the Centers for Disease Control and Prevention and the Food and Drug Administration said in a joint news release.

The release did not recommend people change their vaccine practices, saying the database finding probably did not represent a “true clinical risk.” The CDC said everybody, including people over 65, should stay up to date on their COVID vaccines, including the bivalent booster.

The news release said the Vaccine Safety Datalink (VSD), “a near real-time surveillance system,” raised a safety concern about the Pfizer/BioNTech booster.

“Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-44 following vaccination,” the news release said.

Ischemic strokes are blockages of blood to the brain, often caused by blood clots.

“Although the totality of the data currently suggests that it is very unlikely that the signal in VSD (Vaccine Safety Datalink) represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal,” the release said.

No higher likelihood of strokes linked to the Pfizer bivalent vaccine had been found by Pfizer/BioNTech, the Department of Veterans Affairs, the Vaccine Adverse Event Reporting System maintained by the CDC and the FDA, or other agencies that monitor reactions of vaccines, the news release said. No safety issues about strokes have been identified with the Moderna bivalent vaccine. 

CNN, citing a CDC official, reported that about 550,000 seniors who got Pfizer bivalent boosters were tracked by the VSD, and 130 of them had strokes within 3 weeks of getting the shot. None of those 130 people died, CNN said. The official spoke on the condition of anonymity because they weren’t authorized to share the data. 

The issue will be discussed at the January meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

In a joint statement, Pfizer and BioNTech said: “Neither Pfizer and BioNTech nor the CDC or FDA have observed similar findings across numerous other monitoring systems in the U.S. and globally and there is no evidence to conclude that ischemic stroke is associated with the use of the companies’ COVID-19 vaccines.”

Bivalent boosters contain two strains of vaccine – one to protect against the original COVID-19 virus and another targeting Omicron subvariants.

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

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A vaccine database found a possible link between the Pfizer/BioNTech bivalent COVID-19 vaccine and ischemic strokes in people over 65 who got the shot, the Centers for Disease Control and Prevention and the Food and Drug Administration said in a joint news release.

The release did not recommend people change their vaccine practices, saying the database finding probably did not represent a “true clinical risk.” The CDC said everybody, including people over 65, should stay up to date on their COVID vaccines, including the bivalent booster.

The news release said the Vaccine Safety Datalink (VSD), “a near real-time surveillance system,” raised a safety concern about the Pfizer/BioNTech booster.

“Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-44 following vaccination,” the news release said.

Ischemic strokes are blockages of blood to the brain, often caused by blood clots.

“Although the totality of the data currently suggests that it is very unlikely that the signal in VSD (Vaccine Safety Datalink) represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal,” the release said.

No higher likelihood of strokes linked to the Pfizer bivalent vaccine had been found by Pfizer/BioNTech, the Department of Veterans Affairs, the Vaccine Adverse Event Reporting System maintained by the CDC and the FDA, or other agencies that monitor reactions of vaccines, the news release said. No safety issues about strokes have been identified with the Moderna bivalent vaccine. 

CNN, citing a CDC official, reported that about 550,000 seniors who got Pfizer bivalent boosters were tracked by the VSD, and 130 of them had strokes within 3 weeks of getting the shot. None of those 130 people died, CNN said. The official spoke on the condition of anonymity because they weren’t authorized to share the data. 

The issue will be discussed at the January meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

In a joint statement, Pfizer and BioNTech said: “Neither Pfizer and BioNTech nor the CDC or FDA have observed similar findings across numerous other monitoring systems in the U.S. and globally and there is no evidence to conclude that ischemic stroke is associated with the use of the companies’ COVID-19 vaccines.”

Bivalent boosters contain two strains of vaccine – one to protect against the original COVID-19 virus and another targeting Omicron subvariants.

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

A vaccine database found a possible link between the Pfizer/BioNTech bivalent COVID-19 vaccine and ischemic strokes in people over 65 who got the shot, the Centers for Disease Control and Prevention and the Food and Drug Administration said in a joint news release.

The release did not recommend people change their vaccine practices, saying the database finding probably did not represent a “true clinical risk.” The CDC said everybody, including people over 65, should stay up to date on their COVID vaccines, including the bivalent booster.

The news release said the Vaccine Safety Datalink (VSD), “a near real-time surveillance system,” raised a safety concern about the Pfizer/BioNTech booster.

“Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-44 following vaccination,” the news release said.

Ischemic strokes are blockages of blood to the brain, often caused by blood clots.

“Although the totality of the data currently suggests that it is very unlikely that the signal in VSD (Vaccine Safety Datalink) represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal,” the release said.

No higher likelihood of strokes linked to the Pfizer bivalent vaccine had been found by Pfizer/BioNTech, the Department of Veterans Affairs, the Vaccine Adverse Event Reporting System maintained by the CDC and the FDA, or other agencies that monitor reactions of vaccines, the news release said. No safety issues about strokes have been identified with the Moderna bivalent vaccine. 

CNN, citing a CDC official, reported that about 550,000 seniors who got Pfizer bivalent boosters were tracked by the VSD, and 130 of them had strokes within 3 weeks of getting the shot. None of those 130 people died, CNN said. The official spoke on the condition of anonymity because they weren’t authorized to share the data. 

The issue will be discussed at the January meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

In a joint statement, Pfizer and BioNTech said: “Neither Pfizer and BioNTech nor the CDC or FDA have observed similar findings across numerous other monitoring systems in the U.S. and globally and there is no evidence to conclude that ischemic stroke is associated with the use of the companies’ COVID-19 vaccines.”

Bivalent boosters contain two strains of vaccine – one to protect against the original COVID-19 virus and another targeting Omicron subvariants.

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

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Nearly 50% of patients with dementia experience falls

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Nearly half of older adults with dementia experience falls, suggests new research that also identifies multiple risk factors for these falls.

In a study of more than 5,500 participants, 45.5% of those with dementia experienced one or more falls, compared with 30.9% of their peers without dementia.

Vision impairment and living with a spouse were among the strongest predictors of future fall risk among participants living with dementia. Interestingly, high neighborhood social deprivation, which is reflected by such things as income and education, was associated with lower odds of falling.

Overall, the results highlight the need for a multidisciplinary approach to preventing falls among elderly individuals with dementia, said lead author Safiyyah M. Okoye, PhD, assistant professor, College of Nursing and Health Professions, Drexel University, Philadelphia.

“We need to consider different dimensions and figure out how we can try to go beyond the clinic in our interactions,” she said.

Dr. Okoye noted that in addition to reviewing medications that may contribute to falls and screening for vision problems, clinicians might also consider resources to improve the home environment and ensure that families have appropriate caregiving.

The findings were published online  in Alzheimer’s and Dementia: The Journal of the Alzheimer’s Association.
 

No ‘silver bullet’

Every year, falls cause millions of injuries in older adults, and those with dementia are especially vulnerable. This population has twice the risk of falling and up to three times the risk of incurring serious fall-related injuries, such as fractures, the researchers noted.

Falls are a leading cause of hospitalization among those with dementia. Previous evidence has shown that persons with dementia are more likely to experience negative health consequences, such as delirium, while in hospital, compared with those without dementia. Even minor fall-related injuries are associated with the patient’s being discharged to a nursing home rather than returning home.

Dr. Okoye stressed that many factors contribute to falls, including health status; function, such as the ability to walk and balance; medications; home environment; and activity level.

“There are multidimensional aspects, and we can’t just find one silver bullet to address falls. It should be addressed comprehensively,” she said.

Existing studies “overwhelmingly” focus on factors related to health and function that could be addressed in the doctor’s office or with a referral, rather than on environmental and social factors, Dr. Okoye noted.

And even though the risk of falling is high among community-dwelling seniors with dementia, very few studies have addressed the risk of falls among these adults, she added.

The new analysis included a nationally representative sample of 5,581 community-dwelling adults who participated in both the 2015 and 2016 National Health and Aging Trends Study (NHATS). The NHATS is a population-based survey of health and disability trends and trajectories among Americans aged 65 years and older.

During interviews, participants were asked, personally or by proxy, about falls during the previous 12 months. Having fallen at baseline was evaluated as a possible predictor of falls in the subsequent 12 months.

To determine probable dementia, researchers asked whether a doctor had ever told the participants that they had dementia or Alzheimer’s disease. They also used a dementia screening questionnaire and neuropsychological tests of memory, orientation, and executive function.

Of the total sample, most (n = 5,093) did not have dementia.

Physical environmental factors that were assessed included conditions at home, such as clutter, tripping hazards, and structural issues, as well as neighborhood social and economic deprivation – such as income, education levels, and employment status.
 

 

 

Fall rates and counterintuitive findings

Results showed that significantly more of those with dementia than without experienced one or more falls (45.5% vs. 30.9%; P < .001).

In addition, a history of falling was significantly associated with subsequent falls among those with dementia (odds ratio, 6.20; 95% confidence interval, 3.81-10.09), as was vision impairment (OR, 2.22; 95% CI, 1.12-4.40) and living with a spouse versus alone (OR, 2.43; 95% CI, 1.09-5.43).

A possible explanation for higher fall risk among those living with a partner is that those living alone usually have better functioning, the investigators noted. Also, live-in partners tend to be of a similar age as the person with dementia and may have challenges of their own.

Interestingly, high neighborhood social deprivation was associated with lower odds of falling (OR, 0.55 for the highest deprivation scores; 95% CI, 0.31-0.98), a finding Dr. Okoye said was “counterintuitive.”

This result could be related to the social environment, she noted. “Maybe there are more people around in the house, more people with eyes on the person, or more people in the community who know the person. Despite the low economic resources, there could be social resources there,” she said.

The new findings underscore the idea that falling is a multidimensional phenomenon among older adults with dementia as well as those without dementia, Dr. Okoye noted.

Doctors can play a role in reducing falls among patients with dementia by asking about falls, possibly eliminating medications that are associated with risk of falling, and screening for and correcting vision and hearing impairments, she suggested.

They may also help determine household hazards for a patient, such as clutter and poor lighting, and ensure that these are addressed, Dr. Okoye added.
 

No surprise

Commenting on the study, David S. Knopman, MD, a clinical neurologist at Mayo Clinic, Rochester, Minn., said the finding that visual impairment and a prior history of falling are predictive of subsequent falls “comes as no surprise.”

Dr. Knopman, whose research focuses on late-life cognitive disorders, was not involved with the current study.

Risk reduction is “of course” a key management goal, he said. “Vigilance and optimizing the patient’s living space to reduce fall risks are the major strategies,” he added.

Dr. Knopman reiterated that falls among those with dementia are associated with higher mortality and often lead to loss of the capacity to live outside of an institution.

The study was supported by the National Institute on Aging. The investigators and Dr. Knopman report no relevant financial relationships.

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

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Nearly half of older adults with dementia experience falls, suggests new research that also identifies multiple risk factors for these falls.

In a study of more than 5,500 participants, 45.5% of those with dementia experienced one or more falls, compared with 30.9% of their peers without dementia.

Vision impairment and living with a spouse were among the strongest predictors of future fall risk among participants living with dementia. Interestingly, high neighborhood social deprivation, which is reflected by such things as income and education, was associated with lower odds of falling.

Overall, the results highlight the need for a multidisciplinary approach to preventing falls among elderly individuals with dementia, said lead author Safiyyah M. Okoye, PhD, assistant professor, College of Nursing and Health Professions, Drexel University, Philadelphia.

“We need to consider different dimensions and figure out how we can try to go beyond the clinic in our interactions,” she said.

Dr. Okoye noted that in addition to reviewing medications that may contribute to falls and screening for vision problems, clinicians might also consider resources to improve the home environment and ensure that families have appropriate caregiving.

The findings were published online  in Alzheimer’s and Dementia: The Journal of the Alzheimer’s Association.
 

No ‘silver bullet’

Every year, falls cause millions of injuries in older adults, and those with dementia are especially vulnerable. This population has twice the risk of falling and up to three times the risk of incurring serious fall-related injuries, such as fractures, the researchers noted.

Falls are a leading cause of hospitalization among those with dementia. Previous evidence has shown that persons with dementia are more likely to experience negative health consequences, such as delirium, while in hospital, compared with those without dementia. Even minor fall-related injuries are associated with the patient’s being discharged to a nursing home rather than returning home.

Dr. Okoye stressed that many factors contribute to falls, including health status; function, such as the ability to walk and balance; medications; home environment; and activity level.

“There are multidimensional aspects, and we can’t just find one silver bullet to address falls. It should be addressed comprehensively,” she said.

Existing studies “overwhelmingly” focus on factors related to health and function that could be addressed in the doctor’s office or with a referral, rather than on environmental and social factors, Dr. Okoye noted.

And even though the risk of falling is high among community-dwelling seniors with dementia, very few studies have addressed the risk of falls among these adults, she added.

The new analysis included a nationally representative sample of 5,581 community-dwelling adults who participated in both the 2015 and 2016 National Health and Aging Trends Study (NHATS). The NHATS is a population-based survey of health and disability trends and trajectories among Americans aged 65 years and older.

During interviews, participants were asked, personally or by proxy, about falls during the previous 12 months. Having fallen at baseline was evaluated as a possible predictor of falls in the subsequent 12 months.

To determine probable dementia, researchers asked whether a doctor had ever told the participants that they had dementia or Alzheimer’s disease. They also used a dementia screening questionnaire and neuropsychological tests of memory, orientation, and executive function.

Of the total sample, most (n = 5,093) did not have dementia.

Physical environmental factors that were assessed included conditions at home, such as clutter, tripping hazards, and structural issues, as well as neighborhood social and economic deprivation – such as income, education levels, and employment status.
 

 

 

Fall rates and counterintuitive findings

Results showed that significantly more of those with dementia than without experienced one or more falls (45.5% vs. 30.9%; P < .001).

In addition, a history of falling was significantly associated with subsequent falls among those with dementia (odds ratio, 6.20; 95% confidence interval, 3.81-10.09), as was vision impairment (OR, 2.22; 95% CI, 1.12-4.40) and living with a spouse versus alone (OR, 2.43; 95% CI, 1.09-5.43).

A possible explanation for higher fall risk among those living with a partner is that those living alone usually have better functioning, the investigators noted. Also, live-in partners tend to be of a similar age as the person with dementia and may have challenges of their own.

Interestingly, high neighborhood social deprivation was associated with lower odds of falling (OR, 0.55 for the highest deprivation scores; 95% CI, 0.31-0.98), a finding Dr. Okoye said was “counterintuitive.”

This result could be related to the social environment, she noted. “Maybe there are more people around in the house, more people with eyes on the person, or more people in the community who know the person. Despite the low economic resources, there could be social resources there,” she said.

The new findings underscore the idea that falling is a multidimensional phenomenon among older adults with dementia as well as those without dementia, Dr. Okoye noted.

Doctors can play a role in reducing falls among patients with dementia by asking about falls, possibly eliminating medications that are associated with risk of falling, and screening for and correcting vision and hearing impairments, she suggested.

They may also help determine household hazards for a patient, such as clutter and poor lighting, and ensure that these are addressed, Dr. Okoye added.
 

No surprise

Commenting on the study, David S. Knopman, MD, a clinical neurologist at Mayo Clinic, Rochester, Minn., said the finding that visual impairment and a prior history of falling are predictive of subsequent falls “comes as no surprise.”

Dr. Knopman, whose research focuses on late-life cognitive disorders, was not involved with the current study.

Risk reduction is “of course” a key management goal, he said. “Vigilance and optimizing the patient’s living space to reduce fall risks are the major strategies,” he added.

Dr. Knopman reiterated that falls among those with dementia are associated with higher mortality and often lead to loss of the capacity to live outside of an institution.

The study was supported by the National Institute on Aging. The investigators and Dr. Knopman report no relevant financial relationships.

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

Nearly half of older adults with dementia experience falls, suggests new research that also identifies multiple risk factors for these falls.

In a study of more than 5,500 participants, 45.5% of those with dementia experienced one or more falls, compared with 30.9% of their peers without dementia.

Vision impairment and living with a spouse were among the strongest predictors of future fall risk among participants living with dementia. Interestingly, high neighborhood social deprivation, which is reflected by such things as income and education, was associated with lower odds of falling.

Overall, the results highlight the need for a multidisciplinary approach to preventing falls among elderly individuals with dementia, said lead author Safiyyah M. Okoye, PhD, assistant professor, College of Nursing and Health Professions, Drexel University, Philadelphia.

“We need to consider different dimensions and figure out how we can try to go beyond the clinic in our interactions,” she said.

Dr. Okoye noted that in addition to reviewing medications that may contribute to falls and screening for vision problems, clinicians might also consider resources to improve the home environment and ensure that families have appropriate caregiving.

The findings were published online  in Alzheimer’s and Dementia: The Journal of the Alzheimer’s Association.
 

No ‘silver bullet’

Every year, falls cause millions of injuries in older adults, and those with dementia are especially vulnerable. This population has twice the risk of falling and up to three times the risk of incurring serious fall-related injuries, such as fractures, the researchers noted.

Falls are a leading cause of hospitalization among those with dementia. Previous evidence has shown that persons with dementia are more likely to experience negative health consequences, such as delirium, while in hospital, compared with those without dementia. Even minor fall-related injuries are associated with the patient’s being discharged to a nursing home rather than returning home.

Dr. Okoye stressed that many factors contribute to falls, including health status; function, such as the ability to walk and balance; medications; home environment; and activity level.

“There are multidimensional aspects, and we can’t just find one silver bullet to address falls. It should be addressed comprehensively,” she said.

Existing studies “overwhelmingly” focus on factors related to health and function that could be addressed in the doctor’s office or with a referral, rather than on environmental and social factors, Dr. Okoye noted.

And even though the risk of falling is high among community-dwelling seniors with dementia, very few studies have addressed the risk of falls among these adults, she added.

The new analysis included a nationally representative sample of 5,581 community-dwelling adults who participated in both the 2015 and 2016 National Health and Aging Trends Study (NHATS). The NHATS is a population-based survey of health and disability trends and trajectories among Americans aged 65 years and older.

During interviews, participants were asked, personally or by proxy, about falls during the previous 12 months. Having fallen at baseline was evaluated as a possible predictor of falls in the subsequent 12 months.

To determine probable dementia, researchers asked whether a doctor had ever told the participants that they had dementia or Alzheimer’s disease. They also used a dementia screening questionnaire and neuropsychological tests of memory, orientation, and executive function.

Of the total sample, most (n = 5,093) did not have dementia.

Physical environmental factors that were assessed included conditions at home, such as clutter, tripping hazards, and structural issues, as well as neighborhood social and economic deprivation – such as income, education levels, and employment status.
 

 

 

Fall rates and counterintuitive findings

Results showed that significantly more of those with dementia than without experienced one or more falls (45.5% vs. 30.9%; P < .001).

In addition, a history of falling was significantly associated with subsequent falls among those with dementia (odds ratio, 6.20; 95% confidence interval, 3.81-10.09), as was vision impairment (OR, 2.22; 95% CI, 1.12-4.40) and living with a spouse versus alone (OR, 2.43; 95% CI, 1.09-5.43).

A possible explanation for higher fall risk among those living with a partner is that those living alone usually have better functioning, the investigators noted. Also, live-in partners tend to be of a similar age as the person with dementia and may have challenges of their own.

Interestingly, high neighborhood social deprivation was associated with lower odds of falling (OR, 0.55 for the highest deprivation scores; 95% CI, 0.31-0.98), a finding Dr. Okoye said was “counterintuitive.”

This result could be related to the social environment, she noted. “Maybe there are more people around in the house, more people with eyes on the person, or more people in the community who know the person. Despite the low economic resources, there could be social resources there,” she said.

The new findings underscore the idea that falling is a multidimensional phenomenon among older adults with dementia as well as those without dementia, Dr. Okoye noted.

Doctors can play a role in reducing falls among patients with dementia by asking about falls, possibly eliminating medications that are associated with risk of falling, and screening for and correcting vision and hearing impairments, she suggested.

They may also help determine household hazards for a patient, such as clutter and poor lighting, and ensure that these are addressed, Dr. Okoye added.
 

No surprise

Commenting on the study, David S. Knopman, MD, a clinical neurologist at Mayo Clinic, Rochester, Minn., said the finding that visual impairment and a prior history of falling are predictive of subsequent falls “comes as no surprise.”

Dr. Knopman, whose research focuses on late-life cognitive disorders, was not involved with the current study.

Risk reduction is “of course” a key management goal, he said. “Vigilance and optimizing the patient’s living space to reduce fall risks are the major strategies,” he added.

Dr. Knopman reiterated that falls among those with dementia are associated with higher mortality and often lead to loss of the capacity to live outside of an institution.

The study was supported by the National Institute on Aging. The investigators and Dr. Knopman report no relevant financial relationships.

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

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Ecopipam reduces Tourette’s tics without common side effects in phase 2 trial

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Ecopipam, in development for Tourette syndrome in children and adolescents, has shown in a randomized, controlled trial that, compared with placebo, it reduced tics and reduced the risk for some of the common side effects of other treatments, including weight gain.

Findings of the multicenter, double-blind, trial funded by the drug maker, Emalex Biosciences, were published online in Pediatrics. The trial was conducted at 68 sites in the United States, Canada, Germany, France, and Poland between May 2019 and September 2021.

Donald L. Gilbert, MD, MS, with the division of neurology at Cincinnati Children’s Hospital, and colleagues noted that all Food and Drug Administration–approved medications for Tourette syndrome are antipsychotics. The medications carry a risk of weight gain, electrocardiogram abnormalities, metabolic changes, and drug-induced movement disorders.

First-in-class medication ecopipam, targets the D1 dopamine receptor, while currently approved medications block the D2 receptor. It “may be a safe and effective treatment of Tourette syndrome with advantages over other currently approved therapeutic agents,” the authors wrote.

The study included 153 individuals at least 6 years old up to age 18 with a baseline Yale Global Tic Severity Score Total Tic Score of at least 20.

They were randomly assigned 1:1 to ecopipam or placebo.
 

Significant reduction in tic severity

Researchers saw a 30% reduction in the tic severity score from baseline to week 12 for the ecopipam group compared with the placebo group.

The data showed a least-squares mean difference of 3.44 (95% confidence interval [CI], 6.09-0.79, P = .01). Researchers also saw improvement in Clinical Global Impression of Tourette Syndrome Severity in the ecopipam group (P = .03).

Sara Pawlowski, MD, division chief for primary care mental health integration at University of Vermont Health Network and assistant professor of psychiatry, University of Vermont, Burlington, said in an interview that several things should be considered with this research.

One is that, though the results show a reduction in tics, the study lasted only 12 weeks and “tics can last a lifetime,” she noted.

“They also can ebb and flow with major life events, stressors, and various other variables. So, I wonder how the effects of improvement can be teased out from the natural ebb and flow of the condition in a 3-month window, which is a snapshot into the course of a known relapsing, remitting, lifetime, and chronically variable condition,” she said.
 

Headaches, insomnia among side effects

Weight gain was larger in the placebo group than in the ecopipam group: 17.1% in the ecopipam group and 20.3% of those who got a placebo had a weight gain of more than 7% over the study period.

The most common side effects of the study drug were headache (15.8%), insomnia (14.5%), fatigue (7.9%), and somnolence (7.9%).

A limitation of the study was lack of racial and ethnic diversity, as 93.5% of those in the placebo group and 86.8% in the ecopipam group were White.

Guidelines in North America and Europe agree that behavioral treatments should be the first-line therapy.

Dr. Pawlowski said that although effective medications are needed, she urges focusing on better access to nonmedication treatments “that work for children and adolescents” as children who start taking the medications early may take them for the rest of their lives.

Also, while the research didn’t find weight gain in the ecopipam group, the side effects they did find in the group, including headache and insomnia, “do impact a child’s life,” she noted.

“We also can’t be reassured that over the course of chronic treatment there wouldn’t be movement disorders or metabolic disorders that emerge. Those are side effects or disorders that can emerge surreptitiously over time, and more time than 12 weeks,” she said.

The study was funded by Emalex Biosciences. Dr. Gilbert has received consulting fees from Biogen and PTC therapeutics. Study coauthors disclosed ties with Emalex, Alkermes, and Paragon Biosciences. Dr. Pawlowski reports no relevant financial relationships.

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Ecopipam, in development for Tourette syndrome in children and adolescents, has shown in a randomized, controlled trial that, compared with placebo, it reduced tics and reduced the risk for some of the common side effects of other treatments, including weight gain.

Findings of the multicenter, double-blind, trial funded by the drug maker, Emalex Biosciences, were published online in Pediatrics. The trial was conducted at 68 sites in the United States, Canada, Germany, France, and Poland between May 2019 and September 2021.

Donald L. Gilbert, MD, MS, with the division of neurology at Cincinnati Children’s Hospital, and colleagues noted that all Food and Drug Administration–approved medications for Tourette syndrome are antipsychotics. The medications carry a risk of weight gain, electrocardiogram abnormalities, metabolic changes, and drug-induced movement disorders.

First-in-class medication ecopipam, targets the D1 dopamine receptor, while currently approved medications block the D2 receptor. It “may be a safe and effective treatment of Tourette syndrome with advantages over other currently approved therapeutic agents,” the authors wrote.

The study included 153 individuals at least 6 years old up to age 18 with a baseline Yale Global Tic Severity Score Total Tic Score of at least 20.

They were randomly assigned 1:1 to ecopipam or placebo.
 

Significant reduction in tic severity

Researchers saw a 30% reduction in the tic severity score from baseline to week 12 for the ecopipam group compared with the placebo group.

The data showed a least-squares mean difference of 3.44 (95% confidence interval [CI], 6.09-0.79, P = .01). Researchers also saw improvement in Clinical Global Impression of Tourette Syndrome Severity in the ecopipam group (P = .03).

Sara Pawlowski, MD, division chief for primary care mental health integration at University of Vermont Health Network and assistant professor of psychiatry, University of Vermont, Burlington, said in an interview that several things should be considered with this research.

One is that, though the results show a reduction in tics, the study lasted only 12 weeks and “tics can last a lifetime,” she noted.

“They also can ebb and flow with major life events, stressors, and various other variables. So, I wonder how the effects of improvement can be teased out from the natural ebb and flow of the condition in a 3-month window, which is a snapshot into the course of a known relapsing, remitting, lifetime, and chronically variable condition,” she said.
 

Headaches, insomnia among side effects

Weight gain was larger in the placebo group than in the ecopipam group: 17.1% in the ecopipam group and 20.3% of those who got a placebo had a weight gain of more than 7% over the study period.

The most common side effects of the study drug were headache (15.8%), insomnia (14.5%), fatigue (7.9%), and somnolence (7.9%).

A limitation of the study was lack of racial and ethnic diversity, as 93.5% of those in the placebo group and 86.8% in the ecopipam group were White.

Guidelines in North America and Europe agree that behavioral treatments should be the first-line therapy.

Dr. Pawlowski said that although effective medications are needed, she urges focusing on better access to nonmedication treatments “that work for children and adolescents” as children who start taking the medications early may take them for the rest of their lives.

Also, while the research didn’t find weight gain in the ecopipam group, the side effects they did find in the group, including headache and insomnia, “do impact a child’s life,” she noted.

“We also can’t be reassured that over the course of chronic treatment there wouldn’t be movement disorders or metabolic disorders that emerge. Those are side effects or disorders that can emerge surreptitiously over time, and more time than 12 weeks,” she said.

The study was funded by Emalex Biosciences. Dr. Gilbert has received consulting fees from Biogen and PTC therapeutics. Study coauthors disclosed ties with Emalex, Alkermes, and Paragon Biosciences. Dr. Pawlowski reports no relevant financial relationships.

Ecopipam, in development for Tourette syndrome in children and adolescents, has shown in a randomized, controlled trial that, compared with placebo, it reduced tics and reduced the risk for some of the common side effects of other treatments, including weight gain.

Findings of the multicenter, double-blind, trial funded by the drug maker, Emalex Biosciences, were published online in Pediatrics. The trial was conducted at 68 sites in the United States, Canada, Germany, France, and Poland between May 2019 and September 2021.

Donald L. Gilbert, MD, MS, with the division of neurology at Cincinnati Children’s Hospital, and colleagues noted that all Food and Drug Administration–approved medications for Tourette syndrome are antipsychotics. The medications carry a risk of weight gain, electrocardiogram abnormalities, metabolic changes, and drug-induced movement disorders.

First-in-class medication ecopipam, targets the D1 dopamine receptor, while currently approved medications block the D2 receptor. It “may be a safe and effective treatment of Tourette syndrome with advantages over other currently approved therapeutic agents,” the authors wrote.

The study included 153 individuals at least 6 years old up to age 18 with a baseline Yale Global Tic Severity Score Total Tic Score of at least 20.

They were randomly assigned 1:1 to ecopipam or placebo.
 

Significant reduction in tic severity

Researchers saw a 30% reduction in the tic severity score from baseline to week 12 for the ecopipam group compared with the placebo group.

The data showed a least-squares mean difference of 3.44 (95% confidence interval [CI], 6.09-0.79, P = .01). Researchers also saw improvement in Clinical Global Impression of Tourette Syndrome Severity in the ecopipam group (P = .03).

Sara Pawlowski, MD, division chief for primary care mental health integration at University of Vermont Health Network and assistant professor of psychiatry, University of Vermont, Burlington, said in an interview that several things should be considered with this research.

One is that, though the results show a reduction in tics, the study lasted only 12 weeks and “tics can last a lifetime,” she noted.

“They also can ebb and flow with major life events, stressors, and various other variables. So, I wonder how the effects of improvement can be teased out from the natural ebb and flow of the condition in a 3-month window, which is a snapshot into the course of a known relapsing, remitting, lifetime, and chronically variable condition,” she said.
 

Headaches, insomnia among side effects

Weight gain was larger in the placebo group than in the ecopipam group: 17.1% in the ecopipam group and 20.3% of those who got a placebo had a weight gain of more than 7% over the study period.

The most common side effects of the study drug were headache (15.8%), insomnia (14.5%), fatigue (7.9%), and somnolence (7.9%).

A limitation of the study was lack of racial and ethnic diversity, as 93.5% of those in the placebo group and 86.8% in the ecopipam group were White.

Guidelines in North America and Europe agree that behavioral treatments should be the first-line therapy.

Dr. Pawlowski said that although effective medications are needed, she urges focusing on better access to nonmedication treatments “that work for children and adolescents” as children who start taking the medications early may take them for the rest of their lives.

Also, while the research didn’t find weight gain in the ecopipam group, the side effects they did find in the group, including headache and insomnia, “do impact a child’s life,” she noted.

“We also can’t be reassured that over the course of chronic treatment there wouldn’t be movement disorders or metabolic disorders that emerge. Those are side effects or disorders that can emerge surreptitiously over time, and more time than 12 weeks,” she said.

The study was funded by Emalex Biosciences. Dr. Gilbert has received consulting fees from Biogen and PTC therapeutics. Study coauthors disclosed ties with Emalex, Alkermes, and Paragon Biosciences. Dr. Pawlowski reports no relevant financial relationships.

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Hearing loss strongly tied to increased dementia risk

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Dementia prevalence is 61% higher among older people with moderate to severe hearing loss compared with those with normal hearing, new national data show. Investigators also found that even mild hearing loss was associated with increased dementia risk, although it was not statistically significant, and that hearing aid use was tied to a 32% decrease in dementia prevalence.

“Every 10-decibel increase in hearing loss was associated with 16% greater prevalence of dementia, such that prevalence of dementia in older adults with moderate or greater hearing loss was 61% higher than prevalence in those with normal hearing,” said lead investigator Alison Huang, PhD, senior research associate in epidemiology at Johns Hopkins Bloomberg School of Public Health and core faculty in the Cochlear Center for Hearing and Public Health, Baltimore.

The findings were published online in JAMA.
 

Dose dependent effect

For their study, researchers analyzed data on 2,413 community-dwelling participants in the National Health and Aging Trends Study, a nationally representative, continuous panel study of U.S. Medicare beneficiaries aged 65 and older.

Data from the study was collected during in-home interviews, setting it apart from previous work that relied on data collected in a clinical setting, Dr. Huang said.

“This study was able to capture more vulnerable populations, such as the oldest old and older adults with disabilities, typically excluded from prior epidemiologic studies of the hearing loss–dementia association that use clinic-based data collection, which only captures people who have the ability and means to get to clinics,” Dr. Huang said.

Weighted hearing loss prevalence was 36.7% for mild and 29.8% for moderate to severe hearing loss, and weighted prevalence of dementia was 10.3%.

Those with moderate to severe hearing loss were 61% more likely to have dementia than were those with normal hearing (prevalence ratio, 1.61; 95% confidence interval [CI], 1.09-2.38).

Dementia prevalence increased with increasing severity of hearing loss: Normal hearing: 6.19% (95% CI, 4.31-8.80); mild hearing loss: 8.93% (95% CI, 6.99-11.34); moderate to severe hearing loss: 16.52% (95% CI, 13.81-19.64). But only moderate to severe hearing loss showed a statistically significant association with dementia (P = .02).

Dementia prevalence increased 16% per 10-decibel increase in hearing loss (prevalence ratio 1.16; P < .001).

Among the 853 individuals in the study with moderate to severe hearing loss, those who used hearing aids (n = 414) had a 32% lower risk of dementia compared with those who didn’t use assisted devices (prevalence ratio, 0.68; 95% CI, 0.47-1.00). Similar data were published in JAMA Neurology, suggesting that hearing aids reduce dementia risk.

“With this study, we were able to refine our understanding of the strength of the hearing loss–dementia association in a study more representative of older adults in the United States,” said Dr. Huang.
 

Robust association

Commenting on the findings, Justin S. Golub, MD, associate professor in the department of otolaryngology–head and neck surgery at Columbia University, New York, said the study supports earlier research and suggests a “robust” association between hearing loss and dementia.

“The particular advantage of this study was that it was high quality and nationally representative,” Dr. Golub said. “It is also among a smaller set of studies that have shown hearing aid use to be associated with lower risk of dementia.”

Although not statistically significant, researchers did find increasing prevalence of dementia among people with only mild hearing loss, and clinicians should take note, said Dr. Golub, who was not involved with this study.

“We would expect the relationship between mild hearing loss and dementia to be weaker than severe hearing loss and dementia and, as a result, it might take more participants to show an association among the mild group,” Dr. Golub said.

“Even though this particular study did not specifically find a relationship between mild hearing loss and dementia, I would still recommend people to start treating their hearing loss when it is early,” Dr. Golub added.

The study was funded by the National Institute on Aging. Dr. Golub reports no relevant financial relationships. Full disclosures for study authors are included in the original article.

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

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Dementia prevalence is 61% higher among older people with moderate to severe hearing loss compared with those with normal hearing, new national data show. Investigators also found that even mild hearing loss was associated with increased dementia risk, although it was not statistically significant, and that hearing aid use was tied to a 32% decrease in dementia prevalence.

“Every 10-decibel increase in hearing loss was associated with 16% greater prevalence of dementia, such that prevalence of dementia in older adults with moderate or greater hearing loss was 61% higher than prevalence in those with normal hearing,” said lead investigator Alison Huang, PhD, senior research associate in epidemiology at Johns Hopkins Bloomberg School of Public Health and core faculty in the Cochlear Center for Hearing and Public Health, Baltimore.

The findings were published online in JAMA.
 

Dose dependent effect

For their study, researchers analyzed data on 2,413 community-dwelling participants in the National Health and Aging Trends Study, a nationally representative, continuous panel study of U.S. Medicare beneficiaries aged 65 and older.

Data from the study was collected during in-home interviews, setting it apart from previous work that relied on data collected in a clinical setting, Dr. Huang said.

“This study was able to capture more vulnerable populations, such as the oldest old and older adults with disabilities, typically excluded from prior epidemiologic studies of the hearing loss–dementia association that use clinic-based data collection, which only captures people who have the ability and means to get to clinics,” Dr. Huang said.

Weighted hearing loss prevalence was 36.7% for mild and 29.8% for moderate to severe hearing loss, and weighted prevalence of dementia was 10.3%.

Those with moderate to severe hearing loss were 61% more likely to have dementia than were those with normal hearing (prevalence ratio, 1.61; 95% confidence interval [CI], 1.09-2.38).

Dementia prevalence increased with increasing severity of hearing loss: Normal hearing: 6.19% (95% CI, 4.31-8.80); mild hearing loss: 8.93% (95% CI, 6.99-11.34); moderate to severe hearing loss: 16.52% (95% CI, 13.81-19.64). But only moderate to severe hearing loss showed a statistically significant association with dementia (P = .02).

Dementia prevalence increased 16% per 10-decibel increase in hearing loss (prevalence ratio 1.16; P < .001).

Among the 853 individuals in the study with moderate to severe hearing loss, those who used hearing aids (n = 414) had a 32% lower risk of dementia compared with those who didn’t use assisted devices (prevalence ratio, 0.68; 95% CI, 0.47-1.00). Similar data were published in JAMA Neurology, suggesting that hearing aids reduce dementia risk.

“With this study, we were able to refine our understanding of the strength of the hearing loss–dementia association in a study more representative of older adults in the United States,” said Dr. Huang.
 

Robust association

Commenting on the findings, Justin S. Golub, MD, associate professor in the department of otolaryngology–head and neck surgery at Columbia University, New York, said the study supports earlier research and suggests a “robust” association between hearing loss and dementia.

“The particular advantage of this study was that it was high quality and nationally representative,” Dr. Golub said. “It is also among a smaller set of studies that have shown hearing aid use to be associated with lower risk of dementia.”

Although not statistically significant, researchers did find increasing prevalence of dementia among people with only mild hearing loss, and clinicians should take note, said Dr. Golub, who was not involved with this study.

“We would expect the relationship between mild hearing loss and dementia to be weaker than severe hearing loss and dementia and, as a result, it might take more participants to show an association among the mild group,” Dr. Golub said.

“Even though this particular study did not specifically find a relationship between mild hearing loss and dementia, I would still recommend people to start treating their hearing loss when it is early,” Dr. Golub added.

The study was funded by the National Institute on Aging. Dr. Golub reports no relevant financial relationships. Full disclosures for study authors are included in the original article.

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

Dementia prevalence is 61% higher among older people with moderate to severe hearing loss compared with those with normal hearing, new national data show. Investigators also found that even mild hearing loss was associated with increased dementia risk, although it was not statistically significant, and that hearing aid use was tied to a 32% decrease in dementia prevalence.

“Every 10-decibel increase in hearing loss was associated with 16% greater prevalence of dementia, such that prevalence of dementia in older adults with moderate or greater hearing loss was 61% higher than prevalence in those with normal hearing,” said lead investigator Alison Huang, PhD, senior research associate in epidemiology at Johns Hopkins Bloomberg School of Public Health and core faculty in the Cochlear Center for Hearing and Public Health, Baltimore.

The findings were published online in JAMA.
 

Dose dependent effect

For their study, researchers analyzed data on 2,413 community-dwelling participants in the National Health and Aging Trends Study, a nationally representative, continuous panel study of U.S. Medicare beneficiaries aged 65 and older.

Data from the study was collected during in-home interviews, setting it apart from previous work that relied on data collected in a clinical setting, Dr. Huang said.

“This study was able to capture more vulnerable populations, such as the oldest old and older adults with disabilities, typically excluded from prior epidemiologic studies of the hearing loss–dementia association that use clinic-based data collection, which only captures people who have the ability and means to get to clinics,” Dr. Huang said.

Weighted hearing loss prevalence was 36.7% for mild and 29.8% for moderate to severe hearing loss, and weighted prevalence of dementia was 10.3%.

Those with moderate to severe hearing loss were 61% more likely to have dementia than were those with normal hearing (prevalence ratio, 1.61; 95% confidence interval [CI], 1.09-2.38).

Dementia prevalence increased with increasing severity of hearing loss: Normal hearing: 6.19% (95% CI, 4.31-8.80); mild hearing loss: 8.93% (95% CI, 6.99-11.34); moderate to severe hearing loss: 16.52% (95% CI, 13.81-19.64). But only moderate to severe hearing loss showed a statistically significant association with dementia (P = .02).

Dementia prevalence increased 16% per 10-decibel increase in hearing loss (prevalence ratio 1.16; P < .001).

Among the 853 individuals in the study with moderate to severe hearing loss, those who used hearing aids (n = 414) had a 32% lower risk of dementia compared with those who didn’t use assisted devices (prevalence ratio, 0.68; 95% CI, 0.47-1.00). Similar data were published in JAMA Neurology, suggesting that hearing aids reduce dementia risk.

“With this study, we were able to refine our understanding of the strength of the hearing loss–dementia association in a study more representative of older adults in the United States,” said Dr. Huang.
 

Robust association

Commenting on the findings, Justin S. Golub, MD, associate professor in the department of otolaryngology–head and neck surgery at Columbia University, New York, said the study supports earlier research and suggests a “robust” association between hearing loss and dementia.

“The particular advantage of this study was that it was high quality and nationally representative,” Dr. Golub said. “It is also among a smaller set of studies that have shown hearing aid use to be associated with lower risk of dementia.”

Although not statistically significant, researchers did find increasing prevalence of dementia among people with only mild hearing loss, and clinicians should take note, said Dr. Golub, who was not involved with this study.

“We would expect the relationship between mild hearing loss and dementia to be weaker than severe hearing loss and dementia and, as a result, it might take more participants to show an association among the mild group,” Dr. Golub said.

“Even though this particular study did not specifically find a relationship between mild hearing loss and dementia, I would still recommend people to start treating their hearing loss when it is early,” Dr. Golub added.

The study was funded by the National Institute on Aging. Dr. Golub reports no relevant financial relationships. Full disclosures for study authors are included in the original article.

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

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Can 6 minutes of intense cycling put the brakes on Alzheimer’s?

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Short bouts of intense exercise may help protect the brain from age-related cognitive decline by increasing production of a key protein involved in neuroplasticity, learning, and memory, new research suggests.

In a small study of healthy adults, 6 minutes of high-intensity cycling increased circulating levels of brain-derived neurotrophic factor (BDNF) to a significantly greater extent than prolonged light cycling or fasting.

However, the data do not suggest that 6 minutes of high-intensity exercise “wards off dementia,” cautioned lead investigator Travis Gibbons, MSc, PhD candidate in environmental physiology at the University of Otago (New Zealand), Dunedin, and now postdoctoral fellow at the University of British Columbia – Okanagan, Kelowna.

“Like all science, this is just a small piece that supports a potential mechanistic role for how exercise might improve brain health,” Dr. Gibbons told this news organization.

The findings were published online in the Journal of Physiology.
 

Targeting BDNF

Both intermittent fasting and exercise have previously been shown to have potent neuroprotective effects; and an acute upregulation of BDNF appears to be a common mechanistic link.

To tease apart the influence of fasting and exercise on BDNF production, Dr. Gibbons and colleagues studied 12 aerobically fit, healthy men (n = 6) and women (n = 6) aged 20-40 years.

In a study that employed a repeated-measures crossover design, they assessed circulating BDNF levels after a 20-hour fast, prolonged (90-min) light cycling, short (6-min) high-intensity cycling, and combined fasting and exercise.

Six minutes of high-intensity exercise appeared to be the most efficient way to increase BDNF.

Fasting for 20 hours led to a ninefold increase in ketone body delivery to the brain but had no effect on any metric of BDNF in peripheral circulation at rest or during exercise.

Six minutes of high-intensity exercise increased every metric of circulating BDNF four to five times more than prolonged low-intensity exercise.

In addition, the increase in plasma-derived BDNF correlated with a sixfold increase in circulating lactate irrespective of feeding or fasting state.
 

Lactate delivery?

“My leading theory is that, during and following intense exercise, lactate produced by muscles is delivered and consumed by the brain,” Dr. Gibbons noted.

“It takes high-intensity exercise to provoke this ‘cerebral substrate switch’ from glucose to lactate. Critically, this cerebral substrate switch has been shown to contribute to the early processes that upregulate BDNF production in the brain,” he said.

However, “Whether this translates to ‘warding off dementia’ is not clear,” Dr. Gibbons added.

The study also suggests that increases in plasma volume and platelet concentration appear to play a role in concentrating BDNF in the circulation during exercise.

The investigators note that BDNF and other neurotrophic-based pharmaceutical therapies have shown “great promise” in slowing and even arresting neurodegenerative processes in animals, but attempts to harness the protective power of BDNF in human neurodegeneration have thus far failed.

“Whether episodically upregulating BDNF production with intense exercise is an effective strategy to curb age-related cognitive decline in humans is unknown, but animal models indicate that it is and that BDNF plays a primary role,” the researchers write.

Funding for the study was provided by the Healthcare Otago Charitable Trust. The investigators have reported no relevant financial relationships.

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

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Short bouts of intense exercise may help protect the brain from age-related cognitive decline by increasing production of a key protein involved in neuroplasticity, learning, and memory, new research suggests.

In a small study of healthy adults, 6 minutes of high-intensity cycling increased circulating levels of brain-derived neurotrophic factor (BDNF) to a significantly greater extent than prolonged light cycling or fasting.

However, the data do not suggest that 6 minutes of high-intensity exercise “wards off dementia,” cautioned lead investigator Travis Gibbons, MSc, PhD candidate in environmental physiology at the University of Otago (New Zealand), Dunedin, and now postdoctoral fellow at the University of British Columbia – Okanagan, Kelowna.

“Like all science, this is just a small piece that supports a potential mechanistic role for how exercise might improve brain health,” Dr. Gibbons told this news organization.

The findings were published online in the Journal of Physiology.
 

Targeting BDNF

Both intermittent fasting and exercise have previously been shown to have potent neuroprotective effects; and an acute upregulation of BDNF appears to be a common mechanistic link.

To tease apart the influence of fasting and exercise on BDNF production, Dr. Gibbons and colleagues studied 12 aerobically fit, healthy men (n = 6) and women (n = 6) aged 20-40 years.

In a study that employed a repeated-measures crossover design, they assessed circulating BDNF levels after a 20-hour fast, prolonged (90-min) light cycling, short (6-min) high-intensity cycling, and combined fasting and exercise.

Six minutes of high-intensity exercise appeared to be the most efficient way to increase BDNF.

Fasting for 20 hours led to a ninefold increase in ketone body delivery to the brain but had no effect on any metric of BDNF in peripheral circulation at rest or during exercise.

Six minutes of high-intensity exercise increased every metric of circulating BDNF four to five times more than prolonged low-intensity exercise.

In addition, the increase in plasma-derived BDNF correlated with a sixfold increase in circulating lactate irrespective of feeding or fasting state.
 

Lactate delivery?

“My leading theory is that, during and following intense exercise, lactate produced by muscles is delivered and consumed by the brain,” Dr. Gibbons noted.

“It takes high-intensity exercise to provoke this ‘cerebral substrate switch’ from glucose to lactate. Critically, this cerebral substrate switch has been shown to contribute to the early processes that upregulate BDNF production in the brain,” he said.

However, “Whether this translates to ‘warding off dementia’ is not clear,” Dr. Gibbons added.

The study also suggests that increases in plasma volume and platelet concentration appear to play a role in concentrating BDNF in the circulation during exercise.

The investigators note that BDNF and other neurotrophic-based pharmaceutical therapies have shown “great promise” in slowing and even arresting neurodegenerative processes in animals, but attempts to harness the protective power of BDNF in human neurodegeneration have thus far failed.

“Whether episodically upregulating BDNF production with intense exercise is an effective strategy to curb age-related cognitive decline in humans is unknown, but animal models indicate that it is and that BDNF plays a primary role,” the researchers write.

Funding for the study was provided by the Healthcare Otago Charitable Trust. The investigators have reported no relevant financial relationships.

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

Short bouts of intense exercise may help protect the brain from age-related cognitive decline by increasing production of a key protein involved in neuroplasticity, learning, and memory, new research suggests.

In a small study of healthy adults, 6 minutes of high-intensity cycling increased circulating levels of brain-derived neurotrophic factor (BDNF) to a significantly greater extent than prolonged light cycling or fasting.

However, the data do not suggest that 6 minutes of high-intensity exercise “wards off dementia,” cautioned lead investigator Travis Gibbons, MSc, PhD candidate in environmental physiology at the University of Otago (New Zealand), Dunedin, and now postdoctoral fellow at the University of British Columbia – Okanagan, Kelowna.

“Like all science, this is just a small piece that supports a potential mechanistic role for how exercise might improve brain health,” Dr. Gibbons told this news organization.

The findings were published online in the Journal of Physiology.
 

Targeting BDNF

Both intermittent fasting and exercise have previously been shown to have potent neuroprotective effects; and an acute upregulation of BDNF appears to be a common mechanistic link.

To tease apart the influence of fasting and exercise on BDNF production, Dr. Gibbons and colleagues studied 12 aerobically fit, healthy men (n = 6) and women (n = 6) aged 20-40 years.

In a study that employed a repeated-measures crossover design, they assessed circulating BDNF levels after a 20-hour fast, prolonged (90-min) light cycling, short (6-min) high-intensity cycling, and combined fasting and exercise.

Six minutes of high-intensity exercise appeared to be the most efficient way to increase BDNF.

Fasting for 20 hours led to a ninefold increase in ketone body delivery to the brain but had no effect on any metric of BDNF in peripheral circulation at rest or during exercise.

Six minutes of high-intensity exercise increased every metric of circulating BDNF four to five times more than prolonged low-intensity exercise.

In addition, the increase in plasma-derived BDNF correlated with a sixfold increase in circulating lactate irrespective of feeding or fasting state.
 

Lactate delivery?

“My leading theory is that, during and following intense exercise, lactate produced by muscles is delivered and consumed by the brain,” Dr. Gibbons noted.

“It takes high-intensity exercise to provoke this ‘cerebral substrate switch’ from glucose to lactate. Critically, this cerebral substrate switch has been shown to contribute to the early processes that upregulate BDNF production in the brain,” he said.

However, “Whether this translates to ‘warding off dementia’ is not clear,” Dr. Gibbons added.

The study also suggests that increases in plasma volume and platelet concentration appear to play a role in concentrating BDNF in the circulation during exercise.

The investigators note that BDNF and other neurotrophic-based pharmaceutical therapies have shown “great promise” in slowing and even arresting neurodegenerative processes in animals, but attempts to harness the protective power of BDNF in human neurodegeneration have thus far failed.

“Whether episodically upregulating BDNF production with intense exercise is an effective strategy to curb age-related cognitive decline in humans is unknown, but animal models indicate that it is and that BDNF plays a primary role,” the researchers write.

Funding for the study was provided by the Healthcare Otago Charitable Trust. The investigators have reported no relevant financial relationships.

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

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Singer is paralyzed after delay in care; hospital must pay

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Delay in treatment will cost hospital millions

A Texas hospital must pay a multimillion-dollar judgment for failing to treat a woman’s spinal injury in time to prevent paralysis, according to a report on WFAA.com, among other news sites.

On March 21, 2019, Judy “Jessie” Adams, then part of a singing-songwriting duo with her husband, Richard, went to Premier Interventional Pain Management, in Flower Mound, Tex., prior to the couple’s drive to Ohio for a funeral. At Premier, Jesse received an epidural steroid injection (ESI) that she hoped would ease her back pain during the long drive.

Instead, the injection ended up increasing her pain.

“He [the pain physician] gave me the shot, but I couldn’t feel my legs. They were tingling, but I couldn’t feel them,” Mrs. Adams explained. “The pain was so bad in my back.” In their suit, Adams and her husband alleged that the doctor had probably “nicked a blood vessel during the ESI procedure, causing Jessie to hemorrhage.” (The couple’s suit against the doctor was settled prior to trial.)

Mrs. Adams remained under observation at the pain facility for about 1½ hours, at which point she was taken by ambulance to nearby Texas Health Presbyterian Hospital. There, in the emergency department, staff ordered a “STAT MRI” in preparation for an emergency laminectomy.

For reasons that remain murky, the MRI wasn’t performed for 1 hour and 37 minutes. The emergency laminectomy itself wasn’t started until more than 5 hours after Adams had been admitted to the ED. This was a direct violation of hospital protocol, which required that emergency surgeries be performed within 1 hour of admittance in the first available surgical suite. (At trial, Mrs. Adams’s attorneys from Lyons & Simmons offered evidence that a suite became available 49 minutes after Adams had arrived at the ED.)

During the wait, Mrs. Adams continued to experience excruciating pain. “I kept screaming: ‘Help me,’ ” she recalled. At trial, her attorneys argued that the hospital’s delay in addressing her spinal emergency led directly to her current paralysis, which keeps her confined to a wheelchair and renders her incontinent.

The hospital disagreed. In court, it maintained that Mrs. Adams was already paralyzed when she arrived at the ED and that there was no delay in care.

The jury saw things differently, however. Siding with the plaintiffs, it awarded Mrs. Adams and her husband $10.1 million, including $500,000 for Mr. Adams’s loss of future earnings and $1 million for his “loss of consortium” with his wife.

Their music career now effectively over, Mr. Adams spends most of his time taking care of Mrs. Adams.

“Music was our lifeblood for so many years, and he can’t do it anymore,” Mrs. Adams said. “He goes upstairs to play his guitar and write, and suddenly I need him to come and cath me. I just feel like I’m going to wake up from this bad dream, but it’s the same routine.”
 

Two doctors are absolved in woman’s sudden death

In a 3-2 decision in December 2022, the Pennsylvania Supreme Court ruled that the state’s 2-year statute of limitations in wrongful-death cases applies even in cases in which plaintiffs fail to identify the cause of death in a timely manner, as a report in the Claims Journal indicates.

The decision stems from a lawsuit filed by Linda Reibenstein on behalf of her mother, Mary Ann Whitman, who died in late April 2010 from a ruptured aortic aneurysm.

On April 12, 2010, Ms. Whitman visited Patrick D. Conaboy, MD, a Scranton family physician, complaining of a persistent cough, fever, and lower-back pain. Following an initial examination, Dr. Conaboy ordered an aortic duplex ultrasound scan and a CT scan of the patient’s abdomen.

The ultrasound was performed by radiologist Charles Barax, MD, who reviewed both scans. He identified a “poorly visualized aortic aneurysm.” At this point, Dr. Conaboy referred Ms. Whitman to a vascular surgeon. But before this visit could take place, Whitman’s aneurysm ruptured, killing her. This was listed as the medical cause of death on the patient’s death certificate.

In April 2011, Ms. Reibenstein filed a claim against Dr. Barax, alleging that he had failed to gauge the severity of her mother’s condition. Ms. Reibenstein’s attorney wasn’t able to question Dr. Barax on the record until well after the state’s 2-year statute of limitations had elapsed. When he did testify, Dr. Barax explained that the scans’ image quality prevented him from determining whether Whitman’s aneurysm was rupturing or simply bleeding. Despite this, he insisted that he had warned Dr. Conaboy of the potential for Ms. Whitman’s aneurysm to rupture.

In March 2016, nearly 6 years after her mother’s death, Ms. Reibenstein filed a new lawsuit, this one against Dr. Conaboy, whom she alleged had failed to properly treat her mother’s condition. Dr. Conaboy, in turn, asked the court for summary judgment – that is, a judgment in his favor without a full trial – arguing that the state’s window for filing a wrongful-death claim had long since closed. For their part, Ms. Reibenstein and her attorney argued that the state’s 2-year statute of limitations didn’t start until the plaintiff had discovered the cause of her mother’s death.

Initially refusing to dismiss the case, a lower court reconsidered Dr. Conaboy’s motion for summary judgment and ruled that Ms. Reibenstein had failed to present any evidence of “affirmative misrepresentation or fraudulent concealment.” In other words, in the absence of any willful attempt on the part of the defendant to hide the legal cause of death, which includes “acts, omissions, or events having some causative connection with the death,” the statute of limitations remained in effect, and the defendant’s motion was thereby granted.

Continuing the legal seesaw, a state appeals court reversed the lower-court ruling. Noting that the Pennsylvania malpractice statute was ambiguous, the court argued that it should be interpreted in a way that protects plaintiffs who seek “fair compensation” but encounter willfully erected obstacles in pursuit of their claim.

Dr. Conaboy then took his case to the state’s highest court. In its majority decision, the Pennsylvania Supreme Court staked out a narrow definition of cause of death – one based on the death certificate – and ruled that only willful fraud in that document would constitute the necessary condition for halting the claim’s clock. Furthermore, the high court said, when lawmakers adopted the Medical Care Availability and Reduction of Error Act in 2002, they did so with no guarantee “that all of the information necessary to sustain a claim will be gathered in the limitations period.”

Similarly, the court ruled, “at some point the clock must run out, lest health care providers remain subject to liability exposure indefinitely, with the prospect of a trial marred by the death or diminished memory of material witnesses or the loss of critical evidence.”

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

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Delay in treatment will cost hospital millions

A Texas hospital must pay a multimillion-dollar judgment for failing to treat a woman’s spinal injury in time to prevent paralysis, according to a report on WFAA.com, among other news sites.

On March 21, 2019, Judy “Jessie” Adams, then part of a singing-songwriting duo with her husband, Richard, went to Premier Interventional Pain Management, in Flower Mound, Tex., prior to the couple’s drive to Ohio for a funeral. At Premier, Jesse received an epidural steroid injection (ESI) that she hoped would ease her back pain during the long drive.

Instead, the injection ended up increasing her pain.

“He [the pain physician] gave me the shot, but I couldn’t feel my legs. They were tingling, but I couldn’t feel them,” Mrs. Adams explained. “The pain was so bad in my back.” In their suit, Adams and her husband alleged that the doctor had probably “nicked a blood vessel during the ESI procedure, causing Jessie to hemorrhage.” (The couple’s suit against the doctor was settled prior to trial.)

Mrs. Adams remained under observation at the pain facility for about 1½ hours, at which point she was taken by ambulance to nearby Texas Health Presbyterian Hospital. There, in the emergency department, staff ordered a “STAT MRI” in preparation for an emergency laminectomy.

For reasons that remain murky, the MRI wasn’t performed for 1 hour and 37 minutes. The emergency laminectomy itself wasn’t started until more than 5 hours after Adams had been admitted to the ED. This was a direct violation of hospital protocol, which required that emergency surgeries be performed within 1 hour of admittance in the first available surgical suite. (At trial, Mrs. Adams’s attorneys from Lyons & Simmons offered evidence that a suite became available 49 minutes after Adams had arrived at the ED.)

During the wait, Mrs. Adams continued to experience excruciating pain. “I kept screaming: ‘Help me,’ ” she recalled. At trial, her attorneys argued that the hospital’s delay in addressing her spinal emergency led directly to her current paralysis, which keeps her confined to a wheelchair and renders her incontinent.

The hospital disagreed. In court, it maintained that Mrs. Adams was already paralyzed when she arrived at the ED and that there was no delay in care.

The jury saw things differently, however. Siding with the plaintiffs, it awarded Mrs. Adams and her husband $10.1 million, including $500,000 for Mr. Adams’s loss of future earnings and $1 million for his “loss of consortium” with his wife.

Their music career now effectively over, Mr. Adams spends most of his time taking care of Mrs. Adams.

“Music was our lifeblood for so many years, and he can’t do it anymore,” Mrs. Adams said. “He goes upstairs to play his guitar and write, and suddenly I need him to come and cath me. I just feel like I’m going to wake up from this bad dream, but it’s the same routine.”
 

Two doctors are absolved in woman’s sudden death

In a 3-2 decision in December 2022, the Pennsylvania Supreme Court ruled that the state’s 2-year statute of limitations in wrongful-death cases applies even in cases in which plaintiffs fail to identify the cause of death in a timely manner, as a report in the Claims Journal indicates.

The decision stems from a lawsuit filed by Linda Reibenstein on behalf of her mother, Mary Ann Whitman, who died in late April 2010 from a ruptured aortic aneurysm.

On April 12, 2010, Ms. Whitman visited Patrick D. Conaboy, MD, a Scranton family physician, complaining of a persistent cough, fever, and lower-back pain. Following an initial examination, Dr. Conaboy ordered an aortic duplex ultrasound scan and a CT scan of the patient’s abdomen.

The ultrasound was performed by radiologist Charles Barax, MD, who reviewed both scans. He identified a “poorly visualized aortic aneurysm.” At this point, Dr. Conaboy referred Ms. Whitman to a vascular surgeon. But before this visit could take place, Whitman’s aneurysm ruptured, killing her. This was listed as the medical cause of death on the patient’s death certificate.

In April 2011, Ms. Reibenstein filed a claim against Dr. Barax, alleging that he had failed to gauge the severity of her mother’s condition. Ms. Reibenstein’s attorney wasn’t able to question Dr. Barax on the record until well after the state’s 2-year statute of limitations had elapsed. When he did testify, Dr. Barax explained that the scans’ image quality prevented him from determining whether Whitman’s aneurysm was rupturing or simply bleeding. Despite this, he insisted that he had warned Dr. Conaboy of the potential for Ms. Whitman’s aneurysm to rupture.

In March 2016, nearly 6 years after her mother’s death, Ms. Reibenstein filed a new lawsuit, this one against Dr. Conaboy, whom she alleged had failed to properly treat her mother’s condition. Dr. Conaboy, in turn, asked the court for summary judgment – that is, a judgment in his favor without a full trial – arguing that the state’s window for filing a wrongful-death claim had long since closed. For their part, Ms. Reibenstein and her attorney argued that the state’s 2-year statute of limitations didn’t start until the plaintiff had discovered the cause of her mother’s death.

Initially refusing to dismiss the case, a lower court reconsidered Dr. Conaboy’s motion for summary judgment and ruled that Ms. Reibenstein had failed to present any evidence of “affirmative misrepresentation or fraudulent concealment.” In other words, in the absence of any willful attempt on the part of the defendant to hide the legal cause of death, which includes “acts, omissions, or events having some causative connection with the death,” the statute of limitations remained in effect, and the defendant’s motion was thereby granted.

Continuing the legal seesaw, a state appeals court reversed the lower-court ruling. Noting that the Pennsylvania malpractice statute was ambiguous, the court argued that it should be interpreted in a way that protects plaintiffs who seek “fair compensation” but encounter willfully erected obstacles in pursuit of their claim.

Dr. Conaboy then took his case to the state’s highest court. In its majority decision, the Pennsylvania Supreme Court staked out a narrow definition of cause of death – one based on the death certificate – and ruled that only willful fraud in that document would constitute the necessary condition for halting the claim’s clock. Furthermore, the high court said, when lawmakers adopted the Medical Care Availability and Reduction of Error Act in 2002, they did so with no guarantee “that all of the information necessary to sustain a claim will be gathered in the limitations period.”

Similarly, the court ruled, “at some point the clock must run out, lest health care providers remain subject to liability exposure indefinitely, with the prospect of a trial marred by the death or diminished memory of material witnesses or the loss of critical evidence.”

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

 

Delay in treatment will cost hospital millions

A Texas hospital must pay a multimillion-dollar judgment for failing to treat a woman’s spinal injury in time to prevent paralysis, according to a report on WFAA.com, among other news sites.

On March 21, 2019, Judy “Jessie” Adams, then part of a singing-songwriting duo with her husband, Richard, went to Premier Interventional Pain Management, in Flower Mound, Tex., prior to the couple’s drive to Ohio for a funeral. At Premier, Jesse received an epidural steroid injection (ESI) that she hoped would ease her back pain during the long drive.

Instead, the injection ended up increasing her pain.

“He [the pain physician] gave me the shot, but I couldn’t feel my legs. They were tingling, but I couldn’t feel them,” Mrs. Adams explained. “The pain was so bad in my back.” In their suit, Adams and her husband alleged that the doctor had probably “nicked a blood vessel during the ESI procedure, causing Jessie to hemorrhage.” (The couple’s suit against the doctor was settled prior to trial.)

Mrs. Adams remained under observation at the pain facility for about 1½ hours, at which point she was taken by ambulance to nearby Texas Health Presbyterian Hospital. There, in the emergency department, staff ordered a “STAT MRI” in preparation for an emergency laminectomy.

For reasons that remain murky, the MRI wasn’t performed for 1 hour and 37 minutes. The emergency laminectomy itself wasn’t started until more than 5 hours after Adams had been admitted to the ED. This was a direct violation of hospital protocol, which required that emergency surgeries be performed within 1 hour of admittance in the first available surgical suite. (At trial, Mrs. Adams’s attorneys from Lyons & Simmons offered evidence that a suite became available 49 minutes after Adams had arrived at the ED.)

During the wait, Mrs. Adams continued to experience excruciating pain. “I kept screaming: ‘Help me,’ ” she recalled. At trial, her attorneys argued that the hospital’s delay in addressing her spinal emergency led directly to her current paralysis, which keeps her confined to a wheelchair and renders her incontinent.

The hospital disagreed. In court, it maintained that Mrs. Adams was already paralyzed when she arrived at the ED and that there was no delay in care.

The jury saw things differently, however. Siding with the plaintiffs, it awarded Mrs. Adams and her husband $10.1 million, including $500,000 for Mr. Adams’s loss of future earnings and $1 million for his “loss of consortium” with his wife.

Their music career now effectively over, Mr. Adams spends most of his time taking care of Mrs. Adams.

“Music was our lifeblood for so many years, and he can’t do it anymore,” Mrs. Adams said. “He goes upstairs to play his guitar and write, and suddenly I need him to come and cath me. I just feel like I’m going to wake up from this bad dream, but it’s the same routine.”
 

Two doctors are absolved in woman’s sudden death

In a 3-2 decision in December 2022, the Pennsylvania Supreme Court ruled that the state’s 2-year statute of limitations in wrongful-death cases applies even in cases in which plaintiffs fail to identify the cause of death in a timely manner, as a report in the Claims Journal indicates.

The decision stems from a lawsuit filed by Linda Reibenstein on behalf of her mother, Mary Ann Whitman, who died in late April 2010 from a ruptured aortic aneurysm.

On April 12, 2010, Ms. Whitman visited Patrick D. Conaboy, MD, a Scranton family physician, complaining of a persistent cough, fever, and lower-back pain. Following an initial examination, Dr. Conaboy ordered an aortic duplex ultrasound scan and a CT scan of the patient’s abdomen.

The ultrasound was performed by radiologist Charles Barax, MD, who reviewed both scans. He identified a “poorly visualized aortic aneurysm.” At this point, Dr. Conaboy referred Ms. Whitman to a vascular surgeon. But before this visit could take place, Whitman’s aneurysm ruptured, killing her. This was listed as the medical cause of death on the patient’s death certificate.

In April 2011, Ms. Reibenstein filed a claim against Dr. Barax, alleging that he had failed to gauge the severity of her mother’s condition. Ms. Reibenstein’s attorney wasn’t able to question Dr. Barax on the record until well after the state’s 2-year statute of limitations had elapsed. When he did testify, Dr. Barax explained that the scans’ image quality prevented him from determining whether Whitman’s aneurysm was rupturing or simply bleeding. Despite this, he insisted that he had warned Dr. Conaboy of the potential for Ms. Whitman’s aneurysm to rupture.

In March 2016, nearly 6 years after her mother’s death, Ms. Reibenstein filed a new lawsuit, this one against Dr. Conaboy, whom she alleged had failed to properly treat her mother’s condition. Dr. Conaboy, in turn, asked the court for summary judgment – that is, a judgment in his favor without a full trial – arguing that the state’s window for filing a wrongful-death claim had long since closed. For their part, Ms. Reibenstein and her attorney argued that the state’s 2-year statute of limitations didn’t start until the plaintiff had discovered the cause of her mother’s death.

Initially refusing to dismiss the case, a lower court reconsidered Dr. Conaboy’s motion for summary judgment and ruled that Ms. Reibenstein had failed to present any evidence of “affirmative misrepresentation or fraudulent concealment.” In other words, in the absence of any willful attempt on the part of the defendant to hide the legal cause of death, which includes “acts, omissions, or events having some causative connection with the death,” the statute of limitations remained in effect, and the defendant’s motion was thereby granted.

Continuing the legal seesaw, a state appeals court reversed the lower-court ruling. Noting that the Pennsylvania malpractice statute was ambiguous, the court argued that it should be interpreted in a way that protects plaintiffs who seek “fair compensation” but encounter willfully erected obstacles in pursuit of their claim.

Dr. Conaboy then took his case to the state’s highest court. In its majority decision, the Pennsylvania Supreme Court staked out a narrow definition of cause of death – one based on the death certificate – and ruled that only willful fraud in that document would constitute the necessary condition for halting the claim’s clock. Furthermore, the high court said, when lawmakers adopted the Medical Care Availability and Reduction of Error Act in 2002, they did so with no guarantee “that all of the information necessary to sustain a claim will be gathered in the limitations period.”

Similarly, the court ruled, “at some point the clock must run out, lest health care providers remain subject to liability exposure indefinitely, with the prospect of a trial marred by the death or diminished memory of material witnesses or the loss of critical evidence.”

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

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Magnesium sulfate shown to reduce risk of cerebral palsy in premature babies

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A program to increase the use of magnesium sulfate to reduce the risk of cerebral palsy is effective, say researchers. Giving magnesium sulfate to women at risk of premature birth can reduce the risk of a child having cerebral palsy by a third, and costs just £1 per dose.

However, the authors of the new observational study, published in Archives of Disease in Childhood – Fetal and Neonatal Edition, pointed out that in 2017 only around two-thirds (64%) of eligible women were being given magnesium sulfate in England, Scotland, and Wales, with “wide regional variations.”

To address this, in 2014 the PReCePT (Preventing Cerebral Palsy in Pre Term labor) quality improvement toolkit was developed by both parents and staff with the aim of supporting all maternity units in England to improve maternity staff awareness and increase the use of magnesium sulfate in mothers at risk of giving birth at 30 weeks’ gestation or under. PReCePT provided practical tools and training to support hospital staff to give magnesium sulfate to eligible mothers.

The pilot study in 2015, which involved five maternity units, found an increase in uptake from 21% to 88% associated with the PReCePT approach. Subsequently, in 2018, NHS England funded the National PReCePT Programme, which scaled up the intervention for national roll-out and provided the PReCePT quality toolkit – which includes preterm labor proforma, staff training presentations, parent information leaflet, posters for the unit, and a learning log – to each maternity unit.
 

Improvement ‘over and above’ expectation

For the first evaluation of a U.K. universally implemented national perinatal quality improvement program to increase administration of an evidence-based drug, researchers, led by University of Bristol, England, set out to evaluate the effectiveness and cost-effectiveness of the National PReCePT Programme in increasing use of magnesium sulfate in preterm births.

Using data from the U.K. National Neonatal Research Database for the year before and the year after PReCePT was implemented in maternity units in England, the researchers performed a before-and-after study that involved 137 maternity units within NHS England. Participants were babies born at 30 weeks’ gestation or under admitted to neonatal units in England, and the main outcome measure was magnesium sulfate uptake before and after the implementation of the National PReCePT Programme. In addition, implementation and lifetime costs were estimated.

During the first year, post implementation of the program, uptake increased by an average of 6.3 percentage points (to 83.1%) across all maternity units in England, which the authors explained was “over and above” the increase that would be expected over time as the practice spread organically. The researchers also found that after adjusting for variations in when maternity units started the program, the increase in use of magnesium sulfate was 9.5 percentage points. “By May 2020, on average 86.4% of eligible mothers were receiving magnesium sulfate,” they said.

Professor John Macleod, NIHR ARC West Director, professor in clinical epidemiology and primary care, University of Bristol, and principal investigator of the evaluation, said: “Our in-depth analysis has been able to demonstrate that the PReCePT program is both effective and cost-effective. The program has increased uptake of magnesium sulfate, which we know is a cost-effective medicine to prevent cerebral palsy, much more quickly than we could have otherwise expected.”

From a societal and lifetime perspective, the health gains and cost savings associated with the National PReCePT Programme generated a “net monetary benefit of £866 per preterm baby,” with the probability of the program being cost-effective being “greater than 95%,” the authors highlighted.

The researchers also estimated that the program’s first year could be associated with a lifetime saving to society of £3 million – which accounts for the costs of the program, of administering the treatment, of cerebral palsy to society over a lifetime, and the associated health gains of avoiding cases. “This is across all the extra babies the program helped get access to the treatment during the first year,” they said.

The authors highlighted that in the five pilot sites, the improved use of magnesium sulfate has been “sustained over the years” since PReCePT was implemented. As the program costs were mostly in the first year of implementation, longer-term national analysis may show that PReCePT is “even more cost-effective over a longer period,” they postulated.
 

 

 

Accelerate uptake

Uptake of new evidence or guidelines is often “slow” due to practical barriers, lack of knowledge, and need for behavior change, and can “take decades to become embedded” in perinatal clinical practice, expressed the authors, which in turn comes at a “high clinical and economic cost.”

Karen Luyt, professor in neonatal medicine, University of Bristol, said: “The PReCePT national quality improvement program demonstrates that a collaborative and coordinated perinatal implementation program supporting every hospital in England can accelerate the uptake of new evidence-based treatments into routine practice, enabling equitable health benefits to babies and ultimately reductions in lifetime societal costs.”

The authors said the PReCePT model “may serve as a blueprint for future interventions to improve perinatal care.”

Professor Lucy Chappell, chief executive officer of the National Institute for Health and Care Research, said: “This important study shows the impact of taking a promising intervention that had been shown to work in a research setting and scaling it up across the country. Giving magnesium sulfate to prevent cerebral palsy in premature babies is a simple, inexpensive intervention that can make such a difference to families and the health service.”

Prof. Macleod added: “We are pleased to have played a part in helping get this cheap yet effective treatment to more babies.”

This work was jointly funded by the National Institute for Health and Care Research Applied Research Collaboration West and the AHSN Network funded by NHS England. The Health Foundation funded the health economics evaluation. The authors declare that the study management group has no competing financial, professional, or personal interests that might have influenced the study design or conduct.

A version of this article first appeared on Medscape UK.

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A program to increase the use of magnesium sulfate to reduce the risk of cerebral palsy is effective, say researchers. Giving magnesium sulfate to women at risk of premature birth can reduce the risk of a child having cerebral palsy by a third, and costs just £1 per dose.

However, the authors of the new observational study, published in Archives of Disease in Childhood – Fetal and Neonatal Edition, pointed out that in 2017 only around two-thirds (64%) of eligible women were being given magnesium sulfate in England, Scotland, and Wales, with “wide regional variations.”

To address this, in 2014 the PReCePT (Preventing Cerebral Palsy in Pre Term labor) quality improvement toolkit was developed by both parents and staff with the aim of supporting all maternity units in England to improve maternity staff awareness and increase the use of magnesium sulfate in mothers at risk of giving birth at 30 weeks’ gestation or under. PReCePT provided practical tools and training to support hospital staff to give magnesium sulfate to eligible mothers.

The pilot study in 2015, which involved five maternity units, found an increase in uptake from 21% to 88% associated with the PReCePT approach. Subsequently, in 2018, NHS England funded the National PReCePT Programme, which scaled up the intervention for national roll-out and provided the PReCePT quality toolkit – which includes preterm labor proforma, staff training presentations, parent information leaflet, posters for the unit, and a learning log – to each maternity unit.
 

Improvement ‘over and above’ expectation

For the first evaluation of a U.K. universally implemented national perinatal quality improvement program to increase administration of an evidence-based drug, researchers, led by University of Bristol, England, set out to evaluate the effectiveness and cost-effectiveness of the National PReCePT Programme in increasing use of magnesium sulfate in preterm births.

Using data from the U.K. National Neonatal Research Database for the year before and the year after PReCePT was implemented in maternity units in England, the researchers performed a before-and-after study that involved 137 maternity units within NHS England. Participants were babies born at 30 weeks’ gestation or under admitted to neonatal units in England, and the main outcome measure was magnesium sulfate uptake before and after the implementation of the National PReCePT Programme. In addition, implementation and lifetime costs were estimated.

During the first year, post implementation of the program, uptake increased by an average of 6.3 percentage points (to 83.1%) across all maternity units in England, which the authors explained was “over and above” the increase that would be expected over time as the practice spread organically. The researchers also found that after adjusting for variations in when maternity units started the program, the increase in use of magnesium sulfate was 9.5 percentage points. “By May 2020, on average 86.4% of eligible mothers were receiving magnesium sulfate,” they said.

Professor John Macleod, NIHR ARC West Director, professor in clinical epidemiology and primary care, University of Bristol, and principal investigator of the evaluation, said: “Our in-depth analysis has been able to demonstrate that the PReCePT program is both effective and cost-effective. The program has increased uptake of magnesium sulfate, which we know is a cost-effective medicine to prevent cerebral palsy, much more quickly than we could have otherwise expected.”

From a societal and lifetime perspective, the health gains and cost savings associated with the National PReCePT Programme generated a “net monetary benefit of £866 per preterm baby,” with the probability of the program being cost-effective being “greater than 95%,” the authors highlighted.

The researchers also estimated that the program’s first year could be associated with a lifetime saving to society of £3 million – which accounts for the costs of the program, of administering the treatment, of cerebral palsy to society over a lifetime, and the associated health gains of avoiding cases. “This is across all the extra babies the program helped get access to the treatment during the first year,” they said.

The authors highlighted that in the five pilot sites, the improved use of magnesium sulfate has been “sustained over the years” since PReCePT was implemented. As the program costs were mostly in the first year of implementation, longer-term national analysis may show that PReCePT is “even more cost-effective over a longer period,” they postulated.
 

 

 

Accelerate uptake

Uptake of new evidence or guidelines is often “slow” due to practical barriers, lack of knowledge, and need for behavior change, and can “take decades to become embedded” in perinatal clinical practice, expressed the authors, which in turn comes at a “high clinical and economic cost.”

Karen Luyt, professor in neonatal medicine, University of Bristol, said: “The PReCePT national quality improvement program demonstrates that a collaborative and coordinated perinatal implementation program supporting every hospital in England can accelerate the uptake of new evidence-based treatments into routine practice, enabling equitable health benefits to babies and ultimately reductions in lifetime societal costs.”

The authors said the PReCePT model “may serve as a blueprint for future interventions to improve perinatal care.”

Professor Lucy Chappell, chief executive officer of the National Institute for Health and Care Research, said: “This important study shows the impact of taking a promising intervention that had been shown to work in a research setting and scaling it up across the country. Giving magnesium sulfate to prevent cerebral palsy in premature babies is a simple, inexpensive intervention that can make such a difference to families and the health service.”

Prof. Macleod added: “We are pleased to have played a part in helping get this cheap yet effective treatment to more babies.”

This work was jointly funded by the National Institute for Health and Care Research Applied Research Collaboration West and the AHSN Network funded by NHS England. The Health Foundation funded the health economics evaluation. The authors declare that the study management group has no competing financial, professional, or personal interests that might have influenced the study design or conduct.

A version of this article first appeared on Medscape UK.

A program to increase the use of magnesium sulfate to reduce the risk of cerebral palsy is effective, say researchers. Giving magnesium sulfate to women at risk of premature birth can reduce the risk of a child having cerebral palsy by a third, and costs just £1 per dose.

However, the authors of the new observational study, published in Archives of Disease in Childhood – Fetal and Neonatal Edition, pointed out that in 2017 only around two-thirds (64%) of eligible women were being given magnesium sulfate in England, Scotland, and Wales, with “wide regional variations.”

To address this, in 2014 the PReCePT (Preventing Cerebral Palsy in Pre Term labor) quality improvement toolkit was developed by both parents and staff with the aim of supporting all maternity units in England to improve maternity staff awareness and increase the use of magnesium sulfate in mothers at risk of giving birth at 30 weeks’ gestation or under. PReCePT provided practical tools and training to support hospital staff to give magnesium sulfate to eligible mothers.

The pilot study in 2015, which involved five maternity units, found an increase in uptake from 21% to 88% associated with the PReCePT approach. Subsequently, in 2018, NHS England funded the National PReCePT Programme, which scaled up the intervention for national roll-out and provided the PReCePT quality toolkit – which includes preterm labor proforma, staff training presentations, parent information leaflet, posters for the unit, and a learning log – to each maternity unit.
 

Improvement ‘over and above’ expectation

For the first evaluation of a U.K. universally implemented national perinatal quality improvement program to increase administration of an evidence-based drug, researchers, led by University of Bristol, England, set out to evaluate the effectiveness and cost-effectiveness of the National PReCePT Programme in increasing use of magnesium sulfate in preterm births.

Using data from the U.K. National Neonatal Research Database for the year before and the year after PReCePT was implemented in maternity units in England, the researchers performed a before-and-after study that involved 137 maternity units within NHS England. Participants were babies born at 30 weeks’ gestation or under admitted to neonatal units in England, and the main outcome measure was magnesium sulfate uptake before and after the implementation of the National PReCePT Programme. In addition, implementation and lifetime costs were estimated.

During the first year, post implementation of the program, uptake increased by an average of 6.3 percentage points (to 83.1%) across all maternity units in England, which the authors explained was “over and above” the increase that would be expected over time as the practice spread organically. The researchers also found that after adjusting for variations in when maternity units started the program, the increase in use of magnesium sulfate was 9.5 percentage points. “By May 2020, on average 86.4% of eligible mothers were receiving magnesium sulfate,” they said.

Professor John Macleod, NIHR ARC West Director, professor in clinical epidemiology and primary care, University of Bristol, and principal investigator of the evaluation, said: “Our in-depth analysis has been able to demonstrate that the PReCePT program is both effective and cost-effective. The program has increased uptake of magnesium sulfate, which we know is a cost-effective medicine to prevent cerebral palsy, much more quickly than we could have otherwise expected.”

From a societal and lifetime perspective, the health gains and cost savings associated with the National PReCePT Programme generated a “net monetary benefit of £866 per preterm baby,” with the probability of the program being cost-effective being “greater than 95%,” the authors highlighted.

The researchers also estimated that the program’s first year could be associated with a lifetime saving to society of £3 million – which accounts for the costs of the program, of administering the treatment, of cerebral palsy to society over a lifetime, and the associated health gains of avoiding cases. “This is across all the extra babies the program helped get access to the treatment during the first year,” they said.

The authors highlighted that in the five pilot sites, the improved use of magnesium sulfate has been “sustained over the years” since PReCePT was implemented. As the program costs were mostly in the first year of implementation, longer-term national analysis may show that PReCePT is “even more cost-effective over a longer period,” they postulated.
 

 

 

Accelerate uptake

Uptake of new evidence or guidelines is often “slow” due to practical barriers, lack of knowledge, and need for behavior change, and can “take decades to become embedded” in perinatal clinical practice, expressed the authors, which in turn comes at a “high clinical and economic cost.”

Karen Luyt, professor in neonatal medicine, University of Bristol, said: “The PReCePT national quality improvement program demonstrates that a collaborative and coordinated perinatal implementation program supporting every hospital in England can accelerate the uptake of new evidence-based treatments into routine practice, enabling equitable health benefits to babies and ultimately reductions in lifetime societal costs.”

The authors said the PReCePT model “may serve as a blueprint for future interventions to improve perinatal care.”

Professor Lucy Chappell, chief executive officer of the National Institute for Health and Care Research, said: “This important study shows the impact of taking a promising intervention that had been shown to work in a research setting and scaling it up across the country. Giving magnesium sulfate to prevent cerebral palsy in premature babies is a simple, inexpensive intervention that can make such a difference to families and the health service.”

Prof. Macleod added: “We are pleased to have played a part in helping get this cheap yet effective treatment to more babies.”

This work was jointly funded by the National Institute for Health and Care Research Applied Research Collaboration West and the AHSN Network funded by NHS England. The Health Foundation funded the health economics evaluation. The authors declare that the study management group has no competing financial, professional, or personal interests that might have influenced the study design or conduct.

A version of this article first appeared on Medscape UK.

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Postconcussion symptoms tied to high risk of depression

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Persistent postconcussion symptoms (PPCS) are tied to a significantly increased risk of developing subsequent depressive symptoms, new research shows.

Results of a large meta-analysis that included 18 studies and more than 9,000 patients showed a fourfold higher risk of developing depressive symptoms in those with PPCS versus those without PPCS.

“In this meta-analysis, experiencing PPCS was associated with a higher risk of experiencing depressive symptoms,” write the investigators, led by Maude Lambert, PhD, of the School of Psychology, University of Ottawa, and Bloorview Research Institute, Toronto.

“There are several important clinical and health policy implications of the findings. Most notably, the development of strategies for effective prevention and earlier intervention to optimize mental health recovery following a concussion should be supported,” they add.

The study was published online  in JAMA Network Open.
 

‘Important minority’

An “important minority” of 15%-30% of those with concussions continue to experience symptoms for months, or even years, following the injury, the investigators note.

Symptoms vary but can include headaches, fatigue, dizziness, cognitive difficulties, and emotional changes, which can “significantly impact an individual’s everyday functioning.”

The association between PPCS and mental health outcomes “has emerged as an area of interest” over the past decade, with multiple studies pointing to bidirectional associations between depressive symptoms and PPCS, the researchers note. Individuals with PPCS are at significantly higher risk of experiencing depressive symptoms, and depressive symptoms, in turn, predict more prolonged postconcussion recovery, they add.

The authors conducted a previous scoping review that showed individuals with PPCS had “greater mental health difficulties than individuals who recovered from concussion or healthy controls.”

But “quantitative summaries evaluating the magnitude and nature of the association between PPCS and mental health outcomes were not conducted,” so they decided to conduct a follow-up meta-analysis to corroborate the hypothesis that PPCS may be associated with depressive symptoms.

The researchers also wanted to “investigate potential moderators of that association and determine whether the association between depressive symptoms and PPCS differed based on age, sex, mental illness, history of concussion, and time since the injury.”

This could have “significant public health implications” as it represents an “important step” toward understanding the association between PPCS and mental health, paving the way for the “development of optimal postconcussion intervention strategies, targeting effective prevention and earlier intervention to enhance recovery trajectories, improve mental health, and promote well-being following concussion.”

To be included in the meta-analysis, a study had to focus on participants who had experienced a concussion, diagnosed by a health care professional, or as classified by diagnostic measures, and who experienced greater than or equal to 1 concussion symptom lasting greater than 4 weeks.

There was no explicit upper limit on duration, and individuals of all ages were eligible.

Depressive symptoms were defined as “an outcome that must be measured by a validated and standardized measure of depression.”
 

Biopsychosocial model

Of 580 reports assessed for eligibility, 18 were included in the meta-analysis, incorporating a total of 9,101 participants, with a median (range) sample size of 154 (48-4,462) participants and a mean (SD) participant age of 33.7 (14.4) years.

The mean length of time since the concussion was 21.3 (18.7) weeks. Of the participants, a mean of 36.1% (11.1%) had a history of greater than or equal to 2 concussions.

Close to three-quarters of the studies (72%) used a cross-sectional design, with most studies conducted in North America, and the remaining conducted in Europe, China, and New Zealand.

The researchers found a “significant positive association” between PPCS and postinjury depressive symptoms (odds ratio, 4.87; 95% confidence interval, 3.01-7.90; P < .001), “representing a large effect size.”

Funnel plot and Egger test analyses “suggested the presence of a publication bias.” However, even after accounting for publication bias, the effect size “of large magnitude” remained, the authors report (OR, 4.56; 95% CI, 2.82-7.37; P < .001).

No significant moderators were identified, “likely due to the small number of studies included,” they speculate.

They note that the current study “does not allow inference about the causal directionality of the association” between PPCS and postinjury depressive symptoms, so the question remains: Do PPCS induce depressive symptoms, or do depressive symptoms induce PPCS?”

Despite this unanswered question, the findings still have important clinical and public health implications, highlighting “the need for a greater understanding of the mechanisms of development and etiology of depressive symptoms postconcussion” and emphasizing “the necessary emergence for timely and effective treatment interventions for depressive symptoms to optimize the long-term prognosis of concussion,” the authors note.

They add that several research teams “have aimed to gain more insight into the etiology and underlying mechanisms of development and course of mental health difficulties in individuals who experience a concussion” and have arrived at a biopsychosocial framework, in light of “the myriad of contributing physiological, biological, and psychosocial factors.”

They recommend the establishment of “specialized multidisciplinary or interdisciplinary concussion care programs should include health care professionals with strong clinical foundations and training in mental health conditions.”
 

Speedy multidisciplinary care

Commenting on the research, Charles Tator, MD, PhD, professor of neurosurgery, University of Toronto, Division of Neurosurgery, Toronto Western Hospital, said the researchers “performed a thorough systematic review” showing “emphatically that depression occurs in this population.”

Dr. Tator, the director of the Canadian Concussion Centre, who was not involved with the current study, continued: “Nowadays clinical discoveries are validated through a progression of case reports, single-center retrospective cohort studies like ours, referenced by [Dr.] Lambert et al., and then confirmatory systematic reviews, each adding important layers of evidence.”

“This evaluative process has now endorsed the importance of early treatment of mental health symptoms in patients with persisting symptoms, which can include depression, anxiety, and PTSD,” he said.

He recommended that treatment should start with family physicians and nurse practitioners “but may require escalation to psychologists and social workers and then to psychiatrists who are often more skilled in medication selection.”

He encouraged “speedy multidisciplinary care,” noting that the possibility of suicide is worrisome.

No source of study funding was listed. A study coauthor, Shannon Scratch, PhD, has reported receiving funds from the Holland Bloorview Kids Rehabilitation Hospital Foundation (via the Holland Family Professorship in Acquired Brain Injury) during the conduct of this study. No other disclosures were reported. Dr. Tator has reported no relevant financial relationships.

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

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Persistent postconcussion symptoms (PPCS) are tied to a significantly increased risk of developing subsequent depressive symptoms, new research shows.

Results of a large meta-analysis that included 18 studies and more than 9,000 patients showed a fourfold higher risk of developing depressive symptoms in those with PPCS versus those without PPCS.

“In this meta-analysis, experiencing PPCS was associated with a higher risk of experiencing depressive symptoms,” write the investigators, led by Maude Lambert, PhD, of the School of Psychology, University of Ottawa, and Bloorview Research Institute, Toronto.

“There are several important clinical and health policy implications of the findings. Most notably, the development of strategies for effective prevention and earlier intervention to optimize mental health recovery following a concussion should be supported,” they add.

The study was published online  in JAMA Network Open.
 

‘Important minority’

An “important minority” of 15%-30% of those with concussions continue to experience symptoms for months, or even years, following the injury, the investigators note.

Symptoms vary but can include headaches, fatigue, dizziness, cognitive difficulties, and emotional changes, which can “significantly impact an individual’s everyday functioning.”

The association between PPCS and mental health outcomes “has emerged as an area of interest” over the past decade, with multiple studies pointing to bidirectional associations between depressive symptoms and PPCS, the researchers note. Individuals with PPCS are at significantly higher risk of experiencing depressive symptoms, and depressive symptoms, in turn, predict more prolonged postconcussion recovery, they add.

The authors conducted a previous scoping review that showed individuals with PPCS had “greater mental health difficulties than individuals who recovered from concussion or healthy controls.”

But “quantitative summaries evaluating the magnitude and nature of the association between PPCS and mental health outcomes were not conducted,” so they decided to conduct a follow-up meta-analysis to corroborate the hypothesis that PPCS may be associated with depressive symptoms.

The researchers also wanted to “investigate potential moderators of that association and determine whether the association between depressive symptoms and PPCS differed based on age, sex, mental illness, history of concussion, and time since the injury.”

This could have “significant public health implications” as it represents an “important step” toward understanding the association between PPCS and mental health, paving the way for the “development of optimal postconcussion intervention strategies, targeting effective prevention and earlier intervention to enhance recovery trajectories, improve mental health, and promote well-being following concussion.”

To be included in the meta-analysis, a study had to focus on participants who had experienced a concussion, diagnosed by a health care professional, or as classified by diagnostic measures, and who experienced greater than or equal to 1 concussion symptom lasting greater than 4 weeks.

There was no explicit upper limit on duration, and individuals of all ages were eligible.

Depressive symptoms were defined as “an outcome that must be measured by a validated and standardized measure of depression.”
 

Biopsychosocial model

Of 580 reports assessed for eligibility, 18 were included in the meta-analysis, incorporating a total of 9,101 participants, with a median (range) sample size of 154 (48-4,462) participants and a mean (SD) participant age of 33.7 (14.4) years.

The mean length of time since the concussion was 21.3 (18.7) weeks. Of the participants, a mean of 36.1% (11.1%) had a history of greater than or equal to 2 concussions.

Close to three-quarters of the studies (72%) used a cross-sectional design, with most studies conducted in North America, and the remaining conducted in Europe, China, and New Zealand.

The researchers found a “significant positive association” between PPCS and postinjury depressive symptoms (odds ratio, 4.87; 95% confidence interval, 3.01-7.90; P < .001), “representing a large effect size.”

Funnel plot and Egger test analyses “suggested the presence of a publication bias.” However, even after accounting for publication bias, the effect size “of large magnitude” remained, the authors report (OR, 4.56; 95% CI, 2.82-7.37; P < .001).

No significant moderators were identified, “likely due to the small number of studies included,” they speculate.

They note that the current study “does not allow inference about the causal directionality of the association” between PPCS and postinjury depressive symptoms, so the question remains: Do PPCS induce depressive symptoms, or do depressive symptoms induce PPCS?”

Despite this unanswered question, the findings still have important clinical and public health implications, highlighting “the need for a greater understanding of the mechanisms of development and etiology of depressive symptoms postconcussion” and emphasizing “the necessary emergence for timely and effective treatment interventions for depressive symptoms to optimize the long-term prognosis of concussion,” the authors note.

They add that several research teams “have aimed to gain more insight into the etiology and underlying mechanisms of development and course of mental health difficulties in individuals who experience a concussion” and have arrived at a biopsychosocial framework, in light of “the myriad of contributing physiological, biological, and psychosocial factors.”

They recommend the establishment of “specialized multidisciplinary or interdisciplinary concussion care programs should include health care professionals with strong clinical foundations and training in mental health conditions.”
 

Speedy multidisciplinary care

Commenting on the research, Charles Tator, MD, PhD, professor of neurosurgery, University of Toronto, Division of Neurosurgery, Toronto Western Hospital, said the researchers “performed a thorough systematic review” showing “emphatically that depression occurs in this population.”

Dr. Tator, the director of the Canadian Concussion Centre, who was not involved with the current study, continued: “Nowadays clinical discoveries are validated through a progression of case reports, single-center retrospective cohort studies like ours, referenced by [Dr.] Lambert et al., and then confirmatory systematic reviews, each adding important layers of evidence.”

“This evaluative process has now endorsed the importance of early treatment of mental health symptoms in patients with persisting symptoms, which can include depression, anxiety, and PTSD,” he said.

He recommended that treatment should start with family physicians and nurse practitioners “but may require escalation to psychologists and social workers and then to psychiatrists who are often more skilled in medication selection.”

He encouraged “speedy multidisciplinary care,” noting that the possibility of suicide is worrisome.

No source of study funding was listed. A study coauthor, Shannon Scratch, PhD, has reported receiving funds from the Holland Bloorview Kids Rehabilitation Hospital Foundation (via the Holland Family Professorship in Acquired Brain Injury) during the conduct of this study. No other disclosures were reported. Dr. Tator has reported no relevant financial relationships.

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

Persistent postconcussion symptoms (PPCS) are tied to a significantly increased risk of developing subsequent depressive symptoms, new research shows.

Results of a large meta-analysis that included 18 studies and more than 9,000 patients showed a fourfold higher risk of developing depressive symptoms in those with PPCS versus those without PPCS.

“In this meta-analysis, experiencing PPCS was associated with a higher risk of experiencing depressive symptoms,” write the investigators, led by Maude Lambert, PhD, of the School of Psychology, University of Ottawa, and Bloorview Research Institute, Toronto.

“There are several important clinical and health policy implications of the findings. Most notably, the development of strategies for effective prevention and earlier intervention to optimize mental health recovery following a concussion should be supported,” they add.

The study was published online  in JAMA Network Open.
 

‘Important minority’

An “important minority” of 15%-30% of those with concussions continue to experience symptoms for months, or even years, following the injury, the investigators note.

Symptoms vary but can include headaches, fatigue, dizziness, cognitive difficulties, and emotional changes, which can “significantly impact an individual’s everyday functioning.”

The association between PPCS and mental health outcomes “has emerged as an area of interest” over the past decade, with multiple studies pointing to bidirectional associations between depressive symptoms and PPCS, the researchers note. Individuals with PPCS are at significantly higher risk of experiencing depressive symptoms, and depressive symptoms, in turn, predict more prolonged postconcussion recovery, they add.

The authors conducted a previous scoping review that showed individuals with PPCS had “greater mental health difficulties than individuals who recovered from concussion or healthy controls.”

But “quantitative summaries evaluating the magnitude and nature of the association between PPCS and mental health outcomes were not conducted,” so they decided to conduct a follow-up meta-analysis to corroborate the hypothesis that PPCS may be associated with depressive symptoms.

The researchers also wanted to “investigate potential moderators of that association and determine whether the association between depressive symptoms and PPCS differed based on age, sex, mental illness, history of concussion, and time since the injury.”

This could have “significant public health implications” as it represents an “important step” toward understanding the association between PPCS and mental health, paving the way for the “development of optimal postconcussion intervention strategies, targeting effective prevention and earlier intervention to enhance recovery trajectories, improve mental health, and promote well-being following concussion.”

To be included in the meta-analysis, a study had to focus on participants who had experienced a concussion, diagnosed by a health care professional, or as classified by diagnostic measures, and who experienced greater than or equal to 1 concussion symptom lasting greater than 4 weeks.

There was no explicit upper limit on duration, and individuals of all ages were eligible.

Depressive symptoms were defined as “an outcome that must be measured by a validated and standardized measure of depression.”
 

Biopsychosocial model

Of 580 reports assessed for eligibility, 18 were included in the meta-analysis, incorporating a total of 9,101 participants, with a median (range) sample size of 154 (48-4,462) participants and a mean (SD) participant age of 33.7 (14.4) years.

The mean length of time since the concussion was 21.3 (18.7) weeks. Of the participants, a mean of 36.1% (11.1%) had a history of greater than or equal to 2 concussions.

Close to three-quarters of the studies (72%) used a cross-sectional design, with most studies conducted in North America, and the remaining conducted in Europe, China, and New Zealand.

The researchers found a “significant positive association” between PPCS and postinjury depressive symptoms (odds ratio, 4.87; 95% confidence interval, 3.01-7.90; P < .001), “representing a large effect size.”

Funnel plot and Egger test analyses “suggested the presence of a publication bias.” However, even after accounting for publication bias, the effect size “of large magnitude” remained, the authors report (OR, 4.56; 95% CI, 2.82-7.37; P < .001).

No significant moderators were identified, “likely due to the small number of studies included,” they speculate.

They note that the current study “does not allow inference about the causal directionality of the association” between PPCS and postinjury depressive symptoms, so the question remains: Do PPCS induce depressive symptoms, or do depressive symptoms induce PPCS?”

Despite this unanswered question, the findings still have important clinical and public health implications, highlighting “the need for a greater understanding of the mechanisms of development and etiology of depressive symptoms postconcussion” and emphasizing “the necessary emergence for timely and effective treatment interventions for depressive symptoms to optimize the long-term prognosis of concussion,” the authors note.

They add that several research teams “have aimed to gain more insight into the etiology and underlying mechanisms of development and course of mental health difficulties in individuals who experience a concussion” and have arrived at a biopsychosocial framework, in light of “the myriad of contributing physiological, biological, and psychosocial factors.”

They recommend the establishment of “specialized multidisciplinary or interdisciplinary concussion care programs should include health care professionals with strong clinical foundations and training in mental health conditions.”
 

Speedy multidisciplinary care

Commenting on the research, Charles Tator, MD, PhD, professor of neurosurgery, University of Toronto, Division of Neurosurgery, Toronto Western Hospital, said the researchers “performed a thorough systematic review” showing “emphatically that depression occurs in this population.”

Dr. Tator, the director of the Canadian Concussion Centre, who was not involved with the current study, continued: “Nowadays clinical discoveries are validated through a progression of case reports, single-center retrospective cohort studies like ours, referenced by [Dr.] Lambert et al., and then confirmatory systematic reviews, each adding important layers of evidence.”

“This evaluative process has now endorsed the importance of early treatment of mental health symptoms in patients with persisting symptoms, which can include depression, anxiety, and PTSD,” he said.

He recommended that treatment should start with family physicians and nurse practitioners “but may require escalation to psychologists and social workers and then to psychiatrists who are often more skilled in medication selection.”

He encouraged “speedy multidisciplinary care,” noting that the possibility of suicide is worrisome.

No source of study funding was listed. A study coauthor, Shannon Scratch, PhD, has reported receiving funds from the Holland Bloorview Kids Rehabilitation Hospital Foundation (via the Holland Family Professorship in Acquired Brain Injury) during the conduct of this study. No other disclosures were reported. Dr. Tator has reported no relevant financial relationships.

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

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