Neurology

Physicians in New York, which still leads the nation in reported COVID-19 cases, are reporting significantly more acute, large vessel strokes in young adults infected with COVID-19.

In a rapid communication to be published online April 29 in the New England Journal of Medicine, investigators led by Thomas Oxley, MD, PhD, of the department of neurosurgery at Mount Sinai Health System, reported five cases of large vessel stroke over a 2-week period in COVID-19 patients under age 50 years. This represents a sevenfold increase in what would normally be expected.

The five cases had either no, or mild, COVID-19 symptoms.

“It’s been surprising to learn that the virus appears to cause disease through a process of blood clotting,” Dr. Oxley said in an interview.

The message for neurologists and other physicians is “we’re learning that this can disproportionally affect large vessels more than small vessels in terms of presentation of stroke,” he said.

Inflammation in the blood vessel walls may be driving thrombosis formation, Dr. Oxley added. This report joins other research pointing to this emerging phenomenon.

Recently, investigators in the Netherlands found a “remarkably high” 31% rate of thrombotic complications among 184 critical care patients with COVID-19 pneumonia.

Dr. Oxley and colleagues also suggested that, since the onset of the pandemic, fewer patients may be calling emergency services when they experience signs of a stroke. The physicians noted that two of the five cases in the report delayed calling an ambulance.

“I understand why people do not want to leave the household. I think people are more willing to ignore other [non–COVID-19] symptoms in this environment,” he said.

As previously reported, physicians in hospitals across the United States and elsewhere have reported a significant drop in stroke patients since the COVID-19 pandemic took hold, which suggests that patients may indeed be foregoing emergency care.

The observations from Dr. Oxley and colleagues call for greater awareness of the association between COVID-19 and large vessel strokes in this age group, they add.

One patient in the case series died, one remains hospitalized, two are undergoing rehabilitation, and one was discharged home as of April 24.

Dr. Oxley and colleagues dedicated their report to “our inspiring colleague Gary Sclar, MD, a stroke physician who succumbed to COVID-19 while caring for his patients.”

Dr. Oxley has disclosed no relevant financial relationships.

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

Physicians in New York, which still leads the nation in reported COVID-19 cases, are reporting significantly more acute, large vessel strokes in young adults infected with COVID-19.

In a rapid communication to be published online April 29 in the New England Journal of Medicine, investigators led by Thomas Oxley, MD, PhD, of the department of neurosurgery at Mount Sinai Health System, reported five cases of large vessel stroke over a 2-week period in COVID-19 patients under age 50 years. This represents a sevenfold increase in what would normally be expected.

The five cases had either no, or mild, COVID-19 symptoms.

“It’s been surprising to learn that the virus appears to cause disease through a process of blood clotting,” Dr. Oxley said in an interview.

The message for neurologists and other physicians is “we’re learning that this can disproportionally affect large vessels more than small vessels in terms of presentation of stroke,” he said.

Inflammation in the blood vessel walls may be driving thrombosis formation, Dr. Oxley added. This report joins other research pointing to this emerging phenomenon.

Recently, investigators in the Netherlands found a “remarkably high” 31% rate of thrombotic complications among 184 critical care patients with COVID-19 pneumonia.

Dr. Oxley and colleagues also suggested that, since the onset of the pandemic, fewer patients may be calling emergency services when they experience signs of a stroke. The physicians noted that two of the five cases in the report delayed calling an ambulance.

“I understand why people do not want to leave the household. I think people are more willing to ignore other [non–COVID-19] symptoms in this environment,” he said.

As previously reported, physicians in hospitals across the United States and elsewhere have reported a significant drop in stroke patients since the COVID-19 pandemic took hold, which suggests that patients may indeed be foregoing emergency care.

The observations from Dr. Oxley and colleagues call for greater awareness of the association between COVID-19 and large vessel strokes in this age group, they add.

One patient in the case series died, one remains hospitalized, two are undergoing rehabilitation, and one was discharged home as of April 24.

Dr. Oxley and colleagues dedicated their report to “our inspiring colleague Gary Sclar, MD, a stroke physician who succumbed to COVID-19 while caring for his patients.”

Dr. Oxley has disclosed no relevant financial relationships.

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

Physicians in New York, which still leads the nation in reported COVID-19 cases, are reporting significantly more acute, large vessel strokes in young adults infected with COVID-19.

In a rapid communication to be published online April 29 in the New England Journal of Medicine, investigators led by Thomas Oxley, MD, PhD, of the department of neurosurgery at Mount Sinai Health System, reported five cases of large vessel stroke over a 2-week period in COVID-19 patients under age 50 years. This represents a sevenfold increase in what would normally be expected.

The five cases had either no, or mild, COVID-19 symptoms.

“It’s been surprising to learn that the virus appears to cause disease through a process of blood clotting,” Dr. Oxley said in an interview.

The message for neurologists and other physicians is “we’re learning that this can disproportionally affect large vessels more than small vessels in terms of presentation of stroke,” he said.

Inflammation in the blood vessel walls may be driving thrombosis formation, Dr. Oxley added. This report joins other research pointing to this emerging phenomenon.

Recently, investigators in the Netherlands found a “remarkably high” 31% rate of thrombotic complications among 184 critical care patients with COVID-19 pneumonia.

Dr. Oxley and colleagues also suggested that, since the onset of the pandemic, fewer patients may be calling emergency services when they experience signs of a stroke. The physicians noted that two of the five cases in the report delayed calling an ambulance.

“I understand why people do not want to leave the household. I think people are more willing to ignore other [non–COVID-19] symptoms in this environment,” he said.

As previously reported, physicians in hospitals across the United States and elsewhere have reported a significant drop in stroke patients since the COVID-19 pandemic took hold, which suggests that patients may indeed be foregoing emergency care.

The observations from Dr. Oxley and colleagues call for greater awareness of the association between COVID-19 and large vessel strokes in this age group, they add.

One patient in the case series died, one remains hospitalized, two are undergoing rehabilitation, and one was discharged home as of April 24.

Dr. Oxley and colleagues dedicated their report to “our inspiring colleague Gary Sclar, MD, a stroke physician who succumbed to COVID-19 while caring for his patients.”

Dr. Oxley has disclosed no relevant financial relationships.

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

Brant Oliver, PhD, MS, MPH, APRN-BC, is a health care improvement and implementation scientist, educator, and board-certified family and psychiatric nurse practitioner (FNP-BC, PMHNP-BC). Dr. Oliver's work focuses on applied health care improvement science research, with a focus on "3C" (complex, costly, and chronic) conditions including MS, IBD, CF, RA, and others; coproduction; learning health systems; and shared decision making. He is Associate Professor at the Geisel School of Medicine at Dartmouth and also has been in clinical practice since 2003, working primarily as a certified MS specialist (MSCN) and a MS neurobehavioral nurse practitioner.  

Which patient-reported outcomes (PROs) are commonly assessed in the care of patients with multiple sclerosis (MS)?

BRANT OLIVER, PhD: The current reality is that PROs are not being used routinely in MS clinical care in most settings. They are most commonly being used in research settings, either as part of clinical trials of new treatments, or in epidemiologic studies looking at the prevalence, incidence, and severity of certain symptoms or functional impairments in MS at the population level. A good example is the NARCOMS registry, which has been used to conduct  high-quality epidemiologic studies of MS-related symptoms using self-report questionnaires.

We are starting to see some use of MS PROs in select clinical settings. Oftentimes these are measures of highly prevalent comorbid conditions that have an impact on quality of life, treatment adherence (depression severity and anxiety), and self-efficacy, which is a measure of perceived coping ability related to self-management of a chronic illness. Also, measures of patient experience are being employed in hospital-based clinics, such as the CG-CAHPS satisfaction measures.

The PROMIS (Patient-Reported Outcomes Measurement Information System) battery is a promising set of PRO measures that are being utilized across a number of conditions and that contain some MS-specific measures, such as the Fatigue MS measure. Fatigue is the most common and disabling symptom in MS, so having a good measure of fatigue is of critical importance. Having a sense of a patient’s experience with fatigue over time can also be very helpful from a clinical perspective. The PROMIS measure performs much better than its predecessor, the Modified Fatigue Impact Scale (MFIS). Another strength of the PROMIS measures is that they tend to do well correlating with other conditions. In certain research and improvement settings, PROMIS can help us understand the burden a particular disease or population places on total health system resources. For example, is fatigue burden in MS similar in severity to that in another 3C condition, such as inflammatory bowel disease?

There are other PRO measures that have not been used in MS but which I think we will see used in the future. One of these is called Collaborate, which falls into the category of patient-reported experience measures (PREMs). Collaborate measures the degree of shared decision-making that occurs in a clinical encounter, which becomes especially important as the complexity of disease-modifying treatment decisions increases as more disease-modifying therapies are introduced, each with their own profile of risks and benefits. I anticipate that the ability of clinics to facilitate effective shared decision-making will be of increasing interest to clinicians, patients, and also payers in the future.

What are some of the potential benefits of using PRO measures in terms of clinician/patient communication and clinical decision-making?

BRANT OLIVER, PhD: I think the most important benefit of measuring PROs is that it can make care more patient-centered. The big push for PROs in the first place was to incorporate more of the patient’s voice into their own care. Standard clinical measures, such as magnetic resonance imaging (MRI) or relapse rates, can be very precise and provide a good clinical picture of how the disease is behaving. But if we rely solely on that kind of information, we can lose sight of the person who is experiencing the disease.

PROs, be they just regular PROs (instruments that gather qualitative and/or quantitative patient-reported information) or PROMs (validated and standardized PRO measures) or PREMs (standardized and validated patient-reported experience measures), all aim to improve the ability to get a better story of the person who's experiencing the illness and how that condition affects them. We can also gain insight on what's most important to them regarding how their illness is managed, and what their experience of care is.

Sometimes the PRO picture and the clinical picture don't necessarily align. I'll tell a story about one a person, who's given me permission to share the story. She is an established professional, and her PRO measures concerning her quality of life, support from her workplace environment, and her ability to function in society are very high. She's very high functioning according to the PRO picture.  However,  her clinical measures suggest that she is significantly impaired. Her MRI burden is quite high, and her disability due to the MS, her EDSS (Expanded Disability Status Scale), is also quite high. So there are 2 very different stories provided by 2 different sets of data. The inclusion of PROs data, in connection with clinical data, can provide a more holistic view of this person, who is functioning well despite significant disease burden.

As a clinician working with patients with MS, this gives me much more to work with in trying to help people, not only treating the disease, but also trying to see where the person is most in need of help. A person could be very well controlled on MRI in terms of relapse rate, but have fatigue severity that is through the roof. If I weren't paying closer attention to that with a validated scale that measures fatigue severity over time, like the PROMIS Fatigue MS, I may not have a sense of how well treatment is helping that person's fatigue longitudinally, beyond what I can glean from the history and clinical examination.

PROs can also be helpful in terms of conditions that are harder to quantify. Depression is a significant cause of disability and a significant factor contributing to poor treatment adherence in MS. Also, the suicide rate in persons with MS is much higher than that in the general population. But there is no blood test for depression severity, and oftentimes a patient’s report on exam can be incomplete or misleading. Accompanying the mental status exam and the clinical evaluation with a validated depression severity measure (such as the PHQ9 [Patient Health Questionnaire-9], CES-D [Center for Epidemiologic Studies Depression Scale], or others) can help to determine whether treatments are having an initial effect, and this can also help with self-monitoring and treatment adherence.  

That brings us to the second area where PROs show real promise in MS care: the learning health system (LHS) approach, which uses feed forward information to either predict the needs of people before they come to the office or optimize decision-making at the point of care (as discussed in our review article published in JCOM).¹

PROs can play a significant role in the LHS approach in 2 ways. For example, if I have a good sense before a visit that the person has stable symptoms but is having a lot of trouble coping with MS, that may change how I allocate resources and focus the time at the visit to target the primary concern of the person before the visit even occurs. Over time I'd be able to monitor if those coping scores increase in response to the work we’re doing with the person.

The second part of this approach is a feedback mechanism. These measures can be aggregated at the population level and fed back to clinical MS centers to help clinicians who are trying to improve overall population health outcomes of people with MS to see how well they're doing on things like fatigue management, depression management, coping ability, and pain control, which can't be tested for with biologic methods. So in addition to looking at the MRI scan trends across the population and relapse rate annualized for the population over time, I'd also be able to see fatigue severity and depression severity at a clinic population level and assess the change in these severity levels over time, which I could then use to inform efforts to change how my system (clinic) provides MS care.

This capability of PROs could be of significant interest to payers, especially those who are looking to optimize the value of care that is being provided, given the high cost of MS care. MS treatments are very expensive, and MS care is multidisciplinary and requires a lot of resources. Payers, I think, will have an increasing interest in assessing the value of high-cost care. PROs could help to demonstrate that value, especially if they can help quantify that outcomes can be improved over time at the population level.

The third area where PROs are beneficial is population health research, especially in terms of the major improvement movements going on in the country, such as those advocated for by the Institute for Healthcare Improvement via the Triple Aim: improve population health outcomes, improve the experience of care, and minimize per capita cost. PROs can really help with the first 2 of those Triple Aim categories.

What are some of the factors that limit the use of PRO measures in MS research and clinical practice?

BRANT OLIVER, PhD: In our JCOM paper,¹ we outlined major barriers or constraints or challenges to implementing PRO measures. One is time and technology in clinical care. It's busy. It's fast. A PRO measure requires patients to complete a questionnaire. And to do that, you need some time and space during the clinical visit, or before the visit, to collect this data. In the absence of appropriate technology, this is done using paper-based methods, which can be challenging. Technology can help. Examples include smart phone app-based collection systems, tablet PCs, or an online mechanism. But there are barriers to technology, too. Is the technology good enough? Is the interface with the people using it working well? Do you have an equal amount of access to and understanding of the technology from the people across your population? Is it only being used by a certain subset that is wealthier and more educated, or maybe who has English as a first language? Such constraints can be overcome, but they’re present in any situation where you are gathering PRO data.

Software constraints also extend to the electronic health record (EHR) capability of the clinics. If you can collect PRO data, does the EHR have the capability to present that data in a useful way during a 20- or 30-minute clinical visit? In other words, does it improve the quality of the visit, or does it generate just one more distraction during the visit? Some approaches, such as feed forward dashboards, provide easy visual displays that can quickly and easily add information at the point of care and can get around this limitation. However, a lot of MS care centers in private practice settings may not have the informatics capability of a large academic center.

 Academic centers often have more EHR capability, but can also  move much slower in implementation than more nimble private practice or community clinics. With many competing demands, it can sometimes take months to build one of these surveys into an EHR, for a task that takes just a day or so. But because other departments are in the queue for these changes, implementation often takes longer than we would intuitively think.

A second barrier is the burden on the individuals themselves. As much as we feel that PROs can make a difference, and the growing literature suggests that they really can, this is counterbalanced with the burden they may place on the patient. For example, a person may arrive at a clinic visit already with a lot on their mind, and then they get a questionnaire to complete in the waiting room before their visit (or perhaps they get asked to do it at home before the visit). The patient, rather than perceiving this as beneficial, may instead perceive it as an extra task or stressor. Explaining the purpose of the PRO measures, encouraging their use, and then actually using the results meaningfully during the visit can substantially improve their perceived value.

It’s important to limit the total amount of PROs used. In research, as well as in clinical settings, too many measures can lead to too little data. It's similar to an overly complex treatment plan: the chance that a person will adhere to all of it decreases with each level of complexity added. This can lead to decreased engagement by patients, and gradually they'll move away from participating in the PROs in general. Research and clinical efforts around PROs strive to get to a parsimonious set of critical measures, which will minimize the burden, but maximize the potential benefit.

 A third challenge is interpretability. This gets into the psychometric properties of the PRO measures and setting appropriate clinical thresholds for what constitutes a “positive” or “actionable” result. What is a clinically significant level of fatigue severity on the PROMIS MS Fatigue? We know that the mean range of that instrument is somewhere between 50 and 60. Does that mean that scores above 60 suggest higher than average fatigue levels, or is it more complicated than that? In many cases, the instruments don't have extensive population level research for the populations in which they are used. Setting clinical thresholds can be difficult, and I suspect that this will be a major area of research in the coming years.

Another example is setting appropriate depression thresholds. We know that on the CES-D, for example, the positive threshold for active depression in a patient with MS may be different from that in a patient without MS, because fatigue is a contributing factor to the neurovegetative symptoms that are scored on the CES-D.

So even if we can incorporate PROs into general practice and minimize burden, we also have to pay attention to factors that limit their interpretability and employ them in a way whereby they provide clinically meaningful results that can help inform care. The good news is,  for many PROs, even with these limitations, this can be done.

Following directly from this is error risk. Many PRO measures were designed for large-sample epidemiologic research, not for a smaller sample clinical practice, which can lead to a higher error risk, especially when following single individuals over time. Adjustments in how these scales are interpreted are required in many cases.

The limitations of many of the respondents completing questionnaires needs to be taken into account. Fatigue and cognitive impairment are very common in MS. Respondents may be selecting answers that are not entirely accurate if they're getting fatigued while doing the surveys, or if they have a comprehension deficit or a short-term memory deficit.

            A final challenge is demonstrating, just like any treatment or assessment approach, that the benefit outweighs the burden. PRO measures that are fairly reliable, validated, and quick and easy to complete suddenly become quite valuable because their benefit far outweighs the potential constraints. I think as PROs and the ways of assessing them continue to develop, that will become a bigger issue. The question will be, okay, you can do this, but what is the value added by doing this? That added value could be demonstrated in terms of better clinical outcomes, reduced costs, reduced hospitalizations, better treatment adherence, and so on.

How do you see the use of patient-reported outcomes in MS care evolving over time?

BRANT OLIVER, PhD: I tend to be optimistic regarding PROs. I think they will become part of the new reality, especially in LHS-oriented models of care. As mentioned, LHSs use feed forward data to predict the needs of people or optimize shared decision-making. I think we're going to see more shared decision-making rather than less over time in complex chronic illnesses care.

In environments where there's an increasing focus on value for high-cost, such as complex chronic conditions like MS and inflammatory bowel disease, systems will have to justify the high cost of treatment. PROs will be a critical piece in making that value assessment, especially since that value assessment is coming from the voice of patients rather than only from clinicians or other stakeholders. Arguably, patients may be able to contribute the most to making the value proposition because it is their outcomes and their experiences that matter to payers. Because experience matters (and not just outcomes), I think we'll see more PREMs used over time, including in MS.

I also think over time we'll see studies working to optimize PROs in the clinical environment and for improvement and research. An early example of that is the MS Continuous Quality Improvement (MS-CQI) Collaborative. It is a prospective randomized multicenter study using patient-reported and clinical data in a LHS approach to study population health outcomes and the effect of quality improvement interventions on those outcomes. It's also optimizing how these PRO measures are actually used at the point of care. Studies like MS-CQI will help to better articulate how, when, and for what purpose PROs should best be used and also when they should be avoided.

I think over time the predictive analytics component of PROs will be emphasized. There is a big push in the MS field in developing biomarkers to help predict disease progression over time. From the predictive analytics or machine learning perspective, imagine a situation where PROs could be used to predict a person's trajectory over time: if they were more likely to be lost to follow-up, to be hospitalized, or to have a relapse in the next year or 2. Reliable PROs generating population health data  at scale can inform the development of risk and outcome predictive models.  

Dr. Oliver discloses that he has received research grant support (MS-CQI research study mentioned in interview). He is the principal investigator and developer of the MS-CQI study, which is grant funded by Biogen under a Sponsored Research Agreement.

Brant Oliver, PhD, MS, MPH, APRN-BC, is a health care improvement and implementation scientist, educator, and board-certified family and psychiatric nurse practitioner (FNP-BC, PMHNP-BC). Dr. Oliver's work focuses on applied health care improvement science research, with a focus on "3C" (complex, costly, and chronic) conditions including MS, IBD, CF, RA, and others; coproduction; learning health systems; and shared decision making. He is Associate Professor at the Geisel School of Medicine at Dartmouth and also has been in clinical practice since 2003, working primarily as a certified MS specialist (MSCN) and a MS neurobehavioral nurse practitioner.  

Which patient-reported outcomes (PROs) are commonly assessed in the care of patients with multiple sclerosis (MS)?

BRANT OLIVER, PhD: The current reality is that PROs are not being used routinely in MS clinical care in most settings. They are most commonly being used in research settings, either as part of clinical trials of new treatments, or in epidemiologic studies looking at the prevalence, incidence, and severity of certain symptoms or functional impairments in MS at the population level. A good example is the NARCOMS registry, which has been used to conduct  high-quality epidemiologic studies of MS-related symptoms using self-report questionnaires.

We are starting to see some use of MS PROs in select clinical settings. Oftentimes these are measures of highly prevalent comorbid conditions that have an impact on quality of life, treatment adherence (depression severity and anxiety), and self-efficacy, which is a measure of perceived coping ability related to self-management of a chronic illness. Also, measures of patient experience are being employed in hospital-based clinics, such as the CG-CAHPS satisfaction measures.

The PROMIS (Patient-Reported Outcomes Measurement Information System) battery is a promising set of PRO measures that are being utilized across a number of conditions and that contain some MS-specific measures, such as the Fatigue MS measure. Fatigue is the most common and disabling symptom in MS, so having a good measure of fatigue is of critical importance. Having a sense of a patient’s experience with fatigue over time can also be very helpful from a clinical perspective. The PROMIS measure performs much better than its predecessor, the Modified Fatigue Impact Scale (MFIS). Another strength of the PROMIS measures is that they tend to do well correlating with other conditions. In certain research and improvement settings, PROMIS can help us understand the burden a particular disease or population places on total health system resources. For example, is fatigue burden in MS similar in severity to that in another 3C condition, such as inflammatory bowel disease?

There are other PRO measures that have not been used in MS but which I think we will see used in the future. One of these is called Collaborate, which falls into the category of patient-reported experience measures (PREMs). Collaborate measures the degree of shared decision-making that occurs in a clinical encounter, which becomes especially important as the complexity of disease-modifying treatment decisions increases as more disease-modifying therapies are introduced, each with their own profile of risks and benefits. I anticipate that the ability of clinics to facilitate effective shared decision-making will be of increasing interest to clinicians, patients, and also payers in the future.

What are some of the potential benefits of using PRO measures in terms of clinician/patient communication and clinical decision-making?

BRANT OLIVER, PhD: I think the most important benefit of measuring PROs is that it can make care more patient-centered. The big push for PROs in the first place was to incorporate more of the patient’s voice into their own care. Standard clinical measures, such as magnetic resonance imaging (MRI) or relapse rates, can be very precise and provide a good clinical picture of how the disease is behaving. But if we rely solely on that kind of information, we can lose sight of the person who is experiencing the disease.

PROs, be they just regular PROs (instruments that gather qualitative and/or quantitative patient-reported information) or PROMs (validated and standardized PRO measures) or PREMs (standardized and validated patient-reported experience measures), all aim to improve the ability to get a better story of the person who's experiencing the illness and how that condition affects them. We can also gain insight on what's most important to them regarding how their illness is managed, and what their experience of care is.

Sometimes the PRO picture and the clinical picture don't necessarily align. I'll tell a story about one a person, who's given me permission to share the story. She is an established professional, and her PRO measures concerning her quality of life, support from her workplace environment, and her ability to function in society are very high. She's very high functioning according to the PRO picture.  However,  her clinical measures suggest that she is significantly impaired. Her MRI burden is quite high, and her disability due to the MS, her EDSS (Expanded Disability Status Scale), is also quite high. So there are 2 very different stories provided by 2 different sets of data. The inclusion of PROs data, in connection with clinical data, can provide a more holistic view of this person, who is functioning well despite significant disease burden.

As a clinician working with patients with MS, this gives me much more to work with in trying to help people, not only treating the disease, but also trying to see where the person is most in need of help. A person could be very well controlled on MRI in terms of relapse rate, but have fatigue severity that is through the roof. If I weren't paying closer attention to that with a validated scale that measures fatigue severity over time, like the PROMIS Fatigue MS, I may not have a sense of how well treatment is helping that person's fatigue longitudinally, beyond what I can glean from the history and clinical examination.

PROs can also be helpful in terms of conditions that are harder to quantify. Depression is a significant cause of disability and a significant factor contributing to poor treatment adherence in MS. Also, the suicide rate in persons with MS is much higher than that in the general population. But there is no blood test for depression severity, and oftentimes a patient’s report on exam can be incomplete or misleading. Accompanying the mental status exam and the clinical evaluation with a validated depression severity measure (such as the PHQ9 [Patient Health Questionnaire-9], CES-D [Center for Epidemiologic Studies Depression Scale], or others) can help to determine whether treatments are having an initial effect, and this can also help with self-monitoring and treatment adherence.  

That brings us to the second area where PROs show real promise in MS care: the learning health system (LHS) approach, which uses feed forward information to either predict the needs of people before they come to the office or optimize decision-making at the point of care (as discussed in our review article published in JCOM).¹

PROs can play a significant role in the LHS approach in 2 ways. For example, if I have a good sense before a visit that the person has stable symptoms but is having a lot of trouble coping with MS, that may change how I allocate resources and focus the time at the visit to target the primary concern of the person before the visit even occurs. Over time I'd be able to monitor if those coping scores increase in response to the work we’re doing with the person.

The second part of this approach is a feedback mechanism. These measures can be aggregated at the population level and fed back to clinical MS centers to help clinicians who are trying to improve overall population health outcomes of people with MS to see how well they're doing on things like fatigue management, depression management, coping ability, and pain control, which can't be tested for with biologic methods. So in addition to looking at the MRI scan trends across the population and relapse rate annualized for the population over time, I'd also be able to see fatigue severity and depression severity at a clinic population level and assess the change in these severity levels over time, which I could then use to inform efforts to change how my system (clinic) provides MS care.

This capability of PROs could be of significant interest to payers, especially those who are looking to optimize the value of care that is being provided, given the high cost of MS care. MS treatments are very expensive, and MS care is multidisciplinary and requires a lot of resources. Payers, I think, will have an increasing interest in assessing the value of high-cost care. PROs could help to demonstrate that value, especially if they can help quantify that outcomes can be improved over time at the population level.

The third area where PROs are beneficial is population health research, especially in terms of the major improvement movements going on in the country, such as those advocated for by the Institute for Healthcare Improvement via the Triple Aim: improve population health outcomes, improve the experience of care, and minimize per capita cost. PROs can really help with the first 2 of those Triple Aim categories.

What are some of the factors that limit the use of PRO measures in MS research and clinical practice?

BRANT OLIVER, PhD: In our JCOM paper,¹ we outlined major barriers or constraints or challenges to implementing PRO measures. One is time and technology in clinical care. It's busy. It's fast. A PRO measure requires patients to complete a questionnaire. And to do that, you need some time and space during the clinical visit, or before the visit, to collect this data. In the absence of appropriate technology, this is done using paper-based methods, which can be challenging. Technology can help. Examples include smart phone app-based collection systems, tablet PCs, or an online mechanism. But there are barriers to technology, too. Is the technology good enough? Is the interface with the people using it working well? Do you have an equal amount of access to and understanding of the technology from the people across your population? Is it only being used by a certain subset that is wealthier and more educated, or maybe who has English as a first language? Such constraints can be overcome, but they’re present in any situation where you are gathering PRO data.

Software constraints also extend to the electronic health record (EHR) capability of the clinics. If you can collect PRO data, does the EHR have the capability to present that data in a useful way during a 20- or 30-minute clinical visit? In other words, does it improve the quality of the visit, or does it generate just one more distraction during the visit? Some approaches, such as feed forward dashboards, provide easy visual displays that can quickly and easily add information at the point of care and can get around this limitation. However, a lot of MS care centers in private practice settings may not have the informatics capability of a large academic center.

 Academic centers often have more EHR capability, but can also  move much slower in implementation than more nimble private practice or community clinics. With many competing demands, it can sometimes take months to build one of these surveys into an EHR, for a task that takes just a day or so. But because other departments are in the queue for these changes, implementation often takes longer than we would intuitively think.

A second barrier is the burden on the individuals themselves. As much as we feel that PROs can make a difference, and the growing literature suggests that they really can, this is counterbalanced with the burden they may place on the patient. For example, a person may arrive at a clinic visit already with a lot on their mind, and then they get a questionnaire to complete in the waiting room before their visit (or perhaps they get asked to do it at home before the visit). The patient, rather than perceiving this as beneficial, may instead perceive it as an extra task or stressor. Explaining the purpose of the PRO measures, encouraging their use, and then actually using the results meaningfully during the visit can substantially improve their perceived value.

It’s important to limit the total amount of PROs used. In research, as well as in clinical settings, too many measures can lead to too little data. It's similar to an overly complex treatment plan: the chance that a person will adhere to all of it decreases with each level of complexity added. This can lead to decreased engagement by patients, and gradually they'll move away from participating in the PROs in general. Research and clinical efforts around PROs strive to get to a parsimonious set of critical measures, which will minimize the burden, but maximize the potential benefit.

 A third challenge is interpretability. This gets into the psychometric properties of the PRO measures and setting appropriate clinical thresholds for what constitutes a “positive” or “actionable” result. What is a clinically significant level of fatigue severity on the PROMIS MS Fatigue? We know that the mean range of that instrument is somewhere between 50 and 60. Does that mean that scores above 60 suggest higher than average fatigue levels, or is it more complicated than that? In many cases, the instruments don't have extensive population level research for the populations in which they are used. Setting clinical thresholds can be difficult, and I suspect that this will be a major area of research in the coming years.

Another example is setting appropriate depression thresholds. We know that on the CES-D, for example, the positive threshold for active depression in a patient with MS may be different from that in a patient without MS, because fatigue is a contributing factor to the neurovegetative symptoms that are scored on the CES-D.

So even if we can incorporate PROs into general practice and minimize burden, we also have to pay attention to factors that limit their interpretability and employ them in a way whereby they provide clinically meaningful results that can help inform care. The good news is,  for many PROs, even with these limitations, this can be done.

Following directly from this is error risk. Many PRO measures were designed for large-sample epidemiologic research, not for a smaller sample clinical practice, which can lead to a higher error risk, especially when following single individuals over time. Adjustments in how these scales are interpreted are required in many cases.

The limitations of many of the respondents completing questionnaires needs to be taken into account. Fatigue and cognitive impairment are very common in MS. Respondents may be selecting answers that are not entirely accurate if they're getting fatigued while doing the surveys, or if they have a comprehension deficit or a short-term memory deficit.

            A final challenge is demonstrating, just like any treatment or assessment approach, that the benefit outweighs the burden. PRO measures that are fairly reliable, validated, and quick and easy to complete suddenly become quite valuable because their benefit far outweighs the potential constraints. I think as PROs and the ways of assessing them continue to develop, that will become a bigger issue. The question will be, okay, you can do this, but what is the value added by doing this? That added value could be demonstrated in terms of better clinical outcomes, reduced costs, reduced hospitalizations, better treatment adherence, and so on.

How do you see the use of patient-reported outcomes in MS care evolving over time?

BRANT OLIVER, PhD: I tend to be optimistic regarding PROs. I think they will become part of the new reality, especially in LHS-oriented models of care. As mentioned, LHSs use feed forward data to predict the needs of people or optimize shared decision-making. I think we're going to see more shared decision-making rather than less over time in complex chronic illnesses care.

In environments where there's an increasing focus on value for high-cost, such as complex chronic conditions like MS and inflammatory bowel disease, systems will have to justify the high cost of treatment. PROs will be a critical piece in making that value assessment, especially since that value assessment is coming from the voice of patients rather than only from clinicians or other stakeholders. Arguably, patients may be able to contribute the most to making the value proposition because it is their outcomes and their experiences that matter to payers. Because experience matters (and not just outcomes), I think we'll see more PREMs used over time, including in MS.

I also think over time we'll see studies working to optimize PROs in the clinical environment and for improvement and research. An early example of that is the MS Continuous Quality Improvement (MS-CQI) Collaborative. It is a prospective randomized multicenter study using patient-reported and clinical data in a LHS approach to study population health outcomes and the effect of quality improvement interventions on those outcomes. It's also optimizing how these PRO measures are actually used at the point of care. Studies like MS-CQI will help to better articulate how, when, and for what purpose PROs should best be used and also when they should be avoided.

I think over time the predictive analytics component of PROs will be emphasized. There is a big push in the MS field in developing biomarkers to help predict disease progression over time. From the predictive analytics or machine learning perspective, imagine a situation where PROs could be used to predict a person's trajectory over time: if they were more likely to be lost to follow-up, to be hospitalized, or to have a relapse in the next year or 2. Reliable PROs generating population health data  at scale can inform the development of risk and outcome predictive models.  

Dr. Oliver discloses that he has received research grant support (MS-CQI research study mentioned in interview). He is the principal investigator and developer of the MS-CQI study, which is grant funded by Biogen under a Sponsored Research Agreement.

Brant Oliver, PhD, MS, MPH, APRN-BC, is a health care improvement and implementation scientist, educator, and board-certified family and psychiatric nurse practitioner (FNP-BC, PMHNP-BC). Dr. Oliver's work focuses on applied health care improvement science research, with a focus on "3C" (complex, costly, and chronic) conditions including MS, IBD, CF, RA, and others; coproduction; learning health systems; and shared decision making. He is Associate Professor at the Geisel School of Medicine at Dartmouth and also has been in clinical practice since 2003, working primarily as a certified MS specialist (MSCN) and a MS neurobehavioral nurse practitioner.  

Which patient-reported outcomes (PROs) are commonly assessed in the care of patients with multiple sclerosis (MS)?

BRANT OLIVER, PhD: The current reality is that PROs are not being used routinely in MS clinical care in most settings. They are most commonly being used in research settings, either as part of clinical trials of new treatments, or in epidemiologic studies looking at the prevalence, incidence, and severity of certain symptoms or functional impairments in MS at the population level. A good example is the NARCOMS registry, which has been used to conduct  high-quality epidemiologic studies of MS-related symptoms using self-report questionnaires.

We are starting to see some use of MS PROs in select clinical settings. Oftentimes these are measures of highly prevalent comorbid conditions that have an impact on quality of life, treatment adherence (depression severity and anxiety), and self-efficacy, which is a measure of perceived coping ability related to self-management of a chronic illness. Also, measures of patient experience are being employed in hospital-based clinics, such as the CG-CAHPS satisfaction measures.

The PROMIS (Patient-Reported Outcomes Measurement Information System) battery is a promising set of PRO measures that are being utilized across a number of conditions and that contain some MS-specific measures, such as the Fatigue MS measure. Fatigue is the most common and disabling symptom in MS, so having a good measure of fatigue is of critical importance. Having a sense of a patient’s experience with fatigue over time can also be very helpful from a clinical perspective. The PROMIS measure performs much better than its predecessor, the Modified Fatigue Impact Scale (MFIS). Another strength of the PROMIS measures is that they tend to do well correlating with other conditions. In certain research and improvement settings, PROMIS can help us understand the burden a particular disease or population places on total health system resources. For example, is fatigue burden in MS similar in severity to that in another 3C condition, such as inflammatory bowel disease?

There are other PRO measures that have not been used in MS but which I think we will see used in the future. One of these is called Collaborate, which falls into the category of patient-reported experience measures (PREMs). Collaborate measures the degree of shared decision-making that occurs in a clinical encounter, which becomes especially important as the complexity of disease-modifying treatment decisions increases as more disease-modifying therapies are introduced, each with their own profile of risks and benefits. I anticipate that the ability of clinics to facilitate effective shared decision-making will be of increasing interest to clinicians, patients, and also payers in the future.

What are some of the potential benefits of using PRO measures in terms of clinician/patient communication and clinical decision-making?

BRANT OLIVER, PhD: I think the most important benefit of measuring PROs is that it can make care more patient-centered. The big push for PROs in the first place was to incorporate more of the patient’s voice into their own care. Standard clinical measures, such as magnetic resonance imaging (MRI) or relapse rates, can be very precise and provide a good clinical picture of how the disease is behaving. But if we rely solely on that kind of information, we can lose sight of the person who is experiencing the disease.

PROs, be they just regular PROs (instruments that gather qualitative and/or quantitative patient-reported information) or PROMs (validated and standardized PRO measures) or PREMs (standardized and validated patient-reported experience measures), all aim to improve the ability to get a better story of the person who's experiencing the illness and how that condition affects them. We can also gain insight on what's most important to them regarding how their illness is managed, and what their experience of care is.

Sometimes the PRO picture and the clinical picture don't necessarily align. I'll tell a story about one a person, who's given me permission to share the story. She is an established professional, and her PRO measures concerning her quality of life, support from her workplace environment, and her ability to function in society are very high. She's very high functioning according to the PRO picture.  However,  her clinical measures suggest that she is significantly impaired. Her MRI burden is quite high, and her disability due to the MS, her EDSS (Expanded Disability Status Scale), is also quite high. So there are 2 very different stories provided by 2 different sets of data. The inclusion of PROs data, in connection with clinical data, can provide a more holistic view of this person, who is functioning well despite significant disease burden.

As a clinician working with patients with MS, this gives me much more to work with in trying to help people, not only treating the disease, but also trying to see where the person is most in need of help. A person could be very well controlled on MRI in terms of relapse rate, but have fatigue severity that is through the roof. If I weren't paying closer attention to that with a validated scale that measures fatigue severity over time, like the PROMIS Fatigue MS, I may not have a sense of how well treatment is helping that person's fatigue longitudinally, beyond what I can glean from the history and clinical examination.

PROs can also be helpful in terms of conditions that are harder to quantify. Depression is a significant cause of disability and a significant factor contributing to poor treatment adherence in MS. Also, the suicide rate in persons with MS is much higher than that in the general population. But there is no blood test for depression severity, and oftentimes a patient’s report on exam can be incomplete or misleading. Accompanying the mental status exam and the clinical evaluation with a validated depression severity measure (such as the PHQ9 [Patient Health Questionnaire-9], CES-D [Center for Epidemiologic Studies Depression Scale], or others) can help to determine whether treatments are having an initial effect, and this can also help with self-monitoring and treatment adherence.  

That brings us to the second area where PROs show real promise in MS care: the learning health system (LHS) approach, which uses feed forward information to either predict the needs of people before they come to the office or optimize decision-making at the point of care (as discussed in our review article published in JCOM).¹

PROs can play a significant role in the LHS approach in 2 ways. For example, if I have a good sense before a visit that the person has stable symptoms but is having a lot of trouble coping with MS, that may change how I allocate resources and focus the time at the visit to target the primary concern of the person before the visit even occurs. Over time I'd be able to monitor if those coping scores increase in response to the work we’re doing with the person.

The second part of this approach is a feedback mechanism. These measures can be aggregated at the population level and fed back to clinical MS centers to help clinicians who are trying to improve overall population health outcomes of people with MS to see how well they're doing on things like fatigue management, depression management, coping ability, and pain control, which can't be tested for with biologic methods. So in addition to looking at the MRI scan trends across the population and relapse rate annualized for the population over time, I'd also be able to see fatigue severity and depression severity at a clinic population level and assess the change in these severity levels over time, which I could then use to inform efforts to change how my system (clinic) provides MS care.

This capability of PROs could be of significant interest to payers, especially those who are looking to optimize the value of care that is being provided, given the high cost of MS care. MS treatments are very expensive, and MS care is multidisciplinary and requires a lot of resources. Payers, I think, will have an increasing interest in assessing the value of high-cost care. PROs could help to demonstrate that value, especially if they can help quantify that outcomes can be improved over time at the population level.

The third area where PROs are beneficial is population health research, especially in terms of the major improvement movements going on in the country, such as those advocated for by the Institute for Healthcare Improvement via the Triple Aim: improve population health outcomes, improve the experience of care, and minimize per capita cost. PROs can really help with the first 2 of those Triple Aim categories.

What are some of the factors that limit the use of PRO measures in MS research and clinical practice?

BRANT OLIVER, PhD: In our JCOM paper,¹ we outlined major barriers or constraints or challenges to implementing PRO measures. One is time and technology in clinical care. It's busy. It's fast. A PRO measure requires patients to complete a questionnaire. And to do that, you need some time and space during the clinical visit, or before the visit, to collect this data. In the absence of appropriate technology, this is done using paper-based methods, which can be challenging. Technology can help. Examples include smart phone app-based collection systems, tablet PCs, or an online mechanism. But there are barriers to technology, too. Is the technology good enough? Is the interface with the people using it working well? Do you have an equal amount of access to and understanding of the technology from the people across your population? Is it only being used by a certain subset that is wealthier and more educated, or maybe who has English as a first language? Such constraints can be overcome, but they’re present in any situation where you are gathering PRO data.

Software constraints also extend to the electronic health record (EHR) capability of the clinics. If you can collect PRO data, does the EHR have the capability to present that data in a useful way during a 20- or 30-minute clinical visit? In other words, does it improve the quality of the visit, or does it generate just one more distraction during the visit? Some approaches, such as feed forward dashboards, provide easy visual displays that can quickly and easily add information at the point of care and can get around this limitation. However, a lot of MS care centers in private practice settings may not have the informatics capability of a large academic center.

 Academic centers often have more EHR capability, but can also  move much slower in implementation than more nimble private practice or community clinics. With many competing demands, it can sometimes take months to build one of these surveys into an EHR, for a task that takes just a day or so. But because other departments are in the queue for these changes, implementation often takes longer than we would intuitively think.

A second barrier is the burden on the individuals themselves. As much as we feel that PROs can make a difference, and the growing literature suggests that they really can, this is counterbalanced with the burden they may place on the patient. For example, a person may arrive at a clinic visit already with a lot on their mind, and then they get a questionnaire to complete in the waiting room before their visit (or perhaps they get asked to do it at home before the visit). The patient, rather than perceiving this as beneficial, may instead perceive it as an extra task or stressor. Explaining the purpose of the PRO measures, encouraging their use, and then actually using the results meaningfully during the visit can substantially improve their perceived value.

It’s important to limit the total amount of PROs used. In research, as well as in clinical settings, too many measures can lead to too little data. It's similar to an overly complex treatment plan: the chance that a person will adhere to all of it decreases with each level of complexity added. This can lead to decreased engagement by patients, and gradually they'll move away from participating in the PROs in general. Research and clinical efforts around PROs strive to get to a parsimonious set of critical measures, which will minimize the burden, but maximize the potential benefit.

 A third challenge is interpretability. This gets into the psychometric properties of the PRO measures and setting appropriate clinical thresholds for what constitutes a “positive” or “actionable” result. What is a clinically significant level of fatigue severity on the PROMIS MS Fatigue? We know that the mean range of that instrument is somewhere between 50 and 60. Does that mean that scores above 60 suggest higher than average fatigue levels, or is it more complicated than that? In many cases, the instruments don't have extensive population level research for the populations in which they are used. Setting clinical thresholds can be difficult, and I suspect that this will be a major area of research in the coming years.

Another example is setting appropriate depression thresholds. We know that on the CES-D, for example, the positive threshold for active depression in a patient with MS may be different from that in a patient without MS, because fatigue is a contributing factor to the neurovegetative symptoms that are scored on the CES-D.

So even if we can incorporate PROs into general practice and minimize burden, we also have to pay attention to factors that limit their interpretability and employ them in a way whereby they provide clinically meaningful results that can help inform care. The good news is,  for many PROs, even with these limitations, this can be done.

Following directly from this is error risk. Many PRO measures were designed for large-sample epidemiologic research, not for a smaller sample clinical practice, which can lead to a higher error risk, especially when following single individuals over time. Adjustments in how these scales are interpreted are required in many cases.

The limitations of many of the respondents completing questionnaires needs to be taken into account. Fatigue and cognitive impairment are very common in MS. Respondents may be selecting answers that are not entirely accurate if they're getting fatigued while doing the surveys, or if they have a comprehension deficit or a short-term memory deficit.

            A final challenge is demonstrating, just like any treatment or assessment approach, that the benefit outweighs the burden. PRO measures that are fairly reliable, validated, and quick and easy to complete suddenly become quite valuable because their benefit far outweighs the potential constraints. I think as PROs and the ways of assessing them continue to develop, that will become a bigger issue. The question will be, okay, you can do this, but what is the value added by doing this? That added value could be demonstrated in terms of better clinical outcomes, reduced costs, reduced hospitalizations, better treatment adherence, and so on.

How do you see the use of patient-reported outcomes in MS care evolving over time?

BRANT OLIVER, PhD: I tend to be optimistic regarding PROs. I think they will become part of the new reality, especially in LHS-oriented models of care. As mentioned, LHSs use feed forward data to predict the needs of people or optimize shared decision-making. I think we're going to see more shared decision-making rather than less over time in complex chronic illnesses care.

In environments where there's an increasing focus on value for high-cost, such as complex chronic conditions like MS and inflammatory bowel disease, systems will have to justify the high cost of treatment. PROs will be a critical piece in making that value assessment, especially since that value assessment is coming from the voice of patients rather than only from clinicians or other stakeholders. Arguably, patients may be able to contribute the most to making the value proposition because it is their outcomes and their experiences that matter to payers. Because experience matters (and not just outcomes), I think we'll see more PREMs used over time, including in MS.

I also think over time we'll see studies working to optimize PROs in the clinical environment and for improvement and research. An early example of that is the MS Continuous Quality Improvement (MS-CQI) Collaborative. It is a prospective randomized multicenter study using patient-reported and clinical data in a LHS approach to study population health outcomes and the effect of quality improvement interventions on those outcomes. It's also optimizing how these PRO measures are actually used at the point of care. Studies like MS-CQI will help to better articulate how, when, and for what purpose PROs should best be used and also when they should be avoided.

I think over time the predictive analytics component of PROs will be emphasized. There is a big push in the MS field in developing biomarkers to help predict disease progression over time. From the predictive analytics or machine learning perspective, imagine a situation where PROs could be used to predict a person's trajectory over time: if they were more likely to be lost to follow-up, to be hospitalized, or to have a relapse in the next year or 2. Reliable PROs generating population health data  at scale can inform the development of risk and outcome predictive models.  

Dr. Oliver discloses that he has received research grant support (MS-CQI research study mentioned in interview). He is the principal investigator and developer of the MS-CQI study, which is grant funded by Biogen under a Sponsored Research Agreement.

Chronic conditions such as lung disease, diabetes, and heart disease frequently receive attention for increasing the risk of complications for people who contract the coronavirus. Meanwhile, many members of the epilepsy community continue to wonder how the virus affects them. To address these concerns, the Epilepsy Foundation has released information that answers many common questions that people with epilepsy have about how COVID-19 can impact their health.

Perhaps the most pressing of these questions is: Does epilepsy increase the risk or severity of the coronavirus? According to the Epilepsy Foundation’s website, having epilepsy poses no additional risk for contracting COVID-19 or worsening the severity of the virus.

“The most common thing we’re hearing from patients in my practice is their proactive concern for being at increased risk for getting the coronavirus,” confirmed Selim Benbadis, MD, division director, epilepsy, EEG, and sleep medicine at the University of South Florida in Tampa. “Epilepsy patients are not at increased risk for complications from the coronavirus because epilepsy does not affect the immune system.”

In other words, people who have epilepsy face the same health challenges as people who do not have the condition and are otherwise healthy. For this reason, people who have epilepsy should exercise the same habits and preventative measures that healthy people would typically take, such as social distancing; avoiding contact with sick people; washing hands regularly; disinfecting surfaces regularly; and avoiding touching hands, eyes, nose and mouth.

However, as Dr. Benbadis explained, the high fever associated with coronavirus can trigger seizures. The increased risk is another reason people who have epilepsy should do their best to avoid getting sick.
 

Seizure medications do not increase COVID-19 risk but other conditions can

Similarly, epilepsy medications do not increase the risk of contracting the disease.

“The medications patients take to treat their epilepsy do not affect their immune system,” said Andrew Wilner, MD, associate professor of neurology at the University of Tennessee Health Science Center, Memphis. There are a few exceptions – such as adrenocorticotropic hormone and everolimus – but doctors rarely use these drugs to treat epilepsy.

However, there are some situations and conditions that may pose a risk for people who contact the coronavirus. For instance, people who have problems swallowing their food and tend to suck food down their windpipes are more likely to develop pneumonia. Also, much like the general population, having diabetes, heart disease, or lung problems increase the chances of developing complications from the virus.
 

The best ways to avoid additional risks in epilepsy

Because of the pandemic, people who have epilepsy may have found that many of their doctors’ appointments have been canceled. Many clinics and medical practices have done this in order minimize exposing people who have acute illnesses to the virus. By focusing more on patients with acute conditions, doctors and nurses can better tend to patients with acute problems. As a result, practices have shifted to providing patient care using telemedicine as much as possible.

“Telemedicine services have surged, and I’ve been saying for years that telemedicine was going to grow,” Dr. Benbadis said. “It’s more convenient, and I believe that we’re going to see increased use of telemedicine long after the coronavirus pandemic is over.”

Aside from communicating with their doctors, the Epilepsy Foundation and Dr. Wilner stress that the best way for people who have epilepsy to stay healthy is by taking their medications on a regular basis exactly as prescribed.

“Taking mediation correctly and regularly is the best strategy for epilepsy patients to avoid unnecessary hospitalizations,” Dr. Wilner said. “If they have breakthrough seizures and get sent to the emergency room, then they risk being exposed to the virus in the ER.”

Also, because ERs are more crowded than usual, the Epilepsy Foundation encourages people who suspect they have the coronavirus to call their doctor’s office first. The goal is to try to make sure that people who have severe or life-threatening symptoms have access to treatment in the ER.

As with the general population, the first thing that epilepsy patients who suspect they have the coronavirus should do is call his or her doctor’s office. The health care professional taking the call will ask the patient a series of questions to determine whether the patient has COVID-19 or another condition or needs to seek emergency medical attention.

Fever, cough, and trouble breathing fall among the most commonly reported symptoms of the coronavirus. In many cases, health care providers recommend that people with mild versions of these symptoms stay at home.
 

Helpful tips

The Epilepsy Foundation offers tips on signs to look for when trying to figure out when a seizure requires an ER visit. These are:

• Seizures in which awareness is lost for more than 5 minutes and no reversal medications are available.
• Seizures with an unusual pattern or duration.
• Seizures that cannot be treated safely at home or are not responding to rescue medication even after the medication has had enough time to work.
• Seizures that occur after a severe blow to the head.

Additionally, while COVID-19 can cause death and sudden death in patients, the virus does not cause sudden unexpected death in epilepsy (SUDEP). Because SUDEP is extremely rare, Dr. Benbadis said that there is no information to suggest that contracting the coronavirus will increase the risk,

Finally, no shortages of seizures medications have been reported as a result of COVID-19. However, there were shortages of generic levetiracetam immediate-release and levetiracetam extended-release medications prior to and during COVID-19. Experts expect the shortage to continue.

Overall, people who have epilepsy should be able to stay healthy – provided they exercise healthy and preventative habits.

“The majority of epilepsy patients should be reassured that if they continue their usual care, take their meds as directed, get adequate sleep, nutritious diet, they’re not at any increased risk compared to the general population,” said Dr. Wilner.

Dr. Benbadis reported the following disclosures: consultant for Bioserenity (DigiTrace), Brain Sentinel, Cavion, Ceribell, Eisai, Greenwich, LivaNova, Neuropace, SK biopharmaceuticals, Sunovion; speakers bureau for Eisai, Greenwich, LivaNova, Sunovion; Florida Medical Director of Stratus/Alliance; Member: Epilepsy Study Consortium; grant support from Cavion, LivaNova, Greenwich, SK biopharmaceuticals, Sunovion, Takeda, UCB, Xenon; royalties as an author or editor for Emedicine-Medscape-WebMD, UpToDate; editorial board for the Epilepsy.com (Epilepsy Foundation) controversy section, Emedicine-Medscape-WebMD, Epileptic Disorders, Epilepsy and Behavior, and Expert Review of Neurotherapeutics. Dr. Wilner reports Medical Advisory Board of Accordant Health Services, Greensboro, S.C., and book royalties: “The Locum Life: A Physician’s Guide to Locum Tenens,” Lulu Press.
 

Chronic conditions such as lung disease, diabetes, and heart disease frequently receive attention for increasing the risk of complications for people who contract the coronavirus. Meanwhile, many members of the epilepsy community continue to wonder how the virus affects them. To address these concerns, the Epilepsy Foundation has released information that answers many common questions that people with epilepsy have about how COVID-19 can impact their health.

Perhaps the most pressing of these questions is: Does epilepsy increase the risk or severity of the coronavirus? According to the Epilepsy Foundation’s website, having epilepsy poses no additional risk for contracting COVID-19 or worsening the severity of the virus.

“The most common thing we’re hearing from patients in my practice is their proactive concern for being at increased risk for getting the coronavirus,” confirmed Selim Benbadis, MD, division director, epilepsy, EEG, and sleep medicine at the University of South Florida in Tampa. “Epilepsy patients are not at increased risk for complications from the coronavirus because epilepsy does not affect the immune system.”

In other words, people who have epilepsy face the same health challenges as people who do not have the condition and are otherwise healthy. For this reason, people who have epilepsy should exercise the same habits and preventative measures that healthy people would typically take, such as social distancing; avoiding contact with sick people; washing hands regularly; disinfecting surfaces regularly; and avoiding touching hands, eyes, nose and mouth.

However, as Dr. Benbadis explained, the high fever associated with coronavirus can trigger seizures. The increased risk is another reason people who have epilepsy should do their best to avoid getting sick.
 

Seizure medications do not increase COVID-19 risk but other conditions can

Similarly, epilepsy medications do not increase the risk of contracting the disease.

“The medications patients take to treat their epilepsy do not affect their immune system,” said Andrew Wilner, MD, associate professor of neurology at the University of Tennessee Health Science Center, Memphis. There are a few exceptions – such as adrenocorticotropic hormone and everolimus – but doctors rarely use these drugs to treat epilepsy.

However, there are some situations and conditions that may pose a risk for people who contact the coronavirus. For instance, people who have problems swallowing their food and tend to suck food down their windpipes are more likely to develop pneumonia. Also, much like the general population, having diabetes, heart disease, or lung problems increase the chances of developing complications from the virus.
 

The best ways to avoid additional risks in epilepsy

Because of the pandemic, people who have epilepsy may have found that many of their doctors’ appointments have been canceled. Many clinics and medical practices have done this in order minimize exposing people who have acute illnesses to the virus. By focusing more on patients with acute conditions, doctors and nurses can better tend to patients with acute problems. As a result, practices have shifted to providing patient care using telemedicine as much as possible.

“Telemedicine services have surged, and I’ve been saying for years that telemedicine was going to grow,” Dr. Benbadis said. “It’s more convenient, and I believe that we’re going to see increased use of telemedicine long after the coronavirus pandemic is over.”

Aside from communicating with their doctors, the Epilepsy Foundation and Dr. Wilner stress that the best way for people who have epilepsy to stay healthy is by taking their medications on a regular basis exactly as prescribed.

“Taking mediation correctly and regularly is the best strategy for epilepsy patients to avoid unnecessary hospitalizations,” Dr. Wilner said. “If they have breakthrough seizures and get sent to the emergency room, then they risk being exposed to the virus in the ER.”

Also, because ERs are more crowded than usual, the Epilepsy Foundation encourages people who suspect they have the coronavirus to call their doctor’s office first. The goal is to try to make sure that people who have severe or life-threatening symptoms have access to treatment in the ER.

As with the general population, the first thing that epilepsy patients who suspect they have the coronavirus should do is call his or her doctor’s office. The health care professional taking the call will ask the patient a series of questions to determine whether the patient has COVID-19 or another condition or needs to seek emergency medical attention.

Fever, cough, and trouble breathing fall among the most commonly reported symptoms of the coronavirus. In many cases, health care providers recommend that people with mild versions of these symptoms stay at home.
 

Helpful tips

The Epilepsy Foundation offers tips on signs to look for when trying to figure out when a seizure requires an ER visit. These are:

• Seizures in which awareness is lost for more than 5 minutes and no reversal medications are available.
• Seizures with an unusual pattern or duration.
• Seizures that cannot be treated safely at home or are not responding to rescue medication even after the medication has had enough time to work.
• Seizures that occur after a severe blow to the head.

Additionally, while COVID-19 can cause death and sudden death in patients, the virus does not cause sudden unexpected death in epilepsy (SUDEP). Because SUDEP is extremely rare, Dr. Benbadis said that there is no information to suggest that contracting the coronavirus will increase the risk,

Finally, no shortages of seizures medications have been reported as a result of COVID-19. However, there were shortages of generic levetiracetam immediate-release and levetiracetam extended-release medications prior to and during COVID-19. Experts expect the shortage to continue.

Overall, people who have epilepsy should be able to stay healthy – provided they exercise healthy and preventative habits.

“The majority of epilepsy patients should be reassured that if they continue their usual care, take their meds as directed, get adequate sleep, nutritious diet, they’re not at any increased risk compared to the general population,” said Dr. Wilner.

Dr. Benbadis reported the following disclosures: consultant for Bioserenity (DigiTrace), Brain Sentinel, Cavion, Ceribell, Eisai, Greenwich, LivaNova, Neuropace, SK biopharmaceuticals, Sunovion; speakers bureau for Eisai, Greenwich, LivaNova, Sunovion; Florida Medical Director of Stratus/Alliance; Member: Epilepsy Study Consortium; grant support from Cavion, LivaNova, Greenwich, SK biopharmaceuticals, Sunovion, Takeda, UCB, Xenon; royalties as an author or editor for Emedicine-Medscape-WebMD, UpToDate; editorial board for the Epilepsy.com (Epilepsy Foundation) controversy section, Emedicine-Medscape-WebMD, Epileptic Disorders, Epilepsy and Behavior, and Expert Review of Neurotherapeutics. Dr. Wilner reports Medical Advisory Board of Accordant Health Services, Greensboro, S.C., and book royalties: “The Locum Life: A Physician’s Guide to Locum Tenens,” Lulu Press.
 

Chronic conditions such as lung disease, diabetes, and heart disease frequently receive attention for increasing the risk of complications for people who contract the coronavirus. Meanwhile, many members of the epilepsy community continue to wonder how the virus affects them. To address these concerns, the Epilepsy Foundation has released information that answers many common questions that people with epilepsy have about how COVID-19 can impact their health.

Perhaps the most pressing of these questions is: Does epilepsy increase the risk or severity of the coronavirus? According to the Epilepsy Foundation’s website, having epilepsy poses no additional risk for contracting COVID-19 or worsening the severity of the virus.

“The most common thing we’re hearing from patients in my practice is their proactive concern for being at increased risk for getting the coronavirus,” confirmed Selim Benbadis, MD, division director, epilepsy, EEG, and sleep medicine at the University of South Florida in Tampa. “Epilepsy patients are not at increased risk for complications from the coronavirus because epilepsy does not affect the immune system.”

In other words, people who have epilepsy face the same health challenges as people who do not have the condition and are otherwise healthy. For this reason, people who have epilepsy should exercise the same habits and preventative measures that healthy people would typically take, such as social distancing; avoiding contact with sick people; washing hands regularly; disinfecting surfaces regularly; and avoiding touching hands, eyes, nose and mouth.

However, as Dr. Benbadis explained, the high fever associated with coronavirus can trigger seizures. The increased risk is another reason people who have epilepsy should do their best to avoid getting sick.
 

Seizure medications do not increase COVID-19 risk but other conditions can

Similarly, epilepsy medications do not increase the risk of contracting the disease.

“The medications patients take to treat their epilepsy do not affect their immune system,” said Andrew Wilner, MD, associate professor of neurology at the University of Tennessee Health Science Center, Memphis. There are a few exceptions – such as adrenocorticotropic hormone and everolimus – but doctors rarely use these drugs to treat epilepsy.

However, there are some situations and conditions that may pose a risk for people who contact the coronavirus. For instance, people who have problems swallowing their food and tend to suck food down their windpipes are more likely to develop pneumonia. Also, much like the general population, having diabetes, heart disease, or lung problems increase the chances of developing complications from the virus.
 

The best ways to avoid additional risks in epilepsy

Because of the pandemic, people who have epilepsy may have found that many of their doctors’ appointments have been canceled. Many clinics and medical practices have done this in order minimize exposing people who have acute illnesses to the virus. By focusing more on patients with acute conditions, doctors and nurses can better tend to patients with acute problems. As a result, practices have shifted to providing patient care using telemedicine as much as possible.

“Telemedicine services have surged, and I’ve been saying for years that telemedicine was going to grow,” Dr. Benbadis said. “It’s more convenient, and I believe that we’re going to see increased use of telemedicine long after the coronavirus pandemic is over.”

Aside from communicating with their doctors, the Epilepsy Foundation and Dr. Wilner stress that the best way for people who have epilepsy to stay healthy is by taking their medications on a regular basis exactly as prescribed.

“Taking mediation correctly and regularly is the best strategy for epilepsy patients to avoid unnecessary hospitalizations,” Dr. Wilner said. “If they have breakthrough seizures and get sent to the emergency room, then they risk being exposed to the virus in the ER.”

Also, because ERs are more crowded than usual, the Epilepsy Foundation encourages people who suspect they have the coronavirus to call their doctor’s office first. The goal is to try to make sure that people who have severe or life-threatening symptoms have access to treatment in the ER.

As with the general population, the first thing that epilepsy patients who suspect they have the coronavirus should do is call his or her doctor’s office. The health care professional taking the call will ask the patient a series of questions to determine whether the patient has COVID-19 or another condition or needs to seek emergency medical attention.

Fever, cough, and trouble breathing fall among the most commonly reported symptoms of the coronavirus. In many cases, health care providers recommend that people with mild versions of these symptoms stay at home.
 

Helpful tips

The Epilepsy Foundation offers tips on signs to look for when trying to figure out when a seizure requires an ER visit. These are:

• Seizures in which awareness is lost for more than 5 minutes and no reversal medications are available.
• Seizures with an unusual pattern or duration.
• Seizures that cannot be treated safely at home or are not responding to rescue medication even after the medication has had enough time to work.
• Seizures that occur after a severe blow to the head.

Additionally, while COVID-19 can cause death and sudden death in patients, the virus does not cause sudden unexpected death in epilepsy (SUDEP). Because SUDEP is extremely rare, Dr. Benbadis said that there is no information to suggest that contracting the coronavirus will increase the risk,

Finally, no shortages of seizures medications have been reported as a result of COVID-19. However, there were shortages of generic levetiracetam immediate-release and levetiracetam extended-release medications prior to and during COVID-19. Experts expect the shortage to continue.

Overall, people who have epilepsy should be able to stay healthy – provided they exercise healthy and preventative habits.

“The majority of epilepsy patients should be reassured that if they continue their usual care, take their meds as directed, get adequate sleep, nutritious diet, they’re not at any increased risk compared to the general population,” said Dr. Wilner.

Dr. Benbadis reported the following disclosures: consultant for Bioserenity (DigiTrace), Brain Sentinel, Cavion, Ceribell, Eisai, Greenwich, LivaNova, Neuropace, SK biopharmaceuticals, Sunovion; speakers bureau for Eisai, Greenwich, LivaNova, Sunovion; Florida Medical Director of Stratus/Alliance; Member: Epilepsy Study Consortium; grant support from Cavion, LivaNova, Greenwich, SK biopharmaceuticals, Sunovion, Takeda, UCB, Xenon; royalties as an author or editor for Emedicine-Medscape-WebMD, UpToDate; editorial board for the Epilepsy.com (Epilepsy Foundation) controversy section, Emedicine-Medscape-WebMD, Epileptic Disorders, Epilepsy and Behavior, and Expert Review of Neurotherapeutics. Dr. Wilner reports Medical Advisory Board of Accordant Health Services, Greensboro, S.C., and book royalties: “The Locum Life: A Physician’s Guide to Locum Tenens,” Lulu Press.
 

Children with refractory epilepsy who took pharmaceutical cannabidiol (CBD) had higher serum CBD levels and better seizure control than those who took artisanal CBD, but they had more adverse side effects, preliminary results of a small study indicate.

Given the widespread use of artisanal CBD products, Nathan T. Cohen, MD, pediatric epilepsy fellow, Children’s National Hospital, Washington, DC, and his colleagues wanted to know how these products differ from pharmaceutical grade CBD with respect to seizure control.

“One of the challenges or questions we have is whether there is any information that would guide us and suggest patients transition from artisanal to pharmaceutical grade CBD,” Dr. Cohen, who is lead author of the study, told Medscape Medical News.

The findings were released February 27 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage. The study received no outside funding.

In addition to helping relieve anxiety and stress, CBD, one of many constituents of Cannabis sativa, has antiseizure properties. The US Food and Drug Administration (FDA) has approved a pharmaceutical CBD (Epidiolex, GW Pharmaceuticals) for the management of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome.

This purified oral CBD prescription product does not contain tetrahydrocannabinol (THC), the component of marijuana that produces a “high.”
 

Popular products

Artisanal CBD, which has been around since the late 1970s, is manufactured using variable amounts of CBD and THC. Artisanal products, which typically come in the form of oils that are swallowed, are available in dispensaries and elsewhere, depending on the legal status in individual states.

These artisanal formulations are popular among patients with epilepsy and their families. On the basis of the advertising he sees, Dr. Cohen estimates there are at least 100 artisanal CBD products, but he was quick to stress he’s not an expert on artisanal CBD.

He noted that some families are “searching for an alternative treatment” to help control their child’s seizures, and if the seizure syndrome isn’t LGS or Dravet, “then technically, they don’t qualify for prescription-strength CBD,” said Dr. Cohen.

The current study was a retrospective chart review and included patients with epilepsy who underwent treatment with artisanal or pharmaceutical CBD for whom serum CBD levels were available.

In addition to CBD levels, the researchers had information on patients’ date of birth, gender, epilepsy diagnosis, artisanal or pharmaceutical CBD dose, seizure history, and side effects, among other things.

The analysis included 31 patients (48% female; mean age, about 10 years). Of these, 32% had LGS, 6% had Dravet, and the rest had other epilepsy syndromes.

Of the total, 22 patients participated in a pharmaceutical CBD expanded-access program. The remaining nine patients received artisanal CBD.

The mean serum CBD level was 30.1 ng/mL in the artisanal group and 124 ng/mL in the pharmaceutical group.

Dr. Cohen noted that artisanal products contain lower amounts of CBD because they’re not purified, and they may contain other compounds derived from marijuana.

At the last follow-up, which was a median of 11.8 months, patients who took artisanal CBD had a 70% increase in overall seizures. Dr. Cohen pointed out that some of the hundreds of compounds in marijuana could be “pro-convulsant.”
 

Some seizure free

The prescription CBD group experienced a 39% reduction in seizures. “Some of these kids had up to hundreds of seizures a day and went down to tens, and some kids became seizure free,” said Dr. Cohen.

Because the study was “looking back in time,” the investigators couldn’t determine whether age, type of epilepsy, or other factors affected seizure control in the two groups, said Dr. Cohen. “One of the limitations of a retrospective study is that we’re not able to control for those factors,” he said.

Eleven patients—all in the prescription CBD group—reported adverse effects, including somnolence, emesis, diarrhea, and diminished appetite; six discontinued CBD because of side effects.

Dr. Cohen said he’s not aware of any study that has compared artisanal products “head to head” with pharmaceutical grade CBD. “The whole point of this study was to ask the question, Is there a difference between the groups?, and these new data would suggest that there may be.”

The results appear to support giving encouragement to patients to transition from artisanal to pharmaceutical CBD if appropriate. “Anytime you’re giving your child a medication that has not been produced under the stringent guidelines that all pharmaceutical FDA-approved medications undergo, you don’t know exactly what’s in the product, and not knowing is a potential issue,” said Dr. Cohen.

The findings need to be studied in a more controlled setting “to make sure they’re valid,” said Dr. Cohen. Because this is “a very hot topic,” he’s keen to see what further research his colleagues would be interested in pursuing.

Commenting on the research, Joseph Sirven, MD, a neurologist in Scottsdale, Arizona, said this is an important study.

“It highlights one of the most common questions that I receive almost on a daily basis in my neurology practice,” he said.

Most people think that dispensary-based CBD is the same as prescription-based CBD, said Dr. Sirven. “Technically and theoretically, they certainly could be; however, what this study highlights is that in practice, they are not the same.”

He stressed that prescription CBD has to meet certain quality standards. “That means that whatever the ingredient list states about the concentration of CBD in the product has to be within the product, which is why the FDA approved it. It is, in essence, a quality control issue.”

A dispensary-based product does not need to meet such stringent standards and so “is subject to whatever the manufacturer chooses to put in the product,” said Dr. Sirven.

The study received no outside funding. Drs. Cohen and Sirven reported no relevant financial relationships.

This article first appeared on Medscape.com.

Children with refractory epilepsy who took pharmaceutical cannabidiol (CBD) had higher serum CBD levels and better seizure control than those who took artisanal CBD, but they had more adverse side effects, preliminary results of a small study indicate.

Given the widespread use of artisanal CBD products, Nathan T. Cohen, MD, pediatric epilepsy fellow, Children’s National Hospital, Washington, DC, and his colleagues wanted to know how these products differ from pharmaceutical grade CBD with respect to seizure control.

“One of the challenges or questions we have is whether there is any information that would guide us and suggest patients transition from artisanal to pharmaceutical grade CBD,” Dr. Cohen, who is lead author of the study, told Medscape Medical News.

The findings were released February 27 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage. The study received no outside funding.

In addition to helping relieve anxiety and stress, CBD, one of many constituents of Cannabis sativa, has antiseizure properties. The US Food and Drug Administration (FDA) has approved a pharmaceutical CBD (Epidiolex, GW Pharmaceuticals) for the management of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome.

This purified oral CBD prescription product does not contain tetrahydrocannabinol (THC), the component of marijuana that produces a “high.”
 

Popular products

Artisanal CBD, which has been around since the late 1970s, is manufactured using variable amounts of CBD and THC. Artisanal products, which typically come in the form of oils that are swallowed, are available in dispensaries and elsewhere, depending on the legal status in individual states.

These artisanal formulations are popular among patients with epilepsy and their families. On the basis of the advertising he sees, Dr. Cohen estimates there are at least 100 artisanal CBD products, but he was quick to stress he’s not an expert on artisanal CBD.

He noted that some families are “searching for an alternative treatment” to help control their child’s seizures, and if the seizure syndrome isn’t LGS or Dravet, “then technically, they don’t qualify for prescription-strength CBD,” said Dr. Cohen.

The current study was a retrospective chart review and included patients with epilepsy who underwent treatment with artisanal or pharmaceutical CBD for whom serum CBD levels were available.

In addition to CBD levels, the researchers had information on patients’ date of birth, gender, epilepsy diagnosis, artisanal or pharmaceutical CBD dose, seizure history, and side effects, among other things.

The analysis included 31 patients (48% female; mean age, about 10 years). Of these, 32% had LGS, 6% had Dravet, and the rest had other epilepsy syndromes.

Of the total, 22 patients participated in a pharmaceutical CBD expanded-access program. The remaining nine patients received artisanal CBD.

The mean serum CBD level was 30.1 ng/mL in the artisanal group and 124 ng/mL in the pharmaceutical group.

Dr. Cohen noted that artisanal products contain lower amounts of CBD because they’re not purified, and they may contain other compounds derived from marijuana.

At the last follow-up, which was a median of 11.8 months, patients who took artisanal CBD had a 70% increase in overall seizures. Dr. Cohen pointed out that some of the hundreds of compounds in marijuana could be “pro-convulsant.”
 

Some seizure free

The prescription CBD group experienced a 39% reduction in seizures. “Some of these kids had up to hundreds of seizures a day and went down to tens, and some kids became seizure free,” said Dr. Cohen.

Because the study was “looking back in time,” the investigators couldn’t determine whether age, type of epilepsy, or other factors affected seizure control in the two groups, said Dr. Cohen. “One of the limitations of a retrospective study is that we’re not able to control for those factors,” he said.

Eleven patients—all in the prescription CBD group—reported adverse effects, including somnolence, emesis, diarrhea, and diminished appetite; six discontinued CBD because of side effects.

Dr. Cohen said he’s not aware of any study that has compared artisanal products “head to head” with pharmaceutical grade CBD. “The whole point of this study was to ask the question, Is there a difference between the groups?, and these new data would suggest that there may be.”

The results appear to support giving encouragement to patients to transition from artisanal to pharmaceutical CBD if appropriate. “Anytime you’re giving your child a medication that has not been produced under the stringent guidelines that all pharmaceutical FDA-approved medications undergo, you don’t know exactly what’s in the product, and not knowing is a potential issue,” said Dr. Cohen.

The findings need to be studied in a more controlled setting “to make sure they’re valid,” said Dr. Cohen. Because this is “a very hot topic,” he’s keen to see what further research his colleagues would be interested in pursuing.

Commenting on the research, Joseph Sirven, MD, a neurologist in Scottsdale, Arizona, said this is an important study.

“It highlights one of the most common questions that I receive almost on a daily basis in my neurology practice,” he said.

Most people think that dispensary-based CBD is the same as prescription-based CBD, said Dr. Sirven. “Technically and theoretically, they certainly could be; however, what this study highlights is that in practice, they are not the same.”

He stressed that prescription CBD has to meet certain quality standards. “That means that whatever the ingredient list states about the concentration of CBD in the product has to be within the product, which is why the FDA approved it. It is, in essence, a quality control issue.”

A dispensary-based product does not need to meet such stringent standards and so “is subject to whatever the manufacturer chooses to put in the product,” said Dr. Sirven.

The study received no outside funding. Drs. Cohen and Sirven reported no relevant financial relationships.

This article first appeared on Medscape.com.

Children with refractory epilepsy who took pharmaceutical cannabidiol (CBD) had higher serum CBD levels and better seizure control than those who took artisanal CBD, but they had more adverse side effects, preliminary results of a small study indicate.

Given the widespread use of artisanal CBD products, Nathan T. Cohen, MD, pediatric epilepsy fellow, Children’s National Hospital, Washington, DC, and his colleagues wanted to know how these products differ from pharmaceutical grade CBD with respect to seizure control.

“One of the challenges or questions we have is whether there is any information that would guide us and suggest patients transition from artisanal to pharmaceutical grade CBD,” Dr. Cohen, who is lead author of the study, told Medscape Medical News.

The findings were released February 27 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage. The study received no outside funding.

In addition to helping relieve anxiety and stress, CBD, one of many constituents of Cannabis sativa, has antiseizure properties. The US Food and Drug Administration (FDA) has approved a pharmaceutical CBD (Epidiolex, GW Pharmaceuticals) for the management of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome.

This purified oral CBD prescription product does not contain tetrahydrocannabinol (THC), the component of marijuana that produces a “high.”
 

Popular products

Artisanal CBD, which has been around since the late 1970s, is manufactured using variable amounts of CBD and THC. Artisanal products, which typically come in the form of oils that are swallowed, are available in dispensaries and elsewhere, depending on the legal status in individual states.

These artisanal formulations are popular among patients with epilepsy and their families. On the basis of the advertising he sees, Dr. Cohen estimates there are at least 100 artisanal CBD products, but he was quick to stress he’s not an expert on artisanal CBD.

He noted that some families are “searching for an alternative treatment” to help control their child’s seizures, and if the seizure syndrome isn’t LGS or Dravet, “then technically, they don’t qualify for prescription-strength CBD,” said Dr. Cohen.

The current study was a retrospective chart review and included patients with epilepsy who underwent treatment with artisanal or pharmaceutical CBD for whom serum CBD levels were available.

In addition to CBD levels, the researchers had information on patients’ date of birth, gender, epilepsy diagnosis, artisanal or pharmaceutical CBD dose, seizure history, and side effects, among other things.

The analysis included 31 patients (48% female; mean age, about 10 years). Of these, 32% had LGS, 6% had Dravet, and the rest had other epilepsy syndromes.

Of the total, 22 patients participated in a pharmaceutical CBD expanded-access program. The remaining nine patients received artisanal CBD.

The mean serum CBD level was 30.1 ng/mL in the artisanal group and 124 ng/mL in the pharmaceutical group.

Dr. Cohen noted that artisanal products contain lower amounts of CBD because they’re not purified, and they may contain other compounds derived from marijuana.

At the last follow-up, which was a median of 11.8 months, patients who took artisanal CBD had a 70% increase in overall seizures. Dr. Cohen pointed out that some of the hundreds of compounds in marijuana could be “pro-convulsant.”
 

Some seizure free

The prescription CBD group experienced a 39% reduction in seizures. “Some of these kids had up to hundreds of seizures a day and went down to tens, and some kids became seizure free,” said Dr. Cohen.

Because the study was “looking back in time,” the investigators couldn’t determine whether age, type of epilepsy, or other factors affected seizure control in the two groups, said Dr. Cohen. “One of the limitations of a retrospective study is that we’re not able to control for those factors,” he said.

Eleven patients—all in the prescription CBD group—reported adverse effects, including somnolence, emesis, diarrhea, and diminished appetite; six discontinued CBD because of side effects.

Dr. Cohen said he’s not aware of any study that has compared artisanal products “head to head” with pharmaceutical grade CBD. “The whole point of this study was to ask the question, Is there a difference between the groups?, and these new data would suggest that there may be.”

The results appear to support giving encouragement to patients to transition from artisanal to pharmaceutical CBD if appropriate. “Anytime you’re giving your child a medication that has not been produced under the stringent guidelines that all pharmaceutical FDA-approved medications undergo, you don’t know exactly what’s in the product, and not knowing is a potential issue,” said Dr. Cohen.

The findings need to be studied in a more controlled setting “to make sure they’re valid,” said Dr. Cohen. Because this is “a very hot topic,” he’s keen to see what further research his colleagues would be interested in pursuing.

Commenting on the research, Joseph Sirven, MD, a neurologist in Scottsdale, Arizona, said this is an important study.

“It highlights one of the most common questions that I receive almost on a daily basis in my neurology practice,” he said.

Most people think that dispensary-based CBD is the same as prescription-based CBD, said Dr. Sirven. “Technically and theoretically, they certainly could be; however, what this study highlights is that in practice, they are not the same.”

He stressed that prescription CBD has to meet certain quality standards. “That means that whatever the ingredient list states about the concentration of CBD in the product has to be within the product, which is why the FDA approved it. It is, in essence, a quality control issue.”

A dispensary-based product does not need to meet such stringent standards and so “is subject to whatever the manufacturer chooses to put in the product,” said Dr. Sirven.

The study received no outside funding. Drs. Cohen and Sirven reported no relevant financial relationships.

This article first appeared on Medscape.com.

Boxing may help improve common nonmotor symptoms of Parkinson’s disease, new research suggests. In the study, patients with Parkinson’s disease who participated in a noncontact boxing program experienced improvement in nonmotor symptoms such as fatigue, depression, and anxiety, and had significantly better quality of life compared with their counterparts who did not engage in this type of exercise.

“We know we should be prescribing exercise for our Parkinson’s disease patients because more and more research shows it can delay the progression of the disease, but it can be overwhelming to know what type of exercise to prescribe to patients,” study investigator Danielle Larson, MD, a neurologist and movement disorders fellow at Northwestern University, Chicago, Illinois, told Medscape Medical News.

On a daily basis, patients at Dr. Larson’s clinic who have taken Rock Steady Boxing (RSB) classes “really endorse” this exercise, she said.

The findings were released March 4 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.
 

Global program

A form of noncontact boxing, RSB was created in 2006 for patients with Parkinson’s disease. A typical 90-minute class starts with stretching and cardiovascular exercises, then foot movements and stepping over obstacles.

“Parkinson’s disease patients are slowed down and have difficulty navigating around obstacles,” Dr. Larson noted.

The class also includes “speed training,” such as fast walking or running. In the boxing part of the class, participants use suspended punching bags.

Dr. Larson said the RSB program caters to all patients with Parkinson’s disease, “even those who need a walker for assistance.” Most RSB sites require a release from a physician to ensure patient safety, she said.

There are now about 43,500 participants at 871 RSB sites around the world.

Adults with Parkinson’s disease who were aware of RSB completed a 20-minute anonymous survey, distributed via email and social media by RSB Inc and the Parkinson Foundation.

Of 2,054 survey respondents, 1,709 were eligible for analysis. Of these, 1,333 were currently participating in RSB, 166 had previously participated, and 210 had never participated in the program.

For all three groups, researchers gathered demographic information, such as age, gender, and income, and asked respondents how long they had the condition, who takes care of their illness, etc.

Current and previous RSB participants were asked about the exercise. For example, they were asked how many classes on average they would take per week and whether specific symptoms had improved or not changed with their participation.

RSB participants had a mean age of 69 years, 59% were male, and 96% were white. Demographics were similar for the other groups, although Dr. Larson noted that the group that had never participated was relatively small.

There was no difference between the groups in terms of years since Parkinson’ disease diagnosis or use of a movement disorders specialist.

Less fatigue

Compared with nonparticipants, a higher percentage of participants were retired (76% vs. 65%, P < .01) and married/had a partner (85% vs. 80%, P = .03).

The symptoms for which participants reported at least a 50% improvement were mostly nonmotor symptoms. For example, participants had improvements in social life (70%), fatigue (63%), fear of falling (62%), depression (60%), and anxiety (59%).

More than 50% of respondents in the previous participant group also reported improvement in these symptoms, “just not to the same degree as the current participants,” Dr. Larson said.

“Those symptoms are difficult to treat in Parkinson’s disease,” she noted. “We really don’t have any good medications for those symptoms; so to report, for example, a 63% improvement in fatigue is pretty substantial.”

The survey included the Parkinson’s Disease Questionnaire–39 (PDQ-39). The questionnaire assesses factors associated with daily living, including relationships and the impact of Parkinson’s disease on functioning and well-being.

Compared with nonparticipants, current participants had better mean scores on the PDQ-39 (25 vs. 32, P < .01), which indicates better quality of life, Dr. Larson said. Previous participants had a higher (or worse) score than current participants, she added.

Largest study to date

Researchers also examined likelihood of exercising even with certain barriers, such as distance to the gym, bad weather, or fatigue using the Self Efficacy for Exercise (SEE) Scale. Current participants had better SEE scores compared with nonparticipants (54 vs. 48, P < .01).

“We can’t prove causality. We can’t say it was the RSB that improved their quality of life or their exercise self-efficacy, but at least there’s a correlation,” Dr. Larson said.

For the SEE, again, the previous participants had lower scores than current participants, she noted.

“An interpretation of this is that individuals who previously participated but stopped did so because they had lower exercise self-efficacy – which is the ability to self-motivate and stick with an exercise – to begin with,” she said.

As for Parkinson’s disease–related motor symptoms, the survey found some improvements. “People did report between 20% and 40% improvement on various motor symptoms,” but not more than 50% of respondents.

Dr. Larson noted that some motor symptoms such as tremor would not be expected to improve with exercise.

This study, the largest to date of RSB in patients with Parkinson’s disease, illustrates the benefits of this type of exercise intervention for these patients, she said.

“It’s a step in the right direction in showing that RSB, or noncontact boxing classes, can be a really good option for patients who have previously not been motivated to exercise, or maybe haven’t stuck with an exercise class, or maybe fatigue or anxiety or depression is a barrier for them to exercise.”

Patients who have experienced RSB praise its unique approach, in addition to generating friendships and promoting a sense of camaraderie and team spirit, Dr. Larson said.

“It’s almost like a support group inside an exercise class,” she noted. “We also see that people are really committed to the classes, whereas with other exercises it can be hard to get people to be motivated.”

Some 99% of current and 94% of previous participants indicated they would recommend RSB to others with Parkinson’s disease.

Interpret with caution

Commenting on the research, Michael S. Okun, MD, professor and chair of neurology, University of Florida Health, Gainesville, and medical director at the Parkinson’s Foundation, said many patients with Parkinson’s disease attend RSB classes and report that the regimen has a beneficial effect on symptoms and quality of life.

“The data from this study support these types of observations,” he said.

But Dr. Okun noted that caution is in order. “We should be careful not to overinterpret the results given that the methodology was survey-based,” he said.

To some extent, the results aren’t surprising, as multiple studies have already shown that exercise improves Parkinson’s disease symptoms and quality of life, Dr. Okun said. “We have no reason to believe that Rock Steady Boxing would not result in similar improvements.”

He stressed that a follow-up study will be necessary to better understand the potential benefits, both nonmotor and motor.

Also commenting, movement disorders specialist Anna DePold Hohler, MD, professor of neurology at Tufts University School of Medicine, Boston, and chair of neurology at St. Elizabeth’s Medical Center in Brighton, Massachusetts, said the new results “provide an added incentive” for patients to participate in RSB programs.

Such programs “should be started early and maintained,” Dr. Hohler added.

The study received no outside funding. The study authors have disclosed no relevant financial relationships. Drs. Okun and Hohler have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Boxing may help improve common nonmotor symptoms of Parkinson’s disease, new research suggests. In the study, patients with Parkinson’s disease who participated in a noncontact boxing program experienced improvement in nonmotor symptoms such as fatigue, depression, and anxiety, and had significantly better quality of life compared with their counterparts who did not engage in this type of exercise.

“We know we should be prescribing exercise for our Parkinson’s disease patients because more and more research shows it can delay the progression of the disease, but it can be overwhelming to know what type of exercise to prescribe to patients,” study investigator Danielle Larson, MD, a neurologist and movement disorders fellow at Northwestern University, Chicago, Illinois, told Medscape Medical News.

On a daily basis, patients at Dr. Larson’s clinic who have taken Rock Steady Boxing (RSB) classes “really endorse” this exercise, she said.

The findings were released March 4 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.
 

Global program

A form of noncontact boxing, RSB was created in 2006 for patients with Parkinson’s disease. A typical 90-minute class starts with stretching and cardiovascular exercises, then foot movements and stepping over obstacles.

“Parkinson’s disease patients are slowed down and have difficulty navigating around obstacles,” Dr. Larson noted.

The class also includes “speed training,” such as fast walking or running. In the boxing part of the class, participants use suspended punching bags.

Dr. Larson said the RSB program caters to all patients with Parkinson’s disease, “even those who need a walker for assistance.” Most RSB sites require a release from a physician to ensure patient safety, she said.

There are now about 43,500 participants at 871 RSB sites around the world.

Adults with Parkinson’s disease who were aware of RSB completed a 20-minute anonymous survey, distributed via email and social media by RSB Inc and the Parkinson Foundation.

Of 2,054 survey respondents, 1,709 were eligible for analysis. Of these, 1,333 were currently participating in RSB, 166 had previously participated, and 210 had never participated in the program.

For all three groups, researchers gathered demographic information, such as age, gender, and income, and asked respondents how long they had the condition, who takes care of their illness, etc.

Current and previous RSB participants were asked about the exercise. For example, they were asked how many classes on average they would take per week and whether specific symptoms had improved or not changed with their participation.

RSB participants had a mean age of 69 years, 59% were male, and 96% were white. Demographics were similar for the other groups, although Dr. Larson noted that the group that had never participated was relatively small.

There was no difference between the groups in terms of years since Parkinson’ disease diagnosis or use of a movement disorders specialist.

Less fatigue

Compared with nonparticipants, a higher percentage of participants were retired (76% vs. 65%, P < .01) and married/had a partner (85% vs. 80%, P = .03).

The symptoms for which participants reported at least a 50% improvement were mostly nonmotor symptoms. For example, participants had improvements in social life (70%), fatigue (63%), fear of falling (62%), depression (60%), and anxiety (59%).

More than 50% of respondents in the previous participant group also reported improvement in these symptoms, “just not to the same degree as the current participants,” Dr. Larson said.

“Those symptoms are difficult to treat in Parkinson’s disease,” she noted. “We really don’t have any good medications for those symptoms; so to report, for example, a 63% improvement in fatigue is pretty substantial.”

The survey included the Parkinson’s Disease Questionnaire–39 (PDQ-39). The questionnaire assesses factors associated with daily living, including relationships and the impact of Parkinson’s disease on functioning and well-being.

Compared with nonparticipants, current participants had better mean scores on the PDQ-39 (25 vs. 32, P < .01), which indicates better quality of life, Dr. Larson said. Previous participants had a higher (or worse) score than current participants, she added.

Largest study to date

Researchers also examined likelihood of exercising even with certain barriers, such as distance to the gym, bad weather, or fatigue using the Self Efficacy for Exercise (SEE) Scale. Current participants had better SEE scores compared with nonparticipants (54 vs. 48, P < .01).

“We can’t prove causality. We can’t say it was the RSB that improved their quality of life or their exercise self-efficacy, but at least there’s a correlation,” Dr. Larson said.

For the SEE, again, the previous participants had lower scores than current participants, she noted.

“An interpretation of this is that individuals who previously participated but stopped did so because they had lower exercise self-efficacy – which is the ability to self-motivate and stick with an exercise – to begin with,” she said.

As for Parkinson’s disease–related motor symptoms, the survey found some improvements. “People did report between 20% and 40% improvement on various motor symptoms,” but not more than 50% of respondents.

Dr. Larson noted that some motor symptoms such as tremor would not be expected to improve with exercise.

This study, the largest to date of RSB in patients with Parkinson’s disease, illustrates the benefits of this type of exercise intervention for these patients, she said.

“It’s a step in the right direction in showing that RSB, or noncontact boxing classes, can be a really good option for patients who have previously not been motivated to exercise, or maybe haven’t stuck with an exercise class, or maybe fatigue or anxiety or depression is a barrier for them to exercise.”

Patients who have experienced RSB praise its unique approach, in addition to generating friendships and promoting a sense of camaraderie and team spirit, Dr. Larson said.

“It’s almost like a support group inside an exercise class,” she noted. “We also see that people are really committed to the classes, whereas with other exercises it can be hard to get people to be motivated.”

Some 99% of current and 94% of previous participants indicated they would recommend RSB to others with Parkinson’s disease.

Interpret with caution

Commenting on the research, Michael S. Okun, MD, professor and chair of neurology, University of Florida Health, Gainesville, and medical director at the Parkinson’s Foundation, said many patients with Parkinson’s disease attend RSB classes and report that the regimen has a beneficial effect on symptoms and quality of life.

“The data from this study support these types of observations,” he said.

But Dr. Okun noted that caution is in order. “We should be careful not to overinterpret the results given that the methodology was survey-based,” he said.

To some extent, the results aren’t surprising, as multiple studies have already shown that exercise improves Parkinson’s disease symptoms and quality of life, Dr. Okun said. “We have no reason to believe that Rock Steady Boxing would not result in similar improvements.”

He stressed that a follow-up study will be necessary to better understand the potential benefits, both nonmotor and motor.

Also commenting, movement disorders specialist Anna DePold Hohler, MD, professor of neurology at Tufts University School of Medicine, Boston, and chair of neurology at St. Elizabeth’s Medical Center in Brighton, Massachusetts, said the new results “provide an added incentive” for patients to participate in RSB programs.

Such programs “should be started early and maintained,” Dr. Hohler added.

The study received no outside funding. The study authors have disclosed no relevant financial relationships. Drs. Okun and Hohler have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Boxing may help improve common nonmotor symptoms of Parkinson’s disease, new research suggests. In the study, patients with Parkinson’s disease who participated in a noncontact boxing program experienced improvement in nonmotor symptoms such as fatigue, depression, and anxiety, and had significantly better quality of life compared with their counterparts who did not engage in this type of exercise.

“We know we should be prescribing exercise for our Parkinson’s disease patients because more and more research shows it can delay the progression of the disease, but it can be overwhelming to know what type of exercise to prescribe to patients,” study investigator Danielle Larson, MD, a neurologist and movement disorders fellow at Northwestern University, Chicago, Illinois, told Medscape Medical News.

On a daily basis, patients at Dr. Larson’s clinic who have taken Rock Steady Boxing (RSB) classes “really endorse” this exercise, she said.

The findings were released March 4 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.
 

Global program

A form of noncontact boxing, RSB was created in 2006 for patients with Parkinson’s disease. A typical 90-minute class starts with stretching and cardiovascular exercises, then foot movements and stepping over obstacles.

“Parkinson’s disease patients are slowed down and have difficulty navigating around obstacles,” Dr. Larson noted.

The class also includes “speed training,” such as fast walking or running. In the boxing part of the class, participants use suspended punching bags.

Dr. Larson said the RSB program caters to all patients with Parkinson’s disease, “even those who need a walker for assistance.” Most RSB sites require a release from a physician to ensure patient safety, she said.

There are now about 43,500 participants at 871 RSB sites around the world.

Adults with Parkinson’s disease who were aware of RSB completed a 20-minute anonymous survey, distributed via email and social media by RSB Inc and the Parkinson Foundation.

Of 2,054 survey respondents, 1,709 were eligible for analysis. Of these, 1,333 were currently participating in RSB, 166 had previously participated, and 210 had never participated in the program.

For all three groups, researchers gathered demographic information, such as age, gender, and income, and asked respondents how long they had the condition, who takes care of their illness, etc.

Current and previous RSB participants were asked about the exercise. For example, they were asked how many classes on average they would take per week and whether specific symptoms had improved or not changed with their participation.

RSB participants had a mean age of 69 years, 59% were male, and 96% were white. Demographics were similar for the other groups, although Dr. Larson noted that the group that had never participated was relatively small.

There was no difference between the groups in terms of years since Parkinson’ disease diagnosis or use of a movement disorders specialist.

Less fatigue

Compared with nonparticipants, a higher percentage of participants were retired (76% vs. 65%, P < .01) and married/had a partner (85% vs. 80%, P = .03).

The symptoms for which participants reported at least a 50% improvement were mostly nonmotor symptoms. For example, participants had improvements in social life (70%), fatigue (63%), fear of falling (62%), depression (60%), and anxiety (59%).

More than 50% of respondents in the previous participant group also reported improvement in these symptoms, “just not to the same degree as the current participants,” Dr. Larson said.

“Those symptoms are difficult to treat in Parkinson’s disease,” she noted. “We really don’t have any good medications for those symptoms; so to report, for example, a 63% improvement in fatigue is pretty substantial.”

The survey included the Parkinson’s Disease Questionnaire–39 (PDQ-39). The questionnaire assesses factors associated with daily living, including relationships and the impact of Parkinson’s disease on functioning and well-being.

Compared with nonparticipants, current participants had better mean scores on the PDQ-39 (25 vs. 32, P < .01), which indicates better quality of life, Dr. Larson said. Previous participants had a higher (or worse) score than current participants, she added.

Largest study to date

Researchers also examined likelihood of exercising even with certain barriers, such as distance to the gym, bad weather, or fatigue using the Self Efficacy for Exercise (SEE) Scale. Current participants had better SEE scores compared with nonparticipants (54 vs. 48, P < .01).

“We can’t prove causality. We can’t say it was the RSB that improved their quality of life or their exercise self-efficacy, but at least there’s a correlation,” Dr. Larson said.

For the SEE, again, the previous participants had lower scores than current participants, she noted.

“An interpretation of this is that individuals who previously participated but stopped did so because they had lower exercise self-efficacy – which is the ability to self-motivate and stick with an exercise – to begin with,” she said.

As for Parkinson’s disease–related motor symptoms, the survey found some improvements. “People did report between 20% and 40% improvement on various motor symptoms,” but not more than 50% of respondents.

Dr. Larson noted that some motor symptoms such as tremor would not be expected to improve with exercise.

This study, the largest to date of RSB in patients with Parkinson’s disease, illustrates the benefits of this type of exercise intervention for these patients, she said.

“It’s a step in the right direction in showing that RSB, or noncontact boxing classes, can be a really good option for patients who have previously not been motivated to exercise, or maybe haven’t stuck with an exercise class, or maybe fatigue or anxiety or depression is a barrier for them to exercise.”

Patients who have experienced RSB praise its unique approach, in addition to generating friendships and promoting a sense of camaraderie and team spirit, Dr. Larson said.

“It’s almost like a support group inside an exercise class,” she noted. “We also see that people are really committed to the classes, whereas with other exercises it can be hard to get people to be motivated.”

Some 99% of current and 94% of previous participants indicated they would recommend RSB to others with Parkinson’s disease.

Interpret with caution

Commenting on the research, Michael S. Okun, MD, professor and chair of neurology, University of Florida Health, Gainesville, and medical director at the Parkinson’s Foundation, said many patients with Parkinson’s disease attend RSB classes and report that the regimen has a beneficial effect on symptoms and quality of life.

“The data from this study support these types of observations,” he said.

But Dr. Okun noted that caution is in order. “We should be careful not to overinterpret the results given that the methodology was survey-based,” he said.

To some extent, the results aren’t surprising, as multiple studies have already shown that exercise improves Parkinson’s disease symptoms and quality of life, Dr. Okun said. “We have no reason to believe that Rock Steady Boxing would not result in similar improvements.”

He stressed that a follow-up study will be necessary to better understand the potential benefits, both nonmotor and motor.

Also commenting, movement disorders specialist Anna DePold Hohler, MD, professor of neurology at Tufts University School of Medicine, Boston, and chair of neurology at St. Elizabeth’s Medical Center in Brighton, Massachusetts, said the new results “provide an added incentive” for patients to participate in RSB programs.

Such programs “should be started early and maintained,” Dr. Hohler added.

The study received no outside funding. The study authors have disclosed no relevant financial relationships. Drs. Okun and Hohler have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Playing table tennis, also known as ping-pong, appears to improve motor symptoms in patients with Parkinson’s disease, new research suggests. The results of a small pilot study show that table ping-pong is a safe and effective rehabilitative intervention for patients with Parkinson’s disease that can be easily introduced, study investigator Shinsuke Fujioka, MD, Department of Neurology, Fukuoka University, Japan, told Medscape Medical News.

He emphasized that any rehabilitation for patients with Parkinson’s disease could be beneficial, especially during the early stages of their illness. “The most important thing is that patients have fun when doing rehabilitation.”

The findings were released February 25 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.
 

All exercise beneficial

The idea of studying ping-pong as a therapy for patients with Parkinson’s disease originated when Dr. Fujioka heard about a patient who used a cane but no longer needed it after taking up the exercise as a weekly rehabilitation therapy.

“It’s apparent that the exercise can improve motor function of Parkinson’s disease. However, to date, the effects of the sport have not been well investigated for this patient population, so our study aimed to disclose the effects that table tennis can bring to patients with Parkinson’s disease,” said Dr. Fujioka.

The study included 12 patients with Parkinson’s disease – 10 women and two men. Mean age at disease onset was 67 years, and mean disease duration was 7 years. Mean stage on the Hoehn & Yahr scale, which assesses severity of Parkinson’s disease symptoms, was three, so most patients had balance problems.

Study participants played ping-pong at once-weekly 5-hour sessions that included rest breaks whenever they felt it was necessary.

Researchers assessed participants using the Unified Parkinson’s Disease Rating Scale (UPDRS) part I-IV. Parts II and III assess motor function whereas parts I and IV evaluate nonmotor function and motor complications, respectively.

The main motor symptoms of Parkinson’s disease include bradykinesia and muscle rigidity, tremor, and postural instability.

Researchers also assessed participants using the Montreal Cognitive Assessment (MoCA), Frontal Assessment Battery (FAB), Self-Rating Depression Scale (SDS), and Apathy scale.

Results showed that UPDRS part II significantly improved at 3 and 6 months (both P < 0.001), as did UPDRS part III (P = 0.002 at 3 months; P < 0.001 at 6 months).

Dr. Fujioka speculated, “twisting axial muscles when hitting a ping-pong ball may be the most efficacious for patients, especially for bradykinesia and balance problems.”
 

Significant improvement

Such findings may not be that surprising. Dr. Fujioka pointed to other rehabilitation therapies such as tai chi or tango that may also improve Parkinson’s disease motor symptoms.

For UPDRS part II, subscores of speech, saliva and drooling, dressing, handwriting, doing hobbies and other activities, getting out of bed, a car, or a deep chair, and walking and balance, significantly improved.

In addition, for UPDRS part III, subscores of facial expression, rigidity, postural stability, posture, bradykinesia, and kinetic tremor of the hands also significantly improved.

As for nonmotor symptoms such as mood, anxiety, depression, and apathy assessed in UPDRS part I, scores did not significantly change, which was also the case for part IV.

However, Dr. Fujioka pointed out that patient scores didn’t worsen. “Given the nature of disease, not worsening of nonmotor features can potentially be a good effect of the sport.” MoCA, FAB, SDS, and Apathy scale scores also did not change.

Dr. Fujioka noted that all participants enjoyed the table tennis rehabilitation, and “gradually smiled more during the study period.” All study participants continued the table tennis rehabilitation after the 6-month program.

Dr. Fujioka noted that although patients with Parkinson’s disease often have difficulty moving in a front-to-back direction, they can move relatively easily in a lateral direction.

“In that sense, table tennis is suitable for them,” he said. However, he added, court tennis, handball, and badminton may not be suitable for most patients with Parkinson’s disease.

One patient suffered a fall and another backache. Dr. Fujioka cautioned that more frequent ping-pong playing might increase the risk of adverse events.

He also suggests patients with Parkinson’s disease have their bone density checked before starting regular rehabilitation exercise as they are at increased risk for osteoporosis.

The investigators are currently organizing a prospective, multicenter randomized study to compare the effectiveness of table tennis with conventional rehabilitation and the Lee Silverman Voice Treatment, which is designed to increase vocal intensity in patients with Parkinson’s disease.
 

Fun, engaging

Commenting on the findings, Cynthia Comella, MD, professor emeritus, Neurological Sciences, Rush University Medical Center, New Philadelphia, Ohio, said ping-pong is a “fun and engaging” exercise for patients with Parkinson’s disease. Dr. Comella noted prior studies have shown many types of exercise are beneficial for patients with Parkinson’s disease “provided that they continue” with it.

In that regard, these new results are “promising,” she said. “It may be that this type of community generating, fun exercise would lead to a continuation of the exercise after a study is completed.”

A controlled trial that includes a post-study follow-up to evaluate compliance and continued benefit is needed, she said.

Purchase of equipment, including tables, rackets, and balls, was possible through funds donated by Hisako Kobayashi-Levin, which provides Murakami Karindoh Hospital with an annual fund to improve the quality of their rehabilitation program. The authors reported no relevant financial relationships.

This article first appeared on Medscape.com.

Playing table tennis, also known as ping-pong, appears to improve motor symptoms in patients with Parkinson’s disease, new research suggests. The results of a small pilot study show that table ping-pong is a safe and effective rehabilitative intervention for patients with Parkinson’s disease that can be easily introduced, study investigator Shinsuke Fujioka, MD, Department of Neurology, Fukuoka University, Japan, told Medscape Medical News.

He emphasized that any rehabilitation for patients with Parkinson’s disease could be beneficial, especially during the early stages of their illness. “The most important thing is that patients have fun when doing rehabilitation.”

The findings were released February 25 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.
 

All exercise beneficial

The idea of studying ping-pong as a therapy for patients with Parkinson’s disease originated when Dr. Fujioka heard about a patient who used a cane but no longer needed it after taking up the exercise as a weekly rehabilitation therapy.

“It’s apparent that the exercise can improve motor function of Parkinson’s disease. However, to date, the effects of the sport have not been well investigated for this patient population, so our study aimed to disclose the effects that table tennis can bring to patients with Parkinson’s disease,” said Dr. Fujioka.

The study included 12 patients with Parkinson’s disease – 10 women and two men. Mean age at disease onset was 67 years, and mean disease duration was 7 years. Mean stage on the Hoehn & Yahr scale, which assesses severity of Parkinson’s disease symptoms, was three, so most patients had balance problems.

Study participants played ping-pong at once-weekly 5-hour sessions that included rest breaks whenever they felt it was necessary.

Researchers assessed participants using the Unified Parkinson’s Disease Rating Scale (UPDRS) part I-IV. Parts II and III assess motor function whereas parts I and IV evaluate nonmotor function and motor complications, respectively.

The main motor symptoms of Parkinson’s disease include bradykinesia and muscle rigidity, tremor, and postural instability.

Researchers also assessed participants using the Montreal Cognitive Assessment (MoCA), Frontal Assessment Battery (FAB), Self-Rating Depression Scale (SDS), and Apathy scale.

Results showed that UPDRS part II significantly improved at 3 and 6 months (both P < 0.001), as did UPDRS part III (P = 0.002 at 3 months; P < 0.001 at 6 months).

Dr. Fujioka speculated, “twisting axial muscles when hitting a ping-pong ball may be the most efficacious for patients, especially for bradykinesia and balance problems.”
 

Significant improvement

Such findings may not be that surprising. Dr. Fujioka pointed to other rehabilitation therapies such as tai chi or tango that may also improve Parkinson’s disease motor symptoms.

For UPDRS part II, subscores of speech, saliva and drooling, dressing, handwriting, doing hobbies and other activities, getting out of bed, a car, or a deep chair, and walking and balance, significantly improved.

In addition, for UPDRS part III, subscores of facial expression, rigidity, postural stability, posture, bradykinesia, and kinetic tremor of the hands also significantly improved.

As for nonmotor symptoms such as mood, anxiety, depression, and apathy assessed in UPDRS part I, scores did not significantly change, which was also the case for part IV.

However, Dr. Fujioka pointed out that patient scores didn’t worsen. “Given the nature of disease, not worsening of nonmotor features can potentially be a good effect of the sport.” MoCA, FAB, SDS, and Apathy scale scores also did not change.

Dr. Fujioka noted that all participants enjoyed the table tennis rehabilitation, and “gradually smiled more during the study period.” All study participants continued the table tennis rehabilitation after the 6-month program.

Dr. Fujioka noted that although patients with Parkinson’s disease often have difficulty moving in a front-to-back direction, they can move relatively easily in a lateral direction.

“In that sense, table tennis is suitable for them,” he said. However, he added, court tennis, handball, and badminton may not be suitable for most patients with Parkinson’s disease.

One patient suffered a fall and another backache. Dr. Fujioka cautioned that more frequent ping-pong playing might increase the risk of adverse events.

He also suggests patients with Parkinson’s disease have their bone density checked before starting regular rehabilitation exercise as they are at increased risk for osteoporosis.

The investigators are currently organizing a prospective, multicenter randomized study to compare the effectiveness of table tennis with conventional rehabilitation and the Lee Silverman Voice Treatment, which is designed to increase vocal intensity in patients with Parkinson’s disease.
 

Fun, engaging

Commenting on the findings, Cynthia Comella, MD, professor emeritus, Neurological Sciences, Rush University Medical Center, New Philadelphia, Ohio, said ping-pong is a “fun and engaging” exercise for patients with Parkinson’s disease. Dr. Comella noted prior studies have shown many types of exercise are beneficial for patients with Parkinson’s disease “provided that they continue” with it.

In that regard, these new results are “promising,” she said. “It may be that this type of community generating, fun exercise would lead to a continuation of the exercise after a study is completed.”

A controlled trial that includes a post-study follow-up to evaluate compliance and continued benefit is needed, she said.

Purchase of equipment, including tables, rackets, and balls, was possible through funds donated by Hisako Kobayashi-Levin, which provides Murakami Karindoh Hospital with an annual fund to improve the quality of their rehabilitation program. The authors reported no relevant financial relationships.

This article first appeared on Medscape.com.

Playing table tennis, also known as ping-pong, appears to improve motor symptoms in patients with Parkinson’s disease, new research suggests. The results of a small pilot study show that table ping-pong is a safe and effective rehabilitative intervention for patients with Parkinson’s disease that can be easily introduced, study investigator Shinsuke Fujioka, MD, Department of Neurology, Fukuoka University, Japan, told Medscape Medical News.

He emphasized that any rehabilitation for patients with Parkinson’s disease could be beneficial, especially during the early stages of their illness. “The most important thing is that patients have fun when doing rehabilitation.”

The findings were released February 25 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.
 

All exercise beneficial

The idea of studying ping-pong as a therapy for patients with Parkinson’s disease originated when Dr. Fujioka heard about a patient who used a cane but no longer needed it after taking up the exercise as a weekly rehabilitation therapy.

“It’s apparent that the exercise can improve motor function of Parkinson’s disease. However, to date, the effects of the sport have not been well investigated for this patient population, so our study aimed to disclose the effects that table tennis can bring to patients with Parkinson’s disease,” said Dr. Fujioka.

The study included 12 patients with Parkinson’s disease – 10 women and two men. Mean age at disease onset was 67 years, and mean disease duration was 7 years. Mean stage on the Hoehn & Yahr scale, which assesses severity of Parkinson’s disease symptoms, was three, so most patients had balance problems.

Study participants played ping-pong at once-weekly 5-hour sessions that included rest breaks whenever they felt it was necessary.

Researchers assessed participants using the Unified Parkinson’s Disease Rating Scale (UPDRS) part I-IV. Parts II and III assess motor function whereas parts I and IV evaluate nonmotor function and motor complications, respectively.

The main motor symptoms of Parkinson’s disease include bradykinesia and muscle rigidity, tremor, and postural instability.

Researchers also assessed participants using the Montreal Cognitive Assessment (MoCA), Frontal Assessment Battery (FAB), Self-Rating Depression Scale (SDS), and Apathy scale.

Results showed that UPDRS part II significantly improved at 3 and 6 months (both P < 0.001), as did UPDRS part III (P = 0.002 at 3 months; P < 0.001 at 6 months).

Dr. Fujioka speculated, “twisting axial muscles when hitting a ping-pong ball may be the most efficacious for patients, especially for bradykinesia and balance problems.”
 

Significant improvement

Such findings may not be that surprising. Dr. Fujioka pointed to other rehabilitation therapies such as tai chi or tango that may also improve Parkinson’s disease motor symptoms.

For UPDRS part II, subscores of speech, saliva and drooling, dressing, handwriting, doing hobbies and other activities, getting out of bed, a car, or a deep chair, and walking and balance, significantly improved.

In addition, for UPDRS part III, subscores of facial expression, rigidity, postural stability, posture, bradykinesia, and kinetic tremor of the hands also significantly improved.

As for nonmotor symptoms such as mood, anxiety, depression, and apathy assessed in UPDRS part I, scores did not significantly change, which was also the case for part IV.

However, Dr. Fujioka pointed out that patient scores didn’t worsen. “Given the nature of disease, not worsening of nonmotor features can potentially be a good effect of the sport.” MoCA, FAB, SDS, and Apathy scale scores also did not change.

Dr. Fujioka noted that all participants enjoyed the table tennis rehabilitation, and “gradually smiled more during the study period.” All study participants continued the table tennis rehabilitation after the 6-month program.

Dr. Fujioka noted that although patients with Parkinson’s disease often have difficulty moving in a front-to-back direction, they can move relatively easily in a lateral direction.

“In that sense, table tennis is suitable for them,” he said. However, he added, court tennis, handball, and badminton may not be suitable for most patients with Parkinson’s disease.

One patient suffered a fall and another backache. Dr. Fujioka cautioned that more frequent ping-pong playing might increase the risk of adverse events.

He also suggests patients with Parkinson’s disease have their bone density checked before starting regular rehabilitation exercise as they are at increased risk for osteoporosis.

The investigators are currently organizing a prospective, multicenter randomized study to compare the effectiveness of table tennis with conventional rehabilitation and the Lee Silverman Voice Treatment, which is designed to increase vocal intensity in patients with Parkinson’s disease.
 

Fun, engaging

Commenting on the findings, Cynthia Comella, MD, professor emeritus, Neurological Sciences, Rush University Medical Center, New Philadelphia, Ohio, said ping-pong is a “fun and engaging” exercise for patients with Parkinson’s disease. Dr. Comella noted prior studies have shown many types of exercise are beneficial for patients with Parkinson’s disease “provided that they continue” with it.

In that regard, these new results are “promising,” she said. “It may be that this type of community generating, fun exercise would lead to a continuation of the exercise after a study is completed.”

A controlled trial that includes a post-study follow-up to evaluate compliance and continued benefit is needed, she said.

Purchase of equipment, including tables, rackets, and balls, was possible through funds donated by Hisako Kobayashi-Levin, which provides Murakami Karindoh Hospital with an annual fund to improve the quality of their rehabilitation program. The authors reported no relevant financial relationships.

This article first appeared on Medscape.com.

Hypersomnolence, or excessive daytime sleepiness, in older adults is a risk factor for developing several serious medical conditions, including hypertension, heart disease, cancer, and diabetes, new research suggests. A study of almost 11,000 participants shows those who reported excessive sleepiness were twice as likely as their nonsleepy counterparts to develop these conditions. Hypersomnolence was also linked to development of musculoskeletal and connective tissue conditions.

“Paying attention to sleepiness in older adults could help doctors predict and prevent future medical conditions,” study investigator Maurice M. Ohayon, MD, PhD, Stanford University, California, said in a news release.

The findings were released March 1 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.
 

Early warning sign

Prior research has suggested an association between hypersomnolence and several psychiatric disorders, as well as cognitive decline and Alzheimer’s disease. However, its role in the development of other medical conditions is not as well studied.

The current investigation included 10,930 adults who were interviewed by phone on two separate occasions 3 years apart. At the second interview, 3,701 participants were at least 65 years old and 59% were women.

About 23% of the elderly participants reported hypersomnolence in the first interview and 24% reported it in the second interview. Of these individuals, 41% said during the first and second interviews that excessive daytime sleepiness was a chronic problem.

After adjusting for gender and obstructive sleep apnea status, participants who reported hypersomnolence in the first interview had more than a twofold greater risk of developing diabetes (relative risk [RR], 2.3; 95% CI, 1.5 - 3.4) or hypertension (RR, 2.3; 95% CI, 1.5 - 3.4) 3 years later than those who did not report this problem. They were also twice as likely to develop cancer (RR, 2.0; 95% CI, 1.1 - 3.8).

Of the 840 participants who reported hypersomnolence at the first interview, 52 (6.2%) developed diabetes compared with 74 (2.9%) who did not have excessive daytime sleepiness. Twenty (2.4%) individuals who reported hypersomnolence developed cancer compared with 21 (0.8%) who did not have it. Chronic hypersomnolence was associated with a greater than twofold increased risk of developing heart disease (RR, 2.5; 95% CI, 1.8 - 3.4).

Those who reported hypersomnolence at the second interview also were 50% more likely to have diseases of the musculoskeletal system and connective tissue, such as arthritis, tendinitis, and lupus, than their peers who did not have excessive daytime sleepiness.

The findings suggest that hypersomnolence in the elderly “can be an early sign of a developing medical condition,” the investigators wrote.

A limitation of the study is that it relied on participants’ memories rather than monitoring their sleep length and quality and daytime sleepiness in a sleep clinic, they noted.

Sleep as a vital sign?

Commenting on the findings, Harly Greenberg, MD, medical director at the Northwell Health Sleep Disorders Center, New York City, called the study “informative.”

However, because the findings were associations, “the study does not necessarily indicate that hypersomnolence itself is causal for these conditions. Rather excessive sleepiness may be a marker of sleep disorders that can cause sleepiness as well as contribute to the risk of these medical conditions,” said Dr. Greenberg, who was not involved with the research.

“The takeaway point from this study is that excessive sleepiness should not be ignored. Not only does it impair quality of life, daytime function, and vigilance and increase risk of sleepiness-related accidents, it may also be a marker for serious sleep disorders that can increase risk for medical disorders,” he said.

Also commenting on the study, Nathaniel Watson, MD, professor of neurology at the University of Washington (UW) and director of the UW Medicine Sleep Clinic, said it is “not surprising” that excessive daytime sleepiness might contribute to diabetes, hypertension, and other diseases.

“Sleep is something we spend a third of our lives doing. It impacts nearly every aspect of human physiology and we have a lot of basic science and epidemiologic research that shows when sleep is either inadequate or of poor quality or not timed correctly it can be associated with some of these untoward health outcomes,” said Watson, who is a past president of the American Academy of Sleep Medicine.

“This research just provides further evidence in support of the importance of sleep for overall health and well-being,” he added.

Asking patients about sleepiness, sleep, or sleep quality should be a “vital sign just like temperature, blood pressure, weight, and these other measures,” Dr. Watson said.

The study was supported by the Arrillaga Foundation. Drs. Ohayon, Greenberg, and Watson have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Hypersomnolence, or excessive daytime sleepiness, in older adults is a risk factor for developing several serious medical conditions, including hypertension, heart disease, cancer, and diabetes, new research suggests. A study of almost 11,000 participants shows those who reported excessive sleepiness were twice as likely as their nonsleepy counterparts to develop these conditions. Hypersomnolence was also linked to development of musculoskeletal and connective tissue conditions.

“Paying attention to sleepiness in older adults could help doctors predict and prevent future medical conditions,” study investigator Maurice M. Ohayon, MD, PhD, Stanford University, California, said in a news release.

The findings were released March 1 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.
 

Early warning sign

Prior research has suggested an association between hypersomnolence and several psychiatric disorders, as well as cognitive decline and Alzheimer’s disease. However, its role in the development of other medical conditions is not as well studied.

The current investigation included 10,930 adults who were interviewed by phone on two separate occasions 3 years apart. At the second interview, 3,701 participants were at least 65 years old and 59% were women.

About 23% of the elderly participants reported hypersomnolence in the first interview and 24% reported it in the second interview. Of these individuals, 41% said during the first and second interviews that excessive daytime sleepiness was a chronic problem.

After adjusting for gender and obstructive sleep apnea status, participants who reported hypersomnolence in the first interview had more than a twofold greater risk of developing diabetes (relative risk [RR], 2.3; 95% CI, 1.5 - 3.4) or hypertension (RR, 2.3; 95% CI, 1.5 - 3.4) 3 years later than those who did not report this problem. They were also twice as likely to develop cancer (RR, 2.0; 95% CI, 1.1 - 3.8).

Of the 840 participants who reported hypersomnolence at the first interview, 52 (6.2%) developed diabetes compared with 74 (2.9%) who did not have excessive daytime sleepiness. Twenty (2.4%) individuals who reported hypersomnolence developed cancer compared with 21 (0.8%) who did not have it. Chronic hypersomnolence was associated with a greater than twofold increased risk of developing heart disease (RR, 2.5; 95% CI, 1.8 - 3.4).

Those who reported hypersomnolence at the second interview also were 50% more likely to have diseases of the musculoskeletal system and connective tissue, such as arthritis, tendinitis, and lupus, than their peers who did not have excessive daytime sleepiness.

The findings suggest that hypersomnolence in the elderly “can be an early sign of a developing medical condition,” the investigators wrote.

A limitation of the study is that it relied on participants’ memories rather than monitoring their sleep length and quality and daytime sleepiness in a sleep clinic, they noted.

Sleep as a vital sign?

Commenting on the findings, Harly Greenberg, MD, medical director at the Northwell Health Sleep Disorders Center, New York City, called the study “informative.”

However, because the findings were associations, “the study does not necessarily indicate that hypersomnolence itself is causal for these conditions. Rather excessive sleepiness may be a marker of sleep disorders that can cause sleepiness as well as contribute to the risk of these medical conditions,” said Dr. Greenberg, who was not involved with the research.

“The takeaway point from this study is that excessive sleepiness should not be ignored. Not only does it impair quality of life, daytime function, and vigilance and increase risk of sleepiness-related accidents, it may also be a marker for serious sleep disorders that can increase risk for medical disorders,” he said.

Also commenting on the study, Nathaniel Watson, MD, professor of neurology at the University of Washington (UW) and director of the UW Medicine Sleep Clinic, said it is “not surprising” that excessive daytime sleepiness might contribute to diabetes, hypertension, and other diseases.

“Sleep is something we spend a third of our lives doing. It impacts nearly every aspect of human physiology and we have a lot of basic science and epidemiologic research that shows when sleep is either inadequate or of poor quality or not timed correctly it can be associated with some of these untoward health outcomes,” said Watson, who is a past president of the American Academy of Sleep Medicine.

“This research just provides further evidence in support of the importance of sleep for overall health and well-being,” he added.

Asking patients about sleepiness, sleep, or sleep quality should be a “vital sign just like temperature, blood pressure, weight, and these other measures,” Dr. Watson said.

The study was supported by the Arrillaga Foundation. Drs. Ohayon, Greenberg, and Watson have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Hypersomnolence, or excessive daytime sleepiness, in older adults is a risk factor for developing several serious medical conditions, including hypertension, heart disease, cancer, and diabetes, new research suggests. A study of almost 11,000 participants shows those who reported excessive sleepiness were twice as likely as their nonsleepy counterparts to develop these conditions. Hypersomnolence was also linked to development of musculoskeletal and connective tissue conditions.

“Paying attention to sleepiness in older adults could help doctors predict and prevent future medical conditions,” study investigator Maurice M. Ohayon, MD, PhD, Stanford University, California, said in a news release.

The findings were released March 1 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.
 

Early warning sign

Prior research has suggested an association between hypersomnolence and several psychiatric disorders, as well as cognitive decline and Alzheimer’s disease. However, its role in the development of other medical conditions is not as well studied.

The current investigation included 10,930 adults who were interviewed by phone on two separate occasions 3 years apart. At the second interview, 3,701 participants were at least 65 years old and 59% were women.

About 23% of the elderly participants reported hypersomnolence in the first interview and 24% reported it in the second interview. Of these individuals, 41% said during the first and second interviews that excessive daytime sleepiness was a chronic problem.

After adjusting for gender and obstructive sleep apnea status, participants who reported hypersomnolence in the first interview had more than a twofold greater risk of developing diabetes (relative risk [RR], 2.3; 95% CI, 1.5 - 3.4) or hypertension (RR, 2.3; 95% CI, 1.5 - 3.4) 3 years later than those who did not report this problem. They were also twice as likely to develop cancer (RR, 2.0; 95% CI, 1.1 - 3.8).

Of the 840 participants who reported hypersomnolence at the first interview, 52 (6.2%) developed diabetes compared with 74 (2.9%) who did not have excessive daytime sleepiness. Twenty (2.4%) individuals who reported hypersomnolence developed cancer compared with 21 (0.8%) who did not have it. Chronic hypersomnolence was associated with a greater than twofold increased risk of developing heart disease (RR, 2.5; 95% CI, 1.8 - 3.4).

Those who reported hypersomnolence at the second interview also were 50% more likely to have diseases of the musculoskeletal system and connective tissue, such as arthritis, tendinitis, and lupus, than their peers who did not have excessive daytime sleepiness.

The findings suggest that hypersomnolence in the elderly “can be an early sign of a developing medical condition,” the investigators wrote.

A limitation of the study is that it relied on participants’ memories rather than monitoring their sleep length and quality and daytime sleepiness in a sleep clinic, they noted.

Sleep as a vital sign?

Commenting on the findings, Harly Greenberg, MD, medical director at the Northwell Health Sleep Disorders Center, New York City, called the study “informative.”

However, because the findings were associations, “the study does not necessarily indicate that hypersomnolence itself is causal for these conditions. Rather excessive sleepiness may be a marker of sleep disorders that can cause sleepiness as well as contribute to the risk of these medical conditions,” said Dr. Greenberg, who was not involved with the research.

“The takeaway point from this study is that excessive sleepiness should not be ignored. Not only does it impair quality of life, daytime function, and vigilance and increase risk of sleepiness-related accidents, it may also be a marker for serious sleep disorders that can increase risk for medical disorders,” he said.

Also commenting on the study, Nathaniel Watson, MD, professor of neurology at the University of Washington (UW) and director of the UW Medicine Sleep Clinic, said it is “not surprising” that excessive daytime sleepiness might contribute to diabetes, hypertension, and other diseases.

“Sleep is something we spend a third of our lives doing. It impacts nearly every aspect of human physiology and we have a lot of basic science and epidemiologic research that shows when sleep is either inadequate or of poor quality or not timed correctly it can be associated with some of these untoward health outcomes,” said Watson, who is a past president of the American Academy of Sleep Medicine.

“This research just provides further evidence in support of the importance of sleep for overall health and well-being,” he added.

Asking patients about sleepiness, sleep, or sleep quality should be a “vital sign just like temperature, blood pressure, weight, and these other measures,” Dr. Watson said.

The study was supported by the Arrillaga Foundation. Drs. Ohayon, Greenberg, and Watson have reported no relevant financial relationships.

This article first appeared on Medscape.com.

A healthier heart in young adulthood could mean fewer cognitive problems later in life, new research suggests. New findings from the Coronary Artery Risk Development in Young Adults (CARDIA) study show that individuals who had better cardiovascular health in their 20s scored higher on tests of thinking and memory 30 years later than their peers who had poorer cardiovascular health as young adults.

“We have learned that midlife vascular risk factors, rather than risk factors in older age, are particularly associated with cognition in older age,” study author Farzaneh Sorond, MD, PhD, Northwestern University Feinberg School of Medicine, Chicago, Illinois, told Medscape Medical News

“Our findings from the CARDIA study expand this knowledge and show that vascular health during young adulthood, rather than midlife, is also specifically associated with brain vascular health and cognitive function” in later life, Dr. Sorond said.

“These results indicate that people need to pay close attention to their health even in their early 20s,” she added in a statement.

The findings were released February 26 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.
 

Early prevention key

The analysis examined data from 189 participants (45% women, 45% black) in the CARDIA study who were followed for 30 years. The mean age at baseline was 24 years.

Vascular risk factors were assessed eight times during the 30-year study period. A cardiovascular health score (range, 0 – 10) was calculated on the basis of smoking status, body mass index, blood pressure, total cholesterol level, and fasting glucose level.

At the final assessment, which was conducted 30 years after baseline, dynamic cerebral autoregulation was calculated as the transfer function phase of the spontaneous oscillations in blood pressure and flow velocity in the middle cerebral artery using transcranial Doppler ultrasound.

Good for the heart, good for the brain

Commenting on the findings, Rebecca Edelmayer, PhD, director of scientific engagement for the Alzheimer’s Association, said that the longitudinal study adds to the growing body of research showing that “what is good for the heart is also good for the brain.”

“This is still a relatively small study, and larger studies have been published that show similar results,” said Dr. Edelmayer, who was not involved with the research.

She noted that results of the large SPRINT-MIND trial, published last year in JAMA and reported by Medscape Medical News, “provided the strongest evidence to date about reducing risk of mild cognitive impairment through the management of high blood pressure.”

The Alzheimer’s Association has provided seed funding for SPRINT-MIND 2.0, a 2-year extension of the study to evaluate whether intensive blood pressure management reduces risk for all-cause dementia.

Support for the current study was provided by the National Institutes of Health, the National Heart, Lung, and Blood Institute, the University of Alabama at Birmingham, Northwestern University, the University of Minnesota, and the Kaiser Foundation Research Institute. Drs. Sorond and Edelmayer have reported no relevant financial relationships.

This article first appeared on Medscape.com.

A healthier heart in young adulthood could mean fewer cognitive problems later in life, new research suggests. New findings from the Coronary Artery Risk Development in Young Adults (CARDIA) study show that individuals who had better cardiovascular health in their 20s scored higher on tests of thinking and memory 30 years later than their peers who had poorer cardiovascular health as young adults.

“We have learned that midlife vascular risk factors, rather than risk factors in older age, are particularly associated with cognition in older age,” study author Farzaneh Sorond, MD, PhD, Northwestern University Feinberg School of Medicine, Chicago, Illinois, told Medscape Medical News

“Our findings from the CARDIA study expand this knowledge and show that vascular health during young adulthood, rather than midlife, is also specifically associated with brain vascular health and cognitive function” in later life, Dr. Sorond said.

“These results indicate that people need to pay close attention to their health even in their early 20s,” she added in a statement.

The findings were released February 26 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.
 

Early prevention key

The analysis examined data from 189 participants (45% women, 45% black) in the CARDIA study who were followed for 30 years. The mean age at baseline was 24 years.

Vascular risk factors were assessed eight times during the 30-year study period. A cardiovascular health score (range, 0 – 10) was calculated on the basis of smoking status, body mass index, blood pressure, total cholesterol level, and fasting glucose level.

At the final assessment, which was conducted 30 years after baseline, dynamic cerebral autoregulation was calculated as the transfer function phase of the spontaneous oscillations in blood pressure and flow velocity in the middle cerebral artery using transcranial Doppler ultrasound.

Good for the heart, good for the brain

Commenting on the findings, Rebecca Edelmayer, PhD, director of scientific engagement for the Alzheimer’s Association, said that the longitudinal study adds to the growing body of research showing that “what is good for the heart is also good for the brain.”

“This is still a relatively small study, and larger studies have been published that show similar results,” said Dr. Edelmayer, who was not involved with the research.

She noted that results of the large SPRINT-MIND trial, published last year in JAMA and reported by Medscape Medical News, “provided the strongest evidence to date about reducing risk of mild cognitive impairment through the management of high blood pressure.”

The Alzheimer’s Association has provided seed funding for SPRINT-MIND 2.0, a 2-year extension of the study to evaluate whether intensive blood pressure management reduces risk for all-cause dementia.

Support for the current study was provided by the National Institutes of Health, the National Heart, Lung, and Blood Institute, the University of Alabama at Birmingham, Northwestern University, the University of Minnesota, and the Kaiser Foundation Research Institute. Drs. Sorond and Edelmayer have reported no relevant financial relationships.

This article first appeared on Medscape.com.

A healthier heart in young adulthood could mean fewer cognitive problems later in life, new research suggests. New findings from the Coronary Artery Risk Development in Young Adults (CARDIA) study show that individuals who had better cardiovascular health in their 20s scored higher on tests of thinking and memory 30 years later than their peers who had poorer cardiovascular health as young adults.

“We have learned that midlife vascular risk factors, rather than risk factors in older age, are particularly associated with cognition in older age,” study author Farzaneh Sorond, MD, PhD, Northwestern University Feinberg School of Medicine, Chicago, Illinois, told Medscape Medical News

“Our findings from the CARDIA study expand this knowledge and show that vascular health during young adulthood, rather than midlife, is also specifically associated with brain vascular health and cognitive function” in later life, Dr. Sorond said.

“These results indicate that people need to pay close attention to their health even in their early 20s,” she added in a statement.

The findings were released February 26 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.
 

Early prevention key

The analysis examined data from 189 participants (45% women, 45% black) in the CARDIA study who were followed for 30 years. The mean age at baseline was 24 years.

Vascular risk factors were assessed eight times during the 30-year study period. A cardiovascular health score (range, 0 – 10) was calculated on the basis of smoking status, body mass index, blood pressure, total cholesterol level, and fasting glucose level.

At the final assessment, which was conducted 30 years after baseline, dynamic cerebral autoregulation was calculated as the transfer function phase of the spontaneous oscillations in blood pressure and flow velocity in the middle cerebral artery using transcranial Doppler ultrasound.

Good for the heart, good for the brain

Commenting on the findings, Rebecca Edelmayer, PhD, director of scientific engagement for the Alzheimer’s Association, said that the longitudinal study adds to the growing body of research showing that “what is good for the heart is also good for the brain.”

“This is still a relatively small study, and larger studies have been published that show similar results,” said Dr. Edelmayer, who was not involved with the research.

She noted that results of the large SPRINT-MIND trial, published last year in JAMA and reported by Medscape Medical News, “provided the strongest evidence to date about reducing risk of mild cognitive impairment through the management of high blood pressure.”

The Alzheimer’s Association has provided seed funding for SPRINT-MIND 2.0, a 2-year extension of the study to evaluate whether intensive blood pressure management reduces risk for all-cause dementia.

Support for the current study was provided by the National Institutes of Health, the National Heart, Lung, and Blood Institute, the University of Alabama at Birmingham, Northwestern University, the University of Minnesota, and the Kaiser Foundation Research Institute. Drs. Sorond and Edelmayer have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Patients with a mild traumatic brain injury (mTBI) who are exposed to blue light experience less depression and fewer cognitive and other concussion-related symptoms than those exposed to a placebo light, a new study has found. Exposure to blue light in the morning through a special device may be a “critical factor” in resetting the circadian rhythm and helping people who have suffered a concussion, author William D. “Scott” Killgore, MD, professor of psychiatry, psychology, and medical imaging, the University of Arizona College of Medicine, Tucson, told Medscape Medical News.

“This is very new, so I wouldn’t say it’s the treatment of choice, but we should start looking at using this system as a nonpharmacologic way to perhaps help patients recover faster from a concussion,” he said.

The findings were released March 2 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.

About half of patients with a concussion experience sleep problems, including problems falling asleep, staying asleep, and waking up in the middle of the night, said Dr. Killgore.

Poor sleep interrupts the brain’s repair mechanism. “Sleep is important for cleaning out the neurotoxins that build up in your brain during the day. Sleep also helps build oligodendrocyte precursor cells that provide insulation around nerve cells,” he said.
 

Master clock

Blue light stimulates receptors in the back of the retina that respond only to this wavelength of light, said Dr. Killgore. “It specifically projects to an area in the hypothalamus – essentially the brain’s master clock – that regulates your sleep-wake schedules. So exposure to that bright light essentially resets your circadian rhythm.”

That master clock involves regulating the brain’s production of melatonin. Morning exposure to blue light shifts that production to facilitate sleep at the appropriate time.

The ideal time to be exposed to blue light is from about 8:00 to 11:00 AM. “Timing is critical,” said Dr. Killgore. “If you get light at the wrong time, it will reset your circadian rhythm in the wrong direction.”

Previous research has shown that exposure to blue light leads to improved sleep, which is widely believed to lead to improved mood.

A separate study conducted by Dr. Killgore and colleagues that involved another group of mTBI patients was recently published in Neurobiology of Disease. That study showed that the participants who received blue light experienced a shift in circadian timing of about an hour. “They were going to sleep an hour earlier and waking up an hour earlier,” said Dr. Killgore.

The blue light also appeared to change brain structure and brain function, among other things, he said.

The current study included 35 patients who had suffered an mTBI within the previous 18 months. Most injuries were sports related and occurred while playing football or soccer or riding a bike.

Participants were randomly assigned to use a device fitted with a blue LED light (peak wavelength, 469 nm) or one fitted with an amber-colored LED light. They were instructed to use the device every morning for 30 minutes within 2 hours of waking.

The blue-light group comprised five men and 12 women (mean age, 25.5 years). The amber-light group comprised eight men and 10 women (mean age, 26.3 years).

Researchers told participants only that the study was exploring various aspects of light. “Subjects didn’t know if they were getting a control or active device,” said Dr. Killgore.

Researchers used the Beck Depression Inventory (BDI) to evaluate depression symptoms and the Rivermead Post-Concussion Symptom Questionnaire (RPCSQ). This 16-item questionnaire assesses symptoms in the acute stage as well as those that are more chronic.

After 6 weeks, the blue-light group had lower scores on the BDI compared to the amber-light group (P = .005).

“We found that in the amber-light group, there was essentially no change in terms of depression,” said Dr. Killgore. “But those who got the blue light showed a significant reduction in depressive symptoms, about a 22% decline overall relative to baseline, so a nice drop in overall depression.”

Changes in BDI scores were significantly positively associated with changes in the total chronic symptom score (P = .002) in the blue-light group but not the amber-light group. “Those who got blue light showed a significant reduction in the number of symptoms associated with concussion whereas those who got the amber light stayed the same,” said Dr. Killgore.

There were similar findings for somatic symptoms, such as headache and pain (P = .031), and for cognitive symptoms (P = .014) in the blue-light group.

“These subjects were having fewer problems remembering and paying attention, so their concentration seemed to be improving, at least subjectively,” commented Dr. Killgore.

There was no significant benefit from the blue light for emotional symptoms. “There was a decline, but it wasn’t statistically significant, even though there was a decline in depression,” said Dr. Killgore.

This, he explained, could be due to the small sample size and the greater sensitivity of the BDI for emotional symptoms relative to the RPCSQ. “The BDI has 21 items that are all focused on aspects of depression, whereas the RPCSQ only asks one item for depression and one item for irritability/anger.”

Less daytime sleepiness

The researchers also found a significant improvement in daytime sleepiness. “Subjects were much less sleepy by the end of the study if they got blue light than if they got amber light,” said Dr. Killgore.

Participants wore an actigraphy device that took sleep measurements. Early results indicate that blue-light recipients were getting more sleep by the end of the study.

Researchers are now analyzing additional data to see whether the improvements in depression and post-concussion symptoms are linked to improved sleep. They also gathered data from brain imaging that will be analyzed at a later date.

Dr. Killgore and his colleagues aim to determine what distinguishes people who respond to blue-light therapy from those who don’t. “We want to know what it is that would allow some people to be more responsive than others, so we’re going to be exploring skin color, eye color, genetic factors, and other factors,” he said.

They’re also conducting a study of blue-light therapy in patients with posttraumatic stress disorder, 90% of whom have sleep problems.

“This is quite fascinating,” said Dr. Killgore. “It looks like if you get blue light after your treatment, the treatment sticks better than if you didn’t get the blue light. We think that sleep is probably playing an important role in that.”

Several light devices are available, ranging in price from about $100 to $200.

Commenting on the research, concussion expert Frank Conidi, MD, director of the Florida Center for Headache and Sports Neurology, Port St. Lucie, said the study is interesting from a number of perspectives.

For one thing, it shows that blue-light therapy “provides an inexpensive and minimally invasive way to treat concussion,” he said.

Dr. Conidi said he would recommend blue-light therapy for concussion patients. “I could see neurology practices offering the device to patients as an in-office treatment or to take home for a small fee. I think athletes would be quite receptive to this, as they’re always looking for nonpharmacological ways to treat concussion.”

Dr. Conidi noted that the new results are consistent with other studies that show that decreased depression and improved sleep help with somatic symptoms.

From a research perspective, the study provides a “stepping stone” for larger trials, said Dr. Conidi. He would like to see more studies of acute concussion, such as studies as to whether the therapy shortens the duration of symptoms.

“I would also like to see controlled studies on headache and vestibular symptoms, which are the two most common,” he said.

The study was funded by the US Department of Defense. Killgore and Conidi have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Patients with a mild traumatic brain injury (mTBI) who are exposed to blue light experience less depression and fewer cognitive and other concussion-related symptoms than those exposed to a placebo light, a new study has found. Exposure to blue light in the morning through a special device may be a “critical factor” in resetting the circadian rhythm and helping people who have suffered a concussion, author William D. “Scott” Killgore, MD, professor of psychiatry, psychology, and medical imaging, the University of Arizona College of Medicine, Tucson, told Medscape Medical News.

“This is very new, so I wouldn’t say it’s the treatment of choice, but we should start looking at using this system as a nonpharmacologic way to perhaps help patients recover faster from a concussion,” he said.

The findings were released March 2 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.

About half of patients with a concussion experience sleep problems, including problems falling asleep, staying asleep, and waking up in the middle of the night, said Dr. Killgore.

Poor sleep interrupts the brain’s repair mechanism. “Sleep is important for cleaning out the neurotoxins that build up in your brain during the day. Sleep also helps build oligodendrocyte precursor cells that provide insulation around nerve cells,” he said.
 

Master clock

Blue light stimulates receptors in the back of the retina that respond only to this wavelength of light, said Dr. Killgore. “It specifically projects to an area in the hypothalamus – essentially the brain’s master clock – that regulates your sleep-wake schedules. So exposure to that bright light essentially resets your circadian rhythm.”

That master clock involves regulating the brain’s production of melatonin. Morning exposure to blue light shifts that production to facilitate sleep at the appropriate time.

The ideal time to be exposed to blue light is from about 8:00 to 11:00 AM. “Timing is critical,” said Dr. Killgore. “If you get light at the wrong time, it will reset your circadian rhythm in the wrong direction.”

Previous research has shown that exposure to blue light leads to improved sleep, which is widely believed to lead to improved mood.

A separate study conducted by Dr. Killgore and colleagues that involved another group of mTBI patients was recently published in Neurobiology of Disease. That study showed that the participants who received blue light experienced a shift in circadian timing of about an hour. “They were going to sleep an hour earlier and waking up an hour earlier,” said Dr. Killgore.

The blue light also appeared to change brain structure and brain function, among other things, he said.

The current study included 35 patients who had suffered an mTBI within the previous 18 months. Most injuries were sports related and occurred while playing football or soccer or riding a bike.

Participants were randomly assigned to use a device fitted with a blue LED light (peak wavelength, 469 nm) or one fitted with an amber-colored LED light. They were instructed to use the device every morning for 30 minutes within 2 hours of waking.

The blue-light group comprised five men and 12 women (mean age, 25.5 years). The amber-light group comprised eight men and 10 women (mean age, 26.3 years).

Researchers told participants only that the study was exploring various aspects of light. “Subjects didn’t know if they were getting a control or active device,” said Dr. Killgore.

Researchers used the Beck Depression Inventory (BDI) to evaluate depression symptoms and the Rivermead Post-Concussion Symptom Questionnaire (RPCSQ). This 16-item questionnaire assesses symptoms in the acute stage as well as those that are more chronic.

After 6 weeks, the blue-light group had lower scores on the BDI compared to the amber-light group (P = .005).

“We found that in the amber-light group, there was essentially no change in terms of depression,” said Dr. Killgore. “But those who got the blue light showed a significant reduction in depressive symptoms, about a 22% decline overall relative to baseline, so a nice drop in overall depression.”

Changes in BDI scores were significantly positively associated with changes in the total chronic symptom score (P = .002) in the blue-light group but not the amber-light group. “Those who got blue light showed a significant reduction in the number of symptoms associated with concussion whereas those who got the amber light stayed the same,” said Dr. Killgore.

There were similar findings for somatic symptoms, such as headache and pain (P = .031), and for cognitive symptoms (P = .014) in the blue-light group.

“These subjects were having fewer problems remembering and paying attention, so their concentration seemed to be improving, at least subjectively,” commented Dr. Killgore.

There was no significant benefit from the blue light for emotional symptoms. “There was a decline, but it wasn’t statistically significant, even though there was a decline in depression,” said Dr. Killgore.

This, he explained, could be due to the small sample size and the greater sensitivity of the BDI for emotional symptoms relative to the RPCSQ. “The BDI has 21 items that are all focused on aspects of depression, whereas the RPCSQ only asks one item for depression and one item for irritability/anger.”

Less daytime sleepiness

The researchers also found a significant improvement in daytime sleepiness. “Subjects were much less sleepy by the end of the study if they got blue light than if they got amber light,” said Dr. Killgore.

Participants wore an actigraphy device that took sleep measurements. Early results indicate that blue-light recipients were getting more sleep by the end of the study.

Researchers are now analyzing additional data to see whether the improvements in depression and post-concussion symptoms are linked to improved sleep. They also gathered data from brain imaging that will be analyzed at a later date.

Dr. Killgore and his colleagues aim to determine what distinguishes people who respond to blue-light therapy from those who don’t. “We want to know what it is that would allow some people to be more responsive than others, so we’re going to be exploring skin color, eye color, genetic factors, and other factors,” he said.

They’re also conducting a study of blue-light therapy in patients with posttraumatic stress disorder, 90% of whom have sleep problems.

“This is quite fascinating,” said Dr. Killgore. “It looks like if you get blue light after your treatment, the treatment sticks better than if you didn’t get the blue light. We think that sleep is probably playing an important role in that.”

Several light devices are available, ranging in price from about $100 to $200.

Commenting on the research, concussion expert Frank Conidi, MD, director of the Florida Center for Headache and Sports Neurology, Port St. Lucie, said the study is interesting from a number of perspectives.

For one thing, it shows that blue-light therapy “provides an inexpensive and minimally invasive way to treat concussion,” he said.

Dr. Conidi said he would recommend blue-light therapy for concussion patients. “I could see neurology practices offering the device to patients as an in-office treatment or to take home for a small fee. I think athletes would be quite receptive to this, as they’re always looking for nonpharmacological ways to treat concussion.”

Dr. Conidi noted that the new results are consistent with other studies that show that decreased depression and improved sleep help with somatic symptoms.

From a research perspective, the study provides a “stepping stone” for larger trials, said Dr. Conidi. He would like to see more studies of acute concussion, such as studies as to whether the therapy shortens the duration of symptoms.

“I would also like to see controlled studies on headache and vestibular symptoms, which are the two most common,” he said.

The study was funded by the US Department of Defense. Killgore and Conidi have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Patients with a mild traumatic brain injury (mTBI) who are exposed to blue light experience less depression and fewer cognitive and other concussion-related symptoms than those exposed to a placebo light, a new study has found. Exposure to blue light in the morning through a special device may be a “critical factor” in resetting the circadian rhythm and helping people who have suffered a concussion, author William D. “Scott” Killgore, MD, professor of psychiatry, psychology, and medical imaging, the University of Arizona College of Medicine, Tucson, told Medscape Medical News.

“This is very new, so I wouldn’t say it’s the treatment of choice, but we should start looking at using this system as a nonpharmacologic way to perhaps help patients recover faster from a concussion,” he said.

The findings were released March 2 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.

About half of patients with a concussion experience sleep problems, including problems falling asleep, staying asleep, and waking up in the middle of the night, said Dr. Killgore.

Poor sleep interrupts the brain’s repair mechanism. “Sleep is important for cleaning out the neurotoxins that build up in your brain during the day. Sleep also helps build oligodendrocyte precursor cells that provide insulation around nerve cells,” he said.
 

Master clock

Blue light stimulates receptors in the back of the retina that respond only to this wavelength of light, said Dr. Killgore. “It specifically projects to an area in the hypothalamus – essentially the brain’s master clock – that regulates your sleep-wake schedules. So exposure to that bright light essentially resets your circadian rhythm.”

That master clock involves regulating the brain’s production of melatonin. Morning exposure to blue light shifts that production to facilitate sleep at the appropriate time.

The ideal time to be exposed to blue light is from about 8:00 to 11:00 AM. “Timing is critical,” said Dr. Killgore. “If you get light at the wrong time, it will reset your circadian rhythm in the wrong direction.”

Previous research has shown that exposure to blue light leads to improved sleep, which is widely believed to lead to improved mood.

A separate study conducted by Dr. Killgore and colleagues that involved another group of mTBI patients was recently published in Neurobiology of Disease. That study showed that the participants who received blue light experienced a shift in circadian timing of about an hour. “They were going to sleep an hour earlier and waking up an hour earlier,” said Dr. Killgore.

The blue light also appeared to change brain structure and brain function, among other things, he said.

The current study included 35 patients who had suffered an mTBI within the previous 18 months. Most injuries were sports related and occurred while playing football or soccer or riding a bike.

Participants were randomly assigned to use a device fitted with a blue LED light (peak wavelength, 469 nm) or one fitted with an amber-colored LED light. They were instructed to use the device every morning for 30 minutes within 2 hours of waking.

The blue-light group comprised five men and 12 women (mean age, 25.5 years). The amber-light group comprised eight men and 10 women (mean age, 26.3 years).

Researchers told participants only that the study was exploring various aspects of light. “Subjects didn’t know if they were getting a control or active device,” said Dr. Killgore.

Researchers used the Beck Depression Inventory (BDI) to evaluate depression symptoms and the Rivermead Post-Concussion Symptom Questionnaire (RPCSQ). This 16-item questionnaire assesses symptoms in the acute stage as well as those that are more chronic.

After 6 weeks, the blue-light group had lower scores on the BDI compared to the amber-light group (P = .005).

“We found that in the amber-light group, there was essentially no change in terms of depression,” said Dr. Killgore. “But those who got the blue light showed a significant reduction in depressive symptoms, about a 22% decline overall relative to baseline, so a nice drop in overall depression.”

Changes in BDI scores were significantly positively associated with changes in the total chronic symptom score (P = .002) in the blue-light group but not the amber-light group. “Those who got blue light showed a significant reduction in the number of symptoms associated with concussion whereas those who got the amber light stayed the same,” said Dr. Killgore.

There were similar findings for somatic symptoms, such as headache and pain (P = .031), and for cognitive symptoms (P = .014) in the blue-light group.

“These subjects were having fewer problems remembering and paying attention, so their concentration seemed to be improving, at least subjectively,” commented Dr. Killgore.

There was no significant benefit from the blue light for emotional symptoms. “There was a decline, but it wasn’t statistically significant, even though there was a decline in depression,” said Dr. Killgore.

This, he explained, could be due to the small sample size and the greater sensitivity of the BDI for emotional symptoms relative to the RPCSQ. “The BDI has 21 items that are all focused on aspects of depression, whereas the RPCSQ only asks one item for depression and one item for irritability/anger.”

Less daytime sleepiness

The researchers also found a significant improvement in daytime sleepiness. “Subjects were much less sleepy by the end of the study if they got blue light than if they got amber light,” said Dr. Killgore.

Participants wore an actigraphy device that took sleep measurements. Early results indicate that blue-light recipients were getting more sleep by the end of the study.

Researchers are now analyzing additional data to see whether the improvements in depression and post-concussion symptoms are linked to improved sleep. They also gathered data from brain imaging that will be analyzed at a later date.

Dr. Killgore and his colleagues aim to determine what distinguishes people who respond to blue-light therapy from those who don’t. “We want to know what it is that would allow some people to be more responsive than others, so we’re going to be exploring skin color, eye color, genetic factors, and other factors,” he said.

They’re also conducting a study of blue-light therapy in patients with posttraumatic stress disorder, 90% of whom have sleep problems.

“This is quite fascinating,” said Dr. Killgore. “It looks like if you get blue light after your treatment, the treatment sticks better than if you didn’t get the blue light. We think that sleep is probably playing an important role in that.”

Several light devices are available, ranging in price from about $100 to $200.

Commenting on the research, concussion expert Frank Conidi, MD, director of the Florida Center for Headache and Sports Neurology, Port St. Lucie, said the study is interesting from a number of perspectives.

For one thing, it shows that blue-light therapy “provides an inexpensive and minimally invasive way to treat concussion,” he said.

Dr. Conidi said he would recommend blue-light therapy for concussion patients. “I could see neurology practices offering the device to patients as an in-office treatment or to take home for a small fee. I think athletes would be quite receptive to this, as they’re always looking for nonpharmacological ways to treat concussion.”

Dr. Conidi noted that the new results are consistent with other studies that show that decreased depression and improved sleep help with somatic symptoms.

From a research perspective, the study provides a “stepping stone” for larger trials, said Dr. Conidi. He would like to see more studies of acute concussion, such as studies as to whether the therapy shortens the duration of symptoms.

“I would also like to see controlled studies on headache and vestibular symptoms, which are the two most common,” he said.

The study was funded by the US Department of Defense. Killgore and Conidi have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

The take-home message from a growing number of recent COVID-19 case reports is that the infection might be far more than a respiratory disease.

Although a cause-and-effect relationship is unknown, people with the virus have presented with or developed heart disease, acute liver injury, ongoing GI issues, skin manifestations, neurologic damage, and other problems, especially among sicker people.

For example, French physicians described an association with encephalopathy, agitation, confusion, and corticospinal tract signs among 58 people hospitalized with acute respiratory distress (N Engl J Med. 2020 Apr 15. doi: 10.1056/NEJMc2008597).

In particular, Yale New Haven (Conn.) Hospital is dealing with unexpected complications up close. Almost half of the beds there are occupied by COVID-19 patients. Over 100 people are in the ICU, and almost 70 intubated. Of the more than 750 COVID admissions so far, only about 350 have been discharged. “Even in a bad flu season, you never see something like this; it’s just unheard of,” said Harlan Krumholz, MD, a Yale cardiologist and professor of medicine helping lead the efforts there.
 

Kidney injuries prominent

“When they get to the ICU, we are seeing lots of people with acute kidney injuries; lots of people developing endocrine problems; people having blood sugar control issues, coagulation issues, blood clots. We are just waking up to the wide range of ways this virus can affect people. Our ignorance is profound,” Dr. Krumholz said, but physicians “recognize that this thing has the capability of attacking almost every single organ system, and it may or may not present with respiratory symptoms.”

It’s a similar story at Mt. Sinai South Nassau, a hospital in Oceanside, N.Y. “We’ve seen a lot of renal injury in people having complications, a lot of acute dialysis,” but it’s unclear how much is caused by the virus and how much is simply because people are so sick, said Aaron Glatt, MD, infectious disease professor and chair of medicine at the hospital. However, he said things are looking brighter than at Yale.

“We are not seeing the same level of increase in cases that we had previously, and we are starting to see extubations and discharges. We’ve treated a number of patients with plasma therapy, and hopefully that will be of benefit. We’ve seen some response to” the immunosuppressive “tocilizumab [Actemra], and a lot of response to very good respiratory therapy. I think we are starting to flatten the curve,” Dr. Glatt said.
 

“Look for tricky symptoms”

The growing awareness of COVID’s protean manifestations is evident in Medscape’s Consult forum, an online community where physicians and medical students share information and seek advice; there’s been over 200 COVID-19 cases and questions since January.

Early on, traffic was mostly about typical pulmonary presentations, but lately it’s shifted to nonrespiratory involvement. Physicians want to know if what they are seeing is related to the virus, and if other people are seeing the same things.

There’s a case on Consult of a 37-year-old man with stomach pain, vomiting, and diarrhea, but no respiratory symptoms and a positive COVID test. A chest CT incidental to his abdominal scan revealed significant bilateral lung involvement.

A 69-year-old woman with a history of laparotomy and new onset intestinal subocclusion had only adhesions on a subsequent exploratory laparotomy, and was doing okay otherwise. She suddenly went into respiratory failure with progressive bradycardia and died 3 days later. Aspiration pneumonia, pulmonary embolism, and MI had been ruled out. “The pattern of cardiovascular failure was in favor of myocarditis, but we don’t have any other clue,” the physician said after describing a second similar case.

Another doctor on the forum reported elevated cardiac enzymes without coronary artery obstruction in a positive patient who went into shock, with an ejection fraction of 40% and markedly increased heart wall thickness, but no lung involvement. There are also two cases of idiopathic thrombocytopenia without fever of hypoxia.

An Italian gastroenterologist said: “Look for tricky symptoms.” Expand “patient history, asking about the sudden occurrence of dysgeusia and/or anosmia. These symptoms have become my guiding diagnostic light” in Verona. “Most patients become nauseated, [and] the taste of any food is unbearable. When I find these symptoms by history, the patient is COVID positive 100%.”
 

‘Make sure that they didn’t die in vain’

There was interest in those and other reports on Consult, and comments from physicians who have theories, but no certain answers about what is, and is not, caused by the virus.

Direct viral attack is likely a part of it, said Stanley Perlman, MD, PhD, a professor of microbiology and immunology at the University of Iowa, Iowa City.

The ACE2 receptor the virus uses to enter cells is common in many organs, plus there were extrapulmonary manifestations with severe acute respiratory syndrome (SARS), another pandemic caused by a zoonotic coronavirus almost 20 years ago. At least with SARS, “many organs were infected when examined at autopsy,” he said.

The body’s inflammatory response is almost certainly also in play. Progressive derangements in inflammatory markers – C-reactive protein, D-dimer, ferritin – correlate with worse prognosis, and “the cytokine storm that occurs in these patients can lead to a degree of encephalopathy, myocarditis, liver impairment, and kidney impairment; multiorgan dysfunction, in other words,” said William Shaffner, MD, a professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, Nashville, Tenn.

But in some cases, the virus might simply be a bystander to an unrelated disease process; in others, the experimental treatments being used might cause problems. Indeed, cardiology groups recently warned of torsade de pointes – a dangerously abnormal heart rhythm – with hydroxychloroquine and azithromycin.

“We think it’s some combination,” but don’t really know, Dr. Krumholz said. In the meantime, “we are forced to treat patients by instinct and first principles,” and long-term sequelae are unknown. “We don’t want to be in this position for long.”

To that end, he said, “this is the time for us all to hold hands and be together because we need to learn rapidly from each other. Our job is both to care for the people in front of us and make sure that they didn’t die in vain, that the experience they had is funneled into a larger set of data to make sure the next person is better off.”

[email protected]

The take-home message from a growing number of recent COVID-19 case reports is that the infection might be far more than a respiratory disease.

Although a cause-and-effect relationship is unknown, people with the virus have presented with or developed heart disease, acute liver injury, ongoing GI issues, skin manifestations, neurologic damage, and other problems, especially among sicker people.

For example, French physicians described an association with encephalopathy, agitation, confusion, and corticospinal tract signs among 58 people hospitalized with acute respiratory distress (N Engl J Med. 2020 Apr 15. doi: 10.1056/NEJMc2008597).

In particular, Yale New Haven (Conn.) Hospital is dealing with unexpected complications up close. Almost half of the beds there are occupied by COVID-19 patients. Over 100 people are in the ICU, and almost 70 intubated. Of the more than 750 COVID admissions so far, only about 350 have been discharged. “Even in a bad flu season, you never see something like this; it’s just unheard of,” said Harlan Krumholz, MD, a Yale cardiologist and professor of medicine helping lead the efforts there.
 

Kidney injuries prominent

“When they get to the ICU, we are seeing lots of people with acute kidney injuries; lots of people developing endocrine problems; people having blood sugar control issues, coagulation issues, blood clots. We are just waking up to the wide range of ways this virus can affect people. Our ignorance is profound,” Dr. Krumholz said, but physicians “recognize that this thing has the capability of attacking almost every single organ system, and it may or may not present with respiratory symptoms.”

It’s a similar story at Mt. Sinai South Nassau, a hospital in Oceanside, N.Y. “We’ve seen a lot of renal injury in people having complications, a lot of acute dialysis,” but it’s unclear how much is caused by the virus and how much is simply because people are so sick, said Aaron Glatt, MD, infectious disease professor and chair of medicine at the hospital. However, he said things are looking brighter than at Yale.

“We are not seeing the same level of increase in cases that we had previously, and we are starting to see extubations and discharges. We’ve treated a number of patients with plasma therapy, and hopefully that will be of benefit. We’ve seen some response to” the immunosuppressive “tocilizumab [Actemra], and a lot of response to very good respiratory therapy. I think we are starting to flatten the curve,” Dr. Glatt said.
 

“Look for tricky symptoms”

The growing awareness of COVID’s protean manifestations is evident in Medscape’s Consult forum, an online community where physicians and medical students share information and seek advice; there’s been over 200 COVID-19 cases and questions since January.

Early on, traffic was mostly about typical pulmonary presentations, but lately it’s shifted to nonrespiratory involvement. Physicians want to know if what they are seeing is related to the virus, and if other people are seeing the same things.

There’s a case on Consult of a 37-year-old man with stomach pain, vomiting, and diarrhea, but no respiratory symptoms and a positive COVID test. A chest CT incidental to his abdominal scan revealed significant bilateral lung involvement.

A 69-year-old woman with a history of laparotomy and new onset intestinal subocclusion had only adhesions on a subsequent exploratory laparotomy, and was doing okay otherwise. She suddenly went into respiratory failure with progressive bradycardia and died 3 days later. Aspiration pneumonia, pulmonary embolism, and MI had been ruled out. “The pattern of cardiovascular failure was in favor of myocarditis, but we don’t have any other clue,” the physician said after describing a second similar case.

Another doctor on the forum reported elevated cardiac enzymes without coronary artery obstruction in a positive patient who went into shock, with an ejection fraction of 40% and markedly increased heart wall thickness, but no lung involvement. There are also two cases of idiopathic thrombocytopenia without fever of hypoxia.

An Italian gastroenterologist said: “Look for tricky symptoms.” Expand “patient history, asking about the sudden occurrence of dysgeusia and/or anosmia. These symptoms have become my guiding diagnostic light” in Verona. “Most patients become nauseated, [and] the taste of any food is unbearable. When I find these symptoms by history, the patient is COVID positive 100%.”
 

‘Make sure that they didn’t die in vain’

There was interest in those and other reports on Consult, and comments from physicians who have theories, but no certain answers about what is, and is not, caused by the virus.

Direct viral attack is likely a part of it, said Stanley Perlman, MD, PhD, a professor of microbiology and immunology at the University of Iowa, Iowa City.

The ACE2 receptor the virus uses to enter cells is common in many organs, plus there were extrapulmonary manifestations with severe acute respiratory syndrome (SARS), another pandemic caused by a zoonotic coronavirus almost 20 years ago. At least with SARS, “many organs were infected when examined at autopsy,” he said.

The body’s inflammatory response is almost certainly also in play. Progressive derangements in inflammatory markers – C-reactive protein, D-dimer, ferritin – correlate with worse prognosis, and “the cytokine storm that occurs in these patients can lead to a degree of encephalopathy, myocarditis, liver impairment, and kidney impairment; multiorgan dysfunction, in other words,” said William Shaffner, MD, a professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, Nashville, Tenn.

But in some cases, the virus might simply be a bystander to an unrelated disease process; in others, the experimental treatments being used might cause problems. Indeed, cardiology groups recently warned of torsade de pointes – a dangerously abnormal heart rhythm – with hydroxychloroquine and azithromycin.

“We think it’s some combination,” but don’t really know, Dr. Krumholz said. In the meantime, “we are forced to treat patients by instinct and first principles,” and long-term sequelae are unknown. “We don’t want to be in this position for long.”

To that end, he said, “this is the time for us all to hold hands and be together because we need to learn rapidly from each other. Our job is both to care for the people in front of us and make sure that they didn’t die in vain, that the experience they had is funneled into a larger set of data to make sure the next person is better off.”

[email protected]

The take-home message from a growing number of recent COVID-19 case reports is that the infection might be far more than a respiratory disease.

Although a cause-and-effect relationship is unknown, people with the virus have presented with or developed heart disease, acute liver injury, ongoing GI issues, skin manifestations, neurologic damage, and other problems, especially among sicker people.

For example, French physicians described an association with encephalopathy, agitation, confusion, and corticospinal tract signs among 58 people hospitalized with acute respiratory distress (N Engl J Med. 2020 Apr 15. doi: 10.1056/NEJMc2008597).

In particular, Yale New Haven (Conn.) Hospital is dealing with unexpected complications up close. Almost half of the beds there are occupied by COVID-19 patients. Over 100 people are in the ICU, and almost 70 intubated. Of the more than 750 COVID admissions so far, only about 350 have been discharged. “Even in a bad flu season, you never see something like this; it’s just unheard of,” said Harlan Krumholz, MD, a Yale cardiologist and professor of medicine helping lead the efforts there.
 

Kidney injuries prominent

“When they get to the ICU, we are seeing lots of people with acute kidney injuries; lots of people developing endocrine problems; people having blood sugar control issues, coagulation issues, blood clots. We are just waking up to the wide range of ways this virus can affect people. Our ignorance is profound,” Dr. Krumholz said, but physicians “recognize that this thing has the capability of attacking almost every single organ system, and it may or may not present with respiratory symptoms.”

It’s a similar story at Mt. Sinai South Nassau, a hospital in Oceanside, N.Y. “We’ve seen a lot of renal injury in people having complications, a lot of acute dialysis,” but it’s unclear how much is caused by the virus and how much is simply because people are so sick, said Aaron Glatt, MD, infectious disease professor and chair of medicine at the hospital. However, he said things are looking brighter than at Yale.

“We are not seeing the same level of increase in cases that we had previously, and we are starting to see extubations and discharges. We’ve treated a number of patients with plasma therapy, and hopefully that will be of benefit. We’ve seen some response to” the immunosuppressive “tocilizumab [Actemra], and a lot of response to very good respiratory therapy. I think we are starting to flatten the curve,” Dr. Glatt said.
 

“Look for tricky symptoms”

The growing awareness of COVID’s protean manifestations is evident in Medscape’s Consult forum, an online community where physicians and medical students share information and seek advice; there’s been over 200 COVID-19 cases and questions since January.

Early on, traffic was mostly about typical pulmonary presentations, but lately it’s shifted to nonrespiratory involvement. Physicians want to know if what they are seeing is related to the virus, and if other people are seeing the same things.

There’s a case on Consult of a 37-year-old man with stomach pain, vomiting, and diarrhea, but no respiratory symptoms and a positive COVID test. A chest CT incidental to his abdominal scan revealed significant bilateral lung involvement.

A 69-year-old woman with a history of laparotomy and new onset intestinal subocclusion had only adhesions on a subsequent exploratory laparotomy, and was doing okay otherwise. She suddenly went into respiratory failure with progressive bradycardia and died 3 days later. Aspiration pneumonia, pulmonary embolism, and MI had been ruled out. “The pattern of cardiovascular failure was in favor of myocarditis, but we don’t have any other clue,” the physician said after describing a second similar case.

Another doctor on the forum reported elevated cardiac enzymes without coronary artery obstruction in a positive patient who went into shock, with an ejection fraction of 40% and markedly increased heart wall thickness, but no lung involvement. There are also two cases of idiopathic thrombocytopenia without fever of hypoxia.

An Italian gastroenterologist said: “Look for tricky symptoms.” Expand “patient history, asking about the sudden occurrence of dysgeusia and/or anosmia. These symptoms have become my guiding diagnostic light” in Verona. “Most patients become nauseated, [and] the taste of any food is unbearable. When I find these symptoms by history, the patient is COVID positive 100%.”
 

‘Make sure that they didn’t die in vain’

There was interest in those and other reports on Consult, and comments from physicians who have theories, but no certain answers about what is, and is not, caused by the virus.

Direct viral attack is likely a part of it, said Stanley Perlman, MD, PhD, a professor of microbiology and immunology at the University of Iowa, Iowa City.

The ACE2 receptor the virus uses to enter cells is common in many organs, plus there were extrapulmonary manifestations with severe acute respiratory syndrome (SARS), another pandemic caused by a zoonotic coronavirus almost 20 years ago. At least with SARS, “many organs were infected when examined at autopsy,” he said.

The body’s inflammatory response is almost certainly also in play. Progressive derangements in inflammatory markers – C-reactive protein, D-dimer, ferritin – correlate with worse prognosis, and “the cytokine storm that occurs in these patients can lead to a degree of encephalopathy, myocarditis, liver impairment, and kidney impairment; multiorgan dysfunction, in other words,” said William Shaffner, MD, a professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, Nashville, Tenn.

But in some cases, the virus might simply be a bystander to an unrelated disease process; in others, the experimental treatments being used might cause problems. Indeed, cardiology groups recently warned of torsade de pointes – a dangerously abnormal heart rhythm – with hydroxychloroquine and azithromycin.

“We think it’s some combination,” but don’t really know, Dr. Krumholz said. In the meantime, “we are forced to treat patients by instinct and first principles,” and long-term sequelae are unknown. “We don’t want to be in this position for long.”

To that end, he said, “this is the time for us all to hold hands and be together because we need to learn rapidly from each other. Our job is both to care for the people in front of us and make sure that they didn’t die in vain, that the experience they had is funneled into a larger set of data to make sure the next person is better off.”

[email protected]