Journal of Clinical Outcomes Management

What you really don’t want to do, if you want to improve diversity, equity, and inclusion (DEI) at your academic institution, is to recruit diverse people to your program and then have them come and feel not included, said Vivian Asare, MD. “That can work against your efforts,” she stated in an oral presentation at the annual meeting of the American College of Chest Physicians (CHEST). Dr. Asare is assistant professor and vice chief of DEI for Yale Pulmonary, Critical Care, and Sleep Medicine, and associate medical director of Yale Centers for Sleep Medicine, New Haven, Conn.

In offering a path to successful DEI, Dr. Asare said: “The first step is to build a team and discuss your mission. Invite everyone to participate and include your leadership because they’re the ones who set the stage, ensure sustainability, and can be a liaison with faculty.” Then a DEI leader should be elected, she added.

The next and very important step is to survey the current institutional climate. “You need to tap into how people feel about DEI in your program.” That entails speaking directly with the stakeholders (faculty, staff, trainees) and identifying their specific concerns and what they think is lacking. Retreats, serious group discussions, and self-reflecting (asking “what initiatives would be good for us?”), and meeting one-on-one with individuals for a truly personalized approach are among potentially productive strategies for identifying the priorities and DEI-related topics specific to a particular academic sleep program.

Dr. Asare offered up a sample DEI survey (Am J Obstet Gynecol. 2020 Nov;223[5]:715.e1-715.e7), that made direct statements inviting the respondent to check off one of the following responses: Yes, No, Somewhat, Do not know, and Not applicable. Among sample statements:

• Our department is actively committed to issues of diversity, equity, and inclusion.
• Faculty searches in the department regularly attract a diverse pool of highly qualified candidates and/or attract a pool that represents the availability of MDs in this field.
• Our outreach and recruitment processes employ targeted practices for attracting diverse populations.

Dr. Asare said that a survey can be a simple approach for garnering information that can be useful for prioritizing DEI topics of concern and igniting interest in them. Engagement requires regular DEI committee meetings with minutes or a newsletter and with updates and topics brought to faculty meetings.
 

Key DEI areas of focus

Dr. Asare listed several key DEI areas: Recruitment/retention, mentorship, scholarship, and inclusion and community engagement. Under scholarship, for example, she cited topics for potential inclusion in a DEI curriculum: Unconscious bias and anti-racism training, racism, discrimination and microaggression education (bystander/deescalation training), cultural competency and awareness, workplace civility, and health disparities. “We all know that implicit bias in providers is a reality, unfortunately,” Dr. Asare said. Being aware of these implicit biases is a start, but instruction on how to actively overcome them has to be provided. Tools may include perspective-taking, exploring common identity, and self-reflection.

To create an inclusive environment for all faculty, trainees, and staff may involve establishing a “welcome committee” for new faculty, perhaps with designating a “peer buddy,” creating social events and other opportunities for all opinions and ideas to be heard and valued. Particularly for underserved and disadvantaged patient populations, patient advocacy and community service need to be fostered through support groups and provision of resources.

Summarizing, Dr. Asare reiterated several key elements for a successful DEI program: Build a team and discuss the mission, survey the current climate allowing open communication and dialogue, plan and engage, organize, and form areas of DEI focus. Find out where you are and where you want to be with respect to DEI, she concluded.

Dr. Asare declared that she had no conflicts of interest.

What you really don’t want to do, if you want to improve diversity, equity, and inclusion (DEI) at your academic institution, is to recruit diverse people to your program and then have them come and feel not included, said Vivian Asare, MD. “That can work against your efforts,” she stated in an oral presentation at the annual meeting of the American College of Chest Physicians (CHEST). Dr. Asare is assistant professor and vice chief of DEI for Yale Pulmonary, Critical Care, and Sleep Medicine, and associate medical director of Yale Centers for Sleep Medicine, New Haven, Conn.

In offering a path to successful DEI, Dr. Asare said: “The first step is to build a team and discuss your mission. Invite everyone to participate and include your leadership because they’re the ones who set the stage, ensure sustainability, and can be a liaison with faculty.” Then a DEI leader should be elected, she added.

The next and very important step is to survey the current institutional climate. “You need to tap into how people feel about DEI in your program.” That entails speaking directly with the stakeholders (faculty, staff, trainees) and identifying their specific concerns and what they think is lacking. Retreats, serious group discussions, and self-reflecting (asking “what initiatives would be good for us?”), and meeting one-on-one with individuals for a truly personalized approach are among potentially productive strategies for identifying the priorities and DEI-related topics specific to a particular academic sleep program.

Dr. Asare offered up a sample DEI survey (Am J Obstet Gynecol. 2020 Nov;223[5]:715.e1-715.e7), that made direct statements inviting the respondent to check off one of the following responses: Yes, No, Somewhat, Do not know, and Not applicable. Among sample statements:

• Our department is actively committed to issues of diversity, equity, and inclusion.
• Faculty searches in the department regularly attract a diverse pool of highly qualified candidates and/or attract a pool that represents the availability of MDs in this field.
• Our outreach and recruitment processes employ targeted practices for attracting diverse populations.

Dr. Asare said that a survey can be a simple approach for garnering information that can be useful for prioritizing DEI topics of concern and igniting interest in them. Engagement requires regular DEI committee meetings with minutes or a newsletter and with updates and topics brought to faculty meetings.
 

Key DEI areas of focus

Dr. Asare listed several key DEI areas: Recruitment/retention, mentorship, scholarship, and inclusion and community engagement. Under scholarship, for example, she cited topics for potential inclusion in a DEI curriculum: Unconscious bias and anti-racism training, racism, discrimination and microaggression education (bystander/deescalation training), cultural competency and awareness, workplace civility, and health disparities. “We all know that implicit bias in providers is a reality, unfortunately,” Dr. Asare said. Being aware of these implicit biases is a start, but instruction on how to actively overcome them has to be provided. Tools may include perspective-taking, exploring common identity, and self-reflection.

To create an inclusive environment for all faculty, trainees, and staff may involve establishing a “welcome committee” for new faculty, perhaps with designating a “peer buddy,” creating social events and other opportunities for all opinions and ideas to be heard and valued. Particularly for underserved and disadvantaged patient populations, patient advocacy and community service need to be fostered through support groups and provision of resources.

Summarizing, Dr. Asare reiterated several key elements for a successful DEI program: Build a team and discuss the mission, survey the current climate allowing open communication and dialogue, plan and engage, organize, and form areas of DEI focus. Find out where you are and where you want to be with respect to DEI, she concluded.

Dr. Asare declared that she had no conflicts of interest.

What you really don’t want to do, if you want to improve diversity, equity, and inclusion (DEI) at your academic institution, is to recruit diverse people to your program and then have them come and feel not included, said Vivian Asare, MD. “That can work against your efforts,” she stated in an oral presentation at the annual meeting of the American College of Chest Physicians (CHEST). Dr. Asare is assistant professor and vice chief of DEI for Yale Pulmonary, Critical Care, and Sleep Medicine, and associate medical director of Yale Centers for Sleep Medicine, New Haven, Conn.

In offering a path to successful DEI, Dr. Asare said: “The first step is to build a team and discuss your mission. Invite everyone to participate and include your leadership because they’re the ones who set the stage, ensure sustainability, and can be a liaison with faculty.” Then a DEI leader should be elected, she added.

The next and very important step is to survey the current institutional climate. “You need to tap into how people feel about DEI in your program.” That entails speaking directly with the stakeholders (faculty, staff, trainees) and identifying their specific concerns and what they think is lacking. Retreats, serious group discussions, and self-reflecting (asking “what initiatives would be good for us?”), and meeting one-on-one with individuals for a truly personalized approach are among potentially productive strategies for identifying the priorities and DEI-related topics specific to a particular academic sleep program.

Dr. Asare offered up a sample DEI survey (Am J Obstet Gynecol. 2020 Nov;223[5]:715.e1-715.e7), that made direct statements inviting the respondent to check off one of the following responses: Yes, No, Somewhat, Do not know, and Not applicable. Among sample statements:

• Our department is actively committed to issues of diversity, equity, and inclusion.
• Faculty searches in the department regularly attract a diverse pool of highly qualified candidates and/or attract a pool that represents the availability of MDs in this field.
• Our outreach and recruitment processes employ targeted practices for attracting diverse populations.

Dr. Asare said that a survey can be a simple approach for garnering information that can be useful for prioritizing DEI topics of concern and igniting interest in them. Engagement requires regular DEI committee meetings with minutes or a newsletter and with updates and topics brought to faculty meetings.
 

Key DEI areas of focus

Dr. Asare listed several key DEI areas: Recruitment/retention, mentorship, scholarship, and inclusion and community engagement. Under scholarship, for example, she cited topics for potential inclusion in a DEI curriculum: Unconscious bias and anti-racism training, racism, discrimination and microaggression education (bystander/deescalation training), cultural competency and awareness, workplace civility, and health disparities. “We all know that implicit bias in providers is a reality, unfortunately,” Dr. Asare said. Being aware of these implicit biases is a start, but instruction on how to actively overcome them has to be provided. Tools may include perspective-taking, exploring common identity, and self-reflection.

To create an inclusive environment for all faculty, trainees, and staff may involve establishing a “welcome committee” for new faculty, perhaps with designating a “peer buddy,” creating social events and other opportunities for all opinions and ideas to be heard and valued. Particularly for underserved and disadvantaged patient populations, patient advocacy and community service need to be fostered through support groups and provision of resources.

Summarizing, Dr. Asare reiterated several key elements for a successful DEI program: Build a team and discuss the mission, survey the current climate allowing open communication and dialogue, plan and engage, organize, and form areas of DEI focus. Find out where you are and where you want to be with respect to DEI, she concluded.

Dr. Asare declared that she had no conflicts of interest.

CINCINNATI – A new analysis of data from a phase 3 clinical trial suggests that an inhaled diazepam nasal spray (Valtoco, Neurelis Inc.) works about as well among patients with Lennox-Gastaut Syndrome (LGS) as it does with other patients with pediatric encephalopathies.

LGS is a severe form of epilepsy that generally begins in early childhood and has a poor prognosis and seizures that are often treatment refractory. The findings of the analysis should be encouraging to physicians who may view patients with LGS as not benefiting from treatment, said Daniel C. Tarquinio, DO, who presented the results at the 2022 annual meeting of the Child Neurology Society.

“Their response to their first appropriate weight-based rescue dose of Valtoco was essentially no different. They were subtly different, but they’re not really meaningful differences. Very few needed a second dose. In practice this is helpful because we know that kids with LGS, we think of them as having worse epilepsy, if you will. But if they need rescue, if we prescribe an appropriate rescue dose based on their weight, that the same rescue will work for them as it will for a kid that doesn’t have – quote unquote – as bad epilepsy that needs rescue,” said Dr. Tarquinio, a child neurologist and epileptologist and founder of the Center for Rare Neurological Diseases.

During the Q&A, Dr. Tarquinio was asked if there is something about the biology of LGS that would suggest it might respond differently to the drug. Dr. Tarquinio said no. “The reason we even looked at this is because many clinicians told us that their sense was [that patients with LGS] did not respond as well to rescue in general no matter what they use. This allowed us to go back and look at a controlled data set and say, at least in our controlled dataset, they respond the same,” he said.

Grace Gombolay, MD, who moderated the session, agreed that the results should be encouraging. “It seems like a lot of clinicians have the sense that Lennox-Gastaut Syndrome is a very terrible refractory epilepsy syndrome, and so doing rescue doesn’t seem to make sense if they don’t really respond. I think it’s helpful to know because there are actually studies showing that Valtoco seems to actually work in those patients, so it’s actually useful clinically to prescribe those patients and give it a shot,” said Dr. Gombolay, director of the Pediatric Neuroimmunology and Multiple Sclerosis Clinic at Emory University, Atlanta.

LGS patients may experience hundreds of seizures per day. “It’s really hard for parents to quantify, did they get better? Did the rescue help or not, because they’re still having some seizures. I think the sense is, ‘oh, this isn’t working.’ That’s probably the bias. I think this is good data that if you are able to get Valtoco for your patients, I think it’s worth a shot even in Lennox-Gastaut,” said Dr. Gombolay.

The researchers conducted a post hoc analysis of the phase 3, open-label, repeat-dose safety study of Valtoco. The study included a 12-month treatment period with visits at day 30 and every 60 days following. Patients had the option of staying on the drug following the end of the treatment period. Seizure and dosing information were obtained from a diary. The study enrolled 163 patients whose physicians believed they would need to be treated with a benzodiazepine at least once every other month to achieve seizure control. Dosing was determined by a combination of age and weight. If a second dose was required, caregivers were instructed to provide it 4-12 hours after the first dose.

In the study cohort, 47.9% of patients were aged 6-17 years. The researchers looked specifically at 73 cases of seizure clusters. In nine cases, the patient had LGS (five male, four female). Nearly all (95.9%) of LGS cluster cases were treated with a single dose and 4.1% were exposed to a second dose. Among 64 cases involving a patient with pediatric epileptic encephalopathies, 89.4% were treated with a single dose and 10.6% received a second. The safety profile was similar between patients with LGS and those with pediatric encephalopathies.

Dr. Gombolay has no relevant financial disclosures.

CINCINNATI – A new analysis of data from a phase 3 clinical trial suggests that an inhaled diazepam nasal spray (Valtoco, Neurelis Inc.) works about as well among patients with Lennox-Gastaut Syndrome (LGS) as it does with other patients with pediatric encephalopathies.

LGS is a severe form of epilepsy that generally begins in early childhood and has a poor prognosis and seizures that are often treatment refractory. The findings of the analysis should be encouraging to physicians who may view patients with LGS as not benefiting from treatment, said Daniel C. Tarquinio, DO, who presented the results at the 2022 annual meeting of the Child Neurology Society.

“Their response to their first appropriate weight-based rescue dose of Valtoco was essentially no different. They were subtly different, but they’re not really meaningful differences. Very few needed a second dose. In practice this is helpful because we know that kids with LGS, we think of them as having worse epilepsy, if you will. But if they need rescue, if we prescribe an appropriate rescue dose based on their weight, that the same rescue will work for them as it will for a kid that doesn’t have – quote unquote – as bad epilepsy that needs rescue,” said Dr. Tarquinio, a child neurologist and epileptologist and founder of the Center for Rare Neurological Diseases.

During the Q&A, Dr. Tarquinio was asked if there is something about the biology of LGS that would suggest it might respond differently to the drug. Dr. Tarquinio said no. “The reason we even looked at this is because many clinicians told us that their sense was [that patients with LGS] did not respond as well to rescue in general no matter what they use. This allowed us to go back and look at a controlled data set and say, at least in our controlled dataset, they respond the same,” he said.

Grace Gombolay, MD, who moderated the session, agreed that the results should be encouraging. “It seems like a lot of clinicians have the sense that Lennox-Gastaut Syndrome is a very terrible refractory epilepsy syndrome, and so doing rescue doesn’t seem to make sense if they don’t really respond. I think it’s helpful to know because there are actually studies showing that Valtoco seems to actually work in those patients, so it’s actually useful clinically to prescribe those patients and give it a shot,” said Dr. Gombolay, director of the Pediatric Neuroimmunology and Multiple Sclerosis Clinic at Emory University, Atlanta.

LGS patients may experience hundreds of seizures per day. “It’s really hard for parents to quantify, did they get better? Did the rescue help or not, because they’re still having some seizures. I think the sense is, ‘oh, this isn’t working.’ That’s probably the bias. I think this is good data that if you are able to get Valtoco for your patients, I think it’s worth a shot even in Lennox-Gastaut,” said Dr. Gombolay.

The researchers conducted a post hoc analysis of the phase 3, open-label, repeat-dose safety study of Valtoco. The study included a 12-month treatment period with visits at day 30 and every 60 days following. Patients had the option of staying on the drug following the end of the treatment period. Seizure and dosing information were obtained from a diary. The study enrolled 163 patients whose physicians believed they would need to be treated with a benzodiazepine at least once every other month to achieve seizure control. Dosing was determined by a combination of age and weight. If a second dose was required, caregivers were instructed to provide it 4-12 hours after the first dose.

In the study cohort, 47.9% of patients were aged 6-17 years. The researchers looked specifically at 73 cases of seizure clusters. In nine cases, the patient had LGS (five male, four female). Nearly all (95.9%) of LGS cluster cases were treated with a single dose and 4.1% were exposed to a second dose. Among 64 cases involving a patient with pediatric epileptic encephalopathies, 89.4% were treated with a single dose and 10.6% received a second. The safety profile was similar between patients with LGS and those with pediatric encephalopathies.

Dr. Gombolay has no relevant financial disclosures.

CINCINNATI – A new analysis of data from a phase 3 clinical trial suggests that an inhaled diazepam nasal spray (Valtoco, Neurelis Inc.) works about as well among patients with Lennox-Gastaut Syndrome (LGS) as it does with other patients with pediatric encephalopathies.

LGS is a severe form of epilepsy that generally begins in early childhood and has a poor prognosis and seizures that are often treatment refractory. The findings of the analysis should be encouraging to physicians who may view patients with LGS as not benefiting from treatment, said Daniel C. Tarquinio, DO, who presented the results at the 2022 annual meeting of the Child Neurology Society.

“Their response to their first appropriate weight-based rescue dose of Valtoco was essentially no different. They were subtly different, but they’re not really meaningful differences. Very few needed a second dose. In practice this is helpful because we know that kids with LGS, we think of them as having worse epilepsy, if you will. But if they need rescue, if we prescribe an appropriate rescue dose based on their weight, that the same rescue will work for them as it will for a kid that doesn’t have – quote unquote – as bad epilepsy that needs rescue,” said Dr. Tarquinio, a child neurologist and epileptologist and founder of the Center for Rare Neurological Diseases.

During the Q&A, Dr. Tarquinio was asked if there is something about the biology of LGS that would suggest it might respond differently to the drug. Dr. Tarquinio said no. “The reason we even looked at this is because many clinicians told us that their sense was [that patients with LGS] did not respond as well to rescue in general no matter what they use. This allowed us to go back and look at a controlled data set and say, at least in our controlled dataset, they respond the same,” he said.

Grace Gombolay, MD, who moderated the session, agreed that the results should be encouraging. “It seems like a lot of clinicians have the sense that Lennox-Gastaut Syndrome is a very terrible refractory epilepsy syndrome, and so doing rescue doesn’t seem to make sense if they don’t really respond. I think it’s helpful to know because there are actually studies showing that Valtoco seems to actually work in those patients, so it’s actually useful clinically to prescribe those patients and give it a shot,” said Dr. Gombolay, director of the Pediatric Neuroimmunology and Multiple Sclerosis Clinic at Emory University, Atlanta.

LGS patients may experience hundreds of seizures per day. “It’s really hard for parents to quantify, did they get better? Did the rescue help or not, because they’re still having some seizures. I think the sense is, ‘oh, this isn’t working.’ That’s probably the bias. I think this is good data that if you are able to get Valtoco for your patients, I think it’s worth a shot even in Lennox-Gastaut,” said Dr. Gombolay.

The researchers conducted a post hoc analysis of the phase 3, open-label, repeat-dose safety study of Valtoco. The study included a 12-month treatment period with visits at day 30 and every 60 days following. Patients had the option of staying on the drug following the end of the treatment period. Seizure and dosing information were obtained from a diary. The study enrolled 163 patients whose physicians believed they would need to be treated with a benzodiazepine at least once every other month to achieve seizure control. Dosing was determined by a combination of age and weight. If a second dose was required, caregivers were instructed to provide it 4-12 hours after the first dose.

In the study cohort, 47.9% of patients were aged 6-17 years. The researchers looked specifically at 73 cases of seizure clusters. In nine cases, the patient had LGS (five male, four female). Nearly all (95.9%) of LGS cluster cases were treated with a single dose and 4.1% were exposed to a second dose. Among 64 cases involving a patient with pediatric epileptic encephalopathies, 89.4% were treated with a single dose and 10.6% received a second. The safety profile was similar between patients with LGS and those with pediatric encephalopathies.

Dr. Gombolay has no relevant financial disclosures.

Cardiovascular health (CVH) scores that include sleep predicted CV disease risk among older U.S. adults, supporting the American Heart Association’s recent inclusion of sleep in its own checklist.

Sleep duration is now considered “an essential component for ideal heart and brain health,” according to the AHA’s updated checklist, now called Life’s Essential 8. “Our study is the first to show that sleep metrics add independent predictive value for CVD events over and above the original seven cardiovascular health metrics, providing support for updating the guidelines from Life’s Simple 7 (LS7) to Life’s Essential 8,” lead author Nour Makarem, PhD, of the Mailman School of Public Health at Columbia University Irving Medical Center, New York, said in an interview.

For the study, her team compared four versions of LS7 checklists that included sleep in relation to cardiovascular disease (CVD) risk.

“CVH scores that included sleep duration alone as a measure of overall sleep health, as well as scores that included multiple dimensions of sleep health (that is, sleep duration, efficiency, and regularity, daytime sleepiness, and sleep disorders), were both predictive of future CVD,” she said.

Study participants scoring in the highest tertile of the CVH checklists that included sleep had up to a 47% lower CVD risk.

Sleeping 7 hours or more but less than 9 hours nightly was considered “ideal,” according to the study, which was published online  in the Journal of the American Heart Association.
 

Lower the odds

Dr. Makarem and colleagues analyzed data from participants in the Multi-Ethnic Study of Atherosclerosis (MESA) sleep study using overnight polysomnography, 7-day wrist actigraphy, validated questionnaires, and outcomes. They used the data to evaluate the four iterations of an expanded LS7 score:

• Score 1 included sleep duration;
• Score 2 included sleep characteristics linked to CVD in the literature (sleep duration, insomnia, daytime sleepiness, and obstructive sleep apnea [OSA]);
• Score 3 included sleep characteristics associated with CVD in MESA (sleep duration and efficiency, daytime sleepiness, and OSA); and
• Score 4, also based on CVD in MESA, included sleep regularity.

Among 1,920 participants (mean age 69 years; 54% women; 40%, White individuals), the mean LS7 score was 7.3, and the means of the alternate CVH scores that included sleep ranged from 7.4 to 7.8 (scores range from 0 to 14, with higher scores indicating better CVH).

On actigraphy, 63% of participants slept less than 7 hours; 30% slept less than 6 hours; 39% had high night-to-night variability in sleep duration; and 25% had high variability in sleep onset timing.

Overall, 10% had sleep efficiency less than 85%; 14% had excessive daytime sleepiness; 36% had high insomnia symptoms; and 47% had moderate to severe OSA. Short-duration sleepers also had a higher prevalence of overweight/obesity, diabetes, and hypertension and had lower mean LS7 scores.

During a mean follow-up of 4.4 years, 95 prevalent CVD events and 93 incident cases occurred.

Higher scores on all four expanded versions were related to lower odds of having CVD. Participants in the highest versus the lowest tertile of the LS7 score had 75% lower CVD odds (odds ratio, 0.25). Similarly, those in the highest versus the lowest tertile of CVH scores 1 and 2 had 71% and 80% lower odds of prevalent CVD (OR, 0.29 and OR, 0.20), respectively.

Overall, participants in the highest versus lowest tertile of the LS7 score and all CVH scores had up to 80% lower odds of prevalent CVD; those in the highest versus lowest tertile of CVH score 1, which included sleep duration, and CVH score 4, which included multidimensional sleep health, had 43% and 47% lower incident CVD risk (hazard ratios, 0.57 and 0.53), respectively.

The LS7 score alone was not significantly associated with CVD incidence (HR, 0.62).

“Clinicians should ask patients about their sleep health and emphasize the importance of prioritizing sleep for heart disease prevention,” Dr. Makarem said.
 

Sleep ‘devalued’

“The sleep field has been fighting to get more sleep education into medical education for decades,” AHA volunteer expert Michael A. Grandner, PhD, Director of the Sleep & Health Research Program and of the Behavioral Sleep Medicine Clinic at the University of Arizona College of Medicine, Tucson, said in an interview.

“To my knowledge, there still is not a lot of attention given to it, partly because the culture in medical school and among residents is one of not sleeping,” said Dr. Grandner, who was not involved in the study. “The culture among physicians is ‘Who needs sleep? I function fine without it.’ ”

“Sleep made it to the checklist because it is a biological requirement for human life,” he noted. “We sleep for the same reason we breathe and drink. It’s an imperative. Yet we live in a society that devalues sleep.”

It’s “extremely unusual” for a doctor to ask a patient how they’re sleeping, he said. “It’s also pretty unusual to have sleep-related conversations between doctors and patients, especially in the context of health, not just, ‘Hey, doc, I can’t sleep, throw me a pill.’”

Clinicians should be asking every patient about how they’re sleeping at every visit, Dr. Grandner said. “It’s now part of the official definition of heart health. Just like you would be remiss if you didn’t ask about smoking or test blood pressure, you’d be missing something important by not asking about sleep – something that has similar billing to diet, exercise, blood pressure, and all the other ‘essentials.’ ”

No commercial funding or conflicts of interest were declared.

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

Cardiovascular health (CVH) scores that include sleep predicted CV disease risk among older U.S. adults, supporting the American Heart Association’s recent inclusion of sleep in its own checklist.

Sleep duration is now considered “an essential component for ideal heart and brain health,” according to the AHA’s updated checklist, now called Life’s Essential 8. “Our study is the first to show that sleep metrics add independent predictive value for CVD events over and above the original seven cardiovascular health metrics, providing support for updating the guidelines from Life’s Simple 7 (LS7) to Life’s Essential 8,” lead author Nour Makarem, PhD, of the Mailman School of Public Health at Columbia University Irving Medical Center, New York, said in an interview.

For the study, her team compared four versions of LS7 checklists that included sleep in relation to cardiovascular disease (CVD) risk.

“CVH scores that included sleep duration alone as a measure of overall sleep health, as well as scores that included multiple dimensions of sleep health (that is, sleep duration, efficiency, and regularity, daytime sleepiness, and sleep disorders), were both predictive of future CVD,” she said.

Study participants scoring in the highest tertile of the CVH checklists that included sleep had up to a 47% lower CVD risk.

Sleeping 7 hours or more but less than 9 hours nightly was considered “ideal,” according to the study, which was published online  in the Journal of the American Heart Association.
 

Lower the odds

Dr. Makarem and colleagues analyzed data from participants in the Multi-Ethnic Study of Atherosclerosis (MESA) sleep study using overnight polysomnography, 7-day wrist actigraphy, validated questionnaires, and outcomes. They used the data to evaluate the four iterations of an expanded LS7 score:

• Score 1 included sleep duration;
• Score 2 included sleep characteristics linked to CVD in the literature (sleep duration, insomnia, daytime sleepiness, and obstructive sleep apnea [OSA]);
• Score 3 included sleep characteristics associated with CVD in MESA (sleep duration and efficiency, daytime sleepiness, and OSA); and
• Score 4, also based on CVD in MESA, included sleep regularity.

Among 1,920 participants (mean age 69 years; 54% women; 40%, White individuals), the mean LS7 score was 7.3, and the means of the alternate CVH scores that included sleep ranged from 7.4 to 7.8 (scores range from 0 to 14, with higher scores indicating better CVH).

On actigraphy, 63% of participants slept less than 7 hours; 30% slept less than 6 hours; 39% had high night-to-night variability in sleep duration; and 25% had high variability in sleep onset timing.

Overall, 10% had sleep efficiency less than 85%; 14% had excessive daytime sleepiness; 36% had high insomnia symptoms; and 47% had moderate to severe OSA. Short-duration sleepers also had a higher prevalence of overweight/obesity, diabetes, and hypertension and had lower mean LS7 scores.

During a mean follow-up of 4.4 years, 95 prevalent CVD events and 93 incident cases occurred.

Higher scores on all four expanded versions were related to lower odds of having CVD. Participants in the highest versus the lowest tertile of the LS7 score had 75% lower CVD odds (odds ratio, 0.25). Similarly, those in the highest versus the lowest tertile of CVH scores 1 and 2 had 71% and 80% lower odds of prevalent CVD (OR, 0.29 and OR, 0.20), respectively.

Overall, participants in the highest versus lowest tertile of the LS7 score and all CVH scores had up to 80% lower odds of prevalent CVD; those in the highest versus lowest tertile of CVH score 1, which included sleep duration, and CVH score 4, which included multidimensional sleep health, had 43% and 47% lower incident CVD risk (hazard ratios, 0.57 and 0.53), respectively.

The LS7 score alone was not significantly associated with CVD incidence (HR, 0.62).

“Clinicians should ask patients about their sleep health and emphasize the importance of prioritizing sleep for heart disease prevention,” Dr. Makarem said.
 

Sleep ‘devalued’

“The sleep field has been fighting to get more sleep education into medical education for decades,” AHA volunteer expert Michael A. Grandner, PhD, Director of the Sleep & Health Research Program and of the Behavioral Sleep Medicine Clinic at the University of Arizona College of Medicine, Tucson, said in an interview.

“To my knowledge, there still is not a lot of attention given to it, partly because the culture in medical school and among residents is one of not sleeping,” said Dr. Grandner, who was not involved in the study. “The culture among physicians is ‘Who needs sleep? I function fine without it.’ ”

“Sleep made it to the checklist because it is a biological requirement for human life,” he noted. “We sleep for the same reason we breathe and drink. It’s an imperative. Yet we live in a society that devalues sleep.”

It’s “extremely unusual” for a doctor to ask a patient how they’re sleeping, he said. “It’s also pretty unusual to have sleep-related conversations between doctors and patients, especially in the context of health, not just, ‘Hey, doc, I can’t sleep, throw me a pill.’”

Clinicians should be asking every patient about how they’re sleeping at every visit, Dr. Grandner said. “It’s now part of the official definition of heart health. Just like you would be remiss if you didn’t ask about smoking or test blood pressure, you’d be missing something important by not asking about sleep – something that has similar billing to diet, exercise, blood pressure, and all the other ‘essentials.’ ”

No commercial funding or conflicts of interest were declared.

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

Cardiovascular health (CVH) scores that include sleep predicted CV disease risk among older U.S. adults, supporting the American Heart Association’s recent inclusion of sleep in its own checklist.

Sleep duration is now considered “an essential component for ideal heart and brain health,” according to the AHA’s updated checklist, now called Life’s Essential 8. “Our study is the first to show that sleep metrics add independent predictive value for CVD events over and above the original seven cardiovascular health metrics, providing support for updating the guidelines from Life’s Simple 7 (LS7) to Life’s Essential 8,” lead author Nour Makarem, PhD, of the Mailman School of Public Health at Columbia University Irving Medical Center, New York, said in an interview.

For the study, her team compared four versions of LS7 checklists that included sleep in relation to cardiovascular disease (CVD) risk.

“CVH scores that included sleep duration alone as a measure of overall sleep health, as well as scores that included multiple dimensions of sleep health (that is, sleep duration, efficiency, and regularity, daytime sleepiness, and sleep disorders), were both predictive of future CVD,” she said.

Study participants scoring in the highest tertile of the CVH checklists that included sleep had up to a 47% lower CVD risk.

Sleeping 7 hours or more but less than 9 hours nightly was considered “ideal,” according to the study, which was published online  in the Journal of the American Heart Association.
 

Lower the odds

Dr. Makarem and colleagues analyzed data from participants in the Multi-Ethnic Study of Atherosclerosis (MESA) sleep study using overnight polysomnography, 7-day wrist actigraphy, validated questionnaires, and outcomes. They used the data to evaluate the four iterations of an expanded LS7 score:

• Score 1 included sleep duration;
• Score 2 included sleep characteristics linked to CVD in the literature (sleep duration, insomnia, daytime sleepiness, and obstructive sleep apnea [OSA]);
• Score 3 included sleep characteristics associated with CVD in MESA (sleep duration and efficiency, daytime sleepiness, and OSA); and
• Score 4, also based on CVD in MESA, included sleep regularity.

Among 1,920 participants (mean age 69 years; 54% women; 40%, White individuals), the mean LS7 score was 7.3, and the means of the alternate CVH scores that included sleep ranged from 7.4 to 7.8 (scores range from 0 to 14, with higher scores indicating better CVH).

On actigraphy, 63% of participants slept less than 7 hours; 30% slept less than 6 hours; 39% had high night-to-night variability in sleep duration; and 25% had high variability in sleep onset timing.

Overall, 10% had sleep efficiency less than 85%; 14% had excessive daytime sleepiness; 36% had high insomnia symptoms; and 47% had moderate to severe OSA. Short-duration sleepers also had a higher prevalence of overweight/obesity, diabetes, and hypertension and had lower mean LS7 scores.

During a mean follow-up of 4.4 years, 95 prevalent CVD events and 93 incident cases occurred.

Higher scores on all four expanded versions were related to lower odds of having CVD. Participants in the highest versus the lowest tertile of the LS7 score had 75% lower CVD odds (odds ratio, 0.25). Similarly, those in the highest versus the lowest tertile of CVH scores 1 and 2 had 71% and 80% lower odds of prevalent CVD (OR, 0.29 and OR, 0.20), respectively.

Overall, participants in the highest versus lowest tertile of the LS7 score and all CVH scores had up to 80% lower odds of prevalent CVD; those in the highest versus lowest tertile of CVH score 1, which included sleep duration, and CVH score 4, which included multidimensional sleep health, had 43% and 47% lower incident CVD risk (hazard ratios, 0.57 and 0.53), respectively.

The LS7 score alone was not significantly associated with CVD incidence (HR, 0.62).

“Clinicians should ask patients about their sleep health and emphasize the importance of prioritizing sleep for heart disease prevention,” Dr. Makarem said.
 

Sleep ‘devalued’

“The sleep field has been fighting to get more sleep education into medical education for decades,” AHA volunteer expert Michael A. Grandner, PhD, Director of the Sleep & Health Research Program and of the Behavioral Sleep Medicine Clinic at the University of Arizona College of Medicine, Tucson, said in an interview.

“To my knowledge, there still is not a lot of attention given to it, partly because the culture in medical school and among residents is one of not sleeping,” said Dr. Grandner, who was not involved in the study. “The culture among physicians is ‘Who needs sleep? I function fine without it.’ ”

“Sleep made it to the checklist because it is a biological requirement for human life,” he noted. “We sleep for the same reason we breathe and drink. It’s an imperative. Yet we live in a society that devalues sleep.”

It’s “extremely unusual” for a doctor to ask a patient how they’re sleeping, he said. “It’s also pretty unusual to have sleep-related conversations between doctors and patients, especially in the context of health, not just, ‘Hey, doc, I can’t sleep, throw me a pill.’”

Clinicians should be asking every patient about how they’re sleeping at every visit, Dr. Grandner said. “It’s now part of the official definition of heart health. Just like you would be remiss if you didn’t ask about smoking or test blood pressure, you’d be missing something important by not asking about sleep – something that has similar billing to diet, exercise, blood pressure, and all the other ‘essentials.’ ”

No commercial funding or conflicts of interest were declared.

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

Individuals who are middle-aged and older and who sleep 5 hours or less a night may be at risk for an array of serious and chronic health conditions, ranging from heart disease to cancer, results of a large study show.

Researchers at University College London and Université Paris Cité found that beginning at age 50, those who slept 5 hours or fewer a night had a 30% higher risk of developing multiple chronic diseases over time than those who slept at least 7 hours a night. By the time the participants were aged 70 years, that risk had increased to 40%.

Diseases for which there was a higher risk included diabetes, cancer, coronary heart disease, stroke, heart failure, chronic obstructive pulmonary disease, chronic kidney disease, liver disease, depression, dementia, Parkinson’s disease, and arthritis.

“It is important to take care of our sleep,” lead investigator Séverine Sabia, PhD, said in an interview. Dr. Sabia is a researcher and epidemiologist at Université Paris Cité and INSERM in Paris, and the University College London.

She noted that the source of the sleep problem must be addressed, but in cases in which there is no medical reason for sleep paucity, “healthy sleep habits are a must. These include keeping a regular sleep schedule, a healthy lifestyle – physical activity and light exposure during the day, and a light dinner – and avoidance of screens for a half hour before sleep.”

The study was published online in PLOS Medicine.
 

Risk of multiple chronic diseases

Prior research suggests that sleeping for 5 hours or less or 9 hours or more is associated with cancer and cardiovascular disease (CVD).

For the current study, Dr. Sabia and her team asked nearly 8,000 civil servants in the United Kingdom as part of the Whitehall II cohort study to report the amount of sleep they received beginning at age 50 every 4 to 5 years for the next 25 years. Study participants were free of chronic disease at age 50 and were mostly male (67.5%) and White (90%).

The investigators found that at age 50, those who slept 5 hours or less were 30% more likely to be diagnosed with multiple chronic diseases over time, (hazard ratio, 1.30; 95% confidence interval, 1.12-1.50; P < .001) compared with their peers who slept 7 hours.

At age 60, those who slept 5 hours or less had a 32% greater risk of developing more than one chronic disease (HR, 1.32; 95% CI, 1.13-1.55; P < .001), and by age 70, this risk increased to 40% compared with their peers who slept 7 hours a night (HR, 1.40; 95% CI, 1.16-1.68; P < .001).

For participants who slept 9 or more hours per night, only those aged 60 (HR, 1.54; 95% CI, 1.15-2.06; P = .003) and 70 (HR, 1.51; 95% CI, 1.10-2.08; P = .010) were at increased risk of developing more than one chronic disease.

Dr. Sabia noted that previous studies have shown that those who slept less than 5 hours a night were more likely to develop diabetes, hypertension, CVD, or dementia. “However, chronic diseases often coexist, particularly at older ages, and it remains unclear how sleep duration may be associated with risk of multimorbidity,” she said. She noted that several biological hypotheses have been proposed as underlying the association.

“Sleep is important for the regulation of several body functions, such as metabolic, endocrine, and inflammatory regulation over the day, that in turn, when dysregulated, may contribute to increased risk of several chronic conditions.”

The authors acknowledge several study limitations, including the fact that the data were obtained via participant self-reports, which may be affected by reporting bias. There was also a lack of diversity within the study sample, as the civil servants were mostly male and White. In addition to this, the investigators note that the study population of British civil servants tended to be healthier than the general population.
 

Chicken or egg?

Commenting on the findings for this article, Charlene Gamaldo, MD, urged caution in interpreting the findings. She noted that self-reporting of sleep has been established as “potentially problematic” because it doesn’t always correlate with actual sleep.

Dr. Gamaldo, who is professor of neurology and psychiatry at Johns Hopkins University in Baltimore and the medical director of the JHU Center for Sleep and Wellness, said previous studies have shown that underestimation of sleep can occur among those suffering with insomnia and that overestimation can be seen among individuals with behaviorally based chronic, insufficient sleep.

Dr. Gamaldo also raised the issue of sleep quality.

“Getting 5 hours of high-quality sleep is less worrisome than one getting 8 hours of terrible-quality, based on untreated sleep apnea, for instance,” she noted.

In addition, she pointed out that chronic health problems can interrupt sleep. “Which is the chicken, and which is the egg?” she asked.

“For me, the take-home of current literature and supported by this paper is that individuals with sleep quality complaints, short duration, or related impact in daytime function should address them with their treating provider to assess for the underlying cause.

“Those sleeping under 5 hours without complaints should consider whether 5 hours really represents the amount of sleep they need to wake rested and function at their best. If answer is no, they should prioritize getting more sleep,” she concluded.

The study was funded by the National Institute on Aging, the National Institute of Health, the UK Research Medical Council, the British Heart Foundation, the Wellcome Trust, and the French National Research Agency. The investigators and Dr. Gamaldo report no relevant financial relationships.

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

Individuals who are middle-aged and older and who sleep 5 hours or less a night may be at risk for an array of serious and chronic health conditions, ranging from heart disease to cancer, results of a large study show.

Researchers at University College London and Université Paris Cité found that beginning at age 50, those who slept 5 hours or fewer a night had a 30% higher risk of developing multiple chronic diseases over time than those who slept at least 7 hours a night. By the time the participants were aged 70 years, that risk had increased to 40%.

Diseases for which there was a higher risk included diabetes, cancer, coronary heart disease, stroke, heart failure, chronic obstructive pulmonary disease, chronic kidney disease, liver disease, depression, dementia, Parkinson’s disease, and arthritis.

“It is important to take care of our sleep,” lead investigator Séverine Sabia, PhD, said in an interview. Dr. Sabia is a researcher and epidemiologist at Université Paris Cité and INSERM in Paris, and the University College London.

She noted that the source of the sleep problem must be addressed, but in cases in which there is no medical reason for sleep paucity, “healthy sleep habits are a must. These include keeping a regular sleep schedule, a healthy lifestyle – physical activity and light exposure during the day, and a light dinner – and avoidance of screens for a half hour before sleep.”

The study was published online in PLOS Medicine.
 

Risk of multiple chronic diseases

Prior research suggests that sleeping for 5 hours or less or 9 hours or more is associated with cancer and cardiovascular disease (CVD).

For the current study, Dr. Sabia and her team asked nearly 8,000 civil servants in the United Kingdom as part of the Whitehall II cohort study to report the amount of sleep they received beginning at age 50 every 4 to 5 years for the next 25 years. Study participants were free of chronic disease at age 50 and were mostly male (67.5%) and White (90%).

The investigators found that at age 50, those who slept 5 hours or less were 30% more likely to be diagnosed with multiple chronic diseases over time, (hazard ratio, 1.30; 95% confidence interval, 1.12-1.50; P < .001) compared with their peers who slept 7 hours.

At age 60, those who slept 5 hours or less had a 32% greater risk of developing more than one chronic disease (HR, 1.32; 95% CI, 1.13-1.55; P < .001), and by age 70, this risk increased to 40% compared with their peers who slept 7 hours a night (HR, 1.40; 95% CI, 1.16-1.68; P < .001).

For participants who slept 9 or more hours per night, only those aged 60 (HR, 1.54; 95% CI, 1.15-2.06; P = .003) and 70 (HR, 1.51; 95% CI, 1.10-2.08; P = .010) were at increased risk of developing more than one chronic disease.

Dr. Sabia noted that previous studies have shown that those who slept less than 5 hours a night were more likely to develop diabetes, hypertension, CVD, or dementia. “However, chronic diseases often coexist, particularly at older ages, and it remains unclear how sleep duration may be associated with risk of multimorbidity,” she said. She noted that several biological hypotheses have been proposed as underlying the association.

“Sleep is important for the regulation of several body functions, such as metabolic, endocrine, and inflammatory regulation over the day, that in turn, when dysregulated, may contribute to increased risk of several chronic conditions.”

The authors acknowledge several study limitations, including the fact that the data were obtained via participant self-reports, which may be affected by reporting bias. There was also a lack of diversity within the study sample, as the civil servants were mostly male and White. In addition to this, the investigators note that the study population of British civil servants tended to be healthier than the general population.
 

Chicken or egg?

Commenting on the findings for this article, Charlene Gamaldo, MD, urged caution in interpreting the findings. She noted that self-reporting of sleep has been established as “potentially problematic” because it doesn’t always correlate with actual sleep.

Dr. Gamaldo, who is professor of neurology and psychiatry at Johns Hopkins University in Baltimore and the medical director of the JHU Center for Sleep and Wellness, said previous studies have shown that underestimation of sleep can occur among those suffering with insomnia and that overestimation can be seen among individuals with behaviorally based chronic, insufficient sleep.

Dr. Gamaldo also raised the issue of sleep quality.

“Getting 5 hours of high-quality sleep is less worrisome than one getting 8 hours of terrible-quality, based on untreated sleep apnea, for instance,” she noted.

In addition, she pointed out that chronic health problems can interrupt sleep. “Which is the chicken, and which is the egg?” she asked.

“For me, the take-home of current literature and supported by this paper is that individuals with sleep quality complaints, short duration, or related impact in daytime function should address them with their treating provider to assess for the underlying cause.

“Those sleeping under 5 hours without complaints should consider whether 5 hours really represents the amount of sleep they need to wake rested and function at their best. If answer is no, they should prioritize getting more sleep,” she concluded.

The study was funded by the National Institute on Aging, the National Institute of Health, the UK Research Medical Council, the British Heart Foundation, the Wellcome Trust, and the French National Research Agency. The investigators and Dr. Gamaldo report no relevant financial relationships.

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

Individuals who are middle-aged and older and who sleep 5 hours or less a night may be at risk for an array of serious and chronic health conditions, ranging from heart disease to cancer, results of a large study show.

Researchers at University College London and Université Paris Cité found that beginning at age 50, those who slept 5 hours or fewer a night had a 30% higher risk of developing multiple chronic diseases over time than those who slept at least 7 hours a night. By the time the participants were aged 70 years, that risk had increased to 40%.

Diseases for which there was a higher risk included diabetes, cancer, coronary heart disease, stroke, heart failure, chronic obstructive pulmonary disease, chronic kidney disease, liver disease, depression, dementia, Parkinson’s disease, and arthritis.

“It is important to take care of our sleep,” lead investigator Séverine Sabia, PhD, said in an interview. Dr. Sabia is a researcher and epidemiologist at Université Paris Cité and INSERM in Paris, and the University College London.

She noted that the source of the sleep problem must be addressed, but in cases in which there is no medical reason for sleep paucity, “healthy sleep habits are a must. These include keeping a regular sleep schedule, a healthy lifestyle – physical activity and light exposure during the day, and a light dinner – and avoidance of screens for a half hour before sleep.”

The study was published online in PLOS Medicine.
 

Risk of multiple chronic diseases

Prior research suggests that sleeping for 5 hours or less or 9 hours or more is associated with cancer and cardiovascular disease (CVD).

For the current study, Dr. Sabia and her team asked nearly 8,000 civil servants in the United Kingdom as part of the Whitehall II cohort study to report the amount of sleep they received beginning at age 50 every 4 to 5 years for the next 25 years. Study participants were free of chronic disease at age 50 and were mostly male (67.5%) and White (90%).

The investigators found that at age 50, those who slept 5 hours or less were 30% more likely to be diagnosed with multiple chronic diseases over time, (hazard ratio, 1.30; 95% confidence interval, 1.12-1.50; P < .001) compared with their peers who slept 7 hours.

At age 60, those who slept 5 hours or less had a 32% greater risk of developing more than one chronic disease (HR, 1.32; 95% CI, 1.13-1.55; P < .001), and by age 70, this risk increased to 40% compared with their peers who slept 7 hours a night (HR, 1.40; 95% CI, 1.16-1.68; P < .001).

For participants who slept 9 or more hours per night, only those aged 60 (HR, 1.54; 95% CI, 1.15-2.06; P = .003) and 70 (HR, 1.51; 95% CI, 1.10-2.08; P = .010) were at increased risk of developing more than one chronic disease.

Dr. Sabia noted that previous studies have shown that those who slept less than 5 hours a night were more likely to develop diabetes, hypertension, CVD, or dementia. “However, chronic diseases often coexist, particularly at older ages, and it remains unclear how sleep duration may be associated with risk of multimorbidity,” she said. She noted that several biological hypotheses have been proposed as underlying the association.

“Sleep is important for the regulation of several body functions, such as metabolic, endocrine, and inflammatory regulation over the day, that in turn, when dysregulated, may contribute to increased risk of several chronic conditions.”

The authors acknowledge several study limitations, including the fact that the data were obtained via participant self-reports, which may be affected by reporting bias. There was also a lack of diversity within the study sample, as the civil servants were mostly male and White. In addition to this, the investigators note that the study population of British civil servants tended to be healthier than the general population.
 

Chicken or egg?

Commenting on the findings for this article, Charlene Gamaldo, MD, urged caution in interpreting the findings. She noted that self-reporting of sleep has been established as “potentially problematic” because it doesn’t always correlate with actual sleep.

Dr. Gamaldo, who is professor of neurology and psychiatry at Johns Hopkins University in Baltimore and the medical director of the JHU Center for Sleep and Wellness, said previous studies have shown that underestimation of sleep can occur among those suffering with insomnia and that overestimation can be seen among individuals with behaviorally based chronic, insufficient sleep.

Dr. Gamaldo also raised the issue of sleep quality.

“Getting 5 hours of high-quality sleep is less worrisome than one getting 8 hours of terrible-quality, based on untreated sleep apnea, for instance,” she noted.

In addition, she pointed out that chronic health problems can interrupt sleep. “Which is the chicken, and which is the egg?” she asked.

“For me, the take-home of current literature and supported by this paper is that individuals with sleep quality complaints, short duration, or related impact in daytime function should address them with their treating provider to assess for the underlying cause.

“Those sleeping under 5 hours without complaints should consider whether 5 hours really represents the amount of sleep they need to wake rested and function at their best. If answer is no, they should prioritize getting more sleep,” she concluded.

The study was funded by the National Institute on Aging, the National Institute of Health, the UK Research Medical Council, the British Heart Foundation, the Wellcome Trust, and the French National Research Agency. The investigators and Dr. Gamaldo report no relevant financial relationships.

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

VIENNA – Prescription drugs designed to boost cognition in neurodevelopmental disorders do not increase overall cognitive performance in healthy individuals – and may even reduce productivity, new research suggests.

In a randomized controlled trial, 40 healthy adults were given the attention-deficit/hyperactivity disorder (ADHD) treatments methylphenidate or dexamphetamine or the wakefulness-promoting drug modafinil vs. placebo.

While receiving the so-called “smart drugs,” participants spent more time and made more moves more quickly while solving each problem on a complex cognitive task than when given the placebo. But with no significant improvement in overall performance, all drugs were associated with a significant reduction in efficiency.

The findings “reinforce the idea that, while the drugs administered were motivational, the resulting increase in effort came at a cost in the loss of productivity,” said study presenter David Coghill, MD, PhD, chair of developmental mental health, the University of Melbourne.

This was especially true for individuals who scored high when receiving placebo, “who ended up producing below average productivity when on the drugs,” he noted.

“Overall, these drugs don’t increase the performance. Instead, they cause a regression to the mean, and appear to have a more negative effect on those who performed best at baseline,” Dr. Coghill added.

He presented the findings at the 35th European College of Neuropsychopharmacology (ECNP) Congress.
 

Past evidence ambiguous

Dr. Coghill noted that prescription-only stimulant drugs are increasingly used by employees and students as “smart drugs” to enhance workplace or academic productivity.

He conducted the study with colleagues from the department of economics at his institution, because of “their interest in people using cognitive enhancers within the financial industry, in the hope that that would increase their productivity in what is a very competitive industry on the floor of the trading rooms.”

However, while “there’s a subjective belief” that these drugs are effective as cognitive enhancers, the evidence to actually demonstrate that in healthy individuals “is, at best, ambiguous,” he told meeting attendees.

Improvements in cognitive capacities, such as working memory and improved planning, are most evident in clinical populations such as those with ADHD, which could be due to a “ceiling effect” of the cognitive tasks in healthy individuals, Dr. Coghill noted.

To investigate further, the researchers conducted a randomized, double-blinded trial of standard adult doses of methylphenidate (30 mg), dexamphetamine (15 mg), and modafinil (200 mg) vs. placebo. The healthy participants (n = 40), all of whom were aged 18-35 years, crossed to each of the other treatment groups over the course of four intervention sessions.

All were asked to solve eight instances of the knapsack task, the aim of which is to place theoretical objects in a knapsack to achieve the maximum value within a certain weight limit.

“This looks very simple but as the number of items increases, it becomes incredibly complex to compute, and actually is not computable using standard approaches. You have to deal with trial and error,” Dr. Coghill said.

The participants also completed several CANTAB cognitive tasks.

‘Surprising’ findings

Results showed that, overall, the drugs did not have a significant effect on task performance (slope = –0.16; P = .011).

Moreover, the drugs, both individually and collectively, had a significant negative effect on the value attained during any one attempt at the knapsack task (slope = –0.003; P = .02), an effect that extended “across the whole range” of task complexity, Dr. Coghill reported.

He went on to show that “participants actually looked as if they were working harder” when they took the three active drugs than when they were given a placebo. They also “spent more time solving each problem,” he added.

When taking the active drugs, participants made more moves during each task than when taking placebo, and made their moves more quickly.

“So these medications increased motivation,” Dr. Coghill said. “If you were sitting [and] watching this person, you would think that they were working harder.”

Yet their productivity, defined as the average gain in value per move on the knapsack task, was lower. Regression analysis identified a “significant and sizable drop in productivity” vs. placebo, Dr. Coghill noted.

This was the case for methylphenidate (P < .001), dexamphetamine (P < .001), and modafinil (P < .05), “whether you looked at the mean or median performance,” he said.

“Breaking it down a little bit more, when you looked at the individual participant level, you find substantial heterogeneity across participants,” noted Dr. Coghill.

“More than that, we found a significant negative correlation between productivity under methylphenidate compared to productivity under placebo, and this suggests a regression to the mean,” with participants who performed better under placebo performing worse with methylphenidate, he explained.

While the relationship was “exactly the same with modafinil,” it was not found with dexamphetamine, with a strong negative correlation between the productivity effects between dexamphetamine and methylphenidate (slope = –0.29; P < .0001).

“This is surprising because we assume that methylphenidate and dexamphetamine are working in very similar ways,” Dr. Coghill said.
 

Time to rethink, rewind?

Commenting for this article, session chair John F. Cryan, PhD, department of anatomy and neuroscience, University College Cork, Ireland, said that, based on the current data, “we might need to rethink [how] ‘smart’ psychopharmacological agents are.”

Dr. Cryan, chair of the ECNP Scientific Program Committee, added that there may be a need to revisit the difficulty of different types of cognitive tasks used in studies assessing the abilities of cognitive enhancing drugs and to “rewind conventional wisdom” around them.

Also commenting, Andrew Westbrook, PhD, of the department of cognitive linguistics and psychological sciences, Brown University, Providence, R.I., said the results seem “reasonable” and are “consistent with my own perspective.”

However, he told this news organization, “some caveats are warranted,” not least that the context of the task can have an impact on the results it obtains.

“We have hypothesized that pharmacologically-enhanced striatal dopamine signaling can boost a kind of cognitive impulsivity, leading to errors and diminished performance, especially for people who already have high striatal dopamine functioning.”

He added that this impulsivity can also lead to errors “in situations where there are highly likely actions, thoughts, or behaviors” in a task, “which they would have to override to be successful” in performing it.

Dr. Westbrook gave the example of the “Stroop task where you are presented with words presented in some color ink and your job is to name the color of the ink but not read the word.”

If the word “green,” for example, was presented in green ink, “you may have no trouble naming the ink color,” but if it was presented in red ink “then you may impulsively read the word, because that is what we normally do with words. 

“Overriding this kind of habitual action can be particularly slippery business when striatal dopamine signaling is pharmacologically enhanced,” Dr. Westbrook said.

No funding for the study was reported. Dr. Coghill reported relationships with Medice, Novartis, Servier, Takeda/Shire Cambridge University Press, and Oxford University Press.

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

VIENNA – Prescription drugs designed to boost cognition in neurodevelopmental disorders do not increase overall cognitive performance in healthy individuals – and may even reduce productivity, new research suggests.

In a randomized controlled trial, 40 healthy adults were given the attention-deficit/hyperactivity disorder (ADHD) treatments methylphenidate or dexamphetamine or the wakefulness-promoting drug modafinil vs. placebo.

While receiving the so-called “smart drugs,” participants spent more time and made more moves more quickly while solving each problem on a complex cognitive task than when given the placebo. But with no significant improvement in overall performance, all drugs were associated with a significant reduction in efficiency.

The findings “reinforce the idea that, while the drugs administered were motivational, the resulting increase in effort came at a cost in the loss of productivity,” said study presenter David Coghill, MD, PhD, chair of developmental mental health, the University of Melbourne.

This was especially true for individuals who scored high when receiving placebo, “who ended up producing below average productivity when on the drugs,” he noted.

“Overall, these drugs don’t increase the performance. Instead, they cause a regression to the mean, and appear to have a more negative effect on those who performed best at baseline,” Dr. Coghill added.

He presented the findings at the 35th European College of Neuropsychopharmacology (ECNP) Congress.
 

Past evidence ambiguous

Dr. Coghill noted that prescription-only stimulant drugs are increasingly used by employees and students as “smart drugs” to enhance workplace or academic productivity.

He conducted the study with colleagues from the department of economics at his institution, because of “their interest in people using cognitive enhancers within the financial industry, in the hope that that would increase their productivity in what is a very competitive industry on the floor of the trading rooms.”

However, while “there’s a subjective belief” that these drugs are effective as cognitive enhancers, the evidence to actually demonstrate that in healthy individuals “is, at best, ambiguous,” he told meeting attendees.

Improvements in cognitive capacities, such as working memory and improved planning, are most evident in clinical populations such as those with ADHD, which could be due to a “ceiling effect” of the cognitive tasks in healthy individuals, Dr. Coghill noted.

To investigate further, the researchers conducted a randomized, double-blinded trial of standard adult doses of methylphenidate (30 mg), dexamphetamine (15 mg), and modafinil (200 mg) vs. placebo. The healthy participants (n = 40), all of whom were aged 18-35 years, crossed to each of the other treatment groups over the course of four intervention sessions.

All were asked to solve eight instances of the knapsack task, the aim of which is to place theoretical objects in a knapsack to achieve the maximum value within a certain weight limit.

“This looks very simple but as the number of items increases, it becomes incredibly complex to compute, and actually is not computable using standard approaches. You have to deal with trial and error,” Dr. Coghill said.

The participants also completed several CANTAB cognitive tasks.

‘Surprising’ findings

Results showed that, overall, the drugs did not have a significant effect on task performance (slope = –0.16; P = .011).

Moreover, the drugs, both individually and collectively, had a significant negative effect on the value attained during any one attempt at the knapsack task (slope = –0.003; P = .02), an effect that extended “across the whole range” of task complexity, Dr. Coghill reported.

He went on to show that “participants actually looked as if they were working harder” when they took the three active drugs than when they were given a placebo. They also “spent more time solving each problem,” he added.

When taking the active drugs, participants made more moves during each task than when taking placebo, and made their moves more quickly.

“So these medications increased motivation,” Dr. Coghill said. “If you were sitting [and] watching this person, you would think that they were working harder.”

Yet their productivity, defined as the average gain in value per move on the knapsack task, was lower. Regression analysis identified a “significant and sizable drop in productivity” vs. placebo, Dr. Coghill noted.

This was the case for methylphenidate (P < .001), dexamphetamine (P < .001), and modafinil (P < .05), “whether you looked at the mean or median performance,” he said.

“Breaking it down a little bit more, when you looked at the individual participant level, you find substantial heterogeneity across participants,” noted Dr. Coghill.

“More than that, we found a significant negative correlation between productivity under methylphenidate compared to productivity under placebo, and this suggests a regression to the mean,” with participants who performed better under placebo performing worse with methylphenidate, he explained.

While the relationship was “exactly the same with modafinil,” it was not found with dexamphetamine, with a strong negative correlation between the productivity effects between dexamphetamine and methylphenidate (slope = –0.29; P < .0001).

“This is surprising because we assume that methylphenidate and dexamphetamine are working in very similar ways,” Dr. Coghill said.
 

Time to rethink, rewind?

Commenting for this article, session chair John F. Cryan, PhD, department of anatomy and neuroscience, University College Cork, Ireland, said that, based on the current data, “we might need to rethink [how] ‘smart’ psychopharmacological agents are.”

Dr. Cryan, chair of the ECNP Scientific Program Committee, added that there may be a need to revisit the difficulty of different types of cognitive tasks used in studies assessing the abilities of cognitive enhancing drugs and to “rewind conventional wisdom” around them.

Also commenting, Andrew Westbrook, PhD, of the department of cognitive linguistics and psychological sciences, Brown University, Providence, R.I., said the results seem “reasonable” and are “consistent with my own perspective.”

However, he told this news organization, “some caveats are warranted,” not least that the context of the task can have an impact on the results it obtains.

“We have hypothesized that pharmacologically-enhanced striatal dopamine signaling can boost a kind of cognitive impulsivity, leading to errors and diminished performance, especially for people who already have high striatal dopamine functioning.”

He added that this impulsivity can also lead to errors “in situations where there are highly likely actions, thoughts, or behaviors” in a task, “which they would have to override to be successful” in performing it.

Dr. Westbrook gave the example of the “Stroop task where you are presented with words presented in some color ink and your job is to name the color of the ink but not read the word.”

If the word “green,” for example, was presented in green ink, “you may have no trouble naming the ink color,” but if it was presented in red ink “then you may impulsively read the word, because that is what we normally do with words. 

“Overriding this kind of habitual action can be particularly slippery business when striatal dopamine signaling is pharmacologically enhanced,” Dr. Westbrook said.

No funding for the study was reported. Dr. Coghill reported relationships with Medice, Novartis, Servier, Takeda/Shire Cambridge University Press, and Oxford University Press.

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

VIENNA – Prescription drugs designed to boost cognition in neurodevelopmental disorders do not increase overall cognitive performance in healthy individuals – and may even reduce productivity, new research suggests.

In a randomized controlled trial, 40 healthy adults were given the attention-deficit/hyperactivity disorder (ADHD) treatments methylphenidate or dexamphetamine or the wakefulness-promoting drug modafinil vs. placebo.

While receiving the so-called “smart drugs,” participants spent more time and made more moves more quickly while solving each problem on a complex cognitive task than when given the placebo. But with no significant improvement in overall performance, all drugs were associated with a significant reduction in efficiency.

The findings “reinforce the idea that, while the drugs administered were motivational, the resulting increase in effort came at a cost in the loss of productivity,” said study presenter David Coghill, MD, PhD, chair of developmental mental health, the University of Melbourne.

This was especially true for individuals who scored high when receiving placebo, “who ended up producing below average productivity when on the drugs,” he noted.

“Overall, these drugs don’t increase the performance. Instead, they cause a regression to the mean, and appear to have a more negative effect on those who performed best at baseline,” Dr. Coghill added.

He presented the findings at the 35th European College of Neuropsychopharmacology (ECNP) Congress.
 

Past evidence ambiguous

Dr. Coghill noted that prescription-only stimulant drugs are increasingly used by employees and students as “smart drugs” to enhance workplace or academic productivity.

He conducted the study with colleagues from the department of economics at his institution, because of “their interest in people using cognitive enhancers within the financial industry, in the hope that that would increase their productivity in what is a very competitive industry on the floor of the trading rooms.”

However, while “there’s a subjective belief” that these drugs are effective as cognitive enhancers, the evidence to actually demonstrate that in healthy individuals “is, at best, ambiguous,” he told meeting attendees.

Improvements in cognitive capacities, such as working memory and improved planning, are most evident in clinical populations such as those with ADHD, which could be due to a “ceiling effect” of the cognitive tasks in healthy individuals, Dr. Coghill noted.

To investigate further, the researchers conducted a randomized, double-blinded trial of standard adult doses of methylphenidate (30 mg), dexamphetamine (15 mg), and modafinil (200 mg) vs. placebo. The healthy participants (n = 40), all of whom were aged 18-35 years, crossed to each of the other treatment groups over the course of four intervention sessions.

All were asked to solve eight instances of the knapsack task, the aim of which is to place theoretical objects in a knapsack to achieve the maximum value within a certain weight limit.

“This looks very simple but as the number of items increases, it becomes incredibly complex to compute, and actually is not computable using standard approaches. You have to deal with trial and error,” Dr. Coghill said.

The participants also completed several CANTAB cognitive tasks.

‘Surprising’ findings

Results showed that, overall, the drugs did not have a significant effect on task performance (slope = –0.16; P = .011).

Moreover, the drugs, both individually and collectively, had a significant negative effect on the value attained during any one attempt at the knapsack task (slope = –0.003; P = .02), an effect that extended “across the whole range” of task complexity, Dr. Coghill reported.

He went on to show that “participants actually looked as if they were working harder” when they took the three active drugs than when they were given a placebo. They also “spent more time solving each problem,” he added.

When taking the active drugs, participants made more moves during each task than when taking placebo, and made their moves more quickly.

“So these medications increased motivation,” Dr. Coghill said. “If you were sitting [and] watching this person, you would think that they were working harder.”

Yet their productivity, defined as the average gain in value per move on the knapsack task, was lower. Regression analysis identified a “significant and sizable drop in productivity” vs. placebo, Dr. Coghill noted.

This was the case for methylphenidate (P < .001), dexamphetamine (P < .001), and modafinil (P < .05), “whether you looked at the mean or median performance,” he said.

“Breaking it down a little bit more, when you looked at the individual participant level, you find substantial heterogeneity across participants,” noted Dr. Coghill.

“More than that, we found a significant negative correlation between productivity under methylphenidate compared to productivity under placebo, and this suggests a regression to the mean,” with participants who performed better under placebo performing worse with methylphenidate, he explained.

While the relationship was “exactly the same with modafinil,” it was not found with dexamphetamine, with a strong negative correlation between the productivity effects between dexamphetamine and methylphenidate (slope = –0.29; P < .0001).

“This is surprising because we assume that methylphenidate and dexamphetamine are working in very similar ways,” Dr. Coghill said.
 

Time to rethink, rewind?

Commenting for this article, session chair John F. Cryan, PhD, department of anatomy and neuroscience, University College Cork, Ireland, said that, based on the current data, “we might need to rethink [how] ‘smart’ psychopharmacological agents are.”

Dr. Cryan, chair of the ECNP Scientific Program Committee, added that there may be a need to revisit the difficulty of different types of cognitive tasks used in studies assessing the abilities of cognitive enhancing drugs and to “rewind conventional wisdom” around them.

Also commenting, Andrew Westbrook, PhD, of the department of cognitive linguistics and psychological sciences, Brown University, Providence, R.I., said the results seem “reasonable” and are “consistent with my own perspective.”

However, he told this news organization, “some caveats are warranted,” not least that the context of the task can have an impact on the results it obtains.

“We have hypothesized that pharmacologically-enhanced striatal dopamine signaling can boost a kind of cognitive impulsivity, leading to errors and diminished performance, especially for people who already have high striatal dopamine functioning.”

He added that this impulsivity can also lead to errors “in situations where there are highly likely actions, thoughts, or behaviors” in a task, “which they would have to override to be successful” in performing it.

Dr. Westbrook gave the example of the “Stroop task where you are presented with words presented in some color ink and your job is to name the color of the ink but not read the word.”

If the word “green,” for example, was presented in green ink, “you may have no trouble naming the ink color,” but if it was presented in red ink “then you may impulsively read the word, because that is what we normally do with words. 

“Overriding this kind of habitual action can be particularly slippery business when striatal dopamine signaling is pharmacologically enhanced,” Dr. Westbrook said.

No funding for the study was reported. Dr. Coghill reported relationships with Medice, Novartis, Servier, Takeda/Shire Cambridge University Press, and Oxford University Press.

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

WASHINGTON – The updated Moderna bivalent COVID-19 vaccine that targets the original virus and the Omicron variant was superior to the original COVID booster in adults aged 18 and older, new results indicate.

The bivalent booster was superior regardless of age and whether a person had previously been infected with SARS-CoV-2.

Additionally, no new safety concerns emerged.

Spyros Chalkias, MD, senior medical director of clinical development at Moderna, presented the data during an annual scientific meeting on infectious diseases.

In the phase 2/3 trial, participants received either 50 mcg of the bivalent vaccine mRNA-1273.214 (25 mcg each of the original Wuhan-Hu-1 and Omicron BA.1 spike mRNAs) or 50 mcg of the standard authorized mRNA-1273. The doses were given as second boosters in adults who had previously received a two-dose primary series and a first booster at least 3 months before.

The model-based geometric mean titers (GMTs) ratio of the enhanced booster compared with the standard booster was 1.74 (1.49-2.04), meeting the prespecified bar for superiority against Omicron BA.1.

In participants without prior SARS-CoV-2 infection who received updated booster doses and those who received standard boosters, the neutralizing antibody GMTs against Omicron BA.1 were 2372.4 and 1473.5, respectively.

Additionally, the updated booster elicited higher GMTs (727.4) than the standard booster (492.1) against Omicron subvariants BA.4/BA.5. Safety and reactogenicity were similar for both vaccine groups.

“By the end of this year, we expect to also have clinical trial data from our BA.4/BA.5 bivalent booster,” Dr. Chalkias said.

In the interim, the U.S. Food and Drug Administration recently granted emergency use authorization for Moderna’s BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine in children and adolescents aged 6-17 years.

Pfizer/BioNTech also has recently issued an announcement that their COVID-19 booster, adapted for the BA.4 and the BA.5 Omicron subvariants, generated a strong immune response and was well tolerated in human tests.

Pfizer/BioNTech said data from roughly 80 adult patients showed that the booster led to a substantial increase in neutralizing antibody levels against the BA.4/BA.5 variants after 1 week.
 

Separate study of causes of severe breakthrough infections in early vaccine formulations

Though COVID vaccines reduce the incidence of severe outcomes, there are reports of breakthrough infections in persons who received the original vaccines, and some of these have been serious.

In a separate study, also presented at the meeting, researchers led by first author Austin D. Vo, BS, with the VA Boston Healthcare System, used data collected from Dec. 15, 2020, through Feb. 28, 2022, in a U.S. veteran population to assess those at highest risk for severe disease despite vaccination.

Results of the large, nationwide retrospective study were simultaneously published in JAMA Network Open.

The primary outcome was development of severe COVID, defined as a hospitalization within 14 days of a confirmed positive SARS-CoV-2 test, receipt of supplemental oxygen, mechanical ventilation, or death within 28 days.

Among 110,760 participants with severe disease after primary vaccination, 13% (14,690) were hospitalized with severe COVID-19 or died.

The strongest risk factor for severe disease despite vaccination was age, the researchers found.

Presenting author Westyn Branch-Elliman, MD, associate professor of medicine with VA Boston Healthcare System, said, “We found that age greater than 50 was associated with an adjusted odds ratio of 1.42 for every 5-year increase.”

To put that in perspective, she said, “compared to patients who are 45 to 50, those over 80 had an adjusted odds ratio of 16 for hospitalization or death following breakthrough infection.”

Priya Nori, MD, an infectious disease specialist at Montefiore Medical Center in New York, said in an interview that the evidence that age is a strong risk factor for severe disease – even after vaccination – confirms that attention should be focused on those in the highest age groups, particularly those 80 years and older.

Other top risk factors included having immunocompromising conditions; having received cytotoxic chemotherapy within 6 months (adjusted odds ratio, 2.69; 95% confidence interval, 2.25-3.21); having leukemias/lymphomas (aOR, 1.84; 95% CI, 1.59-2.14); and having chronic conditions associated with end-organ disease.

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

WASHINGTON – The updated Moderna bivalent COVID-19 vaccine that targets the original virus and the Omicron variant was superior to the original COVID booster in adults aged 18 and older, new results indicate.

The bivalent booster was superior regardless of age and whether a person had previously been infected with SARS-CoV-2.

Additionally, no new safety concerns emerged.

Spyros Chalkias, MD, senior medical director of clinical development at Moderna, presented the data during an annual scientific meeting on infectious diseases.

In the phase 2/3 trial, participants received either 50 mcg of the bivalent vaccine mRNA-1273.214 (25 mcg each of the original Wuhan-Hu-1 and Omicron BA.1 spike mRNAs) or 50 mcg of the standard authorized mRNA-1273. The doses were given as second boosters in adults who had previously received a two-dose primary series and a first booster at least 3 months before.

The model-based geometric mean titers (GMTs) ratio of the enhanced booster compared with the standard booster was 1.74 (1.49-2.04), meeting the prespecified bar for superiority against Omicron BA.1.

In participants without prior SARS-CoV-2 infection who received updated booster doses and those who received standard boosters, the neutralizing antibody GMTs against Omicron BA.1 were 2372.4 and 1473.5, respectively.

Additionally, the updated booster elicited higher GMTs (727.4) than the standard booster (492.1) against Omicron subvariants BA.4/BA.5. Safety and reactogenicity were similar for both vaccine groups.

“By the end of this year, we expect to also have clinical trial data from our BA.4/BA.5 bivalent booster,” Dr. Chalkias said.

In the interim, the U.S. Food and Drug Administration recently granted emergency use authorization for Moderna’s BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine in children and adolescents aged 6-17 years.

Pfizer/BioNTech also has recently issued an announcement that their COVID-19 booster, adapted for the BA.4 and the BA.5 Omicron subvariants, generated a strong immune response and was well tolerated in human tests.

Pfizer/BioNTech said data from roughly 80 adult patients showed that the booster led to a substantial increase in neutralizing antibody levels against the BA.4/BA.5 variants after 1 week.
 

Separate study of causes of severe breakthrough infections in early vaccine formulations

Though COVID vaccines reduce the incidence of severe outcomes, there are reports of breakthrough infections in persons who received the original vaccines, and some of these have been serious.

In a separate study, also presented at the meeting, researchers led by first author Austin D. Vo, BS, with the VA Boston Healthcare System, used data collected from Dec. 15, 2020, through Feb. 28, 2022, in a U.S. veteran population to assess those at highest risk for severe disease despite vaccination.

Results of the large, nationwide retrospective study were simultaneously published in JAMA Network Open.

The primary outcome was development of severe COVID, defined as a hospitalization within 14 days of a confirmed positive SARS-CoV-2 test, receipt of supplemental oxygen, mechanical ventilation, or death within 28 days.

Among 110,760 participants with severe disease after primary vaccination, 13% (14,690) were hospitalized with severe COVID-19 or died.

The strongest risk factor for severe disease despite vaccination was age, the researchers found.

Presenting author Westyn Branch-Elliman, MD, associate professor of medicine with VA Boston Healthcare System, said, “We found that age greater than 50 was associated with an adjusted odds ratio of 1.42 for every 5-year increase.”

To put that in perspective, she said, “compared to patients who are 45 to 50, those over 80 had an adjusted odds ratio of 16 for hospitalization or death following breakthrough infection.”

Priya Nori, MD, an infectious disease specialist at Montefiore Medical Center in New York, said in an interview that the evidence that age is a strong risk factor for severe disease – even after vaccination – confirms that attention should be focused on those in the highest age groups, particularly those 80 years and older.

Other top risk factors included having immunocompromising conditions; having received cytotoxic chemotherapy within 6 months (adjusted odds ratio, 2.69; 95% confidence interval, 2.25-3.21); having leukemias/lymphomas (aOR, 1.84; 95% CI, 1.59-2.14); and having chronic conditions associated with end-organ disease.

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

WASHINGTON – The updated Moderna bivalent COVID-19 vaccine that targets the original virus and the Omicron variant was superior to the original COVID booster in adults aged 18 and older, new results indicate.

The bivalent booster was superior regardless of age and whether a person had previously been infected with SARS-CoV-2.

Additionally, no new safety concerns emerged.

Spyros Chalkias, MD, senior medical director of clinical development at Moderna, presented the data during an annual scientific meeting on infectious diseases.

In the phase 2/3 trial, participants received either 50 mcg of the bivalent vaccine mRNA-1273.214 (25 mcg each of the original Wuhan-Hu-1 and Omicron BA.1 spike mRNAs) or 50 mcg of the standard authorized mRNA-1273. The doses were given as second boosters in adults who had previously received a two-dose primary series and a first booster at least 3 months before.

The model-based geometric mean titers (GMTs) ratio of the enhanced booster compared with the standard booster was 1.74 (1.49-2.04), meeting the prespecified bar for superiority against Omicron BA.1.

In participants without prior SARS-CoV-2 infection who received updated booster doses and those who received standard boosters, the neutralizing antibody GMTs against Omicron BA.1 were 2372.4 and 1473.5, respectively.

Additionally, the updated booster elicited higher GMTs (727.4) than the standard booster (492.1) against Omicron subvariants BA.4/BA.5. Safety and reactogenicity were similar for both vaccine groups.

“By the end of this year, we expect to also have clinical trial data from our BA.4/BA.5 bivalent booster,” Dr. Chalkias said.

In the interim, the U.S. Food and Drug Administration recently granted emergency use authorization for Moderna’s BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine in children and adolescents aged 6-17 years.

Pfizer/BioNTech also has recently issued an announcement that their COVID-19 booster, adapted for the BA.4 and the BA.5 Omicron subvariants, generated a strong immune response and was well tolerated in human tests.

Pfizer/BioNTech said data from roughly 80 adult patients showed that the booster led to a substantial increase in neutralizing antibody levels against the BA.4/BA.5 variants after 1 week.
 

Separate study of causes of severe breakthrough infections in early vaccine formulations

Though COVID vaccines reduce the incidence of severe outcomes, there are reports of breakthrough infections in persons who received the original vaccines, and some of these have been serious.

In a separate study, also presented at the meeting, researchers led by first author Austin D. Vo, BS, with the VA Boston Healthcare System, used data collected from Dec. 15, 2020, through Feb. 28, 2022, in a U.S. veteran population to assess those at highest risk for severe disease despite vaccination.

Results of the large, nationwide retrospective study were simultaneously published in JAMA Network Open.

The primary outcome was development of severe COVID, defined as a hospitalization within 14 days of a confirmed positive SARS-CoV-2 test, receipt of supplemental oxygen, mechanical ventilation, or death within 28 days.

Among 110,760 participants with severe disease after primary vaccination, 13% (14,690) were hospitalized with severe COVID-19 or died.

The strongest risk factor for severe disease despite vaccination was age, the researchers found.

Presenting author Westyn Branch-Elliman, MD, associate professor of medicine with VA Boston Healthcare System, said, “We found that age greater than 50 was associated with an adjusted odds ratio of 1.42 for every 5-year increase.”

To put that in perspective, she said, “compared to patients who are 45 to 50, those over 80 had an adjusted odds ratio of 16 for hospitalization or death following breakthrough infection.”

Priya Nori, MD, an infectious disease specialist at Montefiore Medical Center in New York, said in an interview that the evidence that age is a strong risk factor for severe disease – even after vaccination – confirms that attention should be focused on those in the highest age groups, particularly those 80 years and older.

Other top risk factors included having immunocompromising conditions; having received cytotoxic chemotherapy within 6 months (adjusted odds ratio, 2.69; 95% confidence interval, 2.25-3.21); having leukemias/lymphomas (aOR, 1.84; 95% CI, 1.59-2.14); and having chronic conditions associated with end-organ disease.

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

Preexisting statin use may help protect hospitalized patients with COVID-19 against negative outcomes, including death, a large retrospective analysis suggests.

Compared with patients who didn’t take statins, statin users had better health outcomes. For those who used these medications, the researchers saw lower mortality, lower clinical severity, and shorter hospital stays, aligning with previous observational studies, said lead author Ettore Crimi, MD, of the University of Central Florida, Orlando, and colleagues in their abstract, which was part of the agenda for the Anesthesiology annual meeting.

They attributed these clinical improvements to the pleiotropic – non–cholesterol lowering – effects of statins.

“[These] benefits of statins have been reported since the 1990s,” Dr. Crimi said in an interview. “Statin treatment has been associated with a marked reduction of markers of inflammation, such as erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), interleukin-6 (IL-6), ferritin, and white blood cell count, among others.”

He noted that these effects have been studied in an array of conditions, including cancer, autoimmune diseases, chronic inflammatory disease, and in the perioperative setting, and with infectious diseases, including COVID-19.

In those previous studies, “preexisting statin use was protective among hospitalized COVID-19 patients, but a large, multicenter cohort study has not been reported in the United States,” Dr. Crimi and his colleagues wrote in their abstract.

To address this knowledge gap, they turned to electronic medical records from 38,875 patients hospitalized with COVID-19 from January to September 2020. Almost one-third of the population (n = 11,533) were using statins prior to hospitalization, while the remainder (n = 27,342) were nonusers.

The primary outcome was all-cause mortality. Secondary outcomes included death from COVID-19, along with a variety of severe complications. While the analysis did account for a range of potentially confounding variables, the effects of different SARS-CoV-2 variants and new therapeutics were not considered. Vaccines were not yet available at the time the data were collected.

Statin users had a 31% lower rate of all-cause mortality (odds ratio, 0.69; 95% confidence interval, 0.64-0.75; P = .001) and a 37% reduced rate of death from COVID-19 (OR, 0.63; 95% CI, 0.58-0.69; P = .001).

A litany of other secondary variables also favored statin users, including reduced rates of discharge to hospice (OR, 0.79), ICU admission (OR, 0.69), severe acute respiratory distress syndrome (ARDs; OR, 0.72), critical ARDs (OR, 0.57), mechanical ventilation (OR, 0.60), severe sepsis with septic shock (OR, 0.66), and thrombosis (OR, 0.46). Statin users also had, on average, shorter hospital stays and briefer mechanical ventilation.

“Our study showed a strong association between preexisting statin use and reduced mortality and morbidity rates in hospitalized COVID-19 patients,” the investigators concluded. “Pleiotropic benefits of statins could be repurposed for COVID-19 illness.”

Prospective studies needed before practice changes

How to best use statins against COVID-19, if at all, remains unclear, Dr. Crimi said, as initiation upon infection has generated mixed results in other studies, possibly because of statin pharmacodynamics. Cholesterol normalization can take about 6 weeks, so other benefits may track a similar timeline.

“The delayed onset of statins’ pleiotropic effects may likely fail to keep pace with the rapidly progressive, devastating COVID-19 disease,” Dr. Crimi said. “Therefore, initiating statins for an acute disease may not be an ideal first-line treatment.”

Stronger data are on the horizon, he added, noting that 19 federally funded prospective trials are underway to better understand the relationship between statins and COVID-19.

Daniel Rader, MD, of the University of Pennsylvania, Philadelphia, said the present findings are “not especially notable” because they “mostly confirm previous studies, but in a large U.S. cohort.”

Dr. Rader, who wrote about the potential repurposing of statins for COVID-19 back in the first year of the pandemic (Cell Metab. 2020 Aug 4;32[2]:145-7), agreed with the investigators that recommending changes to clinical practice would be imprudent until randomized controlled data confirm the benefits of initiating statins in patients with active COVID-19.

“More research on the impact of cellular cholesterol metabolism on SARS-CoV-2 infection of cells and generation of inflammation would also be of interest,” he added.

The investigators disclosed no competing interests. Dr. Rader disclosed relationships with Novartis, Pfizer, Verve, and others.

Preexisting statin use may help protect hospitalized patients with COVID-19 against negative outcomes, including death, a large retrospective analysis suggests.

Compared with patients who didn’t take statins, statin users had better health outcomes. For those who used these medications, the researchers saw lower mortality, lower clinical severity, and shorter hospital stays, aligning with previous observational studies, said lead author Ettore Crimi, MD, of the University of Central Florida, Orlando, and colleagues in their abstract, which was part of the agenda for the Anesthesiology annual meeting.

They attributed these clinical improvements to the pleiotropic – non–cholesterol lowering – effects of statins.

“[These] benefits of statins have been reported since the 1990s,” Dr. Crimi said in an interview. “Statin treatment has been associated with a marked reduction of markers of inflammation, such as erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), interleukin-6 (IL-6), ferritin, and white blood cell count, among others.”

He noted that these effects have been studied in an array of conditions, including cancer, autoimmune diseases, chronic inflammatory disease, and in the perioperative setting, and with infectious diseases, including COVID-19.

In those previous studies, “preexisting statin use was protective among hospitalized COVID-19 patients, but a large, multicenter cohort study has not been reported in the United States,” Dr. Crimi and his colleagues wrote in their abstract.

To address this knowledge gap, they turned to electronic medical records from 38,875 patients hospitalized with COVID-19 from January to September 2020. Almost one-third of the population (n = 11,533) were using statins prior to hospitalization, while the remainder (n = 27,342) were nonusers.

The primary outcome was all-cause mortality. Secondary outcomes included death from COVID-19, along with a variety of severe complications. While the analysis did account for a range of potentially confounding variables, the effects of different SARS-CoV-2 variants and new therapeutics were not considered. Vaccines were not yet available at the time the data were collected.

Statin users had a 31% lower rate of all-cause mortality (odds ratio, 0.69; 95% confidence interval, 0.64-0.75; P = .001) and a 37% reduced rate of death from COVID-19 (OR, 0.63; 95% CI, 0.58-0.69; P = .001).

A litany of other secondary variables also favored statin users, including reduced rates of discharge to hospice (OR, 0.79), ICU admission (OR, 0.69), severe acute respiratory distress syndrome (ARDs; OR, 0.72), critical ARDs (OR, 0.57), mechanical ventilation (OR, 0.60), severe sepsis with septic shock (OR, 0.66), and thrombosis (OR, 0.46). Statin users also had, on average, shorter hospital stays and briefer mechanical ventilation.

“Our study showed a strong association between preexisting statin use and reduced mortality and morbidity rates in hospitalized COVID-19 patients,” the investigators concluded. “Pleiotropic benefits of statins could be repurposed for COVID-19 illness.”

Prospective studies needed before practice changes

How to best use statins against COVID-19, if at all, remains unclear, Dr. Crimi said, as initiation upon infection has generated mixed results in other studies, possibly because of statin pharmacodynamics. Cholesterol normalization can take about 6 weeks, so other benefits may track a similar timeline.

“The delayed onset of statins’ pleiotropic effects may likely fail to keep pace with the rapidly progressive, devastating COVID-19 disease,” Dr. Crimi said. “Therefore, initiating statins for an acute disease may not be an ideal first-line treatment.”

Stronger data are on the horizon, he added, noting that 19 federally funded prospective trials are underway to better understand the relationship between statins and COVID-19.

Daniel Rader, MD, of the University of Pennsylvania, Philadelphia, said the present findings are “not especially notable” because they “mostly confirm previous studies, but in a large U.S. cohort.”

Dr. Rader, who wrote about the potential repurposing of statins for COVID-19 back in the first year of the pandemic (Cell Metab. 2020 Aug 4;32[2]:145-7), agreed with the investigators that recommending changes to clinical practice would be imprudent until randomized controlled data confirm the benefits of initiating statins in patients with active COVID-19.

“More research on the impact of cellular cholesterol metabolism on SARS-CoV-2 infection of cells and generation of inflammation would also be of interest,” he added.

The investigators disclosed no competing interests. Dr. Rader disclosed relationships with Novartis, Pfizer, Verve, and others.

Preexisting statin use may help protect hospitalized patients with COVID-19 against negative outcomes, including death, a large retrospective analysis suggests.

Compared with patients who didn’t take statins, statin users had better health outcomes. For those who used these medications, the researchers saw lower mortality, lower clinical severity, and shorter hospital stays, aligning with previous observational studies, said lead author Ettore Crimi, MD, of the University of Central Florida, Orlando, and colleagues in their abstract, which was part of the agenda for the Anesthesiology annual meeting.

They attributed these clinical improvements to the pleiotropic – non–cholesterol lowering – effects of statins.

“[These] benefits of statins have been reported since the 1990s,” Dr. Crimi said in an interview. “Statin treatment has been associated with a marked reduction of markers of inflammation, such as erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), interleukin-6 (IL-6), ferritin, and white blood cell count, among others.”

He noted that these effects have been studied in an array of conditions, including cancer, autoimmune diseases, chronic inflammatory disease, and in the perioperative setting, and with infectious diseases, including COVID-19.

In those previous studies, “preexisting statin use was protective among hospitalized COVID-19 patients, but a large, multicenter cohort study has not been reported in the United States,” Dr. Crimi and his colleagues wrote in their abstract.

To address this knowledge gap, they turned to electronic medical records from 38,875 patients hospitalized with COVID-19 from January to September 2020. Almost one-third of the population (n = 11,533) were using statins prior to hospitalization, while the remainder (n = 27,342) were nonusers.

The primary outcome was all-cause mortality. Secondary outcomes included death from COVID-19, along with a variety of severe complications. While the analysis did account for a range of potentially confounding variables, the effects of different SARS-CoV-2 variants and new therapeutics were not considered. Vaccines were not yet available at the time the data were collected.

Statin users had a 31% lower rate of all-cause mortality (odds ratio, 0.69; 95% confidence interval, 0.64-0.75; P = .001) and a 37% reduced rate of death from COVID-19 (OR, 0.63; 95% CI, 0.58-0.69; P = .001).

A litany of other secondary variables also favored statin users, including reduced rates of discharge to hospice (OR, 0.79), ICU admission (OR, 0.69), severe acute respiratory distress syndrome (ARDs; OR, 0.72), critical ARDs (OR, 0.57), mechanical ventilation (OR, 0.60), severe sepsis with septic shock (OR, 0.66), and thrombosis (OR, 0.46). Statin users also had, on average, shorter hospital stays and briefer mechanical ventilation.

“Our study showed a strong association between preexisting statin use and reduced mortality and morbidity rates in hospitalized COVID-19 patients,” the investigators concluded. “Pleiotropic benefits of statins could be repurposed for COVID-19 illness.”

Prospective studies needed before practice changes

How to best use statins against COVID-19, if at all, remains unclear, Dr. Crimi said, as initiation upon infection has generated mixed results in other studies, possibly because of statin pharmacodynamics. Cholesterol normalization can take about 6 weeks, so other benefits may track a similar timeline.

“The delayed onset of statins’ pleiotropic effects may likely fail to keep pace with the rapidly progressive, devastating COVID-19 disease,” Dr. Crimi said. “Therefore, initiating statins for an acute disease may not be an ideal first-line treatment.”

Stronger data are on the horizon, he added, noting that 19 federally funded prospective trials are underway to better understand the relationship between statins and COVID-19.

Daniel Rader, MD, of the University of Pennsylvania, Philadelphia, said the present findings are “not especially notable” because they “mostly confirm previous studies, but in a large U.S. cohort.”

Dr. Rader, who wrote about the potential repurposing of statins for COVID-19 back in the first year of the pandemic (Cell Metab. 2020 Aug 4;32[2]:145-7), agreed with the investigators that recommending changes to clinical practice would be imprudent until randomized controlled data confirm the benefits of initiating statins in patients with active COVID-19.

“More research on the impact of cellular cholesterol metabolism on SARS-CoV-2 infection of cells and generation of inflammation would also be of interest,” he added.

The investigators disclosed no competing interests. Dr. Rader disclosed relationships with Novartis, Pfizer, Verve, and others.

Mind and body practices, especially yoga, improve glycemic control in type 2 diabetes to a similar extent as medications such as metformin, new research shows.

“To our knowledge, this is the first study that has looked across different modalities of mind-body interventions and the first to show that there is a very consistent effect on A1c regardless of which modality you use,” senior author, Richard Watanabe, PhD, professor of biostatistics, Keck School of Medicine of the University of Southern California, Los Angeles, told this news organization.

none needed

Regularity of yoga practice makes the difference

A total of 28 studies of patients with type 2 diabetes published between 1993 and 2022 were included in the meta-analysis. In all studies, patients who were taking insulin or had any medical complications of diabetes were excluded.

A significant mean reduction in A1c of 0.84% was observed across the board for all types of mindfulness interventions (P < .0001).

For mindfulness-based stress reduction, A1c was reduced by 0.48% (P = 0.03), while the practice of qigong – a coordinated body-posture movement – was associated with a 0.66% drop in A1c (P = .01). For meditation, A1c dropped by 0.50% (P = .64).

However, the largest drop in A1c was seen with yoga, where it fell by 1.00% (P < .0001) – about the same degree of glycemic control achieved with metformin, the authors point out.  

Indeed, for every additional day of yoga practiced per week, mean A1c differed by –0.22% (P = .46) between those who engaged in mind-body interventions and those who did not.

There was also a reduction in fasting blood glucose (FBG) with yoga and other practices. “The mean change in FBG was consistent with the mean change in A1c at –22.81 mg/dL (P < .0001),” the authors continue.

The researchers found that the duration of yoga didn’t matter but the frequency did, so it’s the regularity “with which you do yoga that makes the difference,” Dr. Watanabe said.

Dr. Watanabe and his coauthors also point out that because most patients were actively receiving metformin before and throughout the studies, the observed effect of mind and body practices on A1c represents an additional reduction beyond that of medication.

“This raises the question [as to] whether mind and body practices could be useful when initiated early in the course of diabetes therapy along with conventional lifestyle treatments,” they suggest.

While more research is needed to study this specifically, “our results suggest that these mind-body practices might be a good preventative measure,” Dr. Watanabe noted. Mind-body practices may also effectively prevent type 2 diabetes in at-risk patients, the authors propose.
 

Does meditation help alleviate psychological distress?

How mind-body practices work to improve glycemic control isn’t clear, but one possible theory is that patients experience a decrease in psychological distress when they undertake such practices and in so doing, may be more compliant with their prescribed treatment regimen.

A few of the studies analyzed showed that mind-body work resulted in a significant decrease in serum cortisol, the stress hormone that could plausibly mediate the benefit of mind and body practices through reduced inflammation.

In addition, “people with diabetes live with what we call ‘diabetes distress,’ ” Dr. Watanabe explained.

“Management of blood glucose is very stressful. You have to watch what you eat, you have to measure your glucose, and for the average person, that gets stressful. And that stress just contributes to the difficulty of controlling blood glucose,” he noted.

The authors have reported no relevant financial relationships.

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

Mind and body practices, especially yoga, improve glycemic control in type 2 diabetes to a similar extent as medications such as metformin, new research shows.

“To our knowledge, this is the first study that has looked across different modalities of mind-body interventions and the first to show that there is a very consistent effect on A1c regardless of which modality you use,” senior author, Richard Watanabe, PhD, professor of biostatistics, Keck School of Medicine of the University of Southern California, Los Angeles, told this news organization.

none needed

Regularity of yoga practice makes the difference

A total of 28 studies of patients with type 2 diabetes published between 1993 and 2022 were included in the meta-analysis. In all studies, patients who were taking insulin or had any medical complications of diabetes were excluded.

A significant mean reduction in A1c of 0.84% was observed across the board for all types of mindfulness interventions (P < .0001).

For mindfulness-based stress reduction, A1c was reduced by 0.48% (P = 0.03), while the practice of qigong – a coordinated body-posture movement – was associated with a 0.66% drop in A1c (P = .01). For meditation, A1c dropped by 0.50% (P = .64).

However, the largest drop in A1c was seen with yoga, where it fell by 1.00% (P < .0001) – about the same degree of glycemic control achieved with metformin, the authors point out.  

Indeed, for every additional day of yoga practiced per week, mean A1c differed by –0.22% (P = .46) between those who engaged in mind-body interventions and those who did not.

There was also a reduction in fasting blood glucose (FBG) with yoga and other practices. “The mean change in FBG was consistent with the mean change in A1c at –22.81 mg/dL (P < .0001),” the authors continue.

The researchers found that the duration of yoga didn’t matter but the frequency did, so it’s the regularity “with which you do yoga that makes the difference,” Dr. Watanabe said.

Dr. Watanabe and his coauthors also point out that because most patients were actively receiving metformin before and throughout the studies, the observed effect of mind and body practices on A1c represents an additional reduction beyond that of medication.

“This raises the question [as to] whether mind and body practices could be useful when initiated early in the course of diabetes therapy along with conventional lifestyle treatments,” they suggest.

While more research is needed to study this specifically, “our results suggest that these mind-body practices might be a good preventative measure,” Dr. Watanabe noted. Mind-body practices may also effectively prevent type 2 diabetes in at-risk patients, the authors propose.
 

Does meditation help alleviate psychological distress?

How mind-body practices work to improve glycemic control isn’t clear, but one possible theory is that patients experience a decrease in psychological distress when they undertake such practices and in so doing, may be more compliant with their prescribed treatment regimen.

A few of the studies analyzed showed that mind-body work resulted in a significant decrease in serum cortisol, the stress hormone that could plausibly mediate the benefit of mind and body practices through reduced inflammation.

In addition, “people with diabetes live with what we call ‘diabetes distress,’ ” Dr. Watanabe explained.

“Management of blood glucose is very stressful. You have to watch what you eat, you have to measure your glucose, and for the average person, that gets stressful. And that stress just contributes to the difficulty of controlling blood glucose,” he noted.

The authors have reported no relevant financial relationships.

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

Mind and body practices, especially yoga, improve glycemic control in type 2 diabetes to a similar extent as medications such as metformin, new research shows.

“To our knowledge, this is the first study that has looked across different modalities of mind-body interventions and the first to show that there is a very consistent effect on A1c regardless of which modality you use,” senior author, Richard Watanabe, PhD, professor of biostatistics, Keck School of Medicine of the University of Southern California, Los Angeles, told this news organization.

none needed

Regularity of yoga practice makes the difference

A total of 28 studies of patients with type 2 diabetes published between 1993 and 2022 were included in the meta-analysis. In all studies, patients who were taking insulin or had any medical complications of diabetes were excluded.

A significant mean reduction in A1c of 0.84% was observed across the board for all types of mindfulness interventions (P < .0001).

For mindfulness-based stress reduction, A1c was reduced by 0.48% (P = 0.03), while the practice of qigong – a coordinated body-posture movement – was associated with a 0.66% drop in A1c (P = .01). For meditation, A1c dropped by 0.50% (P = .64).

However, the largest drop in A1c was seen with yoga, where it fell by 1.00% (P < .0001) – about the same degree of glycemic control achieved with metformin, the authors point out.  

Indeed, for every additional day of yoga practiced per week, mean A1c differed by –0.22% (P = .46) between those who engaged in mind-body interventions and those who did not.

There was also a reduction in fasting blood glucose (FBG) with yoga and other practices. “The mean change in FBG was consistent with the mean change in A1c at –22.81 mg/dL (P < .0001),” the authors continue.

The researchers found that the duration of yoga didn’t matter but the frequency did, so it’s the regularity “with which you do yoga that makes the difference,” Dr. Watanabe said.

Dr. Watanabe and his coauthors also point out that because most patients were actively receiving metformin before and throughout the studies, the observed effect of mind and body practices on A1c represents an additional reduction beyond that of medication.

“This raises the question [as to] whether mind and body practices could be useful when initiated early in the course of diabetes therapy along with conventional lifestyle treatments,” they suggest.

While more research is needed to study this specifically, “our results suggest that these mind-body practices might be a good preventative measure,” Dr. Watanabe noted. Mind-body practices may also effectively prevent type 2 diabetes in at-risk patients, the authors propose.
 

Does meditation help alleviate psychological distress?

How mind-body practices work to improve glycemic control isn’t clear, but one possible theory is that patients experience a decrease in psychological distress when they undertake such practices and in so doing, may be more compliant with their prescribed treatment regimen.

A few of the studies analyzed showed that mind-body work resulted in a significant decrease in serum cortisol, the stress hormone that could plausibly mediate the benefit of mind and body practices through reduced inflammation.

In addition, “people with diabetes live with what we call ‘diabetes distress,’ ” Dr. Watanabe explained.

“Management of blood glucose is very stressful. You have to watch what you eat, you have to measure your glucose, and for the average person, that gets stressful. And that stress just contributes to the difficulty of controlling blood glucose,” he noted.

The authors have reported no relevant financial relationships.

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

A pregnant patient who had COVID-19 showed up at a hospital with respiratory difficulty caused by her illness. Physicians had to perform an emergency delivery of her near-term baby.

The infant survived, but the woman lost oxygen during the ordeal and suffered hypoxic brain damage. She is now suing an obstetrician, a pulmonologist, and an intensive care unit physician for medical malpractice.

The plaintiff contends there was a failure “to adequately recognize and treat her condition,” said Peter Kolbert, senior vice president for claim and litigation services for Healthcare Risk Advisors, part of TDC Group, which includes national medical liability insurer The Doctors Company.

“The physicians involved vehemently disagree and believe they treated her appropriately,” Mr. Kolbert said. “In fact, we believe their actions were heroic.”

In another case, a patient with COVID-19 and multiple comorbidities was admitted to a hospital. Physicians sedated and intubated the patient to maintain her airway. She recovered, but the patient now alleges doctors were negligent because she developed ulcers during her hospital stay. The case occurred during the height of the pandemic. In addition to the hospital, a pulmonologist, an ICU physician, and an acute care physician are named in the suit.

Both of these lawsuits are being defined as COVID claims because at the time, the plaintiffs either had COVID and needed care because of COVID, or because the care that physicians provided was affected by COVID in some way.

In the second case, the patient had COVID and needed treatment. During her recovery, ulcers developed. A significant aspect of this case is that it occurred during the height of the pandemic. Hospitals were overcrowded, the staff was swamped, and resources were limited. One factor may be that physicians were doing the best they could at the time but that the pandemic affected the extent of care they could provide.

Physicians have long worried about the legal consequences of COVID-19 and whether lawsuits might arise from the care that was provided or that was delayed by the pandemic. Now, new data reflect the grim news: COVID claims have arrived. These cases from the claims database of The Doctors Company are just two examples of many COVID-related claims that have been levied since the pandemic started.

Currently, there are 162 open COVID-related claims in The Doctors Company database, according to Mr. Kolbert. A September 2022 benchmark report from Aon and the American Society for Health Care Risk Management indicates that 245 claims that pertain to patients with confirmed or suspected COVID-19 have been filed since the pandemic began. The findings in this report stem from an analysis of 95,600 hospital and physician liability claims that occurred between 2012 and 2021.

Of the 245 cases, 89 claims have been closed. The average cost was $43,000 per claim, said Kanika Vats, a director and actuary for Aon, a global firm that provides risk, reinsurance, and health solutions. Six of the claims cost $300,000 or more; the highest settlement was for $700,000.

“Most of the allegations in these claims revolve around delay in treatment or delay in diagnosis,” Ms. Vats said.
 

Which specialties are involved in legal actions?

Physicians working in acute care settings such as emergency departments and urgent care centers are the primary targets in COVID-related lawsuits involving doctors, say legal analysts. However, other specialties are also being affected. Physicians being sued include some who practiced telemedicine during the pandemic.

In one case, a primary care physician saw a patient via telemedicine because the physical medical office was closed. The patient was evaluated virtually and was sent for bloodwork and an x-ray.

The patient is now suing the primary care physician, alleging that failure to immediately send her to a hospital resulted in tuberculosis going untreated and that the failure led to a bad outcome. The allegation is that the physician underevaluated the case during the telemedicine visit, Mr. Kolbert said.

Drew Graham, an attorney at Hall Booth Smith PC, which is based in New York, said that most of the COVID-related liability claims he has seen involve facilities that provide postacute care, such as nursing homes and assisted living facilities. His firm has also seen a small number of COVID-related claims against physicians.

At least two of the claims involved allegations of improper treatment of COVID during hospitalizations, he said. Another involved a telehealth visit in which the patient claimed the virtual care that was provided was improper and that their condition required an in-person examination. Mr. Graham declined to specify the specialties of the physicians sued.

The Medical Professional Liability Association reports similar trends in COVID-related claims. Long-term facilities and hospitals are the most common focus of COVID-19 claims, followed by emergency medicine, primary care, and ob/gyn medical specialties, according to Kwon Miller, manager of data and analytics for MPL Association, a national trade association for medical liability insurers that operates a large claims database.

Between January 2020 and June 2022, the MPL Association Data Sharing Project recorded 280 COVID-19 events. “Events” refers to notifications, licensing board inquiries, and claims involving COVID. Of these events, 180 were closed with no indemnity payment, and 13 were closed with an average indemnity payment of $3,816, Mr. Miller said.

Complaints of delayed care associated with the pandemic are also on the rise. For example, one patient is suing a gastroenterologist for delaying his colonoscopy, alleging the postponement led to a delayed colon cancer diagnosis and worse prognosis, Mr. Kolbert said.

“It was delayed because all elective procedures at the time were being put off,” he said. “The patient claims that had they received the scheduled screening, the cancer would have been diagnosed at stage I as opposed to stage III.”
 

Why isn’t federal immunity shielding physicians?

A pressing question about the growing number of COVID claims is why state and federal immunity isn’t preventing such lawsuits.

In 2020, the U.S. Department of Health & Human Services published a declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) that provided liability immunity to health care professionals for any activity related to medical countermeasures against COVID-19. The act allows an exception for negligence claims associated with death or serious injury caused by willful misconduct.

At the same time, most states implemented laws or executive orders shielding physicians from liability claims related to the prevention and treatment of COVID-19, unless gross negligence or willful misconduct is proven.

Mr. Graham said some COVID-related claims against physicians have included allegations of gross negligence to avoid the application of state immunity, while others combine allegations of deviations from standard of care unrelated to the pandemic.

Some plaintiffs are attempting to skirt the protections by making complaints sound as if they’re not related to COVID-19, Mr. Kolbert said. That way, they don’t have to prove gross negligence or willful misconduct at all.

“The filings at first blush may not tell you it’s a COVID case, but it may be a COVID case,” he said. “Plaintiffs’ attorneys are trying to assert that COVID defenses do not apply and that these cases are ‘traditional physician negligence’ claims. They’re trying to plead around the protections.”

The federal and state immunities are likely keeping the volume of COVID claims down overall and are discouraging some complaints from moving forward, attorneys say.

But because some plaintiffs are downplaying or ignoring the COVID association, it’s likely that more COVID lawsuits exist than anyone realizes, according to Mr. Kolbert.

“I expect there’s an underestimation of how many COVID claims are really out there,” he said.
 

What does the future hold for COVID claims?

Currently, the frequency and the severity of COVID claims are low, Ms. Vats said. She believes the cost of such claims will continue to remain at low levels.

“But again, there is a lot of uncertainty,” she said. “This year, states have started to roll back their immunity protections, and in a lot of states, there is no cap in awarding [noneconomic] damages. There could well be a scenario where they allege wrongful death, and in a state with no cap on the pain and suffering component, if juries continue to behave the way they have been behaving, we could see aberration verdicts.”

Another lingering issue concerns which court systems have jurisdiction in cases involving COVID-related claims. Because of the nationwide response to the pandemic, Mr. Graham thinks it makes sense that federal courts handle the cases, but the plaintiffs’ bar has generally been opposed to federal jurisdiction.

“A second issue is the long-term impact of COVID litigation on our providers,” he said. “If the protections in place to limit liability are determined to be ineffective, our state and federal leaders must act aggressively and in a bipartisan way to make sure our health care providers are protected when we face the next crisis.”

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

A pregnant patient who had COVID-19 showed up at a hospital with respiratory difficulty caused by her illness. Physicians had to perform an emergency delivery of her near-term baby.

The infant survived, but the woman lost oxygen during the ordeal and suffered hypoxic brain damage. She is now suing an obstetrician, a pulmonologist, and an intensive care unit physician for medical malpractice.

The plaintiff contends there was a failure “to adequately recognize and treat her condition,” said Peter Kolbert, senior vice president for claim and litigation services for Healthcare Risk Advisors, part of TDC Group, which includes national medical liability insurer The Doctors Company.

“The physicians involved vehemently disagree and believe they treated her appropriately,” Mr. Kolbert said. “In fact, we believe their actions were heroic.”

In another case, a patient with COVID-19 and multiple comorbidities was admitted to a hospital. Physicians sedated and intubated the patient to maintain her airway. She recovered, but the patient now alleges doctors were negligent because she developed ulcers during her hospital stay. The case occurred during the height of the pandemic. In addition to the hospital, a pulmonologist, an ICU physician, and an acute care physician are named in the suit.

Both of these lawsuits are being defined as COVID claims because at the time, the plaintiffs either had COVID and needed care because of COVID, or because the care that physicians provided was affected by COVID in some way.

In the second case, the patient had COVID and needed treatment. During her recovery, ulcers developed. A significant aspect of this case is that it occurred during the height of the pandemic. Hospitals were overcrowded, the staff was swamped, and resources were limited. One factor may be that physicians were doing the best they could at the time but that the pandemic affected the extent of care they could provide.

Physicians have long worried about the legal consequences of COVID-19 and whether lawsuits might arise from the care that was provided or that was delayed by the pandemic. Now, new data reflect the grim news: COVID claims have arrived. These cases from the claims database of The Doctors Company are just two examples of many COVID-related claims that have been levied since the pandemic started.

Currently, there are 162 open COVID-related claims in The Doctors Company database, according to Mr. Kolbert. A September 2022 benchmark report from Aon and the American Society for Health Care Risk Management indicates that 245 claims that pertain to patients with confirmed or suspected COVID-19 have been filed since the pandemic began. The findings in this report stem from an analysis of 95,600 hospital and physician liability claims that occurred between 2012 and 2021.

Of the 245 cases, 89 claims have been closed. The average cost was $43,000 per claim, said Kanika Vats, a director and actuary for Aon, a global firm that provides risk, reinsurance, and health solutions. Six of the claims cost $300,000 or more; the highest settlement was for $700,000.

“Most of the allegations in these claims revolve around delay in treatment or delay in diagnosis,” Ms. Vats said.
 

Which specialties are involved in legal actions?

Physicians working in acute care settings such as emergency departments and urgent care centers are the primary targets in COVID-related lawsuits involving doctors, say legal analysts. However, other specialties are also being affected. Physicians being sued include some who practiced telemedicine during the pandemic.

In one case, a primary care physician saw a patient via telemedicine because the physical medical office was closed. The patient was evaluated virtually and was sent for bloodwork and an x-ray.

The patient is now suing the primary care physician, alleging that failure to immediately send her to a hospital resulted in tuberculosis going untreated and that the failure led to a bad outcome. The allegation is that the physician underevaluated the case during the telemedicine visit, Mr. Kolbert said.

Drew Graham, an attorney at Hall Booth Smith PC, which is based in New York, said that most of the COVID-related liability claims he has seen involve facilities that provide postacute care, such as nursing homes and assisted living facilities. His firm has also seen a small number of COVID-related claims against physicians.

At least two of the claims involved allegations of improper treatment of COVID during hospitalizations, he said. Another involved a telehealth visit in which the patient claimed the virtual care that was provided was improper and that their condition required an in-person examination. Mr. Graham declined to specify the specialties of the physicians sued.

The Medical Professional Liability Association reports similar trends in COVID-related claims. Long-term facilities and hospitals are the most common focus of COVID-19 claims, followed by emergency medicine, primary care, and ob/gyn medical specialties, according to Kwon Miller, manager of data and analytics for MPL Association, a national trade association for medical liability insurers that operates a large claims database.

Between January 2020 and June 2022, the MPL Association Data Sharing Project recorded 280 COVID-19 events. “Events” refers to notifications, licensing board inquiries, and claims involving COVID. Of these events, 180 were closed with no indemnity payment, and 13 were closed with an average indemnity payment of $3,816, Mr. Miller said.

Complaints of delayed care associated with the pandemic are also on the rise. For example, one patient is suing a gastroenterologist for delaying his colonoscopy, alleging the postponement led to a delayed colon cancer diagnosis and worse prognosis, Mr. Kolbert said.

“It was delayed because all elective procedures at the time were being put off,” he said. “The patient claims that had they received the scheduled screening, the cancer would have been diagnosed at stage I as opposed to stage III.”
 

Why isn’t federal immunity shielding physicians?

A pressing question about the growing number of COVID claims is why state and federal immunity isn’t preventing such lawsuits.

In 2020, the U.S. Department of Health & Human Services published a declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) that provided liability immunity to health care professionals for any activity related to medical countermeasures against COVID-19. The act allows an exception for negligence claims associated with death or serious injury caused by willful misconduct.

At the same time, most states implemented laws or executive orders shielding physicians from liability claims related to the prevention and treatment of COVID-19, unless gross negligence or willful misconduct is proven.

Mr. Graham said some COVID-related claims against physicians have included allegations of gross negligence to avoid the application of state immunity, while others combine allegations of deviations from standard of care unrelated to the pandemic.

Some plaintiffs are attempting to skirt the protections by making complaints sound as if they’re not related to COVID-19, Mr. Kolbert said. That way, they don’t have to prove gross negligence or willful misconduct at all.

“The filings at first blush may not tell you it’s a COVID case, but it may be a COVID case,” he said. “Plaintiffs’ attorneys are trying to assert that COVID defenses do not apply and that these cases are ‘traditional physician negligence’ claims. They’re trying to plead around the protections.”

The federal and state immunities are likely keeping the volume of COVID claims down overall and are discouraging some complaints from moving forward, attorneys say.

But because some plaintiffs are downplaying or ignoring the COVID association, it’s likely that more COVID lawsuits exist than anyone realizes, according to Mr. Kolbert.

“I expect there’s an underestimation of how many COVID claims are really out there,” he said.
 

What does the future hold for COVID claims?

Currently, the frequency and the severity of COVID claims are low, Ms. Vats said. She believes the cost of such claims will continue to remain at low levels.

“But again, there is a lot of uncertainty,” she said. “This year, states have started to roll back their immunity protections, and in a lot of states, there is no cap in awarding [noneconomic] damages. There could well be a scenario where they allege wrongful death, and in a state with no cap on the pain and suffering component, if juries continue to behave the way they have been behaving, we could see aberration verdicts.”

Another lingering issue concerns which court systems have jurisdiction in cases involving COVID-related claims. Because of the nationwide response to the pandemic, Mr. Graham thinks it makes sense that federal courts handle the cases, but the plaintiffs’ bar has generally been opposed to federal jurisdiction.

“A second issue is the long-term impact of COVID litigation on our providers,” he said. “If the protections in place to limit liability are determined to be ineffective, our state and federal leaders must act aggressively and in a bipartisan way to make sure our health care providers are protected when we face the next crisis.”

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

A pregnant patient who had COVID-19 showed up at a hospital with respiratory difficulty caused by her illness. Physicians had to perform an emergency delivery of her near-term baby.

The infant survived, but the woman lost oxygen during the ordeal and suffered hypoxic brain damage. She is now suing an obstetrician, a pulmonologist, and an intensive care unit physician for medical malpractice.

The plaintiff contends there was a failure “to adequately recognize and treat her condition,” said Peter Kolbert, senior vice president for claim and litigation services for Healthcare Risk Advisors, part of TDC Group, which includes national medical liability insurer The Doctors Company.

“The physicians involved vehemently disagree and believe they treated her appropriately,” Mr. Kolbert said. “In fact, we believe their actions were heroic.”

In another case, a patient with COVID-19 and multiple comorbidities was admitted to a hospital. Physicians sedated and intubated the patient to maintain her airway. She recovered, but the patient now alleges doctors were negligent because she developed ulcers during her hospital stay. The case occurred during the height of the pandemic. In addition to the hospital, a pulmonologist, an ICU physician, and an acute care physician are named in the suit.

Both of these lawsuits are being defined as COVID claims because at the time, the plaintiffs either had COVID and needed care because of COVID, or because the care that physicians provided was affected by COVID in some way.

In the second case, the patient had COVID and needed treatment. During her recovery, ulcers developed. A significant aspect of this case is that it occurred during the height of the pandemic. Hospitals were overcrowded, the staff was swamped, and resources were limited. One factor may be that physicians were doing the best they could at the time but that the pandemic affected the extent of care they could provide.

Physicians have long worried about the legal consequences of COVID-19 and whether lawsuits might arise from the care that was provided or that was delayed by the pandemic. Now, new data reflect the grim news: COVID claims have arrived. These cases from the claims database of The Doctors Company are just two examples of many COVID-related claims that have been levied since the pandemic started.

Currently, there are 162 open COVID-related claims in The Doctors Company database, according to Mr. Kolbert. A September 2022 benchmark report from Aon and the American Society for Health Care Risk Management indicates that 245 claims that pertain to patients with confirmed or suspected COVID-19 have been filed since the pandemic began. The findings in this report stem from an analysis of 95,600 hospital and physician liability claims that occurred between 2012 and 2021.

Of the 245 cases, 89 claims have been closed. The average cost was $43,000 per claim, said Kanika Vats, a director and actuary for Aon, a global firm that provides risk, reinsurance, and health solutions. Six of the claims cost $300,000 or more; the highest settlement was for $700,000.

“Most of the allegations in these claims revolve around delay in treatment or delay in diagnosis,” Ms. Vats said.
 

Which specialties are involved in legal actions?

Physicians working in acute care settings such as emergency departments and urgent care centers are the primary targets in COVID-related lawsuits involving doctors, say legal analysts. However, other specialties are also being affected. Physicians being sued include some who practiced telemedicine during the pandemic.

In one case, a primary care physician saw a patient via telemedicine because the physical medical office was closed. The patient was evaluated virtually and was sent for bloodwork and an x-ray.

The patient is now suing the primary care physician, alleging that failure to immediately send her to a hospital resulted in tuberculosis going untreated and that the failure led to a bad outcome. The allegation is that the physician underevaluated the case during the telemedicine visit, Mr. Kolbert said.

Drew Graham, an attorney at Hall Booth Smith PC, which is based in New York, said that most of the COVID-related liability claims he has seen involve facilities that provide postacute care, such as nursing homes and assisted living facilities. His firm has also seen a small number of COVID-related claims against physicians.

At least two of the claims involved allegations of improper treatment of COVID during hospitalizations, he said. Another involved a telehealth visit in which the patient claimed the virtual care that was provided was improper and that their condition required an in-person examination. Mr. Graham declined to specify the specialties of the physicians sued.

The Medical Professional Liability Association reports similar trends in COVID-related claims. Long-term facilities and hospitals are the most common focus of COVID-19 claims, followed by emergency medicine, primary care, and ob/gyn medical specialties, according to Kwon Miller, manager of data and analytics for MPL Association, a national trade association for medical liability insurers that operates a large claims database.

Between January 2020 and June 2022, the MPL Association Data Sharing Project recorded 280 COVID-19 events. “Events” refers to notifications, licensing board inquiries, and claims involving COVID. Of these events, 180 were closed with no indemnity payment, and 13 were closed with an average indemnity payment of $3,816, Mr. Miller said.

Complaints of delayed care associated with the pandemic are also on the rise. For example, one patient is suing a gastroenterologist for delaying his colonoscopy, alleging the postponement led to a delayed colon cancer diagnosis and worse prognosis, Mr. Kolbert said.

“It was delayed because all elective procedures at the time were being put off,” he said. “The patient claims that had they received the scheduled screening, the cancer would have been diagnosed at stage I as opposed to stage III.”
 

Why isn’t federal immunity shielding physicians?

A pressing question about the growing number of COVID claims is why state and federal immunity isn’t preventing such lawsuits.

In 2020, the U.S. Department of Health & Human Services published a declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) that provided liability immunity to health care professionals for any activity related to medical countermeasures against COVID-19. The act allows an exception for negligence claims associated with death or serious injury caused by willful misconduct.

At the same time, most states implemented laws or executive orders shielding physicians from liability claims related to the prevention and treatment of COVID-19, unless gross negligence or willful misconduct is proven.

Mr. Graham said some COVID-related claims against physicians have included allegations of gross negligence to avoid the application of state immunity, while others combine allegations of deviations from standard of care unrelated to the pandemic.

Some plaintiffs are attempting to skirt the protections by making complaints sound as if they’re not related to COVID-19, Mr. Kolbert said. That way, they don’t have to prove gross negligence or willful misconduct at all.

“The filings at first blush may not tell you it’s a COVID case, but it may be a COVID case,” he said. “Plaintiffs’ attorneys are trying to assert that COVID defenses do not apply and that these cases are ‘traditional physician negligence’ claims. They’re trying to plead around the protections.”

The federal and state immunities are likely keeping the volume of COVID claims down overall and are discouraging some complaints from moving forward, attorneys say.

But because some plaintiffs are downplaying or ignoring the COVID association, it’s likely that more COVID lawsuits exist than anyone realizes, according to Mr. Kolbert.

“I expect there’s an underestimation of how many COVID claims are really out there,” he said.
 

What does the future hold for COVID claims?

Currently, the frequency and the severity of COVID claims are low, Ms. Vats said. She believes the cost of such claims will continue to remain at low levels.

“But again, there is a lot of uncertainty,” she said. “This year, states have started to roll back their immunity protections, and in a lot of states, there is no cap in awarding [noneconomic] damages. There could well be a scenario where they allege wrongful death, and in a state with no cap on the pain and suffering component, if juries continue to behave the way they have been behaving, we could see aberration verdicts.”

Another lingering issue concerns which court systems have jurisdiction in cases involving COVID-related claims. Because of the nationwide response to the pandemic, Mr. Graham thinks it makes sense that federal courts handle the cases, but the plaintiffs’ bar has generally been opposed to federal jurisdiction.

“A second issue is the long-term impact of COVID litigation on our providers,” he said. “If the protections in place to limit liability are determined to be ineffective, our state and federal leaders must act aggressively and in a bipartisan way to make sure our health care providers are protected when we face the next crisis.”

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

The authors of a new evidence review recommend the Canadian TIA Risk Score for managing patients who present to the emergency department or physician’s office with an apparent transient ischemic attack (TIA) or minor stroke.

“Many hospitals do not have enough stroke neurologists to see every patient with TIA or minor stroke within 24 hours. Likewise, many emergency departments around the world are stretched beyond capacity,” study author Jeffery J. Perry, MD, senior scientist at the Ottawa Hospital Research Institute, said in an interview.

“This review corresponds to most of the recommendations by the American Heart Association and the Canadian Stroke Best Practice Recommendations,” he said. “It does, however, go further to differentiate high-risk versus low-risk patients for subsequent stroke using the Canadian TIA Score and offers practical suggestions for how to provide high-quality care in environments without the capacity to provide immediate vascular imaging, immediate MRI scanning, and immediate stroke specialist assessments.”

Most patients at low risk of a subsequent stroke (that is, patients with < 1% risk for a subsequent stroke at 7 days) can be managed safely as outpatients without causing delays in their departure for vascular imaging or neurology consultation during their initial emergency department visits, Dr. Perry added. “The Canadian TIA Score can be used to determine the urgency for an assessment by a stroke neurologist.”

The study was published  in CMAJ.
 

Score stratifies risk

Dr. Perry, lead author of the Canadian TIA Score validation study, said that the CMAJ editorial board approached him to write the review and to incorporate the new score into the latest recommendations. To include the latest evidence, Dr. Perry and colleagues reviewed the most recent position statements on TIA and minor stroke management and searched the literature for relevant articles. They note that the nomenclature related to TIA and minor stroke is inconsistent, that it’s not necessary to differentiate between the two from a clinical standpoint, and that the term “acute ischemic cerebrovascular syndrome” has been proposed to include both.

Broadly, the team’s recommended strategy for the diagnosis and management of the condition includes the following steps:

• Diagnosis: Sudden loss of motor function and impaired speech are strong indicators; symptoms tend to be negative (for example, loss of vision rather than flashing lights).
• Risk assessment: Use of the Canadian TIA Score to stratify 7-day stroke risk (low risk: < 1%, medium risk: 1%-5%, high risk: > 5%).
• Investigations: Urgent CT within 48 hours; vascular imaging to identify acutely symptomatic carotid stenosis in medium- to high-risk patients, as determined on the basis of the TIA score; ECG to identify atrial fibrillation or flutter and to optimize anticoagulant use; if the index of suspicion is high, echocardiography should be employed to look for cardioembolic sources.
• Management: Dual antiplatelet therapy for 21 days in medium- and high-risk patients; hypertension should be managed; patients should be referred for stroke clinic assessment; aggressive lifestyle changes should be initiated to lower lipid levels.

“I believe that our recommendations should be incorporated with the clinical guidelines,” said Dr. Perry.
 

Caveats and concerns

Commenting on the article, Steven M. Greenberg, MD, PhD, vice chair for faculty development of the department of neurology at Massachusetts General Hospital and a professor of neurology at Harvard Medical School, both in Boston, said, “Although the proposed guidelines are broadly evidence-based and consistent with standard of care, there are several areas where stroke specialists might disagree and suggest alternative strategies.” Dr. Greenberg was not involved in the study.

While some lower-risk features, such as repetitive or stereotyped symptoms or vertigo, can be more suggestive of TIA mimics, he said that “these features need to be scrutinized quite carefully. Critical carotid stenosis, for example, can give rise to brief, repetitive, stereotyped low-flow TIAs that require urgent revascularization.”

Vertigo might be a feature of brainstem or cerebellar TIA or minor stroke, said Dr. Greenberg, especially in the setting of other posterior circulation symptoms. Validated guidelines for differentiating peripheral vertigo and CNS vertigo are available, he noted.

“Another caveat is that the studies demonstrating benefit of brief dual antiplatelet therapy following acute TIA or minor stroke were based on ABCD2 rather than the Canadian TIA score,” he said. “It is therefore important for any score-based recommendations to be applied in the overall context of existing stroke prevention guidelines.”

In addition to the recommendation for urgent vascular imaging of patients whose presentations suggest bona fide TIA or minor stroke, most guidelines also recommend extended cardiac monitoring and transthoracic ECG to identify potential sources of embolism, Dr. Greenberg added. “Users of these guidelines should also be aware of the limited yield of head CT, which is able to detect some old strokes, large acute strokes – presumably not relevant to patients presenting with TIA or minor stroke – and acute intracranial hemorrhages.”

Louis R. Caplan, MD, founder of the Harvard Stroke Registry at Beth Israel Deaconess Medical Center, Boston, and a professor of neurology at Harvard Medical School, also commented on the study.

While the review “is okay for care by nonstroke specialists, ideally, major referral centers could have a TIA or stroke clinic, as is present in much of Western Europe,” he said. This would allow the stroke etiology to be investigated for each patient.

“Many patients can be treated with the regimen outlined by the authors, but some with other conditions, such as atrial cardiopathy, patent foramen ovale, atrial myxoma, thrombus within the cardiac ventricle or atrium, will require anticoagulants,” he noted. “Thrombolysis and mechanical thrombectomy would be considered in some. Each stroke patient is different, and management cannot be homogenized into one remedy. One size does not fit all.”

In an accompanying commentary, Shelagh B. Coutts, MD, and Michael D. Hill, MD, both of the University of Calgary (Alta.), presented their team’s approach to the acute management of patients with likely cerebral ischemia. Such management includes risk assessment and stratification by clinical symptoms, rather than a particular score. They also typically conduct CT angiography. “If the CTA is completely normal (that is, no occlusion, no atherosclerosis or arterial dissection and no other vascular abnormality), we rely on the high negative predictive value of this result and discharge the patient home on antiplatelet treatment with outpatient follow-up, including MRI of the brain (since CT cannot reliably rule out minor ischemia) within the first week,” they write.

The review was conducted without commercial funding. Dr. Perry, Dr. Greenberg, Dr. Caplan, Dr. Coutts, and Dr. Hill have disclosed no relevant financial relationships.

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

The authors of a new evidence review recommend the Canadian TIA Risk Score for managing patients who present to the emergency department or physician’s office with an apparent transient ischemic attack (TIA) or minor stroke.

“Many hospitals do not have enough stroke neurologists to see every patient with TIA or minor stroke within 24 hours. Likewise, many emergency departments around the world are stretched beyond capacity,” study author Jeffery J. Perry, MD, senior scientist at the Ottawa Hospital Research Institute, said in an interview.

“This review corresponds to most of the recommendations by the American Heart Association and the Canadian Stroke Best Practice Recommendations,” he said. “It does, however, go further to differentiate high-risk versus low-risk patients for subsequent stroke using the Canadian TIA Score and offers practical suggestions for how to provide high-quality care in environments without the capacity to provide immediate vascular imaging, immediate MRI scanning, and immediate stroke specialist assessments.”

Most patients at low risk of a subsequent stroke (that is, patients with < 1% risk for a subsequent stroke at 7 days) can be managed safely as outpatients without causing delays in their departure for vascular imaging or neurology consultation during their initial emergency department visits, Dr. Perry added. “The Canadian TIA Score can be used to determine the urgency for an assessment by a stroke neurologist.”

The study was published  in CMAJ.
 

Score stratifies risk

Dr. Perry, lead author of the Canadian TIA Score validation study, said that the CMAJ editorial board approached him to write the review and to incorporate the new score into the latest recommendations. To include the latest evidence, Dr. Perry and colleagues reviewed the most recent position statements on TIA and minor stroke management and searched the literature for relevant articles. They note that the nomenclature related to TIA and minor stroke is inconsistent, that it’s not necessary to differentiate between the two from a clinical standpoint, and that the term “acute ischemic cerebrovascular syndrome” has been proposed to include both.

Broadly, the team’s recommended strategy for the diagnosis and management of the condition includes the following steps:

• Diagnosis: Sudden loss of motor function and impaired speech are strong indicators; symptoms tend to be negative (for example, loss of vision rather than flashing lights).
• Risk assessment: Use of the Canadian TIA Score to stratify 7-day stroke risk (low risk: < 1%, medium risk: 1%-5%, high risk: > 5%).
• Investigations: Urgent CT within 48 hours; vascular imaging to identify acutely symptomatic carotid stenosis in medium- to high-risk patients, as determined on the basis of the TIA score; ECG to identify atrial fibrillation or flutter and to optimize anticoagulant use; if the index of suspicion is high, echocardiography should be employed to look for cardioembolic sources.
• Management: Dual antiplatelet therapy for 21 days in medium- and high-risk patients; hypertension should be managed; patients should be referred for stroke clinic assessment; aggressive lifestyle changes should be initiated to lower lipid levels.

“I believe that our recommendations should be incorporated with the clinical guidelines,” said Dr. Perry.
 

Caveats and concerns

Commenting on the article, Steven M. Greenberg, MD, PhD, vice chair for faculty development of the department of neurology at Massachusetts General Hospital and a professor of neurology at Harvard Medical School, both in Boston, said, “Although the proposed guidelines are broadly evidence-based and consistent with standard of care, there are several areas where stroke specialists might disagree and suggest alternative strategies.” Dr. Greenberg was not involved in the study.

While some lower-risk features, such as repetitive or stereotyped symptoms or vertigo, can be more suggestive of TIA mimics, he said that “these features need to be scrutinized quite carefully. Critical carotid stenosis, for example, can give rise to brief, repetitive, stereotyped low-flow TIAs that require urgent revascularization.”

Vertigo might be a feature of brainstem or cerebellar TIA or minor stroke, said Dr. Greenberg, especially in the setting of other posterior circulation symptoms. Validated guidelines for differentiating peripheral vertigo and CNS vertigo are available, he noted.

“Another caveat is that the studies demonstrating benefit of brief dual antiplatelet therapy following acute TIA or minor stroke were based on ABCD2 rather than the Canadian TIA score,” he said. “It is therefore important for any score-based recommendations to be applied in the overall context of existing stroke prevention guidelines.”

In addition to the recommendation for urgent vascular imaging of patients whose presentations suggest bona fide TIA or minor stroke, most guidelines also recommend extended cardiac monitoring and transthoracic ECG to identify potential sources of embolism, Dr. Greenberg added. “Users of these guidelines should also be aware of the limited yield of head CT, which is able to detect some old strokes, large acute strokes – presumably not relevant to patients presenting with TIA or minor stroke – and acute intracranial hemorrhages.”

Louis R. Caplan, MD, founder of the Harvard Stroke Registry at Beth Israel Deaconess Medical Center, Boston, and a professor of neurology at Harvard Medical School, also commented on the study.

While the review “is okay for care by nonstroke specialists, ideally, major referral centers could have a TIA or stroke clinic, as is present in much of Western Europe,” he said. This would allow the stroke etiology to be investigated for each patient.

“Many patients can be treated with the regimen outlined by the authors, but some with other conditions, such as atrial cardiopathy, patent foramen ovale, atrial myxoma, thrombus within the cardiac ventricle or atrium, will require anticoagulants,” he noted. “Thrombolysis and mechanical thrombectomy would be considered in some. Each stroke patient is different, and management cannot be homogenized into one remedy. One size does not fit all.”

In an accompanying commentary, Shelagh B. Coutts, MD, and Michael D. Hill, MD, both of the University of Calgary (Alta.), presented their team’s approach to the acute management of patients with likely cerebral ischemia. Such management includes risk assessment and stratification by clinical symptoms, rather than a particular score. They also typically conduct CT angiography. “If the CTA is completely normal (that is, no occlusion, no atherosclerosis or arterial dissection and no other vascular abnormality), we rely on the high negative predictive value of this result and discharge the patient home on antiplatelet treatment with outpatient follow-up, including MRI of the brain (since CT cannot reliably rule out minor ischemia) within the first week,” they write.

The review was conducted without commercial funding. Dr. Perry, Dr. Greenberg, Dr. Caplan, Dr. Coutts, and Dr. Hill have disclosed no relevant financial relationships.

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

The authors of a new evidence review recommend the Canadian TIA Risk Score for managing patients who present to the emergency department or physician’s office with an apparent transient ischemic attack (TIA) or minor stroke.

“Many hospitals do not have enough stroke neurologists to see every patient with TIA or minor stroke within 24 hours. Likewise, many emergency departments around the world are stretched beyond capacity,” study author Jeffery J. Perry, MD, senior scientist at the Ottawa Hospital Research Institute, said in an interview.

“This review corresponds to most of the recommendations by the American Heart Association and the Canadian Stroke Best Practice Recommendations,” he said. “It does, however, go further to differentiate high-risk versus low-risk patients for subsequent stroke using the Canadian TIA Score and offers practical suggestions for how to provide high-quality care in environments without the capacity to provide immediate vascular imaging, immediate MRI scanning, and immediate stroke specialist assessments.”

Most patients at low risk of a subsequent stroke (that is, patients with < 1% risk for a subsequent stroke at 7 days) can be managed safely as outpatients without causing delays in their departure for vascular imaging or neurology consultation during their initial emergency department visits, Dr. Perry added. “The Canadian TIA Score can be used to determine the urgency for an assessment by a stroke neurologist.”

The study was published  in CMAJ.
 

Score stratifies risk

Dr. Perry, lead author of the Canadian TIA Score validation study, said that the CMAJ editorial board approached him to write the review and to incorporate the new score into the latest recommendations. To include the latest evidence, Dr. Perry and colleagues reviewed the most recent position statements on TIA and minor stroke management and searched the literature for relevant articles. They note that the nomenclature related to TIA and minor stroke is inconsistent, that it’s not necessary to differentiate between the two from a clinical standpoint, and that the term “acute ischemic cerebrovascular syndrome” has been proposed to include both.

Broadly, the team’s recommended strategy for the diagnosis and management of the condition includes the following steps:

• Diagnosis: Sudden loss of motor function and impaired speech are strong indicators; symptoms tend to be negative (for example, loss of vision rather than flashing lights).
• Risk assessment: Use of the Canadian TIA Score to stratify 7-day stroke risk (low risk: < 1%, medium risk: 1%-5%, high risk: > 5%).
• Investigations: Urgent CT within 48 hours; vascular imaging to identify acutely symptomatic carotid stenosis in medium- to high-risk patients, as determined on the basis of the TIA score; ECG to identify atrial fibrillation or flutter and to optimize anticoagulant use; if the index of suspicion is high, echocardiography should be employed to look for cardioembolic sources.
• Management: Dual antiplatelet therapy for 21 days in medium- and high-risk patients; hypertension should be managed; patients should be referred for stroke clinic assessment; aggressive lifestyle changes should be initiated to lower lipid levels.

“I believe that our recommendations should be incorporated with the clinical guidelines,” said Dr. Perry.
 

Caveats and concerns

Commenting on the article, Steven M. Greenberg, MD, PhD, vice chair for faculty development of the department of neurology at Massachusetts General Hospital and a professor of neurology at Harvard Medical School, both in Boston, said, “Although the proposed guidelines are broadly evidence-based and consistent with standard of care, there are several areas where stroke specialists might disagree and suggest alternative strategies.” Dr. Greenberg was not involved in the study.

While some lower-risk features, such as repetitive or stereotyped symptoms or vertigo, can be more suggestive of TIA mimics, he said that “these features need to be scrutinized quite carefully. Critical carotid stenosis, for example, can give rise to brief, repetitive, stereotyped low-flow TIAs that require urgent revascularization.”

Vertigo might be a feature of brainstem or cerebellar TIA or minor stroke, said Dr. Greenberg, especially in the setting of other posterior circulation symptoms. Validated guidelines for differentiating peripheral vertigo and CNS vertigo are available, he noted.

“Another caveat is that the studies demonstrating benefit of brief dual antiplatelet therapy following acute TIA or minor stroke were based on ABCD2 rather than the Canadian TIA score,” he said. “It is therefore important for any score-based recommendations to be applied in the overall context of existing stroke prevention guidelines.”

In addition to the recommendation for urgent vascular imaging of patients whose presentations suggest bona fide TIA or minor stroke, most guidelines also recommend extended cardiac monitoring and transthoracic ECG to identify potential sources of embolism, Dr. Greenberg added. “Users of these guidelines should also be aware of the limited yield of head CT, which is able to detect some old strokes, large acute strokes – presumably not relevant to patients presenting with TIA or minor stroke – and acute intracranial hemorrhages.”

Louis R. Caplan, MD, founder of the Harvard Stroke Registry at Beth Israel Deaconess Medical Center, Boston, and a professor of neurology at Harvard Medical School, also commented on the study.

While the review “is okay for care by nonstroke specialists, ideally, major referral centers could have a TIA or stroke clinic, as is present in much of Western Europe,” he said. This would allow the stroke etiology to be investigated for each patient.

“Many patients can be treated with the regimen outlined by the authors, but some with other conditions, such as atrial cardiopathy, patent foramen ovale, atrial myxoma, thrombus within the cardiac ventricle or atrium, will require anticoagulants,” he noted. “Thrombolysis and mechanical thrombectomy would be considered in some. Each stroke patient is different, and management cannot be homogenized into one remedy. One size does not fit all.”

In an accompanying commentary, Shelagh B. Coutts, MD, and Michael D. Hill, MD, both of the University of Calgary (Alta.), presented their team’s approach to the acute management of patients with likely cerebral ischemia. Such management includes risk assessment and stratification by clinical symptoms, rather than a particular score. They also typically conduct CT angiography. “If the CTA is completely normal (that is, no occlusion, no atherosclerosis or arterial dissection and no other vascular abnormality), we rely on the high negative predictive value of this result and discharge the patient home on antiplatelet treatment with outpatient follow-up, including MRI of the brain (since CT cannot reliably rule out minor ischemia) within the first week,” they write.

The review was conducted without commercial funding. Dr. Perry, Dr. Greenberg, Dr. Caplan, Dr. Coutts, and Dr. Hill have disclosed no relevant financial relationships.

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