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extacy
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A peer-reviewed clinical journal serving healthcare professionals working with the Department of Veterans Affairs, the Department of Defense, and the Public Health Service.
New smart device shows highly accurate AFib detection: mAFA II
Screening for heart rhythm disorders with a smartphone app and a wearable device had a high rate of correctly detecting atrial fibrillation (AFib) in a large new study.
The mAFA II study, conducted in a mass low-risk population in China, showed that more than 93% of possible AFib episodes detected by the smartphone app were confirmed to be AFib on further monitoring.
The study also used the app to screen for obstructive sleep apnea and found that sleep apnea was the most common risk factor associated with increased AFib susceptibility, and those identified as having the most severe sleep apnea were 1.5 times more likely to have AFib than those who did not have this condition.
This suggests that tools suitable for detecting both AFib and sleep apnea can work synergistically to further enhance health monitoring, said lead author, Yutao Guo, MD, professor of internal medicine at Chinese PLA General Hospital, Beijing.
Dr. Guo presented the mAFA II study at the American College of Cardiology (ACC) 2022 Scientific Session held in Washington, D.C., and online.
The trial, which involved more than 2.8 million participants, is the largest study to date to demonstrate how wearable consumer technologies can be used to screen for heart problems during everyday activities, Dr. Guo noted.
“Consumer-led screening with these technologies could increase early diagnosis of AFib and facilitate an integrated approach to fully implement clustered risk management to reduce AFib burden and its related complications,” she concluded.
Discussant of the study at the ACC session at which it was presented, Jodie Hurwitz, MD, Director of the Electrophysiology Lab at Medical City Hospital, Dallas, called this “a pretty impressive study. To get a 93.8% confirmation of AFib with these devices is great.”
But Dr. Hurwitz pointed out that the age of patients in the study was relatively young (average 37 years), and the group who really need to use such a device is much older than that.
“The take-home messages from this study are that AFib wearable detection algorithms have the ability to detect true AFib and that they might also be able to detect risk factors (such as sleep apnea) that predispose to AFib possibly even before AFib is present,” Dr. Hurwitz commented.
Moderator of the session, Edward Fry, MD, cardiologist at Ascension St. Vincent Heart Center, Indianapolis, and incoming president of the ACC, described the area of AFib screening with smart devices as “fascinating, especially with the perspective of the scalability of these types of studies.”
The mAFA II study tracked more than 2.8 million people who used a Huawei phone app together with Huawei and Honor smart devices incorporating photoplethysmography (PPG) technology, a light-based method to monitor blood flow and pulse. If an abnormal rhythm was detected, the wearer would be contacted by a clinician to set up an appointment for a clinical assessment.
Over the course of 4 years of the study, 12,244 (0.4%) of users received a notification of suspected AFib. Among 5,227 people who chose to follow up with a clinician, AFib was confirmed in 93.8% of patients using standard AFib diagnostic tools, including clinical evaluation, an electrocardiogram, and 24-hour Holter monitoring.
In this study, a subset of the individuals screened for AFib were also screened for signs of sleep apnea using the same PPG technology to detect physiological changes in parameters including oxygenation and respiratory rates. The app is also able to determine whether the individual is awake or asleep. Dr. Guo noted that the PPG algorithm for obstructive sleep apnea risk has been validated, compared with polysomnography or home sleep apnea tests.
Using measurements of apnea (signalled by a reduced respiratory rate) and hypopnea (when oxygenation would decrease), the apnea–hypopnea index (AHI) is calculated to determine the severity of the sleep apnea.
Of the 961,931 participants screened for sleep apnea, about 18,000 were notified they may have the condition.
Obstructive sleep apnea was the most reported common risk factor associated with increased AFib susceptibility, and those individuals with the highest risk sleep apnea (more than 80% monitoring measures with AHI greater than or equal to 30 during sleep) resulted in a 1.5-fold increase in prevalent AFib, Dr. Guo reported.
The mAFA II is the latest of several studies to show that AFib can be detected with various smartphone apps and wearable devices. Previous studies have included the Fitbit Heart Study and the Apple Heart Study.
Dr. Hurwitz told this news organization that the electrophysiologist community is enthusiastic about this new smart device technology.
“I sent my sister one so she could determine if she develops AFib: That’s a pretty good endorsement,” she commented, but added that there are still concerns about the rate of false-positive results.
Dr. Hurwitz said she suspected that there will probably be meaningful differences between the different apps and devices, but the algorithms are all proprietary, and the use of photoplethysmography seems to make a big difference.
She noted that the detection of sleep apnea in the current study was a novel approach. “This is important, as sleep apnea is felt to contribute to AFib, and treating it is felt to decrease the frequency of AFib. Perhaps if patients with sleep apnea were treated before they had documented AFib, the AFib burden could be reduced,” she said.
She added that further studies were needed to fine tune the algorithms and to try and identify other factors or heart rate variabilities that may predict future risk of AFib.
The study was funded by the National Natural Science Foundation of China. Dr. Guo reports no disclosures.
A version of this article first appeared on Medscape.com.
Screening for heart rhythm disorders with a smartphone app and a wearable device had a high rate of correctly detecting atrial fibrillation (AFib) in a large new study.
The mAFA II study, conducted in a mass low-risk population in China, showed that more than 93% of possible AFib episodes detected by the smartphone app were confirmed to be AFib on further monitoring.
The study also used the app to screen for obstructive sleep apnea and found that sleep apnea was the most common risk factor associated with increased AFib susceptibility, and those identified as having the most severe sleep apnea were 1.5 times more likely to have AFib than those who did not have this condition.
This suggests that tools suitable for detecting both AFib and sleep apnea can work synergistically to further enhance health monitoring, said lead author, Yutao Guo, MD, professor of internal medicine at Chinese PLA General Hospital, Beijing.
Dr. Guo presented the mAFA II study at the American College of Cardiology (ACC) 2022 Scientific Session held in Washington, D.C., and online.
The trial, which involved more than 2.8 million participants, is the largest study to date to demonstrate how wearable consumer technologies can be used to screen for heart problems during everyday activities, Dr. Guo noted.
“Consumer-led screening with these technologies could increase early diagnosis of AFib and facilitate an integrated approach to fully implement clustered risk management to reduce AFib burden and its related complications,” she concluded.
Discussant of the study at the ACC session at which it was presented, Jodie Hurwitz, MD, Director of the Electrophysiology Lab at Medical City Hospital, Dallas, called this “a pretty impressive study. To get a 93.8% confirmation of AFib with these devices is great.”
But Dr. Hurwitz pointed out that the age of patients in the study was relatively young (average 37 years), and the group who really need to use such a device is much older than that.
“The take-home messages from this study are that AFib wearable detection algorithms have the ability to detect true AFib and that they might also be able to detect risk factors (such as sleep apnea) that predispose to AFib possibly even before AFib is present,” Dr. Hurwitz commented.
Moderator of the session, Edward Fry, MD, cardiologist at Ascension St. Vincent Heart Center, Indianapolis, and incoming president of the ACC, described the area of AFib screening with smart devices as “fascinating, especially with the perspective of the scalability of these types of studies.”
The mAFA II study tracked more than 2.8 million people who used a Huawei phone app together with Huawei and Honor smart devices incorporating photoplethysmography (PPG) technology, a light-based method to monitor blood flow and pulse. If an abnormal rhythm was detected, the wearer would be contacted by a clinician to set up an appointment for a clinical assessment.
Over the course of 4 years of the study, 12,244 (0.4%) of users received a notification of suspected AFib. Among 5,227 people who chose to follow up with a clinician, AFib was confirmed in 93.8% of patients using standard AFib diagnostic tools, including clinical evaluation, an electrocardiogram, and 24-hour Holter monitoring.
In this study, a subset of the individuals screened for AFib were also screened for signs of sleep apnea using the same PPG technology to detect physiological changes in parameters including oxygenation and respiratory rates. The app is also able to determine whether the individual is awake or asleep. Dr. Guo noted that the PPG algorithm for obstructive sleep apnea risk has been validated, compared with polysomnography or home sleep apnea tests.
Using measurements of apnea (signalled by a reduced respiratory rate) and hypopnea (when oxygenation would decrease), the apnea–hypopnea index (AHI) is calculated to determine the severity of the sleep apnea.
Of the 961,931 participants screened for sleep apnea, about 18,000 were notified they may have the condition.
Obstructive sleep apnea was the most reported common risk factor associated with increased AFib susceptibility, and those individuals with the highest risk sleep apnea (more than 80% monitoring measures with AHI greater than or equal to 30 during sleep) resulted in a 1.5-fold increase in prevalent AFib, Dr. Guo reported.
The mAFA II is the latest of several studies to show that AFib can be detected with various smartphone apps and wearable devices. Previous studies have included the Fitbit Heart Study and the Apple Heart Study.
Dr. Hurwitz told this news organization that the electrophysiologist community is enthusiastic about this new smart device technology.
“I sent my sister one so she could determine if she develops AFib: That’s a pretty good endorsement,” she commented, but added that there are still concerns about the rate of false-positive results.
Dr. Hurwitz said she suspected that there will probably be meaningful differences between the different apps and devices, but the algorithms are all proprietary, and the use of photoplethysmography seems to make a big difference.
She noted that the detection of sleep apnea in the current study was a novel approach. “This is important, as sleep apnea is felt to contribute to AFib, and treating it is felt to decrease the frequency of AFib. Perhaps if patients with sleep apnea were treated before they had documented AFib, the AFib burden could be reduced,” she said.
She added that further studies were needed to fine tune the algorithms and to try and identify other factors or heart rate variabilities that may predict future risk of AFib.
The study was funded by the National Natural Science Foundation of China. Dr. Guo reports no disclosures.
A version of this article first appeared on Medscape.com.
Screening for heart rhythm disorders with a smartphone app and a wearable device had a high rate of correctly detecting atrial fibrillation (AFib) in a large new study.
The mAFA II study, conducted in a mass low-risk population in China, showed that more than 93% of possible AFib episodes detected by the smartphone app were confirmed to be AFib on further monitoring.
The study also used the app to screen for obstructive sleep apnea and found that sleep apnea was the most common risk factor associated with increased AFib susceptibility, and those identified as having the most severe sleep apnea were 1.5 times more likely to have AFib than those who did not have this condition.
This suggests that tools suitable for detecting both AFib and sleep apnea can work synergistically to further enhance health monitoring, said lead author, Yutao Guo, MD, professor of internal medicine at Chinese PLA General Hospital, Beijing.
Dr. Guo presented the mAFA II study at the American College of Cardiology (ACC) 2022 Scientific Session held in Washington, D.C., and online.
The trial, which involved more than 2.8 million participants, is the largest study to date to demonstrate how wearable consumer technologies can be used to screen for heart problems during everyday activities, Dr. Guo noted.
“Consumer-led screening with these technologies could increase early diagnosis of AFib and facilitate an integrated approach to fully implement clustered risk management to reduce AFib burden and its related complications,” she concluded.
Discussant of the study at the ACC session at which it was presented, Jodie Hurwitz, MD, Director of the Electrophysiology Lab at Medical City Hospital, Dallas, called this “a pretty impressive study. To get a 93.8% confirmation of AFib with these devices is great.”
But Dr. Hurwitz pointed out that the age of patients in the study was relatively young (average 37 years), and the group who really need to use such a device is much older than that.
“The take-home messages from this study are that AFib wearable detection algorithms have the ability to detect true AFib and that they might also be able to detect risk factors (such as sleep apnea) that predispose to AFib possibly even before AFib is present,” Dr. Hurwitz commented.
Moderator of the session, Edward Fry, MD, cardiologist at Ascension St. Vincent Heart Center, Indianapolis, and incoming president of the ACC, described the area of AFib screening with smart devices as “fascinating, especially with the perspective of the scalability of these types of studies.”
The mAFA II study tracked more than 2.8 million people who used a Huawei phone app together with Huawei and Honor smart devices incorporating photoplethysmography (PPG) technology, a light-based method to monitor blood flow and pulse. If an abnormal rhythm was detected, the wearer would be contacted by a clinician to set up an appointment for a clinical assessment.
Over the course of 4 years of the study, 12,244 (0.4%) of users received a notification of suspected AFib. Among 5,227 people who chose to follow up with a clinician, AFib was confirmed in 93.8% of patients using standard AFib diagnostic tools, including clinical evaluation, an electrocardiogram, and 24-hour Holter monitoring.
In this study, a subset of the individuals screened for AFib were also screened for signs of sleep apnea using the same PPG technology to detect physiological changes in parameters including oxygenation and respiratory rates. The app is also able to determine whether the individual is awake or asleep. Dr. Guo noted that the PPG algorithm for obstructive sleep apnea risk has been validated, compared with polysomnography or home sleep apnea tests.
Using measurements of apnea (signalled by a reduced respiratory rate) and hypopnea (when oxygenation would decrease), the apnea–hypopnea index (AHI) is calculated to determine the severity of the sleep apnea.
Of the 961,931 participants screened for sleep apnea, about 18,000 were notified they may have the condition.
Obstructive sleep apnea was the most reported common risk factor associated with increased AFib susceptibility, and those individuals with the highest risk sleep apnea (more than 80% monitoring measures with AHI greater than or equal to 30 during sleep) resulted in a 1.5-fold increase in prevalent AFib, Dr. Guo reported.
The mAFA II is the latest of several studies to show that AFib can be detected with various smartphone apps and wearable devices. Previous studies have included the Fitbit Heart Study and the Apple Heart Study.
Dr. Hurwitz told this news organization that the electrophysiologist community is enthusiastic about this new smart device technology.
“I sent my sister one so she could determine if she develops AFib: That’s a pretty good endorsement,” she commented, but added that there are still concerns about the rate of false-positive results.
Dr. Hurwitz said she suspected that there will probably be meaningful differences between the different apps and devices, but the algorithms are all proprietary, and the use of photoplethysmography seems to make a big difference.
She noted that the detection of sleep apnea in the current study was a novel approach. “This is important, as sleep apnea is felt to contribute to AFib, and treating it is felt to decrease the frequency of AFib. Perhaps if patients with sleep apnea were treated before they had documented AFib, the AFib burden could be reduced,” she said.
She added that further studies were needed to fine tune the algorithms and to try and identify other factors or heart rate variabilities that may predict future risk of AFib.
The study was funded by the National Natural Science Foundation of China. Dr. Guo reports no disclosures.
A version of this article first appeared on Medscape.com.
Depression in homeless patients: What can be done?
In a recent article published in JAMA Psychiatry, Joshua E. J. Buckman and coauthors described the results of a large research study which concludes that depression is harder to treat in those who are homeless or unemployed.
It is always good to get more data and this article adds to the literature about the social determinants of depression. A frustrating aspect is that this is no surprise at all, not least for anyone in the mental health field. We have known that intuitively for decades.
Again, data is always good to bolster intuition with science. But what are the actionable items to take from the paper?
However, there are a few policy and clinical points I would like to make, reflecting some of the chapters in a recently published book – edited by me and my colleague Maria D. Llorente – “Clinical Management of the Homeless Patient: Social Medical and Psychiatric Issues” (New York: Springer, May 2021).
The first is, if you really tackle homelessness, with a combination of federal, state, and local resources, you can make a difference. The Department of Veterans Affairs, under the leadership of former VA Secretary Eric Shinseki and others, has been markedly successful. Note, for instance, the Health Care for Homeless Veterans program , which conducts outreach to vulnerable veterans not currently receiving services and engages them in treatment and rehabilitative programs.
Secondly, there is a marked absence of shelters that can care for the homeless with medical problems. This leads to extended and extensive hospital stays. This is especially frustrating during the COVID era, when hospital beds are in such short supply. Having a safe place to discharge patients who still need wound or diabetes care would save money for the overall health care system and be best for the patient.
Third, it may be best to modify discharge regimens for those patients who are unhoused. For example, metformin, taken by mouth once a day, is more practical for unhoused patients with diabetes than insulin, which needs to be refrigerated and injected multiple times a day. While one can argue whether care for the homeless should differ from those who are housed, in practical terms, simplifying regimens is more likely to promote compliance.
My last take-home point is check the Feet. So many of our homeless patients who end up on hospital wards have been wearing ill-fitting or no shoes while they are out on the street. Their toenails may be long and thick. They may have cellulitis or ulcers. Or gangrene. Unfortunately, these medical issues can also cause surgical amputations of the lower extremities.
Back to the article by Buckman and colleagues. The data they provide is good to have. But we need more action to provide appropriate and compassionate care for those who are unhoused and ill – care that is good for them, good for the nation’s finances, and good for our moral standing in the world.
Dr. Ritchie is chair of psychiatry at Medstar Washington (D.C.) Hospital Center. She is a member of the Clinical Psychiatry News editorial advisory board, and has no conflicts of interest.
In a recent article published in JAMA Psychiatry, Joshua E. J. Buckman and coauthors described the results of a large research study which concludes that depression is harder to treat in those who are homeless or unemployed.
It is always good to get more data and this article adds to the literature about the social determinants of depression. A frustrating aspect is that this is no surprise at all, not least for anyone in the mental health field. We have known that intuitively for decades.
Again, data is always good to bolster intuition with science. But what are the actionable items to take from the paper?
However, there are a few policy and clinical points I would like to make, reflecting some of the chapters in a recently published book – edited by me and my colleague Maria D. Llorente – “Clinical Management of the Homeless Patient: Social Medical and Psychiatric Issues” (New York: Springer, May 2021).
The first is, if you really tackle homelessness, with a combination of federal, state, and local resources, you can make a difference. The Department of Veterans Affairs, under the leadership of former VA Secretary Eric Shinseki and others, has been markedly successful. Note, for instance, the Health Care for Homeless Veterans program , which conducts outreach to vulnerable veterans not currently receiving services and engages them in treatment and rehabilitative programs.
Secondly, there is a marked absence of shelters that can care for the homeless with medical problems. This leads to extended and extensive hospital stays. This is especially frustrating during the COVID era, when hospital beds are in such short supply. Having a safe place to discharge patients who still need wound or diabetes care would save money for the overall health care system and be best for the patient.
Third, it may be best to modify discharge regimens for those patients who are unhoused. For example, metformin, taken by mouth once a day, is more practical for unhoused patients with diabetes than insulin, which needs to be refrigerated and injected multiple times a day. While one can argue whether care for the homeless should differ from those who are housed, in practical terms, simplifying regimens is more likely to promote compliance.
My last take-home point is check the Feet. So many of our homeless patients who end up on hospital wards have been wearing ill-fitting or no shoes while they are out on the street. Their toenails may be long and thick. They may have cellulitis or ulcers. Or gangrene. Unfortunately, these medical issues can also cause surgical amputations of the lower extremities.
Back to the article by Buckman and colleagues. The data they provide is good to have. But we need more action to provide appropriate and compassionate care for those who are unhoused and ill – care that is good for them, good for the nation’s finances, and good for our moral standing in the world.
Dr. Ritchie is chair of psychiatry at Medstar Washington (D.C.) Hospital Center. She is a member of the Clinical Psychiatry News editorial advisory board, and has no conflicts of interest.
In a recent article published in JAMA Psychiatry, Joshua E. J. Buckman and coauthors described the results of a large research study which concludes that depression is harder to treat in those who are homeless or unemployed.
It is always good to get more data and this article adds to the literature about the social determinants of depression. A frustrating aspect is that this is no surprise at all, not least for anyone in the mental health field. We have known that intuitively for decades.
Again, data is always good to bolster intuition with science. But what are the actionable items to take from the paper?
However, there are a few policy and clinical points I would like to make, reflecting some of the chapters in a recently published book – edited by me and my colleague Maria D. Llorente – “Clinical Management of the Homeless Patient: Social Medical and Psychiatric Issues” (New York: Springer, May 2021).
The first is, if you really tackle homelessness, with a combination of federal, state, and local resources, you can make a difference. The Department of Veterans Affairs, under the leadership of former VA Secretary Eric Shinseki and others, has been markedly successful. Note, for instance, the Health Care for Homeless Veterans program , which conducts outreach to vulnerable veterans not currently receiving services and engages them in treatment and rehabilitative programs.
Secondly, there is a marked absence of shelters that can care for the homeless with medical problems. This leads to extended and extensive hospital stays. This is especially frustrating during the COVID era, when hospital beds are in such short supply. Having a safe place to discharge patients who still need wound or diabetes care would save money for the overall health care system and be best for the patient.
Third, it may be best to modify discharge regimens for those patients who are unhoused. For example, metformin, taken by mouth once a day, is more practical for unhoused patients with diabetes than insulin, which needs to be refrigerated and injected multiple times a day. While one can argue whether care for the homeless should differ from those who are housed, in practical terms, simplifying regimens is more likely to promote compliance.
My last take-home point is check the Feet. So many of our homeless patients who end up on hospital wards have been wearing ill-fitting or no shoes while they are out on the street. Their toenails may be long and thick. They may have cellulitis or ulcers. Or gangrene. Unfortunately, these medical issues can also cause surgical amputations of the lower extremities.
Back to the article by Buckman and colleagues. The data they provide is good to have. But we need more action to provide appropriate and compassionate care for those who are unhoused and ill – care that is good for them, good for the nation’s finances, and good for our moral standing in the world.
Dr. Ritchie is chair of psychiatry at Medstar Washington (D.C.) Hospital Center. She is a member of the Clinical Psychiatry News editorial advisory board, and has no conflicts of interest.
Asymptomatic C. difficile carriers may infect the people they live with after hospitalization
Hospitalized patients who are asymptomatic Clostridioides difficile carriers may infect people they live with after they return home, a study based on U.S. insurance claim data suggests.
Although C. difficile infection (CDI) is considered to be a common hospital-acquired infection, reports of community-associated CDI in patients who have not been hospitalized are increasing, the authors wrote in Emerging Infectious Diseases.
“Individuals in households where another family member was recently hospitalized but not diagnosed with a CDI appear to be at increased risk for CDI,” said lead author Aaron C. Miller, PhD, a research assistant professor in the department of internal medicine at the University of Iowa, Iowa City. “When individuals are hospitalized, they may become colonized with C. difficile without developing symptoms and subsequently transmit the pathogen to other family members after they return home,” he said by email.
Dr. Miller and colleagues analyzed insurance claims data from 2001 through 2017 using the U.S. Commercial Claims and Medicare Supplemental datasets of IBM MarketScan Research Databases. Over that period, they searched employer-sponsored commercial insurance claims and Medicare supplemental claims of 194,424 enrollees, and they linked claims from multiple family members in the same enrollment plan.
They identified 224,818 CDI cases, and 3,871 of them were considered potential asymptomatic C. difficile transmissions from a recently hospitalized family member.
The researchers gathered monthly C. difficile incidence data from households with a family member who had been hospitalized within the past 60 days and compared them with data from households without a hospitalized family member.
Enrollees exposed to a recently hospitalized family member had a 73% greater incidence of CDI compared with enrollees who were not exposed. The longer the family member’s hospital stay, the greater the risk that someone in the household became infected.
Compared with people whose family members were hospitalized less than 1 day, people whose family members were hospitalized from 1 to 3 days had an incidence rate ratio (IRR) of 1.30 (95% confidence interval [CI], 1.19-1.41), and those whose family members were hospitalized for more than 30 days had an IRR of 2.45 (95% CI, 1.66-3.60).
CDI incidence increased with age. Compared with people 17 years of age or younger, the IRR increased to 9.32 (95% CI, 8.92-9.73) for those over 65.
Females had higher CDI incidence than males (IRR 1.30; 95% CI, 1.28-1.33).
Households with an infant also had higher CDI incidence than those without (IRR 1.5; 95% CI, 1.44-1.58).
People taking antimicrobials had higher CDI IRRs: 2.69 (95% CI, 2.59-2.79) for low-CDI-risk antibiotics and 8.83 (95% CI, 8.63-9.03) for high-CDI-risk antibiotics.
People taking proton-pump inhibitors had an IRR of 2.23 (95% CI, 2.15-2.30).
Reactions from four experts
Douglas S. Paauw MD, MACP, professor of medicine and the chair for patient-centered clinical education at the University of Washington, Seattle, was not surprised by the findings. “We have wondered for a while how community-acquired CDI occurs,” he said in an email. “This important study offers a plausible explanation for some cases.”
Dr. Paauw advises doctors to consider CDI in their patients who have been exposed to hospitalized people.
David M. Aronoff, MD, FIDSA, FAAM, professor of medicine and the chair of the department of medicine at Indiana University, Indianapolis, advises providers to educate hospital patients being discharged about how CDI is spread and how they can practice good hand hygiene at home.
“An open question of this strong study is whether we should be testing certain hospital patients for asymptomatic C. difficile carriage before they are discharged,” he added in an email.
In a phone interview, Paul G. Auwaerter, MD, MBA, professor of medicine and clinical director of the division of infectious diseases at Johns Hopkins University, Baltimore, noted that community-acquired CDI is frequent enough that his institution performs routine C. difficile testing on all patients with unexplained severe diarrhea.
“This intriguing study bears additional research and follow-up because clearly these spores are hardy,” he said. “But a key point in this billings- and claims-based study is that no one knows where household members acquired CDI, whether it was actually through household transmission.”
Ramin Asgary, MD, MPH, FASTMH, associate professor of global health in the Milken Institute School of Public Health at George Washington University, Washington, cautioned about “an increasing issue with drug-resistant CDI.
“This important, timely study provides another step in the right direction to better understanding and addressing CDI and other hospital-based infections that have become increasing threats to the safety of our patients, their families, and health care in general,” he said in an email.
Dr. Miller said that the scale and scope of the data are strengths of the study, and he acknowledged that its basis in claims and billing data is a limitation. He and his group plan to explore genetic relationships involved in CDI transmission.
The study was funded by the Centers for Disease Control and Prevention. All authors and independent experts have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Hospitalized patients who are asymptomatic Clostridioides difficile carriers may infect people they live with after they return home, a study based on U.S. insurance claim data suggests.
Although C. difficile infection (CDI) is considered to be a common hospital-acquired infection, reports of community-associated CDI in patients who have not been hospitalized are increasing, the authors wrote in Emerging Infectious Diseases.
“Individuals in households where another family member was recently hospitalized but not diagnosed with a CDI appear to be at increased risk for CDI,” said lead author Aaron C. Miller, PhD, a research assistant professor in the department of internal medicine at the University of Iowa, Iowa City. “When individuals are hospitalized, they may become colonized with C. difficile without developing symptoms and subsequently transmit the pathogen to other family members after they return home,” he said by email.
Dr. Miller and colleagues analyzed insurance claims data from 2001 through 2017 using the U.S. Commercial Claims and Medicare Supplemental datasets of IBM MarketScan Research Databases. Over that period, they searched employer-sponsored commercial insurance claims and Medicare supplemental claims of 194,424 enrollees, and they linked claims from multiple family members in the same enrollment plan.
They identified 224,818 CDI cases, and 3,871 of them were considered potential asymptomatic C. difficile transmissions from a recently hospitalized family member.
The researchers gathered monthly C. difficile incidence data from households with a family member who had been hospitalized within the past 60 days and compared them with data from households without a hospitalized family member.
Enrollees exposed to a recently hospitalized family member had a 73% greater incidence of CDI compared with enrollees who were not exposed. The longer the family member’s hospital stay, the greater the risk that someone in the household became infected.
Compared with people whose family members were hospitalized less than 1 day, people whose family members were hospitalized from 1 to 3 days had an incidence rate ratio (IRR) of 1.30 (95% confidence interval [CI], 1.19-1.41), and those whose family members were hospitalized for more than 30 days had an IRR of 2.45 (95% CI, 1.66-3.60).
CDI incidence increased with age. Compared with people 17 years of age or younger, the IRR increased to 9.32 (95% CI, 8.92-9.73) for those over 65.
Females had higher CDI incidence than males (IRR 1.30; 95% CI, 1.28-1.33).
Households with an infant also had higher CDI incidence than those without (IRR 1.5; 95% CI, 1.44-1.58).
People taking antimicrobials had higher CDI IRRs: 2.69 (95% CI, 2.59-2.79) for low-CDI-risk antibiotics and 8.83 (95% CI, 8.63-9.03) for high-CDI-risk antibiotics.
People taking proton-pump inhibitors had an IRR of 2.23 (95% CI, 2.15-2.30).
Reactions from four experts
Douglas S. Paauw MD, MACP, professor of medicine and the chair for patient-centered clinical education at the University of Washington, Seattle, was not surprised by the findings. “We have wondered for a while how community-acquired CDI occurs,” he said in an email. “This important study offers a plausible explanation for some cases.”
Dr. Paauw advises doctors to consider CDI in their patients who have been exposed to hospitalized people.
David M. Aronoff, MD, FIDSA, FAAM, professor of medicine and the chair of the department of medicine at Indiana University, Indianapolis, advises providers to educate hospital patients being discharged about how CDI is spread and how they can practice good hand hygiene at home.
“An open question of this strong study is whether we should be testing certain hospital patients for asymptomatic C. difficile carriage before they are discharged,” he added in an email.
In a phone interview, Paul G. Auwaerter, MD, MBA, professor of medicine and clinical director of the division of infectious diseases at Johns Hopkins University, Baltimore, noted that community-acquired CDI is frequent enough that his institution performs routine C. difficile testing on all patients with unexplained severe diarrhea.
“This intriguing study bears additional research and follow-up because clearly these spores are hardy,” he said. “But a key point in this billings- and claims-based study is that no one knows where household members acquired CDI, whether it was actually through household transmission.”
Ramin Asgary, MD, MPH, FASTMH, associate professor of global health in the Milken Institute School of Public Health at George Washington University, Washington, cautioned about “an increasing issue with drug-resistant CDI.
“This important, timely study provides another step in the right direction to better understanding and addressing CDI and other hospital-based infections that have become increasing threats to the safety of our patients, their families, and health care in general,” he said in an email.
Dr. Miller said that the scale and scope of the data are strengths of the study, and he acknowledged that its basis in claims and billing data is a limitation. He and his group plan to explore genetic relationships involved in CDI transmission.
The study was funded by the Centers for Disease Control and Prevention. All authors and independent experts have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Hospitalized patients who are asymptomatic Clostridioides difficile carriers may infect people they live with after they return home, a study based on U.S. insurance claim data suggests.
Although C. difficile infection (CDI) is considered to be a common hospital-acquired infection, reports of community-associated CDI in patients who have not been hospitalized are increasing, the authors wrote in Emerging Infectious Diseases.
“Individuals in households where another family member was recently hospitalized but not diagnosed with a CDI appear to be at increased risk for CDI,” said lead author Aaron C. Miller, PhD, a research assistant professor in the department of internal medicine at the University of Iowa, Iowa City. “When individuals are hospitalized, they may become colonized with C. difficile without developing symptoms and subsequently transmit the pathogen to other family members after they return home,” he said by email.
Dr. Miller and colleagues analyzed insurance claims data from 2001 through 2017 using the U.S. Commercial Claims and Medicare Supplemental datasets of IBM MarketScan Research Databases. Over that period, they searched employer-sponsored commercial insurance claims and Medicare supplemental claims of 194,424 enrollees, and they linked claims from multiple family members in the same enrollment plan.
They identified 224,818 CDI cases, and 3,871 of them were considered potential asymptomatic C. difficile transmissions from a recently hospitalized family member.
The researchers gathered monthly C. difficile incidence data from households with a family member who had been hospitalized within the past 60 days and compared them with data from households without a hospitalized family member.
Enrollees exposed to a recently hospitalized family member had a 73% greater incidence of CDI compared with enrollees who were not exposed. The longer the family member’s hospital stay, the greater the risk that someone in the household became infected.
Compared with people whose family members were hospitalized less than 1 day, people whose family members were hospitalized from 1 to 3 days had an incidence rate ratio (IRR) of 1.30 (95% confidence interval [CI], 1.19-1.41), and those whose family members were hospitalized for more than 30 days had an IRR of 2.45 (95% CI, 1.66-3.60).
CDI incidence increased with age. Compared with people 17 years of age or younger, the IRR increased to 9.32 (95% CI, 8.92-9.73) for those over 65.
Females had higher CDI incidence than males (IRR 1.30; 95% CI, 1.28-1.33).
Households with an infant also had higher CDI incidence than those without (IRR 1.5; 95% CI, 1.44-1.58).
People taking antimicrobials had higher CDI IRRs: 2.69 (95% CI, 2.59-2.79) for low-CDI-risk antibiotics and 8.83 (95% CI, 8.63-9.03) for high-CDI-risk antibiotics.
People taking proton-pump inhibitors had an IRR of 2.23 (95% CI, 2.15-2.30).
Reactions from four experts
Douglas S. Paauw MD, MACP, professor of medicine and the chair for patient-centered clinical education at the University of Washington, Seattle, was not surprised by the findings. “We have wondered for a while how community-acquired CDI occurs,” he said in an email. “This important study offers a plausible explanation for some cases.”
Dr. Paauw advises doctors to consider CDI in their patients who have been exposed to hospitalized people.
David M. Aronoff, MD, FIDSA, FAAM, professor of medicine and the chair of the department of medicine at Indiana University, Indianapolis, advises providers to educate hospital patients being discharged about how CDI is spread and how they can practice good hand hygiene at home.
“An open question of this strong study is whether we should be testing certain hospital patients for asymptomatic C. difficile carriage before they are discharged,” he added in an email.
In a phone interview, Paul G. Auwaerter, MD, MBA, professor of medicine and clinical director of the division of infectious diseases at Johns Hopkins University, Baltimore, noted that community-acquired CDI is frequent enough that his institution performs routine C. difficile testing on all patients with unexplained severe diarrhea.
“This intriguing study bears additional research and follow-up because clearly these spores are hardy,” he said. “But a key point in this billings- and claims-based study is that no one knows where household members acquired CDI, whether it was actually through household transmission.”
Ramin Asgary, MD, MPH, FASTMH, associate professor of global health in the Milken Institute School of Public Health at George Washington University, Washington, cautioned about “an increasing issue with drug-resistant CDI.
“This important, timely study provides another step in the right direction to better understanding and addressing CDI and other hospital-based infections that have become increasing threats to the safety of our patients, their families, and health care in general,” he said in an email.
Dr. Miller said that the scale and scope of the data are strengths of the study, and he acknowledged that its basis in claims and billing data is a limitation. He and his group plan to explore genetic relationships involved in CDI transmission.
The study was funded by the Centers for Disease Control and Prevention. All authors and independent experts have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AHA statement addresses CVD risk in NAFLD
At least one in four adults worldwide is thought to have nonalcoholic fatty liver disease, a major risk factor for cardiovascular disease (CVD), which is the leading cause of death in NAFLD, but the condition is widely underdiagnosed, according to a new American Heart Association scientific statement on NAFLD and cardiovascular risks.
The statement, published in Arteriosclerosis, Thrombosis, and Vascular Biology, aims to increase awareness of NAFLD among cardiologists and other clinicians treating vulnerable patients. It pulls together the existing evidence for using imaging to diagnose NAFLD as well as the role of current and emerging treatments for managing the disease.
“NAFLD is common, but most patients are undiagnosed,” statement writing committee chair P. Barton Duell, MD, said in an interview. “The identification of normal liver enzyme levels does not exclude the diagnosis of NAFLD. Early diagnosis and treatment are necessary to improve the health of patients with established NAFLD, as well as preventing the development of NAFLD in patients who are at risk for the condition.”
Dr. Duell is a professor at the Knight Cardiovascular Institute and division of endocrinology, diabetes and clinical nutrition at Oregon Health & Science University, Portland.
This is the AHA’s first scientific statement on NAFLD. In 2021, the association issued a statement on obesity and CVD). Also in 2021, a multiorganization group headed by the American Gastroenterological Association published a “Call to Action” on nonalcoholic steatohepatitis (NASH) , a form of NAFLD that’s characterized by inflammation and scarring of the liver, and typically requires a liver biopsy for diagnosis.
Key take-homes
The AHA statement on NAFLD is sweeping. Among its key take-home messages:
- Calling into question the effectiveness of AST and ALT testing for diagnosing NAFLD and NASH.
- Providing context to the role of insulin resistance – either with or without diabetes – as well as obesity (particularly visceral adiposity), metabolic syndrome, and dyslipidemia in NAFLD.
- Advocating for lifestyle interventions – diet, exercise, weight loss and alcohol avoidance – as the key therapeutic intervention for NAFLD.
- Asserting that glucagonlike peptide–1 receptor agonists may modestly improve NAFLD.
The statement also tackles the differences in terminology different organizations use to describe NAFLD. “The terminology section is important to ensure everyone is using the right terminology in assessing patients, as well as choosing appropriate treatment interventions,” Dr. Duell said.
The statement also explores genetic factors that can predispose people to NAFLD, Dr. Duell pointed out, and it goes into detail about strategies for screening NAFLD and NASH. “It is not possible to diagnose NAFLD without understanding the pros and cons of various screening modalities, as well as the lack of sensitivity of some tests for detection of NAFLD We hope this information will increase success in screening for and early identification of NAFLD.”
Dr. Duell explained the rationale for issuing the statement. “Rates of NAFLD are increasing worldwide in association with rising rates of elevated body mass index and the metabolic syndrome, but the condition is commonly undiagnosed,” he said. “This allows patients to experience progression of disease, leading to hepatic and cardiovascular complications.”
Avoiding NAFLD risk factors along with early diagnosis and treatment “may have the potential to mitigate long-term complications from NAFLD,” Dr. Duell said.
“This is one of first times where we really look at cardiovascular risks associated with NAFLD and pinpoint the risk factors, the imaging tools that can be used for diagnosing fatty liver disease, and ultimately what potential treatments we can consider,” Tiffany M. Powell-Wiley, MD, MPH, author of the AHA statement on obesity and CV risk, said in an interview.
“NAFLD has not been at the forefront of cardiologists’ minds, but this statement highlights the importance of liver fat as a fat depot,” said Dr. Powell-Wiley, chief of the Social Determinants of Obesity and Cardiovascular Risk Laboratory at the National Heart, Lung, and Blood Institute in Bethesda, Md.
“It does provide greater clarity for us as cardiologists, especially when thinking about what is required for diagnosis and ultimately how this relates to cardiovascular disease for people with fatty liver disease,” she said.
Dr. Duell and Dr. Powell-Wiley have no relevant relationships to disclose.
At least one in four adults worldwide is thought to have nonalcoholic fatty liver disease, a major risk factor for cardiovascular disease (CVD), which is the leading cause of death in NAFLD, but the condition is widely underdiagnosed, according to a new American Heart Association scientific statement on NAFLD and cardiovascular risks.
The statement, published in Arteriosclerosis, Thrombosis, and Vascular Biology, aims to increase awareness of NAFLD among cardiologists and other clinicians treating vulnerable patients. It pulls together the existing evidence for using imaging to diagnose NAFLD as well as the role of current and emerging treatments for managing the disease.
“NAFLD is common, but most patients are undiagnosed,” statement writing committee chair P. Barton Duell, MD, said in an interview. “The identification of normal liver enzyme levels does not exclude the diagnosis of NAFLD. Early diagnosis and treatment are necessary to improve the health of patients with established NAFLD, as well as preventing the development of NAFLD in patients who are at risk for the condition.”
Dr. Duell is a professor at the Knight Cardiovascular Institute and division of endocrinology, diabetes and clinical nutrition at Oregon Health & Science University, Portland.
This is the AHA’s first scientific statement on NAFLD. In 2021, the association issued a statement on obesity and CVD). Also in 2021, a multiorganization group headed by the American Gastroenterological Association published a “Call to Action” on nonalcoholic steatohepatitis (NASH) , a form of NAFLD that’s characterized by inflammation and scarring of the liver, and typically requires a liver biopsy for diagnosis.
Key take-homes
The AHA statement on NAFLD is sweeping. Among its key take-home messages:
- Calling into question the effectiveness of AST and ALT testing for diagnosing NAFLD and NASH.
- Providing context to the role of insulin resistance – either with or without diabetes – as well as obesity (particularly visceral adiposity), metabolic syndrome, and dyslipidemia in NAFLD.
- Advocating for lifestyle interventions – diet, exercise, weight loss and alcohol avoidance – as the key therapeutic intervention for NAFLD.
- Asserting that glucagonlike peptide–1 receptor agonists may modestly improve NAFLD.
The statement also tackles the differences in terminology different organizations use to describe NAFLD. “The terminology section is important to ensure everyone is using the right terminology in assessing patients, as well as choosing appropriate treatment interventions,” Dr. Duell said.
The statement also explores genetic factors that can predispose people to NAFLD, Dr. Duell pointed out, and it goes into detail about strategies for screening NAFLD and NASH. “It is not possible to diagnose NAFLD without understanding the pros and cons of various screening modalities, as well as the lack of sensitivity of some tests for detection of NAFLD We hope this information will increase success in screening for and early identification of NAFLD.”
Dr. Duell explained the rationale for issuing the statement. “Rates of NAFLD are increasing worldwide in association with rising rates of elevated body mass index and the metabolic syndrome, but the condition is commonly undiagnosed,” he said. “This allows patients to experience progression of disease, leading to hepatic and cardiovascular complications.”
Avoiding NAFLD risk factors along with early diagnosis and treatment “may have the potential to mitigate long-term complications from NAFLD,” Dr. Duell said.
“This is one of first times where we really look at cardiovascular risks associated with NAFLD and pinpoint the risk factors, the imaging tools that can be used for diagnosing fatty liver disease, and ultimately what potential treatments we can consider,” Tiffany M. Powell-Wiley, MD, MPH, author of the AHA statement on obesity and CV risk, said in an interview.
“NAFLD has not been at the forefront of cardiologists’ minds, but this statement highlights the importance of liver fat as a fat depot,” said Dr. Powell-Wiley, chief of the Social Determinants of Obesity and Cardiovascular Risk Laboratory at the National Heart, Lung, and Blood Institute in Bethesda, Md.
“It does provide greater clarity for us as cardiologists, especially when thinking about what is required for diagnosis and ultimately how this relates to cardiovascular disease for people with fatty liver disease,” she said.
Dr. Duell and Dr. Powell-Wiley have no relevant relationships to disclose.
At least one in four adults worldwide is thought to have nonalcoholic fatty liver disease, a major risk factor for cardiovascular disease (CVD), which is the leading cause of death in NAFLD, but the condition is widely underdiagnosed, according to a new American Heart Association scientific statement on NAFLD and cardiovascular risks.
The statement, published in Arteriosclerosis, Thrombosis, and Vascular Biology, aims to increase awareness of NAFLD among cardiologists and other clinicians treating vulnerable patients. It pulls together the existing evidence for using imaging to diagnose NAFLD as well as the role of current and emerging treatments for managing the disease.
“NAFLD is common, but most patients are undiagnosed,” statement writing committee chair P. Barton Duell, MD, said in an interview. “The identification of normal liver enzyme levels does not exclude the diagnosis of NAFLD. Early diagnosis and treatment are necessary to improve the health of patients with established NAFLD, as well as preventing the development of NAFLD in patients who are at risk for the condition.”
Dr. Duell is a professor at the Knight Cardiovascular Institute and division of endocrinology, diabetes and clinical nutrition at Oregon Health & Science University, Portland.
This is the AHA’s first scientific statement on NAFLD. In 2021, the association issued a statement on obesity and CVD). Also in 2021, a multiorganization group headed by the American Gastroenterological Association published a “Call to Action” on nonalcoholic steatohepatitis (NASH) , a form of NAFLD that’s characterized by inflammation and scarring of the liver, and typically requires a liver biopsy for diagnosis.
Key take-homes
The AHA statement on NAFLD is sweeping. Among its key take-home messages:
- Calling into question the effectiveness of AST and ALT testing for diagnosing NAFLD and NASH.
- Providing context to the role of insulin resistance – either with or without diabetes – as well as obesity (particularly visceral adiposity), metabolic syndrome, and dyslipidemia in NAFLD.
- Advocating for lifestyle interventions – diet, exercise, weight loss and alcohol avoidance – as the key therapeutic intervention for NAFLD.
- Asserting that glucagonlike peptide–1 receptor agonists may modestly improve NAFLD.
The statement also tackles the differences in terminology different organizations use to describe NAFLD. “The terminology section is important to ensure everyone is using the right terminology in assessing patients, as well as choosing appropriate treatment interventions,” Dr. Duell said.
The statement also explores genetic factors that can predispose people to NAFLD, Dr. Duell pointed out, and it goes into detail about strategies for screening NAFLD and NASH. “It is not possible to diagnose NAFLD without understanding the pros and cons of various screening modalities, as well as the lack of sensitivity of some tests for detection of NAFLD We hope this information will increase success in screening for and early identification of NAFLD.”
Dr. Duell explained the rationale for issuing the statement. “Rates of NAFLD are increasing worldwide in association with rising rates of elevated body mass index and the metabolic syndrome, but the condition is commonly undiagnosed,” he said. “This allows patients to experience progression of disease, leading to hepatic and cardiovascular complications.”
Avoiding NAFLD risk factors along with early diagnosis and treatment “may have the potential to mitigate long-term complications from NAFLD,” Dr. Duell said.
“This is one of first times where we really look at cardiovascular risks associated with NAFLD and pinpoint the risk factors, the imaging tools that can be used for diagnosing fatty liver disease, and ultimately what potential treatments we can consider,” Tiffany M. Powell-Wiley, MD, MPH, author of the AHA statement on obesity and CV risk, said in an interview.
“NAFLD has not been at the forefront of cardiologists’ minds, but this statement highlights the importance of liver fat as a fat depot,” said Dr. Powell-Wiley, chief of the Social Determinants of Obesity and Cardiovascular Risk Laboratory at the National Heart, Lung, and Blood Institute in Bethesda, Md.
“It does provide greater clarity for us as cardiologists, especially when thinking about what is required for diagnosis and ultimately how this relates to cardiovascular disease for people with fatty liver disease,” she said.
Dr. Duell and Dr. Powell-Wiley have no relevant relationships to disclose.
FROM ARTERIOSCLEROSIS, THROMBOSIS, AND VASCULAR BIOLOGY
Cardiac issues after COVID infection and vaccination: New data
The new information comes from the Centers for Disease Control and Prevention’s National Patient-Centered Clinical Research Network (PCORnet) and from a separate large international clinical study published online in Circulation.
CDC data
The CDC study analyzed electronic health record data from 40 U.S. health care systems from Jan. 1, 2021, to Jan. 31, 2022, on more than 15 million people aged 5 years or older.
It reports a rate of myocarditis or pericarditis after mRNA COVID-19 vaccination of 0-35.9 per 100,000 for males and 0-10.9 per 100,000 for females across different age groups and vaccine cohorts.
Rates of myocarditis or pericarditis after SARS-CoV-2 infection ranged from 12.6 to 114 per 100,000 for males and from 5.4 to 61.7 per 100,000 for females across different age groups.
Even among males aged 12-17 years, the group with the highest incidence of cardiac complications after receipt of a second mRNA COVID-19 vaccine dose, the risk was 1.8-5.6 times higher after SARS-CoV-2 infection than after vaccination, the CDC report notes.
“These findings provide important context for balancing risks and benefits of mRNA COVID-19 vaccination among eligible persons greater than or equal to 5 years,” the report states. They also “support the continued use of recommended mRNA vaccines among all eligible persons aged greater than or equal to 5 years,” it concludes.
International study
The international study focused on prevalence, clinical characteristics, and outcomes of clinically manifest acute myocarditis in patients with COVID-19 infection.
The study showed a rate of acute myocarditis of 2.4 per 1,000 patients hospitalized with COVID-19.
“A small study previously indicated acute myocarditis is a rare occurrence in people infected with COVID-19. Our analysis of international data offers better insight to the occurrence of acute myocarditis during COVID-19 hospitalization, particularly before the COVID-19 vaccines were widely available,” coauthor Enrico Ammirati, MD, PhD, Niguarda Hospital, Milan, commented.
“This analysis indicates that, although rare, hospitalized patients with acute myocarditis associated with COVID-19 infection have a much greater need for intensive care unit admission, in up to 70.5% of the cases, despite the average age of the individuals in the study being much younger than expected, at 38 years old,” added coauthor Marco Metra, MD, University of Brescia, Italy.
The researchers report that the use of corticosteroids in patients with acute myocarditis appeared safe, and, in most cases, a rapid increase in the left ventricular ejection fraction was observed. In addition, they say that discharged patients with acute myocarditis had “an excellent short-term prognosis without occurrence of cardiovascular events.”
The authors also point out that these data show much higher frequency and severity of acute myocarditis linked to COVID-19 infection, compared with myocarditis cases linked to the mRNA COVID-19 vaccines.
The international study examined health data on 56,963 patients who were hospitalized with COVID-19 at 23 hospitals across the United States and Europe from February 2020 through April 2021.
Among these patients, 97 with possible acute myocarditis were identified (4.1 per 1,000), of whom 54 (2.4 per 1,000) were classified as having “definite or probable” acute myocarditis supported by endomyocardial biopsy (31.5% of cases) or magnetic resonance imaging (92.6% of cases).
The median age of definite/probable acute myocarditis cases was 38 years, and 39% were female. On admission, chest pain and dyspnea were the most frequent symptoms (55.5% and 53.7%, respectively), and 31 cases (57.4%) occurred in the absence of COVID-19–associated pneumonia. A fulminant presentation requiring inotropic support or temporary mechanical circulatory support occurred in 21 cases (39%).
Overall, 38 patients (70.4%) were admitted to the intensive care unit for a median time of 6 days. Ten patients (18.5%) received temporary mechanical circulatory support for a median time of 5 days. Three patients died (5.5%) during the index hospitalization, all of whom also had pneumonia. At 120 days, estimated mortality was 6.6%. Patients with pneumonia were more likely to develop hemodynamic instability, require mechanical circulatory support, and die, compared with those without pneumonia.
The authors note that their reported prevalence of acute myocarditis associated with COVID-19 is lower, compared with studies that performed universal cardiac MRI screening during the convalescent COVID-19 period.
They say that underestimation of the prevalence of mild or subclinical acute myocarditis is likely in this study because of the retrospective nature of the registry, the lack of systematic cardiac MRI, and the possibility of missing some diagnoses, particularly during the first pandemic wave when cardiac MRI and endomyocardial biopsy were less frequently performed.
The authors also point out that data on myocarditis after COVID-19 vaccination suggest that vaccination-linked myocarditis is milder than that associated with the virus itself.
With regard to the prevalence of acute myocarditis after vaccination, they report that among 2.8 million doses of mRNA COVID-19 vaccine in the armed forces, 23 individuals had evidence of acute myocarditis, suggesting a prevalence of less than 1 case of acute myocarditis per 100,000 mRNA COVID-19 vaccine doses.
They note that the CDC has also reported 399 reports of myocarditis among 129 million fully vaccinated individuals with the mRNA COVID-19 vaccines.
“These figures appear reassuring, compared with the prevalence of clinically manifest acute myocarditis observed in this study among hospitalized patients with COVID-19,” they conclude.
A version of this article first appeared on Medscape.com.
The new information comes from the Centers for Disease Control and Prevention’s National Patient-Centered Clinical Research Network (PCORnet) and from a separate large international clinical study published online in Circulation.
CDC data
The CDC study analyzed electronic health record data from 40 U.S. health care systems from Jan. 1, 2021, to Jan. 31, 2022, on more than 15 million people aged 5 years or older.
It reports a rate of myocarditis or pericarditis after mRNA COVID-19 vaccination of 0-35.9 per 100,000 for males and 0-10.9 per 100,000 for females across different age groups and vaccine cohorts.
Rates of myocarditis or pericarditis after SARS-CoV-2 infection ranged from 12.6 to 114 per 100,000 for males and from 5.4 to 61.7 per 100,000 for females across different age groups.
Even among males aged 12-17 years, the group with the highest incidence of cardiac complications after receipt of a second mRNA COVID-19 vaccine dose, the risk was 1.8-5.6 times higher after SARS-CoV-2 infection than after vaccination, the CDC report notes.
“These findings provide important context for balancing risks and benefits of mRNA COVID-19 vaccination among eligible persons greater than or equal to 5 years,” the report states. They also “support the continued use of recommended mRNA vaccines among all eligible persons aged greater than or equal to 5 years,” it concludes.
International study
The international study focused on prevalence, clinical characteristics, and outcomes of clinically manifest acute myocarditis in patients with COVID-19 infection.
The study showed a rate of acute myocarditis of 2.4 per 1,000 patients hospitalized with COVID-19.
“A small study previously indicated acute myocarditis is a rare occurrence in people infected with COVID-19. Our analysis of international data offers better insight to the occurrence of acute myocarditis during COVID-19 hospitalization, particularly before the COVID-19 vaccines were widely available,” coauthor Enrico Ammirati, MD, PhD, Niguarda Hospital, Milan, commented.
“This analysis indicates that, although rare, hospitalized patients with acute myocarditis associated with COVID-19 infection have a much greater need for intensive care unit admission, in up to 70.5% of the cases, despite the average age of the individuals in the study being much younger than expected, at 38 years old,” added coauthor Marco Metra, MD, University of Brescia, Italy.
The researchers report that the use of corticosteroids in patients with acute myocarditis appeared safe, and, in most cases, a rapid increase in the left ventricular ejection fraction was observed. In addition, they say that discharged patients with acute myocarditis had “an excellent short-term prognosis without occurrence of cardiovascular events.”
The authors also point out that these data show much higher frequency and severity of acute myocarditis linked to COVID-19 infection, compared with myocarditis cases linked to the mRNA COVID-19 vaccines.
The international study examined health data on 56,963 patients who were hospitalized with COVID-19 at 23 hospitals across the United States and Europe from February 2020 through April 2021.
Among these patients, 97 with possible acute myocarditis were identified (4.1 per 1,000), of whom 54 (2.4 per 1,000) were classified as having “definite or probable” acute myocarditis supported by endomyocardial biopsy (31.5% of cases) or magnetic resonance imaging (92.6% of cases).
The median age of definite/probable acute myocarditis cases was 38 years, and 39% were female. On admission, chest pain and dyspnea were the most frequent symptoms (55.5% and 53.7%, respectively), and 31 cases (57.4%) occurred in the absence of COVID-19–associated pneumonia. A fulminant presentation requiring inotropic support or temporary mechanical circulatory support occurred in 21 cases (39%).
Overall, 38 patients (70.4%) were admitted to the intensive care unit for a median time of 6 days. Ten patients (18.5%) received temporary mechanical circulatory support for a median time of 5 days. Three patients died (5.5%) during the index hospitalization, all of whom also had pneumonia. At 120 days, estimated mortality was 6.6%. Patients with pneumonia were more likely to develop hemodynamic instability, require mechanical circulatory support, and die, compared with those without pneumonia.
The authors note that their reported prevalence of acute myocarditis associated with COVID-19 is lower, compared with studies that performed universal cardiac MRI screening during the convalescent COVID-19 period.
They say that underestimation of the prevalence of mild or subclinical acute myocarditis is likely in this study because of the retrospective nature of the registry, the lack of systematic cardiac MRI, and the possibility of missing some diagnoses, particularly during the first pandemic wave when cardiac MRI and endomyocardial biopsy were less frequently performed.
The authors also point out that data on myocarditis after COVID-19 vaccination suggest that vaccination-linked myocarditis is milder than that associated with the virus itself.
With regard to the prevalence of acute myocarditis after vaccination, they report that among 2.8 million doses of mRNA COVID-19 vaccine in the armed forces, 23 individuals had evidence of acute myocarditis, suggesting a prevalence of less than 1 case of acute myocarditis per 100,000 mRNA COVID-19 vaccine doses.
They note that the CDC has also reported 399 reports of myocarditis among 129 million fully vaccinated individuals with the mRNA COVID-19 vaccines.
“These figures appear reassuring, compared with the prevalence of clinically manifest acute myocarditis observed in this study among hospitalized patients with COVID-19,” they conclude.
A version of this article first appeared on Medscape.com.
The new information comes from the Centers for Disease Control and Prevention’s National Patient-Centered Clinical Research Network (PCORnet) and from a separate large international clinical study published online in Circulation.
CDC data
The CDC study analyzed electronic health record data from 40 U.S. health care systems from Jan. 1, 2021, to Jan. 31, 2022, on more than 15 million people aged 5 years or older.
It reports a rate of myocarditis or pericarditis after mRNA COVID-19 vaccination of 0-35.9 per 100,000 for males and 0-10.9 per 100,000 for females across different age groups and vaccine cohorts.
Rates of myocarditis or pericarditis after SARS-CoV-2 infection ranged from 12.6 to 114 per 100,000 for males and from 5.4 to 61.7 per 100,000 for females across different age groups.
Even among males aged 12-17 years, the group with the highest incidence of cardiac complications after receipt of a second mRNA COVID-19 vaccine dose, the risk was 1.8-5.6 times higher after SARS-CoV-2 infection than after vaccination, the CDC report notes.
“These findings provide important context for balancing risks and benefits of mRNA COVID-19 vaccination among eligible persons greater than or equal to 5 years,” the report states. They also “support the continued use of recommended mRNA vaccines among all eligible persons aged greater than or equal to 5 years,” it concludes.
International study
The international study focused on prevalence, clinical characteristics, and outcomes of clinically manifest acute myocarditis in patients with COVID-19 infection.
The study showed a rate of acute myocarditis of 2.4 per 1,000 patients hospitalized with COVID-19.
“A small study previously indicated acute myocarditis is a rare occurrence in people infected with COVID-19. Our analysis of international data offers better insight to the occurrence of acute myocarditis during COVID-19 hospitalization, particularly before the COVID-19 vaccines were widely available,” coauthor Enrico Ammirati, MD, PhD, Niguarda Hospital, Milan, commented.
“This analysis indicates that, although rare, hospitalized patients with acute myocarditis associated with COVID-19 infection have a much greater need for intensive care unit admission, in up to 70.5% of the cases, despite the average age of the individuals in the study being much younger than expected, at 38 years old,” added coauthor Marco Metra, MD, University of Brescia, Italy.
The researchers report that the use of corticosteroids in patients with acute myocarditis appeared safe, and, in most cases, a rapid increase in the left ventricular ejection fraction was observed. In addition, they say that discharged patients with acute myocarditis had “an excellent short-term prognosis without occurrence of cardiovascular events.”
The authors also point out that these data show much higher frequency and severity of acute myocarditis linked to COVID-19 infection, compared with myocarditis cases linked to the mRNA COVID-19 vaccines.
The international study examined health data on 56,963 patients who were hospitalized with COVID-19 at 23 hospitals across the United States and Europe from February 2020 through April 2021.
Among these patients, 97 with possible acute myocarditis were identified (4.1 per 1,000), of whom 54 (2.4 per 1,000) were classified as having “definite or probable” acute myocarditis supported by endomyocardial biopsy (31.5% of cases) or magnetic resonance imaging (92.6% of cases).
The median age of definite/probable acute myocarditis cases was 38 years, and 39% were female. On admission, chest pain and dyspnea were the most frequent symptoms (55.5% and 53.7%, respectively), and 31 cases (57.4%) occurred in the absence of COVID-19–associated pneumonia. A fulminant presentation requiring inotropic support or temporary mechanical circulatory support occurred in 21 cases (39%).
Overall, 38 patients (70.4%) were admitted to the intensive care unit for a median time of 6 days. Ten patients (18.5%) received temporary mechanical circulatory support for a median time of 5 days. Three patients died (5.5%) during the index hospitalization, all of whom also had pneumonia. At 120 days, estimated mortality was 6.6%. Patients with pneumonia were more likely to develop hemodynamic instability, require mechanical circulatory support, and die, compared with those without pneumonia.
The authors note that their reported prevalence of acute myocarditis associated with COVID-19 is lower, compared with studies that performed universal cardiac MRI screening during the convalescent COVID-19 period.
They say that underestimation of the prevalence of mild or subclinical acute myocarditis is likely in this study because of the retrospective nature of the registry, the lack of systematic cardiac MRI, and the possibility of missing some diagnoses, particularly during the first pandemic wave when cardiac MRI and endomyocardial biopsy were less frequently performed.
The authors also point out that data on myocarditis after COVID-19 vaccination suggest that vaccination-linked myocarditis is milder than that associated with the virus itself.
With regard to the prevalence of acute myocarditis after vaccination, they report that among 2.8 million doses of mRNA COVID-19 vaccine in the armed forces, 23 individuals had evidence of acute myocarditis, suggesting a prevalence of less than 1 case of acute myocarditis per 100,000 mRNA COVID-19 vaccine doses.
They note that the CDC has also reported 399 reports of myocarditis among 129 million fully vaccinated individuals with the mRNA COVID-19 vaccines.
“These figures appear reassuring, compared with the prevalence of clinically manifest acute myocarditis observed in this study among hospitalized patients with COVID-19,” they conclude.
A version of this article first appeared on Medscape.com.
Fourth Pfizer dose better for severe than symptomatic COVID: Study
A fourth dose of the Pfizer-BioNTech vaccine is effective in reducing the short-term risk for COVID-19 infection, hospitalization, and death in people who got a third dose at least 4 months before, a large study shows.
However, Paul Offit, MD, author of an editorial accompanying the study, told this news organization, “I would argue, without fear of contradiction, that this is going to have no impact on this pandemic.”
“We are still in the midst of a zero-tolerance policy for this virus. We don’t accept mild illness and if we’re not going to accept mild illness, we think we have to boost it away, which would mean probably about two doses every year. That’s not a reasonable public health strategy,” said Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
Booster confusion
Results of the research out of Israel, published in the New England Journal of Medicine, make a case for a fourth booster for people 60 and over.
Researchers, led by Ori Magen, MD, Clalit Research Institute, innovation division, Clalit Health Services, Tel Aviv, analyzed data comparing 182,122 matched pairs recorded by the largest health care organization in Israel from Jan. 3 to Feb. 18, 2022. With more than 4.7 million members, Clalit Health Services covers more than half of the population of Israel.
The researchers compared outcomes in people 60 or older (average age, 72 years) who got a fourth dose with outcomes in those who had only a third dose. They individually matched people from the two groups, considering factors such as age, health status, and ethnicity.
Relative vaccine effectiveness in days 7-30 after the fourth dose was estimated to be 45% (95% confidence interval, 44%-47%) against confirmed SARS-CoV-2 infection, 55% (95% CI, 53%-58%) against symptomatic COVID-19, 68% (95% CI, 59%-74%) against hospitalization, 62% (95% CI, 50%-74%) against severe COVID, and 74% (95% CI, 50%-90%) against COVID-related death.
Several countries, including the United States, have begun offering a fourth vaccine dose for higher-risk populations in light of evidence of waning immunity after the third dose and waves of infection, driven by Omicron and its variants, in some parts of the world. But the recommended age groups differ considerably.
In the United States, for instance, the Food and Drug Administration in late March approved a fourth dose of the Pfizer or Moderna vaccine for anyone over 50 and people over 18 who have gotten a solid organ transplant or have a similar level of immune risk.
Dr. Offit pointed out that Israel offers the fourth vaccine for people 60 and over and the European Medical Association offers it for those over 80. No surprise that confusion over the fourth dose is rampant.
Booster advice
Dr. Offit offered this perspective: People who are immunocompromised could reasonably get a fourth dose, depending on the manner in which they are compromised.
“Someone who has a solid organ transplant is not the same as someone who is getting a monoclonal antibody for their rheumatoid arthritis,” Dr. Offit said, adding that people could also make a reasonable argument for the fourth dose if they are over 65 and have multiple comorbidities.
“I’m over 65,” Dr. Offit said. “I’m generally healthy. I’m not going to get a fourth dose.”
People with multiple comorbidities over age 12 could reasonably get a third dose, he said. “For everybody else – healthy people less than 65 – I would argue this is a two-dose vaccine.”
CHOP, he noted as an example, mandates the vaccine but doesn’t mandate three doses and he says that’s not unusual for hospital systems.
“How many lives are you really saving with that fourth dose? If you really want to have an effect on this pandemic, vaccinate the unvaccinated,” Dr. Offit said.
Focus on the memory cells
Dr. Offit wrote in the editorial: “Arguably, the most disappointing error surrounding the use of COVID-19 vaccines was the labeling of mild illnesses or asymptomatic infections after vaccination as ‘breakthroughs.’ As is true for all mucosal vaccines, the goal is to protect against serious illness – to keep people out of the hospital, intensive care unit, and morgue. The term ‘breakthrough,’ which implies failure, created unrealistic expectations and led to the adoption of a zero-tolerance strategy for this virus.”
Dr. Offit said that the focus should be on the memory cells, not the neutralizing antibodies.
Regarding mRNA vaccines, Dr. Offit said “the surprise of this vaccine – it surprised me and other vaccine researchers – is that with these two doses of mRNA separated by 3-4 weeks, you actually appear to have long-lived memory response.
“That’s not the history of vaccines. If you look at the inactivated polio vaccine or the inactivated hepatitis A vaccine, you really do need a 4- to 6-month interval between doses to get high frequencies of memory cells. That doesn’t appear to be the case here. It looks like two doses given close together do just that. Memory cells last for years if not, sometimes, decades.”
Neutralizing antibodies, on the other hand, protect against mild illness and their effectiveness wanes after months.
“At some point we are going to have to get used to mild illness,” Dr. Offit said.
The Centers for Disease Control and Prevention must now determine who will benefit most from booster dosing and educate the public about the limits of mucosal vaccines, Dr. Offit wrote in the editorial.
“Otherwise, a zero-tolerance strategy for mild or asymptomatic infection, which can be implemented only with frequent booster doses, will continue to mislead the public about what COVID-19 vaccines can and cannot do.”
The work was funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.
A version of this article first appeared on Medscape.com.
A fourth dose of the Pfizer-BioNTech vaccine is effective in reducing the short-term risk for COVID-19 infection, hospitalization, and death in people who got a third dose at least 4 months before, a large study shows.
However, Paul Offit, MD, author of an editorial accompanying the study, told this news organization, “I would argue, without fear of contradiction, that this is going to have no impact on this pandemic.”
“We are still in the midst of a zero-tolerance policy for this virus. We don’t accept mild illness and if we’re not going to accept mild illness, we think we have to boost it away, which would mean probably about two doses every year. That’s not a reasonable public health strategy,” said Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
Booster confusion
Results of the research out of Israel, published in the New England Journal of Medicine, make a case for a fourth booster for people 60 and over.
Researchers, led by Ori Magen, MD, Clalit Research Institute, innovation division, Clalit Health Services, Tel Aviv, analyzed data comparing 182,122 matched pairs recorded by the largest health care organization in Israel from Jan. 3 to Feb. 18, 2022. With more than 4.7 million members, Clalit Health Services covers more than half of the population of Israel.
The researchers compared outcomes in people 60 or older (average age, 72 years) who got a fourth dose with outcomes in those who had only a third dose. They individually matched people from the two groups, considering factors such as age, health status, and ethnicity.
Relative vaccine effectiveness in days 7-30 after the fourth dose was estimated to be 45% (95% confidence interval, 44%-47%) against confirmed SARS-CoV-2 infection, 55% (95% CI, 53%-58%) against symptomatic COVID-19, 68% (95% CI, 59%-74%) against hospitalization, 62% (95% CI, 50%-74%) against severe COVID, and 74% (95% CI, 50%-90%) against COVID-related death.
Several countries, including the United States, have begun offering a fourth vaccine dose for higher-risk populations in light of evidence of waning immunity after the third dose and waves of infection, driven by Omicron and its variants, in some parts of the world. But the recommended age groups differ considerably.
In the United States, for instance, the Food and Drug Administration in late March approved a fourth dose of the Pfizer or Moderna vaccine for anyone over 50 and people over 18 who have gotten a solid organ transplant or have a similar level of immune risk.
Dr. Offit pointed out that Israel offers the fourth vaccine for people 60 and over and the European Medical Association offers it for those over 80. No surprise that confusion over the fourth dose is rampant.
Booster advice
Dr. Offit offered this perspective: People who are immunocompromised could reasonably get a fourth dose, depending on the manner in which they are compromised.
“Someone who has a solid organ transplant is not the same as someone who is getting a monoclonal antibody for their rheumatoid arthritis,” Dr. Offit said, adding that people could also make a reasonable argument for the fourth dose if they are over 65 and have multiple comorbidities.
“I’m over 65,” Dr. Offit said. “I’m generally healthy. I’m not going to get a fourth dose.”
People with multiple comorbidities over age 12 could reasonably get a third dose, he said. “For everybody else – healthy people less than 65 – I would argue this is a two-dose vaccine.”
CHOP, he noted as an example, mandates the vaccine but doesn’t mandate three doses and he says that’s not unusual for hospital systems.
“How many lives are you really saving with that fourth dose? If you really want to have an effect on this pandemic, vaccinate the unvaccinated,” Dr. Offit said.
Focus on the memory cells
Dr. Offit wrote in the editorial: “Arguably, the most disappointing error surrounding the use of COVID-19 vaccines was the labeling of mild illnesses or asymptomatic infections after vaccination as ‘breakthroughs.’ As is true for all mucosal vaccines, the goal is to protect against serious illness – to keep people out of the hospital, intensive care unit, and morgue. The term ‘breakthrough,’ which implies failure, created unrealistic expectations and led to the adoption of a zero-tolerance strategy for this virus.”
Dr. Offit said that the focus should be on the memory cells, not the neutralizing antibodies.
Regarding mRNA vaccines, Dr. Offit said “the surprise of this vaccine – it surprised me and other vaccine researchers – is that with these two doses of mRNA separated by 3-4 weeks, you actually appear to have long-lived memory response.
“That’s not the history of vaccines. If you look at the inactivated polio vaccine or the inactivated hepatitis A vaccine, you really do need a 4- to 6-month interval between doses to get high frequencies of memory cells. That doesn’t appear to be the case here. It looks like two doses given close together do just that. Memory cells last for years if not, sometimes, decades.”
Neutralizing antibodies, on the other hand, protect against mild illness and their effectiveness wanes after months.
“At some point we are going to have to get used to mild illness,” Dr. Offit said.
The Centers for Disease Control and Prevention must now determine who will benefit most from booster dosing and educate the public about the limits of mucosal vaccines, Dr. Offit wrote in the editorial.
“Otherwise, a zero-tolerance strategy for mild or asymptomatic infection, which can be implemented only with frequent booster doses, will continue to mislead the public about what COVID-19 vaccines can and cannot do.”
The work was funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.
A version of this article first appeared on Medscape.com.
A fourth dose of the Pfizer-BioNTech vaccine is effective in reducing the short-term risk for COVID-19 infection, hospitalization, and death in people who got a third dose at least 4 months before, a large study shows.
However, Paul Offit, MD, author of an editorial accompanying the study, told this news organization, “I would argue, without fear of contradiction, that this is going to have no impact on this pandemic.”
“We are still in the midst of a zero-tolerance policy for this virus. We don’t accept mild illness and if we’re not going to accept mild illness, we think we have to boost it away, which would mean probably about two doses every year. That’s not a reasonable public health strategy,” said Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
Booster confusion
Results of the research out of Israel, published in the New England Journal of Medicine, make a case for a fourth booster for people 60 and over.
Researchers, led by Ori Magen, MD, Clalit Research Institute, innovation division, Clalit Health Services, Tel Aviv, analyzed data comparing 182,122 matched pairs recorded by the largest health care organization in Israel from Jan. 3 to Feb. 18, 2022. With more than 4.7 million members, Clalit Health Services covers more than half of the population of Israel.
The researchers compared outcomes in people 60 or older (average age, 72 years) who got a fourth dose with outcomes in those who had only a third dose. They individually matched people from the two groups, considering factors such as age, health status, and ethnicity.
Relative vaccine effectiveness in days 7-30 after the fourth dose was estimated to be 45% (95% confidence interval, 44%-47%) against confirmed SARS-CoV-2 infection, 55% (95% CI, 53%-58%) against symptomatic COVID-19, 68% (95% CI, 59%-74%) against hospitalization, 62% (95% CI, 50%-74%) against severe COVID, and 74% (95% CI, 50%-90%) against COVID-related death.
Several countries, including the United States, have begun offering a fourth vaccine dose for higher-risk populations in light of evidence of waning immunity after the third dose and waves of infection, driven by Omicron and its variants, in some parts of the world. But the recommended age groups differ considerably.
In the United States, for instance, the Food and Drug Administration in late March approved a fourth dose of the Pfizer or Moderna vaccine for anyone over 50 and people over 18 who have gotten a solid organ transplant or have a similar level of immune risk.
Dr. Offit pointed out that Israel offers the fourth vaccine for people 60 and over and the European Medical Association offers it for those over 80. No surprise that confusion over the fourth dose is rampant.
Booster advice
Dr. Offit offered this perspective: People who are immunocompromised could reasonably get a fourth dose, depending on the manner in which they are compromised.
“Someone who has a solid organ transplant is not the same as someone who is getting a monoclonal antibody for their rheumatoid arthritis,” Dr. Offit said, adding that people could also make a reasonable argument for the fourth dose if they are over 65 and have multiple comorbidities.
“I’m over 65,” Dr. Offit said. “I’m generally healthy. I’m not going to get a fourth dose.”
People with multiple comorbidities over age 12 could reasonably get a third dose, he said. “For everybody else – healthy people less than 65 – I would argue this is a two-dose vaccine.”
CHOP, he noted as an example, mandates the vaccine but doesn’t mandate three doses and he says that’s not unusual for hospital systems.
“How many lives are you really saving with that fourth dose? If you really want to have an effect on this pandemic, vaccinate the unvaccinated,” Dr. Offit said.
Focus on the memory cells
Dr. Offit wrote in the editorial: “Arguably, the most disappointing error surrounding the use of COVID-19 vaccines was the labeling of mild illnesses or asymptomatic infections after vaccination as ‘breakthroughs.’ As is true for all mucosal vaccines, the goal is to protect against serious illness – to keep people out of the hospital, intensive care unit, and morgue. The term ‘breakthrough,’ which implies failure, created unrealistic expectations and led to the adoption of a zero-tolerance strategy for this virus.”
Dr. Offit said that the focus should be on the memory cells, not the neutralizing antibodies.
Regarding mRNA vaccines, Dr. Offit said “the surprise of this vaccine – it surprised me and other vaccine researchers – is that with these two doses of mRNA separated by 3-4 weeks, you actually appear to have long-lived memory response.
“That’s not the history of vaccines. If you look at the inactivated polio vaccine or the inactivated hepatitis A vaccine, you really do need a 4- to 6-month interval between doses to get high frequencies of memory cells. That doesn’t appear to be the case here. It looks like two doses given close together do just that. Memory cells last for years if not, sometimes, decades.”
Neutralizing antibodies, on the other hand, protect against mild illness and their effectiveness wanes after months.
“At some point we are going to have to get used to mild illness,” Dr. Offit said.
The Centers for Disease Control and Prevention must now determine who will benefit most from booster dosing and educate the public about the limits of mucosal vaccines, Dr. Offit wrote in the editorial.
“Otherwise, a zero-tolerance strategy for mild or asymptomatic infection, which can be implemented only with frequent booster doses, will continue to mislead the public about what COVID-19 vaccines can and cannot do.”
The work was funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.
A version of this article first appeared on Medscape.com.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Woman who faked medical degree practiced for 3 years
Who needs medical degrees anyway?
It’s no secret that doctors make a fair chunk of change. It’s a lucrative profession, but that big fat paycheck is siloed behind long, tough years of medical school and residency. It’s not an easy path doctors walk. Or at least, it’s not supposed to be. Anything’s easy if you’re willing to lie.
That brings us to Sonia, a 31-year-old woman from northern France with a bachelor’s degree in real estate management who wasn’t bringing in enough money for her three children, at least not to her satisfaction. Naturally, the only decision was to forge some diplomas from the University of Strasbourg, as well as a certificate from the French Order of Physicians. Sonia got hired as a general practitioner by using the identities of two doctors who shared her name. She had no experience, had no idea what she was doing, and was wearing a GPS tagging bracelet for an unrelated crime, so she was quickly caught and exposed in October 2021, after, um, 3 years of fake doctoring, according to France Live.
Not to be deterred by this temporary setback, Sonia proceeded to immediately find work as an ophthalmologist, a career that requires more than 10 years of training, continuing her fraudulent medical career until recently, when she was caught again and sentenced to 3 years in prison. She did make 70,000 euros a year as a fake doctor, which isn’t exactly huge money, but certainly not bad either.
We certainly hope she’s learned her lesson about impersonating a doctor, at this point, but maybe she should just go to medical school. If not, northern France might just end up with a new endocrinologist or oncologist floating around in 3 years.
No need to ‘guess what size horse you are’
Is COVID-19 warming up for yet another surge? Maybe. That means it’s also time for the return of its remora-like follower, ivermectin. Our thanks go out to the Tennessee state legislature for bringing the proven-to-be-ineffective treatment for COVID back into our hearts and minds and emergency rooms.
Both the state House and Senate have approved a bill that allows pharmacists to dispense the antiparasitic drug without a prescription while shielding them “from any liability that could arise from dispensing ivermectin,” Nashville Public Radio reported.
The drug’s manufacturer, Merck, said over a year ago that there is “no scientific basis for a potential therapeutic effect against COVID-19 from preclinical studies … and a concerning lack of safety data.” More recently, a study published in the New England Journal of Medicine showed that ivermectin treatment had no important benefits in patients with COVID.
Last week, the bill’s Senate sponsor, Frank Niceley of Strawberry Plains, said that it was all about safety, as he explained to NPR station WPLN: “It’s a lot safer to go to your pharmacist and let him tell you how much ivermectin to take than it is to go to the co-op and guess what size horse you are.”
And on that note, here are a few more items of business that just might end up on the legislature’s calendar:
- Horses will be allowed to “share” their unused ivermectin with humans and other mammals.
- An apple a day not only keeps the doctor away, but the IRS and the FDA as well.
- Colon cleansing is more fun than humans should be allowed to have.
- TikTok videos qualify as CME.
Who needs medical degrees anyway?
It’s no secret that doctors make a fair chunk of change. It’s a lucrative profession, but that big fat paycheck is siloed behind long, tough years of medical school and residency. It’s not an easy path doctors walk. Or at least, it’s not supposed to be. Anything’s easy if you’re willing to lie.
That brings us to Sonia, a 31-year-old woman from northern France with a bachelor’s degree in real estate management who wasn’t bringing in enough money for her three children, at least not to her satisfaction. Naturally, the only decision was to forge some diplomas from the University of Strasbourg, as well as a certificate from the French Order of Physicians. Sonia got hired as a general practitioner by using the identities of two doctors who shared her name. She had no experience, had no idea what she was doing, and was wearing a GPS tagging bracelet for an unrelated crime, so she was quickly caught and exposed in October 2021, after, um, 3 years of fake doctoring, according to France Live.
Not to be deterred by this temporary setback, Sonia proceeded to immediately find work as an ophthalmologist, a career that requires more than 10 years of training, continuing her fraudulent medical career until recently, when she was caught again and sentenced to 3 years in prison. She did make 70,000 euros a year as a fake doctor, which isn’t exactly huge money, but certainly not bad either.
We certainly hope she’s learned her lesson about impersonating a doctor, at this point, but maybe she should just go to medical school. If not, northern France might just end up with a new endocrinologist or oncologist floating around in 3 years.
Speak louder, I can’t see you
With the introduction of FaceTime and the pandemic pushing work and social events to Zoom, video calls have become ubiquitous. Along the way, however, we’ve had to learn to adjust to technical difficulties. Often by yelling at the screen when the video quality is disrupted. Waving our hands and arms, speaking louder. Sound like you?
Well, a new study published in Royal Society Open Science shows that it sounds like a lot of us.
James Trujillo of the Max Planck Institute for Psycholinguistics in Nijmegen, the Netherlands, who was lead author of the paper, said on Eurekalert that “previous research has shown that speech and gestures are linked, but ours is the first to look into how visuals impact our behavior in those fields.”
He and his associates set up 40 participants in separate rooms to have conversations in pairs over a video chat. Over the course of 40 minutes, the video quality started to deteriorate from clear to extremely blurry. When the video quality was affected, participants started with gestures but as the quality continued to lessen the gestures increased and so did the decibels of their voices.
Even when the participants could barely see each other, they still gestured and their voices were even louder, positively supporting the idea that gestures and speech are a dynamically linked when it comes to communication. Even on regular phone calls, when we can’t see each other at all, people make small movements and gestures, Mr. Trujillo said.
So, the next time the Wifi is terrible and your video calls keep cutting out, don’t worry about looking foolish screaming at the computer. We’ve all been there.
Seek a doctor if standing at attention for more than 4 hours
Imbrochável. In Brazil, it means “unfloppable” or “flaccid proof.” It’s also a word that Brazilian president Jair Bolsonaro likes to use when referring to himself. Gives you a good idea of what he’s all about. Imagine his embarrassment when news recently broke about more than 30,000 pills of Viagra that had been secretly distributed to the Brazilian military.
The military offered a simple and plausible explanation: The Viagra had been prescribed to treat pulmonary hypertension. Fair, but when a Brazilian newspaper dug a little deeper, they found that this was not the case. The Viagra was, in general, being used for its, shall we say, traditional purpose.
Many Brazilians reacted poorly to the news that their tax dollars were being used to provide Brazilian soldiers with downstairs assistance, with the standard associated furor on social media. A rival politician, Ciro Gomes, who is planning on challenging the president in an upcoming election, had perhaps the best remark on the situation: “Unless they’re able to prove they’re developing some kind of secret weapon – capable of revolutionizing the international arms industry – it’ll be tough to justify the purchase of 35,000 units of a erectile dysfunction drug.”
Hmm, secret weapon. Well, a certain Russian fellow has made a bit of a thrust into world affairs recently. Does anyone know if Putin is sitting on a big Viagra stash?
Who needs medical degrees anyway?
It’s no secret that doctors make a fair chunk of change. It’s a lucrative profession, but that big fat paycheck is siloed behind long, tough years of medical school and residency. It’s not an easy path doctors walk. Or at least, it’s not supposed to be. Anything’s easy if you’re willing to lie.
That brings us to Sonia, a 31-year-old woman from northern France with a bachelor’s degree in real estate management who wasn’t bringing in enough money for her three children, at least not to her satisfaction. Naturally, the only decision was to forge some diplomas from the University of Strasbourg, as well as a certificate from the French Order of Physicians. Sonia got hired as a general practitioner by using the identities of two doctors who shared her name. She had no experience, had no idea what she was doing, and was wearing a GPS tagging bracelet for an unrelated crime, so she was quickly caught and exposed in October 2021, after, um, 3 years of fake doctoring, according to France Live.
Not to be deterred by this temporary setback, Sonia proceeded to immediately find work as an ophthalmologist, a career that requires more than 10 years of training, continuing her fraudulent medical career until recently, when she was caught again and sentenced to 3 years in prison. She did make 70,000 euros a year as a fake doctor, which isn’t exactly huge money, but certainly not bad either.
We certainly hope she’s learned her lesson about impersonating a doctor, at this point, but maybe she should just go to medical school. If not, northern France might just end up with a new endocrinologist or oncologist floating around in 3 years.
No need to ‘guess what size horse you are’
Is COVID-19 warming up for yet another surge? Maybe. That means it’s also time for the return of its remora-like follower, ivermectin. Our thanks go out to the Tennessee state legislature for bringing the proven-to-be-ineffective treatment for COVID back into our hearts and minds and emergency rooms.
Both the state House and Senate have approved a bill that allows pharmacists to dispense the antiparasitic drug without a prescription while shielding them “from any liability that could arise from dispensing ivermectin,” Nashville Public Radio reported.
The drug’s manufacturer, Merck, said over a year ago that there is “no scientific basis for a potential therapeutic effect against COVID-19 from preclinical studies … and a concerning lack of safety data.” More recently, a study published in the New England Journal of Medicine showed that ivermectin treatment had no important benefits in patients with COVID.
Last week, the bill’s Senate sponsor, Frank Niceley of Strawberry Plains, said that it was all about safety, as he explained to NPR station WPLN: “It’s a lot safer to go to your pharmacist and let him tell you how much ivermectin to take than it is to go to the co-op and guess what size horse you are.”
And on that note, here are a few more items of business that just might end up on the legislature’s calendar:
- Horses will be allowed to “share” their unused ivermectin with humans and other mammals.
- An apple a day not only keeps the doctor away, but the IRS and the FDA as well.
- Colon cleansing is more fun than humans should be allowed to have.
- TikTok videos qualify as CME.
Who needs medical degrees anyway?
It’s no secret that doctors make a fair chunk of change. It’s a lucrative profession, but that big fat paycheck is siloed behind long, tough years of medical school and residency. It’s not an easy path doctors walk. Or at least, it’s not supposed to be. Anything’s easy if you’re willing to lie.
That brings us to Sonia, a 31-year-old woman from northern France with a bachelor’s degree in real estate management who wasn’t bringing in enough money for her three children, at least not to her satisfaction. Naturally, the only decision was to forge some diplomas from the University of Strasbourg, as well as a certificate from the French Order of Physicians. Sonia got hired as a general practitioner by using the identities of two doctors who shared her name. She had no experience, had no idea what she was doing, and was wearing a GPS tagging bracelet for an unrelated crime, so she was quickly caught and exposed in October 2021, after, um, 3 years of fake doctoring, according to France Live.
Not to be deterred by this temporary setback, Sonia proceeded to immediately find work as an ophthalmologist, a career that requires more than 10 years of training, continuing her fraudulent medical career until recently, when she was caught again and sentenced to 3 years in prison. She did make 70,000 euros a year as a fake doctor, which isn’t exactly huge money, but certainly not bad either.
We certainly hope she’s learned her lesson about impersonating a doctor, at this point, but maybe she should just go to medical school. If not, northern France might just end up with a new endocrinologist or oncologist floating around in 3 years.
Speak louder, I can’t see you
With the introduction of FaceTime and the pandemic pushing work and social events to Zoom, video calls have become ubiquitous. Along the way, however, we’ve had to learn to adjust to technical difficulties. Often by yelling at the screen when the video quality is disrupted. Waving our hands and arms, speaking louder. Sound like you?
Well, a new study published in Royal Society Open Science shows that it sounds like a lot of us.
James Trujillo of the Max Planck Institute for Psycholinguistics in Nijmegen, the Netherlands, who was lead author of the paper, said on Eurekalert that “previous research has shown that speech and gestures are linked, but ours is the first to look into how visuals impact our behavior in those fields.”
He and his associates set up 40 participants in separate rooms to have conversations in pairs over a video chat. Over the course of 40 minutes, the video quality started to deteriorate from clear to extremely blurry. When the video quality was affected, participants started with gestures but as the quality continued to lessen the gestures increased and so did the decibels of their voices.
Even when the participants could barely see each other, they still gestured and their voices were even louder, positively supporting the idea that gestures and speech are a dynamically linked when it comes to communication. Even on regular phone calls, when we can’t see each other at all, people make small movements and gestures, Mr. Trujillo said.
So, the next time the Wifi is terrible and your video calls keep cutting out, don’t worry about looking foolish screaming at the computer. We’ve all been there.
Seek a doctor if standing at attention for more than 4 hours
Imbrochável. In Brazil, it means “unfloppable” or “flaccid proof.” It’s also a word that Brazilian president Jair Bolsonaro likes to use when referring to himself. Gives you a good idea of what he’s all about. Imagine his embarrassment when news recently broke about more than 30,000 pills of Viagra that had been secretly distributed to the Brazilian military.
The military offered a simple and plausible explanation: The Viagra had been prescribed to treat pulmonary hypertension. Fair, but when a Brazilian newspaper dug a little deeper, they found that this was not the case. The Viagra was, in general, being used for its, shall we say, traditional purpose.
Many Brazilians reacted poorly to the news that their tax dollars were being used to provide Brazilian soldiers with downstairs assistance, with the standard associated furor on social media. A rival politician, Ciro Gomes, who is planning on challenging the president in an upcoming election, had perhaps the best remark on the situation: “Unless they’re able to prove they’re developing some kind of secret weapon – capable of revolutionizing the international arms industry – it’ll be tough to justify the purchase of 35,000 units of a erectile dysfunction drug.”
Hmm, secret weapon. Well, a certain Russian fellow has made a bit of a thrust into world affairs recently. Does anyone know if Putin is sitting on a big Viagra stash?
Who needs medical degrees anyway?
It’s no secret that doctors make a fair chunk of change. It’s a lucrative profession, but that big fat paycheck is siloed behind long, tough years of medical school and residency. It’s not an easy path doctors walk. Or at least, it’s not supposed to be. Anything’s easy if you’re willing to lie.
That brings us to Sonia, a 31-year-old woman from northern France with a bachelor’s degree in real estate management who wasn’t bringing in enough money for her three children, at least not to her satisfaction. Naturally, the only decision was to forge some diplomas from the University of Strasbourg, as well as a certificate from the French Order of Physicians. Sonia got hired as a general practitioner by using the identities of two doctors who shared her name. She had no experience, had no idea what she was doing, and was wearing a GPS tagging bracelet for an unrelated crime, so she was quickly caught and exposed in October 2021, after, um, 3 years of fake doctoring, according to France Live.
Not to be deterred by this temporary setback, Sonia proceeded to immediately find work as an ophthalmologist, a career that requires more than 10 years of training, continuing her fraudulent medical career until recently, when she was caught again and sentenced to 3 years in prison. She did make 70,000 euros a year as a fake doctor, which isn’t exactly huge money, but certainly not bad either.
We certainly hope she’s learned her lesson about impersonating a doctor, at this point, but maybe she should just go to medical school. If not, northern France might just end up with a new endocrinologist or oncologist floating around in 3 years.
No need to ‘guess what size horse you are’
Is COVID-19 warming up for yet another surge? Maybe. That means it’s also time for the return of its remora-like follower, ivermectin. Our thanks go out to the Tennessee state legislature for bringing the proven-to-be-ineffective treatment for COVID back into our hearts and minds and emergency rooms.
Both the state House and Senate have approved a bill that allows pharmacists to dispense the antiparasitic drug without a prescription while shielding them “from any liability that could arise from dispensing ivermectin,” Nashville Public Radio reported.
The drug’s manufacturer, Merck, said over a year ago that there is “no scientific basis for a potential therapeutic effect against COVID-19 from preclinical studies … and a concerning lack of safety data.” More recently, a study published in the New England Journal of Medicine showed that ivermectin treatment had no important benefits in patients with COVID.
Last week, the bill’s Senate sponsor, Frank Niceley of Strawberry Plains, said that it was all about safety, as he explained to NPR station WPLN: “It’s a lot safer to go to your pharmacist and let him tell you how much ivermectin to take than it is to go to the co-op and guess what size horse you are.”
And on that note, here are a few more items of business that just might end up on the legislature’s calendar:
- Horses will be allowed to “share” their unused ivermectin with humans and other mammals.
- An apple a day not only keeps the doctor away, but the IRS and the FDA as well.
- Colon cleansing is more fun than humans should be allowed to have.
- TikTok videos qualify as CME.
Who needs medical degrees anyway?
It’s no secret that doctors make a fair chunk of change. It’s a lucrative profession, but that big fat paycheck is siloed behind long, tough years of medical school and residency. It’s not an easy path doctors walk. Or at least, it’s not supposed to be. Anything’s easy if you’re willing to lie.
That brings us to Sonia, a 31-year-old woman from northern France with a bachelor’s degree in real estate management who wasn’t bringing in enough money for her three children, at least not to her satisfaction. Naturally, the only decision was to forge some diplomas from the University of Strasbourg, as well as a certificate from the French Order of Physicians. Sonia got hired as a general practitioner by using the identities of two doctors who shared her name. She had no experience, had no idea what she was doing, and was wearing a GPS tagging bracelet for an unrelated crime, so she was quickly caught and exposed in October 2021, after, um, 3 years of fake doctoring, according to France Live.
Not to be deterred by this temporary setback, Sonia proceeded to immediately find work as an ophthalmologist, a career that requires more than 10 years of training, continuing her fraudulent medical career until recently, when she was caught again and sentenced to 3 years in prison. She did make 70,000 euros a year as a fake doctor, which isn’t exactly huge money, but certainly not bad either.
We certainly hope she’s learned her lesson about impersonating a doctor, at this point, but maybe she should just go to medical school. If not, northern France might just end up with a new endocrinologist or oncologist floating around in 3 years.
Speak louder, I can’t see you
With the introduction of FaceTime and the pandemic pushing work and social events to Zoom, video calls have become ubiquitous. Along the way, however, we’ve had to learn to adjust to technical difficulties. Often by yelling at the screen when the video quality is disrupted. Waving our hands and arms, speaking louder. Sound like you?
Well, a new study published in Royal Society Open Science shows that it sounds like a lot of us.
James Trujillo of the Max Planck Institute for Psycholinguistics in Nijmegen, the Netherlands, who was lead author of the paper, said on Eurekalert that “previous research has shown that speech and gestures are linked, but ours is the first to look into how visuals impact our behavior in those fields.”
He and his associates set up 40 participants in separate rooms to have conversations in pairs over a video chat. Over the course of 40 minutes, the video quality started to deteriorate from clear to extremely blurry. When the video quality was affected, participants started with gestures but as the quality continued to lessen the gestures increased and so did the decibels of their voices.
Even when the participants could barely see each other, they still gestured and their voices were even louder, positively supporting the idea that gestures and speech are a dynamically linked when it comes to communication. Even on regular phone calls, when we can’t see each other at all, people make small movements and gestures, Mr. Trujillo said.
So, the next time the Wifi is terrible and your video calls keep cutting out, don’t worry about looking foolish screaming at the computer. We’ve all been there.
Seek a doctor if standing at attention for more than 4 hours
Imbrochável. In Brazil, it means “unfloppable” or “flaccid proof.” It’s also a word that Brazilian president Jair Bolsonaro likes to use when referring to himself. Gives you a good idea of what he’s all about. Imagine his embarrassment when news recently broke about more than 30,000 pills of Viagra that had been secretly distributed to the Brazilian military.
The military offered a simple and plausible explanation: The Viagra had been prescribed to treat pulmonary hypertension. Fair, but when a Brazilian newspaper dug a little deeper, they found that this was not the case. The Viagra was, in general, being used for its, shall we say, traditional purpose.
Many Brazilians reacted poorly to the news that their tax dollars were being used to provide Brazilian soldiers with downstairs assistance, with the standard associated furor on social media. A rival politician, Ciro Gomes, who is planning on challenging the president in an upcoming election, had perhaps the best remark on the situation: “Unless they’re able to prove they’re developing some kind of secret weapon – capable of revolutionizing the international arms industry – it’ll be tough to justify the purchase of 35,000 units of a erectile dysfunction drug.”
Hmm, secret weapon. Well, a certain Russian fellow has made a bit of a thrust into world affairs recently. Does anyone know if Putin is sitting on a big Viagra stash?
Harmonizing Magnetic Resonance Imaging Protocols for Veterans With Multiple Sclerosis
Multiple sclerosis (MS) is a lifelong disease that affects about a million people in the United States.1,2 Since 1998 more than 45,000 veterans have been diagnosed with MS and about 20,000 are evaluated in the Veterans Health Administration (VHA) annually.3
Magnetic resonance imaging (MRI) is a cornerstone for the assessment of persons with multiple sclerosis (pwMS).4-6 MRI assists with disease diagnosis, allowing for timely therapeutic interventions and withthe evaluation of its progression, treatment effect, and safety. 4,5 MRI-based outcomes also are used as primary endpoints in clinical trials.4,5
MS has its clinical onset in early adulthood in most individuals and is diagnosed at a mean age of 30 years.7 As a result, pwMS may receive care and MRIs in different facilities during their lifetime. Mitigating interscan variabilities that can challenge intra- and interperson comparisons is crucial for accurate care. Radiologists may find it difficult to compare scans acquired in different facilities, as dissimilarities in acquisition protocols may mask or uncover focal disease, creating false negative or false positive findings. Moreover, lack of a standardized method to report MRI changes may compromise neurologists’ ability to correctly interpret scans and disease progression.
Accordingly, in October 2019, an international task force of neurologists, radiologists, MRI technologists, and imaging scientists with expertise in MS, including representatives from the VHA, worked together to update guidelines for imaging the brain, spinal cord, and optic nerve in pwMS.8,9 Recognizing the importance of this effort, the VHA Multiple Sclerosis Centers of Excellence (MSCoE), in collaboration with a team of subject matter expert neuroradiologists promptly committed to this effort, advocating the updated consensus recommendations, and favoring their dissemination within the VHA.10
As part of this commitment and dissemination effort, in this report we summarize the core points of the newly proposed MRI guidelines and ways to adapt them for use within the VHA. We then discuss key elements for their successful implementation and dissemination, specifically regarding the clinical operations of VHA.
Updated Guidelines
MRI Scan at Different Timepoints of MS
There are 3 crucial milestones within a the lifespan of a pwMS that require an MRI to reach appropriate conclusions and avoid clinical errors. These include the initial diagnosis, the follow-up to monitor disease and/or treatment effect, and the assessment of medication safety.
In the interest of efficiency, MRI protocols may vary slightly depending on these clinical indications. The Table lists core sequences of the updated 2021 consensus recommendations at each timepoint along with the proposed alternatives or preferences from the VHA workgroup.
At the time of diagnosis, both brain and spine (cervical and thoracic) MRIs are recommended. Routine MRI of the optic nerve is considered optional at diagnosis. However, imaging the optic nerve may be useful in specific clinical scenarios when the optic nerve is selectively involved, and the diagnosis or etiology of an optic neuritis is not clear. A repeat brain MRI is advised every 6 to 12 months in patients with clinically or radiologically isolated syndrome who do not fulfill the diagnostic criteria of MS but present risk factors for conversion to MS or paraclinical features of it.
Once the diagnosis is established, brain MRI is recommended for follow-up and for surveillance of drug safety. Spinal cord and optic nerve MRIs are desirable but optional in the follow-up of pwMS and are not required for drug surveillance. Spinal cord MRIs are required at follow-up for patients whose progression cannot be explained by brain MRI features, or who manifest with recurrent spinal cord symptoms, or have spinal cord comorbidities. In these cases, spinal cord MRI also may assist with treatment decisions. Similarly, optic nerve MRI is necessary during follow-up only when optic nerve comorbidities are suspected or when there is progression or reoccurrence of optic nerve–related symptoms.
Brain MRIs are recommended for monitoring drug effect yearly (or at longer intervals, after a few years of disease stability). Conversely, a repeat brain MRI is advised after 6 months if nonsymptomatic radiological disease activity is discovered on surveillance scans.
Abbreviated but more frequent serial brain MRI protocols (eg, every 3 to 4 months) are recommended for pwMS treated with natalizumab and at high risk of developing progressive multifocal leukoencephalopathy (eg, pwMS who are John Cunningham virus [JCV]–positive, and have been treated with natalizumabfor ≥ 18 months, have a JCV antibody index > 0.9, or have a history of immunosuppression). A similar approach is recommended for carryover cases, such as those with high JCV antibody index who are switched to other immunosuppressive treatments.
MRI Field, Scan Resolution, and Coverage
Both 1.5-Tesla (1.5-T) and 3-T scans are believed to be equally effective in imaging pwMS, providing that the 1.5-T scans are good quality. Although imaging at < 1.5 T is not recommended due to suboptimal disease detection, the use of scanners > 3 T is equally discouraged outside the supervision of trained investigators. Signal-to-noise ratio and resolution are key factors impacting scan quality, and their optimization is prioritized over the number of sequences in the updated 2021 consensus recommendations. For brain imaging, a resolution of 1 mm3 isotropic is preferred for 3-dimensional (3D) imaging and slice thickness ≤ 3 mm without gap (≤ 5 mm with 10-30% gaps for diffusion-weighted imaging only) is recommended for 2D sequences. Images should cover the entire brain and as much of the cervical spine as possible; images should be prescribed axial for 2D or reformatted axial oblique for 3D using the subcallosal plane as reference. For spine imaging, sites should aim at an in-plane resolution of 1 mm2; using sagittal slices ≤ 3 mm thick and axial slices ≤ 5 mm thick, both with no gap. Scans should cover the entire cervical and thoracolumbar region inclusive of the conus. For the optic nerve images, slices should be ≤ 2 or 3 mm thick with an in-plane resolution of 1 mm2. Images should be aligned to the orientation of the optic nerve and chiasms, both of which should be entirely covered.
Postgadolinium Images Use
The discovery of the higher sensitivity of post-gadolinium (Gd) T1-weighted (T1-w) MRI relative to high iodine (88.1 g I) computed tomography scans in demonstrating contrast-enhancing MS lesions has revolutionized the way clinicians diagnose and monitor this disease.11 However, in recent years the role of postcontrast MRI has been debated, considering the potential safety concerns secondary to Gd tissue deposition. For this reason, an intentionally more judicious use of postcontrast MRI is proposed by the consensus recommendations. At disease diagnosis, the use of Gd is advisable to (1) show disease dissemination in time; (2) differentiate the diagnosis based on the Gd pattern; (3) predict short-term disease activity; and (4) characterize activity in the setting of progression. When monitoring pwMS, the use of Gd may be useful in the first year of follow-up, particularly if in the setting of low potency medications or for patients for whom the detection of one or more active lesions would lead to a change in disease-modifying agents. Gd also should be used to first, confirm a clinical exacerbation (if needed); second, further characterize a lesion suggestive of progressive multifocal encephalopathy or monitor this disease over time; and third, monitor lesion burden change in patients with large confluent lesions, the count of which otherwise may be difficult.
MRI During Pregnancy and Lactation
The consensus recommendations state that Gd contrast–enhanced MRI is not absolutely contraindicated during pregnancy, although its use should be limited to strictly necessary situations, particularly those involving differential diagnosis, such as cerebral venous thrombosis or monitoring of possibly enlarging lesion burden. The use of Gd is not contraindicated during lactation, as only a small proportion (< 0.4%) passes into the breast milk, leading to an exposure to < 1% of the permitted Gd dose for neonates.12,13
Harmonizing MRI Reports
The consensus recommendations propose reporting the exact lesion count on T2-weighted (T2-w) images when lesions are < 20, or specifying if the number of T2 lesions is between 20 and 50, between 50 and 100, or uncountable, eg, confluent large lesions. Similarly, for the spinal cord, the consensus recommendations propose reporting the exact lesion count on T2-w images when lesions are < 10, or otherwise report that > 10 lesions are seen.
The VHA workgroup proposed reporting a mild, moderate, or severe T2-lesion burden for a T2-lesion count < 20, between 20 and 50, and > 50, respectively. For follow-up MRIs, notation should be made if there is any change in lesion number, indicating the number of new lesions whenever possible. At each timepoint, the presence of active lesions on postcontrast images should be accurately defined.
Dissemination and Implementation
To implement and disseminate these proposed recommendations within the VHA, a workgroup of neurologists and radiologists was formed in late 2020. A review and discussion of the importance of each of the proposed MRI protocols for veterans with MS was held along with possible modifications to balance the intent of meeting standards of care with resources of individual US Department of Veterans Affairs (VA) medical centers and veterans’ needs. The final protocol recommendations were agreed on by group consensus.
In general, this VHA workgroup felt that the current adopted MRI protocols in several VA medical centers (based on previously proposed recommendations) were similar to the ones newly proposed and that implementing changes to meet the 2021 criteria would not be a major challenge.14,15 Possible regional and nonregional barriers were discussed. The result of these discussions led to a modified version of what could be considered more stringent guidelines to accommodate medical centers that had fewer imaging resources. This modified protocol offers a viable alternative that allows for minimizing heterogeneities while recognizing the capabilities of the available scanner fleet and meeting the needs of specific centers or veterans. Finally, the workgroup recognized a fundamental obstacle toward this harmonization process in the heterogeneity in vendors and scanner field strength, factors that have previously limited implementation.
The guidelines and proposed changes were then presented to the VA National Radiology Program Office, examined, and discussed for consensus. No changes were felt to be needed, and the recommendation to implement these guidelines in MS regional programs, whenever possible, was deemed appropriate.
At this time, a focused communication plan has been implemented to diffuse the use of this protocol at MS regional programs in the MSCoE network. We will work iteratively with individual sites to practically apply the guidelines, learn about challenges, and work through them to optimize local implementation.
Conclusions
Standardized MRI protocols are fundamental for the care of veterans with MS. Mitigating interscan variabilities should be recognized as a priority by scientific and clinical expert committees. Several guidelines have been developed over the years to standardize MRI acquisition protocols and interpretations, while updating the same to the latest discoveries.4,5,8,14,15 The VHA has been historically committed to these international efforts, with the goal to excel in the care of veterans with MS by providing access to state-of-the-art technologies. To this end, the initial Consortium of MS Centers MRI protocol was implemented in several MSCoE VA Regional Program sites a decade ago.14 Efforts continue to update protocol recommendations as needed and to promote their dissemination across the VHA enterprise.
This commentary is part of the continuous effort of the MSCoE to align with contemporary guidelines, apply the highest scientific standards, and achieve consistent outcomes for veterans with MS. For more important details of the clinical scenarios when additional/optional sequences or scans can be acquired, we advise the reader to refer to the 2021 MAGNIMS-CMSC-NAIMS Consensus Recommendations on the Use of MRI in Patients With Multiple Sclerosis.8
1. Wallin MT, Culpepper WJ, Campbell JD, et al. The prevalence of MS in the United States: A population-based estimate using health claims data. Neurology. 2019;92(10):e1029-e1040. doi:10.1212/WNL.0000000000007035
2. Nelson LM, Wallin MT, Marrie RA, et al. A new way to estimate neurologic disease prevalence in the United States: Illustrated with MS. Neurology. 2019;92(10):469-480. doi:10.1212/WNL.0000000000007044
3. Culpepper WJ, Wallin MT, Magder LS, et al. VHA Multiple Sclerosis Surveillance Registry and its similarities to other contemporary multiple sclerosis cohorts. J Rehabil Res Dev. 2015;52(3):263-272. doi:10.1682/JRRD.2014.07.0172
4. Wattjes MP, Rovira À, Miller D, et al. Evidence-based guidelines: MAGNIMS consensus guidelines on the use of MRI in multiple sclerosis--establishing disease prognosis and monitoring patients. Nat Rev Neurol. 2015;11(10):597-606. doi:10.1038/nrneurol.2015.157
5. Rovira À, Wattjes MP, Tintoré M, et al. Evidence-based guidelines: MAGNIMS consensus guidelines on the use of MRI in multiple sclerosis-clinical implementation in the diagnostic process. Nat Rev Neurol. 2015;11(8):471-482. doi:10.1038/nrneurol.2015.106
6. Thompson AJ, Banwell BL, Barkhof F, et al. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018;17(2):162-173. doi:10.1016/S1474-4422(17)30470-2
7. Reich DS, Lucchinetti CF, Calabresi PA. Multiple sclerosis. N Engl J Med. 2018;378(2):169-180. doi:10.1056/NEJMra1401483
8. Wattjes MP, Ciccarelli O, Reich DS, et al. 2021 MAGNIMS-CMSC-NAIMS consensus recommendations on the use of MRI in patients with multiple sclerosis. Lancet Neurol. 2021;20(8):653-670. doi:10.1016/S1474-4422(21)00095-8
9. Saslow L, Li DKB, Halper J, et al. An International Standardized Magnetic Resonance Imaging Protocol for Diagnosis and Follow-up of Patients with Multiple Sclerosis: Advocacy, Dissemination, and Implementation Strategies. Int J MS Care. 2020;22(5):226-232. doi:10.7224/1537-2073.2020-094
10. Cameron MH, Haselkorn JK, Wallin MT. The Multiple Sclerosis Centers of Excellence: a model of excellence in the VA. Fed Pract. 2020;37(suppl 1):S6-S10.
11. Grossman RI, Gonzalez-Scarano F, Atlas SW, Galetta S, Silberberg DH. Multiple sclerosis: gadolinium enhancement in MR imaging. Radiology. 1986;161(3):721-725. doi:10.1148/radiology.161.3.3786722
12. European Society of Urogenital Radiology. ESUR guidelines on contrast agent, 10.0. March 2018. Accessed March 11, 2022. https://www.esur.org/fileadmin/content/2019/ESUR_Guidelines_10.0_Final_Version.pdf
13. Sundgren PC, Leander P. Is administration of gadolinium-based contrast media to pregnant women and small children justified?. J Magn Reson Imaging. 2011;34(4):750-757. doi:10.1002/jmri.22413
14. Simon JH, Li D, Traboulsee A, et al. Standardized MR imaging protocol for multiple sclerosis: Consortium of MS Centers consensus guidelines. AJNR Am J Neuroradiol. 2006;27(2):455-461.
15. Traboulsee A, Simon JH, Stone L, et al. Revised Recommendations of the Consortium of MS Centers Task Force for a Standardized MRI Protocol and Clinical Guidelines for the Diagnosis and Follow-Up of Multiple Sclerosis. AJNR Am J Neuroradiol. 2016;37(3):394-401. doi:10.3174/ajnr.A4539
Multiple sclerosis (MS) is a lifelong disease that affects about a million people in the United States.1,2 Since 1998 more than 45,000 veterans have been diagnosed with MS and about 20,000 are evaluated in the Veterans Health Administration (VHA) annually.3
Magnetic resonance imaging (MRI) is a cornerstone for the assessment of persons with multiple sclerosis (pwMS).4-6 MRI assists with disease diagnosis, allowing for timely therapeutic interventions and withthe evaluation of its progression, treatment effect, and safety. 4,5 MRI-based outcomes also are used as primary endpoints in clinical trials.4,5
MS has its clinical onset in early adulthood in most individuals and is diagnosed at a mean age of 30 years.7 As a result, pwMS may receive care and MRIs in different facilities during their lifetime. Mitigating interscan variabilities that can challenge intra- and interperson comparisons is crucial for accurate care. Radiologists may find it difficult to compare scans acquired in different facilities, as dissimilarities in acquisition protocols may mask or uncover focal disease, creating false negative or false positive findings. Moreover, lack of a standardized method to report MRI changes may compromise neurologists’ ability to correctly interpret scans and disease progression.
Accordingly, in October 2019, an international task force of neurologists, radiologists, MRI technologists, and imaging scientists with expertise in MS, including representatives from the VHA, worked together to update guidelines for imaging the brain, spinal cord, and optic nerve in pwMS.8,9 Recognizing the importance of this effort, the VHA Multiple Sclerosis Centers of Excellence (MSCoE), in collaboration with a team of subject matter expert neuroradiologists promptly committed to this effort, advocating the updated consensus recommendations, and favoring their dissemination within the VHA.10
As part of this commitment and dissemination effort, in this report we summarize the core points of the newly proposed MRI guidelines and ways to adapt them for use within the VHA. We then discuss key elements for their successful implementation and dissemination, specifically regarding the clinical operations of VHA.
Updated Guidelines
MRI Scan at Different Timepoints of MS
There are 3 crucial milestones within a the lifespan of a pwMS that require an MRI to reach appropriate conclusions and avoid clinical errors. These include the initial diagnosis, the follow-up to monitor disease and/or treatment effect, and the assessment of medication safety.
In the interest of efficiency, MRI protocols may vary slightly depending on these clinical indications. The Table lists core sequences of the updated 2021 consensus recommendations at each timepoint along with the proposed alternatives or preferences from the VHA workgroup.
At the time of diagnosis, both brain and spine (cervical and thoracic) MRIs are recommended. Routine MRI of the optic nerve is considered optional at diagnosis. However, imaging the optic nerve may be useful in specific clinical scenarios when the optic nerve is selectively involved, and the diagnosis or etiology of an optic neuritis is not clear. A repeat brain MRI is advised every 6 to 12 months in patients with clinically or radiologically isolated syndrome who do not fulfill the diagnostic criteria of MS but present risk factors for conversion to MS or paraclinical features of it.
Once the diagnosis is established, brain MRI is recommended for follow-up and for surveillance of drug safety. Spinal cord and optic nerve MRIs are desirable but optional in the follow-up of pwMS and are not required for drug surveillance. Spinal cord MRIs are required at follow-up for patients whose progression cannot be explained by brain MRI features, or who manifest with recurrent spinal cord symptoms, or have spinal cord comorbidities. In these cases, spinal cord MRI also may assist with treatment decisions. Similarly, optic nerve MRI is necessary during follow-up only when optic nerve comorbidities are suspected or when there is progression or reoccurrence of optic nerve–related symptoms.
Brain MRIs are recommended for monitoring drug effect yearly (or at longer intervals, after a few years of disease stability). Conversely, a repeat brain MRI is advised after 6 months if nonsymptomatic radiological disease activity is discovered on surveillance scans.
Abbreviated but more frequent serial brain MRI protocols (eg, every 3 to 4 months) are recommended for pwMS treated with natalizumab and at high risk of developing progressive multifocal leukoencephalopathy (eg, pwMS who are John Cunningham virus [JCV]–positive, and have been treated with natalizumabfor ≥ 18 months, have a JCV antibody index > 0.9, or have a history of immunosuppression). A similar approach is recommended for carryover cases, such as those with high JCV antibody index who are switched to other immunosuppressive treatments.
MRI Field, Scan Resolution, and Coverage
Both 1.5-Tesla (1.5-T) and 3-T scans are believed to be equally effective in imaging pwMS, providing that the 1.5-T scans are good quality. Although imaging at < 1.5 T is not recommended due to suboptimal disease detection, the use of scanners > 3 T is equally discouraged outside the supervision of trained investigators. Signal-to-noise ratio and resolution are key factors impacting scan quality, and their optimization is prioritized over the number of sequences in the updated 2021 consensus recommendations. For brain imaging, a resolution of 1 mm3 isotropic is preferred for 3-dimensional (3D) imaging and slice thickness ≤ 3 mm without gap (≤ 5 mm with 10-30% gaps for diffusion-weighted imaging only) is recommended for 2D sequences. Images should cover the entire brain and as much of the cervical spine as possible; images should be prescribed axial for 2D or reformatted axial oblique for 3D using the subcallosal plane as reference. For spine imaging, sites should aim at an in-plane resolution of 1 mm2; using sagittal slices ≤ 3 mm thick and axial slices ≤ 5 mm thick, both with no gap. Scans should cover the entire cervical and thoracolumbar region inclusive of the conus. For the optic nerve images, slices should be ≤ 2 or 3 mm thick with an in-plane resolution of 1 mm2. Images should be aligned to the orientation of the optic nerve and chiasms, both of which should be entirely covered.
Postgadolinium Images Use
The discovery of the higher sensitivity of post-gadolinium (Gd) T1-weighted (T1-w) MRI relative to high iodine (88.1 g I) computed tomography scans in demonstrating contrast-enhancing MS lesions has revolutionized the way clinicians diagnose and monitor this disease.11 However, in recent years the role of postcontrast MRI has been debated, considering the potential safety concerns secondary to Gd tissue deposition. For this reason, an intentionally more judicious use of postcontrast MRI is proposed by the consensus recommendations. At disease diagnosis, the use of Gd is advisable to (1) show disease dissemination in time; (2) differentiate the diagnosis based on the Gd pattern; (3) predict short-term disease activity; and (4) characterize activity in the setting of progression. When monitoring pwMS, the use of Gd may be useful in the first year of follow-up, particularly if in the setting of low potency medications or for patients for whom the detection of one or more active lesions would lead to a change in disease-modifying agents. Gd also should be used to first, confirm a clinical exacerbation (if needed); second, further characterize a lesion suggestive of progressive multifocal encephalopathy or monitor this disease over time; and third, monitor lesion burden change in patients with large confluent lesions, the count of which otherwise may be difficult.
MRI During Pregnancy and Lactation
The consensus recommendations state that Gd contrast–enhanced MRI is not absolutely contraindicated during pregnancy, although its use should be limited to strictly necessary situations, particularly those involving differential diagnosis, such as cerebral venous thrombosis or monitoring of possibly enlarging lesion burden. The use of Gd is not contraindicated during lactation, as only a small proportion (< 0.4%) passes into the breast milk, leading to an exposure to < 1% of the permitted Gd dose for neonates.12,13
Harmonizing MRI Reports
The consensus recommendations propose reporting the exact lesion count on T2-weighted (T2-w) images when lesions are < 20, or specifying if the number of T2 lesions is between 20 and 50, between 50 and 100, or uncountable, eg, confluent large lesions. Similarly, for the spinal cord, the consensus recommendations propose reporting the exact lesion count on T2-w images when lesions are < 10, or otherwise report that > 10 lesions are seen.
The VHA workgroup proposed reporting a mild, moderate, or severe T2-lesion burden for a T2-lesion count < 20, between 20 and 50, and > 50, respectively. For follow-up MRIs, notation should be made if there is any change in lesion number, indicating the number of new lesions whenever possible. At each timepoint, the presence of active lesions on postcontrast images should be accurately defined.
Dissemination and Implementation
To implement and disseminate these proposed recommendations within the VHA, a workgroup of neurologists and radiologists was formed in late 2020. A review and discussion of the importance of each of the proposed MRI protocols for veterans with MS was held along with possible modifications to balance the intent of meeting standards of care with resources of individual US Department of Veterans Affairs (VA) medical centers and veterans’ needs. The final protocol recommendations were agreed on by group consensus.
In general, this VHA workgroup felt that the current adopted MRI protocols in several VA medical centers (based on previously proposed recommendations) were similar to the ones newly proposed and that implementing changes to meet the 2021 criteria would not be a major challenge.14,15 Possible regional and nonregional barriers were discussed. The result of these discussions led to a modified version of what could be considered more stringent guidelines to accommodate medical centers that had fewer imaging resources. This modified protocol offers a viable alternative that allows for minimizing heterogeneities while recognizing the capabilities of the available scanner fleet and meeting the needs of specific centers or veterans. Finally, the workgroup recognized a fundamental obstacle toward this harmonization process in the heterogeneity in vendors and scanner field strength, factors that have previously limited implementation.
The guidelines and proposed changes were then presented to the VA National Radiology Program Office, examined, and discussed for consensus. No changes were felt to be needed, and the recommendation to implement these guidelines in MS regional programs, whenever possible, was deemed appropriate.
At this time, a focused communication plan has been implemented to diffuse the use of this protocol at MS regional programs in the MSCoE network. We will work iteratively with individual sites to practically apply the guidelines, learn about challenges, and work through them to optimize local implementation.
Conclusions
Standardized MRI protocols are fundamental for the care of veterans with MS. Mitigating interscan variabilities should be recognized as a priority by scientific and clinical expert committees. Several guidelines have been developed over the years to standardize MRI acquisition protocols and interpretations, while updating the same to the latest discoveries.4,5,8,14,15 The VHA has been historically committed to these international efforts, with the goal to excel in the care of veterans with MS by providing access to state-of-the-art technologies. To this end, the initial Consortium of MS Centers MRI protocol was implemented in several MSCoE VA Regional Program sites a decade ago.14 Efforts continue to update protocol recommendations as needed and to promote their dissemination across the VHA enterprise.
This commentary is part of the continuous effort of the MSCoE to align with contemporary guidelines, apply the highest scientific standards, and achieve consistent outcomes for veterans with MS. For more important details of the clinical scenarios when additional/optional sequences or scans can be acquired, we advise the reader to refer to the 2021 MAGNIMS-CMSC-NAIMS Consensus Recommendations on the Use of MRI in Patients With Multiple Sclerosis.8
Multiple sclerosis (MS) is a lifelong disease that affects about a million people in the United States.1,2 Since 1998 more than 45,000 veterans have been diagnosed with MS and about 20,000 are evaluated in the Veterans Health Administration (VHA) annually.3
Magnetic resonance imaging (MRI) is a cornerstone for the assessment of persons with multiple sclerosis (pwMS).4-6 MRI assists with disease diagnosis, allowing for timely therapeutic interventions and withthe evaluation of its progression, treatment effect, and safety. 4,5 MRI-based outcomes also are used as primary endpoints in clinical trials.4,5
MS has its clinical onset in early adulthood in most individuals and is diagnosed at a mean age of 30 years.7 As a result, pwMS may receive care and MRIs in different facilities during their lifetime. Mitigating interscan variabilities that can challenge intra- and interperson comparisons is crucial for accurate care. Radiologists may find it difficult to compare scans acquired in different facilities, as dissimilarities in acquisition protocols may mask or uncover focal disease, creating false negative or false positive findings. Moreover, lack of a standardized method to report MRI changes may compromise neurologists’ ability to correctly interpret scans and disease progression.
Accordingly, in October 2019, an international task force of neurologists, radiologists, MRI technologists, and imaging scientists with expertise in MS, including representatives from the VHA, worked together to update guidelines for imaging the brain, spinal cord, and optic nerve in pwMS.8,9 Recognizing the importance of this effort, the VHA Multiple Sclerosis Centers of Excellence (MSCoE), in collaboration with a team of subject matter expert neuroradiologists promptly committed to this effort, advocating the updated consensus recommendations, and favoring their dissemination within the VHA.10
As part of this commitment and dissemination effort, in this report we summarize the core points of the newly proposed MRI guidelines and ways to adapt them for use within the VHA. We then discuss key elements for their successful implementation and dissemination, specifically regarding the clinical operations of VHA.
Updated Guidelines
MRI Scan at Different Timepoints of MS
There are 3 crucial milestones within a the lifespan of a pwMS that require an MRI to reach appropriate conclusions and avoid clinical errors. These include the initial diagnosis, the follow-up to monitor disease and/or treatment effect, and the assessment of medication safety.
In the interest of efficiency, MRI protocols may vary slightly depending on these clinical indications. The Table lists core sequences of the updated 2021 consensus recommendations at each timepoint along with the proposed alternatives or preferences from the VHA workgroup.
At the time of diagnosis, both brain and spine (cervical and thoracic) MRIs are recommended. Routine MRI of the optic nerve is considered optional at diagnosis. However, imaging the optic nerve may be useful in specific clinical scenarios when the optic nerve is selectively involved, and the diagnosis or etiology of an optic neuritis is not clear. A repeat brain MRI is advised every 6 to 12 months in patients with clinically or radiologically isolated syndrome who do not fulfill the diagnostic criteria of MS but present risk factors for conversion to MS or paraclinical features of it.
Once the diagnosis is established, brain MRI is recommended for follow-up and for surveillance of drug safety. Spinal cord and optic nerve MRIs are desirable but optional in the follow-up of pwMS and are not required for drug surveillance. Spinal cord MRIs are required at follow-up for patients whose progression cannot be explained by brain MRI features, or who manifest with recurrent spinal cord symptoms, or have spinal cord comorbidities. In these cases, spinal cord MRI also may assist with treatment decisions. Similarly, optic nerve MRI is necessary during follow-up only when optic nerve comorbidities are suspected or when there is progression or reoccurrence of optic nerve–related symptoms.
Brain MRIs are recommended for monitoring drug effect yearly (or at longer intervals, after a few years of disease stability). Conversely, a repeat brain MRI is advised after 6 months if nonsymptomatic radiological disease activity is discovered on surveillance scans.
Abbreviated but more frequent serial brain MRI protocols (eg, every 3 to 4 months) are recommended for pwMS treated with natalizumab and at high risk of developing progressive multifocal leukoencephalopathy (eg, pwMS who are John Cunningham virus [JCV]–positive, and have been treated with natalizumabfor ≥ 18 months, have a JCV antibody index > 0.9, or have a history of immunosuppression). A similar approach is recommended for carryover cases, such as those with high JCV antibody index who are switched to other immunosuppressive treatments.
MRI Field, Scan Resolution, and Coverage
Both 1.5-Tesla (1.5-T) and 3-T scans are believed to be equally effective in imaging pwMS, providing that the 1.5-T scans are good quality. Although imaging at < 1.5 T is not recommended due to suboptimal disease detection, the use of scanners > 3 T is equally discouraged outside the supervision of trained investigators. Signal-to-noise ratio and resolution are key factors impacting scan quality, and their optimization is prioritized over the number of sequences in the updated 2021 consensus recommendations. For brain imaging, a resolution of 1 mm3 isotropic is preferred for 3-dimensional (3D) imaging and slice thickness ≤ 3 mm without gap (≤ 5 mm with 10-30% gaps for diffusion-weighted imaging only) is recommended for 2D sequences. Images should cover the entire brain and as much of the cervical spine as possible; images should be prescribed axial for 2D or reformatted axial oblique for 3D using the subcallosal plane as reference. For spine imaging, sites should aim at an in-plane resolution of 1 mm2; using sagittal slices ≤ 3 mm thick and axial slices ≤ 5 mm thick, both with no gap. Scans should cover the entire cervical and thoracolumbar region inclusive of the conus. For the optic nerve images, slices should be ≤ 2 or 3 mm thick with an in-plane resolution of 1 mm2. Images should be aligned to the orientation of the optic nerve and chiasms, both of which should be entirely covered.
Postgadolinium Images Use
The discovery of the higher sensitivity of post-gadolinium (Gd) T1-weighted (T1-w) MRI relative to high iodine (88.1 g I) computed tomography scans in demonstrating contrast-enhancing MS lesions has revolutionized the way clinicians diagnose and monitor this disease.11 However, in recent years the role of postcontrast MRI has been debated, considering the potential safety concerns secondary to Gd tissue deposition. For this reason, an intentionally more judicious use of postcontrast MRI is proposed by the consensus recommendations. At disease diagnosis, the use of Gd is advisable to (1) show disease dissemination in time; (2) differentiate the diagnosis based on the Gd pattern; (3) predict short-term disease activity; and (4) characterize activity in the setting of progression. When monitoring pwMS, the use of Gd may be useful in the first year of follow-up, particularly if in the setting of low potency medications or for patients for whom the detection of one or more active lesions would lead to a change in disease-modifying agents. Gd also should be used to first, confirm a clinical exacerbation (if needed); second, further characterize a lesion suggestive of progressive multifocal encephalopathy or monitor this disease over time; and third, monitor lesion burden change in patients with large confluent lesions, the count of which otherwise may be difficult.
MRI During Pregnancy and Lactation
The consensus recommendations state that Gd contrast–enhanced MRI is not absolutely contraindicated during pregnancy, although its use should be limited to strictly necessary situations, particularly those involving differential diagnosis, such as cerebral venous thrombosis or monitoring of possibly enlarging lesion burden. The use of Gd is not contraindicated during lactation, as only a small proportion (< 0.4%) passes into the breast milk, leading to an exposure to < 1% of the permitted Gd dose for neonates.12,13
Harmonizing MRI Reports
The consensus recommendations propose reporting the exact lesion count on T2-weighted (T2-w) images when lesions are < 20, or specifying if the number of T2 lesions is between 20 and 50, between 50 and 100, or uncountable, eg, confluent large lesions. Similarly, for the spinal cord, the consensus recommendations propose reporting the exact lesion count on T2-w images when lesions are < 10, or otherwise report that > 10 lesions are seen.
The VHA workgroup proposed reporting a mild, moderate, or severe T2-lesion burden for a T2-lesion count < 20, between 20 and 50, and > 50, respectively. For follow-up MRIs, notation should be made if there is any change in lesion number, indicating the number of new lesions whenever possible. At each timepoint, the presence of active lesions on postcontrast images should be accurately defined.
Dissemination and Implementation
To implement and disseminate these proposed recommendations within the VHA, a workgroup of neurologists and radiologists was formed in late 2020. A review and discussion of the importance of each of the proposed MRI protocols for veterans with MS was held along with possible modifications to balance the intent of meeting standards of care with resources of individual US Department of Veterans Affairs (VA) medical centers and veterans’ needs. The final protocol recommendations were agreed on by group consensus.
In general, this VHA workgroup felt that the current adopted MRI protocols in several VA medical centers (based on previously proposed recommendations) were similar to the ones newly proposed and that implementing changes to meet the 2021 criteria would not be a major challenge.14,15 Possible regional and nonregional barriers were discussed. The result of these discussions led to a modified version of what could be considered more stringent guidelines to accommodate medical centers that had fewer imaging resources. This modified protocol offers a viable alternative that allows for minimizing heterogeneities while recognizing the capabilities of the available scanner fleet and meeting the needs of specific centers or veterans. Finally, the workgroup recognized a fundamental obstacle toward this harmonization process in the heterogeneity in vendors and scanner field strength, factors that have previously limited implementation.
The guidelines and proposed changes were then presented to the VA National Radiology Program Office, examined, and discussed for consensus. No changes were felt to be needed, and the recommendation to implement these guidelines in MS regional programs, whenever possible, was deemed appropriate.
At this time, a focused communication plan has been implemented to diffuse the use of this protocol at MS regional programs in the MSCoE network. We will work iteratively with individual sites to practically apply the guidelines, learn about challenges, and work through them to optimize local implementation.
Conclusions
Standardized MRI protocols are fundamental for the care of veterans with MS. Mitigating interscan variabilities should be recognized as a priority by scientific and clinical expert committees. Several guidelines have been developed over the years to standardize MRI acquisition protocols and interpretations, while updating the same to the latest discoveries.4,5,8,14,15 The VHA has been historically committed to these international efforts, with the goal to excel in the care of veterans with MS by providing access to state-of-the-art technologies. To this end, the initial Consortium of MS Centers MRI protocol was implemented in several MSCoE VA Regional Program sites a decade ago.14 Efforts continue to update protocol recommendations as needed and to promote their dissemination across the VHA enterprise.
This commentary is part of the continuous effort of the MSCoE to align with contemporary guidelines, apply the highest scientific standards, and achieve consistent outcomes for veterans with MS. For more important details of the clinical scenarios when additional/optional sequences or scans can be acquired, we advise the reader to refer to the 2021 MAGNIMS-CMSC-NAIMS Consensus Recommendations on the Use of MRI in Patients With Multiple Sclerosis.8
1. Wallin MT, Culpepper WJ, Campbell JD, et al. The prevalence of MS in the United States: A population-based estimate using health claims data. Neurology. 2019;92(10):e1029-e1040. doi:10.1212/WNL.0000000000007035
2. Nelson LM, Wallin MT, Marrie RA, et al. A new way to estimate neurologic disease prevalence in the United States: Illustrated with MS. Neurology. 2019;92(10):469-480. doi:10.1212/WNL.0000000000007044
3. Culpepper WJ, Wallin MT, Magder LS, et al. VHA Multiple Sclerosis Surveillance Registry and its similarities to other contemporary multiple sclerosis cohorts. J Rehabil Res Dev. 2015;52(3):263-272. doi:10.1682/JRRD.2014.07.0172
4. Wattjes MP, Rovira À, Miller D, et al. Evidence-based guidelines: MAGNIMS consensus guidelines on the use of MRI in multiple sclerosis--establishing disease prognosis and monitoring patients. Nat Rev Neurol. 2015;11(10):597-606. doi:10.1038/nrneurol.2015.157
5. Rovira À, Wattjes MP, Tintoré M, et al. Evidence-based guidelines: MAGNIMS consensus guidelines on the use of MRI in multiple sclerosis-clinical implementation in the diagnostic process. Nat Rev Neurol. 2015;11(8):471-482. doi:10.1038/nrneurol.2015.106
6. Thompson AJ, Banwell BL, Barkhof F, et al. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018;17(2):162-173. doi:10.1016/S1474-4422(17)30470-2
7. Reich DS, Lucchinetti CF, Calabresi PA. Multiple sclerosis. N Engl J Med. 2018;378(2):169-180. doi:10.1056/NEJMra1401483
8. Wattjes MP, Ciccarelli O, Reich DS, et al. 2021 MAGNIMS-CMSC-NAIMS consensus recommendations on the use of MRI in patients with multiple sclerosis. Lancet Neurol. 2021;20(8):653-670. doi:10.1016/S1474-4422(21)00095-8
9. Saslow L, Li DKB, Halper J, et al. An International Standardized Magnetic Resonance Imaging Protocol for Diagnosis and Follow-up of Patients with Multiple Sclerosis: Advocacy, Dissemination, and Implementation Strategies. Int J MS Care. 2020;22(5):226-232. doi:10.7224/1537-2073.2020-094
10. Cameron MH, Haselkorn JK, Wallin MT. The Multiple Sclerosis Centers of Excellence: a model of excellence in the VA. Fed Pract. 2020;37(suppl 1):S6-S10.
11. Grossman RI, Gonzalez-Scarano F, Atlas SW, Galetta S, Silberberg DH. Multiple sclerosis: gadolinium enhancement in MR imaging. Radiology. 1986;161(3):721-725. doi:10.1148/radiology.161.3.3786722
12. European Society of Urogenital Radiology. ESUR guidelines on contrast agent, 10.0. March 2018. Accessed March 11, 2022. https://www.esur.org/fileadmin/content/2019/ESUR_Guidelines_10.0_Final_Version.pdf
13. Sundgren PC, Leander P. Is administration of gadolinium-based contrast media to pregnant women and small children justified?. J Magn Reson Imaging. 2011;34(4):750-757. doi:10.1002/jmri.22413
14. Simon JH, Li D, Traboulsee A, et al. Standardized MR imaging protocol for multiple sclerosis: Consortium of MS Centers consensus guidelines. AJNR Am J Neuroradiol. 2006;27(2):455-461.
15. Traboulsee A, Simon JH, Stone L, et al. Revised Recommendations of the Consortium of MS Centers Task Force for a Standardized MRI Protocol and Clinical Guidelines for the Diagnosis and Follow-Up of Multiple Sclerosis. AJNR Am J Neuroradiol. 2016;37(3):394-401. doi:10.3174/ajnr.A4539
1. Wallin MT, Culpepper WJ, Campbell JD, et al. The prevalence of MS in the United States: A population-based estimate using health claims data. Neurology. 2019;92(10):e1029-e1040. doi:10.1212/WNL.0000000000007035
2. Nelson LM, Wallin MT, Marrie RA, et al. A new way to estimate neurologic disease prevalence in the United States: Illustrated with MS. Neurology. 2019;92(10):469-480. doi:10.1212/WNL.0000000000007044
3. Culpepper WJ, Wallin MT, Magder LS, et al. VHA Multiple Sclerosis Surveillance Registry and its similarities to other contemporary multiple sclerosis cohorts. J Rehabil Res Dev. 2015;52(3):263-272. doi:10.1682/JRRD.2014.07.0172
4. Wattjes MP, Rovira À, Miller D, et al. Evidence-based guidelines: MAGNIMS consensus guidelines on the use of MRI in multiple sclerosis--establishing disease prognosis and monitoring patients. Nat Rev Neurol. 2015;11(10):597-606. doi:10.1038/nrneurol.2015.157
5. Rovira À, Wattjes MP, Tintoré M, et al. Evidence-based guidelines: MAGNIMS consensus guidelines on the use of MRI in multiple sclerosis-clinical implementation in the diagnostic process. Nat Rev Neurol. 2015;11(8):471-482. doi:10.1038/nrneurol.2015.106
6. Thompson AJ, Banwell BL, Barkhof F, et al. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018;17(2):162-173. doi:10.1016/S1474-4422(17)30470-2
7. Reich DS, Lucchinetti CF, Calabresi PA. Multiple sclerosis. N Engl J Med. 2018;378(2):169-180. doi:10.1056/NEJMra1401483
8. Wattjes MP, Ciccarelli O, Reich DS, et al. 2021 MAGNIMS-CMSC-NAIMS consensus recommendations on the use of MRI in patients with multiple sclerosis. Lancet Neurol. 2021;20(8):653-670. doi:10.1016/S1474-4422(21)00095-8
9. Saslow L, Li DKB, Halper J, et al. An International Standardized Magnetic Resonance Imaging Protocol for Diagnosis and Follow-up of Patients with Multiple Sclerosis: Advocacy, Dissemination, and Implementation Strategies. Int J MS Care. 2020;22(5):226-232. doi:10.7224/1537-2073.2020-094
10. Cameron MH, Haselkorn JK, Wallin MT. The Multiple Sclerosis Centers of Excellence: a model of excellence in the VA. Fed Pract. 2020;37(suppl 1):S6-S10.
11. Grossman RI, Gonzalez-Scarano F, Atlas SW, Galetta S, Silberberg DH. Multiple sclerosis: gadolinium enhancement in MR imaging. Radiology. 1986;161(3):721-725. doi:10.1148/radiology.161.3.3786722
12. European Society of Urogenital Radiology. ESUR guidelines on contrast agent, 10.0. March 2018. Accessed March 11, 2022. https://www.esur.org/fileadmin/content/2019/ESUR_Guidelines_10.0_Final_Version.pdf
13. Sundgren PC, Leander P. Is administration of gadolinium-based contrast media to pregnant women and small children justified?. J Magn Reson Imaging. 2011;34(4):750-757. doi:10.1002/jmri.22413
14. Simon JH, Li D, Traboulsee A, et al. Standardized MR imaging protocol for multiple sclerosis: Consortium of MS Centers consensus guidelines. AJNR Am J Neuroradiol. 2006;27(2):455-461.
15. Traboulsee A, Simon JH, Stone L, et al. Revised Recommendations of the Consortium of MS Centers Task Force for a Standardized MRI Protocol and Clinical Guidelines for the Diagnosis and Follow-Up of Multiple Sclerosis. AJNR Am J Neuroradiol. 2016;37(3):394-401. doi:10.3174/ajnr.A4539
Impact of Clinical Pharmacists on Access to Care in an Epilepsy Clinic
Epilepsy affects about 1% of the world population and is one of the most burdensome in terms of disability-adjusted life-years.1,2 Veterans are at increased risk of developing epilepsy when compared with the general population due to a variety of factors, including a higher frequency of traumatic brain injuries.3 A recent study from the US Centers for Disease Control and Prevention found that veterans who developed epilepsy during their service not only had a higher rate of mental and physical comorbidities, but also were 2.6 times more likely to die compared with veterans without epilepsy.4
Oral antiseizure medications (ASM) remain the mainstay of outpatient epilepsy treatment. Patterns of ASM use are complex within the US Department of Veterans Affairs (VA) patient population, particularly within patients at the Epilepsy Centers of Excellence (ECoE). For example, many patients are transitioned from older ASMs with greater adverse effects (AEs) to better tolerated newer generation ASMs or polytherapy regimens with complex pharmacokinetic profiles and drug interactions.5 Multiple factors are considered when choosing an ASM, including age, sex, epilepsy/seizure type, comorbidities, past medication trials, AEs, and drug interactions. The complex pharmacologic profile of both older and newer ASMs can confound the optimal management of epilepsy, and suboptimal management can lead to neurologic, psychological, physical, and social consequences, including sudden unexplained death in epilepsy.6,7 Psychiatric and behavioral problems are seen in up to 30% of patients with newly diagnosed epilepsy and 50% in those with pharmacoresistant epilepsy.8 Early screening, detection, and treatment for psychiatric comorbidities are an integral part of evidence-based care in epilepsy.
Being familiar with ASM AEs and comorbid conditions such as anxiety and depression can allow for quick identification and intervention to improve safety and quality of life. A 2007 population-based study found that measures of suicidality had a strong association with epilepsy, and performing mental health screenings, such as the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder Screener (GAD-7), and the Brief Irritability Test (BITe), can assist in identifying those patients at risk.9
During the COVID-19 pandemic, it has become increasingly clear that the health care sector is facing increasing pressure. The combination of patient acuity as well as critical health care professional (HCP) shortages may be of particular concern in certain specialty clinics where access to practitioners may already be limited. While this is a multifaceted problem, a pragmatic approach would be to increase the use of clinicians, such as clinical pharmacist practitioners (CPPs).
The William S. Middleton Memorial Veterans Hospital (WSMVH) in Madison, Wisconsin, is 1 of 17 VA ECoE sites. The VA ECoE provides high-quality, comprehensive epilepsy evaluation and care to veterans. In fiscal year (FY) 2020, the 17 sites provided care to 5544 veterans.10 The WSMVH epilepsy clinic sees about 400 veterans each year, receiving referrals from other VA medical centers, and prescribes ASMs, neuromodulation devices, and resective surgeries for epilepsy. The multidisciplinary team consists of an epileptologist, neurophysiology fellow, psychiatrist, nurse practitioner, CPP, and neurology residents. The WSMVH epilepsy clinic has employed CPPs at their highest level of clinical practice authority since 1991.
The WSMVH epilepsy clinic is open 4 hours once weekly. The clinic offers fourteen 30-minute appointment slots either in person or via telehealth. The epileptologist reviews patient charts prior to clinic and assigns each patient to the appropriate HCP. When making the determination to assign a patient to a CPP or pharmacy resident, the epileptologist considers current treatment response, mental health issues as well as medication-related concerns (eg, potential pharmacokinetic/pharmacodynamic interactions, AEs, adherence). The CPP can independently lead routine follow-up appointments and address acute as well as ongoing ASM therapy needs. Pharmacy residents are fully integrated into the clinic workflow, seeing assigned patients independently when appropriate but ensuring that each patient has access to either the epileptologist, CPP, or psychiatrist prior to finalizing the treatment plan. The epilepsy clinic rotation is required for first-year pharmacy residents and is an elective rotation in the second year.
While this level of service has been in place at WSMVH for more than 3 decades, a systematic evaluation on workload and clinical impact has not been conducted.11 The purpose of this analysis is to evaluate and quantify the breadth and impact of CPPs in this specialty setting. The WSMVH/University of Wisconsin-Madison institutional review board deemed this quality improvement study exempt from review.
Methods
This study was a single-center, retrospective, quality improvement project evaluating the impact of a CPP and clinical pharmacy resident have within the WSMVH epilepsy clinic on access to epilepsy care and medication management. The secondary outcomes were the types of interventions made by the CPP and mental health screening performed.
Between October 2019 and May 2021, 591 appointments were scheduled at the epilepsy clinic for medical, psychiatry, neurosurgery, and pharmacy residents; the epileptologist; CPP; psychiatrist; epilepsy fellow; or nurse practitioner. A retrospective chart review of the 446 patients seen by either a CPP or clinical pharmacy resident from October 2017 to June 2021 assessed pharmacist-led interventions made during each appointment. The following treatment interventions were assessed: medication initiations/discontinuations, dose changes, and nonpharmacologic interventions, including education. Additionally, any mental health screenings completed, consultations to other specialties placed, or laboratory tests ordered were documented.
Results
In the epilepsy clinic, 591 appointments were completed from October 1, 2019, to May 31, 2021. Of those appointments, 255 (43.2%) were led by pharmacists; 156 (26.4%) by pharmacy residents and 99 (16.8%) by CPPs (16.8%) (Table 1). Appointments held by other HCPs included 139 (23.5%) by nurse practitioner, 108 (18.3%) by the attending epileptologist, 41 (6.9%) by fellows, 22 (3.7%) by psychiatrists, 19 (3.2) by medical residents, 4 (0.7%) by neurosurgery residents, and 3 (0.5%) by psychiatry residents. Medication interventions included 55 (11.8%) dose increases, 52 (11.1%) medication initiations, and 32 (6.9%) dose decreases (Table 2). Mental health screening was conducted for 229 (49.1%) patients with PHQ-9, 225 (48.3%) with GAD-7, and 111 (23.8) with BITe. Some veterans received multiple screeners at a clinic visit, and others received none (most commonly during telephone follow-up appointments). The mean time spent with each patient was 27 minutes.
Discussion
Within the private sector, access to a neurologist or epileptologist is limited, and the US Health Resources and Services Administration National Center for Workforce Analysis projected that the demand for these specialists would exceed supply by 2025.12 In 2017, Kobau and colleagues found that only 1 in 10 adults with epilepsy saw a neurologist within the year, similar to previous years. As demand for specialty care exceeds capacity, additional members of the health care team are needed to ensure timely, effective, and safe care for patients with epilepsy.
One way to increase health care access is to use an interdisciplinary model of care, integrating pharmacists in the management of epilepsy in collaboration with other HCPs, a strategy that has been endorsed by the American Epilepsy Society (AES).13 As experts in pharmacotherapy, pharmacists can uniquely provide medication management for this complex disease as ASMs continue to remain the first-line treatment.14
In addition to increased demand for specialty services, there also is an increase in health care spending with a push to limit additional spending. In 2016, despite similar health care use in other high-income countries, health care costs are approximately twice as much in the US, mostly driven by prices of pharmaceuticals and administrative costs.15 Bond and colleagues evaluated 9380 Medicare patients with epilepsy or seizure disorders throughout US hospitals in 1998.16 They found that hospitals without pharmacist-managed ASM therapy had Medicare charges that were 11.2% higher than hospitals with pharmacist-managed therapy. Many factors contribute to the rise in cost, including an increase in laboratory charges for serum drug assays, legal litigations related to drug AEs, and an increase in hospital length of stay (about 14 additional days). Similar to pharmacist-managed anticoagulation, vancomycin, and aminoglycoside therapy, direct involvement of pharmacists with ASM management decreases health care costs.14
The American Academy of Neurology (AAN) developed 8 epilepsy quality measures: seizure type and frequency, etiology or epilepsy syndrome, review of electroencephalogram and imaging findings, counseling of ASM AEs, consideration of surgical treatment of intractable epilepsy, epilepsy-specific safety issues, and counseling for women of childbearing potential on contraception and pregnancy. These measures serve as a guide for evidence-based therapy and standardization of epilepsy care.17 Additionally, bone health, depression, and awareness of sudden unexplained death in epilepsy are increasing in importance when providing quality epilepsy care. Wasade and colleagues surveyed Michigan neurologists and found that only 37% of the respondents addressed ASM AEs at every clinic visit. They also found that just 26% of responding neurologists inquire about depression at every clinic visit, and 17% inquire only once a year. In our practice, screening for depression, suicidality, and counseling on ASM AEs are routinely provided by CPPs during each clinic visit.
Within the VA, CPPs are granted a scope of practice that allows them to perform comprehensive medication management, including but not limited to, prescribing medication regimens, ordering laboratory tests and diagnostic studies, and performing physical assessments. In our practice, the most common interventions made by CPPs were patient-focused counseling, bone health screening, mental health triage and referral, and ASM regimen adjustments. Assessment of ASM adherence also was noted to be an active area of CPP-patient engagement. These most common interventions align well with the AAN quality measures. It is now well recognized that nonadherence in patients with epilepsy not only can lead to loss of seizure control, but injury and death as well.18,19 Malek and colleagues found that patients with epilepsy who are nonadherent to their ASM regimens have a 3-times greater risk of mortality compared with those who were adherent.20 Adherence to the appropriate medication regimen in epilepsy can result in seizure-freedom in 70% of patients; therefore, exploring nonadherence in this population is crucial.21
The COVID-19 pandemic precipitated changes to the health care industry, including the heavy reliance on telehealth. Following the Wisconsin stay-at-home order on March 25, 2020, all nonessential face-to-face appointments at the WSMVH halted. The epilepsy clinic transitioned the majority of appointments to either telephone or VA Video Connect (VVC), which is a program on the veteran’s computer, tablet, or mobile device upon which the appointment is held. Although it became more challenging to obtain a mental health screening during virtual appointments and the frequency did decrease, patients were asked for a subjective report of their mood during each telephone or video appointment. The AES has since put forth a statement of support for the continuation of telehealth following the COVID-19 pandemic due to the flexibility that telehealth provides people with epilepsy. Additionally, the AES taskforce provided suggestions for continued pharmacist engagement within the epilepsy care team, including the triaging of patients, management of ASMs, and involvement in the delivery of telehealth.
Limitations
There is limited research available on the impact that a CPP has on medication management and access to care within an epilepsy clinic, especially those with a scope of practice. One limitation of this retrospective chart review is that the appropriateness of each medication intervention was not assessed; therefore, the impact of each intervention was not captured. Additionally, this single-site study of veterans may not reflect the general population. However, we believe that this model could be adapted to nonspecialty neurology practices. Of note the scope of this study did not include a comparison of medication interventions for the other specialties within the clinic.
Conclusions
The integration of a CPP and pharmacy residents into the WSMVH epilepsy clinic has allowed for greater and more timely access to care, managing 43.2% of all patients within the clinic during the study. Pharmacy scope of practice allows for collaborative autonomy with ASM adjustments and for the epileptologist time to focus on higher acuity cases. In settings where pharmacists do not have prescriptive status, medication management services, such as comprehensive medication reviews, identifying drug-drug and drug-disease interactions, recognizing adherence barriers, and medication safety surveillance, can still be performed to improve management of epilepsy.
Acknowledgments
Ellina S. Seckel, PharmD, BCACP, DPLA; Anita Kashyap, PharmD, BCACP; Brooke Keenan, NP; Leigh Heffner, PharmD
1. Stafstrom CE, Carmant L. Seizures and epilepsy: an overview for neuroscientists. Cold Spring Harb Perspect Med. 2015;5(6):a022426. doi:10.1101/cshperspect.a022426
2. GBD 2017 US Neurological Disorders Collaborators, Feigin VL, Vos T, et al. Burden of neurological disorders across the US from 1990-2017: a global burden of disease study. JAMA Neurol. 2021;78(2):165-176. doi:10.1001/jamaneurol.2020.4152
3. Rehman R, Kelly PR, Husain AM, Tran TT. Characteristics of veterans diagnosed with seizures within Veterans Health Administration. J Rehabil Res Dev. 2015;52(7):751-762. doi:10.1682/JRRD.2014.10.0241
4. Pugh MJ, Van Cott AC, Amuan M, et al. Epilepsy among Iraq and Afghanistan War veterans - United States, 2002-2015. MMWR Morb Mortal Wkly Rep. 2016;65(44):1224-1227. doi:10.15585/mmwr.mm6544a5
5. Rohde NN, Baca CB, Van Cott AC, Parko KL, Amuan ME, Pugh MJ. Antiepileptic drug prescribing patterns in Iraq and Afghanistan war veterans with epilepsy. Epilepsy Behav. 2015;46:133-139. doi:10.1016/j.yebeh.2015.03.027
6. Laxer KD, Trinka E, Hirsch LJ, et al. The consequences of refractory epilepsy and its treatment. Epilepsy Behav. 2014;37:59-70. doi:10.1016/j.yebeh.2014.05.031
7. Devinsky O, Hesdorffer DC, Thurman DJ, Lhatoo S, Richerson G. Sudden unexpected death in epilepsy: epidemiology, mechanisms, and prevention. Lancet Neurol. 2016;15(10):1075-1088. doi:10.1016/S1474-4422(16)30158-2
8. Tolchin B, Hirsch LJ, LaFrance WC Jr. Neuropsychiatric aspects of epilepsy. Psychiatr Clin North Am. 2020;43(2):275-290. doi:10.1016/j.psc.2020.02.002
9. Rai D, Kerr MP, McManus S, Jordanova V, Lewis G, Brugha TS. Epilepsy and psychiatric comorbidity: a nationally representative population-based study. Epilepsia. 2012;53(6):1095-1103. doi:10.1111/j.1528-1167.2012.03500.x
10. US Department of Veterans Affairs. Epilepsy Centers of Excellence. Annual report fiscal year 2020. Accessed March 11, 2022. https://www.epilepsy.va.gov/docs/ECoENational_AnnualReportFY20_web_508c.pdf
11. Fogg A, Staufenberg EF, Small I, Bhattacharya D. An exploratory study of primary care pharmacist-led epilepsy consultations. Int J Pharm Pract. 2012;20(5):294-302. doi:10.1111/j.2042-7174.2012.00207.x
12. Kobau R, Sapkota S, Pennell PB, Croft JB. Epilepsy by the numbers - from the US Centers for Disease Control and Prevention: six in 10 adults with active epilepsy saw a neurologist or epilepsy specialist in the past year, United States, 2017. Epilepsy Behav. 2020;112:107348. doi:10.1016/j.yebeh.2020.107348
13. Shawahna R. Development of key performance indicators to capture in measuring the impact of pharmacists in caring for patients with epilepsy in primary healthcare: A Delphi consensual study. Epilepsy Behav. 2019;98(pt A):129-138. doi:10.1016/j.yebeh.2019.07.034
14. Asadi-Pooya AA, Beniczky S, Rubboli G, Sperling MR, Rampp S, Perucca E. A pragmatic algorithm to select appropriate antiseizure medications in patients with epilepsy. Epilepsia. 2020;61(8):1668-1677. doi:10.1111/epi.16610
15. Papanicolas I, Woskie LR, Jha AK. Health Care Spending in the United States and Other High-Income Countries. JAMA. 2018;319(10):1024-1039. doi:10.1001/jama.2018.1150
16. Bond CA, Raehl CL. Clinical and economic outcomes of pharmacist-managed aminoglycoside or vancomycin therapy. Am J Health Syst Pharm. 2005;62(15):1596-1605. doi:10.2146/ajhp040555
17. Wasade VS, Spanaki M, Iyengar R, Barkley GL, Schultz L. AAN Epilepsy Quality Measures in clinical practice: a survey of neurologists. Epilepsy Behav. 2012;24(4):468-473. doi:10.1016/j.yebeh.2012.05.017
18. Hovinga CA, Asato MR, Manjunath R, et al. Association of non-adherence to antiepileptic drugs and seizures, quality of life, and productivity: survey of patients with epilepsy and physicians. Epilepsy Behav. 2008;13(2):316-322. doi:10.1016/j.yebeh.2008.03.009
19. Faught RE, Weiner JR, Guérin A, Cunnington MC, Duh MS. Impact of nonadherence to antiepileptic drugs on health care utilization and costs: findings from the RANSOM study. Epilepsia. 2009;50(3):501-509. doi:10.1111/j.1528-1167.2008.01794.x
20. Malek N, Heath CA, Greene J. A review of medication adherence in people with epilepsy. Acta Neurol Scand. 2017;135(5):507-515. doi:10.1111/ane.12703
21. O’ Rourke G, O’ Brien JJ. Identifying the barriers to antiepileptic drug adherence among adults with epilepsy. Seizure. 2017;45:160-168. doi:10.1016/j.seizure.2016.12.006
Epilepsy affects about 1% of the world population and is one of the most burdensome in terms of disability-adjusted life-years.1,2 Veterans are at increased risk of developing epilepsy when compared with the general population due to a variety of factors, including a higher frequency of traumatic brain injuries.3 A recent study from the US Centers for Disease Control and Prevention found that veterans who developed epilepsy during their service not only had a higher rate of mental and physical comorbidities, but also were 2.6 times more likely to die compared with veterans without epilepsy.4
Oral antiseizure medications (ASM) remain the mainstay of outpatient epilepsy treatment. Patterns of ASM use are complex within the US Department of Veterans Affairs (VA) patient population, particularly within patients at the Epilepsy Centers of Excellence (ECoE). For example, many patients are transitioned from older ASMs with greater adverse effects (AEs) to better tolerated newer generation ASMs or polytherapy regimens with complex pharmacokinetic profiles and drug interactions.5 Multiple factors are considered when choosing an ASM, including age, sex, epilepsy/seizure type, comorbidities, past medication trials, AEs, and drug interactions. The complex pharmacologic profile of both older and newer ASMs can confound the optimal management of epilepsy, and suboptimal management can lead to neurologic, psychological, physical, and social consequences, including sudden unexplained death in epilepsy.6,7 Psychiatric and behavioral problems are seen in up to 30% of patients with newly diagnosed epilepsy and 50% in those with pharmacoresistant epilepsy.8 Early screening, detection, and treatment for psychiatric comorbidities are an integral part of evidence-based care in epilepsy.
Being familiar with ASM AEs and comorbid conditions such as anxiety and depression can allow for quick identification and intervention to improve safety and quality of life. A 2007 population-based study found that measures of suicidality had a strong association with epilepsy, and performing mental health screenings, such as the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder Screener (GAD-7), and the Brief Irritability Test (BITe), can assist in identifying those patients at risk.9
During the COVID-19 pandemic, it has become increasingly clear that the health care sector is facing increasing pressure. The combination of patient acuity as well as critical health care professional (HCP) shortages may be of particular concern in certain specialty clinics where access to practitioners may already be limited. While this is a multifaceted problem, a pragmatic approach would be to increase the use of clinicians, such as clinical pharmacist practitioners (CPPs).
The William S. Middleton Memorial Veterans Hospital (WSMVH) in Madison, Wisconsin, is 1 of 17 VA ECoE sites. The VA ECoE provides high-quality, comprehensive epilepsy evaluation and care to veterans. In fiscal year (FY) 2020, the 17 sites provided care to 5544 veterans.10 The WSMVH epilepsy clinic sees about 400 veterans each year, receiving referrals from other VA medical centers, and prescribes ASMs, neuromodulation devices, and resective surgeries for epilepsy. The multidisciplinary team consists of an epileptologist, neurophysiology fellow, psychiatrist, nurse practitioner, CPP, and neurology residents. The WSMVH epilepsy clinic has employed CPPs at their highest level of clinical practice authority since 1991.
The WSMVH epilepsy clinic is open 4 hours once weekly. The clinic offers fourteen 30-minute appointment slots either in person or via telehealth. The epileptologist reviews patient charts prior to clinic and assigns each patient to the appropriate HCP. When making the determination to assign a patient to a CPP or pharmacy resident, the epileptologist considers current treatment response, mental health issues as well as medication-related concerns (eg, potential pharmacokinetic/pharmacodynamic interactions, AEs, adherence). The CPP can independently lead routine follow-up appointments and address acute as well as ongoing ASM therapy needs. Pharmacy residents are fully integrated into the clinic workflow, seeing assigned patients independently when appropriate but ensuring that each patient has access to either the epileptologist, CPP, or psychiatrist prior to finalizing the treatment plan. The epilepsy clinic rotation is required for first-year pharmacy residents and is an elective rotation in the second year.
While this level of service has been in place at WSMVH for more than 3 decades, a systematic evaluation on workload and clinical impact has not been conducted.11 The purpose of this analysis is to evaluate and quantify the breadth and impact of CPPs in this specialty setting. The WSMVH/University of Wisconsin-Madison institutional review board deemed this quality improvement study exempt from review.
Methods
This study was a single-center, retrospective, quality improvement project evaluating the impact of a CPP and clinical pharmacy resident have within the WSMVH epilepsy clinic on access to epilepsy care and medication management. The secondary outcomes were the types of interventions made by the CPP and mental health screening performed.
Between October 2019 and May 2021, 591 appointments were scheduled at the epilepsy clinic for medical, psychiatry, neurosurgery, and pharmacy residents; the epileptologist; CPP; psychiatrist; epilepsy fellow; or nurse practitioner. A retrospective chart review of the 446 patients seen by either a CPP or clinical pharmacy resident from October 2017 to June 2021 assessed pharmacist-led interventions made during each appointment. The following treatment interventions were assessed: medication initiations/discontinuations, dose changes, and nonpharmacologic interventions, including education. Additionally, any mental health screenings completed, consultations to other specialties placed, or laboratory tests ordered were documented.
Results
In the epilepsy clinic, 591 appointments were completed from October 1, 2019, to May 31, 2021. Of those appointments, 255 (43.2%) were led by pharmacists; 156 (26.4%) by pharmacy residents and 99 (16.8%) by CPPs (16.8%) (Table 1). Appointments held by other HCPs included 139 (23.5%) by nurse practitioner, 108 (18.3%) by the attending epileptologist, 41 (6.9%) by fellows, 22 (3.7%) by psychiatrists, 19 (3.2) by medical residents, 4 (0.7%) by neurosurgery residents, and 3 (0.5%) by psychiatry residents. Medication interventions included 55 (11.8%) dose increases, 52 (11.1%) medication initiations, and 32 (6.9%) dose decreases (Table 2). Mental health screening was conducted for 229 (49.1%) patients with PHQ-9, 225 (48.3%) with GAD-7, and 111 (23.8) with BITe. Some veterans received multiple screeners at a clinic visit, and others received none (most commonly during telephone follow-up appointments). The mean time spent with each patient was 27 minutes.
Discussion
Within the private sector, access to a neurologist or epileptologist is limited, and the US Health Resources and Services Administration National Center for Workforce Analysis projected that the demand for these specialists would exceed supply by 2025.12 In 2017, Kobau and colleagues found that only 1 in 10 adults with epilepsy saw a neurologist within the year, similar to previous years. As demand for specialty care exceeds capacity, additional members of the health care team are needed to ensure timely, effective, and safe care for patients with epilepsy.
One way to increase health care access is to use an interdisciplinary model of care, integrating pharmacists in the management of epilepsy in collaboration with other HCPs, a strategy that has been endorsed by the American Epilepsy Society (AES).13 As experts in pharmacotherapy, pharmacists can uniquely provide medication management for this complex disease as ASMs continue to remain the first-line treatment.14
In addition to increased demand for specialty services, there also is an increase in health care spending with a push to limit additional spending. In 2016, despite similar health care use in other high-income countries, health care costs are approximately twice as much in the US, mostly driven by prices of pharmaceuticals and administrative costs.15 Bond and colleagues evaluated 9380 Medicare patients with epilepsy or seizure disorders throughout US hospitals in 1998.16 They found that hospitals without pharmacist-managed ASM therapy had Medicare charges that were 11.2% higher than hospitals with pharmacist-managed therapy. Many factors contribute to the rise in cost, including an increase in laboratory charges for serum drug assays, legal litigations related to drug AEs, and an increase in hospital length of stay (about 14 additional days). Similar to pharmacist-managed anticoagulation, vancomycin, and aminoglycoside therapy, direct involvement of pharmacists with ASM management decreases health care costs.14
The American Academy of Neurology (AAN) developed 8 epilepsy quality measures: seizure type and frequency, etiology or epilepsy syndrome, review of electroencephalogram and imaging findings, counseling of ASM AEs, consideration of surgical treatment of intractable epilepsy, epilepsy-specific safety issues, and counseling for women of childbearing potential on contraception and pregnancy. These measures serve as a guide for evidence-based therapy and standardization of epilepsy care.17 Additionally, bone health, depression, and awareness of sudden unexplained death in epilepsy are increasing in importance when providing quality epilepsy care. Wasade and colleagues surveyed Michigan neurologists and found that only 37% of the respondents addressed ASM AEs at every clinic visit. They also found that just 26% of responding neurologists inquire about depression at every clinic visit, and 17% inquire only once a year. In our practice, screening for depression, suicidality, and counseling on ASM AEs are routinely provided by CPPs during each clinic visit.
Within the VA, CPPs are granted a scope of practice that allows them to perform comprehensive medication management, including but not limited to, prescribing medication regimens, ordering laboratory tests and diagnostic studies, and performing physical assessments. In our practice, the most common interventions made by CPPs were patient-focused counseling, bone health screening, mental health triage and referral, and ASM regimen adjustments. Assessment of ASM adherence also was noted to be an active area of CPP-patient engagement. These most common interventions align well with the AAN quality measures. It is now well recognized that nonadherence in patients with epilepsy not only can lead to loss of seizure control, but injury and death as well.18,19 Malek and colleagues found that patients with epilepsy who are nonadherent to their ASM regimens have a 3-times greater risk of mortality compared with those who were adherent.20 Adherence to the appropriate medication regimen in epilepsy can result in seizure-freedom in 70% of patients; therefore, exploring nonadherence in this population is crucial.21
The COVID-19 pandemic precipitated changes to the health care industry, including the heavy reliance on telehealth. Following the Wisconsin stay-at-home order on March 25, 2020, all nonessential face-to-face appointments at the WSMVH halted. The epilepsy clinic transitioned the majority of appointments to either telephone or VA Video Connect (VVC), which is a program on the veteran’s computer, tablet, or mobile device upon which the appointment is held. Although it became more challenging to obtain a mental health screening during virtual appointments and the frequency did decrease, patients were asked for a subjective report of their mood during each telephone or video appointment. The AES has since put forth a statement of support for the continuation of telehealth following the COVID-19 pandemic due to the flexibility that telehealth provides people with epilepsy. Additionally, the AES taskforce provided suggestions for continued pharmacist engagement within the epilepsy care team, including the triaging of patients, management of ASMs, and involvement in the delivery of telehealth.
Limitations
There is limited research available on the impact that a CPP has on medication management and access to care within an epilepsy clinic, especially those with a scope of practice. One limitation of this retrospective chart review is that the appropriateness of each medication intervention was not assessed; therefore, the impact of each intervention was not captured. Additionally, this single-site study of veterans may not reflect the general population. However, we believe that this model could be adapted to nonspecialty neurology practices. Of note the scope of this study did not include a comparison of medication interventions for the other specialties within the clinic.
Conclusions
The integration of a CPP and pharmacy residents into the WSMVH epilepsy clinic has allowed for greater and more timely access to care, managing 43.2% of all patients within the clinic during the study. Pharmacy scope of practice allows for collaborative autonomy with ASM adjustments and for the epileptologist time to focus on higher acuity cases. In settings where pharmacists do not have prescriptive status, medication management services, such as comprehensive medication reviews, identifying drug-drug and drug-disease interactions, recognizing adherence barriers, and medication safety surveillance, can still be performed to improve management of epilepsy.
Acknowledgments
Ellina S. Seckel, PharmD, BCACP, DPLA; Anita Kashyap, PharmD, BCACP; Brooke Keenan, NP; Leigh Heffner, PharmD
Epilepsy affects about 1% of the world population and is one of the most burdensome in terms of disability-adjusted life-years.1,2 Veterans are at increased risk of developing epilepsy when compared with the general population due to a variety of factors, including a higher frequency of traumatic brain injuries.3 A recent study from the US Centers for Disease Control and Prevention found that veterans who developed epilepsy during their service not only had a higher rate of mental and physical comorbidities, but also were 2.6 times more likely to die compared with veterans without epilepsy.4
Oral antiseizure medications (ASM) remain the mainstay of outpatient epilepsy treatment. Patterns of ASM use are complex within the US Department of Veterans Affairs (VA) patient population, particularly within patients at the Epilepsy Centers of Excellence (ECoE). For example, many patients are transitioned from older ASMs with greater adverse effects (AEs) to better tolerated newer generation ASMs or polytherapy regimens with complex pharmacokinetic profiles and drug interactions.5 Multiple factors are considered when choosing an ASM, including age, sex, epilepsy/seizure type, comorbidities, past medication trials, AEs, and drug interactions. The complex pharmacologic profile of both older and newer ASMs can confound the optimal management of epilepsy, and suboptimal management can lead to neurologic, psychological, physical, and social consequences, including sudden unexplained death in epilepsy.6,7 Psychiatric and behavioral problems are seen in up to 30% of patients with newly diagnosed epilepsy and 50% in those with pharmacoresistant epilepsy.8 Early screening, detection, and treatment for psychiatric comorbidities are an integral part of evidence-based care in epilepsy.
Being familiar with ASM AEs and comorbid conditions such as anxiety and depression can allow for quick identification and intervention to improve safety and quality of life. A 2007 population-based study found that measures of suicidality had a strong association with epilepsy, and performing mental health screenings, such as the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder Screener (GAD-7), and the Brief Irritability Test (BITe), can assist in identifying those patients at risk.9
During the COVID-19 pandemic, it has become increasingly clear that the health care sector is facing increasing pressure. The combination of patient acuity as well as critical health care professional (HCP) shortages may be of particular concern in certain specialty clinics where access to practitioners may already be limited. While this is a multifaceted problem, a pragmatic approach would be to increase the use of clinicians, such as clinical pharmacist practitioners (CPPs).
The William S. Middleton Memorial Veterans Hospital (WSMVH) in Madison, Wisconsin, is 1 of 17 VA ECoE sites. The VA ECoE provides high-quality, comprehensive epilepsy evaluation and care to veterans. In fiscal year (FY) 2020, the 17 sites provided care to 5544 veterans.10 The WSMVH epilepsy clinic sees about 400 veterans each year, receiving referrals from other VA medical centers, and prescribes ASMs, neuromodulation devices, and resective surgeries for epilepsy. The multidisciplinary team consists of an epileptologist, neurophysiology fellow, psychiatrist, nurse practitioner, CPP, and neurology residents. The WSMVH epilepsy clinic has employed CPPs at their highest level of clinical practice authority since 1991.
The WSMVH epilepsy clinic is open 4 hours once weekly. The clinic offers fourteen 30-minute appointment slots either in person or via telehealth. The epileptologist reviews patient charts prior to clinic and assigns each patient to the appropriate HCP. When making the determination to assign a patient to a CPP or pharmacy resident, the epileptologist considers current treatment response, mental health issues as well as medication-related concerns (eg, potential pharmacokinetic/pharmacodynamic interactions, AEs, adherence). The CPP can independently lead routine follow-up appointments and address acute as well as ongoing ASM therapy needs. Pharmacy residents are fully integrated into the clinic workflow, seeing assigned patients independently when appropriate but ensuring that each patient has access to either the epileptologist, CPP, or psychiatrist prior to finalizing the treatment plan. The epilepsy clinic rotation is required for first-year pharmacy residents and is an elective rotation in the second year.
While this level of service has been in place at WSMVH for more than 3 decades, a systematic evaluation on workload and clinical impact has not been conducted.11 The purpose of this analysis is to evaluate and quantify the breadth and impact of CPPs in this specialty setting. The WSMVH/University of Wisconsin-Madison institutional review board deemed this quality improvement study exempt from review.
Methods
This study was a single-center, retrospective, quality improvement project evaluating the impact of a CPP and clinical pharmacy resident have within the WSMVH epilepsy clinic on access to epilepsy care and medication management. The secondary outcomes were the types of interventions made by the CPP and mental health screening performed.
Between October 2019 and May 2021, 591 appointments were scheduled at the epilepsy clinic for medical, psychiatry, neurosurgery, and pharmacy residents; the epileptologist; CPP; psychiatrist; epilepsy fellow; or nurse practitioner. A retrospective chart review of the 446 patients seen by either a CPP or clinical pharmacy resident from October 2017 to June 2021 assessed pharmacist-led interventions made during each appointment. The following treatment interventions were assessed: medication initiations/discontinuations, dose changes, and nonpharmacologic interventions, including education. Additionally, any mental health screenings completed, consultations to other specialties placed, or laboratory tests ordered were documented.
Results
In the epilepsy clinic, 591 appointments were completed from October 1, 2019, to May 31, 2021. Of those appointments, 255 (43.2%) were led by pharmacists; 156 (26.4%) by pharmacy residents and 99 (16.8%) by CPPs (16.8%) (Table 1). Appointments held by other HCPs included 139 (23.5%) by nurse practitioner, 108 (18.3%) by the attending epileptologist, 41 (6.9%) by fellows, 22 (3.7%) by psychiatrists, 19 (3.2) by medical residents, 4 (0.7%) by neurosurgery residents, and 3 (0.5%) by psychiatry residents. Medication interventions included 55 (11.8%) dose increases, 52 (11.1%) medication initiations, and 32 (6.9%) dose decreases (Table 2). Mental health screening was conducted for 229 (49.1%) patients with PHQ-9, 225 (48.3%) with GAD-7, and 111 (23.8) with BITe. Some veterans received multiple screeners at a clinic visit, and others received none (most commonly during telephone follow-up appointments). The mean time spent with each patient was 27 minutes.
Discussion
Within the private sector, access to a neurologist or epileptologist is limited, and the US Health Resources and Services Administration National Center for Workforce Analysis projected that the demand for these specialists would exceed supply by 2025.12 In 2017, Kobau and colleagues found that only 1 in 10 adults with epilepsy saw a neurologist within the year, similar to previous years. As demand for specialty care exceeds capacity, additional members of the health care team are needed to ensure timely, effective, and safe care for patients with epilepsy.
One way to increase health care access is to use an interdisciplinary model of care, integrating pharmacists in the management of epilepsy in collaboration with other HCPs, a strategy that has been endorsed by the American Epilepsy Society (AES).13 As experts in pharmacotherapy, pharmacists can uniquely provide medication management for this complex disease as ASMs continue to remain the first-line treatment.14
In addition to increased demand for specialty services, there also is an increase in health care spending with a push to limit additional spending. In 2016, despite similar health care use in other high-income countries, health care costs are approximately twice as much in the US, mostly driven by prices of pharmaceuticals and administrative costs.15 Bond and colleagues evaluated 9380 Medicare patients with epilepsy or seizure disorders throughout US hospitals in 1998.16 They found that hospitals without pharmacist-managed ASM therapy had Medicare charges that were 11.2% higher than hospitals with pharmacist-managed therapy. Many factors contribute to the rise in cost, including an increase in laboratory charges for serum drug assays, legal litigations related to drug AEs, and an increase in hospital length of stay (about 14 additional days). Similar to pharmacist-managed anticoagulation, vancomycin, and aminoglycoside therapy, direct involvement of pharmacists with ASM management decreases health care costs.14
The American Academy of Neurology (AAN) developed 8 epilepsy quality measures: seizure type and frequency, etiology or epilepsy syndrome, review of electroencephalogram and imaging findings, counseling of ASM AEs, consideration of surgical treatment of intractable epilepsy, epilepsy-specific safety issues, and counseling for women of childbearing potential on contraception and pregnancy. These measures serve as a guide for evidence-based therapy and standardization of epilepsy care.17 Additionally, bone health, depression, and awareness of sudden unexplained death in epilepsy are increasing in importance when providing quality epilepsy care. Wasade and colleagues surveyed Michigan neurologists and found that only 37% of the respondents addressed ASM AEs at every clinic visit. They also found that just 26% of responding neurologists inquire about depression at every clinic visit, and 17% inquire only once a year. In our practice, screening for depression, suicidality, and counseling on ASM AEs are routinely provided by CPPs during each clinic visit.
Within the VA, CPPs are granted a scope of practice that allows them to perform comprehensive medication management, including but not limited to, prescribing medication regimens, ordering laboratory tests and diagnostic studies, and performing physical assessments. In our practice, the most common interventions made by CPPs were patient-focused counseling, bone health screening, mental health triage and referral, and ASM regimen adjustments. Assessment of ASM adherence also was noted to be an active area of CPP-patient engagement. These most common interventions align well with the AAN quality measures. It is now well recognized that nonadherence in patients with epilepsy not only can lead to loss of seizure control, but injury and death as well.18,19 Malek and colleagues found that patients with epilepsy who are nonadherent to their ASM regimens have a 3-times greater risk of mortality compared with those who were adherent.20 Adherence to the appropriate medication regimen in epilepsy can result in seizure-freedom in 70% of patients; therefore, exploring nonadherence in this population is crucial.21
The COVID-19 pandemic precipitated changes to the health care industry, including the heavy reliance on telehealth. Following the Wisconsin stay-at-home order on March 25, 2020, all nonessential face-to-face appointments at the WSMVH halted. The epilepsy clinic transitioned the majority of appointments to either telephone or VA Video Connect (VVC), which is a program on the veteran’s computer, tablet, or mobile device upon which the appointment is held. Although it became more challenging to obtain a mental health screening during virtual appointments and the frequency did decrease, patients were asked for a subjective report of their mood during each telephone or video appointment. The AES has since put forth a statement of support for the continuation of telehealth following the COVID-19 pandemic due to the flexibility that telehealth provides people with epilepsy. Additionally, the AES taskforce provided suggestions for continued pharmacist engagement within the epilepsy care team, including the triaging of patients, management of ASMs, and involvement in the delivery of telehealth.
Limitations
There is limited research available on the impact that a CPP has on medication management and access to care within an epilepsy clinic, especially those with a scope of practice. One limitation of this retrospective chart review is that the appropriateness of each medication intervention was not assessed; therefore, the impact of each intervention was not captured. Additionally, this single-site study of veterans may not reflect the general population. However, we believe that this model could be adapted to nonspecialty neurology practices. Of note the scope of this study did not include a comparison of medication interventions for the other specialties within the clinic.
Conclusions
The integration of a CPP and pharmacy residents into the WSMVH epilepsy clinic has allowed for greater and more timely access to care, managing 43.2% of all patients within the clinic during the study. Pharmacy scope of practice allows for collaborative autonomy with ASM adjustments and for the epileptologist time to focus on higher acuity cases. In settings where pharmacists do not have prescriptive status, medication management services, such as comprehensive medication reviews, identifying drug-drug and drug-disease interactions, recognizing adherence barriers, and medication safety surveillance, can still be performed to improve management of epilepsy.
Acknowledgments
Ellina S. Seckel, PharmD, BCACP, DPLA; Anita Kashyap, PharmD, BCACP; Brooke Keenan, NP; Leigh Heffner, PharmD
1. Stafstrom CE, Carmant L. Seizures and epilepsy: an overview for neuroscientists. Cold Spring Harb Perspect Med. 2015;5(6):a022426. doi:10.1101/cshperspect.a022426
2. GBD 2017 US Neurological Disorders Collaborators, Feigin VL, Vos T, et al. Burden of neurological disorders across the US from 1990-2017: a global burden of disease study. JAMA Neurol. 2021;78(2):165-176. doi:10.1001/jamaneurol.2020.4152
3. Rehman R, Kelly PR, Husain AM, Tran TT. Characteristics of veterans diagnosed with seizures within Veterans Health Administration. J Rehabil Res Dev. 2015;52(7):751-762. doi:10.1682/JRRD.2014.10.0241
4. Pugh MJ, Van Cott AC, Amuan M, et al. Epilepsy among Iraq and Afghanistan War veterans - United States, 2002-2015. MMWR Morb Mortal Wkly Rep. 2016;65(44):1224-1227. doi:10.15585/mmwr.mm6544a5
5. Rohde NN, Baca CB, Van Cott AC, Parko KL, Amuan ME, Pugh MJ. Antiepileptic drug prescribing patterns in Iraq and Afghanistan war veterans with epilepsy. Epilepsy Behav. 2015;46:133-139. doi:10.1016/j.yebeh.2015.03.027
6. Laxer KD, Trinka E, Hirsch LJ, et al. The consequences of refractory epilepsy and its treatment. Epilepsy Behav. 2014;37:59-70. doi:10.1016/j.yebeh.2014.05.031
7. Devinsky O, Hesdorffer DC, Thurman DJ, Lhatoo S, Richerson G. Sudden unexpected death in epilepsy: epidemiology, mechanisms, and prevention. Lancet Neurol. 2016;15(10):1075-1088. doi:10.1016/S1474-4422(16)30158-2
8. Tolchin B, Hirsch LJ, LaFrance WC Jr. Neuropsychiatric aspects of epilepsy. Psychiatr Clin North Am. 2020;43(2):275-290. doi:10.1016/j.psc.2020.02.002
9. Rai D, Kerr MP, McManus S, Jordanova V, Lewis G, Brugha TS. Epilepsy and psychiatric comorbidity: a nationally representative population-based study. Epilepsia. 2012;53(6):1095-1103. doi:10.1111/j.1528-1167.2012.03500.x
10. US Department of Veterans Affairs. Epilepsy Centers of Excellence. Annual report fiscal year 2020. Accessed March 11, 2022. https://www.epilepsy.va.gov/docs/ECoENational_AnnualReportFY20_web_508c.pdf
11. Fogg A, Staufenberg EF, Small I, Bhattacharya D. An exploratory study of primary care pharmacist-led epilepsy consultations. Int J Pharm Pract. 2012;20(5):294-302. doi:10.1111/j.2042-7174.2012.00207.x
12. Kobau R, Sapkota S, Pennell PB, Croft JB. Epilepsy by the numbers - from the US Centers for Disease Control and Prevention: six in 10 adults with active epilepsy saw a neurologist or epilepsy specialist in the past year, United States, 2017. Epilepsy Behav. 2020;112:107348. doi:10.1016/j.yebeh.2020.107348
13. Shawahna R. Development of key performance indicators to capture in measuring the impact of pharmacists in caring for patients with epilepsy in primary healthcare: A Delphi consensual study. Epilepsy Behav. 2019;98(pt A):129-138. doi:10.1016/j.yebeh.2019.07.034
14. Asadi-Pooya AA, Beniczky S, Rubboli G, Sperling MR, Rampp S, Perucca E. A pragmatic algorithm to select appropriate antiseizure medications in patients with epilepsy. Epilepsia. 2020;61(8):1668-1677. doi:10.1111/epi.16610
15. Papanicolas I, Woskie LR, Jha AK. Health Care Spending in the United States and Other High-Income Countries. JAMA. 2018;319(10):1024-1039. doi:10.1001/jama.2018.1150
16. Bond CA, Raehl CL. Clinical and economic outcomes of pharmacist-managed aminoglycoside or vancomycin therapy. Am J Health Syst Pharm. 2005;62(15):1596-1605. doi:10.2146/ajhp040555
17. Wasade VS, Spanaki M, Iyengar R, Barkley GL, Schultz L. AAN Epilepsy Quality Measures in clinical practice: a survey of neurologists. Epilepsy Behav. 2012;24(4):468-473. doi:10.1016/j.yebeh.2012.05.017
18. Hovinga CA, Asato MR, Manjunath R, et al. Association of non-adherence to antiepileptic drugs and seizures, quality of life, and productivity: survey of patients with epilepsy and physicians. Epilepsy Behav. 2008;13(2):316-322. doi:10.1016/j.yebeh.2008.03.009
19. Faught RE, Weiner JR, Guérin A, Cunnington MC, Duh MS. Impact of nonadherence to antiepileptic drugs on health care utilization and costs: findings from the RANSOM study. Epilepsia. 2009;50(3):501-509. doi:10.1111/j.1528-1167.2008.01794.x
20. Malek N, Heath CA, Greene J. A review of medication adherence in people with epilepsy. Acta Neurol Scand. 2017;135(5):507-515. doi:10.1111/ane.12703
21. O’ Rourke G, O’ Brien JJ. Identifying the barriers to antiepileptic drug adherence among adults with epilepsy. Seizure. 2017;45:160-168. doi:10.1016/j.seizure.2016.12.006
1. Stafstrom CE, Carmant L. Seizures and epilepsy: an overview for neuroscientists. Cold Spring Harb Perspect Med. 2015;5(6):a022426. doi:10.1101/cshperspect.a022426
2. GBD 2017 US Neurological Disorders Collaborators, Feigin VL, Vos T, et al. Burden of neurological disorders across the US from 1990-2017: a global burden of disease study. JAMA Neurol. 2021;78(2):165-176. doi:10.1001/jamaneurol.2020.4152
3. Rehman R, Kelly PR, Husain AM, Tran TT. Characteristics of veterans diagnosed with seizures within Veterans Health Administration. J Rehabil Res Dev. 2015;52(7):751-762. doi:10.1682/JRRD.2014.10.0241
4. Pugh MJ, Van Cott AC, Amuan M, et al. Epilepsy among Iraq and Afghanistan War veterans - United States, 2002-2015. MMWR Morb Mortal Wkly Rep. 2016;65(44):1224-1227. doi:10.15585/mmwr.mm6544a5
5. Rohde NN, Baca CB, Van Cott AC, Parko KL, Amuan ME, Pugh MJ. Antiepileptic drug prescribing patterns in Iraq and Afghanistan war veterans with epilepsy. Epilepsy Behav. 2015;46:133-139. doi:10.1016/j.yebeh.2015.03.027
6. Laxer KD, Trinka E, Hirsch LJ, et al. The consequences of refractory epilepsy and its treatment. Epilepsy Behav. 2014;37:59-70. doi:10.1016/j.yebeh.2014.05.031
7. Devinsky O, Hesdorffer DC, Thurman DJ, Lhatoo S, Richerson G. Sudden unexpected death in epilepsy: epidemiology, mechanisms, and prevention. Lancet Neurol. 2016;15(10):1075-1088. doi:10.1016/S1474-4422(16)30158-2
8. Tolchin B, Hirsch LJ, LaFrance WC Jr. Neuropsychiatric aspects of epilepsy. Psychiatr Clin North Am. 2020;43(2):275-290. doi:10.1016/j.psc.2020.02.002
9. Rai D, Kerr MP, McManus S, Jordanova V, Lewis G, Brugha TS. Epilepsy and psychiatric comorbidity: a nationally representative population-based study. Epilepsia. 2012;53(6):1095-1103. doi:10.1111/j.1528-1167.2012.03500.x
10. US Department of Veterans Affairs. Epilepsy Centers of Excellence. Annual report fiscal year 2020. Accessed March 11, 2022. https://www.epilepsy.va.gov/docs/ECoENational_AnnualReportFY20_web_508c.pdf
11. Fogg A, Staufenberg EF, Small I, Bhattacharya D. An exploratory study of primary care pharmacist-led epilepsy consultations. Int J Pharm Pract. 2012;20(5):294-302. doi:10.1111/j.2042-7174.2012.00207.x
12. Kobau R, Sapkota S, Pennell PB, Croft JB. Epilepsy by the numbers - from the US Centers for Disease Control and Prevention: six in 10 adults with active epilepsy saw a neurologist or epilepsy specialist in the past year, United States, 2017. Epilepsy Behav. 2020;112:107348. doi:10.1016/j.yebeh.2020.107348
13. Shawahna R. Development of key performance indicators to capture in measuring the impact of pharmacists in caring for patients with epilepsy in primary healthcare: A Delphi consensual study. Epilepsy Behav. 2019;98(pt A):129-138. doi:10.1016/j.yebeh.2019.07.034
14. Asadi-Pooya AA, Beniczky S, Rubboli G, Sperling MR, Rampp S, Perucca E. A pragmatic algorithm to select appropriate antiseizure medications in patients with epilepsy. Epilepsia. 2020;61(8):1668-1677. doi:10.1111/epi.16610
15. Papanicolas I, Woskie LR, Jha AK. Health Care Spending in the United States and Other High-Income Countries. JAMA. 2018;319(10):1024-1039. doi:10.1001/jama.2018.1150
16. Bond CA, Raehl CL. Clinical and economic outcomes of pharmacist-managed aminoglycoside or vancomycin therapy. Am J Health Syst Pharm. 2005;62(15):1596-1605. doi:10.2146/ajhp040555
17. Wasade VS, Spanaki M, Iyengar R, Barkley GL, Schultz L. AAN Epilepsy Quality Measures in clinical practice: a survey of neurologists. Epilepsy Behav. 2012;24(4):468-473. doi:10.1016/j.yebeh.2012.05.017
18. Hovinga CA, Asato MR, Manjunath R, et al. Association of non-adherence to antiepileptic drugs and seizures, quality of life, and productivity: survey of patients with epilepsy and physicians. Epilepsy Behav. 2008;13(2):316-322. doi:10.1016/j.yebeh.2008.03.009
19. Faught RE, Weiner JR, Guérin A, Cunnington MC, Duh MS. Impact of nonadherence to antiepileptic drugs on health care utilization and costs: findings from the RANSOM study. Epilepsia. 2009;50(3):501-509. doi:10.1111/j.1528-1167.2008.01794.x
20. Malek N, Heath CA, Greene J. A review of medication adherence in people with epilepsy. Acta Neurol Scand. 2017;135(5):507-515. doi:10.1111/ane.12703
21. O’ Rourke G, O’ Brien JJ. Identifying the barriers to antiepileptic drug adherence among adults with epilepsy. Seizure. 2017;45:160-168. doi:10.1016/j.seizure.2016.12.006