Cardiology News

Habitual coffee drinking was not associated with a heightened risk of cardiac arrhythmias in a study of more than 300,000 people.

In fact, an adjusted analysis found that “each additional cup of coffee intake was associated with a 3% lower risk of incident arrhythmia,” Eun-jeong Kim, MD, of the division of cardiology at the University of California, San Francisco, and colleagues reported in JAMA Internal Medicine.

In addition, genetic differences that affect caffeine metabolism did not significantly influence the odds of arrhythmias, the researchers found.

Still, these findings should not necessarily encourage people to start drinking coffee if they don’t already, or to guzzle additional cups with abandon, they said.

American Heart Association

“We certainly don’t want to say drink coffee and it will reduce your risk of arrhythmias,” study author Gregory M. Marcus, MD, MAS, associate chief of cardiology for research at UCSF Health, said in an interview. “But rather, we think the main point is that a blanket prohibition against coffee or caffeine to reduce the risk of arrhythmias among patients who have a diagnosis of arrhythmias is likely unwarranted. And given some evidence that coffee consumption may actually have other benefits regarding diabetes, mood, and perhaps overall mortality, it may be problematic to admonish patients to avoid coffee or caffeine when it is not really warranted.”
 

Methods and results

The conventional wisdom that caffeine increases arrhythmic risk has not been well substantiated. To further examine whether moderate, habitual coffee drinking relates to arrhythmia risk, and whether certain genetic variants influence the association, Dr. Kim and colleagues analyzed data from the UK Biobank. They focused on longitudinal data collected between 2006 and 2018 from 386,258 people who did not have a prior diagnosis of arrhythmia.

Participants had an average age of 56 years, and about 52% were female. They provided information about their coffee consumption, and the researchers grouped the participants into eight categories based on their daily coffee intake: 0, less than 1, 1, 2, 3, 4, 5, and 6 or more cups per day.

Over an average follow-up of 4.5 years, 16,979 participants developed an incident arrhythmia. After adjusting for demographic characteristics, comorbid conditions, and lifestyle habits, the decreased risk with each cup of coffee was similar for atrial fibrillation or flutter (hazard ratio, 0.97) and supraventricular tachycardia (HR, 0.96).

Taking into account genetic variations that relate to caffeine metabolism did not modify the findings. Mendelian randomization analyses that used a polygenic score of inherited caffeine metabolism patterns “failed to provide evidence that caffeine consumption leads to a greater risk of arrhythmias,” the researchers said.

Professional society guidelines have suggested staying away from caffeinated products to reduce the risk of arrhythmia, but this guidance has “relied on assumed mechanisms and a small observational study from 1980,” the authors wrote. Subsequent research has indicated that coffee’s reputation of increasing the risk of arrhythmia may be undeserved.

“The investigators should be commended on performing a high-quality observational study to try to further understand the association between coffee consumption and arrhythmias, or the lack of one,” commented Zachary D. Goldberger, MD, MS, with the division of cardiovascular medicine at the University of Wisconsin–Madison, who was not involved in the study. “This is not a randomized, controlled trial, and coffee consumption was self-reported, but the methods employed are rigorous, despite these and other important limitations. However, we need to be extremely cautious in how we interpret these findings, and not use these data as a prescription for more coffee. It’s important to recognize that this study is not telling us to drink more coffee, or start drinking coffee, to protect against developing arrhythmias. However, it should offer more reassurance that moderate coffee consumption is not necessarily harmful, and will not always lead to arrhythmias. This is important, given the widespread notion that coffee is universally proarrhythmic.”
 

A call for personalized guidance

“As the investigators note, there are definitely biologically plausible reasons how coffee and caffeine may not cause arrhythmias, and may be possibly protective in some, despite being a stimulant,” Dr. Goldberger said. “However, if your patient is reporting palpitations or symptoms of an arrhythmia, and feels they be related to coffee or caffeine, we should not use this study to tell them that coffee may not be the culprit. We need to listen to our patients, and the decision to reduce coffee consumption to reduce these symptoms needs to be personalized.”

The effect size was small, and only about 4% of the participants developed an arrhythmia, Dr. Goldberger and Rodney A. Hayward, MD, wrote in an invited commentary on the study in JAMA Internal Medicine. Dr. Hayward is a professor of public health and internal medicine at the University of Michigan, Ann Arbor, and a senior investigator at the Ann Arbor Veterans Affairs Center for Clinical Management Research.

“Unfortunately, coffee consumption was self-reported at a single time point. Not only can this lead to recall bias, but subsequent and substantial changes in coffee consumption are also possible, including reductions due to new signs or symptoms,” they said.
 

No evidence that coffee ups risk for developing arrhythmias

Another recent study suggests that people may alter their coffee consumption depending on their baseline cardiovascular health, according to the commentary.

Overall, the results “strengthen the evidence that caffeine is not proarrhythmic, but they should not be taken as proving that coffee is an antiarrhythmic—this distinction is of paramount importance,” Dr. Goldberger and Dr. Hayward wrote. “Health care professionals can reassure patients that there is no evidence that drinking coffee increases the risk for developing arrhythmias. This is particularly important for the many patients with benign palpitations who are devastated when they think, or are told, that they have to stop drinking coffee. Given current evidence, this is entirely a patient-preference decision, not a medical one.”

Dr. Marcus, a cardiac electrophysiologist, sees patients with arrhythmias all the time. They tend to “come in fairly convinced that caffeine is to be avoided when they have arrhythmias,” he said. “Often, they been told by their primary care physician or their general cardiologist to avoid caffeine because they have an arrhythmia.

“What I suggest to my patients is that they feel free to go ahead and experiment and try coffee,” Dr. Marcus said.

Still, Dr. Marcus suspects that there are some individuals in whom caffeine is a trigger for the arrhythmia. But evidence indicates these cases likely are rare, and avoiding caffeine need not apply to the general population, particularly “given the potential health benefits of benefits of coffee and also, frankly, just the enhanced quality of life that people can enjoy drinking a good cup of coffee.”

The research was conducted using the UK Biobank resource, which was established by the Wellcome Trust, the Medical Research Council, the U.K. Department of Health, and the Scottish government. The UK Biobank has received funding from other agencies and foundations as well. Dr. Marcus disclosed grants from Baylis, Medtronic, and Eight Sleep outside the submitted work. In addition, he reported consulting for Johnson & Johnson and InCarda, and holding equity in InCarda. A coauthor received salary support from the National Institutes of Health during the study. Dr. Goldberger and Dr. Hayward disclosed no conflicts of interest.

jremaly@mdedge.com

Habitual coffee drinking was not associated with a heightened risk of cardiac arrhythmias in a study of more than 300,000 people.

In fact, an adjusted analysis found that “each additional cup of coffee intake was associated with a 3% lower risk of incident arrhythmia,” Eun-jeong Kim, MD, of the division of cardiology at the University of California, San Francisco, and colleagues reported in JAMA Internal Medicine.

In addition, genetic differences that affect caffeine metabolism did not significantly influence the odds of arrhythmias, the researchers found.

Still, these findings should not necessarily encourage people to start drinking coffee if they don’t already, or to guzzle additional cups with abandon, they said.

American Heart Association

“We certainly don’t want to say drink coffee and it will reduce your risk of arrhythmias,” study author Gregory M. Marcus, MD, MAS, associate chief of cardiology for research at UCSF Health, said in an interview. “But rather, we think the main point is that a blanket prohibition against coffee or caffeine to reduce the risk of arrhythmias among patients who have a diagnosis of arrhythmias is likely unwarranted. And given some evidence that coffee consumption may actually have other benefits regarding diabetes, mood, and perhaps overall mortality, it may be problematic to admonish patients to avoid coffee or caffeine when it is not really warranted.”
 

Methods and results

The conventional wisdom that caffeine increases arrhythmic risk has not been well substantiated. To further examine whether moderate, habitual coffee drinking relates to arrhythmia risk, and whether certain genetic variants influence the association, Dr. Kim and colleagues analyzed data from the UK Biobank. They focused on longitudinal data collected between 2006 and 2018 from 386,258 people who did not have a prior diagnosis of arrhythmia.

Participants had an average age of 56 years, and about 52% were female. They provided information about their coffee consumption, and the researchers grouped the participants into eight categories based on their daily coffee intake: 0, less than 1, 1, 2, 3, 4, 5, and 6 or more cups per day.

Over an average follow-up of 4.5 years, 16,979 participants developed an incident arrhythmia. After adjusting for demographic characteristics, comorbid conditions, and lifestyle habits, the decreased risk with each cup of coffee was similar for atrial fibrillation or flutter (hazard ratio, 0.97) and supraventricular tachycardia (HR, 0.96).

Taking into account genetic variations that relate to caffeine metabolism did not modify the findings. Mendelian randomization analyses that used a polygenic score of inherited caffeine metabolism patterns “failed to provide evidence that caffeine consumption leads to a greater risk of arrhythmias,” the researchers said.

Professional society guidelines have suggested staying away from caffeinated products to reduce the risk of arrhythmia, but this guidance has “relied on assumed mechanisms and a small observational study from 1980,” the authors wrote. Subsequent research has indicated that coffee’s reputation of increasing the risk of arrhythmia may be undeserved.

“The investigators should be commended on performing a high-quality observational study to try to further understand the association between coffee consumption and arrhythmias, or the lack of one,” commented Zachary D. Goldberger, MD, MS, with the division of cardiovascular medicine at the University of Wisconsin–Madison, who was not involved in the study. “This is not a randomized, controlled trial, and coffee consumption was self-reported, but the methods employed are rigorous, despite these and other important limitations. However, we need to be extremely cautious in how we interpret these findings, and not use these data as a prescription for more coffee. It’s important to recognize that this study is not telling us to drink more coffee, or start drinking coffee, to protect against developing arrhythmias. However, it should offer more reassurance that moderate coffee consumption is not necessarily harmful, and will not always lead to arrhythmias. This is important, given the widespread notion that coffee is universally proarrhythmic.”
 

A call for personalized guidance

“As the investigators note, there are definitely biologically plausible reasons how coffee and caffeine may not cause arrhythmias, and may be possibly protective in some, despite being a stimulant,” Dr. Goldberger said. “However, if your patient is reporting palpitations or symptoms of an arrhythmia, and feels they be related to coffee or caffeine, we should not use this study to tell them that coffee may not be the culprit. We need to listen to our patients, and the decision to reduce coffee consumption to reduce these symptoms needs to be personalized.”

The effect size was small, and only about 4% of the participants developed an arrhythmia, Dr. Goldberger and Rodney A. Hayward, MD, wrote in an invited commentary on the study in JAMA Internal Medicine. Dr. Hayward is a professor of public health and internal medicine at the University of Michigan, Ann Arbor, and a senior investigator at the Ann Arbor Veterans Affairs Center for Clinical Management Research.

“Unfortunately, coffee consumption was self-reported at a single time point. Not only can this lead to recall bias, but subsequent and substantial changes in coffee consumption are also possible, including reductions due to new signs or symptoms,” they said.
 

No evidence that coffee ups risk for developing arrhythmias

Another recent study suggests that people may alter their coffee consumption depending on their baseline cardiovascular health, according to the commentary.

Overall, the results “strengthen the evidence that caffeine is not proarrhythmic, but they should not be taken as proving that coffee is an antiarrhythmic—this distinction is of paramount importance,” Dr. Goldberger and Dr. Hayward wrote. “Health care professionals can reassure patients that there is no evidence that drinking coffee increases the risk for developing arrhythmias. This is particularly important for the many patients with benign palpitations who are devastated when they think, or are told, that they have to stop drinking coffee. Given current evidence, this is entirely a patient-preference decision, not a medical one.”

Dr. Marcus, a cardiac electrophysiologist, sees patients with arrhythmias all the time. They tend to “come in fairly convinced that caffeine is to be avoided when they have arrhythmias,” he said. “Often, they been told by their primary care physician or their general cardiologist to avoid caffeine because they have an arrhythmia.

“What I suggest to my patients is that they feel free to go ahead and experiment and try coffee,” Dr. Marcus said.

Still, Dr. Marcus suspects that there are some individuals in whom caffeine is a trigger for the arrhythmia. But evidence indicates these cases likely are rare, and avoiding caffeine need not apply to the general population, particularly “given the potential health benefits of benefits of coffee and also, frankly, just the enhanced quality of life that people can enjoy drinking a good cup of coffee.”

The research was conducted using the UK Biobank resource, which was established by the Wellcome Trust, the Medical Research Council, the U.K. Department of Health, and the Scottish government. The UK Biobank has received funding from other agencies and foundations as well. Dr. Marcus disclosed grants from Baylis, Medtronic, and Eight Sleep outside the submitted work. In addition, he reported consulting for Johnson & Johnson and InCarda, and holding equity in InCarda. A coauthor received salary support from the National Institutes of Health during the study. Dr. Goldberger and Dr. Hayward disclosed no conflicts of interest.

jremaly@mdedge.com

Habitual coffee drinking was not associated with a heightened risk of cardiac arrhythmias in a study of more than 300,000 people.

In fact, an adjusted analysis found that “each additional cup of coffee intake was associated with a 3% lower risk of incident arrhythmia,” Eun-jeong Kim, MD, of the division of cardiology at the University of California, San Francisco, and colleagues reported in JAMA Internal Medicine.

In addition, genetic differences that affect caffeine metabolism did not significantly influence the odds of arrhythmias, the researchers found.

Still, these findings should not necessarily encourage people to start drinking coffee if they don’t already, or to guzzle additional cups with abandon, they said.

American Heart Association

“We certainly don’t want to say drink coffee and it will reduce your risk of arrhythmias,” study author Gregory M. Marcus, MD, MAS, associate chief of cardiology for research at UCSF Health, said in an interview. “But rather, we think the main point is that a blanket prohibition against coffee or caffeine to reduce the risk of arrhythmias among patients who have a diagnosis of arrhythmias is likely unwarranted. And given some evidence that coffee consumption may actually have other benefits regarding diabetes, mood, and perhaps overall mortality, it may be problematic to admonish patients to avoid coffee or caffeine when it is not really warranted.”
 

Methods and results

The conventional wisdom that caffeine increases arrhythmic risk has not been well substantiated. To further examine whether moderate, habitual coffee drinking relates to arrhythmia risk, and whether certain genetic variants influence the association, Dr. Kim and colleagues analyzed data from the UK Biobank. They focused on longitudinal data collected between 2006 and 2018 from 386,258 people who did not have a prior diagnosis of arrhythmia.

Participants had an average age of 56 years, and about 52% were female. They provided information about their coffee consumption, and the researchers grouped the participants into eight categories based on their daily coffee intake: 0, less than 1, 1, 2, 3, 4, 5, and 6 or more cups per day.

Over an average follow-up of 4.5 years, 16,979 participants developed an incident arrhythmia. After adjusting for demographic characteristics, comorbid conditions, and lifestyle habits, the decreased risk with each cup of coffee was similar for atrial fibrillation or flutter (hazard ratio, 0.97) and supraventricular tachycardia (HR, 0.96).

Taking into account genetic variations that relate to caffeine metabolism did not modify the findings. Mendelian randomization analyses that used a polygenic score of inherited caffeine metabolism patterns “failed to provide evidence that caffeine consumption leads to a greater risk of arrhythmias,” the researchers said.

Professional society guidelines have suggested staying away from caffeinated products to reduce the risk of arrhythmia, but this guidance has “relied on assumed mechanisms and a small observational study from 1980,” the authors wrote. Subsequent research has indicated that coffee’s reputation of increasing the risk of arrhythmia may be undeserved.

“The investigators should be commended on performing a high-quality observational study to try to further understand the association between coffee consumption and arrhythmias, or the lack of one,” commented Zachary D. Goldberger, MD, MS, with the division of cardiovascular medicine at the University of Wisconsin–Madison, who was not involved in the study. “This is not a randomized, controlled trial, and coffee consumption was self-reported, but the methods employed are rigorous, despite these and other important limitations. However, we need to be extremely cautious in how we interpret these findings, and not use these data as a prescription for more coffee. It’s important to recognize that this study is not telling us to drink more coffee, or start drinking coffee, to protect against developing arrhythmias. However, it should offer more reassurance that moderate coffee consumption is not necessarily harmful, and will not always lead to arrhythmias. This is important, given the widespread notion that coffee is universally proarrhythmic.”
 

A call for personalized guidance

“As the investigators note, there are definitely biologically plausible reasons how coffee and caffeine may not cause arrhythmias, and may be possibly protective in some, despite being a stimulant,” Dr. Goldberger said. “However, if your patient is reporting palpitations or symptoms of an arrhythmia, and feels they be related to coffee or caffeine, we should not use this study to tell them that coffee may not be the culprit. We need to listen to our patients, and the decision to reduce coffee consumption to reduce these symptoms needs to be personalized.”

The effect size was small, and only about 4% of the participants developed an arrhythmia, Dr. Goldberger and Rodney A. Hayward, MD, wrote in an invited commentary on the study in JAMA Internal Medicine. Dr. Hayward is a professor of public health and internal medicine at the University of Michigan, Ann Arbor, and a senior investigator at the Ann Arbor Veterans Affairs Center for Clinical Management Research.

“Unfortunately, coffee consumption was self-reported at a single time point. Not only can this lead to recall bias, but subsequent and substantial changes in coffee consumption are also possible, including reductions due to new signs or symptoms,” they said.
 

No evidence that coffee ups risk for developing arrhythmias

Another recent study suggests that people may alter their coffee consumption depending on their baseline cardiovascular health, according to the commentary.

Overall, the results “strengthen the evidence that caffeine is not proarrhythmic, but they should not be taken as proving that coffee is an antiarrhythmic—this distinction is of paramount importance,” Dr. Goldberger and Dr. Hayward wrote. “Health care professionals can reassure patients that there is no evidence that drinking coffee increases the risk for developing arrhythmias. This is particularly important for the many patients with benign palpitations who are devastated when they think, or are told, that they have to stop drinking coffee. Given current evidence, this is entirely a patient-preference decision, not a medical one.”

Dr. Marcus, a cardiac electrophysiologist, sees patients with arrhythmias all the time. They tend to “come in fairly convinced that caffeine is to be avoided when they have arrhythmias,” he said. “Often, they been told by their primary care physician or their general cardiologist to avoid caffeine because they have an arrhythmia.

“What I suggest to my patients is that they feel free to go ahead and experiment and try coffee,” Dr. Marcus said.

Still, Dr. Marcus suspects that there are some individuals in whom caffeine is a trigger for the arrhythmia. But evidence indicates these cases likely are rare, and avoiding caffeine need not apply to the general population, particularly “given the potential health benefits of benefits of coffee and also, frankly, just the enhanced quality of life that people can enjoy drinking a good cup of coffee.”

The research was conducted using the UK Biobank resource, which was established by the Wellcome Trust, the Medical Research Council, the U.K. Department of Health, and the Scottish government. The UK Biobank has received funding from other agencies and foundations as well. Dr. Marcus disclosed grants from Baylis, Medtronic, and Eight Sleep outside the submitted work. In addition, he reported consulting for Johnson & Johnson and InCarda, and holding equity in InCarda. A coauthor received salary support from the National Institutes of Health during the study. Dr. Goldberger and Dr. Hayward disclosed no conflicts of interest.

jremaly@mdedge.com

Following a transcatheter aortic valve replacement (TAVR), direct oral anticoagulants (DOACs) are preferable to vitamin K antagonists (VKAs) in patients who are candidates for oral anticoagulants, according to data drawn from a large multicenter French TAVR registry.

When oral anticoagulation is appropriate following TAVR, such as in patients with atrial fibrillation, “DOACs are associated with improved survival and lower incidence of bleeding, compared to VKA,” reported a team of investigators led by Martine Gilard, MD, PhD, director of interventional cardiology, Brest (France) University Hospital Center.

The comparison, using propensity score matching, is not definitive, but it might be the best data currently available to support DOACs over VKA until a randomized trial is completed, according to Dr. Gilard, senior author of the newly published study.

Asked in an interview if DOACs should now be used preferentially after TAVR when patients are indicated for oral anticoagulation, Dr. Gilard replied, “My answer is yes.”

Of more than 24,000 TAVR patients in the French TAVI and FRANCE2 multicenter registries, which are linked to the French single-payer claims database (SNDS), 8,962 (36.4%) received an oral anticoagulant following their procedure. Of these, 2,180 (24.3%) received a DOAC and the remaining received VKA.

By linking data from the registries to the SNDS, outcomes were tracked. Propensity matching was employed to control for differences in baseline characteristics, including age, body mass index, functional class, diabetes, comorbidities, and past medical history.

On the primary endpoint of mortality at the end of 3 years, the rates were 35.6% and 31.2% for VKA and DOACs, respectively. This translated in a 37% greater hazard ratio for death among those treated with VKA (P < .005).

The rate of major bleeding, a secondary endpoint, was also higher (12.3% vs. 8.4%) and significantly different (HR, 1.65; P < .005) for VKA versus DOACs. The rates of ischemic stroke, acute coronary syndrome, and hemorrhagic stroke were all numerically higher in patients treated with VKA than DOACs, although none of these differences reached statistical significance.
 

Residual confounding cannot be discounted

“The large number of events allowed for taking into account a higher number of potential confounders with appropriate statistical power,” according to the authors. However, they acknowledged that residual confounding cannot be eliminated by propensity matching and conceded that prospective data are needed for a definitive comparison.

In an accompanying editorial, Daniele Giacoppo, MD, a cardiologist at Alto Vicentino Hospital, Santorso, Italy, enlarged on this point . In addition to the inherent limitations of retrospective data, he also noted that data from other studies addressing the same question have been inconsistent.

Of these studies, he pointed to the ATLANTIS trial, presented 2 months ago at the annual meeting of the American College of Cardiology. This study failed to show an advantage for the DOAC apixaban over VKA in TAVR patients for the primary composite outcome of time to death, myocardial infarction, systemic emboli, valve thrombosis, or major bleeding. Although this study was not limited to patients with an indication for oral anticoagulants, Dr. Giacoppo pointed out that there was no advantage, even among the subgroup of patients who did have an indication.
 

Data are supportive in absence of trial results

In general, Dr. Giacoppo agreed that the French registry are generally supportive of DOACs over VKA in TAVR patients with an indication for oral anticoagulation, but he cautioned that blanket statements are difficult. He anticipates better information from a randomized trial called ENVISAGE-TAVI AF, which is comparing edoxaban with VKA following TAVR in atrial fibrillation patients who have an indication for oral anticoagulation, but he indicated that some individualization of choice will be needed among those high or low relative risks of thrombotic events or bleeding.

“The concerns related to DOACs after TAVR are most confined to patients without an indication for oral anticoagulation,” Dr. Giacoppo said in an interview. In patients with an indication, “oral anticoagulation alone without antithrombotic therapy significantly reduced the risk of bleeding” in several studies, he added, citing in particular the POPular TAVI trial.

Issues about when to employ – or not employ – both oral anticoagulation and antithrombotic therapy based on such factors as bleeding risk remain unresolved, but “in aggregate, waiting for additional high-quality data, the use of a DOAC in patients with an indication for oral anticoagulation who underwent TAVR seems to be safe,” Dr. Giacoppo said. He thinks that the “higher predictability of DOACS compared to vitamin K antagonists might translate into lower bleeding rates over time in a real-world, unselected population.”
 

Benefit-to-risk ratio requires attention

A similar concern about balancing risks and benefits of oral anticoagulation in TAVR patients with an indication for oral anticoagulation was emphasized by Ron Waksman, MD, associate director, division of cardiology, MedStar Washington (D.C.) Hospital Center.

“The TAVR population is elderly in general and so are at high risk for bleeding with any additional anticoagulation,” Dr. Waksman said. He cited data that bring into question the utility of using a DOAC in TAVR patients without an additional indication for anticoagulation, but he believes DOACs do make sense in those who were on and had an indication for a DOAC even before TAVR.

Patients who had atrial fibrillation or another indication “should continue to take the DOAC after TAVR. This population can be assumed to have less bleeding risk as they are vetted as safe for DOACs before their TAVR procedure,” he said.

Although mortality was the primary endpoint of the French registry evaluation, it is the bleeding risk that is a dominant concern, according to Romain Didier, MD, PhD, the first author of this study who performed this work in collaboration with Dr. Gilard.

“We really believe that VKA use in real life after TAVR, even with INR monitoring, is associated with a higher risk of bleeding as compared to DOACs,” he said. It is for this reason that “we currently use DOACs as a first choice in patients who require anticoagulant after TAVR.”

Dr. Gilard, Dr. Didier, and Dr. Giacoppo reported no potential conflicts of interest. Dr. Waksman reported financial relationships with Amgen, AstraZeneca, Boston Scientific, Cardioset, Cardiovascular Systems, Chiesi, MedAlliance, Medtronic, and Pi-Cardia.

Following a transcatheter aortic valve replacement (TAVR), direct oral anticoagulants (DOACs) are preferable to vitamin K antagonists (VKAs) in patients who are candidates for oral anticoagulants, according to data drawn from a large multicenter French TAVR registry.

When oral anticoagulation is appropriate following TAVR, such as in patients with atrial fibrillation, “DOACs are associated with improved survival and lower incidence of bleeding, compared to VKA,” reported a team of investigators led by Martine Gilard, MD, PhD, director of interventional cardiology, Brest (France) University Hospital Center.

The comparison, using propensity score matching, is not definitive, but it might be the best data currently available to support DOACs over VKA until a randomized trial is completed, according to Dr. Gilard, senior author of the newly published study.

Asked in an interview if DOACs should now be used preferentially after TAVR when patients are indicated for oral anticoagulation, Dr. Gilard replied, “My answer is yes.”

Of more than 24,000 TAVR patients in the French TAVI and FRANCE2 multicenter registries, which are linked to the French single-payer claims database (SNDS), 8,962 (36.4%) received an oral anticoagulant following their procedure. Of these, 2,180 (24.3%) received a DOAC and the remaining received VKA.

By linking data from the registries to the SNDS, outcomes were tracked. Propensity matching was employed to control for differences in baseline characteristics, including age, body mass index, functional class, diabetes, comorbidities, and past medical history.

On the primary endpoint of mortality at the end of 3 years, the rates were 35.6% and 31.2% for VKA and DOACs, respectively. This translated in a 37% greater hazard ratio for death among those treated with VKA (P < .005).

The rate of major bleeding, a secondary endpoint, was also higher (12.3% vs. 8.4%) and significantly different (HR, 1.65; P < .005) for VKA versus DOACs. The rates of ischemic stroke, acute coronary syndrome, and hemorrhagic stroke were all numerically higher in patients treated with VKA than DOACs, although none of these differences reached statistical significance.
 

Residual confounding cannot be discounted

“The large number of events allowed for taking into account a higher number of potential confounders with appropriate statistical power,” according to the authors. However, they acknowledged that residual confounding cannot be eliminated by propensity matching and conceded that prospective data are needed for a definitive comparison.

In an accompanying editorial, Daniele Giacoppo, MD, a cardiologist at Alto Vicentino Hospital, Santorso, Italy, enlarged on this point . In addition to the inherent limitations of retrospective data, he also noted that data from other studies addressing the same question have been inconsistent.

Of these studies, he pointed to the ATLANTIS trial, presented 2 months ago at the annual meeting of the American College of Cardiology. This study failed to show an advantage for the DOAC apixaban over VKA in TAVR patients for the primary composite outcome of time to death, myocardial infarction, systemic emboli, valve thrombosis, or major bleeding. Although this study was not limited to patients with an indication for oral anticoagulants, Dr. Giacoppo pointed out that there was no advantage, even among the subgroup of patients who did have an indication.
 

Data are supportive in absence of trial results

In general, Dr. Giacoppo agreed that the French registry are generally supportive of DOACs over VKA in TAVR patients with an indication for oral anticoagulation, but he cautioned that blanket statements are difficult. He anticipates better information from a randomized trial called ENVISAGE-TAVI AF, which is comparing edoxaban with VKA following TAVR in atrial fibrillation patients who have an indication for oral anticoagulation, but he indicated that some individualization of choice will be needed among those high or low relative risks of thrombotic events or bleeding.

“The concerns related to DOACs after TAVR are most confined to patients without an indication for oral anticoagulation,” Dr. Giacoppo said in an interview. In patients with an indication, “oral anticoagulation alone without antithrombotic therapy significantly reduced the risk of bleeding” in several studies, he added, citing in particular the POPular TAVI trial.

Issues about when to employ – or not employ – both oral anticoagulation and antithrombotic therapy based on such factors as bleeding risk remain unresolved, but “in aggregate, waiting for additional high-quality data, the use of a DOAC in patients with an indication for oral anticoagulation who underwent TAVR seems to be safe,” Dr. Giacoppo said. He thinks that the “higher predictability of DOACS compared to vitamin K antagonists might translate into lower bleeding rates over time in a real-world, unselected population.”
 

Benefit-to-risk ratio requires attention

A similar concern about balancing risks and benefits of oral anticoagulation in TAVR patients with an indication for oral anticoagulation was emphasized by Ron Waksman, MD, associate director, division of cardiology, MedStar Washington (D.C.) Hospital Center.

“The TAVR population is elderly in general and so are at high risk for bleeding with any additional anticoagulation,” Dr. Waksman said. He cited data that bring into question the utility of using a DOAC in TAVR patients without an additional indication for anticoagulation, but he believes DOACs do make sense in those who were on and had an indication for a DOAC even before TAVR.

Patients who had atrial fibrillation or another indication “should continue to take the DOAC after TAVR. This population can be assumed to have less bleeding risk as they are vetted as safe for DOACs before their TAVR procedure,” he said.

Although mortality was the primary endpoint of the French registry evaluation, it is the bleeding risk that is a dominant concern, according to Romain Didier, MD, PhD, the first author of this study who performed this work in collaboration with Dr. Gilard.

“We really believe that VKA use in real life after TAVR, even with INR monitoring, is associated with a higher risk of bleeding as compared to DOACs,” he said. It is for this reason that “we currently use DOACs as a first choice in patients who require anticoagulant after TAVR.”

Dr. Gilard, Dr. Didier, and Dr. Giacoppo reported no potential conflicts of interest. Dr. Waksman reported financial relationships with Amgen, AstraZeneca, Boston Scientific, Cardioset, Cardiovascular Systems, Chiesi, MedAlliance, Medtronic, and Pi-Cardia.

Following a transcatheter aortic valve replacement (TAVR), direct oral anticoagulants (DOACs) are preferable to vitamin K antagonists (VKAs) in patients who are candidates for oral anticoagulants, according to data drawn from a large multicenter French TAVR registry.

When oral anticoagulation is appropriate following TAVR, such as in patients with atrial fibrillation, “DOACs are associated with improved survival and lower incidence of bleeding, compared to VKA,” reported a team of investigators led by Martine Gilard, MD, PhD, director of interventional cardiology, Brest (France) University Hospital Center.

The comparison, using propensity score matching, is not definitive, but it might be the best data currently available to support DOACs over VKA until a randomized trial is completed, according to Dr. Gilard, senior author of the newly published study.

Asked in an interview if DOACs should now be used preferentially after TAVR when patients are indicated for oral anticoagulation, Dr. Gilard replied, “My answer is yes.”

Of more than 24,000 TAVR patients in the French TAVI and FRANCE2 multicenter registries, which are linked to the French single-payer claims database (SNDS), 8,962 (36.4%) received an oral anticoagulant following their procedure. Of these, 2,180 (24.3%) received a DOAC and the remaining received VKA.

By linking data from the registries to the SNDS, outcomes were tracked. Propensity matching was employed to control for differences in baseline characteristics, including age, body mass index, functional class, diabetes, comorbidities, and past medical history.

On the primary endpoint of mortality at the end of 3 years, the rates were 35.6% and 31.2% for VKA and DOACs, respectively. This translated in a 37% greater hazard ratio for death among those treated with VKA (P < .005).

The rate of major bleeding, a secondary endpoint, was also higher (12.3% vs. 8.4%) and significantly different (HR, 1.65; P < .005) for VKA versus DOACs. The rates of ischemic stroke, acute coronary syndrome, and hemorrhagic stroke were all numerically higher in patients treated with VKA than DOACs, although none of these differences reached statistical significance.
 

Residual confounding cannot be discounted

“The large number of events allowed for taking into account a higher number of potential confounders with appropriate statistical power,” according to the authors. However, they acknowledged that residual confounding cannot be eliminated by propensity matching and conceded that prospective data are needed for a definitive comparison.

In an accompanying editorial, Daniele Giacoppo, MD, a cardiologist at Alto Vicentino Hospital, Santorso, Italy, enlarged on this point . In addition to the inherent limitations of retrospective data, he also noted that data from other studies addressing the same question have been inconsistent.

Of these studies, he pointed to the ATLANTIS trial, presented 2 months ago at the annual meeting of the American College of Cardiology. This study failed to show an advantage for the DOAC apixaban over VKA in TAVR patients for the primary composite outcome of time to death, myocardial infarction, systemic emboli, valve thrombosis, or major bleeding. Although this study was not limited to patients with an indication for oral anticoagulants, Dr. Giacoppo pointed out that there was no advantage, even among the subgroup of patients who did have an indication.
 

Data are supportive in absence of trial results

In general, Dr. Giacoppo agreed that the French registry are generally supportive of DOACs over VKA in TAVR patients with an indication for oral anticoagulation, but he cautioned that blanket statements are difficult. He anticipates better information from a randomized trial called ENVISAGE-TAVI AF, which is comparing edoxaban with VKA following TAVR in atrial fibrillation patients who have an indication for oral anticoagulation, but he indicated that some individualization of choice will be needed among those high or low relative risks of thrombotic events or bleeding.

“The concerns related to DOACs after TAVR are most confined to patients without an indication for oral anticoagulation,” Dr. Giacoppo said in an interview. In patients with an indication, “oral anticoagulation alone without antithrombotic therapy significantly reduced the risk of bleeding” in several studies, he added, citing in particular the POPular TAVI trial.

Issues about when to employ – or not employ – both oral anticoagulation and antithrombotic therapy based on such factors as bleeding risk remain unresolved, but “in aggregate, waiting for additional high-quality data, the use of a DOAC in patients with an indication for oral anticoagulation who underwent TAVR seems to be safe,” Dr. Giacoppo said. He thinks that the “higher predictability of DOACS compared to vitamin K antagonists might translate into lower bleeding rates over time in a real-world, unselected population.”
 

Benefit-to-risk ratio requires attention

A similar concern about balancing risks and benefits of oral anticoagulation in TAVR patients with an indication for oral anticoagulation was emphasized by Ron Waksman, MD, associate director, division of cardiology, MedStar Washington (D.C.) Hospital Center.

“The TAVR population is elderly in general and so are at high risk for bleeding with any additional anticoagulation,” Dr. Waksman said. He cited data that bring into question the utility of using a DOAC in TAVR patients without an additional indication for anticoagulation, but he believes DOACs do make sense in those who were on and had an indication for a DOAC even before TAVR.

Patients who had atrial fibrillation or another indication “should continue to take the DOAC after TAVR. This population can be assumed to have less bleeding risk as they are vetted as safe for DOACs before their TAVR procedure,” he said.

Although mortality was the primary endpoint of the French registry evaluation, it is the bleeding risk that is a dominant concern, according to Romain Didier, MD, PhD, the first author of this study who performed this work in collaboration with Dr. Gilard.

“We really believe that VKA use in real life after TAVR, even with INR monitoring, is associated with a higher risk of bleeding as compared to DOACs,” he said. It is for this reason that “we currently use DOACs as a first choice in patients who require anticoagulant after TAVR.”

Dr. Gilard, Dr. Didier, and Dr. Giacoppo reported no potential conflicts of interest. Dr. Waksman reported financial relationships with Amgen, AstraZeneca, Boston Scientific, Cardioset, Cardiovascular Systems, Chiesi, MedAlliance, Medtronic, and Pi-Cardia.

Should a hospital or medical practice fulfill a patient’s request to be treated or cared for only by vaccinated health care providers?The answer is yes, in a perfect world. Patients should feel assured that their health care providers – clinicians and caregivers – are not exposing them to infectious diseases.But issues are being raised – subquestions that need to be answered to understand the current situation and assist health care employers in their decision-making:

• Must health care employers ensure that their employees are vaccinated?
• Can health care employers require that their employees be vaccinated?
• Do employees have any rights to refuse vaccination or to refuse to supply their employer with their vaccination status?
• Can a health care employer terminate an employee who refuses vaccination?
• Does a patient have a legal right to a vaccinated health care provider?

At present, federal policy says that employers may, but are not required to, insist that employees be vaccinated. The currently prevailing state case law says that hospitals and other employers can require staff to be vaccinated and can terminate employees who refuse vaccination. In June, a Texas court dismissed a case in which 117 employees sued a hospital for requiring that employees be vaccinated. More cases are pending in other states, and there may be differing decisions in other states and on appeal.

State laws enacted years ago also weigh in on employer obligations. In at least one state, Oregon, employers of health care providers may not require vaccination, even though other employers may. Other states have laws about what an employer may or may not require of an employee regarding vaccination, and some have introduced laws which are pending.

So, in most states, health care employers may, not must, require that employees be vaccinated. In most states, hospitals and medical practices may terminate employees who refuse vaccination. However, employers should research the laws of their own states before requiring vaccinations and before terminating employees who are not vaccinated.

The issue of employer mandates is complicated further by the practicality that, in some areas of the country, health care providers are in scarce supply. Employers don’t want to lose the providers they have.

And there are additional questions about how certain federal laws affect the situation. Federal law that may apply includes:

• U.S. Food and Drug Administration regulation on approval of vaccines
• The Americans With Disabilities Act (ADA)
• The Health Insurance Portability and Accountability Act of 1996, which protects sensitive patient health information from being disclosed without the patient’s consent
• Civil rights laws
• Patients’ rights

FDA. Some health care providers who refuse vaccination argue that employers have no legal right to require a vaccine that is not fully approved by the FDA. COVID-19 vaccinations have emergency use authorization – something less than full approval. Courts have not yet ruled on this issue.

ADA. Some attorneys believe that honoring a patient’s request to be attended only by a vaccinated health care provider can implicate the ADA. However, the ADA doesn’t protect healthy individuals who don’t want to be vaccinated. The ADA protects the person who, because of their disability, shouldn’t get the vaccination. If an employer mandates vaccination, the employer must, under the ADA, consider requests for exemptions from disabled individuals. However, even when an employee has a disability that may qualify the employee for an exemption to the vaccination requirement, an employer may argue that giving an exemption would be a direct threat to the safety of others; in that case, the ADA may require that the disabled employee and hospital work something out. A compromise might be that the unvaccinated disabled individual would not provide direct patient care or would wear a mask and maintain physical distance.

HIPAA. Some argue that federal privacy law enters into the discussion, maintaining that health care employers can’t disclose employees’ vaccination status under HIPAA. That is not true. Employers are not “covered entities” under HIPAA. It is health care providers who are precluded under HIPAA from disclosing a patient’s personal information. So, if an employer were to ask an employee’s health care provider about the employee’s vaccination status, the health care provider could disclose that status only if the employee consented to the disclosure. An employer may ask an employee for the employee’s proof of vaccination card. However, employers must not ask for unnecessary details that might reveal disability information protected by the ADA.

Civil rights law. Civil rights laws may protect certain individuals from employment consequences of refusing vaccination. Specifically, individuals with sincerely held religious convictions against vaccinations are protected from retaliation by employers for refusing vaccination, under the Constitutional right of freedom of religion. The individual without sincerely held religious convictions against vaccinations and without a relevant disability doesn’t have legal remedies under civil rights laws.

Civil rights laws may apply if employers don’t apply their vaccination requirements to all employees equally. That is, employers can’t require vaccinations of some employees but not others.

Patients’ rights. Legal protections for patients who want a vaccinated health care provider are nowhere to be seen, at this time. It is unlikely that a single patient will be able to convince a hospital or medical practice to require that its staff be vaccinated. However, if a patient becomes infected with COVID-19 and can prove that the illness is causally related to interacting with an unvaccinated health care worker, the patient may have a case against the employer. The legal theory would be malpractice or negligence under informed consent law: That is, the patient did not consent to be treated by an unvaccinated person.
 

Employer options

So, what can health care employers do? They have three options:

• Require vaccination of all employees, independent contractors, and other providers who have privileges to see patients. Then, as long as the employer enforces the vaccination mandate, the employer can tell patients that all providers are vaccinated.
• Not require that employees and others with access to patients be vaccinated, and if a patient requests to be seen only by vaccinated providers, provide that patient with a vaccinated provider. It is especially important that health care employers take care with patients who are unvaccinated and who have been advised not to be vaccinated because of a medical condition. Both the patient and the health care employer would be protected best by avoiding having two unvaccinated individuals interact. Masks and physical distancing may decrease the risk.
• Not require that employees be vaccinated and refuse to guarantee that providers are vaccinated. To avoid risk for future lawsuits, employers should inform patients that there is no assurance that providers are vaccinated. That leaves it to each patient to ask individual providers about the provider’s vaccination status. If a patient doesn’t like a provider’s answer, then the patient has the right to leave. It’s not clear that the patient has a legal right to stay and demand a vaccinated provider.

Option three is problematic for a number of reasons. Patients aren’t always in a position to query each provider who enters the room about vaccination status. Patients may be sedated or too ill to exert that effort. And it puts supervisors in the position of having to mediate situations where a patient wants to leave against medical advice but the option of staying may also be dangerous.

Health care employers should discuss the options with their legal counsel before deciding which option to adopt.

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

Should a hospital or medical practice fulfill a patient’s request to be treated or cared for only by vaccinated health care providers?The answer is yes, in a perfect world. Patients should feel assured that their health care providers – clinicians and caregivers – are not exposing them to infectious diseases.But issues are being raised – subquestions that need to be answered to understand the current situation and assist health care employers in their decision-making:

• Must health care employers ensure that their employees are vaccinated?
• Can health care employers require that their employees be vaccinated?
• Do employees have any rights to refuse vaccination or to refuse to supply their employer with their vaccination status?
• Can a health care employer terminate an employee who refuses vaccination?
• Does a patient have a legal right to a vaccinated health care provider?

At present, federal policy says that employers may, but are not required to, insist that employees be vaccinated. The currently prevailing state case law says that hospitals and other employers can require staff to be vaccinated and can terminate employees who refuse vaccination. In June, a Texas court dismissed a case in which 117 employees sued a hospital for requiring that employees be vaccinated. More cases are pending in other states, and there may be differing decisions in other states and on appeal.

State laws enacted years ago also weigh in on employer obligations. In at least one state, Oregon, employers of health care providers may not require vaccination, even though other employers may. Other states have laws about what an employer may or may not require of an employee regarding vaccination, and some have introduced laws which are pending.

So, in most states, health care employers may, not must, require that employees be vaccinated. In most states, hospitals and medical practices may terminate employees who refuse vaccination. However, employers should research the laws of their own states before requiring vaccinations and before terminating employees who are not vaccinated.

The issue of employer mandates is complicated further by the practicality that, in some areas of the country, health care providers are in scarce supply. Employers don’t want to lose the providers they have.

And there are additional questions about how certain federal laws affect the situation. Federal law that may apply includes:

• U.S. Food and Drug Administration regulation on approval of vaccines
• The Americans With Disabilities Act (ADA)
• The Health Insurance Portability and Accountability Act of 1996, which protects sensitive patient health information from being disclosed without the patient’s consent
• Civil rights laws
• Patients’ rights

FDA. Some health care providers who refuse vaccination argue that employers have no legal right to require a vaccine that is not fully approved by the FDA. COVID-19 vaccinations have emergency use authorization – something less than full approval. Courts have not yet ruled on this issue.

ADA. Some attorneys believe that honoring a patient’s request to be attended only by a vaccinated health care provider can implicate the ADA. However, the ADA doesn’t protect healthy individuals who don’t want to be vaccinated. The ADA protects the person who, because of their disability, shouldn’t get the vaccination. If an employer mandates vaccination, the employer must, under the ADA, consider requests for exemptions from disabled individuals. However, even when an employee has a disability that may qualify the employee for an exemption to the vaccination requirement, an employer may argue that giving an exemption would be a direct threat to the safety of others; in that case, the ADA may require that the disabled employee and hospital work something out. A compromise might be that the unvaccinated disabled individual would not provide direct patient care or would wear a mask and maintain physical distance.

HIPAA. Some argue that federal privacy law enters into the discussion, maintaining that health care employers can’t disclose employees’ vaccination status under HIPAA. That is not true. Employers are not “covered entities” under HIPAA. It is health care providers who are precluded under HIPAA from disclosing a patient’s personal information. So, if an employer were to ask an employee’s health care provider about the employee’s vaccination status, the health care provider could disclose that status only if the employee consented to the disclosure. An employer may ask an employee for the employee’s proof of vaccination card. However, employers must not ask for unnecessary details that might reveal disability information protected by the ADA.

Civil rights law. Civil rights laws may protect certain individuals from employment consequences of refusing vaccination. Specifically, individuals with sincerely held religious convictions against vaccinations are protected from retaliation by employers for refusing vaccination, under the Constitutional right of freedom of religion. The individual without sincerely held religious convictions against vaccinations and without a relevant disability doesn’t have legal remedies under civil rights laws.

Civil rights laws may apply if employers don’t apply their vaccination requirements to all employees equally. That is, employers can’t require vaccinations of some employees but not others.

Patients’ rights. Legal protections for patients who want a vaccinated health care provider are nowhere to be seen, at this time. It is unlikely that a single patient will be able to convince a hospital or medical practice to require that its staff be vaccinated. However, if a patient becomes infected with COVID-19 and can prove that the illness is causally related to interacting with an unvaccinated health care worker, the patient may have a case against the employer. The legal theory would be malpractice or negligence under informed consent law: That is, the patient did not consent to be treated by an unvaccinated person.
 

Employer options

So, what can health care employers do? They have three options:

• Require vaccination of all employees, independent contractors, and other providers who have privileges to see patients. Then, as long as the employer enforces the vaccination mandate, the employer can tell patients that all providers are vaccinated.
• Not require that employees and others with access to patients be vaccinated, and if a patient requests to be seen only by vaccinated providers, provide that patient with a vaccinated provider. It is especially important that health care employers take care with patients who are unvaccinated and who have been advised not to be vaccinated because of a medical condition. Both the patient and the health care employer would be protected best by avoiding having two unvaccinated individuals interact. Masks and physical distancing may decrease the risk.
• Not require that employees be vaccinated and refuse to guarantee that providers are vaccinated. To avoid risk for future lawsuits, employers should inform patients that there is no assurance that providers are vaccinated. That leaves it to each patient to ask individual providers about the provider’s vaccination status. If a patient doesn’t like a provider’s answer, then the patient has the right to leave. It’s not clear that the patient has a legal right to stay and demand a vaccinated provider.

Option three is problematic for a number of reasons. Patients aren’t always in a position to query each provider who enters the room about vaccination status. Patients may be sedated or too ill to exert that effort. And it puts supervisors in the position of having to mediate situations where a patient wants to leave against medical advice but the option of staying may also be dangerous.

Health care employers should discuss the options with their legal counsel before deciding which option to adopt.

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

Should a hospital or medical practice fulfill a patient’s request to be treated or cared for only by vaccinated health care providers?The answer is yes, in a perfect world. Patients should feel assured that their health care providers – clinicians and caregivers – are not exposing them to infectious diseases.But issues are being raised – subquestions that need to be answered to understand the current situation and assist health care employers in their decision-making:

• Must health care employers ensure that their employees are vaccinated?
• Can health care employers require that their employees be vaccinated?
• Do employees have any rights to refuse vaccination or to refuse to supply their employer with their vaccination status?
• Can a health care employer terminate an employee who refuses vaccination?
• Does a patient have a legal right to a vaccinated health care provider?

At present, federal policy says that employers may, but are not required to, insist that employees be vaccinated. The currently prevailing state case law says that hospitals and other employers can require staff to be vaccinated and can terminate employees who refuse vaccination. In June, a Texas court dismissed a case in which 117 employees sued a hospital for requiring that employees be vaccinated. More cases are pending in other states, and there may be differing decisions in other states and on appeal.

State laws enacted years ago also weigh in on employer obligations. In at least one state, Oregon, employers of health care providers may not require vaccination, even though other employers may. Other states have laws about what an employer may or may not require of an employee regarding vaccination, and some have introduced laws which are pending.

So, in most states, health care employers may, not must, require that employees be vaccinated. In most states, hospitals and medical practices may terminate employees who refuse vaccination. However, employers should research the laws of their own states before requiring vaccinations and before terminating employees who are not vaccinated.

The issue of employer mandates is complicated further by the practicality that, in some areas of the country, health care providers are in scarce supply. Employers don’t want to lose the providers they have.

And there are additional questions about how certain federal laws affect the situation. Federal law that may apply includes:

• U.S. Food and Drug Administration regulation on approval of vaccines
• The Americans With Disabilities Act (ADA)
• The Health Insurance Portability and Accountability Act of 1996, which protects sensitive patient health information from being disclosed without the patient’s consent
• Civil rights laws
• Patients’ rights

FDA. Some health care providers who refuse vaccination argue that employers have no legal right to require a vaccine that is not fully approved by the FDA. COVID-19 vaccinations have emergency use authorization – something less than full approval. Courts have not yet ruled on this issue.

ADA. Some attorneys believe that honoring a patient’s request to be attended only by a vaccinated health care provider can implicate the ADA. However, the ADA doesn’t protect healthy individuals who don’t want to be vaccinated. The ADA protects the person who, because of their disability, shouldn’t get the vaccination. If an employer mandates vaccination, the employer must, under the ADA, consider requests for exemptions from disabled individuals. However, even when an employee has a disability that may qualify the employee for an exemption to the vaccination requirement, an employer may argue that giving an exemption would be a direct threat to the safety of others; in that case, the ADA may require that the disabled employee and hospital work something out. A compromise might be that the unvaccinated disabled individual would not provide direct patient care or would wear a mask and maintain physical distance.

HIPAA. Some argue that federal privacy law enters into the discussion, maintaining that health care employers can’t disclose employees’ vaccination status under HIPAA. That is not true. Employers are not “covered entities” under HIPAA. It is health care providers who are precluded under HIPAA from disclosing a patient’s personal information. So, if an employer were to ask an employee’s health care provider about the employee’s vaccination status, the health care provider could disclose that status only if the employee consented to the disclosure. An employer may ask an employee for the employee’s proof of vaccination card. However, employers must not ask for unnecessary details that might reveal disability information protected by the ADA.

Civil rights law. Civil rights laws may protect certain individuals from employment consequences of refusing vaccination. Specifically, individuals with sincerely held religious convictions against vaccinations are protected from retaliation by employers for refusing vaccination, under the Constitutional right of freedom of religion. The individual without sincerely held religious convictions against vaccinations and without a relevant disability doesn’t have legal remedies under civil rights laws.

Civil rights laws may apply if employers don’t apply their vaccination requirements to all employees equally. That is, employers can’t require vaccinations of some employees but not others.

Patients’ rights. Legal protections for patients who want a vaccinated health care provider are nowhere to be seen, at this time. It is unlikely that a single patient will be able to convince a hospital or medical practice to require that its staff be vaccinated. However, if a patient becomes infected with COVID-19 and can prove that the illness is causally related to interacting with an unvaccinated health care worker, the patient may have a case against the employer. The legal theory would be malpractice or negligence under informed consent law: That is, the patient did not consent to be treated by an unvaccinated person.
 

Employer options

So, what can health care employers do? They have three options:

• Require vaccination of all employees, independent contractors, and other providers who have privileges to see patients. Then, as long as the employer enforces the vaccination mandate, the employer can tell patients that all providers are vaccinated.
• Not require that employees and others with access to patients be vaccinated, and if a patient requests to be seen only by vaccinated providers, provide that patient with a vaccinated provider. It is especially important that health care employers take care with patients who are unvaccinated and who have been advised not to be vaccinated because of a medical condition. Both the patient and the health care employer would be protected best by avoiding having two unvaccinated individuals interact. Masks and physical distancing may decrease the risk.
• Not require that employees be vaccinated and refuse to guarantee that providers are vaccinated. To avoid risk for future lawsuits, employers should inform patients that there is no assurance that providers are vaccinated. That leaves it to each patient to ask individual providers about the provider’s vaccination status. If a patient doesn’t like a provider’s answer, then the patient has the right to leave. It’s not clear that the patient has a legal right to stay and demand a vaccinated provider.

Option three is problematic for a number of reasons. Patients aren’t always in a position to query each provider who enters the room about vaccination status. Patients may be sedated or too ill to exert that effort. And it puts supervisors in the position of having to mediate situations where a patient wants to leave against medical advice but the option of staying may also be dangerous.

Health care employers should discuss the options with their legal counsel before deciding which option to adopt.

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

Statins are associated with a low risk of adverse events in patients without a history of heart disease, but the potential harms are small and should not deter their use in primary prevention, a new systematic review and meta-analysis concludes.

RogerAshford/Thinkstock

As reported July 14 in BMJ, the analysis showed a slightly increased risk for self-reported muscle symptoms after treatment with statins but no increased risk for clinically confirmed muscle disorders. Statins were associated with liver dysfunction, renal insufficiency, and eye conditions, but not with diabetes.

“These risks are very, very small and, in fact, the adverse events we’re talking about are potentially quite mild, so if you weigh them against the benefits in terms of reduction in major cardiovascular events, the benefit-to-harm ratio is very much in favor of prescribing treatment for almost all patients,” senior author James P. Sheppard, MD, University of Oxford (England), said in an interview.

Although there’s an abundance of data showing that statins prevent recurrent cardiovascular events, their use is controversial in primary prevention, owing partly to the lower risk for cardiovascular disease (CVD). The absolute benefits of statins are smaller in primary prevention than in those with existing CVD, and the benefit-to-harm balance of treatment might be less favorable, the authors note.

A 2019 review suggested that the use of statins in primary prevention may be an example of “low-value care, having little benefit and potential to cause harm,” and a meta-analysis with more than 94,000 trial participants showed statins significantly increased risks for myopathy, renal dysfunction, and hepatic dysfunction.

Nevertheless, clinical guidelines have recommended wider use of statins for primary prevention, calling on physicians to weigh the benefits and harms.

“This is a reasonable expectation but, at present, the data on the harms of treatment are much less well understood in comparison to the benefits and there’s quite a lot of debate about the extent to which statins are associated with adverse events,” Dr. Sheppard said. “So we wanted to look at this in a bit more detail.”

The investigators analyzed results from 62 randomized controlled trials with 120,456 participants (mean age, 61; 40% women) followed for a mean of 3.9 years. All but two studies enrolled participants with hyperlipidemia or dyslipidemia. Common comorbidities were diabetes (11 studies), asymptomatic atherosclerosis (nine studies), and hypertension (four studies).

Statins increased risks for self-reported muscle symptoms in 21 trials (odds ratio [OR], 1.06), liver dysfunction in 21 trials (OR, 1.33), renal insufficiency in eight trials (OR, 1.14), and cataracts or other eye-related conditions in six trials (OR, 1.23).

At the same time, statins decreased risks for myocardial infarction in 22 trials (OR, 0.72), stroke in 17 trials (OR, 0.80), and CVD death in 22 trials (OR, 0.83).

These risks translated into 15 more events of muscle symptoms, 8 more liver events, 12 more kidney events, and 14 more eye conditions per 10,000 patients treated for a year.

Statins were estimated to prevent 19 myocardial infarctions, 9 strokes, and 8 CVD deaths per 10,000 patients treated for a year.

Dr. Sheppard suggested that the inclusion of previously omitted trials and the decision to classify muscle problems as self-reported symptoms or clinically defined muscle disorders based on changes in creatine kinase might explain why they found the association with statins, whereas most systematic reviews have not.

“Some people would argue that these side effects are so small and so negligible that we shouldn’t talk about them, but the problem with doing that is if you’ve got a patient who has a preconceived idea that statins are harmful,” he added. “So having some empirical data where you can actually say: ‘Look, just 15 people out of 10,000 patients who’ve been treated for a year might experience one of those self-reported muscle symptoms,’ hopefully, will be helpful for physicians having discussions in practice.”

The analysis is “another data point indicating the overall safety and net benefit of statins for patients, even in primary prevention,” Donald M. Lloyd-Jones, MD, ScM, chair of preventive medicine, Northwestern University, Chicago, said in an interview.

He noted that the renal insufficiency findings are difficult to interpret, given that the endpoint was defined as “any decline in renal function,” but that most will have been clinically unimportant. In general, most studies didn’t systematically look to ascertain some of adverse events but relied on participant or physician report. “Nonetheless, there is little reason to suspect bias in the collection of these data among the blinded studies.

“Although not definitive, given the study design and inclusion of very different types of studies and variable ascertainment of adverse events, the findings are reassuring that the risks of adverse events were small, and the potential adverse events identified were not very clinically significant and clearly outweighed by the important beneficial reductions in major cardiovascular events,” said Dr. Lloyd-Jones.

“This study is yet another reminder of the safety of statins,” Ann Marie Navar, MD, PhD, a specialist in preventive cardiology at UT Southwestern Medical School, Dallas, said in an email.

“I’m pleased to have a comprehensive study like this – a well-done, systematic review of randomized trials – to help combat the vast amounts of misinformation about statins circulating on the Internet.”

Dr. Lloyd-Jones also acknowledged the need to address misinformation, pointing out that the loss of contact with physicians and the adverse effects of the pandemic on weight and other health behaviors mean that many patients have had worsening of their cardiovascular risk factors.

“We must continue to help patients and the public understand that statins are beneficial for patients at sufficient risk for cardiovascular disease because of elevated cholesterol or their total burden of risk factors,” Dr. Lloyd-Jones said. “We must also be upfront about the risks of potential side effects, which are uncommon and almost always very easily managed with washout and dose reduction or switching to a different drug in the same class.”

Analyses by type of statin, however, showed few significant differences in adverse events. Rosuvastatin was associated with increased risks for self-reported muscle symptoms, renal insufficiency, diabetes, and eye conditions, whereas atorvastatin and lovastatin increased the risk for liver dysfunction.

In dose-response meta-analyses, a possible modest dose-response relationship was detected only for the effect of atorvastatin on liver dysfunction.

The current data do not support tailoring the type of statin or dosage to reduce adverse events, the authors say, although routine monitoring of liver function during treatment is probably warranted in primary prevention, given the increased risk for liver dysfunction.

To help improve adherence to statins, the investigators said, additional studies are needed to identify patient characteristics crucial to the small risks of adverse events.

Limitations of the research, they said, are that many of the analyses were underpowered to detect between-group differences, many trials had short periods of follow-up, and some trials excluded vulnerable people more likely to have adverse events, such as those with high serum creatinine.

The study was funded by a British Heart Foundation PhD Scholarship held by first author Ting Cai. Dr. Sheppard reports receiving funding from a Wellcome Trust/Royal Society Sir Henry Dale Fellowship. Disclosures for other authors are listed in the paper. Dr. Lloyd-Jones and Dr. Navar report having no conflicts of interest.

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

Statins are associated with a low risk of adverse events in patients without a history of heart disease, but the potential harms are small and should not deter their use in primary prevention, a new systematic review and meta-analysis concludes.

RogerAshford/Thinkstock

As reported July 14 in BMJ, the analysis showed a slightly increased risk for self-reported muscle symptoms after treatment with statins but no increased risk for clinically confirmed muscle disorders. Statins were associated with liver dysfunction, renal insufficiency, and eye conditions, but not with diabetes.

“These risks are very, very small and, in fact, the adverse events we’re talking about are potentially quite mild, so if you weigh them against the benefits in terms of reduction in major cardiovascular events, the benefit-to-harm ratio is very much in favor of prescribing treatment for almost all patients,” senior author James P. Sheppard, MD, University of Oxford (England), said in an interview.

Although there’s an abundance of data showing that statins prevent recurrent cardiovascular events, their use is controversial in primary prevention, owing partly to the lower risk for cardiovascular disease (CVD). The absolute benefits of statins are smaller in primary prevention than in those with existing CVD, and the benefit-to-harm balance of treatment might be less favorable, the authors note.

A 2019 review suggested that the use of statins in primary prevention may be an example of “low-value care, having little benefit and potential to cause harm,” and a meta-analysis with more than 94,000 trial participants showed statins significantly increased risks for myopathy, renal dysfunction, and hepatic dysfunction.

Nevertheless, clinical guidelines have recommended wider use of statins for primary prevention, calling on physicians to weigh the benefits and harms.

“This is a reasonable expectation but, at present, the data on the harms of treatment are much less well understood in comparison to the benefits and there’s quite a lot of debate about the extent to which statins are associated with adverse events,” Dr. Sheppard said. “So we wanted to look at this in a bit more detail.”

The investigators analyzed results from 62 randomized controlled trials with 120,456 participants (mean age, 61; 40% women) followed for a mean of 3.9 years. All but two studies enrolled participants with hyperlipidemia or dyslipidemia. Common comorbidities were diabetes (11 studies), asymptomatic atherosclerosis (nine studies), and hypertension (four studies).

Statins increased risks for self-reported muscle symptoms in 21 trials (odds ratio [OR], 1.06), liver dysfunction in 21 trials (OR, 1.33), renal insufficiency in eight trials (OR, 1.14), and cataracts or other eye-related conditions in six trials (OR, 1.23).

At the same time, statins decreased risks for myocardial infarction in 22 trials (OR, 0.72), stroke in 17 trials (OR, 0.80), and CVD death in 22 trials (OR, 0.83).

These risks translated into 15 more events of muscle symptoms, 8 more liver events, 12 more kidney events, and 14 more eye conditions per 10,000 patients treated for a year.

Statins were estimated to prevent 19 myocardial infarctions, 9 strokes, and 8 CVD deaths per 10,000 patients treated for a year.

Dr. Sheppard suggested that the inclusion of previously omitted trials and the decision to classify muscle problems as self-reported symptoms or clinically defined muscle disorders based on changes in creatine kinase might explain why they found the association with statins, whereas most systematic reviews have not.

“Some people would argue that these side effects are so small and so negligible that we shouldn’t talk about them, but the problem with doing that is if you’ve got a patient who has a preconceived idea that statins are harmful,” he added. “So having some empirical data where you can actually say: ‘Look, just 15 people out of 10,000 patients who’ve been treated for a year might experience one of those self-reported muscle symptoms,’ hopefully, will be helpful for physicians having discussions in practice.”

The analysis is “another data point indicating the overall safety and net benefit of statins for patients, even in primary prevention,” Donald M. Lloyd-Jones, MD, ScM, chair of preventive medicine, Northwestern University, Chicago, said in an interview.

He noted that the renal insufficiency findings are difficult to interpret, given that the endpoint was defined as “any decline in renal function,” but that most will have been clinically unimportant. In general, most studies didn’t systematically look to ascertain some of adverse events but relied on participant or physician report. “Nonetheless, there is little reason to suspect bias in the collection of these data among the blinded studies.

“Although not definitive, given the study design and inclusion of very different types of studies and variable ascertainment of adverse events, the findings are reassuring that the risks of adverse events were small, and the potential adverse events identified were not very clinically significant and clearly outweighed by the important beneficial reductions in major cardiovascular events,” said Dr. Lloyd-Jones.

“This study is yet another reminder of the safety of statins,” Ann Marie Navar, MD, PhD, a specialist in preventive cardiology at UT Southwestern Medical School, Dallas, said in an email.

“I’m pleased to have a comprehensive study like this – a well-done, systematic review of randomized trials – to help combat the vast amounts of misinformation about statins circulating on the Internet.”

Dr. Lloyd-Jones also acknowledged the need to address misinformation, pointing out that the loss of contact with physicians and the adverse effects of the pandemic on weight and other health behaviors mean that many patients have had worsening of their cardiovascular risk factors.

“We must continue to help patients and the public understand that statins are beneficial for patients at sufficient risk for cardiovascular disease because of elevated cholesterol or their total burden of risk factors,” Dr. Lloyd-Jones said. “We must also be upfront about the risks of potential side effects, which are uncommon and almost always very easily managed with washout and dose reduction or switching to a different drug in the same class.”

Analyses by type of statin, however, showed few significant differences in adverse events. Rosuvastatin was associated with increased risks for self-reported muscle symptoms, renal insufficiency, diabetes, and eye conditions, whereas atorvastatin and lovastatin increased the risk for liver dysfunction.

In dose-response meta-analyses, a possible modest dose-response relationship was detected only for the effect of atorvastatin on liver dysfunction.

The current data do not support tailoring the type of statin or dosage to reduce adverse events, the authors say, although routine monitoring of liver function during treatment is probably warranted in primary prevention, given the increased risk for liver dysfunction.

To help improve adherence to statins, the investigators said, additional studies are needed to identify patient characteristics crucial to the small risks of adverse events.

Limitations of the research, they said, are that many of the analyses were underpowered to detect between-group differences, many trials had short periods of follow-up, and some trials excluded vulnerable people more likely to have adverse events, such as those with high serum creatinine.

The study was funded by a British Heart Foundation PhD Scholarship held by first author Ting Cai. Dr. Sheppard reports receiving funding from a Wellcome Trust/Royal Society Sir Henry Dale Fellowship. Disclosures for other authors are listed in the paper. Dr. Lloyd-Jones and Dr. Navar report having no conflicts of interest.

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

Statins are associated with a low risk of adverse events in patients without a history of heart disease, but the potential harms are small and should not deter their use in primary prevention, a new systematic review and meta-analysis concludes.

RogerAshford/Thinkstock

As reported July 14 in BMJ, the analysis showed a slightly increased risk for self-reported muscle symptoms after treatment with statins but no increased risk for clinically confirmed muscle disorders. Statins were associated with liver dysfunction, renal insufficiency, and eye conditions, but not with diabetes.

“These risks are very, very small and, in fact, the adverse events we’re talking about are potentially quite mild, so if you weigh them against the benefits in terms of reduction in major cardiovascular events, the benefit-to-harm ratio is very much in favor of prescribing treatment for almost all patients,” senior author James P. Sheppard, MD, University of Oxford (England), said in an interview.

Although there’s an abundance of data showing that statins prevent recurrent cardiovascular events, their use is controversial in primary prevention, owing partly to the lower risk for cardiovascular disease (CVD). The absolute benefits of statins are smaller in primary prevention than in those with existing CVD, and the benefit-to-harm balance of treatment might be less favorable, the authors note.

A 2019 review suggested that the use of statins in primary prevention may be an example of “low-value care, having little benefit and potential to cause harm,” and a meta-analysis with more than 94,000 trial participants showed statins significantly increased risks for myopathy, renal dysfunction, and hepatic dysfunction.

Nevertheless, clinical guidelines have recommended wider use of statins for primary prevention, calling on physicians to weigh the benefits and harms.

“This is a reasonable expectation but, at present, the data on the harms of treatment are much less well understood in comparison to the benefits and there’s quite a lot of debate about the extent to which statins are associated with adverse events,” Dr. Sheppard said. “So we wanted to look at this in a bit more detail.”

The investigators analyzed results from 62 randomized controlled trials with 120,456 participants (mean age, 61; 40% women) followed for a mean of 3.9 years. All but two studies enrolled participants with hyperlipidemia or dyslipidemia. Common comorbidities were diabetes (11 studies), asymptomatic atherosclerosis (nine studies), and hypertension (four studies).

Statins increased risks for self-reported muscle symptoms in 21 trials (odds ratio [OR], 1.06), liver dysfunction in 21 trials (OR, 1.33), renal insufficiency in eight trials (OR, 1.14), and cataracts or other eye-related conditions in six trials (OR, 1.23).

At the same time, statins decreased risks for myocardial infarction in 22 trials (OR, 0.72), stroke in 17 trials (OR, 0.80), and CVD death in 22 trials (OR, 0.83).

These risks translated into 15 more events of muscle symptoms, 8 more liver events, 12 more kidney events, and 14 more eye conditions per 10,000 patients treated for a year.

Statins were estimated to prevent 19 myocardial infarctions, 9 strokes, and 8 CVD deaths per 10,000 patients treated for a year.

Dr. Sheppard suggested that the inclusion of previously omitted trials and the decision to classify muscle problems as self-reported symptoms or clinically defined muscle disorders based on changes in creatine kinase might explain why they found the association with statins, whereas most systematic reviews have not.

“Some people would argue that these side effects are so small and so negligible that we shouldn’t talk about them, but the problem with doing that is if you’ve got a patient who has a preconceived idea that statins are harmful,” he added. “So having some empirical data where you can actually say: ‘Look, just 15 people out of 10,000 patients who’ve been treated for a year might experience one of those self-reported muscle symptoms,’ hopefully, will be helpful for physicians having discussions in practice.”

The analysis is “another data point indicating the overall safety and net benefit of statins for patients, even in primary prevention,” Donald M. Lloyd-Jones, MD, ScM, chair of preventive medicine, Northwestern University, Chicago, said in an interview.

He noted that the renal insufficiency findings are difficult to interpret, given that the endpoint was defined as “any decline in renal function,” but that most will have been clinically unimportant. In general, most studies didn’t systematically look to ascertain some of adverse events but relied on participant or physician report. “Nonetheless, there is little reason to suspect bias in the collection of these data among the blinded studies.

“Although not definitive, given the study design and inclusion of very different types of studies and variable ascertainment of adverse events, the findings are reassuring that the risks of adverse events were small, and the potential adverse events identified were not very clinically significant and clearly outweighed by the important beneficial reductions in major cardiovascular events,” said Dr. Lloyd-Jones.

“This study is yet another reminder of the safety of statins,” Ann Marie Navar, MD, PhD, a specialist in preventive cardiology at UT Southwestern Medical School, Dallas, said in an email.

“I’m pleased to have a comprehensive study like this – a well-done, systematic review of randomized trials – to help combat the vast amounts of misinformation about statins circulating on the Internet.”

Dr. Lloyd-Jones also acknowledged the need to address misinformation, pointing out that the loss of contact with physicians and the adverse effects of the pandemic on weight and other health behaviors mean that many patients have had worsening of their cardiovascular risk factors.

“We must continue to help patients and the public understand that statins are beneficial for patients at sufficient risk for cardiovascular disease because of elevated cholesterol or their total burden of risk factors,” Dr. Lloyd-Jones said. “We must also be upfront about the risks of potential side effects, which are uncommon and almost always very easily managed with washout and dose reduction or switching to a different drug in the same class.”

Analyses by type of statin, however, showed few significant differences in adverse events. Rosuvastatin was associated with increased risks for self-reported muscle symptoms, renal insufficiency, diabetes, and eye conditions, whereas atorvastatin and lovastatin increased the risk for liver dysfunction.

In dose-response meta-analyses, a possible modest dose-response relationship was detected only for the effect of atorvastatin on liver dysfunction.

The current data do not support tailoring the type of statin or dosage to reduce adverse events, the authors say, although routine monitoring of liver function during treatment is probably warranted in primary prevention, given the increased risk for liver dysfunction.

To help improve adherence to statins, the investigators said, additional studies are needed to identify patient characteristics crucial to the small risks of adverse events.

Limitations of the research, they said, are that many of the analyses were underpowered to detect between-group differences, many trials had short periods of follow-up, and some trials excluded vulnerable people more likely to have adverse events, such as those with high serum creatinine.

The study was funded by a British Heart Foundation PhD Scholarship held by first author Ting Cai. Dr. Sheppard reports receiving funding from a Wellcome Trust/Royal Society Sir Henry Dale Fellowship. Disclosures for other authors are listed in the paper. Dr. Lloyd-Jones and Dr. Navar report having no conflicts of interest.

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

Only 1 child from a cohort of 45 children hospitalized with multisystem inflammatory syndrome following COVID-19 infection had persistent mild cardiac dysfunction after 9 months, according to data from patients younger than 21 years seen at a single center in 2020.

In a study published in Pediatrics, Kanwal M. Farooqi, MD, of Columbia University, New York, and colleagues provided the first report on longitudinal cardiac and immunologic outcomes in North American children hospitalized with multisystem inflammatory syndrome (MIS-C). In response to the COVID-19 pandemic, clinicians at New York–Presbyterian Hospital consolidated pediatric admissions and developed an interdisciplinary inpatient and outpatient MIS-C follow-up program to monitor cardiac and immunologic outcomes in their patients.

The study included all children younger than 21 years admitted to Columbia University Irving Medical Center/New York–Presbyterian Morgan Stanley Children’s Hospital for MIS-C in 2020. The median age of the patients was 9 years, and the median length of hospital stay was 5 days. Follow-up visits occurred at 1-4 weeks (average 2 weeks), 1-4 months (average 2 months), and 4-9 months (average 6 months) after hospital discharge. Follow-up visits included echocardiograms and measures of inflammatory markers.

Most of the children (84%) had no underlying medical conditions, but 24% presented with some level of respiratory distress or oxygen requirement, and 64% had vasodilatory shock. In addition, 80% had at least mild cardiac abnormalities and 66% had significant lymphopenia on admission.

Inflammatory profiles on admission showed elevation of C-reactive protein, ferritin, and D-dimer in 87%-98% of the patients. Consistent with cardiac involvement, 64% of the patients also had elevated troponin levels, and 91% had elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.

“These parameters peaked at or shortly after admission and then gradually normalized,” the researchers said. “By the first follow-up, [C-reactive protein], troponin, and NT-proBNP had normalized in nearly all tested patients (97%-100%),” they noted.

By the first follow-up period at 1-4 weeks, all patients had normal coronary arteries, and 18% (seven patients) had mild echocardiographic findings. However, approximately one-third (32%) of the patients had persistent lymphocytosis at 1-4 weeks, and 23 of the 24 patients assessed had elevated double-negative T cells, which persisted in 96% of the patients at 1-4 months’ follow-up. However, during the last follow-up of 4-9 months, only one patient had persistent mild biventricular dysfunction and a second patient had mild mitral and tricuspid valve regurgitation.

All patients were treated with steroids and immunoglobulins (2 g/kg), as well as enoxaparin prophylaxis or low-dose aspirin and GI prophylaxis. Treatment with methylprednisolone varied based on disease severity; patients with mild presentation received 2 mg/kg per day; those with moderate presentation received a methylprednisolone pulse of 10 mg/kg per day, followed by 2 mg/kg per day; those with severe disease received methylprednisolone at 20-30 mg/kg per day for 1-3 days, followed by 2 mg/kg per day.

“Aggressive use of steroids may also explain the lower incidence of coronary artery abnormalities in our cohort,” the researchers noted.

The study findings were limited by the observational design and inability to make definitive conclusions about treatment and outcomes, as well as the evolving case definitions for MIS-C, the researchers said.

The persistence of double-negative T cells was surprising, and “likely represent a prolonged postinflammatory recovery cell population, but further study is ongoing to better define this observation,” they noted.

“Our study reveals generally encouraging medium-term outcomes, including rapid normalization of inflammatory markers and significant cardiac abnormalities in the majority of patients with MIS-C,” the researchers said. “The exact nature and potential for long-term cardiac fibrosis, exercise intolerance, or other changes remain unknown,” and long-term caution and follow-up are recommended, they concluded.
 

Cautious optimism, long-term monitoring

The study is important to provide guidance for clinicians on how to manage their patients who have been hospitalized with MIS-C, said Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H.

“It was both surprising and reassuring to see that so many of the patients had positive outcomes in terms of cardiac function and that during the acute stage there were no deaths,” said Dr. Boulter. “Hospitalizations were brief, averaging just 5 days. The patients had many symptoms, but unlike adults, there was not a preponderance of underlying risk factors in this cohort of patients,” she said.

The results suggest optimism for MIS-C patients in that they generally recover, but the take-home message for clinicians is that these patients will require careful monitoring for long-term issues, Dr. Boulter said.

“These patients should be followed for years to assess long-term effects on morbidity and mortality,” Dr. Boulter emphasized.

The study was funded by Genentech. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Only 1 child from a cohort of 45 children hospitalized with multisystem inflammatory syndrome following COVID-19 infection had persistent mild cardiac dysfunction after 9 months, according to data from patients younger than 21 years seen at a single center in 2020.

In a study published in Pediatrics, Kanwal M. Farooqi, MD, of Columbia University, New York, and colleagues provided the first report on longitudinal cardiac and immunologic outcomes in North American children hospitalized with multisystem inflammatory syndrome (MIS-C). In response to the COVID-19 pandemic, clinicians at New York–Presbyterian Hospital consolidated pediatric admissions and developed an interdisciplinary inpatient and outpatient MIS-C follow-up program to monitor cardiac and immunologic outcomes in their patients.

The study included all children younger than 21 years admitted to Columbia University Irving Medical Center/New York–Presbyterian Morgan Stanley Children’s Hospital for MIS-C in 2020. The median age of the patients was 9 years, and the median length of hospital stay was 5 days. Follow-up visits occurred at 1-4 weeks (average 2 weeks), 1-4 months (average 2 months), and 4-9 months (average 6 months) after hospital discharge. Follow-up visits included echocardiograms and measures of inflammatory markers.

Most of the children (84%) had no underlying medical conditions, but 24% presented with some level of respiratory distress or oxygen requirement, and 64% had vasodilatory shock. In addition, 80% had at least mild cardiac abnormalities and 66% had significant lymphopenia on admission.

Inflammatory profiles on admission showed elevation of C-reactive protein, ferritin, and D-dimer in 87%-98% of the patients. Consistent with cardiac involvement, 64% of the patients also had elevated troponin levels, and 91% had elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.

“These parameters peaked at or shortly after admission and then gradually normalized,” the researchers said. “By the first follow-up, [C-reactive protein], troponin, and NT-proBNP had normalized in nearly all tested patients (97%-100%),” they noted.

By the first follow-up period at 1-4 weeks, all patients had normal coronary arteries, and 18% (seven patients) had mild echocardiographic findings. However, approximately one-third (32%) of the patients had persistent lymphocytosis at 1-4 weeks, and 23 of the 24 patients assessed had elevated double-negative T cells, which persisted in 96% of the patients at 1-4 months’ follow-up. However, during the last follow-up of 4-9 months, only one patient had persistent mild biventricular dysfunction and a second patient had mild mitral and tricuspid valve regurgitation.

All patients were treated with steroids and immunoglobulins (2 g/kg), as well as enoxaparin prophylaxis or low-dose aspirin and GI prophylaxis. Treatment with methylprednisolone varied based on disease severity; patients with mild presentation received 2 mg/kg per day; those with moderate presentation received a methylprednisolone pulse of 10 mg/kg per day, followed by 2 mg/kg per day; those with severe disease received methylprednisolone at 20-30 mg/kg per day for 1-3 days, followed by 2 mg/kg per day.

“Aggressive use of steroids may also explain the lower incidence of coronary artery abnormalities in our cohort,” the researchers noted.

The study findings were limited by the observational design and inability to make definitive conclusions about treatment and outcomes, as well as the evolving case definitions for MIS-C, the researchers said.

The persistence of double-negative T cells was surprising, and “likely represent a prolonged postinflammatory recovery cell population, but further study is ongoing to better define this observation,” they noted.

“Our study reveals generally encouraging medium-term outcomes, including rapid normalization of inflammatory markers and significant cardiac abnormalities in the majority of patients with MIS-C,” the researchers said. “The exact nature and potential for long-term cardiac fibrosis, exercise intolerance, or other changes remain unknown,” and long-term caution and follow-up are recommended, they concluded.
 

Cautious optimism, long-term monitoring

The study is important to provide guidance for clinicians on how to manage their patients who have been hospitalized with MIS-C, said Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H.

“It was both surprising and reassuring to see that so many of the patients had positive outcomes in terms of cardiac function and that during the acute stage there were no deaths,” said Dr. Boulter. “Hospitalizations were brief, averaging just 5 days. The patients had many symptoms, but unlike adults, there was not a preponderance of underlying risk factors in this cohort of patients,” she said.

The results suggest optimism for MIS-C patients in that they generally recover, but the take-home message for clinicians is that these patients will require careful monitoring for long-term issues, Dr. Boulter said.

“These patients should be followed for years to assess long-term effects on morbidity and mortality,” Dr. Boulter emphasized.

The study was funded by Genentech. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Only 1 child from a cohort of 45 children hospitalized with multisystem inflammatory syndrome following COVID-19 infection had persistent mild cardiac dysfunction after 9 months, according to data from patients younger than 21 years seen at a single center in 2020.

In a study published in Pediatrics, Kanwal M. Farooqi, MD, of Columbia University, New York, and colleagues provided the first report on longitudinal cardiac and immunologic outcomes in North American children hospitalized with multisystem inflammatory syndrome (MIS-C). In response to the COVID-19 pandemic, clinicians at New York–Presbyterian Hospital consolidated pediatric admissions and developed an interdisciplinary inpatient and outpatient MIS-C follow-up program to monitor cardiac and immunologic outcomes in their patients.

The study included all children younger than 21 years admitted to Columbia University Irving Medical Center/New York–Presbyterian Morgan Stanley Children’s Hospital for MIS-C in 2020. The median age of the patients was 9 years, and the median length of hospital stay was 5 days. Follow-up visits occurred at 1-4 weeks (average 2 weeks), 1-4 months (average 2 months), and 4-9 months (average 6 months) after hospital discharge. Follow-up visits included echocardiograms and measures of inflammatory markers.

Most of the children (84%) had no underlying medical conditions, but 24% presented with some level of respiratory distress or oxygen requirement, and 64% had vasodilatory shock. In addition, 80% had at least mild cardiac abnormalities and 66% had significant lymphopenia on admission.

Inflammatory profiles on admission showed elevation of C-reactive protein, ferritin, and D-dimer in 87%-98% of the patients. Consistent with cardiac involvement, 64% of the patients also had elevated troponin levels, and 91% had elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.

“These parameters peaked at or shortly after admission and then gradually normalized,” the researchers said. “By the first follow-up, [C-reactive protein], troponin, and NT-proBNP had normalized in nearly all tested patients (97%-100%),” they noted.

By the first follow-up period at 1-4 weeks, all patients had normal coronary arteries, and 18% (seven patients) had mild echocardiographic findings. However, approximately one-third (32%) of the patients had persistent lymphocytosis at 1-4 weeks, and 23 of the 24 patients assessed had elevated double-negative T cells, which persisted in 96% of the patients at 1-4 months’ follow-up. However, during the last follow-up of 4-9 months, only one patient had persistent mild biventricular dysfunction and a second patient had mild mitral and tricuspid valve regurgitation.

All patients were treated with steroids and immunoglobulins (2 g/kg), as well as enoxaparin prophylaxis or low-dose aspirin and GI prophylaxis. Treatment with methylprednisolone varied based on disease severity; patients with mild presentation received 2 mg/kg per day; those with moderate presentation received a methylprednisolone pulse of 10 mg/kg per day, followed by 2 mg/kg per day; those with severe disease received methylprednisolone at 20-30 mg/kg per day for 1-3 days, followed by 2 mg/kg per day.

“Aggressive use of steroids may also explain the lower incidence of coronary artery abnormalities in our cohort,” the researchers noted.

The study findings were limited by the observational design and inability to make definitive conclusions about treatment and outcomes, as well as the evolving case definitions for MIS-C, the researchers said.

The persistence of double-negative T cells was surprising, and “likely represent a prolonged postinflammatory recovery cell population, but further study is ongoing to better define this observation,” they noted.

“Our study reveals generally encouraging medium-term outcomes, including rapid normalization of inflammatory markers and significant cardiac abnormalities in the majority of patients with MIS-C,” the researchers said. “The exact nature and potential for long-term cardiac fibrosis, exercise intolerance, or other changes remain unknown,” and long-term caution and follow-up are recommended, they concluded.
 

Cautious optimism, long-term monitoring

The study is important to provide guidance for clinicians on how to manage their patients who have been hospitalized with MIS-C, said Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H.

“It was both surprising and reassuring to see that so many of the patients had positive outcomes in terms of cardiac function and that during the acute stage there were no deaths,” said Dr. Boulter. “Hospitalizations were brief, averaging just 5 days. The patients had many symptoms, but unlike adults, there was not a preponderance of underlying risk factors in this cohort of patients,” she said.

The results suggest optimism for MIS-C patients in that they generally recover, but the take-home message for clinicians is that these patients will require careful monitoring for long-term issues, Dr. Boulter said.

“These patients should be followed for years to assess long-term effects on morbidity and mortality,” Dr. Boulter emphasized.

The study was funded by Genentech. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

In what could be a model for other states, Texas has become the first state to exempt physicians from prior authorizations for meeting insurer benchmarks.

The law was passed in June and will take effect in September. It excuses physicians from having to obtain prior authorization if, during the previous 6 months, 90% of their treatments met medical necessity criteria by the health insurer. Through this law, doctors in the state will spend less time getting approvals for treatments for their patients.

Automatic approval of authorizations for treatments – or what the Texas Medical Association (TMA) calls a “gold card” – “allows patients to get the care they need in a more timely fashion,” says Debra Patt, MD, an Austin, Tex.–based oncologist and former chair of the council on legislation for the TMA.

Eighty-seven percent of Texas physicians reported a “drastic increase over the past five years in the burden of prior authorization on their patients and their practices,” per a 2020 survey by the TMA. Nearly half (48%) of Texas physicians have hired staff whose work focuses on processing requests for prior authorization, according to the survey.

Jack Resneck Jr., MD, a San Francisco–based dermatologist and president-elect of the American Medical Association (AMA), said other states have investigated ways to ease the impact of prior authorizations on physicians, but no other state has passed such a law.

Administrative burdens plague physicians around the country. The Medscape Physician Compensation Report 2021 found that physicians spend on average 15.6 hours per week on paperwork and administrative duties.
 

Better outcomes, less anxiety for patients

Dr. Patt, who testified in support of the law’s passage in the Texas legislature, says automatic approval of authorizations “is better for patients because it reduces their anxiety about whether they’re able to get the treatments they need now, and they will have better outcomes if they’re able to receive more timely care.”

Recently, a chemotherapy treatment Dr. Patt prescribed for one of her patients was not authorized by an insurer. The result is “a lot of anxiety and potentially health problems” for the patient, said Dr. Patt.

She expects that automatic approval for treatments will be based on prescribing patterns during the preceding 6 months. “It means that when I order a test today, the [health insurer] looks back at my record 6 months previously,” she said. Still, Dr. Patt awaits guidance from the Texas Department of Insurance, which regulates health insurers in the state, regarding the law.

Dr. Resneck said the pharmacy counter is where most patients encounter prior authorization delays. “That’s when the pharmacist looks at them and says, ‘Actually, this isn’t covered by your health insurer’s formulary,’ or it isn’t covered fully on their formulary.”

One of Dr. Resneck’s patients had a life-altering case of eczema that lasted many years. Because of the condition, the patient couldn’t work or maintain meaningful bonds with family members. A biologic treatment transformed his patient’s life. The patient was able to return to work and to re-engage with family, said Dr. Resneck. But a year after his patient started the treatment, the health insurer wouldn’t authorize the treatment because the patient wasn’t experiencing the same symptoms.

The patient didn’t have the same symptoms because the biologic treatment worked, said Dr. Resneck.

Kristine Grow, a spokesperson for America’s Health Insurance Plans, a national association for health insurers, said, “The use of prior authorization is relatively small – typically, less than 15% – and can help ensure safer opioid prescribing, help prevent dangerous drug interactions, and help protect patients from unnecessary exposure to potentially harmful radiation for inappropriate diagnostic imaging. Numerous studies show that Americans frequently receive inappropriate care, and 25% of unnecessary treatments are associated with complications or adverse events.”

Medical management tools, such as prior authorization, are an “an important way” to deliver “safe, high-quality care” to patients, she added.
 

State and federal efforts to curb prior authorization

In addition to efforts to curb prior authorization in other states, the AMA supports the Improving Seniors’ Timely Access to Care Act (HR 3173). The act includes a provision related to “gold-carding,” said Robert Mills, an AMA spokesperson.

The bill establishes requirements and standards for prior authorization processes related to Medicare Advantage (MA) plans. The requirements and standards for MA plans include the following:

• Establishing an electronic prior authorization program that meets specific standards, such as the ability to provide real-time decisions in response to requests for items and services that are routinely approved.
• Publishing on an annual basis specific prior authorization information, including the percentage of requests approved and the average response time.
• Meeting standards set by the Centers for Medicare & Medicaid Services related to the quality and timeliness of prior authorization determinations.

The act was introduced to the U.S. House of Representatives in May, after which it was referred to two committees for consideration.

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

In what could be a model for other states, Texas has become the first state to exempt physicians from prior authorizations for meeting insurer benchmarks.

The law was passed in June and will take effect in September. It excuses physicians from having to obtain prior authorization if, during the previous 6 months, 90% of their treatments met medical necessity criteria by the health insurer. Through this law, doctors in the state will spend less time getting approvals for treatments for their patients.

Automatic approval of authorizations for treatments – or what the Texas Medical Association (TMA) calls a “gold card” – “allows patients to get the care they need in a more timely fashion,” says Debra Patt, MD, an Austin, Tex.–based oncologist and former chair of the council on legislation for the TMA.

Eighty-seven percent of Texas physicians reported a “drastic increase over the past five years in the burden of prior authorization on their patients and their practices,” per a 2020 survey by the TMA. Nearly half (48%) of Texas physicians have hired staff whose work focuses on processing requests for prior authorization, according to the survey.

Jack Resneck Jr., MD, a San Francisco–based dermatologist and president-elect of the American Medical Association (AMA), said other states have investigated ways to ease the impact of prior authorizations on physicians, but no other state has passed such a law.

Administrative burdens plague physicians around the country. The Medscape Physician Compensation Report 2021 found that physicians spend on average 15.6 hours per week on paperwork and administrative duties.
 

Better outcomes, less anxiety for patients

Dr. Patt, who testified in support of the law’s passage in the Texas legislature, says automatic approval of authorizations “is better for patients because it reduces their anxiety about whether they’re able to get the treatments they need now, and they will have better outcomes if they’re able to receive more timely care.”

Recently, a chemotherapy treatment Dr. Patt prescribed for one of her patients was not authorized by an insurer. The result is “a lot of anxiety and potentially health problems” for the patient, said Dr. Patt.

She expects that automatic approval for treatments will be based on prescribing patterns during the preceding 6 months. “It means that when I order a test today, the [health insurer] looks back at my record 6 months previously,” she said. Still, Dr. Patt awaits guidance from the Texas Department of Insurance, which regulates health insurers in the state, regarding the law.

Dr. Resneck said the pharmacy counter is where most patients encounter prior authorization delays. “That’s when the pharmacist looks at them and says, ‘Actually, this isn’t covered by your health insurer’s formulary,’ or it isn’t covered fully on their formulary.”

One of Dr. Resneck’s patients had a life-altering case of eczema that lasted many years. Because of the condition, the patient couldn’t work or maintain meaningful bonds with family members. A biologic treatment transformed his patient’s life. The patient was able to return to work and to re-engage with family, said Dr. Resneck. But a year after his patient started the treatment, the health insurer wouldn’t authorize the treatment because the patient wasn’t experiencing the same symptoms.

The patient didn’t have the same symptoms because the biologic treatment worked, said Dr. Resneck.

Kristine Grow, a spokesperson for America’s Health Insurance Plans, a national association for health insurers, said, “The use of prior authorization is relatively small – typically, less than 15% – and can help ensure safer opioid prescribing, help prevent dangerous drug interactions, and help protect patients from unnecessary exposure to potentially harmful radiation for inappropriate diagnostic imaging. Numerous studies show that Americans frequently receive inappropriate care, and 25% of unnecessary treatments are associated with complications or adverse events.”

Medical management tools, such as prior authorization, are an “an important way” to deliver “safe, high-quality care” to patients, she added.
 

State and federal efforts to curb prior authorization

In addition to efforts to curb prior authorization in other states, the AMA supports the Improving Seniors’ Timely Access to Care Act (HR 3173). The act includes a provision related to “gold-carding,” said Robert Mills, an AMA spokesperson.

The bill establishes requirements and standards for prior authorization processes related to Medicare Advantage (MA) plans. The requirements and standards for MA plans include the following:

• Establishing an electronic prior authorization program that meets specific standards, such as the ability to provide real-time decisions in response to requests for items and services that are routinely approved.
• Publishing on an annual basis specific prior authorization information, including the percentage of requests approved and the average response time.
• Meeting standards set by the Centers for Medicare & Medicaid Services related to the quality and timeliness of prior authorization determinations.

The act was introduced to the U.S. House of Representatives in May, after which it was referred to two committees for consideration.

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

In what could be a model for other states, Texas has become the first state to exempt physicians from prior authorizations for meeting insurer benchmarks.

The law was passed in June and will take effect in September. It excuses physicians from having to obtain prior authorization if, during the previous 6 months, 90% of their treatments met medical necessity criteria by the health insurer. Through this law, doctors in the state will spend less time getting approvals for treatments for their patients.

Automatic approval of authorizations for treatments – or what the Texas Medical Association (TMA) calls a “gold card” – “allows patients to get the care they need in a more timely fashion,” says Debra Patt, MD, an Austin, Tex.–based oncologist and former chair of the council on legislation for the TMA.

Eighty-seven percent of Texas physicians reported a “drastic increase over the past five years in the burden of prior authorization on their patients and their practices,” per a 2020 survey by the TMA. Nearly half (48%) of Texas physicians have hired staff whose work focuses on processing requests for prior authorization, according to the survey.

Jack Resneck Jr., MD, a San Francisco–based dermatologist and president-elect of the American Medical Association (AMA), said other states have investigated ways to ease the impact of prior authorizations on physicians, but no other state has passed such a law.

Administrative burdens plague physicians around the country. The Medscape Physician Compensation Report 2021 found that physicians spend on average 15.6 hours per week on paperwork and administrative duties.
 

Better outcomes, less anxiety for patients

Dr. Patt, who testified in support of the law’s passage in the Texas legislature, says automatic approval of authorizations “is better for patients because it reduces their anxiety about whether they’re able to get the treatments they need now, and they will have better outcomes if they’re able to receive more timely care.”

Recently, a chemotherapy treatment Dr. Patt prescribed for one of her patients was not authorized by an insurer. The result is “a lot of anxiety and potentially health problems” for the patient, said Dr. Patt.

She expects that automatic approval for treatments will be based on prescribing patterns during the preceding 6 months. “It means that when I order a test today, the [health insurer] looks back at my record 6 months previously,” she said. Still, Dr. Patt awaits guidance from the Texas Department of Insurance, which regulates health insurers in the state, regarding the law.

Dr. Resneck said the pharmacy counter is where most patients encounter prior authorization delays. “That’s when the pharmacist looks at them and says, ‘Actually, this isn’t covered by your health insurer’s formulary,’ or it isn’t covered fully on their formulary.”

One of Dr. Resneck’s patients had a life-altering case of eczema that lasted many years. Because of the condition, the patient couldn’t work or maintain meaningful bonds with family members. A biologic treatment transformed his patient’s life. The patient was able to return to work and to re-engage with family, said Dr. Resneck. But a year after his patient started the treatment, the health insurer wouldn’t authorize the treatment because the patient wasn’t experiencing the same symptoms.

The patient didn’t have the same symptoms because the biologic treatment worked, said Dr. Resneck.

Kristine Grow, a spokesperson for America’s Health Insurance Plans, a national association for health insurers, said, “The use of prior authorization is relatively small – typically, less than 15% – and can help ensure safer opioid prescribing, help prevent dangerous drug interactions, and help protect patients from unnecessary exposure to potentially harmful radiation for inappropriate diagnostic imaging. Numerous studies show that Americans frequently receive inappropriate care, and 25% of unnecessary treatments are associated with complications or adverse events.”

Medical management tools, such as prior authorization, are an “an important way” to deliver “safe, high-quality care” to patients, she added.
 

State and federal efforts to curb prior authorization

In addition to efforts to curb prior authorization in other states, the AMA supports the Improving Seniors’ Timely Access to Care Act (HR 3173). The act includes a provision related to “gold-carding,” said Robert Mills, an AMA spokesperson.

The bill establishes requirements and standards for prior authorization processes related to Medicare Advantage (MA) plans. The requirements and standards for MA plans include the following:

• Establishing an electronic prior authorization program that meets specific standards, such as the ability to provide real-time decisions in response to requests for items and services that are routinely approved.
• Publishing on an annual basis specific prior authorization information, including the percentage of requests approved and the average response time.
• Meeting standards set by the Centers for Medicare & Medicaid Services related to the quality and timeliness of prior authorization determinations.

The act was introduced to the U.S. House of Representatives in May, after which it was referred to two committees for consideration.

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

Early treatment with low-molecular-weight heparin (LMWH) reduces the risk for death in patients with COVID-19, a retrospective cohort study shows.

Heparin could reduce the risk for blood clots, Andrea De Vito, MD, of the unit of infectious diseases at the University of Sassari, Italy, said during his online presentation of the findings at the 31st European Congress of Clinical Microbiology & Infectious Diseases.

“Several studies try to describe the role played by coagulopathies in COVID-19 death,” but the mechanism causing them is still unclear, Dr. De Vito explained.

Some guidelines have suggested heparin as a treatment for hospitalized COVID-19 patients, but few have looked at nonhospitalized patients. In fact, the National Institutes of Health discourages the use of heparin in nonhospitalized COVID-19 patients, and guidance for the home care of COVID-19 patients from the World Health Organization doesn’t mention heparin treatment at all, he said.

To examine the benefits of early heparin – whether administered at home or in the hospital – Dr. De Vito and colleagues looked at a cohort of older adults with COVID-19 who were evaluated or treated at an Italian university hospital.

“Some patients were hospitalized immediately after symptoms onset; other people preferred to call their general practitioner and started the treatment at home,” Dr. De Vito said in an interview. “Other people were hospitalized for worsening of symptoms later in the course of the disease.”

Of the 734 patients, 296 received heparin within 5 days of the onset of symptoms or a positive COVID-19 test. Of the remaining 438 patients, 196 received LMWH treatment later during the disease course, and the rest never received LMWH.

All patients who received early heparin were treated with LMWH 4,000 IU, or 6,000 IU if their body mass index was above 30 kg/m². This was reduced to 2,000 IU if estimated glomerular filtration rate (eGFR) dropped below 30 mL/min. None of the patients had previously received heparin.

Median age was slightly younger for patients who received early heparin than for those who did not (76.8 vs. 78.5 years).

Other demographic characteristics, such as sex and BMI, were similar in the two groups, as were rates of comorbidities, such as hypertension, cardiovascular disease, diabetes, chronic obstructive pulmonary disease, kidney disease, and neurologic conditions. Also similar were the frequency of symptoms (such as fever, cough, and shortness of breath) and rates of treatment with remdesivir or steroids.

Rates of hospital admission were not significantly different between patients who received early heparin and those who did not (65% vs. 61%). There was also no significant difference in use of a venturi mask (35% vs. 28%), noninvasive ventilation (13% vs. 14%), or intubation (5% vs. 8%).

However, rates of death were significantly lower in patients who received early heparin than in those who did not (13% vs. 25%; P < .0001).

There was a trend toward shorter hospital stays for patients treated with early heparin, but the difference was not significant (median, 10 vs. 13 days; P = .08).

Researchers also conducted a separate analysis of 219 COVID-19 patients who received LMWH at home, regardless of when during their disease course they received it. These patients were significantly less likely to be hospitalized than were patients who did not receive LMWH at home (odds ratio, 0.2; P < .0001).

Comparatively, early heparin treatment had a greater effect on the risk for death and the risk for hospitalization than did other factors.

“Thromboemboli are a major complication of COVID. There is good consensus that hospitalized patients with COVID should receive anticoagulants prophylactically, although the best dose is being studied,” said Judy Stone, MD, an infectious disease physician and journalist who was not involved in the study.

“This study extends those findings of benefit from anticoagulants to nonhospitalized patients, with fewer deaths in those treated with low-molecular-weight heparin,” Dr. Stone told this news organization. “The major limitation is that the study is retrospective and observational. The next step would be to confirm these findings prospectively, randomizing a similar group to LMWH or no anticoagulation.”

Another limitation of the study is that some of the patients lived in nursing homes and might have received care from nurses that eliminated the need for hospitalization, Dr. De Vito added.

The study did not note any external funding. The authors have disclosed no relevant financial relationships. Dr. Stone is a member of the advisory committee for the C-Path CURE Drug Repurposing Collaboratory (CDRC) program and has written for Medscape.

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

Early treatment with low-molecular-weight heparin (LMWH) reduces the risk for death in patients with COVID-19, a retrospective cohort study shows.

Heparin could reduce the risk for blood clots, Andrea De Vito, MD, of the unit of infectious diseases at the University of Sassari, Italy, said during his online presentation of the findings at the 31st European Congress of Clinical Microbiology & Infectious Diseases.

“Several studies try to describe the role played by coagulopathies in COVID-19 death,” but the mechanism causing them is still unclear, Dr. De Vito explained.

Some guidelines have suggested heparin as a treatment for hospitalized COVID-19 patients, but few have looked at nonhospitalized patients. In fact, the National Institutes of Health discourages the use of heparin in nonhospitalized COVID-19 patients, and guidance for the home care of COVID-19 patients from the World Health Organization doesn’t mention heparin treatment at all, he said.

To examine the benefits of early heparin – whether administered at home or in the hospital – Dr. De Vito and colleagues looked at a cohort of older adults with COVID-19 who were evaluated or treated at an Italian university hospital.

“Some patients were hospitalized immediately after symptoms onset; other people preferred to call their general practitioner and started the treatment at home,” Dr. De Vito said in an interview. “Other people were hospitalized for worsening of symptoms later in the course of the disease.”

Of the 734 patients, 296 received heparin within 5 days of the onset of symptoms or a positive COVID-19 test. Of the remaining 438 patients, 196 received LMWH treatment later during the disease course, and the rest never received LMWH.

All patients who received early heparin were treated with LMWH 4,000 IU, or 6,000 IU if their body mass index was above 30 kg/m². This was reduced to 2,000 IU if estimated glomerular filtration rate (eGFR) dropped below 30 mL/min. None of the patients had previously received heparin.

Median age was slightly younger for patients who received early heparin than for those who did not (76.8 vs. 78.5 years).

Other demographic characteristics, such as sex and BMI, were similar in the two groups, as were rates of comorbidities, such as hypertension, cardiovascular disease, diabetes, chronic obstructive pulmonary disease, kidney disease, and neurologic conditions. Also similar were the frequency of symptoms (such as fever, cough, and shortness of breath) and rates of treatment with remdesivir or steroids.

Rates of hospital admission were not significantly different between patients who received early heparin and those who did not (65% vs. 61%). There was also no significant difference in use of a venturi mask (35% vs. 28%), noninvasive ventilation (13% vs. 14%), or intubation (5% vs. 8%).

However, rates of death were significantly lower in patients who received early heparin than in those who did not (13% vs. 25%; P < .0001).

There was a trend toward shorter hospital stays for patients treated with early heparin, but the difference was not significant (median, 10 vs. 13 days; P = .08).

Researchers also conducted a separate analysis of 219 COVID-19 patients who received LMWH at home, regardless of when during their disease course they received it. These patients were significantly less likely to be hospitalized than were patients who did not receive LMWH at home (odds ratio, 0.2; P < .0001).

Comparatively, early heparin treatment had a greater effect on the risk for death and the risk for hospitalization than did other factors.

“Thromboemboli are a major complication of COVID. There is good consensus that hospitalized patients with COVID should receive anticoagulants prophylactically, although the best dose is being studied,” said Judy Stone, MD, an infectious disease physician and journalist who was not involved in the study.

“This study extends those findings of benefit from anticoagulants to nonhospitalized patients, with fewer deaths in those treated with low-molecular-weight heparin,” Dr. Stone told this news organization. “The major limitation is that the study is retrospective and observational. The next step would be to confirm these findings prospectively, randomizing a similar group to LMWH or no anticoagulation.”

Another limitation of the study is that some of the patients lived in nursing homes and might have received care from nurses that eliminated the need for hospitalization, Dr. De Vito added.

The study did not note any external funding. The authors have disclosed no relevant financial relationships. Dr. Stone is a member of the advisory committee for the C-Path CURE Drug Repurposing Collaboratory (CDRC) program and has written for Medscape.

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

Early treatment with low-molecular-weight heparin (LMWH) reduces the risk for death in patients with COVID-19, a retrospective cohort study shows.

Heparin could reduce the risk for blood clots, Andrea De Vito, MD, of the unit of infectious diseases at the University of Sassari, Italy, said during his online presentation of the findings at the 31st European Congress of Clinical Microbiology & Infectious Diseases.

“Several studies try to describe the role played by coagulopathies in COVID-19 death,” but the mechanism causing them is still unclear, Dr. De Vito explained.

Some guidelines have suggested heparin as a treatment for hospitalized COVID-19 patients, but few have looked at nonhospitalized patients. In fact, the National Institutes of Health discourages the use of heparin in nonhospitalized COVID-19 patients, and guidance for the home care of COVID-19 patients from the World Health Organization doesn’t mention heparin treatment at all, he said.

To examine the benefits of early heparin – whether administered at home or in the hospital – Dr. De Vito and colleagues looked at a cohort of older adults with COVID-19 who were evaluated or treated at an Italian university hospital.

“Some patients were hospitalized immediately after symptoms onset; other people preferred to call their general practitioner and started the treatment at home,” Dr. De Vito said in an interview. “Other people were hospitalized for worsening of symptoms later in the course of the disease.”

Of the 734 patients, 296 received heparin within 5 days of the onset of symptoms or a positive COVID-19 test. Of the remaining 438 patients, 196 received LMWH treatment later during the disease course, and the rest never received LMWH.

All patients who received early heparin were treated with LMWH 4,000 IU, or 6,000 IU if their body mass index was above 30 kg/m². This was reduced to 2,000 IU if estimated glomerular filtration rate (eGFR) dropped below 30 mL/min. None of the patients had previously received heparin.

Median age was slightly younger for patients who received early heparin than for those who did not (76.8 vs. 78.5 years).

Other demographic characteristics, such as sex and BMI, were similar in the two groups, as were rates of comorbidities, such as hypertension, cardiovascular disease, diabetes, chronic obstructive pulmonary disease, kidney disease, and neurologic conditions. Also similar were the frequency of symptoms (such as fever, cough, and shortness of breath) and rates of treatment with remdesivir or steroids.

Rates of hospital admission were not significantly different between patients who received early heparin and those who did not (65% vs. 61%). There was also no significant difference in use of a venturi mask (35% vs. 28%), noninvasive ventilation (13% vs. 14%), or intubation (5% vs. 8%).

However, rates of death were significantly lower in patients who received early heparin than in those who did not (13% vs. 25%; P < .0001).

There was a trend toward shorter hospital stays for patients treated with early heparin, but the difference was not significant (median, 10 vs. 13 days; P = .08).

Researchers also conducted a separate analysis of 219 COVID-19 patients who received LMWH at home, regardless of when during their disease course they received it. These patients were significantly less likely to be hospitalized than were patients who did not receive LMWH at home (odds ratio, 0.2; P < .0001).

Comparatively, early heparin treatment had a greater effect on the risk for death and the risk for hospitalization than did other factors.

“Thromboemboli are a major complication of COVID. There is good consensus that hospitalized patients with COVID should receive anticoagulants prophylactically, although the best dose is being studied,” said Judy Stone, MD, an infectious disease physician and journalist who was not involved in the study.

“This study extends those findings of benefit from anticoagulants to nonhospitalized patients, with fewer deaths in those treated with low-molecular-weight heparin,” Dr. Stone told this news organization. “The major limitation is that the study is retrospective and observational. The next step would be to confirm these findings prospectively, randomizing a similar group to LMWH or no anticoagulation.”

Another limitation of the study is that some of the patients lived in nursing homes and might have received care from nurses that eliminated the need for hospitalization, Dr. De Vito added.

The study did not note any external funding. The authors have disclosed no relevant financial relationships. Dr. Stone is a member of the advisory committee for the C-Path CURE Drug Repurposing Collaboratory (CDRC) program and has written for Medscape.

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

Tennessee officials have fired the state’s top vaccination manager, who faced recent criticism from Republican lawmakers about her efforts to vaccinate teens against COVID-19.

Michelle Fiscus, MD, the medical director for vaccine-preventable diseases and immunization programs at the Tennessee Department of Health, was terminated on July 12. The termination letter doesn’t explain the reason for her dismissal, according to the newspaper, which received a copy of the letter.

“It was my job to provide evidence-based education and vaccine access so that Tennesseans could protect themselves against COVID-19,” Dr. Fiscus told the Tennessean. “I have now been terminated for doing exactly that.”

In May, Dr. Fiscus sent a memo to medical providers that described the state’s “Mature Minor Doctrine,” a legal mechanism established in 1987 that allows some minors between the ages if 14 and 17 years to receive medical care without parental consent. Tennessee is one of five states that allows health care providers to decide if a minor has the capacity to consent to care, according to CNN.

Dr. Fiscus said she sent the letter in response to providers’ questions and that it contained no new information. She also said the wording was approved by the health department’s attorney and the governor’s office, the newspaper reported.

At a June 16 hearing of the state’s Joint Government Operations Committee, however, Republican officials criticized the memo and Dr. Fiscus, saying that the state misinterpreted its legal authority. During the meeting, some lawmakers discussed dissolving the state health department to stop it from promoting vaccines to teens, the newspaper reported.

Since then, the health department has backed down from promoting vaccines to teens by deleting social media posts that recommended vaccines to anyone over age 12. Internal emails, which were obtained by the Tennessean, showed that department leaders ordered county-level employees to avoid holding vaccine events targeted toward adolescents.

Dr. Fiscus’s firing comes as vaccination efforts lag in the state. About 38% of residents have been fully vaccinated. At the current pace, Tennessee won’t pass the 50% mark until next March, according to an internal report obtained by the newspaper.

COVID-19 cases are beginning to climb again, particularly with the Delta variant circulating among unvaccinated residents. After months of a decline in cases, the average of daily cases has more than doubled since the end of June. The state’s test positivity rate has increased from 2% to 4.5% during that time as well.

In a long written statement, Dr. Fiscus said she was the 25th of 64 state and territorial immunization program directors to leave their positions during the pandemic, whether through resignation or termination. With a loss of institutional knowledge and leadership, COVID-19 vaccine efforts will fall behind.

“Each of us should be waking up every morning with one question on our minds: ‘What can I do protect the people of Tennessee against COVID-19?’ ” she wrote. “Instead, our leaders are putting barriers in place to ensure the people of Tennessee remain at risk, even with the Delta variant bearing down upon us.”

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

Tennessee officials have fired the state’s top vaccination manager, who faced recent criticism from Republican lawmakers about her efforts to vaccinate teens against COVID-19.

Michelle Fiscus, MD, the medical director for vaccine-preventable diseases and immunization programs at the Tennessee Department of Health, was terminated on July 12. The termination letter doesn’t explain the reason for her dismissal, according to the newspaper, which received a copy of the letter.

“It was my job to provide evidence-based education and vaccine access so that Tennesseans could protect themselves against COVID-19,” Dr. Fiscus told the Tennessean. “I have now been terminated for doing exactly that.”

In May, Dr. Fiscus sent a memo to medical providers that described the state’s “Mature Minor Doctrine,” a legal mechanism established in 1987 that allows some minors between the ages if 14 and 17 years to receive medical care without parental consent. Tennessee is one of five states that allows health care providers to decide if a minor has the capacity to consent to care, according to CNN.

Dr. Fiscus said she sent the letter in response to providers’ questions and that it contained no new information. She also said the wording was approved by the health department’s attorney and the governor’s office, the newspaper reported.

At a June 16 hearing of the state’s Joint Government Operations Committee, however, Republican officials criticized the memo and Dr. Fiscus, saying that the state misinterpreted its legal authority. During the meeting, some lawmakers discussed dissolving the state health department to stop it from promoting vaccines to teens, the newspaper reported.

Since then, the health department has backed down from promoting vaccines to teens by deleting social media posts that recommended vaccines to anyone over age 12. Internal emails, which were obtained by the Tennessean, showed that department leaders ordered county-level employees to avoid holding vaccine events targeted toward adolescents.

Dr. Fiscus’s firing comes as vaccination efforts lag in the state. About 38% of residents have been fully vaccinated. At the current pace, Tennessee won’t pass the 50% mark until next March, according to an internal report obtained by the newspaper.

COVID-19 cases are beginning to climb again, particularly with the Delta variant circulating among unvaccinated residents. After months of a decline in cases, the average of daily cases has more than doubled since the end of June. The state’s test positivity rate has increased from 2% to 4.5% during that time as well.

In a long written statement, Dr. Fiscus said she was the 25th of 64 state and territorial immunization program directors to leave their positions during the pandemic, whether through resignation or termination. With a loss of institutional knowledge and leadership, COVID-19 vaccine efforts will fall behind.

“Each of us should be waking up every morning with one question on our minds: ‘What can I do protect the people of Tennessee against COVID-19?’ ” she wrote. “Instead, our leaders are putting barriers in place to ensure the people of Tennessee remain at risk, even with the Delta variant bearing down upon us.”

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

Tennessee officials have fired the state’s top vaccination manager, who faced recent criticism from Republican lawmakers about her efforts to vaccinate teens against COVID-19.

Michelle Fiscus, MD, the medical director for vaccine-preventable diseases and immunization programs at the Tennessee Department of Health, was terminated on July 12. The termination letter doesn’t explain the reason for her dismissal, according to the newspaper, which received a copy of the letter.

“It was my job to provide evidence-based education and vaccine access so that Tennesseans could protect themselves against COVID-19,” Dr. Fiscus told the Tennessean. “I have now been terminated for doing exactly that.”

In May, Dr. Fiscus sent a memo to medical providers that described the state’s “Mature Minor Doctrine,” a legal mechanism established in 1987 that allows some minors between the ages if 14 and 17 years to receive medical care without parental consent. Tennessee is one of five states that allows health care providers to decide if a minor has the capacity to consent to care, according to CNN.

Dr. Fiscus said she sent the letter in response to providers’ questions and that it contained no new information. She also said the wording was approved by the health department’s attorney and the governor’s office, the newspaper reported.

At a June 16 hearing of the state’s Joint Government Operations Committee, however, Republican officials criticized the memo and Dr. Fiscus, saying that the state misinterpreted its legal authority. During the meeting, some lawmakers discussed dissolving the state health department to stop it from promoting vaccines to teens, the newspaper reported.

Since then, the health department has backed down from promoting vaccines to teens by deleting social media posts that recommended vaccines to anyone over age 12. Internal emails, which were obtained by the Tennessean, showed that department leaders ordered county-level employees to avoid holding vaccine events targeted toward adolescents.

Dr. Fiscus’s firing comes as vaccination efforts lag in the state. About 38% of residents have been fully vaccinated. At the current pace, Tennessee won’t pass the 50% mark until next March, according to an internal report obtained by the newspaper.

COVID-19 cases are beginning to climb again, particularly with the Delta variant circulating among unvaccinated residents. After months of a decline in cases, the average of daily cases has more than doubled since the end of June. The state’s test positivity rate has increased from 2% to 4.5% during that time as well.

In a long written statement, Dr. Fiscus said she was the 25th of 64 state and territorial immunization program directors to leave their positions during the pandemic, whether through resignation or termination. With a loss of institutional knowledge and leadership, COVID-19 vaccine efforts will fall behind.

“Each of us should be waking up every morning with one question on our minds: ‘What can I do protect the people of Tennessee against COVID-19?’ ” she wrote. “Instead, our leaders are putting barriers in place to ensure the people of Tennessee remain at risk, even with the Delta variant bearing down upon us.”

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

Bullying in academic medicine, especially among women, is rife, underreported, and remains largely unaddressed, new research suggests.

Investigators reviewed close to 70 studies, encompassing over 82,000 medical consultants or trainees in academic medical settings, and found that men were identified as the most common perpetrators – close to 70% of respondents – whereas women were the most common victims (56%).

Collectively, respondents in all of the studies identified the most common bullies to be consultants (54%), followed by residents (22%), and nurses (15%).

Disturbingly, less than one-third of victims overall reported that they were bullied, and close to 60% who formally reported the abuse said they did not have a positive outcome.

“We found that bullies are commonly men and senior consultants, while more than half of their victims are women,” senior author Harriette G.C. Van Spall, MD, MPH, associate professor of medicine and director of e-health and virtual care, Division of Cardiology, McMaster University, Hamilton, Ont., said in an interview.

“The greatest barriers to addressing academic bullying are the fear of reprisal, lack of impact of reporting, and non-enforcement of anti-bullying policies,” she added.

The study was published online July 12 in BMJ Open.
 

Personal experience

The study was “inspired by experiences that I endured over a period of time and am grateful to have survived,” said Dr. Van Spall.

“Some behaviors were excruciating to deal with, protesting against them would bring more on, and every day was filled with dread. It took sheer will to show up at work to care for patients, to complete research I was leading, and to have hope, and my academic output, income, and personal well-being dropped during those years,” she added.

Dr. Van Spall thought the subject “merited research because our performance as clinicians, researchers, and educators relies on our work environment.”

To investigate, the researchers reviewed 68 studies (n = 82,349 respondents) conducted between 1999 and 2021 in academic medical settings, in which victims were either consultants or trainees. Many of the studies (31) were conducted in the U.S.

Other countries included the United Kingdom, Canada, Australia, Pakistan, Egypt, Iran, Turkey, New Zealand, Lithuania, Greece, India, Germany, Nigeria, Oman, and Finland.

Studies were required to describe the method and impact of bullying; characteristics of the perpetrators and victims; or interventions that were used to address the bullying.

“Bullying” was defined as “the abuse of authority by a perpetrator who targets the victim in an academic setting through punishing behaviors that include overwork, destabilization, and isolation in order to impede the education or career of the target.”
 

Systemic sexism

Bullying behaviors, reported in 28 studies (n = 35,779 respondents), were grouped into destabilization, threats to professional status, overwork, and isolation, with overwork found to be the most common form of bullying.

The most common impact of being bullied was psychological distress, reported by 39.1% of respondents in 14 studies, followed by considerations of quitting (35.9%; 7 studies), and worsening of clinical performance (34.6%, 8 studies).

“Among demographic groups, men were identified as the most common perpetrators (67.2% of 4,722 respondents in 5 studies) and women the most common victims (56.2% of 15,246 respondents in 27 studies),” the authors report.

“Academic medicine in many institutions is encumbered by systemic sexism that is evident in processes around remuneration, recognition, opportunities for advancement, and leadership positions,” said Dr. Van Spall.

“There are fewer women at decision-making tables in academic medicine, the climb is uphill at the best of times, and women are likely easier targets for bullies, as their voices are easier to drown out,” she added.

She noted that many men do “exhibit wonderful attributes of professionalism and decency,” but “some in positions of power are given impunity by virtue of other accomplishments.”
 

Multiple deterrents

Thirty-one studies (n = 15,868) described characteristics of the bullies and showed the most common to be consultants (53.6% [30 studies]), residents (22% [22 studies]), and nurses (14.9% [21 studies]).

Only a minority of victims (28.9% of 9,410 victims [10 studies]) formally reported the bullying. The researchers identified multiple deterrents to reporting.

When a formal complaint was submitted (n = 1,139 respondents), it most frequently had no perceived effect (35.6%); more than one-fifth (21.9%) experienced worsening of the bullying, and only 13.7% reported improvement.

The common institutional facilitators of bullying, described in 25 studies, included lack of enforcement of anti-bullying policies (13 studies), the hierarchical structure of medicine (7 studies), and normalization of bullying (10 studies).

Forty-nine studies looked at strategies to address academic bullying, including anti-bullying policies, mandatory workshops on mistreatment, establishing an anti-bullying oversight committee, and institutional support for victims. However, the studies testing the effectiveness of these interventions “had a high risk of bias.”
 

Support available

Commenting on the research for this news organization, Roberta Gebhard, DO, past president of the American Medical Women’s Association (AMWA) and a member of the advisory board for Physician Just Equity, called it a “good study, large, international, and well-written.”

Dr. Gebhard, a member of the Governing Council for the American Medical Association Women Physician Section, was not associated with this study but said she is currently researching women who left medical school and residency.

“A common reason for leaving is being bullied. Bullying is often not reported and if reported, often not addressed. Or, if addressed, the person who reports it is often retaliated against, which is a common experience, especially in women.”

She advised female physicians who are bullied to get support from other female physicians – for example, by joining the AMWA, which has an online women’s leadership group.

“Having other women physicians throughout the country you can call for advice and support can be helpful,” said Dr. Gebhard, a family practice physician based in Grand Island, New York.

Dr. Van Spall receives support from the Canadian Institutes of Health Research, the Heart and Stroke Foundation, the Women As One Escalator Award, and McMaster Department of Medicine. The study authors and Dr. Gebhard have disclosed no relevant financial relationships.

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

Bullying in academic medicine, especially among women, is rife, underreported, and remains largely unaddressed, new research suggests.

Investigators reviewed close to 70 studies, encompassing over 82,000 medical consultants or trainees in academic medical settings, and found that men were identified as the most common perpetrators – close to 70% of respondents – whereas women were the most common victims (56%).

Collectively, respondents in all of the studies identified the most common bullies to be consultants (54%), followed by residents (22%), and nurses (15%).

Disturbingly, less than one-third of victims overall reported that they were bullied, and close to 60% who formally reported the abuse said they did not have a positive outcome.

“We found that bullies are commonly men and senior consultants, while more than half of their victims are women,” senior author Harriette G.C. Van Spall, MD, MPH, associate professor of medicine and director of e-health and virtual care, Division of Cardiology, McMaster University, Hamilton, Ont., said in an interview.

“The greatest barriers to addressing academic bullying are the fear of reprisal, lack of impact of reporting, and non-enforcement of anti-bullying policies,” she added.

The study was published online July 12 in BMJ Open.
 

Personal experience

The study was “inspired by experiences that I endured over a period of time and am grateful to have survived,” said Dr. Van Spall.

“Some behaviors were excruciating to deal with, protesting against them would bring more on, and every day was filled with dread. It took sheer will to show up at work to care for patients, to complete research I was leading, and to have hope, and my academic output, income, and personal well-being dropped during those years,” she added.

Dr. Van Spall thought the subject “merited research because our performance as clinicians, researchers, and educators relies on our work environment.”

To investigate, the researchers reviewed 68 studies (n = 82,349 respondents) conducted between 1999 and 2021 in academic medical settings, in which victims were either consultants or trainees. Many of the studies (31) were conducted in the U.S.

Other countries included the United Kingdom, Canada, Australia, Pakistan, Egypt, Iran, Turkey, New Zealand, Lithuania, Greece, India, Germany, Nigeria, Oman, and Finland.

Studies were required to describe the method and impact of bullying; characteristics of the perpetrators and victims; or interventions that were used to address the bullying.

“Bullying” was defined as “the abuse of authority by a perpetrator who targets the victim in an academic setting through punishing behaviors that include overwork, destabilization, and isolation in order to impede the education or career of the target.”
 

Systemic sexism

Bullying behaviors, reported in 28 studies (n = 35,779 respondents), were grouped into destabilization, threats to professional status, overwork, and isolation, with overwork found to be the most common form of bullying.

The most common impact of being bullied was psychological distress, reported by 39.1% of respondents in 14 studies, followed by considerations of quitting (35.9%; 7 studies), and worsening of clinical performance (34.6%, 8 studies).

“Among demographic groups, men were identified as the most common perpetrators (67.2% of 4,722 respondents in 5 studies) and women the most common victims (56.2% of 15,246 respondents in 27 studies),” the authors report.

“Academic medicine in many institutions is encumbered by systemic sexism that is evident in processes around remuneration, recognition, opportunities for advancement, and leadership positions,” said Dr. Van Spall.

“There are fewer women at decision-making tables in academic medicine, the climb is uphill at the best of times, and women are likely easier targets for bullies, as their voices are easier to drown out,” she added.

She noted that many men do “exhibit wonderful attributes of professionalism and decency,” but “some in positions of power are given impunity by virtue of other accomplishments.”
 

Multiple deterrents

Thirty-one studies (n = 15,868) described characteristics of the bullies and showed the most common to be consultants (53.6% [30 studies]), residents (22% [22 studies]), and nurses (14.9% [21 studies]).

Only a minority of victims (28.9% of 9,410 victims [10 studies]) formally reported the bullying. The researchers identified multiple deterrents to reporting.

When a formal complaint was submitted (n = 1,139 respondents), it most frequently had no perceived effect (35.6%); more than one-fifth (21.9%) experienced worsening of the bullying, and only 13.7% reported improvement.

The common institutional facilitators of bullying, described in 25 studies, included lack of enforcement of anti-bullying policies (13 studies), the hierarchical structure of medicine (7 studies), and normalization of bullying (10 studies).

Forty-nine studies looked at strategies to address academic bullying, including anti-bullying policies, mandatory workshops on mistreatment, establishing an anti-bullying oversight committee, and institutional support for victims. However, the studies testing the effectiveness of these interventions “had a high risk of bias.”
 

Support available

Commenting on the research for this news organization, Roberta Gebhard, DO, past president of the American Medical Women’s Association (AMWA) and a member of the advisory board for Physician Just Equity, called it a “good study, large, international, and well-written.”

Dr. Gebhard, a member of the Governing Council for the American Medical Association Women Physician Section, was not associated with this study but said she is currently researching women who left medical school and residency.

“A common reason for leaving is being bullied. Bullying is often not reported and if reported, often not addressed. Or, if addressed, the person who reports it is often retaliated against, which is a common experience, especially in women.”

She advised female physicians who are bullied to get support from other female physicians – for example, by joining the AMWA, which has an online women’s leadership group.

“Having other women physicians throughout the country you can call for advice and support can be helpful,” said Dr. Gebhard, a family practice physician based in Grand Island, New York.

Dr. Van Spall receives support from the Canadian Institutes of Health Research, the Heart and Stroke Foundation, the Women As One Escalator Award, and McMaster Department of Medicine. The study authors and Dr. Gebhard have disclosed no relevant financial relationships.

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

Bullying in academic medicine, especially among women, is rife, underreported, and remains largely unaddressed, new research suggests.

Investigators reviewed close to 70 studies, encompassing over 82,000 medical consultants or trainees in academic medical settings, and found that men were identified as the most common perpetrators – close to 70% of respondents – whereas women were the most common victims (56%).

Collectively, respondents in all of the studies identified the most common bullies to be consultants (54%), followed by residents (22%), and nurses (15%).

Disturbingly, less than one-third of victims overall reported that they were bullied, and close to 60% who formally reported the abuse said they did not have a positive outcome.

“We found that bullies are commonly men and senior consultants, while more than half of their victims are women,” senior author Harriette G.C. Van Spall, MD, MPH, associate professor of medicine and director of e-health and virtual care, Division of Cardiology, McMaster University, Hamilton, Ont., said in an interview.

“The greatest barriers to addressing academic bullying are the fear of reprisal, lack of impact of reporting, and non-enforcement of anti-bullying policies,” she added.

The study was published online July 12 in BMJ Open.
 

Personal experience

The study was “inspired by experiences that I endured over a period of time and am grateful to have survived,” said Dr. Van Spall.

“Some behaviors were excruciating to deal with, protesting against them would bring more on, and every day was filled with dread. It took sheer will to show up at work to care for patients, to complete research I was leading, and to have hope, and my academic output, income, and personal well-being dropped during those years,” she added.

Dr. Van Spall thought the subject “merited research because our performance as clinicians, researchers, and educators relies on our work environment.”

To investigate, the researchers reviewed 68 studies (n = 82,349 respondents) conducted between 1999 and 2021 in academic medical settings, in which victims were either consultants or trainees. Many of the studies (31) were conducted in the U.S.

Other countries included the United Kingdom, Canada, Australia, Pakistan, Egypt, Iran, Turkey, New Zealand, Lithuania, Greece, India, Germany, Nigeria, Oman, and Finland.

Studies were required to describe the method and impact of bullying; characteristics of the perpetrators and victims; or interventions that were used to address the bullying.

“Bullying” was defined as “the abuse of authority by a perpetrator who targets the victim in an academic setting through punishing behaviors that include overwork, destabilization, and isolation in order to impede the education or career of the target.”
 

Systemic sexism

Bullying behaviors, reported in 28 studies (n = 35,779 respondents), were grouped into destabilization, threats to professional status, overwork, and isolation, with overwork found to be the most common form of bullying.

The most common impact of being bullied was psychological distress, reported by 39.1% of respondents in 14 studies, followed by considerations of quitting (35.9%; 7 studies), and worsening of clinical performance (34.6%, 8 studies).

“Among demographic groups, men were identified as the most common perpetrators (67.2% of 4,722 respondents in 5 studies) and women the most common victims (56.2% of 15,246 respondents in 27 studies),” the authors report.

“Academic medicine in many institutions is encumbered by systemic sexism that is evident in processes around remuneration, recognition, opportunities for advancement, and leadership positions,” said Dr. Van Spall.

“There are fewer women at decision-making tables in academic medicine, the climb is uphill at the best of times, and women are likely easier targets for bullies, as their voices are easier to drown out,” she added.

She noted that many men do “exhibit wonderful attributes of professionalism and decency,” but “some in positions of power are given impunity by virtue of other accomplishments.”
 

Multiple deterrents

Thirty-one studies (n = 15,868) described characteristics of the bullies and showed the most common to be consultants (53.6% [30 studies]), residents (22% [22 studies]), and nurses (14.9% [21 studies]).

Only a minority of victims (28.9% of 9,410 victims [10 studies]) formally reported the bullying. The researchers identified multiple deterrents to reporting.

When a formal complaint was submitted (n = 1,139 respondents), it most frequently had no perceived effect (35.6%); more than one-fifth (21.9%) experienced worsening of the bullying, and only 13.7% reported improvement.

The common institutional facilitators of bullying, described in 25 studies, included lack of enforcement of anti-bullying policies (13 studies), the hierarchical structure of medicine (7 studies), and normalization of bullying (10 studies).

Forty-nine studies looked at strategies to address academic bullying, including anti-bullying policies, mandatory workshops on mistreatment, establishing an anti-bullying oversight committee, and institutional support for victims. However, the studies testing the effectiveness of these interventions “had a high risk of bias.”
 

Support available

Commenting on the research for this news organization, Roberta Gebhard, DO, past president of the American Medical Women’s Association (AMWA) and a member of the advisory board for Physician Just Equity, called it a “good study, large, international, and well-written.”

Dr. Gebhard, a member of the Governing Council for the American Medical Association Women Physician Section, was not associated with this study but said she is currently researching women who left medical school and residency.

“A common reason for leaving is being bullied. Bullying is often not reported and if reported, often not addressed. Or, if addressed, the person who reports it is often retaliated against, which is a common experience, especially in women.”

She advised female physicians who are bullied to get support from other female physicians – for example, by joining the AMWA, which has an online women’s leadership group.

“Having other women physicians throughout the country you can call for advice and support can be helpful,” said Dr. Gebhard, a family practice physician based in Grand Island, New York.

Dr. Van Spall receives support from the Canadian Institutes of Health Research, the Heart and Stroke Foundation, the Women As One Escalator Award, and McMaster Department of Medicine. The study authors and Dr. Gebhard have disclosed no relevant financial relationships.

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

An extreme price to pay for immortality

We know that men don’t live as long as women, but the reasons aren’t entirely clear. However, some New Zealand scientists have a thought on the subject, thanks to a sheep called Shrek.

Max Pixel

The researchers were inspired by a famous old sheep who escaped captivity, but was captured 6 years later at the age of 10. The sheep then lived 6 more years, far beyond the lifespan of a normal sheep, capturing the hearts and minds of Kiwis everywhere. Look, it’s New Zealand, sheep are life, so it’s only natural the country got attached. Scientists from the University of Otago suspected that Shrek lived such a long life because he was castrated.

So they undertook a study of sheep, and lo and behold, sheep that were castrated lived significantly longer than their uncastrated kin, thanks to a slowing of their epigenetic clocks – the DNA aged noticeably slower in the castrated sheep.

Although the research can most immediately be applied to the improvement of the New Zealand sheep industry, the implication for humanity is also apparent. Want to live longer? Get rid of the testosterone. An extreme solution to be sure. As previously reported in this column, researchers wanted to torture our mouths to get us to lose weight, and now they want to castrate people for longer life. What exactly is going on down there in New Zealand?

Man’s best mind reader

There are a lot of reasons why dogs are sometimes called “man’s best friend,” but the root of it may actually have something to do with how easily we communicate with each other. Researchers dug deeper and fetched something that Fido is born with, but his wild wolf cousin isn’t.

FreeImages.com/Boris Benko

That something is known as the “theory of mind” ability. Have you noticed that when you point and tell dogs to grab a leash or toy, they react as if they understood the language you spoke? Researchers from Duke University wondered if this ability is a canine thing or just a domesticated dog thing.

They compared 44 canine puppies and 37 wolf pups between 5 and 18 weeks old. The wolf pups were taken into human homes and raised with a great amount of human interaction, while the dog pups were left with their mothers and raised with less human interaction.

All the puppies were then put through multiple tests. In one test, they were given clues to find a treat under a bowl. In another test, a block of wood was placed next to the treat as a physical marker. During yet another test, researchers pointed to the food directly.

The researchers discovered that the dog puppies knew where the treat was every time, while their wild relatives didn’t.

“This study really solidifies the evidence that the social genius of dogs is a product of domestication,” senior author Brian Hare said in a separate statement.

The domestication hypothesis theorizes that dogs picked up the human social cues through thousands of years of interaction. The more friendly and cooperative a wolf was with humans, the more likely it was to survive and pass on those same traits and practices. Even within the study, the dog puppies were 30 times more likely to approach a stranger than were the wolf pups.

You may think your dog understands everything you say, but it’s actually body language that Fido is most fluent in.

I’m not a dentist, but I play one on TikTok

In last week’s column, it was garlic cloves up the nose to treat a cold. This week, TikTok brings us a new way to whiten teeth.

pxfuel

Familiar with the Mr. Clean Magic Eraser? If not, we’ll save you the trouble of Googling it: Check it out here and here.

Have you heard anything about using it to clean your teeth? No, neither did we, and we did a lot of Googling. Proctor & Gamble, which makes the Magic Eraser, goes so far as to say on the package: “Do not use on skin or other parts of the body. Using on skin will likely cause abrasions.” (The warning is actually in all caps, but we are stylistically forbidden by our editorial overlords to do that.)

But it’s magic, right? How can you not use it on your teeth? Enter TikTok. Heather Dunn posted a video in which she rubbed a bit of a Magic Eraser on her teeth – being careful to avoid her gums, because you can never be too careful – “as the product squeaked back and forth,” the Miami Herald reported. The video has almost 256,000 likes so far.

“Yeah, your teeth are white because you scrubbed all the enamel off them. So don’t do this,” Dr. Benjamin Winters, aka the Bentist, said in a YouTube video that has 105,000 likes.

In this race for common sense, common sense is losing. Please help the Bentist restore sanity to the dental world by liking his video. It would make Mr. Clean happy.

Don’t let an expiration date boss you around

Surely you’ve been there: It’s Taco Tuesday and you’re rummaging through the refrigerator to find that shredded cheese you’re sure you have. Jackpot! You find it, but realize it’s probably been in the refrigerator for a while. You open the bag, it smells and looks fine, but the expiration date was 2 days ago. Now you have a decision to make. Maybe you’ll be fine, or maybe you’ll risk food poisoning right before your brother’s wedding.

Richard Franki/MDedge News

But here’s the truth: Americans throw away perfectly good food every day. The average American family throws out $1,365 to $2,275 worth of food a year, according to a 2013 study.

Truthfully, expiration dates are not for buyers, rather they’re for stores to have an idea of their stock’s freshness. Emily Broad Leib, director of the Harvard Law School Food and Policy Clinic and lead author of the 2013 study, told Vox that manufacturers use the dates as a way of “protecting the brand” to keep consumers from eating food that’s just a little past its peak.

With approximately 40 million people in the United States concerned about where their next meal is coming from, the Vox article noted, we need to reevaluate our system. Our national misunderstanding of expiration labels is hurting both suppliers and consumers because perfectly good food is wasted.

Sure, there is always that chance that something might be a little funky after a certain amount of time, but all in all, food probably stays fresh a lot longer than we think. Don’t always judge the shredded cheese by its expiration date.

An extreme price to pay for immortality

We know that men don’t live as long as women, but the reasons aren’t entirely clear. However, some New Zealand scientists have a thought on the subject, thanks to a sheep called Shrek.

Max Pixel

The researchers were inspired by a famous old sheep who escaped captivity, but was captured 6 years later at the age of 10. The sheep then lived 6 more years, far beyond the lifespan of a normal sheep, capturing the hearts and minds of Kiwis everywhere. Look, it’s New Zealand, sheep are life, so it’s only natural the country got attached. Scientists from the University of Otago suspected that Shrek lived such a long life because he was castrated.

So they undertook a study of sheep, and lo and behold, sheep that were castrated lived significantly longer than their uncastrated kin, thanks to a slowing of their epigenetic clocks – the DNA aged noticeably slower in the castrated sheep.

Although the research can most immediately be applied to the improvement of the New Zealand sheep industry, the implication for humanity is also apparent. Want to live longer? Get rid of the testosterone. An extreme solution to be sure. As previously reported in this column, researchers wanted to torture our mouths to get us to lose weight, and now they want to castrate people for longer life. What exactly is going on down there in New Zealand?

Man’s best mind reader

There are a lot of reasons why dogs are sometimes called “man’s best friend,” but the root of it may actually have something to do with how easily we communicate with each other. Researchers dug deeper and fetched something that Fido is born with, but his wild wolf cousin isn’t.

FreeImages.com/Boris Benko

That something is known as the “theory of mind” ability. Have you noticed that when you point and tell dogs to grab a leash or toy, they react as if they understood the language you spoke? Researchers from Duke University wondered if this ability is a canine thing or just a domesticated dog thing.

They compared 44 canine puppies and 37 wolf pups between 5 and 18 weeks old. The wolf pups were taken into human homes and raised with a great amount of human interaction, while the dog pups were left with their mothers and raised with less human interaction.

All the puppies were then put through multiple tests. In one test, they were given clues to find a treat under a bowl. In another test, a block of wood was placed next to the treat as a physical marker. During yet another test, researchers pointed to the food directly.

The researchers discovered that the dog puppies knew where the treat was every time, while their wild relatives didn’t.

“This study really solidifies the evidence that the social genius of dogs is a product of domestication,” senior author Brian Hare said in a separate statement.

The domestication hypothesis theorizes that dogs picked up the human social cues through thousands of years of interaction. The more friendly and cooperative a wolf was with humans, the more likely it was to survive and pass on those same traits and practices. Even within the study, the dog puppies were 30 times more likely to approach a stranger than were the wolf pups.

You may think your dog understands everything you say, but it’s actually body language that Fido is most fluent in.

I’m not a dentist, but I play one on TikTok

In last week’s column, it was garlic cloves up the nose to treat a cold. This week, TikTok brings us a new way to whiten teeth.

pxfuel

Familiar with the Mr. Clean Magic Eraser? If not, we’ll save you the trouble of Googling it: Check it out here and here.

Have you heard anything about using it to clean your teeth? No, neither did we, and we did a lot of Googling. Proctor & Gamble, which makes the Magic Eraser, goes so far as to say on the package: “Do not use on skin or other parts of the body. Using on skin will likely cause abrasions.” (The warning is actually in all caps, but we are stylistically forbidden by our editorial overlords to do that.)

But it’s magic, right? How can you not use it on your teeth? Enter TikTok. Heather Dunn posted a video in which she rubbed a bit of a Magic Eraser on her teeth – being careful to avoid her gums, because you can never be too careful – “as the product squeaked back and forth,” the Miami Herald reported. The video has almost 256,000 likes so far.

“Yeah, your teeth are white because you scrubbed all the enamel off them. So don’t do this,” Dr. Benjamin Winters, aka the Bentist, said in a YouTube video that has 105,000 likes.

In this race for common sense, common sense is losing. Please help the Bentist restore sanity to the dental world by liking his video. It would make Mr. Clean happy.

Don’t let an expiration date boss you around

Surely you’ve been there: It’s Taco Tuesday and you’re rummaging through the refrigerator to find that shredded cheese you’re sure you have. Jackpot! You find it, but realize it’s probably been in the refrigerator for a while. You open the bag, it smells and looks fine, but the expiration date was 2 days ago. Now you have a decision to make. Maybe you’ll be fine, or maybe you’ll risk food poisoning right before your brother’s wedding.

Richard Franki/MDedge News

But here’s the truth: Americans throw away perfectly good food every day. The average American family throws out $1,365 to $2,275 worth of food a year, according to a 2013 study.

Truthfully, expiration dates are not for buyers, rather they’re for stores to have an idea of their stock’s freshness. Emily Broad Leib, director of the Harvard Law School Food and Policy Clinic and lead author of the 2013 study, told Vox that manufacturers use the dates as a way of “protecting the brand” to keep consumers from eating food that’s just a little past its peak.

With approximately 40 million people in the United States concerned about where their next meal is coming from, the Vox article noted, we need to reevaluate our system. Our national misunderstanding of expiration labels is hurting both suppliers and consumers because perfectly good food is wasted.

Sure, there is always that chance that something might be a little funky after a certain amount of time, but all in all, food probably stays fresh a lot longer than we think. Don’t always judge the shredded cheese by its expiration date.

An extreme price to pay for immortality

We know that men don’t live as long as women, but the reasons aren’t entirely clear. However, some New Zealand scientists have a thought on the subject, thanks to a sheep called Shrek.

Max Pixel

The researchers were inspired by a famous old sheep who escaped captivity, but was captured 6 years later at the age of 10. The sheep then lived 6 more years, far beyond the lifespan of a normal sheep, capturing the hearts and minds of Kiwis everywhere. Look, it’s New Zealand, sheep are life, so it’s only natural the country got attached. Scientists from the University of Otago suspected that Shrek lived such a long life because he was castrated.

So they undertook a study of sheep, and lo and behold, sheep that were castrated lived significantly longer than their uncastrated kin, thanks to a slowing of their epigenetic clocks – the DNA aged noticeably slower in the castrated sheep.

Although the research can most immediately be applied to the improvement of the New Zealand sheep industry, the implication for humanity is also apparent. Want to live longer? Get rid of the testosterone. An extreme solution to be sure. As previously reported in this column, researchers wanted to torture our mouths to get us to lose weight, and now they want to castrate people for longer life. What exactly is going on down there in New Zealand?

Man’s best mind reader

There are a lot of reasons why dogs are sometimes called “man’s best friend,” but the root of it may actually have something to do with how easily we communicate with each other. Researchers dug deeper and fetched something that Fido is born with, but his wild wolf cousin isn’t.

FreeImages.com/Boris Benko

That something is known as the “theory of mind” ability. Have you noticed that when you point and tell dogs to grab a leash or toy, they react as if they understood the language you spoke? Researchers from Duke University wondered if this ability is a canine thing or just a domesticated dog thing.

They compared 44 canine puppies and 37 wolf pups between 5 and 18 weeks old. The wolf pups were taken into human homes and raised with a great amount of human interaction, while the dog pups were left with their mothers and raised with less human interaction.

All the puppies were then put through multiple tests. In one test, they were given clues to find a treat under a bowl. In another test, a block of wood was placed next to the treat as a physical marker. During yet another test, researchers pointed to the food directly.

The researchers discovered that the dog puppies knew where the treat was every time, while their wild relatives didn’t.

“This study really solidifies the evidence that the social genius of dogs is a product of domestication,” senior author Brian Hare said in a separate statement.

The domestication hypothesis theorizes that dogs picked up the human social cues through thousands of years of interaction. The more friendly and cooperative a wolf was with humans, the more likely it was to survive and pass on those same traits and practices. Even within the study, the dog puppies were 30 times more likely to approach a stranger than were the wolf pups.

You may think your dog understands everything you say, but it’s actually body language that Fido is most fluent in.

I’m not a dentist, but I play one on TikTok

In last week’s column, it was garlic cloves up the nose to treat a cold. This week, TikTok brings us a new way to whiten teeth.

pxfuel

Familiar with the Mr. Clean Magic Eraser? If not, we’ll save you the trouble of Googling it: Check it out here and here.

Have you heard anything about using it to clean your teeth? No, neither did we, and we did a lot of Googling. Proctor & Gamble, which makes the Magic Eraser, goes so far as to say on the package: “Do not use on skin or other parts of the body. Using on skin will likely cause abrasions.” (The warning is actually in all caps, but we are stylistically forbidden by our editorial overlords to do that.)

But it’s magic, right? How can you not use it on your teeth? Enter TikTok. Heather Dunn posted a video in which she rubbed a bit of a Magic Eraser on her teeth – being careful to avoid her gums, because you can never be too careful – “as the product squeaked back and forth,” the Miami Herald reported. The video has almost 256,000 likes so far.

“Yeah, your teeth are white because you scrubbed all the enamel off them. So don’t do this,” Dr. Benjamin Winters, aka the Bentist, said in a YouTube video that has 105,000 likes.

In this race for common sense, common sense is losing. Please help the Bentist restore sanity to the dental world by liking his video. It would make Mr. Clean happy.

Don’t let an expiration date boss you around

Surely you’ve been there: It’s Taco Tuesday and you’re rummaging through the refrigerator to find that shredded cheese you’re sure you have. Jackpot! You find it, but realize it’s probably been in the refrigerator for a while. You open the bag, it smells and looks fine, but the expiration date was 2 days ago. Now you have a decision to make. Maybe you’ll be fine, or maybe you’ll risk food poisoning right before your brother’s wedding.

Richard Franki/MDedge News

But here’s the truth: Americans throw away perfectly good food every day. The average American family throws out $1,365 to $2,275 worth of food a year, according to a 2013 study.

Truthfully, expiration dates are not for buyers, rather they’re for stores to have an idea of their stock’s freshness. Emily Broad Leib, director of the Harvard Law School Food and Policy Clinic and lead author of the 2013 study, told Vox that manufacturers use the dates as a way of “protecting the brand” to keep consumers from eating food that’s just a little past its peak.

With approximately 40 million people in the United States concerned about where their next meal is coming from, the Vox article noted, we need to reevaluate our system. Our national misunderstanding of expiration labels is hurting both suppliers and consumers because perfectly good food is wasted.

Sure, there is always that chance that something might be a little funky after a certain amount of time, but all in all, food probably stays fresh a lot longer than we think. Don’t always judge the shredded cheese by its expiration date.