Journal of Clinical Outcomes Management

Cyclic sighing is more effective than mindfulness meditation for improving mood and reducing stress, new research suggests.

In a randomized controlled study, daily breathwork – especially cyclic breathing, which emphasizes shorter inhalations and prolonged exhalations – was associated with greater improvement in mood and a slower respiratory rate than mindfulness meditation.

“We were pleased that just 5 minutes a day of the breathing exercises positively affected mood and resulted in slower respiratory rate, indicating reduced arousal,” coinvestigator David Spiegel, MD, who directs the Center for Stress and Health at Stanford (Calif.) University, told this news organization.

The findings were published online in Cell Reports Medicine.
 

Intentional breath control

Controlled breathwork has emerged as a potential tool to manage stress and boost well-being.

In the new study, researchers compared three different daily 5-minute breathwork exercises to an equal amount of mindfulness meditation over 1 month in 108 healthy adults recruited mostly from an undergraduate psychology class at Stanford: 33 participants practiced cyclic hyperventilation, which emphasizes robust inhalation, short retention and rapid exhalation, 30 did exhale-focused cyclic sighing, 21 performed box breathing, which emphasizes equal duration of inhalation, breath retention, and exhalation, and 24 practiced mindfulness meditation (the control group).

The primary endpoints were improvement in mood and anxiety, as well as reduced physiologic arousal (respiratory rate, heart rate, and heart rate variability). Physiological data was collected using a wearable WHOOP strap.

All four groups showed significant daily improvement in mood, as well as reduction in anxiety and negative mood, but there were significant differences between mindfulness meditation and breathwork.

Using a mixed-effects model, the researchers showed that breathwork, especially the exhale-focused cyclic sighing, produced greater improvement in mood (P < .05) and reduction in respiratory rate (P < .05), compared with mindfulness meditation.
 

Specific patterns vs. passive attention

The finding supports the team’s hypothesis that intentional control over breath with specific breathing patterns produces more benefit to mood than passive attention to one’s breath, as in mindfulness meditation practice.

“It turned out that the cyclic sighing was indeed most soothing,” Dr. Spiegel noted.

“We expected that because of respiratory sinus arrhythmia. Exhaling is accomplished by increasing pressure in the chest, which increases venous return to the heart, triggering parasympathetic slowing of heart rate via the sinoatrial node,” he said.

Dr. Spiegel added that, conversely, inspiration reduces venous return, triggering sympathetic activity and increased heart rate.

“The magnitude of this heart rate variability is associated with better health, including recovery from myocardial infarction and even cancer survival. So self-soothing is a good thing, and we expected an advantage for cyclic sighing,” he said.

“If you’re looking to improve sleep and reduce daytime stress, recover from intense work, life, and/or training, then interventions that facilitate autonomic control (and indeed you can control it), brief (5 minutes) structured breathwork is among the more powerful (and zero cost) tools,” tweeted senior investigator Andrew Huberman, PhD, professor of neurobiology at Stanford.
 

Immediate application?

Sara Lazar, PhD, Massachusetts General Hospital and Harvard Medical School, Boston, said the findings are “interesting” but cautioned that this is “just one study with a pretty small sample size,” and it only enrolled healthy college students.

courtesy Massachusetts General Hospital

Dr. Lazar, who also runs the Lazar Lab for Meditation Research at Mass General, noted that she would want to see a future study “done with working-age adults and with clinical populations.”

“It should also be noted that mindfulness had a bigger effect on negative affect, which could have implications for conditions such as depression or trauma,” said Dr. Lazar, who was not involved with the current research.

Also weighing in, Steven R. Thorp, PhD, professor at California School of Professional Psychology, Alliant International University, San Diego, said in an interview the study is “really interesting and well done.”

“Although breathing exercises and breathing retraining are commonly found in psychosocial interventions, especially for anxiety disorders, there have been few empirical studies comparing different breathing protocols,” Dr. Thorp said.

In this study, the passive observation of breaths (mindfulness) and specific breathwork interventions “all worked to decrease state anxiety; but the breathwork, particularly the cyclic sighing protocol, produced a greater overall reduction in respiratory rate and increase in positive mood,” he noted.

“These techniques can be recommended by all clinicians because all clients have access to their breath at all times – and only 5 minutes of daily practice can yield the benefits. Moreover, as the authors note, the immediate benefits may encourage clients to engage with the breathwork and potentially other aspects of treatment,” Dr. Thorp said.

The study was funded by Victor and Winnie Koo and Tianren Culture and a Stanford School of Medicine Discovery Innovation Award. WHOOP donated the wrist straps used in the study, but was not involved in the study’s design or analysis. Dr. Huberman is an advisor to WHOOP. Dr. Lazar and Dr. Thorp have reported no relevant financial relationships.

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

Cyclic sighing is more effective than mindfulness meditation for improving mood and reducing stress, new research suggests.

In a randomized controlled study, daily breathwork – especially cyclic breathing, which emphasizes shorter inhalations and prolonged exhalations – was associated with greater improvement in mood and a slower respiratory rate than mindfulness meditation.

“We were pleased that just 5 minutes a day of the breathing exercises positively affected mood and resulted in slower respiratory rate, indicating reduced arousal,” coinvestigator David Spiegel, MD, who directs the Center for Stress and Health at Stanford (Calif.) University, told this news organization.

The findings were published online in Cell Reports Medicine.
 

Intentional breath control

Controlled breathwork has emerged as a potential tool to manage stress and boost well-being.

In the new study, researchers compared three different daily 5-minute breathwork exercises to an equal amount of mindfulness meditation over 1 month in 108 healthy adults recruited mostly from an undergraduate psychology class at Stanford: 33 participants practiced cyclic hyperventilation, which emphasizes robust inhalation, short retention and rapid exhalation, 30 did exhale-focused cyclic sighing, 21 performed box breathing, which emphasizes equal duration of inhalation, breath retention, and exhalation, and 24 practiced mindfulness meditation (the control group).

The primary endpoints were improvement in mood and anxiety, as well as reduced physiologic arousal (respiratory rate, heart rate, and heart rate variability). Physiological data was collected using a wearable WHOOP strap.

All four groups showed significant daily improvement in mood, as well as reduction in anxiety and negative mood, but there were significant differences between mindfulness meditation and breathwork.

Using a mixed-effects model, the researchers showed that breathwork, especially the exhale-focused cyclic sighing, produced greater improvement in mood (P < .05) and reduction in respiratory rate (P < .05), compared with mindfulness meditation.
 

Specific patterns vs. passive attention

The finding supports the team’s hypothesis that intentional control over breath with specific breathing patterns produces more benefit to mood than passive attention to one’s breath, as in mindfulness meditation practice.

“It turned out that the cyclic sighing was indeed most soothing,” Dr. Spiegel noted.

“We expected that because of respiratory sinus arrhythmia. Exhaling is accomplished by increasing pressure in the chest, which increases venous return to the heart, triggering parasympathetic slowing of heart rate via the sinoatrial node,” he said.

Dr. Spiegel added that, conversely, inspiration reduces venous return, triggering sympathetic activity and increased heart rate.

“The magnitude of this heart rate variability is associated with better health, including recovery from myocardial infarction and even cancer survival. So self-soothing is a good thing, and we expected an advantage for cyclic sighing,” he said.

“If you’re looking to improve sleep and reduce daytime stress, recover from intense work, life, and/or training, then interventions that facilitate autonomic control (and indeed you can control it), brief (5 minutes) structured breathwork is among the more powerful (and zero cost) tools,” tweeted senior investigator Andrew Huberman, PhD, professor of neurobiology at Stanford.
 

Immediate application?

Sara Lazar, PhD, Massachusetts General Hospital and Harvard Medical School, Boston, said the findings are “interesting” but cautioned that this is “just one study with a pretty small sample size,” and it only enrolled healthy college students.

courtesy Massachusetts General Hospital

Dr. Lazar, who also runs the Lazar Lab for Meditation Research at Mass General, noted that she would want to see a future study “done with working-age adults and with clinical populations.”

“It should also be noted that mindfulness had a bigger effect on negative affect, which could have implications for conditions such as depression or trauma,” said Dr. Lazar, who was not involved with the current research.

Also weighing in, Steven R. Thorp, PhD, professor at California School of Professional Psychology, Alliant International University, San Diego, said in an interview the study is “really interesting and well done.”

“Although breathing exercises and breathing retraining are commonly found in psychosocial interventions, especially for anxiety disorders, there have been few empirical studies comparing different breathing protocols,” Dr. Thorp said.

In this study, the passive observation of breaths (mindfulness) and specific breathwork interventions “all worked to decrease state anxiety; but the breathwork, particularly the cyclic sighing protocol, produced a greater overall reduction in respiratory rate and increase in positive mood,” he noted.

“These techniques can be recommended by all clinicians because all clients have access to their breath at all times – and only 5 minutes of daily practice can yield the benefits. Moreover, as the authors note, the immediate benefits may encourage clients to engage with the breathwork and potentially other aspects of treatment,” Dr. Thorp said.

The study was funded by Victor and Winnie Koo and Tianren Culture and a Stanford School of Medicine Discovery Innovation Award. WHOOP donated the wrist straps used in the study, but was not involved in the study’s design or analysis. Dr. Huberman is an advisor to WHOOP. Dr. Lazar and Dr. Thorp have reported no relevant financial relationships.

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

Cyclic sighing is more effective than mindfulness meditation for improving mood and reducing stress, new research suggests.

In a randomized controlled study, daily breathwork – especially cyclic breathing, which emphasizes shorter inhalations and prolonged exhalations – was associated with greater improvement in mood and a slower respiratory rate than mindfulness meditation.

“We were pleased that just 5 minutes a day of the breathing exercises positively affected mood and resulted in slower respiratory rate, indicating reduced arousal,” coinvestigator David Spiegel, MD, who directs the Center for Stress and Health at Stanford (Calif.) University, told this news organization.

The findings were published online in Cell Reports Medicine.
 

Intentional breath control

Controlled breathwork has emerged as a potential tool to manage stress and boost well-being.

In the new study, researchers compared three different daily 5-minute breathwork exercises to an equal amount of mindfulness meditation over 1 month in 108 healthy adults recruited mostly from an undergraduate psychology class at Stanford: 33 participants practiced cyclic hyperventilation, which emphasizes robust inhalation, short retention and rapid exhalation, 30 did exhale-focused cyclic sighing, 21 performed box breathing, which emphasizes equal duration of inhalation, breath retention, and exhalation, and 24 practiced mindfulness meditation (the control group).

The primary endpoints were improvement in mood and anxiety, as well as reduced physiologic arousal (respiratory rate, heart rate, and heart rate variability). Physiological data was collected using a wearable WHOOP strap.

All four groups showed significant daily improvement in mood, as well as reduction in anxiety and negative mood, but there were significant differences between mindfulness meditation and breathwork.

Using a mixed-effects model, the researchers showed that breathwork, especially the exhale-focused cyclic sighing, produced greater improvement in mood (P < .05) and reduction in respiratory rate (P < .05), compared with mindfulness meditation.
 

Specific patterns vs. passive attention

The finding supports the team’s hypothesis that intentional control over breath with specific breathing patterns produces more benefit to mood than passive attention to one’s breath, as in mindfulness meditation practice.

“It turned out that the cyclic sighing was indeed most soothing,” Dr. Spiegel noted.

“We expected that because of respiratory sinus arrhythmia. Exhaling is accomplished by increasing pressure in the chest, which increases venous return to the heart, triggering parasympathetic slowing of heart rate via the sinoatrial node,” he said.

Dr. Spiegel added that, conversely, inspiration reduces venous return, triggering sympathetic activity and increased heart rate.

“The magnitude of this heart rate variability is associated with better health, including recovery from myocardial infarction and even cancer survival. So self-soothing is a good thing, and we expected an advantage for cyclic sighing,” he said.

“If you’re looking to improve sleep and reduce daytime stress, recover from intense work, life, and/or training, then interventions that facilitate autonomic control (and indeed you can control it), brief (5 minutes) structured breathwork is among the more powerful (and zero cost) tools,” tweeted senior investigator Andrew Huberman, PhD, professor of neurobiology at Stanford.
 

Immediate application?

Sara Lazar, PhD, Massachusetts General Hospital and Harvard Medical School, Boston, said the findings are “interesting” but cautioned that this is “just one study with a pretty small sample size,” and it only enrolled healthy college students.

courtesy Massachusetts General Hospital

Dr. Lazar, who also runs the Lazar Lab for Meditation Research at Mass General, noted that she would want to see a future study “done with working-age adults and with clinical populations.”

“It should also be noted that mindfulness had a bigger effect on negative affect, which could have implications for conditions such as depression or trauma,” said Dr. Lazar, who was not involved with the current research.

Also weighing in, Steven R. Thorp, PhD, professor at California School of Professional Psychology, Alliant International University, San Diego, said in an interview the study is “really interesting and well done.”

“Although breathing exercises and breathing retraining are commonly found in psychosocial interventions, especially for anxiety disorders, there have been few empirical studies comparing different breathing protocols,” Dr. Thorp said.

In this study, the passive observation of breaths (mindfulness) and specific breathwork interventions “all worked to decrease state anxiety; but the breathwork, particularly the cyclic sighing protocol, produced a greater overall reduction in respiratory rate and increase in positive mood,” he noted.

“These techniques can be recommended by all clinicians because all clients have access to their breath at all times – and only 5 minutes of daily practice can yield the benefits. Moreover, as the authors note, the immediate benefits may encourage clients to engage with the breathwork and potentially other aspects of treatment,” Dr. Thorp said.

The study was funded by Victor and Winnie Koo and Tianren Culture and a Stanford School of Medicine Discovery Innovation Award. WHOOP donated the wrist straps used in the study, but was not involved in the study’s design or analysis. Dr. Huberman is an advisor to WHOOP. Dr. Lazar and Dr. Thorp have reported no relevant financial relationships.

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

Doctors are more likely to miss appendicitis in patients who are Black, research shows.

This phenomenon, first described in children, occurs in adults as well, according to a study published in JAMA Surgery.

Some hospitals fare better than others: Those with more diverse patient populations were less likely to have missed the diagnosis, the researchers found.

“We don’t think the amount of melanin in your skin predicts how you present with appendicitis,” said Jonathan Carter, MD, professor of surgery at the University of California, San Francisco. “There’s no biological explanation,” Dr. Carter, who wrote an invited commentary on the research, said in an interview. “It’s really what’s going on in the social environment of those emergency rooms.”

For the study, Anne Stey, MD, assistant professor of surgery at Northwestern University in Chicago and her colleagues analyzed data from more than 80,000 men and women in four states – Florida, Maryland, New York, and Wisconsin – who underwent appendectomy in 2016-2017.

They identified those who had been seen for abdominal complaints at a hospital in the week before surgery but did not receive a diagnosis of appendicitis at that time, indicating a missed opportunity to intervene sooner.

Among Black patients, the proportion who had experienced this type of delay was 3.6%, whereas for White patients, it was 2.5%. For Hispanic patients, the share was 2.4%, while for Asian or Pacific Islander patients, the figure was 1.5%.

An analysis that controlled for patient and hospital variables found that among non-Hispanic Black patients, the rate of delayed diagnosis was 1.41 times higher than for non-Hispanic White patients (95% confidence interval, 1.21-1.63).

Other patient factors associated with delayed diagnosis included female sex, comorbidities, and living in a low-income zip code.

A key factor was where patients sought care. A delayed diagnosis of appendicitis was 3.51 times more likely for patients who went to hospitals where most patients are insured by Medicaid. Prior research has shown that “safety-net hospitals have fewer resources and may provide lower-quality care than hospitals with a larger private payer population,” Dr. Stey’s group writes.

On the other hand, going to a hospital with a more diverse patient population reduced the odds of a delayed diagnosis.

“Patients presenting to hospitals with a greater than 50% Black and Hispanic population were 0.73 (95% CI, 0.59-0.91) times less likely to have a delayed diagnosis, compared with patients presenting to hospitals with a less than 25% Black and Hispanic population,” the researchers report.

In the 30 days after discharge following appendectomy, Black patients returned to the hospital at a higher rate than White patients did (17.5% vs. 11.4%), indicating worse outcomes.

“Delayed diagnosis may account for some of the racial and ethnic disparities observed in outcomes after appendicitis,” according to the authors.

“It may be hospitals that are more used to serving racial-ethnic minority patients are better at diagnosing them, because they’re more culturally informed and have a better understanding of these patients,” Dr. Stey said in a news release about their findings.
 

Great masquerader

Diagnosing appendicitis can be challenging, Dr. Carter said. The early signs can be subtle, and the condition is sometimes called the great masquerader. It is not uncommon for patients to be diagnosed with gastroenteritis or pain associated with their menstrual period, for example, and sent home.

Scoring systems based on patients’ symptoms and liberal use of imaging have improved detection of appendicitis, but “no physician or health care system is perfect in the diagnosis,” he said.

The increased odds of delayed diagnosis for Black patients remained when the researchers focused on healthier patients who had fewer comorbidities, and it also held when they considered patients with private insurance in high-income areas, Dr. Carter noted.

“Once again, with this study we see the association of structural and systematic racism with access to health care, especially for Black patients, in emergency departments and hospitals,” he wrote. “We must redouble our efforts to become anti-racist in ourselves, our institutions, and our profession.”
 

‘Our health care system itself’

Elizabeth Garner, MD, MPH, a pharmaceutical executive who was not involved in the study, commented on Twitter that the study points to an underlying issue that has existed in medicine “for quite some time.”

“Minority populations are not taken as seriously as their white counterparts,” she wrote. “This needs to change.”

Measures of hospital quality need to be tied to health equity, according to Mofya Diallo, MD, MPH, of the department of anesthesiology at the Children’s Hospital Los Angeles and the University of Southern California, Los Angeles.

“Top hospitals should take pride in outcomes that do not vary based on race, income or literacy,” she tweeted in response to the study.

To better understand possible reasons for delayed diagnosis, future researchers could assess whether patients who are Black are less likely to receive a surgical consultation, imaging studies, or lab work, Dr. Carter told this news organization. He pointed to a recent analysis of patients insured by Medicare that found that Black patients were less likely than White patients to receive a surgical consultation after they were admitted with colorectal, general abdominal, hepatopancreatobiliary, intestinal obstruction, or upper gastrointestinal diagnoses.

While social determinants of health, such as income, education, housing, early childhood development, employment, and social inclusion, may account for a substantial portion of health outcomes, “Our health care system itself can be viewed as another social determinant of health,” Dr. Carter wrote. “Insurance coverage, health care professional availability, health care professional linguistic and cultural competency, and quality of care all have an effect on health outcomes.”

Dr. Stey was supported by grants from the American College of Surgeons and the National Institutes of Health.

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

Doctors are more likely to miss appendicitis in patients who are Black, research shows.

This phenomenon, first described in children, occurs in adults as well, according to a study published in JAMA Surgery.

Some hospitals fare better than others: Those with more diverse patient populations were less likely to have missed the diagnosis, the researchers found.

“We don’t think the amount of melanin in your skin predicts how you present with appendicitis,” said Jonathan Carter, MD, professor of surgery at the University of California, San Francisco. “There’s no biological explanation,” Dr. Carter, who wrote an invited commentary on the research, said in an interview. “It’s really what’s going on in the social environment of those emergency rooms.”

For the study, Anne Stey, MD, assistant professor of surgery at Northwestern University in Chicago and her colleagues analyzed data from more than 80,000 men and women in four states – Florida, Maryland, New York, and Wisconsin – who underwent appendectomy in 2016-2017.

They identified those who had been seen for abdominal complaints at a hospital in the week before surgery but did not receive a diagnosis of appendicitis at that time, indicating a missed opportunity to intervene sooner.

Among Black patients, the proportion who had experienced this type of delay was 3.6%, whereas for White patients, it was 2.5%. For Hispanic patients, the share was 2.4%, while for Asian or Pacific Islander patients, the figure was 1.5%.

An analysis that controlled for patient and hospital variables found that among non-Hispanic Black patients, the rate of delayed diagnosis was 1.41 times higher than for non-Hispanic White patients (95% confidence interval, 1.21-1.63).

Other patient factors associated with delayed diagnosis included female sex, comorbidities, and living in a low-income zip code.

A key factor was where patients sought care. A delayed diagnosis of appendicitis was 3.51 times more likely for patients who went to hospitals where most patients are insured by Medicaid. Prior research has shown that “safety-net hospitals have fewer resources and may provide lower-quality care than hospitals with a larger private payer population,” Dr. Stey’s group writes.

On the other hand, going to a hospital with a more diverse patient population reduced the odds of a delayed diagnosis.

“Patients presenting to hospitals with a greater than 50% Black and Hispanic population were 0.73 (95% CI, 0.59-0.91) times less likely to have a delayed diagnosis, compared with patients presenting to hospitals with a less than 25% Black and Hispanic population,” the researchers report.

In the 30 days after discharge following appendectomy, Black patients returned to the hospital at a higher rate than White patients did (17.5% vs. 11.4%), indicating worse outcomes.

“Delayed diagnosis may account for some of the racial and ethnic disparities observed in outcomes after appendicitis,” according to the authors.

“It may be hospitals that are more used to serving racial-ethnic minority patients are better at diagnosing them, because they’re more culturally informed and have a better understanding of these patients,” Dr. Stey said in a news release about their findings.
 

Great masquerader

Diagnosing appendicitis can be challenging, Dr. Carter said. The early signs can be subtle, and the condition is sometimes called the great masquerader. It is not uncommon for patients to be diagnosed with gastroenteritis or pain associated with their menstrual period, for example, and sent home.

Scoring systems based on patients’ symptoms and liberal use of imaging have improved detection of appendicitis, but “no physician or health care system is perfect in the diagnosis,” he said.

The increased odds of delayed diagnosis for Black patients remained when the researchers focused on healthier patients who had fewer comorbidities, and it also held when they considered patients with private insurance in high-income areas, Dr. Carter noted.

“Once again, with this study we see the association of structural and systematic racism with access to health care, especially for Black patients, in emergency departments and hospitals,” he wrote. “We must redouble our efforts to become anti-racist in ourselves, our institutions, and our profession.”
 

‘Our health care system itself’

Elizabeth Garner, MD, MPH, a pharmaceutical executive who was not involved in the study, commented on Twitter that the study points to an underlying issue that has existed in medicine “for quite some time.”

“Minority populations are not taken as seriously as their white counterparts,” she wrote. “This needs to change.”

Measures of hospital quality need to be tied to health equity, according to Mofya Diallo, MD, MPH, of the department of anesthesiology at the Children’s Hospital Los Angeles and the University of Southern California, Los Angeles.

“Top hospitals should take pride in outcomes that do not vary based on race, income or literacy,” she tweeted in response to the study.

To better understand possible reasons for delayed diagnosis, future researchers could assess whether patients who are Black are less likely to receive a surgical consultation, imaging studies, or lab work, Dr. Carter told this news organization. He pointed to a recent analysis of patients insured by Medicare that found that Black patients were less likely than White patients to receive a surgical consultation after they were admitted with colorectal, general abdominal, hepatopancreatobiliary, intestinal obstruction, or upper gastrointestinal diagnoses.

While social determinants of health, such as income, education, housing, early childhood development, employment, and social inclusion, may account for a substantial portion of health outcomes, “Our health care system itself can be viewed as another social determinant of health,” Dr. Carter wrote. “Insurance coverage, health care professional availability, health care professional linguistic and cultural competency, and quality of care all have an effect on health outcomes.”

Dr. Stey was supported by grants from the American College of Surgeons and the National Institutes of Health.

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

Doctors are more likely to miss appendicitis in patients who are Black, research shows.

This phenomenon, first described in children, occurs in adults as well, according to a study published in JAMA Surgery.

Some hospitals fare better than others: Those with more diverse patient populations were less likely to have missed the diagnosis, the researchers found.

“We don’t think the amount of melanin in your skin predicts how you present with appendicitis,” said Jonathan Carter, MD, professor of surgery at the University of California, San Francisco. “There’s no biological explanation,” Dr. Carter, who wrote an invited commentary on the research, said in an interview. “It’s really what’s going on in the social environment of those emergency rooms.”

For the study, Anne Stey, MD, assistant professor of surgery at Northwestern University in Chicago and her colleagues analyzed data from more than 80,000 men and women in four states – Florida, Maryland, New York, and Wisconsin – who underwent appendectomy in 2016-2017.

They identified those who had been seen for abdominal complaints at a hospital in the week before surgery but did not receive a diagnosis of appendicitis at that time, indicating a missed opportunity to intervene sooner.

Among Black patients, the proportion who had experienced this type of delay was 3.6%, whereas for White patients, it was 2.5%. For Hispanic patients, the share was 2.4%, while for Asian or Pacific Islander patients, the figure was 1.5%.

An analysis that controlled for patient and hospital variables found that among non-Hispanic Black patients, the rate of delayed diagnosis was 1.41 times higher than for non-Hispanic White patients (95% confidence interval, 1.21-1.63).

Other patient factors associated with delayed diagnosis included female sex, comorbidities, and living in a low-income zip code.

A key factor was where patients sought care. A delayed diagnosis of appendicitis was 3.51 times more likely for patients who went to hospitals where most patients are insured by Medicaid. Prior research has shown that “safety-net hospitals have fewer resources and may provide lower-quality care than hospitals with a larger private payer population,” Dr. Stey’s group writes.

On the other hand, going to a hospital with a more diverse patient population reduced the odds of a delayed diagnosis.

“Patients presenting to hospitals with a greater than 50% Black and Hispanic population were 0.73 (95% CI, 0.59-0.91) times less likely to have a delayed diagnosis, compared with patients presenting to hospitals with a less than 25% Black and Hispanic population,” the researchers report.

In the 30 days after discharge following appendectomy, Black patients returned to the hospital at a higher rate than White patients did (17.5% vs. 11.4%), indicating worse outcomes.

“Delayed diagnosis may account for some of the racial and ethnic disparities observed in outcomes after appendicitis,” according to the authors.

“It may be hospitals that are more used to serving racial-ethnic minority patients are better at diagnosing them, because they’re more culturally informed and have a better understanding of these patients,” Dr. Stey said in a news release about their findings.
 

Great masquerader

Diagnosing appendicitis can be challenging, Dr. Carter said. The early signs can be subtle, and the condition is sometimes called the great masquerader. It is not uncommon for patients to be diagnosed with gastroenteritis or pain associated with their menstrual period, for example, and sent home.

Scoring systems based on patients’ symptoms and liberal use of imaging have improved detection of appendicitis, but “no physician or health care system is perfect in the diagnosis,” he said.

The increased odds of delayed diagnosis for Black patients remained when the researchers focused on healthier patients who had fewer comorbidities, and it also held when they considered patients with private insurance in high-income areas, Dr. Carter noted.

“Once again, with this study we see the association of structural and systematic racism with access to health care, especially for Black patients, in emergency departments and hospitals,” he wrote. “We must redouble our efforts to become anti-racist in ourselves, our institutions, and our profession.”
 

‘Our health care system itself’

Elizabeth Garner, MD, MPH, a pharmaceutical executive who was not involved in the study, commented on Twitter that the study points to an underlying issue that has existed in medicine “for quite some time.”

“Minority populations are not taken as seriously as their white counterparts,” she wrote. “This needs to change.”

Measures of hospital quality need to be tied to health equity, according to Mofya Diallo, MD, MPH, of the department of anesthesiology at the Children’s Hospital Los Angeles and the University of Southern California, Los Angeles.

“Top hospitals should take pride in outcomes that do not vary based on race, income or literacy,” she tweeted in response to the study.

To better understand possible reasons for delayed diagnosis, future researchers could assess whether patients who are Black are less likely to receive a surgical consultation, imaging studies, or lab work, Dr. Carter told this news organization. He pointed to a recent analysis of patients insured by Medicare that found that Black patients were less likely than White patients to receive a surgical consultation after they were admitted with colorectal, general abdominal, hepatopancreatobiliary, intestinal obstruction, or upper gastrointestinal diagnoses.

While social determinants of health, such as income, education, housing, early childhood development, employment, and social inclusion, may account for a substantial portion of health outcomes, “Our health care system itself can be viewed as another social determinant of health,” Dr. Carter wrote. “Insurance coverage, health care professional availability, health care professional linguistic and cultural competency, and quality of care all have an effect on health outcomes.”

Dr. Stey was supported by grants from the American College of Surgeons and the National Institutes of Health.

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

Off-label use of ketamine, the anesthetic-turned-potential treatment for resistant depression, is soaring in the United States and has many experts in the psychiatric community concerned.

The number of ketamine clinics has risen dramatically, with little to no oversight. Prescriptions are being written by providers who lack training in safe ketamine use and online startups are selling the drug for at-home use, taking advantage of a temporary federal regulation that makes it easier to prescribe controlled substances without an in-person patient assessment.

All of this comes at a time when recreational use of ketamine, known on the street as “Special K,” is rising, and reports to poison control centers and drug seizures by the U.S. Drug Enforcement Agency (DEA) are climbing.

In a scenario where enthusiasm for the drug is larger than the body of evidence supporting its clinical use, support is growing for the creation of a ketamine registry to collect data on dosage, treatment frequency, adverse events, and long-term outcomes in patients receiving the therapy for depression and other mental health conditions.

“In the past, there was this question of whether a registry was even needed,” said Gerard Sanacora, MD, PhD, a professor of psychiatry at Yale University, New Haven, Conn., who has pushed for a registry for more than 5 years.

“Now, not only are people being treated with this in large numbers, but it’s also started to push the envelope with at-home dosing,” Dr. Sanacora said in an interview. “It’s come to the point that everybody agrees we do need some way to track it.”
 

An idea whose time has come

Interest in ketamine’s antidepressant effects has grown since 2000, when a small study suggested the drug rapidly improved depressive symptoms. Research now suggests ketamine reduces symptoms in patients with treatment-resistant depression (TRD).

Studies linking ketamine to relief of depressive symptoms are small and mostly retrospective, and none has offered longitudinal information on long-term outcomes, including side effects and the risk of addiction.

Still, clinicians desperate to help the one-third of patients with major depression who fail to respond to first-line treatments often prescribe the drug anyway.

In 2017, Dr. Sanacora, who also is director of the Yale Depression Research Program at the Yale School of Medicine, was the lead author of a consensus statement that sought to help physicians administer ketamine safely and appropriately in patients with severe depression and other mood disorders.

In that paper, Dr. Sanacora and his coauthors advocated for the creation of a ketamine registry. Such a database, they argued, would provide much-needed data for large, long-term studies, which could be used to develop treatment guidelines, certification programs, and possibly even accreditation standards for providers. Meanwhile, researchers and clinicians in the United Kingdom were also calling for a ketamine registry.

While there seemed to be wide consensus that such a registry was needed, there was no clear path to creating one and no clear line to an agency that would take responsibility for maintaining it.

Because the registry wouldn’t be tied to a drug indication, Dr. Sanacora was told the U.S. Food and Drug Administration wouldn’t take it on. The project also fell outside the purview of the U.S. Department of Health & Human Services, the National Institute of Mental Health (NIMH), and the DEA.

“I haven’t met anybody who has said this is a terrible idea, but nobody seems to have a clear mechanism of doing it, and it doesn’t seem to fall directly under anybody’s jurisdiction,” Dr. Sanacora said.

Dr. Sanacora and other ketamine registry advocates were met with an endless stream of questions. Who would pay for it? How would they get providers to participate? Who would run it and how would the data be shared? The barriers to implementation seemed insurmountable.
 

A changing landscape

Five years later, these barriers remain. However, advocates note support for a registry is growing, due in large part to a series of developments over the past 6 years that they believe have altered the ketamine landscape.

Chief among these was the 2019 FDA approval of esketamine, a nasal formulation of ketamine, for the treatment of resistant depression. The drug’s indication was expanded in 2020 to include major depressive disorder and acute suicidal ideation or behavior. The drug is only available through a restricted distribution system – the Spravato Risk Evaluation and Mitigation Strategy (REMS) – because of the risk for serious adverse events, including sedation and dissociation, as well as the potential for abuse or misuse.

A sharp increase in the number of ketamine prescribers and clinics has also heightened interest in a ketamine registry. In the last year alone, membership in the American Society of Ketamine Physicians, Psychotherapists, and Practitioners (ASKP) – a nonprofit trade organization for clinicians who prescribe ketamine for mental health disorders and pain conditions – swelled from 300 individual providers to more than 500.

The number of ketamine clinics in the United States has also grown exponentially and is estimated to be anywhere from 500 to 750. A spokesperson with HHS said such clinics are not regulated by the department or any other federal agency but instead are subject to oversight by individual states.

Although recreational use of ketamine remains low overall, there are signs that illicit use is rising, including an increase in DEA seizures of illicit ketamine and reports of ketamine-related poisonings to the nation’s poison control centers. Data on recreational use is spotty, at best. The Centers for Disease Control and Prevention National Vital Statistics System – the primary source of information on drug-related mortality in the United States – does not report on ketamine.
 

At-home ketamine use soars

Perhaps the most significant development came in March 2020 in the early days of the pandemic. To ease access to therapeutic schedule II-V controlled substances, the DEA issued a waiver that relaxed restrictions in the Ryan Haight Act, legislation that requires that patients be seen at least once in person before receiving a prescription for this class of drugs.

Under the waiver, DEA-registered practitioners are allowed to prescribe these substances – including ketamine, a schedule III substance – via telemedicine, without an in-person exam.

Startup companies cropped up almost overnight to prescribe oral ketamine online for at-home use, with almost no oversight. A spokesperson with the DEA told this news organization that the agency is working to make these “temporary” regulations permanent.

Under the relaxed DEA guidelines, a prescriber only needs to have a DEA license to dispense a ketamine prescription. An alarming number of clinics and online startups are staffed by individuals with no training in ketamine use and, in some cases, no formal mental health training at all, said Lisa Harding, MD, vice president of ASKP and a clinical instructor of psychiatry at Yale School of Medicine.

“The biggest problem is not the ketamine itself, it’s that the majority of practitioners are not psychiatrists, so they don’t have mental health training,” Dr. Harding said. “The fact that an untrained person, any practitioner with no mental health training, can administer this treatment once they have a state license to give ketamine ... then how are you protecting the patients?”

That question prompted ASKP to create the first known program to train psychiatrists, and other qualified mental health practitioners who prescribe ketamine, how to use the drug safely and effectively. The program, scheduled for June, will also include discussion by leaders in the field about how a ketamine registry might address these and other patient safety concerns.

“Nobody is really investigating the standard to which these clinics and online companies should be held, and I think a registry would help with that,” she said in an interview.
 

The path forward

While ASKP leadership supports the idea of a ketamine registry, Dr. Harding said the organization would need assurances the effort would not create a barrier to treatment.

“It will take somebody bringing all of us to the table and figuring that out,” Dr. Harding said.

Conversations like that with stakeholders would be one of the first steps toward creating a registry, Dr. Sanacora said.

“The more complicated we make this registry, the less compliance we’re going to get,” Dr. Sanacora said. “Our first step is to understand the major impediments and figure out how we can make this easier for people.”

Ideally, the registry would take advantage of existing data-collection tools, such as electronic health records (EHR), and include some sort of patient data entry mechanism, Dr. Sanacora said. The effort will also require skilled biostatisticians and a database system that is easy to manage.

And, of course, the registry will need a large number of patients to gather sufficient data to conduct high-quality research to develop treatment guidelines, training, and accreditation standards. A good target would be about 10,000 patients, Dr. Sanacora said.

All of this requires funding, which is the first hurdle registry advocates must clear. Dr. Sanacora is working on identifying funding sources and said that after working on this for years, he is hopeful that progress can be made.

“I had reached a point where it felt like there was no path forward,” Dr. Sanacora said. “But now I have renewed optimism that something can be done. And something does need to be done, largely for public health reasons but also to optimize the treatment.”

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

Off-label use of ketamine, the anesthetic-turned-potential treatment for resistant depression, is soaring in the United States and has many experts in the psychiatric community concerned.

The number of ketamine clinics has risen dramatically, with little to no oversight. Prescriptions are being written by providers who lack training in safe ketamine use and online startups are selling the drug for at-home use, taking advantage of a temporary federal regulation that makes it easier to prescribe controlled substances without an in-person patient assessment.

All of this comes at a time when recreational use of ketamine, known on the street as “Special K,” is rising, and reports to poison control centers and drug seizures by the U.S. Drug Enforcement Agency (DEA) are climbing.

In a scenario where enthusiasm for the drug is larger than the body of evidence supporting its clinical use, support is growing for the creation of a ketamine registry to collect data on dosage, treatment frequency, adverse events, and long-term outcomes in patients receiving the therapy for depression and other mental health conditions.

“In the past, there was this question of whether a registry was even needed,” said Gerard Sanacora, MD, PhD, a professor of psychiatry at Yale University, New Haven, Conn., who has pushed for a registry for more than 5 years.

“Now, not only are people being treated with this in large numbers, but it’s also started to push the envelope with at-home dosing,” Dr. Sanacora said in an interview. “It’s come to the point that everybody agrees we do need some way to track it.”
 

An idea whose time has come

Interest in ketamine’s antidepressant effects has grown since 2000, when a small study suggested the drug rapidly improved depressive symptoms. Research now suggests ketamine reduces symptoms in patients with treatment-resistant depression (TRD).

Studies linking ketamine to relief of depressive symptoms are small and mostly retrospective, and none has offered longitudinal information on long-term outcomes, including side effects and the risk of addiction.

Still, clinicians desperate to help the one-third of patients with major depression who fail to respond to first-line treatments often prescribe the drug anyway.

In 2017, Dr. Sanacora, who also is director of the Yale Depression Research Program at the Yale School of Medicine, was the lead author of a consensus statement that sought to help physicians administer ketamine safely and appropriately in patients with severe depression and other mood disorders.

In that paper, Dr. Sanacora and his coauthors advocated for the creation of a ketamine registry. Such a database, they argued, would provide much-needed data for large, long-term studies, which could be used to develop treatment guidelines, certification programs, and possibly even accreditation standards for providers. Meanwhile, researchers and clinicians in the United Kingdom were also calling for a ketamine registry.

While there seemed to be wide consensus that such a registry was needed, there was no clear path to creating one and no clear line to an agency that would take responsibility for maintaining it.

Because the registry wouldn’t be tied to a drug indication, Dr. Sanacora was told the U.S. Food and Drug Administration wouldn’t take it on. The project also fell outside the purview of the U.S. Department of Health & Human Services, the National Institute of Mental Health (NIMH), and the DEA.

“I haven’t met anybody who has said this is a terrible idea, but nobody seems to have a clear mechanism of doing it, and it doesn’t seem to fall directly under anybody’s jurisdiction,” Dr. Sanacora said.

Dr. Sanacora and other ketamine registry advocates were met with an endless stream of questions. Who would pay for it? How would they get providers to participate? Who would run it and how would the data be shared? The barriers to implementation seemed insurmountable.
 

A changing landscape

Five years later, these barriers remain. However, advocates note support for a registry is growing, due in large part to a series of developments over the past 6 years that they believe have altered the ketamine landscape.

Chief among these was the 2019 FDA approval of esketamine, a nasal formulation of ketamine, for the treatment of resistant depression. The drug’s indication was expanded in 2020 to include major depressive disorder and acute suicidal ideation or behavior. The drug is only available through a restricted distribution system – the Spravato Risk Evaluation and Mitigation Strategy (REMS) – because of the risk for serious adverse events, including sedation and dissociation, as well as the potential for abuse or misuse.

A sharp increase in the number of ketamine prescribers and clinics has also heightened interest in a ketamine registry. In the last year alone, membership in the American Society of Ketamine Physicians, Psychotherapists, and Practitioners (ASKP) – a nonprofit trade organization for clinicians who prescribe ketamine for mental health disorders and pain conditions – swelled from 300 individual providers to more than 500.

The number of ketamine clinics in the United States has also grown exponentially and is estimated to be anywhere from 500 to 750. A spokesperson with HHS said such clinics are not regulated by the department or any other federal agency but instead are subject to oversight by individual states.

Although recreational use of ketamine remains low overall, there are signs that illicit use is rising, including an increase in DEA seizures of illicit ketamine and reports of ketamine-related poisonings to the nation’s poison control centers. Data on recreational use is spotty, at best. The Centers for Disease Control and Prevention National Vital Statistics System – the primary source of information on drug-related mortality in the United States – does not report on ketamine.
 

At-home ketamine use soars

Perhaps the most significant development came in March 2020 in the early days of the pandemic. To ease access to therapeutic schedule II-V controlled substances, the DEA issued a waiver that relaxed restrictions in the Ryan Haight Act, legislation that requires that patients be seen at least once in person before receiving a prescription for this class of drugs.

Under the waiver, DEA-registered practitioners are allowed to prescribe these substances – including ketamine, a schedule III substance – via telemedicine, without an in-person exam.

Startup companies cropped up almost overnight to prescribe oral ketamine online for at-home use, with almost no oversight. A spokesperson with the DEA told this news organization that the agency is working to make these “temporary” regulations permanent.

Under the relaxed DEA guidelines, a prescriber only needs to have a DEA license to dispense a ketamine prescription. An alarming number of clinics and online startups are staffed by individuals with no training in ketamine use and, in some cases, no formal mental health training at all, said Lisa Harding, MD, vice president of ASKP and a clinical instructor of psychiatry at Yale School of Medicine.

“The biggest problem is not the ketamine itself, it’s that the majority of practitioners are not psychiatrists, so they don’t have mental health training,” Dr. Harding said. “The fact that an untrained person, any practitioner with no mental health training, can administer this treatment once they have a state license to give ketamine ... then how are you protecting the patients?”

That question prompted ASKP to create the first known program to train psychiatrists, and other qualified mental health practitioners who prescribe ketamine, how to use the drug safely and effectively. The program, scheduled for June, will also include discussion by leaders in the field about how a ketamine registry might address these and other patient safety concerns.

“Nobody is really investigating the standard to which these clinics and online companies should be held, and I think a registry would help with that,” she said in an interview.
 

The path forward

While ASKP leadership supports the idea of a ketamine registry, Dr. Harding said the organization would need assurances the effort would not create a barrier to treatment.

“It will take somebody bringing all of us to the table and figuring that out,” Dr. Harding said.

Conversations like that with stakeholders would be one of the first steps toward creating a registry, Dr. Sanacora said.

“The more complicated we make this registry, the less compliance we’re going to get,” Dr. Sanacora said. “Our first step is to understand the major impediments and figure out how we can make this easier for people.”

Ideally, the registry would take advantage of existing data-collection tools, such as electronic health records (EHR), and include some sort of patient data entry mechanism, Dr. Sanacora said. The effort will also require skilled biostatisticians and a database system that is easy to manage.

And, of course, the registry will need a large number of patients to gather sufficient data to conduct high-quality research to develop treatment guidelines, training, and accreditation standards. A good target would be about 10,000 patients, Dr. Sanacora said.

All of this requires funding, which is the first hurdle registry advocates must clear. Dr. Sanacora is working on identifying funding sources and said that after working on this for years, he is hopeful that progress can be made.

“I had reached a point where it felt like there was no path forward,” Dr. Sanacora said. “But now I have renewed optimism that something can be done. And something does need to be done, largely for public health reasons but also to optimize the treatment.”

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

Off-label use of ketamine, the anesthetic-turned-potential treatment for resistant depression, is soaring in the United States and has many experts in the psychiatric community concerned.

The number of ketamine clinics has risen dramatically, with little to no oversight. Prescriptions are being written by providers who lack training in safe ketamine use and online startups are selling the drug for at-home use, taking advantage of a temporary federal regulation that makes it easier to prescribe controlled substances without an in-person patient assessment.

All of this comes at a time when recreational use of ketamine, known on the street as “Special K,” is rising, and reports to poison control centers and drug seizures by the U.S. Drug Enforcement Agency (DEA) are climbing.

In a scenario where enthusiasm for the drug is larger than the body of evidence supporting its clinical use, support is growing for the creation of a ketamine registry to collect data on dosage, treatment frequency, adverse events, and long-term outcomes in patients receiving the therapy for depression and other mental health conditions.

“In the past, there was this question of whether a registry was even needed,” said Gerard Sanacora, MD, PhD, a professor of psychiatry at Yale University, New Haven, Conn., who has pushed for a registry for more than 5 years.

“Now, not only are people being treated with this in large numbers, but it’s also started to push the envelope with at-home dosing,” Dr. Sanacora said in an interview. “It’s come to the point that everybody agrees we do need some way to track it.”
 

An idea whose time has come

Interest in ketamine’s antidepressant effects has grown since 2000, when a small study suggested the drug rapidly improved depressive symptoms. Research now suggests ketamine reduces symptoms in patients with treatment-resistant depression (TRD).

Studies linking ketamine to relief of depressive symptoms are small and mostly retrospective, and none has offered longitudinal information on long-term outcomes, including side effects and the risk of addiction.

Still, clinicians desperate to help the one-third of patients with major depression who fail to respond to first-line treatments often prescribe the drug anyway.

In 2017, Dr. Sanacora, who also is director of the Yale Depression Research Program at the Yale School of Medicine, was the lead author of a consensus statement that sought to help physicians administer ketamine safely and appropriately in patients with severe depression and other mood disorders.

In that paper, Dr. Sanacora and his coauthors advocated for the creation of a ketamine registry. Such a database, they argued, would provide much-needed data for large, long-term studies, which could be used to develop treatment guidelines, certification programs, and possibly even accreditation standards for providers. Meanwhile, researchers and clinicians in the United Kingdom were also calling for a ketamine registry.

While there seemed to be wide consensus that such a registry was needed, there was no clear path to creating one and no clear line to an agency that would take responsibility for maintaining it.

Because the registry wouldn’t be tied to a drug indication, Dr. Sanacora was told the U.S. Food and Drug Administration wouldn’t take it on. The project also fell outside the purview of the U.S. Department of Health & Human Services, the National Institute of Mental Health (NIMH), and the DEA.

“I haven’t met anybody who has said this is a terrible idea, but nobody seems to have a clear mechanism of doing it, and it doesn’t seem to fall directly under anybody’s jurisdiction,” Dr. Sanacora said.

Dr. Sanacora and other ketamine registry advocates were met with an endless stream of questions. Who would pay for it? How would they get providers to participate? Who would run it and how would the data be shared? The barriers to implementation seemed insurmountable.
 

A changing landscape

Five years later, these barriers remain. However, advocates note support for a registry is growing, due in large part to a series of developments over the past 6 years that they believe have altered the ketamine landscape.

Chief among these was the 2019 FDA approval of esketamine, a nasal formulation of ketamine, for the treatment of resistant depression. The drug’s indication was expanded in 2020 to include major depressive disorder and acute suicidal ideation or behavior. The drug is only available through a restricted distribution system – the Spravato Risk Evaluation and Mitigation Strategy (REMS) – because of the risk for serious adverse events, including sedation and dissociation, as well as the potential for abuse or misuse.

A sharp increase in the number of ketamine prescribers and clinics has also heightened interest in a ketamine registry. In the last year alone, membership in the American Society of Ketamine Physicians, Psychotherapists, and Practitioners (ASKP) – a nonprofit trade organization for clinicians who prescribe ketamine for mental health disorders and pain conditions – swelled from 300 individual providers to more than 500.

The number of ketamine clinics in the United States has also grown exponentially and is estimated to be anywhere from 500 to 750. A spokesperson with HHS said such clinics are not regulated by the department or any other federal agency but instead are subject to oversight by individual states.

Although recreational use of ketamine remains low overall, there are signs that illicit use is rising, including an increase in DEA seizures of illicit ketamine and reports of ketamine-related poisonings to the nation’s poison control centers. Data on recreational use is spotty, at best. The Centers for Disease Control and Prevention National Vital Statistics System – the primary source of information on drug-related mortality in the United States – does not report on ketamine.
 

At-home ketamine use soars

Perhaps the most significant development came in March 2020 in the early days of the pandemic. To ease access to therapeutic schedule II-V controlled substances, the DEA issued a waiver that relaxed restrictions in the Ryan Haight Act, legislation that requires that patients be seen at least once in person before receiving a prescription for this class of drugs.

Under the waiver, DEA-registered practitioners are allowed to prescribe these substances – including ketamine, a schedule III substance – via telemedicine, without an in-person exam.

Startup companies cropped up almost overnight to prescribe oral ketamine online for at-home use, with almost no oversight. A spokesperson with the DEA told this news organization that the agency is working to make these “temporary” regulations permanent.

Under the relaxed DEA guidelines, a prescriber only needs to have a DEA license to dispense a ketamine prescription. An alarming number of clinics and online startups are staffed by individuals with no training in ketamine use and, in some cases, no formal mental health training at all, said Lisa Harding, MD, vice president of ASKP and a clinical instructor of psychiatry at Yale School of Medicine.

“The biggest problem is not the ketamine itself, it’s that the majority of practitioners are not psychiatrists, so they don’t have mental health training,” Dr. Harding said. “The fact that an untrained person, any practitioner with no mental health training, can administer this treatment once they have a state license to give ketamine ... then how are you protecting the patients?”

That question prompted ASKP to create the first known program to train psychiatrists, and other qualified mental health practitioners who prescribe ketamine, how to use the drug safely and effectively. The program, scheduled for June, will also include discussion by leaders in the field about how a ketamine registry might address these and other patient safety concerns.

“Nobody is really investigating the standard to which these clinics and online companies should be held, and I think a registry would help with that,” she said in an interview.
 

The path forward

While ASKP leadership supports the idea of a ketamine registry, Dr. Harding said the organization would need assurances the effort would not create a barrier to treatment.

“It will take somebody bringing all of us to the table and figuring that out,” Dr. Harding said.

Conversations like that with stakeholders would be one of the first steps toward creating a registry, Dr. Sanacora said.

“The more complicated we make this registry, the less compliance we’re going to get,” Dr. Sanacora said. “Our first step is to understand the major impediments and figure out how we can make this easier for people.”

Ideally, the registry would take advantage of existing data-collection tools, such as electronic health records (EHR), and include some sort of patient data entry mechanism, Dr. Sanacora said. The effort will also require skilled biostatisticians and a database system that is easy to manage.

And, of course, the registry will need a large number of patients to gather sufficient data to conduct high-quality research to develop treatment guidelines, training, and accreditation standards. A good target would be about 10,000 patients, Dr. Sanacora said.

All of this requires funding, which is the first hurdle registry advocates must clear. Dr. Sanacora is working on identifying funding sources and said that after working on this for years, he is hopeful that progress can be made.

“I had reached a point where it felt like there was no path forward,” Dr. Sanacora said. “But now I have renewed optimism that something can be done. And something does need to be done, largely for public health reasons but also to optimize the treatment.”

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

An oncologist who says she was fired for whistleblower retaliation and gender discrimination has now filed a lawsuit against her former employer.

Anne Grand’Maison, MD, was employed at Roswell Park Comprehensive Cancer Center in Buffalo, N.Y., for 5 years and was the first medical oncologist specifically trained in sarcoma to join the center since it was founded more than 130 years ago.

The lawsuit, filed on Jan. 31, alleges that she was pushed out of her job after raising numerous concerns about egregious medical misconduct and lack of patient safety at the facility.

Roswell Park Cancer Center “denies these unfounded claims, and will vigorously defend itself in this matter,” the organization said in a statement issued to this news organization.

The 75-page complaint alleges that Dr. Grand’Maison observed unacceptable conduct and treatment of patients, including sarcoma pathology reports replete with diagnostic errors, physicians who were not well educated in the latest sarcoma research, and senior doctors refusing to seek out second opinions even in difficult cases.

All of these issues put patient safety and lives at serious risk, according to the lawsuit, and Dr. Grand’Maison raised her concerns internally and attempted to create the necessary changes.

Of specific concern to Dr. Grand’Maison was the competence of Carl Morrison, MD, DVM, Roswell Park’s lead sarcoma pathologist and chair of pathology, whom she had questioned on many occasions and voiced concerns about to other senior staff. But once she made it known that she had gathered up medical records to prove that he had made numerous specific misdiagnoses that led to mistreatments, Dr. Grand’Maison was forced out of her job and the hospital, she said.

“Roswell failed the cancer patients who entrusted their lives to the hospital by ignoring risks to their safety,” Dr. Grand’Maison said in an interview. “The heart of my practice as an oncologist is the well-being of my patients and that is why I could not stay silent.

“I hope that by coming forward, Roswell will be held accountable for putting lives at risk,” she said.
 

Not up to date with best practices

Before joining Roswell, Dr. Grand’Maison had worked at the University of Texas MD Anderson Cancer Center, which is the top cancer center in the nation, noted David E. Gottlieb, a partner at Wigdor, the law firm that is representing her.

MD Anderson has set the standard for sarcoma care, as they treat the highest volume of sarcoma cases of any hospital in North America and they have the best survival outcomes for sarcoma patients, he said in an interview.

“She was bringing this knowledge and background to Roswell Park,” Mr. Gottlieb said. “She felt that Dr. Morrison was not up to date with best practices as far as diagnosing and treating sarcoma, and she raised numerous issues.

“He was not open to being critiqued and even rejected her request to send something out for a second opinion,” Mr. Gottlieb said. “Second opinions are routine in medicine, and it’s the standard of care. We are dealing with a person’s life and it’s not a personal attack – you could be wrong, and getting another opinion can save a patient’s life.”

But Dr. Morrison has been at Roswell Park for many years, is a good friend of Roswell’s president and CEO Candace Johnson, PhD, and is part of the “old guard,” and “really at the top of the organization,” Mr. Gottlieb said  “Whereas Dr. Grand’Maison was relatively new, and her opinions were not popular.”

The complaint was filed against defendants Roswell Park Comprehensive Care Center; Health Research Inc. Roswell Park Division; Candace Johnson, PhD; Carl Morrison, MD, DVM; Renier Brentjens, MD, PhD, deputy director and chair of medicine; and two other senior physicians.
 

Denial of ‘unfounded claims’

In its statement, Roswell Park pointed out that it is one of few centers in the nation recognized by the Sarcoma Alliance as a hospital with specialized expertise and resources for patients with sarcoma. “Our physician experts not only adhere strictly to national best practices in the diagnosis and care of patients with sarcoma, they determine and disseminate the standards of appropriate medical care as lead authors of national guidelines,” the center stated.

“The facts demonstrate that Roswell Park is a richly diverse and inclusive organization committed to optimizing cancer care by incorporating the expertise of teams of specialists from many subspecialties and disciplines,” according to the statement.
 

Resistance and male egos

Dr. Grand’Maison has been a licensed physician for more than 30 years, and received her MD in 1988 after graduating from Sherbrooke University in Quebec. Over the next few decades she worked in clinical medicine and research, both in Canada and the United States. In 2014, she became certified in medical oncology and then secured a clinical and research fellowship focusing on sarcoma at MD Anderson.

Two years later, after completing her fellowship, she accepted a full-time position as an assistant professor of oncology in the department of medical oncology’s sarcoma division at Roswell Park. She became the first medical oncologist with a subspecialty in sarcoma, and also brought with her the advanced techniques and aggressive treatment that had been pioneered by MD Anderson, and which had never been used at Roswell Park, according to the complaint.

However, Dr. Grand’Maison said that she began to encounter some resistance from those more familiar with Roswell’s previous standard operating procedures. For example, her practice of seeing patients on days when chemotherapy was administered was viewed by some of the advanced practice clinicians as a lack of confidence in their abilities.

According to the complaint, Dr. Grand’Maison found the sarcoma tumor board at Roswell to be “male-dominated, ego-driven, fraught with defensiveness, and rife with a lack of collegiality almost from the very beginning,” which was very different from her experience at MD Anderson.

Less than 6 months after joining Roswell, she said that Dr. Morrison began treating her in a condescending manner at the tumor board meetings when she asked him questions pertaining to a diagnosis. She viewed his “physically intimidating and aggressive conduct toward her as sexist, and it was a pattern of conduct that would persist in the years that followed.” Dr. Grand’Maison observed that Dr. Morrison never behaved that way toward the men when discussing a case.

Over time, Dr. Grand’Maison made numerous and near endless efforts to raise her concerns about patient safety and gender discrimination at Roswell Park and had reached out to her supervisor and to others in upper management, the complaint alleges. All of this appeared to fall on completely deaf ears as hospital “politics” and doctor egos took precedence. Dr. Morrison continued to try to intimidate her into “silence” and block her attempts to refine diagnoses to ensure proper treatment, and several other senior physicians enabled his behavior and ignored the risk it posed to patient safety, the complaint alleges.  

“While she raised complaints about gender discrimination, the crux of her complaint was patient safety,” Mr. Gottlieb emphasized.

Another issue was that Dr. Grand’Maison never received the proper clinical support she repeatedly requested and that was urgently needed. Thus, her patients faced other elevated safety risks as a result of the underresourced sarcoma clinic, she said.
 

Fired or resigned?

Dr. Grand’Maison left Roswell Park Cancer center last May, and has not worked since.

Although Dr. Grand’Maison stated that she was fired in retaliation for raising serious concerns, Roswell Park insists that she voluntarily resigned. Dr. Grand’Maison acknowledged that she wrote an email in January 2022 to the clinical practice plan coordinator in which she mentioned that her husband was planning to relocate back to Canada and that her last date at Roswell Park would be May 1, 2022. The coordinator never responded to that email. In the interim, her husband, also a physician with privileges at Roswell Park, made it known that he was not moving to Canada.

Dr. Grand’Maison said that, as she had not resigned, and everyone knew her husband wasn’t moving, she did not follow up on that January 2022 email, and then forgot about it.

“That email was used as the basis to force her out,”said her lawyer, Mr. Gottlieb. “The day after she put together a summary and extensively documented serious patient safety concerns, she got an email that her resignation had been accepted.”

None of the standard protocols for resignation had been completed, either by human resources or by her supervisors, Mr. Gottlieb contended. “The law says that they can’t take adverse action against her for filing a complaint, so they fired her under the guise of a resignation,” he said.

Roswell Park refused to rescind Dr. Grand’Maison’s resignation, despite multiple attempts on her part. She even contacted the CEO and stated that her January 2022 email was being used a pretext to push her out in retaliation, but she received no response, only that the matter had been referred to someone else.

“I am speaking out because time and again female doctors are unable to deliver on the promise of their medical training because of discrimination,” said Dr. Grand’Maison. “Roswell dismissed my expertise and diminished my value. While I worry that coming forward may affect my career, I am taking that risk to make the path easier for the women who will come behind me.”

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

An oncologist who says she was fired for whistleblower retaliation and gender discrimination has now filed a lawsuit against her former employer.

Anne Grand’Maison, MD, was employed at Roswell Park Comprehensive Cancer Center in Buffalo, N.Y., for 5 years and was the first medical oncologist specifically trained in sarcoma to join the center since it was founded more than 130 years ago.

The lawsuit, filed on Jan. 31, alleges that she was pushed out of her job after raising numerous concerns about egregious medical misconduct and lack of patient safety at the facility.

Roswell Park Cancer Center “denies these unfounded claims, and will vigorously defend itself in this matter,” the organization said in a statement issued to this news organization.

The 75-page complaint alleges that Dr. Grand’Maison observed unacceptable conduct and treatment of patients, including sarcoma pathology reports replete with diagnostic errors, physicians who were not well educated in the latest sarcoma research, and senior doctors refusing to seek out second opinions even in difficult cases.

All of these issues put patient safety and lives at serious risk, according to the lawsuit, and Dr. Grand’Maison raised her concerns internally and attempted to create the necessary changes.

Of specific concern to Dr. Grand’Maison was the competence of Carl Morrison, MD, DVM, Roswell Park’s lead sarcoma pathologist and chair of pathology, whom she had questioned on many occasions and voiced concerns about to other senior staff. But once she made it known that she had gathered up medical records to prove that he had made numerous specific misdiagnoses that led to mistreatments, Dr. Grand’Maison was forced out of her job and the hospital, she said.

“Roswell failed the cancer patients who entrusted their lives to the hospital by ignoring risks to their safety,” Dr. Grand’Maison said in an interview. “The heart of my practice as an oncologist is the well-being of my patients and that is why I could not stay silent.

“I hope that by coming forward, Roswell will be held accountable for putting lives at risk,” she said.
 

Not up to date with best practices

Before joining Roswell, Dr. Grand’Maison had worked at the University of Texas MD Anderson Cancer Center, which is the top cancer center in the nation, noted David E. Gottlieb, a partner at Wigdor, the law firm that is representing her.

MD Anderson has set the standard for sarcoma care, as they treat the highest volume of sarcoma cases of any hospital in North America and they have the best survival outcomes for sarcoma patients, he said in an interview.

“She was bringing this knowledge and background to Roswell Park,” Mr. Gottlieb said. “She felt that Dr. Morrison was not up to date with best practices as far as diagnosing and treating sarcoma, and she raised numerous issues.

“He was not open to being critiqued and even rejected her request to send something out for a second opinion,” Mr. Gottlieb said. “Second opinions are routine in medicine, and it’s the standard of care. We are dealing with a person’s life and it’s not a personal attack – you could be wrong, and getting another opinion can save a patient’s life.”

But Dr. Morrison has been at Roswell Park for many years, is a good friend of Roswell’s president and CEO Candace Johnson, PhD, and is part of the “old guard,” and “really at the top of the organization,” Mr. Gottlieb said  “Whereas Dr. Grand’Maison was relatively new, and her opinions were not popular.”

The complaint was filed against defendants Roswell Park Comprehensive Care Center; Health Research Inc. Roswell Park Division; Candace Johnson, PhD; Carl Morrison, MD, DVM; Renier Brentjens, MD, PhD, deputy director and chair of medicine; and two other senior physicians.
 

Denial of ‘unfounded claims’

In its statement, Roswell Park pointed out that it is one of few centers in the nation recognized by the Sarcoma Alliance as a hospital with specialized expertise and resources for patients with sarcoma. “Our physician experts not only adhere strictly to national best practices in the diagnosis and care of patients with sarcoma, they determine and disseminate the standards of appropriate medical care as lead authors of national guidelines,” the center stated.

“The facts demonstrate that Roswell Park is a richly diverse and inclusive organization committed to optimizing cancer care by incorporating the expertise of teams of specialists from many subspecialties and disciplines,” according to the statement.
 

Resistance and male egos

Dr. Grand’Maison has been a licensed physician for more than 30 years, and received her MD in 1988 after graduating from Sherbrooke University in Quebec. Over the next few decades she worked in clinical medicine and research, both in Canada and the United States. In 2014, she became certified in medical oncology and then secured a clinical and research fellowship focusing on sarcoma at MD Anderson.

Two years later, after completing her fellowship, she accepted a full-time position as an assistant professor of oncology in the department of medical oncology’s sarcoma division at Roswell Park. She became the first medical oncologist with a subspecialty in sarcoma, and also brought with her the advanced techniques and aggressive treatment that had been pioneered by MD Anderson, and which had never been used at Roswell Park, according to the complaint.

However, Dr. Grand’Maison said that she began to encounter some resistance from those more familiar with Roswell’s previous standard operating procedures. For example, her practice of seeing patients on days when chemotherapy was administered was viewed by some of the advanced practice clinicians as a lack of confidence in their abilities.

According to the complaint, Dr. Grand’Maison found the sarcoma tumor board at Roswell to be “male-dominated, ego-driven, fraught with defensiveness, and rife with a lack of collegiality almost from the very beginning,” which was very different from her experience at MD Anderson.

Less than 6 months after joining Roswell, she said that Dr. Morrison began treating her in a condescending manner at the tumor board meetings when she asked him questions pertaining to a diagnosis. She viewed his “physically intimidating and aggressive conduct toward her as sexist, and it was a pattern of conduct that would persist in the years that followed.” Dr. Grand’Maison observed that Dr. Morrison never behaved that way toward the men when discussing a case.

Over time, Dr. Grand’Maison made numerous and near endless efforts to raise her concerns about patient safety and gender discrimination at Roswell Park and had reached out to her supervisor and to others in upper management, the complaint alleges. All of this appeared to fall on completely deaf ears as hospital “politics” and doctor egos took precedence. Dr. Morrison continued to try to intimidate her into “silence” and block her attempts to refine diagnoses to ensure proper treatment, and several other senior physicians enabled his behavior and ignored the risk it posed to patient safety, the complaint alleges.  

“While she raised complaints about gender discrimination, the crux of her complaint was patient safety,” Mr. Gottlieb emphasized.

Another issue was that Dr. Grand’Maison never received the proper clinical support she repeatedly requested and that was urgently needed. Thus, her patients faced other elevated safety risks as a result of the underresourced sarcoma clinic, she said.
 

Fired or resigned?

Dr. Grand’Maison left Roswell Park Cancer center last May, and has not worked since.

Although Dr. Grand’Maison stated that she was fired in retaliation for raising serious concerns, Roswell Park insists that she voluntarily resigned. Dr. Grand’Maison acknowledged that she wrote an email in January 2022 to the clinical practice plan coordinator in which she mentioned that her husband was planning to relocate back to Canada and that her last date at Roswell Park would be May 1, 2022. The coordinator never responded to that email. In the interim, her husband, also a physician with privileges at Roswell Park, made it known that he was not moving to Canada.

Dr. Grand’Maison said that, as she had not resigned, and everyone knew her husband wasn’t moving, she did not follow up on that January 2022 email, and then forgot about it.

“That email was used as the basis to force her out,”said her lawyer, Mr. Gottlieb. “The day after she put together a summary and extensively documented serious patient safety concerns, she got an email that her resignation had been accepted.”

None of the standard protocols for resignation had been completed, either by human resources or by her supervisors, Mr. Gottlieb contended. “The law says that they can’t take adverse action against her for filing a complaint, so they fired her under the guise of a resignation,” he said.

Roswell Park refused to rescind Dr. Grand’Maison’s resignation, despite multiple attempts on her part. She even contacted the CEO and stated that her January 2022 email was being used a pretext to push her out in retaliation, but she received no response, only that the matter had been referred to someone else.

“I am speaking out because time and again female doctors are unable to deliver on the promise of their medical training because of discrimination,” said Dr. Grand’Maison. “Roswell dismissed my expertise and diminished my value. While I worry that coming forward may affect my career, I am taking that risk to make the path easier for the women who will come behind me.”

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

An oncologist who says she was fired for whistleblower retaliation and gender discrimination has now filed a lawsuit against her former employer.

Anne Grand’Maison, MD, was employed at Roswell Park Comprehensive Cancer Center in Buffalo, N.Y., for 5 years and was the first medical oncologist specifically trained in sarcoma to join the center since it was founded more than 130 years ago.

The lawsuit, filed on Jan. 31, alleges that she was pushed out of her job after raising numerous concerns about egregious medical misconduct and lack of patient safety at the facility.

Roswell Park Cancer Center “denies these unfounded claims, and will vigorously defend itself in this matter,” the organization said in a statement issued to this news organization.

The 75-page complaint alleges that Dr. Grand’Maison observed unacceptable conduct and treatment of patients, including sarcoma pathology reports replete with diagnostic errors, physicians who were not well educated in the latest sarcoma research, and senior doctors refusing to seek out second opinions even in difficult cases.

All of these issues put patient safety and lives at serious risk, according to the lawsuit, and Dr. Grand’Maison raised her concerns internally and attempted to create the necessary changes.

Of specific concern to Dr. Grand’Maison was the competence of Carl Morrison, MD, DVM, Roswell Park’s lead sarcoma pathologist and chair of pathology, whom she had questioned on many occasions and voiced concerns about to other senior staff. But once she made it known that she had gathered up medical records to prove that he had made numerous specific misdiagnoses that led to mistreatments, Dr. Grand’Maison was forced out of her job and the hospital, she said.

“Roswell failed the cancer patients who entrusted their lives to the hospital by ignoring risks to their safety,” Dr. Grand’Maison said in an interview. “The heart of my practice as an oncologist is the well-being of my patients and that is why I could not stay silent.

“I hope that by coming forward, Roswell will be held accountable for putting lives at risk,” she said.
 

Not up to date with best practices

Before joining Roswell, Dr. Grand’Maison had worked at the University of Texas MD Anderson Cancer Center, which is the top cancer center in the nation, noted David E. Gottlieb, a partner at Wigdor, the law firm that is representing her.

MD Anderson has set the standard for sarcoma care, as they treat the highest volume of sarcoma cases of any hospital in North America and they have the best survival outcomes for sarcoma patients, he said in an interview.

“She was bringing this knowledge and background to Roswell Park,” Mr. Gottlieb said. “She felt that Dr. Morrison was not up to date with best practices as far as diagnosing and treating sarcoma, and she raised numerous issues.

“He was not open to being critiqued and even rejected her request to send something out for a second opinion,” Mr. Gottlieb said. “Second opinions are routine in medicine, and it’s the standard of care. We are dealing with a person’s life and it’s not a personal attack – you could be wrong, and getting another opinion can save a patient’s life.”

But Dr. Morrison has been at Roswell Park for many years, is a good friend of Roswell’s president and CEO Candace Johnson, PhD, and is part of the “old guard,” and “really at the top of the organization,” Mr. Gottlieb said  “Whereas Dr. Grand’Maison was relatively new, and her opinions were not popular.”

The complaint was filed against defendants Roswell Park Comprehensive Care Center; Health Research Inc. Roswell Park Division; Candace Johnson, PhD; Carl Morrison, MD, DVM; Renier Brentjens, MD, PhD, deputy director and chair of medicine; and two other senior physicians.
 

Denial of ‘unfounded claims’

In its statement, Roswell Park pointed out that it is one of few centers in the nation recognized by the Sarcoma Alliance as a hospital with specialized expertise and resources for patients with sarcoma. “Our physician experts not only adhere strictly to national best practices in the diagnosis and care of patients with sarcoma, they determine and disseminate the standards of appropriate medical care as lead authors of national guidelines,” the center stated.

“The facts demonstrate that Roswell Park is a richly diverse and inclusive organization committed to optimizing cancer care by incorporating the expertise of teams of specialists from many subspecialties and disciplines,” according to the statement.
 

Resistance and male egos

Dr. Grand’Maison has been a licensed physician for more than 30 years, and received her MD in 1988 after graduating from Sherbrooke University in Quebec. Over the next few decades she worked in clinical medicine and research, both in Canada and the United States. In 2014, she became certified in medical oncology and then secured a clinical and research fellowship focusing on sarcoma at MD Anderson.

Two years later, after completing her fellowship, she accepted a full-time position as an assistant professor of oncology in the department of medical oncology’s sarcoma division at Roswell Park. She became the first medical oncologist with a subspecialty in sarcoma, and also brought with her the advanced techniques and aggressive treatment that had been pioneered by MD Anderson, and which had never been used at Roswell Park, according to the complaint.

However, Dr. Grand’Maison said that she began to encounter some resistance from those more familiar with Roswell’s previous standard operating procedures. For example, her practice of seeing patients on days when chemotherapy was administered was viewed by some of the advanced practice clinicians as a lack of confidence in their abilities.

According to the complaint, Dr. Grand’Maison found the sarcoma tumor board at Roswell to be “male-dominated, ego-driven, fraught with defensiveness, and rife with a lack of collegiality almost from the very beginning,” which was very different from her experience at MD Anderson.

Less than 6 months after joining Roswell, she said that Dr. Morrison began treating her in a condescending manner at the tumor board meetings when she asked him questions pertaining to a diagnosis. She viewed his “physically intimidating and aggressive conduct toward her as sexist, and it was a pattern of conduct that would persist in the years that followed.” Dr. Grand’Maison observed that Dr. Morrison never behaved that way toward the men when discussing a case.

Over time, Dr. Grand’Maison made numerous and near endless efforts to raise her concerns about patient safety and gender discrimination at Roswell Park and had reached out to her supervisor and to others in upper management, the complaint alleges. All of this appeared to fall on completely deaf ears as hospital “politics” and doctor egos took precedence. Dr. Morrison continued to try to intimidate her into “silence” and block her attempts to refine diagnoses to ensure proper treatment, and several other senior physicians enabled his behavior and ignored the risk it posed to patient safety, the complaint alleges.  

“While she raised complaints about gender discrimination, the crux of her complaint was patient safety,” Mr. Gottlieb emphasized.

Another issue was that Dr. Grand’Maison never received the proper clinical support she repeatedly requested and that was urgently needed. Thus, her patients faced other elevated safety risks as a result of the underresourced sarcoma clinic, she said.
 

Fired or resigned?

Dr. Grand’Maison left Roswell Park Cancer center last May, and has not worked since.

Although Dr. Grand’Maison stated that she was fired in retaliation for raising serious concerns, Roswell Park insists that she voluntarily resigned. Dr. Grand’Maison acknowledged that she wrote an email in January 2022 to the clinical practice plan coordinator in which she mentioned that her husband was planning to relocate back to Canada and that her last date at Roswell Park would be May 1, 2022. The coordinator never responded to that email. In the interim, her husband, also a physician with privileges at Roswell Park, made it known that he was not moving to Canada.

Dr. Grand’Maison said that, as she had not resigned, and everyone knew her husband wasn’t moving, she did not follow up on that January 2022 email, and then forgot about it.

“That email was used as the basis to force her out,”said her lawyer, Mr. Gottlieb. “The day after she put together a summary and extensively documented serious patient safety concerns, she got an email that her resignation had been accepted.”

None of the standard protocols for resignation had been completed, either by human resources or by her supervisors, Mr. Gottlieb contended. “The law says that they can’t take adverse action against her for filing a complaint, so they fired her under the guise of a resignation,” he said.

Roswell Park refused to rescind Dr. Grand’Maison’s resignation, despite multiple attempts on her part. She even contacted the CEO and stated that her January 2022 email was being used a pretext to push her out in retaliation, but she received no response, only that the matter had been referred to someone else.

“I am speaking out because time and again female doctors are unable to deliver on the promise of their medical training because of discrimination,” said Dr. Grand’Maison. “Roswell dismissed my expertise and diminished my value. While I worry that coming forward may affect my career, I am taking that risk to make the path easier for the women who will come behind me.”

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

The increased risk for diabetes following COVID-19 infection has persisted into the Omicron era, but vaccination against SARS-CoV-2 appears to diminish that likelihood, new data suggest.

The findings, from more than 20,000 patients in the Cedars-Sinai Health System in Los Angeles, suggest that “continued efforts to prevent COVID-19 infection may be beneficial to patient health until we develop better understanding of the effects of potential long-term effects of COVID-19,” lead author Alan C. Kwan, MD, of the department of cardiology at Cedars Sinai’s Smidt Heart Institute, said in an interview.

Several studies conducted early in the pandemic suggested increased risks for both new-onset diabetes and cardiometabolic diseases following COVID-19 infection, possibly because of persistent inflammation contributing to insulin resistance.

However, it hasn’t been clear if those risks have persisted with the more recent predominance of the less-virulent Omicron variant or whether the COVID-19 vaccine influences the risk. This new study suggests that both are the case.

“Our results verify that the risk of developing type 2 diabetes after a COVID-19 infection was not just an early observation but, in fact, a real risk that has, unfortunately, persisted through the Omicron era,” Dr. Kwan noted.

“While the level of evidence by our study and others may not reach the degree needed to affect formal guidelines at this time, we believe it is reasonable to have increased clinical suspicion for diabetes after COVID-19 infection and a lower threshold for testing,” he added.

Moreover, “we believe that our study and others suggest the potential role of COVID-19 to affect cardiovascular risk, and so both prevention of COVID-19 infection, through reasonable personal practices and vaccination, and an increased attention to cardiovascular health after COVID-19 infection is warranted.”

The findings were published online in JAMA Network Open.

Dr. Kwan and colleagues analyzed data for a total of 23,709 patients treated (inpatient and outpatient) for at least one COVID-19 infection between March 2020 and June 2022.

Rates of new-onset diabetes (using ICD-10 codes, primarily type 2 diabetes), hypertension, and hyperlipidemia were all elevated in the 90 days following COVID-19 infection compared with the 90 days prior. The same was true of two diagnoses unrelated to COVID-19, urinary tract infection and gastroesophageal reflux, used as benchmarks of health care engagement.

The highest odds for post versus preinfection were for diabetes (odds ratio, 2.35; P < .001), followed by hypertension (OR, 1.54; P < .001), the benchmark diagnoses (OR, 1.42; P < .001), and hyperlipidemia (OR, 1.22; P = .03).

Following adjustments, the risk versus the benchmark conditions for new-onset diabetes before versus after COVID-19 was significantly elevated (OR, 1.58; P < .001), while the risks for hypertension and hyperlipidemia versus benchmark diagnoses were not (OR, 1.06; P = .52 and 0.91, P = .43, respectively).

The diabetes risk after versus before COVID-19 infection was higher among those who had not been vaccinated (OR, 1.78; P < .001), compared with those who had received the vaccine (OR, 1.07; P = .80).

However, there was no significant interaction between vaccination and diabetes diagnosis (P = .08). “For this reason, we believe our data are suggestive of a protective effect in the population who received vaccination prior to infection, but [this is] not definitive,” Dr. Kwan said.

There were no apparent interactions by age, sex, or pre-existing cardiovascular risk factors, including hypertension or hyperlipidemia. Age, sex, and timing of index infection regarding the Omicron variant were not associated with an increased risk of a new cardiometabolic diagnosis before or after COVID-19 infection in any of the models.

Dr. Kwan said in an interview: “We have continued to be surprised by the evolving understanding of the SARS-CoV-2 virus and the effects on human health. In the beginning of the pandemic it was framed as a purely respiratory virus, which we now know to be a severely limited description of all of its potential effects on the human body. We believe that our research and others raise a concern for increased cardiometabolic risk after COVID infection.”

He added that, “while knowledge is incomplete on this topic, we believe that clinical providers may wish to have a higher degree of suspicion for both diabetes and risk of future cardiac events in patients after COVID infection, and that continued efforts to prevent COVID infection may be beneficial to patient health until we develop better understanding of the potential long-term effects of COVID.”

This study was funded by the Erika J. Glazer Family Foundation, the Doris Duke Charitable Foundation, and grants from the National Institutes of Health. Dr. Kwan reported receiving grants from the Doris Duke Charitable Foundation during the conduct of the study.

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

The increased risk for diabetes following COVID-19 infection has persisted into the Omicron era, but vaccination against SARS-CoV-2 appears to diminish that likelihood, new data suggest.

The findings, from more than 20,000 patients in the Cedars-Sinai Health System in Los Angeles, suggest that “continued efforts to prevent COVID-19 infection may be beneficial to patient health until we develop better understanding of the effects of potential long-term effects of COVID-19,” lead author Alan C. Kwan, MD, of the department of cardiology at Cedars Sinai’s Smidt Heart Institute, said in an interview.

Several studies conducted early in the pandemic suggested increased risks for both new-onset diabetes and cardiometabolic diseases following COVID-19 infection, possibly because of persistent inflammation contributing to insulin resistance.

However, it hasn’t been clear if those risks have persisted with the more recent predominance of the less-virulent Omicron variant or whether the COVID-19 vaccine influences the risk. This new study suggests that both are the case.

“Our results verify that the risk of developing type 2 diabetes after a COVID-19 infection was not just an early observation but, in fact, a real risk that has, unfortunately, persisted through the Omicron era,” Dr. Kwan noted.

“While the level of evidence by our study and others may not reach the degree needed to affect formal guidelines at this time, we believe it is reasonable to have increased clinical suspicion for diabetes after COVID-19 infection and a lower threshold for testing,” he added.

Moreover, “we believe that our study and others suggest the potential role of COVID-19 to affect cardiovascular risk, and so both prevention of COVID-19 infection, through reasonable personal practices and vaccination, and an increased attention to cardiovascular health after COVID-19 infection is warranted.”

The findings were published online in JAMA Network Open.

Dr. Kwan and colleagues analyzed data for a total of 23,709 patients treated (inpatient and outpatient) for at least one COVID-19 infection between March 2020 and June 2022.

Rates of new-onset diabetes (using ICD-10 codes, primarily type 2 diabetes), hypertension, and hyperlipidemia were all elevated in the 90 days following COVID-19 infection compared with the 90 days prior. The same was true of two diagnoses unrelated to COVID-19, urinary tract infection and gastroesophageal reflux, used as benchmarks of health care engagement.

The highest odds for post versus preinfection were for diabetes (odds ratio, 2.35; P < .001), followed by hypertension (OR, 1.54; P < .001), the benchmark diagnoses (OR, 1.42; P < .001), and hyperlipidemia (OR, 1.22; P = .03).

Following adjustments, the risk versus the benchmark conditions for new-onset diabetes before versus after COVID-19 was significantly elevated (OR, 1.58; P < .001), while the risks for hypertension and hyperlipidemia versus benchmark diagnoses were not (OR, 1.06; P = .52 and 0.91, P = .43, respectively).

The diabetes risk after versus before COVID-19 infection was higher among those who had not been vaccinated (OR, 1.78; P < .001), compared with those who had received the vaccine (OR, 1.07; P = .80).

However, there was no significant interaction between vaccination and diabetes diagnosis (P = .08). “For this reason, we believe our data are suggestive of a protective effect in the population who received vaccination prior to infection, but [this is] not definitive,” Dr. Kwan said.

There were no apparent interactions by age, sex, or pre-existing cardiovascular risk factors, including hypertension or hyperlipidemia. Age, sex, and timing of index infection regarding the Omicron variant were not associated with an increased risk of a new cardiometabolic diagnosis before or after COVID-19 infection in any of the models.

Dr. Kwan said in an interview: “We have continued to be surprised by the evolving understanding of the SARS-CoV-2 virus and the effects on human health. In the beginning of the pandemic it was framed as a purely respiratory virus, which we now know to be a severely limited description of all of its potential effects on the human body. We believe that our research and others raise a concern for increased cardiometabolic risk after COVID infection.”

He added that, “while knowledge is incomplete on this topic, we believe that clinical providers may wish to have a higher degree of suspicion for both diabetes and risk of future cardiac events in patients after COVID infection, and that continued efforts to prevent COVID infection may be beneficial to patient health until we develop better understanding of the potential long-term effects of COVID.”

This study was funded by the Erika J. Glazer Family Foundation, the Doris Duke Charitable Foundation, and grants from the National Institutes of Health. Dr. Kwan reported receiving grants from the Doris Duke Charitable Foundation during the conduct of the study.

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

The increased risk for diabetes following COVID-19 infection has persisted into the Omicron era, but vaccination against SARS-CoV-2 appears to diminish that likelihood, new data suggest.

The findings, from more than 20,000 patients in the Cedars-Sinai Health System in Los Angeles, suggest that “continued efforts to prevent COVID-19 infection may be beneficial to patient health until we develop better understanding of the effects of potential long-term effects of COVID-19,” lead author Alan C. Kwan, MD, of the department of cardiology at Cedars Sinai’s Smidt Heart Institute, said in an interview.

Several studies conducted early in the pandemic suggested increased risks for both new-onset diabetes and cardiometabolic diseases following COVID-19 infection, possibly because of persistent inflammation contributing to insulin resistance.

However, it hasn’t been clear if those risks have persisted with the more recent predominance of the less-virulent Omicron variant or whether the COVID-19 vaccine influences the risk. This new study suggests that both are the case.

“Our results verify that the risk of developing type 2 diabetes after a COVID-19 infection was not just an early observation but, in fact, a real risk that has, unfortunately, persisted through the Omicron era,” Dr. Kwan noted.

“While the level of evidence by our study and others may not reach the degree needed to affect formal guidelines at this time, we believe it is reasonable to have increased clinical suspicion for diabetes after COVID-19 infection and a lower threshold for testing,” he added.

Moreover, “we believe that our study and others suggest the potential role of COVID-19 to affect cardiovascular risk, and so both prevention of COVID-19 infection, through reasonable personal practices and vaccination, and an increased attention to cardiovascular health after COVID-19 infection is warranted.”

The findings were published online in JAMA Network Open.

Dr. Kwan and colleagues analyzed data for a total of 23,709 patients treated (inpatient and outpatient) for at least one COVID-19 infection between March 2020 and June 2022.

Rates of new-onset diabetes (using ICD-10 codes, primarily type 2 diabetes), hypertension, and hyperlipidemia were all elevated in the 90 days following COVID-19 infection compared with the 90 days prior. The same was true of two diagnoses unrelated to COVID-19, urinary tract infection and gastroesophageal reflux, used as benchmarks of health care engagement.

The highest odds for post versus preinfection were for diabetes (odds ratio, 2.35; P < .001), followed by hypertension (OR, 1.54; P < .001), the benchmark diagnoses (OR, 1.42; P < .001), and hyperlipidemia (OR, 1.22; P = .03).

Following adjustments, the risk versus the benchmark conditions for new-onset diabetes before versus after COVID-19 was significantly elevated (OR, 1.58; P < .001), while the risks for hypertension and hyperlipidemia versus benchmark diagnoses were not (OR, 1.06; P = .52 and 0.91, P = .43, respectively).

The diabetes risk after versus before COVID-19 infection was higher among those who had not been vaccinated (OR, 1.78; P < .001), compared with those who had received the vaccine (OR, 1.07; P = .80).

However, there was no significant interaction between vaccination and diabetes diagnosis (P = .08). “For this reason, we believe our data are suggestive of a protective effect in the population who received vaccination prior to infection, but [this is] not definitive,” Dr. Kwan said.

There were no apparent interactions by age, sex, or pre-existing cardiovascular risk factors, including hypertension or hyperlipidemia. Age, sex, and timing of index infection regarding the Omicron variant were not associated with an increased risk of a new cardiometabolic diagnosis before or after COVID-19 infection in any of the models.

Dr. Kwan said in an interview: “We have continued to be surprised by the evolving understanding of the SARS-CoV-2 virus and the effects on human health. In the beginning of the pandemic it was framed as a purely respiratory virus, which we now know to be a severely limited description of all of its potential effects on the human body. We believe that our research and others raise a concern for increased cardiometabolic risk after COVID infection.”

He added that, “while knowledge is incomplete on this topic, we believe that clinical providers may wish to have a higher degree of suspicion for both diabetes and risk of future cardiac events in patients after COVID infection, and that continued efforts to prevent COVID infection may be beneficial to patient health until we develop better understanding of the potential long-term effects of COVID.”

This study was funded by the Erika J. Glazer Family Foundation, the Doris Duke Charitable Foundation, and grants from the National Institutes of Health. Dr. Kwan reported receiving grants from the Doris Duke Charitable Foundation during the conduct of the study.

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

Family medicine physician Kenneth Cheng, DO, was on-call at a local hospital when a nurse told him that a patient needing evaluation hated Asians.

“I talked to him about whether he was okay seeing me and he said yes,” Dr. Cheng said. “But I remained vigilant and conscious of what the patient was doing the whole time so he couldn’t take advantage of the situation.”

Dr. Cheng never turned his back to the patient and even backed out of the exam room. That encounter passed without incident. However, a urologist Dr. Cheng knew from residency wasn’t so fortunate. Ronald Gilbert, MD, of Newport Beach, Calif., was shot and killed by a patient in his office. The patient blamed him for complications following prostate surgery 25 years earlier.

In 2022, a gunman in Tulsa, Okla., blamed his physician for pain from a recent back surgery and shot and killed him, another physician, and two others in a medical building before taking his own life.

Nearly 9 in 10 physicians reported in a recent Medscape poll that they had experienced one or more violent or potentially violent incidents in the past year. The most common patient behaviors were verbal abuse, getting angry and leaving, and behaving erratically.

About one in three respondents said that the patients threatened to harm them, and about one in five said that the patients became violent.

Experts say that many factors contribute to this potentially lethal situation: Health care services have become more impersonal, patients experience longer wait times, some abuse prescription drugs, mental health services are lacking, and security is poor or nonexistent at some health care facilities.

Violence against hospital workers has become so common that a bill was introduced in 2022 in Congress to better protect them. The Safety From Violence for Healthcare Employees Act includes stiffer penalties for acts involving the use of a dangerous weapon or committed during a public emergency and would also provide $25 million in grants to hospitals for programs aimed at reducing violent incidents in health care settings, including de-escalation training. The American Hospital Association and American College of Emergency Physicians support the bill, which is now before the House Judiciary Subcommittee on Crime, Terrorism, and Homeland Security.
 

The worst day of their lives

“You have people who already are having the worst day of their lives and feeling on edge. If they already have a short fuse or substance abuse issues, that can translate into agitation, violence, or aggression,” said Scott Zeller, MD, vice president of acute psychiatry at Vituity, a physician-owned multispecialty group that operates in several states.

Health care workers in psychiatric and substance abuse hospitals were 10 times more likely to experience nonfatal injuries by others in 2018 than were health care workers in ambulatory settings, according to an April 2020 Bureau of Labor Statistics report. In addition, health care workers were five times more likely to suffer a workplace violence injury than were workers overall in 2018.

Psychiatrists who responded to the poll were the specialists most likely to report that they encountered violent patients and potentially violent patients. “Historically, inpatient psychiatry, which requires more acute care and monitoring, is considered the most dangerous profession outside of the police,” said Dr. Zeller.

Emergency physicians have reported an uptick in violence from patients; 85% said in a survey by ACEP in 2022 that they believed the rate of violence in emergency departments has increased over the past 5 years, whereas 45% indicated that it has greatly increased.

Some doctors have been threatened with violence or actually killed by family members. Alex Skog, MD, president-elect of ACEP’s Oregon chapter, told HealthCare Dive that “a patient’s family member with a gun holster on his hip threatened to kill me and kill my entire family after I told his father that he needed to be admitted because he had coronavirus.”

“I’ve been scared for my safety as well as the safety of my family,” Dr. Skog said. “That was just not something that we were seeing 3, 4, or 5 years ago.”

Many patients are already upset by the time they see doctors, according to the poll.

“The most common reason patients are upset is that they’re already in a lot of pain, which can be expressed as anger, hostility, or aggression. They’re very anxious and afraid of what’s happening and may be thinking about the worst-case scenario – that a bump or lump is cancer,” Dr. Zeller said.

Patients may also get upset if they disagree with their doctors’ diagnosis or treatment plan or the doctor refuses to prescribe them the drugs or tests they want.

“One doctor commented recently: ‘After over 30 years in this business, I can say patients are worse now than at any point in my career. Entitled, demanding, obnoxious. Any denial is met with outrage and indignity, whether it’s an opioid request or a demand for MRI of something because they ‘want to know.’ ”

An orthopedic surgeon in Indiana lost his life after he refused to prescribe opioids to a patient. Her angry husband shot and killed the doctor in the parking lot only 2 hours after confronting him in his office.
 

Decreased physician-patient trust

“When doctors experience something frightening, they become more apprehensive in the future. There’s no doubt that after the first violent experience, they think of things differently,” said Dr. Zeller.

More than half of the doctors who reported experiencing at least one violent or potentially violent incident in the poll said they trusted patients less.

This diminished trust can negatively impact the physician-patient relationship, said the authors of a recent Health Affairs article.

“The more patients harm their health care providers, intentionally or unintentionally, the more difficult it will be for those providers to trust them, leading to yet another unfortunate pattern: physicians pulling back on some of the behaviors thought to be most trust-building, for example, talking about their personal lives, building rapport, displaying compassion, or giving out their personal cell phone numbers,” the article stated.
 

What doctors can do

Most doctors who experienced a violent or potentially violent incident said they had tried to defuse the situation and that they succeeded at least some of the time, the poll results show.

One of the best ways to defuse a situation is to be empathetic and show the person that you’re on their side and not the enemy, said Dr. Cheng,.

“Rather than making general statements like ‘I understand that you’re upset,’ it’s better to be specific about the reason the person is upset. For example: ‘I understand that you’re upset that the pharmacy didn’t fill your prescription’ or ‘I understand how you’re feeling about Doctor So-and-so, who didn’t treat you right,’ ” Dr. Cheng stated.

Dr. Zeller urged physicians to talk to patients about why they’re upset and how they can help them. That approach worked with a patient who was having a psychotic episode.

“I told the staff, who wanted to forcibly restrain him and inject him with medication, that I would talk to him. I asked the patient, who was screaming ‘ya ya ya ya,’ whether he would take his medication if I gave it to him and he said yes. When he was calm, he explained that he was screaming to stop the voices telling him to kill his parents. He then got the help he needed,” said Dr. Zeller.

Dr. Cheng was trained in de-escalation techniques as an Orange County reserve deputy sheriff. He and Dr. Zeller recommended that physicians and staff receive training in how to spot potentially violent behavior and defuse these situations before they escalate.

Dr. Cheng suggests looking at the person’s body language for signs of increasing agitation or tension, such as clenched fists, tense posture, tight jaw, or fidgeting that may be accompanied by shouting and/or verbal abuse.

Physicians also need to consider where they are physically in relation to patients they see. “You don’t want to be too close to the patient or stand in front of them, which can be seen as confrontational. Instead, stand or sit off to the side, and never block the door if the patient’s upset,” said Dr. Cheng.

He recommended that physician practices prepare for violent incidents by developing detailed plans, including how and when to escape, how to protect patients, and how to cooperate with law enforcement.

“If a violent incident is inescapable, physicians and staff must be ready to fight back with whatever tools they have available, which may include fire extinguishers, chairs, or scalpels,” said Dr. Cheng.

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

Family medicine physician Kenneth Cheng, DO, was on-call at a local hospital when a nurse told him that a patient needing evaluation hated Asians.

“I talked to him about whether he was okay seeing me and he said yes,” Dr. Cheng said. “But I remained vigilant and conscious of what the patient was doing the whole time so he couldn’t take advantage of the situation.”

Dr. Cheng never turned his back to the patient and even backed out of the exam room. That encounter passed without incident. However, a urologist Dr. Cheng knew from residency wasn’t so fortunate. Ronald Gilbert, MD, of Newport Beach, Calif., was shot and killed by a patient in his office. The patient blamed him for complications following prostate surgery 25 years earlier.

In 2022, a gunman in Tulsa, Okla., blamed his physician for pain from a recent back surgery and shot and killed him, another physician, and two others in a medical building before taking his own life.

Nearly 9 in 10 physicians reported in a recent Medscape poll that they had experienced one or more violent or potentially violent incidents in the past year. The most common patient behaviors were verbal abuse, getting angry and leaving, and behaving erratically.

About one in three respondents said that the patients threatened to harm them, and about one in five said that the patients became violent.

Experts say that many factors contribute to this potentially lethal situation: Health care services have become more impersonal, patients experience longer wait times, some abuse prescription drugs, mental health services are lacking, and security is poor or nonexistent at some health care facilities.

Violence against hospital workers has become so common that a bill was introduced in 2022 in Congress to better protect them. The Safety From Violence for Healthcare Employees Act includes stiffer penalties for acts involving the use of a dangerous weapon or committed during a public emergency and would also provide $25 million in grants to hospitals for programs aimed at reducing violent incidents in health care settings, including de-escalation training. The American Hospital Association and American College of Emergency Physicians support the bill, which is now before the House Judiciary Subcommittee on Crime, Terrorism, and Homeland Security.
 

The worst day of their lives

“You have people who already are having the worst day of their lives and feeling on edge. If they already have a short fuse or substance abuse issues, that can translate into agitation, violence, or aggression,” said Scott Zeller, MD, vice president of acute psychiatry at Vituity, a physician-owned multispecialty group that operates in several states.

Health care workers in psychiatric and substance abuse hospitals were 10 times more likely to experience nonfatal injuries by others in 2018 than were health care workers in ambulatory settings, according to an April 2020 Bureau of Labor Statistics report. In addition, health care workers were five times more likely to suffer a workplace violence injury than were workers overall in 2018.

Psychiatrists who responded to the poll were the specialists most likely to report that they encountered violent patients and potentially violent patients. “Historically, inpatient psychiatry, which requires more acute care and monitoring, is considered the most dangerous profession outside of the police,” said Dr. Zeller.

Emergency physicians have reported an uptick in violence from patients; 85% said in a survey by ACEP in 2022 that they believed the rate of violence in emergency departments has increased over the past 5 years, whereas 45% indicated that it has greatly increased.

Some doctors have been threatened with violence or actually killed by family members. Alex Skog, MD, president-elect of ACEP’s Oregon chapter, told HealthCare Dive that “a patient’s family member with a gun holster on his hip threatened to kill me and kill my entire family after I told his father that he needed to be admitted because he had coronavirus.”

“I’ve been scared for my safety as well as the safety of my family,” Dr. Skog said. “That was just not something that we were seeing 3, 4, or 5 years ago.”

Many patients are already upset by the time they see doctors, according to the poll.

“The most common reason patients are upset is that they’re already in a lot of pain, which can be expressed as anger, hostility, or aggression. They’re very anxious and afraid of what’s happening and may be thinking about the worst-case scenario – that a bump or lump is cancer,” Dr. Zeller said.

Patients may also get upset if they disagree with their doctors’ diagnosis or treatment plan or the doctor refuses to prescribe them the drugs or tests they want.

“One doctor commented recently: ‘After over 30 years in this business, I can say patients are worse now than at any point in my career. Entitled, demanding, obnoxious. Any denial is met with outrage and indignity, whether it’s an opioid request or a demand for MRI of something because they ‘want to know.’ ”

An orthopedic surgeon in Indiana lost his life after he refused to prescribe opioids to a patient. Her angry husband shot and killed the doctor in the parking lot only 2 hours after confronting him in his office.
 

Decreased physician-patient trust

“When doctors experience something frightening, they become more apprehensive in the future. There’s no doubt that after the first violent experience, they think of things differently,” said Dr. Zeller.

More than half of the doctors who reported experiencing at least one violent or potentially violent incident in the poll said they trusted patients less.

This diminished trust can negatively impact the physician-patient relationship, said the authors of a recent Health Affairs article.

“The more patients harm their health care providers, intentionally or unintentionally, the more difficult it will be for those providers to trust them, leading to yet another unfortunate pattern: physicians pulling back on some of the behaviors thought to be most trust-building, for example, talking about their personal lives, building rapport, displaying compassion, or giving out their personal cell phone numbers,” the article stated.
 

What doctors can do

Most doctors who experienced a violent or potentially violent incident said they had tried to defuse the situation and that they succeeded at least some of the time, the poll results show.

One of the best ways to defuse a situation is to be empathetic and show the person that you’re on their side and not the enemy, said Dr. Cheng,.

“Rather than making general statements like ‘I understand that you’re upset,’ it’s better to be specific about the reason the person is upset. For example: ‘I understand that you’re upset that the pharmacy didn’t fill your prescription’ or ‘I understand how you’re feeling about Doctor So-and-so, who didn’t treat you right,’ ” Dr. Cheng stated.

Dr. Zeller urged physicians to talk to patients about why they’re upset and how they can help them. That approach worked with a patient who was having a psychotic episode.

“I told the staff, who wanted to forcibly restrain him and inject him with medication, that I would talk to him. I asked the patient, who was screaming ‘ya ya ya ya,’ whether he would take his medication if I gave it to him and he said yes. When he was calm, he explained that he was screaming to stop the voices telling him to kill his parents. He then got the help he needed,” said Dr. Zeller.

Dr. Cheng was trained in de-escalation techniques as an Orange County reserve deputy sheriff. He and Dr. Zeller recommended that physicians and staff receive training in how to spot potentially violent behavior and defuse these situations before they escalate.

Dr. Cheng suggests looking at the person’s body language for signs of increasing agitation or tension, such as clenched fists, tense posture, tight jaw, or fidgeting that may be accompanied by shouting and/or verbal abuse.

Physicians also need to consider where they are physically in relation to patients they see. “You don’t want to be too close to the patient or stand in front of them, which can be seen as confrontational. Instead, stand or sit off to the side, and never block the door if the patient’s upset,” said Dr. Cheng.

He recommended that physician practices prepare for violent incidents by developing detailed plans, including how and when to escape, how to protect patients, and how to cooperate with law enforcement.

“If a violent incident is inescapable, physicians and staff must be ready to fight back with whatever tools they have available, which may include fire extinguishers, chairs, or scalpels,” said Dr. Cheng.

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

Family medicine physician Kenneth Cheng, DO, was on-call at a local hospital when a nurse told him that a patient needing evaluation hated Asians.

“I talked to him about whether he was okay seeing me and he said yes,” Dr. Cheng said. “But I remained vigilant and conscious of what the patient was doing the whole time so he couldn’t take advantage of the situation.”

Dr. Cheng never turned his back to the patient and even backed out of the exam room. That encounter passed without incident. However, a urologist Dr. Cheng knew from residency wasn’t so fortunate. Ronald Gilbert, MD, of Newport Beach, Calif., was shot and killed by a patient in his office. The patient blamed him for complications following prostate surgery 25 years earlier.

In 2022, a gunman in Tulsa, Okla., blamed his physician for pain from a recent back surgery and shot and killed him, another physician, and two others in a medical building before taking his own life.

Nearly 9 in 10 physicians reported in a recent Medscape poll that they had experienced one or more violent or potentially violent incidents in the past year. The most common patient behaviors were verbal abuse, getting angry and leaving, and behaving erratically.

About one in three respondents said that the patients threatened to harm them, and about one in five said that the patients became violent.

Experts say that many factors contribute to this potentially lethal situation: Health care services have become more impersonal, patients experience longer wait times, some abuse prescription drugs, mental health services are lacking, and security is poor or nonexistent at some health care facilities.

Violence against hospital workers has become so common that a bill was introduced in 2022 in Congress to better protect them. The Safety From Violence for Healthcare Employees Act includes stiffer penalties for acts involving the use of a dangerous weapon or committed during a public emergency and would also provide $25 million in grants to hospitals for programs aimed at reducing violent incidents in health care settings, including de-escalation training. The American Hospital Association and American College of Emergency Physicians support the bill, which is now before the House Judiciary Subcommittee on Crime, Terrorism, and Homeland Security.
 

The worst day of their lives

“You have people who already are having the worst day of their lives and feeling on edge. If they already have a short fuse or substance abuse issues, that can translate into agitation, violence, or aggression,” said Scott Zeller, MD, vice president of acute psychiatry at Vituity, a physician-owned multispecialty group that operates in several states.

Health care workers in psychiatric and substance abuse hospitals were 10 times more likely to experience nonfatal injuries by others in 2018 than were health care workers in ambulatory settings, according to an April 2020 Bureau of Labor Statistics report. In addition, health care workers were five times more likely to suffer a workplace violence injury than were workers overall in 2018.

Psychiatrists who responded to the poll were the specialists most likely to report that they encountered violent patients and potentially violent patients. “Historically, inpatient psychiatry, which requires more acute care and monitoring, is considered the most dangerous profession outside of the police,” said Dr. Zeller.

Emergency physicians have reported an uptick in violence from patients; 85% said in a survey by ACEP in 2022 that they believed the rate of violence in emergency departments has increased over the past 5 years, whereas 45% indicated that it has greatly increased.

Some doctors have been threatened with violence or actually killed by family members. Alex Skog, MD, president-elect of ACEP’s Oregon chapter, told HealthCare Dive that “a patient’s family member with a gun holster on his hip threatened to kill me and kill my entire family after I told his father that he needed to be admitted because he had coronavirus.”

“I’ve been scared for my safety as well as the safety of my family,” Dr. Skog said. “That was just not something that we were seeing 3, 4, or 5 years ago.”

Many patients are already upset by the time they see doctors, according to the poll.

“The most common reason patients are upset is that they’re already in a lot of pain, which can be expressed as anger, hostility, or aggression. They’re very anxious and afraid of what’s happening and may be thinking about the worst-case scenario – that a bump or lump is cancer,” Dr. Zeller said.

Patients may also get upset if they disagree with their doctors’ diagnosis or treatment plan or the doctor refuses to prescribe them the drugs or tests they want.

“One doctor commented recently: ‘After over 30 years in this business, I can say patients are worse now than at any point in my career. Entitled, demanding, obnoxious. Any denial is met with outrage and indignity, whether it’s an opioid request or a demand for MRI of something because they ‘want to know.’ ”

An orthopedic surgeon in Indiana lost his life after he refused to prescribe opioids to a patient. Her angry husband shot and killed the doctor in the parking lot only 2 hours after confronting him in his office.
 

Decreased physician-patient trust

“When doctors experience something frightening, they become more apprehensive in the future. There’s no doubt that after the first violent experience, they think of things differently,” said Dr. Zeller.

More than half of the doctors who reported experiencing at least one violent or potentially violent incident in the poll said they trusted patients less.

This diminished trust can negatively impact the physician-patient relationship, said the authors of a recent Health Affairs article.

“The more patients harm their health care providers, intentionally or unintentionally, the more difficult it will be for those providers to trust them, leading to yet another unfortunate pattern: physicians pulling back on some of the behaviors thought to be most trust-building, for example, talking about their personal lives, building rapport, displaying compassion, or giving out their personal cell phone numbers,” the article stated.
 

What doctors can do

Most doctors who experienced a violent or potentially violent incident said they had tried to defuse the situation and that they succeeded at least some of the time, the poll results show.

One of the best ways to defuse a situation is to be empathetic and show the person that you’re on their side and not the enemy, said Dr. Cheng,.

“Rather than making general statements like ‘I understand that you’re upset,’ it’s better to be specific about the reason the person is upset. For example: ‘I understand that you’re upset that the pharmacy didn’t fill your prescription’ or ‘I understand how you’re feeling about Doctor So-and-so, who didn’t treat you right,’ ” Dr. Cheng stated.

Dr. Zeller urged physicians to talk to patients about why they’re upset and how they can help them. That approach worked with a patient who was having a psychotic episode.

“I told the staff, who wanted to forcibly restrain him and inject him with medication, that I would talk to him. I asked the patient, who was screaming ‘ya ya ya ya,’ whether he would take his medication if I gave it to him and he said yes. When he was calm, he explained that he was screaming to stop the voices telling him to kill his parents. He then got the help he needed,” said Dr. Zeller.

Dr. Cheng was trained in de-escalation techniques as an Orange County reserve deputy sheriff. He and Dr. Zeller recommended that physicians and staff receive training in how to spot potentially violent behavior and defuse these situations before they escalate.

Dr. Cheng suggests looking at the person’s body language for signs of increasing agitation or tension, such as clenched fists, tense posture, tight jaw, or fidgeting that may be accompanied by shouting and/or verbal abuse.

Physicians also need to consider where they are physically in relation to patients they see. “You don’t want to be too close to the patient or stand in front of them, which can be seen as confrontational. Instead, stand or sit off to the side, and never block the door if the patient’s upset,” said Dr. Cheng.

He recommended that physician practices prepare for violent incidents by developing detailed plans, including how and when to escape, how to protect patients, and how to cooperate with law enforcement.

“If a violent incident is inescapable, physicians and staff must be ready to fight back with whatever tools they have available, which may include fire extinguishers, chairs, or scalpels,” said Dr. Cheng.

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

A new meta-analysis has added evidence questioning the utility and efficacy of prophylactic low-dose aspirin for preventing cardiovascular events in people who don’t have atherosclerotic cardiovascular disease (ASCVD), whether or not they’re also taking statins, and finds that at every level of ASCVD risk the aspirin carries a risk of major bleeding that exceeds its potentially protective benefits.

In a study published online in JACC: Advances, the researchers, led by Safi U. Khan, MD, MS, analyzed data from 16 trials with 171,215 individuals, with a median age of 64 years. Of the population analyzed, 35% were taking statins.

“This study focused on patients without ASCVD who are taking aspirin with or without statin therapy to prevent ASCVD events,” Dr. Khan, a cardiovascular disease fellow at Houston Methodist DeBakey Heart and Vascular Institute, told this news organization. “We noted that the absolute risk of major bleeding in this patient population exceeds the absolute reduction in MI by aspirin across different ASCVD risk categories. Furthermore, concomitant statin therapy use further diminishes aspirin’s cardiovascular effects without influencing bleeding risk.”

Across the 16 studies, people taking aspirin had a relative risk reduction of 15% for MI vs. controls (RR .85; 95% confidence interval [CI], .77 to .95; P < .001). However, they had a 48% greater risk of major bleeding (RR, 1.48; 95% CI, 1.31-1.66; P < .001).

The meta-analysis also found that aspirin, either as monotherapy or with a statin, carried a slight to significant benefit depending on the estimated risk of developing ASCVD. The risk of major bleeding exceeded the benefit across all three risk-stratified groups. The greatest benefit, and greatest risk, was in the groups with high to very-high ASCVD risk groups, defined as a 20%-30% and 30% or greater ASCVD risk, respectively: 20-37 fewer MIs per 10,000 with monotherapy and 27-49 fewer with statin, but 78-98 more major bleeding events with monotherapy and 74-95 more with statin.

And aspirin, either as monotherapy or with statin, didn’t reduce the risk of other key endpoints: stroke, all-cause mortality, or cardiovascular mortality. While aspirin was associated with a lower risk of nonfatal MI (RR, .82; 95% CI, .72 to .94; P ≤. 001), it  wasn’t associated with reducing the risk of nonfatal stroke. Aspirin patients had a significantly 32% greater risk of intracranial hemorrhage (RR, 1.32; 95% CI, 1.12-1.55; P ≤ .001) and 51% increased risk of gastrointestinal bleeding (RR, 1.51; 95% CI, 1.33-1.72; P ≤ .001).

“We used randomized data from all key primary prevention of aspirin trials and estimated the absolute effects of aspirin therapy with or without concomitant statin across different baseline risks of the patients,” Dr. Khan said. “This approach allowed us to identify aspirin therapy’s risk-benefit equilibrium, which is tilted towards more harm than benefit.”

He acknowledged study limitations included using study-level rather than patient-level meta-analysis, and the inability to calculate effects in younger populations at high absolute risk.  

The investigators acknowledged the controversy surrounding aspirin use to prevent ASCVD, noting the three major guidelines: the 2019 American College of Cardiology/American Heart Association and the 2021 European Society of Cardiology guidelines for aspirin only among asymptomatic individuals with high risk of ASCVD events, low bleeding risk, and age 70 years and younger; and the United States Preventive Services Task Force guidelines, updated in 2022, recommending individualized low-dose aspirin only among adults ages 40-59 years with 10-year ASCVD risk of 10% or greater and a low bleeding risk.

The findings are not a clarion call to halt aspirin therapy, Dr. Khan said. “This research focuses only on patients who do not have ASCVD,” he said. “Patients who do have ASCVD should continue with aspirin and statin therapy. However, we noted that aspirin has a limited role for patients who do not have ASCVD beyond lifestyle modifications, smoking cessation, exercise, and preventive statin therapy. Therefore, they should only consider using aspirin if their physicians suggest that the risk of having a cardiovascular event exceeds their bleeding risk. Otherwise, they should discuss with their physicians about omitting aspirin.”

The study confirms the move away from low-dose aspirin to prevent ASCVD, said Tahmid Rahman, MD, cardiologist and associate director of the Center for Advanced Lipid Management at Stony Brook (N.Y.) Heart Institute. “The study really continues to add to essentially what we already know,” he said. “There was a big push that aspirin, initially before the major statin trials, was the way to go to prevent heart disease, but with later studies, and especially now with newer antiplatelet therapies and longer duration of medication for people with both secondary prevention and primary prevention, we are getting away from routine aspirin, especially in primary prevention.”

A new meta-analysis has added evidence questioning the utility and efficacy of prophylactic low-dose aspirin for preventing cardiovascular events in people who don’t have atherosclerotic cardiovascular disease (ASCVD), whether or not they’re also taking statins, and finds that at every level of ASCVD risk the aspirin carries a risk of major bleeding that exceeds its potentially protective benefits.

In a study published online in JACC: Advances, the researchers, led by Safi U. Khan, MD, MS, analyzed data from 16 trials with 171,215 individuals, with a median age of 64 years. Of the population analyzed, 35% were taking statins.

“This study focused on patients without ASCVD who are taking aspirin with or without statin therapy to prevent ASCVD events,” Dr. Khan, a cardiovascular disease fellow at Houston Methodist DeBakey Heart and Vascular Institute, told this news organization. “We noted that the absolute risk of major bleeding in this patient population exceeds the absolute reduction in MI by aspirin across different ASCVD risk categories. Furthermore, concomitant statin therapy use further diminishes aspirin’s cardiovascular effects without influencing bleeding risk.”

Across the 16 studies, people taking aspirin had a relative risk reduction of 15% for MI vs. controls (RR .85; 95% confidence interval [CI], .77 to .95; P < .001). However, they had a 48% greater risk of major bleeding (RR, 1.48; 95% CI, 1.31-1.66; P < .001).

The meta-analysis also found that aspirin, either as monotherapy or with a statin, carried a slight to significant benefit depending on the estimated risk of developing ASCVD. The risk of major bleeding exceeded the benefit across all three risk-stratified groups. The greatest benefit, and greatest risk, was in the groups with high to very-high ASCVD risk groups, defined as a 20%-30% and 30% or greater ASCVD risk, respectively: 20-37 fewer MIs per 10,000 with monotherapy and 27-49 fewer with statin, but 78-98 more major bleeding events with monotherapy and 74-95 more with statin.

And aspirin, either as monotherapy or with statin, didn’t reduce the risk of other key endpoints: stroke, all-cause mortality, or cardiovascular mortality. While aspirin was associated with a lower risk of nonfatal MI (RR, .82; 95% CI, .72 to .94; P ≤. 001), it  wasn’t associated with reducing the risk of nonfatal stroke. Aspirin patients had a significantly 32% greater risk of intracranial hemorrhage (RR, 1.32; 95% CI, 1.12-1.55; P ≤ .001) and 51% increased risk of gastrointestinal bleeding (RR, 1.51; 95% CI, 1.33-1.72; P ≤ .001).

“We used randomized data from all key primary prevention of aspirin trials and estimated the absolute effects of aspirin therapy with or without concomitant statin across different baseline risks of the patients,” Dr. Khan said. “This approach allowed us to identify aspirin therapy’s risk-benefit equilibrium, which is tilted towards more harm than benefit.”

He acknowledged study limitations included using study-level rather than patient-level meta-analysis, and the inability to calculate effects in younger populations at high absolute risk.  

The investigators acknowledged the controversy surrounding aspirin use to prevent ASCVD, noting the three major guidelines: the 2019 American College of Cardiology/American Heart Association and the 2021 European Society of Cardiology guidelines for aspirin only among asymptomatic individuals with high risk of ASCVD events, low bleeding risk, and age 70 years and younger; and the United States Preventive Services Task Force guidelines, updated in 2022, recommending individualized low-dose aspirin only among adults ages 40-59 years with 10-year ASCVD risk of 10% or greater and a low bleeding risk.

The findings are not a clarion call to halt aspirin therapy, Dr. Khan said. “This research focuses only on patients who do not have ASCVD,” he said. “Patients who do have ASCVD should continue with aspirin and statin therapy. However, we noted that aspirin has a limited role for patients who do not have ASCVD beyond lifestyle modifications, smoking cessation, exercise, and preventive statin therapy. Therefore, they should only consider using aspirin if their physicians suggest that the risk of having a cardiovascular event exceeds their bleeding risk. Otherwise, they should discuss with their physicians about omitting aspirin.”

The study confirms the move away from low-dose aspirin to prevent ASCVD, said Tahmid Rahman, MD, cardiologist and associate director of the Center for Advanced Lipid Management at Stony Brook (N.Y.) Heart Institute. “The study really continues to add to essentially what we already know,” he said. “There was a big push that aspirin, initially before the major statin trials, was the way to go to prevent heart disease, but with later studies, and especially now with newer antiplatelet therapies and longer duration of medication for people with both secondary prevention and primary prevention, we are getting away from routine aspirin, especially in primary prevention.”

A new meta-analysis has added evidence questioning the utility and efficacy of prophylactic low-dose aspirin for preventing cardiovascular events in people who don’t have atherosclerotic cardiovascular disease (ASCVD), whether or not they’re also taking statins, and finds that at every level of ASCVD risk the aspirin carries a risk of major bleeding that exceeds its potentially protective benefits.

In a study published online in JACC: Advances, the researchers, led by Safi U. Khan, MD, MS, analyzed data from 16 trials with 171,215 individuals, with a median age of 64 years. Of the population analyzed, 35% were taking statins.

“This study focused on patients without ASCVD who are taking aspirin with or without statin therapy to prevent ASCVD events,” Dr. Khan, a cardiovascular disease fellow at Houston Methodist DeBakey Heart and Vascular Institute, told this news organization. “We noted that the absolute risk of major bleeding in this patient population exceeds the absolute reduction in MI by aspirin across different ASCVD risk categories. Furthermore, concomitant statin therapy use further diminishes aspirin’s cardiovascular effects without influencing bleeding risk.”

Across the 16 studies, people taking aspirin had a relative risk reduction of 15% for MI vs. controls (RR .85; 95% confidence interval [CI], .77 to .95; P < .001). However, they had a 48% greater risk of major bleeding (RR, 1.48; 95% CI, 1.31-1.66; P < .001).

The meta-analysis also found that aspirin, either as monotherapy or with a statin, carried a slight to significant benefit depending on the estimated risk of developing ASCVD. The risk of major bleeding exceeded the benefit across all three risk-stratified groups. The greatest benefit, and greatest risk, was in the groups with high to very-high ASCVD risk groups, defined as a 20%-30% and 30% or greater ASCVD risk, respectively: 20-37 fewer MIs per 10,000 with monotherapy and 27-49 fewer with statin, but 78-98 more major bleeding events with monotherapy and 74-95 more with statin.

And aspirin, either as monotherapy or with statin, didn’t reduce the risk of other key endpoints: stroke, all-cause mortality, or cardiovascular mortality. While aspirin was associated with a lower risk of nonfatal MI (RR, .82; 95% CI, .72 to .94; P ≤. 001), it  wasn’t associated with reducing the risk of nonfatal stroke. Aspirin patients had a significantly 32% greater risk of intracranial hemorrhage (RR, 1.32; 95% CI, 1.12-1.55; P ≤ .001) and 51% increased risk of gastrointestinal bleeding (RR, 1.51; 95% CI, 1.33-1.72; P ≤ .001).

“We used randomized data from all key primary prevention of aspirin trials and estimated the absolute effects of aspirin therapy with or without concomitant statin across different baseline risks of the patients,” Dr. Khan said. “This approach allowed us to identify aspirin therapy’s risk-benefit equilibrium, which is tilted towards more harm than benefit.”

He acknowledged study limitations included using study-level rather than patient-level meta-analysis, and the inability to calculate effects in younger populations at high absolute risk.  

The investigators acknowledged the controversy surrounding aspirin use to prevent ASCVD, noting the three major guidelines: the 2019 American College of Cardiology/American Heart Association and the 2021 European Society of Cardiology guidelines for aspirin only among asymptomatic individuals with high risk of ASCVD events, low bleeding risk, and age 70 years and younger; and the United States Preventive Services Task Force guidelines, updated in 2022, recommending individualized low-dose aspirin only among adults ages 40-59 years with 10-year ASCVD risk of 10% or greater and a low bleeding risk.

The findings are not a clarion call to halt aspirin therapy, Dr. Khan said. “This research focuses only on patients who do not have ASCVD,” he said. “Patients who do have ASCVD should continue with aspirin and statin therapy. However, we noted that aspirin has a limited role for patients who do not have ASCVD beyond lifestyle modifications, smoking cessation, exercise, and preventive statin therapy. Therefore, they should only consider using aspirin if their physicians suggest that the risk of having a cardiovascular event exceeds their bleeding risk. Otherwise, they should discuss with their physicians about omitting aspirin.”

The study confirms the move away from low-dose aspirin to prevent ASCVD, said Tahmid Rahman, MD, cardiologist and associate director of the Center for Advanced Lipid Management at Stony Brook (N.Y.) Heart Institute. “The study really continues to add to essentially what we already know,” he said. “There was a big push that aspirin, initially before the major statin trials, was the way to go to prevent heart disease, but with later studies, and especially now with newer antiplatelet therapies and longer duration of medication for people with both secondary prevention and primary prevention, we are getting away from routine aspirin, especially in primary prevention.”

This linear pattern of hyper-pigmented, often verrucous tissue oriented along Blaschko skin lines is typical for linear epidermal nevi (LEN). In some cases, lesions are not in a linear pattern and are actually in more of a localized or whorled pattern (called epidermal nevi).

LEN are usually present at birth, as in this individual. They are frequently seen on the head and neck region and are often asymptomatic. LEN are considered a birthmark that develops because of a genetic abnormality that typically affects keratinocytes. This genetic mutation only affects a portion of the body (mosaicism) without affecting the overall genetics of the individual. This is important to note because LEN do not typically have a hereditary component or implications for offspring. While usually asymptomatic and localized, LEN can be associated with extracutaneous and neurologic difficulties. In these situations, it is called epidermal nevus syndrome, and is more common if the LEN occur on the face or head.¹

Since LEN are usually asymptomatic, treatment is not required unless the lesions affect the function of adjacent structures, such as the eyes, lips, or nose. Due to their frequent presence on the face or other visible areas, some patients may choose to get these lesions treated for cosmetic purposes. In the past, full-thickness excision was recommended. Topical medications are ineffective, and superficial shave excision usually leads to recurrence. More recently, destructive laser treatments have been used, with success, to reduce the appearance of the lesions.²

This patient was not concerned about the appearance of the asymptomatic lesions and chose not to have any treatment.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

This linear pattern of hyper-pigmented, often verrucous tissue oriented along Blaschko skin lines is typical for linear epidermal nevi (LEN). In some cases, lesions are not in a linear pattern and are actually in more of a localized or whorled pattern (called epidermal nevi).

LEN are usually present at birth, as in this individual. They are frequently seen on the head and neck region and are often asymptomatic. LEN are considered a birthmark that develops because of a genetic abnormality that typically affects keratinocytes. This genetic mutation only affects a portion of the body (mosaicism) without affecting the overall genetics of the individual. This is important to note because LEN do not typically have a hereditary component or implications for offspring. While usually asymptomatic and localized, LEN can be associated with extracutaneous and neurologic difficulties. In these situations, it is called epidermal nevus syndrome, and is more common if the LEN occur on the face or head.¹

Since LEN are usually asymptomatic, treatment is not required unless the lesions affect the function of adjacent structures, such as the eyes, lips, or nose. Due to their frequent presence on the face or other visible areas, some patients may choose to get these lesions treated for cosmetic purposes. In the past, full-thickness excision was recommended. Topical medications are ineffective, and superficial shave excision usually leads to recurrence. More recently, destructive laser treatments have been used, with success, to reduce the appearance of the lesions.²

This patient was not concerned about the appearance of the asymptomatic lesions and chose not to have any treatment.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

This linear pattern of hyper-pigmented, often verrucous tissue oriented along Blaschko skin lines is typical for linear epidermal nevi (LEN). In some cases, lesions are not in a linear pattern and are actually in more of a localized or whorled pattern (called epidermal nevi).

LEN are usually present at birth, as in this individual. They are frequently seen on the head and neck region and are often asymptomatic. LEN are considered a birthmark that develops because of a genetic abnormality that typically affects keratinocytes. This genetic mutation only affects a portion of the body (mosaicism) without affecting the overall genetics of the individual. This is important to note because LEN do not typically have a hereditary component or implications for offspring. While usually asymptomatic and localized, LEN can be associated with extracutaneous and neurologic difficulties. In these situations, it is called epidermal nevus syndrome, and is more common if the LEN occur on the face or head.¹

Since LEN are usually asymptomatic, treatment is not required unless the lesions affect the function of adjacent structures, such as the eyes, lips, or nose. Due to their frequent presence on the face or other visible areas, some patients may choose to get these lesions treated for cosmetic purposes. In the past, full-thickness excision was recommended. Topical medications are ineffective, and superficial shave excision usually leads to recurrence. More recently, destructive laser treatments have been used, with success, to reduce the appearance of the lesions.²

This patient was not concerned about the appearance of the asymptomatic lesions and chose not to have any treatment.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

A jump in natriuretic peptide levels over several years in middle-aged adults points to worsened long-term risks for incident heart failure (HF) and death. But their predicted long-term survival improves if serial testing shows a drop in those levels, suggests a new analysis based on a well-known longitudinal study cohort.

The findings support the risk-stratification potential of serial natriuretic peptide testing, which may improve on individual assays for predicting future HF. Such serial assays might also be useful for guiding therapy aimed at preventing, for example, progression to clinical HF, researchers speculate on the basis of the current study,

The analysis of almost 1,000 members of the ARIC (Atherosclerosis Risk in Community) cohort had been free of clinical HF at the first of two NT-proBNP assays, which were performed 6 years apart. Their 20-year clinical risk was linked to the trajectory of NT-proBNP levels across the two earlier assays.

For example, adjusted risk of incident HF more than doubled for participants with NT-proBNP levels exceeding 125 pg/mL on both assays, compared with levels that stayed under the cut point at both assays. Their mortality risk climbed by about two-thirds.

Risk for incident HF and of death climbed 86% and 32%, respectively, if NT-proBNP levels rose over the 6 years from less than to greater than 125 pg/mL. But long-term survival improved if serial assays showed a drop from the higher to the lower level.

Rising NT-proBNP levels over several years probably reflect ongoing exposure to risk factors such as hypertension or diabetes. Conversely, decreasing NT-proBNP levels likely reflect some success at keeping such risk factors under control, propose the authors of the analysis published in JAMA Cardiology. The study was led by Xiaoming Jia, MD, Baylor College of Medicine, Houston.

The findings raise the possibility that reducing NT-proBNP levels through risk-factor modification, tracked by serial assays, may potentially improve long-term risk for death or incident HF.

Such therapy, guided by natriuretic peptides, might prove especially useful in asymptomatic adults with modifiable HF risk factors but without known NT-proBNP elevation or cardiac structural changes, so-called stage A HF, senior author Vijay Nambi, MD, PhD, also of Baylor, observed for this news organization.

The best populations for serial NT-proBNP assays to guide therapy, Dr. Nambi said, should become clear “as more data emerges.” But the threshold for ordering such tests would probably be lower for people in stage A whose rising NT-proBNP levels later reclassify them as stage B, also called pre-HF.

In such cases, he speculated, intensified therapy of HF risk factors such as uncontrolled hypertension or diabetes – prompted by greater NT-proBNP levels at serial testing – might possibly avert progression to clinical HF.

Mitchel L. Zoler/MDedge News

“These investigators have nicely demonstrated that one measurement of the biomarker may not be sufficient, that maybe it undercaptures the true burden of people who eventually will develop heart failure,” Muthiah Vaduganathan, MD, MPH, told this news organization.

The study raises the possibility “that the serial natriuretic peptide strategy may be more efficient and more comprehensive in identifying those who will eventually progress,” said Dr. Vaduganathan, of Brigham and Women’s Hospital and Harvard Medical School, Boston, who was not associated with the ARIC analysis.

An open question, he added, is whether the predicted risk is modifiable. “If you are able to provide the biomarker information to treating clinicians, can they do something to attenuate the risk?”

The outlook is hopeful, given contemporary therapies “that can slow and even prevent heart failure in at-risk populations,” Dr. Vaduganathan said. For example, “The selective allocation of SGLT2 inhibitors to those with elevated natriuretic peptide levels, perhaps as captured in serial measurements, would be of great interest.”

The analysis included 9,776 adults (56.5% women, 21.3% Black) without HF who underwent NT-proBNP testing at the second and – about 6 years later – the fourth scheduled clinical visits in the ARIC study, which had enrolled persons aged 45-64 from four diverse communities from across the United States.

Adjusted hazard ratios for incident HF according to NT-proBNP changes from the first to second assays relative to 125 pg/mL were as follows:

• 1.86 (95% confidence interval, 1.60-2.16) when levels rose to higher than the cut point.
• 2.40 (95% CI, 2.00-2.88) when both levels exceeded the cut point.

The corresponding adjusted HRs for death from any cause were as follows:

• 1.32 (95%CI, 1.19-1.47) when levels rose to higher than 125 mg/mL.
• 1.68 (95% CI, 1.47-1.91) when both levels were above the cut point.

The risks for incident HF and for death rose significantly by 6% and 5%, respectively, per standard deviation NT-proBNP increase from the first to second assay.

Risks for HF and mortality for participants whose NT-proBNP levels declined from greater than to less than 125 pg/mL were similar to those whose levels remained low at both assays.

Cost-effectiveness would be another issue when implementing a strategy that calls for multiple biomarker assays, Dr. Vaduganathan observed.

“Surely, we would want to demonstrate that the laboratory measurement costs are offset by downstream prevention of heart failure events that could be averted by use of effective medical therapy, such SGLT2 inhibitors.”

ARIC has been funded by the National Institutes of Health and Department of Health and Human Services. Dr. Nambi discloses receiving grants from the National Institutes of Health during the conduct of the study; support from Amgen; and stocks from Abbott Laboratories. Disclosures for the other authors are in the report. Dr. Vaduganathan has disclosed receiving grants or serving on advisory boards for American Regent, Amgen, AstraZeneca, Bayer AG, Baxter Healthcare, Boehringer Ingelheim, Cytokinetics, Lexicon Pharmaceuticals, Novartis, Pharmacosmos, Relypsa, Roche Diagnostics, Sanofi, and Tricog Health; speaking for AstraZeneca, Novartis, and Roche Diagnostics; and serving on trial committees for studies sponsored by Galmed, Novartis, Bayer AG, Occlutech, and Impulse Dynamics.

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

A jump in natriuretic peptide levels over several years in middle-aged adults points to worsened long-term risks for incident heart failure (HF) and death. But their predicted long-term survival improves if serial testing shows a drop in those levels, suggests a new analysis based on a well-known longitudinal study cohort.

The findings support the risk-stratification potential of serial natriuretic peptide testing, which may improve on individual assays for predicting future HF. Such serial assays might also be useful for guiding therapy aimed at preventing, for example, progression to clinical HF, researchers speculate on the basis of the current study,

The analysis of almost 1,000 members of the ARIC (Atherosclerosis Risk in Community) cohort had been free of clinical HF at the first of two NT-proBNP assays, which were performed 6 years apart. Their 20-year clinical risk was linked to the trajectory of NT-proBNP levels across the two earlier assays.

For example, adjusted risk of incident HF more than doubled for participants with NT-proBNP levels exceeding 125 pg/mL on both assays, compared with levels that stayed under the cut point at both assays. Their mortality risk climbed by about two-thirds.

Risk for incident HF and of death climbed 86% and 32%, respectively, if NT-proBNP levels rose over the 6 years from less than to greater than 125 pg/mL. But long-term survival improved if serial assays showed a drop from the higher to the lower level.

Rising NT-proBNP levels over several years probably reflect ongoing exposure to risk factors such as hypertension or diabetes. Conversely, decreasing NT-proBNP levels likely reflect some success at keeping such risk factors under control, propose the authors of the analysis published in JAMA Cardiology. The study was led by Xiaoming Jia, MD, Baylor College of Medicine, Houston.

The findings raise the possibility that reducing NT-proBNP levels through risk-factor modification, tracked by serial assays, may potentially improve long-term risk for death or incident HF.

Such therapy, guided by natriuretic peptides, might prove especially useful in asymptomatic adults with modifiable HF risk factors but without known NT-proBNP elevation or cardiac structural changes, so-called stage A HF, senior author Vijay Nambi, MD, PhD, also of Baylor, observed for this news organization.

The best populations for serial NT-proBNP assays to guide therapy, Dr. Nambi said, should become clear “as more data emerges.” But the threshold for ordering such tests would probably be lower for people in stage A whose rising NT-proBNP levels later reclassify them as stage B, also called pre-HF.

In such cases, he speculated, intensified therapy of HF risk factors such as uncontrolled hypertension or diabetes – prompted by greater NT-proBNP levels at serial testing – might possibly avert progression to clinical HF.

Mitchel L. Zoler/MDedge News

“These investigators have nicely demonstrated that one measurement of the biomarker may not be sufficient, that maybe it undercaptures the true burden of people who eventually will develop heart failure,” Muthiah Vaduganathan, MD, MPH, told this news organization.

The study raises the possibility “that the serial natriuretic peptide strategy may be more efficient and more comprehensive in identifying those who will eventually progress,” said Dr. Vaduganathan, of Brigham and Women’s Hospital and Harvard Medical School, Boston, who was not associated with the ARIC analysis.

An open question, he added, is whether the predicted risk is modifiable. “If you are able to provide the biomarker information to treating clinicians, can they do something to attenuate the risk?”

The outlook is hopeful, given contemporary therapies “that can slow and even prevent heart failure in at-risk populations,” Dr. Vaduganathan said. For example, “The selective allocation of SGLT2 inhibitors to those with elevated natriuretic peptide levels, perhaps as captured in serial measurements, would be of great interest.”

The analysis included 9,776 adults (56.5% women, 21.3% Black) without HF who underwent NT-proBNP testing at the second and – about 6 years later – the fourth scheduled clinical visits in the ARIC study, which had enrolled persons aged 45-64 from four diverse communities from across the United States.

Adjusted hazard ratios for incident HF according to NT-proBNP changes from the first to second assays relative to 125 pg/mL were as follows:

• 1.86 (95% confidence interval, 1.60-2.16) when levels rose to higher than the cut point.
• 2.40 (95% CI, 2.00-2.88) when both levels exceeded the cut point.

The corresponding adjusted HRs for death from any cause were as follows:

• 1.32 (95%CI, 1.19-1.47) when levels rose to higher than 125 mg/mL.
• 1.68 (95% CI, 1.47-1.91) when both levels were above the cut point.

The risks for incident HF and for death rose significantly by 6% and 5%, respectively, per standard deviation NT-proBNP increase from the first to second assay.

Risks for HF and mortality for participants whose NT-proBNP levels declined from greater than to less than 125 pg/mL were similar to those whose levels remained low at both assays.

Cost-effectiveness would be another issue when implementing a strategy that calls for multiple biomarker assays, Dr. Vaduganathan observed.

“Surely, we would want to demonstrate that the laboratory measurement costs are offset by downstream prevention of heart failure events that could be averted by use of effective medical therapy, such SGLT2 inhibitors.”

ARIC has been funded by the National Institutes of Health and Department of Health and Human Services. Dr. Nambi discloses receiving grants from the National Institutes of Health during the conduct of the study; support from Amgen; and stocks from Abbott Laboratories. Disclosures for the other authors are in the report. Dr. Vaduganathan has disclosed receiving grants or serving on advisory boards for American Regent, Amgen, AstraZeneca, Bayer AG, Baxter Healthcare, Boehringer Ingelheim, Cytokinetics, Lexicon Pharmaceuticals, Novartis, Pharmacosmos, Relypsa, Roche Diagnostics, Sanofi, and Tricog Health; speaking for AstraZeneca, Novartis, and Roche Diagnostics; and serving on trial committees for studies sponsored by Galmed, Novartis, Bayer AG, Occlutech, and Impulse Dynamics.

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

A jump in natriuretic peptide levels over several years in middle-aged adults points to worsened long-term risks for incident heart failure (HF) and death. But their predicted long-term survival improves if serial testing shows a drop in those levels, suggests a new analysis based on a well-known longitudinal study cohort.

The findings support the risk-stratification potential of serial natriuretic peptide testing, which may improve on individual assays for predicting future HF. Such serial assays might also be useful for guiding therapy aimed at preventing, for example, progression to clinical HF, researchers speculate on the basis of the current study,

The analysis of almost 1,000 members of the ARIC (Atherosclerosis Risk in Community) cohort had been free of clinical HF at the first of two NT-proBNP assays, which were performed 6 years apart. Their 20-year clinical risk was linked to the trajectory of NT-proBNP levels across the two earlier assays.

For example, adjusted risk of incident HF more than doubled for participants with NT-proBNP levels exceeding 125 pg/mL on both assays, compared with levels that stayed under the cut point at both assays. Their mortality risk climbed by about two-thirds.

Risk for incident HF and of death climbed 86% and 32%, respectively, if NT-proBNP levels rose over the 6 years from less than to greater than 125 pg/mL. But long-term survival improved if serial assays showed a drop from the higher to the lower level.

Rising NT-proBNP levels over several years probably reflect ongoing exposure to risk factors such as hypertension or diabetes. Conversely, decreasing NT-proBNP levels likely reflect some success at keeping such risk factors under control, propose the authors of the analysis published in JAMA Cardiology. The study was led by Xiaoming Jia, MD, Baylor College of Medicine, Houston.

The findings raise the possibility that reducing NT-proBNP levels through risk-factor modification, tracked by serial assays, may potentially improve long-term risk for death or incident HF.

Such therapy, guided by natriuretic peptides, might prove especially useful in asymptomatic adults with modifiable HF risk factors but without known NT-proBNP elevation or cardiac structural changes, so-called stage A HF, senior author Vijay Nambi, MD, PhD, also of Baylor, observed for this news organization.

The best populations for serial NT-proBNP assays to guide therapy, Dr. Nambi said, should become clear “as more data emerges.” But the threshold for ordering such tests would probably be lower for people in stage A whose rising NT-proBNP levels later reclassify them as stage B, also called pre-HF.

In such cases, he speculated, intensified therapy of HF risk factors such as uncontrolled hypertension or diabetes – prompted by greater NT-proBNP levels at serial testing – might possibly avert progression to clinical HF.

Mitchel L. Zoler/MDedge News

“These investigators have nicely demonstrated that one measurement of the biomarker may not be sufficient, that maybe it undercaptures the true burden of people who eventually will develop heart failure,” Muthiah Vaduganathan, MD, MPH, told this news organization.

The study raises the possibility “that the serial natriuretic peptide strategy may be more efficient and more comprehensive in identifying those who will eventually progress,” said Dr. Vaduganathan, of Brigham and Women’s Hospital and Harvard Medical School, Boston, who was not associated with the ARIC analysis.

An open question, he added, is whether the predicted risk is modifiable. “If you are able to provide the biomarker information to treating clinicians, can they do something to attenuate the risk?”

The outlook is hopeful, given contemporary therapies “that can slow and even prevent heart failure in at-risk populations,” Dr. Vaduganathan said. For example, “The selective allocation of SGLT2 inhibitors to those with elevated natriuretic peptide levels, perhaps as captured in serial measurements, would be of great interest.”

The analysis included 9,776 adults (56.5% women, 21.3% Black) without HF who underwent NT-proBNP testing at the second and – about 6 years later – the fourth scheduled clinical visits in the ARIC study, which had enrolled persons aged 45-64 from four diverse communities from across the United States.

Adjusted hazard ratios for incident HF according to NT-proBNP changes from the first to second assays relative to 125 pg/mL were as follows:

• 1.86 (95% confidence interval, 1.60-2.16) when levels rose to higher than the cut point.
• 2.40 (95% CI, 2.00-2.88) when both levels exceeded the cut point.

The corresponding adjusted HRs for death from any cause were as follows:

• 1.32 (95%CI, 1.19-1.47) when levels rose to higher than 125 mg/mL.
• 1.68 (95% CI, 1.47-1.91) when both levels were above the cut point.

The risks for incident HF and for death rose significantly by 6% and 5%, respectively, per standard deviation NT-proBNP increase from the first to second assay.

Risks for HF and mortality for participants whose NT-proBNP levels declined from greater than to less than 125 pg/mL were similar to those whose levels remained low at both assays.

Cost-effectiveness would be another issue when implementing a strategy that calls for multiple biomarker assays, Dr. Vaduganathan observed.

“Surely, we would want to demonstrate that the laboratory measurement costs are offset by downstream prevention of heart failure events that could be averted by use of effective medical therapy, such SGLT2 inhibitors.”

ARIC has been funded by the National Institutes of Health and Department of Health and Human Services. Dr. Nambi discloses receiving grants from the National Institutes of Health during the conduct of the study; support from Amgen; and stocks from Abbott Laboratories. Disclosures for the other authors are in the report. Dr. Vaduganathan has disclosed receiving grants or serving on advisory boards for American Regent, Amgen, AstraZeneca, Bayer AG, Baxter Healthcare, Boehringer Ingelheim, Cytokinetics, Lexicon Pharmaceuticals, Novartis, Pharmacosmos, Relypsa, Roche Diagnostics, Sanofi, and Tricog Health; speaking for AstraZeneca, Novartis, and Roche Diagnostics; and serving on trial committees for studies sponsored by Galmed, Novartis, Bayer AG, Occlutech, and Impulse Dynamics.

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

Hospitalized COVID-19 patients with high troponin levels are twice as likely to have cardiac abnormalities than those with normal troponin, with or without COVID-19, a multicenter U.K. study suggests.

The causes were diverse, myocarditis prevalence was lower than previously reported, and myocardial scar emerged as an independent risk factor for adverse cardiovascular outcomes at 12 months.

“We know that multiorgan involvement in hospitalized patients with COVID-19 is common ... and may result in acute myocardial injury, detected by an increase in cardiac troponin concentrations,” John P. Greenwood, PhD, of the University of Leeds (England), told this news organization. “Elevated cardiac troponin is associated with a worse prognosis.”

“Multiple mechanisms of myocardial injury have been proposed and ... mitigation or prevention strategies likely depend on the underpinning mechanisms,” he said. “The sequelae of scar may predispose to late events.”

The study, published online  in Circulation, also identified a new pattern of microinfarction on cardiac magnetic resonance (CMR) imaging, highlighting the pro-thrombotic nature of SARS-CoV-2, Dr. Greenwood said.
 

Injury patterns different

Three hundred and forty-two patients with COVID-19 and elevated troponin levels (COVID+/troponin+) across 25 centers were enrolled between June 2020 and March 2021 in COVID-HEART, deemed an “urgent public health study” in the United Kingdom. The aim was to characterize myocardial injury and its associations and sequelae in convalescent patients after hospitalization with COVID-19.

Enrollment took place during the Wuhan and Alpha waves of COVID-19: before vaccination and when dexamethasone and anticoagulant protocols were emerging. All participants underwent CMR at a median of 21 days after discharge.

Two prospective control groups also were recruited: 64 patients with COVID-19 and normal troponin levels (COVID+/troponin−) and 113 without COVID-19 or elevated troponin matched by age and cardiovascular comorbidities (COVID−/comorbidity+).

Overall, participants’ median age was 61 years and 69% were men. Common comorbidities included hypertension (47%), obesity (43%), and diabetes (25%).

The frequency of any heart abnormality – for example, left or right ventricular impairment, scar, or pericardial disease – was twice as great (61%) in COVID+/troponin+ cases, compared with controls (36% for COVID+/troponin− patients versus 31% for COVID−/comorbidity+ patients).

Specifically, more cases than controls had ventricular impairment (17.2% vs. 3.1% and 7.1%) or scar (42% vs. 7% and 23%).

The myocardial injury pattern differed between cases and controls, with cases more likely to have infarction (13% vs. 2% and 7%) or microinfarction (9% vs. 0% and 1%).

However, there was no between-group difference in nonischemic scar (13% vs. 5% and 14%).

The prevalence of probable recent myocarditis was 6.7% in cases, compared with 1.7% in controls without COVID-19 – “much lower” than in previous studies, Dr. Greenwood noted.

During follow-up, four COVID+/troponin+ patients (1.2%) died, and 34 (10%) experienced a subsequent major adverse cardiovascular event (MACE; 10.2%), which was similar to controls (6.1%).

Myocardial scar, but not previous COVID-19 infection or troponin level, was an independent predictor of MACE (odds ratio, 2.25).

“These findings suggest that macroangiopathic and microangiopathic thrombosis may be the key pathologic process for myocardial injury in COVID-19 survivors,” the authors conclude.

Dr. Greenwood added, “We are currently analyzing the 6-month follow-up CMR scans, the quality-of-life questionnaires, and the 6-minute walk tests. These will give us great understanding of how the heart repairs after acute myocardial injury associated with COVID-19. It will also allow us to assess the impact on patient quality of life and functional capacity.”
 

‘Tour de force’

James A. de Lemos, MD, co-chair of the American Heart Association’s COVID-19 CVD Registry Steering Committee and a professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said, “This is a tour de force collaboration – obtaining this many MRIs across multiple centers in the pandemic is quite remarkable. The study highlights the multiple different processes that lead to cardiac injury in COVID patients, complements autopsy studies and prior smaller MRI studies, [and] also provides the best data on the rate of myocarditis to date among the subset of COVID patients with cardiac injury.”

Overall, he said, the findings “do support closer follow-up for patients who had COVID and elevated troponins. We need to see follow-up MRI results in this cohort, as well as longer term outcomes. We also need studies on newer, more benign variants that are likely to have lower rates of cardiac injury and even fewer MRI abnormalities.”

Matthias Stuber, PhD, and Aaron L. Baggish, MD, both of Lausanne University Hospital and University of Lausanne, Switzerland, noted in a related editorial, “We are also reminded that the clinical severity of COVID-19 is most often dictated by the presence of pre-existing comorbidity, with antecedent ischemic scar now added to the long list of bad actors. Although not the primary focus of the COVID-HEART study, the question of whether cardiac troponin levels should be checked routinely and universally during the index admission for COVID-19 remains unresolved,” they noted.

“In general, we are most effective as clinicians when we use tests to confirm or rule out the specific disease processes suspected by careful basic clinical assessment rather than in a shotgun manner among undifferentiated all-comers,” they conclude.

No commercial funding or relevant financial relationships were reported.

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

Hospitalized COVID-19 patients with high troponin levels are twice as likely to have cardiac abnormalities than those with normal troponin, with or without COVID-19, a multicenter U.K. study suggests.

The causes were diverse, myocarditis prevalence was lower than previously reported, and myocardial scar emerged as an independent risk factor for adverse cardiovascular outcomes at 12 months.

“We know that multiorgan involvement in hospitalized patients with COVID-19 is common ... and may result in acute myocardial injury, detected by an increase in cardiac troponin concentrations,” John P. Greenwood, PhD, of the University of Leeds (England), told this news organization. “Elevated cardiac troponin is associated with a worse prognosis.”

“Multiple mechanisms of myocardial injury have been proposed and ... mitigation or prevention strategies likely depend on the underpinning mechanisms,” he said. “The sequelae of scar may predispose to late events.”

The study, published online  in Circulation, also identified a new pattern of microinfarction on cardiac magnetic resonance (CMR) imaging, highlighting the pro-thrombotic nature of SARS-CoV-2, Dr. Greenwood said.
 

Injury patterns different

Three hundred and forty-two patients with COVID-19 and elevated troponin levels (COVID+/troponin+) across 25 centers were enrolled between June 2020 and March 2021 in COVID-HEART, deemed an “urgent public health study” in the United Kingdom. The aim was to characterize myocardial injury and its associations and sequelae in convalescent patients after hospitalization with COVID-19.

Enrollment took place during the Wuhan and Alpha waves of COVID-19: before vaccination and when dexamethasone and anticoagulant protocols were emerging. All participants underwent CMR at a median of 21 days after discharge.

Two prospective control groups also were recruited: 64 patients with COVID-19 and normal troponin levels (COVID+/troponin−) and 113 without COVID-19 or elevated troponin matched by age and cardiovascular comorbidities (COVID−/comorbidity+).

Overall, participants’ median age was 61 years and 69% were men. Common comorbidities included hypertension (47%), obesity (43%), and diabetes (25%).

The frequency of any heart abnormality – for example, left or right ventricular impairment, scar, or pericardial disease – was twice as great (61%) in COVID+/troponin+ cases, compared with controls (36% for COVID+/troponin− patients versus 31% for COVID−/comorbidity+ patients).

Specifically, more cases than controls had ventricular impairment (17.2% vs. 3.1% and 7.1%) or scar (42% vs. 7% and 23%).

The myocardial injury pattern differed between cases and controls, with cases more likely to have infarction (13% vs. 2% and 7%) or microinfarction (9% vs. 0% and 1%).

However, there was no between-group difference in nonischemic scar (13% vs. 5% and 14%).

The prevalence of probable recent myocarditis was 6.7% in cases, compared with 1.7% in controls without COVID-19 – “much lower” than in previous studies, Dr. Greenwood noted.

During follow-up, four COVID+/troponin+ patients (1.2%) died, and 34 (10%) experienced a subsequent major adverse cardiovascular event (MACE; 10.2%), which was similar to controls (6.1%).

Myocardial scar, but not previous COVID-19 infection or troponin level, was an independent predictor of MACE (odds ratio, 2.25).

“These findings suggest that macroangiopathic and microangiopathic thrombosis may be the key pathologic process for myocardial injury in COVID-19 survivors,” the authors conclude.

Dr. Greenwood added, “We are currently analyzing the 6-month follow-up CMR scans, the quality-of-life questionnaires, and the 6-minute walk tests. These will give us great understanding of how the heart repairs after acute myocardial injury associated with COVID-19. It will also allow us to assess the impact on patient quality of life and functional capacity.”
 

‘Tour de force’

James A. de Lemos, MD, co-chair of the American Heart Association’s COVID-19 CVD Registry Steering Committee and a professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said, “This is a tour de force collaboration – obtaining this many MRIs across multiple centers in the pandemic is quite remarkable. The study highlights the multiple different processes that lead to cardiac injury in COVID patients, complements autopsy studies and prior smaller MRI studies, [and] also provides the best data on the rate of myocarditis to date among the subset of COVID patients with cardiac injury.”

Overall, he said, the findings “do support closer follow-up for patients who had COVID and elevated troponins. We need to see follow-up MRI results in this cohort, as well as longer term outcomes. We also need studies on newer, more benign variants that are likely to have lower rates of cardiac injury and even fewer MRI abnormalities.”

Matthias Stuber, PhD, and Aaron L. Baggish, MD, both of Lausanne University Hospital and University of Lausanne, Switzerland, noted in a related editorial, “We are also reminded that the clinical severity of COVID-19 is most often dictated by the presence of pre-existing comorbidity, with antecedent ischemic scar now added to the long list of bad actors. Although not the primary focus of the COVID-HEART study, the question of whether cardiac troponin levels should be checked routinely and universally during the index admission for COVID-19 remains unresolved,” they noted.

“In general, we are most effective as clinicians when we use tests to confirm or rule out the specific disease processes suspected by careful basic clinical assessment rather than in a shotgun manner among undifferentiated all-comers,” they conclude.

No commercial funding or relevant financial relationships were reported.

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

Hospitalized COVID-19 patients with high troponin levels are twice as likely to have cardiac abnormalities than those with normal troponin, with or without COVID-19, a multicenter U.K. study suggests.

The causes were diverse, myocarditis prevalence was lower than previously reported, and myocardial scar emerged as an independent risk factor for adverse cardiovascular outcomes at 12 months.

“We know that multiorgan involvement in hospitalized patients with COVID-19 is common ... and may result in acute myocardial injury, detected by an increase in cardiac troponin concentrations,” John P. Greenwood, PhD, of the University of Leeds (England), told this news organization. “Elevated cardiac troponin is associated with a worse prognosis.”

“Multiple mechanisms of myocardial injury have been proposed and ... mitigation or prevention strategies likely depend on the underpinning mechanisms,” he said. “The sequelae of scar may predispose to late events.”

The study, published online  in Circulation, also identified a new pattern of microinfarction on cardiac magnetic resonance (CMR) imaging, highlighting the pro-thrombotic nature of SARS-CoV-2, Dr. Greenwood said.
 

Injury patterns different

Three hundred and forty-two patients with COVID-19 and elevated troponin levels (COVID+/troponin+) across 25 centers were enrolled between June 2020 and March 2021 in COVID-HEART, deemed an “urgent public health study” in the United Kingdom. The aim was to characterize myocardial injury and its associations and sequelae in convalescent patients after hospitalization with COVID-19.

Enrollment took place during the Wuhan and Alpha waves of COVID-19: before vaccination and when dexamethasone and anticoagulant protocols were emerging. All participants underwent CMR at a median of 21 days after discharge.

Two prospective control groups also were recruited: 64 patients with COVID-19 and normal troponin levels (COVID+/troponin−) and 113 without COVID-19 or elevated troponin matched by age and cardiovascular comorbidities (COVID−/comorbidity+).

Overall, participants’ median age was 61 years and 69% were men. Common comorbidities included hypertension (47%), obesity (43%), and diabetes (25%).

The frequency of any heart abnormality – for example, left or right ventricular impairment, scar, or pericardial disease – was twice as great (61%) in COVID+/troponin+ cases, compared with controls (36% for COVID+/troponin− patients versus 31% for COVID−/comorbidity+ patients).

Specifically, more cases than controls had ventricular impairment (17.2% vs. 3.1% and 7.1%) or scar (42% vs. 7% and 23%).

The myocardial injury pattern differed between cases and controls, with cases more likely to have infarction (13% vs. 2% and 7%) or microinfarction (9% vs. 0% and 1%).

However, there was no between-group difference in nonischemic scar (13% vs. 5% and 14%).

The prevalence of probable recent myocarditis was 6.7% in cases, compared with 1.7% in controls without COVID-19 – “much lower” than in previous studies, Dr. Greenwood noted.

During follow-up, four COVID+/troponin+ patients (1.2%) died, and 34 (10%) experienced a subsequent major adverse cardiovascular event (MACE; 10.2%), which was similar to controls (6.1%).

Myocardial scar, but not previous COVID-19 infection or troponin level, was an independent predictor of MACE (odds ratio, 2.25).

“These findings suggest that macroangiopathic and microangiopathic thrombosis may be the key pathologic process for myocardial injury in COVID-19 survivors,” the authors conclude.

Dr. Greenwood added, “We are currently analyzing the 6-month follow-up CMR scans, the quality-of-life questionnaires, and the 6-minute walk tests. These will give us great understanding of how the heart repairs after acute myocardial injury associated with COVID-19. It will also allow us to assess the impact on patient quality of life and functional capacity.”
 

‘Tour de force’

James A. de Lemos, MD, co-chair of the American Heart Association’s COVID-19 CVD Registry Steering Committee and a professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said, “This is a tour de force collaboration – obtaining this many MRIs across multiple centers in the pandemic is quite remarkable. The study highlights the multiple different processes that lead to cardiac injury in COVID patients, complements autopsy studies and prior smaller MRI studies, [and] also provides the best data on the rate of myocarditis to date among the subset of COVID patients with cardiac injury.”

Overall, he said, the findings “do support closer follow-up for patients who had COVID and elevated troponins. We need to see follow-up MRI results in this cohort, as well as longer term outcomes. We also need studies on newer, more benign variants that are likely to have lower rates of cardiac injury and even fewer MRI abnormalities.”

Matthias Stuber, PhD, and Aaron L. Baggish, MD, both of Lausanne University Hospital and University of Lausanne, Switzerland, noted in a related editorial, “We are also reminded that the clinical severity of COVID-19 is most often dictated by the presence of pre-existing comorbidity, with antecedent ischemic scar now added to the long list of bad actors. Although not the primary focus of the COVID-HEART study, the question of whether cardiac troponin levels should be checked routinely and universally during the index admission for COVID-19 remains unresolved,” they noted.

“In general, we are most effective as clinicians when we use tests to confirm or rule out the specific disease processes suspected by careful basic clinical assessment rather than in a shotgun manner among undifferentiated all-comers,” they conclude.

No commercial funding or relevant financial relationships were reported.

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