Roughly 40% of all U.S. cases of incident diabetes during 2013-2016 were directly attributable to obesity, a finding that further solidifies the major etiologic role for obesity in the current American diabetes epidemic.

Researchers used data from a diverse cohort of 4,200 American adults in the MESA study during 2000-2017 to calculate a relative risk for developing diabetes of 2.7 in people with obesity compared with similar participants without obesity.

They then applied this relative risk estimate to obesity prevalence rates during serial iterations of NHANES, the recurring U.S.-wide survey of vital statistics in a representative cross-sectional population.

Their calculations showed that, during 2013-2016, 41% of U.S. adults who developed new onset diabetes did so because of obesity, after the researchers adjusted for potential confounders.

This “population attributable fraction,” or disease burden attributable to obesity, varied somewhat by sex, and by racial and ethnic subgrouping. Obesity was linked with the highest attributable rate among non-Hispanic White women, a rate of 53%, and with the lowest rate among non-Hispanic Black men, with an attributable fraction of 30%, Natalie A. Cameron, MD, and colleagues reported in their study, published online Feb. 10 in the Journal of the American Heart Association.
 

Potential for “meaningful impact” by reducing obesity

“Our study highlights the meaningful impact that reducing obesity could have on type 2 diabetes prevention in the United States. Decreasing obesity needs to be a priority,” Dr. Cameron, of the McGaw Medical Center of Northwestern University in Chicago, said in a statement issued by the American Heart Association.

“Public health efforts that support healthy lifestyles, such as increasing access to nutritious foods, promoting physical activity, and developing community programs to prevent obesity, could substantially reduce new cases of type 2 diabetes,” she added.

MESA (Multi-Ethnic Study of Atherosclerosis) enrolled adults aged 45-84 years and free from clinical cardiovascular disease at six U.S. sites during 2000-2002, and then followed them with four additional examinations through 2017.

For the current study, researchers narrowed the cohort down to 4,200 participants who were aged 45-79 years and free from diabetes at entry, and also restricted this subgroup to participants classified as non-Hispanic White (54% of the cohort), non-Hispanic Black (33%), or Mexican American (13%). At entry, 34% of the cohort had obesity, with a body mass index of at least 30 kg/m².

During a median follow-up of just over 9 years, 12% of the cohort developed incident diabetes. After adjustment for possible confounders, a hazard ratio model showed an overall 2.7-fold higher rate of incident diabetes among people with obesity compared to those without.

The researchers then applied this hazard ratio to obesity prevalence statistics from NHANES (National Health and Nutrition Examination Survey) during the same time period, with data from the biennial NHANES project collapsed into four time strata: 2001-2004, 2005-2008, 2009-2012, and 2013-2016. They again limited their analysis to NHANES data collected from people aged 45-79 years who self-reported categorization as non-Hispanic White, non-Hispanic Black, or Mexican American.

During the period from 2001-2004 to 2013-2016, overall obesity prevalence tallied by NHANES data rose from 34% to 41%. Among people with type 2 diabetes during 2013-2016, obesity prevalence was 65%.

To calculate the population attributable fraction researchers combined the MESA and NHANES estimates and adjusted for potential confounders and found that, overall, in 41% of people with incident diabetes during 2013-2016, the disease was attributable to obesity.

The study received no commercial funding, and none of the authors had disclosures.

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

Roughly 40% of all U.S. cases of incident diabetes during 2013-2016 were directly attributable to obesity, a finding that further solidifies the major etiologic role for obesity in the current American diabetes epidemic.

Researchers used data from a diverse cohort of 4,200 American adults in the MESA study during 2000-2017 to calculate a relative risk for developing diabetes of 2.7 in people with obesity compared with similar participants without obesity.

They then applied this relative risk estimate to obesity prevalence rates during serial iterations of NHANES, the recurring U.S.-wide survey of vital statistics in a representative cross-sectional population.

Their calculations showed that, during 2013-2016, 41% of U.S. adults who developed new onset diabetes did so because of obesity, after the researchers adjusted for potential confounders.

This “population attributable fraction,” or disease burden attributable to obesity, varied somewhat by sex, and by racial and ethnic subgrouping. Obesity was linked with the highest attributable rate among non-Hispanic White women, a rate of 53%, and with the lowest rate among non-Hispanic Black men, with an attributable fraction of 30%, Natalie A. Cameron, MD, and colleagues reported in their study, published online Feb. 10 in the Journal of the American Heart Association.
 

Potential for “meaningful impact” by reducing obesity

“Our study highlights the meaningful impact that reducing obesity could have on type 2 diabetes prevention in the United States. Decreasing obesity needs to be a priority,” Dr. Cameron, of the McGaw Medical Center of Northwestern University in Chicago, said in a statement issued by the American Heart Association.

“Public health efforts that support healthy lifestyles, such as increasing access to nutritious foods, promoting physical activity, and developing community programs to prevent obesity, could substantially reduce new cases of type 2 diabetes,” she added.

MESA (Multi-Ethnic Study of Atherosclerosis) enrolled adults aged 45-84 years and free from clinical cardiovascular disease at six U.S. sites during 2000-2002, and then followed them with four additional examinations through 2017.

For the current study, researchers narrowed the cohort down to 4,200 participants who were aged 45-79 years and free from diabetes at entry, and also restricted this subgroup to participants classified as non-Hispanic White (54% of the cohort), non-Hispanic Black (33%), or Mexican American (13%). At entry, 34% of the cohort had obesity, with a body mass index of at least 30 kg/m².

During a median follow-up of just over 9 years, 12% of the cohort developed incident diabetes. After adjustment for possible confounders, a hazard ratio model showed an overall 2.7-fold higher rate of incident diabetes among people with obesity compared to those without.

The researchers then applied this hazard ratio to obesity prevalence statistics from NHANES (National Health and Nutrition Examination Survey) during the same time period, with data from the biennial NHANES project collapsed into four time strata: 2001-2004, 2005-2008, 2009-2012, and 2013-2016. They again limited their analysis to NHANES data collected from people aged 45-79 years who self-reported categorization as non-Hispanic White, non-Hispanic Black, or Mexican American.

During the period from 2001-2004 to 2013-2016, overall obesity prevalence tallied by NHANES data rose from 34% to 41%. Among people with type 2 diabetes during 2013-2016, obesity prevalence was 65%.

To calculate the population attributable fraction researchers combined the MESA and NHANES estimates and adjusted for potential confounders and found that, overall, in 41% of people with incident diabetes during 2013-2016, the disease was attributable to obesity.

The study received no commercial funding, and none of the authors had disclosures.

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

Roughly 40% of all U.S. cases of incident diabetes during 2013-2016 were directly attributable to obesity, a finding that further solidifies the major etiologic role for obesity in the current American diabetes epidemic.

Researchers used data from a diverse cohort of 4,200 American adults in the MESA study during 2000-2017 to calculate a relative risk for developing diabetes of 2.7 in people with obesity compared with similar participants without obesity.

They then applied this relative risk estimate to obesity prevalence rates during serial iterations of NHANES, the recurring U.S.-wide survey of vital statistics in a representative cross-sectional population.

Their calculations showed that, during 2013-2016, 41% of U.S. adults who developed new onset diabetes did so because of obesity, after the researchers adjusted for potential confounders.

This “population attributable fraction,” or disease burden attributable to obesity, varied somewhat by sex, and by racial and ethnic subgrouping. Obesity was linked with the highest attributable rate among non-Hispanic White women, a rate of 53%, and with the lowest rate among non-Hispanic Black men, with an attributable fraction of 30%, Natalie A. Cameron, MD, and colleagues reported in their study, published online Feb. 10 in the Journal of the American Heart Association.
 

Potential for “meaningful impact” by reducing obesity

“Our study highlights the meaningful impact that reducing obesity could have on type 2 diabetes prevention in the United States. Decreasing obesity needs to be a priority,” Dr. Cameron, of the McGaw Medical Center of Northwestern University in Chicago, said in a statement issued by the American Heart Association.

“Public health efforts that support healthy lifestyles, such as increasing access to nutritious foods, promoting physical activity, and developing community programs to prevent obesity, could substantially reduce new cases of type 2 diabetes,” she added.

MESA (Multi-Ethnic Study of Atherosclerosis) enrolled adults aged 45-84 years and free from clinical cardiovascular disease at six U.S. sites during 2000-2002, and then followed them with four additional examinations through 2017.

For the current study, researchers narrowed the cohort down to 4,200 participants who were aged 45-79 years and free from diabetes at entry, and also restricted this subgroup to participants classified as non-Hispanic White (54% of the cohort), non-Hispanic Black (33%), or Mexican American (13%). At entry, 34% of the cohort had obesity, with a body mass index of at least 30 kg/m².

During a median follow-up of just over 9 years, 12% of the cohort developed incident diabetes. After adjustment for possible confounders, a hazard ratio model showed an overall 2.7-fold higher rate of incident diabetes among people with obesity compared to those without.

The researchers then applied this hazard ratio to obesity prevalence statistics from NHANES (National Health and Nutrition Examination Survey) during the same time period, with data from the biennial NHANES project collapsed into four time strata: 2001-2004, 2005-2008, 2009-2012, and 2013-2016. They again limited their analysis to NHANES data collected from people aged 45-79 years who self-reported categorization as non-Hispanic White, non-Hispanic Black, or Mexican American.

During the period from 2001-2004 to 2013-2016, overall obesity prevalence tallied by NHANES data rose from 34% to 41%. Among people with type 2 diabetes during 2013-2016, obesity prevalence was 65%.

To calculate the population attributable fraction researchers combined the MESA and NHANES estimates and adjusted for potential confounders and found that, overall, in 41% of people with incident diabetes during 2013-2016, the disease was attributable to obesity.

The study received no commercial funding, and none of the authors had disclosures.

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

Researchers have developed a proprietary computer adaptive screening tool that may help emergency departments more accurately predict suicide attempts in adolescents, according to a recent study in JAMA Psychiatry.

The computerized adaptive screen for suicidal youth (CASSY) had an area under the curve (AUC) of 0.87 in an independent validation cohort that predicted an adolescent suicide attempt within 3 months, according to Cheryl A. King, PhD, of the department of psychiatry at the University of Michigan in Ann Arbor, and colleagues. CASSY’s adaptive design, which presents different questions based on a respondent’s answers, means “an individual’s initial item responses are used to determine a provisional estimate of their standing on the measured trait,” the researchers said.

Dr. King and colleagues evaluated the CASSY algorithm in a first study that consisted of 2,845 adolescents who were mean 15.1 years old, mostly girls (63%) enrolled from 13 different emergency departments across the United States within the Pediatric Emergency Care Applied Research Network (PECARN) between June 2015 and July 2016. To develop the CASSY algorithm, the participants received a 92-item self-report survey at baseline with three “anchor” questions from the Ask Suicide-Screening Questions (ASQ) and Columbia–Suicide Severity Rating Scale (C-SSRS). Based on the answers to the baseline survey, the researchers categorized participants as being at low, medium, or high risk for a suicide attempt, and followed participants for 3 months to record suicide attempts reported by a patient or parent.

Retention of participants at 3 months was 72.9%, leaving data available for 2,075 adolescents for review. The researchers found that the AUC was 0.89 (95% confidence interval, 0.85-0.91) in the first study, with a sensitivity of 82.4% and a specificity of 80%. Participants answered a mean number of 11 items during an assessment (range, 5-21 items) administered in a median time of 1 minute, 24 seconds.

In a second study consisting of a validation cohort, 4,050 adolescents from 14 PECARN emergency departments and 1 Indian Health Service hospital were followed, with a retention of 2,754 participants (69.5%) at the end of 3 months. Of the adolescents available at the end of 3 months, 62.1% were girls with a mean age of 15.0 years. The AUC for this validation group was 0.87 (95% CI, 0.85-0.89). Of these participants, 71.5% reported no previous suicide attempts, 9% reported one prior attempt, 18.2% reported multiple attempts, and 1.2% had an unknown number of suicide attempts. During the 3-month window of the second study, 6.0% of participants had at least one suicide attempt.

The researchers said that while the CASSY instrument may be advantageous for some emergency departments, “a standard screen such as the ASQ, which consists of fewer items, may be preferred in some settings, particularly those in which the cost and technical setup of a computerized adaptive screen poses too high a barrier.”

“Important next steps will be to measure the CASSY’s test-retest reliability and develop triage recommendations and conduct implementation studies,” Dr. King and colleagues concluded.
 

Climbing adolescent suicide rate

In an interview, Igor Galynker, MD, PhD, professor in the department of psychiatry, and director of the suicide lab and the Zirinsky Center for Bipolar Disorder at the Icahn School of Medicine at Mount Sinai, New York, said the study by Dr. King and colleagues is important during a time when the suicide rate for adolescents is substantially increasing.

According to data from the CDC’s Web-based Injury Statistics Query and Reporting System, 1,750 adolescents died of suicide in 2018, and the rate of deaths by suicide has increased by 62% since the year 2000. “The issue really needs to be addressed,” said Dr. Galynker, who was not involved with the study.

Some methods of screening suicidal ideation that open with a direct question can miss suicide attempts in individuals who do not express these suicidal ideations, he explained, and the problem can be magnified in adolescent patients. “This is particularly difficult with adolescents because they’re notoriously poor historians. They cannot describe their feelings as well. It’s even more important to have methods that work for suicide prevention for adolescents and to support those predictors which do not rely on self-report,” he said.

Dr. Galynker said that CASSY is innovative because asking whether the patient is suicidal is not the “gateway question” and does not categorize people into groups determined to be at low, medium, or high risk for a suicide attempt.

“When you categorize people – adolescents in this particular case – you remove clinical judgment from [the] clinician. You deprive [the] clinician of exercising their clinical judgment in terms of somebody is or is not likely to die by suicide. That’s a serious problem,” he said, noting it may be one reason why these screening tools have difficulty identifying patients at risk of suicide.

Regarding limitations, the 3-month follow-up window for patients in the study may be too long to be clinically meaningful.

“If somebody is in treatment, 3 months is a long time. You want to know whether somebody is going to attempt suicide before the next time you see them, which is usually a month or a week,” he said.

But a strength of the CASSY instrument, Dr. Galynker said, is its ability to capture the patient’s mental state in the moment, as opposed to relying only a patient’s electronic medical record. The study also demonstrates “it should be possible to introduce detailed suicide risk assessment in the emergency rooms, and [it] should be done,” he said.

This study was funded with support from the Health Resources and Services Administration, the Maternal and Child Health Bureau, and the Emergency Medical Services for Children Network Development Demonstration Program, and a grant by the National Institute of Mental Health for the Emergency Department Screen for Teens at Risk for Suicide. Twelve authors reported personal and institutional relationships in the form of fees, grants, consultancies, royalties, copyrighted work, founding of technologies, and scientific council memberships for a variety of agencies, societies, foundations, and other organizations inside and outside of the study. Dr. Galynker reported his work unrelated to the study is supported by the National Institute of Mental Health and the American Foundation for Suicide Prevention. But he has no proprietary interests.
 

[email protected]

Researchers have developed a proprietary computer adaptive screening tool that may help emergency departments more accurately predict suicide attempts in adolescents, according to a recent study in JAMA Psychiatry.

The computerized adaptive screen for suicidal youth (CASSY) had an area under the curve (AUC) of 0.87 in an independent validation cohort that predicted an adolescent suicide attempt within 3 months, according to Cheryl A. King, PhD, of the department of psychiatry at the University of Michigan in Ann Arbor, and colleagues. CASSY’s adaptive design, which presents different questions based on a respondent’s answers, means “an individual’s initial item responses are used to determine a provisional estimate of their standing on the measured trait,” the researchers said.

Dr. King and colleagues evaluated the CASSY algorithm in a first study that consisted of 2,845 adolescents who were mean 15.1 years old, mostly girls (63%) enrolled from 13 different emergency departments across the United States within the Pediatric Emergency Care Applied Research Network (PECARN) between June 2015 and July 2016. To develop the CASSY algorithm, the participants received a 92-item self-report survey at baseline with three “anchor” questions from the Ask Suicide-Screening Questions (ASQ) and Columbia–Suicide Severity Rating Scale (C-SSRS). Based on the answers to the baseline survey, the researchers categorized participants as being at low, medium, or high risk for a suicide attempt, and followed participants for 3 months to record suicide attempts reported by a patient or parent.

Retention of participants at 3 months was 72.9%, leaving data available for 2,075 adolescents for review. The researchers found that the AUC was 0.89 (95% confidence interval, 0.85-0.91) in the first study, with a sensitivity of 82.4% and a specificity of 80%. Participants answered a mean number of 11 items during an assessment (range, 5-21 items) administered in a median time of 1 minute, 24 seconds.

In a second study consisting of a validation cohort, 4,050 adolescents from 14 PECARN emergency departments and 1 Indian Health Service hospital were followed, with a retention of 2,754 participants (69.5%) at the end of 3 months. Of the adolescents available at the end of 3 months, 62.1% were girls with a mean age of 15.0 years. The AUC for this validation group was 0.87 (95% CI, 0.85-0.89). Of these participants, 71.5% reported no previous suicide attempts, 9% reported one prior attempt, 18.2% reported multiple attempts, and 1.2% had an unknown number of suicide attempts. During the 3-month window of the second study, 6.0% of participants had at least one suicide attempt.

The researchers said that while the CASSY instrument may be advantageous for some emergency departments, “a standard screen such as the ASQ, which consists of fewer items, may be preferred in some settings, particularly those in which the cost and technical setup of a computerized adaptive screen poses too high a barrier.”

“Important next steps will be to measure the CASSY’s test-retest reliability and develop triage recommendations and conduct implementation studies,” Dr. King and colleagues concluded.
 

Climbing adolescent suicide rate

In an interview, Igor Galynker, MD, PhD, professor in the department of psychiatry, and director of the suicide lab and the Zirinsky Center for Bipolar Disorder at the Icahn School of Medicine at Mount Sinai, New York, said the study by Dr. King and colleagues is important during a time when the suicide rate for adolescents is substantially increasing.

According to data from the CDC’s Web-based Injury Statistics Query and Reporting System, 1,750 adolescents died of suicide in 2018, and the rate of deaths by suicide has increased by 62% since the year 2000. “The issue really needs to be addressed,” said Dr. Galynker, who was not involved with the study.

Some methods of screening suicidal ideation that open with a direct question can miss suicide attempts in individuals who do not express these suicidal ideations, he explained, and the problem can be magnified in adolescent patients. “This is particularly difficult with adolescents because they’re notoriously poor historians. They cannot describe their feelings as well. It’s even more important to have methods that work for suicide prevention for adolescents and to support those predictors which do not rely on self-report,” he said.

Dr. Galynker said that CASSY is innovative because asking whether the patient is suicidal is not the “gateway question” and does not categorize people into groups determined to be at low, medium, or high risk for a suicide attempt.

“When you categorize people – adolescents in this particular case – you remove clinical judgment from [the] clinician. You deprive [the] clinician of exercising their clinical judgment in terms of somebody is or is not likely to die by suicide. That’s a serious problem,” he said, noting it may be one reason why these screening tools have difficulty identifying patients at risk of suicide.

Regarding limitations, the 3-month follow-up window for patients in the study may be too long to be clinically meaningful.

“If somebody is in treatment, 3 months is a long time. You want to know whether somebody is going to attempt suicide before the next time you see them, which is usually a month or a week,” he said.

But a strength of the CASSY instrument, Dr. Galynker said, is its ability to capture the patient’s mental state in the moment, as opposed to relying only a patient’s electronic medical record. The study also demonstrates “it should be possible to introduce detailed suicide risk assessment in the emergency rooms, and [it] should be done,” he said.

This study was funded with support from the Health Resources and Services Administration, the Maternal and Child Health Bureau, and the Emergency Medical Services for Children Network Development Demonstration Program, and a grant by the National Institute of Mental Health for the Emergency Department Screen for Teens at Risk for Suicide. Twelve authors reported personal and institutional relationships in the form of fees, grants, consultancies, royalties, copyrighted work, founding of technologies, and scientific council memberships for a variety of agencies, societies, foundations, and other organizations inside and outside of the study. Dr. Galynker reported his work unrelated to the study is supported by the National Institute of Mental Health and the American Foundation for Suicide Prevention. But he has no proprietary interests.
 

[email protected]

Researchers have developed a proprietary computer adaptive screening tool that may help emergency departments more accurately predict suicide attempts in adolescents, according to a recent study in JAMA Psychiatry.

The computerized adaptive screen for suicidal youth (CASSY) had an area under the curve (AUC) of 0.87 in an independent validation cohort that predicted an adolescent suicide attempt within 3 months, according to Cheryl A. King, PhD, of the department of psychiatry at the University of Michigan in Ann Arbor, and colleagues. CASSY’s adaptive design, which presents different questions based on a respondent’s answers, means “an individual’s initial item responses are used to determine a provisional estimate of their standing on the measured trait,” the researchers said.

Dr. King and colleagues evaluated the CASSY algorithm in a first study that consisted of 2,845 adolescents who were mean 15.1 years old, mostly girls (63%) enrolled from 13 different emergency departments across the United States within the Pediatric Emergency Care Applied Research Network (PECARN) between June 2015 and July 2016. To develop the CASSY algorithm, the participants received a 92-item self-report survey at baseline with three “anchor” questions from the Ask Suicide-Screening Questions (ASQ) and Columbia–Suicide Severity Rating Scale (C-SSRS). Based on the answers to the baseline survey, the researchers categorized participants as being at low, medium, or high risk for a suicide attempt, and followed participants for 3 months to record suicide attempts reported by a patient or parent.

Retention of participants at 3 months was 72.9%, leaving data available for 2,075 adolescents for review. The researchers found that the AUC was 0.89 (95% confidence interval, 0.85-0.91) in the first study, with a sensitivity of 82.4% and a specificity of 80%. Participants answered a mean number of 11 items during an assessment (range, 5-21 items) administered in a median time of 1 minute, 24 seconds.

In a second study consisting of a validation cohort, 4,050 adolescents from 14 PECARN emergency departments and 1 Indian Health Service hospital were followed, with a retention of 2,754 participants (69.5%) at the end of 3 months. Of the adolescents available at the end of 3 months, 62.1% were girls with a mean age of 15.0 years. The AUC for this validation group was 0.87 (95% CI, 0.85-0.89). Of these participants, 71.5% reported no previous suicide attempts, 9% reported one prior attempt, 18.2% reported multiple attempts, and 1.2% had an unknown number of suicide attempts. During the 3-month window of the second study, 6.0% of participants had at least one suicide attempt.

The researchers said that while the CASSY instrument may be advantageous for some emergency departments, “a standard screen such as the ASQ, which consists of fewer items, may be preferred in some settings, particularly those in which the cost and technical setup of a computerized adaptive screen poses too high a barrier.”

“Important next steps will be to measure the CASSY’s test-retest reliability and develop triage recommendations and conduct implementation studies,” Dr. King and colleagues concluded.
 

Climbing adolescent suicide rate

In an interview, Igor Galynker, MD, PhD, professor in the department of psychiatry, and director of the suicide lab and the Zirinsky Center for Bipolar Disorder at the Icahn School of Medicine at Mount Sinai, New York, said the study by Dr. King and colleagues is important during a time when the suicide rate for adolescents is substantially increasing.

According to data from the CDC’s Web-based Injury Statistics Query and Reporting System, 1,750 adolescents died of suicide in 2018, and the rate of deaths by suicide has increased by 62% since the year 2000. “The issue really needs to be addressed,” said Dr. Galynker, who was not involved with the study.

Some methods of screening suicidal ideation that open with a direct question can miss suicide attempts in individuals who do not express these suicidal ideations, he explained, and the problem can be magnified in adolescent patients. “This is particularly difficult with adolescents because they’re notoriously poor historians. They cannot describe their feelings as well. It’s even more important to have methods that work for suicide prevention for adolescents and to support those predictors which do not rely on self-report,” he said.

Dr. Galynker said that CASSY is innovative because asking whether the patient is suicidal is not the “gateway question” and does not categorize people into groups determined to be at low, medium, or high risk for a suicide attempt.

“When you categorize people – adolescents in this particular case – you remove clinical judgment from [the] clinician. You deprive [the] clinician of exercising their clinical judgment in terms of somebody is or is not likely to die by suicide. That’s a serious problem,” he said, noting it may be one reason why these screening tools have difficulty identifying patients at risk of suicide.

Regarding limitations, the 3-month follow-up window for patients in the study may be too long to be clinically meaningful.

“If somebody is in treatment, 3 months is a long time. You want to know whether somebody is going to attempt suicide before the next time you see them, which is usually a month or a week,” he said.

But a strength of the CASSY instrument, Dr. Galynker said, is its ability to capture the patient’s mental state in the moment, as opposed to relying only a patient’s electronic medical record. The study also demonstrates “it should be possible to introduce detailed suicide risk assessment in the emergency rooms, and [it] should be done,” he said.

This study was funded with support from the Health Resources and Services Administration, the Maternal and Child Health Bureau, and the Emergency Medical Services for Children Network Development Demonstration Program, and a grant by the National Institute of Mental Health for the Emergency Department Screen for Teens at Risk for Suicide. Twelve authors reported personal and institutional relationships in the form of fees, grants, consultancies, royalties, copyrighted work, founding of technologies, and scientific council memberships for a variety of agencies, societies, foundations, and other organizations inside and outside of the study. Dr. Galynker reported his work unrelated to the study is supported by the National Institute of Mental Health and the American Foundation for Suicide Prevention. But he has no proprietary interests.
 

[email protected]

In a time when this country is struggling to find topics on which we can achieve broad consensus, the question of whether in-class learning is important stands as an outlier. Parents, teachers, students, and pediatricians all agree that having children learn in a social, face-to-face environment is critical to their education and mental health. Because school has become a de facto daycare source for many families, employers have joined in the chorus supporting a return to in-class education.

Of course, beyond that basic point of agreement the myriad of questions relating to when and how that return to the educational norm can be achieved we divide into groups with almost as many answers as there are questions. Part of the problem stems from the national leadership vacuum that fed the confusion. In this void the topic of school reopening has become politicized.

On Jan. 5, 2021, the American Academy of Pediatrics released an updated interim COVID-19 Guidance for Safe Schools at services.aap.org. It is a thorough and well thought out document that should function as a roadmap for communities and pediatricians who serve as official and unofficial advisers to their local school departments. At the very outset it reminds us that “school transmission mirrors but does not drive community transmission.”

Unfortunately, timing is everything and while the document’s salient points received some media attention it was mostly buried by the tsunami of press coverage in the wake of the storming of the Capitol the next day and the postinauguration reshuffling of the federal government. Even if it had been released on one of those seldom seen quiet news days, I fear the document’s message encouraging the return to in-class learning would have still not received the attention it deserved.

The lack of a high-visibility celebrity spokesperson and a system of short-tenure presidencies puts the AAP at a disadvantage when it comes to getting its message across to a national audience. The advocacy role filters down to those of us in our own communities who must convince school boards that not only is in-class learning critical but there are safe ways to do it.

In some communities the timing of return to in-class learning may pit pediatricians against teachers. Usually, these two groups share an enthusiastic advocacy for children. However, facing what has up to this point been a poorly defined health risk, teachers are understandably resistant to return to the classroom although they acknowledge its importance.

Armed with the AAP’s guidance document, pediatricians should encourage school boards and state and local health departments to look closely at the epidemiologic evidence and consider creative ways to prioritize teachers for what currently are limited and erratic vaccine supplies. Strategies might include offering vaccines to teachers based strictly on their age and/or health status. However, teachers and in-class education are so critical to the educational process and the national economy that an open offer to all teachers makes more sense.

While some states have already prioritized teachers for vaccines, the AAP must continue to speak loudly that in-class education is critical and urge all states to do what is necessary to make teachers feel safe to return to the classroom.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

In a time when this country is struggling to find topics on which we can achieve broad consensus, the question of whether in-class learning is important stands as an outlier. Parents, teachers, students, and pediatricians all agree that having children learn in a social, face-to-face environment is critical to their education and mental health. Because school has become a de facto daycare source for many families, employers have joined in the chorus supporting a return to in-class education.

Of course, beyond that basic point of agreement the myriad of questions relating to when and how that return to the educational norm can be achieved we divide into groups with almost as many answers as there are questions. Part of the problem stems from the national leadership vacuum that fed the confusion. In this void the topic of school reopening has become politicized.

On Jan. 5, 2021, the American Academy of Pediatrics released an updated interim COVID-19 Guidance for Safe Schools at services.aap.org. It is a thorough and well thought out document that should function as a roadmap for communities and pediatricians who serve as official and unofficial advisers to their local school departments. At the very outset it reminds us that “school transmission mirrors but does not drive community transmission.”

Unfortunately, timing is everything and while the document’s salient points received some media attention it was mostly buried by the tsunami of press coverage in the wake of the storming of the Capitol the next day and the postinauguration reshuffling of the federal government. Even if it had been released on one of those seldom seen quiet news days, I fear the document’s message encouraging the return to in-class learning would have still not received the attention it deserved.

The lack of a high-visibility celebrity spokesperson and a system of short-tenure presidencies puts the AAP at a disadvantage when it comes to getting its message across to a national audience. The advocacy role filters down to those of us in our own communities who must convince school boards that not only is in-class learning critical but there are safe ways to do it.

In some communities the timing of return to in-class learning may pit pediatricians against teachers. Usually, these two groups share an enthusiastic advocacy for children. However, facing what has up to this point been a poorly defined health risk, teachers are understandably resistant to return to the classroom although they acknowledge its importance.

Armed with the AAP’s guidance document, pediatricians should encourage school boards and state and local health departments to look closely at the epidemiologic evidence and consider creative ways to prioritize teachers for what currently are limited and erratic vaccine supplies. Strategies might include offering vaccines to teachers based strictly on their age and/or health status. However, teachers and in-class education are so critical to the educational process and the national economy that an open offer to all teachers makes more sense.

While some states have already prioritized teachers for vaccines, the AAP must continue to speak loudly that in-class education is critical and urge all states to do what is necessary to make teachers feel safe to return to the classroom.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

In a time when this country is struggling to find topics on which we can achieve broad consensus, the question of whether in-class learning is important stands as an outlier. Parents, teachers, students, and pediatricians all agree that having children learn in a social, face-to-face environment is critical to their education and mental health. Because school has become a de facto daycare source for many families, employers have joined in the chorus supporting a return to in-class education.

Of course, beyond that basic point of agreement the myriad of questions relating to when and how that return to the educational norm can be achieved we divide into groups with almost as many answers as there are questions. Part of the problem stems from the national leadership vacuum that fed the confusion. In this void the topic of school reopening has become politicized.

On Jan. 5, 2021, the American Academy of Pediatrics released an updated interim COVID-19 Guidance for Safe Schools at services.aap.org. It is a thorough and well thought out document that should function as a roadmap for communities and pediatricians who serve as official and unofficial advisers to their local school departments. At the very outset it reminds us that “school transmission mirrors but does not drive community transmission.”

Unfortunately, timing is everything and while the document’s salient points received some media attention it was mostly buried by the tsunami of press coverage in the wake of the storming of the Capitol the next day and the postinauguration reshuffling of the federal government. Even if it had been released on one of those seldom seen quiet news days, I fear the document’s message encouraging the return to in-class learning would have still not received the attention it deserved.

The lack of a high-visibility celebrity spokesperson and a system of short-tenure presidencies puts the AAP at a disadvantage when it comes to getting its message across to a national audience. The advocacy role filters down to those of us in our own communities who must convince school boards that not only is in-class learning critical but there are safe ways to do it.

In some communities the timing of return to in-class learning may pit pediatricians against teachers. Usually, these two groups share an enthusiastic advocacy for children. However, facing what has up to this point been a poorly defined health risk, teachers are understandably resistant to return to the classroom although they acknowledge its importance.

Armed with the AAP’s guidance document, pediatricians should encourage school boards and state and local health departments to look closely at the epidemiologic evidence and consider creative ways to prioritize teachers for what currently are limited and erratic vaccine supplies. Strategies might include offering vaccines to teachers based strictly on their age and/or health status. However, teachers and in-class education are so critical to the educational process and the national economy that an open offer to all teachers makes more sense.

While some states have already prioritized teachers for vaccines, the AAP must continue to speak loudly that in-class education is critical and urge all states to do what is necessary to make teachers feel safe to return to the classroom.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

The Food and Drug Administration has approved cemiplimab-rwlc (Libtayo) for the treatment of advanced non–small cell lung cancer (NSCLC).

Specifically, the indication is for first-line treatment as monotherapy for patients with locally advanced or metastatic disease who are not candidates for surgical resection or definitive chemoradiotherapy and whose tumors have a high expression of programmed death–ligand 1 (PD-L1) (Tumor Proportion Score >50%), as determined by an FDA-approved test, with no EGFR, ALK, or ROS1 aberrations.

This is the third indication for cemiplimab-rlwc, a monoclonal antibody and PD-1 inhibitor.

In February, it was approved as the first immunotherapy to treat patients with locally advanced or metastatic basal cell carcinoma that was previously treated with a hedgehog pathway inhibitor or for whom a hedgehog inhibitor is inappropriate.

Cemiplimab-rlwc previously received FDA approval in 2018 for locally advanced or metastatic cutaneous squamous cell carcinoma for patients who were not eligible for curative surgery or radiotherapy. At the time, Karl Lewis, MD, a professor at the University of Colorado at Denver, Aurora, and a trial investigator, predicted that the drug “will change the treatment paradigm for patients with advanced basal cell carcinoma.”
 

Outperforms chemotherapy

The approval for use in NSCLC is based on results from the phase 3, open-label EMPOWER-Lung 1 trial, which randomly assigned 710 patients in a 1:1 ratio to receive either cemiplimab-rwlc or platinum-doublet chemotherapy. Patients had either locally advanced NSCLC and were not candidates for surgical resection or definitive chemoradiotherapy, or they had metastatic NSCLC.

Patients in the experimental arm received cemiplimab-rwlc 350 mg intravenously every 3 weeks. The primary efficacy outcome measures were overall survival (OS) and progression-free survival (PFS), determined on the basis of blinded independent central review.

Results showed statistically significant improvements in both outcomes. Median OS was 22.1 months with cemiplimab-rwlc versus 14.3 months with chemotherapy (hazard ratio, 0.68; P = .0022). Median PFS was 6.2 months versus 5.6 months (HR, 0.59; P < .0001).

The confirmed overall response rate was 37% for the cemiplimab arm versus 21% for the chemotherapy arm.

The most common adverse reactions (>10%) with cemiplimab-rlwc were musculoskeletal pain, rash, anemia, fatigue, decreased appetite, pneumonia, and cough.

This approval “means physicians and patients have a potent new treatment option against this deadly disease,” said Naiyer Rizvi, MD, Price Family Professor of Medicine, director of thoracic oncology, and codirector of cancer immunotherapy at Columbia University Irving Medical Center, New York, in a statement. He was a steering committee member on the EMPOWER-Lung-1 Trial.

“Notably, Libtayo was approved based on a pivotal trial where most chemotherapy patients crossed over to Libtayo following disease progression, and that allowed for frequently underrepresented patients who had pretreated and clinically stable brain metastases or who had locally advanced disease and were not candidates for definitive chemoradiation,” said Dr. Rizvi. “This gives doctors important new data when considering Libtayo for the varied patients and situations they treat in daily clinical practice.”

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

The Food and Drug Administration has approved cemiplimab-rwlc (Libtayo) for the treatment of advanced non–small cell lung cancer (NSCLC).

Specifically, the indication is for first-line treatment as monotherapy for patients with locally advanced or metastatic disease who are not candidates for surgical resection or definitive chemoradiotherapy and whose tumors have a high expression of programmed death–ligand 1 (PD-L1) (Tumor Proportion Score >50%), as determined by an FDA-approved test, with no EGFR, ALK, or ROS1 aberrations.

This is the third indication for cemiplimab-rlwc, a monoclonal antibody and PD-1 inhibitor.

In February, it was approved as the first immunotherapy to treat patients with locally advanced or metastatic basal cell carcinoma that was previously treated with a hedgehog pathway inhibitor or for whom a hedgehog inhibitor is inappropriate.

Cemiplimab-rlwc previously received FDA approval in 2018 for locally advanced or metastatic cutaneous squamous cell carcinoma for patients who were not eligible for curative surgery or radiotherapy. At the time, Karl Lewis, MD, a professor at the University of Colorado at Denver, Aurora, and a trial investigator, predicted that the drug “will change the treatment paradigm for patients with advanced basal cell carcinoma.”
 

Outperforms chemotherapy

The approval for use in NSCLC is based on results from the phase 3, open-label EMPOWER-Lung 1 trial, which randomly assigned 710 patients in a 1:1 ratio to receive either cemiplimab-rwlc or platinum-doublet chemotherapy. Patients had either locally advanced NSCLC and were not candidates for surgical resection or definitive chemoradiotherapy, or they had metastatic NSCLC.

Patients in the experimental arm received cemiplimab-rwlc 350 mg intravenously every 3 weeks. The primary efficacy outcome measures were overall survival (OS) and progression-free survival (PFS), determined on the basis of blinded independent central review.

Results showed statistically significant improvements in both outcomes. Median OS was 22.1 months with cemiplimab-rwlc versus 14.3 months with chemotherapy (hazard ratio, 0.68; P = .0022). Median PFS was 6.2 months versus 5.6 months (HR, 0.59; P < .0001).

The confirmed overall response rate was 37% for the cemiplimab arm versus 21% for the chemotherapy arm.

The most common adverse reactions (>10%) with cemiplimab-rlwc were musculoskeletal pain, rash, anemia, fatigue, decreased appetite, pneumonia, and cough.

This approval “means physicians and patients have a potent new treatment option against this deadly disease,” said Naiyer Rizvi, MD, Price Family Professor of Medicine, director of thoracic oncology, and codirector of cancer immunotherapy at Columbia University Irving Medical Center, New York, in a statement. He was a steering committee member on the EMPOWER-Lung-1 Trial.

“Notably, Libtayo was approved based on a pivotal trial where most chemotherapy patients crossed over to Libtayo following disease progression, and that allowed for frequently underrepresented patients who had pretreated and clinically stable brain metastases or who had locally advanced disease and were not candidates for definitive chemoradiation,” said Dr. Rizvi. “This gives doctors important new data when considering Libtayo for the varied patients and situations they treat in daily clinical practice.”

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

The Food and Drug Administration has approved cemiplimab-rwlc (Libtayo) for the treatment of advanced non–small cell lung cancer (NSCLC).

Specifically, the indication is for first-line treatment as monotherapy for patients with locally advanced or metastatic disease who are not candidates for surgical resection or definitive chemoradiotherapy and whose tumors have a high expression of programmed death–ligand 1 (PD-L1) (Tumor Proportion Score >50%), as determined by an FDA-approved test, with no EGFR, ALK, or ROS1 aberrations.

This is the third indication for cemiplimab-rlwc, a monoclonal antibody and PD-1 inhibitor.

In February, it was approved as the first immunotherapy to treat patients with locally advanced or metastatic basal cell carcinoma that was previously treated with a hedgehog pathway inhibitor or for whom a hedgehog inhibitor is inappropriate.

Cemiplimab-rlwc previously received FDA approval in 2018 for locally advanced or metastatic cutaneous squamous cell carcinoma for patients who were not eligible for curative surgery or radiotherapy. At the time, Karl Lewis, MD, a professor at the University of Colorado at Denver, Aurora, and a trial investigator, predicted that the drug “will change the treatment paradigm for patients with advanced basal cell carcinoma.”
 

Outperforms chemotherapy

The approval for use in NSCLC is based on results from the phase 3, open-label EMPOWER-Lung 1 trial, which randomly assigned 710 patients in a 1:1 ratio to receive either cemiplimab-rwlc or platinum-doublet chemotherapy. Patients had either locally advanced NSCLC and were not candidates for surgical resection or definitive chemoradiotherapy, or they had metastatic NSCLC.

Patients in the experimental arm received cemiplimab-rwlc 350 mg intravenously every 3 weeks. The primary efficacy outcome measures were overall survival (OS) and progression-free survival (PFS), determined on the basis of blinded independent central review.

Results showed statistically significant improvements in both outcomes. Median OS was 22.1 months with cemiplimab-rwlc versus 14.3 months with chemotherapy (hazard ratio, 0.68; P = .0022). Median PFS was 6.2 months versus 5.6 months (HR, 0.59; P < .0001).

The confirmed overall response rate was 37% for the cemiplimab arm versus 21% for the chemotherapy arm.

The most common adverse reactions (>10%) with cemiplimab-rlwc were musculoskeletal pain, rash, anemia, fatigue, decreased appetite, pneumonia, and cough.

This approval “means physicians and patients have a potent new treatment option against this deadly disease,” said Naiyer Rizvi, MD, Price Family Professor of Medicine, director of thoracic oncology, and codirector of cancer immunotherapy at Columbia University Irving Medical Center, New York, in a statement. He was a steering committee member on the EMPOWER-Lung-1 Trial.

“Notably, Libtayo was approved based on a pivotal trial where most chemotherapy patients crossed over to Libtayo following disease progression, and that allowed for frequently underrepresented patients who had pretreated and clinically stable brain metastases or who had locally advanced disease and were not candidates for definitive chemoradiation,” said Dr. Rizvi. “This gives doctors important new data when considering Libtayo for the varied patients and situations they treat in daily clinical practice.”

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

Despite their similar functions, each current and emerging therapy for treating hemophilia has a unique safety profile, and each needs to be weighed apart from agents both within and outside its pharmacologic class, a hemophilia specialist said.

“My view is that each new molecule coming to the hemophilia space, including variant factor molecules, needs to be scrutinized separately, without class assumptions or extrapolations, and it’s clear that thrombosis risk has become a priority safety consideration,” said Dan Hart, MBChB, MRCP, FRCPath, PhD, from Barts and the London School of Medicine and Dentistry.

He reviewed the comparative safety of standard and novel therapies for hemophilia at the annual congress of the European Association for Haemophilia and Allied Disorders.
 

Factor inhibitors

Inhibitors occur in both hemophilia A and hemophilia B, and are primarily seen in patients with childhood exposure to factor concentrates. Inhibitors, which include anti–factor VIII and factor IX alloantibodies, are more common among patients with severe hemophilia and those with more disruptive factor VIII and factor IX mutations.

“There can be transient vs. persistent inhibitors, and arguably the more you look, the more you find, but clinically we never miss high-titer inhibitors that have a big impact on individuals and the subsequent decisions about management,” he said.
 

Hamster vs. human

It’s currently unclear whether there is an immunologic advantage for previously untreated patients to be started on factor VIII concentrates derived from recombinant human cells lines, or from products derived from Chinese hamster ovary (CHO) or baby hamster kidney (BHK) cell lines, Dr. Hart said.

“We need to ensure that we’re not selective about comparator choice for new products in the absence of head-to-head studies,” he said.
 

Route of administration matters

Inhibitors appear to be a more common occurrence among patients who received factor concentrates subcutaneously, compared with intravenously, Dr. Hart noted, pointing to a 2011 study indicating a background annual risk of 5 cases of inhibitor development per 1,000 treatment years in previously treated patients who received intravenous therapy (Blood. 2011 Jun 9;117[23]:6367-70).

In contrast, in a phase 1 trial of subcutaneous turoctocog alfa pegol, 5 out of 26 patients had detectable N8-GP–binding antibodies after 42-91 exposure days. Of these patients, one developed an inhibitor to factor VIII, and anti–N8-GP antibody appearance was associated with a decline in factor VIII plasma activity in four of the five patients. In addition, five patients reported a total of nine bleeding episodes requiring treatment during prophylaxis. As a result of this trial, further clinical development of the subcutaneous version was suspended. (J Thromb Haemost. 2020 Feb;18[2]:341-51).

Other subcutaneously administered factors are currently in development, Dr. Hart noted.
 

Nonfactor inhibitors?

“The nonfactor agents do have the risk of generating antibodies: Monoclonal antibodies outside the hemophilia setting provoke antidrug antibodies,” he said.

Although there is no consensus regarding which assay can best monitor antidrug antibodies (ADA), enzyme-linked immunosorbent assay (ELISA) can detect neutralizing antibodies and other antibodies.

In the hemophilia setting, surrogate markers for loss of drug efficacy include longer activated partial thromboplastin time (ATTP) or a drop in serum drug levels. Worsening bleeding phenotype can also be a marker for loss of efficacy, albeit an imperfect one.

Emicizumab (Hemlibara), the first nonfactor monoclonal agent to make it to market, has the largest dataset available, and evidence suggests a rate of neutralizing antibodies with this agent of less than 1% in the HAVEN clinical trial series, but 5.2% in the single-arm STASEY trial.

“We shouldn’t assume that other biophenotypics will have a similar ADA rate, and this needs to be evaluated for each molecule, as it will need to be for other monoclonals” such as anti–tissue factor pathway (TFPI) antibodies, Dr. Hart emphasized.
 

Pegylation

Pegylated compounds include polyethylene glycol, an inert polymer, covalently bound to the therapeutic protein to extend its half-life, and theoretically, reduce immunogenicity.

Many patients may already have exposure to pegylated products in the form of peginterferon to treat hepatitis C, consumer products such as toothpaste, cough medicine, and cosmetics, and, more recently, in vaccines against COVID-19.

Safety considerations with pegylated agents in hemophilia include concerns about accumulation of polyethylene glycol (PEG), although “some of the preclinical models looking at excretion of PEG are difficult to interpret in my view, and people debate about whether studies are long enough, but it’s undoubtedly the case that toxicology dosing is order of magnitude higher than the routine dosing in hemophilia,” he said.

After more than 5 years of experience with pegylated products there is no clinical evidence of concern, although “it’s not clear, actually, what we’re looking for, whether it’s a clinical parameter, or imaging or histological parameter.”

Patients may also not have lifelong exposure to pegylated products, as it is unlikely that they will stay on the same product for decades, Dr. Hart said.
 

Thrombosis

As of June 30, 2020, more than 7,200 persons with hemophilia have received emicizumab, and there have been 23 reported thrombotic events, 19 of which occurred in the postmarketing period. Of the reported cases, six patients had a myocardial infarction, and all of these patients had at least one cardiovascular risk factor.

The antithrombin agent fitusiran was associated with one fatal thrombotic event in a phase 2, open-label extension trial, leading to a pause and resumption with mitigation protocols, but that trial has since been paused again because of additional, nonfatal thrombotic events.

Nonfatal thrombotic events have also occurred in clinical trials for the investigational anti-TFPI monoclonal antibodies BAY 1093884 and concizumab, but none have thus far been reported in phase 3 trial of marstacimab.

“We need renewed efforts for prospective reporting and independent review of all adverse events of all agents, old and new: This will need some guidance nationally and internationally, and I think the relevant trial [serious adverse events] need to be reported in peer review literature, and clinicaltrials.gov updated in a timely manner, regardless of whether that strategy was successful or unsuccessful,” Dr. Hart said.
 

Risk with longer-acting agents?

In the question and answer following his presentation, Christoph Königs, MD, PhD, from University Hospital Frankfurt, asked whether there was potential for increased thrombosis risk with second-generation extended half-life (EHL) molecules in clinical trials.

“As we edge towards normalization of hemostasis, clearly the other non–hemophilia dependent issues of thrombosis risk come into play,” Dr. Hart acknowledged. “I think it will be an inevitability that there will be events, and we need to understand what the denominators are – hence my pitch for there being a renewed effort to try and collate sufficient data that we can really define events happening with people treated with standard half-life [products] through into the novel agents,” he said.

Dr. Hart disclosed grant/research support and speaker bureau activities for Bayer, Octapharma, Takeda, and others. Dr. Königs has reported no relevant disclosures.

Despite their similar functions, each current and emerging therapy for treating hemophilia has a unique safety profile, and each needs to be weighed apart from agents both within and outside its pharmacologic class, a hemophilia specialist said.

“My view is that each new molecule coming to the hemophilia space, including variant factor molecules, needs to be scrutinized separately, without class assumptions or extrapolations, and it’s clear that thrombosis risk has become a priority safety consideration,” said Dan Hart, MBChB, MRCP, FRCPath, PhD, from Barts and the London School of Medicine and Dentistry.

He reviewed the comparative safety of standard and novel therapies for hemophilia at the annual congress of the European Association for Haemophilia and Allied Disorders.
 

Factor inhibitors

Inhibitors occur in both hemophilia A and hemophilia B, and are primarily seen in patients with childhood exposure to factor concentrates. Inhibitors, which include anti–factor VIII and factor IX alloantibodies, are more common among patients with severe hemophilia and those with more disruptive factor VIII and factor IX mutations.

“There can be transient vs. persistent inhibitors, and arguably the more you look, the more you find, but clinically we never miss high-titer inhibitors that have a big impact on individuals and the subsequent decisions about management,” he said.
 

Hamster vs. human

It’s currently unclear whether there is an immunologic advantage for previously untreated patients to be started on factor VIII concentrates derived from recombinant human cells lines, or from products derived from Chinese hamster ovary (CHO) or baby hamster kidney (BHK) cell lines, Dr. Hart said.

“We need to ensure that we’re not selective about comparator choice for new products in the absence of head-to-head studies,” he said.
 

Route of administration matters

Inhibitors appear to be a more common occurrence among patients who received factor concentrates subcutaneously, compared with intravenously, Dr. Hart noted, pointing to a 2011 study indicating a background annual risk of 5 cases of inhibitor development per 1,000 treatment years in previously treated patients who received intravenous therapy (Blood. 2011 Jun 9;117[23]:6367-70).

In contrast, in a phase 1 trial of subcutaneous turoctocog alfa pegol, 5 out of 26 patients had detectable N8-GP–binding antibodies after 42-91 exposure days. Of these patients, one developed an inhibitor to factor VIII, and anti–N8-GP antibody appearance was associated with a decline in factor VIII plasma activity in four of the five patients. In addition, five patients reported a total of nine bleeding episodes requiring treatment during prophylaxis. As a result of this trial, further clinical development of the subcutaneous version was suspended. (J Thromb Haemost. 2020 Feb;18[2]:341-51).

Other subcutaneously administered factors are currently in development, Dr. Hart noted.
 

Nonfactor inhibitors?

“The nonfactor agents do have the risk of generating antibodies: Monoclonal antibodies outside the hemophilia setting provoke antidrug antibodies,” he said.

Although there is no consensus regarding which assay can best monitor antidrug antibodies (ADA), enzyme-linked immunosorbent assay (ELISA) can detect neutralizing antibodies and other antibodies.

In the hemophilia setting, surrogate markers for loss of drug efficacy include longer activated partial thromboplastin time (ATTP) or a drop in serum drug levels. Worsening bleeding phenotype can also be a marker for loss of efficacy, albeit an imperfect one.

Emicizumab (Hemlibara), the first nonfactor monoclonal agent to make it to market, has the largest dataset available, and evidence suggests a rate of neutralizing antibodies with this agent of less than 1% in the HAVEN clinical trial series, but 5.2% in the single-arm STASEY trial.

“We shouldn’t assume that other biophenotypics will have a similar ADA rate, and this needs to be evaluated for each molecule, as it will need to be for other monoclonals” such as anti–tissue factor pathway (TFPI) antibodies, Dr. Hart emphasized.
 

Pegylation

Pegylated compounds include polyethylene glycol, an inert polymer, covalently bound to the therapeutic protein to extend its half-life, and theoretically, reduce immunogenicity.

Many patients may already have exposure to pegylated products in the form of peginterferon to treat hepatitis C, consumer products such as toothpaste, cough medicine, and cosmetics, and, more recently, in vaccines against COVID-19.

Safety considerations with pegylated agents in hemophilia include concerns about accumulation of polyethylene glycol (PEG), although “some of the preclinical models looking at excretion of PEG are difficult to interpret in my view, and people debate about whether studies are long enough, but it’s undoubtedly the case that toxicology dosing is order of magnitude higher than the routine dosing in hemophilia,” he said.

After more than 5 years of experience with pegylated products there is no clinical evidence of concern, although “it’s not clear, actually, what we’re looking for, whether it’s a clinical parameter, or imaging or histological parameter.”

Patients may also not have lifelong exposure to pegylated products, as it is unlikely that they will stay on the same product for decades, Dr. Hart said.
 

Thrombosis

As of June 30, 2020, more than 7,200 persons with hemophilia have received emicizumab, and there have been 23 reported thrombotic events, 19 of which occurred in the postmarketing period. Of the reported cases, six patients had a myocardial infarction, and all of these patients had at least one cardiovascular risk factor.

The antithrombin agent fitusiran was associated with one fatal thrombotic event in a phase 2, open-label extension trial, leading to a pause and resumption with mitigation protocols, but that trial has since been paused again because of additional, nonfatal thrombotic events.

Nonfatal thrombotic events have also occurred in clinical trials for the investigational anti-TFPI monoclonal antibodies BAY 1093884 and concizumab, but none have thus far been reported in phase 3 trial of marstacimab.

“We need renewed efforts for prospective reporting and independent review of all adverse events of all agents, old and new: This will need some guidance nationally and internationally, and I think the relevant trial [serious adverse events] need to be reported in peer review literature, and clinicaltrials.gov updated in a timely manner, regardless of whether that strategy was successful or unsuccessful,” Dr. Hart said.
 

Risk with longer-acting agents?

In the question and answer following his presentation, Christoph Königs, MD, PhD, from University Hospital Frankfurt, asked whether there was potential for increased thrombosis risk with second-generation extended half-life (EHL) molecules in clinical trials.

“As we edge towards normalization of hemostasis, clearly the other non–hemophilia dependent issues of thrombosis risk come into play,” Dr. Hart acknowledged. “I think it will be an inevitability that there will be events, and we need to understand what the denominators are – hence my pitch for there being a renewed effort to try and collate sufficient data that we can really define events happening with people treated with standard half-life [products] through into the novel agents,” he said.

Dr. Hart disclosed grant/research support and speaker bureau activities for Bayer, Octapharma, Takeda, and others. Dr. Königs has reported no relevant disclosures.

Despite their similar functions, each current and emerging therapy for treating hemophilia has a unique safety profile, and each needs to be weighed apart from agents both within and outside its pharmacologic class, a hemophilia specialist said.

“My view is that each new molecule coming to the hemophilia space, including variant factor molecules, needs to be scrutinized separately, without class assumptions or extrapolations, and it’s clear that thrombosis risk has become a priority safety consideration,” said Dan Hart, MBChB, MRCP, FRCPath, PhD, from Barts and the London School of Medicine and Dentistry.

He reviewed the comparative safety of standard and novel therapies for hemophilia at the annual congress of the European Association for Haemophilia and Allied Disorders.
 

Factor inhibitors

Inhibitors occur in both hemophilia A and hemophilia B, and are primarily seen in patients with childhood exposure to factor concentrates. Inhibitors, which include anti–factor VIII and factor IX alloantibodies, are more common among patients with severe hemophilia and those with more disruptive factor VIII and factor IX mutations.

“There can be transient vs. persistent inhibitors, and arguably the more you look, the more you find, but clinically we never miss high-titer inhibitors that have a big impact on individuals and the subsequent decisions about management,” he said.
 

Hamster vs. human

It’s currently unclear whether there is an immunologic advantage for previously untreated patients to be started on factor VIII concentrates derived from recombinant human cells lines, or from products derived from Chinese hamster ovary (CHO) or baby hamster kidney (BHK) cell lines, Dr. Hart said.

“We need to ensure that we’re not selective about comparator choice for new products in the absence of head-to-head studies,” he said.
 

Route of administration matters

Inhibitors appear to be a more common occurrence among patients who received factor concentrates subcutaneously, compared with intravenously, Dr. Hart noted, pointing to a 2011 study indicating a background annual risk of 5 cases of inhibitor development per 1,000 treatment years in previously treated patients who received intravenous therapy (Blood. 2011 Jun 9;117[23]:6367-70).

In contrast, in a phase 1 trial of subcutaneous turoctocog alfa pegol, 5 out of 26 patients had detectable N8-GP–binding antibodies after 42-91 exposure days. Of these patients, one developed an inhibitor to factor VIII, and anti–N8-GP antibody appearance was associated with a decline in factor VIII plasma activity in four of the five patients. In addition, five patients reported a total of nine bleeding episodes requiring treatment during prophylaxis. As a result of this trial, further clinical development of the subcutaneous version was suspended. (J Thromb Haemost. 2020 Feb;18[2]:341-51).

Other subcutaneously administered factors are currently in development, Dr. Hart noted.
 

Nonfactor inhibitors?

“The nonfactor agents do have the risk of generating antibodies: Monoclonal antibodies outside the hemophilia setting provoke antidrug antibodies,” he said.

Although there is no consensus regarding which assay can best monitor antidrug antibodies (ADA), enzyme-linked immunosorbent assay (ELISA) can detect neutralizing antibodies and other antibodies.

In the hemophilia setting, surrogate markers for loss of drug efficacy include longer activated partial thromboplastin time (ATTP) or a drop in serum drug levels. Worsening bleeding phenotype can also be a marker for loss of efficacy, albeit an imperfect one.

Emicizumab (Hemlibara), the first nonfactor monoclonal agent to make it to market, has the largest dataset available, and evidence suggests a rate of neutralizing antibodies with this agent of less than 1% in the HAVEN clinical trial series, but 5.2% in the single-arm STASEY trial.

“We shouldn’t assume that other biophenotypics will have a similar ADA rate, and this needs to be evaluated for each molecule, as it will need to be for other monoclonals” such as anti–tissue factor pathway (TFPI) antibodies, Dr. Hart emphasized.
 

Pegylation

Pegylated compounds include polyethylene glycol, an inert polymer, covalently bound to the therapeutic protein to extend its half-life, and theoretically, reduce immunogenicity.

Many patients may already have exposure to pegylated products in the form of peginterferon to treat hepatitis C, consumer products such as toothpaste, cough medicine, and cosmetics, and, more recently, in vaccines against COVID-19.

Safety considerations with pegylated agents in hemophilia include concerns about accumulation of polyethylene glycol (PEG), although “some of the preclinical models looking at excretion of PEG are difficult to interpret in my view, and people debate about whether studies are long enough, but it’s undoubtedly the case that toxicology dosing is order of magnitude higher than the routine dosing in hemophilia,” he said.

After more than 5 years of experience with pegylated products there is no clinical evidence of concern, although “it’s not clear, actually, what we’re looking for, whether it’s a clinical parameter, or imaging or histological parameter.”

Patients may also not have lifelong exposure to pegylated products, as it is unlikely that they will stay on the same product for decades, Dr. Hart said.
 

Thrombosis

As of June 30, 2020, more than 7,200 persons with hemophilia have received emicizumab, and there have been 23 reported thrombotic events, 19 of which occurred in the postmarketing period. Of the reported cases, six patients had a myocardial infarction, and all of these patients had at least one cardiovascular risk factor.

The antithrombin agent fitusiran was associated with one fatal thrombotic event in a phase 2, open-label extension trial, leading to a pause and resumption with mitigation protocols, but that trial has since been paused again because of additional, nonfatal thrombotic events.

Nonfatal thrombotic events have also occurred in clinical trials for the investigational anti-TFPI monoclonal antibodies BAY 1093884 and concizumab, but none have thus far been reported in phase 3 trial of marstacimab.

“We need renewed efforts for prospective reporting and independent review of all adverse events of all agents, old and new: This will need some guidance nationally and internationally, and I think the relevant trial [serious adverse events] need to be reported in peer review literature, and clinicaltrials.gov updated in a timely manner, regardless of whether that strategy was successful or unsuccessful,” Dr. Hart said.
 

Risk with longer-acting agents?

In the question and answer following his presentation, Christoph Königs, MD, PhD, from University Hospital Frankfurt, asked whether there was potential for increased thrombosis risk with second-generation extended half-life (EHL) molecules in clinical trials.

“As we edge towards normalization of hemostasis, clearly the other non–hemophilia dependent issues of thrombosis risk come into play,” Dr. Hart acknowledged. “I think it will be an inevitability that there will be events, and we need to understand what the denominators are – hence my pitch for there being a renewed effort to try and collate sufficient data that we can really define events happening with people treated with standard half-life [products] through into the novel agents,” he said.

Dr. Hart disclosed grant/research support and speaker bureau activities for Bayer, Octapharma, Takeda, and others. Dr. Königs has reported no relevant disclosures.

People with rheumatic diseases should get vaccinated against SARS-CoV-2 as soon as possible, the American College of Rheumatology (ACR) recommends.

Choreograph/iStock/Getty Images

“It may be that people with rheumatic diseases are at increased risk of developing COVID or serious COVID-related complications,” Jonathan Hausmann, MD, assistant professor of medicine at Harvard Medical School, Boston, said in an ACR podcast. “So the need to prevent COVID-19 is incredibly important in this group of patients.”

The guidelines recommend a delay in vaccination only in rare circumstances, such as for patients with very severe illness or who have recently been administered rituximab, Jeffrey R. Curtis, MD, MPH, lead author of the guidelines, said in the podcast.

“Our members have been inundated with questions and concerns from their patients on whether they should receive the vaccine,” ACR President David Karp, MD, PhD, said in a press release.

So the ACR convened a panel of nine rheumatologists, two infectious disease specialists, and two public health experts. Over the course of 8 weeks, the task force reviewed the literature and agreed on recommendations. The organization posted a summary of the guidelines on its website after its board of directors approved it Feb. 8. The paper is pending journal peer review.
 

Some risks are real

The task force confined its research to the COVID-19 vaccines being offered by Pfizer and Moderna because they are currently the only ones approved by the Food and Drug Administration. It found no reason to distinguish between the two vaccines in its recommendations.

Because little research has directly addressed the question concerning COVID-19 vaccination for patients with rheumatic diseases, the task force extrapolated from data on other vaccinations in people with rheumatic disease and on the COVID-19 vaccinations in other populations.

It analyzed reports that other types of vaccination, such as for influenza, triggered flares of rheumatic conditions. “It is really individual case reports or small cohorts where there may be a somewhat higher incidence of flare, but it’s usually not very large in its magnitude nor duration,” said Dr. Curtis of the University of Alabama at Birmingham.

The task force also considered the possibility that vaccinations could lead to a new autoimmune disorder, such as Guillain-Barré syndrome or Bell palsy. The risk is real, the task force decided, but not significant enough to influence their recommendations.

Likewise, in immunocompromised people, vaccinations with live virus, such as those for shingles, might trigger the infection the vaccination is meant to prevent. But this can’t happen with the Pfizer and Moderna COVID-19 vaccines because they contain messenger RNA instead of live viruses, Dr. Curtis said.

Courtesy University of Alabama at Birmingham

How well does it work?

One unanswered question is whether the COVID-19 vaccines work as well for patients with rheumatic diseases. The task force was reassured by data showing efficacy across a range of subgroups, including some with immunosenescence, Dr. Curtis said. “But until we have data in rheumatology patients, we’re just not going to know,” he said.

The guidelines specify that some drug regimens be modified when patients are vaccinated.

For patients taking rituximab, vaccination should be delayed, but only for those who are able to maintain safe social distancing to reduce the risk for COVID-19 exposure, Dr. Curtis said. “If somebody has just gotten rituximab recently, it might be more ideal to complete the vaccine series about 2-4 weeks before the next rituximab dose,” he said. “So if you are giving that therapy, say, at 6-month intervals, if you could vaccinate them at around month 5 from the most recent rituximab cycle, that might be more ideal.”

The guidance calls for withholding JAK inhibitors for a week after each vaccine dose is administered.

It calls for holding SQ abatacept 1 week prior and 1 week after the first COVID-19 vaccine dose, with no interruption after the second dose.

For abatacept IV, clinicians should “time vaccine administration so that the first vaccination will occur 4 weeks after abatacept infusion (i.e., the entire dosing interval), and postpone the subsequent abatacept infusion by 1 week (i.e., a 5-week gap in total).” It recommends no medication adjustment for the second vaccine dose.

For cyclophosphamide, the guidance recommends timing administration to occur about a week after each vaccine dose, when feasible.

None of this advice should supersede clinical judgment, Dr. Curtis said.

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

People with rheumatic diseases should get vaccinated against SARS-CoV-2 as soon as possible, the American College of Rheumatology (ACR) recommends.

Choreograph/iStock/Getty Images

“It may be that people with rheumatic diseases are at increased risk of developing COVID or serious COVID-related complications,” Jonathan Hausmann, MD, assistant professor of medicine at Harvard Medical School, Boston, said in an ACR podcast. “So the need to prevent COVID-19 is incredibly important in this group of patients.”

The guidelines recommend a delay in vaccination only in rare circumstances, such as for patients with very severe illness or who have recently been administered rituximab, Jeffrey R. Curtis, MD, MPH, lead author of the guidelines, said in the podcast.

“Our members have been inundated with questions and concerns from their patients on whether they should receive the vaccine,” ACR President David Karp, MD, PhD, said in a press release.

So the ACR convened a panel of nine rheumatologists, two infectious disease specialists, and two public health experts. Over the course of 8 weeks, the task force reviewed the literature and agreed on recommendations. The organization posted a summary of the guidelines on its website after its board of directors approved it Feb. 8. The paper is pending journal peer review.
 

Some risks are real

The task force confined its research to the COVID-19 vaccines being offered by Pfizer and Moderna because they are currently the only ones approved by the Food and Drug Administration. It found no reason to distinguish between the two vaccines in its recommendations.

Because little research has directly addressed the question concerning COVID-19 vaccination for patients with rheumatic diseases, the task force extrapolated from data on other vaccinations in people with rheumatic disease and on the COVID-19 vaccinations in other populations.

It analyzed reports that other types of vaccination, such as for influenza, triggered flares of rheumatic conditions. “It is really individual case reports or small cohorts where there may be a somewhat higher incidence of flare, but it’s usually not very large in its magnitude nor duration,” said Dr. Curtis of the University of Alabama at Birmingham.

The task force also considered the possibility that vaccinations could lead to a new autoimmune disorder, such as Guillain-Barré syndrome or Bell palsy. The risk is real, the task force decided, but not significant enough to influence their recommendations.

Likewise, in immunocompromised people, vaccinations with live virus, such as those for shingles, might trigger the infection the vaccination is meant to prevent. But this can’t happen with the Pfizer and Moderna COVID-19 vaccines because they contain messenger RNA instead of live viruses, Dr. Curtis said.

Courtesy University of Alabama at Birmingham

How well does it work?

One unanswered question is whether the COVID-19 vaccines work as well for patients with rheumatic diseases. The task force was reassured by data showing efficacy across a range of subgroups, including some with immunosenescence, Dr. Curtis said. “But until we have data in rheumatology patients, we’re just not going to know,” he said.

The guidelines specify that some drug regimens be modified when patients are vaccinated.

For patients taking rituximab, vaccination should be delayed, but only for those who are able to maintain safe social distancing to reduce the risk for COVID-19 exposure, Dr. Curtis said. “If somebody has just gotten rituximab recently, it might be more ideal to complete the vaccine series about 2-4 weeks before the next rituximab dose,” he said. “So if you are giving that therapy, say, at 6-month intervals, if you could vaccinate them at around month 5 from the most recent rituximab cycle, that might be more ideal.”

The guidance calls for withholding JAK inhibitors for a week after each vaccine dose is administered.

It calls for holding SQ abatacept 1 week prior and 1 week after the first COVID-19 vaccine dose, with no interruption after the second dose.

For abatacept IV, clinicians should “time vaccine administration so that the first vaccination will occur 4 weeks after abatacept infusion (i.e., the entire dosing interval), and postpone the subsequent abatacept infusion by 1 week (i.e., a 5-week gap in total).” It recommends no medication adjustment for the second vaccine dose.

For cyclophosphamide, the guidance recommends timing administration to occur about a week after each vaccine dose, when feasible.

None of this advice should supersede clinical judgment, Dr. Curtis said.

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

People with rheumatic diseases should get vaccinated against SARS-CoV-2 as soon as possible, the American College of Rheumatology (ACR) recommends.

Choreograph/iStock/Getty Images

“It may be that people with rheumatic diseases are at increased risk of developing COVID or serious COVID-related complications,” Jonathan Hausmann, MD, assistant professor of medicine at Harvard Medical School, Boston, said in an ACR podcast. “So the need to prevent COVID-19 is incredibly important in this group of patients.”

The guidelines recommend a delay in vaccination only in rare circumstances, such as for patients with very severe illness or who have recently been administered rituximab, Jeffrey R. Curtis, MD, MPH, lead author of the guidelines, said in the podcast.

“Our members have been inundated with questions and concerns from their patients on whether they should receive the vaccine,” ACR President David Karp, MD, PhD, said in a press release.

So the ACR convened a panel of nine rheumatologists, two infectious disease specialists, and two public health experts. Over the course of 8 weeks, the task force reviewed the literature and agreed on recommendations. The organization posted a summary of the guidelines on its website after its board of directors approved it Feb. 8. The paper is pending journal peer review.
 

Some risks are real

The task force confined its research to the COVID-19 vaccines being offered by Pfizer and Moderna because they are currently the only ones approved by the Food and Drug Administration. It found no reason to distinguish between the two vaccines in its recommendations.

Because little research has directly addressed the question concerning COVID-19 vaccination for patients with rheumatic diseases, the task force extrapolated from data on other vaccinations in people with rheumatic disease and on the COVID-19 vaccinations in other populations.

It analyzed reports that other types of vaccination, such as for influenza, triggered flares of rheumatic conditions. “It is really individual case reports or small cohorts where there may be a somewhat higher incidence of flare, but it’s usually not very large in its magnitude nor duration,” said Dr. Curtis of the University of Alabama at Birmingham.

The task force also considered the possibility that vaccinations could lead to a new autoimmune disorder, such as Guillain-Barré syndrome or Bell palsy. The risk is real, the task force decided, but not significant enough to influence their recommendations.

Likewise, in immunocompromised people, vaccinations with live virus, such as those for shingles, might trigger the infection the vaccination is meant to prevent. But this can’t happen with the Pfizer and Moderna COVID-19 vaccines because they contain messenger RNA instead of live viruses, Dr. Curtis said.

Courtesy University of Alabama at Birmingham

How well does it work?

One unanswered question is whether the COVID-19 vaccines work as well for patients with rheumatic diseases. The task force was reassured by data showing efficacy across a range of subgroups, including some with immunosenescence, Dr. Curtis said. “But until we have data in rheumatology patients, we’re just not going to know,” he said.

The guidelines specify that some drug regimens be modified when patients are vaccinated.

For patients taking rituximab, vaccination should be delayed, but only for those who are able to maintain safe social distancing to reduce the risk for COVID-19 exposure, Dr. Curtis said. “If somebody has just gotten rituximab recently, it might be more ideal to complete the vaccine series about 2-4 weeks before the next rituximab dose,” he said. “So if you are giving that therapy, say, at 6-month intervals, if you could vaccinate them at around month 5 from the most recent rituximab cycle, that might be more ideal.”

The guidance calls for withholding JAK inhibitors for a week after each vaccine dose is administered.

It calls for holding SQ abatacept 1 week prior and 1 week after the first COVID-19 vaccine dose, with no interruption after the second dose.

For abatacept IV, clinicians should “time vaccine administration so that the first vaccination will occur 4 weeks after abatacept infusion (i.e., the entire dosing interval), and postpone the subsequent abatacept infusion by 1 week (i.e., a 5-week gap in total).” It recommends no medication adjustment for the second vaccine dose.

For cyclophosphamide, the guidance recommends timing administration to occur about a week after each vaccine dose, when feasible.

None of this advice should supersede clinical judgment, Dr. Curtis said.

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

The COVID-19 pandemic, multiple national displays of racial and social injustice, and recent political strife have left many feeling uncertain, anxious, sad, angry, grief-stricken, and struggling to cope. Coping may be especially difficult for our clients already grappling with mental health concerns, and many are looking to mental health professionals to restore a sense of well-being.

Marija Jovovic/Getty Images

As professionals, we may be unsure about the best approach; after all, we haven’t experienced anything like this before! We’re facing many unknowns and unanswered questions, but one thing we do know is that we’re dealing with constant change. And, in fact, the only certainty is continued change and uncertainty. The truth of uncertainty can be challenging to contend with, especially when so much, including our country’s future, is in question. In times like this, there is likely no perfect treatment, but mindfulness can serve as a powerful intervention for coping with uncertainty and change, and for managing a range of difficult reactions.

The ‘what’ of mindfulness: Awareness, being in the now, and nonattachment

It’s crucial that we understand what mindfulness really is. It’s become something of a buzzword in American society, complete with misconceptions. Mindfulness has roots in many faith traditions, but as it’s practiced in the Western world, it usually has roots in Hinduism and Buddhism.

Mindfulness roughly means “awareness”; this is an approximate translation of the Pali (an ancient Indian language) word “Sati.” Mindfulness is moment-to-moment awareness and acceptance of our present experiences, thoughts, and feelings, without judgment or attachment. Attachment relates to the continually changing nature of all thoughts, feelings, and situations. Because everything is continuously changing, we needn’t become attached; attachment can keep us from being in the now. Acceptance means facing the now, which is essential when we feel tempted to avoid or deny painful feelings or situations. Acceptance doesn’t mean that we’ve resigned to being in pain forever; it merely means that we’re willing to see things as they actually are right now. This honest assessment of the present can prepare us for next steps.

Being in touch with the now helps us reconnect with ourselves, promote clarity about our situation and choices, and increases our awareness of our thoughts and feelings, moment to moment. It can also help us realize when we’ve fallen into unhelpful or catastrophic thinking, the risk of which is high during intense stress and uncertainty like what we’re facing now. Mindfulness helps us catch ourselves so we have the opportunity to make different choices, and feel better.
 

The how of mindfulness: Symptom management and changes in the brain

Research on mindfulness suggests that it can improve coping with anxiety,¹ regulate mood,² improve depression,³ reduce rumination,⁴ and mitigate trauma symptom severity.

Because mindfulness can effectively address psychiatric concerns, mindfulness-based clinical interventions such as mindfulness-based stress reduction and mindfulness-based cognitive therapy have been developed. These may reduce anxiety,⁵ depression, and posttraumatic stress disorder.⁶ Mindfulness can have a powerful impact on the brain; it’s been shown to improve the functioning of the regions associated with emotional regulation⁷ and change the regions related to awareness and fear.⁸ So, whether mindfulness is practiced in our clients’ everyday lives or used as the basis of therapeutic programs, it can promote well-being.
 

The how of mindfulness: In everyday life and treatment

How can we help our clients enjoy mindfulness’ benefits? I suggest that we start with ourselves. We’ll be more effective at guiding our clients in using mindfulness if we have our own experience.

And, mindfulness may help us to be more attentive to and effective in treatment. There is research demonstrating that treatment providers can benefit from mindfulness practices,⁹ and that clinicians who practice mindfulness report higher levels of empathy toward their clients.¹⁰ Because mindfulness is about attention and nonjudgmental and nonattached observation, it can be incorporated into many aspects of everyday life. Many options are available; we might encourage our clients to begin their day with a mindful pause, simply breathing and observing thoughts, feelings, sensations, or anything else that comes up. If they find themselves fixated on negative thinking or feelings, nonjudgmentally recognizing these experiences as temporary can help to prevent immersion and overwhelm. We can also encourage mindful pauses throughout the day, perhaps during tasks such as housekeeping, working, talking with others, exercising, and even eating.

It can be beneficial to practice mindfulness before, during, and after situations that our clients know may bring on increased stress, anxiety, negative mood, and other undesirable experiences, such as watching the news or using some forms of social media. For clients who want more structure or guidance, several mobile apps are available, such as InsightTimer, Ten Percent Happier, or for Black clients, Liberate, which may be especially helpful for the impacts of racial injustice. Apps may also help clients who want to establish a formal mindfulness meditation practice, which may decrease anxiety and depression in some clinical populations.¹¹ And, of course, with training, we can incorporate mindfulness into treatment. We may encourage clients to start our treatment or therapy sessions with a mindful pause to help them attain calm and focus, and depending on their concerns and needs, during times at which they feel particularly strong emotions. Clients may consider taking a Mindfulness-Based Stress Reduction course if something more intensive is needed, or clinicians may consider becoming trained in mindfulness-based cognitive therapy. Because recognition is increasing that mindfulness can address many clinical concerns, and because we’re contending with unprecedented challenges, mindfulness training for clinicians has become widely available.


 

Calm, clarity, and choices

None of us as individuals can eliminate the strife our country is living through, and none of us as clinicians can completely prevent or alleviate our clients’ pain. But by employing mindfulness, we can help clients cope with change and uncertainty, gain greater awareness of themselves and their experiences, feel calmer, attain more clarity to make better choices, and ultimately, feel better.

References

1. Bernstein A et al. J Cogn Psychother. 2011;25(2):99-113.

2. Remmers C et al. Mindfulness. 2016;7(4):829-37.

3. Rodrigues MF et al. Trends Psychiatry Psychother. Jul-Sep 2017;39(3):207-15.

4. Chambers R et al. Cogn Ther Res. 2008;32(3):303-22.

5. Montero-Marin et al. Psychol Med. 2019 Oct;49(13)2118-33.

6. Khusid MA, Vythilingam M. Mil Med. 2016 Sep;181(9):961-8.

7. Kral TRA et al. Neuroimage. 2018 Nov 1;181:301-13.

8. Desbordes G et al. Front Hum Neurosci. 2012 Nov 1. doi: 10.33891/fnhum.2012.00292.

9. Escuriex BF, Labbé EE. Mindfulness. 2011;2(4):242-53.

10. Aiken GA. Dissertation Abstracts Int Sec B: Sci Eng. 2006;67(4-B),2212.

11. Goyal M et al. JAMA Intern Med. 2014 Mar;174:357-68.

Dr. Collins is a Brooklyn-based licensed counseling psychologist, educator, and speaker. She is experienced in addressing a wide range of mental health concerns within youth, adult, and family populations. Her work has a strong social justice emphasis, and she is particularly skilled at working with clients of color. She has been a mindfulness practitioner for 10 years and is passionate about sharing the practice with others. Dr. Collins has no conflicts of interest.

The COVID-19 pandemic, multiple national displays of racial and social injustice, and recent political strife have left many feeling uncertain, anxious, sad, angry, grief-stricken, and struggling to cope. Coping may be especially difficult for our clients already grappling with mental health concerns, and many are looking to mental health professionals to restore a sense of well-being.

Marija Jovovic/Getty Images

As professionals, we may be unsure about the best approach; after all, we haven’t experienced anything like this before! We’re facing many unknowns and unanswered questions, but one thing we do know is that we’re dealing with constant change. And, in fact, the only certainty is continued change and uncertainty. The truth of uncertainty can be challenging to contend with, especially when so much, including our country’s future, is in question. In times like this, there is likely no perfect treatment, but mindfulness can serve as a powerful intervention for coping with uncertainty and change, and for managing a range of difficult reactions.

The ‘what’ of mindfulness: Awareness, being in the now, and nonattachment

It’s crucial that we understand what mindfulness really is. It’s become something of a buzzword in American society, complete with misconceptions. Mindfulness has roots in many faith traditions, but as it’s practiced in the Western world, it usually has roots in Hinduism and Buddhism.

Mindfulness roughly means “awareness”; this is an approximate translation of the Pali (an ancient Indian language) word “Sati.” Mindfulness is moment-to-moment awareness and acceptance of our present experiences, thoughts, and feelings, without judgment or attachment. Attachment relates to the continually changing nature of all thoughts, feelings, and situations. Because everything is continuously changing, we needn’t become attached; attachment can keep us from being in the now. Acceptance means facing the now, which is essential when we feel tempted to avoid or deny painful feelings or situations. Acceptance doesn’t mean that we’ve resigned to being in pain forever; it merely means that we’re willing to see things as they actually are right now. This honest assessment of the present can prepare us for next steps.

Being in touch with the now helps us reconnect with ourselves, promote clarity about our situation and choices, and increases our awareness of our thoughts and feelings, moment to moment. It can also help us realize when we’ve fallen into unhelpful or catastrophic thinking, the risk of which is high during intense stress and uncertainty like what we’re facing now. Mindfulness helps us catch ourselves so we have the opportunity to make different choices, and feel better.
 

The how of mindfulness: Symptom management and changes in the brain

Research on mindfulness suggests that it can improve coping with anxiety,¹ regulate mood,² improve depression,³ reduce rumination,⁴ and mitigate trauma symptom severity.

Because mindfulness can effectively address psychiatric concerns, mindfulness-based clinical interventions such as mindfulness-based stress reduction and mindfulness-based cognitive therapy have been developed. These may reduce anxiety,⁵ depression, and posttraumatic stress disorder.⁶ Mindfulness can have a powerful impact on the brain; it’s been shown to improve the functioning of the regions associated with emotional regulation⁷ and change the regions related to awareness and fear.⁸ So, whether mindfulness is practiced in our clients’ everyday lives or used as the basis of therapeutic programs, it can promote well-being.
 

The how of mindfulness: In everyday life and treatment

How can we help our clients enjoy mindfulness’ benefits? I suggest that we start with ourselves. We’ll be more effective at guiding our clients in using mindfulness if we have our own experience.

And, mindfulness may help us to be more attentive to and effective in treatment. There is research demonstrating that treatment providers can benefit from mindfulness practices,⁹ and that clinicians who practice mindfulness report higher levels of empathy toward their clients.¹⁰ Because mindfulness is about attention and nonjudgmental and nonattached observation, it can be incorporated into many aspects of everyday life. Many options are available; we might encourage our clients to begin their day with a mindful pause, simply breathing and observing thoughts, feelings, sensations, or anything else that comes up. If they find themselves fixated on negative thinking or feelings, nonjudgmentally recognizing these experiences as temporary can help to prevent immersion and overwhelm. We can also encourage mindful pauses throughout the day, perhaps during tasks such as housekeeping, working, talking with others, exercising, and even eating.

It can be beneficial to practice mindfulness before, during, and after situations that our clients know may bring on increased stress, anxiety, negative mood, and other undesirable experiences, such as watching the news or using some forms of social media. For clients who want more structure or guidance, several mobile apps are available, such as InsightTimer, Ten Percent Happier, or for Black clients, Liberate, which may be especially helpful for the impacts of racial injustice. Apps may also help clients who want to establish a formal mindfulness meditation practice, which may decrease anxiety and depression in some clinical populations.¹¹ And, of course, with training, we can incorporate mindfulness into treatment. We may encourage clients to start our treatment or therapy sessions with a mindful pause to help them attain calm and focus, and depending on their concerns and needs, during times at which they feel particularly strong emotions. Clients may consider taking a Mindfulness-Based Stress Reduction course if something more intensive is needed, or clinicians may consider becoming trained in mindfulness-based cognitive therapy. Because recognition is increasing that mindfulness can address many clinical concerns, and because we’re contending with unprecedented challenges, mindfulness training for clinicians has become widely available.


 

Calm, clarity, and choices

None of us as individuals can eliminate the strife our country is living through, and none of us as clinicians can completely prevent or alleviate our clients’ pain. But by employing mindfulness, we can help clients cope with change and uncertainty, gain greater awareness of themselves and their experiences, feel calmer, attain more clarity to make better choices, and ultimately, feel better.

References

1. Bernstein A et al. J Cogn Psychother. 2011;25(2):99-113.

2. Remmers C et al. Mindfulness. 2016;7(4):829-37.

3. Rodrigues MF et al. Trends Psychiatry Psychother. Jul-Sep 2017;39(3):207-15.

4. Chambers R et al. Cogn Ther Res. 2008;32(3):303-22.

5. Montero-Marin et al. Psychol Med. 2019 Oct;49(13)2118-33.

6. Khusid MA, Vythilingam M. Mil Med. 2016 Sep;181(9):961-8.

7. Kral TRA et al. Neuroimage. 2018 Nov 1;181:301-13.

8. Desbordes G et al. Front Hum Neurosci. 2012 Nov 1. doi: 10.33891/fnhum.2012.00292.

9. Escuriex BF, Labbé EE. Mindfulness. 2011;2(4):242-53.

10. Aiken GA. Dissertation Abstracts Int Sec B: Sci Eng. 2006;67(4-B),2212.

11. Goyal M et al. JAMA Intern Med. 2014 Mar;174:357-68.

Dr. Collins is a Brooklyn-based licensed counseling psychologist, educator, and speaker. She is experienced in addressing a wide range of mental health concerns within youth, adult, and family populations. Her work has a strong social justice emphasis, and she is particularly skilled at working with clients of color. She has been a mindfulness practitioner for 10 years and is passionate about sharing the practice with others. Dr. Collins has no conflicts of interest.

The COVID-19 pandemic, multiple national displays of racial and social injustice, and recent political strife have left many feeling uncertain, anxious, sad, angry, grief-stricken, and struggling to cope. Coping may be especially difficult for our clients already grappling with mental health concerns, and many are looking to mental health professionals to restore a sense of well-being.

Marija Jovovic/Getty Images

As professionals, we may be unsure about the best approach; after all, we haven’t experienced anything like this before! We’re facing many unknowns and unanswered questions, but one thing we do know is that we’re dealing with constant change. And, in fact, the only certainty is continued change and uncertainty. The truth of uncertainty can be challenging to contend with, especially when so much, including our country’s future, is in question. In times like this, there is likely no perfect treatment, but mindfulness can serve as a powerful intervention for coping with uncertainty and change, and for managing a range of difficult reactions.

The ‘what’ of mindfulness: Awareness, being in the now, and nonattachment

It’s crucial that we understand what mindfulness really is. It’s become something of a buzzword in American society, complete with misconceptions. Mindfulness has roots in many faith traditions, but as it’s practiced in the Western world, it usually has roots in Hinduism and Buddhism.

Mindfulness roughly means “awareness”; this is an approximate translation of the Pali (an ancient Indian language) word “Sati.” Mindfulness is moment-to-moment awareness and acceptance of our present experiences, thoughts, and feelings, without judgment or attachment. Attachment relates to the continually changing nature of all thoughts, feelings, and situations. Because everything is continuously changing, we needn’t become attached; attachment can keep us from being in the now. Acceptance means facing the now, which is essential when we feel tempted to avoid or deny painful feelings or situations. Acceptance doesn’t mean that we’ve resigned to being in pain forever; it merely means that we’re willing to see things as they actually are right now. This honest assessment of the present can prepare us for next steps.

Being in touch with the now helps us reconnect with ourselves, promote clarity about our situation and choices, and increases our awareness of our thoughts and feelings, moment to moment. It can also help us realize when we’ve fallen into unhelpful or catastrophic thinking, the risk of which is high during intense stress and uncertainty like what we’re facing now. Mindfulness helps us catch ourselves so we have the opportunity to make different choices, and feel better.
 

The how of mindfulness: Symptom management and changes in the brain

Research on mindfulness suggests that it can improve coping with anxiety,¹ regulate mood,² improve depression,³ reduce rumination,⁴ and mitigate trauma symptom severity.

Because mindfulness can effectively address psychiatric concerns, mindfulness-based clinical interventions such as mindfulness-based stress reduction and mindfulness-based cognitive therapy have been developed. These may reduce anxiety,⁵ depression, and posttraumatic stress disorder.⁶ Mindfulness can have a powerful impact on the brain; it’s been shown to improve the functioning of the regions associated with emotional regulation⁷ and change the regions related to awareness and fear.⁸ So, whether mindfulness is practiced in our clients’ everyday lives or used as the basis of therapeutic programs, it can promote well-being.
 

The how of mindfulness: In everyday life and treatment

How can we help our clients enjoy mindfulness’ benefits? I suggest that we start with ourselves. We’ll be more effective at guiding our clients in using mindfulness if we have our own experience.

And, mindfulness may help us to be more attentive to and effective in treatment. There is research demonstrating that treatment providers can benefit from mindfulness practices,⁹ and that clinicians who practice mindfulness report higher levels of empathy toward their clients.¹⁰ Because mindfulness is about attention and nonjudgmental and nonattached observation, it can be incorporated into many aspects of everyday life. Many options are available; we might encourage our clients to begin their day with a mindful pause, simply breathing and observing thoughts, feelings, sensations, or anything else that comes up. If they find themselves fixated on negative thinking or feelings, nonjudgmentally recognizing these experiences as temporary can help to prevent immersion and overwhelm. We can also encourage mindful pauses throughout the day, perhaps during tasks such as housekeeping, working, talking with others, exercising, and even eating.

It can be beneficial to practice mindfulness before, during, and after situations that our clients know may bring on increased stress, anxiety, negative mood, and other undesirable experiences, such as watching the news or using some forms of social media. For clients who want more structure or guidance, several mobile apps are available, such as InsightTimer, Ten Percent Happier, or for Black clients, Liberate, which may be especially helpful for the impacts of racial injustice. Apps may also help clients who want to establish a formal mindfulness meditation practice, which may decrease anxiety and depression in some clinical populations.¹¹ And, of course, with training, we can incorporate mindfulness into treatment. We may encourage clients to start our treatment or therapy sessions with a mindful pause to help them attain calm and focus, and depending on their concerns and needs, during times at which they feel particularly strong emotions. Clients may consider taking a Mindfulness-Based Stress Reduction course if something more intensive is needed, or clinicians may consider becoming trained in mindfulness-based cognitive therapy. Because recognition is increasing that mindfulness can address many clinical concerns, and because we’re contending with unprecedented challenges, mindfulness training for clinicians has become widely available.


 

Calm, clarity, and choices

None of us as individuals can eliminate the strife our country is living through, and none of us as clinicians can completely prevent or alleviate our clients’ pain. But by employing mindfulness, we can help clients cope with change and uncertainty, gain greater awareness of themselves and their experiences, feel calmer, attain more clarity to make better choices, and ultimately, feel better.

References

1. Bernstein A et al. J Cogn Psychother. 2011;25(2):99-113.

2. Remmers C et al. Mindfulness. 2016;7(4):829-37.

3. Rodrigues MF et al. Trends Psychiatry Psychother. Jul-Sep 2017;39(3):207-15.

4. Chambers R et al. Cogn Ther Res. 2008;32(3):303-22.

5. Montero-Marin et al. Psychol Med. 2019 Oct;49(13)2118-33.

6. Khusid MA, Vythilingam M. Mil Med. 2016 Sep;181(9):961-8.

7. Kral TRA et al. Neuroimage. 2018 Nov 1;181:301-13.

8. Desbordes G et al. Front Hum Neurosci. 2012 Nov 1. doi: 10.33891/fnhum.2012.00292.

9. Escuriex BF, Labbé EE. Mindfulness. 2011;2(4):242-53.

10. Aiken GA. Dissertation Abstracts Int Sec B: Sci Eng. 2006;67(4-B),2212.

11. Goyal M et al. JAMA Intern Med. 2014 Mar;174:357-68.

Dr. Collins is a Brooklyn-based licensed counseling psychologist, educator, and speaker. She is experienced in addressing a wide range of mental health concerns within youth, adult, and family populations. Her work has a strong social justice emphasis, and she is particularly skilled at working with clients of color. She has been a mindfulness practitioner for 10 years and is passionate about sharing the practice with others. Dr. Collins has no conflicts of interest.

If you have had the chance to watch any TV over the last 6 months, you have probably seen the commercials for home devices that allow patients to quickly check for atrial fibrillation in the comfort of their own home.

In an ad for one of these products, KardiaMobile, a cardiologist says this device “detects atrial fibrillation, one of the major causes of stroke.” You might also have heard that the Apple Watch has an opt-in feature that constantly screens for atrial fibrillation without any effort being made by the patient, or can check on-demand for AFib if a wearer experiences palpitations or an abnormal heart beat. Both of these devices generate a standard limb–lead ECG (essentially lead I) by connecting the device to both arms and producing a 30-second rhythm strip.

KardiaMobile recently introduced a newer device. When you place this device on a bare knee and touch one electrode with fingers from the right hand and another electrode with fingers from the left hand, the device produces a six-lead ECG. These small devices send an image of the ECG to a patient’s smartphone over Bluetooth, and the results can be easily read, printed out, or sent to the doctor for further analysis. Additionally, both of KardiaMobile’s devices utilize artificial intelligence to analyze a rhythm strip in real time and let the patient know if the ECG is normal, shows AFib, or is unable to be analyzed.

The electrocardiographic technology was formerly only available in a medical setting. It required an expensive machine and could only be interpreted by someone with expertise developed through years of training. Now it is readily available to patients in their homes. But how accurate is the technology and how are we going to use it?
 

How effective is KardiaMobile at detecting AFib?

Studies have looked at both KardiaMobile and the Apple Watch. One study of KardiaMobile in patients with Afib who were admitted for antiarrhythmic drug initiation showed that about a quarter of readings could not be classified because of artifact and other reasons. After exclusion of unclassified recordings, the KardiaMobile interpretation had 97% sensitivity and 94% specificity for AFib detection when compared with physician-interpreted ECGs.¹ In a large review of the device’s accuracy, there was about 85% sensitivity and specificity of the automated readings.²

How does the Apple Watch find AFib?

Like the KardiaMobile device, the Apple Watch can be used whenever patients notice symptoms or whenever they and their physicians decide the device would be useful. In addition, though, the Apple Watch has a function where the wearer can opt in to have the watch screen for AFib in the background whenever the watch is worn.

The watch monitors heart rate using photoplethysmography, where light-sensitive photodiodes detect blood pulses to assess heart rate variability. When an irregular heart rate is detected, the AW alerts the user of possible AFib. Once alerted, the wearer can then utilize a second function to obtain a single-lead ECG. Heart rate, rhythm, and a 30-second ECG tracing are saved in the Bluetooth-linked iPhone’s health app and can be exported for review by a physician.

In a study of over 400,000 participants, among participants notified of an irregular pulse through screening there was a positive predictive value of 84%.³ Single-lead EKGs initiated by watch wearers had a specificity for AFib of 99.6% among tracings with good wave forms, indicating very few false positives. Only 1 individual of the 263 individuals who had normal sinus rhythm on 12-lead ECG was classified as having AFib, though in 7% sinus rhythm could not be confirmed because of poor tracings.^4,5
 

^{What should we do with the results?}

It’s impressive that these devices deliver accurate information with very good specificity. Our hope is that detecting AFib with one of these devices will lead to an intervention being made that will decrease a patient’s risk of stroke. But it is not clear if routine screening in asymptomatic adults will accomplish this.

While more data is needed, we must acknowledge that our patients will soon be bringing us results from home. Regardless of what we think of this technology, we need to decide what to do when patients call us with results from these devices.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. William A et al. Heart Rhythm. 2018 Oct;15(10):1561-5.

2. KardiaMobile for the ambulatory detection of atrial fibrillation. NICE Medtech innovation briefing. 29 October 2020 Oct 29. www.nice.org.uk/guidance/mib232.

3. Perez MV et al. N Engl J Med. 2019; 381:1909-17.

4. Using Apple Watch for Arrhythmia Detection, December 2018. Apple. https://www.apple.com/healthcare/site/docs/Apple_Watch_Arrhythmia_Detection.pdf. Accessed 2019 Apr 5.

5. De Novo Classification Request for ECG App. https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180044.pdf. Accessed 2019 Apr 29.

If you have had the chance to watch any TV over the last 6 months, you have probably seen the commercials for home devices that allow patients to quickly check for atrial fibrillation in the comfort of their own home.

In an ad for one of these products, KardiaMobile, a cardiologist says this device “detects atrial fibrillation, one of the major causes of stroke.” You might also have heard that the Apple Watch has an opt-in feature that constantly screens for atrial fibrillation without any effort being made by the patient, or can check on-demand for AFib if a wearer experiences palpitations or an abnormal heart beat. Both of these devices generate a standard limb–lead ECG (essentially lead I) by connecting the device to both arms and producing a 30-second rhythm strip.

KardiaMobile recently introduced a newer device. When you place this device on a bare knee and touch one electrode with fingers from the right hand and another electrode with fingers from the left hand, the device produces a six-lead ECG. These small devices send an image of the ECG to a patient’s smartphone over Bluetooth, and the results can be easily read, printed out, or sent to the doctor for further analysis. Additionally, both of KardiaMobile’s devices utilize artificial intelligence to analyze a rhythm strip in real time and let the patient know if the ECG is normal, shows AFib, or is unable to be analyzed.

The electrocardiographic technology was formerly only available in a medical setting. It required an expensive machine and could only be interpreted by someone with expertise developed through years of training. Now it is readily available to patients in their homes. But how accurate is the technology and how are we going to use it?
 

How effective is KardiaMobile at detecting AFib?

Studies have looked at both KardiaMobile and the Apple Watch. One study of KardiaMobile in patients with Afib who were admitted for antiarrhythmic drug initiation showed that about a quarter of readings could not be classified because of artifact and other reasons. After exclusion of unclassified recordings, the KardiaMobile interpretation had 97% sensitivity and 94% specificity for AFib detection when compared with physician-interpreted ECGs.¹ In a large review of the device’s accuracy, there was about 85% sensitivity and specificity of the automated readings.²

How does the Apple Watch find AFib?

Like the KardiaMobile device, the Apple Watch can be used whenever patients notice symptoms or whenever they and their physicians decide the device would be useful. In addition, though, the Apple Watch has a function where the wearer can opt in to have the watch screen for AFib in the background whenever the watch is worn.

The watch monitors heart rate using photoplethysmography, where light-sensitive photodiodes detect blood pulses to assess heart rate variability. When an irregular heart rate is detected, the AW alerts the user of possible AFib. Once alerted, the wearer can then utilize a second function to obtain a single-lead ECG. Heart rate, rhythm, and a 30-second ECG tracing are saved in the Bluetooth-linked iPhone’s health app and can be exported for review by a physician.

In a study of over 400,000 participants, among participants notified of an irregular pulse through screening there was a positive predictive value of 84%.³ Single-lead EKGs initiated by watch wearers had a specificity for AFib of 99.6% among tracings with good wave forms, indicating very few false positives. Only 1 individual of the 263 individuals who had normal sinus rhythm on 12-lead ECG was classified as having AFib, though in 7% sinus rhythm could not be confirmed because of poor tracings.^4,5
 

^{What should we do with the results?}

It’s impressive that these devices deliver accurate information with very good specificity. Our hope is that detecting AFib with one of these devices will lead to an intervention being made that will decrease a patient’s risk of stroke. But it is not clear if routine screening in asymptomatic adults will accomplish this.

While more data is needed, we must acknowledge that our patients will soon be bringing us results from home. Regardless of what we think of this technology, we need to decide what to do when patients call us with results from these devices.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. William A et al. Heart Rhythm. 2018 Oct;15(10):1561-5.

2. KardiaMobile for the ambulatory detection of atrial fibrillation. NICE Medtech innovation briefing. 29 October 2020 Oct 29. www.nice.org.uk/guidance/mib232.

3. Perez MV et al. N Engl J Med. 2019; 381:1909-17.

4. Using Apple Watch for Arrhythmia Detection, December 2018. Apple. https://www.apple.com/healthcare/site/docs/Apple_Watch_Arrhythmia_Detection.pdf. Accessed 2019 Apr 5.

5. De Novo Classification Request for ECG App. https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180044.pdf. Accessed 2019 Apr 29.

If you have had the chance to watch any TV over the last 6 months, you have probably seen the commercials for home devices that allow patients to quickly check for atrial fibrillation in the comfort of their own home.

In an ad for one of these products, KardiaMobile, a cardiologist says this device “detects atrial fibrillation, one of the major causes of stroke.” You might also have heard that the Apple Watch has an opt-in feature that constantly screens for atrial fibrillation without any effort being made by the patient, or can check on-demand for AFib if a wearer experiences palpitations or an abnormal heart beat. Both of these devices generate a standard limb–lead ECG (essentially lead I) by connecting the device to both arms and producing a 30-second rhythm strip.

KardiaMobile recently introduced a newer device. When you place this device on a bare knee and touch one electrode with fingers from the right hand and another electrode with fingers from the left hand, the device produces a six-lead ECG. These small devices send an image of the ECG to a patient’s smartphone over Bluetooth, and the results can be easily read, printed out, or sent to the doctor for further analysis. Additionally, both of KardiaMobile’s devices utilize artificial intelligence to analyze a rhythm strip in real time and let the patient know if the ECG is normal, shows AFib, or is unable to be analyzed.

The electrocardiographic technology was formerly only available in a medical setting. It required an expensive machine and could only be interpreted by someone with expertise developed through years of training. Now it is readily available to patients in their homes. But how accurate is the technology and how are we going to use it?
 

How effective is KardiaMobile at detecting AFib?

Studies have looked at both KardiaMobile and the Apple Watch. One study of KardiaMobile in patients with Afib who were admitted for antiarrhythmic drug initiation showed that about a quarter of readings could not be classified because of artifact and other reasons. After exclusion of unclassified recordings, the KardiaMobile interpretation had 97% sensitivity and 94% specificity for AFib detection when compared with physician-interpreted ECGs.¹ In a large review of the device’s accuracy, there was about 85% sensitivity and specificity of the automated readings.²

How does the Apple Watch find AFib?

Like the KardiaMobile device, the Apple Watch can be used whenever patients notice symptoms or whenever they and their physicians decide the device would be useful. In addition, though, the Apple Watch has a function where the wearer can opt in to have the watch screen for AFib in the background whenever the watch is worn.

The watch monitors heart rate using photoplethysmography, where light-sensitive photodiodes detect blood pulses to assess heart rate variability. When an irregular heart rate is detected, the AW alerts the user of possible AFib. Once alerted, the wearer can then utilize a second function to obtain a single-lead ECG. Heart rate, rhythm, and a 30-second ECG tracing are saved in the Bluetooth-linked iPhone’s health app and can be exported for review by a physician.

In a study of over 400,000 participants, among participants notified of an irregular pulse through screening there was a positive predictive value of 84%.³ Single-lead EKGs initiated by watch wearers had a specificity for AFib of 99.6% among tracings with good wave forms, indicating very few false positives. Only 1 individual of the 263 individuals who had normal sinus rhythm on 12-lead ECG was classified as having AFib, though in 7% sinus rhythm could not be confirmed because of poor tracings.^4,5
 

^{What should we do with the results?}

It’s impressive that these devices deliver accurate information with very good specificity. Our hope is that detecting AFib with one of these devices will lead to an intervention being made that will decrease a patient’s risk of stroke. But it is not clear if routine screening in asymptomatic adults will accomplish this.

While more data is needed, we must acknowledge that our patients will soon be bringing us results from home. Regardless of what we think of this technology, we need to decide what to do when patients call us with results from these devices.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. William A et al. Heart Rhythm. 2018 Oct;15(10):1561-5.

2. KardiaMobile for the ambulatory detection of atrial fibrillation. NICE Medtech innovation briefing. 29 October 2020 Oct 29. www.nice.org.uk/guidance/mib232.

3. Perez MV et al. N Engl J Med. 2019; 381:1909-17.

4. Using Apple Watch for Arrhythmia Detection, December 2018. Apple. https://www.apple.com/healthcare/site/docs/Apple_Watch_Arrhythmia_Detection.pdf. Accessed 2019 Apr 5.

5. De Novo Classification Request for ECG App. https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180044.pdf. Accessed 2019 Apr 29.

More than 50% of health care workers infected with SARS-CoV-2 report that their sense of smell has not returned to normal an average of 5 months post infection, new research shows.

Nenad Cavoski/iStock/Getty Images Plus

The findings illustrate that olfactory problems are common not only during the acute COVID-19 phase but also “in the long run” and that these problems should be “taken into consideration” when following up these patients, study investigator Johannes Frasnelli, MD, professor, department of anatomy, Université du Québec à Trois-Rivières, said in an interview.

Loss of the sense of smell can affect quality of life because it affects eating and drinking, and may even be dangerous, said Dr. Frasnelli. “If your sense of smell is impaired, you may unknowingly eat spoiled food, or you may not smell smoke or gas in your home,” he said. In addition, Dr. Frasnelli noted that an impaired sense of smell is associated with higher rates of depression. The findings will be presented at the annual meeting of the American Academy of Neurology in April.

‘Striking’ finding

Research shows that about 60% of patients with COVID-19 lose their sense of smell to some degree during the acute phase of the disease. “But we wanted to go further and look at the longer-term effects of loss of smell and taste,” said Dr. Frasnelli.

The analysis included 813 health care workers in the province of Quebec. For all the patients, SARS-CoV-2 infection was confirmed through testing with a nasopharyngeal viral swab.

Participants completed a 64-item online questionnaire that asked about three senses: olfactory; gustatory, which includes tastes such as sweet, sour, bitter, salty, savory and umami; and trigeminal, which includes sensations such as spiciness of hot peppers and “coolness” of mint.

They were asked to rate these on a scale of 0 (no perception) to 10 (very strong perception) before the infection, during the infection, and currently. They were also asked about other symptoms, including fatigue.

Most respondents had been infected in the first wave of the virus in March and April of 2020 and responded to the questionnaire an average of 5 months later.

The vast majority of respondents (84.1%) were women, which Dr. Frasnelli said was not surprising because women predominate in the health care field.

The analysis showed that average smell ratings were 8.98 before infection, 2.85 during the acute phase, and 7.41 when respondents answered the questionnaire. The sense of taste was less affected and recovered faster than did the sense of smell. Results for taste were 9.20 before infection, 3.59 during the acute phase, and 8.05 after COVID-19.

Among 580 respondents who indicated a compromised sense of smell during the acute phase, the average smell rating when answering the questionnaire was 6.89, compared to 9.03 before the infection. More than half (51.2%) reported not regaining full olfactory function.

The fact that the sense of smell had not returned to normal for half the participants so long after being infected is “novel and quite striking,” said Dr. Frasnelli.

However, he noted, this doesn’t necessarily mean all those with a compromised sense of smell “have huge problems.” In some cases, he said, the problem “is more subtle.”
 

Not a CNS problem?

Respondents also completed a chemosensory dysfunction home test (CD-HT). They were asked to prepare common household food items, such as peanut butter, sugar, salt, and vinegar, in a particular way – for example, to add sugar or salt to water – and provide feedback on how they smell and taste.

For this CD-HT analysis, 18.4% of respondents reported having persistent loss of smell. This, Dr. Frasnelli said, adds to evidence from self-reported responses and suggests that in some cases, the problem is more than senses not returning to normal.

“From the questionnaires, roughly 50% said their sense of smell is still not back to normal, and when we look at the CD home test, we see that almost 20% of subjects indeed have pretty strong impairment of their sense of smell,” he said.

The results showed no sex differences, although Dr. Frasnelli noted that most of the sample were women. “It’s tricky to look at the data with regard to sex because it’s a bit skewed,” he said.

Male respondents were older than female participants, but there was no difference in impairment between age groups. Dr. Frasnelli said this was “quite interesting,” inasmuch as older people usually lose some sense of smell.

The researchers have not yet examined whether the results differ by type of health care worker.

They also have not examined in detail whether infection severity affects the risk for extended olfactory impairment. Although some research suggests that the problem with smell is more common in less severe cases, Dr. Frasnelli noted this could be because loss of smell is not a huge problem for patients battling grave health problems.

As for other symptoms, many respondents reported lingering fatigue; some reported debilitating fatigue, said Dr. Frasnelli. However, he cautioned that this is difficult to interpret, because the participants were health care workers, many of whom returned to work during the pandemic and perhaps had not fully rested.

He also noted that he and his colleagues have not “made the link” between impaired smell and the degree of fatigue.

The COVID-19 virus appears to attack supporting sustentacular cells in the olfactory epithelium, not nerve cells.

“Right now, it seems that the smell problem is not a central nervous system problem but a peripheral problem,” said Dr. Frasnelli. “But we don’t know for sure; it may be that the virus somehow gets into the brain and some symptoms are caused by the effects of the infection on the brain.”

The researchers will extend their research with another questionnaire to assess senses 10-12 months after COVID-19.

Limitations of the study include the subjective nature of the smell and taste ratings and the single time point at which data were collected.
 

Confirmatory findings

Commenting on the research in an interview, Thomas Hummel, MD, professor, smell and taste clinic, department of otorhinolaryngology, Technische Universität Dresden (Germany), said the new results regarding loss of smell after COVID-19 are “very congruent” with what he and his colleagues have observed.

Research shows that up to one in five of those infected with SARS-CoV-2 experience olfactory loss. “While the numbers may vary a bit from study to study or lab to lab, I think 5% to 20% of post–COVID-19 patients exhibit long-term olfactory loss,” Dr. Hummel said.

His group has observed that “many more are not back to normal,” which conforms with what Dr. Frasnelli’s study reveals, said Dr. Hummel.

Also commenting on the research, Kenneth L. Tyler, MD, professor of neurology, University of Colorado at Denver, Aurora, and a fellow of the American Academy of Neurology, said the study was relatively large and the results “interesting.”

Although it “provides more evidence there’s a subset of patients with symptoms even well past the acute phase” of COVID-19, the results are “mostly confirmatory” and include “nothing super surprising,” Dr. Tyler said in an interview.

However, the investigators did attempt to make the study “a little more quantitative” and “to confirm the self-reporting with their validated CD home test,” he said.

Dr. Tyler wondered how representative the sample was and whether the study drew more participants with impaired senses. “If I had a loss of smell or taste, maybe I would be more likely to respond to such a survey,” he said.

He also noted the difficulty of separating loss of smell from loss of taste.

“If you lose your sense of smell, things don’t taste right, so it can be confounding as to how to separate out those two,” he noted.
The study was supported by the Foundation of the Université du Québec à Trois-Rivières and the Province of Quebec. Dr. Frasnelli has received royalties from Styriabooks in Austria for a book on olfaction published in 2019 and has received honoraria for speaking engagements. Dr. Hummel and Dr. Tyler have disclosed no relevant financial relationships.

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

More than 50% of health care workers infected with SARS-CoV-2 report that their sense of smell has not returned to normal an average of 5 months post infection, new research shows.

Nenad Cavoski/iStock/Getty Images Plus

The findings illustrate that olfactory problems are common not only during the acute COVID-19 phase but also “in the long run” and that these problems should be “taken into consideration” when following up these patients, study investigator Johannes Frasnelli, MD, professor, department of anatomy, Université du Québec à Trois-Rivières, said in an interview.

Loss of the sense of smell can affect quality of life because it affects eating and drinking, and may even be dangerous, said Dr. Frasnelli. “If your sense of smell is impaired, you may unknowingly eat spoiled food, or you may not smell smoke or gas in your home,” he said. In addition, Dr. Frasnelli noted that an impaired sense of smell is associated with higher rates of depression. The findings will be presented at the annual meeting of the American Academy of Neurology in April.

‘Striking’ finding

Research shows that about 60% of patients with COVID-19 lose their sense of smell to some degree during the acute phase of the disease. “But we wanted to go further and look at the longer-term effects of loss of smell and taste,” said Dr. Frasnelli.

The analysis included 813 health care workers in the province of Quebec. For all the patients, SARS-CoV-2 infection was confirmed through testing with a nasopharyngeal viral swab.

Participants completed a 64-item online questionnaire that asked about three senses: olfactory; gustatory, which includes tastes such as sweet, sour, bitter, salty, savory and umami; and trigeminal, which includes sensations such as spiciness of hot peppers and “coolness” of mint.

They were asked to rate these on a scale of 0 (no perception) to 10 (very strong perception) before the infection, during the infection, and currently. They were also asked about other symptoms, including fatigue.

Most respondents had been infected in the first wave of the virus in March and April of 2020 and responded to the questionnaire an average of 5 months later.

The vast majority of respondents (84.1%) were women, which Dr. Frasnelli said was not surprising because women predominate in the health care field.

The analysis showed that average smell ratings were 8.98 before infection, 2.85 during the acute phase, and 7.41 when respondents answered the questionnaire. The sense of taste was less affected and recovered faster than did the sense of smell. Results for taste were 9.20 before infection, 3.59 during the acute phase, and 8.05 after COVID-19.

Among 580 respondents who indicated a compromised sense of smell during the acute phase, the average smell rating when answering the questionnaire was 6.89, compared to 9.03 before the infection. More than half (51.2%) reported not regaining full olfactory function.

The fact that the sense of smell had not returned to normal for half the participants so long after being infected is “novel and quite striking,” said Dr. Frasnelli.

However, he noted, this doesn’t necessarily mean all those with a compromised sense of smell “have huge problems.” In some cases, he said, the problem “is more subtle.”
 

Not a CNS problem?

Respondents also completed a chemosensory dysfunction home test (CD-HT). They were asked to prepare common household food items, such as peanut butter, sugar, salt, and vinegar, in a particular way – for example, to add sugar or salt to water – and provide feedback on how they smell and taste.

For this CD-HT analysis, 18.4% of respondents reported having persistent loss of smell. This, Dr. Frasnelli said, adds to evidence from self-reported responses and suggests that in some cases, the problem is more than senses not returning to normal.

“From the questionnaires, roughly 50% said their sense of smell is still not back to normal, and when we look at the CD home test, we see that almost 20% of subjects indeed have pretty strong impairment of their sense of smell,” he said.

The results showed no sex differences, although Dr. Frasnelli noted that most of the sample were women. “It’s tricky to look at the data with regard to sex because it’s a bit skewed,” he said.

Male respondents were older than female participants, but there was no difference in impairment between age groups. Dr. Frasnelli said this was “quite interesting,” inasmuch as older people usually lose some sense of smell.

The researchers have not yet examined whether the results differ by type of health care worker.

They also have not examined in detail whether infection severity affects the risk for extended olfactory impairment. Although some research suggests that the problem with smell is more common in less severe cases, Dr. Frasnelli noted this could be because loss of smell is not a huge problem for patients battling grave health problems.

As for other symptoms, many respondents reported lingering fatigue; some reported debilitating fatigue, said Dr. Frasnelli. However, he cautioned that this is difficult to interpret, because the participants were health care workers, many of whom returned to work during the pandemic and perhaps had not fully rested.

He also noted that he and his colleagues have not “made the link” between impaired smell and the degree of fatigue.

The COVID-19 virus appears to attack supporting sustentacular cells in the olfactory epithelium, not nerve cells.

“Right now, it seems that the smell problem is not a central nervous system problem but a peripheral problem,” said Dr. Frasnelli. “But we don’t know for sure; it may be that the virus somehow gets into the brain and some symptoms are caused by the effects of the infection on the brain.”

The researchers will extend their research with another questionnaire to assess senses 10-12 months after COVID-19.

Limitations of the study include the subjective nature of the smell and taste ratings and the single time point at which data were collected.
 

Confirmatory findings

Commenting on the research in an interview, Thomas Hummel, MD, professor, smell and taste clinic, department of otorhinolaryngology, Technische Universität Dresden (Germany), said the new results regarding loss of smell after COVID-19 are “very congruent” with what he and his colleagues have observed.

Research shows that up to one in five of those infected with SARS-CoV-2 experience olfactory loss. “While the numbers may vary a bit from study to study or lab to lab, I think 5% to 20% of post–COVID-19 patients exhibit long-term olfactory loss,” Dr. Hummel said.

His group has observed that “many more are not back to normal,” which conforms with what Dr. Frasnelli’s study reveals, said Dr. Hummel.

Also commenting on the research, Kenneth L. Tyler, MD, professor of neurology, University of Colorado at Denver, Aurora, and a fellow of the American Academy of Neurology, said the study was relatively large and the results “interesting.”

Although it “provides more evidence there’s a subset of patients with symptoms even well past the acute phase” of COVID-19, the results are “mostly confirmatory” and include “nothing super surprising,” Dr. Tyler said in an interview.

However, the investigators did attempt to make the study “a little more quantitative” and “to confirm the self-reporting with their validated CD home test,” he said.

Dr. Tyler wondered how representative the sample was and whether the study drew more participants with impaired senses. “If I had a loss of smell or taste, maybe I would be more likely to respond to such a survey,” he said.

He also noted the difficulty of separating loss of smell from loss of taste.

“If you lose your sense of smell, things don’t taste right, so it can be confounding as to how to separate out those two,” he noted.
The study was supported by the Foundation of the Université du Québec à Trois-Rivières and the Province of Quebec. Dr. Frasnelli has received royalties from Styriabooks in Austria for a book on olfaction published in 2019 and has received honoraria for speaking engagements. Dr. Hummel and Dr. Tyler have disclosed no relevant financial relationships.

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

More than 50% of health care workers infected with SARS-CoV-2 report that their sense of smell has not returned to normal an average of 5 months post infection, new research shows.

Nenad Cavoski/iStock/Getty Images Plus

The findings illustrate that olfactory problems are common not only during the acute COVID-19 phase but also “in the long run” and that these problems should be “taken into consideration” when following up these patients, study investigator Johannes Frasnelli, MD, professor, department of anatomy, Université du Québec à Trois-Rivières, said in an interview.

Loss of the sense of smell can affect quality of life because it affects eating and drinking, and may even be dangerous, said Dr. Frasnelli. “If your sense of smell is impaired, you may unknowingly eat spoiled food, or you may not smell smoke or gas in your home,” he said. In addition, Dr. Frasnelli noted that an impaired sense of smell is associated with higher rates of depression. The findings will be presented at the annual meeting of the American Academy of Neurology in April.

‘Striking’ finding

Research shows that about 60% of patients with COVID-19 lose their sense of smell to some degree during the acute phase of the disease. “But we wanted to go further and look at the longer-term effects of loss of smell and taste,” said Dr. Frasnelli.

The analysis included 813 health care workers in the province of Quebec. For all the patients, SARS-CoV-2 infection was confirmed through testing with a nasopharyngeal viral swab.

Participants completed a 64-item online questionnaire that asked about three senses: olfactory; gustatory, which includes tastes such as sweet, sour, bitter, salty, savory and umami; and trigeminal, which includes sensations such as spiciness of hot peppers and “coolness” of mint.

They were asked to rate these on a scale of 0 (no perception) to 10 (very strong perception) before the infection, during the infection, and currently. They were also asked about other symptoms, including fatigue.

Most respondents had been infected in the first wave of the virus in March and April of 2020 and responded to the questionnaire an average of 5 months later.

The vast majority of respondents (84.1%) were women, which Dr. Frasnelli said was not surprising because women predominate in the health care field.

The analysis showed that average smell ratings were 8.98 before infection, 2.85 during the acute phase, and 7.41 when respondents answered the questionnaire. The sense of taste was less affected and recovered faster than did the sense of smell. Results for taste were 9.20 before infection, 3.59 during the acute phase, and 8.05 after COVID-19.

Among 580 respondents who indicated a compromised sense of smell during the acute phase, the average smell rating when answering the questionnaire was 6.89, compared to 9.03 before the infection. More than half (51.2%) reported not regaining full olfactory function.

The fact that the sense of smell had not returned to normal for half the participants so long after being infected is “novel and quite striking,” said Dr. Frasnelli.

However, he noted, this doesn’t necessarily mean all those with a compromised sense of smell “have huge problems.” In some cases, he said, the problem “is more subtle.”
 

Not a CNS problem?

Respondents also completed a chemosensory dysfunction home test (CD-HT). They were asked to prepare common household food items, such as peanut butter, sugar, salt, and vinegar, in a particular way – for example, to add sugar or salt to water – and provide feedback on how they smell and taste.

For this CD-HT analysis, 18.4% of respondents reported having persistent loss of smell. This, Dr. Frasnelli said, adds to evidence from self-reported responses and suggests that in some cases, the problem is more than senses not returning to normal.

“From the questionnaires, roughly 50% said their sense of smell is still not back to normal, and when we look at the CD home test, we see that almost 20% of subjects indeed have pretty strong impairment of their sense of smell,” he said.

The results showed no sex differences, although Dr. Frasnelli noted that most of the sample were women. “It’s tricky to look at the data with regard to sex because it’s a bit skewed,” he said.

Male respondents were older than female participants, but there was no difference in impairment between age groups. Dr. Frasnelli said this was “quite interesting,” inasmuch as older people usually lose some sense of smell.

The researchers have not yet examined whether the results differ by type of health care worker.

They also have not examined in detail whether infection severity affects the risk for extended olfactory impairment. Although some research suggests that the problem with smell is more common in less severe cases, Dr. Frasnelli noted this could be because loss of smell is not a huge problem for patients battling grave health problems.

As for other symptoms, many respondents reported lingering fatigue; some reported debilitating fatigue, said Dr. Frasnelli. However, he cautioned that this is difficult to interpret, because the participants were health care workers, many of whom returned to work during the pandemic and perhaps had not fully rested.

He also noted that he and his colleagues have not “made the link” between impaired smell and the degree of fatigue.

The COVID-19 virus appears to attack supporting sustentacular cells in the olfactory epithelium, not nerve cells.

“Right now, it seems that the smell problem is not a central nervous system problem but a peripheral problem,” said Dr. Frasnelli. “But we don’t know for sure; it may be that the virus somehow gets into the brain and some symptoms are caused by the effects of the infection on the brain.”

The researchers will extend their research with another questionnaire to assess senses 10-12 months after COVID-19.

Limitations of the study include the subjective nature of the smell and taste ratings and the single time point at which data were collected.
 

Confirmatory findings

Commenting on the research in an interview, Thomas Hummel, MD, professor, smell and taste clinic, department of otorhinolaryngology, Technische Universität Dresden (Germany), said the new results regarding loss of smell after COVID-19 are “very congruent” with what he and his colleagues have observed.

Research shows that up to one in five of those infected with SARS-CoV-2 experience olfactory loss. “While the numbers may vary a bit from study to study or lab to lab, I think 5% to 20% of post–COVID-19 patients exhibit long-term olfactory loss,” Dr. Hummel said.

His group has observed that “many more are not back to normal,” which conforms with what Dr. Frasnelli’s study reveals, said Dr. Hummel.

Also commenting on the research, Kenneth L. Tyler, MD, professor of neurology, University of Colorado at Denver, Aurora, and a fellow of the American Academy of Neurology, said the study was relatively large and the results “interesting.”

Although it “provides more evidence there’s a subset of patients with symptoms even well past the acute phase” of COVID-19, the results are “mostly confirmatory” and include “nothing super surprising,” Dr. Tyler said in an interview.

However, the investigators did attempt to make the study “a little more quantitative” and “to confirm the self-reporting with their validated CD home test,” he said.

Dr. Tyler wondered how representative the sample was and whether the study drew more participants with impaired senses. “If I had a loss of smell or taste, maybe I would be more likely to respond to such a survey,” he said.

He also noted the difficulty of separating loss of smell from loss of taste.

“If you lose your sense of smell, things don’t taste right, so it can be confounding as to how to separate out those two,” he noted.
The study was supported by the Foundation of the Université du Québec à Trois-Rivières and the Province of Quebec. Dr. Frasnelli has received royalties from Styriabooks in Austria for a book on olfaction published in 2019 and has received honoraria for speaking engagements. Dr. Hummel and Dr. Tyler have disclosed no relevant financial relationships.

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

In recent decades, natural products have had increased consumer attention in industrialized nations. One of the challenges is that “natural” can be more of a perception than a standard. “Herbal products” is a more frequently used and perhaps a more apt term. Herbal products come in many forms, including herbs used in food preparation, teas, infusions, caplets, dried extracts, essential oils, and tinctures.

Multiple prescription medications have pharmacologically active compounds that originated from herbal products, both historically and currently. Examples include the cardiac stimulant digoxin (foxglove plant), the antimalarial quinine (Cinchona bark), and antihypertensives (Rauwolfia serpentina). Indeed, the first pharmacologically active compound, morphine, was extracted from the seed pods of opium poppies approximately 200 years ago. This demonstrated that medications could be purified from plants and that a precise dose could be determined for administration. However, herbal products are grown and harvested in varying seasonal conditions and soil types, which, over time and geography, may contribute to variability in the levels of active compound in the final products.

The importance of active compound purification and consistent precise dosage in herbal products brings up the topic of regulation. Herbal products are considered dietary supplements and as such are Food and Drug Administration regulated as a food under the 1994 Dietary Supplement Health Education Act. Regulation as a food product does not involve the same level of scrutiny as a medication. There is no requirement that manufacturers check for purity and consistency of their product’s active compound(s). Manufacturers must ensure that the claims they make about herbal products are not false or misleading. They must also support their claims with evidence. However, there is no requirement for the manufacturers to submit this evidence to the FDA. This can translate into a discrepancy between the claim on the product label and scientific evidence that the product does what it claims to do. In other words, the product may not be effective.

With uncertain efficacy, the safety of herbal products comes into focus. Very few herbal products (or their specific active compounds) have been scientifically studied for safety in pregnancy and lactation. Further, herbal products may contain contaminants. Metals such as lead and mercury occur naturally. Yet, because of human activities, both may have collected in areas where herbal products are grown. From a safety perspective, both can be concerning in pregnancy or lactation. Lead and mercury are two examples of metal contaminants. Other contaminants may include pesticides, chemicals, and bacteria or other microorganisms. Some liquid herbal products such as tinctures contain alcohol, which should be avoided in pregnancy. An additional consideration would be the potential for herbal products, including any of their known or unknown product contents, to interact with prescribed medications or anesthesia.
 

Select examples of herbal products

Astragalus is the root of an herb and it is used for reasons of boosting immunity, energy, and other functions. These and its purported promotion of breast milk flow (galactagogue) are unsupported. Safety concerns include irregular heartbeat and dizziness, rendering it unsafe for use in pregnancy and of unknown efficacy and safety in lactation.

Kombucha is an herbal product made from leaves (tea), sugar, a culture, and other varying products. Like many herbal products, it is both manufactured and home brewed. It is used for probiotic and antioxidant reasons. As a fermented product, kombucha may contain 0.2%-0.5% alcohol. There is no known safe level of alcohol and no known safe type of alcohol for use in pregnancy. Alcohol exposure in pregnancy can result in fetal alcohol spectrum disorders, involving a range of birth defects and life-long intellectual, learning and behavioral disorders. Alcohol found in breast milk approximates the level of alcohol found in the maternal bloodstream. Alcohol-containing products should be avoided in pregnancy and lactation.

Nux vomica is an herbal product and is used for reasons of reducing nausea or vomiting in pregnancy. It comes from the raw seeds (toxic) of an evergreen tree. It has serious safety concerns and yet it is still in use. It contains strychnine, which can harm both the pregnant individual and the developing fetus. It is not recommended in lactation.

Red raspberry leaf is a leaf, brewed and ingested as a tea. It is used for reasons of preventing miscarriage, relieving nausea and stomach discomfort, toning the uterus, reducing labor pain, increasing breast milk production, and other functions. In low doses, it appears to be safe. In high doses, it can induce smooth muscle relaxation. Efficacy has not been demonstrated with labor and delivery or in increasing breast milk production.

Tabacum is an herbal product and is used for reasons of reducing nausea or vomiting in pregnancy. Its full name is Nicotiana tabacum (tobacco) and it contains 2%-8% nicotine, which should be avoided in pregnancy. Nicotine is a health danger for the pregnant individual and can damage a developing fetus’ brain and lungs.

Unless otherwise scientifically demonstrated, herbal products should be considered medications with pharmacologic activity, potential adverse effects, and potential toxicity in pregnancy and lactation. It’s easy for a patient to forget about reporting any nonprescription medications during a patient-provider visit. As a provider, purposefully asking about all over-the-counter and herbal products during each visit can prompt the patient to provide this important information. Further, it may facilitate discussion about the continuation/discontinuation of products of unknown safety and unknown benefit, culminating in the serious reflection: “Is it really worth the risk?”

For further information about the safety of herbal products, consult local Poison Control Centers, MothertoBaby, MothertoBaby affiliates, and the National Institutes of Health Drugs and Lactation Database, LactMed.

Dr. Hardy is a consultant on global maternal-child health and pharmacoepidemiology, and represents the Society for Birth Defects Research and Prevention and the Organization of Teratology Information Specialists at PRGLAC meetings. Dr. Hardy has worked with multiple pharmaceutical manufacturers regarding studies of medication safety in pregnancy, most recently Biohaven Pharmaceuticals, New Haven, CT.

.

In recent decades, natural products have had increased consumer attention in industrialized nations. One of the challenges is that “natural” can be more of a perception than a standard. “Herbal products” is a more frequently used and perhaps a more apt term. Herbal products come in many forms, including herbs used in food preparation, teas, infusions, caplets, dried extracts, essential oils, and tinctures.

Multiple prescription medications have pharmacologically active compounds that originated from herbal products, both historically and currently. Examples include the cardiac stimulant digoxin (foxglove plant), the antimalarial quinine (Cinchona bark), and antihypertensives (Rauwolfia serpentina). Indeed, the first pharmacologically active compound, morphine, was extracted from the seed pods of opium poppies approximately 200 years ago. This demonstrated that medications could be purified from plants and that a precise dose could be determined for administration. However, herbal products are grown and harvested in varying seasonal conditions and soil types, which, over time and geography, may contribute to variability in the levels of active compound in the final products.

The importance of active compound purification and consistent precise dosage in herbal products brings up the topic of regulation. Herbal products are considered dietary supplements and as such are Food and Drug Administration regulated as a food under the 1994 Dietary Supplement Health Education Act. Regulation as a food product does not involve the same level of scrutiny as a medication. There is no requirement that manufacturers check for purity and consistency of their product’s active compound(s). Manufacturers must ensure that the claims they make about herbal products are not false or misleading. They must also support their claims with evidence. However, there is no requirement for the manufacturers to submit this evidence to the FDA. This can translate into a discrepancy between the claim on the product label and scientific evidence that the product does what it claims to do. In other words, the product may not be effective.

With uncertain efficacy, the safety of herbal products comes into focus. Very few herbal products (or their specific active compounds) have been scientifically studied for safety in pregnancy and lactation. Further, herbal products may contain contaminants. Metals such as lead and mercury occur naturally. Yet, because of human activities, both may have collected in areas where herbal products are grown. From a safety perspective, both can be concerning in pregnancy or lactation. Lead and mercury are two examples of metal contaminants. Other contaminants may include pesticides, chemicals, and bacteria or other microorganisms. Some liquid herbal products such as tinctures contain alcohol, which should be avoided in pregnancy. An additional consideration would be the potential for herbal products, including any of their known or unknown product contents, to interact with prescribed medications or anesthesia.
 

Select examples of herbal products

Astragalus is the root of an herb and it is used for reasons of boosting immunity, energy, and other functions. These and its purported promotion of breast milk flow (galactagogue) are unsupported. Safety concerns include irregular heartbeat and dizziness, rendering it unsafe for use in pregnancy and of unknown efficacy and safety in lactation.

Kombucha is an herbal product made from leaves (tea), sugar, a culture, and other varying products. Like many herbal products, it is both manufactured and home brewed. It is used for probiotic and antioxidant reasons. As a fermented product, kombucha may contain 0.2%-0.5% alcohol. There is no known safe level of alcohol and no known safe type of alcohol for use in pregnancy. Alcohol exposure in pregnancy can result in fetal alcohol spectrum disorders, involving a range of birth defects and life-long intellectual, learning and behavioral disorders. Alcohol found in breast milk approximates the level of alcohol found in the maternal bloodstream. Alcohol-containing products should be avoided in pregnancy and lactation.

Nux vomica is an herbal product and is used for reasons of reducing nausea or vomiting in pregnancy. It comes from the raw seeds (toxic) of an evergreen tree. It has serious safety concerns and yet it is still in use. It contains strychnine, which can harm both the pregnant individual and the developing fetus. It is not recommended in lactation.

Red raspberry leaf is a leaf, brewed and ingested as a tea. It is used for reasons of preventing miscarriage, relieving nausea and stomach discomfort, toning the uterus, reducing labor pain, increasing breast milk production, and other functions. In low doses, it appears to be safe. In high doses, it can induce smooth muscle relaxation. Efficacy has not been demonstrated with labor and delivery or in increasing breast milk production.

Tabacum is an herbal product and is used for reasons of reducing nausea or vomiting in pregnancy. Its full name is Nicotiana tabacum (tobacco) and it contains 2%-8% nicotine, which should be avoided in pregnancy. Nicotine is a health danger for the pregnant individual and can damage a developing fetus’ brain and lungs.

Unless otherwise scientifically demonstrated, herbal products should be considered medications with pharmacologic activity, potential adverse effects, and potential toxicity in pregnancy and lactation. It’s easy for a patient to forget about reporting any nonprescription medications during a patient-provider visit. As a provider, purposefully asking about all over-the-counter and herbal products during each visit can prompt the patient to provide this important information. Further, it may facilitate discussion about the continuation/discontinuation of products of unknown safety and unknown benefit, culminating in the serious reflection: “Is it really worth the risk?”

For further information about the safety of herbal products, consult local Poison Control Centers, MothertoBaby, MothertoBaby affiliates, and the National Institutes of Health Drugs and Lactation Database, LactMed.

Dr. Hardy is a consultant on global maternal-child health and pharmacoepidemiology, and represents the Society for Birth Defects Research and Prevention and the Organization of Teratology Information Specialists at PRGLAC meetings. Dr. Hardy has worked with multiple pharmaceutical manufacturers regarding studies of medication safety in pregnancy, most recently Biohaven Pharmaceuticals, New Haven, CT.

.

In recent decades, natural products have had increased consumer attention in industrialized nations. One of the challenges is that “natural” can be more of a perception than a standard. “Herbal products” is a more frequently used and perhaps a more apt term. Herbal products come in many forms, including herbs used in food preparation, teas, infusions, caplets, dried extracts, essential oils, and tinctures.

Multiple prescription medications have pharmacologically active compounds that originated from herbal products, both historically and currently. Examples include the cardiac stimulant digoxin (foxglove plant), the antimalarial quinine (Cinchona bark), and antihypertensives (Rauwolfia serpentina). Indeed, the first pharmacologically active compound, morphine, was extracted from the seed pods of opium poppies approximately 200 years ago. This demonstrated that medications could be purified from plants and that a precise dose could be determined for administration. However, herbal products are grown and harvested in varying seasonal conditions and soil types, which, over time and geography, may contribute to variability in the levels of active compound in the final products.

The importance of active compound purification and consistent precise dosage in herbal products brings up the topic of regulation. Herbal products are considered dietary supplements and as such are Food and Drug Administration regulated as a food under the 1994 Dietary Supplement Health Education Act. Regulation as a food product does not involve the same level of scrutiny as a medication. There is no requirement that manufacturers check for purity and consistency of their product’s active compound(s). Manufacturers must ensure that the claims they make about herbal products are not false or misleading. They must also support their claims with evidence. However, there is no requirement for the manufacturers to submit this evidence to the FDA. This can translate into a discrepancy between the claim on the product label and scientific evidence that the product does what it claims to do. In other words, the product may not be effective.

With uncertain efficacy, the safety of herbal products comes into focus. Very few herbal products (or their specific active compounds) have been scientifically studied for safety in pregnancy and lactation. Further, herbal products may contain contaminants. Metals such as lead and mercury occur naturally. Yet, because of human activities, both may have collected in areas where herbal products are grown. From a safety perspective, both can be concerning in pregnancy or lactation. Lead and mercury are two examples of metal contaminants. Other contaminants may include pesticides, chemicals, and bacteria or other microorganisms. Some liquid herbal products such as tinctures contain alcohol, which should be avoided in pregnancy. An additional consideration would be the potential for herbal products, including any of their known or unknown product contents, to interact with prescribed medications or anesthesia.
 

Select examples of herbal products

Astragalus is the root of an herb and it is used for reasons of boosting immunity, energy, and other functions. These and its purported promotion of breast milk flow (galactagogue) are unsupported. Safety concerns include irregular heartbeat and dizziness, rendering it unsafe for use in pregnancy and of unknown efficacy and safety in lactation.

Kombucha is an herbal product made from leaves (tea), sugar, a culture, and other varying products. Like many herbal products, it is both manufactured and home brewed. It is used for probiotic and antioxidant reasons. As a fermented product, kombucha may contain 0.2%-0.5% alcohol. There is no known safe level of alcohol and no known safe type of alcohol for use in pregnancy. Alcohol exposure in pregnancy can result in fetal alcohol spectrum disorders, involving a range of birth defects and life-long intellectual, learning and behavioral disorders. Alcohol found in breast milk approximates the level of alcohol found in the maternal bloodstream. Alcohol-containing products should be avoided in pregnancy and lactation.

Nux vomica is an herbal product and is used for reasons of reducing nausea or vomiting in pregnancy. It comes from the raw seeds (toxic) of an evergreen tree. It has serious safety concerns and yet it is still in use. It contains strychnine, which can harm both the pregnant individual and the developing fetus. It is not recommended in lactation.

Red raspberry leaf is a leaf, brewed and ingested as a tea. It is used for reasons of preventing miscarriage, relieving nausea and stomach discomfort, toning the uterus, reducing labor pain, increasing breast milk production, and other functions. In low doses, it appears to be safe. In high doses, it can induce smooth muscle relaxation. Efficacy has not been demonstrated with labor and delivery or in increasing breast milk production.

Tabacum is an herbal product and is used for reasons of reducing nausea or vomiting in pregnancy. Its full name is Nicotiana tabacum (tobacco) and it contains 2%-8% nicotine, which should be avoided in pregnancy. Nicotine is a health danger for the pregnant individual and can damage a developing fetus’ brain and lungs.

Unless otherwise scientifically demonstrated, herbal products should be considered medications with pharmacologic activity, potential adverse effects, and potential toxicity in pregnancy and lactation. It’s easy for a patient to forget about reporting any nonprescription medications during a patient-provider visit. As a provider, purposefully asking about all over-the-counter and herbal products during each visit can prompt the patient to provide this important information. Further, it may facilitate discussion about the continuation/discontinuation of products of unknown safety and unknown benefit, culminating in the serious reflection: “Is it really worth the risk?”

For further information about the safety of herbal products, consult local Poison Control Centers, MothertoBaby, MothertoBaby affiliates, and the National Institutes of Health Drugs and Lactation Database, LactMed.

Dr. Hardy is a consultant on global maternal-child health and pharmacoepidemiology, and represents the Society for Birth Defects Research and Prevention and the Organization of Teratology Information Specialists at PRGLAC meetings. Dr. Hardy has worked with multiple pharmaceutical manufacturers regarding studies of medication safety in pregnancy, most recently Biohaven Pharmaceuticals, New Haven, CT.

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