MDedge Neurology

Thousands of doctors get a shout out every year when they make the “Top Doctor” lists in various magazines. Some may be your colleagues or competitors. Should you be concerned if you’re not on the list?

Best Doctor lists are clearly popular with readers and make money for the magazines.  They can also bring in patient revenue for doctors and their employers who promote them in news releases and on their websites.

For doctors on some of the top lists, the recognition can bring not only patients, but national or international visibility.

But many doctors don’t make it onto these lists. Will they lose business or prestige?

While the dollar value is hard to come by, some doctors say that these lists have attracted new patients to their practice.

Sarah St. Louis, MD, a physician manager of Associates in Urogynecology, is one of Orlando Style magazine’s Doctors of the Year and Orlando Family Magazine’s Top Doctors.

Several new patients have told her that they read about her in the magazines’ Top Doctor lists. “Urogynecology is not a well-known specialty – it’s a helpful way to get the word out about the women’s health specialty and what I do,” said Dr. St. Louis, an early career physician who started her practice in 2017.

The additional patient revenue has been worth the cost of displaying her profile in Orlando Style, which was about $800 for a half-page spread with her photo.

Top Doctor lists also work well for specialty practices whose patients can self-refer, such as plastic surgery, dermatology, orthopedics, gastroenterology, and geriatric medicine, said Andrea Eliscu, RN, founder and president of Medical Marketing in Orlando.

Being in a competitive market also matters. If a practice is the only one in town, those doctors may not need the publicity as much as doctors in an urban practice that faces stiff competition.
 

How do doctors get on these lists?

In most cases, doctors have to be nominated by their peers, a process that some say is flawed because it may shut out doctors who are less popular or well-connected. 

Forty-eight regional magazines, including Chicago magazine and Philadelphia Magazine , partner with Castle Connolly to use their online Top Doctor database of more than 61,000 physicians in every major metropolitan area, said Steve Leibforth, managing director of Castle Connolly’s Top Doctors.

The company says it sends annual surveys to tens of thousands of practicing doctors asking them to nominate colleagues in their specialty. The nominated doctors are vetted by Castle Connolly’s physician-led research team on several criteria including professional qualifications, education, hospital and faculty appointments, research leadership, professional reputation and disciplinary history, and outcomes data when available, said Mr. Leibforth.

Washingtonian magazine says it sends annual online surveys to 13,500 physicians in the DC metro area asking them to nominate one colleague in their specialty. The top vote-getters in each of 39 categories are designated Top Doctors.

Orlando Family Magazine  says its annual Top Doctor selections are based on reader polls and doctor nominations.

Consumers’ Research Council of America uses a point system based on each year the doctor has been in practice, education and continuing education, board certification, and membership in professional medical societies. 

Doctors have many ways to promote that they’re listed as a “top” doctor. Dr. St. Louis takes advantage of the magazine’s free reprints, which she puts in her waiting room.

Others buy plaques to hang up in their waiting rooms or offices and announce the distinction on their websites, blogs, or social media. “They have to maximize the magazine distinction or it’s worthless,” said Ms. Eliscu.

Employers also like to spread the word when their doctors make it on “Top Doctor” lists.

“With Emory physicians making up nearly 50 percent of the list, that’s more than any other health system in Atlanta,” said an Emory University press release after nearly half of the university’s doctors made the Top Doctors list in Atlanta magazine.
 

Patients may be impressed: What about your peers?

Dr. St. Louis said that making some of these lists is less impressive than having a peer-reviewed journal article or receiving professional awards.

“Just because a physician is listed in a magazine as a ‘top doctor’ does not mean they are the best. There are far more medical, clinical, and scientific points to consider than just a pretty picture in a style magazine,” she said.  

Wanda Filer, MD, MBA, who practiced family medicine until last year when she became chief medical officer for VaxCare in Orlando, said she ignores the many congratulatory letters in the mail announcing that she’s made one list or another.

“I don’t put much credence in the lists. I get notifications fairly often, and to me it always looks like they’re trying to sell a plaque. I’d rather let my work speak for itself.”

Arlen Meyers, MD, MBA, president and CEO of the Society of Physician Entrepreneurs and a paid strategic adviser to RYTE, a data-driven site for “best doctors” and “best hospitals,” said he received several of these “top doctor” awards when he was a professor of otolaryngology at the University of Colorado. 

He has been critical of these awards for some time. “These doctor beauty pageants may be good for business but have little value for patients.”

He would like to see a new approach that is driven by data and what patients value. “If I have a lump in my thyroid, I want to know the best doctor to treat me based on outcomes data.”

He said a good rating system would include a data-driven approach based on treatment outcomes, publicly available data, price transparency, and patient values.

Whether a physician feels honored to be named a top physician or sees little value in it, most doctors are aware of the list’s marketing value for their practices and many choose to make use of it.

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

Thousands of doctors get a shout out every year when they make the “Top Doctor” lists in various magazines. Some may be your colleagues or competitors. Should you be concerned if you’re not on the list?

Best Doctor lists are clearly popular with readers and make money for the magazines.  They can also bring in patient revenue for doctors and their employers who promote them in news releases and on their websites.

For doctors on some of the top lists, the recognition can bring not only patients, but national or international visibility.

But many doctors don’t make it onto these lists. Will they lose business or prestige?

While the dollar value is hard to come by, some doctors say that these lists have attracted new patients to their practice.

Sarah St. Louis, MD, a physician manager of Associates in Urogynecology, is one of Orlando Style magazine’s Doctors of the Year and Orlando Family Magazine’s Top Doctors.

Several new patients have told her that they read about her in the magazines’ Top Doctor lists. “Urogynecology is not a well-known specialty – it’s a helpful way to get the word out about the women’s health specialty and what I do,” said Dr. St. Louis, an early career physician who started her practice in 2017.

The additional patient revenue has been worth the cost of displaying her profile in Orlando Style, which was about $800 for a half-page spread with her photo.

Top Doctor lists also work well for specialty practices whose patients can self-refer, such as plastic surgery, dermatology, orthopedics, gastroenterology, and geriatric medicine, said Andrea Eliscu, RN, founder and president of Medical Marketing in Orlando.

Being in a competitive market also matters. If a practice is the only one in town, those doctors may not need the publicity as much as doctors in an urban practice that faces stiff competition.
 

How do doctors get on these lists?

In most cases, doctors have to be nominated by their peers, a process that some say is flawed because it may shut out doctors who are less popular or well-connected. 

Forty-eight regional magazines, including Chicago magazine and Philadelphia Magazine , partner with Castle Connolly to use their online Top Doctor database of more than 61,000 physicians in every major metropolitan area, said Steve Leibforth, managing director of Castle Connolly’s Top Doctors.

The company says it sends annual surveys to tens of thousands of practicing doctors asking them to nominate colleagues in their specialty. The nominated doctors are vetted by Castle Connolly’s physician-led research team on several criteria including professional qualifications, education, hospital and faculty appointments, research leadership, professional reputation and disciplinary history, and outcomes data when available, said Mr. Leibforth.

Washingtonian magazine says it sends annual online surveys to 13,500 physicians in the DC metro area asking them to nominate one colleague in their specialty. The top vote-getters in each of 39 categories are designated Top Doctors.

Orlando Family Magazine  says its annual Top Doctor selections are based on reader polls and doctor nominations.

Consumers’ Research Council of America uses a point system based on each year the doctor has been in practice, education and continuing education, board certification, and membership in professional medical societies. 

Doctors have many ways to promote that they’re listed as a “top” doctor. Dr. St. Louis takes advantage of the magazine’s free reprints, which she puts in her waiting room.

Others buy plaques to hang up in their waiting rooms or offices and announce the distinction on their websites, blogs, or social media. “They have to maximize the magazine distinction or it’s worthless,” said Ms. Eliscu.

Employers also like to spread the word when their doctors make it on “Top Doctor” lists.

“With Emory physicians making up nearly 50 percent of the list, that’s more than any other health system in Atlanta,” said an Emory University press release after nearly half of the university’s doctors made the Top Doctors list in Atlanta magazine.
 

Patients may be impressed: What about your peers?

Dr. St. Louis said that making some of these lists is less impressive than having a peer-reviewed journal article or receiving professional awards.

“Just because a physician is listed in a magazine as a ‘top doctor’ does not mean they are the best. There are far more medical, clinical, and scientific points to consider than just a pretty picture in a style magazine,” she said.  

Wanda Filer, MD, MBA, who practiced family medicine until last year when she became chief medical officer for VaxCare in Orlando, said she ignores the many congratulatory letters in the mail announcing that she’s made one list or another.

“I don’t put much credence in the lists. I get notifications fairly often, and to me it always looks like they’re trying to sell a plaque. I’d rather let my work speak for itself.”

Arlen Meyers, MD, MBA, president and CEO of the Society of Physician Entrepreneurs and a paid strategic adviser to RYTE, a data-driven site for “best doctors” and “best hospitals,” said he received several of these “top doctor” awards when he was a professor of otolaryngology at the University of Colorado. 

He has been critical of these awards for some time. “These doctor beauty pageants may be good for business but have little value for patients.”

He would like to see a new approach that is driven by data and what patients value. “If I have a lump in my thyroid, I want to know the best doctor to treat me based on outcomes data.”

He said a good rating system would include a data-driven approach based on treatment outcomes, publicly available data, price transparency, and patient values.

Whether a physician feels honored to be named a top physician or sees little value in it, most doctors are aware of the list’s marketing value for their practices and many choose to make use of it.

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

Thousands of doctors get a shout out every year when they make the “Top Doctor” lists in various magazines. Some may be your colleagues or competitors. Should you be concerned if you’re not on the list?

Best Doctor lists are clearly popular with readers and make money for the magazines.  They can also bring in patient revenue for doctors and their employers who promote them in news releases and on their websites.

For doctors on some of the top lists, the recognition can bring not only patients, but national or international visibility.

But many doctors don’t make it onto these lists. Will they lose business or prestige?

While the dollar value is hard to come by, some doctors say that these lists have attracted new patients to their practice.

Sarah St. Louis, MD, a physician manager of Associates in Urogynecology, is one of Orlando Style magazine’s Doctors of the Year and Orlando Family Magazine’s Top Doctors.

Several new patients have told her that they read about her in the magazines’ Top Doctor lists. “Urogynecology is not a well-known specialty – it’s a helpful way to get the word out about the women’s health specialty and what I do,” said Dr. St. Louis, an early career physician who started her practice in 2017.

The additional patient revenue has been worth the cost of displaying her profile in Orlando Style, which was about $800 for a half-page spread with her photo.

Top Doctor lists also work well for specialty practices whose patients can self-refer, such as plastic surgery, dermatology, orthopedics, gastroenterology, and geriatric medicine, said Andrea Eliscu, RN, founder and president of Medical Marketing in Orlando.

Being in a competitive market also matters. If a practice is the only one in town, those doctors may not need the publicity as much as doctors in an urban practice that faces stiff competition.
 

How do doctors get on these lists?

In most cases, doctors have to be nominated by their peers, a process that some say is flawed because it may shut out doctors who are less popular or well-connected. 

Forty-eight regional magazines, including Chicago magazine and Philadelphia Magazine , partner with Castle Connolly to use their online Top Doctor database of more than 61,000 physicians in every major metropolitan area, said Steve Leibforth, managing director of Castle Connolly’s Top Doctors.

The company says it sends annual surveys to tens of thousands of practicing doctors asking them to nominate colleagues in their specialty. The nominated doctors are vetted by Castle Connolly’s physician-led research team on several criteria including professional qualifications, education, hospital and faculty appointments, research leadership, professional reputation and disciplinary history, and outcomes data when available, said Mr. Leibforth.

Washingtonian magazine says it sends annual online surveys to 13,500 physicians in the DC metro area asking them to nominate one colleague in their specialty. The top vote-getters in each of 39 categories are designated Top Doctors.

Orlando Family Magazine  says its annual Top Doctor selections are based on reader polls and doctor nominations.

Consumers’ Research Council of America uses a point system based on each year the doctor has been in practice, education and continuing education, board certification, and membership in professional medical societies. 

Doctors have many ways to promote that they’re listed as a “top” doctor. Dr. St. Louis takes advantage of the magazine’s free reprints, which she puts in her waiting room.

Others buy plaques to hang up in their waiting rooms or offices and announce the distinction on their websites, blogs, or social media. “They have to maximize the magazine distinction or it’s worthless,” said Ms. Eliscu.

Employers also like to spread the word when their doctors make it on “Top Doctor” lists.

“With Emory physicians making up nearly 50 percent of the list, that’s more than any other health system in Atlanta,” said an Emory University press release after nearly half of the university’s doctors made the Top Doctors list in Atlanta magazine.
 

Patients may be impressed: What about your peers?

Dr. St. Louis said that making some of these lists is less impressive than having a peer-reviewed journal article or receiving professional awards.

“Just because a physician is listed in a magazine as a ‘top doctor’ does not mean they are the best. There are far more medical, clinical, and scientific points to consider than just a pretty picture in a style magazine,” she said.  

Wanda Filer, MD, MBA, who practiced family medicine until last year when she became chief medical officer for VaxCare in Orlando, said she ignores the many congratulatory letters in the mail announcing that she’s made one list or another.

“I don’t put much credence in the lists. I get notifications fairly often, and to me it always looks like they’re trying to sell a plaque. I’d rather let my work speak for itself.”

Arlen Meyers, MD, MBA, president and CEO of the Society of Physician Entrepreneurs and a paid strategic adviser to RYTE, a data-driven site for “best doctors” and “best hospitals,” said he received several of these “top doctor” awards when he was a professor of otolaryngology at the University of Colorado. 

He has been critical of these awards for some time. “These doctor beauty pageants may be good for business but have little value for patients.”

He would like to see a new approach that is driven by data and what patients value. “If I have a lump in my thyroid, I want to know the best doctor to treat me based on outcomes data.”

He said a good rating system would include a data-driven approach based on treatment outcomes, publicly available data, price transparency, and patient values.

Whether a physician feels honored to be named a top physician or sees little value in it, most doctors are aware of the list’s marketing value for their practices and many choose to make use of it.

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

There has been a flattening of sleep apnea–related mortality rates in the United States over the past 10 years. The exception is among Black men, for whom mortality from sleep apnea has continuously increased over the past 21 years, new research shows.

“OSA (obstructive sleep apnea) has been recognized as an important cause of medical morbidity and mortality and contributes to the development of systemic hypertension, cardiovascular disease, and abnormalities in glucose metabolism,” noted Yu-Che Lee, MD, University at Buffalo–Catholic Health System, Buffalo, N.Y., and colleagues.

“This study provides the first systematic assessment and demonstrates remarkable demographic disparities of age-adjusted sleep apnea–related mortality in the U.S., with higher rates in males than females and Blacks than Whites,” they concluded.

The study was published online in Sleep Medicine.
 

Twenty-one year interval

Data on sleep apnea–related mortality were obtained from the National Center for Health Statistics and were provided by the Centers for Disease Control and Prevention for the years 1999-2019. Over that 21-year interval, sleep apnea was documented as the underlying cause of death in 17,053 decedents, including 2,593 Black patients and 14,127 White patients.

The age-adjusted mortality rate attributed to sleep apnea was 2.5 per 1,000,000 population. The mortality rate was higher for men, at 3.1 per 1,000,000, than among women, 1.9 per 1,000,000 (P < .001). For both sexes, “unadjusted mortality rates were higher in groups aged ≥ 35 years, and the highest mortality rates were observed in groups aged 75-84,” the authors noted. The rate was 11.3 per 1,000,000 for those aged 75-84 and 13.3 per 1,000,000 for those older than 85.

This was also true among Black and White patients, the authors added, although the age-adjusted mortality rate was higher among Black patients than among other racial groups, at 3.5 per 1,000,000 (P < .001). “Over the 21-year study period, the overall age-adjusted mortality rate rose from 1.2 per 1,000,000 population in 1999 to 2.8 per 1,000,000 in 2019,” Dr. Lee and colleagues noted. While the annual percentage change in sleep apnea–related mortality rose by 10.2% (95% confidence interval [CI], 8.4%-12.0%) between 1999 and 2018, no significant change was observed between 2008 and 2019.

On the other hand, when examined by race and sex, age-adjusted mortality rates increased significantly by an annual percentage change of 7.5% (95% CI, 3.3%-11.9%) among Black women and by 8.2% (95% CI, 6.8%-9.6%) between 1999 and 2009 in White men and by 11.5% (95% CI, 8.9%-14.1%) in White women. “Again, these uptrends were no longer observed after that time interval,” the authors stressed.

Only among Black men was there no turning point in age-adjusted mortality rates; they experienced a steady, significant, 2.7% (95% CI, 1.2%-4.2%) annual percent increase in age-adjusted mortality rate between 1999 and 2019. The highest age-adjusted mortality rate for Black persons was recorded in Indiana, at 6.5 per 1,000,000 population; Utah recorded the highest mortality rate for White persons, at 5.7 per 1,000,000.

For both Black persons and White persons, the lowest mortality rates were in New York, at 1.2 per 1,000,000 and 1.5 per 1,000,000, respectively. Among four geographic regions analyzed, the highest age-adjusted mortality rates were in the Midwest for both sexes; Black men in the West and those in three other regional groups in the Northwest had the lowest mortality rates.
 

Multiple causes of death

Black women were more likely to have multiple causes of death, including cardiac arrest, heart failure, and hypertension. White women were more likely to die of arrhythmia, respiratory failure, pneumonia, and depression. Black men were also more likely to die of cardiac arrest, hypertension, and obesity; arrhythmias, ischemic heart disease, and chronic obstructive pulmonary disease were more common in White men.

The authors pointed out that continuous positive airway pressure (CPAP) is the mainstay of therapy for adults with OSA, but many studies have demonstrated decreased CPAP adherence among Black persons. For example, one report indicated that Black persons use CPAP on average 92 minutes less a day after 1 month of therapy than do White persons, for reasons that are not well understood. Asked by this news organization why Black men are so adversely affected by sleep apnea, Dr. Lee pointed out that studies have shown that sleep apnea is more severe in Black men when first diagnosed.

“We know that the severity of sleep apnea is a risk factor for mortality and cardiovascular outcomes,” he said, “so maybe delayed diagnosis, delayed treatment, and noncompliance with CPAP among Black men may help explain why mortality from sleep apnea among Black men has continued to increase.” Why nonadherence to CPAP is higher among Black men is also not clear. Even when access to CPAP is equal for Black patients and White patients, studies have found that rates of noncompliance to CPAP are higher among Black persons than among White patients.

“This is again a hypothesis,” Dr. Lee emphasized, “but perhaps health literacy among Blacks is lower than it is among White patients, and they may not realize that CPAP can improve health outcomes from sleep apnea,” he suggested. The use of CPAP requires a high level of self-advocacy, which might explain part of their noncompliance.

Other health behaviors and environmental factors may contribute to the tendency among Black patients to be noncompliant with CPAP. “I think this is the first study to show that there is a significant racial disparity in mortality from sleep apnea among Black males, and it should give physicians some insight into the problem; they can develop strategies or interventions to try and reduce racial disparities in outcomes from sleep apnea,” Dr. Lee said.

“So, this study is only the beginning, and we need to have more insight and strategies to improve outcomes among Black males,” he affirmed.

Asked to comment on the findings, Diego Mazzotti, PhD, said the study helps bring attention to existing health disparities related to sleep disorders. “Some of the trends observed by the authors seem to explain the increased recognition that sleep apnea may be a risk factor for cardiovascular morbidity and mortality,” said Dr. Mazzotti, assistant professor in the division of medical informatics at the University of Kansas Medical Center in Kansas City.

“Trends in certain minority groups and certain regions in the U.S. suggest that physicians need to recognize the impact of untreated sleep apnea on the cardiovascular health of these patients,” he said.

Dr. Lee and Dr. Mazzotti have disclosed no relevant financial relationships.

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

There has been a flattening of sleep apnea–related mortality rates in the United States over the past 10 years. The exception is among Black men, for whom mortality from sleep apnea has continuously increased over the past 21 years, new research shows.

“OSA (obstructive sleep apnea) has been recognized as an important cause of medical morbidity and mortality and contributes to the development of systemic hypertension, cardiovascular disease, and abnormalities in glucose metabolism,” noted Yu-Che Lee, MD, University at Buffalo–Catholic Health System, Buffalo, N.Y., and colleagues.

“This study provides the first systematic assessment and demonstrates remarkable demographic disparities of age-adjusted sleep apnea–related mortality in the U.S., with higher rates in males than females and Blacks than Whites,” they concluded.

The study was published online in Sleep Medicine.
 

Twenty-one year interval

Data on sleep apnea–related mortality were obtained from the National Center for Health Statistics and were provided by the Centers for Disease Control and Prevention for the years 1999-2019. Over that 21-year interval, sleep apnea was documented as the underlying cause of death in 17,053 decedents, including 2,593 Black patients and 14,127 White patients.

The age-adjusted mortality rate attributed to sleep apnea was 2.5 per 1,000,000 population. The mortality rate was higher for men, at 3.1 per 1,000,000, than among women, 1.9 per 1,000,000 (P < .001). For both sexes, “unadjusted mortality rates were higher in groups aged ≥ 35 years, and the highest mortality rates were observed in groups aged 75-84,” the authors noted. The rate was 11.3 per 1,000,000 for those aged 75-84 and 13.3 per 1,000,000 for those older than 85.

This was also true among Black and White patients, the authors added, although the age-adjusted mortality rate was higher among Black patients than among other racial groups, at 3.5 per 1,000,000 (P < .001). “Over the 21-year study period, the overall age-adjusted mortality rate rose from 1.2 per 1,000,000 population in 1999 to 2.8 per 1,000,000 in 2019,” Dr. Lee and colleagues noted. While the annual percentage change in sleep apnea–related mortality rose by 10.2% (95% confidence interval [CI], 8.4%-12.0%) between 1999 and 2018, no significant change was observed between 2008 and 2019.

On the other hand, when examined by race and sex, age-adjusted mortality rates increased significantly by an annual percentage change of 7.5% (95% CI, 3.3%-11.9%) among Black women and by 8.2% (95% CI, 6.8%-9.6%) between 1999 and 2009 in White men and by 11.5% (95% CI, 8.9%-14.1%) in White women. “Again, these uptrends were no longer observed after that time interval,” the authors stressed.

Only among Black men was there no turning point in age-adjusted mortality rates; they experienced a steady, significant, 2.7% (95% CI, 1.2%-4.2%) annual percent increase in age-adjusted mortality rate between 1999 and 2019. The highest age-adjusted mortality rate for Black persons was recorded in Indiana, at 6.5 per 1,000,000 population; Utah recorded the highest mortality rate for White persons, at 5.7 per 1,000,000.

For both Black persons and White persons, the lowest mortality rates were in New York, at 1.2 per 1,000,000 and 1.5 per 1,000,000, respectively. Among four geographic regions analyzed, the highest age-adjusted mortality rates were in the Midwest for both sexes; Black men in the West and those in three other regional groups in the Northwest had the lowest mortality rates.
 

Multiple causes of death

Black women were more likely to have multiple causes of death, including cardiac arrest, heart failure, and hypertension. White women were more likely to die of arrhythmia, respiratory failure, pneumonia, and depression. Black men were also more likely to die of cardiac arrest, hypertension, and obesity; arrhythmias, ischemic heart disease, and chronic obstructive pulmonary disease were more common in White men.

The authors pointed out that continuous positive airway pressure (CPAP) is the mainstay of therapy for adults with OSA, but many studies have demonstrated decreased CPAP adherence among Black persons. For example, one report indicated that Black persons use CPAP on average 92 minutes less a day after 1 month of therapy than do White persons, for reasons that are not well understood. Asked by this news organization why Black men are so adversely affected by sleep apnea, Dr. Lee pointed out that studies have shown that sleep apnea is more severe in Black men when first diagnosed.

“We know that the severity of sleep apnea is a risk factor for mortality and cardiovascular outcomes,” he said, “so maybe delayed diagnosis, delayed treatment, and noncompliance with CPAP among Black men may help explain why mortality from sleep apnea among Black men has continued to increase.” Why nonadherence to CPAP is higher among Black men is also not clear. Even when access to CPAP is equal for Black patients and White patients, studies have found that rates of noncompliance to CPAP are higher among Black persons than among White patients.

“This is again a hypothesis,” Dr. Lee emphasized, “but perhaps health literacy among Blacks is lower than it is among White patients, and they may not realize that CPAP can improve health outcomes from sleep apnea,” he suggested. The use of CPAP requires a high level of self-advocacy, which might explain part of their noncompliance.

Other health behaviors and environmental factors may contribute to the tendency among Black patients to be noncompliant with CPAP. “I think this is the first study to show that there is a significant racial disparity in mortality from sleep apnea among Black males, and it should give physicians some insight into the problem; they can develop strategies or interventions to try and reduce racial disparities in outcomes from sleep apnea,” Dr. Lee said.

“So, this study is only the beginning, and we need to have more insight and strategies to improve outcomes among Black males,” he affirmed.

Asked to comment on the findings, Diego Mazzotti, PhD, said the study helps bring attention to existing health disparities related to sleep disorders. “Some of the trends observed by the authors seem to explain the increased recognition that sleep apnea may be a risk factor for cardiovascular morbidity and mortality,” said Dr. Mazzotti, assistant professor in the division of medical informatics at the University of Kansas Medical Center in Kansas City.

“Trends in certain minority groups and certain regions in the U.S. suggest that physicians need to recognize the impact of untreated sleep apnea on the cardiovascular health of these patients,” he said.

Dr. Lee and Dr. Mazzotti have disclosed no relevant financial relationships.

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

There has been a flattening of sleep apnea–related mortality rates in the United States over the past 10 years. The exception is among Black men, for whom mortality from sleep apnea has continuously increased over the past 21 years, new research shows.

“OSA (obstructive sleep apnea) has been recognized as an important cause of medical morbidity and mortality and contributes to the development of systemic hypertension, cardiovascular disease, and abnormalities in glucose metabolism,” noted Yu-Che Lee, MD, University at Buffalo–Catholic Health System, Buffalo, N.Y., and colleagues.

“This study provides the first systematic assessment and demonstrates remarkable demographic disparities of age-adjusted sleep apnea–related mortality in the U.S., with higher rates in males than females and Blacks than Whites,” they concluded.

The study was published online in Sleep Medicine.
 

Twenty-one year interval

Data on sleep apnea–related mortality were obtained from the National Center for Health Statistics and were provided by the Centers for Disease Control and Prevention for the years 1999-2019. Over that 21-year interval, sleep apnea was documented as the underlying cause of death in 17,053 decedents, including 2,593 Black patients and 14,127 White patients.

The age-adjusted mortality rate attributed to sleep apnea was 2.5 per 1,000,000 population. The mortality rate was higher for men, at 3.1 per 1,000,000, than among women, 1.9 per 1,000,000 (P < .001). For both sexes, “unadjusted mortality rates were higher in groups aged ≥ 35 years, and the highest mortality rates were observed in groups aged 75-84,” the authors noted. The rate was 11.3 per 1,000,000 for those aged 75-84 and 13.3 per 1,000,000 for those older than 85.

This was also true among Black and White patients, the authors added, although the age-adjusted mortality rate was higher among Black patients than among other racial groups, at 3.5 per 1,000,000 (P < .001). “Over the 21-year study period, the overall age-adjusted mortality rate rose from 1.2 per 1,000,000 population in 1999 to 2.8 per 1,000,000 in 2019,” Dr. Lee and colleagues noted. While the annual percentage change in sleep apnea–related mortality rose by 10.2% (95% confidence interval [CI], 8.4%-12.0%) between 1999 and 2018, no significant change was observed between 2008 and 2019.

On the other hand, when examined by race and sex, age-adjusted mortality rates increased significantly by an annual percentage change of 7.5% (95% CI, 3.3%-11.9%) among Black women and by 8.2% (95% CI, 6.8%-9.6%) between 1999 and 2009 in White men and by 11.5% (95% CI, 8.9%-14.1%) in White women. “Again, these uptrends were no longer observed after that time interval,” the authors stressed.

Only among Black men was there no turning point in age-adjusted mortality rates; they experienced a steady, significant, 2.7% (95% CI, 1.2%-4.2%) annual percent increase in age-adjusted mortality rate between 1999 and 2019. The highest age-adjusted mortality rate for Black persons was recorded in Indiana, at 6.5 per 1,000,000 population; Utah recorded the highest mortality rate for White persons, at 5.7 per 1,000,000.

For both Black persons and White persons, the lowest mortality rates were in New York, at 1.2 per 1,000,000 and 1.5 per 1,000,000, respectively. Among four geographic regions analyzed, the highest age-adjusted mortality rates were in the Midwest for both sexes; Black men in the West and those in three other regional groups in the Northwest had the lowest mortality rates.
 

Multiple causes of death

Black women were more likely to have multiple causes of death, including cardiac arrest, heart failure, and hypertension. White women were more likely to die of arrhythmia, respiratory failure, pneumonia, and depression. Black men were also more likely to die of cardiac arrest, hypertension, and obesity; arrhythmias, ischemic heart disease, and chronic obstructive pulmonary disease were more common in White men.

The authors pointed out that continuous positive airway pressure (CPAP) is the mainstay of therapy for adults with OSA, but many studies have demonstrated decreased CPAP adherence among Black persons. For example, one report indicated that Black persons use CPAP on average 92 minutes less a day after 1 month of therapy than do White persons, for reasons that are not well understood. Asked by this news organization why Black men are so adversely affected by sleep apnea, Dr. Lee pointed out that studies have shown that sleep apnea is more severe in Black men when first diagnosed.

“We know that the severity of sleep apnea is a risk factor for mortality and cardiovascular outcomes,” he said, “so maybe delayed diagnosis, delayed treatment, and noncompliance with CPAP among Black men may help explain why mortality from sleep apnea among Black men has continued to increase.” Why nonadherence to CPAP is higher among Black men is also not clear. Even when access to CPAP is equal for Black patients and White patients, studies have found that rates of noncompliance to CPAP are higher among Black persons than among White patients.

“This is again a hypothesis,” Dr. Lee emphasized, “but perhaps health literacy among Blacks is lower than it is among White patients, and they may not realize that CPAP can improve health outcomes from sleep apnea,” he suggested. The use of CPAP requires a high level of self-advocacy, which might explain part of their noncompliance.

Other health behaviors and environmental factors may contribute to the tendency among Black patients to be noncompliant with CPAP. “I think this is the first study to show that there is a significant racial disparity in mortality from sleep apnea among Black males, and it should give physicians some insight into the problem; they can develop strategies or interventions to try and reduce racial disparities in outcomes from sleep apnea,” Dr. Lee said.

“So, this study is only the beginning, and we need to have more insight and strategies to improve outcomes among Black males,” he affirmed.

Asked to comment on the findings, Diego Mazzotti, PhD, said the study helps bring attention to existing health disparities related to sleep disorders. “Some of the trends observed by the authors seem to explain the increased recognition that sleep apnea may be a risk factor for cardiovascular morbidity and mortality,” said Dr. Mazzotti, assistant professor in the division of medical informatics at the University of Kansas Medical Center in Kansas City.

“Trends in certain minority groups and certain regions in the U.S. suggest that physicians need to recognize the impact of untreated sleep apnea on the cardiovascular health of these patients,” he said.

Dr. Lee and Dr. Mazzotti have disclosed no relevant financial relationships.

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

Even very light alcohol intake is associated with an increased risk for cardiovascular disease, compared with not drinking at all, and the risk increases exponentially as alcohol intake rises, even at moderate levels, a new study shows.

“Our findings suggest that the observed benefit in individuals with light to moderate alcohol intake, which is consistently shown in epidemiological studies, is likely due to other positive lifestyle factors that are common in these individuals who drink lightly,” senior author Krishna Aragam, MD, Massachusetts General Hospital, Boston, told this news organization.

“Our results also showed that while all levels of alcohol were linked to increased risk of cardiovascular disease, the association was not linear. Rather, light alcohol intake was associated with rather modest risk increases, but there were exponential increases in cardiovascular risk with increasing amounts of alcohol consumption,” he said.

As the risk gradient appeared to increase quite sharply even between 1 and 2 drinks per day, Dr. Aragam suggested that what might be regarded as safe levels of drinking may trend downward in the future.

Kirby Hamilton/iStockphoto

They also conducted genetic analyses to examine the effect of alcohol and cardiovascular disease.   

Dr. Aragam explained that previous work has shown good evidence, in individuals who choose to drink, that several relevant genetic variants predict levels of alcohol consumption quite accurately.

“Mendelian randomization using these gene variants allows for stronger inferences about potential causality than do observational studies, as they are less affected by confounding factors,” he noted.

Newer techniques in Mendelian randomization in which data on several gene variants linked to alcohol consumption are combined into a score allow for a greater understanding of the risk linked to different amount of alcohol intake, he added.

In these Mendelian randomization analyses, a 1-standard deviation increase in genetically predicted alcohol consumption was associated with 1.3-fold higher risk of hypertension (P < .001) and 1.4-fold higher risk of coronary artery disease (P = .006).

Further analyses suggested nonlinear associations between alcohol consumption and both hypertension and coronary artery disease; light alcohol intake was associated with minimal increases in cardiovascular risk, whereas heavier consumption was associated with exponential increases in risk of both clinical and subclinical cardiovascular disease.

These results were replicated in a second database of 30,716 individuals from the Mass General Brigham Biobank.

“The findings of this study suggest that the observed cardioprotective effects of light to moderate alcohol intake may be largely mediated by confounding lifestyle factors,” the researchers conclude. “Genetic analyses suggest causal associations between alcohol intake and cardiovascular disease but with unequal and exponential increases in risk at greater levels of intake, which should be accounted for in health recommendations around the habitual consumption of alcohol.”

What is an acceptable level? 

“Specifically, our results suggest that consuming as many as 7 drinks per week is associated with relatively modest increases in cardiovascular risk,” they write.

But they point out that there are unequal increases in cardiovascular risk when progressing from 0 to 7 versus 7 to 14 drinks per week in both men and women.

“Although risk thresholds are inherently somewhat subjective, these findings again bring into question whether an average consumption of 2 drinks per day (14 drinks per week) should be designated a low-risk behavior,” they say.

“Furthermore, as several-fold increases in risk were observed for those consuming 21 or more drinks per week, our results emphasize the importance of aggressive efforts to reduce alcohol intake among heavy drinkers,” they add.

Dr. Aragam elaborated: “Our data suggest that reducing alcohol intake will reduce cardiovascular risk in all individuals, but the extent of the relative risk reduction is quite different depending on the current levels of consumption. For the same absolute reduction in alcohol intake, the gains in terms of reduction in cardiovascular risk will be more pronounced in those who drink heavily and will be more modest in those who drink at a light level.”

The results also suggest that while all levels of alcohol intake increase cardiovascular risk, there are low levels of alcohol consumption that do not carry major elevations in risk, but these are probably lower than those currently recommended, Dr. Aragam pointed out. 

“This doesn’t mean that everyone has to give up drinking alcohol completely, just that you shouldn’t consume with the goal of improving cardiovascular health. In fact, our analyses suggest that in an otherwise healthy person, up to 1 drink per day may not pose outsized risks,” he said. “And, even in a less healthy person who might be smoking, eating poorly, and drinking up to 1 drink per day, it may be a higher priority to focus on smoking cessation and diet than cutting back further on alcohol.”

“Beyond that amount, though, the jury is still out. Our models suggested marked increases in risk even between 1 and 2 drinks per day, and of course even greater risk increases beyond that. So, it’s probably worth revisiting what one might consider a ‘safe’ amount within the moderate drinking categories. The conservative move for now might be to advise a limit of 1 drink per day,” he said.   

Dr. Aragam is supported by grants from the National Institutes of Health and the American Heart Association. He reports receiving speaking fees from the Novartis Institute for Biomedical Research.

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

Even very light alcohol intake is associated with an increased risk for cardiovascular disease, compared with not drinking at all, and the risk increases exponentially as alcohol intake rises, even at moderate levels, a new study shows.

“Our findings suggest that the observed benefit in individuals with light to moderate alcohol intake, which is consistently shown in epidemiological studies, is likely due to other positive lifestyle factors that are common in these individuals who drink lightly,” senior author Krishna Aragam, MD, Massachusetts General Hospital, Boston, told this news organization.

“Our results also showed that while all levels of alcohol were linked to increased risk of cardiovascular disease, the association was not linear. Rather, light alcohol intake was associated with rather modest risk increases, but there were exponential increases in cardiovascular risk with increasing amounts of alcohol consumption,” he said.

As the risk gradient appeared to increase quite sharply even between 1 and 2 drinks per day, Dr. Aragam suggested that what might be regarded as safe levels of drinking may trend downward in the future.

Kirby Hamilton/iStockphoto

They also conducted genetic analyses to examine the effect of alcohol and cardiovascular disease.   

Dr. Aragam explained that previous work has shown good evidence, in individuals who choose to drink, that several relevant genetic variants predict levels of alcohol consumption quite accurately.

“Mendelian randomization using these gene variants allows for stronger inferences about potential causality than do observational studies, as they are less affected by confounding factors,” he noted.

Newer techniques in Mendelian randomization in which data on several gene variants linked to alcohol consumption are combined into a score allow for a greater understanding of the risk linked to different amount of alcohol intake, he added.

In these Mendelian randomization analyses, a 1-standard deviation increase in genetically predicted alcohol consumption was associated with 1.3-fold higher risk of hypertension (P < .001) and 1.4-fold higher risk of coronary artery disease (P = .006).

Further analyses suggested nonlinear associations between alcohol consumption and both hypertension and coronary artery disease; light alcohol intake was associated with minimal increases in cardiovascular risk, whereas heavier consumption was associated with exponential increases in risk of both clinical and subclinical cardiovascular disease.

These results were replicated in a second database of 30,716 individuals from the Mass General Brigham Biobank.

“The findings of this study suggest that the observed cardioprotective effects of light to moderate alcohol intake may be largely mediated by confounding lifestyle factors,” the researchers conclude. “Genetic analyses suggest causal associations between alcohol intake and cardiovascular disease but with unequal and exponential increases in risk at greater levels of intake, which should be accounted for in health recommendations around the habitual consumption of alcohol.”

What is an acceptable level? 

“Specifically, our results suggest that consuming as many as 7 drinks per week is associated with relatively modest increases in cardiovascular risk,” they write.

But they point out that there are unequal increases in cardiovascular risk when progressing from 0 to 7 versus 7 to 14 drinks per week in both men and women.

“Although risk thresholds are inherently somewhat subjective, these findings again bring into question whether an average consumption of 2 drinks per day (14 drinks per week) should be designated a low-risk behavior,” they say.

“Furthermore, as several-fold increases in risk were observed for those consuming 21 or more drinks per week, our results emphasize the importance of aggressive efforts to reduce alcohol intake among heavy drinkers,” they add.

Dr. Aragam elaborated: “Our data suggest that reducing alcohol intake will reduce cardiovascular risk in all individuals, but the extent of the relative risk reduction is quite different depending on the current levels of consumption. For the same absolute reduction in alcohol intake, the gains in terms of reduction in cardiovascular risk will be more pronounced in those who drink heavily and will be more modest in those who drink at a light level.”

The results also suggest that while all levels of alcohol intake increase cardiovascular risk, there are low levels of alcohol consumption that do not carry major elevations in risk, but these are probably lower than those currently recommended, Dr. Aragam pointed out. 

“This doesn’t mean that everyone has to give up drinking alcohol completely, just that you shouldn’t consume with the goal of improving cardiovascular health. In fact, our analyses suggest that in an otherwise healthy person, up to 1 drink per day may not pose outsized risks,” he said. “And, even in a less healthy person who might be smoking, eating poorly, and drinking up to 1 drink per day, it may be a higher priority to focus on smoking cessation and diet than cutting back further on alcohol.”

“Beyond that amount, though, the jury is still out. Our models suggested marked increases in risk even between 1 and 2 drinks per day, and of course even greater risk increases beyond that. So, it’s probably worth revisiting what one might consider a ‘safe’ amount within the moderate drinking categories. The conservative move for now might be to advise a limit of 1 drink per day,” he said.   

Dr. Aragam is supported by grants from the National Institutes of Health and the American Heart Association. He reports receiving speaking fees from the Novartis Institute for Biomedical Research.

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

Even very light alcohol intake is associated with an increased risk for cardiovascular disease, compared with not drinking at all, and the risk increases exponentially as alcohol intake rises, even at moderate levels, a new study shows.

“Our findings suggest that the observed benefit in individuals with light to moderate alcohol intake, which is consistently shown in epidemiological studies, is likely due to other positive lifestyle factors that are common in these individuals who drink lightly,” senior author Krishna Aragam, MD, Massachusetts General Hospital, Boston, told this news organization.

“Our results also showed that while all levels of alcohol were linked to increased risk of cardiovascular disease, the association was not linear. Rather, light alcohol intake was associated with rather modest risk increases, but there were exponential increases in cardiovascular risk with increasing amounts of alcohol consumption,” he said.

As the risk gradient appeared to increase quite sharply even between 1 and 2 drinks per day, Dr. Aragam suggested that what might be regarded as safe levels of drinking may trend downward in the future.

Kirby Hamilton/iStockphoto

They also conducted genetic analyses to examine the effect of alcohol and cardiovascular disease.   

Dr. Aragam explained that previous work has shown good evidence, in individuals who choose to drink, that several relevant genetic variants predict levels of alcohol consumption quite accurately.

“Mendelian randomization using these gene variants allows for stronger inferences about potential causality than do observational studies, as they are less affected by confounding factors,” he noted.

Newer techniques in Mendelian randomization in which data on several gene variants linked to alcohol consumption are combined into a score allow for a greater understanding of the risk linked to different amount of alcohol intake, he added.

In these Mendelian randomization analyses, a 1-standard deviation increase in genetically predicted alcohol consumption was associated with 1.3-fold higher risk of hypertension (P < .001) and 1.4-fold higher risk of coronary artery disease (P = .006).

Further analyses suggested nonlinear associations between alcohol consumption and both hypertension and coronary artery disease; light alcohol intake was associated with minimal increases in cardiovascular risk, whereas heavier consumption was associated with exponential increases in risk of both clinical and subclinical cardiovascular disease.

These results were replicated in a second database of 30,716 individuals from the Mass General Brigham Biobank.

“The findings of this study suggest that the observed cardioprotective effects of light to moderate alcohol intake may be largely mediated by confounding lifestyle factors,” the researchers conclude. “Genetic analyses suggest causal associations between alcohol intake and cardiovascular disease but with unequal and exponential increases in risk at greater levels of intake, which should be accounted for in health recommendations around the habitual consumption of alcohol.”

What is an acceptable level? 

“Specifically, our results suggest that consuming as many as 7 drinks per week is associated with relatively modest increases in cardiovascular risk,” they write.

But they point out that there are unequal increases in cardiovascular risk when progressing from 0 to 7 versus 7 to 14 drinks per week in both men and women.

“Although risk thresholds are inherently somewhat subjective, these findings again bring into question whether an average consumption of 2 drinks per day (14 drinks per week) should be designated a low-risk behavior,” they say.

“Furthermore, as several-fold increases in risk were observed for those consuming 21 or more drinks per week, our results emphasize the importance of aggressive efforts to reduce alcohol intake among heavy drinkers,” they add.

Dr. Aragam elaborated: “Our data suggest that reducing alcohol intake will reduce cardiovascular risk in all individuals, but the extent of the relative risk reduction is quite different depending on the current levels of consumption. For the same absolute reduction in alcohol intake, the gains in terms of reduction in cardiovascular risk will be more pronounced in those who drink heavily and will be more modest in those who drink at a light level.”

The results also suggest that while all levels of alcohol intake increase cardiovascular risk, there are low levels of alcohol consumption that do not carry major elevations in risk, but these are probably lower than those currently recommended, Dr. Aragam pointed out. 

“This doesn’t mean that everyone has to give up drinking alcohol completely, just that you shouldn’t consume with the goal of improving cardiovascular health. In fact, our analyses suggest that in an otherwise healthy person, up to 1 drink per day may not pose outsized risks,” he said. “And, even in a less healthy person who might be smoking, eating poorly, and drinking up to 1 drink per day, it may be a higher priority to focus on smoking cessation and diet than cutting back further on alcohol.”

“Beyond that amount, though, the jury is still out. Our models suggested marked increases in risk even between 1 and 2 drinks per day, and of course even greater risk increases beyond that. So, it’s probably worth revisiting what one might consider a ‘safe’ amount within the moderate drinking categories. The conservative move for now might be to advise a limit of 1 drink per day,” he said.   

Dr. Aragam is supported by grants from the National Institutes of Health and the American Heart Association. He reports receiving speaking fees from the Novartis Institute for Biomedical Research.

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

Older adults taking psychotropic medication before contracting COVID-19 are at increased risk of dementia in the year following the illness, new research suggests.

Results from a large study of more than 1,700 patients who had been hospitalized with COVID showed a greater than twofold increased risk for post-COVID dementia in those taking antipsychotics and mood stabilizers/anticonvulsants – medications often used to treat schizophrenia, psychosis, bipolar disorder, and seizures.

“We know that pre-existing psychiatric illness is associated with poor COVID-19 outcomes, but our study is the first to show an association with certain psychiatric medications and dementia,” co-investigator Liron Sinvani, MD, the Feinstein Institutes for Medical Research, Manhasset, New York, said in an interview.

Feinstein Institutes for Medical Research

‘Striking’ dementia rate

Using electronic health records, the researchers evaluated pre-COVID psychotropic medication use and post-COVID dementia onset in 1,755 adults aged 65 and older. All were hospitalized with COVID-19 at Northwell Health between March 1 and April 20, 2020.

A “striking” 13% of the participants (n = 223) developed dementia within 1-year of follow-up, the investigators report.

Among the 438 patients (25%) exposed to at least one psychotropic medication before COVID-19, 105 (24%) developed dementia in the year following COVID versus 118 of 1,317 (9%) patients with no pre-COVID exposure to psychotropic medication (odds ratio, 3.2; 95% confidence interval, 2.37-4.32).

Both pre-COVID psychotropic medication use (OR, 2.7; 95% CI, 1.8-4.0, P < .001) and delirium (OR, 3.0; 95% CI, 1.9-4.6, P < .001) were significantly associated with post-COVID dementia at 1 year.

In a sensitivity analysis in the subset of 423 patients with at least one documented neurologic or psychiatric diagnosis at the time of COVID admission, and after adjusting for confounding factors, pre-COVID psychotropic medication use remained significantly linked to post-COVID dementia onset (OR, 3.09; 95% CI, 1.5-6.6, P = .002).

Drug classes most strongly associated with 1-year post-COVID dementia onset were antipsychotics (OR, 2.8, 95% CI, 1.7-4.4, P < .001) and mood stabilizers/anticonvulsants (OR, 2.4, 95% CI, 1.39-4.02, P = .001).

In a further exploratory analysis, the psychotropics valproic acid (multiple brands) and haloperidol (Haldol) had the largest association with post-COVID dementia.

Antidepressants as a class were not associated with post-COVID dementia, but the potential effects of two commonly prescribed antidepressants in older adults, mirtazapine (Remeron) and escitalopram (Lexapro), “warrant further investigation,” the researchers note.
 

Predictive risk marker?

“This research shows that psychotropic medications can be considered a predictive risk marker for post-COVID dementia. In patients taking psychotropic medications, COVID-19 could have accelerated progression of dementia after hospitalization,” lead author Yun Freudenberg-Hua, MD, the Feinstein Institutes, said in a news release.

It is unclear why psychotropic medications may raise the risk for dementia onset after COVID, the investigators note.

“It is intuitive that psychotropic medications indicate pre-existing neuropsychiatric conditions in which COVID-19 occurs. It is possible that psychotropic medications may potentiate the neurostructural changes that have been found in the brain of those who have recovered from COVID-19,” they write.

The sensitivity analysis in patients with documented neurologic and psychiatric diagnoses supports this interpretation. 

COVID-19 may also accelerate the underlying brain disorders for which psychotropic medications were prescribed, leading to the greater incidence of post-COVID dementia, the researchers write.

“It is important to note that this study is in no way recommending people should stop taking antipsychotics but simply that clinicians need to factor in a patient’s medication history while considering post-COVID aftereffects,” Dr. Freudenberg-Hua said.

“Given that the number of patients with dementia is projected to triple in the next 30 years, these findings have significant public health implications,” Dr. Sinvani added.

She noted that “care partners and health care professionals” should look for early signs of dementia, such as forgetfulness and depressive symptoms, in their patients.

“Future studies must continue to evaluate these associations, which are key for potential future interventions to prevent dementia,” Dr. Sinvani said.

The study was funded by the National Institutes of Health. Dr. Freudenberg-Hua co-owns stock and stock options from Regeneron Pharmaceuticals. Dr. Sinvani has disclosed no relevant financial relationships.

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

Older adults taking psychotropic medication before contracting COVID-19 are at increased risk of dementia in the year following the illness, new research suggests.

Results from a large study of more than 1,700 patients who had been hospitalized with COVID showed a greater than twofold increased risk for post-COVID dementia in those taking antipsychotics and mood stabilizers/anticonvulsants – medications often used to treat schizophrenia, psychosis, bipolar disorder, and seizures.

“We know that pre-existing psychiatric illness is associated with poor COVID-19 outcomes, but our study is the first to show an association with certain psychiatric medications and dementia,” co-investigator Liron Sinvani, MD, the Feinstein Institutes for Medical Research, Manhasset, New York, said in an interview.

Feinstein Institutes for Medical Research

‘Striking’ dementia rate

Using electronic health records, the researchers evaluated pre-COVID psychotropic medication use and post-COVID dementia onset in 1,755 adults aged 65 and older. All were hospitalized with COVID-19 at Northwell Health between March 1 and April 20, 2020.

A “striking” 13% of the participants (n = 223) developed dementia within 1-year of follow-up, the investigators report.

Among the 438 patients (25%) exposed to at least one psychotropic medication before COVID-19, 105 (24%) developed dementia in the year following COVID versus 118 of 1,317 (9%) patients with no pre-COVID exposure to psychotropic medication (odds ratio, 3.2; 95% confidence interval, 2.37-4.32).

Both pre-COVID psychotropic medication use (OR, 2.7; 95% CI, 1.8-4.0, P < .001) and delirium (OR, 3.0; 95% CI, 1.9-4.6, P < .001) were significantly associated with post-COVID dementia at 1 year.

In a sensitivity analysis in the subset of 423 patients with at least one documented neurologic or psychiatric diagnosis at the time of COVID admission, and after adjusting for confounding factors, pre-COVID psychotropic medication use remained significantly linked to post-COVID dementia onset (OR, 3.09; 95% CI, 1.5-6.6, P = .002).

Drug classes most strongly associated with 1-year post-COVID dementia onset were antipsychotics (OR, 2.8, 95% CI, 1.7-4.4, P < .001) and mood stabilizers/anticonvulsants (OR, 2.4, 95% CI, 1.39-4.02, P = .001).

In a further exploratory analysis, the psychotropics valproic acid (multiple brands) and haloperidol (Haldol) had the largest association with post-COVID dementia.

Antidepressants as a class were not associated with post-COVID dementia, but the potential effects of two commonly prescribed antidepressants in older adults, mirtazapine (Remeron) and escitalopram (Lexapro), “warrant further investigation,” the researchers note.
 

Predictive risk marker?

“This research shows that psychotropic medications can be considered a predictive risk marker for post-COVID dementia. In patients taking psychotropic medications, COVID-19 could have accelerated progression of dementia after hospitalization,” lead author Yun Freudenberg-Hua, MD, the Feinstein Institutes, said in a news release.

It is unclear why psychotropic medications may raise the risk for dementia onset after COVID, the investigators note.

“It is intuitive that psychotropic medications indicate pre-existing neuropsychiatric conditions in which COVID-19 occurs. It is possible that psychotropic medications may potentiate the neurostructural changes that have been found in the brain of those who have recovered from COVID-19,” they write.

The sensitivity analysis in patients with documented neurologic and psychiatric diagnoses supports this interpretation. 

COVID-19 may also accelerate the underlying brain disorders for which psychotropic medications were prescribed, leading to the greater incidence of post-COVID dementia, the researchers write.

“It is important to note that this study is in no way recommending people should stop taking antipsychotics but simply that clinicians need to factor in a patient’s medication history while considering post-COVID aftereffects,” Dr. Freudenberg-Hua said.

“Given that the number of patients with dementia is projected to triple in the next 30 years, these findings have significant public health implications,” Dr. Sinvani added.

She noted that “care partners and health care professionals” should look for early signs of dementia, such as forgetfulness and depressive symptoms, in their patients.

“Future studies must continue to evaluate these associations, which are key for potential future interventions to prevent dementia,” Dr. Sinvani said.

The study was funded by the National Institutes of Health. Dr. Freudenberg-Hua co-owns stock and stock options from Regeneron Pharmaceuticals. Dr. Sinvani has disclosed no relevant financial relationships.

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

Older adults taking psychotropic medication before contracting COVID-19 are at increased risk of dementia in the year following the illness, new research suggests.

Results from a large study of more than 1,700 patients who had been hospitalized with COVID showed a greater than twofold increased risk for post-COVID dementia in those taking antipsychotics and mood stabilizers/anticonvulsants – medications often used to treat schizophrenia, psychosis, bipolar disorder, and seizures.

“We know that pre-existing psychiatric illness is associated with poor COVID-19 outcomes, but our study is the first to show an association with certain psychiatric medications and dementia,” co-investigator Liron Sinvani, MD, the Feinstein Institutes for Medical Research, Manhasset, New York, said in an interview.

Feinstein Institutes for Medical Research

‘Striking’ dementia rate

Using electronic health records, the researchers evaluated pre-COVID psychotropic medication use and post-COVID dementia onset in 1,755 adults aged 65 and older. All were hospitalized with COVID-19 at Northwell Health between March 1 and April 20, 2020.

A “striking” 13% of the participants (n = 223) developed dementia within 1-year of follow-up, the investigators report.

Among the 438 patients (25%) exposed to at least one psychotropic medication before COVID-19, 105 (24%) developed dementia in the year following COVID versus 118 of 1,317 (9%) patients with no pre-COVID exposure to psychotropic medication (odds ratio, 3.2; 95% confidence interval, 2.37-4.32).

Both pre-COVID psychotropic medication use (OR, 2.7; 95% CI, 1.8-4.0, P < .001) and delirium (OR, 3.0; 95% CI, 1.9-4.6, P < .001) were significantly associated with post-COVID dementia at 1 year.

In a sensitivity analysis in the subset of 423 patients with at least one documented neurologic or psychiatric diagnosis at the time of COVID admission, and after adjusting for confounding factors, pre-COVID psychotropic medication use remained significantly linked to post-COVID dementia onset (OR, 3.09; 95% CI, 1.5-6.6, P = .002).

Drug classes most strongly associated with 1-year post-COVID dementia onset were antipsychotics (OR, 2.8, 95% CI, 1.7-4.4, P < .001) and mood stabilizers/anticonvulsants (OR, 2.4, 95% CI, 1.39-4.02, P = .001).

In a further exploratory analysis, the psychotropics valproic acid (multiple brands) and haloperidol (Haldol) had the largest association with post-COVID dementia.

Antidepressants as a class were not associated with post-COVID dementia, but the potential effects of two commonly prescribed antidepressants in older adults, mirtazapine (Remeron) and escitalopram (Lexapro), “warrant further investigation,” the researchers note.
 

Predictive risk marker?

“This research shows that psychotropic medications can be considered a predictive risk marker for post-COVID dementia. In patients taking psychotropic medications, COVID-19 could have accelerated progression of dementia after hospitalization,” lead author Yun Freudenberg-Hua, MD, the Feinstein Institutes, said in a news release.

It is unclear why psychotropic medications may raise the risk for dementia onset after COVID, the investigators note.

“It is intuitive that psychotropic medications indicate pre-existing neuropsychiatric conditions in which COVID-19 occurs. It is possible that psychotropic medications may potentiate the neurostructural changes that have been found in the brain of those who have recovered from COVID-19,” they write.

The sensitivity analysis in patients with documented neurologic and psychiatric diagnoses supports this interpretation. 

COVID-19 may also accelerate the underlying brain disorders for which psychotropic medications were prescribed, leading to the greater incidence of post-COVID dementia, the researchers write.

“It is important to note that this study is in no way recommending people should stop taking antipsychotics but simply that clinicians need to factor in a patient’s medication history while considering post-COVID aftereffects,” Dr. Freudenberg-Hua said.

“Given that the number of patients with dementia is projected to triple in the next 30 years, these findings have significant public health implications,” Dr. Sinvani added.

She noted that “care partners and health care professionals” should look for early signs of dementia, such as forgetfulness and depressive symptoms, in their patients.

“Future studies must continue to evaluate these associations, which are key for potential future interventions to prevent dementia,” Dr. Sinvani said.

The study was funded by the National Institutes of Health. Dr. Freudenberg-Hua co-owns stock and stock options from Regeneron Pharmaceuticals. Dr. Sinvani has disclosed no relevant financial relationships.

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

Children at risk of neonatal hypoglycemia who were screened and treated if needed showed no difference in educational achievement from controls at age 9-10 years, based on data from 480 children.

Previous studies have shown an increased risk of poor executive and visual-motor function in children with neonatal hypoglycemia, but the effect on later childhood academic performance remains unclear, wrote Rajesh Shah, PhD, of the University of Auckland, New Zealand, and colleagues.

In a prospective cohort study published in JAMA, the researchers enrolled moderate to late preterm and term infants born at increased risk for hypoglycemia; those with episodes of hypoglycemia were treated to maintain a blood glucose concentration of at least 47 mg/dL.

The study population was enrolled between 2006 and 2010 at a regional perinatal center in New Zealand, and their educational achievement was assessed 9-10 years later. The primary outcome of low educational achievement was defined as performing below the normal curriculum level in standardized tests of reading comprehension or math. The researchers also identified 47 secondary outcomes related to executive function, visual-motor function, psychosocial adaptation, and general health.

Rates of low educational achievement were not significantly different for children with and without neonatal hypoglycemia (47% vs. 48%, adjusted risk ratio 0.95).

No significant differences appeared between the two groups for any secondary outcomes, including reading comprehension, math, behavior manifestations of executive function, fine motor function, autism traits, and overall well-being, the researchers noted.

However, children with neonatal hypoglycemia were significantly less likely to be rated as below or well below reading curriculum level by teachers compared to those without neonatal hypoglycemia (24% vs. 31%).

The researchers cited a previous study of the same patient cohort at age 4.5 years, which suggested an association between adverse neurodevelopmental outcomes and infant hypoglycemia. However, the reason this association did not persist at age 9-10 years remains unclear, the researchers wrote in their discussion. “Early disturbances in brain development may have diminishing effects over time due to neuroplasticity, that is, reorganization of neural networks, or delayed maturation with mid-childhood catch-up in neurocognitive function,” they said.

The study findings were limited by several factors including the lack of data on several measures of cognition, notably processing speed, and a lack of adjustment for intelligence quotient at age 4.5 years, the lack of data on any treatment for developmental impairment, and the inclusion of a population with well-managed hypoglycemia, the researchers said.

However, the results were strengthened by having a sample size large enough to detect associations, the prospective design, and the accurate measure of neonatal glycemic exposure, they said. Although the results suggest that at-risk children reach similar endpoints by the end of primary school, “efforts to prevent and optimize adverse pregnancy conditions remain important, and developmental surveillance after birth should be considered for at-risk infants,” they concluded.

In a related study published in JAMA, Taygen Edwards and colleagues found that prophylactic oral dextrose gel had no significant effect on neurosensory function.

The study, a prospective follow-up of a multicenter randomized trial, included 1,197 later preterm or term infants deemed at risk for neonatal hypoglycemia. The infants (49% of whom were female) were randomized to prophylactic 40% dextrose gel or a placebo, massaged into the buccal mucosa at 1 hour after birth.

The primary outcome was neurosensory impairment at 2 years of age, which was assessed by neurologic examination, parent-reported medical questionnaires, Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), performance-based executive function, Behavior Rating Inventory of Executive Function–Preschool Version, motion coherence thresholds, growth, and body composition.

At 2 years of age, the prevalence of neurosensory impairment was 21% and 19%, respectively, in infants randomized to prophylactic oral dextrose gel and placebo, a nonsignificant difference. No differences between the two groups were noted for cognitive and language delays, or low performance-based overall executive function. However, infants randomized to dextrose gel had significantly higher risk of motor delay compared to placebo (2.5% vs. 0.7%) and significantly lower Bayley-III composite scores for cognitive, language, and motor performance.

No significant differences were noted between the groups in the areas of moderate or severe neurosensory impairment, hearing impairment, cerebral palsy, developmental delay, above-average development, socioemotional and adaptive behavior, questionnaire-based executive function, low visual processing, history of seizures, allergic and infectious diseases, growth, and body composition.

The results are consistent with previous studies on the safety of dextrose gel, the researchers wrote in their discussion. However, the absolute difference of 7% in the primary outcome may be clinically important, they noted. “Caution is warranted before using prophylactic dextrose gel,” they said.

The researchers noted the results of a dose-finding trial that suggested improved scores on language, executive function, and motor skills in unadjusted analysis with higher doses of dextrose gel, but the reason for these findings remains unknown, they said.

The study findings were limited by the potential underpowering to detect small, but significant differences, and possible lack of generalizability because the majority of the participants were children of mothers with diabetes.

The results were strengthened by the high follow-up rate and comprehensive assessments, and highlight the need for additional research with longer follow-up, the researchers said.
 

Findings fuel further exploration

Although hypoglycemia is common in newborns, its management and potential outcomes remain subjects for debate, Paul J. Rozance, MD, of the University of Colorado, Aurora, wrote in an editorial accompanying both studies.

“Often, the same features that increase the risk of hypoglycemia in newborns also increase the risk for poor outcomes independent of hypoglycemia,” he said.

The study by Shah and colleagues was not a randomized trial of a specific management strategy, Dr. Rozance noted. However, the high rate of low educational attainment in children not exposed to dextrose gel emphasizes the need for more effective management of infant hypoglycemia, he said. “The findings also suggest that antenatal conditions that are associated with increased risk of hypoglycemia among newborns are associated with increased risk for impaired neurodevelopment and educational achievement, independent of neonatal hypoglycemia,” he said. The study findings contrast with those of an earlier study showing low academic achievement association with early transient hypoglycemia, which could argue for earlier intervention, he noted.

The study by Edwards and colleagues addressed the potential value of dextrose gel as an early intervention to prevent neonatal hypoglycemia, said Dr. Rozance.

“The 95% CI for the primary outcome of neurosensory impairment included up to a 7% increased risk for neurosensory impairment in the prophylactic dextrose gel group. The 7% increased risk was defined by the investigators as potentially clinically important, and the study may have been underpowered to detect small differences in the primary outcome,” he wrote.

Although the reasons for adverse outcomes in children given prophylactic dextrose gel remain unclear, “incorporation of prophylactic dextrose gel into clinical practice should await further research,” he said.

Regarding such research, Dr. Rozance proposed an “ideal study,” that would “randomize newborns with hypoglycemia to treatment or no treatment, although equipoise and ethical support for such a study are lacking. Another strategy would be to randomize newborns with hypoglycemia to receive low- or high-treatment glucose concentration goals,” he noted.

The relationship between hypoglycemia and impaired neurodevelopment is yet to be determined, but the two studies provide new evidence for the clinical importance and need for management of neonatal hypoglycemia and subsequent neurodevelopmental outcomes, he concluded.

The study by Shah and colleagues was supported by the Health Research Council of New Zealand and the Maurice and Phyllis Paykel Trust. Dr. Shah disclosed a doctoral fellowship from the University of Auckland. The study by Edwards and colleagues was supported by the Health Research Council of New Zealand and the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health. Ms. Edwards had no financial conflicts to disclose. Dr. Rozance disclosed receiving a StatStrip from Nova Biomedical for use in his laboratory.

Children at risk of neonatal hypoglycemia who were screened and treated if needed showed no difference in educational achievement from controls at age 9-10 years, based on data from 480 children.

Previous studies have shown an increased risk of poor executive and visual-motor function in children with neonatal hypoglycemia, but the effect on later childhood academic performance remains unclear, wrote Rajesh Shah, PhD, of the University of Auckland, New Zealand, and colleagues.

In a prospective cohort study published in JAMA, the researchers enrolled moderate to late preterm and term infants born at increased risk for hypoglycemia; those with episodes of hypoglycemia were treated to maintain a blood glucose concentration of at least 47 mg/dL.

The study population was enrolled between 2006 and 2010 at a regional perinatal center in New Zealand, and their educational achievement was assessed 9-10 years later. The primary outcome of low educational achievement was defined as performing below the normal curriculum level in standardized tests of reading comprehension or math. The researchers also identified 47 secondary outcomes related to executive function, visual-motor function, psychosocial adaptation, and general health.

Rates of low educational achievement were not significantly different for children with and without neonatal hypoglycemia (47% vs. 48%, adjusted risk ratio 0.95).

No significant differences appeared between the two groups for any secondary outcomes, including reading comprehension, math, behavior manifestations of executive function, fine motor function, autism traits, and overall well-being, the researchers noted.

However, children with neonatal hypoglycemia were significantly less likely to be rated as below or well below reading curriculum level by teachers compared to those without neonatal hypoglycemia (24% vs. 31%).

The researchers cited a previous study of the same patient cohort at age 4.5 years, which suggested an association between adverse neurodevelopmental outcomes and infant hypoglycemia. However, the reason this association did not persist at age 9-10 years remains unclear, the researchers wrote in their discussion. “Early disturbances in brain development may have diminishing effects over time due to neuroplasticity, that is, reorganization of neural networks, or delayed maturation with mid-childhood catch-up in neurocognitive function,” they said.

The study findings were limited by several factors including the lack of data on several measures of cognition, notably processing speed, and a lack of adjustment for intelligence quotient at age 4.5 years, the lack of data on any treatment for developmental impairment, and the inclusion of a population with well-managed hypoglycemia, the researchers said.

However, the results were strengthened by having a sample size large enough to detect associations, the prospective design, and the accurate measure of neonatal glycemic exposure, they said. Although the results suggest that at-risk children reach similar endpoints by the end of primary school, “efforts to prevent and optimize adverse pregnancy conditions remain important, and developmental surveillance after birth should be considered for at-risk infants,” they concluded.

In a related study published in JAMA, Taygen Edwards and colleagues found that prophylactic oral dextrose gel had no significant effect on neurosensory function.

The study, a prospective follow-up of a multicenter randomized trial, included 1,197 later preterm or term infants deemed at risk for neonatal hypoglycemia. The infants (49% of whom were female) were randomized to prophylactic 40% dextrose gel or a placebo, massaged into the buccal mucosa at 1 hour after birth.

The primary outcome was neurosensory impairment at 2 years of age, which was assessed by neurologic examination, parent-reported medical questionnaires, Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), performance-based executive function, Behavior Rating Inventory of Executive Function–Preschool Version, motion coherence thresholds, growth, and body composition.

At 2 years of age, the prevalence of neurosensory impairment was 21% and 19%, respectively, in infants randomized to prophylactic oral dextrose gel and placebo, a nonsignificant difference. No differences between the two groups were noted for cognitive and language delays, or low performance-based overall executive function. However, infants randomized to dextrose gel had significantly higher risk of motor delay compared to placebo (2.5% vs. 0.7%) and significantly lower Bayley-III composite scores for cognitive, language, and motor performance.

No significant differences were noted between the groups in the areas of moderate or severe neurosensory impairment, hearing impairment, cerebral palsy, developmental delay, above-average development, socioemotional and adaptive behavior, questionnaire-based executive function, low visual processing, history of seizures, allergic and infectious diseases, growth, and body composition.

The results are consistent with previous studies on the safety of dextrose gel, the researchers wrote in their discussion. However, the absolute difference of 7% in the primary outcome may be clinically important, they noted. “Caution is warranted before using prophylactic dextrose gel,” they said.

The researchers noted the results of a dose-finding trial that suggested improved scores on language, executive function, and motor skills in unadjusted analysis with higher doses of dextrose gel, but the reason for these findings remains unknown, they said.

The study findings were limited by the potential underpowering to detect small, but significant differences, and possible lack of generalizability because the majority of the participants were children of mothers with diabetes.

The results were strengthened by the high follow-up rate and comprehensive assessments, and highlight the need for additional research with longer follow-up, the researchers said.
 

Findings fuel further exploration

Although hypoglycemia is common in newborns, its management and potential outcomes remain subjects for debate, Paul J. Rozance, MD, of the University of Colorado, Aurora, wrote in an editorial accompanying both studies.

“Often, the same features that increase the risk of hypoglycemia in newborns also increase the risk for poor outcomes independent of hypoglycemia,” he said.

The study by Shah and colleagues was not a randomized trial of a specific management strategy, Dr. Rozance noted. However, the high rate of low educational attainment in children not exposed to dextrose gel emphasizes the need for more effective management of infant hypoglycemia, he said. “The findings also suggest that antenatal conditions that are associated with increased risk of hypoglycemia among newborns are associated with increased risk for impaired neurodevelopment and educational achievement, independent of neonatal hypoglycemia,” he said. The study findings contrast with those of an earlier study showing low academic achievement association with early transient hypoglycemia, which could argue for earlier intervention, he noted.

The study by Edwards and colleagues addressed the potential value of dextrose gel as an early intervention to prevent neonatal hypoglycemia, said Dr. Rozance.

“The 95% CI for the primary outcome of neurosensory impairment included up to a 7% increased risk for neurosensory impairment in the prophylactic dextrose gel group. The 7% increased risk was defined by the investigators as potentially clinically important, and the study may have been underpowered to detect small differences in the primary outcome,” he wrote.

Although the reasons for adverse outcomes in children given prophylactic dextrose gel remain unclear, “incorporation of prophylactic dextrose gel into clinical practice should await further research,” he said.

Regarding such research, Dr. Rozance proposed an “ideal study,” that would “randomize newborns with hypoglycemia to treatment or no treatment, although equipoise and ethical support for such a study are lacking. Another strategy would be to randomize newborns with hypoglycemia to receive low- or high-treatment glucose concentration goals,” he noted.

The relationship between hypoglycemia and impaired neurodevelopment is yet to be determined, but the two studies provide new evidence for the clinical importance and need for management of neonatal hypoglycemia and subsequent neurodevelopmental outcomes, he concluded.

The study by Shah and colleagues was supported by the Health Research Council of New Zealand and the Maurice and Phyllis Paykel Trust. Dr. Shah disclosed a doctoral fellowship from the University of Auckland. The study by Edwards and colleagues was supported by the Health Research Council of New Zealand and the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health. Ms. Edwards had no financial conflicts to disclose. Dr. Rozance disclosed receiving a StatStrip from Nova Biomedical for use in his laboratory.

Children at risk of neonatal hypoglycemia who were screened and treated if needed showed no difference in educational achievement from controls at age 9-10 years, based on data from 480 children.

Previous studies have shown an increased risk of poor executive and visual-motor function in children with neonatal hypoglycemia, but the effect on later childhood academic performance remains unclear, wrote Rajesh Shah, PhD, of the University of Auckland, New Zealand, and colleagues.

In a prospective cohort study published in JAMA, the researchers enrolled moderate to late preterm and term infants born at increased risk for hypoglycemia; those with episodes of hypoglycemia were treated to maintain a blood glucose concentration of at least 47 mg/dL.

The study population was enrolled between 2006 and 2010 at a regional perinatal center in New Zealand, and their educational achievement was assessed 9-10 years later. The primary outcome of low educational achievement was defined as performing below the normal curriculum level in standardized tests of reading comprehension or math. The researchers also identified 47 secondary outcomes related to executive function, visual-motor function, psychosocial adaptation, and general health.

Rates of low educational achievement were not significantly different for children with and without neonatal hypoglycemia (47% vs. 48%, adjusted risk ratio 0.95).

No significant differences appeared between the two groups for any secondary outcomes, including reading comprehension, math, behavior manifestations of executive function, fine motor function, autism traits, and overall well-being, the researchers noted.

However, children with neonatal hypoglycemia were significantly less likely to be rated as below or well below reading curriculum level by teachers compared to those without neonatal hypoglycemia (24% vs. 31%).

The researchers cited a previous study of the same patient cohort at age 4.5 years, which suggested an association between adverse neurodevelopmental outcomes and infant hypoglycemia. However, the reason this association did not persist at age 9-10 years remains unclear, the researchers wrote in their discussion. “Early disturbances in brain development may have diminishing effects over time due to neuroplasticity, that is, reorganization of neural networks, or delayed maturation with mid-childhood catch-up in neurocognitive function,” they said.

The study findings were limited by several factors including the lack of data on several measures of cognition, notably processing speed, and a lack of adjustment for intelligence quotient at age 4.5 years, the lack of data on any treatment for developmental impairment, and the inclusion of a population with well-managed hypoglycemia, the researchers said.

However, the results were strengthened by having a sample size large enough to detect associations, the prospective design, and the accurate measure of neonatal glycemic exposure, they said. Although the results suggest that at-risk children reach similar endpoints by the end of primary school, “efforts to prevent and optimize adverse pregnancy conditions remain important, and developmental surveillance after birth should be considered for at-risk infants,” they concluded.

In a related study published in JAMA, Taygen Edwards and colleagues found that prophylactic oral dextrose gel had no significant effect on neurosensory function.

The study, a prospective follow-up of a multicenter randomized trial, included 1,197 later preterm or term infants deemed at risk for neonatal hypoglycemia. The infants (49% of whom were female) were randomized to prophylactic 40% dextrose gel or a placebo, massaged into the buccal mucosa at 1 hour after birth.

The primary outcome was neurosensory impairment at 2 years of age, which was assessed by neurologic examination, parent-reported medical questionnaires, Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), performance-based executive function, Behavior Rating Inventory of Executive Function–Preschool Version, motion coherence thresholds, growth, and body composition.

At 2 years of age, the prevalence of neurosensory impairment was 21% and 19%, respectively, in infants randomized to prophylactic oral dextrose gel and placebo, a nonsignificant difference. No differences between the two groups were noted for cognitive and language delays, or low performance-based overall executive function. However, infants randomized to dextrose gel had significantly higher risk of motor delay compared to placebo (2.5% vs. 0.7%) and significantly lower Bayley-III composite scores for cognitive, language, and motor performance.

No significant differences were noted between the groups in the areas of moderate or severe neurosensory impairment, hearing impairment, cerebral palsy, developmental delay, above-average development, socioemotional and adaptive behavior, questionnaire-based executive function, low visual processing, history of seizures, allergic and infectious diseases, growth, and body composition.

The results are consistent with previous studies on the safety of dextrose gel, the researchers wrote in their discussion. However, the absolute difference of 7% in the primary outcome may be clinically important, they noted. “Caution is warranted before using prophylactic dextrose gel,” they said.

The researchers noted the results of a dose-finding trial that suggested improved scores on language, executive function, and motor skills in unadjusted analysis with higher doses of dextrose gel, but the reason for these findings remains unknown, they said.

The study findings were limited by the potential underpowering to detect small, but significant differences, and possible lack of generalizability because the majority of the participants were children of mothers with diabetes.

The results were strengthened by the high follow-up rate and comprehensive assessments, and highlight the need for additional research with longer follow-up, the researchers said.
 

Findings fuel further exploration

Although hypoglycemia is common in newborns, its management and potential outcomes remain subjects for debate, Paul J. Rozance, MD, of the University of Colorado, Aurora, wrote in an editorial accompanying both studies.

“Often, the same features that increase the risk of hypoglycemia in newborns also increase the risk for poor outcomes independent of hypoglycemia,” he said.

The study by Shah and colleagues was not a randomized trial of a specific management strategy, Dr. Rozance noted. However, the high rate of low educational attainment in children not exposed to dextrose gel emphasizes the need for more effective management of infant hypoglycemia, he said. “The findings also suggest that antenatal conditions that are associated with increased risk of hypoglycemia among newborns are associated with increased risk for impaired neurodevelopment and educational achievement, independent of neonatal hypoglycemia,” he said. The study findings contrast with those of an earlier study showing low academic achievement association with early transient hypoglycemia, which could argue for earlier intervention, he noted.

The study by Edwards and colleagues addressed the potential value of dextrose gel as an early intervention to prevent neonatal hypoglycemia, said Dr. Rozance.

“The 95% CI for the primary outcome of neurosensory impairment included up to a 7% increased risk for neurosensory impairment in the prophylactic dextrose gel group. The 7% increased risk was defined by the investigators as potentially clinically important, and the study may have been underpowered to detect small differences in the primary outcome,” he wrote.

Although the reasons for adverse outcomes in children given prophylactic dextrose gel remain unclear, “incorporation of prophylactic dextrose gel into clinical practice should await further research,” he said.

Regarding such research, Dr. Rozance proposed an “ideal study,” that would “randomize newborns with hypoglycemia to treatment or no treatment, although equipoise and ethical support for such a study are lacking. Another strategy would be to randomize newborns with hypoglycemia to receive low- or high-treatment glucose concentration goals,” he noted.

The relationship between hypoglycemia and impaired neurodevelopment is yet to be determined, but the two studies provide new evidence for the clinical importance and need for management of neonatal hypoglycemia and subsequent neurodevelopmental outcomes, he concluded.

The study by Shah and colleagues was supported by the Health Research Council of New Zealand and the Maurice and Phyllis Paykel Trust. Dr. Shah disclosed a doctoral fellowship from the University of Auckland. The study by Edwards and colleagues was supported by the Health Research Council of New Zealand and the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health. Ms. Edwards had no financial conflicts to disclose. Dr. Rozance disclosed receiving a StatStrip from Nova Biomedical for use in his laboratory.

The pandemic not only disrupted sleep but may have also triggered an uptick in the use of wearable tech. Sleep tracking was featured at the Cardiovascular Health Tech virtual conference 2022, sponsored by the Institute of Electrical and Electronics Engineers Engineering in Medicine & Biology Society technical committee on Cardiopulmonary Systems and Physiology-Based Engineering.

This news organization interviewed presenter Kelly Glazer Baron, PhD, MPH, DBSM, an associate professor at the University of Utah, Salt Lake City, and a clinical psychologist specializing in behavioral sleep medicine.

The interview has been edited for length and clarity.
 

Question: Are consumer sleep trackers mainly divided into “nearables” – things that you put at the side of the bed or under the pillow – vs. wearables?

Dr. Baron: There are so many different devices these days. There are things that you put under your mattress or pillow; there are bedside recording devices; then there are headbands, rings, wrist-worn, all kinds of things.

Q: At the conference, Philip de Chazal, PhD, (University of Sydney) described the evidence on sleep tracking smartphone apps as woeful. Would you agree with that?

A: Yes. I would agree if you’re looking at how accurate they are at recording sleep, particularly compared with what we would define as the gold standard, which is a sleep study wherein you have electrodes on the scalp and you’re measuring the electrical activity directly.

Devices that go under the pillow are extremely poor at deciphering sleep from wake time, which is really the main goal. They are best at detecting when you get into the bed and when you get out. But even then, there isn’t good evidence that they do that accurately when there are two people in the bed.

Overall, they may give you a general gist of what’s happening in terms of time in and out of bed, but we’re doubtful on their recording ability to tell sleep from wake time.
 

Q: Are the wrist-worn devices better for sleep tracking?

A: They’re getting better. We’ve used wrist activity monitors in research for years. They use an accelerometer to measure movement, and then an algorithm determines whether an interval of time is called sleep or wake.

Recently, they’ve incorporated more sensors, such as heart rate, and they can more accurately decipher rapid eye movement (REM) sleep from non-REM. They’re still not as good as doing a full sleep study. But they’re getting closer.
 

Q: If asked how you slept, most of us think we can answer without needing to look at a smartphone, but maybe not. Can you explain “paradoxical insomnia”?

A: You can’t really know if you’re sleeping because if you know you’re asleep, then you can’t be asleep because it’s a state of unconsciousness. How people decide whether they had a good night’s sleep probably depends on a lot of things about how they feel when they wake up in the morning or if they remember being up in the night.

Quality of sleep is not really something that people can directly ascertain. There is a selection of people who feel awake all night but they actually are sleeping. They feel that their sleep quality is poor: They’re suffering; they have insomnia, but from the objective data, they are sleeping fine.
 

Q: Is this related to non-REM stage 1 sleep, when you may not be aware that you’re asleep?

A: No. I’m talking about people who come into the sleep lab for an overnight study and get hooked up. And in the morning, they’ll tell the tech I was awake all night, but the tech will see that their sleep was just fine.

There is a disconnect between how people perceive their sleep and how they actually sleep. For most people it’s impossible to be completely accurate to know how much you’re sleeping. Then there are some people who perceive it very differently.

Sleep trackers don’t have the level of detail of sleep studies that use scalp electrodes. When we get into the details of sleep measurement, we’re measuring 30-second epochs (sampling periods), where we look at broad measures of electrical activity. There is even more detail there that can be pulled out using other techniques, such as analyzing the spectrum of the EEG. For example, some studies have found a beta frequency in the EEG of people with insomnia, so even though they are sleeping, they often feel awake.

Basically, the subjective experience of sleep somewhat overlaps with the objective recording of what’s happening on a sleep study, but not completely.
 

Q: You said that first thing in the morning might not be the best time to assess your sleep – if you wake up groggy and are already thinking, “The day is shot.”

A: In general, people really feel worst in the morning. Their circadian drive is low, especially if they’re a little sleep deprived. You shouldn’t judge the day on the first hour after waking – most people are pretty cognitively impaired. I tell people they need some boot-up time.

You feel differently as the day goes on and even at different points of the day. There’s a lull in the early afternoon because of your circadian dip and then we get a second wind in the evening. How you feel isn’t one flat line; it’s really a rhythm throughout the day
 

Q: Would you say that consumer sleep trackers are okay for individuals to use to see a pattern but are maybe not accurate enough to use more globally in research?

A: I think there is a huge opportunity to understand sleep at a population level. For example, if there’s been a hurricane or an earthquake or Superbowl Sunday, companies have an opportunity to look at the impact – say, daylight saving time and how it affects sleep across different countries, or men vs. women, or different age groups.

There was a paper about sleep among hospital workers in Wuhan during the outbreak of the pandemic. That was a creative use of wearable devices to look at sleep in a large population.

Now, of course, the devices are not given out randomly; the people who buy them are probably a little bit healthier, maybe a little bit younger – that sort of thing. It is a biased sample.
 

Q: As you note, mobile health trackers tend to be used by the “worried well.” Can you tell us about your paper that introduced the term “orthosomnia,” or “a perfectionistic quest for the ideal sleep in order to optimize daytime function”?

A: As these devices came out, more people were coming into the clinic and shoving their data in front of us saying, “I don’t feel well, and I don’t sleep 7 hours.” They were focused on this specific number. Back when we wrote this paper, the devices were primarily movement based (now the devices are a bit more accurate). Some would say, “My sleep is light, and it’s not deep.” We’d do a sleep study that showed that they have deep sleep, but they would still believe their device even though the device really wasn’t able to classify sleep accurately.

We even found people making their sleep worse because of the device. For example, trying to get the number higher by spending more time lying in bed trying to sleep which is the opposite of what you want someone with insomnia to do. These people held the data so tight and really felt that it characterized their experience, even though we sleep medicine practitioners didn’t find it very accurate and felt that it was somewhat unhelpful to their treatment.
 

Q: What advice would you give the harried primary care physician presented with a patient’s hypnogram or sleep pattern?

A: As someone once pointed out to me, it’s a conversation opener about their sleep. Did they buy the device because they’re worried about their sleep? It’s unlikely that you can glean anything clinically useful from the data.

I briefly look at it to see the duration of their sleep, the regularity in their sleep pattern – the pattern of awakenings during the night might suggest that they have some insomnia. But it doesn’t take the place of clinical assessment for conditions like sleep apnea: Are they snoring? Are they unrefreshed?

I had a patient in the orthosomnia study who was given a sleep tracker by a family member. He brought the data to his doctor who ordered a sleep study that found he had sleep apnea. He would say, “The device diagnosed my sleep apnea.” But that wasn’t actually the case; it just opened the conversation and the clinician said, “Well, let’s order a sleep study.”
 

Q: The device told him he wasn’t getting much sleep and then the sleep study told him it was apnea.

A: Right. It’s impossible to pick up sleep apnea. Some of the latest devices have some oximetry reading but it is not a clinically validated oximetry that could diagnose sleep apnea.

When these first came out I thought I’d get more referrals. So far, I haven’t had a single person come in and ask if they have sleep apnea. If you have a patient saying, “Hey, I’m worried about my oxygen level and here’s my data,” then the clinician should consider whether they need a sleep study for sleep apnea.
 

Q: You did a survey that suggests that clinicians are less keen on these devices than consumers. Conor Heneghan of Fitbit/Google also mentioned a study using the Fitbit Charge and a SleepLife portal. The patients were very engaged but only one physician (out of 49) logged into the portal to look at the data.

A: Our survey of sleep professionals (which we need to publish) showed that they were wary of the data. They found it frustrating in some ways because it took time out of the clinical encounter.

Some of them said that parents are putting trackers on their children and then catastrophizing their children’s sleep.
 

Q: Is there such a thing as an ideal hypnogram or does it vary by individual?

A: I would say that it depends on a lot of things. If you think about a hypnogram from a sleep study, the patient is not sleeping in their home environment, and it’s only one night. There’s a range of what would be considered normal, and it’s related to your sex and your age.

One night is not going to be sufficient to characterize your percentage in this or that sleep stage. Our patients come in saying, “I’m not getting enough REM.” But there isn’t a sleep disorder called lack of REM; there’s no treatment for that. It’s probably pretty normal for them or maybe they’re taking medications that suppress their REM, such as antidepressants.

The tech world is very interested to sense REM properly and to display it. But on the treatment side of things, there’s not much that we do with that data. We’re more interested in the consolidation of their sleep, the duration of their sleep, breathing-related sleep disorders, those sorts of things.
 

Q: Is there any reason to be concerned about the amount of REM sleep in terms of outcomes? We know that poor sleep can lead to bad cardiovascular outcomes, but has any of that correlated to sleep stage?

A: There are studies where they’ve experimentally deprived people of certain stages of sleep, but they’re not very useful in the real world. We’re looking at sleep holistically: Do you have a good sleep pattern? Any breathing-related sleep disorders? Insomnia? We don’t treat sleep by the stage.

Q: Any concern that people who are focused on a device may be ignoring the basic tenets of good sleep hygiene?

A: If people are doing things that are obviously bad for their sleep, like working too late, not exercising enough, sleeping in on weekends to compensate for being up late during the week, or probably the biggest thing contributing to insomnia – stress. A device itself won’t fix those things but it could show you the evidence.

If somebody really has a sleep disorder, then sleep hygiene alone is probably not going to be enough. They’re going to need to engage in a more extensive program to improve their sleep, such as cognitive-behavioral therapy for insomnia.
 

Q: Is there anything else you want to mention?

A: I don’t want to leave with a reputation of being against sleep trackers. I think they are a great opportunity for people to get excited about and learn about their sleep and try to improve it. We have a lot to learn about what people want from their data and how we can use that data to improve people’s sleep.

As providers, we can engage with our patients – sleep is an automatic process, but improving sleep takes some effort. Buying a device is not going to automatically make you sleep better. It takes work to establish a better sleep pattern; it may require some cognitive-behavioral therapy or treating a sleep disorder. That takes some work.

Dr. Baron reported no conflicts of interest.A version of this article first appeared on Medscape.com.

The pandemic not only disrupted sleep but may have also triggered an uptick in the use of wearable tech. Sleep tracking was featured at the Cardiovascular Health Tech virtual conference 2022, sponsored by the Institute of Electrical and Electronics Engineers Engineering in Medicine & Biology Society technical committee on Cardiopulmonary Systems and Physiology-Based Engineering.

This news organization interviewed presenter Kelly Glazer Baron, PhD, MPH, DBSM, an associate professor at the University of Utah, Salt Lake City, and a clinical psychologist specializing in behavioral sleep medicine.

The interview has been edited for length and clarity.
 

Question: Are consumer sleep trackers mainly divided into “nearables” – things that you put at the side of the bed or under the pillow – vs. wearables?

Dr. Baron: There are so many different devices these days. There are things that you put under your mattress or pillow; there are bedside recording devices; then there are headbands, rings, wrist-worn, all kinds of things.

Q: At the conference, Philip de Chazal, PhD, (University of Sydney) described the evidence on sleep tracking smartphone apps as woeful. Would you agree with that?

A: Yes. I would agree if you’re looking at how accurate they are at recording sleep, particularly compared with what we would define as the gold standard, which is a sleep study wherein you have electrodes on the scalp and you’re measuring the electrical activity directly.

Devices that go under the pillow are extremely poor at deciphering sleep from wake time, which is really the main goal. They are best at detecting when you get into the bed and when you get out. But even then, there isn’t good evidence that they do that accurately when there are two people in the bed.

Overall, they may give you a general gist of what’s happening in terms of time in and out of bed, but we’re doubtful on their recording ability to tell sleep from wake time.
 

Q: Are the wrist-worn devices better for sleep tracking?

A: They’re getting better. We’ve used wrist activity monitors in research for years. They use an accelerometer to measure movement, and then an algorithm determines whether an interval of time is called sleep or wake.

Recently, they’ve incorporated more sensors, such as heart rate, and they can more accurately decipher rapid eye movement (REM) sleep from non-REM. They’re still not as good as doing a full sleep study. But they’re getting closer.
 

Q: If asked how you slept, most of us think we can answer without needing to look at a smartphone, but maybe not. Can you explain “paradoxical insomnia”?

A: You can’t really know if you’re sleeping because if you know you’re asleep, then you can’t be asleep because it’s a state of unconsciousness. How people decide whether they had a good night’s sleep probably depends on a lot of things about how they feel when they wake up in the morning or if they remember being up in the night.

Quality of sleep is not really something that people can directly ascertain. There is a selection of people who feel awake all night but they actually are sleeping. They feel that their sleep quality is poor: They’re suffering; they have insomnia, but from the objective data, they are sleeping fine.
 

Q: Is this related to non-REM stage 1 sleep, when you may not be aware that you’re asleep?

A: No. I’m talking about people who come into the sleep lab for an overnight study and get hooked up. And in the morning, they’ll tell the tech I was awake all night, but the tech will see that their sleep was just fine.

There is a disconnect between how people perceive their sleep and how they actually sleep. For most people it’s impossible to be completely accurate to know how much you’re sleeping. Then there are some people who perceive it very differently.

Sleep trackers don’t have the level of detail of sleep studies that use scalp electrodes. When we get into the details of sleep measurement, we’re measuring 30-second epochs (sampling periods), where we look at broad measures of electrical activity. There is even more detail there that can be pulled out using other techniques, such as analyzing the spectrum of the EEG. For example, some studies have found a beta frequency in the EEG of people with insomnia, so even though they are sleeping, they often feel awake.

Basically, the subjective experience of sleep somewhat overlaps with the objective recording of what’s happening on a sleep study, but not completely.
 

Q: You said that first thing in the morning might not be the best time to assess your sleep – if you wake up groggy and are already thinking, “The day is shot.”

A: In general, people really feel worst in the morning. Their circadian drive is low, especially if they’re a little sleep deprived. You shouldn’t judge the day on the first hour after waking – most people are pretty cognitively impaired. I tell people they need some boot-up time.

You feel differently as the day goes on and even at different points of the day. There’s a lull in the early afternoon because of your circadian dip and then we get a second wind in the evening. How you feel isn’t one flat line; it’s really a rhythm throughout the day
 

Q: Would you say that consumer sleep trackers are okay for individuals to use to see a pattern but are maybe not accurate enough to use more globally in research?

A: I think there is a huge opportunity to understand sleep at a population level. For example, if there’s been a hurricane or an earthquake or Superbowl Sunday, companies have an opportunity to look at the impact – say, daylight saving time and how it affects sleep across different countries, or men vs. women, or different age groups.

There was a paper about sleep among hospital workers in Wuhan during the outbreak of the pandemic. That was a creative use of wearable devices to look at sleep in a large population.

Now, of course, the devices are not given out randomly; the people who buy them are probably a little bit healthier, maybe a little bit younger – that sort of thing. It is a biased sample.
 

Q: As you note, mobile health trackers tend to be used by the “worried well.” Can you tell us about your paper that introduced the term “orthosomnia,” or “a perfectionistic quest for the ideal sleep in order to optimize daytime function”?

A: As these devices came out, more people were coming into the clinic and shoving their data in front of us saying, “I don’t feel well, and I don’t sleep 7 hours.” They were focused on this specific number. Back when we wrote this paper, the devices were primarily movement based (now the devices are a bit more accurate). Some would say, “My sleep is light, and it’s not deep.” We’d do a sleep study that showed that they have deep sleep, but they would still believe their device even though the device really wasn’t able to classify sleep accurately.

We even found people making their sleep worse because of the device. For example, trying to get the number higher by spending more time lying in bed trying to sleep which is the opposite of what you want someone with insomnia to do. These people held the data so tight and really felt that it characterized their experience, even though we sleep medicine practitioners didn’t find it very accurate and felt that it was somewhat unhelpful to their treatment.
 

Q: What advice would you give the harried primary care physician presented with a patient’s hypnogram or sleep pattern?

A: As someone once pointed out to me, it’s a conversation opener about their sleep. Did they buy the device because they’re worried about their sleep? It’s unlikely that you can glean anything clinically useful from the data.

I briefly look at it to see the duration of their sleep, the regularity in their sleep pattern – the pattern of awakenings during the night might suggest that they have some insomnia. But it doesn’t take the place of clinical assessment for conditions like sleep apnea: Are they snoring? Are they unrefreshed?

I had a patient in the orthosomnia study who was given a sleep tracker by a family member. He brought the data to his doctor who ordered a sleep study that found he had sleep apnea. He would say, “The device diagnosed my sleep apnea.” But that wasn’t actually the case; it just opened the conversation and the clinician said, “Well, let’s order a sleep study.”
 

Q: The device told him he wasn’t getting much sleep and then the sleep study told him it was apnea.

A: Right. It’s impossible to pick up sleep apnea. Some of the latest devices have some oximetry reading but it is not a clinically validated oximetry that could diagnose sleep apnea.

When these first came out I thought I’d get more referrals. So far, I haven’t had a single person come in and ask if they have sleep apnea. If you have a patient saying, “Hey, I’m worried about my oxygen level and here’s my data,” then the clinician should consider whether they need a sleep study for sleep apnea.
 

Q: You did a survey that suggests that clinicians are less keen on these devices than consumers. Conor Heneghan of Fitbit/Google also mentioned a study using the Fitbit Charge and a SleepLife portal. The patients were very engaged but only one physician (out of 49) logged into the portal to look at the data.

A: Our survey of sleep professionals (which we need to publish) showed that they were wary of the data. They found it frustrating in some ways because it took time out of the clinical encounter.

Some of them said that parents are putting trackers on their children and then catastrophizing their children’s sleep.
 

Q: Is there such a thing as an ideal hypnogram or does it vary by individual?

A: I would say that it depends on a lot of things. If you think about a hypnogram from a sleep study, the patient is not sleeping in their home environment, and it’s only one night. There’s a range of what would be considered normal, and it’s related to your sex and your age.

One night is not going to be sufficient to characterize your percentage in this or that sleep stage. Our patients come in saying, “I’m not getting enough REM.” But there isn’t a sleep disorder called lack of REM; there’s no treatment for that. It’s probably pretty normal for them or maybe they’re taking medications that suppress their REM, such as antidepressants.

The tech world is very interested to sense REM properly and to display it. But on the treatment side of things, there’s not much that we do with that data. We’re more interested in the consolidation of their sleep, the duration of their sleep, breathing-related sleep disorders, those sorts of things.
 

Q: Is there any reason to be concerned about the amount of REM sleep in terms of outcomes? We know that poor sleep can lead to bad cardiovascular outcomes, but has any of that correlated to sleep stage?

A: There are studies where they’ve experimentally deprived people of certain stages of sleep, but they’re not very useful in the real world. We’re looking at sleep holistically: Do you have a good sleep pattern? Any breathing-related sleep disorders? Insomnia? We don’t treat sleep by the stage.

Q: Any concern that people who are focused on a device may be ignoring the basic tenets of good sleep hygiene?

A: If people are doing things that are obviously bad for their sleep, like working too late, not exercising enough, sleeping in on weekends to compensate for being up late during the week, or probably the biggest thing contributing to insomnia – stress. A device itself won’t fix those things but it could show you the evidence.

If somebody really has a sleep disorder, then sleep hygiene alone is probably not going to be enough. They’re going to need to engage in a more extensive program to improve their sleep, such as cognitive-behavioral therapy for insomnia.
 

Q: Is there anything else you want to mention?

A: I don’t want to leave with a reputation of being against sleep trackers. I think they are a great opportunity for people to get excited about and learn about their sleep and try to improve it. We have a lot to learn about what people want from their data and how we can use that data to improve people’s sleep.

As providers, we can engage with our patients – sleep is an automatic process, but improving sleep takes some effort. Buying a device is not going to automatically make you sleep better. It takes work to establish a better sleep pattern; it may require some cognitive-behavioral therapy or treating a sleep disorder. That takes some work.

Dr. Baron reported no conflicts of interest.A version of this article first appeared on Medscape.com.

The pandemic not only disrupted sleep but may have also triggered an uptick in the use of wearable tech. Sleep tracking was featured at the Cardiovascular Health Tech virtual conference 2022, sponsored by the Institute of Electrical and Electronics Engineers Engineering in Medicine & Biology Society technical committee on Cardiopulmonary Systems and Physiology-Based Engineering.

This news organization interviewed presenter Kelly Glazer Baron, PhD, MPH, DBSM, an associate professor at the University of Utah, Salt Lake City, and a clinical psychologist specializing in behavioral sleep medicine.

The interview has been edited for length and clarity.
 

Question: Are consumer sleep trackers mainly divided into “nearables” – things that you put at the side of the bed or under the pillow – vs. wearables?

Dr. Baron: There are so many different devices these days. There are things that you put under your mattress or pillow; there are bedside recording devices; then there are headbands, rings, wrist-worn, all kinds of things.

Q: At the conference, Philip de Chazal, PhD, (University of Sydney) described the evidence on sleep tracking smartphone apps as woeful. Would you agree with that?

A: Yes. I would agree if you’re looking at how accurate they are at recording sleep, particularly compared with what we would define as the gold standard, which is a sleep study wherein you have electrodes on the scalp and you’re measuring the electrical activity directly.

Devices that go under the pillow are extremely poor at deciphering sleep from wake time, which is really the main goal. They are best at detecting when you get into the bed and when you get out. But even then, there isn’t good evidence that they do that accurately when there are two people in the bed.

Overall, they may give you a general gist of what’s happening in terms of time in and out of bed, but we’re doubtful on their recording ability to tell sleep from wake time.
 

Q: Are the wrist-worn devices better for sleep tracking?

A: They’re getting better. We’ve used wrist activity monitors in research for years. They use an accelerometer to measure movement, and then an algorithm determines whether an interval of time is called sleep or wake.

Recently, they’ve incorporated more sensors, such as heart rate, and they can more accurately decipher rapid eye movement (REM) sleep from non-REM. They’re still not as good as doing a full sleep study. But they’re getting closer.
 

Q: If asked how you slept, most of us think we can answer without needing to look at a smartphone, but maybe not. Can you explain “paradoxical insomnia”?

A: You can’t really know if you’re sleeping because if you know you’re asleep, then you can’t be asleep because it’s a state of unconsciousness. How people decide whether they had a good night’s sleep probably depends on a lot of things about how they feel when they wake up in the morning or if they remember being up in the night.

Quality of sleep is not really something that people can directly ascertain. There is a selection of people who feel awake all night but they actually are sleeping. They feel that their sleep quality is poor: They’re suffering; they have insomnia, but from the objective data, they are sleeping fine.
 

Q: Is this related to non-REM stage 1 sleep, when you may not be aware that you’re asleep?

A: No. I’m talking about people who come into the sleep lab for an overnight study and get hooked up. And in the morning, they’ll tell the tech I was awake all night, but the tech will see that their sleep was just fine.

There is a disconnect between how people perceive their sleep and how they actually sleep. For most people it’s impossible to be completely accurate to know how much you’re sleeping. Then there are some people who perceive it very differently.

Sleep trackers don’t have the level of detail of sleep studies that use scalp electrodes. When we get into the details of sleep measurement, we’re measuring 30-second epochs (sampling periods), where we look at broad measures of electrical activity. There is even more detail there that can be pulled out using other techniques, such as analyzing the spectrum of the EEG. For example, some studies have found a beta frequency in the EEG of people with insomnia, so even though they are sleeping, they often feel awake.

Basically, the subjective experience of sleep somewhat overlaps with the objective recording of what’s happening on a sleep study, but not completely.
 

Q: You said that first thing in the morning might not be the best time to assess your sleep – if you wake up groggy and are already thinking, “The day is shot.”

A: In general, people really feel worst in the morning. Their circadian drive is low, especially if they’re a little sleep deprived. You shouldn’t judge the day on the first hour after waking – most people are pretty cognitively impaired. I tell people they need some boot-up time.

You feel differently as the day goes on and even at different points of the day. There’s a lull in the early afternoon because of your circadian dip and then we get a second wind in the evening. How you feel isn’t one flat line; it’s really a rhythm throughout the day
 

Q: Would you say that consumer sleep trackers are okay for individuals to use to see a pattern but are maybe not accurate enough to use more globally in research?

A: I think there is a huge opportunity to understand sleep at a population level. For example, if there’s been a hurricane or an earthquake or Superbowl Sunday, companies have an opportunity to look at the impact – say, daylight saving time and how it affects sleep across different countries, or men vs. women, or different age groups.

There was a paper about sleep among hospital workers in Wuhan during the outbreak of the pandemic. That was a creative use of wearable devices to look at sleep in a large population.

Now, of course, the devices are not given out randomly; the people who buy them are probably a little bit healthier, maybe a little bit younger – that sort of thing. It is a biased sample.
 

Q: As you note, mobile health trackers tend to be used by the “worried well.” Can you tell us about your paper that introduced the term “orthosomnia,” or “a perfectionistic quest for the ideal sleep in order to optimize daytime function”?

A: As these devices came out, more people were coming into the clinic and shoving their data in front of us saying, “I don’t feel well, and I don’t sleep 7 hours.” They were focused on this specific number. Back when we wrote this paper, the devices were primarily movement based (now the devices are a bit more accurate). Some would say, “My sleep is light, and it’s not deep.” We’d do a sleep study that showed that they have deep sleep, but they would still believe their device even though the device really wasn’t able to classify sleep accurately.

We even found people making their sleep worse because of the device. For example, trying to get the number higher by spending more time lying in bed trying to sleep which is the opposite of what you want someone with insomnia to do. These people held the data so tight and really felt that it characterized their experience, even though we sleep medicine practitioners didn’t find it very accurate and felt that it was somewhat unhelpful to their treatment.
 

Q: What advice would you give the harried primary care physician presented with a patient’s hypnogram or sleep pattern?

A: As someone once pointed out to me, it’s a conversation opener about their sleep. Did they buy the device because they’re worried about their sleep? It’s unlikely that you can glean anything clinically useful from the data.

I briefly look at it to see the duration of their sleep, the regularity in their sleep pattern – the pattern of awakenings during the night might suggest that they have some insomnia. But it doesn’t take the place of clinical assessment for conditions like sleep apnea: Are they snoring? Are they unrefreshed?

I had a patient in the orthosomnia study who was given a sleep tracker by a family member. He brought the data to his doctor who ordered a sleep study that found he had sleep apnea. He would say, “The device diagnosed my sleep apnea.” But that wasn’t actually the case; it just opened the conversation and the clinician said, “Well, let’s order a sleep study.”
 

Q: The device told him he wasn’t getting much sleep and then the sleep study told him it was apnea.

A: Right. It’s impossible to pick up sleep apnea. Some of the latest devices have some oximetry reading but it is not a clinically validated oximetry that could diagnose sleep apnea.

When these first came out I thought I’d get more referrals. So far, I haven’t had a single person come in and ask if they have sleep apnea. If you have a patient saying, “Hey, I’m worried about my oxygen level and here’s my data,” then the clinician should consider whether they need a sleep study for sleep apnea.
 

Q: You did a survey that suggests that clinicians are less keen on these devices than consumers. Conor Heneghan of Fitbit/Google also mentioned a study using the Fitbit Charge and a SleepLife portal. The patients were very engaged but only one physician (out of 49) logged into the portal to look at the data.

A: Our survey of sleep professionals (which we need to publish) showed that they were wary of the data. They found it frustrating in some ways because it took time out of the clinical encounter.

Some of them said that parents are putting trackers on their children and then catastrophizing their children’s sleep.
 

Q: Is there such a thing as an ideal hypnogram or does it vary by individual?

A: I would say that it depends on a lot of things. If you think about a hypnogram from a sleep study, the patient is not sleeping in their home environment, and it’s only one night. There’s a range of what would be considered normal, and it’s related to your sex and your age.

One night is not going to be sufficient to characterize your percentage in this or that sleep stage. Our patients come in saying, “I’m not getting enough REM.” But there isn’t a sleep disorder called lack of REM; there’s no treatment for that. It’s probably pretty normal for them or maybe they’re taking medications that suppress their REM, such as antidepressants.

The tech world is very interested to sense REM properly and to display it. But on the treatment side of things, there’s not much that we do with that data. We’re more interested in the consolidation of their sleep, the duration of their sleep, breathing-related sleep disorders, those sorts of things.
 

Q: Is there any reason to be concerned about the amount of REM sleep in terms of outcomes? We know that poor sleep can lead to bad cardiovascular outcomes, but has any of that correlated to sleep stage?

A: There are studies where they’ve experimentally deprived people of certain stages of sleep, but they’re not very useful in the real world. We’re looking at sleep holistically: Do you have a good sleep pattern? Any breathing-related sleep disorders? Insomnia? We don’t treat sleep by the stage.

Q: Any concern that people who are focused on a device may be ignoring the basic tenets of good sleep hygiene?

A: If people are doing things that are obviously bad for their sleep, like working too late, not exercising enough, sleeping in on weekends to compensate for being up late during the week, or probably the biggest thing contributing to insomnia – stress. A device itself won’t fix those things but it could show you the evidence.

If somebody really has a sleep disorder, then sleep hygiene alone is probably not going to be enough. They’re going to need to engage in a more extensive program to improve their sleep, such as cognitive-behavioral therapy for insomnia.
 

Q: Is there anything else you want to mention?

A: I don’t want to leave with a reputation of being against sleep trackers. I think they are a great opportunity for people to get excited about and learn about their sleep and try to improve it. We have a lot to learn about what people want from their data and how we can use that data to improve people’s sleep.

As providers, we can engage with our patients – sleep is an automatic process, but improving sleep takes some effort. Buying a device is not going to automatically make you sleep better. It takes work to establish a better sleep pattern; it may require some cognitive-behavioral therapy or treating a sleep disorder. That takes some work.

Dr. Baron reported no conflicts of interest.A version of this article first appeared on Medscape.com.

About one in six patients with Creutzfeldt-Jakob disease (CJD) undergo surgery, raising the risk of iatrogenic transmission of this rare but universally fatal prion disease.

In a retrospective analysis, researchers found that 26 of 121 (21%) patients with probable or definite CJD at four U.S. academic medical centers underwent a total of 55 procedures.

These included high-risk procedures for two patients with neuropathologically proven CJD. One underwent ophthalmic artery aneurysm clipping for unruptured aneurysm, and the other underwent diagnostic brain biopsy.

“The findings were definitely surprising to me and my team – particularly the high frequency with which patients with an irreversible and particularly transmissible neurologic disease underwent invasive medical procedures either just before or shortly after the emergence of symptoms later attributed to CJD,” study investigator Gregory Day, MD, with the Mayo Clinic, Jacksonville, Fla., said in an interview.

The study was published online March 9, 2022, in JAMA Network Open.
 

Poor infection control

The investigators noted that the majority of CJD cases are sporadic or are inherited, but research shows that prion transmission can occur via contaminated tissues or reusable medical equipment.

While the risk of iatrogenic transmission is highest following procedures involving the central nervous system, where prion burden is highest, experimental models suggest CJD transmission can occur after contact with other tissues, including nasal mucosa, lung, lymph nodes, and spleen, the researchers noted.

“If these models are accurate, surgical procedures involving these tissues may pose a risk to patients,” the investigators wrote.

To determine the potential scope of this problem, the researchers examined the frequency of invasive procedures performed in patients with CJD at four tertiary care centers.

“In several cases, these procedures were done with clear indications [such as] fixation or joint replacement following a fracture. In several others, however, the procedures were unlikely to help the patient. For instance, a hip replacement for walking difficulties that were actually due to changes in the brain due to CJD,” Dr. Day said.

“Even more surprising was the low frequency with which appropriate surgical precautions/infection control procedures were used in patients with established diagnoses of CJD,” he noted.

Only one procedure was performed with sterilization techniques adequate to prevent CJD.

Dr. Day said the findings aren’t necessarily cause for immediate alarm, but they do highlight an area for potential improvement, including better screening of patients who have new and unexplained symptoms before proceeding with surgery, especially surgery of the central nervous system, where prion burden is high.

Another potential solution is to develop and support program surveillance and to work with public health organizations such the Centers for Disease Control and Prevention and the National Prion Disease Pathology Surveillance Center to elicit a surgical history in patients diagnosed with prion disease.

“Active nationwide surveillance is needed to determine the true scope of this potential problem and to develop strategies to mitigate the potential risk of iatrogenic prion transmission to future patients,” Dr. Day said.
 

True prevalence unknown

The authors of an invited commentary noted that, while most CJD infections occur sporadically, iatrogenic transmission is possible. Approximately 500 such cases have been reported worldwide to date.

“Yet, reported transmission from surgical procedures remains rare, with fewer than 10 confirmed CJD cases described in the literature, although the true prevalence is difficult to quantify as confirmed diagnosis requires autopsy,” wrote Beatrice Sun, MD, and Joseph Forrester, MD, with the department of surgery, Stanford (Calif.) University.

They noted that, over a 15-year period, 19 suspected iatrogenic CJD exposures were reported to the CDC – two from ophthalmology procedures, and 17 from neurosurgical procedures.

In all 19 cases, the diagnosis of CJD was unknown before the intervention, and all surgical instruments underwent normal decontamination protocols, which are inadequate to eradicate prion disease.

For patients with suspected or confirmed CJD, the World Health Organization has published infection control guidelines to prevent transmission of spongiform encephalopathies.

The guidelines recommend proper communication with all staff involved in the surgical procedure and the sterilization of supplies to be aware of potential exposure; minimizing the number of staff in the operating room; using single-use equipment whenever possible and disposing of it by incineration; using protective coverings for all nondisposable equipment; and scheduling such procedures at the end of the day to allow adequate time for decontamination.

Funding for the study was provided by the National Institutes of Health. Dr. Day owns stock in ANI Pharmaceuticals; serves as a consultant for Parabon Nanolabs, as a topic editor (dementia) for DynaMed, and as the clinical director of the Anti-NMDA Receptor Encephalitis Foundation (uncompensated). Dr. Forrester reported receiving unrestricted research funding from Varian and has received grant funding from the Surgical Infections Society.

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

About one in six patients with Creutzfeldt-Jakob disease (CJD) undergo surgery, raising the risk of iatrogenic transmission of this rare but universally fatal prion disease.

In a retrospective analysis, researchers found that 26 of 121 (21%) patients with probable or definite CJD at four U.S. academic medical centers underwent a total of 55 procedures.

These included high-risk procedures for two patients with neuropathologically proven CJD. One underwent ophthalmic artery aneurysm clipping for unruptured aneurysm, and the other underwent diagnostic brain biopsy.

“The findings were definitely surprising to me and my team – particularly the high frequency with which patients with an irreversible and particularly transmissible neurologic disease underwent invasive medical procedures either just before or shortly after the emergence of symptoms later attributed to CJD,” study investigator Gregory Day, MD, with the Mayo Clinic, Jacksonville, Fla., said in an interview.

The study was published online March 9, 2022, in JAMA Network Open.
 

Poor infection control

The investigators noted that the majority of CJD cases are sporadic or are inherited, but research shows that prion transmission can occur via contaminated tissues or reusable medical equipment.

While the risk of iatrogenic transmission is highest following procedures involving the central nervous system, where prion burden is highest, experimental models suggest CJD transmission can occur after contact with other tissues, including nasal mucosa, lung, lymph nodes, and spleen, the researchers noted.

“If these models are accurate, surgical procedures involving these tissues may pose a risk to patients,” the investigators wrote.

To determine the potential scope of this problem, the researchers examined the frequency of invasive procedures performed in patients with CJD at four tertiary care centers.

“In several cases, these procedures were done with clear indications [such as] fixation or joint replacement following a fracture. In several others, however, the procedures were unlikely to help the patient. For instance, a hip replacement for walking difficulties that were actually due to changes in the brain due to CJD,” Dr. Day said.

“Even more surprising was the low frequency with which appropriate surgical precautions/infection control procedures were used in patients with established diagnoses of CJD,” he noted.

Only one procedure was performed with sterilization techniques adequate to prevent CJD.

Dr. Day said the findings aren’t necessarily cause for immediate alarm, but they do highlight an area for potential improvement, including better screening of patients who have new and unexplained symptoms before proceeding with surgery, especially surgery of the central nervous system, where prion burden is high.

Another potential solution is to develop and support program surveillance and to work with public health organizations such the Centers for Disease Control and Prevention and the National Prion Disease Pathology Surveillance Center to elicit a surgical history in patients diagnosed with prion disease.

“Active nationwide surveillance is needed to determine the true scope of this potential problem and to develop strategies to mitigate the potential risk of iatrogenic prion transmission to future patients,” Dr. Day said.
 

True prevalence unknown

The authors of an invited commentary noted that, while most CJD infections occur sporadically, iatrogenic transmission is possible. Approximately 500 such cases have been reported worldwide to date.

“Yet, reported transmission from surgical procedures remains rare, with fewer than 10 confirmed CJD cases described in the literature, although the true prevalence is difficult to quantify as confirmed diagnosis requires autopsy,” wrote Beatrice Sun, MD, and Joseph Forrester, MD, with the department of surgery, Stanford (Calif.) University.

They noted that, over a 15-year period, 19 suspected iatrogenic CJD exposures were reported to the CDC – two from ophthalmology procedures, and 17 from neurosurgical procedures.

In all 19 cases, the diagnosis of CJD was unknown before the intervention, and all surgical instruments underwent normal decontamination protocols, which are inadequate to eradicate prion disease.

For patients with suspected or confirmed CJD, the World Health Organization has published infection control guidelines to prevent transmission of spongiform encephalopathies.

The guidelines recommend proper communication with all staff involved in the surgical procedure and the sterilization of supplies to be aware of potential exposure; minimizing the number of staff in the operating room; using single-use equipment whenever possible and disposing of it by incineration; using protective coverings for all nondisposable equipment; and scheduling such procedures at the end of the day to allow adequate time for decontamination.

Funding for the study was provided by the National Institutes of Health. Dr. Day owns stock in ANI Pharmaceuticals; serves as a consultant for Parabon Nanolabs, as a topic editor (dementia) for DynaMed, and as the clinical director of the Anti-NMDA Receptor Encephalitis Foundation (uncompensated). Dr. Forrester reported receiving unrestricted research funding from Varian and has received grant funding from the Surgical Infections Society.

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

About one in six patients with Creutzfeldt-Jakob disease (CJD) undergo surgery, raising the risk of iatrogenic transmission of this rare but universally fatal prion disease.

In a retrospective analysis, researchers found that 26 of 121 (21%) patients with probable or definite CJD at four U.S. academic medical centers underwent a total of 55 procedures.

These included high-risk procedures for two patients with neuropathologically proven CJD. One underwent ophthalmic artery aneurysm clipping for unruptured aneurysm, and the other underwent diagnostic brain biopsy.

“The findings were definitely surprising to me and my team – particularly the high frequency with which patients with an irreversible and particularly transmissible neurologic disease underwent invasive medical procedures either just before or shortly after the emergence of symptoms later attributed to CJD,” study investigator Gregory Day, MD, with the Mayo Clinic, Jacksonville, Fla., said in an interview.

The study was published online March 9, 2022, in JAMA Network Open.
 

Poor infection control

The investigators noted that the majority of CJD cases are sporadic or are inherited, but research shows that prion transmission can occur via contaminated tissues or reusable medical equipment.

While the risk of iatrogenic transmission is highest following procedures involving the central nervous system, where prion burden is highest, experimental models suggest CJD transmission can occur after contact with other tissues, including nasal mucosa, lung, lymph nodes, and spleen, the researchers noted.

“If these models are accurate, surgical procedures involving these tissues may pose a risk to patients,” the investigators wrote.

To determine the potential scope of this problem, the researchers examined the frequency of invasive procedures performed in patients with CJD at four tertiary care centers.

“In several cases, these procedures were done with clear indications [such as] fixation or joint replacement following a fracture. In several others, however, the procedures were unlikely to help the patient. For instance, a hip replacement for walking difficulties that were actually due to changes in the brain due to CJD,” Dr. Day said.

“Even more surprising was the low frequency with which appropriate surgical precautions/infection control procedures were used in patients with established diagnoses of CJD,” he noted.

Only one procedure was performed with sterilization techniques adequate to prevent CJD.

Dr. Day said the findings aren’t necessarily cause for immediate alarm, but they do highlight an area for potential improvement, including better screening of patients who have new and unexplained symptoms before proceeding with surgery, especially surgery of the central nervous system, where prion burden is high.

Another potential solution is to develop and support program surveillance and to work with public health organizations such the Centers for Disease Control and Prevention and the National Prion Disease Pathology Surveillance Center to elicit a surgical history in patients diagnosed with prion disease.

“Active nationwide surveillance is needed to determine the true scope of this potential problem and to develop strategies to mitigate the potential risk of iatrogenic prion transmission to future patients,” Dr. Day said.
 

True prevalence unknown

The authors of an invited commentary noted that, while most CJD infections occur sporadically, iatrogenic transmission is possible. Approximately 500 such cases have been reported worldwide to date.

“Yet, reported transmission from surgical procedures remains rare, with fewer than 10 confirmed CJD cases described in the literature, although the true prevalence is difficult to quantify as confirmed diagnosis requires autopsy,” wrote Beatrice Sun, MD, and Joseph Forrester, MD, with the department of surgery, Stanford (Calif.) University.

They noted that, over a 15-year period, 19 suspected iatrogenic CJD exposures were reported to the CDC – two from ophthalmology procedures, and 17 from neurosurgical procedures.

In all 19 cases, the diagnosis of CJD was unknown before the intervention, and all surgical instruments underwent normal decontamination protocols, which are inadequate to eradicate prion disease.

For patients with suspected or confirmed CJD, the World Health Organization has published infection control guidelines to prevent transmission of spongiform encephalopathies.

The guidelines recommend proper communication with all staff involved in the surgical procedure and the sterilization of supplies to be aware of potential exposure; minimizing the number of staff in the operating room; using single-use equipment whenever possible and disposing of it by incineration; using protective coverings for all nondisposable equipment; and scheduling such procedures at the end of the day to allow adequate time for decontamination.

Funding for the study was provided by the National Institutes of Health. Dr. Day owns stock in ANI Pharmaceuticals; serves as a consultant for Parabon Nanolabs, as a topic editor (dementia) for DynaMed, and as the clinical director of the Anti-NMDA Receptor Encephalitis Foundation (uncompensated). Dr. Forrester reported receiving unrestricted research funding from Varian and has received grant funding from the Surgical Infections Society.

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

The Food and Drug Administration today authorized Americans over the age of 50 to receive a second COVID-19 booster shot, even though many top infectious disease experts questioned the need before the agency’s decision.

The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.

The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.

“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.

Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.

“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”

Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.

“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
 

To boost or not to boost

Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.

“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.

The current vaccine — with a booster — has prevented severe disease, he said.

An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.

A just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.

A small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.

Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.

And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.

“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
 

Booster confusion

The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.

Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.

What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.

The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).

The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.

That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.

Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.

The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.

Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”

There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.

“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”

Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.

“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”

Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
 

Supply issues?

Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.

That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.

Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.

On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”

But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”

Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”

Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.

He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”

Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”

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

The Food and Drug Administration today authorized Americans over the age of 50 to receive a second COVID-19 booster shot, even though many top infectious disease experts questioned the need before the agency’s decision.

The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.

The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.

“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.

Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.

“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”

Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.

“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
 

To boost or not to boost

Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.

“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.

The current vaccine — with a booster — has prevented severe disease, he said.

An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.

A just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.

A small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.

Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.

And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.

“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
 

Booster confusion

The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.

Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.

What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.

The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).

The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.

That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.

Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.

The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.

Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”

There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.

“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”

Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.

“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”

Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
 

Supply issues?

Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.

That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.

Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.

On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”

But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”

Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”

Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.

He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”

Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”

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

The Food and Drug Administration today authorized Americans over the age of 50 to receive a second COVID-19 booster shot, even though many top infectious disease experts questioned the need before the agency’s decision.

The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.

The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.

“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.

Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.

“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”

Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.

“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
 

To boost or not to boost

Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.

“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.

The current vaccine — with a booster — has prevented severe disease, he said.

An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.

A just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.

A small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.

Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.

And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.

“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
 

Booster confusion

The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.

Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.

What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.

The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).

The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.

That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.

Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.

The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.

Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”

There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.

“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”

Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.

“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”

Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
 

Supply issues?

Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.

That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.

Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.

On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”

But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”

Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”

Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.

He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”

Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”

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

Before working to create standards for electronic prior authorization, the entire process itself needs some work.

That was the message from groups representing physicians, medical practices, and hospitals in response to a request for input from the Office of the National Coordinator for Health Information Technology (ONC). In January, ONC requested public feedback on how making the process for insurer approvals digital can “ease the burden of prior authorization tasks on patients, providers, and payers.”

According to a study conducted by America’s Health Insurance Plans, 71% of providers who implemented electronic prior authorization experienced “faster time to patient care.” The organization, which represents many of the nation’s health insurers, also reported that electronic prior authorization reduced the time it took to receive a decision by a health plan by 69%.

In its response to ONC, the American Association of Family Physicians (AAFP) called out prior authorization as a “leading cause of physician burden” and wrote that the organization is “strongly supportive of efforts to reform and streamline the prior authorization process.”

AAFP, which represents 127,600 family physicians, residents, and students, cited in its comments an AMA survey in which 88% of physicians said that prior authorization “generates high or extremely high administrative burden” for their practices. Practices are responsible for an average of 41 prior authorizations per physician each week, which can take almost 2 days of a physician’s time each week, according to the AAFP.

Delayed care, increased confusion, reduced treatment adherence, and even discontinuation of treatment are some of the harms prior authorization causes patients, wrote AAFP board chair Ada D. Stewart, MD.

Electronic prior authorization is “just one step in addressing the flaws of utilization management practices, and comprehensive reform is needed to reduce the volume of prior authorizations and ensure patients’ timely access to care,” wrote Dr. Stewart.
 

AHA: Most common prior auth means are phones, fax

The American Hospital Association (AHA) highlighted the variety of prior authorization requests from different payers, writing, “While some plans accept electronic means, the most common method remains using fax machines and contacting call centers, with regular hold times of 20 to 30 minutes.”

The AHA’s Senior Vice President Ashley Thompson wrote that the various prior authorization processes required by payers take up staff time and increase the chance of data entry errors.

To fix this, the AHA calls for an “end-to-end automated prior authorization process that integrates with clinicians’ EHR workflow.” According to the AHA, this approach can help physicians have access to the required prior authorization information during treatment planning.

In response to the federal agency’s question about the functional capabilities for certified health IT modules to facilitate electronic prior authorization, the AAFP wrote that the standards should include communicating to providers the expected timeline from a payer on a response, the ability to access payers’ reasoning for denials, and the creation of a process for appealing decisions.

The ONC also asked for input on the use of three fast health care interoperability resources (FHIR)–based Da Vinci implementation guides in electronic prior authorization.

Developed by the Da Vinci Project in coordination with the HL7 Clinical Decision Support Workgroup, the FHIR-based implementation guides create a mechanism for reducing the burden on provider organizations and simplifying processes by establishing electronic versions of administrative and clinical requirements that are a part of providers’ workflow.

In its response, the AHA requested that prior authorization solutions “be fully developed and tested prior to wide scale industry rollout.”

The AAFP largely agreed with the AHA in its response, writing, “Only standards and [implementation guides] that have been proven effective and adoptable in real world testing should be candidates for mandatory certification and utilization, including the Da Vinci standards.”

The Medical Group Management Association (MGMA), which represents more than 60,000 medical practice administrators, executives, and leaders, supports the idea that electronic prior authorization “has the potential to decrease administrative burden through automation but only if implemented properly.”

In its comments, the MGMA called for broader reform of prior authorization. One way to accomplish that goal is by aligning electronic prior authorization standards “with payment and quality reporting programs, as well as care delivery models, to minimize burden and overhead costs.”

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

Before working to create standards for electronic prior authorization, the entire process itself needs some work.

That was the message from groups representing physicians, medical practices, and hospitals in response to a request for input from the Office of the National Coordinator for Health Information Technology (ONC). In January, ONC requested public feedback on how making the process for insurer approvals digital can “ease the burden of prior authorization tasks on patients, providers, and payers.”

According to a study conducted by America’s Health Insurance Plans, 71% of providers who implemented electronic prior authorization experienced “faster time to patient care.” The organization, which represents many of the nation’s health insurers, also reported that electronic prior authorization reduced the time it took to receive a decision by a health plan by 69%.

In its response to ONC, the American Association of Family Physicians (AAFP) called out prior authorization as a “leading cause of physician burden” and wrote that the organization is “strongly supportive of efforts to reform and streamline the prior authorization process.”

AAFP, which represents 127,600 family physicians, residents, and students, cited in its comments an AMA survey in which 88% of physicians said that prior authorization “generates high or extremely high administrative burden” for their practices. Practices are responsible for an average of 41 prior authorizations per physician each week, which can take almost 2 days of a physician’s time each week, according to the AAFP.

Delayed care, increased confusion, reduced treatment adherence, and even discontinuation of treatment are some of the harms prior authorization causes patients, wrote AAFP board chair Ada D. Stewart, MD.

Electronic prior authorization is “just one step in addressing the flaws of utilization management practices, and comprehensive reform is needed to reduce the volume of prior authorizations and ensure patients’ timely access to care,” wrote Dr. Stewart.
 

AHA: Most common prior auth means are phones, fax

The American Hospital Association (AHA) highlighted the variety of prior authorization requests from different payers, writing, “While some plans accept electronic means, the most common method remains using fax machines and contacting call centers, with regular hold times of 20 to 30 minutes.”

The AHA’s Senior Vice President Ashley Thompson wrote that the various prior authorization processes required by payers take up staff time and increase the chance of data entry errors.

To fix this, the AHA calls for an “end-to-end automated prior authorization process that integrates with clinicians’ EHR workflow.” According to the AHA, this approach can help physicians have access to the required prior authorization information during treatment planning.

In response to the federal agency’s question about the functional capabilities for certified health IT modules to facilitate electronic prior authorization, the AAFP wrote that the standards should include communicating to providers the expected timeline from a payer on a response, the ability to access payers’ reasoning for denials, and the creation of a process for appealing decisions.

The ONC also asked for input on the use of three fast health care interoperability resources (FHIR)–based Da Vinci implementation guides in electronic prior authorization.

Developed by the Da Vinci Project in coordination with the HL7 Clinical Decision Support Workgroup, the FHIR-based implementation guides create a mechanism for reducing the burden on provider organizations and simplifying processes by establishing electronic versions of administrative and clinical requirements that are a part of providers’ workflow.

In its response, the AHA requested that prior authorization solutions “be fully developed and tested prior to wide scale industry rollout.”

The AAFP largely agreed with the AHA in its response, writing, “Only standards and [implementation guides] that have been proven effective and adoptable in real world testing should be candidates for mandatory certification and utilization, including the Da Vinci standards.”

The Medical Group Management Association (MGMA), which represents more than 60,000 medical practice administrators, executives, and leaders, supports the idea that electronic prior authorization “has the potential to decrease administrative burden through automation but only if implemented properly.”

In its comments, the MGMA called for broader reform of prior authorization. One way to accomplish that goal is by aligning electronic prior authorization standards “with payment and quality reporting programs, as well as care delivery models, to minimize burden and overhead costs.”

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

Before working to create standards for electronic prior authorization, the entire process itself needs some work.

That was the message from groups representing physicians, medical practices, and hospitals in response to a request for input from the Office of the National Coordinator for Health Information Technology (ONC). In January, ONC requested public feedback on how making the process for insurer approvals digital can “ease the burden of prior authorization tasks on patients, providers, and payers.”

According to a study conducted by America’s Health Insurance Plans, 71% of providers who implemented electronic prior authorization experienced “faster time to patient care.” The organization, which represents many of the nation’s health insurers, also reported that electronic prior authorization reduced the time it took to receive a decision by a health plan by 69%.

In its response to ONC, the American Association of Family Physicians (AAFP) called out prior authorization as a “leading cause of physician burden” and wrote that the organization is “strongly supportive of efforts to reform and streamline the prior authorization process.”

AAFP, which represents 127,600 family physicians, residents, and students, cited in its comments an AMA survey in which 88% of physicians said that prior authorization “generates high or extremely high administrative burden” for their practices. Practices are responsible for an average of 41 prior authorizations per physician each week, which can take almost 2 days of a physician’s time each week, according to the AAFP.

Delayed care, increased confusion, reduced treatment adherence, and even discontinuation of treatment are some of the harms prior authorization causes patients, wrote AAFP board chair Ada D. Stewart, MD.

Electronic prior authorization is “just one step in addressing the flaws of utilization management practices, and comprehensive reform is needed to reduce the volume of prior authorizations and ensure patients’ timely access to care,” wrote Dr. Stewart.
 

AHA: Most common prior auth means are phones, fax

The American Hospital Association (AHA) highlighted the variety of prior authorization requests from different payers, writing, “While some plans accept electronic means, the most common method remains using fax machines and contacting call centers, with regular hold times of 20 to 30 minutes.”

The AHA’s Senior Vice President Ashley Thompson wrote that the various prior authorization processes required by payers take up staff time and increase the chance of data entry errors.

To fix this, the AHA calls for an “end-to-end automated prior authorization process that integrates with clinicians’ EHR workflow.” According to the AHA, this approach can help physicians have access to the required prior authorization information during treatment planning.

In response to the federal agency’s question about the functional capabilities for certified health IT modules to facilitate electronic prior authorization, the AAFP wrote that the standards should include communicating to providers the expected timeline from a payer on a response, the ability to access payers’ reasoning for denials, and the creation of a process for appealing decisions.

The ONC also asked for input on the use of three fast health care interoperability resources (FHIR)–based Da Vinci implementation guides in electronic prior authorization.

Developed by the Da Vinci Project in coordination with the HL7 Clinical Decision Support Workgroup, the FHIR-based implementation guides create a mechanism for reducing the burden on provider organizations and simplifying processes by establishing electronic versions of administrative and clinical requirements that are a part of providers’ workflow.

In its response, the AHA requested that prior authorization solutions “be fully developed and tested prior to wide scale industry rollout.”

The AAFP largely agreed with the AHA in its response, writing, “Only standards and [implementation guides] that have been proven effective and adoptable in real world testing should be candidates for mandatory certification and utilization, including the Da Vinci standards.”

The Medical Group Management Association (MGMA), which represents more than 60,000 medical practice administrators, executives, and leaders, supports the idea that electronic prior authorization “has the potential to decrease administrative burden through automation but only if implemented properly.”

In its comments, the MGMA called for broader reform of prior authorization. One way to accomplish that goal is by aligning electronic prior authorization standards “with payment and quality reporting programs, as well as care delivery models, to minimize burden and overhead costs.”

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

Earlier this month one of our dogs needed surgery. Early one morning I dropped her off at the veterinarian’s office.

About 10 minutes after leaving, they called and asked me to come back and get her. The vet had called in sick, so all her surgeries for the day had to be rescheduled.

It’s a pain in the rear, but what can you do? It happens to the best of us. My staff has had their share of times where they had to frantically call and reschedule patients when I was too sick to work.

So I drove back and waited in line. Most people were understanding, but some less so. The lady in front of me was demanding her dog’s surgery (which hadn’t happened yet) be free due to her being inconvenienced. A staff member at another desk was dealing with an angry man who was demanding the veterinarian’s home phone number.

When I got up to the front I picked up my dog and rescheduled the surgery for 2 weeks later. The young lady at the desk handed me a reminder card and said “Thank you for not yelling at me.”

How sad is that? Is this what our society has come to, where people feel obliged to thank you for not being an ass?

Common courtesy should be the rule rather than the exception, right? What’s wrong with politeness?

Yeah, going back to have to get my dog and reschedule her surgery is an inconvenience, but that’s about it. Certainly not something to get worked up over, or to scream at another person who’s just doing their job. Getting sick is part of life. It’s happened to me, it’s happened to you, and on this day it happened to our veterinarian.

Our supposedly polite society seems to have gone in reverse during the pandemic, though the change had probably started before then. Although we all went through it together, for some it’s removed the thin veneer of civilization, leaving them angry, bitter, and hostile over things that are beyond the control of mortals.

Whatever happened to the Golden Rule? It takes less effort to be nice than nasty, and it’s definitely better for your blood pressure.

I really don’t understand this. What’s to be gained by going through the world angry at things you can’t control? Especially when they’re so minor, like having to reschedule a veterinarian’s appointment.

It just ain’t worth it to be like that. For you, or the innocent person you’re abusing.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Earlier this month one of our dogs needed surgery. Early one morning I dropped her off at the veterinarian’s office.

About 10 minutes after leaving, they called and asked me to come back and get her. The vet had called in sick, so all her surgeries for the day had to be rescheduled.

It’s a pain in the rear, but what can you do? It happens to the best of us. My staff has had their share of times where they had to frantically call and reschedule patients when I was too sick to work.

So I drove back and waited in line. Most people were understanding, but some less so. The lady in front of me was demanding her dog’s surgery (which hadn’t happened yet) be free due to her being inconvenienced. A staff member at another desk was dealing with an angry man who was demanding the veterinarian’s home phone number.

When I got up to the front I picked up my dog and rescheduled the surgery for 2 weeks later. The young lady at the desk handed me a reminder card and said “Thank you for not yelling at me.”

How sad is that? Is this what our society has come to, where people feel obliged to thank you for not being an ass?

Common courtesy should be the rule rather than the exception, right? What’s wrong with politeness?

Yeah, going back to have to get my dog and reschedule her surgery is an inconvenience, but that’s about it. Certainly not something to get worked up over, or to scream at another person who’s just doing their job. Getting sick is part of life. It’s happened to me, it’s happened to you, and on this day it happened to our veterinarian.

Our supposedly polite society seems to have gone in reverse during the pandemic, though the change had probably started before then. Although we all went through it together, for some it’s removed the thin veneer of civilization, leaving them angry, bitter, and hostile over things that are beyond the control of mortals.

Whatever happened to the Golden Rule? It takes less effort to be nice than nasty, and it’s definitely better for your blood pressure.

I really don’t understand this. What’s to be gained by going through the world angry at things you can’t control? Especially when they’re so minor, like having to reschedule a veterinarian’s appointment.

It just ain’t worth it to be like that. For you, or the innocent person you’re abusing.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Earlier this month one of our dogs needed surgery. Early one morning I dropped her off at the veterinarian’s office.

About 10 minutes after leaving, they called and asked me to come back and get her. The vet had called in sick, so all her surgeries for the day had to be rescheduled.

It’s a pain in the rear, but what can you do? It happens to the best of us. My staff has had their share of times where they had to frantically call and reschedule patients when I was too sick to work.

So I drove back and waited in line. Most people were understanding, but some less so. The lady in front of me was demanding her dog’s surgery (which hadn’t happened yet) be free due to her being inconvenienced. A staff member at another desk was dealing with an angry man who was demanding the veterinarian’s home phone number.

When I got up to the front I picked up my dog and rescheduled the surgery for 2 weeks later. The young lady at the desk handed me a reminder card and said “Thank you for not yelling at me.”

How sad is that? Is this what our society has come to, where people feel obliged to thank you for not being an ass?

Common courtesy should be the rule rather than the exception, right? What’s wrong with politeness?

Yeah, going back to have to get my dog and reschedule her surgery is an inconvenience, but that’s about it. Certainly not something to get worked up over, or to scream at another person who’s just doing their job. Getting sick is part of life. It’s happened to me, it’s happened to you, and on this day it happened to our veterinarian.

Our supposedly polite society seems to have gone in reverse during the pandemic, though the change had probably started before then. Although we all went through it together, for some it’s removed the thin veneer of civilization, leaving them angry, bitter, and hostile over things that are beyond the control of mortals.

Whatever happened to the Golden Rule? It takes less effort to be nice than nasty, and it’s definitely better for your blood pressure.

I really don’t understand this. What’s to be gained by going through the world angry at things you can’t control? Especially when they’re so minor, like having to reschedule a veterinarian’s appointment.

It just ain’t worth it to be like that. For you, or the innocent person you’re abusing.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.