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Johnson & Johnson asked the Food and Drug Administration (FDA) on Tuesday to authorize an extra dose of its COVID-19 vaccine as a booster shot.

The company said it filed a request for people ages 18 and older who have received the one-shot vaccine. Johnson & Johnson submitted data for several different booster intervals -- ranging from 2 months to 6 months -- but didn’t formally recommend one to the FDA, The Associated Press reported.

“We’re describing the data to them,” Mathai Mammen, MD, head of global research and development for Janssen, the company’s vaccine division, told CNN.

“The process is not that we asked for a very specific interval -- we’re providing them data and we’re going to be presenting to the committee,” he said. “They’ll take all that into consideration when they ultimately decide on an appropriate interval.”

The FDA’s independent vaccine advisory committee meets next week to review data on booster shots from both Johnson & Johnson and Moderna. It’s the first step in the review process, which then requires approval from leaders at the FDA and Centers for Disease Control and Prevention. If both agencies authorize the extra shots, Americans could receive boosters from Johnson & Johnson and Moderna later this month, the AP reported.

Johnson & Johnson previously released data that showed the vaccine remains highly effective against COVID-19 at least 5 months after vaccination, with 81% efficacy against hospitalizations in the United States.

Two weeks ago, the company reported that a booster dose at 2 months or 6 months further lifted immunity, with a booster at 2 months providing 94% protection against moderate and severe COVID-19. The company said the 6-month booster raised antibodies by 12 times but didn’t release additional data at that time.

In September, the FDA authorized booster shots of the Pfizer vaccine for ages 65 and older, those who live in long-term care facilities, and those with higher risks for contracting COVID-19. The Biden administration is supporting a booster campaign to address potential waning vaccine immunity and remaining surges of the more contagious Delta variant, the AP reported.

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

Johnson & Johnson asked the Food and Drug Administration (FDA) on Tuesday to authorize an extra dose of its COVID-19 vaccine as a booster shot.

The company said it filed a request for people ages 18 and older who have received the one-shot vaccine. Johnson & Johnson submitted data for several different booster intervals -- ranging from 2 months to 6 months -- but didn’t formally recommend one to the FDA, The Associated Press reported.

“We’re describing the data to them,” Mathai Mammen, MD, head of global research and development for Janssen, the company’s vaccine division, told CNN.

“The process is not that we asked for a very specific interval -- we’re providing them data and we’re going to be presenting to the committee,” he said. “They’ll take all that into consideration when they ultimately decide on an appropriate interval.”

The FDA’s independent vaccine advisory committee meets next week to review data on booster shots from both Johnson & Johnson and Moderna. It’s the first step in the review process, which then requires approval from leaders at the FDA and Centers for Disease Control and Prevention. If both agencies authorize the extra shots, Americans could receive boosters from Johnson & Johnson and Moderna later this month, the AP reported.

Johnson & Johnson previously released data that showed the vaccine remains highly effective against COVID-19 at least 5 months after vaccination, with 81% efficacy against hospitalizations in the United States.

Two weeks ago, the company reported that a booster dose at 2 months or 6 months further lifted immunity, with a booster at 2 months providing 94% protection against moderate and severe COVID-19. The company said the 6-month booster raised antibodies by 12 times but didn’t release additional data at that time.

In September, the FDA authorized booster shots of the Pfizer vaccine for ages 65 and older, those who live in long-term care facilities, and those with higher risks for contracting COVID-19. The Biden administration is supporting a booster campaign to address potential waning vaccine immunity and remaining surges of the more contagious Delta variant, the AP reported.

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

Johnson & Johnson asked the Food and Drug Administration (FDA) on Tuesday to authorize an extra dose of its COVID-19 vaccine as a booster shot.

The company said it filed a request for people ages 18 and older who have received the one-shot vaccine. Johnson & Johnson submitted data for several different booster intervals -- ranging from 2 months to 6 months -- but didn’t formally recommend one to the FDA, The Associated Press reported.

“We’re describing the data to them,” Mathai Mammen, MD, head of global research and development for Janssen, the company’s vaccine division, told CNN.

“The process is not that we asked for a very specific interval -- we’re providing them data and we’re going to be presenting to the committee,” he said. “They’ll take all that into consideration when they ultimately decide on an appropriate interval.”

The FDA’s independent vaccine advisory committee meets next week to review data on booster shots from both Johnson & Johnson and Moderna. It’s the first step in the review process, which then requires approval from leaders at the FDA and Centers for Disease Control and Prevention. If both agencies authorize the extra shots, Americans could receive boosters from Johnson & Johnson and Moderna later this month, the AP reported.

Johnson & Johnson previously released data that showed the vaccine remains highly effective against COVID-19 at least 5 months after vaccination, with 81% efficacy against hospitalizations in the United States.

Two weeks ago, the company reported that a booster dose at 2 months or 6 months further lifted immunity, with a booster at 2 months providing 94% protection against moderate and severe COVID-19. The company said the 6-month booster raised antibodies by 12 times but didn’t release additional data at that time.

In September, the FDA authorized booster shots of the Pfizer vaccine for ages 65 and older, those who live in long-term care facilities, and those with higher risks for contracting COVID-19. The Biden administration is supporting a booster campaign to address potential waning vaccine immunity and remaining surges of the more contagious Delta variant, the AP reported.

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

Antibody levels may wane after 7 months for people who got the Pfizer-BioNTech vaccine, according to a new study published on the bioRxiv preprint server.

In the study, which hasn’t yet been peer-reviewed or formally published in a medical journal, researchers analyzed blood samples from 46 healthy young or middle-aged adults after receiving two doses, and then 6 months after the second dose.

“Our study shows vaccination with the Pfizer-BioNTech vaccine induces high levels of neutralizing antibodies against the original vaccine strain, but these levels drop by nearly 10-fold by 7 months,” the researchers told Reuters.

In about half of the adults, neutralizing antibodies were undetectable at 6 months after the second dose, particularly against coronavirus variants such as Delta, Beta, and Mu.

Neutralizing antibodies only make up part of the body’s immune defense against the virus, Reuters noted, but they are still “critically important” in protecting against coronavirus infections.

“These findings suggest that administering a booster dose at around 6 to 7 months following the initial immunization will likely enhance protection,” the study authors wrote.

BioNTech said a new vaccine formula will likely be needed by mid-2022 to protect against future mutations of the virus, according to the Financial Times.

“This year, [a different vaccine] is completely unneeded, but by mid-next year, it could be a different situation,” Ugur Sahin, MD, cofounder and CEO of BioNTech, told the news outlet.

Current variants, namely the Delta variant, are more contagious than the original coronavirus strain but not different enough to evade current vaccines, he said. But new strains may be able to evade boosters.

“This virus will stay, and the virus will further adapt,” Dr. Sahin said. “This is a continuous evolution, and that evolution has just started.”

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

Antibody levels may wane after 7 months for people who got the Pfizer-BioNTech vaccine, according to a new study published on the bioRxiv preprint server.

In the study, which hasn’t yet been peer-reviewed or formally published in a medical journal, researchers analyzed blood samples from 46 healthy young or middle-aged adults after receiving two doses, and then 6 months after the second dose.

“Our study shows vaccination with the Pfizer-BioNTech vaccine induces high levels of neutralizing antibodies against the original vaccine strain, but these levels drop by nearly 10-fold by 7 months,” the researchers told Reuters.

In about half of the adults, neutralizing antibodies were undetectable at 6 months after the second dose, particularly against coronavirus variants such as Delta, Beta, and Mu.

Neutralizing antibodies only make up part of the body’s immune defense against the virus, Reuters noted, but they are still “critically important” in protecting against coronavirus infections.

“These findings suggest that administering a booster dose at around 6 to 7 months following the initial immunization will likely enhance protection,” the study authors wrote.

BioNTech said a new vaccine formula will likely be needed by mid-2022 to protect against future mutations of the virus, according to the Financial Times.

“This year, [a different vaccine] is completely unneeded, but by mid-next year, it could be a different situation,” Ugur Sahin, MD, cofounder and CEO of BioNTech, told the news outlet.

Current variants, namely the Delta variant, are more contagious than the original coronavirus strain but not different enough to evade current vaccines, he said. But new strains may be able to evade boosters.

“This virus will stay, and the virus will further adapt,” Dr. Sahin said. “This is a continuous evolution, and that evolution has just started.”

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

Antibody levels may wane after 7 months for people who got the Pfizer-BioNTech vaccine, according to a new study published on the bioRxiv preprint server.

In the study, which hasn’t yet been peer-reviewed or formally published in a medical journal, researchers analyzed blood samples from 46 healthy young or middle-aged adults after receiving two doses, and then 6 months after the second dose.

“Our study shows vaccination with the Pfizer-BioNTech vaccine induces high levels of neutralizing antibodies against the original vaccine strain, but these levels drop by nearly 10-fold by 7 months,” the researchers told Reuters.

In about half of the adults, neutralizing antibodies were undetectable at 6 months after the second dose, particularly against coronavirus variants such as Delta, Beta, and Mu.

Neutralizing antibodies only make up part of the body’s immune defense against the virus, Reuters noted, but they are still “critically important” in protecting against coronavirus infections.

“These findings suggest that administering a booster dose at around 6 to 7 months following the initial immunization will likely enhance protection,” the study authors wrote.

BioNTech said a new vaccine formula will likely be needed by mid-2022 to protect against future mutations of the virus, according to the Financial Times.

“This year, [a different vaccine] is completely unneeded, but by mid-next year, it could be a different situation,” Ugur Sahin, MD, cofounder and CEO of BioNTech, told the news outlet.

Current variants, namely the Delta variant, are more contagious than the original coronavirus strain but not different enough to evade current vaccines, he said. But new strains may be able to evade boosters.

“This virus will stay, and the virus will further adapt,” Dr. Sahin said. “This is a continuous evolution, and that evolution has just started.”

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

Lead poisoning remains a significant threat to the health of young children in the United States, based on data from blood tests of more than 1 million children.

Any level of lead is potentially harmful, although blood lead levels have decreased over the past several decades in part because of the elimination of lead from many consumer products, as well as from gas, paint, and plumbing fixtures, wrote Marissa Hauptman, MD, of Boston Children’s Hospital and colleagues.

However, “numerous environmental sources of legacy lead still exist,” and children living in poverty and in older housing in particular remain at increased risk for lead exposure, they noted.

In a study published in JAMA Pediatrics, the researchers analyzed deidentified results from blood lead tests performed at a single clinical laboratory for 1,141,441 children younger than 6 years between Oct. 1, 2018, and Feb. 29, 2020. The mean age of the children was 2.3 years; approximately half were boys.

Overall, 50.5% of the children tested (576,092 children) had detectable blood lead levels (BLLs), defined as 1.0 mcg/dL or higher, and 1.9% (21,172 children) had elevated BLLs, defined as 5.0 mcg/dL or higher.

In multivariate analysis, both detectable BLLs and elevated BLLs were significantly more common among children with public insurance (adjusted odds ratios, 2.01 and 1.08, respectively).

Children in the highest vs. lowest quintile of pre-1950s housing had significantly greater odds of both detectable and elevated BLLs (aOR, 1.65 and aOR, 3.06); those in the highest vs. lowest quintiles of poverty showed similarly increased risk of detectable and elevated BLLs (aOR, 1.89 and aOR, 1.99, respectively; P < .001 for all).

When the data were broken out by ZIP code, children in predominantly Black non-Hispanic and non-Latino neighborhoods were more likely than those living in other ZIP codes to have detectable BLLs (aOR, 1.13), but less likely to have elevated BLLs (aOR, 0.83). States with the highest overall proportions of children with detectable BLLs were Nebraska (83%), Missouri (82%), and Michigan (78%).

The study findings were limited by several factors, especially the potential for selection bias because of the use of a single reference laboratory (Quest Diagnostics), that does not perform all lead testing in the United States, the researchers noted. Other limitations included variability in testing at the state level, and the use of ZIP code–level data to estimate race, ethnicity, housing, and poverty, they said.

However, the results suggest that lead exposure remains a problem in young children, with significant disparities at the individual and community level, and national efforts must focus on further reductions of lead exposure in areas of highest risk, they concluded.
 

Step up lead elimination efforts

“The removal of lead from gasoline and new paint produced a precipitous decrease in blood lead levels from a population mean of 17 mcg/dL (all ages) in 1976 to 4 mcg/dL in the early 1990s to less than 2 mcg/dL today,” wrote Philip J. Landrigan, MD, of Boston College and David Bellinger, PhD, of Harvard University, Boston, in an accompanying editorial. However, “The findings from this study underscore the urgent need to eliminate all sources of lead exposure from U.S. children’s environments,” and highlight the persistent disparities in children’s lead exposure, they said.

The authors emphasized the need to remove existing lead paint from U.S. homes, as not only the paint itself, but the dust that enters the environment as the pain wears over time, continue to account for most detectable and elevated BLLs in children. A comprehensive lead paint removal effort would be an investment that would protect children now and would protect future generations, they emphasized. They proposed “creating a lead paint removal workforce through federally supported partnerships between city governments and major unions,” that would not only protect children from disease and disability, but could potentially provide jobs and vocational programs that would have a significant impact on communities.
 

Elevated lead levels may be underreported

In fact, the situation of children’s lead exposure in the United States may be more severe than indicated by the study findings, given the variation in testing at the state and local levels, said Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn.

“There are no available lead test kits in our offices, so I do worry that many elevated lead levels will be missed,” she said.

“The recent case of elevated lead levels in drinking water in Flint, Michigan, was largely detected through pediatric clinic screening and showed that elevated lead levels may remain a major issue in some communities,” said Tim Joos, MD, a clinician in combined internal medicine/pediatrics in Seattle, Wash., in an interview.

“It is important to highlight to what extent baseline and point-source lead contamination still exists, monitor progress towards lowering levels, and identify communities at high risk,” Dr. Joos emphasized. “The exact prevalence of elevated lead levels among the general pediatric populations is hard to estimate from this study because of the methodology, which looked at demographic characteristics of the subset of the pediatric population that had venous samples sent to Quest Lab,” he noted.

“As the authors pointed out, it is hard to know what biases went into deciding whether to screen or not, and whether these were confirmatory tests for elevated point of care testing done earlier in the clinic,” said Dr. Joos. “Nonetheless, it does point to the role of poverty and pre-1950s housing in elevated blood lead levels,” he added. “The study also highlights that, as the CDC considers lowering the level for what is considered an ‘elevated blood lead level’ from 5.0 to perhaps 3.5 mcg/dL, we still have a lot more work to do,” he said.

The study was funded by Quest Diagnostics and the company provided salaries to several coauthors during the study. Dr. Hauptmann disclosed support from the National Institutes of Health/National Institute of Environmental Health Sciences during the current study and support from the Agency for Toxic Substances and Disease Registry and the U.S. Environmental Protection Agency unrelated to the current study. Dr. Landrigan had no financial conflicts to disclose. Dr. Bellinger disclosed fees from attorneys for testimony in cases unrelated to the editorial. Dr. Kinsella had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Pediatric News. Dr. Joos had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Lead poisoning remains a significant threat to the health of young children in the United States, based on data from blood tests of more than 1 million children.

Any level of lead is potentially harmful, although blood lead levels have decreased over the past several decades in part because of the elimination of lead from many consumer products, as well as from gas, paint, and plumbing fixtures, wrote Marissa Hauptman, MD, of Boston Children’s Hospital and colleagues.

However, “numerous environmental sources of legacy lead still exist,” and children living in poverty and in older housing in particular remain at increased risk for lead exposure, they noted.

In a study published in JAMA Pediatrics, the researchers analyzed deidentified results from blood lead tests performed at a single clinical laboratory for 1,141,441 children younger than 6 years between Oct. 1, 2018, and Feb. 29, 2020. The mean age of the children was 2.3 years; approximately half were boys.

Overall, 50.5% of the children tested (576,092 children) had detectable blood lead levels (BLLs), defined as 1.0 mcg/dL or higher, and 1.9% (21,172 children) had elevated BLLs, defined as 5.0 mcg/dL or higher.

In multivariate analysis, both detectable BLLs and elevated BLLs were significantly more common among children with public insurance (adjusted odds ratios, 2.01 and 1.08, respectively).

Children in the highest vs. lowest quintile of pre-1950s housing had significantly greater odds of both detectable and elevated BLLs (aOR, 1.65 and aOR, 3.06); those in the highest vs. lowest quintiles of poverty showed similarly increased risk of detectable and elevated BLLs (aOR, 1.89 and aOR, 1.99, respectively; P < .001 for all).

When the data were broken out by ZIP code, children in predominantly Black non-Hispanic and non-Latino neighborhoods were more likely than those living in other ZIP codes to have detectable BLLs (aOR, 1.13), but less likely to have elevated BLLs (aOR, 0.83). States with the highest overall proportions of children with detectable BLLs were Nebraska (83%), Missouri (82%), and Michigan (78%).

The study findings were limited by several factors, especially the potential for selection bias because of the use of a single reference laboratory (Quest Diagnostics), that does not perform all lead testing in the United States, the researchers noted. Other limitations included variability in testing at the state level, and the use of ZIP code–level data to estimate race, ethnicity, housing, and poverty, they said.

However, the results suggest that lead exposure remains a problem in young children, with significant disparities at the individual and community level, and national efforts must focus on further reductions of lead exposure in areas of highest risk, they concluded.
 

Step up lead elimination efforts

“The removal of lead from gasoline and new paint produced a precipitous decrease in blood lead levels from a population mean of 17 mcg/dL (all ages) in 1976 to 4 mcg/dL in the early 1990s to less than 2 mcg/dL today,” wrote Philip J. Landrigan, MD, of Boston College and David Bellinger, PhD, of Harvard University, Boston, in an accompanying editorial. However, “The findings from this study underscore the urgent need to eliminate all sources of lead exposure from U.S. children’s environments,” and highlight the persistent disparities in children’s lead exposure, they said.

The authors emphasized the need to remove existing lead paint from U.S. homes, as not only the paint itself, but the dust that enters the environment as the pain wears over time, continue to account for most detectable and elevated BLLs in children. A comprehensive lead paint removal effort would be an investment that would protect children now and would protect future generations, they emphasized. They proposed “creating a lead paint removal workforce through federally supported partnerships between city governments and major unions,” that would not only protect children from disease and disability, but could potentially provide jobs and vocational programs that would have a significant impact on communities.
 

Elevated lead levels may be underreported

In fact, the situation of children’s lead exposure in the United States may be more severe than indicated by the study findings, given the variation in testing at the state and local levels, said Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn.

“There are no available lead test kits in our offices, so I do worry that many elevated lead levels will be missed,” she said.

“The recent case of elevated lead levels in drinking water in Flint, Michigan, was largely detected through pediatric clinic screening and showed that elevated lead levels may remain a major issue in some communities,” said Tim Joos, MD, a clinician in combined internal medicine/pediatrics in Seattle, Wash., in an interview.

“It is important to highlight to what extent baseline and point-source lead contamination still exists, monitor progress towards lowering levels, and identify communities at high risk,” Dr. Joos emphasized. “The exact prevalence of elevated lead levels among the general pediatric populations is hard to estimate from this study because of the methodology, which looked at demographic characteristics of the subset of the pediatric population that had venous samples sent to Quest Lab,” he noted.

“As the authors pointed out, it is hard to know what biases went into deciding whether to screen or not, and whether these were confirmatory tests for elevated point of care testing done earlier in the clinic,” said Dr. Joos. “Nonetheless, it does point to the role of poverty and pre-1950s housing in elevated blood lead levels,” he added. “The study also highlights that, as the CDC considers lowering the level for what is considered an ‘elevated blood lead level’ from 5.0 to perhaps 3.5 mcg/dL, we still have a lot more work to do,” he said.

The study was funded by Quest Diagnostics and the company provided salaries to several coauthors during the study. Dr. Hauptmann disclosed support from the National Institutes of Health/National Institute of Environmental Health Sciences during the current study and support from the Agency for Toxic Substances and Disease Registry and the U.S. Environmental Protection Agency unrelated to the current study. Dr. Landrigan had no financial conflicts to disclose. Dr. Bellinger disclosed fees from attorneys for testimony in cases unrelated to the editorial. Dr. Kinsella had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Pediatric News. Dr. Joos had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Lead poisoning remains a significant threat to the health of young children in the United States, based on data from blood tests of more than 1 million children.

Any level of lead is potentially harmful, although blood lead levels have decreased over the past several decades in part because of the elimination of lead from many consumer products, as well as from gas, paint, and plumbing fixtures, wrote Marissa Hauptman, MD, of Boston Children’s Hospital and colleagues.

However, “numerous environmental sources of legacy lead still exist,” and children living in poverty and in older housing in particular remain at increased risk for lead exposure, they noted.

In a study published in JAMA Pediatrics, the researchers analyzed deidentified results from blood lead tests performed at a single clinical laboratory for 1,141,441 children younger than 6 years between Oct. 1, 2018, and Feb. 29, 2020. The mean age of the children was 2.3 years; approximately half were boys.

Overall, 50.5% of the children tested (576,092 children) had detectable blood lead levels (BLLs), defined as 1.0 mcg/dL or higher, and 1.9% (21,172 children) had elevated BLLs, defined as 5.0 mcg/dL or higher.

In multivariate analysis, both detectable BLLs and elevated BLLs were significantly more common among children with public insurance (adjusted odds ratios, 2.01 and 1.08, respectively).

Children in the highest vs. lowest quintile of pre-1950s housing had significantly greater odds of both detectable and elevated BLLs (aOR, 1.65 and aOR, 3.06); those in the highest vs. lowest quintiles of poverty showed similarly increased risk of detectable and elevated BLLs (aOR, 1.89 and aOR, 1.99, respectively; P < .001 for all).

When the data were broken out by ZIP code, children in predominantly Black non-Hispanic and non-Latino neighborhoods were more likely than those living in other ZIP codes to have detectable BLLs (aOR, 1.13), but less likely to have elevated BLLs (aOR, 0.83). States with the highest overall proportions of children with detectable BLLs were Nebraska (83%), Missouri (82%), and Michigan (78%).

The study findings were limited by several factors, especially the potential for selection bias because of the use of a single reference laboratory (Quest Diagnostics), that does not perform all lead testing in the United States, the researchers noted. Other limitations included variability in testing at the state level, and the use of ZIP code–level data to estimate race, ethnicity, housing, and poverty, they said.

However, the results suggest that lead exposure remains a problem in young children, with significant disparities at the individual and community level, and national efforts must focus on further reductions of lead exposure in areas of highest risk, they concluded.
 

Step up lead elimination efforts

“The removal of lead from gasoline and new paint produced a precipitous decrease in blood lead levels from a population mean of 17 mcg/dL (all ages) in 1976 to 4 mcg/dL in the early 1990s to less than 2 mcg/dL today,” wrote Philip J. Landrigan, MD, of Boston College and David Bellinger, PhD, of Harvard University, Boston, in an accompanying editorial. However, “The findings from this study underscore the urgent need to eliminate all sources of lead exposure from U.S. children’s environments,” and highlight the persistent disparities in children’s lead exposure, they said.

The authors emphasized the need to remove existing lead paint from U.S. homes, as not only the paint itself, but the dust that enters the environment as the pain wears over time, continue to account for most detectable and elevated BLLs in children. A comprehensive lead paint removal effort would be an investment that would protect children now and would protect future generations, they emphasized. They proposed “creating a lead paint removal workforce through federally supported partnerships between city governments and major unions,” that would not only protect children from disease and disability, but could potentially provide jobs and vocational programs that would have a significant impact on communities.
 

Elevated lead levels may be underreported

In fact, the situation of children’s lead exposure in the United States may be more severe than indicated by the study findings, given the variation in testing at the state and local levels, said Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn.

“There are no available lead test kits in our offices, so I do worry that many elevated lead levels will be missed,” she said.

“The recent case of elevated lead levels in drinking water in Flint, Michigan, was largely detected through pediatric clinic screening and showed that elevated lead levels may remain a major issue in some communities,” said Tim Joos, MD, a clinician in combined internal medicine/pediatrics in Seattle, Wash., in an interview.

“It is important to highlight to what extent baseline and point-source lead contamination still exists, monitor progress towards lowering levels, and identify communities at high risk,” Dr. Joos emphasized. “The exact prevalence of elevated lead levels among the general pediatric populations is hard to estimate from this study because of the methodology, which looked at demographic characteristics of the subset of the pediatric population that had venous samples sent to Quest Lab,” he noted.

“As the authors pointed out, it is hard to know what biases went into deciding whether to screen or not, and whether these were confirmatory tests for elevated point of care testing done earlier in the clinic,” said Dr. Joos. “Nonetheless, it does point to the role of poverty and pre-1950s housing in elevated blood lead levels,” he added. “The study also highlights that, as the CDC considers lowering the level for what is considered an ‘elevated blood lead level’ from 5.0 to perhaps 3.5 mcg/dL, we still have a lot more work to do,” he said.

The study was funded by Quest Diagnostics and the company provided salaries to several coauthors during the study. Dr. Hauptmann disclosed support from the National Institutes of Health/National Institute of Environmental Health Sciences during the current study and support from the Agency for Toxic Substances and Disease Registry and the U.S. Environmental Protection Agency unrelated to the current study. Dr. Landrigan had no financial conflicts to disclose. Dr. Bellinger disclosed fees from attorneys for testimony in cases unrelated to the editorial. Dr. Kinsella had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Pediatric News. Dr. Joos had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Physiologist David Julius, PhD, University of California San Francisco, and neuroscientist Ardem Patapoutian, PhD, Scripps Research in La Jolla, Calif., have jointly been awarded the 2021 Nobel Prize in Physiology or Medicine for their discoveries of receptors for temperature and touch.

Their discoveries paved the way for new treatments for a wide range of disease conditions, including chronic pain.

“Our ability to sense heat, cold, and touch is essential for survival and underpins our interaction with the world around us,” the Nobel committee, in Stockholm, said in a news release.

“In our daily lives we take these sensations for granted, but how are nerve impulses initiated so that temperature and pressure can be perceived? This question has been solved by this year’s Nobel Prize laureates,” the committee added.
 

Science heats up

Dr. Julius and his collaborators used capsaicin, a pungent compound found in chili peppers that produces a burning sensation, to identify TRPV1, an ion channel activated by painful heat.

“The discovery of TRPV1 was a major breakthrough leading the way to the unravelling of additional temperature-sensing receptors,” the committee said.

Both Dr. Julius and Dr. Patapoutian used menthol to identify another receptor called TRPM8 that is activated by cold. Additional ion channels related to TRPV1 and TRPM8 were identified and found to be activated by a range of different temperatures.

The discoveries fueled other scientists to investigate the roles of these channels in thermal sensation.

“Julius’ discovery of TRPV1 was the breakthrough that allowed us to understand how differences in temperature can induce electrical signals in the nervous system,” the committee noted.
 

Science under pressure

As the mechanisms for temperature sensation began to unravel, Dr. Patapoutian and his collaborators used cultured pressure-sensitive cells to identify an ion channel activated by mechanical stimuli in the skin and internal organs. It was given the name Piezo1, after the Greek word for pressure.

Through its similarity to Piezo1, a second gene was discovered and named Piezo2. Sensory neurons were found to express high levels of Piezo2 and further studies firmly established that Piezo1 and Piezo2 are ion channels that are directly activated by the exertion of pressure on cell membranes.

“The groundbreaking discoveries of the TRPV1, TRPM8, and Piezo channels by this year’s Nobel Prize laureates have allowed us to understand how heat, cold, and mechanical force can initiate the nerve impulses that allow us to perceive and adapt to the world around us,” the Nobel committee said.

Dr. Julius and Dr. Patapoutian will receive a gold medal and share the $1.14 million prize money.

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

Physiologist David Julius, PhD, University of California San Francisco, and neuroscientist Ardem Patapoutian, PhD, Scripps Research in La Jolla, Calif., have jointly been awarded the 2021 Nobel Prize in Physiology or Medicine for their discoveries of receptors for temperature and touch.

Their discoveries paved the way for new treatments for a wide range of disease conditions, including chronic pain.

“Our ability to sense heat, cold, and touch is essential for survival and underpins our interaction with the world around us,” the Nobel committee, in Stockholm, said in a news release.

“In our daily lives we take these sensations for granted, but how are nerve impulses initiated so that temperature and pressure can be perceived? This question has been solved by this year’s Nobel Prize laureates,” the committee added.
 

Science heats up

Dr. Julius and his collaborators used capsaicin, a pungent compound found in chili peppers that produces a burning sensation, to identify TRPV1, an ion channel activated by painful heat.

“The discovery of TRPV1 was a major breakthrough leading the way to the unravelling of additional temperature-sensing receptors,” the committee said.

Both Dr. Julius and Dr. Patapoutian used menthol to identify another receptor called TRPM8 that is activated by cold. Additional ion channels related to TRPV1 and TRPM8 were identified and found to be activated by a range of different temperatures.

The discoveries fueled other scientists to investigate the roles of these channels in thermal sensation.

“Julius’ discovery of TRPV1 was the breakthrough that allowed us to understand how differences in temperature can induce electrical signals in the nervous system,” the committee noted.
 

Science under pressure

As the mechanisms for temperature sensation began to unravel, Dr. Patapoutian and his collaborators used cultured pressure-sensitive cells to identify an ion channel activated by mechanical stimuli in the skin and internal organs. It was given the name Piezo1, after the Greek word for pressure.

Through its similarity to Piezo1, a second gene was discovered and named Piezo2. Sensory neurons were found to express high levels of Piezo2 and further studies firmly established that Piezo1 and Piezo2 are ion channels that are directly activated by the exertion of pressure on cell membranes.

“The groundbreaking discoveries of the TRPV1, TRPM8, and Piezo channels by this year’s Nobel Prize laureates have allowed us to understand how heat, cold, and mechanical force can initiate the nerve impulses that allow us to perceive and adapt to the world around us,” the Nobel committee said.

Dr. Julius and Dr. Patapoutian will receive a gold medal and share the $1.14 million prize money.

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

Physiologist David Julius, PhD, University of California San Francisco, and neuroscientist Ardem Patapoutian, PhD, Scripps Research in La Jolla, Calif., have jointly been awarded the 2021 Nobel Prize in Physiology or Medicine for their discoveries of receptors for temperature and touch.

Their discoveries paved the way for new treatments for a wide range of disease conditions, including chronic pain.

“Our ability to sense heat, cold, and touch is essential for survival and underpins our interaction with the world around us,” the Nobel committee, in Stockholm, said in a news release.

“In our daily lives we take these sensations for granted, but how are nerve impulses initiated so that temperature and pressure can be perceived? This question has been solved by this year’s Nobel Prize laureates,” the committee added.
 

Science heats up

Dr. Julius and his collaborators used capsaicin, a pungent compound found in chili peppers that produces a burning sensation, to identify TRPV1, an ion channel activated by painful heat.

“The discovery of TRPV1 was a major breakthrough leading the way to the unravelling of additional temperature-sensing receptors,” the committee said.

Both Dr. Julius and Dr. Patapoutian used menthol to identify another receptor called TRPM8 that is activated by cold. Additional ion channels related to TRPV1 and TRPM8 were identified and found to be activated by a range of different temperatures.

The discoveries fueled other scientists to investigate the roles of these channels in thermal sensation.

“Julius’ discovery of TRPV1 was the breakthrough that allowed us to understand how differences in temperature can induce electrical signals in the nervous system,” the committee noted.
 

Science under pressure

As the mechanisms for temperature sensation began to unravel, Dr. Patapoutian and his collaborators used cultured pressure-sensitive cells to identify an ion channel activated by mechanical stimuli in the skin and internal organs. It was given the name Piezo1, after the Greek word for pressure.

Through its similarity to Piezo1, a second gene was discovered and named Piezo2. Sensory neurons were found to express high levels of Piezo2 and further studies firmly established that Piezo1 and Piezo2 are ion channels that are directly activated by the exertion of pressure on cell membranes.

“The groundbreaking discoveries of the TRPV1, TRPM8, and Piezo channels by this year’s Nobel Prize laureates have allowed us to understand how heat, cold, and mechanical force can initiate the nerve impulses that allow us to perceive and adapt to the world around us,” the Nobel committee said.

Dr. Julius and Dr. Patapoutian will receive a gold medal and share the $1.14 million prize money.

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

Telehealth use, although much higher than before the COVID-19 pandemic, accounted for less than 20% of weekly outpatient visits 6 months into the pandemic, according to a new report from the American Medical Association. Ten percent of weekly visits were conducted via videoconferencing, and 8.1% of visits were conducted using the telephone.

Those figures may overstate the true level of telehealth use in fall 2020. A study by the Commonwealth Fund, Harvard University, Boston, and Phreesia found that in December of that year, only 8% of outpatient visits involved the use of telemedicine – and that was up from 6% in October. In contrast to the AMA results, which came from its 2020 benchmark survey of physicians, the Commonwealth Fund study used data from practice management systems and an online patient registration platform, as well as electronic health record data.

A more recent survey of hospital executives found that as of September 2021, hospital telehealth visits had leveled off at 10% to 20% of appointments. Similarly, a McKinsey survey in July showed that telehealth encounters made up 13% to 17% of evaluation and management visits across all specialties.

RichLegg/E+

Big jump during pandemic

The AMA report offers a wealth of data on how physicians use telehealth and the differences between specialties in this area.

The report found that 70.3% of physicians worked in practices that used videoconferencing to provide patient visits in September 2020, compared to 14.3% of physicians in September 2018. Sixty-seven percent of physicians worked in practices that used telephone visits (the comparable figure for 2018 was unavailable).

Overall, 79% of physicians worked in a practice that used telehealth, compared to 25% in 2018.

Not every doctor in practices that utilized telehealth conducted virtual visits. In contrast to the 70.3% of doctors who were in practices that had video visits, only 59.1% of the respondents had personally conducted a videoconferencing visit in the previous week. The average numbers of weekly video and telephone visits per physician were 9.9 and 7.6, respectively, including those who did none.

There were big differences in virtual visit use among specialties as well. Eighty-five percent of psychiatrists were in practices that provided online appointments, according to the AMA survey, and three-quarters of primary care physicians said their practices offered telehealth appointments. Pediatricians were much less likely than family practice/general practice physicians (FPs/GPs) or general internists to do so.

The practices of many medical specialists were also highly likely to provide telehealth. Over 75% of practices in cardiology, endocrinology/diabetes, gastroenterology, nephrology, and neurology offered telehealth visits. About 88% of hematologists/oncologists offered video visits. Far fewer surgeons reported that their practice used virtual visits; the exceptions were urologists and dermatologists, 87% of whose practices used telehealth.
 

How telehealth was used

Across all specialties, 58% of physicians said clinicians in their practices used it to diagnose or treat patients; 59.2%, to manage patients with chronic disease; 50.4%, to provide acute care; and 34.3%, to provide preventive care.

Seventy-two percent of FP/GP and pediatric practices used telehealth to diagnose or treat patients. Just 64.9% of internists said their practices did so, and only 61.9% of them said their practices provided acute care via telehealth, versus 70% of FPs/GPs and pediatricians.

Among medical specialties, endocrinologists/diabetes physicians were those most likely to report the practice-level use of telehealth to diagnose or treat patients (71.9%), manage patients with chronic disease (92.1%), and provide preventive care (52.6%).

Significantly, 33% of medical specialists said their practices used remote patient monitoring. This finding was driven by high rates of use among cardiology practices (63.3%) and endocrinology practices (41.6%). Overall, the practice-level use of remote patient monitoring rose from 10.4% of practices in 2018 to 19.9% in 2020.
 

Virtual consults with peers

Some practices used telehealth to enable physicians to consult with colleagues. Twelve percent of respondents said their practices used telehealth to seek a second opinion from a health care professional in 2020, compared to 6.9% in 2018. Formal consultations via telehealth were also increasingly common: 17.2% of doctors said their practices did this in 2020, compared to 11.3% in 2018.

Also of note, 22.4% of physicians said their practices used telehealth for after-hours care or night calls in 2020, versus 9.9% in 2018.

The AMA report credited telehealth and expanded coverage and payment rules for enabling physician practices to keep their revenue streams positive and their practices open. However, the Commonwealth Fund study found “a substantial cumulative reduction in visits across all specialties over the course of the pandemic in 2020.” These ranged from a drop of 27% in pediatric visits to a decline of 8% in rheumatology visits during the period from March to December 2020.

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

Telehealth use, although much higher than before the COVID-19 pandemic, accounted for less than 20% of weekly outpatient visits 6 months into the pandemic, according to a new report from the American Medical Association. Ten percent of weekly visits were conducted via videoconferencing, and 8.1% of visits were conducted using the telephone.

Those figures may overstate the true level of telehealth use in fall 2020. A study by the Commonwealth Fund, Harvard University, Boston, and Phreesia found that in December of that year, only 8% of outpatient visits involved the use of telemedicine – and that was up from 6% in October. In contrast to the AMA results, which came from its 2020 benchmark survey of physicians, the Commonwealth Fund study used data from practice management systems and an online patient registration platform, as well as electronic health record data.

A more recent survey of hospital executives found that as of September 2021, hospital telehealth visits had leveled off at 10% to 20% of appointments. Similarly, a McKinsey survey in July showed that telehealth encounters made up 13% to 17% of evaluation and management visits across all specialties.

RichLegg/E+

Big jump during pandemic

The AMA report offers a wealth of data on how physicians use telehealth and the differences between specialties in this area.

The report found that 70.3% of physicians worked in practices that used videoconferencing to provide patient visits in September 2020, compared to 14.3% of physicians in September 2018. Sixty-seven percent of physicians worked in practices that used telephone visits (the comparable figure for 2018 was unavailable).

Overall, 79% of physicians worked in a practice that used telehealth, compared to 25% in 2018.

Not every doctor in practices that utilized telehealth conducted virtual visits. In contrast to the 70.3% of doctors who were in practices that had video visits, only 59.1% of the respondents had personally conducted a videoconferencing visit in the previous week. The average numbers of weekly video and telephone visits per physician were 9.9 and 7.6, respectively, including those who did none.

There were big differences in virtual visit use among specialties as well. Eighty-five percent of psychiatrists were in practices that provided online appointments, according to the AMA survey, and three-quarters of primary care physicians said their practices offered telehealth appointments. Pediatricians were much less likely than family practice/general practice physicians (FPs/GPs) or general internists to do so.

The practices of many medical specialists were also highly likely to provide telehealth. Over 75% of practices in cardiology, endocrinology/diabetes, gastroenterology, nephrology, and neurology offered telehealth visits. About 88% of hematologists/oncologists offered video visits. Far fewer surgeons reported that their practice used virtual visits; the exceptions were urologists and dermatologists, 87% of whose practices used telehealth.
 

How telehealth was used

Across all specialties, 58% of physicians said clinicians in their practices used it to diagnose or treat patients; 59.2%, to manage patients with chronic disease; 50.4%, to provide acute care; and 34.3%, to provide preventive care.

Seventy-two percent of FP/GP and pediatric practices used telehealth to diagnose or treat patients. Just 64.9% of internists said their practices did so, and only 61.9% of them said their practices provided acute care via telehealth, versus 70% of FPs/GPs and pediatricians.

Among medical specialties, endocrinologists/diabetes physicians were those most likely to report the practice-level use of telehealth to diagnose or treat patients (71.9%), manage patients with chronic disease (92.1%), and provide preventive care (52.6%).

Significantly, 33% of medical specialists said their practices used remote patient monitoring. This finding was driven by high rates of use among cardiology practices (63.3%) and endocrinology practices (41.6%). Overall, the practice-level use of remote patient monitoring rose from 10.4% of practices in 2018 to 19.9% in 2020.
 

Virtual consults with peers

Some practices used telehealth to enable physicians to consult with colleagues. Twelve percent of respondents said their practices used telehealth to seek a second opinion from a health care professional in 2020, compared to 6.9% in 2018. Formal consultations via telehealth were also increasingly common: 17.2% of doctors said their practices did this in 2020, compared to 11.3% in 2018.

Also of note, 22.4% of physicians said their practices used telehealth for after-hours care or night calls in 2020, versus 9.9% in 2018.

The AMA report credited telehealth and expanded coverage and payment rules for enabling physician practices to keep their revenue streams positive and their practices open. However, the Commonwealth Fund study found “a substantial cumulative reduction in visits across all specialties over the course of the pandemic in 2020.” These ranged from a drop of 27% in pediatric visits to a decline of 8% in rheumatology visits during the period from March to December 2020.

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

Telehealth use, although much higher than before the COVID-19 pandemic, accounted for less than 20% of weekly outpatient visits 6 months into the pandemic, according to a new report from the American Medical Association. Ten percent of weekly visits were conducted via videoconferencing, and 8.1% of visits were conducted using the telephone.

Those figures may overstate the true level of telehealth use in fall 2020. A study by the Commonwealth Fund, Harvard University, Boston, and Phreesia found that in December of that year, only 8% of outpatient visits involved the use of telemedicine – and that was up from 6% in October. In contrast to the AMA results, which came from its 2020 benchmark survey of physicians, the Commonwealth Fund study used data from practice management systems and an online patient registration platform, as well as electronic health record data.

A more recent survey of hospital executives found that as of September 2021, hospital telehealth visits had leveled off at 10% to 20% of appointments. Similarly, a McKinsey survey in July showed that telehealth encounters made up 13% to 17% of evaluation and management visits across all specialties.

RichLegg/E+

Big jump during pandemic

The AMA report offers a wealth of data on how physicians use telehealth and the differences between specialties in this area.

The report found that 70.3% of physicians worked in practices that used videoconferencing to provide patient visits in September 2020, compared to 14.3% of physicians in September 2018. Sixty-seven percent of physicians worked in practices that used telephone visits (the comparable figure for 2018 was unavailable).

Overall, 79% of physicians worked in a practice that used telehealth, compared to 25% in 2018.

Not every doctor in practices that utilized telehealth conducted virtual visits. In contrast to the 70.3% of doctors who were in practices that had video visits, only 59.1% of the respondents had personally conducted a videoconferencing visit in the previous week. The average numbers of weekly video and telephone visits per physician were 9.9 and 7.6, respectively, including those who did none.

There were big differences in virtual visit use among specialties as well. Eighty-five percent of psychiatrists were in practices that provided online appointments, according to the AMA survey, and three-quarters of primary care physicians said their practices offered telehealth appointments. Pediatricians were much less likely than family practice/general practice physicians (FPs/GPs) or general internists to do so.

The practices of many medical specialists were also highly likely to provide telehealth. Over 75% of practices in cardiology, endocrinology/diabetes, gastroenterology, nephrology, and neurology offered telehealth visits. About 88% of hematologists/oncologists offered video visits. Far fewer surgeons reported that their practice used virtual visits; the exceptions were urologists and dermatologists, 87% of whose practices used telehealth.
 

How telehealth was used

Across all specialties, 58% of physicians said clinicians in their practices used it to diagnose or treat patients; 59.2%, to manage patients with chronic disease; 50.4%, to provide acute care; and 34.3%, to provide preventive care.

Seventy-two percent of FP/GP and pediatric practices used telehealth to diagnose or treat patients. Just 64.9% of internists said their practices did so, and only 61.9% of them said their practices provided acute care via telehealth, versus 70% of FPs/GPs and pediatricians.

Among medical specialties, endocrinologists/diabetes physicians were those most likely to report the practice-level use of telehealth to diagnose or treat patients (71.9%), manage patients with chronic disease (92.1%), and provide preventive care (52.6%).

Significantly, 33% of medical specialists said their practices used remote patient monitoring. This finding was driven by high rates of use among cardiology practices (63.3%) and endocrinology practices (41.6%). Overall, the practice-level use of remote patient monitoring rose from 10.4% of practices in 2018 to 19.9% in 2020.
 

Virtual consults with peers

Some practices used telehealth to enable physicians to consult with colleagues. Twelve percent of respondents said their practices used telehealth to seek a second opinion from a health care professional in 2020, compared to 6.9% in 2018. Formal consultations via telehealth were also increasingly common: 17.2% of doctors said their practices did this in 2020, compared to 11.3% in 2018.

Also of note, 22.4% of physicians said their practices used telehealth for after-hours care or night calls in 2020, versus 9.9% in 2018.

The AMA report credited telehealth and expanded coverage and payment rules for enabling physician practices to keep their revenue streams positive and their practices open. However, the Commonwealth Fund study found “a substantial cumulative reduction in visits across all specialties over the course of the pandemic in 2020.” These ranged from a drop of 27% in pediatric visits to a decline of 8% in rheumatology visits during the period from March to December 2020.

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

The number of physicians who have chosen early retirement or have left medicine because of the COVID-19 pandemic may be considerably lower than previously thought, results of a new study suggest.

The research letter in the Journal of the American Medical Association, based on Medicare claims data, stated that “practice interruption rates were similar before and during the COVID-19 pandemic, except for a spike in April 2020.”

By contrast, in a Physicians Foundation Survey conducted in August 2020, 8% of physicians said they had closed their practices as a result of COVID, and 4% of the respondents said they planned to leave their practices within the next 12 months.

Similarly, a Jackson Physician Search survey in the fourth quarter of 2020 found that 54% of physicians surveyed had changed their employment plans. Of those doctors, 21% said they might hang up their white coat for early retirement. That works out to about 11% of the respondents.

The JAMA study’s authors analyzed the Medicare claims data from Jan. 1, 2019, to Dec. 30, 2020, to see how many physicians with Medicare patients had stopped filing claims for a period during those 2 years.

If a doctor had ceased submitting claims and then resumed filing them within 6 months after the last billing month, the lapse in filing was defined as “interruption with return.” If a physician stopped filing claims to Medicare and did not resume within 6 months, the gap in filing was called “interruption without return.”

In April 2020, 6.9% of physicians billing Medicare had a practice interruption, compared to 1.4% in 2019. But only 1.1% of physicians stopped practice in April 2020 and did not return, compared with 0.33% in 2019.

Physicians aged 55 or older had higher rates of interruption both with and without return than younger doctors did. The change in interruption rates for older doctors was 7.2% vs. 3.9% for younger physicians. The change in older physicians’ interruption-without-return rate was 1.3% vs. 0.34% for younger colleagues.

“Female physicians, specialists, physicians in smaller practices, those not in a health professional shortage area, and those practicing in a metropolitan area experienced greater increases in practice interruption rates in April 2020 vs. April 2019,” the study states. “But those groups typically had higher rates of return, so the overall changes in practice interruptions without return were similar across characteristics other than age.”
 

Significance for retirement rate

Discussing these results, the authors stressed that practice interruptions without return can’t necessarily be attributed to retirement, and that practice interruptions with return don’t necessarily signify that doctors had been furloughed from their practices.

Also, they said, “this measure of practice interruption likely misses meaningful interruptions that lasted for less than a month or did not involve complete cessation in treating Medicare patients.”

Nevertheless, “the study does capture a signal of some doctors probably retiring,” Jonathan Weiner, DPH, professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health, said in an interview.

But he added, “Some of those people who interrupted their practices and didn’t return may still come back. And there are probably a lot of other doctors who are leaving or changing practices that they didn’t capture.” For example, it’s possible that some doctors who went to work for other health care organizations stopped billing under their own names.

In Dr. Weiner’s view, the true percentage of physicians who have retired since the start of the pandemic is probably somewhere between the portion of doctors who interrupted their practice without return, according to the JAMA study, and the percentage of physicians who said they had closed their practices in the Physicians Foundation survey.
 

No mass exodus seen

Michael Belkin, JD, divisional vice president of recruiting for Merritt Hawkins, a physician search firm, said in an interview that the real number may be closer to the interruption-without-return figure in the JAMA study.

While many physician practices were disrupted in spring of 2020, he said, “it really didn’t result in a mass exodus [from health care]. We’re not talking to a lot of candidates who retired or walked away from their practices. We are talking to candidates who slowed down last year and then realized that they wanted to get back into medicine. And now they’re actively looking.”

One change in job candidates’ attitude, Mr. Belkin said, is that, because of COVID-19–related burnout, their quality of life is more important to them.

“They want to know, ‘What’s the culture of the employer like? What did they do last year during COVID? How did they handle it? Have they put together any protocols for the next pandemic?’ “
 

Demand for doctors has returned

In the summer of 2020, there was a major drop in physician recruitment by hospitals and health systems, partly because of fewer patient visits and procedures. But demand for doctors has bounced back over the past year, Mr. Belkin noted. One reason is the pent-up need for care among patients who avoided health care providers in 2020.

Another reason is that some employed doctors – particularly older physicians – have slowed down. Many doctors prefer to work remotely 1 or 2 days a week, providing telehealth visits to patients. That has led to a loss of productivity in many health care organizations and, consequently, a need to hire additional physicians.

Nevertheless, not many doctors are heading for the exit earlier than physicians did before COVID-19.

“They may work reduced hours,” Mr. Belkin said. “But the sense from a physician’s perspective is that this is all they know. For them to walk away from their life in medicine, from who they are, is problematic. So they’re continuing to practice, but at a reduced capacity.”

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

The number of physicians who have chosen early retirement or have left medicine because of the COVID-19 pandemic may be considerably lower than previously thought, results of a new study suggest.

The research letter in the Journal of the American Medical Association, based on Medicare claims data, stated that “practice interruption rates were similar before and during the COVID-19 pandemic, except for a spike in April 2020.”

By contrast, in a Physicians Foundation Survey conducted in August 2020, 8% of physicians said they had closed their practices as a result of COVID, and 4% of the respondents said they planned to leave their practices within the next 12 months.

Similarly, a Jackson Physician Search survey in the fourth quarter of 2020 found that 54% of physicians surveyed had changed their employment plans. Of those doctors, 21% said they might hang up their white coat for early retirement. That works out to about 11% of the respondents.

The JAMA study’s authors analyzed the Medicare claims data from Jan. 1, 2019, to Dec. 30, 2020, to see how many physicians with Medicare patients had stopped filing claims for a period during those 2 years.

If a doctor had ceased submitting claims and then resumed filing them within 6 months after the last billing month, the lapse in filing was defined as “interruption with return.” If a physician stopped filing claims to Medicare and did not resume within 6 months, the gap in filing was called “interruption without return.”

In April 2020, 6.9% of physicians billing Medicare had a practice interruption, compared to 1.4% in 2019. But only 1.1% of physicians stopped practice in April 2020 and did not return, compared with 0.33% in 2019.

Physicians aged 55 or older had higher rates of interruption both with and without return than younger doctors did. The change in interruption rates for older doctors was 7.2% vs. 3.9% for younger physicians. The change in older physicians’ interruption-without-return rate was 1.3% vs. 0.34% for younger colleagues.

“Female physicians, specialists, physicians in smaller practices, those not in a health professional shortage area, and those practicing in a metropolitan area experienced greater increases in practice interruption rates in April 2020 vs. April 2019,” the study states. “But those groups typically had higher rates of return, so the overall changes in practice interruptions without return were similar across characteristics other than age.”
 

Significance for retirement rate

Discussing these results, the authors stressed that practice interruptions without return can’t necessarily be attributed to retirement, and that practice interruptions with return don’t necessarily signify that doctors had been furloughed from their practices.

Also, they said, “this measure of practice interruption likely misses meaningful interruptions that lasted for less than a month or did not involve complete cessation in treating Medicare patients.”

Nevertheless, “the study does capture a signal of some doctors probably retiring,” Jonathan Weiner, DPH, professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health, said in an interview.

But he added, “Some of those people who interrupted their practices and didn’t return may still come back. And there are probably a lot of other doctors who are leaving or changing practices that they didn’t capture.” For example, it’s possible that some doctors who went to work for other health care organizations stopped billing under their own names.

In Dr. Weiner’s view, the true percentage of physicians who have retired since the start of the pandemic is probably somewhere between the portion of doctors who interrupted their practice without return, according to the JAMA study, and the percentage of physicians who said they had closed their practices in the Physicians Foundation survey.
 

No mass exodus seen

Michael Belkin, JD, divisional vice president of recruiting for Merritt Hawkins, a physician search firm, said in an interview that the real number may be closer to the interruption-without-return figure in the JAMA study.

While many physician practices were disrupted in spring of 2020, he said, “it really didn’t result in a mass exodus [from health care]. We’re not talking to a lot of candidates who retired or walked away from their practices. We are talking to candidates who slowed down last year and then realized that they wanted to get back into medicine. And now they’re actively looking.”

One change in job candidates’ attitude, Mr. Belkin said, is that, because of COVID-19–related burnout, their quality of life is more important to them.

“They want to know, ‘What’s the culture of the employer like? What did they do last year during COVID? How did they handle it? Have they put together any protocols for the next pandemic?’ “
 

Demand for doctors has returned

In the summer of 2020, there was a major drop in physician recruitment by hospitals and health systems, partly because of fewer patient visits and procedures. But demand for doctors has bounced back over the past year, Mr. Belkin noted. One reason is the pent-up need for care among patients who avoided health care providers in 2020.

Another reason is that some employed doctors – particularly older physicians – have slowed down. Many doctors prefer to work remotely 1 or 2 days a week, providing telehealth visits to patients. That has led to a loss of productivity in many health care organizations and, consequently, a need to hire additional physicians.

Nevertheless, not many doctors are heading for the exit earlier than physicians did before COVID-19.

“They may work reduced hours,” Mr. Belkin said. “But the sense from a physician’s perspective is that this is all they know. For them to walk away from their life in medicine, from who they are, is problematic. So they’re continuing to practice, but at a reduced capacity.”

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

The number of physicians who have chosen early retirement or have left medicine because of the COVID-19 pandemic may be considerably lower than previously thought, results of a new study suggest.

The research letter in the Journal of the American Medical Association, based on Medicare claims data, stated that “practice interruption rates were similar before and during the COVID-19 pandemic, except for a spike in April 2020.”

By contrast, in a Physicians Foundation Survey conducted in August 2020, 8% of physicians said they had closed their practices as a result of COVID, and 4% of the respondents said they planned to leave their practices within the next 12 months.

Similarly, a Jackson Physician Search survey in the fourth quarter of 2020 found that 54% of physicians surveyed had changed their employment plans. Of those doctors, 21% said they might hang up their white coat for early retirement. That works out to about 11% of the respondents.

The JAMA study’s authors analyzed the Medicare claims data from Jan. 1, 2019, to Dec. 30, 2020, to see how many physicians with Medicare patients had stopped filing claims for a period during those 2 years.

If a doctor had ceased submitting claims and then resumed filing them within 6 months after the last billing month, the lapse in filing was defined as “interruption with return.” If a physician stopped filing claims to Medicare and did not resume within 6 months, the gap in filing was called “interruption without return.”

In April 2020, 6.9% of physicians billing Medicare had a practice interruption, compared to 1.4% in 2019. But only 1.1% of physicians stopped practice in April 2020 and did not return, compared with 0.33% in 2019.

Physicians aged 55 or older had higher rates of interruption both with and without return than younger doctors did. The change in interruption rates for older doctors was 7.2% vs. 3.9% for younger physicians. The change in older physicians’ interruption-without-return rate was 1.3% vs. 0.34% for younger colleagues.

“Female physicians, specialists, physicians in smaller practices, those not in a health professional shortage area, and those practicing in a metropolitan area experienced greater increases in practice interruption rates in April 2020 vs. April 2019,” the study states. “But those groups typically had higher rates of return, so the overall changes in practice interruptions without return were similar across characteristics other than age.”
 

Significance for retirement rate

Discussing these results, the authors stressed that practice interruptions without return can’t necessarily be attributed to retirement, and that practice interruptions with return don’t necessarily signify that doctors had been furloughed from their practices.

Also, they said, “this measure of practice interruption likely misses meaningful interruptions that lasted for less than a month or did not involve complete cessation in treating Medicare patients.”

Nevertheless, “the study does capture a signal of some doctors probably retiring,” Jonathan Weiner, DPH, professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health, said in an interview.

But he added, “Some of those people who interrupted their practices and didn’t return may still come back. And there are probably a lot of other doctors who are leaving or changing practices that they didn’t capture.” For example, it’s possible that some doctors who went to work for other health care organizations stopped billing under their own names.

In Dr. Weiner’s view, the true percentage of physicians who have retired since the start of the pandemic is probably somewhere between the portion of doctors who interrupted their practice without return, according to the JAMA study, and the percentage of physicians who said they had closed their practices in the Physicians Foundation survey.
 

No mass exodus seen

Michael Belkin, JD, divisional vice president of recruiting for Merritt Hawkins, a physician search firm, said in an interview that the real number may be closer to the interruption-without-return figure in the JAMA study.

While many physician practices were disrupted in spring of 2020, he said, “it really didn’t result in a mass exodus [from health care]. We’re not talking to a lot of candidates who retired or walked away from their practices. We are talking to candidates who slowed down last year and then realized that they wanted to get back into medicine. And now they’re actively looking.”

One change in job candidates’ attitude, Mr. Belkin said, is that, because of COVID-19–related burnout, their quality of life is more important to them.

“They want to know, ‘What’s the culture of the employer like? What did they do last year during COVID? How did they handle it? Have they put together any protocols for the next pandemic?’ “
 

Demand for doctors has returned

In the summer of 2020, there was a major drop in physician recruitment by hospitals and health systems, partly because of fewer patient visits and procedures. But demand for doctors has bounced back over the past year, Mr. Belkin noted. One reason is the pent-up need for care among patients who avoided health care providers in 2020.

Another reason is that some employed doctors – particularly older physicians – have slowed down. Many doctors prefer to work remotely 1 or 2 days a week, providing telehealth visits to patients. That has led to a loss of productivity in many health care organizations and, consequently, a need to hire additional physicians.

Nevertheless, not many doctors are heading for the exit earlier than physicians did before COVID-19.

“They may work reduced hours,” Mr. Belkin said. “But the sense from a physician’s perspective is that this is all they know. For them to walk away from their life in medicine, from who they are, is problematic. So they’re continuing to practice, but at a reduced capacity.”

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

Adherence to the MIND diet can improve memory and thinking skills of older adults, even in the presence of Alzheimer’s disease pathology, new data from the Rush Memory and Aging Project (MAP) show.

Suprijono Suharjoto/Fotolia

“The MIND diet was associated with better cognitive functions independently of brain pathologies related to Alzheimer’s disease, suggesting that diet may contribute to cognitive resilience, which ultimately indicates that it is never too late for dementia prevention,” lead author Klodian Dhana, MD, PhD, with the Rush Institute of Healthy Aging at Rush University, Chicago, said in an interview.

The study was published online Sept. 14, 2021, in the Journal of Alzheimer’s Disease.
 

Impact on brain pathology

“While previous investigations determined that the MIND diet is associated with a slower cognitive decline, the current study furthered the diet and brain health evidence by assessing the impact of brain pathology in the diet-cognition relationship,” Dr. Dhana said.

The MIND diet was pioneered by the late Martha Clare Morris, ScD, a Rush nutritional epidemiologist, who died in 2020 of cancer at age 64. A hybrid of the Mediterranean and DASH (Dietary Approaches to Stop Hypertension) diets, the MIND diet includes green leafy vegetables, fish, nuts, berries, beans, and whole grains and limits consumption of fried and fast foods, sweets, and pastries.

The current study focused on 569 older adults who died while participating in the MAP study, which began in 1997. Participants in the study were mostly White and were without known dementia. All of the participants agreed to undergo annual clinical evaluations. They also agreed to undergo brain autopsy after death.

Beginning in 2004, participants completed annual food frequency questionnaires, which were used to calculate a MIND diet score based on how often the participants ate specific foods.

The researchers used a series of regression analyses to examine associations of the MIND diet, dementia-related brain pathologies, and global cognition near the time of death. Analyses were adjusted for age, sex, education, apo E4, late-life cognitive activities, and total energy intake.

The results show that a higher MIND diet score was associated with better global cognitive functioning around the time of death (beta, 0.119; P = .003).

Notably, the researchers said, neither the strength nor the significance of association changed markedly when AD pathology and other brain pathologies were included in the model (beta, 0.111; P = .003).

The relationship between better adherence to the MIND diet and better cognition remained significant when the analysis was restricted to individuals without mild cognitive impairment at baseline (beta, 0.121; P = .005) as well as to persons in whom a postmortem diagnosis of AD was made on the basis of NIA-Reagan consensus recommendations (beta, 0.114; P = .023).

The limitations of the study include the reliance on self-reported diet information and a sample made up of mostly White volunteers who agreed to annual evaluations and postmortem organ donation, thus limiting generalizability.

Strengths of the study include the prospective design with annual assessment of cognitive function using standardized tests and collection of the dietary information using validated questionnaires. Also, the neuropathologic evaluations were performed by examiners blinded to clinical data.

“Diet changes can impact cognitive functioning and risk of dementia, for better or worse. There are fairly simple diet and lifestyle changes a person could make that may help to slow cognitive decline with aging and contribute to brain health,” Dr. Dhana said in a news release.
 

Builds resilience

Weighing in on the study, Heather Snyder, PhD, vice president of medical and scientific relations for the Alzheimer’s Association, said this “interesting study sheds light on the impact of nutrition on cognitive function.

“The findings add to the growing literature that lifestyle factors – like access to a heart-healthy diet – may help the brain be more resilient to disease-specific changes,” Snyder said in an interview.

“The Alzheimer’s Association’s US POINTER study is investigating how lifestyle interventions, including nutrition guidance, like the MIND diet, may impact a person’s risk of cognitive decline. An ancillary study of the US POINTER will include brain imaging to investigate how these lifestyle interventions impact the biology of the brain,” Dr. Snyder noted.

The research was supported by the National Institute on Aging of the National Institutes of Health. Dr. Dhana and Dr. Snyder disclosed no relevant financial relationships.

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

Adherence to the MIND diet can improve memory and thinking skills of older adults, even in the presence of Alzheimer’s disease pathology, new data from the Rush Memory and Aging Project (MAP) show.

Suprijono Suharjoto/Fotolia

“The MIND diet was associated with better cognitive functions independently of brain pathologies related to Alzheimer’s disease, suggesting that diet may contribute to cognitive resilience, which ultimately indicates that it is never too late for dementia prevention,” lead author Klodian Dhana, MD, PhD, with the Rush Institute of Healthy Aging at Rush University, Chicago, said in an interview.

The study was published online Sept. 14, 2021, in the Journal of Alzheimer’s Disease.
 

Impact on brain pathology

“While previous investigations determined that the MIND diet is associated with a slower cognitive decline, the current study furthered the diet and brain health evidence by assessing the impact of brain pathology in the diet-cognition relationship,” Dr. Dhana said.

The MIND diet was pioneered by the late Martha Clare Morris, ScD, a Rush nutritional epidemiologist, who died in 2020 of cancer at age 64. A hybrid of the Mediterranean and DASH (Dietary Approaches to Stop Hypertension) diets, the MIND diet includes green leafy vegetables, fish, nuts, berries, beans, and whole grains and limits consumption of fried and fast foods, sweets, and pastries.

The current study focused on 569 older adults who died while participating in the MAP study, which began in 1997. Participants in the study were mostly White and were without known dementia. All of the participants agreed to undergo annual clinical evaluations. They also agreed to undergo brain autopsy after death.

Beginning in 2004, participants completed annual food frequency questionnaires, which were used to calculate a MIND diet score based on how often the participants ate specific foods.

The researchers used a series of regression analyses to examine associations of the MIND diet, dementia-related brain pathologies, and global cognition near the time of death. Analyses were adjusted for age, sex, education, apo E4, late-life cognitive activities, and total energy intake.

The results show that a higher MIND diet score was associated with better global cognitive functioning around the time of death (beta, 0.119; P = .003).

Notably, the researchers said, neither the strength nor the significance of association changed markedly when AD pathology and other brain pathologies were included in the model (beta, 0.111; P = .003).

The relationship between better adherence to the MIND diet and better cognition remained significant when the analysis was restricted to individuals without mild cognitive impairment at baseline (beta, 0.121; P = .005) as well as to persons in whom a postmortem diagnosis of AD was made on the basis of NIA-Reagan consensus recommendations (beta, 0.114; P = .023).

The limitations of the study include the reliance on self-reported diet information and a sample made up of mostly White volunteers who agreed to annual evaluations and postmortem organ donation, thus limiting generalizability.

Strengths of the study include the prospective design with annual assessment of cognitive function using standardized tests and collection of the dietary information using validated questionnaires. Also, the neuropathologic evaluations were performed by examiners blinded to clinical data.

“Diet changes can impact cognitive functioning and risk of dementia, for better or worse. There are fairly simple diet and lifestyle changes a person could make that may help to slow cognitive decline with aging and contribute to brain health,” Dr. Dhana said in a news release.
 

Builds resilience

Weighing in on the study, Heather Snyder, PhD, vice president of medical and scientific relations for the Alzheimer’s Association, said this “interesting study sheds light on the impact of nutrition on cognitive function.

“The findings add to the growing literature that lifestyle factors – like access to a heart-healthy diet – may help the brain be more resilient to disease-specific changes,” Snyder said in an interview.

“The Alzheimer’s Association’s US POINTER study is investigating how lifestyle interventions, including nutrition guidance, like the MIND diet, may impact a person’s risk of cognitive decline. An ancillary study of the US POINTER will include brain imaging to investigate how these lifestyle interventions impact the biology of the brain,” Dr. Snyder noted.

The research was supported by the National Institute on Aging of the National Institutes of Health. Dr. Dhana and Dr. Snyder disclosed no relevant financial relationships.

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

Adherence to the MIND diet can improve memory and thinking skills of older adults, even in the presence of Alzheimer’s disease pathology, new data from the Rush Memory and Aging Project (MAP) show.

Suprijono Suharjoto/Fotolia

“The MIND diet was associated with better cognitive functions independently of brain pathologies related to Alzheimer’s disease, suggesting that diet may contribute to cognitive resilience, which ultimately indicates that it is never too late for dementia prevention,” lead author Klodian Dhana, MD, PhD, with the Rush Institute of Healthy Aging at Rush University, Chicago, said in an interview.

The study was published online Sept. 14, 2021, in the Journal of Alzheimer’s Disease.
 

Impact on brain pathology

“While previous investigations determined that the MIND diet is associated with a slower cognitive decline, the current study furthered the diet and brain health evidence by assessing the impact of brain pathology in the diet-cognition relationship,” Dr. Dhana said.

The MIND diet was pioneered by the late Martha Clare Morris, ScD, a Rush nutritional epidemiologist, who died in 2020 of cancer at age 64. A hybrid of the Mediterranean and DASH (Dietary Approaches to Stop Hypertension) diets, the MIND diet includes green leafy vegetables, fish, nuts, berries, beans, and whole grains and limits consumption of fried and fast foods, sweets, and pastries.

The current study focused on 569 older adults who died while participating in the MAP study, which began in 1997. Participants in the study were mostly White and were without known dementia. All of the participants agreed to undergo annual clinical evaluations. They also agreed to undergo brain autopsy after death.

Beginning in 2004, participants completed annual food frequency questionnaires, which were used to calculate a MIND diet score based on how often the participants ate specific foods.

The researchers used a series of regression analyses to examine associations of the MIND diet, dementia-related brain pathologies, and global cognition near the time of death. Analyses were adjusted for age, sex, education, apo E4, late-life cognitive activities, and total energy intake.

The results show that a higher MIND diet score was associated with better global cognitive functioning around the time of death (beta, 0.119; P = .003).

Notably, the researchers said, neither the strength nor the significance of association changed markedly when AD pathology and other brain pathologies were included in the model (beta, 0.111; P = .003).

The relationship between better adherence to the MIND diet and better cognition remained significant when the analysis was restricted to individuals without mild cognitive impairment at baseline (beta, 0.121; P = .005) as well as to persons in whom a postmortem diagnosis of AD was made on the basis of NIA-Reagan consensus recommendations (beta, 0.114; P = .023).

The limitations of the study include the reliance on self-reported diet information and a sample made up of mostly White volunteers who agreed to annual evaluations and postmortem organ donation, thus limiting generalizability.

Strengths of the study include the prospective design with annual assessment of cognitive function using standardized tests and collection of the dietary information using validated questionnaires. Also, the neuropathologic evaluations were performed by examiners blinded to clinical data.

“Diet changes can impact cognitive functioning and risk of dementia, for better or worse. There are fairly simple diet and lifestyle changes a person could make that may help to slow cognitive decline with aging and contribute to brain health,” Dr. Dhana said in a news release.
 

Builds resilience

Weighing in on the study, Heather Snyder, PhD, vice president of medical and scientific relations for the Alzheimer’s Association, said this “interesting study sheds light on the impact of nutrition on cognitive function.

“The findings add to the growing literature that lifestyle factors – like access to a heart-healthy diet – may help the brain be more resilient to disease-specific changes,” Snyder said in an interview.

“The Alzheimer’s Association’s US POINTER study is investigating how lifestyle interventions, including nutrition guidance, like the MIND diet, may impact a person’s risk of cognitive decline. An ancillary study of the US POINTER will include brain imaging to investigate how these lifestyle interventions impact the biology of the brain,” Dr. Snyder noted.

The research was supported by the National Institute on Aging of the National Institutes of Health. Dr. Dhana and Dr. Snyder disclosed no relevant financial relationships.

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

Paying people to participate in clinical trials remains controversial. But to date, most reservations are based on hypothetical scenarios or expert opinion with few real-world data to support them.

Research released this week could change that.

Investigators offered nearly 1,300 participants in two clinical trials either no payment or incentives up to $500 to partake in a smoking cessation study or an analysis of a behavioral intervention to increase ambulation in hospitalized patients.

More cash was associated with greater agreement to participate in the smoking cessation study but not the ambulation trial.

But the bigger news may be that offering payment did not appear to get people to accept more risks or skew participation to lower-income individuals, as some ethicists have warned.

“With the publication of our study, investigators finally have data that they can cite to put to rest any lingering concerns about offering moderate incentives in low-risk trials,” lead author Scott D. Halpern, MD, PhD, the John M. Eisenberg Professor of Medicine, Epidemiology, and Medical Ethics & Health Policy at the University of Pennsylvania, Philadelphia, told this news organization.

This initial real-world data centers on low-risk interventions and more research is needed to analyze the ethics and effectiveness of paying people to join clinical trials with more inherent risk, the researchers note.

The study was published online Sept. 20 in JAMA Internal Medicine.
 

A good first step?

“Payments to research participants are notoriously controversial. Many people oppose payments altogether or insist on minimal payments out of concern that people might be unduly influenced to participate,” Ana S. Iltis, PhD, told this news organization when asked for comment. “Others worry that incentives will disproportionately motivate the less well-off to participate.” 

“This is an important study that begins to assess whether these concerns are justified in a real-world context,” added Dr. Iltis, director of the Center for Bioethics, Health and Society and professor of philosophy at Wake Forest University in Winston-Salem, N.C.

In an accompanying invited commentary, Sang Ngo, Anthony S. Kim, MD, and Winston Chiong, MD, PhD, write: “This work is welcome, as it presents experimental data to a bioethical debate that so far has been largely driven by conjecture and competing suppositions.”

The commentary authors, however, question the conclusiveness of the findings. “Interpreting the authors’ findings is complex and illustrates some of the challenges inherent to applying empirical data to ethical problems,” they write.
 

Recruitment realities

When asked his advice for researchers considering financial incentives, Dr. Halpern said: “All researchers would happily include incentives in their trial budgets if not for concerns that the sponsor or institutional review board might not approve of them.”

“By far the biggest threat to a trial’s success is the inability to enroll enough participants,” he added.

Dr. Iltis agreed, framing the need to boost enrollment in ethical terms. “There is another important ethical issue that often gets ignored, and that is the issue of studies that fail to enroll enough participants and are never completed or are underpowered,” she said.

“These studies end up exposing people to research risks and burdens without a compensating social benefit.”

“If incentives help to increase enrollment and do not necessarily result in undue influence or unfair participant selection, then there might be ethical reasons to offer incentives,” Dr. Iltis added.

Building on previous work assessing financial incentives in hypothetical clinical trials, Dr. Halpern and colleagues studied 654 participants with major depressive disorder in a smoking cessation trial. They also studied another 642 participants in a study that compared a gamification strategy to usual care for encouraging hospitalized patients to get out of bed and walk.

Dr. Halpern and colleagues randomly assigned people in the smoking cessation study to receive no financial compensation, $200, or $500. In the ambulation trial, participants were randomly allocated to receive no compensation, $100, or $300.
 

Key findings

A total of 22% of those offered no incentive enrolled in the smoking cessation study. In contrast, 36% offered $200 agreed, as did 47% of those offered $500, which the investigators say supports offering cash incentives to boost enrollment. The differences were significant (P < .001).

In contrast, the amount offered did not significantly incentivize more people to participate in the ambulation trial (P = .62). Rates were 45% with no compensation, 48% with $100 payment, and 43% with $300 payment.

In an analysis that adjusted for demographic differences, financial well-being, and Research Attitudes Questionnaire (RAQ-7) scores, each increase in cash incentive increased the odds of enrollment in the smoking cessation trial by 70% (adjusted odds ratio, 1.70; 95% confidence interval, 1.34-2.17).

The same effect was not seen in the ambulation trial, where each higher cash incentive did not make a significant difference (aOR, 0.88; 95% CI, 0.64-1.22).

“The ambulation trial was a lower-risk trial in which patients’ willingness to participate was higher in general. So there were likely fewer people whose participation decisions could be influenced by offers of money,” Dr. Halpern said.
 

Inducement vs. coercion

The incentives in the study “did not function as unjust inducements, as they were not preferentially motivating across groups with different income levels or financial well-being in either trial,” the researchers note.

Dr. Halpern and colleagues also checked for any perceptions of coercion. More than 70% of participants in each smoking cessation trial group perceived no coercion, as did more than 93% of participants in each ambulation trial group, according to scores on a modified Perceived Coercion Scale of the MacArthur Admission Experience Survey. 

Furthermore, perception of risks did not significantly alter the association between cash incentives and enrollment in either trial.

After collecting the findings, Dr. Halpern and colleagues informed participants about their participation in RETAIN and explained the rationale for using different cash incentives. They also let all participants know they would ultimately receive the maximum incentive – either $500 or $300, depending on the trial.
 

Research implications

A study limitation was reliance on participant risk perception, as was an inability to measure perceived coercion among people who chose not to participant in the trials. Another potential limitation is that “neither of these parent trials posed particularly high risks. Future tests of incentives of different sizes, and in the context of higher-risk parent trials, including trials that test treatments of serious illnesses, are warranted,” the researchers note.

“While there are many more questions to ask and contexts in which to study the effects of incentives, this study calls on opponents of incentivizing research participants with money to be more humble,” Dr. Iltis said. “Incentives might not have the effects they assume they have and which they have long held make such incentives unethical.”

“I encourage researchers who are offering incentives to consider working with people doing ethics research to assess the effects of incentives in their studies,” Dr. Halpern said. “Real-world, as opposed to hypothetical studies that can improve our understanding of the impact of incentives can improve the ethical conduct of research over time.”
 

Responding to criticism

The authors of the invited commentary questioned the definitions Dr. Halpern and colleagues used for undue or unjust inducement. “Among bioethicists, there is no consensus about what counts as undue inducement or an unjust distribution of research burdens. In this article, the authors have operationalized these constructs based on their own interpretations of undue and unjust inducement, which may not capture all the concerns that scholars have raised about inducement.”

Asked to respond to this and other criticisms raised in the commentary, Dr. Halpern said: “Did our study answer all possible questions about incentives? Absolutely not. But when it comes to incentives for research participation, an ounce of data is worth a pound of conjecture.”

There was agreement, however, that the findings could now put the onus on opponents of financial incentives for trial participants.

“I agree with the commentary’s authors that our study essentially shifts the burden of proof, such that, as they say, ‘those who would limit [incentives’] application may owe us an applicable criterion,’ ” Dr. Halpern said.  

The authors of the invited commentary also criticized use of the study’s noninferiority design to rule out undue or unjust inducement. They note this design “may be unfamiliar to many bioethicists and can place substantial evaluative demands on readers.”

“As for the authors’ claim that noninferiority designs are difficult to interpret and unfamiliar to most clinicians and ethicists, I certainly agree,” Dr. Halpern said. “But that is hardly a reason to not employ the most rigorous methods possible to answer important questions.”

The study was supported by funding from the National Cancer Institute.

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

Paying people to participate in clinical trials remains controversial. But to date, most reservations are based on hypothetical scenarios or expert opinion with few real-world data to support them.

Research released this week could change that.

Investigators offered nearly 1,300 participants in two clinical trials either no payment or incentives up to $500 to partake in a smoking cessation study or an analysis of a behavioral intervention to increase ambulation in hospitalized patients.

More cash was associated with greater agreement to participate in the smoking cessation study but not the ambulation trial.

But the bigger news may be that offering payment did not appear to get people to accept more risks or skew participation to lower-income individuals, as some ethicists have warned.

“With the publication of our study, investigators finally have data that they can cite to put to rest any lingering concerns about offering moderate incentives in low-risk trials,” lead author Scott D. Halpern, MD, PhD, the John M. Eisenberg Professor of Medicine, Epidemiology, and Medical Ethics & Health Policy at the University of Pennsylvania, Philadelphia, told this news organization.

This initial real-world data centers on low-risk interventions and more research is needed to analyze the ethics and effectiveness of paying people to join clinical trials with more inherent risk, the researchers note.

The study was published online Sept. 20 in JAMA Internal Medicine.
 

A good first step?

“Payments to research participants are notoriously controversial. Many people oppose payments altogether or insist on minimal payments out of concern that people might be unduly influenced to participate,” Ana S. Iltis, PhD, told this news organization when asked for comment. “Others worry that incentives will disproportionately motivate the less well-off to participate.” 

“This is an important study that begins to assess whether these concerns are justified in a real-world context,” added Dr. Iltis, director of the Center for Bioethics, Health and Society and professor of philosophy at Wake Forest University in Winston-Salem, N.C.

In an accompanying invited commentary, Sang Ngo, Anthony S. Kim, MD, and Winston Chiong, MD, PhD, write: “This work is welcome, as it presents experimental data to a bioethical debate that so far has been largely driven by conjecture and competing suppositions.”

The commentary authors, however, question the conclusiveness of the findings. “Interpreting the authors’ findings is complex and illustrates some of the challenges inherent to applying empirical data to ethical problems,” they write.
 

Recruitment realities

When asked his advice for researchers considering financial incentives, Dr. Halpern said: “All researchers would happily include incentives in their trial budgets if not for concerns that the sponsor or institutional review board might not approve of them.”

“By far the biggest threat to a trial’s success is the inability to enroll enough participants,” he added.

Dr. Iltis agreed, framing the need to boost enrollment in ethical terms. “There is another important ethical issue that often gets ignored, and that is the issue of studies that fail to enroll enough participants and are never completed or are underpowered,” she said.

“These studies end up exposing people to research risks and burdens without a compensating social benefit.”

“If incentives help to increase enrollment and do not necessarily result in undue influence or unfair participant selection, then there might be ethical reasons to offer incentives,” Dr. Iltis added.

Building on previous work assessing financial incentives in hypothetical clinical trials, Dr. Halpern and colleagues studied 654 participants with major depressive disorder in a smoking cessation trial. They also studied another 642 participants in a study that compared a gamification strategy to usual care for encouraging hospitalized patients to get out of bed and walk.

Dr. Halpern and colleagues randomly assigned people in the smoking cessation study to receive no financial compensation, $200, or $500. In the ambulation trial, participants were randomly allocated to receive no compensation, $100, or $300.
 

Key findings

A total of 22% of those offered no incentive enrolled in the smoking cessation study. In contrast, 36% offered $200 agreed, as did 47% of those offered $500, which the investigators say supports offering cash incentives to boost enrollment. The differences were significant (P < .001).

In contrast, the amount offered did not significantly incentivize more people to participate in the ambulation trial (P = .62). Rates were 45% with no compensation, 48% with $100 payment, and 43% with $300 payment.

In an analysis that adjusted for demographic differences, financial well-being, and Research Attitudes Questionnaire (RAQ-7) scores, each increase in cash incentive increased the odds of enrollment in the smoking cessation trial by 70% (adjusted odds ratio, 1.70; 95% confidence interval, 1.34-2.17).

The same effect was not seen in the ambulation trial, where each higher cash incentive did not make a significant difference (aOR, 0.88; 95% CI, 0.64-1.22).

“The ambulation trial was a lower-risk trial in which patients’ willingness to participate was higher in general. So there were likely fewer people whose participation decisions could be influenced by offers of money,” Dr. Halpern said.
 

Inducement vs. coercion

The incentives in the study “did not function as unjust inducements, as they were not preferentially motivating across groups with different income levels or financial well-being in either trial,” the researchers note.

Dr. Halpern and colleagues also checked for any perceptions of coercion. More than 70% of participants in each smoking cessation trial group perceived no coercion, as did more than 93% of participants in each ambulation trial group, according to scores on a modified Perceived Coercion Scale of the MacArthur Admission Experience Survey. 

Furthermore, perception of risks did not significantly alter the association between cash incentives and enrollment in either trial.

After collecting the findings, Dr. Halpern and colleagues informed participants about their participation in RETAIN and explained the rationale for using different cash incentives. They also let all participants know they would ultimately receive the maximum incentive – either $500 or $300, depending on the trial.
 

Research implications

A study limitation was reliance on participant risk perception, as was an inability to measure perceived coercion among people who chose not to participant in the trials. Another potential limitation is that “neither of these parent trials posed particularly high risks. Future tests of incentives of different sizes, and in the context of higher-risk parent trials, including trials that test treatments of serious illnesses, are warranted,” the researchers note.

“While there are many more questions to ask and contexts in which to study the effects of incentives, this study calls on opponents of incentivizing research participants with money to be more humble,” Dr. Iltis said. “Incentives might not have the effects they assume they have and which they have long held make such incentives unethical.”

“I encourage researchers who are offering incentives to consider working with people doing ethics research to assess the effects of incentives in their studies,” Dr. Halpern said. “Real-world, as opposed to hypothetical studies that can improve our understanding of the impact of incentives can improve the ethical conduct of research over time.”
 

Responding to criticism

The authors of the invited commentary questioned the definitions Dr. Halpern and colleagues used for undue or unjust inducement. “Among bioethicists, there is no consensus about what counts as undue inducement or an unjust distribution of research burdens. In this article, the authors have operationalized these constructs based on their own interpretations of undue and unjust inducement, which may not capture all the concerns that scholars have raised about inducement.”

Asked to respond to this and other criticisms raised in the commentary, Dr. Halpern said: “Did our study answer all possible questions about incentives? Absolutely not. But when it comes to incentives for research participation, an ounce of data is worth a pound of conjecture.”

There was agreement, however, that the findings could now put the onus on opponents of financial incentives for trial participants.

“I agree with the commentary’s authors that our study essentially shifts the burden of proof, such that, as they say, ‘those who would limit [incentives’] application may owe us an applicable criterion,’ ” Dr. Halpern said.  

The authors of the invited commentary also criticized use of the study’s noninferiority design to rule out undue or unjust inducement. They note this design “may be unfamiliar to many bioethicists and can place substantial evaluative demands on readers.”

“As for the authors’ claim that noninferiority designs are difficult to interpret and unfamiliar to most clinicians and ethicists, I certainly agree,” Dr. Halpern said. “But that is hardly a reason to not employ the most rigorous methods possible to answer important questions.”

The study was supported by funding from the National Cancer Institute.

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

Paying people to participate in clinical trials remains controversial. But to date, most reservations are based on hypothetical scenarios or expert opinion with few real-world data to support them.

Research released this week could change that.

Investigators offered nearly 1,300 participants in two clinical trials either no payment or incentives up to $500 to partake in a smoking cessation study or an analysis of a behavioral intervention to increase ambulation in hospitalized patients.

More cash was associated with greater agreement to participate in the smoking cessation study but not the ambulation trial.

But the bigger news may be that offering payment did not appear to get people to accept more risks or skew participation to lower-income individuals, as some ethicists have warned.

“With the publication of our study, investigators finally have data that they can cite to put to rest any lingering concerns about offering moderate incentives in low-risk trials,” lead author Scott D. Halpern, MD, PhD, the John M. Eisenberg Professor of Medicine, Epidemiology, and Medical Ethics & Health Policy at the University of Pennsylvania, Philadelphia, told this news organization.

This initial real-world data centers on low-risk interventions and more research is needed to analyze the ethics and effectiveness of paying people to join clinical trials with more inherent risk, the researchers note.

The study was published online Sept. 20 in JAMA Internal Medicine.
 

A good first step?

“Payments to research participants are notoriously controversial. Many people oppose payments altogether or insist on minimal payments out of concern that people might be unduly influenced to participate,” Ana S. Iltis, PhD, told this news organization when asked for comment. “Others worry that incentives will disproportionately motivate the less well-off to participate.” 

“This is an important study that begins to assess whether these concerns are justified in a real-world context,” added Dr. Iltis, director of the Center for Bioethics, Health and Society and professor of philosophy at Wake Forest University in Winston-Salem, N.C.

In an accompanying invited commentary, Sang Ngo, Anthony S. Kim, MD, and Winston Chiong, MD, PhD, write: “This work is welcome, as it presents experimental data to a bioethical debate that so far has been largely driven by conjecture and competing suppositions.”

The commentary authors, however, question the conclusiveness of the findings. “Interpreting the authors’ findings is complex and illustrates some of the challenges inherent to applying empirical data to ethical problems,” they write.
 

Recruitment realities

When asked his advice for researchers considering financial incentives, Dr. Halpern said: “All researchers would happily include incentives in their trial budgets if not for concerns that the sponsor or institutional review board might not approve of them.”

“By far the biggest threat to a trial’s success is the inability to enroll enough participants,” he added.

Dr. Iltis agreed, framing the need to boost enrollment in ethical terms. “There is another important ethical issue that often gets ignored, and that is the issue of studies that fail to enroll enough participants and are never completed or are underpowered,” she said.

“These studies end up exposing people to research risks and burdens without a compensating social benefit.”

“If incentives help to increase enrollment and do not necessarily result in undue influence or unfair participant selection, then there might be ethical reasons to offer incentives,” Dr. Iltis added.

Building on previous work assessing financial incentives in hypothetical clinical trials, Dr. Halpern and colleagues studied 654 participants with major depressive disorder in a smoking cessation trial. They also studied another 642 participants in a study that compared a gamification strategy to usual care for encouraging hospitalized patients to get out of bed and walk.

Dr. Halpern and colleagues randomly assigned people in the smoking cessation study to receive no financial compensation, $200, or $500. In the ambulation trial, participants were randomly allocated to receive no compensation, $100, or $300.
 

Key findings

A total of 22% of those offered no incentive enrolled in the smoking cessation study. In contrast, 36% offered $200 agreed, as did 47% of those offered $500, which the investigators say supports offering cash incentives to boost enrollment. The differences were significant (P < .001).

In contrast, the amount offered did not significantly incentivize more people to participate in the ambulation trial (P = .62). Rates were 45% with no compensation, 48% with $100 payment, and 43% with $300 payment.

In an analysis that adjusted for demographic differences, financial well-being, and Research Attitudes Questionnaire (RAQ-7) scores, each increase in cash incentive increased the odds of enrollment in the smoking cessation trial by 70% (adjusted odds ratio, 1.70; 95% confidence interval, 1.34-2.17).

The same effect was not seen in the ambulation trial, where each higher cash incentive did not make a significant difference (aOR, 0.88; 95% CI, 0.64-1.22).

“The ambulation trial was a lower-risk trial in which patients’ willingness to participate was higher in general. So there were likely fewer people whose participation decisions could be influenced by offers of money,” Dr. Halpern said.
 

Inducement vs. coercion

The incentives in the study “did not function as unjust inducements, as they were not preferentially motivating across groups with different income levels or financial well-being in either trial,” the researchers note.

Dr. Halpern and colleagues also checked for any perceptions of coercion. More than 70% of participants in each smoking cessation trial group perceived no coercion, as did more than 93% of participants in each ambulation trial group, according to scores on a modified Perceived Coercion Scale of the MacArthur Admission Experience Survey. 

Furthermore, perception of risks did not significantly alter the association between cash incentives and enrollment in either trial.

After collecting the findings, Dr. Halpern and colleagues informed participants about their participation in RETAIN and explained the rationale for using different cash incentives. They also let all participants know they would ultimately receive the maximum incentive – either $500 or $300, depending on the trial.
 

Research implications

A study limitation was reliance on participant risk perception, as was an inability to measure perceived coercion among people who chose not to participant in the trials. Another potential limitation is that “neither of these parent trials posed particularly high risks. Future tests of incentives of different sizes, and in the context of higher-risk parent trials, including trials that test treatments of serious illnesses, are warranted,” the researchers note.

“While there are many more questions to ask and contexts in which to study the effects of incentives, this study calls on opponents of incentivizing research participants with money to be more humble,” Dr. Iltis said. “Incentives might not have the effects they assume they have and which they have long held make such incentives unethical.”

“I encourage researchers who are offering incentives to consider working with people doing ethics research to assess the effects of incentives in their studies,” Dr. Halpern said. “Real-world, as opposed to hypothetical studies that can improve our understanding of the impact of incentives can improve the ethical conduct of research over time.”
 

Responding to criticism

The authors of the invited commentary questioned the definitions Dr. Halpern and colleagues used for undue or unjust inducement. “Among bioethicists, there is no consensus about what counts as undue inducement or an unjust distribution of research burdens. In this article, the authors have operationalized these constructs based on their own interpretations of undue and unjust inducement, which may not capture all the concerns that scholars have raised about inducement.”

Asked to respond to this and other criticisms raised in the commentary, Dr. Halpern said: “Did our study answer all possible questions about incentives? Absolutely not. But when it comes to incentives for research participation, an ounce of data is worth a pound of conjecture.”

There was agreement, however, that the findings could now put the onus on opponents of financial incentives for trial participants.

“I agree with the commentary’s authors that our study essentially shifts the burden of proof, such that, as they say, ‘those who would limit [incentives’] application may owe us an applicable criterion,’ ” Dr. Halpern said.  

The authors of the invited commentary also criticized use of the study’s noninferiority design to rule out undue or unjust inducement. They note this design “may be unfamiliar to many bioethicists and can place substantial evaluative demands on readers.”

“As for the authors’ claim that noninferiority designs are difficult to interpret and unfamiliar to most clinicians and ethicists, I certainly agree,” Dr. Halpern said. “But that is hardly a reason to not employ the most rigorous methods possible to answer important questions.”

The study was supported by funding from the National Cancer Institute.

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

Judy C. Washington, MD, a mentor of many young academic family physicians, particularly underrepresented-in-medicine (URM) physicians, advises her mentees on how to see ahead and plot paths to leadership.

Courtesy Dr. Judy C. Washington

For URM physicians, she also imparts a shared experience of being a minority in the field and helps prepare them for the challenges of facing racism or feeling marginalized or not equitably supported in academic life – and for making change.

While family medicine’s demographics have become more diverse over time, and more so than other specialties, they are not yet representative of the U.S. population. Within academia, male physicians who are Black or African American, or Hispanic or Latino, comprised about 4% and 5% of family medicine faculty, respectively, at the end of 2019, according to data from the Association of American Medical Colleges. For women, these numbers were about 9% and 4%, respectively. (Only those with an MD degree exclusively were included in the report.)

“When you have the privilege to serve in leadership, you have the responsibility to reach back and identify and help others who would not otherwise have the opportunity to be recognized,” Dr. Washington said.

Her mentorship work stems in large part from her long-time involvement and leadership roles in the Society of Teachers of Family Medicine (STFM) – roles she considers a pillar of her professional life. She currently serves as president of the STFM Foundation and is associate chief medical officer of the Atlantic Medical Group, a large multisite physician-led organization. She is also coordinator of women’s health for the Overlook Family Medicine Residency Program, which is affiliated with Atlantic Medical Group.

In Dr. Washington’s role as associate chief medical officer of Atlantic Medical Group in Summit, N.J., she focuses on physician engagement, satisfaction, and diversity. She also assists in areas such as population health. For the Overlook Family Medicine Residency Program also in Summit, she precepts residents in the obstetrics clinic and in the family medicine outpatient clinic.

Diana N. Carvajal, MD, MPH, one of Dr. Washington’s mentees, called her an “inspirational leader” for young academic faculty and said she is a familiar speaker at STFM meetings on topics of workforce diversity, equity, and leadership. She is “passionate” about mentorship, Dr. Carvajal said, and has understood “that URMs and women of color were not always getting [the mentorship they need to be successful].”
 

Guiding future leaders

Ivonne McLean, MD, assistant professor of family and community medicine at Icahn School of Medicine at Mount Sinai, New York, and an attending at a community health center in the Bronx, called Dr. Washington for advice a couple of years ago when she was considering her next career move.

Courtesy Society of Teachers of Family Medicine Foundation

“She took a genuine interest in me. She never said, this is what you should do. But the questions she asked and the examples she gave from her own life were incredibly helpful to me [in deciding to pursue a research fellowship] ... it was a pivotal conversation,” said Dr. McLean, associate director of a reproductive health fellowship and a research fellow in a New York State–funded program.

“From a lived experience angle, she also told me, here are some of the challenges you’ll have as a woman of color, and here are some of the ways you can approach that,” she said.

Dr. Carvajal, also a URM family physician, credits Dr. Washington’s mentorship with the development of a day-long workshop – held before the annual Society of Teachers of Family Medicine (STFM) meeting – on the low and declining rates of Black males in medicine. “We’d planned it as a presentation, and [she heard of it and] helped us expand it,” she said, calling Dr. Washington “warm, welcoming, and encouraging.

“That work and collaboration with her and the others she brought [into the process] have resulted in publications and more presentations and strategy building for diversifying the workforce,” said Dr. Carvajal, assistant professor, director of reproductive health education in family medicine, and codirector of the research section, all in the department of family and community medicine at the University of Maryland, Baltimore.

STFM involvement

Dr. Washington, who says that all or almost all of her mentees are now leaders in their academic institutions and communities, has been instrumental in developing STFM’s mentoring programming and in facilitating the organization’s multifaceted URM Initiative.

She has been active in STFM since the start of her academic career, and in 2009, while serving as assistant program director for the residency program in which she’d trained, she joined two other African American women, Monique Y. Davis-Smith, MD, and Joedrecka Brown-Speights, MD, in cochairing the society’s Group on Minority and Multicultural Health.

It was in this space, that Dr. Washington said she “heard people’s stories of being in major academic institutions and not feeling supported, not being given roadmaps to success, not getting assistance with publishing, or just kind of feeling like an outsider ... of not being pulled in.” Hispanic and African American females, in particular, “were feeling marginalized,” she said.

In 2018, having co-led development of the STFM Quality Mentoring Program for URM faculty, Dr. Washington was asked to join the STFM Foundation and subsequently led the STFM Foundation’s fundraising campaign for a new URM Initiative. She exceeded her goal, increasing support for URM participation in meetings and activities, and then participated in an STFM steering committee to create broader and longer-lasting support for URM faculty, community teachers, and medical students and residents going into academic family medicine.

Increasing the percentage of URM family medicine faculty in leadership positions – and raising awareness of structural barriers to achievement – is one of the current pillars of the URM Initiative.
 

Navigating the ‘minority tax’

As part of her mentoring, Dr. Washington helps URM physicians navigate the minority tax – a term referring to the uncompensated citizenship tasks that are more often assigned to Black and other URM physicians than to White physicians, and that take time away from scholarship, further perpetuating inequities.

Courtesy Society of Teahcers of Family Medicine Foundation

“Some of our young faculty members find themselves thrust into being the diversity and inclusion leaders in their institutions at a level at which they feel little power and little buy-in from [leadership],” she noted.

A commentary written by Dr. Washington and several colleagues on the minority tax as it impacts women – and the need to build a “tax shelter” to make academic medicine a more just environment for URM women – was published earlier this year in the Journal of Women’s Health.

She also answers e-mails and fields phone calls from young URM faculty who are mulling career moves and facing other familiar challenges.

Physicians who are URM, and African American physicians in particular, tend to “get pulled into the [often underserved] communities, into the patient care and community service areas,” Dr. Washington explained. “But unless you convert these projects into scholarship and publications, and unless you serve on a national committee outside of your institution, you’re not going to be promoted.”

Dr. Washington helps junior faculty envision themselves 5-plus years down the road, find what she calls scholarly “passion projects,” and prepare themselves for their next steps.

She helps her mentees navigate other parts of the continuum of unconscious bias and racism as well, from microaggressions from colleagues to overt discrimination from patients.

“I spend countless minutes fielding texts and phone calls from those who need support,” she wrote in a blog post. “They are a constant reminder that I must continue to speak up when I get the opportunity to do so.”
 

A journey through family medicine, and through bias and racism

Dr. Washington’s early days in medicine included graduating from Meharry Medical College in 1983 and the Mountainside Family Practice Residency Program in 1990. Following 6 years of working in a private practice in rural Maryland, she moved to academia, spending 6 years at East Tennessee State University and 4 years at the UMDNJ–New Jersey Medical School in Newark as an assistant professor of family medicine.

As had happened in rural Maryland, bias and racism have too often lurked during her career as a physician.

“I grew up in Alabama so I was pretty much ready to deal with racism in the South,” Dr. Washington said. “What I was not ready for was coming to the Northeast and seeing that you’re marginalized because you’re not invited into the room. Or if you do go into spaces when you’re the only one, you often don’t feel as welcomed as you thought you might be.”

Her ideas and contributions were too often dismissed, she wrote in a 2020 blog entry posted on her LinkedIn page. And during contract negotiations, “I was not aware of all the information that my White colleagues had. They had the advantage of inside information.”

Dr. Washington says that “it took a village” to make her who she is today: teachers in her segregated schools in Alabama, one of her college professors, her best friend in medical school – and STFM, “where the list [of her own mentors] is long.”

Judy C. Washington, MD, a mentor of many young academic family physicians, particularly underrepresented-in-medicine (URM) physicians, advises her mentees on how to see ahead and plot paths to leadership.

Courtesy Dr. Judy C. Washington

For URM physicians, she also imparts a shared experience of being a minority in the field and helps prepare them for the challenges of facing racism or feeling marginalized or not equitably supported in academic life – and for making change.

While family medicine’s demographics have become more diverse over time, and more so than other specialties, they are not yet representative of the U.S. population. Within academia, male physicians who are Black or African American, or Hispanic or Latino, comprised about 4% and 5% of family medicine faculty, respectively, at the end of 2019, according to data from the Association of American Medical Colleges. For women, these numbers were about 9% and 4%, respectively. (Only those with an MD degree exclusively were included in the report.)

“When you have the privilege to serve in leadership, you have the responsibility to reach back and identify and help others who would not otherwise have the opportunity to be recognized,” Dr. Washington said.

Her mentorship work stems in large part from her long-time involvement and leadership roles in the Society of Teachers of Family Medicine (STFM) – roles she considers a pillar of her professional life. She currently serves as president of the STFM Foundation and is associate chief medical officer of the Atlantic Medical Group, a large multisite physician-led organization. She is also coordinator of women’s health for the Overlook Family Medicine Residency Program, which is affiliated with Atlantic Medical Group.

In Dr. Washington’s role as associate chief medical officer of Atlantic Medical Group in Summit, N.J., she focuses on physician engagement, satisfaction, and diversity. She also assists in areas such as population health. For the Overlook Family Medicine Residency Program also in Summit, she precepts residents in the obstetrics clinic and in the family medicine outpatient clinic.

Diana N. Carvajal, MD, MPH, one of Dr. Washington’s mentees, called her an “inspirational leader” for young academic faculty and said she is a familiar speaker at STFM meetings on topics of workforce diversity, equity, and leadership. She is “passionate” about mentorship, Dr. Carvajal said, and has understood “that URMs and women of color were not always getting [the mentorship they need to be successful].”
 

Guiding future leaders

Ivonne McLean, MD, assistant professor of family and community medicine at Icahn School of Medicine at Mount Sinai, New York, and an attending at a community health center in the Bronx, called Dr. Washington for advice a couple of years ago when she was considering her next career move.

Courtesy Society of Teachers of Family Medicine Foundation

“She took a genuine interest in me. She never said, this is what you should do. But the questions she asked and the examples she gave from her own life were incredibly helpful to me [in deciding to pursue a research fellowship] ... it was a pivotal conversation,” said Dr. McLean, associate director of a reproductive health fellowship and a research fellow in a New York State–funded program.

“From a lived experience angle, she also told me, here are some of the challenges you’ll have as a woman of color, and here are some of the ways you can approach that,” she said.

Dr. Carvajal, also a URM family physician, credits Dr. Washington’s mentorship with the development of a day-long workshop – held before the annual Society of Teachers of Family Medicine (STFM) meeting – on the low and declining rates of Black males in medicine. “We’d planned it as a presentation, and [she heard of it and] helped us expand it,” she said, calling Dr. Washington “warm, welcoming, and encouraging.

“That work and collaboration with her and the others she brought [into the process] have resulted in publications and more presentations and strategy building for diversifying the workforce,” said Dr. Carvajal, assistant professor, director of reproductive health education in family medicine, and codirector of the research section, all in the department of family and community medicine at the University of Maryland, Baltimore.

STFM involvement

Dr. Washington, who says that all or almost all of her mentees are now leaders in their academic institutions and communities, has been instrumental in developing STFM’s mentoring programming and in facilitating the organization’s multifaceted URM Initiative.

She has been active in STFM since the start of her academic career, and in 2009, while serving as assistant program director for the residency program in which she’d trained, she joined two other African American women, Monique Y. Davis-Smith, MD, and Joedrecka Brown-Speights, MD, in cochairing the society’s Group on Minority and Multicultural Health.

It was in this space, that Dr. Washington said she “heard people’s stories of being in major academic institutions and not feeling supported, not being given roadmaps to success, not getting assistance with publishing, or just kind of feeling like an outsider ... of not being pulled in.” Hispanic and African American females, in particular, “were feeling marginalized,” she said.

In 2018, having co-led development of the STFM Quality Mentoring Program for URM faculty, Dr. Washington was asked to join the STFM Foundation and subsequently led the STFM Foundation’s fundraising campaign for a new URM Initiative. She exceeded her goal, increasing support for URM participation in meetings and activities, and then participated in an STFM steering committee to create broader and longer-lasting support for URM faculty, community teachers, and medical students and residents going into academic family medicine.

Increasing the percentage of URM family medicine faculty in leadership positions – and raising awareness of structural barriers to achievement – is one of the current pillars of the URM Initiative.
 

Navigating the ‘minority tax’

As part of her mentoring, Dr. Washington helps URM physicians navigate the minority tax – a term referring to the uncompensated citizenship tasks that are more often assigned to Black and other URM physicians than to White physicians, and that take time away from scholarship, further perpetuating inequities.

Courtesy Society of Teahcers of Family Medicine Foundation

“Some of our young faculty members find themselves thrust into being the diversity and inclusion leaders in their institutions at a level at which they feel little power and little buy-in from [leadership],” she noted.

A commentary written by Dr. Washington and several colleagues on the minority tax as it impacts women – and the need to build a “tax shelter” to make academic medicine a more just environment for URM women – was published earlier this year in the Journal of Women’s Health.

She also answers e-mails and fields phone calls from young URM faculty who are mulling career moves and facing other familiar challenges.

Physicians who are URM, and African American physicians in particular, tend to “get pulled into the [often underserved] communities, into the patient care and community service areas,” Dr. Washington explained. “But unless you convert these projects into scholarship and publications, and unless you serve on a national committee outside of your institution, you’re not going to be promoted.”

Dr. Washington helps junior faculty envision themselves 5-plus years down the road, find what she calls scholarly “passion projects,” and prepare themselves for their next steps.

She helps her mentees navigate other parts of the continuum of unconscious bias and racism as well, from microaggressions from colleagues to overt discrimination from patients.

“I spend countless minutes fielding texts and phone calls from those who need support,” she wrote in a blog post. “They are a constant reminder that I must continue to speak up when I get the opportunity to do so.”
 

A journey through family medicine, and through bias and racism

Dr. Washington’s early days in medicine included graduating from Meharry Medical College in 1983 and the Mountainside Family Practice Residency Program in 1990. Following 6 years of working in a private practice in rural Maryland, she moved to academia, spending 6 years at East Tennessee State University and 4 years at the UMDNJ–New Jersey Medical School in Newark as an assistant professor of family medicine.

As had happened in rural Maryland, bias and racism have too often lurked during her career as a physician.

“I grew up in Alabama so I was pretty much ready to deal with racism in the South,” Dr. Washington said. “What I was not ready for was coming to the Northeast and seeing that you’re marginalized because you’re not invited into the room. Or if you do go into spaces when you’re the only one, you often don’t feel as welcomed as you thought you might be.”

Her ideas and contributions were too often dismissed, she wrote in a 2020 blog entry posted on her LinkedIn page. And during contract negotiations, “I was not aware of all the information that my White colleagues had. They had the advantage of inside information.”

Dr. Washington says that “it took a village” to make her who she is today: teachers in her segregated schools in Alabama, one of her college professors, her best friend in medical school – and STFM, “where the list [of her own mentors] is long.”

Judy C. Washington, MD, a mentor of many young academic family physicians, particularly underrepresented-in-medicine (URM) physicians, advises her mentees on how to see ahead and plot paths to leadership.

Courtesy Dr. Judy C. Washington

For URM physicians, she also imparts a shared experience of being a minority in the field and helps prepare them for the challenges of facing racism or feeling marginalized or not equitably supported in academic life – and for making change.

While family medicine’s demographics have become more diverse over time, and more so than other specialties, they are not yet representative of the U.S. population. Within academia, male physicians who are Black or African American, or Hispanic or Latino, comprised about 4% and 5% of family medicine faculty, respectively, at the end of 2019, according to data from the Association of American Medical Colleges. For women, these numbers were about 9% and 4%, respectively. (Only those with an MD degree exclusively were included in the report.)

“When you have the privilege to serve in leadership, you have the responsibility to reach back and identify and help others who would not otherwise have the opportunity to be recognized,” Dr. Washington said.

Her mentorship work stems in large part from her long-time involvement and leadership roles in the Society of Teachers of Family Medicine (STFM) – roles she considers a pillar of her professional life. She currently serves as president of the STFM Foundation and is associate chief medical officer of the Atlantic Medical Group, a large multisite physician-led organization. She is also coordinator of women’s health for the Overlook Family Medicine Residency Program, which is affiliated with Atlantic Medical Group.

In Dr. Washington’s role as associate chief medical officer of Atlantic Medical Group in Summit, N.J., she focuses on physician engagement, satisfaction, and diversity. She also assists in areas such as population health. For the Overlook Family Medicine Residency Program also in Summit, she precepts residents in the obstetrics clinic and in the family medicine outpatient clinic.

Diana N. Carvajal, MD, MPH, one of Dr. Washington’s mentees, called her an “inspirational leader” for young academic faculty and said she is a familiar speaker at STFM meetings on topics of workforce diversity, equity, and leadership. She is “passionate” about mentorship, Dr. Carvajal said, and has understood “that URMs and women of color were not always getting [the mentorship they need to be successful].”
 

Guiding future leaders

Ivonne McLean, MD, assistant professor of family and community medicine at Icahn School of Medicine at Mount Sinai, New York, and an attending at a community health center in the Bronx, called Dr. Washington for advice a couple of years ago when she was considering her next career move.

Courtesy Society of Teachers of Family Medicine Foundation

“She took a genuine interest in me. She never said, this is what you should do. But the questions she asked and the examples she gave from her own life were incredibly helpful to me [in deciding to pursue a research fellowship] ... it was a pivotal conversation,” said Dr. McLean, associate director of a reproductive health fellowship and a research fellow in a New York State–funded program.

“From a lived experience angle, she also told me, here are some of the challenges you’ll have as a woman of color, and here are some of the ways you can approach that,” she said.

Dr. Carvajal, also a URM family physician, credits Dr. Washington’s mentorship with the development of a day-long workshop – held before the annual Society of Teachers of Family Medicine (STFM) meeting – on the low and declining rates of Black males in medicine. “We’d planned it as a presentation, and [she heard of it and] helped us expand it,” she said, calling Dr. Washington “warm, welcoming, and encouraging.

“That work and collaboration with her and the others she brought [into the process] have resulted in publications and more presentations and strategy building for diversifying the workforce,” said Dr. Carvajal, assistant professor, director of reproductive health education in family medicine, and codirector of the research section, all in the department of family and community medicine at the University of Maryland, Baltimore.

STFM involvement

Dr. Washington, who says that all or almost all of her mentees are now leaders in their academic institutions and communities, has been instrumental in developing STFM’s mentoring programming and in facilitating the organization’s multifaceted URM Initiative.

She has been active in STFM since the start of her academic career, and in 2009, while serving as assistant program director for the residency program in which she’d trained, she joined two other African American women, Monique Y. Davis-Smith, MD, and Joedrecka Brown-Speights, MD, in cochairing the society’s Group on Minority and Multicultural Health.

It was in this space, that Dr. Washington said she “heard people’s stories of being in major academic institutions and not feeling supported, not being given roadmaps to success, not getting assistance with publishing, or just kind of feeling like an outsider ... of not being pulled in.” Hispanic and African American females, in particular, “were feeling marginalized,” she said.

In 2018, having co-led development of the STFM Quality Mentoring Program for URM faculty, Dr. Washington was asked to join the STFM Foundation and subsequently led the STFM Foundation’s fundraising campaign for a new URM Initiative. She exceeded her goal, increasing support for URM participation in meetings and activities, and then participated in an STFM steering committee to create broader and longer-lasting support for URM faculty, community teachers, and medical students and residents going into academic family medicine.

Increasing the percentage of URM family medicine faculty in leadership positions – and raising awareness of structural barriers to achievement – is one of the current pillars of the URM Initiative.
 

Navigating the ‘minority tax’

As part of her mentoring, Dr. Washington helps URM physicians navigate the minority tax – a term referring to the uncompensated citizenship tasks that are more often assigned to Black and other URM physicians than to White physicians, and that take time away from scholarship, further perpetuating inequities.

Courtesy Society of Teahcers of Family Medicine Foundation

“Some of our young faculty members find themselves thrust into being the diversity and inclusion leaders in their institutions at a level at which they feel little power and little buy-in from [leadership],” she noted.

A commentary written by Dr. Washington and several colleagues on the minority tax as it impacts women – and the need to build a “tax shelter” to make academic medicine a more just environment for URM women – was published earlier this year in the Journal of Women’s Health.

She also answers e-mails and fields phone calls from young URM faculty who are mulling career moves and facing other familiar challenges.

Physicians who are URM, and African American physicians in particular, tend to “get pulled into the [often underserved] communities, into the patient care and community service areas,” Dr. Washington explained. “But unless you convert these projects into scholarship and publications, and unless you serve on a national committee outside of your institution, you’re not going to be promoted.”

Dr. Washington helps junior faculty envision themselves 5-plus years down the road, find what she calls scholarly “passion projects,” and prepare themselves for their next steps.

She helps her mentees navigate other parts of the continuum of unconscious bias and racism as well, from microaggressions from colleagues to overt discrimination from patients.

“I spend countless minutes fielding texts and phone calls from those who need support,” she wrote in a blog post. “They are a constant reminder that I must continue to speak up when I get the opportunity to do so.”
 

A journey through family medicine, and through bias and racism

Dr. Washington’s early days in medicine included graduating from Meharry Medical College in 1983 and the Mountainside Family Practice Residency Program in 1990. Following 6 years of working in a private practice in rural Maryland, she moved to academia, spending 6 years at East Tennessee State University and 4 years at the UMDNJ–New Jersey Medical School in Newark as an assistant professor of family medicine.

As had happened in rural Maryland, bias and racism have too often lurked during her career as a physician.

“I grew up in Alabama so I was pretty much ready to deal with racism in the South,” Dr. Washington said. “What I was not ready for was coming to the Northeast and seeing that you’re marginalized because you’re not invited into the room. Or if you do go into spaces when you’re the only one, you often don’t feel as welcomed as you thought you might be.”

Her ideas and contributions were too often dismissed, she wrote in a 2020 blog entry posted on her LinkedIn page. And during contract negotiations, “I was not aware of all the information that my White colleagues had. They had the advantage of inside information.”

Dr. Washington says that “it took a village” to make her who she is today: teachers in her segregated schools in Alabama, one of her college professors, her best friend in medical school – and STFM, “where the list [of her own mentors] is long.”

A new series of cases of cerebral venous sinus thrombosis (CVST) linked to the adenoviral vector COVID-19 vaccines has been reported, confirming the severity of the reaction and the associated high mortality rate.

The new series comes from an international registry of consecutive patients who experienced CVST within 28 days of COVID-19 vaccination between March 29 and June 18, 2021, from 81 hospitals in 19 countries.

The cases are described in an article published online on Sept. 28. in JAMA Neurology.

“This is a reliable description on the clinical condition of these patients with CVST associated with COVID-19 vaccination. It is striking that this a much worse condition than CVST not associated with COVID-19 vaccination, with a much higher rate of intracerebral hemorrhage and coma and a much higher mortality rate,” senior author Jonathan M. Coutinho, MD, Amsterdam University Medical Centers, told this news organization.

These data confirm the observations from an earlier U.K. cohort in which cases of cerebral venous thrombosis linked to COVID-19 vaccination occurred.

“This is the biggest series, and as an international series, it gives a broader perspective from a larger range of countries,” Dr. Coutinho said. “All the data together show that, although this side effect is rare, the consequences are very severe,” he added.

In the current study, the researchers regarded CVST as being linked to the vaccine if it was accompanied by thrombosis with thrombocytopenia syndrome (TTS), as evidenced by thrombosis and new-onset thrombocytopenia.

In the cohort of 116 patients with CVST after COVID-19 vaccination, 78 (67.2%) had thrombosis with TTS and were thus classified as having had a vaccine-related adverse event. These patients were frequently comatose at presentation (24%) and often had intracerebral hemorrhage (68%) and concomitant thromboembolism (36%); 47% died during hospitalization.

These patients were compared with the 38 patients in the same cohort who had CVST but in whom there was no indication of concomitant thrombosis and thrombocytopenia. The case patients were also compared with a control group of 207 patients with CVST who were included in a separate international registry before the COVID-19 pandemic.

Mortality rates were much higher among the patients deemed to have had a vaccine-related CVST. The in-hospital mortality rate was 47%, compared with 5% among the patients in the same cohort who did not have TTS and 3.9% among the prepandemic control group.

The mortality rate was even higher (61%) among patients in the TTS group for whom the diagnosis was made before the condition garnered attention in the scientific community. The mortality rate was 42% among patients diagnosed later.

Of the 78 patients in whom CVST and TTS occurred after COVID-19 vaccination in this cohort, 76 had received the AstraZeneca vaccine (in 75 patients, CVST and TTS occurred after the first vaccination; in one patient, they occurred after the second vaccination). One patient had received the Johnson & Johnson vaccine, and one had received the Pfizer vaccine.

“After more analysis, the case after the Pfizer vaccination is not believed to be caused by the vaccine,” Dr. Coutinho said. “In that case, the patient had a platelet count just below the lower limit and was taking an immunomodulator drug that is known to be associated with thrombocytopenia.”

For two patients who received the AstraZeneca vaccine, there was also an alternative explanation for the thrombocytopenia.

Dr. Coutinho also pointed out that the Johnson & Johnson vaccine has been used mainly in the United States, and these data were largely from other countries.

The median time from vaccination to CVST symptom onset was 9 days in the TTS group. The median platelet count at hospital admission among patients with postvaccination CVST-TTS was 45. Three patients presented with a normal platelet count and developed thrombocytopenia during admission; two patients presented with mild thrombocytopenia, 30 presented with moderate thrombocytopenia, and 43 presented with severe thrombocytopenia.

Antibodies against platelet factor 4 (PF4) were measured in 69 patients with TTS, of whom 63 (91%) tested positive (the one patient in whom TTS occurred after the patient received the Pfizer vaccine did not test positive). However, the researchers note that sensitivity varies among different PF4 ELISA tests. Findings of platelet activation assays were positive in all 36 tested patients.

In the TTS group, 52 patients (67%) received immunomodulation therapy, most often intravenous immunoglobulins (IVIG). Among patients treated with IVIG, the mortality rate was lower (28%).
 

Different from CVST linked to natural COVID-19 infection

Dr. Coutinho noted that CVST can occur in natural SARS-CoV-2 infection but that vaccine-associated CVST is very different.

“In natural COVID-19 infection, there is an increased risk of thrombosis, and some patients can get CVST as a part of this, but in these cases, this is not accompanied by thrombocytopenia. While the CVST in natural COVID-19 infection is also associated with a bad prognosis, this is more to do with the underlying disease. It is normally the very sick COVID patients who develop CVST, and these patients usually die from the underlying disease rather than the CVST itself,” he explained.

“Clinicians need to be aware of vaccine-related CVST, as it requires very specific and rapid treatment,” Dr. Coutinho stressed.

“Patients presenting with an extremely severe headache (unlike any headache they’ve had before) or with seizures or a focal deficit (weakness in arm or problems with speaking or vision) within 4 weeks of an adenovirus COVID-19 vaccination should ring alarm bells. It is important to do diagnostics quickly, with a platelet count the most important first step, and a rapid CT/MRI scan,” he said.

Other tests that should be conducted are D-dimer for thrombosis and the PF4 antibody test. But results for the PF4 antibody test can take days to come back, and clinicians shouldn’t wait for that, Dr. Coutinho notes.

“Specific treatment needs to be given immediately – with anticoagulation (preferably nonheparin) and immunomodulation with IVIG to stop the immune reaction. Platelets should not be given – that may seem counterintuitive in patients with a low platelet count, but giving platelets makes it worse,” he said.
 

Is there a geographic difference?

Dr. Coutinho pointed out that fewer cases of this vaccine-related CVST are being reported at the current time.

“We are not sure why this is the case. These adenovirus vaccines are not being used much now in Western countries, but our collaboration covers many less developed countries in South America and Asia, which are relying heavily on these vaccines. We are now shifting focus to these countries, but so far we have only seen a handful of cases from these areas,” he said.

He suggested that this may be because these countries started their vaccination programs later and are vaccinating their elderly (who are not so susceptible to this side effect) first, or it may be because of some environmental or genetic factor that has not yet been discovered.

“This is now an important research question – is the risk of vaccine-induced CVST the same in different countries or ethnicities? This could influence decisions on future vaccine strategies,” Dr. Coutinho said.

“So far, female sex is the strongest risk factor for vaccine-induced CVST. In our cohort, 81% of cases were in women. In addition, 95% were White, but that doesn’t allow us to conclude that this is a risk factor, as the majority of people who have been vaccinated are White. So, we have no clear insight into that yet,” he said.

In a comment for this news organization, the lead author of the previous U.K. report of a series of 70 cases of cerebral venous thrombosis linked to COVID-19 vaccination, Richard Perry, PhD, University College Hospital, London, described this new report as “an excellent study, with many of the same strengths and weaknesses as our study and has very similar results.”

Dr. Perry noted that the two studies used slightly different definitions of vaccine-induced thrombotic thrombocytopenia, but the cases reported appear to be very similar overall. “It is reassuring and gratifying to see that they have made such similar observations,” he said.

“And as they have drawn their cases from a broad range of countries whereas ours were all from the U.K., this provides evidence that the observations from both studies are reasonably generalizable,” he added.

Dr. Perry pointed out that this new report states that TTS occurred in one patient after the patient had received a second dose of the AstraZeneca vaccine. “I would like to know more about this case, because we didn’t see any cases after a second dose in our cohort,” he said.

Dr. Coutinho responded that he didn’t believe this was the first reported case after the second dose.

The study did not receive any specific funding. Dr. Coutinho has received grants paid to his institution from Boehringer Ingelheim and Bayer and payments paid to his institution for data safety monitoring board participation by Bayer.

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

A new series of cases of cerebral venous sinus thrombosis (CVST) linked to the adenoviral vector COVID-19 vaccines has been reported, confirming the severity of the reaction and the associated high mortality rate.

The new series comes from an international registry of consecutive patients who experienced CVST within 28 days of COVID-19 vaccination between March 29 and June 18, 2021, from 81 hospitals in 19 countries.

The cases are described in an article published online on Sept. 28. in JAMA Neurology.

“This is a reliable description on the clinical condition of these patients with CVST associated with COVID-19 vaccination. It is striking that this a much worse condition than CVST not associated with COVID-19 vaccination, with a much higher rate of intracerebral hemorrhage and coma and a much higher mortality rate,” senior author Jonathan M. Coutinho, MD, Amsterdam University Medical Centers, told this news organization.

These data confirm the observations from an earlier U.K. cohort in which cases of cerebral venous thrombosis linked to COVID-19 vaccination occurred.

“This is the biggest series, and as an international series, it gives a broader perspective from a larger range of countries,” Dr. Coutinho said. “All the data together show that, although this side effect is rare, the consequences are very severe,” he added.

In the current study, the researchers regarded CVST as being linked to the vaccine if it was accompanied by thrombosis with thrombocytopenia syndrome (TTS), as evidenced by thrombosis and new-onset thrombocytopenia.

In the cohort of 116 patients with CVST after COVID-19 vaccination, 78 (67.2%) had thrombosis with TTS and were thus classified as having had a vaccine-related adverse event. These patients were frequently comatose at presentation (24%) and often had intracerebral hemorrhage (68%) and concomitant thromboembolism (36%); 47% died during hospitalization.

These patients were compared with the 38 patients in the same cohort who had CVST but in whom there was no indication of concomitant thrombosis and thrombocytopenia. The case patients were also compared with a control group of 207 patients with CVST who were included in a separate international registry before the COVID-19 pandemic.

Mortality rates were much higher among the patients deemed to have had a vaccine-related CVST. The in-hospital mortality rate was 47%, compared with 5% among the patients in the same cohort who did not have TTS and 3.9% among the prepandemic control group.

The mortality rate was even higher (61%) among patients in the TTS group for whom the diagnosis was made before the condition garnered attention in the scientific community. The mortality rate was 42% among patients diagnosed later.

Of the 78 patients in whom CVST and TTS occurred after COVID-19 vaccination in this cohort, 76 had received the AstraZeneca vaccine (in 75 patients, CVST and TTS occurred after the first vaccination; in one patient, they occurred after the second vaccination). One patient had received the Johnson & Johnson vaccine, and one had received the Pfizer vaccine.

“After more analysis, the case after the Pfizer vaccination is not believed to be caused by the vaccine,” Dr. Coutinho said. “In that case, the patient had a platelet count just below the lower limit and was taking an immunomodulator drug that is known to be associated with thrombocytopenia.”

For two patients who received the AstraZeneca vaccine, there was also an alternative explanation for the thrombocytopenia.

Dr. Coutinho also pointed out that the Johnson & Johnson vaccine has been used mainly in the United States, and these data were largely from other countries.

The median time from vaccination to CVST symptom onset was 9 days in the TTS group. The median platelet count at hospital admission among patients with postvaccination CVST-TTS was 45. Three patients presented with a normal platelet count and developed thrombocytopenia during admission; two patients presented with mild thrombocytopenia, 30 presented with moderate thrombocytopenia, and 43 presented with severe thrombocytopenia.

Antibodies against platelet factor 4 (PF4) were measured in 69 patients with TTS, of whom 63 (91%) tested positive (the one patient in whom TTS occurred after the patient received the Pfizer vaccine did not test positive). However, the researchers note that sensitivity varies among different PF4 ELISA tests. Findings of platelet activation assays were positive in all 36 tested patients.

In the TTS group, 52 patients (67%) received immunomodulation therapy, most often intravenous immunoglobulins (IVIG). Among patients treated with IVIG, the mortality rate was lower (28%).
 

Different from CVST linked to natural COVID-19 infection

Dr. Coutinho noted that CVST can occur in natural SARS-CoV-2 infection but that vaccine-associated CVST is very different.

“In natural COVID-19 infection, there is an increased risk of thrombosis, and some patients can get CVST as a part of this, but in these cases, this is not accompanied by thrombocytopenia. While the CVST in natural COVID-19 infection is also associated with a bad prognosis, this is more to do with the underlying disease. It is normally the very sick COVID patients who develop CVST, and these patients usually die from the underlying disease rather than the CVST itself,” he explained.

“Clinicians need to be aware of vaccine-related CVST, as it requires very specific and rapid treatment,” Dr. Coutinho stressed.

“Patients presenting with an extremely severe headache (unlike any headache they’ve had before) or with seizures or a focal deficit (weakness in arm or problems with speaking or vision) within 4 weeks of an adenovirus COVID-19 vaccination should ring alarm bells. It is important to do diagnostics quickly, with a platelet count the most important first step, and a rapid CT/MRI scan,” he said.

Other tests that should be conducted are D-dimer for thrombosis and the PF4 antibody test. But results for the PF4 antibody test can take days to come back, and clinicians shouldn’t wait for that, Dr. Coutinho notes.

“Specific treatment needs to be given immediately – with anticoagulation (preferably nonheparin) and immunomodulation with IVIG to stop the immune reaction. Platelets should not be given – that may seem counterintuitive in patients with a low platelet count, but giving platelets makes it worse,” he said.
 

Is there a geographic difference?

Dr. Coutinho pointed out that fewer cases of this vaccine-related CVST are being reported at the current time.

“We are not sure why this is the case. These adenovirus vaccines are not being used much now in Western countries, but our collaboration covers many less developed countries in South America and Asia, which are relying heavily on these vaccines. We are now shifting focus to these countries, but so far we have only seen a handful of cases from these areas,” he said.

He suggested that this may be because these countries started their vaccination programs later and are vaccinating their elderly (who are not so susceptible to this side effect) first, or it may be because of some environmental or genetic factor that has not yet been discovered.

“This is now an important research question – is the risk of vaccine-induced CVST the same in different countries or ethnicities? This could influence decisions on future vaccine strategies,” Dr. Coutinho said.

“So far, female sex is the strongest risk factor for vaccine-induced CVST. In our cohort, 81% of cases were in women. In addition, 95% were White, but that doesn’t allow us to conclude that this is a risk factor, as the majority of people who have been vaccinated are White. So, we have no clear insight into that yet,” he said.

In a comment for this news organization, the lead author of the previous U.K. report of a series of 70 cases of cerebral venous thrombosis linked to COVID-19 vaccination, Richard Perry, PhD, University College Hospital, London, described this new report as “an excellent study, with many of the same strengths and weaknesses as our study and has very similar results.”

Dr. Perry noted that the two studies used slightly different definitions of vaccine-induced thrombotic thrombocytopenia, but the cases reported appear to be very similar overall. “It is reassuring and gratifying to see that they have made such similar observations,” he said.

“And as they have drawn their cases from a broad range of countries whereas ours were all from the U.K., this provides evidence that the observations from both studies are reasonably generalizable,” he added.

Dr. Perry pointed out that this new report states that TTS occurred in one patient after the patient had received a second dose of the AstraZeneca vaccine. “I would like to know more about this case, because we didn’t see any cases after a second dose in our cohort,” he said.

Dr. Coutinho responded that he didn’t believe this was the first reported case after the second dose.

The study did not receive any specific funding. Dr. Coutinho has received grants paid to his institution from Boehringer Ingelheim and Bayer and payments paid to his institution for data safety monitoring board participation by Bayer.

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

A new series of cases of cerebral venous sinus thrombosis (CVST) linked to the adenoviral vector COVID-19 vaccines has been reported, confirming the severity of the reaction and the associated high mortality rate.

The new series comes from an international registry of consecutive patients who experienced CVST within 28 days of COVID-19 vaccination between March 29 and June 18, 2021, from 81 hospitals in 19 countries.

The cases are described in an article published online on Sept. 28. in JAMA Neurology.

“This is a reliable description on the clinical condition of these patients with CVST associated with COVID-19 vaccination. It is striking that this a much worse condition than CVST not associated with COVID-19 vaccination, with a much higher rate of intracerebral hemorrhage and coma and a much higher mortality rate,” senior author Jonathan M. Coutinho, MD, Amsterdam University Medical Centers, told this news organization.

These data confirm the observations from an earlier U.K. cohort in which cases of cerebral venous thrombosis linked to COVID-19 vaccination occurred.

“This is the biggest series, and as an international series, it gives a broader perspective from a larger range of countries,” Dr. Coutinho said. “All the data together show that, although this side effect is rare, the consequences are very severe,” he added.

In the current study, the researchers regarded CVST as being linked to the vaccine if it was accompanied by thrombosis with thrombocytopenia syndrome (TTS), as evidenced by thrombosis and new-onset thrombocytopenia.

In the cohort of 116 patients with CVST after COVID-19 vaccination, 78 (67.2%) had thrombosis with TTS and were thus classified as having had a vaccine-related adverse event. These patients were frequently comatose at presentation (24%) and often had intracerebral hemorrhage (68%) and concomitant thromboembolism (36%); 47% died during hospitalization.

These patients were compared with the 38 patients in the same cohort who had CVST but in whom there was no indication of concomitant thrombosis and thrombocytopenia. The case patients were also compared with a control group of 207 patients with CVST who were included in a separate international registry before the COVID-19 pandemic.

Mortality rates were much higher among the patients deemed to have had a vaccine-related CVST. The in-hospital mortality rate was 47%, compared with 5% among the patients in the same cohort who did not have TTS and 3.9% among the prepandemic control group.

The mortality rate was even higher (61%) among patients in the TTS group for whom the diagnosis was made before the condition garnered attention in the scientific community. The mortality rate was 42% among patients diagnosed later.

Of the 78 patients in whom CVST and TTS occurred after COVID-19 vaccination in this cohort, 76 had received the AstraZeneca vaccine (in 75 patients, CVST and TTS occurred after the first vaccination; in one patient, they occurred after the second vaccination). One patient had received the Johnson & Johnson vaccine, and one had received the Pfizer vaccine.

“After more analysis, the case after the Pfizer vaccination is not believed to be caused by the vaccine,” Dr. Coutinho said. “In that case, the patient had a platelet count just below the lower limit and was taking an immunomodulator drug that is known to be associated with thrombocytopenia.”

For two patients who received the AstraZeneca vaccine, there was also an alternative explanation for the thrombocytopenia.

Dr. Coutinho also pointed out that the Johnson & Johnson vaccine has been used mainly in the United States, and these data were largely from other countries.

The median time from vaccination to CVST symptom onset was 9 days in the TTS group. The median platelet count at hospital admission among patients with postvaccination CVST-TTS was 45. Three patients presented with a normal platelet count and developed thrombocytopenia during admission; two patients presented with mild thrombocytopenia, 30 presented with moderate thrombocytopenia, and 43 presented with severe thrombocytopenia.

Antibodies against platelet factor 4 (PF4) were measured in 69 patients with TTS, of whom 63 (91%) tested positive (the one patient in whom TTS occurred after the patient received the Pfizer vaccine did not test positive). However, the researchers note that sensitivity varies among different PF4 ELISA tests. Findings of platelet activation assays were positive in all 36 tested patients.

In the TTS group, 52 patients (67%) received immunomodulation therapy, most often intravenous immunoglobulins (IVIG). Among patients treated with IVIG, the mortality rate was lower (28%).
 

Different from CVST linked to natural COVID-19 infection

Dr. Coutinho noted that CVST can occur in natural SARS-CoV-2 infection but that vaccine-associated CVST is very different.

“In natural COVID-19 infection, there is an increased risk of thrombosis, and some patients can get CVST as a part of this, but in these cases, this is not accompanied by thrombocytopenia. While the CVST in natural COVID-19 infection is also associated with a bad prognosis, this is more to do with the underlying disease. It is normally the very sick COVID patients who develop CVST, and these patients usually die from the underlying disease rather than the CVST itself,” he explained.

“Clinicians need to be aware of vaccine-related CVST, as it requires very specific and rapid treatment,” Dr. Coutinho stressed.

“Patients presenting with an extremely severe headache (unlike any headache they’ve had before) or with seizures or a focal deficit (weakness in arm or problems with speaking or vision) within 4 weeks of an adenovirus COVID-19 vaccination should ring alarm bells. It is important to do diagnostics quickly, with a platelet count the most important first step, and a rapid CT/MRI scan,” he said.

Other tests that should be conducted are D-dimer for thrombosis and the PF4 antibody test. But results for the PF4 antibody test can take days to come back, and clinicians shouldn’t wait for that, Dr. Coutinho notes.

“Specific treatment needs to be given immediately – with anticoagulation (preferably nonheparin) and immunomodulation with IVIG to stop the immune reaction. Platelets should not be given – that may seem counterintuitive in patients with a low platelet count, but giving platelets makes it worse,” he said.
 

Is there a geographic difference?

Dr. Coutinho pointed out that fewer cases of this vaccine-related CVST are being reported at the current time.

“We are not sure why this is the case. These adenovirus vaccines are not being used much now in Western countries, but our collaboration covers many less developed countries in South America and Asia, which are relying heavily on these vaccines. We are now shifting focus to these countries, but so far we have only seen a handful of cases from these areas,” he said.

He suggested that this may be because these countries started their vaccination programs later and are vaccinating their elderly (who are not so susceptible to this side effect) first, or it may be because of some environmental or genetic factor that has not yet been discovered.

“This is now an important research question – is the risk of vaccine-induced CVST the same in different countries or ethnicities? This could influence decisions on future vaccine strategies,” Dr. Coutinho said.

“So far, female sex is the strongest risk factor for vaccine-induced CVST. In our cohort, 81% of cases were in women. In addition, 95% were White, but that doesn’t allow us to conclude that this is a risk factor, as the majority of people who have been vaccinated are White. So, we have no clear insight into that yet,” he said.

In a comment for this news organization, the lead author of the previous U.K. report of a series of 70 cases of cerebral venous thrombosis linked to COVID-19 vaccination, Richard Perry, PhD, University College Hospital, London, described this new report as “an excellent study, with many of the same strengths and weaknesses as our study and has very similar results.”

Dr. Perry noted that the two studies used slightly different definitions of vaccine-induced thrombotic thrombocytopenia, but the cases reported appear to be very similar overall. “It is reassuring and gratifying to see that they have made such similar observations,” he said.

“And as they have drawn their cases from a broad range of countries whereas ours were all from the U.K., this provides evidence that the observations from both studies are reasonably generalizable,” he added.

Dr. Perry pointed out that this new report states that TTS occurred in one patient after the patient had received a second dose of the AstraZeneca vaccine. “I would like to know more about this case, because we didn’t see any cases after a second dose in our cohort,” he said.

Dr. Coutinho responded that he didn’t believe this was the first reported case after the second dose.

The study did not receive any specific funding. Dr. Coutinho has received grants paid to his institution from Boehringer Ingelheim and Bayer and payments paid to his institution for data safety monitoring board participation by Bayer.

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