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Infant BCG vaccine protects only those under age 5 years

Article Type
Changed
Mon, 12/05/2022 - 16:47

Bacillus Calmette-Guérin (BCG) vaccines are given to more than 100 million children every year, but there is considerable debate regarding the effectiveness of BCG vaccination in preventing tuberculosis and death, particularly among older children and adults.

The most extensive study ever conducted on the efficacy of the BCG vaccine for protection against tuberculosis, stratified by age and history of previous tuberculosis, was published in September 2022 in The Lancet Global Health. The study, which comprises a systematic review and meta-analysis, analyzed individual-level data from 26 case-contact cohort studies published over the past 20 years. The studies included data from 70,000 participants. The primary outcome was a composite of prevalent (diagnosed at or within 90 days of baseline) and incident (diagnosed more than 90 days after baseline) tuberculosis in contacts exposed to tuberculosis. Secondary outcomes were pulmonary tuberculosis, extrapulmonary tuberculosis, and mortality.

Participants were characterized as having been exposed to tuberculosis if they were reported to have been a close contact (either living in the same household or having substantial interaction outside the household) of a person with microbiologically or radiologically diagnosed pulmonary tuberculosis. Previous tuberculosis was defined as a positive interferon-gamma (IFN-gamma) release assay or tuberculin skin test, also known as PPD or Mantoux test.

Most studies included in the analysis were conducted in the past 10 years in countries with a high tuberculosis burden. Those countries included India, South Africa, China, Vietnam, Indonesia, Uganda, the Gambia, and Brazil.
 

Primary outcomes

The study’s main findings included the following:

  • The overall effectiveness of BCG vaccination against all forms of tuberculosis was 18% (adjusted odds ratio, 0.82; 95% CI, 0.74-0.91).
  • Stratified by age, BCG vaccination only significantly protected against all tuberculosis in children younger than 5 years (aOR, 0.63; 95% CI, 0.49-0.81).
  • There was no protective effect among those whose previous tests for tuberculosis were negative unless they were younger than 5 years (aOR, 0.54; 95% CI, 0.32-0.90).
  • Among contacts who had a positive tuberculin skin test or IFN-gamma release assay, BCG vaccination significantly protected against tuberculosis among all participants (aOR, 0.81; 95% CI, 0.69-0.96), participants younger than 5 years (aOR, 0.68; 95% CI, 0.47-0.97), and participants aged 5-9 years (aOR, 0.62; 95% CI, 0.38-0.99).
  • BCG vaccination was protective against pulmonary tuberculosis (19% effectiveness), but this effect was only seen in children younger than 3 years (42% effectiveness) when stratified by age.
  • Protection against all tuberculosis and pulmonary tuberculosis was greater among female participants than male participants.

“This is a definitive BCG protection study because it involves a significant number of individuals evaluated using this meta-analysis. Protection is clearly lost with age. From as early as age 5, no protective effect can be observed. Protection, including against pulmonary tuberculosis, can be observed up to 3 years of age,” stated study author Julio Croda, MD, PhD, chair of the Brazilian Society of Tropical Medicine.

Dr. Croda emphasized that the findings from their study indicate that BCG vaccine protects against pulmonary tuberculosis and that those results differ from results of some previous studies.

“Every physician believes the BCG vaccine protects against serious forms of tuberculosis up to age 5. That fact is not surprising at all,” Dr. Croda remarked. “However, the fact that it protects against pulmonary tuberculosis, especially in children younger than 3, was surprising. In medical practice, we did not believe in this protection.”

Currently, 1.2% of new tuberculosis cases in Brazil occur among those younger than 5. Nevertheless, these cases represent 40.1% of new diagnoses recorded among those younger than 15, highlighting the importance of protection for this age group. An increase in extrapulmonary tuberculosis cases was recently observed in patients younger than 5.

Isabella Ballalai, MD, PhD, is deputy chair of the Brazilian Society of Immunizations. Although she did not participate in this study, she commented on its findings. “All publications are welcome; they help us think,” she explained. She emphasized that the BCG vaccine is not optimal. “There are studies indicating 80% efficacy and others indicating 0%. So, what we can look at is decades of effectiveness in practice.”

Dr. Ballalai explained that the BCG vaccine could keep severe forms of tuberculosis, meningitis, and miliary tuberculosis at bay. She shared her experience of caring for several patients with tuberculous meningitis shortly after she had graduated. “Today, thanks to the BCG vaccine, we don’t see it anymore.” However, she pointed out that the vaccine›s efficacy and effectiveness against pulmonary tuberculosis are low and that pulmonary tuberculosis remains the most significant problem among adults.

Dr. Ballalai also emphasized a few shortcomings of the study. “One is the definition of ‘vaccinated’ and ‘unvaccinated,’ which was based on the presence or absence of a mark on the arm. Today, we know that the absence of a mark does not indicate that the child has not been vaccinated, nor that the vaccine has not been effective. Therefore, several vaccinated participants may have been included amongst the unvaccinated participants.”

The authors emphasized that the definition of “vaccinated” and “unvaccinated” was based on a scar and on vaccination records, and they recognized that participants who did not have a scar on their arm could have been misclassified. Regardless, it is still considered a sensitive indicator. “Few vaccinated children from various settings do not show a scar years after vaccine administration,” they stated in their article.
 

 

 

Adults unprotected

Dr. Ballalai also shared her concerns regarding the lack of protection for older individuals. “We know those older than 60 are at greater risk for complications of tuberculosis. Individuals in this age group naturally have a lower immunity, and they usually have comorbidities. From this study, I can only conclude what was already expected: that adults who received a BCG vaccine as infants are not clear of pulmonary tuberculosis.”

Dr. Croda agreed that it was already evident that the BCG vaccine administered at birth did not provide protection for adults. “In the past, even with 80%-90% vaccine coverage, there were numerous tuberculosis cases in adults in Brazil.”
 

Are boosters needed?

The authors concluded that immunoprotection needs to be boosted in older populations, as vaccination at birth is ineffective for adolescents and adults. They have also discussed whether children older than 10 years and adults could benefit from a booster shot.

Dr. Croda emphasized that there is no indication for this, because there are no data regarding protection with a booster dose during adulthood. However, he cited a study conducted in South Africa in which the BCG vaccine was compared with another vaccine, and another study, which is being conducted in India, is assessing whether a BCG booster offers protection against pulmonary tuberculosis. “There are few studies. Perhaps the revaccination of more vulnerable groups could be of interest, but additional studies are needed first.”

Dr. Croda intends to assess revaccination in those deprived of liberty, in which the incidence of tuberculosis is very high. From 2015 to 2021, many new cases were recorded in this population in Brazil. The number rose from 5,860 to 6,773 during that period.

“However, BCG revaccination carries a significant risk of patients presenting with serious adverse events,” Dr. Ballalai pointed out. He noted that several years ago, to extend protection, Brazil adopted a booster program for persons aged 10 years or older, but the program was discontinued owing to the numerous adverse events reported and the absence of evidence of benefit from increased protection against tuberculosis.

“The adult groups at greater risk for severe tuberculosis manifestations normally presented with an underlying disease, particularly in immunocompromised patient groups. The [administration of the] BCG [vaccine] is contraindicated for those who are immunocompromised. And, for the older population, we do not have data on [vaccine] safety,” she emphasized.
 

Nonspecific immune protection

One of the study’s secondary outcomes regarded mortality. Four studies in the meta-analysis followed up tuberculosis contacts for death. In these studies, which evaluated 20,000 participants, BCG vaccination was shown to be significantly protective against death for participants younger than 15 years.

However, the authors urged caution in interpreting these data. They emphasized that they were unable to identify specific mechanisms by which BCG vaccination might have reduced mortality, and there are possible study biases that could have led to an overestimation of mortality benefit. Moreover, given the observational nature of the included studies, vaccinated children might have had higher socioeconomic status and greater access to health care, and they may have been more likely to have received other vaccinations, compared with children who did not receive BCG vaccines.

Nevertheless, previous experimental and observational studies have found that BCG vaccination might provide nonspecific or off-target immune protection against an array of other pathogens.

“In small studies conducted in Africa, those younger than 5 were protected not only against tuberculosis but also against other respiratory diseases,” Dr. Croda affirmed. “However, these are small studies, and for now, there is no recommendation for using BCG vaccination to prevent other respiratory infections.”

A long-awaited, critical study on the impact of the BCG vaccine on COVID-19, in which Brazilian researchers participated, will be published in the New England Journal of Medicine.
 

 

 

New vaccines needed

The BCG vaccine is one of the oldest vaccines, but there are still several crucial unanswered questions about its use.

Previously published studies that examined the protective effect of BCG vaccination only considered low-burden settings and the historical literature before 1950. These studies need updating, but doing so has not been a simple task. To answer their questions, individual-level participant data for a prespecified list of variables, including the characteristics of the exposed participant (contact), the index case, and the environment, were requested from authors of all eligible studies.

Much of the data used in the published research were found through discussions with authors and experts in the field, as well as through data deposited in data storage repositories, conference abstracts, dissertations, and even direct requests to the authors. “The Pan-American Health Organization helped with this data collection and contacting some authors,” said Dr. Croda.

With the new data, the authors confirmed that infant BCG vaccination, although important to young children who are at high risk for tuberculosis, does not prevent adult-type cavitary tuberculosis and is therefore insufficient to impede the tuberculosis epidemic. “Novel vaccines are urgently needed,” they concluded.

“We need to develop novel, more effective vaccines, which, when administered during infancy, would ensure lifelong protection,” Dr. Croda added.

Dr. Croda and Dr. Ballalai reported no relevant financial relationships.

This article was translated from the Medscape Portuguese edition. A version of this article appeared on Medscape.com.

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Bacillus Calmette-Guérin (BCG) vaccines are given to more than 100 million children every year, but there is considerable debate regarding the effectiveness of BCG vaccination in preventing tuberculosis and death, particularly among older children and adults.

The most extensive study ever conducted on the efficacy of the BCG vaccine for protection against tuberculosis, stratified by age and history of previous tuberculosis, was published in September 2022 in The Lancet Global Health. The study, which comprises a systematic review and meta-analysis, analyzed individual-level data from 26 case-contact cohort studies published over the past 20 years. The studies included data from 70,000 participants. The primary outcome was a composite of prevalent (diagnosed at or within 90 days of baseline) and incident (diagnosed more than 90 days after baseline) tuberculosis in contacts exposed to tuberculosis. Secondary outcomes were pulmonary tuberculosis, extrapulmonary tuberculosis, and mortality.

Participants were characterized as having been exposed to tuberculosis if they were reported to have been a close contact (either living in the same household or having substantial interaction outside the household) of a person with microbiologically or radiologically diagnosed pulmonary tuberculosis. Previous tuberculosis was defined as a positive interferon-gamma (IFN-gamma) release assay or tuberculin skin test, also known as PPD or Mantoux test.

Most studies included in the analysis were conducted in the past 10 years in countries with a high tuberculosis burden. Those countries included India, South Africa, China, Vietnam, Indonesia, Uganda, the Gambia, and Brazil.
 

Primary outcomes

The study’s main findings included the following:

  • The overall effectiveness of BCG vaccination against all forms of tuberculosis was 18% (adjusted odds ratio, 0.82; 95% CI, 0.74-0.91).
  • Stratified by age, BCG vaccination only significantly protected against all tuberculosis in children younger than 5 years (aOR, 0.63; 95% CI, 0.49-0.81).
  • There was no protective effect among those whose previous tests for tuberculosis were negative unless they were younger than 5 years (aOR, 0.54; 95% CI, 0.32-0.90).
  • Among contacts who had a positive tuberculin skin test or IFN-gamma release assay, BCG vaccination significantly protected against tuberculosis among all participants (aOR, 0.81; 95% CI, 0.69-0.96), participants younger than 5 years (aOR, 0.68; 95% CI, 0.47-0.97), and participants aged 5-9 years (aOR, 0.62; 95% CI, 0.38-0.99).
  • BCG vaccination was protective against pulmonary tuberculosis (19% effectiveness), but this effect was only seen in children younger than 3 years (42% effectiveness) when stratified by age.
  • Protection against all tuberculosis and pulmonary tuberculosis was greater among female participants than male participants.

“This is a definitive BCG protection study because it involves a significant number of individuals evaluated using this meta-analysis. Protection is clearly lost with age. From as early as age 5, no protective effect can be observed. Protection, including against pulmonary tuberculosis, can be observed up to 3 years of age,” stated study author Julio Croda, MD, PhD, chair of the Brazilian Society of Tropical Medicine.

Dr. Croda emphasized that the findings from their study indicate that BCG vaccine protects against pulmonary tuberculosis and that those results differ from results of some previous studies.

“Every physician believes the BCG vaccine protects against serious forms of tuberculosis up to age 5. That fact is not surprising at all,” Dr. Croda remarked. “However, the fact that it protects against pulmonary tuberculosis, especially in children younger than 3, was surprising. In medical practice, we did not believe in this protection.”

Currently, 1.2% of new tuberculosis cases in Brazil occur among those younger than 5. Nevertheless, these cases represent 40.1% of new diagnoses recorded among those younger than 15, highlighting the importance of protection for this age group. An increase in extrapulmonary tuberculosis cases was recently observed in patients younger than 5.

Isabella Ballalai, MD, PhD, is deputy chair of the Brazilian Society of Immunizations. Although she did not participate in this study, she commented on its findings. “All publications are welcome; they help us think,” she explained. She emphasized that the BCG vaccine is not optimal. “There are studies indicating 80% efficacy and others indicating 0%. So, what we can look at is decades of effectiveness in practice.”

Dr. Ballalai explained that the BCG vaccine could keep severe forms of tuberculosis, meningitis, and miliary tuberculosis at bay. She shared her experience of caring for several patients with tuberculous meningitis shortly after she had graduated. “Today, thanks to the BCG vaccine, we don’t see it anymore.” However, she pointed out that the vaccine›s efficacy and effectiveness against pulmonary tuberculosis are low and that pulmonary tuberculosis remains the most significant problem among adults.

Dr. Ballalai also emphasized a few shortcomings of the study. “One is the definition of ‘vaccinated’ and ‘unvaccinated,’ which was based on the presence or absence of a mark on the arm. Today, we know that the absence of a mark does not indicate that the child has not been vaccinated, nor that the vaccine has not been effective. Therefore, several vaccinated participants may have been included amongst the unvaccinated participants.”

The authors emphasized that the definition of “vaccinated” and “unvaccinated” was based on a scar and on vaccination records, and they recognized that participants who did not have a scar on their arm could have been misclassified. Regardless, it is still considered a sensitive indicator. “Few vaccinated children from various settings do not show a scar years after vaccine administration,” they stated in their article.
 

 

 

Adults unprotected

Dr. Ballalai also shared her concerns regarding the lack of protection for older individuals. “We know those older than 60 are at greater risk for complications of tuberculosis. Individuals in this age group naturally have a lower immunity, and they usually have comorbidities. From this study, I can only conclude what was already expected: that adults who received a BCG vaccine as infants are not clear of pulmonary tuberculosis.”

Dr. Croda agreed that it was already evident that the BCG vaccine administered at birth did not provide protection for adults. “In the past, even with 80%-90% vaccine coverage, there were numerous tuberculosis cases in adults in Brazil.”
 

Are boosters needed?

The authors concluded that immunoprotection needs to be boosted in older populations, as vaccination at birth is ineffective for adolescents and adults. They have also discussed whether children older than 10 years and adults could benefit from a booster shot.

Dr. Croda emphasized that there is no indication for this, because there are no data regarding protection with a booster dose during adulthood. However, he cited a study conducted in South Africa in which the BCG vaccine was compared with another vaccine, and another study, which is being conducted in India, is assessing whether a BCG booster offers protection against pulmonary tuberculosis. “There are few studies. Perhaps the revaccination of more vulnerable groups could be of interest, but additional studies are needed first.”

Dr. Croda intends to assess revaccination in those deprived of liberty, in which the incidence of tuberculosis is very high. From 2015 to 2021, many new cases were recorded in this population in Brazil. The number rose from 5,860 to 6,773 during that period.

“However, BCG revaccination carries a significant risk of patients presenting with serious adverse events,” Dr. Ballalai pointed out. He noted that several years ago, to extend protection, Brazil adopted a booster program for persons aged 10 years or older, but the program was discontinued owing to the numerous adverse events reported and the absence of evidence of benefit from increased protection against tuberculosis.

“The adult groups at greater risk for severe tuberculosis manifestations normally presented with an underlying disease, particularly in immunocompromised patient groups. The [administration of the] BCG [vaccine] is contraindicated for those who are immunocompromised. And, for the older population, we do not have data on [vaccine] safety,” she emphasized.
 

Nonspecific immune protection

One of the study’s secondary outcomes regarded mortality. Four studies in the meta-analysis followed up tuberculosis contacts for death. In these studies, which evaluated 20,000 participants, BCG vaccination was shown to be significantly protective against death for participants younger than 15 years.

However, the authors urged caution in interpreting these data. They emphasized that they were unable to identify specific mechanisms by which BCG vaccination might have reduced mortality, and there are possible study biases that could have led to an overestimation of mortality benefit. Moreover, given the observational nature of the included studies, vaccinated children might have had higher socioeconomic status and greater access to health care, and they may have been more likely to have received other vaccinations, compared with children who did not receive BCG vaccines.

Nevertheless, previous experimental and observational studies have found that BCG vaccination might provide nonspecific or off-target immune protection against an array of other pathogens.

“In small studies conducted in Africa, those younger than 5 were protected not only against tuberculosis but also against other respiratory diseases,” Dr. Croda affirmed. “However, these are small studies, and for now, there is no recommendation for using BCG vaccination to prevent other respiratory infections.”

A long-awaited, critical study on the impact of the BCG vaccine on COVID-19, in which Brazilian researchers participated, will be published in the New England Journal of Medicine.
 

 

 

New vaccines needed

The BCG vaccine is one of the oldest vaccines, but there are still several crucial unanswered questions about its use.

Previously published studies that examined the protective effect of BCG vaccination only considered low-burden settings and the historical literature before 1950. These studies need updating, but doing so has not been a simple task. To answer their questions, individual-level participant data for a prespecified list of variables, including the characteristics of the exposed participant (contact), the index case, and the environment, were requested from authors of all eligible studies.

Much of the data used in the published research were found through discussions with authors and experts in the field, as well as through data deposited in data storage repositories, conference abstracts, dissertations, and even direct requests to the authors. “The Pan-American Health Organization helped with this data collection and contacting some authors,” said Dr. Croda.

With the new data, the authors confirmed that infant BCG vaccination, although important to young children who are at high risk for tuberculosis, does not prevent adult-type cavitary tuberculosis and is therefore insufficient to impede the tuberculosis epidemic. “Novel vaccines are urgently needed,” they concluded.

“We need to develop novel, more effective vaccines, which, when administered during infancy, would ensure lifelong protection,” Dr. Croda added.

Dr. Croda and Dr. Ballalai reported no relevant financial relationships.

This article was translated from the Medscape Portuguese edition. A version of this article appeared on Medscape.com.

Bacillus Calmette-Guérin (BCG) vaccines are given to more than 100 million children every year, but there is considerable debate regarding the effectiveness of BCG vaccination in preventing tuberculosis and death, particularly among older children and adults.

The most extensive study ever conducted on the efficacy of the BCG vaccine for protection against tuberculosis, stratified by age and history of previous tuberculosis, was published in September 2022 in The Lancet Global Health. The study, which comprises a systematic review and meta-analysis, analyzed individual-level data from 26 case-contact cohort studies published over the past 20 years. The studies included data from 70,000 participants. The primary outcome was a composite of prevalent (diagnosed at or within 90 days of baseline) and incident (diagnosed more than 90 days after baseline) tuberculosis in contacts exposed to tuberculosis. Secondary outcomes were pulmonary tuberculosis, extrapulmonary tuberculosis, and mortality.

Participants were characterized as having been exposed to tuberculosis if they were reported to have been a close contact (either living in the same household or having substantial interaction outside the household) of a person with microbiologically or radiologically diagnosed pulmonary tuberculosis. Previous tuberculosis was defined as a positive interferon-gamma (IFN-gamma) release assay or tuberculin skin test, also known as PPD or Mantoux test.

Most studies included in the analysis were conducted in the past 10 years in countries with a high tuberculosis burden. Those countries included India, South Africa, China, Vietnam, Indonesia, Uganda, the Gambia, and Brazil.
 

Primary outcomes

The study’s main findings included the following:

  • The overall effectiveness of BCG vaccination against all forms of tuberculosis was 18% (adjusted odds ratio, 0.82; 95% CI, 0.74-0.91).
  • Stratified by age, BCG vaccination only significantly protected against all tuberculosis in children younger than 5 years (aOR, 0.63; 95% CI, 0.49-0.81).
  • There was no protective effect among those whose previous tests for tuberculosis were negative unless they were younger than 5 years (aOR, 0.54; 95% CI, 0.32-0.90).
  • Among contacts who had a positive tuberculin skin test or IFN-gamma release assay, BCG vaccination significantly protected against tuberculosis among all participants (aOR, 0.81; 95% CI, 0.69-0.96), participants younger than 5 years (aOR, 0.68; 95% CI, 0.47-0.97), and participants aged 5-9 years (aOR, 0.62; 95% CI, 0.38-0.99).
  • BCG vaccination was protective against pulmonary tuberculosis (19% effectiveness), but this effect was only seen in children younger than 3 years (42% effectiveness) when stratified by age.
  • Protection against all tuberculosis and pulmonary tuberculosis was greater among female participants than male participants.

“This is a definitive BCG protection study because it involves a significant number of individuals evaluated using this meta-analysis. Protection is clearly lost with age. From as early as age 5, no protective effect can be observed. Protection, including against pulmonary tuberculosis, can be observed up to 3 years of age,” stated study author Julio Croda, MD, PhD, chair of the Brazilian Society of Tropical Medicine.

Dr. Croda emphasized that the findings from their study indicate that BCG vaccine protects against pulmonary tuberculosis and that those results differ from results of some previous studies.

“Every physician believes the BCG vaccine protects against serious forms of tuberculosis up to age 5. That fact is not surprising at all,” Dr. Croda remarked. “However, the fact that it protects against pulmonary tuberculosis, especially in children younger than 3, was surprising. In medical practice, we did not believe in this protection.”

Currently, 1.2% of new tuberculosis cases in Brazil occur among those younger than 5. Nevertheless, these cases represent 40.1% of new diagnoses recorded among those younger than 15, highlighting the importance of protection for this age group. An increase in extrapulmonary tuberculosis cases was recently observed in patients younger than 5.

Isabella Ballalai, MD, PhD, is deputy chair of the Brazilian Society of Immunizations. Although she did not participate in this study, she commented on its findings. “All publications are welcome; they help us think,” she explained. She emphasized that the BCG vaccine is not optimal. “There are studies indicating 80% efficacy and others indicating 0%. So, what we can look at is decades of effectiveness in practice.”

Dr. Ballalai explained that the BCG vaccine could keep severe forms of tuberculosis, meningitis, and miliary tuberculosis at bay. She shared her experience of caring for several patients with tuberculous meningitis shortly after she had graduated. “Today, thanks to the BCG vaccine, we don’t see it anymore.” However, she pointed out that the vaccine›s efficacy and effectiveness against pulmonary tuberculosis are low and that pulmonary tuberculosis remains the most significant problem among adults.

Dr. Ballalai also emphasized a few shortcomings of the study. “One is the definition of ‘vaccinated’ and ‘unvaccinated,’ which was based on the presence or absence of a mark on the arm. Today, we know that the absence of a mark does not indicate that the child has not been vaccinated, nor that the vaccine has not been effective. Therefore, several vaccinated participants may have been included amongst the unvaccinated participants.”

The authors emphasized that the definition of “vaccinated” and “unvaccinated” was based on a scar and on vaccination records, and they recognized that participants who did not have a scar on their arm could have been misclassified. Regardless, it is still considered a sensitive indicator. “Few vaccinated children from various settings do not show a scar years after vaccine administration,” they stated in their article.
 

 

 

Adults unprotected

Dr. Ballalai also shared her concerns regarding the lack of protection for older individuals. “We know those older than 60 are at greater risk for complications of tuberculosis. Individuals in this age group naturally have a lower immunity, and they usually have comorbidities. From this study, I can only conclude what was already expected: that adults who received a BCG vaccine as infants are not clear of pulmonary tuberculosis.”

Dr. Croda agreed that it was already evident that the BCG vaccine administered at birth did not provide protection for adults. “In the past, even with 80%-90% vaccine coverage, there were numerous tuberculosis cases in adults in Brazil.”
 

Are boosters needed?

The authors concluded that immunoprotection needs to be boosted in older populations, as vaccination at birth is ineffective for adolescents and adults. They have also discussed whether children older than 10 years and adults could benefit from a booster shot.

Dr. Croda emphasized that there is no indication for this, because there are no data regarding protection with a booster dose during adulthood. However, he cited a study conducted in South Africa in which the BCG vaccine was compared with another vaccine, and another study, which is being conducted in India, is assessing whether a BCG booster offers protection against pulmonary tuberculosis. “There are few studies. Perhaps the revaccination of more vulnerable groups could be of interest, but additional studies are needed first.”

Dr. Croda intends to assess revaccination in those deprived of liberty, in which the incidence of tuberculosis is very high. From 2015 to 2021, many new cases were recorded in this population in Brazil. The number rose from 5,860 to 6,773 during that period.

“However, BCG revaccination carries a significant risk of patients presenting with serious adverse events,” Dr. Ballalai pointed out. He noted that several years ago, to extend protection, Brazil adopted a booster program for persons aged 10 years or older, but the program was discontinued owing to the numerous adverse events reported and the absence of evidence of benefit from increased protection against tuberculosis.

“The adult groups at greater risk for severe tuberculosis manifestations normally presented with an underlying disease, particularly in immunocompromised patient groups. The [administration of the] BCG [vaccine] is contraindicated for those who are immunocompromised. And, for the older population, we do not have data on [vaccine] safety,” she emphasized.
 

Nonspecific immune protection

One of the study’s secondary outcomes regarded mortality. Four studies in the meta-analysis followed up tuberculosis contacts for death. In these studies, which evaluated 20,000 participants, BCG vaccination was shown to be significantly protective against death for participants younger than 15 years.

However, the authors urged caution in interpreting these data. They emphasized that they were unable to identify specific mechanisms by which BCG vaccination might have reduced mortality, and there are possible study biases that could have led to an overestimation of mortality benefit. Moreover, given the observational nature of the included studies, vaccinated children might have had higher socioeconomic status and greater access to health care, and they may have been more likely to have received other vaccinations, compared with children who did not receive BCG vaccines.

Nevertheless, previous experimental and observational studies have found that BCG vaccination might provide nonspecific or off-target immune protection against an array of other pathogens.

“In small studies conducted in Africa, those younger than 5 were protected not only against tuberculosis but also against other respiratory diseases,” Dr. Croda affirmed. “However, these are small studies, and for now, there is no recommendation for using BCG vaccination to prevent other respiratory infections.”

A long-awaited, critical study on the impact of the BCG vaccine on COVID-19, in which Brazilian researchers participated, will be published in the New England Journal of Medicine.
 

 

 

New vaccines needed

The BCG vaccine is one of the oldest vaccines, but there are still several crucial unanswered questions about its use.

Previously published studies that examined the protective effect of BCG vaccination only considered low-burden settings and the historical literature before 1950. These studies need updating, but doing so has not been a simple task. To answer their questions, individual-level participant data for a prespecified list of variables, including the characteristics of the exposed participant (contact), the index case, and the environment, were requested from authors of all eligible studies.

Much of the data used in the published research were found through discussions with authors and experts in the field, as well as through data deposited in data storage repositories, conference abstracts, dissertations, and even direct requests to the authors. “The Pan-American Health Organization helped with this data collection and contacting some authors,” said Dr. Croda.

With the new data, the authors confirmed that infant BCG vaccination, although important to young children who are at high risk for tuberculosis, does not prevent adult-type cavitary tuberculosis and is therefore insufficient to impede the tuberculosis epidemic. “Novel vaccines are urgently needed,” they concluded.

“We need to develop novel, more effective vaccines, which, when administered during infancy, would ensure lifelong protection,” Dr. Croda added.

Dr. Croda and Dr. Ballalai reported no relevant financial relationships.

This article was translated from the Medscape Portuguese edition. A version of this article appeared on Medscape.com.

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FDA pulls U.S. authorization for Eli Lilly’s COVID drug bebtelovimab

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Thu, 12/15/2022 - 14:23

(Reuters) – Eli Lilly’s COVID-19 drug bebtelovimab is not currently authorized for emergency use in the United States, the Food and Drug Administration said, citing it is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron.

The announcement on Nov. 30 takes away authorization from the last COVID-19 monoclonal antibody treatment, leaving Pfizer’s antiviral drug Paxlovid, Merck’s Lagevrio, and Gilead Sciences’ Veklury as treatments for the disease, besides convalescent plasma for some patients.

AstraZeneca’s monoclonal antibody Evusheld is also authorized for protection against COVID-19 infection in some people.

Eli Lilly and its authorized distributors have paused commercial distribution of the monoclonal antibody until further notice from the agency, while the U.S. government has also paused fulfillment of any pending requests under its scheme to help uninsured and underinsured Americans access the drug.

The drug, which was discovered by Abcellera and commercialized by Eli Lilly, received an authorization from the FDA in February.

BQ.1 and BQ.1.1 have become the dominant strains in the United States after a steady increase in prevalence over the last 2 months, surpassing Omicron’s BA.5 subvariant, which had driven cases earlier in the year.

The subvariants accounted for around 57% of the cases nationally, as per government data last week.

Reuters Health Information © 2022 

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(Reuters) – Eli Lilly’s COVID-19 drug bebtelovimab is not currently authorized for emergency use in the United States, the Food and Drug Administration said, citing it is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron.

The announcement on Nov. 30 takes away authorization from the last COVID-19 monoclonal antibody treatment, leaving Pfizer’s antiviral drug Paxlovid, Merck’s Lagevrio, and Gilead Sciences’ Veklury as treatments for the disease, besides convalescent plasma for some patients.

AstraZeneca’s monoclonal antibody Evusheld is also authorized for protection against COVID-19 infection in some people.

Eli Lilly and its authorized distributors have paused commercial distribution of the monoclonal antibody until further notice from the agency, while the U.S. government has also paused fulfillment of any pending requests under its scheme to help uninsured and underinsured Americans access the drug.

The drug, which was discovered by Abcellera and commercialized by Eli Lilly, received an authorization from the FDA in February.

BQ.1 and BQ.1.1 have become the dominant strains in the United States after a steady increase in prevalence over the last 2 months, surpassing Omicron’s BA.5 subvariant, which had driven cases earlier in the year.

The subvariants accounted for around 57% of the cases nationally, as per government data last week.

Reuters Health Information © 2022 

(Reuters) – Eli Lilly’s COVID-19 drug bebtelovimab is not currently authorized for emergency use in the United States, the Food and Drug Administration said, citing it is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron.

The announcement on Nov. 30 takes away authorization from the last COVID-19 monoclonal antibody treatment, leaving Pfizer’s antiviral drug Paxlovid, Merck’s Lagevrio, and Gilead Sciences’ Veklury as treatments for the disease, besides convalescent plasma for some patients.

AstraZeneca’s monoclonal antibody Evusheld is also authorized for protection against COVID-19 infection in some people.

Eli Lilly and its authorized distributors have paused commercial distribution of the monoclonal antibody until further notice from the agency, while the U.S. government has also paused fulfillment of any pending requests under its scheme to help uninsured and underinsured Americans access the drug.

The drug, which was discovered by Abcellera and commercialized by Eli Lilly, received an authorization from the FDA in February.

BQ.1 and BQ.1.1 have become the dominant strains in the United States after a steady increase in prevalence over the last 2 months, surpassing Omicron’s BA.5 subvariant, which had driven cases earlier in the year.

The subvariants accounted for around 57% of the cases nationally, as per government data last week.

Reuters Health Information © 2022 

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RSV surge stuns parents and strains providers, but doctors offer help

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Thu, 12/15/2022 - 14:23

Doctors suspect the worst respiratory syncytial virus (RSV) season in years just ended, and the story of a child who had a serious respiratory infection provides a glimpse of what health care providers saw in the fall of 2022.

RSV cases peaked in mid-November, according to the latest Centers for Disease Control and Prevention data, with RSV-associated hospitalizations in the United States among patients 0-4 years having maxed out five times higher than they were at the same time in 2021. These surges strained providers and left parents scrambling for care. Fortunately, pediatric hospitalizations appear to be subsiding.

In interviews, the parents of the child who had a severe case of RSV reflected on their son’s bout with the illness, and doctors described challenges to dealing with the surge in RSV cases this season. The physicians also offered advice on how recognize and respond to future cases of the virus.
 

Sebastian Witt’s story

“I didn’t even know what RSV was,” said Malte Witt, whose son, Sebastian, 2, was recently hospitalized for RSV in Denver.

Mr. Witt and his wife, Emily Witt, both 32, thought they were dealing with a typical cold until Sebastian’s condition dramatically deteriorated about 36 hours after symptom onset.

“He basically just slumped over and collapsed, coughing uncontrollably,” Mr. Witt said in an interview. “He couldn’t catch his breath.”

The Witts rushed Sebastian to the ED at Children’s Hospital Colorado, expecting to see a doctor immediately. Instead, they spent the night in an overcrowded waiting room alongside many other families in the same situation.

“There was no room for anyone to sit anywhere,” Mr. Witt said. “There were people sitting on the floor. I counted maybe six children hooked up to oxygen when we walked in.”

After waiting approximately 45 minutes, a nurse checked Sebastian’s oxygen saturation. The readings were 79%-83%. This range is significantly below thresholds for supplemental oxygen described by most pediatric guidelines, which range from 90 to 94%.

The nurse connected Sebastian to bottled oxygen in the waiting room, and a recheck 4 hours later showed that his oxygen saturation had improved.

But the improvement didn’t last.

“At roughly hour 10 in the waiting room – it was 4 in the morning – you could tell that Seb was exhausted, really not acting like himself,” Mr. Witt said. “We thought maybe it’s just late at night, he hasn’t really slept. But then Emily noticed that his oxygen tank had run out.”

Mr. Witt told a nurse, and after another check revealed low oxygen saturation, Sebastian was finally admitted.
 

Early RSV surge strains pediatric providers

With RSV-associated hospitalizations peaking at 48 per 100,000 children, Colorado has been among the states hardest hit by the virus. New Mexico – where hospitalizations peaked at 56.4 per 100,000 children – comes in second. Even in states like California, where hospitalization rates have been almost 10-fold lower than New Mexico, pediatric providers have been stretched to their limits.

Dr. Dean Blumberg

“Many hospitals are really being overwhelmed with admissions for RSV, both routine RSV – relatively mild hospitalizations with bronchiolitis – as well as kids in the ICU with more severe cases,” said Dean Blumberg, MD, chief of the division of pediatric infectious diseases at UC Davis Health, Sacramento, said in an interview.

Dr. Blumberg believes the severity of the 2022-2023 RSV season is likely COVID related.

“All community-associated respiratory viral infections are out of whack because of the pandemic, and all the masking and social distancing that was occurring,” he said.

This may also explain why older kids are coming down with more severe cases of RSV.

“Some children are getting RSV for the first time as older children,” Dr. Blumberg said, noting that, historically, most children were infected in the first 2 years of life. “There are reports of children 3 or 4 years of age being admitted with their first episode of RSV because of the [COVID] pandemic.”

This year’s RSV season is also notable for arriving early, potentially catching the community off guard, according to Jennifer D. Kusma, MD, a primary care pediatrician at Ann & Robert H. Lurie Children’s Hospital of Chicago.

“People who should have been protected often weren’t protected yet,” Dr. Kusma said in an interview.
 

 

 

Treatments new, old, and unproven

On Nov. 17, in the midst of the RSV surge, the American Academy of Pediatrics issued updated guidance for palivizumab, an RSV-targeting monoclonal antibody labeled for children at risk of severe RSV, including those with pre-existing lung or heart conditions, and infants with a history of premature birth (less than or equal to 35 weeks’ gestational age).

“If RSV disease activity persists at high levels in a given region through the fall and winter, the AAP supports providing more than five consecutive doses of palivizumab to eligible children,” the update stated.

Insurance companies appear to be responding in kind, covering additional doses for children in need.

“[Payers] have agreed that, if [palivizumab] needs to be given for an additional month or 2 or 3, then they’re making a commitment that they’ll reimburse hospitals for providing that,” Dr. Blumberg said.

For ineligible patients, such as Sebastian, who was born prematurely at 36 weeks – 1 week shy of the label requirement – treatment relies upon supportive care with oxygen and IV fluids.

At home, parents are left with simpler options.

Dr. Blumberg and Dr. Kusma recommended keeping children hydrated, maintaining humidified air, and using saline nose drops with bulb suction to clear mucus.

In the Witts’ experience, that last step may be easier said than done.

“Every time a nurse would walk into the room, Sebastian would yell: ‘Go away, doctor! I don’t want snot sucker!’” Mr. Witt said.

“If you over snot-suck, that’s really uncomfortable for the kid, and really hard for you,” Ms. Witt said. “And it doesn’t make much of a difference. It’s just very hard to find a middle ground, where you’re helping and keeping them comfortable.”

Some parents are turning to novel strategies, such as nebulized hypertonic saline, currently marketed on Amazon for children with RSV.

Although the AAP offers a weak recommendation for nebulized hypertonic saline in children hospitalized more than 72 hours, they advise against it in the emergency setting, citing inconsistent findings in clinical trials.

To any parents tempted by thousands of positive Amazon reviews, Dr. Blumberg said, “I wouldn’t waste my money on that.”

Dr. Kusma agreed.

“[Nebulized hypertonic saline] can be irritating,” she said. “It’s saltwater, essentially. If a parent is in the position where they’re worried about their child’s breathing to the point that they think they need to use it, I would err on the side of calling your pediatrician and being seen.”
 

Going in, coming home

Dr. Kusma said parents should seek medical attention if a child is breathing faster and working harder to get air. Increased work of breathing is characterized by pulling of the skin at the notch where the throat meets the chest bone (tracheal tugging), and flattening of the belly that makes the ribcage more prominent.

Mr. Witt saw these signs in Sebastian. He knew they were significant, because a friend who is a nurse had previously shown him some examples of children who exhibited these symptoms online.

“That’s how I knew that things were actually really dangerous,” Mr. Witt said. “Had she not shown me those videos a month and a half before this happened, I don’t know that we would have hit the alarm bell as quickly as we did.”

After spending their second night and the following day in a cramped preoperative room converted to manage overflow from the emergency department, Sebastian’s condition improved, and he was discharged. The Witts are relieved to be home, but frustrations from their ordeal remain, especially considering the estimated $5,000 in out-of-pocket costs they expect to pay.

“How is this our health care system?” Ms. Witt asked. “This is unbelievable.”
 

 

 

An optimistic outlook

RSV seasons typically demonstrate a clear peak, followed by a decline through the rest of the season, suggesting better times lie ahead; however, this season has been anything but typical.

“I’m hopeful that it will just go away and stay away,” Dr. Kusma said, citing this trend. “But I can’t know for sure.”

To anxious parents, Dr. Blumberg offered an optimistic view of RSV seasons to come.

“There’s hope,” he said. “There are vaccines that are being developed that are very close to FDA approval. So, it’s possible that this time next year, we might have widespread RSV vaccination available for children so that we don’t have to go through this nightmare again.”

Dr. Blumberg and Dr. Kusma disclosed no relevant conflicts of interest.

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Doctors suspect the worst respiratory syncytial virus (RSV) season in years just ended, and the story of a child who had a serious respiratory infection provides a glimpse of what health care providers saw in the fall of 2022.

RSV cases peaked in mid-November, according to the latest Centers for Disease Control and Prevention data, with RSV-associated hospitalizations in the United States among patients 0-4 years having maxed out five times higher than they were at the same time in 2021. These surges strained providers and left parents scrambling for care. Fortunately, pediatric hospitalizations appear to be subsiding.

In interviews, the parents of the child who had a severe case of RSV reflected on their son’s bout with the illness, and doctors described challenges to dealing with the surge in RSV cases this season. The physicians also offered advice on how recognize and respond to future cases of the virus.
 

Sebastian Witt’s story

“I didn’t even know what RSV was,” said Malte Witt, whose son, Sebastian, 2, was recently hospitalized for RSV in Denver.

Mr. Witt and his wife, Emily Witt, both 32, thought they were dealing with a typical cold until Sebastian’s condition dramatically deteriorated about 36 hours after symptom onset.

“He basically just slumped over and collapsed, coughing uncontrollably,” Mr. Witt said in an interview. “He couldn’t catch his breath.”

The Witts rushed Sebastian to the ED at Children’s Hospital Colorado, expecting to see a doctor immediately. Instead, they spent the night in an overcrowded waiting room alongside many other families in the same situation.

“There was no room for anyone to sit anywhere,” Mr. Witt said. “There were people sitting on the floor. I counted maybe six children hooked up to oxygen when we walked in.”

After waiting approximately 45 minutes, a nurse checked Sebastian’s oxygen saturation. The readings were 79%-83%. This range is significantly below thresholds for supplemental oxygen described by most pediatric guidelines, which range from 90 to 94%.

The nurse connected Sebastian to bottled oxygen in the waiting room, and a recheck 4 hours later showed that his oxygen saturation had improved.

But the improvement didn’t last.

“At roughly hour 10 in the waiting room – it was 4 in the morning – you could tell that Seb was exhausted, really not acting like himself,” Mr. Witt said. “We thought maybe it’s just late at night, he hasn’t really slept. But then Emily noticed that his oxygen tank had run out.”

Mr. Witt told a nurse, and after another check revealed low oxygen saturation, Sebastian was finally admitted.
 

Early RSV surge strains pediatric providers

With RSV-associated hospitalizations peaking at 48 per 100,000 children, Colorado has been among the states hardest hit by the virus. New Mexico – where hospitalizations peaked at 56.4 per 100,000 children – comes in second. Even in states like California, where hospitalization rates have been almost 10-fold lower than New Mexico, pediatric providers have been stretched to their limits.

Dr. Dean Blumberg

“Many hospitals are really being overwhelmed with admissions for RSV, both routine RSV – relatively mild hospitalizations with bronchiolitis – as well as kids in the ICU with more severe cases,” said Dean Blumberg, MD, chief of the division of pediatric infectious diseases at UC Davis Health, Sacramento, said in an interview.

Dr. Blumberg believes the severity of the 2022-2023 RSV season is likely COVID related.

“All community-associated respiratory viral infections are out of whack because of the pandemic, and all the masking and social distancing that was occurring,” he said.

This may also explain why older kids are coming down with more severe cases of RSV.

“Some children are getting RSV for the first time as older children,” Dr. Blumberg said, noting that, historically, most children were infected in the first 2 years of life. “There are reports of children 3 or 4 years of age being admitted with their first episode of RSV because of the [COVID] pandemic.”

This year’s RSV season is also notable for arriving early, potentially catching the community off guard, according to Jennifer D. Kusma, MD, a primary care pediatrician at Ann & Robert H. Lurie Children’s Hospital of Chicago.

“People who should have been protected often weren’t protected yet,” Dr. Kusma said in an interview.
 

 

 

Treatments new, old, and unproven

On Nov. 17, in the midst of the RSV surge, the American Academy of Pediatrics issued updated guidance for palivizumab, an RSV-targeting monoclonal antibody labeled for children at risk of severe RSV, including those with pre-existing lung or heart conditions, and infants with a history of premature birth (less than or equal to 35 weeks’ gestational age).

“If RSV disease activity persists at high levels in a given region through the fall and winter, the AAP supports providing more than five consecutive doses of palivizumab to eligible children,” the update stated.

Insurance companies appear to be responding in kind, covering additional doses for children in need.

“[Payers] have agreed that, if [palivizumab] needs to be given for an additional month or 2 or 3, then they’re making a commitment that they’ll reimburse hospitals for providing that,” Dr. Blumberg said.

For ineligible patients, such as Sebastian, who was born prematurely at 36 weeks – 1 week shy of the label requirement – treatment relies upon supportive care with oxygen and IV fluids.

At home, parents are left with simpler options.

Dr. Blumberg and Dr. Kusma recommended keeping children hydrated, maintaining humidified air, and using saline nose drops with bulb suction to clear mucus.

In the Witts’ experience, that last step may be easier said than done.

“Every time a nurse would walk into the room, Sebastian would yell: ‘Go away, doctor! I don’t want snot sucker!’” Mr. Witt said.

“If you over snot-suck, that’s really uncomfortable for the kid, and really hard for you,” Ms. Witt said. “And it doesn’t make much of a difference. It’s just very hard to find a middle ground, where you’re helping and keeping them comfortable.”

Some parents are turning to novel strategies, such as nebulized hypertonic saline, currently marketed on Amazon for children with RSV.

Although the AAP offers a weak recommendation for nebulized hypertonic saline in children hospitalized more than 72 hours, they advise against it in the emergency setting, citing inconsistent findings in clinical trials.

To any parents tempted by thousands of positive Amazon reviews, Dr. Blumberg said, “I wouldn’t waste my money on that.”

Dr. Kusma agreed.

“[Nebulized hypertonic saline] can be irritating,” she said. “It’s saltwater, essentially. If a parent is in the position where they’re worried about their child’s breathing to the point that they think they need to use it, I would err on the side of calling your pediatrician and being seen.”
 

Going in, coming home

Dr. Kusma said parents should seek medical attention if a child is breathing faster and working harder to get air. Increased work of breathing is characterized by pulling of the skin at the notch where the throat meets the chest bone (tracheal tugging), and flattening of the belly that makes the ribcage more prominent.

Mr. Witt saw these signs in Sebastian. He knew they were significant, because a friend who is a nurse had previously shown him some examples of children who exhibited these symptoms online.

“That’s how I knew that things were actually really dangerous,” Mr. Witt said. “Had she not shown me those videos a month and a half before this happened, I don’t know that we would have hit the alarm bell as quickly as we did.”

After spending their second night and the following day in a cramped preoperative room converted to manage overflow from the emergency department, Sebastian’s condition improved, and he was discharged. The Witts are relieved to be home, but frustrations from their ordeal remain, especially considering the estimated $5,000 in out-of-pocket costs they expect to pay.

“How is this our health care system?” Ms. Witt asked. “This is unbelievable.”
 

 

 

An optimistic outlook

RSV seasons typically demonstrate a clear peak, followed by a decline through the rest of the season, suggesting better times lie ahead; however, this season has been anything but typical.

“I’m hopeful that it will just go away and stay away,” Dr. Kusma said, citing this trend. “But I can’t know for sure.”

To anxious parents, Dr. Blumberg offered an optimistic view of RSV seasons to come.

“There’s hope,” he said. “There are vaccines that are being developed that are very close to FDA approval. So, it’s possible that this time next year, we might have widespread RSV vaccination available for children so that we don’t have to go through this nightmare again.”

Dr. Blumberg and Dr. Kusma disclosed no relevant conflicts of interest.

Doctors suspect the worst respiratory syncytial virus (RSV) season in years just ended, and the story of a child who had a serious respiratory infection provides a glimpse of what health care providers saw in the fall of 2022.

RSV cases peaked in mid-November, according to the latest Centers for Disease Control and Prevention data, with RSV-associated hospitalizations in the United States among patients 0-4 years having maxed out five times higher than they were at the same time in 2021. These surges strained providers and left parents scrambling for care. Fortunately, pediatric hospitalizations appear to be subsiding.

In interviews, the parents of the child who had a severe case of RSV reflected on their son’s bout with the illness, and doctors described challenges to dealing with the surge in RSV cases this season. The physicians also offered advice on how recognize and respond to future cases of the virus.
 

Sebastian Witt’s story

“I didn’t even know what RSV was,” said Malte Witt, whose son, Sebastian, 2, was recently hospitalized for RSV in Denver.

Mr. Witt and his wife, Emily Witt, both 32, thought they were dealing with a typical cold until Sebastian’s condition dramatically deteriorated about 36 hours after symptom onset.

“He basically just slumped over and collapsed, coughing uncontrollably,” Mr. Witt said in an interview. “He couldn’t catch his breath.”

The Witts rushed Sebastian to the ED at Children’s Hospital Colorado, expecting to see a doctor immediately. Instead, they spent the night in an overcrowded waiting room alongside many other families in the same situation.

“There was no room for anyone to sit anywhere,” Mr. Witt said. “There were people sitting on the floor. I counted maybe six children hooked up to oxygen when we walked in.”

After waiting approximately 45 minutes, a nurse checked Sebastian’s oxygen saturation. The readings were 79%-83%. This range is significantly below thresholds for supplemental oxygen described by most pediatric guidelines, which range from 90 to 94%.

The nurse connected Sebastian to bottled oxygen in the waiting room, and a recheck 4 hours later showed that his oxygen saturation had improved.

But the improvement didn’t last.

“At roughly hour 10 in the waiting room – it was 4 in the morning – you could tell that Seb was exhausted, really not acting like himself,” Mr. Witt said. “We thought maybe it’s just late at night, he hasn’t really slept. But then Emily noticed that his oxygen tank had run out.”

Mr. Witt told a nurse, and after another check revealed low oxygen saturation, Sebastian was finally admitted.
 

Early RSV surge strains pediatric providers

With RSV-associated hospitalizations peaking at 48 per 100,000 children, Colorado has been among the states hardest hit by the virus. New Mexico – where hospitalizations peaked at 56.4 per 100,000 children – comes in second. Even in states like California, where hospitalization rates have been almost 10-fold lower than New Mexico, pediatric providers have been stretched to their limits.

Dr. Dean Blumberg

“Many hospitals are really being overwhelmed with admissions for RSV, both routine RSV – relatively mild hospitalizations with bronchiolitis – as well as kids in the ICU with more severe cases,” said Dean Blumberg, MD, chief of the division of pediatric infectious diseases at UC Davis Health, Sacramento, said in an interview.

Dr. Blumberg believes the severity of the 2022-2023 RSV season is likely COVID related.

“All community-associated respiratory viral infections are out of whack because of the pandemic, and all the masking and social distancing that was occurring,” he said.

This may also explain why older kids are coming down with more severe cases of RSV.

“Some children are getting RSV for the first time as older children,” Dr. Blumberg said, noting that, historically, most children were infected in the first 2 years of life. “There are reports of children 3 or 4 years of age being admitted with their first episode of RSV because of the [COVID] pandemic.”

This year’s RSV season is also notable for arriving early, potentially catching the community off guard, according to Jennifer D. Kusma, MD, a primary care pediatrician at Ann & Robert H. Lurie Children’s Hospital of Chicago.

“People who should have been protected often weren’t protected yet,” Dr. Kusma said in an interview.
 

 

 

Treatments new, old, and unproven

On Nov. 17, in the midst of the RSV surge, the American Academy of Pediatrics issued updated guidance for palivizumab, an RSV-targeting monoclonal antibody labeled for children at risk of severe RSV, including those with pre-existing lung or heart conditions, and infants with a history of premature birth (less than or equal to 35 weeks’ gestational age).

“If RSV disease activity persists at high levels in a given region through the fall and winter, the AAP supports providing more than five consecutive doses of palivizumab to eligible children,” the update stated.

Insurance companies appear to be responding in kind, covering additional doses for children in need.

“[Payers] have agreed that, if [palivizumab] needs to be given for an additional month or 2 or 3, then they’re making a commitment that they’ll reimburse hospitals for providing that,” Dr. Blumberg said.

For ineligible patients, such as Sebastian, who was born prematurely at 36 weeks – 1 week shy of the label requirement – treatment relies upon supportive care with oxygen and IV fluids.

At home, parents are left with simpler options.

Dr. Blumberg and Dr. Kusma recommended keeping children hydrated, maintaining humidified air, and using saline nose drops with bulb suction to clear mucus.

In the Witts’ experience, that last step may be easier said than done.

“Every time a nurse would walk into the room, Sebastian would yell: ‘Go away, doctor! I don’t want snot sucker!’” Mr. Witt said.

“If you over snot-suck, that’s really uncomfortable for the kid, and really hard for you,” Ms. Witt said. “And it doesn’t make much of a difference. It’s just very hard to find a middle ground, where you’re helping and keeping them comfortable.”

Some parents are turning to novel strategies, such as nebulized hypertonic saline, currently marketed on Amazon for children with RSV.

Although the AAP offers a weak recommendation for nebulized hypertonic saline in children hospitalized more than 72 hours, they advise against it in the emergency setting, citing inconsistent findings in clinical trials.

To any parents tempted by thousands of positive Amazon reviews, Dr. Blumberg said, “I wouldn’t waste my money on that.”

Dr. Kusma agreed.

“[Nebulized hypertonic saline] can be irritating,” she said. “It’s saltwater, essentially. If a parent is in the position where they’re worried about their child’s breathing to the point that they think they need to use it, I would err on the side of calling your pediatrician and being seen.”
 

Going in, coming home

Dr. Kusma said parents should seek medical attention if a child is breathing faster and working harder to get air. Increased work of breathing is characterized by pulling of the skin at the notch where the throat meets the chest bone (tracheal tugging), and flattening of the belly that makes the ribcage more prominent.

Mr. Witt saw these signs in Sebastian. He knew they were significant, because a friend who is a nurse had previously shown him some examples of children who exhibited these symptoms online.

“That’s how I knew that things were actually really dangerous,” Mr. Witt said. “Had she not shown me those videos a month and a half before this happened, I don’t know that we would have hit the alarm bell as quickly as we did.”

After spending their second night and the following day in a cramped preoperative room converted to manage overflow from the emergency department, Sebastian’s condition improved, and he was discharged. The Witts are relieved to be home, but frustrations from their ordeal remain, especially considering the estimated $5,000 in out-of-pocket costs they expect to pay.

“How is this our health care system?” Ms. Witt asked. “This is unbelievable.”
 

 

 

An optimistic outlook

RSV seasons typically demonstrate a clear peak, followed by a decline through the rest of the season, suggesting better times lie ahead; however, this season has been anything but typical.

“I’m hopeful that it will just go away and stay away,” Dr. Kusma said, citing this trend. “But I can’t know for sure.”

To anxious parents, Dr. Blumberg offered an optimistic view of RSV seasons to come.

“There’s hope,” he said. “There are vaccines that are being developed that are very close to FDA approval. So, it’s possible that this time next year, we might have widespread RSV vaccination available for children so that we don’t have to go through this nightmare again.”

Dr. Blumberg and Dr. Kusma disclosed no relevant conflicts of interest.

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Flu, RSV infecting children at staggering rates

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Tue, 12/06/2022 - 08:40

There has been no ebb in the flurry of respiratory illnesses infecting America’s youngest children. More pediatric wards across the country are announcing crises as beds reach capacity, the pediatric death toll jumped significantly in the past week, and sometimes children are being infected with more than one virus at a time.

In Oregon, for example, the governor announced an official state of emergency to help hospitals deal with the surge of respiratory viruses. Doernbecher Children’s Hospital in Portland, which houses half of all pediatric ICU beds statewide, moved to “crisis mode” and said every pediatric ICU bed was full, Oregon Public Broadcasting reported.

Last month, pediatricians nationwide called for a similar emergency declaration from the federal government to help them respond to the wave of illnesses, which include influenza and respiratory syncytial virus (RSV).

“What’s concerning to us are not only the number of infections, but the severity of these infections, leading to a high number of emergency room visits and hospitalizations,” pediatric infectious disease expert Oscar G. Gómez-Duarte, MD, PhD, said in a news release.

Five more pediatric deaths due to the flu were logged by the CDC in the past week, bringing the total for pediatric flu deaths this season to 12. Nearly 21 per 100,000 children ages 4 and under are being hospitalized for the flu, which is double the rate for children ages 5-17. Last year at this time, fewer than 1 child under age 4 per 100,000 were being hospitalized for the flu.

RSV rates are also stunningly high.

“If we look at CDC data, the RSV hospitalization rate is 10 times higher than usual for this point in the season,” American Medical Association Vice President Andrea Garcia, JD, said in this week’s AMA podcast. “And 171 out of every 100,000 infants younger than 6 months were hospitalized with RSV for the week ending Nov. 12. That is more than double the RSV hospitalization rate for newborns last year and seven times the rate in 2018, which is the last complete season we saw before the pandemic.”

Dr. Gómez-Duarte said hospitals are admitting children with respiratory illnesses who had otherwise been healthy, and sometimes they are even seeing patients with more than one illness.

“Yes, some children are getting what we call coinfections, where they become infected with more than one virus at a time. In some instances, a child becomes initially infected with flu, begins to recover, and subsequently comes down with rhinovirus (a common cold virus), RSV, or any other respiratory virus,” he said. “These coinfections tend to be more severe than when the child just has one infection.”

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

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There has been no ebb in the flurry of respiratory illnesses infecting America’s youngest children. More pediatric wards across the country are announcing crises as beds reach capacity, the pediatric death toll jumped significantly in the past week, and sometimes children are being infected with more than one virus at a time.

In Oregon, for example, the governor announced an official state of emergency to help hospitals deal with the surge of respiratory viruses. Doernbecher Children’s Hospital in Portland, which houses half of all pediatric ICU beds statewide, moved to “crisis mode” and said every pediatric ICU bed was full, Oregon Public Broadcasting reported.

Last month, pediatricians nationwide called for a similar emergency declaration from the federal government to help them respond to the wave of illnesses, which include influenza and respiratory syncytial virus (RSV).

“What’s concerning to us are not only the number of infections, but the severity of these infections, leading to a high number of emergency room visits and hospitalizations,” pediatric infectious disease expert Oscar G. Gómez-Duarte, MD, PhD, said in a news release.

Five more pediatric deaths due to the flu were logged by the CDC in the past week, bringing the total for pediatric flu deaths this season to 12. Nearly 21 per 100,000 children ages 4 and under are being hospitalized for the flu, which is double the rate for children ages 5-17. Last year at this time, fewer than 1 child under age 4 per 100,000 were being hospitalized for the flu.

RSV rates are also stunningly high.

“If we look at CDC data, the RSV hospitalization rate is 10 times higher than usual for this point in the season,” American Medical Association Vice President Andrea Garcia, JD, said in this week’s AMA podcast. “And 171 out of every 100,000 infants younger than 6 months were hospitalized with RSV for the week ending Nov. 12. That is more than double the RSV hospitalization rate for newborns last year and seven times the rate in 2018, which is the last complete season we saw before the pandemic.”

Dr. Gómez-Duarte said hospitals are admitting children with respiratory illnesses who had otherwise been healthy, and sometimes they are even seeing patients with more than one illness.

“Yes, some children are getting what we call coinfections, where they become infected with more than one virus at a time. In some instances, a child becomes initially infected with flu, begins to recover, and subsequently comes down with rhinovirus (a common cold virus), RSV, or any other respiratory virus,” he said. “These coinfections tend to be more severe than when the child just has one infection.”

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

There has been no ebb in the flurry of respiratory illnesses infecting America’s youngest children. More pediatric wards across the country are announcing crises as beds reach capacity, the pediatric death toll jumped significantly in the past week, and sometimes children are being infected with more than one virus at a time.

In Oregon, for example, the governor announced an official state of emergency to help hospitals deal with the surge of respiratory viruses. Doernbecher Children’s Hospital in Portland, which houses half of all pediatric ICU beds statewide, moved to “crisis mode” and said every pediatric ICU bed was full, Oregon Public Broadcasting reported.

Last month, pediatricians nationwide called for a similar emergency declaration from the federal government to help them respond to the wave of illnesses, which include influenza and respiratory syncytial virus (RSV).

“What’s concerning to us are not only the number of infections, but the severity of these infections, leading to a high number of emergency room visits and hospitalizations,” pediatric infectious disease expert Oscar G. Gómez-Duarte, MD, PhD, said in a news release.

Five more pediatric deaths due to the flu were logged by the CDC in the past week, bringing the total for pediatric flu deaths this season to 12. Nearly 21 per 100,000 children ages 4 and under are being hospitalized for the flu, which is double the rate for children ages 5-17. Last year at this time, fewer than 1 child under age 4 per 100,000 were being hospitalized for the flu.

RSV rates are also stunningly high.

“If we look at CDC data, the RSV hospitalization rate is 10 times higher than usual for this point in the season,” American Medical Association Vice President Andrea Garcia, JD, said in this week’s AMA podcast. “And 171 out of every 100,000 infants younger than 6 months were hospitalized with RSV for the week ending Nov. 12. That is more than double the RSV hospitalization rate for newborns last year and seven times the rate in 2018, which is the last complete season we saw before the pandemic.”

Dr. Gómez-Duarte said hospitals are admitting children with respiratory illnesses who had otherwise been healthy, and sometimes they are even seeing patients with more than one illness.

“Yes, some children are getting what we call coinfections, where they become infected with more than one virus at a time. In some instances, a child becomes initially infected with flu, begins to recover, and subsequently comes down with rhinovirus (a common cold virus), RSV, or any other respiratory virus,” he said. “These coinfections tend to be more severe than when the child just has one infection.”

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

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Women docs: How your next job contract can reflect your real goals

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Tue, 12/06/2022 - 08:42

Rebecca Chester, MD, an Arizona-based interventional cardiologist, recently left her position in a private practice and started employment at a hospital system.

“When I was negotiating my previous contract with the private practice, I found that navigating contracts from the standpoint of a woman still in childbearing years was a little disappointing and challenging,” Dr. Chester told this news organization.

“I wanted to have more children and hired a lawyer recommended by a male colleague to help me not only understand the contract but also negotiate time off and maternity leave, but the lawyer discouraged me from advocating for maternity leave, feeling that it might stigmatize me and prevent me from getting a job,” she says.

He also didn’t explain very much. “He just said it falls under ‘disability leave’ and left it at that.”

Fortunately, Dr. Chester had a good experience with the group. “As things turned out, I did have a child later that year, and they treated me well – I actually got time off – and they didn’t make me take extra call. But it might have turned out very differently because I didn’t know what I was getting into. If I hadn’t worked for such a conscientious group, I might have been in a much tougher situation.”

Since then, Dr. Chester has spoken to female colleagues who received “more support from their legal advisors regarding maternity leave.” She suggests turning to female physicians for recommendations to a lawyer.

Although the central components of a contract (for example, noncompete covenants, malpractice “tail” coverage, bonus structure, vacation time, disability, and call) are relevant to physicians of all genders, the needs of women and men are often different.

Dennis Hursh, managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, told this news organization that women physicians have “several issues that need special attention when negotiating their physician employment agreements.”
 

It starts with the interview

“Women have to be sensitive to the interviewer’s casual ‘let’s-get-to-know-each-other’ types of questions that may seem natural but really are unlawful to bring into an employment interview,” said Mr. Hursh.

He warned women to beware of questions such as “Are you married? Do you have kids? Are you planning to start a family?” These may be friendly chit-chat for male interviewees but there may be other agendas when asked to a prospective female employee.

Many of Mr. Hursh’s female clients have been asked this type of question, which “should be regarded as a ‘red flag.’ Yes, it may be an innocent, well-intentioned ice-breaker, but it’s actually unlawful to bring that up in an employment setting and, according to the Equal Opportunity Commission, can be seen as a form of discrimination.” He advises female physicians not to engage with the question and simply to refocus the discussion.
 

Know your worth and go for it

Medscape’s Physician Compensation surveys have consistently found discrepancies in earnings between male and female physicians, both in primary care and in specialties. In 2022, male primary care physicians earned 23% more than their female counterparts, whereas male specialists earned 31% more.

One reason may be that women tend to be more timid about negotiating for better compensation packages. Amanda Hill of Hill Health Law, a health care practice based in Austin, Tex., told this news organization that in her experience one of the most “overarching” features of female physicians is “that they either don’t know what they’re worth or they undersell themselves.”

In contrast to men, “many women are afraid of coming across as greedy or crass, or even demanding or bossy. But it’s a misperception that if you ask for more money, your future employer will hate you or won’t hire you,” said Ms. Hill.

Ms. Hill and Mr. Hursh encourage physicians to find out what they’re worth, which varies by region and specialty, by consulting benchmarks provided by companies such as Medical Group Management Association.

Jon Appino, MBA, principal and founder of Contract Diagnostics, a Kansas City–based consulting company that specializes in physician employment contract reviews, told this news organization that it’s important to look beyond the salary at other aspects of the position. For example, some figures “don’t take into account how much call a physician is taking. You may know what the average ob.gyn. is making, but an ob.gyn. may be working 3 days a week, while another one is working 6 days a week, one may be on call 15 times per month and another may be on call 15 times a quarter.” Other components of compensation include relative value unit (RVU) thresholds and bonuses.

Once you have that information, “don’t be intimidated, even if you’re sitting in front of several executives who are savvy about negotiations, and don’t worry about coming across as ‘high-maintenance’ or ‘all about money,’ ” Mr. Appino says. Proceed with confidence, knowing your worth and pursuing it.
 

Part-time vs. full-time

Mr. Appino has seen “more female than male physicians who want to work less than full-time. So it’s important to clarify whether that’s a possibility now or in the future and to understand the implications of working part-time.”

He explained that a full-time employee typically puts in a 40-hour work week, which translates into 1.0 Full-Time Equivalent (FTE), or one unit of work. “For example, if a person wants to work 0.8 FTEs – 4 days a week – is vacation time pro-rated? At what point is there a medical insurance fall-off or a higher monthly premium?”

In medical settings, FTEs may be tied to different metrics rather than the number of weekly hours – for example, for a hospitalist, it might be a certain number of shifts and might also vary by specialty. And it affects the call schedule too. “Call is hard to pro-rate. Many hospital bylaws mandate that call be divided equally, but if one surgeon is working 1.0 FTEs and another is working 0.8 FTEs, how does that call schedule get divided?”
 

Maternity leave: A tricky question

Many attorneys counsel against raising the question out of fear of scaring away potential employers.

“On the one hand, it is and should be absolutely reasonable to ask about the maternity leave policy or even negotiate for paid leave or additional leave, but it also highlights that you’re planning to have a baby and be out for months,” said Ms. Hill.

“And as much as we want people to be fair and reasonable, on the side of the employer, bias still very much exists, especially in a situation where revenue is based on group numbers. So suddenly, the employer thinks up some ‘nondiscriminatory’ reason why that person isn’t a great fit for the organization.”

Andrew Knoll, MD, JD, a former hospitalist who is now a partner with Cohen Compagni Beckman Appler & Knoll PLLC in Syracuse, N.Y., said that maternity leave is “rare” in an employment agreement, except sometimes in small private practice groups, because it often falls under the purview of “disability leave,” and “from a legal perspective, it’s no different than any other type of disability leave.”

The Family and Medical Leave Act (FMLA), which applies if a group is large enough, allows employees 12 weeks of unpaid leave, during which time their job is protected and their benefits maintained. And some states require employers to offer paid family leave.

“During this time, the woman can take time off – albeit without pay sometimes – to bond with the baby,” Dr. Knoll says. “Since there are statutory laws that protect the employee’s job, offering specific paid maternity leave is very unlikely.”

Ms. Hill advises carefully examining the employer’s comprehensive benefits plan to ascertain if paid maternity leave is included in the benefits. “But unless you’re currently pregnant and want to start off the relationship with true transparency – ‘I’m due in April and curious how we can handle that if you hire me now’ – I would keep the family planning questions to yourself before you get the job.”

Mr. Hursh, author of “The Final Hurdle: A Physician’s Guide to Negotiating a Fair Employment Agreement” (Charleston, S.C.: Advantage, 2012), has a different perspective. “I think all women, no matter how old they are, should ask about maternity leave, whether or not they’re planning a family,” he said.

“The employer may say, ‘We treat maternity leave like any other disability; our policy is such-and-such.’ If they cite an unacceptable policy, it’s a red flag about how they treat women, and should give a woman pause before accepting a position at that organization. Even if your rights are protected under the law and the organization’s policy is violating the law, no one wants to go to battle with HR or to have to go to court.”
 

 

 

Do you want partnership?

Not all female physicians entering a private practice want to advance to becoming partners. Many who are balancing family and work commitments “would prefer to just go into the office, perform their clinical responsibilities, go home, and be done” without the extra headaches, tasks, and time involved with business leadership, says Mr. Appino.

Some private practices have different contracts for those on partnership vs. nonpartnership tracks, so “you should ascertain this information and make sure it’s not automatically assumed that you would like to be on a partnership track,” says Mr. Appino.

On the other hand, you may want to become a partner. “I always suggest asking about the possibility of obtaining a leadership position in an organization or becoming an owner in a private practice,” says Mr. Hursh. “You may be told, ‘We’ve never had a woman in leadership before.’ This might be innocent if you’re the first woman hired, but it might be a red flag as to how women are regarded.” Either way, it’s important to have the information and know what your options are.
 

The impact of shift schedule

Mr. Hursh advises drilling down into the specifics of the schedule if you’re considering becoming a hospitalist. “Does a ‘week-on/week-off’ shift schedule assume you’ll be taking your vacation time or completing your CME requirements during the week off? This is important for all physicians, but especially for women who might want to use their weeks off to attend to children and family.”

Moreover, “there should be limits on shifts. You shouldn’t have a full day shift followed by a night shift. And there should be a limit on the number of shifts you work without time off. Twelve would be a brutal schedule. Seven is a reasonable amount. Make sure this is in writing and that the contract protects you. Don’t allow the employer to say, ‘We expect you to do the work we assign’ and leave it vague.”

Often, hospitalists will receive an annual salary under the assumption that a certain minimum number of shifts will be completed, but there is no maximum. “It’s important that the salary includes the minimum number of shifts, but that a compensation structure is created so that additional shifts receive additional compensation,” Mr. Hursh said.
 

Removing the ‘golden handcuffs’

Ms. Hill observes that there are some “really terrible contracts out there, which physicians – especially women – often feel pressured into signing.” They’re told, “This is our standard contract. You won’t find anything better.” Or, “Don’t worry about the small print and legalese.” The physician “gets scared or is artificially reassured, signs an overwhelmingly unfair contract, and then feels stuck.”

Being stuck in a bad contract “is debilitating and adds to burnout, feeling of depression, and the sense that there is no recourse and nowhere to go, especially if your family depends on you,” Ms. Hill said.

“More women than men feel hamstrung or are resigned to being harassed – which is not uncommon in the medical setting, especially in surgical specialties – or just accept poor treatment,” Ms. Hill added. Yes, you can “fight the system and go to HR, but fighting the system is very hard.”

She urges women “not to feel stuck or imprisoned by the ‘golden handcuffs’ but to consult a good lawyer, even if you have to break the contract.” Be aware of the reasons for your unhappiness and bring them to your lawyer – perhaps the system has engaged in fraud, perhaps there has been sexual or racial harassment, perhaps the organization hasn’t followed its own compliance policies.

Dr. Chester consulted Ms. Hill before signing the contract for her current position. “I wanted someone who could give me personalized advice, not only generic advice, and who understood my needs as a woman.”

Ms. Hill helped her to understand “what was and wasn’t fair and reasonable, what changes I could request based on my goals and whether they were realistic, and how to pick my battles. For example, I tried to negotiate tail coverage up front in my previous job but was unsuccessful. The new employer paid tail for me, both from my previous employment and for my current employment.”

Dr. Chester advises other female physicians “never to sign anything without having a lawyer review it and to make sure that the lawyer is sensitive to their specific needs.”

It can be hard to be a female physician. Having the right knowledge and ammunition and knowing how to negotiate well paves the way for success and thriving in an often male-dominated market.

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

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Rebecca Chester, MD, an Arizona-based interventional cardiologist, recently left her position in a private practice and started employment at a hospital system.

“When I was negotiating my previous contract with the private practice, I found that navigating contracts from the standpoint of a woman still in childbearing years was a little disappointing and challenging,” Dr. Chester told this news organization.

“I wanted to have more children and hired a lawyer recommended by a male colleague to help me not only understand the contract but also negotiate time off and maternity leave, but the lawyer discouraged me from advocating for maternity leave, feeling that it might stigmatize me and prevent me from getting a job,” she says.

He also didn’t explain very much. “He just said it falls under ‘disability leave’ and left it at that.”

Fortunately, Dr. Chester had a good experience with the group. “As things turned out, I did have a child later that year, and they treated me well – I actually got time off – and they didn’t make me take extra call. But it might have turned out very differently because I didn’t know what I was getting into. If I hadn’t worked for such a conscientious group, I might have been in a much tougher situation.”

Since then, Dr. Chester has spoken to female colleagues who received “more support from their legal advisors regarding maternity leave.” She suggests turning to female physicians for recommendations to a lawyer.

Although the central components of a contract (for example, noncompete covenants, malpractice “tail” coverage, bonus structure, vacation time, disability, and call) are relevant to physicians of all genders, the needs of women and men are often different.

Dennis Hursh, managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, told this news organization that women physicians have “several issues that need special attention when negotiating their physician employment agreements.”
 

It starts with the interview

“Women have to be sensitive to the interviewer’s casual ‘let’s-get-to-know-each-other’ types of questions that may seem natural but really are unlawful to bring into an employment interview,” said Mr. Hursh.

He warned women to beware of questions such as “Are you married? Do you have kids? Are you planning to start a family?” These may be friendly chit-chat for male interviewees but there may be other agendas when asked to a prospective female employee.

Many of Mr. Hursh’s female clients have been asked this type of question, which “should be regarded as a ‘red flag.’ Yes, it may be an innocent, well-intentioned ice-breaker, but it’s actually unlawful to bring that up in an employment setting and, according to the Equal Opportunity Commission, can be seen as a form of discrimination.” He advises female physicians not to engage with the question and simply to refocus the discussion.
 

Know your worth and go for it

Medscape’s Physician Compensation surveys have consistently found discrepancies in earnings between male and female physicians, both in primary care and in specialties. In 2022, male primary care physicians earned 23% more than their female counterparts, whereas male specialists earned 31% more.

One reason may be that women tend to be more timid about negotiating for better compensation packages. Amanda Hill of Hill Health Law, a health care practice based in Austin, Tex., told this news organization that in her experience one of the most “overarching” features of female physicians is “that they either don’t know what they’re worth or they undersell themselves.”

In contrast to men, “many women are afraid of coming across as greedy or crass, or even demanding or bossy. But it’s a misperception that if you ask for more money, your future employer will hate you or won’t hire you,” said Ms. Hill.

Ms. Hill and Mr. Hursh encourage physicians to find out what they’re worth, which varies by region and specialty, by consulting benchmarks provided by companies such as Medical Group Management Association.

Jon Appino, MBA, principal and founder of Contract Diagnostics, a Kansas City–based consulting company that specializes in physician employment contract reviews, told this news organization that it’s important to look beyond the salary at other aspects of the position. For example, some figures “don’t take into account how much call a physician is taking. You may know what the average ob.gyn. is making, but an ob.gyn. may be working 3 days a week, while another one is working 6 days a week, one may be on call 15 times per month and another may be on call 15 times a quarter.” Other components of compensation include relative value unit (RVU) thresholds and bonuses.

Once you have that information, “don’t be intimidated, even if you’re sitting in front of several executives who are savvy about negotiations, and don’t worry about coming across as ‘high-maintenance’ or ‘all about money,’ ” Mr. Appino says. Proceed with confidence, knowing your worth and pursuing it.
 

Part-time vs. full-time

Mr. Appino has seen “more female than male physicians who want to work less than full-time. So it’s important to clarify whether that’s a possibility now or in the future and to understand the implications of working part-time.”

He explained that a full-time employee typically puts in a 40-hour work week, which translates into 1.0 Full-Time Equivalent (FTE), or one unit of work. “For example, if a person wants to work 0.8 FTEs – 4 days a week – is vacation time pro-rated? At what point is there a medical insurance fall-off or a higher monthly premium?”

In medical settings, FTEs may be tied to different metrics rather than the number of weekly hours – for example, for a hospitalist, it might be a certain number of shifts and might also vary by specialty. And it affects the call schedule too. “Call is hard to pro-rate. Many hospital bylaws mandate that call be divided equally, but if one surgeon is working 1.0 FTEs and another is working 0.8 FTEs, how does that call schedule get divided?”
 

Maternity leave: A tricky question

Many attorneys counsel against raising the question out of fear of scaring away potential employers.

“On the one hand, it is and should be absolutely reasonable to ask about the maternity leave policy or even negotiate for paid leave or additional leave, but it also highlights that you’re planning to have a baby and be out for months,” said Ms. Hill.

“And as much as we want people to be fair and reasonable, on the side of the employer, bias still very much exists, especially in a situation where revenue is based on group numbers. So suddenly, the employer thinks up some ‘nondiscriminatory’ reason why that person isn’t a great fit for the organization.”

Andrew Knoll, MD, JD, a former hospitalist who is now a partner with Cohen Compagni Beckman Appler & Knoll PLLC in Syracuse, N.Y., said that maternity leave is “rare” in an employment agreement, except sometimes in small private practice groups, because it often falls under the purview of “disability leave,” and “from a legal perspective, it’s no different than any other type of disability leave.”

The Family and Medical Leave Act (FMLA), which applies if a group is large enough, allows employees 12 weeks of unpaid leave, during which time their job is protected and their benefits maintained. And some states require employers to offer paid family leave.

“During this time, the woman can take time off – albeit without pay sometimes – to bond with the baby,” Dr. Knoll says. “Since there are statutory laws that protect the employee’s job, offering specific paid maternity leave is very unlikely.”

Ms. Hill advises carefully examining the employer’s comprehensive benefits plan to ascertain if paid maternity leave is included in the benefits. “But unless you’re currently pregnant and want to start off the relationship with true transparency – ‘I’m due in April and curious how we can handle that if you hire me now’ – I would keep the family planning questions to yourself before you get the job.”

Mr. Hursh, author of “The Final Hurdle: A Physician’s Guide to Negotiating a Fair Employment Agreement” (Charleston, S.C.: Advantage, 2012), has a different perspective. “I think all women, no matter how old they are, should ask about maternity leave, whether or not they’re planning a family,” he said.

“The employer may say, ‘We treat maternity leave like any other disability; our policy is such-and-such.’ If they cite an unacceptable policy, it’s a red flag about how they treat women, and should give a woman pause before accepting a position at that organization. Even if your rights are protected under the law and the organization’s policy is violating the law, no one wants to go to battle with HR or to have to go to court.”
 

 

 

Do you want partnership?

Not all female physicians entering a private practice want to advance to becoming partners. Many who are balancing family and work commitments “would prefer to just go into the office, perform their clinical responsibilities, go home, and be done” without the extra headaches, tasks, and time involved with business leadership, says Mr. Appino.

Some private practices have different contracts for those on partnership vs. nonpartnership tracks, so “you should ascertain this information and make sure it’s not automatically assumed that you would like to be on a partnership track,” says Mr. Appino.

On the other hand, you may want to become a partner. “I always suggest asking about the possibility of obtaining a leadership position in an organization or becoming an owner in a private practice,” says Mr. Hursh. “You may be told, ‘We’ve never had a woman in leadership before.’ This might be innocent if you’re the first woman hired, but it might be a red flag as to how women are regarded.” Either way, it’s important to have the information and know what your options are.
 

The impact of shift schedule

Mr. Hursh advises drilling down into the specifics of the schedule if you’re considering becoming a hospitalist. “Does a ‘week-on/week-off’ shift schedule assume you’ll be taking your vacation time or completing your CME requirements during the week off? This is important for all physicians, but especially for women who might want to use their weeks off to attend to children and family.”

Moreover, “there should be limits on shifts. You shouldn’t have a full day shift followed by a night shift. And there should be a limit on the number of shifts you work without time off. Twelve would be a brutal schedule. Seven is a reasonable amount. Make sure this is in writing and that the contract protects you. Don’t allow the employer to say, ‘We expect you to do the work we assign’ and leave it vague.”

Often, hospitalists will receive an annual salary under the assumption that a certain minimum number of shifts will be completed, but there is no maximum. “It’s important that the salary includes the minimum number of shifts, but that a compensation structure is created so that additional shifts receive additional compensation,” Mr. Hursh said.
 

Removing the ‘golden handcuffs’

Ms. Hill observes that there are some “really terrible contracts out there, which physicians – especially women – often feel pressured into signing.” They’re told, “This is our standard contract. You won’t find anything better.” Or, “Don’t worry about the small print and legalese.” The physician “gets scared or is artificially reassured, signs an overwhelmingly unfair contract, and then feels stuck.”

Being stuck in a bad contract “is debilitating and adds to burnout, feeling of depression, and the sense that there is no recourse and nowhere to go, especially if your family depends on you,” Ms. Hill said.

“More women than men feel hamstrung or are resigned to being harassed – which is not uncommon in the medical setting, especially in surgical specialties – or just accept poor treatment,” Ms. Hill added. Yes, you can “fight the system and go to HR, but fighting the system is very hard.”

She urges women “not to feel stuck or imprisoned by the ‘golden handcuffs’ but to consult a good lawyer, even if you have to break the contract.” Be aware of the reasons for your unhappiness and bring them to your lawyer – perhaps the system has engaged in fraud, perhaps there has been sexual or racial harassment, perhaps the organization hasn’t followed its own compliance policies.

Dr. Chester consulted Ms. Hill before signing the contract for her current position. “I wanted someone who could give me personalized advice, not only generic advice, and who understood my needs as a woman.”

Ms. Hill helped her to understand “what was and wasn’t fair and reasonable, what changes I could request based on my goals and whether they were realistic, and how to pick my battles. For example, I tried to negotiate tail coverage up front in my previous job but was unsuccessful. The new employer paid tail for me, both from my previous employment and for my current employment.”

Dr. Chester advises other female physicians “never to sign anything without having a lawyer review it and to make sure that the lawyer is sensitive to their specific needs.”

It can be hard to be a female physician. Having the right knowledge and ammunition and knowing how to negotiate well paves the way for success and thriving in an often male-dominated market.

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

Rebecca Chester, MD, an Arizona-based interventional cardiologist, recently left her position in a private practice and started employment at a hospital system.

“When I was negotiating my previous contract with the private practice, I found that navigating contracts from the standpoint of a woman still in childbearing years was a little disappointing and challenging,” Dr. Chester told this news organization.

“I wanted to have more children and hired a lawyer recommended by a male colleague to help me not only understand the contract but also negotiate time off and maternity leave, but the lawyer discouraged me from advocating for maternity leave, feeling that it might stigmatize me and prevent me from getting a job,” she says.

He also didn’t explain very much. “He just said it falls under ‘disability leave’ and left it at that.”

Fortunately, Dr. Chester had a good experience with the group. “As things turned out, I did have a child later that year, and they treated me well – I actually got time off – and they didn’t make me take extra call. But it might have turned out very differently because I didn’t know what I was getting into. If I hadn’t worked for such a conscientious group, I might have been in a much tougher situation.”

Since then, Dr. Chester has spoken to female colleagues who received “more support from their legal advisors regarding maternity leave.” She suggests turning to female physicians for recommendations to a lawyer.

Although the central components of a contract (for example, noncompete covenants, malpractice “tail” coverage, bonus structure, vacation time, disability, and call) are relevant to physicians of all genders, the needs of women and men are often different.

Dennis Hursh, managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, told this news organization that women physicians have “several issues that need special attention when negotiating their physician employment agreements.”
 

It starts with the interview

“Women have to be sensitive to the interviewer’s casual ‘let’s-get-to-know-each-other’ types of questions that may seem natural but really are unlawful to bring into an employment interview,” said Mr. Hursh.

He warned women to beware of questions such as “Are you married? Do you have kids? Are you planning to start a family?” These may be friendly chit-chat for male interviewees but there may be other agendas when asked to a prospective female employee.

Many of Mr. Hursh’s female clients have been asked this type of question, which “should be regarded as a ‘red flag.’ Yes, it may be an innocent, well-intentioned ice-breaker, but it’s actually unlawful to bring that up in an employment setting and, according to the Equal Opportunity Commission, can be seen as a form of discrimination.” He advises female physicians not to engage with the question and simply to refocus the discussion.
 

Know your worth and go for it

Medscape’s Physician Compensation surveys have consistently found discrepancies in earnings between male and female physicians, both in primary care and in specialties. In 2022, male primary care physicians earned 23% more than their female counterparts, whereas male specialists earned 31% more.

One reason may be that women tend to be more timid about negotiating for better compensation packages. Amanda Hill of Hill Health Law, a health care practice based in Austin, Tex., told this news organization that in her experience one of the most “overarching” features of female physicians is “that they either don’t know what they’re worth or they undersell themselves.”

In contrast to men, “many women are afraid of coming across as greedy or crass, or even demanding or bossy. But it’s a misperception that if you ask for more money, your future employer will hate you or won’t hire you,” said Ms. Hill.

Ms. Hill and Mr. Hursh encourage physicians to find out what they’re worth, which varies by region and specialty, by consulting benchmarks provided by companies such as Medical Group Management Association.

Jon Appino, MBA, principal and founder of Contract Diagnostics, a Kansas City–based consulting company that specializes in physician employment contract reviews, told this news organization that it’s important to look beyond the salary at other aspects of the position. For example, some figures “don’t take into account how much call a physician is taking. You may know what the average ob.gyn. is making, but an ob.gyn. may be working 3 days a week, while another one is working 6 days a week, one may be on call 15 times per month and another may be on call 15 times a quarter.” Other components of compensation include relative value unit (RVU) thresholds and bonuses.

Once you have that information, “don’t be intimidated, even if you’re sitting in front of several executives who are savvy about negotiations, and don’t worry about coming across as ‘high-maintenance’ or ‘all about money,’ ” Mr. Appino says. Proceed with confidence, knowing your worth and pursuing it.
 

Part-time vs. full-time

Mr. Appino has seen “more female than male physicians who want to work less than full-time. So it’s important to clarify whether that’s a possibility now or in the future and to understand the implications of working part-time.”

He explained that a full-time employee typically puts in a 40-hour work week, which translates into 1.0 Full-Time Equivalent (FTE), or one unit of work. “For example, if a person wants to work 0.8 FTEs – 4 days a week – is vacation time pro-rated? At what point is there a medical insurance fall-off or a higher monthly premium?”

In medical settings, FTEs may be tied to different metrics rather than the number of weekly hours – for example, for a hospitalist, it might be a certain number of shifts and might also vary by specialty. And it affects the call schedule too. “Call is hard to pro-rate. Many hospital bylaws mandate that call be divided equally, but if one surgeon is working 1.0 FTEs and another is working 0.8 FTEs, how does that call schedule get divided?”
 

Maternity leave: A tricky question

Many attorneys counsel against raising the question out of fear of scaring away potential employers.

“On the one hand, it is and should be absolutely reasonable to ask about the maternity leave policy or even negotiate for paid leave or additional leave, but it also highlights that you’re planning to have a baby and be out for months,” said Ms. Hill.

“And as much as we want people to be fair and reasonable, on the side of the employer, bias still very much exists, especially in a situation where revenue is based on group numbers. So suddenly, the employer thinks up some ‘nondiscriminatory’ reason why that person isn’t a great fit for the organization.”

Andrew Knoll, MD, JD, a former hospitalist who is now a partner with Cohen Compagni Beckman Appler & Knoll PLLC in Syracuse, N.Y., said that maternity leave is “rare” in an employment agreement, except sometimes in small private practice groups, because it often falls under the purview of “disability leave,” and “from a legal perspective, it’s no different than any other type of disability leave.”

The Family and Medical Leave Act (FMLA), which applies if a group is large enough, allows employees 12 weeks of unpaid leave, during which time their job is protected and their benefits maintained. And some states require employers to offer paid family leave.

“During this time, the woman can take time off – albeit without pay sometimes – to bond with the baby,” Dr. Knoll says. “Since there are statutory laws that protect the employee’s job, offering specific paid maternity leave is very unlikely.”

Ms. Hill advises carefully examining the employer’s comprehensive benefits plan to ascertain if paid maternity leave is included in the benefits. “But unless you’re currently pregnant and want to start off the relationship with true transparency – ‘I’m due in April and curious how we can handle that if you hire me now’ – I would keep the family planning questions to yourself before you get the job.”

Mr. Hursh, author of “The Final Hurdle: A Physician’s Guide to Negotiating a Fair Employment Agreement” (Charleston, S.C.: Advantage, 2012), has a different perspective. “I think all women, no matter how old they are, should ask about maternity leave, whether or not they’re planning a family,” he said.

“The employer may say, ‘We treat maternity leave like any other disability; our policy is such-and-such.’ If they cite an unacceptable policy, it’s a red flag about how they treat women, and should give a woman pause before accepting a position at that organization. Even if your rights are protected under the law and the organization’s policy is violating the law, no one wants to go to battle with HR or to have to go to court.”
 

 

 

Do you want partnership?

Not all female physicians entering a private practice want to advance to becoming partners. Many who are balancing family and work commitments “would prefer to just go into the office, perform their clinical responsibilities, go home, and be done” without the extra headaches, tasks, and time involved with business leadership, says Mr. Appino.

Some private practices have different contracts for those on partnership vs. nonpartnership tracks, so “you should ascertain this information and make sure it’s not automatically assumed that you would like to be on a partnership track,” says Mr. Appino.

On the other hand, you may want to become a partner. “I always suggest asking about the possibility of obtaining a leadership position in an organization or becoming an owner in a private practice,” says Mr. Hursh. “You may be told, ‘We’ve never had a woman in leadership before.’ This might be innocent if you’re the first woman hired, but it might be a red flag as to how women are regarded.” Either way, it’s important to have the information and know what your options are.
 

The impact of shift schedule

Mr. Hursh advises drilling down into the specifics of the schedule if you’re considering becoming a hospitalist. “Does a ‘week-on/week-off’ shift schedule assume you’ll be taking your vacation time or completing your CME requirements during the week off? This is important for all physicians, but especially for women who might want to use their weeks off to attend to children and family.”

Moreover, “there should be limits on shifts. You shouldn’t have a full day shift followed by a night shift. And there should be a limit on the number of shifts you work without time off. Twelve would be a brutal schedule. Seven is a reasonable amount. Make sure this is in writing and that the contract protects you. Don’t allow the employer to say, ‘We expect you to do the work we assign’ and leave it vague.”

Often, hospitalists will receive an annual salary under the assumption that a certain minimum number of shifts will be completed, but there is no maximum. “It’s important that the salary includes the minimum number of shifts, but that a compensation structure is created so that additional shifts receive additional compensation,” Mr. Hursh said.
 

Removing the ‘golden handcuffs’

Ms. Hill observes that there are some “really terrible contracts out there, which physicians – especially women – often feel pressured into signing.” They’re told, “This is our standard contract. You won’t find anything better.” Or, “Don’t worry about the small print and legalese.” The physician “gets scared or is artificially reassured, signs an overwhelmingly unfair contract, and then feels stuck.”

Being stuck in a bad contract “is debilitating and adds to burnout, feeling of depression, and the sense that there is no recourse and nowhere to go, especially if your family depends on you,” Ms. Hill said.

“More women than men feel hamstrung or are resigned to being harassed – which is not uncommon in the medical setting, especially in surgical specialties – or just accept poor treatment,” Ms. Hill added. Yes, you can “fight the system and go to HR, but fighting the system is very hard.”

She urges women “not to feel stuck or imprisoned by the ‘golden handcuffs’ but to consult a good lawyer, even if you have to break the contract.” Be aware of the reasons for your unhappiness and bring them to your lawyer – perhaps the system has engaged in fraud, perhaps there has been sexual or racial harassment, perhaps the organization hasn’t followed its own compliance policies.

Dr. Chester consulted Ms. Hill before signing the contract for her current position. “I wanted someone who could give me personalized advice, not only generic advice, and who understood my needs as a woman.”

Ms. Hill helped her to understand “what was and wasn’t fair and reasonable, what changes I could request based on my goals and whether they were realistic, and how to pick my battles. For example, I tried to negotiate tail coverage up front in my previous job but was unsuccessful. The new employer paid tail for me, both from my previous employment and for my current employment.”

Dr. Chester advises other female physicians “never to sign anything without having a lawyer review it and to make sure that the lawyer is sensitive to their specific needs.”

It can be hard to be a female physician. Having the right knowledge and ammunition and knowing how to negotiate well paves the way for success and thriving in an often male-dominated market.

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

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Buzzy Lancet long COVID paper under investigation for ‘data errors’

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Thu, 12/15/2022 - 14:23

An early and influential paper on long COVID that appeared in The Lancet has been flagged with an expression of concern while the journal investigates “data errors” brought to light by a reader.

An editorial that accompanied the paper when it was published in January of last year described it as “the first large cohort study with 6-months’ follow-up” of people hospitalized with COVID-19. The article has received plenty of attention since then.

Titled “6-month consequences of COVID-19 in patients discharged from hospital: a cohort study,” the paper has been cited nearly 1,600 times, according to Clarivate’s Web of Science. Altmetric finds references to it in multiple documents from the World Health Organization.

According to the expression of concern, dated November 24, a reader found inconsistencies between the data in the article and a later paper describing the same cohort of patients after a year of follow-up. That discovery sparked an investigation that is still ongoing:

  • On Jan 8, 2021, The Lancet published an Article, 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study, by Chaolin Huang and colleagues. On Aug 28, 2021, The Lancet published an Article, 1-year outcomes in hospital survivors with COVID-19: a longitudinal cohort study, by Lixue Huang and colleagues. We received an inquiry from a researcher on data inconsistencies between these two Articles, and we sought an explanation from the corresponding author of the two papers. On Nov 7, 2022, Lancet editors were informed that inconsistencies between the 6-month and the 1-year data were due to “some variables in the dataset used for the 6-month paper were mistakenly disrupted in order”. In view of the extent of these data errors, we now issue an Expression of Concern about the 6-month paper while we investigate further, including further statistical and clinical review of the corrected data. We will update this notice as soon as we have further information.

The corresponding author of both papers, Bin Cao of China’s National Center for Respiratory Medicine and the China-Japan Friendship Hospital in Beijing, has not responded to our request for comment.

profile of Cao published in Lancet Infectious Diseases last March described him as “a leading researcher in pneumonia and influenza” who “has been instrumental in increasing knowledge about COVID-19.” In addition to the follow-up study of hospitalized COVID patients:

  • Cao’s seminal papers during the COVID-19 pandemic include the first report of the clinical characteristics of COVID-19 patients in Wuhan, the description of the risk factors for mortality for adult inpatients, and the results of trials testing the use of antiviral drugs, including lopinavir-ritonavir, to treat COVID-19 in China.

We reached out to The Lancet’s press office and Richard Horton, the journal’s editor-in-chief, and received this statement:

  • The Lancet Group treats all communications between editors and authors or readers as confidential. Investigations are continuing, and the Expression of Concern will be updated as soon as we have further information to share. More information about our policies is available here: 

This year, The Lancet overtook the New England Journal of Medicine as the medical journal with the highest impact factor, in large part due to the papers it published about COVID-19.

We’ve counted retractions for three of those papers, most notably a paper about the use of the drug hydroxychloroquine that claimed to use medical data from a company called Surgisphere. As Retraction Watch readers may remember, the article was retracted after sleuths questioned if the data were real, and the company would not produce it for review.

This article first appeared on Retraction Watch.

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An early and influential paper on long COVID that appeared in The Lancet has been flagged with an expression of concern while the journal investigates “data errors” brought to light by a reader.

An editorial that accompanied the paper when it was published in January of last year described it as “the first large cohort study with 6-months’ follow-up” of people hospitalized with COVID-19. The article has received plenty of attention since then.

Titled “6-month consequences of COVID-19 in patients discharged from hospital: a cohort study,” the paper has been cited nearly 1,600 times, according to Clarivate’s Web of Science. Altmetric finds references to it in multiple documents from the World Health Organization.

According to the expression of concern, dated November 24, a reader found inconsistencies between the data in the article and a later paper describing the same cohort of patients after a year of follow-up. That discovery sparked an investigation that is still ongoing:

  • On Jan 8, 2021, The Lancet published an Article, 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study, by Chaolin Huang and colleagues. On Aug 28, 2021, The Lancet published an Article, 1-year outcomes in hospital survivors with COVID-19: a longitudinal cohort study, by Lixue Huang and colleagues. We received an inquiry from a researcher on data inconsistencies between these two Articles, and we sought an explanation from the corresponding author of the two papers. On Nov 7, 2022, Lancet editors were informed that inconsistencies between the 6-month and the 1-year data were due to “some variables in the dataset used for the 6-month paper were mistakenly disrupted in order”. In view of the extent of these data errors, we now issue an Expression of Concern about the 6-month paper while we investigate further, including further statistical and clinical review of the corrected data. We will update this notice as soon as we have further information.

The corresponding author of both papers, Bin Cao of China’s National Center for Respiratory Medicine and the China-Japan Friendship Hospital in Beijing, has not responded to our request for comment.

profile of Cao published in Lancet Infectious Diseases last March described him as “a leading researcher in pneumonia and influenza” who “has been instrumental in increasing knowledge about COVID-19.” In addition to the follow-up study of hospitalized COVID patients:

  • Cao’s seminal papers during the COVID-19 pandemic include the first report of the clinical characteristics of COVID-19 patients in Wuhan, the description of the risk factors for mortality for adult inpatients, and the results of trials testing the use of antiviral drugs, including lopinavir-ritonavir, to treat COVID-19 in China.

We reached out to The Lancet’s press office and Richard Horton, the journal’s editor-in-chief, and received this statement:

  • The Lancet Group treats all communications between editors and authors or readers as confidential. Investigations are continuing, and the Expression of Concern will be updated as soon as we have further information to share. More information about our policies is available here: 

This year, The Lancet overtook the New England Journal of Medicine as the medical journal with the highest impact factor, in large part due to the papers it published about COVID-19.

We’ve counted retractions for three of those papers, most notably a paper about the use of the drug hydroxychloroquine that claimed to use medical data from a company called Surgisphere. As Retraction Watch readers may remember, the article was retracted after sleuths questioned if the data were real, and the company would not produce it for review.

This article first appeared on Retraction Watch.

An early and influential paper on long COVID that appeared in The Lancet has been flagged with an expression of concern while the journal investigates “data errors” brought to light by a reader.

An editorial that accompanied the paper when it was published in January of last year described it as “the first large cohort study with 6-months’ follow-up” of people hospitalized with COVID-19. The article has received plenty of attention since then.

Titled “6-month consequences of COVID-19 in patients discharged from hospital: a cohort study,” the paper has been cited nearly 1,600 times, according to Clarivate’s Web of Science. Altmetric finds references to it in multiple documents from the World Health Organization.

According to the expression of concern, dated November 24, a reader found inconsistencies between the data in the article and a later paper describing the same cohort of patients after a year of follow-up. That discovery sparked an investigation that is still ongoing:

  • On Jan 8, 2021, The Lancet published an Article, 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study, by Chaolin Huang and colleagues. On Aug 28, 2021, The Lancet published an Article, 1-year outcomes in hospital survivors with COVID-19: a longitudinal cohort study, by Lixue Huang and colleagues. We received an inquiry from a researcher on data inconsistencies between these two Articles, and we sought an explanation from the corresponding author of the two papers. On Nov 7, 2022, Lancet editors were informed that inconsistencies between the 6-month and the 1-year data were due to “some variables in the dataset used for the 6-month paper were mistakenly disrupted in order”. In view of the extent of these data errors, we now issue an Expression of Concern about the 6-month paper while we investigate further, including further statistical and clinical review of the corrected data. We will update this notice as soon as we have further information.

The corresponding author of both papers, Bin Cao of China’s National Center for Respiratory Medicine and the China-Japan Friendship Hospital in Beijing, has not responded to our request for comment.

profile of Cao published in Lancet Infectious Diseases last March described him as “a leading researcher in pneumonia and influenza” who “has been instrumental in increasing knowledge about COVID-19.” In addition to the follow-up study of hospitalized COVID patients:

  • Cao’s seminal papers during the COVID-19 pandemic include the first report of the clinical characteristics of COVID-19 patients in Wuhan, the description of the risk factors for mortality for adult inpatients, and the results of trials testing the use of antiviral drugs, including lopinavir-ritonavir, to treat COVID-19 in China.

We reached out to The Lancet’s press office and Richard Horton, the journal’s editor-in-chief, and received this statement:

  • The Lancet Group treats all communications between editors and authors or readers as confidential. Investigations are continuing, and the Expression of Concern will be updated as soon as we have further information to share. More information about our policies is available here: 

This year, The Lancet overtook the New England Journal of Medicine as the medical journal with the highest impact factor, in large part due to the papers it published about COVID-19.

We’ve counted retractions for three of those papers, most notably a paper about the use of the drug hydroxychloroquine that claimed to use medical data from a company called Surgisphere. As Retraction Watch readers may remember, the article was retracted after sleuths questioned if the data were real, and the company would not produce it for review.

This article first appeared on Retraction Watch.

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How blunt is too blunt for informed consent?

Article Type
Changed
Mon, 12/05/2022 - 16:24

Sitting across from a patient explaining a complicated treatment proposal, protocol, or medication may be one of the most complex yet crucial tasks you have as a physician. Although informed consent is at the forefront of shared decisions between you and your patient, there’s a fine line between providing enough information on the risks and benefits of a particular treatment and knowing you’ve explained it well enough to fully educate your patient about their choices.

According to the Medscape “Right and Wrong in Medicine: Life, Death, and Wrenching Choices” report, how you handle the informed consent process can be the difference between a positive outcome and a negative one.

“It is a bit of a fine line because unless your patient happens to be a health care provider, medicine is complicated for patients to understand,” said David L. Feldman, MD, chief medical officer at The Doctors Company, the nation’s largest medical malpractice insurer in New York.

In addition, documenting the interaction is critical, said James Giordano, PhD, MPhil, professor in the departments of neurology and biochemistry and chief of the neuroethics studies program at the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center, Washington.

“As with anything in medicine, the key rule is that if it’s not documented, it’s not done,” he said. “This also means diligent documentation in all aspects of the medical record, including the electronic medical record and the written one.”

That said, it’s important to know what’s enough and what’s too granular when you discuss a procedure with your patients, said Erum N. Ilyas, MD, a board-certified dermatologist at Schweiger Dermatology and a bioethicist near Philadelphia.

“One of the most challenging aspects of informed consent, especially for young physicians, is how to discuss a procedure or a medication in a manner that is both relevant and concise,” Dr. llyas said. “I’ve had residents about to perform a skin biopsy spend several minutes covering every aspect of every potential outcome of a routine skin biopsy. The patient is left traumatized and confused as to whether they should proceed with the small procedure.”

Instead, the goal of informed consent is to ensure that the patient has a general overview of the procedure and is empowered, knowing that the decision to proceed is, indeed, part of their decision-making process.

How long an informed consent discussion takes depends on the procedure.

“When I was in practice as a plastic surgeon, the conversations varied from the straightforward ‘I’m taking this mole off your cheek, and there’s a risk of scarring and bleeding’ to talking about a mastectomy and breast reconstruction, which could take an hour or more to discuss,” Dr. Feldman said.

Ultimately, it’s as essential for doctors to explain the risks associated with a procedure as it is for patients to understand precisely what’s involved, Dr. Ilyas added.

She also recommends creating a flow to the conversation that places the discussion of risks within the context of why the procedure is being performed. This way, clarity about both the risks and the need for the treatment or procedure can be achieved.

When doing so, it’s critical to make sure you’re speaking your patient’s language – literally.

“Have a translator in the room if needed,” Dr. Feldman added. “If your patient is hearing or sight impaired, you need to have every contingency ready to ensure that everyone is in complete communication.”
 

 

 

Document, document, document!

To best protect yourself, the patient must consent to each procedure and intervention via active, informed consent, said Dr. Giordano.

“It’s not enough to hand a patient a piece of paper and say sign it,” he said. “There should be some documented evidence that the patient has not only read the document but that the key parts of the document have been explained and that the patient’s level of comprehension has been assessed and verified.”

It is vital if the patient has a disability, a neurological impairment, or a neurocognitive or psychiatric condition that might impede his or her ability to understand the consent that’s being sought.

In addition, it’s best if a ‘clinical proxy’ handles the consent (for example, a nurse, office worker, or case manager).

“This can be very helpful because it means you’ve had third-party documentation of informed consent,” Dr. Giordano said. “It should then be re-documented with you as the clinician and stated that the patient has affirmatively and actively agreed to treatment.”
 

What happens when things go wrong?

If you’re sued over informed consent, with the patient claiming that you didn’t fully explain the potential risks, the first thing to consider is why this happened.

“Very often, these situations occur if there was some difficulty or competency of communication,” Dr. Giordano said. “You may have done everything right, but somehow the patient hasn’t gained an understanding of the procedure required.”

Physicians must take a hard look at how they’re explaining risks and possible side effects. For doctors who perform these procedures regularly, the risks may seem small, and they may unconsciously minimize them to the patient. But when something goes wrong, the patient may then feel that they didn’t fully understand the frequency of poor outcomes, or the potential severity.

Next, it’s important to perform a ‘gap analysis’ to assess why something went awry. That means, look at all the potential factors involved to identify which one was the weak link.

“It might be that the patient was on a signing frenzy and signed away but didn’t receive active and informed content,” Dr. Giordano said. “The goal is to learn how to close the gap for this case and for future cases.”

To protect yourself, consider using technology to your advantage, especially since lawsuits over informed consent usually happen several years after the procedure. This is when a patient might argue that you didn’t tell them about possible complications and that they might have opted out of the procedure if they had known about those issues ahead of time.

“Even before the statute of limitations is up for a lawsuit, it could be five years from the time the procedure occurred due to the length of time a lawsuit can take,” Dr. Feldman said. “That’s why it’s important to take a video of your conversation or make a recording of the informed consent conversation. This way if there’s a question of what you said, there’s a video of it.”

For many physicians, this would be a big change – to video record and then store all their informed consent conversations. It could most likely help you if a lawsuit occurs, but some physicians may feel that process to be cumbersome and time-consuming, and they’d rather find another way to ensure that patients understand the risks.

Ultimately, however, if there’s a legal question involved with informed consent, the general thinking is that the effect on the patient must be harmful for it to stand up.

“The question becomes whether the outcome rendered that gap in the consenting process forgivable,” Dr. Giordano said. “The hope is that there was nothing harmful to the patient and that the benefit of the procedure was demonstrable despite any gaps in the informed consent process.”

In the end, informed consent should be a matter of good communication before, during, and after any treatment or procedure.

“When you form a relationship with a patient who needs any procedure, small or large, you’re going to be guiding them through a very scary thing,” Dr. Feldman said. “You want to make patients feel like you care about them and that, while neither you nor the system is perfect, you’ll take care of them. That’s the bottom line.”

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

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Sitting across from a patient explaining a complicated treatment proposal, protocol, or medication may be one of the most complex yet crucial tasks you have as a physician. Although informed consent is at the forefront of shared decisions between you and your patient, there’s a fine line between providing enough information on the risks and benefits of a particular treatment and knowing you’ve explained it well enough to fully educate your patient about their choices.

According to the Medscape “Right and Wrong in Medicine: Life, Death, and Wrenching Choices” report, how you handle the informed consent process can be the difference between a positive outcome and a negative one.

“It is a bit of a fine line because unless your patient happens to be a health care provider, medicine is complicated for patients to understand,” said David L. Feldman, MD, chief medical officer at The Doctors Company, the nation’s largest medical malpractice insurer in New York.

In addition, documenting the interaction is critical, said James Giordano, PhD, MPhil, professor in the departments of neurology and biochemistry and chief of the neuroethics studies program at the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center, Washington.

“As with anything in medicine, the key rule is that if it’s not documented, it’s not done,” he said. “This also means diligent documentation in all aspects of the medical record, including the electronic medical record and the written one.”

That said, it’s important to know what’s enough and what’s too granular when you discuss a procedure with your patients, said Erum N. Ilyas, MD, a board-certified dermatologist at Schweiger Dermatology and a bioethicist near Philadelphia.

“One of the most challenging aspects of informed consent, especially for young physicians, is how to discuss a procedure or a medication in a manner that is both relevant and concise,” Dr. llyas said. “I’ve had residents about to perform a skin biopsy spend several minutes covering every aspect of every potential outcome of a routine skin biopsy. The patient is left traumatized and confused as to whether they should proceed with the small procedure.”

Instead, the goal of informed consent is to ensure that the patient has a general overview of the procedure and is empowered, knowing that the decision to proceed is, indeed, part of their decision-making process.

How long an informed consent discussion takes depends on the procedure.

“When I was in practice as a plastic surgeon, the conversations varied from the straightforward ‘I’m taking this mole off your cheek, and there’s a risk of scarring and bleeding’ to talking about a mastectomy and breast reconstruction, which could take an hour or more to discuss,” Dr. Feldman said.

Ultimately, it’s as essential for doctors to explain the risks associated with a procedure as it is for patients to understand precisely what’s involved, Dr. Ilyas added.

She also recommends creating a flow to the conversation that places the discussion of risks within the context of why the procedure is being performed. This way, clarity about both the risks and the need for the treatment or procedure can be achieved.

When doing so, it’s critical to make sure you’re speaking your patient’s language – literally.

“Have a translator in the room if needed,” Dr. Feldman added. “If your patient is hearing or sight impaired, you need to have every contingency ready to ensure that everyone is in complete communication.”
 

 

 

Document, document, document!

To best protect yourself, the patient must consent to each procedure and intervention via active, informed consent, said Dr. Giordano.

“It’s not enough to hand a patient a piece of paper and say sign it,” he said. “There should be some documented evidence that the patient has not only read the document but that the key parts of the document have been explained and that the patient’s level of comprehension has been assessed and verified.”

It is vital if the patient has a disability, a neurological impairment, or a neurocognitive or psychiatric condition that might impede his or her ability to understand the consent that’s being sought.

In addition, it’s best if a ‘clinical proxy’ handles the consent (for example, a nurse, office worker, or case manager).

“This can be very helpful because it means you’ve had third-party documentation of informed consent,” Dr. Giordano said. “It should then be re-documented with you as the clinician and stated that the patient has affirmatively and actively agreed to treatment.”
 

What happens when things go wrong?

If you’re sued over informed consent, with the patient claiming that you didn’t fully explain the potential risks, the first thing to consider is why this happened.

“Very often, these situations occur if there was some difficulty or competency of communication,” Dr. Giordano said. “You may have done everything right, but somehow the patient hasn’t gained an understanding of the procedure required.”

Physicians must take a hard look at how they’re explaining risks and possible side effects. For doctors who perform these procedures regularly, the risks may seem small, and they may unconsciously minimize them to the patient. But when something goes wrong, the patient may then feel that they didn’t fully understand the frequency of poor outcomes, or the potential severity.

Next, it’s important to perform a ‘gap analysis’ to assess why something went awry. That means, look at all the potential factors involved to identify which one was the weak link.

“It might be that the patient was on a signing frenzy and signed away but didn’t receive active and informed content,” Dr. Giordano said. “The goal is to learn how to close the gap for this case and for future cases.”

To protect yourself, consider using technology to your advantage, especially since lawsuits over informed consent usually happen several years after the procedure. This is when a patient might argue that you didn’t tell them about possible complications and that they might have opted out of the procedure if they had known about those issues ahead of time.

“Even before the statute of limitations is up for a lawsuit, it could be five years from the time the procedure occurred due to the length of time a lawsuit can take,” Dr. Feldman said. “That’s why it’s important to take a video of your conversation or make a recording of the informed consent conversation. This way if there’s a question of what you said, there’s a video of it.”

For many physicians, this would be a big change – to video record and then store all their informed consent conversations. It could most likely help you if a lawsuit occurs, but some physicians may feel that process to be cumbersome and time-consuming, and they’d rather find another way to ensure that patients understand the risks.

Ultimately, however, if there’s a legal question involved with informed consent, the general thinking is that the effect on the patient must be harmful for it to stand up.

“The question becomes whether the outcome rendered that gap in the consenting process forgivable,” Dr. Giordano said. “The hope is that there was nothing harmful to the patient and that the benefit of the procedure was demonstrable despite any gaps in the informed consent process.”

In the end, informed consent should be a matter of good communication before, during, and after any treatment or procedure.

“When you form a relationship with a patient who needs any procedure, small or large, you’re going to be guiding them through a very scary thing,” Dr. Feldman said. “You want to make patients feel like you care about them and that, while neither you nor the system is perfect, you’ll take care of them. That’s the bottom line.”

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

Sitting across from a patient explaining a complicated treatment proposal, protocol, or medication may be one of the most complex yet crucial tasks you have as a physician. Although informed consent is at the forefront of shared decisions between you and your patient, there’s a fine line between providing enough information on the risks and benefits of a particular treatment and knowing you’ve explained it well enough to fully educate your patient about their choices.

According to the Medscape “Right and Wrong in Medicine: Life, Death, and Wrenching Choices” report, how you handle the informed consent process can be the difference between a positive outcome and a negative one.

“It is a bit of a fine line because unless your patient happens to be a health care provider, medicine is complicated for patients to understand,” said David L. Feldman, MD, chief medical officer at The Doctors Company, the nation’s largest medical malpractice insurer in New York.

In addition, documenting the interaction is critical, said James Giordano, PhD, MPhil, professor in the departments of neurology and biochemistry and chief of the neuroethics studies program at the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center, Washington.

“As with anything in medicine, the key rule is that if it’s not documented, it’s not done,” he said. “This also means diligent documentation in all aspects of the medical record, including the electronic medical record and the written one.”

That said, it’s important to know what’s enough and what’s too granular when you discuss a procedure with your patients, said Erum N. Ilyas, MD, a board-certified dermatologist at Schweiger Dermatology and a bioethicist near Philadelphia.

“One of the most challenging aspects of informed consent, especially for young physicians, is how to discuss a procedure or a medication in a manner that is both relevant and concise,” Dr. llyas said. “I’ve had residents about to perform a skin biopsy spend several minutes covering every aspect of every potential outcome of a routine skin biopsy. The patient is left traumatized and confused as to whether they should proceed with the small procedure.”

Instead, the goal of informed consent is to ensure that the patient has a general overview of the procedure and is empowered, knowing that the decision to proceed is, indeed, part of their decision-making process.

How long an informed consent discussion takes depends on the procedure.

“When I was in practice as a plastic surgeon, the conversations varied from the straightforward ‘I’m taking this mole off your cheek, and there’s a risk of scarring and bleeding’ to talking about a mastectomy and breast reconstruction, which could take an hour or more to discuss,” Dr. Feldman said.

Ultimately, it’s as essential for doctors to explain the risks associated with a procedure as it is for patients to understand precisely what’s involved, Dr. Ilyas added.

She also recommends creating a flow to the conversation that places the discussion of risks within the context of why the procedure is being performed. This way, clarity about both the risks and the need for the treatment or procedure can be achieved.

When doing so, it’s critical to make sure you’re speaking your patient’s language – literally.

“Have a translator in the room if needed,” Dr. Feldman added. “If your patient is hearing or sight impaired, you need to have every contingency ready to ensure that everyone is in complete communication.”
 

 

 

Document, document, document!

To best protect yourself, the patient must consent to each procedure and intervention via active, informed consent, said Dr. Giordano.

“It’s not enough to hand a patient a piece of paper and say sign it,” he said. “There should be some documented evidence that the patient has not only read the document but that the key parts of the document have been explained and that the patient’s level of comprehension has been assessed and verified.”

It is vital if the patient has a disability, a neurological impairment, or a neurocognitive or psychiatric condition that might impede his or her ability to understand the consent that’s being sought.

In addition, it’s best if a ‘clinical proxy’ handles the consent (for example, a nurse, office worker, or case manager).

“This can be very helpful because it means you’ve had third-party documentation of informed consent,” Dr. Giordano said. “It should then be re-documented with you as the clinician and stated that the patient has affirmatively and actively agreed to treatment.”
 

What happens when things go wrong?

If you’re sued over informed consent, with the patient claiming that you didn’t fully explain the potential risks, the first thing to consider is why this happened.

“Very often, these situations occur if there was some difficulty or competency of communication,” Dr. Giordano said. “You may have done everything right, but somehow the patient hasn’t gained an understanding of the procedure required.”

Physicians must take a hard look at how they’re explaining risks and possible side effects. For doctors who perform these procedures regularly, the risks may seem small, and they may unconsciously minimize them to the patient. But when something goes wrong, the patient may then feel that they didn’t fully understand the frequency of poor outcomes, or the potential severity.

Next, it’s important to perform a ‘gap analysis’ to assess why something went awry. That means, look at all the potential factors involved to identify which one was the weak link.

“It might be that the patient was on a signing frenzy and signed away but didn’t receive active and informed content,” Dr. Giordano said. “The goal is to learn how to close the gap for this case and for future cases.”

To protect yourself, consider using technology to your advantage, especially since lawsuits over informed consent usually happen several years after the procedure. This is when a patient might argue that you didn’t tell them about possible complications and that they might have opted out of the procedure if they had known about those issues ahead of time.

“Even before the statute of limitations is up for a lawsuit, it could be five years from the time the procedure occurred due to the length of time a lawsuit can take,” Dr. Feldman said. “That’s why it’s important to take a video of your conversation or make a recording of the informed consent conversation. This way if there’s a question of what you said, there’s a video of it.”

For many physicians, this would be a big change – to video record and then store all their informed consent conversations. It could most likely help you if a lawsuit occurs, but some physicians may feel that process to be cumbersome and time-consuming, and they’d rather find another way to ensure that patients understand the risks.

Ultimately, however, if there’s a legal question involved with informed consent, the general thinking is that the effect on the patient must be harmful for it to stand up.

“The question becomes whether the outcome rendered that gap in the consenting process forgivable,” Dr. Giordano said. “The hope is that there was nothing harmful to the patient and that the benefit of the procedure was demonstrable despite any gaps in the informed consent process.”

In the end, informed consent should be a matter of good communication before, during, and after any treatment or procedure.

“When you form a relationship with a patient who needs any procedure, small or large, you’re going to be guiding them through a very scary thing,” Dr. Feldman said. “You want to make patients feel like you care about them and that, while neither you nor the system is perfect, you’ll take care of them. That’s the bottom line.”

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

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Analysis of doctors’ EHR email finds infrequent but notable hostility

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Tue, 12/06/2022 - 08:45

In a study published online, researchers used artificial intelligence to analyze more than 1.4 million electronic health record emails to physicians – and the results aren’t pretty.

Among the emails, 43% were from patients; the remainder were mostly from other physicians or clinicians, or automated. The content of the messages wasn’t associated with doctor burnout, as the researchers had hypothesized. And only about 5% of the messages had negative sentiment.

But the researchers were struck by the hostility of that sentiment, displayed in messages like these that surely would be distressing for physicians to read:

“I hope and expect that you will spend eternity in he**. You are an abusive, nasty, cheap person.”

“Your office is full of liars, hypocrites and I will do everything in my power to prevent anyone from going to your bullsh** office again.”

About 5% of emails had an overall negative sentiment, with high-frequency words like “cancel,” “pain,” or “problem.” Among patient messages, 3% were negative and contained words and expletives suggesting hatred, hostility, or violence.

“F***” was the most common expletive used by patients.

Researchers provided examples of profanity-laced messages, including one patient who said, “I am so upset that I was told the blood work would include the gender of the baby. I have been waiting 5 [days] to find it, and it wasn’t even fu**ing tested!!!! What a disappointment in your office and the bullsh** I was told. I will be switching plans because this is sh**!”

Researchers also noted some high-frequency words associated with violence, such as “shoot,” “fight,” and “kill.”

“This is concerning, especially given documentation of patient-inflicted violence against physicians. Health systems should be proactive in ensuring that the in-basket does not become a venue for physician abuse and cyberbullying,” the researchers wrote in JAMA Network Open.

“Posting reminders in EHR patient portals to use kind language when sending messages, applying filters for expletives or threatening words, and creating frameworks for identifying patients who frequently send negative messages are potential strategies for mitigating this risk.”

Using a form of artificial intelligence technology called natural language processing (NLP), researchers at the University of California, San Diego, analyzed the characteristics of more than 1.4 million emails received by the university’s physicians, 43% of them from patients. They specifically looked at the volume of messages, word count, and overall sentiment.

Whereas other studies have examined the growing burden of EHR messaging for doctors, this type of email sentiment analysis could help in creating solutions. Researchers say that one such solution could involve applying filters for expletives or threatening words. It also could help identify fixable health system issues that make patients so angry, the researchers say.

Among the emails from physicians to physicians, just over half reported burnout, which correlated to the following phrases: “I am beginning to burn out and have one or more symptoms of burnout” and “I feel completely burned out [and] am at the point where I may need to seek help.”

On average, physicians who reported burnout received a greater volume of patient messages. The odds of burnout were significantly higher among Hispanic/Latinx physicians and females. Physicians with more than 15 years of clinical practice had markedly lower burnout.

Despite physicians now spending more time on EHR in-basket tasks than they did before the pandemic, the study found no significant associations between message characteristics and burnout.

Data for the cross-sectional study were collected from multiple specialties from April to September 2020. Physicians then completed a survey and assessed their burnout on a 5-point scale. Of the 609 physician responses, approximately 49% of participants were women, 56% were White, and 64% worked in outpatient settings. About 70% of the doctors had been in practice for 15 years or less.

The sentiment score was based on word content as well as the use of negation, punctuation, degree modifiers, all caps, emoticons, emojis, and acronyms. Positive patient messages were more likely to convey gratitude and thanks, along with casual expressions, such as “fyi” and “lol.”

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

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In a study published online, researchers used artificial intelligence to analyze more than 1.4 million electronic health record emails to physicians – and the results aren’t pretty.

Among the emails, 43% were from patients; the remainder were mostly from other physicians or clinicians, or automated. The content of the messages wasn’t associated with doctor burnout, as the researchers had hypothesized. And only about 5% of the messages had negative sentiment.

But the researchers were struck by the hostility of that sentiment, displayed in messages like these that surely would be distressing for physicians to read:

“I hope and expect that you will spend eternity in he**. You are an abusive, nasty, cheap person.”

“Your office is full of liars, hypocrites and I will do everything in my power to prevent anyone from going to your bullsh** office again.”

About 5% of emails had an overall negative sentiment, with high-frequency words like “cancel,” “pain,” or “problem.” Among patient messages, 3% were negative and contained words and expletives suggesting hatred, hostility, or violence.

“F***” was the most common expletive used by patients.

Researchers provided examples of profanity-laced messages, including one patient who said, “I am so upset that I was told the blood work would include the gender of the baby. I have been waiting 5 [days] to find it, and it wasn’t even fu**ing tested!!!! What a disappointment in your office and the bullsh** I was told. I will be switching plans because this is sh**!”

Researchers also noted some high-frequency words associated with violence, such as “shoot,” “fight,” and “kill.”

“This is concerning, especially given documentation of patient-inflicted violence against physicians. Health systems should be proactive in ensuring that the in-basket does not become a venue for physician abuse and cyberbullying,” the researchers wrote in JAMA Network Open.

“Posting reminders in EHR patient portals to use kind language when sending messages, applying filters for expletives or threatening words, and creating frameworks for identifying patients who frequently send negative messages are potential strategies for mitigating this risk.”

Using a form of artificial intelligence technology called natural language processing (NLP), researchers at the University of California, San Diego, analyzed the characteristics of more than 1.4 million emails received by the university’s physicians, 43% of them from patients. They specifically looked at the volume of messages, word count, and overall sentiment.

Whereas other studies have examined the growing burden of EHR messaging for doctors, this type of email sentiment analysis could help in creating solutions. Researchers say that one such solution could involve applying filters for expletives or threatening words. It also could help identify fixable health system issues that make patients so angry, the researchers say.

Among the emails from physicians to physicians, just over half reported burnout, which correlated to the following phrases: “I am beginning to burn out and have one or more symptoms of burnout” and “I feel completely burned out [and] am at the point where I may need to seek help.”

On average, physicians who reported burnout received a greater volume of patient messages. The odds of burnout were significantly higher among Hispanic/Latinx physicians and females. Physicians with more than 15 years of clinical practice had markedly lower burnout.

Despite physicians now spending more time on EHR in-basket tasks than they did before the pandemic, the study found no significant associations between message characteristics and burnout.

Data for the cross-sectional study were collected from multiple specialties from April to September 2020. Physicians then completed a survey and assessed their burnout on a 5-point scale. Of the 609 physician responses, approximately 49% of participants were women, 56% were White, and 64% worked in outpatient settings. About 70% of the doctors had been in practice for 15 years or less.

The sentiment score was based on word content as well as the use of negation, punctuation, degree modifiers, all caps, emoticons, emojis, and acronyms. Positive patient messages were more likely to convey gratitude and thanks, along with casual expressions, such as “fyi” and “lol.”

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

In a study published online, researchers used artificial intelligence to analyze more than 1.4 million electronic health record emails to physicians – and the results aren’t pretty.

Among the emails, 43% were from patients; the remainder were mostly from other physicians or clinicians, or automated. The content of the messages wasn’t associated with doctor burnout, as the researchers had hypothesized. And only about 5% of the messages had negative sentiment.

But the researchers were struck by the hostility of that sentiment, displayed in messages like these that surely would be distressing for physicians to read:

“I hope and expect that you will spend eternity in he**. You are an abusive, nasty, cheap person.”

“Your office is full of liars, hypocrites and I will do everything in my power to prevent anyone from going to your bullsh** office again.”

About 5% of emails had an overall negative sentiment, with high-frequency words like “cancel,” “pain,” or “problem.” Among patient messages, 3% were negative and contained words and expletives suggesting hatred, hostility, or violence.

“F***” was the most common expletive used by patients.

Researchers provided examples of profanity-laced messages, including one patient who said, “I am so upset that I was told the blood work would include the gender of the baby. I have been waiting 5 [days] to find it, and it wasn’t even fu**ing tested!!!! What a disappointment in your office and the bullsh** I was told. I will be switching plans because this is sh**!”

Researchers also noted some high-frequency words associated with violence, such as “shoot,” “fight,” and “kill.”

“This is concerning, especially given documentation of patient-inflicted violence against physicians. Health systems should be proactive in ensuring that the in-basket does not become a venue for physician abuse and cyberbullying,” the researchers wrote in JAMA Network Open.

“Posting reminders in EHR patient portals to use kind language when sending messages, applying filters for expletives or threatening words, and creating frameworks for identifying patients who frequently send negative messages are potential strategies for mitigating this risk.”

Using a form of artificial intelligence technology called natural language processing (NLP), researchers at the University of California, San Diego, analyzed the characteristics of more than 1.4 million emails received by the university’s physicians, 43% of them from patients. They specifically looked at the volume of messages, word count, and overall sentiment.

Whereas other studies have examined the growing burden of EHR messaging for doctors, this type of email sentiment analysis could help in creating solutions. Researchers say that one such solution could involve applying filters for expletives or threatening words. It also could help identify fixable health system issues that make patients so angry, the researchers say.

Among the emails from physicians to physicians, just over half reported burnout, which correlated to the following phrases: “I am beginning to burn out and have one or more symptoms of burnout” and “I feel completely burned out [and] am at the point where I may need to seek help.”

On average, physicians who reported burnout received a greater volume of patient messages. The odds of burnout were significantly higher among Hispanic/Latinx physicians and females. Physicians with more than 15 years of clinical practice had markedly lower burnout.

Despite physicians now spending more time on EHR in-basket tasks than they did before the pandemic, the study found no significant associations between message characteristics and burnout.

Data for the cross-sectional study were collected from multiple specialties from April to September 2020. Physicians then completed a survey and assessed their burnout on a 5-point scale. Of the 609 physician responses, approximately 49% of participants were women, 56% were White, and 64% worked in outpatient settings. About 70% of the doctors had been in practice for 15 years or less.

The sentiment score was based on word content as well as the use of negation, punctuation, degree modifiers, all caps, emoticons, emojis, and acronyms. Positive patient messages were more likely to convey gratitude and thanks, along with casual expressions, such as “fyi” and “lol.”

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

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Covid vax prevents death in children regardless of variant

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Thu, 12/15/2022 - 14:23

COVID-19 vaccines retained the ability to prevent deaths from COVID-19 in children and adolescents regardless of the dominant circulating variant, in a new study.

The vaccine’s effectiveness against infection in the short term has been established, as has the waning effectiveness of the vaccine over time, wrote Juan Manuel Castelli, MD, of the Ministry of Health of Argentina, Buenos Aires, and colleagues, in the British Medical Journal.

However, data on the impact of vaccine effectiveness on mortality in children and adolescents are limited, especially during periods of omicron variant dominance, the researchers said.

In their new study, the researchers reviewed data from 844,460 children and adolescents aged 3-17 years from the National Surveillance System and the Nominalized Federal Vaccination Registry of Argentina, during a time that included a period of omicron dominance.

Argentina began vaccinating adolescents aged 12-17 years against COVID-19 in August 2021 and added children aged 3-11 years in October 2021. Those aged 12-17 years who were considered fully vaccinated received two doses of either Pfizer-BioNTech and/or Moderna vaccines, and fully-vaccinated 3- to 11-year-olds received two doses of Sinopharm vaccine.

The average time from the second vaccine dose to a COVID-19 test was 66 days for those aged 12-17 years and 54 days for 3- to 11-year-olds. The researchers matched COVID-19 cases with uninfected controls, and a total of 139,321 cases were included in the analysis.

Overall, the estimated vaccine effectiveness against COVID-19 was 64.2% during a period of delta dominance (61.2% in children aged 3-11 years and 66.8% in adolescents aged 12-17 years).

During a period of omicron dominance, estimated vaccine effectiveness was 19.9% across all ages (15.9% and 26.0% for younger and older age groups, respectively).

Effectiveness of the vaccine decreased over time, regardless of the dominant variant, but the decline was greater during the omicron dominant period, the researchers noted. During the omicron period, effectiveness in children aged 3-11 years decreased from 37.6% at 15-30 days postvaccination to 2.0% at 60 days or longer after vaccination. In adolescents aged 12-17 years, vaccine effectiveness during the omicron period decreased from 55.8% at 15-30 days postvaccination to 12.4% at 60 days or longer after vaccination.

Despite the waning protection against infection, the vaccine’s effectiveness against death from COVID-19 was 66.9% in children aged 3-11 years and 97.6% in adolescents aged 12-17 during the period of omicron dominance, the researchers noted.

The results are consistent with similar studies showing a decreased vaccine effectiveness against infection but a persistent effectiveness against deaths over time, the researchers wrote in the discussion section of their paper.

“Our results suggest that the primary vaccination schedule is effective in preventing mortality in children and adolescents with COVID-19 regardless of the circulating SARS-CoV-2 variant,” the researchers said.
 

Study limitations and strengths

The study was limited by several factors including the incomplete data on symptoms and hospital admissions, the possible impact of unmeasured confounding variables, and the observational design that prevents conclusions of causality, the researchers noted. However, the results were strengthened by the large sample size and access to detailed vaccination records, they said.

Both heterologous and homologous mRNA vaccine schedules showed similar effectiveness in preventing short-term infection and mortality from COVID-19 during periods of differing dominant variants, they noted.

The study findings support the vaccination of children against COVID-19 as an important public health measure to prevent mortality in children and adolescents, they concluded.
 

Data support value of vaccination, outside experts say

“COVID vaccines may not be as effective over time as the gene variants in the SARS-CoV-2 virus change,” Adrienne G. Randolph, MD, a pediatrician at Harvard Medical School and Boston Children’s Hospital, said in an interview. “Therefore, it is essential to assess vaccine effectiveness over time to look at effectiveness against variants and duration of effectiveness.” Dr. Randolph, who was not involved in the study, said she was not surprised by the findings, which she described as consistent with data from the United States. “COVID vaccines are very effective against preventing life-threatening disease, but the effectiveness against less severe illness for COVID vaccines is not as effective against Omicron,” she noted. 

The take-home message for clinicians is that it’s important to get children vaccinated against COVID to prevent severe and life-threatening illness, said Dr. Randolph. “Although these cases are uncommon in children, it is not possible to predict which children will be the most severely affected by COVID,” she emphasized.

However, “we need more data on the new COVID booster vaccines in children that are designed to be more effective against Omicron’s newer variants,” Dr. Randolph said in an interview. “We also need more data on COVID vaccine effectiveness in the youngest children, under 5 years of age, and data on vaccinating mothers to prevent COVID in infants,” she said.

Tim Joos, MD, a Seattle-based clinician who practices a combination of internal medicine and pediatrics, agreed that future research should continue to assess how the new COVID boosters are faring against new variants, noting that the current study did not include data from children who received the new bivalent vaccine.

“The methodology of this study uses a test negative case control design which is common for estimating vaccine effectiveness post-release of a vaccine, but is subject to biases,” Dr. Joos explained. “These are not the clean effectiveness numbers of the prospective randomized control trials that we are used to hearing about when a vaccine is first being approved.”

“Nevertheless, the study reinforces the initial manufacturers’ studies that the vaccines are effective at preventing infection in the pediatric population,” Dr. Joos said in an interview. The current study also reinforces the effectiveness of vaccines in preventing “the rare but devastating mortality from COVID-19 in the pediatric population.”

Commenting on other research showing an increasing ratio of COVID deaths among vaccinated individuals compared to total COVID deaths, he noted that this finding is “likely reflecting a denominator effect of rapidly declining COVID deaths overall,” partly from the vaccines and partly from immunity after previous natural infection.

The study received no outside funding. The researchers, Dr. Randolph, and Dr. Joos had no financial conflicts to disclose. Dr. Joos serves on the Editorial Advisory Board of Pediatric News.

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COVID-19 vaccines retained the ability to prevent deaths from COVID-19 in children and adolescents regardless of the dominant circulating variant, in a new study.

The vaccine’s effectiveness against infection in the short term has been established, as has the waning effectiveness of the vaccine over time, wrote Juan Manuel Castelli, MD, of the Ministry of Health of Argentina, Buenos Aires, and colleagues, in the British Medical Journal.

However, data on the impact of vaccine effectiveness on mortality in children and adolescents are limited, especially during periods of omicron variant dominance, the researchers said.

In their new study, the researchers reviewed data from 844,460 children and adolescents aged 3-17 years from the National Surveillance System and the Nominalized Federal Vaccination Registry of Argentina, during a time that included a period of omicron dominance.

Argentina began vaccinating adolescents aged 12-17 years against COVID-19 in August 2021 and added children aged 3-11 years in October 2021. Those aged 12-17 years who were considered fully vaccinated received two doses of either Pfizer-BioNTech and/or Moderna vaccines, and fully-vaccinated 3- to 11-year-olds received two doses of Sinopharm vaccine.

The average time from the second vaccine dose to a COVID-19 test was 66 days for those aged 12-17 years and 54 days for 3- to 11-year-olds. The researchers matched COVID-19 cases with uninfected controls, and a total of 139,321 cases were included in the analysis.

Overall, the estimated vaccine effectiveness against COVID-19 was 64.2% during a period of delta dominance (61.2% in children aged 3-11 years and 66.8% in adolescents aged 12-17 years).

During a period of omicron dominance, estimated vaccine effectiveness was 19.9% across all ages (15.9% and 26.0% for younger and older age groups, respectively).

Effectiveness of the vaccine decreased over time, regardless of the dominant variant, but the decline was greater during the omicron dominant period, the researchers noted. During the omicron period, effectiveness in children aged 3-11 years decreased from 37.6% at 15-30 days postvaccination to 2.0% at 60 days or longer after vaccination. In adolescents aged 12-17 years, vaccine effectiveness during the omicron period decreased from 55.8% at 15-30 days postvaccination to 12.4% at 60 days or longer after vaccination.

Despite the waning protection against infection, the vaccine’s effectiveness against death from COVID-19 was 66.9% in children aged 3-11 years and 97.6% in adolescents aged 12-17 during the period of omicron dominance, the researchers noted.

The results are consistent with similar studies showing a decreased vaccine effectiveness against infection but a persistent effectiveness against deaths over time, the researchers wrote in the discussion section of their paper.

“Our results suggest that the primary vaccination schedule is effective in preventing mortality in children and adolescents with COVID-19 regardless of the circulating SARS-CoV-2 variant,” the researchers said.
 

Study limitations and strengths

The study was limited by several factors including the incomplete data on symptoms and hospital admissions, the possible impact of unmeasured confounding variables, and the observational design that prevents conclusions of causality, the researchers noted. However, the results were strengthened by the large sample size and access to detailed vaccination records, they said.

Both heterologous and homologous mRNA vaccine schedules showed similar effectiveness in preventing short-term infection and mortality from COVID-19 during periods of differing dominant variants, they noted.

The study findings support the vaccination of children against COVID-19 as an important public health measure to prevent mortality in children and adolescents, they concluded.
 

Data support value of vaccination, outside experts say

“COVID vaccines may not be as effective over time as the gene variants in the SARS-CoV-2 virus change,” Adrienne G. Randolph, MD, a pediatrician at Harvard Medical School and Boston Children’s Hospital, said in an interview. “Therefore, it is essential to assess vaccine effectiveness over time to look at effectiveness against variants and duration of effectiveness.” Dr. Randolph, who was not involved in the study, said she was not surprised by the findings, which she described as consistent with data from the United States. “COVID vaccines are very effective against preventing life-threatening disease, but the effectiveness against less severe illness for COVID vaccines is not as effective against Omicron,” she noted. 

The take-home message for clinicians is that it’s important to get children vaccinated against COVID to prevent severe and life-threatening illness, said Dr. Randolph. “Although these cases are uncommon in children, it is not possible to predict which children will be the most severely affected by COVID,” she emphasized.

However, “we need more data on the new COVID booster vaccines in children that are designed to be more effective against Omicron’s newer variants,” Dr. Randolph said in an interview. “We also need more data on COVID vaccine effectiveness in the youngest children, under 5 years of age, and data on vaccinating mothers to prevent COVID in infants,” she said.

Tim Joos, MD, a Seattle-based clinician who practices a combination of internal medicine and pediatrics, agreed that future research should continue to assess how the new COVID boosters are faring against new variants, noting that the current study did not include data from children who received the new bivalent vaccine.

“The methodology of this study uses a test negative case control design which is common for estimating vaccine effectiveness post-release of a vaccine, but is subject to biases,” Dr. Joos explained. “These are not the clean effectiveness numbers of the prospective randomized control trials that we are used to hearing about when a vaccine is first being approved.”

“Nevertheless, the study reinforces the initial manufacturers’ studies that the vaccines are effective at preventing infection in the pediatric population,” Dr. Joos said in an interview. The current study also reinforces the effectiveness of vaccines in preventing “the rare but devastating mortality from COVID-19 in the pediatric population.”

Commenting on other research showing an increasing ratio of COVID deaths among vaccinated individuals compared to total COVID deaths, he noted that this finding is “likely reflecting a denominator effect of rapidly declining COVID deaths overall,” partly from the vaccines and partly from immunity after previous natural infection.

The study received no outside funding. The researchers, Dr. Randolph, and Dr. Joos had no financial conflicts to disclose. Dr. Joos serves on the Editorial Advisory Board of Pediatric News.

COVID-19 vaccines retained the ability to prevent deaths from COVID-19 in children and adolescents regardless of the dominant circulating variant, in a new study.

The vaccine’s effectiveness against infection in the short term has been established, as has the waning effectiveness of the vaccine over time, wrote Juan Manuel Castelli, MD, of the Ministry of Health of Argentina, Buenos Aires, and colleagues, in the British Medical Journal.

However, data on the impact of vaccine effectiveness on mortality in children and adolescents are limited, especially during periods of omicron variant dominance, the researchers said.

In their new study, the researchers reviewed data from 844,460 children and adolescents aged 3-17 years from the National Surveillance System and the Nominalized Federal Vaccination Registry of Argentina, during a time that included a period of omicron dominance.

Argentina began vaccinating adolescents aged 12-17 years against COVID-19 in August 2021 and added children aged 3-11 years in October 2021. Those aged 12-17 years who were considered fully vaccinated received two doses of either Pfizer-BioNTech and/or Moderna vaccines, and fully-vaccinated 3- to 11-year-olds received two doses of Sinopharm vaccine.

The average time from the second vaccine dose to a COVID-19 test was 66 days for those aged 12-17 years and 54 days for 3- to 11-year-olds. The researchers matched COVID-19 cases with uninfected controls, and a total of 139,321 cases were included in the analysis.

Overall, the estimated vaccine effectiveness against COVID-19 was 64.2% during a period of delta dominance (61.2% in children aged 3-11 years and 66.8% in adolescents aged 12-17 years).

During a period of omicron dominance, estimated vaccine effectiveness was 19.9% across all ages (15.9% and 26.0% for younger and older age groups, respectively).

Effectiveness of the vaccine decreased over time, regardless of the dominant variant, but the decline was greater during the omicron dominant period, the researchers noted. During the omicron period, effectiveness in children aged 3-11 years decreased from 37.6% at 15-30 days postvaccination to 2.0% at 60 days or longer after vaccination. In adolescents aged 12-17 years, vaccine effectiveness during the omicron period decreased from 55.8% at 15-30 days postvaccination to 12.4% at 60 days or longer after vaccination.

Despite the waning protection against infection, the vaccine’s effectiveness against death from COVID-19 was 66.9% in children aged 3-11 years and 97.6% in adolescents aged 12-17 during the period of omicron dominance, the researchers noted.

The results are consistent with similar studies showing a decreased vaccine effectiveness against infection but a persistent effectiveness against deaths over time, the researchers wrote in the discussion section of their paper.

“Our results suggest that the primary vaccination schedule is effective in preventing mortality in children and adolescents with COVID-19 regardless of the circulating SARS-CoV-2 variant,” the researchers said.
 

Study limitations and strengths

The study was limited by several factors including the incomplete data on symptoms and hospital admissions, the possible impact of unmeasured confounding variables, and the observational design that prevents conclusions of causality, the researchers noted. However, the results were strengthened by the large sample size and access to detailed vaccination records, they said.

Both heterologous and homologous mRNA vaccine schedules showed similar effectiveness in preventing short-term infection and mortality from COVID-19 during periods of differing dominant variants, they noted.

The study findings support the vaccination of children against COVID-19 as an important public health measure to prevent mortality in children and adolescents, they concluded.
 

Data support value of vaccination, outside experts say

“COVID vaccines may not be as effective over time as the gene variants in the SARS-CoV-2 virus change,” Adrienne G. Randolph, MD, a pediatrician at Harvard Medical School and Boston Children’s Hospital, said in an interview. “Therefore, it is essential to assess vaccine effectiveness over time to look at effectiveness against variants and duration of effectiveness.” Dr. Randolph, who was not involved in the study, said she was not surprised by the findings, which she described as consistent with data from the United States. “COVID vaccines are very effective against preventing life-threatening disease, but the effectiveness against less severe illness for COVID vaccines is not as effective against Omicron,” she noted. 

The take-home message for clinicians is that it’s important to get children vaccinated against COVID to prevent severe and life-threatening illness, said Dr. Randolph. “Although these cases are uncommon in children, it is not possible to predict which children will be the most severely affected by COVID,” she emphasized.

However, “we need more data on the new COVID booster vaccines in children that are designed to be more effective against Omicron’s newer variants,” Dr. Randolph said in an interview. “We also need more data on COVID vaccine effectiveness in the youngest children, under 5 years of age, and data on vaccinating mothers to prevent COVID in infants,” she said.

Tim Joos, MD, a Seattle-based clinician who practices a combination of internal medicine and pediatrics, agreed that future research should continue to assess how the new COVID boosters are faring against new variants, noting that the current study did not include data from children who received the new bivalent vaccine.

“The methodology of this study uses a test negative case control design which is common for estimating vaccine effectiveness post-release of a vaccine, but is subject to biases,” Dr. Joos explained. “These are not the clean effectiveness numbers of the prospective randomized control trials that we are used to hearing about when a vaccine is first being approved.”

“Nevertheless, the study reinforces the initial manufacturers’ studies that the vaccines are effective at preventing infection in the pediatric population,” Dr. Joos said in an interview. The current study also reinforces the effectiveness of vaccines in preventing “the rare but devastating mortality from COVID-19 in the pediatric population.”

Commenting on other research showing an increasing ratio of COVID deaths among vaccinated individuals compared to total COVID deaths, he noted that this finding is “likely reflecting a denominator effect of rapidly declining COVID deaths overall,” partly from the vaccines and partly from immunity after previous natural infection.

The study received no outside funding. The researchers, Dr. Randolph, and Dr. Joos had no financial conflicts to disclose. Dr. Joos serves on the Editorial Advisory Board of Pediatric News.

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A new use for dating apps: Chasing STDs

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Wed, 12/07/2022 - 10:21

Heather Meador and Anna Herber-Downey use dating apps on the job – and their boss knows it.

Both are public health nurses employed by Linn County Public Health in eastern Iowa. They’ve learned that dating apps are the most efficient way to inform users that people they previously met on the sites may have exposed them to sexually transmitted infections.

A nationwide surge in STIs, also known as STDs – with reported cases of gonorrhea and syphilis increasing 10% and 7%, respectively, from 2019 to 2020, according to the Centers for Disease Control and Prevention – isn’t sparing Iowa. The duo has found that the telephone call, a traditional method of contact tracing, no longer works well.

“When I started 12 years ago, we called everyone,” said Ms. Meador, the county health department’s clinical branch supervisor. “It’s getting harder and harder to just call someone on the phone.”

Even texting is ineffective, they said. And people aren’t necessarily answering messages on Facebook. The dating apps are where they’re at.

Because many people are meeting sex partners online – via sites like Grindr or Snapchat, which are headquartered in West Hollywood and Santa Monica, Calif., respectively – contact tracers often don’t have much information to go on, just a screen name or a picture.

So, about a year ago, Ms. Meador and her colleagues got approval from their bosses at the local level to build profiles on the app, through which they can contact the sex partners of infected people.

Traditionally, contact tracers interview people infected with an STI about their recent encounters and then reach out to those partners to tell them about the potential exposure.

Linn County contact tracers use the apps throughout their workday. Grindr, in particular, relies on geolocation, showing users matches who are close by. So the tracers use the apps when they’re out and about, hoping to wander into the same neighborhoods as the person diagnosed with an STI. Sometimes users “tap” the contract tracers to see whether they’re interested – in dating, that is.

When the public health officials spot someone they’re looking for, they send a message asking for a call. It’s a successful method: Ms. Herber-Downey estimated they make an initial contact 75% of the time.

Linn County’s decision to move online comes as STI rates rise nationally, funding to fight them falls, and people adopt new technologies to meet people and seek fun. “STIs are increasing way faster than the funding we have,” said Leo Parker, director of prevention programs for the National Coalition of STD Directors, all while public health departments – many underfunded – are grappling with new behaviors.

“Social media companies have billions; we have tens of thousands,” said Jeffrey Klausner, MD, MPH, a University of Southern California, Los Angeles, public health professor, who previously served as San Francisco’s director of STD prevention and control services. That funding disparity means few public health departments have staff members who can go online. “It’s only really in major cities that they have anyone who’s tasked for that,” Dr. Klausner said.

Even when departments have enough employees to take on the challenge, institutional support can be lacking. Some public health officials question employees who log into the apps. Dr. Klausner once testified on behalf of a Ventura County, Calif., contact tracer who was fired for using sex sites for work.

But with people migrating online to meet partners, following them there makes sense. “We’re now in a digital age,” Mr. Parker said. Individuals might not be out, or might be questioning their identity, making online venues comfortable, anonymous spaces for romance – which, in turn, means people are harder to reach face-to-face, at least at first.

What’s more, online spaces like Grindr are effective public health tools beyond contact tracing. They can be useful ways to get the word out about public health concerns.

Mr. Parker and the Linn County officials said public service announcements on dating apps – advocating for condom use or sharing the business hours for sexual health clinics – do seem to lead people to services. “We do have individuals coming in, saying, ‘I saw you had free testing. I saw it on Grindr,’ ” Mr. Parker said.

Grindr, which touts itself as the biggest dating app focused on LGBTQ+ people, pushes out messages and information to its members, said Jack Harrison-Quintana, director of Grindr for Equality. That engagement intensified during a 2015 meningitis outbreak among LGBTQ+ communities in Chicago, for example.

During that outbreak, the app sent citywide messages about vaccination. Then Mr. Harrison-Quintana took advantage of the service’s design: Using the site’s geolocating capabilities, Grindr workers targeted messages to specific neighborhoods. “We could go in and really go block to block and say, ‘Is this where the cases are showing up?’ ” he said. If so, they sent more messages to that area.

That campaign encouraged further efforts from the app, which regularly sends public health messages about everything from COVID-19 to monkeypox to the platform’s base of roughly 11 million monthly users. Grindr also allows users to display their HIV status and indicate whether they’re vaccinated against COVID, monkeypox, and meningitis.

There are a couple of things Grindr won’t do, however. The company won’t allow public health departments to create institutional accounts. And it won’t allow automated notifications about STI exposures to be sent to users.

That’s due to privacy concerns, the company said, despite calls from public health advocates to deploy better messaging features. Grindr believes that a government presence on the app would be too intrusive and that even anonymous notifications would allow users to trace infections back to their source. (When asked about public health officials who join the site on their own, company spokesperson Patrick Lenihan said: “Individuals are free to say something like ‘I’m a public health professional – ask me about my work!’ in their profile and are free to discuss sexual and public health matters however they see fit.”)

Grindr’s position – however disappointing to some in the public health world – reflects a longtime balancing act attempted by the private sector, which aims to square government concerns with users’ privacy interests.

Dr. Klausner pointed to a 1999 syphilis outbreak in San Francisco as one of the first times he saw how those interests could be at odds. The outbreak was traced to an AOL chatroom. Based on his research, Dr. Klausner said it seemed as though people could go online and “get a sex partner faster than you can get a pizza delivered.”

But persuading New York–based Time Warner, eventually AOL’s corporate parent, to cooperate was time-intensive and tricky – gaining entrée into the chatroom required help from the New York attorney general’s office.

The online industry has advanced since then, Dr. Klausner said. He helped one service develop a system to send digital postcards to potentially exposed people. “Congratulations, you got syphilis,” the postcards read. “They were edgy postcards,” he said, although some options were less “snarky.”

Overall, however, the dating app world is still “bifurcated,” he said. For public health efforts, apps that appeal to LGBTQ+ users are generally more helpful than those that predominantly cater to heterosexual clients.

That’s due to the community’s history with sexual health, explained Jen Hecht, a leader of Building Healthy Online Communities, a public health group partnering with dating apps. “Folks in the queer community have – what – 30, 40 years of thinking about HIV?” she said.

Even though STIs affect everyone, “the norm and the expectation is not there” for straight-focused dating apps, she said. Indeed, neither Match Group nor Bumble – the corporations with the biggest apps focused on heterosexual dating, both based in Texas – responded to multiple requests for comment from KHN.

But users, at least so far, seem to appreciate the app-based interventions. Mr. Harrison-Quintana said Grindr has landed on a just-the-facts approach to conveying health information. He has never received any backlash, “which has been very nice.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Heather Meador and Anna Herber-Downey use dating apps on the job – and their boss knows it.

Both are public health nurses employed by Linn County Public Health in eastern Iowa. They’ve learned that dating apps are the most efficient way to inform users that people they previously met on the sites may have exposed them to sexually transmitted infections.

A nationwide surge in STIs, also known as STDs – with reported cases of gonorrhea and syphilis increasing 10% and 7%, respectively, from 2019 to 2020, according to the Centers for Disease Control and Prevention – isn’t sparing Iowa. The duo has found that the telephone call, a traditional method of contact tracing, no longer works well.

“When I started 12 years ago, we called everyone,” said Ms. Meador, the county health department’s clinical branch supervisor. “It’s getting harder and harder to just call someone on the phone.”

Even texting is ineffective, they said. And people aren’t necessarily answering messages on Facebook. The dating apps are where they’re at.

Because many people are meeting sex partners online – via sites like Grindr or Snapchat, which are headquartered in West Hollywood and Santa Monica, Calif., respectively – contact tracers often don’t have much information to go on, just a screen name or a picture.

So, about a year ago, Ms. Meador and her colleagues got approval from their bosses at the local level to build profiles on the app, through which they can contact the sex partners of infected people.

Traditionally, contact tracers interview people infected with an STI about their recent encounters and then reach out to those partners to tell them about the potential exposure.

Linn County contact tracers use the apps throughout their workday. Grindr, in particular, relies on geolocation, showing users matches who are close by. So the tracers use the apps when they’re out and about, hoping to wander into the same neighborhoods as the person diagnosed with an STI. Sometimes users “tap” the contract tracers to see whether they’re interested – in dating, that is.

When the public health officials spot someone they’re looking for, they send a message asking for a call. It’s a successful method: Ms. Herber-Downey estimated they make an initial contact 75% of the time.

Linn County’s decision to move online comes as STI rates rise nationally, funding to fight them falls, and people adopt new technologies to meet people and seek fun. “STIs are increasing way faster than the funding we have,” said Leo Parker, director of prevention programs for the National Coalition of STD Directors, all while public health departments – many underfunded – are grappling with new behaviors.

“Social media companies have billions; we have tens of thousands,” said Jeffrey Klausner, MD, MPH, a University of Southern California, Los Angeles, public health professor, who previously served as San Francisco’s director of STD prevention and control services. That funding disparity means few public health departments have staff members who can go online. “It’s only really in major cities that they have anyone who’s tasked for that,” Dr. Klausner said.

Even when departments have enough employees to take on the challenge, institutional support can be lacking. Some public health officials question employees who log into the apps. Dr. Klausner once testified on behalf of a Ventura County, Calif., contact tracer who was fired for using sex sites for work.

But with people migrating online to meet partners, following them there makes sense. “We’re now in a digital age,” Mr. Parker said. Individuals might not be out, or might be questioning their identity, making online venues comfortable, anonymous spaces for romance – which, in turn, means people are harder to reach face-to-face, at least at first.

What’s more, online spaces like Grindr are effective public health tools beyond contact tracing. They can be useful ways to get the word out about public health concerns.

Mr. Parker and the Linn County officials said public service announcements on dating apps – advocating for condom use or sharing the business hours for sexual health clinics – do seem to lead people to services. “We do have individuals coming in, saying, ‘I saw you had free testing. I saw it on Grindr,’ ” Mr. Parker said.

Grindr, which touts itself as the biggest dating app focused on LGBTQ+ people, pushes out messages and information to its members, said Jack Harrison-Quintana, director of Grindr for Equality. That engagement intensified during a 2015 meningitis outbreak among LGBTQ+ communities in Chicago, for example.

During that outbreak, the app sent citywide messages about vaccination. Then Mr. Harrison-Quintana took advantage of the service’s design: Using the site’s geolocating capabilities, Grindr workers targeted messages to specific neighborhoods. “We could go in and really go block to block and say, ‘Is this where the cases are showing up?’ ” he said. If so, they sent more messages to that area.

That campaign encouraged further efforts from the app, which regularly sends public health messages about everything from COVID-19 to monkeypox to the platform’s base of roughly 11 million monthly users. Grindr also allows users to display their HIV status and indicate whether they’re vaccinated against COVID, monkeypox, and meningitis.

There are a couple of things Grindr won’t do, however. The company won’t allow public health departments to create institutional accounts. And it won’t allow automated notifications about STI exposures to be sent to users.

That’s due to privacy concerns, the company said, despite calls from public health advocates to deploy better messaging features. Grindr believes that a government presence on the app would be too intrusive and that even anonymous notifications would allow users to trace infections back to their source. (When asked about public health officials who join the site on their own, company spokesperson Patrick Lenihan said: “Individuals are free to say something like ‘I’m a public health professional – ask me about my work!’ in their profile and are free to discuss sexual and public health matters however they see fit.”)

Grindr’s position – however disappointing to some in the public health world – reflects a longtime balancing act attempted by the private sector, which aims to square government concerns with users’ privacy interests.

Dr. Klausner pointed to a 1999 syphilis outbreak in San Francisco as one of the first times he saw how those interests could be at odds. The outbreak was traced to an AOL chatroom. Based on his research, Dr. Klausner said it seemed as though people could go online and “get a sex partner faster than you can get a pizza delivered.”

But persuading New York–based Time Warner, eventually AOL’s corporate parent, to cooperate was time-intensive and tricky – gaining entrée into the chatroom required help from the New York attorney general’s office.

The online industry has advanced since then, Dr. Klausner said. He helped one service develop a system to send digital postcards to potentially exposed people. “Congratulations, you got syphilis,” the postcards read. “They were edgy postcards,” he said, although some options were less “snarky.”

Overall, however, the dating app world is still “bifurcated,” he said. For public health efforts, apps that appeal to LGBTQ+ users are generally more helpful than those that predominantly cater to heterosexual clients.

That’s due to the community’s history with sexual health, explained Jen Hecht, a leader of Building Healthy Online Communities, a public health group partnering with dating apps. “Folks in the queer community have – what – 30, 40 years of thinking about HIV?” she said.

Even though STIs affect everyone, “the norm and the expectation is not there” for straight-focused dating apps, she said. Indeed, neither Match Group nor Bumble – the corporations with the biggest apps focused on heterosexual dating, both based in Texas – responded to multiple requests for comment from KHN.

But users, at least so far, seem to appreciate the app-based interventions. Mr. Harrison-Quintana said Grindr has landed on a just-the-facts approach to conveying health information. He has never received any backlash, “which has been very nice.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Heather Meador and Anna Herber-Downey use dating apps on the job – and their boss knows it.

Both are public health nurses employed by Linn County Public Health in eastern Iowa. They’ve learned that dating apps are the most efficient way to inform users that people they previously met on the sites may have exposed them to sexually transmitted infections.

A nationwide surge in STIs, also known as STDs – with reported cases of gonorrhea and syphilis increasing 10% and 7%, respectively, from 2019 to 2020, according to the Centers for Disease Control and Prevention – isn’t sparing Iowa. The duo has found that the telephone call, a traditional method of contact tracing, no longer works well.

“When I started 12 years ago, we called everyone,” said Ms. Meador, the county health department’s clinical branch supervisor. “It’s getting harder and harder to just call someone on the phone.”

Even texting is ineffective, they said. And people aren’t necessarily answering messages on Facebook. The dating apps are where they’re at.

Because many people are meeting sex partners online – via sites like Grindr or Snapchat, which are headquartered in West Hollywood and Santa Monica, Calif., respectively – contact tracers often don’t have much information to go on, just a screen name or a picture.

So, about a year ago, Ms. Meador and her colleagues got approval from their bosses at the local level to build profiles on the app, through which they can contact the sex partners of infected people.

Traditionally, contact tracers interview people infected with an STI about their recent encounters and then reach out to those partners to tell them about the potential exposure.

Linn County contact tracers use the apps throughout their workday. Grindr, in particular, relies on geolocation, showing users matches who are close by. So the tracers use the apps when they’re out and about, hoping to wander into the same neighborhoods as the person diagnosed with an STI. Sometimes users “tap” the contract tracers to see whether they’re interested – in dating, that is.

When the public health officials spot someone they’re looking for, they send a message asking for a call. It’s a successful method: Ms. Herber-Downey estimated they make an initial contact 75% of the time.

Linn County’s decision to move online comes as STI rates rise nationally, funding to fight them falls, and people adopt new technologies to meet people and seek fun. “STIs are increasing way faster than the funding we have,” said Leo Parker, director of prevention programs for the National Coalition of STD Directors, all while public health departments – many underfunded – are grappling with new behaviors.

“Social media companies have billions; we have tens of thousands,” said Jeffrey Klausner, MD, MPH, a University of Southern California, Los Angeles, public health professor, who previously served as San Francisco’s director of STD prevention and control services. That funding disparity means few public health departments have staff members who can go online. “It’s only really in major cities that they have anyone who’s tasked for that,” Dr. Klausner said.

Even when departments have enough employees to take on the challenge, institutional support can be lacking. Some public health officials question employees who log into the apps. Dr. Klausner once testified on behalf of a Ventura County, Calif., contact tracer who was fired for using sex sites for work.

But with people migrating online to meet partners, following them there makes sense. “We’re now in a digital age,” Mr. Parker said. Individuals might not be out, or might be questioning their identity, making online venues comfortable, anonymous spaces for romance – which, in turn, means people are harder to reach face-to-face, at least at first.

What’s more, online spaces like Grindr are effective public health tools beyond contact tracing. They can be useful ways to get the word out about public health concerns.

Mr. Parker and the Linn County officials said public service announcements on dating apps – advocating for condom use or sharing the business hours for sexual health clinics – do seem to lead people to services. “We do have individuals coming in, saying, ‘I saw you had free testing. I saw it on Grindr,’ ” Mr. Parker said.

Grindr, which touts itself as the biggest dating app focused on LGBTQ+ people, pushes out messages and information to its members, said Jack Harrison-Quintana, director of Grindr for Equality. That engagement intensified during a 2015 meningitis outbreak among LGBTQ+ communities in Chicago, for example.

During that outbreak, the app sent citywide messages about vaccination. Then Mr. Harrison-Quintana took advantage of the service’s design: Using the site’s geolocating capabilities, Grindr workers targeted messages to specific neighborhoods. “We could go in and really go block to block and say, ‘Is this where the cases are showing up?’ ” he said. If so, they sent more messages to that area.

That campaign encouraged further efforts from the app, which regularly sends public health messages about everything from COVID-19 to monkeypox to the platform’s base of roughly 11 million monthly users. Grindr also allows users to display their HIV status and indicate whether they’re vaccinated against COVID, monkeypox, and meningitis.

There are a couple of things Grindr won’t do, however. The company won’t allow public health departments to create institutional accounts. And it won’t allow automated notifications about STI exposures to be sent to users.

That’s due to privacy concerns, the company said, despite calls from public health advocates to deploy better messaging features. Grindr believes that a government presence on the app would be too intrusive and that even anonymous notifications would allow users to trace infections back to their source. (When asked about public health officials who join the site on their own, company spokesperson Patrick Lenihan said: “Individuals are free to say something like ‘I’m a public health professional – ask me about my work!’ in their profile and are free to discuss sexual and public health matters however they see fit.”)

Grindr’s position – however disappointing to some in the public health world – reflects a longtime balancing act attempted by the private sector, which aims to square government concerns with users’ privacy interests.

Dr. Klausner pointed to a 1999 syphilis outbreak in San Francisco as one of the first times he saw how those interests could be at odds. The outbreak was traced to an AOL chatroom. Based on his research, Dr. Klausner said it seemed as though people could go online and “get a sex partner faster than you can get a pizza delivered.”

But persuading New York–based Time Warner, eventually AOL’s corporate parent, to cooperate was time-intensive and tricky – gaining entrée into the chatroom required help from the New York attorney general’s office.

The online industry has advanced since then, Dr. Klausner said. He helped one service develop a system to send digital postcards to potentially exposed people. “Congratulations, you got syphilis,” the postcards read. “They were edgy postcards,” he said, although some options were less “snarky.”

Overall, however, the dating app world is still “bifurcated,” he said. For public health efforts, apps that appeal to LGBTQ+ users are generally more helpful than those that predominantly cater to heterosexual clients.

That’s due to the community’s history with sexual health, explained Jen Hecht, a leader of Building Healthy Online Communities, a public health group partnering with dating apps. “Folks in the queer community have – what – 30, 40 years of thinking about HIV?” she said.

Even though STIs affect everyone, “the norm and the expectation is not there” for straight-focused dating apps, she said. Indeed, neither Match Group nor Bumble – the corporations with the biggest apps focused on heterosexual dating, both based in Texas – responded to multiple requests for comment from KHN.

But users, at least so far, seem to appreciate the app-based interventions. Mr. Harrison-Quintana said Grindr has landed on a just-the-facts approach to conveying health information. He has never received any backlash, “which has been very nice.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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