Infectious Disease Practitioner

Vaccinated people who have a breakthrough case of Omicron will have better protection against COVID-19 variants than vaccinated people who receive a booster shot, two preprint studies show.

The University of Washington, Seattle, working with Vir Biotechnology of San Francisco, looked at blood samples of vaccinated people who had breakthrough cases of Delta or Omicron and compared the samples with three other groups: people who caught COVID and were later vaccinated, vaccinated people who were never infected, and people who were infected and never vaccinated.

The vaccinated people who had a breakthrough case of Omicron produced antibodies that helped protect against coronavirus variants, whereas unvaccinated people who caught Omicron didn’t produce as many antibodies, the study showed.

BioNTech, the German biotechnology company, found that people who’d been double and triple vaccinated and then became infected with Omicron had a better B-cell response than people who’d gotten a booster shot but had not been infected.

The University of Washington research team also came up with similar findings about B cells.

The findings don’t mean people should deliberately try to become infected with COVID, said Alexandra Walls, PhD, one of the University of Washington scientists, according to Business Standard.

But the study does indicate “that we are at the point where we may want to consider having a different vaccine to boost people,” said David Veesler, PhD, of the University of Washington team.

“We should think about breakthrough infections as essentially equivalent to another dose of vaccine,” John Wherry, PhD, a professor and director of the Institute for Immunology at the University of Pennsylvania, Philadelphia, told Business Standard. Dr. Wherry was not involved in the studies but reviewed the BioNTech study.

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

Vaccinated people who have a breakthrough case of Omicron will have better protection against COVID-19 variants than vaccinated people who receive a booster shot, two preprint studies show.

The University of Washington, Seattle, working with Vir Biotechnology of San Francisco, looked at blood samples of vaccinated people who had breakthrough cases of Delta or Omicron and compared the samples with three other groups: people who caught COVID and were later vaccinated, vaccinated people who were never infected, and people who were infected and never vaccinated.

The vaccinated people who had a breakthrough case of Omicron produced antibodies that helped protect against coronavirus variants, whereas unvaccinated people who caught Omicron didn’t produce as many antibodies, the study showed.

BioNTech, the German biotechnology company, found that people who’d been double and triple vaccinated and then became infected with Omicron had a better B-cell response than people who’d gotten a booster shot but had not been infected.

The University of Washington research team also came up with similar findings about B cells.

The findings don’t mean people should deliberately try to become infected with COVID, said Alexandra Walls, PhD, one of the University of Washington scientists, according to Business Standard.

But the study does indicate “that we are at the point where we may want to consider having a different vaccine to boost people,” said David Veesler, PhD, of the University of Washington team.

“We should think about breakthrough infections as essentially equivalent to another dose of vaccine,” John Wherry, PhD, a professor and director of the Institute for Immunology at the University of Pennsylvania, Philadelphia, told Business Standard. Dr. Wherry was not involved in the studies but reviewed the BioNTech study.

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

Vaccinated people who have a breakthrough case of Omicron will have better protection against COVID-19 variants than vaccinated people who receive a booster shot, two preprint studies show.

The University of Washington, Seattle, working with Vir Biotechnology of San Francisco, looked at blood samples of vaccinated people who had breakthrough cases of Delta or Omicron and compared the samples with three other groups: people who caught COVID and were later vaccinated, vaccinated people who were never infected, and people who were infected and never vaccinated.

The vaccinated people who had a breakthrough case of Omicron produced antibodies that helped protect against coronavirus variants, whereas unvaccinated people who caught Omicron didn’t produce as many antibodies, the study showed.

BioNTech, the German biotechnology company, found that people who’d been double and triple vaccinated and then became infected with Omicron had a better B-cell response than people who’d gotten a booster shot but had not been infected.

The University of Washington research team also came up with similar findings about B cells.

The findings don’t mean people should deliberately try to become infected with COVID, said Alexandra Walls, PhD, one of the University of Washington scientists, according to Business Standard.

But the study does indicate “that we are at the point where we may want to consider having a different vaccine to boost people,” said David Veesler, PhD, of the University of Washington team.

“We should think about breakthrough infections as essentially equivalent to another dose of vaccine,” John Wherry, PhD, a professor and director of the Institute for Immunology at the University of Pennsylvania, Philadelphia, told Business Standard. Dr. Wherry was not involved in the studies but reviewed the BioNTech study.

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

In the run up to the midterm elections in November, President Biden has warmed to student loan forgiveness. However, before even being proposed, severe restrictions have been attached to the forgiveness that would severely limit any effective forgiveness for physicians.

What was the plan?

During the 2020 election, student loan forgiveness was a hot topic as the COVID epidemic raged. The CARES Act has placed all federal student loans in forbearance, with no payments made and the interest rate set to 0% to prevent further accrual. While this was tremendously useful to 45 million borrowers around the country (including the author), nothing material was done to deal with the loans.

The Biden Administration’s approach at that time was multi-tiered and chaotic. Plans were put forward that either expanded Public Service Loan Forgiveness (PSLF) or capped it. Plans were put forward that either extended free undergraduate or severely limited it through Pell Grants. Unfortunately, that duality continues today, with current plans not having a clear goal or a target group of beneficiaries.
 

Necessary CARES Act extensions

The Biden Administration has attempted repeatedly to turn the student loan apparatus back on, restarting payments en masse. However, each time, they are beset by challenges, ranging from repeat COVID spikes to servicer withdrawals or macroeconomic indicators of a recession.

At each step, the administration has had little choice but to extend the CARES Act forbearance, lest they suffer retribution for hastily resuming payments for 45 million borrowers without the apparatus to do so. Two years ago, the major federal servicers laid off hundreds, if not thousands, of staffers responsible for payment processing, accounting, customer care, and taxation. Hiring, training, and staffing these positions is nontrivial.

The administration has been out of step with servicers such that three of the largest have chosen not to renew their contracts: Navient, MyFedLoan, and Granite State Management and Resources. This has left 15 million borrowers in the lurch, not knowing who their servicer is – and, even worse, losing track of qualifying payments toward programs like PSLF.
 

Avenues of forgiveness

There are two major pathways to forgiveness. It is widely believed that the executive branch has the authority to broadly forgive student loans under executive order and managed through the U.S. Department of Education.

The alternative is through congressional action, voting on forgiveness as an economic stimulus plan. There is little appetite in Congress for forgiveness, and prominent congresspeople like Senator Warren and Senator Schumer have both pushed the executive branch for forgiveness in recognition of this.
 

What has been proposed?

First, it’s important to state that as headline-grabbing as it is to see that $50,000 of forgiveness has been proposed, the reality is that President Biden has repeatedly stated that he will not be in favor of that level of forgiveness. Instead, the number most commonly being discussed is $10,000. This would represent an unprecedented amount of support, alleviating 35% of borrowers of all student debt.

The impact of proposed forgiveness plans for physicians

For the medical community, sadly, this doesn’t represent a significant amount of forgiveness. At graduation, the average MD has $203,000 in debt, and the average DO has $258,000 in debt. These numbers grow during residency for years before any meaningful payments are made.

Further weakening forgiveness plans for physicians has been two caps proposed by the administration in recent days. The first is an income cap of $125,000. While this would maintain forgiveness for nearly all residents and fellows, this would exclude nearly every practicing physician. The alternative to an income cap is specific exclusion of certain careers seen to be high-earning: doctors and lawyers.
 

The bottom line

Physicians are unlikely to be included in any forgiveness plans being proposed recently by the Biden Administration. If they are considered, it will be for exclusion from any forgiveness offered.

For physicians no longer eligible for PSLF, this exclusion needs to be considered in managing the student loan debt associated with becoming a doctor.

Dr. Palmer is a part-time instructor, department of pediatrics, Harvard Medical School, Boston, and staff physician, department of medical critical care, Boston Children’s Hospital. He disclosed that he serves as director for Panacea Financial.

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

In the run up to the midterm elections in November, President Biden has warmed to student loan forgiveness. However, before even being proposed, severe restrictions have been attached to the forgiveness that would severely limit any effective forgiveness for physicians.

What was the plan?

During the 2020 election, student loan forgiveness was a hot topic as the COVID epidemic raged. The CARES Act has placed all federal student loans in forbearance, with no payments made and the interest rate set to 0% to prevent further accrual. While this was tremendously useful to 45 million borrowers around the country (including the author), nothing material was done to deal with the loans.

The Biden Administration’s approach at that time was multi-tiered and chaotic. Plans were put forward that either expanded Public Service Loan Forgiveness (PSLF) or capped it. Plans were put forward that either extended free undergraduate or severely limited it through Pell Grants. Unfortunately, that duality continues today, with current plans not having a clear goal or a target group of beneficiaries.
 

Necessary CARES Act extensions

The Biden Administration has attempted repeatedly to turn the student loan apparatus back on, restarting payments en masse. However, each time, they are beset by challenges, ranging from repeat COVID spikes to servicer withdrawals or macroeconomic indicators of a recession.

At each step, the administration has had little choice but to extend the CARES Act forbearance, lest they suffer retribution for hastily resuming payments for 45 million borrowers without the apparatus to do so. Two years ago, the major federal servicers laid off hundreds, if not thousands, of staffers responsible for payment processing, accounting, customer care, and taxation. Hiring, training, and staffing these positions is nontrivial.

The administration has been out of step with servicers such that three of the largest have chosen not to renew their contracts: Navient, MyFedLoan, and Granite State Management and Resources. This has left 15 million borrowers in the lurch, not knowing who their servicer is – and, even worse, losing track of qualifying payments toward programs like PSLF.
 

Avenues of forgiveness

There are two major pathways to forgiveness. It is widely believed that the executive branch has the authority to broadly forgive student loans under executive order and managed through the U.S. Department of Education.

The alternative is through congressional action, voting on forgiveness as an economic stimulus plan. There is little appetite in Congress for forgiveness, and prominent congresspeople like Senator Warren and Senator Schumer have both pushed the executive branch for forgiveness in recognition of this.
 

What has been proposed?

First, it’s important to state that as headline-grabbing as it is to see that $50,000 of forgiveness has been proposed, the reality is that President Biden has repeatedly stated that he will not be in favor of that level of forgiveness. Instead, the number most commonly being discussed is $10,000. This would represent an unprecedented amount of support, alleviating 35% of borrowers of all student debt.

The impact of proposed forgiveness plans for physicians

For the medical community, sadly, this doesn’t represent a significant amount of forgiveness. At graduation, the average MD has $203,000 in debt, and the average DO has $258,000 in debt. These numbers grow during residency for years before any meaningful payments are made.

Further weakening forgiveness plans for physicians has been two caps proposed by the administration in recent days. The first is an income cap of $125,000. While this would maintain forgiveness for nearly all residents and fellows, this would exclude nearly every practicing physician. The alternative to an income cap is specific exclusion of certain careers seen to be high-earning: doctors and lawyers.
 

The bottom line

Physicians are unlikely to be included in any forgiveness plans being proposed recently by the Biden Administration. If they are considered, it will be for exclusion from any forgiveness offered.

For physicians no longer eligible for PSLF, this exclusion needs to be considered in managing the student loan debt associated with becoming a doctor.

Dr. Palmer is a part-time instructor, department of pediatrics, Harvard Medical School, Boston, and staff physician, department of medical critical care, Boston Children’s Hospital. He disclosed that he serves as director for Panacea Financial.

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

In the run up to the midterm elections in November, President Biden has warmed to student loan forgiveness. However, before even being proposed, severe restrictions have been attached to the forgiveness that would severely limit any effective forgiveness for physicians.

What was the plan?

During the 2020 election, student loan forgiveness was a hot topic as the COVID epidemic raged. The CARES Act has placed all federal student loans in forbearance, with no payments made and the interest rate set to 0% to prevent further accrual. While this was tremendously useful to 45 million borrowers around the country (including the author), nothing material was done to deal with the loans.

The Biden Administration’s approach at that time was multi-tiered and chaotic. Plans were put forward that either expanded Public Service Loan Forgiveness (PSLF) or capped it. Plans were put forward that either extended free undergraduate or severely limited it through Pell Grants. Unfortunately, that duality continues today, with current plans not having a clear goal or a target group of beneficiaries.
 

Necessary CARES Act extensions

The Biden Administration has attempted repeatedly to turn the student loan apparatus back on, restarting payments en masse. However, each time, they are beset by challenges, ranging from repeat COVID spikes to servicer withdrawals or macroeconomic indicators of a recession.

At each step, the administration has had little choice but to extend the CARES Act forbearance, lest they suffer retribution for hastily resuming payments for 45 million borrowers without the apparatus to do so. Two years ago, the major federal servicers laid off hundreds, if not thousands, of staffers responsible for payment processing, accounting, customer care, and taxation. Hiring, training, and staffing these positions is nontrivial.

The administration has been out of step with servicers such that three of the largest have chosen not to renew their contracts: Navient, MyFedLoan, and Granite State Management and Resources. This has left 15 million borrowers in the lurch, not knowing who their servicer is – and, even worse, losing track of qualifying payments toward programs like PSLF.
 

Avenues of forgiveness

There are two major pathways to forgiveness. It is widely believed that the executive branch has the authority to broadly forgive student loans under executive order and managed through the U.S. Department of Education.

The alternative is through congressional action, voting on forgiveness as an economic stimulus plan. There is little appetite in Congress for forgiveness, and prominent congresspeople like Senator Warren and Senator Schumer have both pushed the executive branch for forgiveness in recognition of this.
 

What has been proposed?

First, it’s important to state that as headline-grabbing as it is to see that $50,000 of forgiveness has been proposed, the reality is that President Biden has repeatedly stated that he will not be in favor of that level of forgiveness. Instead, the number most commonly being discussed is $10,000. This would represent an unprecedented amount of support, alleviating 35% of borrowers of all student debt.

The impact of proposed forgiveness plans for physicians

For the medical community, sadly, this doesn’t represent a significant amount of forgiveness. At graduation, the average MD has $203,000 in debt, and the average DO has $258,000 in debt. These numbers grow during residency for years before any meaningful payments are made.

Further weakening forgiveness plans for physicians has been two caps proposed by the administration in recent days. The first is an income cap of $125,000. While this would maintain forgiveness for nearly all residents and fellows, this would exclude nearly every practicing physician. The alternative to an income cap is specific exclusion of certain careers seen to be high-earning: doctors and lawyers.
 

The bottom line

Physicians are unlikely to be included in any forgiveness plans being proposed recently by the Biden Administration. If they are considered, it will be for exclusion from any forgiveness offered.

For physicians no longer eligible for PSLF, this exclusion needs to be considered in managing the student loan debt associated with becoming a doctor.

Dr. Palmer is a part-time instructor, department of pediatrics, Harvard Medical School, Boston, and staff physician, department of medical critical care, Boston Children’s Hospital. He disclosed that he serves as director for Panacea Financial.

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

The Food and Drug Administration has expanded an emergency use authorization (EUA), allowing the Pfizer-BioNTech COVID-19 booster shot for children ages 5 to 11 who are at least 5 months out from their first vaccine series.

According to the most recent data from the Centers for Disease Control and Prevention, 28.6% of children in this age group have received both initial doses of Pfizer’s COVID-19 vaccine, and 35.3% have received their first dose.

Pfizer’s vaccine trial involving 4,500 children showed few side effects among children younger than 12 who received a booster, or third dose, according to a company statement.

Pfizer asked the FDA for an amended authorization in April, after submitting data showing that a third dose in children between 5 and 11 raised antibodies targeting the Omicron variant by 36 times.

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer-term effects, even following initially mild disease,” FDA Commissioner Robert M. Califf, MD, said in a news release.

A study done by the New York State Department of Health showed the effectiveness of Pfizer’s two-dose vaccine series fell from 68% to 12% 4-5 months after the second dose was given to children 5 to 11 during the Omicron surge. A CDC study published in March also showed that the Pfizer shot reduced the risk of Omicron by 31% in children 5 to 11, a significantly lower rate than for kids 12 to 15, who had a 59% risk reduction after receiving two doses.

To some experts, this data suggest an even greater need for children under 12 to be eligible for a third dose.

“Since authorizing the vaccine for children down to 5 years of age in October 2021, emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations,” says Peter Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation and Research.

The CDC still needs to sign off on the shots before they can be allowed. The agency’s Advisory Committee on Immunization Practices is set to meet on May 19 to discuss boosters in this age group.

FDA advisory panels plan to meet next month to discuss allowing Pfizer’s and Moderna’s COVID-19 vaccines for children under 6 years old.

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

The Food and Drug Administration has expanded an emergency use authorization (EUA), allowing the Pfizer-BioNTech COVID-19 booster shot for children ages 5 to 11 who are at least 5 months out from their first vaccine series.

According to the most recent data from the Centers for Disease Control and Prevention, 28.6% of children in this age group have received both initial doses of Pfizer’s COVID-19 vaccine, and 35.3% have received their first dose.

Pfizer’s vaccine trial involving 4,500 children showed few side effects among children younger than 12 who received a booster, or third dose, according to a company statement.

Pfizer asked the FDA for an amended authorization in April, after submitting data showing that a third dose in children between 5 and 11 raised antibodies targeting the Omicron variant by 36 times.

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer-term effects, even following initially mild disease,” FDA Commissioner Robert M. Califf, MD, said in a news release.

A study done by the New York State Department of Health showed the effectiveness of Pfizer’s two-dose vaccine series fell from 68% to 12% 4-5 months after the second dose was given to children 5 to 11 during the Omicron surge. A CDC study published in March also showed that the Pfizer shot reduced the risk of Omicron by 31% in children 5 to 11, a significantly lower rate than for kids 12 to 15, who had a 59% risk reduction after receiving two doses.

To some experts, this data suggest an even greater need for children under 12 to be eligible for a third dose.

“Since authorizing the vaccine for children down to 5 years of age in October 2021, emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations,” says Peter Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation and Research.

The CDC still needs to sign off on the shots before they can be allowed. The agency’s Advisory Committee on Immunization Practices is set to meet on May 19 to discuss boosters in this age group.

FDA advisory panels plan to meet next month to discuss allowing Pfizer’s and Moderna’s COVID-19 vaccines for children under 6 years old.

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

The Food and Drug Administration has expanded an emergency use authorization (EUA), allowing the Pfizer-BioNTech COVID-19 booster shot for children ages 5 to 11 who are at least 5 months out from their first vaccine series.

According to the most recent data from the Centers for Disease Control and Prevention, 28.6% of children in this age group have received both initial doses of Pfizer’s COVID-19 vaccine, and 35.3% have received their first dose.

Pfizer’s vaccine trial involving 4,500 children showed few side effects among children younger than 12 who received a booster, or third dose, according to a company statement.

Pfizer asked the FDA for an amended authorization in April, after submitting data showing that a third dose in children between 5 and 11 raised antibodies targeting the Omicron variant by 36 times.

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer-term effects, even following initially mild disease,” FDA Commissioner Robert M. Califf, MD, said in a news release.

A study done by the New York State Department of Health showed the effectiveness of Pfizer’s two-dose vaccine series fell from 68% to 12% 4-5 months after the second dose was given to children 5 to 11 during the Omicron surge. A CDC study published in March also showed that the Pfizer shot reduced the risk of Omicron by 31% in children 5 to 11, a significantly lower rate than for kids 12 to 15, who had a 59% risk reduction after receiving two doses.

To some experts, this data suggest an even greater need for children under 12 to be eligible for a third dose.

“Since authorizing the vaccine for children down to 5 years of age in October 2021, emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations,” says Peter Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation and Research.

The CDC still needs to sign off on the shots before they can be allowed. The agency’s Advisory Committee on Immunization Practices is set to meet on May 19 to discuss boosters in this age group.

FDA advisory panels plan to meet next month to discuss allowing Pfizer’s and Moderna’s COVID-19 vaccines for children under 6 years old.

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

It’s no secret that, for decades, the participants in clinical trials for new drugs and medical devices haven’t accurately represented the diverse groups of patients the drugs and devices were designed for.

In a recently published draft guidance, the Food and Drug Administration recommended that companies in charge of running these trials should submit a proposal to the agency that would address how they plan to enroll more “clinically relevant populations” and historically underrepresented racial and ethnic groups.

It’s an issue that the U.S. has been trying to fix for years. In 1993, the NIH Revitalization Act was passed into law. It mandated the appropriate inclusion of women and racial minorities in all National Institutes of Health–funded research.

Since then, the FDA has put out plans that encourage trial sponsors to recruit more diverse enrollees, offering strategies and best practices rather than establishing requirements or quotas that companies would be forced to meet. Despite its efforts to encourage inclusion, people of color continue to be largely underrepresented in clinical trials.

Experts aren’t just calling for trial cohorts to reflect U.S. census data. Rather, the demographics of participants should match those of the diagnosis being studied. An analysis of 24 clinical trials of cardiovascular drugs, for example, found that Black Americans made up 2.9% of trial participants, compared with 83.1% for White people. Given that cardiovascular diseases affect Black Americans at almost the same rate as Whites (23.5% and 23.7%, respectively) – and keeping in mind that Black Americans make up 13.4% of the population and White people represent 76.3% – the degree of underrepresentation is glaring.

One commonly cited reason for this lack of representation is that people of color, especially Black Americans, have lingering feelings of mistrust toward the medical field. The U.S.-run Tuskegee study – during which researchers documented the natural progression of syphilis in hundreds of Black men who were kept from life-saving treatment – is, justifiably, often named as a notable source of that suspicion.

But blaming the disproportionately low numbers of Black participants in clinical trials on medical mistrust is an easy answer to a much more complicated issue, said cardiologist Clyde Yancy, MD, who also serves as the vice dean for diversity and inclusion at Northwestern University’s Feinberg School of Medicine, Chicago.

“We need to not put the onus on the back of the patient cohort, and say they are the problem,” Dr. Yancy said, adding that many trials add financial barriers and don’t provide proper transportation for participants who may live farther away.

The diversity of the study team itself – the institutions, researchers, and recruiters – also contributes to a lack of diversity in the participant pool. When considering all of these factors, “you begin to understand the complexity and the multidimensionality of why we have underrepresentation,” said Dr. Yancy. “So I would not promulgate the notion that this is simply because patients don’t trust the system.”

Soumya Niranjan, PhD, worked as a study coordinator at the Tulane Cancer Center in New Orleans, La., where she recruited patients for a prostate cancer study. After researching the impact of clinicians’ biases on the recruitment of racial and ethnic minorities in oncology trials, she found that some recruiters view patients of color as less promising participants.

“Who ends up being approached for a clinical trial is based on a preset rubric that one has in mind about a patient who may be eligible for a cancer study,” said Dr. Niranjan. “There is a characterization of, ‘we want to make sure this patient is compliant, that they will be a good historian and seem responsible.’ ... Our study showed that it kind of fell along racial lines.”

In her study, published in the journal Cancer in 2020, Dr. Niranjan wrote that researchers sometimes “perceived racial minority groups to have low knowledge of cancer clinical trials. This was considered to be a hindrance while explaining cancer clinical trials in the face of limited provider time during a clinical encounter.”

Some researchers believed minority participants, especially Black women, would be less likely to file study protocols. Others said people of color are more likely to be selfish.

She quoted one research investigator as saying Black people are less knowledgeable.

“African Americans I think have less knowledge,” the unnamed researcher said. “We take a little bit more time to explain to African American [sic]. I think ... they have more questions because we know they are not more knowledgeable so I think it takes time. They have a lot of questions.”
 

Progress over the years

The FDA’s recent draft builds upon a guidance from 2016, which already recommended that trial teams submit an inclusion plan to the agency at the earliest phase of development. While the recent announcement is another step in the right direction, it may not be substantial enough.

“There’s always an enrollment plan,” Dr. Niranjan said. “But those enrollment plans are not enforced. So if it’s not enforced, what does that look like?”

In an emailed statement to this news organization, Lola Fashoyin-Aje, MD, the deputy director of the FDA Oncology Center of Excellence’s division to expand diversity, emphasized that the draft guidance does not require anything, but that the agency “expect[s] sponsors will follow FDA’s recommendations as described in the draft guidance.”

Without requirements, it’s up to the sponsor to make the effort to enroll people with varied racial and ethnic backgrounds. During the development of the COVID-19 vaccine, Moderna announced that the company would slow the trial’s enrollment to ensure minority groups were properly represented.

Not every sponsor is as motivated to make this a concerted effort, and some simply don’t have the funds to allocate to strengthening the enrollment process.

“There’s so much red tape and paperwork to get the funding for a clinical trial,” said Julie Silver, MD, professor of physical medicine and rehabilitation at Harvard Medical School, Boston, who studies workforce diversity and inclusion. “Even when people are equitably included, the amount of funding they have to do the trial might not be enough to do an analysis that shows potential differences.”

Whether the FDA will enforce enrollment plans in the future remains an open question; however, Dr. Yancy said the most effective way to do this would be through incentives, rather than penalties.

According to Dr. Fashoyin-Aje, the FDA and sponsors “will learn from these submissions and over time, whether and how these diversity plans lead to meaningful changes in clinical trial representation will need to be assessed, including whether additional steps need to be taken.”

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

It’s no secret that, for decades, the participants in clinical trials for new drugs and medical devices haven’t accurately represented the diverse groups of patients the drugs and devices were designed for.

In a recently published draft guidance, the Food and Drug Administration recommended that companies in charge of running these trials should submit a proposal to the agency that would address how they plan to enroll more “clinically relevant populations” and historically underrepresented racial and ethnic groups.

It’s an issue that the U.S. has been trying to fix for years. In 1993, the NIH Revitalization Act was passed into law. It mandated the appropriate inclusion of women and racial minorities in all National Institutes of Health–funded research.

Since then, the FDA has put out plans that encourage trial sponsors to recruit more diverse enrollees, offering strategies and best practices rather than establishing requirements or quotas that companies would be forced to meet. Despite its efforts to encourage inclusion, people of color continue to be largely underrepresented in clinical trials.

Experts aren’t just calling for trial cohorts to reflect U.S. census data. Rather, the demographics of participants should match those of the diagnosis being studied. An analysis of 24 clinical trials of cardiovascular drugs, for example, found that Black Americans made up 2.9% of trial participants, compared with 83.1% for White people. Given that cardiovascular diseases affect Black Americans at almost the same rate as Whites (23.5% and 23.7%, respectively) – and keeping in mind that Black Americans make up 13.4% of the population and White people represent 76.3% – the degree of underrepresentation is glaring.

One commonly cited reason for this lack of representation is that people of color, especially Black Americans, have lingering feelings of mistrust toward the medical field. The U.S.-run Tuskegee study – during which researchers documented the natural progression of syphilis in hundreds of Black men who were kept from life-saving treatment – is, justifiably, often named as a notable source of that suspicion.

But blaming the disproportionately low numbers of Black participants in clinical trials on medical mistrust is an easy answer to a much more complicated issue, said cardiologist Clyde Yancy, MD, who also serves as the vice dean for diversity and inclusion at Northwestern University’s Feinberg School of Medicine, Chicago.

“We need to not put the onus on the back of the patient cohort, and say they are the problem,” Dr. Yancy said, adding that many trials add financial barriers and don’t provide proper transportation for participants who may live farther away.

The diversity of the study team itself – the institutions, researchers, and recruiters – also contributes to a lack of diversity in the participant pool. When considering all of these factors, “you begin to understand the complexity and the multidimensionality of why we have underrepresentation,” said Dr. Yancy. “So I would not promulgate the notion that this is simply because patients don’t trust the system.”

Soumya Niranjan, PhD, worked as a study coordinator at the Tulane Cancer Center in New Orleans, La., where she recruited patients for a prostate cancer study. After researching the impact of clinicians’ biases on the recruitment of racial and ethnic minorities in oncology trials, she found that some recruiters view patients of color as less promising participants.

“Who ends up being approached for a clinical trial is based on a preset rubric that one has in mind about a patient who may be eligible for a cancer study,” said Dr. Niranjan. “There is a characterization of, ‘we want to make sure this patient is compliant, that they will be a good historian and seem responsible.’ ... Our study showed that it kind of fell along racial lines.”

In her study, published in the journal Cancer in 2020, Dr. Niranjan wrote that researchers sometimes “perceived racial minority groups to have low knowledge of cancer clinical trials. This was considered to be a hindrance while explaining cancer clinical trials in the face of limited provider time during a clinical encounter.”

Some researchers believed minority participants, especially Black women, would be less likely to file study protocols. Others said people of color are more likely to be selfish.

She quoted one research investigator as saying Black people are less knowledgeable.

“African Americans I think have less knowledge,” the unnamed researcher said. “We take a little bit more time to explain to African American [sic]. I think ... they have more questions because we know they are not more knowledgeable so I think it takes time. They have a lot of questions.”
 

Progress over the years

The FDA’s recent draft builds upon a guidance from 2016, which already recommended that trial teams submit an inclusion plan to the agency at the earliest phase of development. While the recent announcement is another step in the right direction, it may not be substantial enough.

“There’s always an enrollment plan,” Dr. Niranjan said. “But those enrollment plans are not enforced. So if it’s not enforced, what does that look like?”

In an emailed statement to this news organization, Lola Fashoyin-Aje, MD, the deputy director of the FDA Oncology Center of Excellence’s division to expand diversity, emphasized that the draft guidance does not require anything, but that the agency “expect[s] sponsors will follow FDA’s recommendations as described in the draft guidance.”

Without requirements, it’s up to the sponsor to make the effort to enroll people with varied racial and ethnic backgrounds. During the development of the COVID-19 vaccine, Moderna announced that the company would slow the trial’s enrollment to ensure minority groups were properly represented.

Not every sponsor is as motivated to make this a concerted effort, and some simply don’t have the funds to allocate to strengthening the enrollment process.

“There’s so much red tape and paperwork to get the funding for a clinical trial,” said Julie Silver, MD, professor of physical medicine and rehabilitation at Harvard Medical School, Boston, who studies workforce diversity and inclusion. “Even when people are equitably included, the amount of funding they have to do the trial might not be enough to do an analysis that shows potential differences.”

Whether the FDA will enforce enrollment plans in the future remains an open question; however, Dr. Yancy said the most effective way to do this would be through incentives, rather than penalties.

According to Dr. Fashoyin-Aje, the FDA and sponsors “will learn from these submissions and over time, whether and how these diversity plans lead to meaningful changes in clinical trial representation will need to be assessed, including whether additional steps need to be taken.”

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

It’s no secret that, for decades, the participants in clinical trials for new drugs and medical devices haven’t accurately represented the diverse groups of patients the drugs and devices were designed for.

In a recently published draft guidance, the Food and Drug Administration recommended that companies in charge of running these trials should submit a proposal to the agency that would address how they plan to enroll more “clinically relevant populations” and historically underrepresented racial and ethnic groups.

It’s an issue that the U.S. has been trying to fix for years. In 1993, the NIH Revitalization Act was passed into law. It mandated the appropriate inclusion of women and racial minorities in all National Institutes of Health–funded research.

Since then, the FDA has put out plans that encourage trial sponsors to recruit more diverse enrollees, offering strategies and best practices rather than establishing requirements or quotas that companies would be forced to meet. Despite its efforts to encourage inclusion, people of color continue to be largely underrepresented in clinical trials.

Experts aren’t just calling for trial cohorts to reflect U.S. census data. Rather, the demographics of participants should match those of the diagnosis being studied. An analysis of 24 clinical trials of cardiovascular drugs, for example, found that Black Americans made up 2.9% of trial participants, compared with 83.1% for White people. Given that cardiovascular diseases affect Black Americans at almost the same rate as Whites (23.5% and 23.7%, respectively) – and keeping in mind that Black Americans make up 13.4% of the population and White people represent 76.3% – the degree of underrepresentation is glaring.

One commonly cited reason for this lack of representation is that people of color, especially Black Americans, have lingering feelings of mistrust toward the medical field. The U.S.-run Tuskegee study – during which researchers documented the natural progression of syphilis in hundreds of Black men who were kept from life-saving treatment – is, justifiably, often named as a notable source of that suspicion.

But blaming the disproportionately low numbers of Black participants in clinical trials on medical mistrust is an easy answer to a much more complicated issue, said cardiologist Clyde Yancy, MD, who also serves as the vice dean for diversity and inclusion at Northwestern University’s Feinberg School of Medicine, Chicago.

“We need to not put the onus on the back of the patient cohort, and say they are the problem,” Dr. Yancy said, adding that many trials add financial barriers and don’t provide proper transportation for participants who may live farther away.

The diversity of the study team itself – the institutions, researchers, and recruiters – also contributes to a lack of diversity in the participant pool. When considering all of these factors, “you begin to understand the complexity and the multidimensionality of why we have underrepresentation,” said Dr. Yancy. “So I would not promulgate the notion that this is simply because patients don’t trust the system.”

Soumya Niranjan, PhD, worked as a study coordinator at the Tulane Cancer Center in New Orleans, La., where she recruited patients for a prostate cancer study. After researching the impact of clinicians’ biases on the recruitment of racial and ethnic minorities in oncology trials, she found that some recruiters view patients of color as less promising participants.

“Who ends up being approached for a clinical trial is based on a preset rubric that one has in mind about a patient who may be eligible for a cancer study,” said Dr. Niranjan. “There is a characterization of, ‘we want to make sure this patient is compliant, that they will be a good historian and seem responsible.’ ... Our study showed that it kind of fell along racial lines.”

In her study, published in the journal Cancer in 2020, Dr. Niranjan wrote that researchers sometimes “perceived racial minority groups to have low knowledge of cancer clinical trials. This was considered to be a hindrance while explaining cancer clinical trials in the face of limited provider time during a clinical encounter.”

Some researchers believed minority participants, especially Black women, would be less likely to file study protocols. Others said people of color are more likely to be selfish.

She quoted one research investigator as saying Black people are less knowledgeable.

“African Americans I think have less knowledge,” the unnamed researcher said. “We take a little bit more time to explain to African American [sic]. I think ... they have more questions because we know they are not more knowledgeable so I think it takes time. They have a lot of questions.”
 

Progress over the years

The FDA’s recent draft builds upon a guidance from 2016, which already recommended that trial teams submit an inclusion plan to the agency at the earliest phase of development. While the recent announcement is another step in the right direction, it may not be substantial enough.

“There’s always an enrollment plan,” Dr. Niranjan said. “But those enrollment plans are not enforced. So if it’s not enforced, what does that look like?”

In an emailed statement to this news organization, Lola Fashoyin-Aje, MD, the deputy director of the FDA Oncology Center of Excellence’s division to expand diversity, emphasized that the draft guidance does not require anything, but that the agency “expect[s] sponsors will follow FDA’s recommendations as described in the draft guidance.”

Without requirements, it’s up to the sponsor to make the effort to enroll people with varied racial and ethnic backgrounds. During the development of the COVID-19 vaccine, Moderna announced that the company would slow the trial’s enrollment to ensure minority groups were properly represented.

Not every sponsor is as motivated to make this a concerted effort, and some simply don’t have the funds to allocate to strengthening the enrollment process.

“There’s so much red tape and paperwork to get the funding for a clinical trial,” said Julie Silver, MD, professor of physical medicine and rehabilitation at Harvard Medical School, Boston, who studies workforce diversity and inclusion. “Even when people are equitably included, the amount of funding they have to do the trial might not be enough to do an analysis that shows potential differences.”

Whether the FDA will enforce enrollment plans in the future remains an open question; however, Dr. Yancy said the most effective way to do this would be through incentives, rather than penalties.

According to Dr. Fashoyin-Aje, the FDA and sponsors “will learn from these submissions and over time, whether and how these diversity plans lead to meaningful changes in clinical trial representation will need to be assessed, including whether additional steps need to be taken.”

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

COVID-19 forced consumers to adopt digital and virtual platforms to receive medical care, and more than 2 years after the start of the pandemic, it doesn’t appear that that will change.

“During the pandemic we witnessed a very steep rise in the utilization of digital health care transactions. And as we have now witnessed a plateau, we see that digital health care transactions have not fallen back to the way things were prepandemic,” said Bart M. Demaerschalk, MD, professor and chair of cerebrovascular diseases for digital health research at the Mayo Clinic in Phoenix, Ariz. “At Mayo Clinic and other health care organizations, approximately 20% ... of the composite care is occurring by digital means.”

Dr. Demaerschalk was among a panel representing retail and traditional health care organizations at the American Telemedicine Association conference in Boston.

The pandemic created this new reality, and health care leaders are now trying to make the most of all digital tools. Marcus Osborne, former senior vice president at Walmart Health, said that to progress, the health care industry needs to move beyond the conception of a world in which consumers interact with care providers via one-off in-person or digital experiences.

“What we’re actually seeing in other sectors and in life in general is that the world is not multichannel. The world is omnichannel,” Mr. Osborne said. Under an omnichannel paradigm, provider organizations integrate multiple digital and in-person health delivery methods, making it possible to “create whole new experiences for consumers that no one channel could deliver,” he added.

Creagh Milford, DO, vice president and head of enterprise virtual care at CVS Health, agreed and added that “the retail footprint will evolve” from offering separate physical and virtual care experiences to a “blended” experience.

Three key digital technology strategies

In addition to supporting an omnichannel experience, the panelists pointed out that traditional and retail health care providers can make the most of digital technologies in a few different ways.

One is by helping consumers manage innovation. With venture capital investments in digital technologies at an all-time high, the health care industry is drowning in innovation, <r/ Osborne pointed out.

“So on one hand, we have been blessed with this eruption of innovation. On the other hand – and I’m saying this as a consumer – it [doesn’t] really matter. I’m overwhelmed, and I think the market is overwhelmed,” Mr. Osborne said. “So if we’re overwhelmed, it means we’re not going to leverage that innovation as effectively as we should.” The challenge, then, is to find a way to “not get overwhelmed by the sheer force of innovations occurring” and to instead leverage these new technologies to drive real transformation in our health care system.

To meet this challenge, health care organizations will have to provide consumers with “some guidance as to how to tailor that journey,” Dr. Demaerschalk said. “It’s the responsibility of all of us to be creating that tailored and individual guidance for our patients.” By doing so, health care organizations ultimately can help consumers feel less overwhelmed.

Another strategy is to ensure that the use of technology promotes health equity. Mr. Osborne pointed out that events such as the pandemic and George Floyd’s murder have resulted in a “much more robust conversation around the need to address health inequities in America. I’ve also heard a lot of people say they believe that digital health solutions are the answer.”

As such, health care organizations need to ensure that digital innovations are leveraged to “fundamentally address the inequities that we’re facing today and support the care of all Americans,” Mr. Osborne noted.

To move in this direction, leaders need to address one glaring gap: “We talk all the time about fancy technology, like artificial intelligence. Most of my clients, they’re just trying to get basic Internet access at home,” Dr. McCann said. “So, there’s a technology challenge we first have to solve.”

Once this hurdle is overcome, however, digital technologies could pay off in spades, especially for consumers who struggle to access in-person services because they live 2 or 3 hours away from the hospital, are working two jobs, and have child care responsibilities, Dr. McCann noted.

Health care must also address staffing issues, said the panelists. Leaders need to create new career paths for clinicians as digital care delivery becomes more prominent.

Some health care organizations have already discovered that using digital technologies to support hospital-at-home programs can also enhance the work lives of clinicians.

When working in hospital-at-home programs, clinicians can “deliver care in the way that they have always wanted to but have never been able to within an acute inpatient facility. They’re able to go into patients’ homes and spend an hour with them, actually develop a proper relationship and look at social determinants of health and medications and do things in a way they’ve never been able to do before. And that has dramatically reduced rates of burnout,” Dr. McCann said.

While these strategies will help organizations support “this exciting digital ecosystem,” health care technology innovators need to “really study the costs and the health outcomes related to these digital health transactions in order to move the entire field and the science forward,” Dr. Demaerschalk concluded.

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

COVID-19 forced consumers to adopt digital and virtual platforms to receive medical care, and more than 2 years after the start of the pandemic, it doesn’t appear that that will change.

“During the pandemic we witnessed a very steep rise in the utilization of digital health care transactions. And as we have now witnessed a plateau, we see that digital health care transactions have not fallen back to the way things were prepandemic,” said Bart M. Demaerschalk, MD, professor and chair of cerebrovascular diseases for digital health research at the Mayo Clinic in Phoenix, Ariz. “At Mayo Clinic and other health care organizations, approximately 20% ... of the composite care is occurring by digital means.”

Dr. Demaerschalk was among a panel representing retail and traditional health care organizations at the American Telemedicine Association conference in Boston.

The pandemic created this new reality, and health care leaders are now trying to make the most of all digital tools. Marcus Osborne, former senior vice president at Walmart Health, said that to progress, the health care industry needs to move beyond the conception of a world in which consumers interact with care providers via one-off in-person or digital experiences.

“What we’re actually seeing in other sectors and in life in general is that the world is not multichannel. The world is omnichannel,” Mr. Osborne said. Under an omnichannel paradigm, provider organizations integrate multiple digital and in-person health delivery methods, making it possible to “create whole new experiences for consumers that no one channel could deliver,” he added.

Creagh Milford, DO, vice president and head of enterprise virtual care at CVS Health, agreed and added that “the retail footprint will evolve” from offering separate physical and virtual care experiences to a “blended” experience.

Three key digital technology strategies

In addition to supporting an omnichannel experience, the panelists pointed out that traditional and retail health care providers can make the most of digital technologies in a few different ways.

One is by helping consumers manage innovation. With venture capital investments in digital technologies at an all-time high, the health care industry is drowning in innovation, <r/ Osborne pointed out.

“So on one hand, we have been blessed with this eruption of innovation. On the other hand – and I’m saying this as a consumer – it [doesn’t] really matter. I’m overwhelmed, and I think the market is overwhelmed,” Mr. Osborne said. “So if we’re overwhelmed, it means we’re not going to leverage that innovation as effectively as we should.” The challenge, then, is to find a way to “not get overwhelmed by the sheer force of innovations occurring” and to instead leverage these new technologies to drive real transformation in our health care system.

To meet this challenge, health care organizations will have to provide consumers with “some guidance as to how to tailor that journey,” Dr. Demaerschalk said. “It’s the responsibility of all of us to be creating that tailored and individual guidance for our patients.” By doing so, health care organizations ultimately can help consumers feel less overwhelmed.

Another strategy is to ensure that the use of technology promotes health equity. Mr. Osborne pointed out that events such as the pandemic and George Floyd’s murder have resulted in a “much more robust conversation around the need to address health inequities in America. I’ve also heard a lot of people say they believe that digital health solutions are the answer.”

As such, health care organizations need to ensure that digital innovations are leveraged to “fundamentally address the inequities that we’re facing today and support the care of all Americans,” Mr. Osborne noted.

To move in this direction, leaders need to address one glaring gap: “We talk all the time about fancy technology, like artificial intelligence. Most of my clients, they’re just trying to get basic Internet access at home,” Dr. McCann said. “So, there’s a technology challenge we first have to solve.”

Once this hurdle is overcome, however, digital technologies could pay off in spades, especially for consumers who struggle to access in-person services because they live 2 or 3 hours away from the hospital, are working two jobs, and have child care responsibilities, Dr. McCann noted.

Health care must also address staffing issues, said the panelists. Leaders need to create new career paths for clinicians as digital care delivery becomes more prominent.

Some health care organizations have already discovered that using digital technologies to support hospital-at-home programs can also enhance the work lives of clinicians.

When working in hospital-at-home programs, clinicians can “deliver care in the way that they have always wanted to but have never been able to within an acute inpatient facility. They’re able to go into patients’ homes and spend an hour with them, actually develop a proper relationship and look at social determinants of health and medications and do things in a way they’ve never been able to do before. And that has dramatically reduced rates of burnout,” Dr. McCann said.

While these strategies will help organizations support “this exciting digital ecosystem,” health care technology innovators need to “really study the costs and the health outcomes related to these digital health transactions in order to move the entire field and the science forward,” Dr. Demaerschalk concluded.

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

COVID-19 forced consumers to adopt digital and virtual platforms to receive medical care, and more than 2 years after the start of the pandemic, it doesn’t appear that that will change.

“During the pandemic we witnessed a very steep rise in the utilization of digital health care transactions. And as we have now witnessed a plateau, we see that digital health care transactions have not fallen back to the way things were prepandemic,” said Bart M. Demaerschalk, MD, professor and chair of cerebrovascular diseases for digital health research at the Mayo Clinic in Phoenix, Ariz. “At Mayo Clinic and other health care organizations, approximately 20% ... of the composite care is occurring by digital means.”

Dr. Demaerschalk was among a panel representing retail and traditional health care organizations at the American Telemedicine Association conference in Boston.

The pandemic created this new reality, and health care leaders are now trying to make the most of all digital tools. Marcus Osborne, former senior vice president at Walmart Health, said that to progress, the health care industry needs to move beyond the conception of a world in which consumers interact with care providers via one-off in-person or digital experiences.

“What we’re actually seeing in other sectors and in life in general is that the world is not multichannel. The world is omnichannel,” Mr. Osborne said. Under an omnichannel paradigm, provider organizations integrate multiple digital and in-person health delivery methods, making it possible to “create whole new experiences for consumers that no one channel could deliver,” he added.

Creagh Milford, DO, vice president and head of enterprise virtual care at CVS Health, agreed and added that “the retail footprint will evolve” from offering separate physical and virtual care experiences to a “blended” experience.

Three key digital technology strategies

In addition to supporting an omnichannel experience, the panelists pointed out that traditional and retail health care providers can make the most of digital technologies in a few different ways.

One is by helping consumers manage innovation. With venture capital investments in digital technologies at an all-time high, the health care industry is drowning in innovation, <r/ Osborne pointed out.

“So on one hand, we have been blessed with this eruption of innovation. On the other hand – and I’m saying this as a consumer – it [doesn’t] really matter. I’m overwhelmed, and I think the market is overwhelmed,” Mr. Osborne said. “So if we’re overwhelmed, it means we’re not going to leverage that innovation as effectively as we should.” The challenge, then, is to find a way to “not get overwhelmed by the sheer force of innovations occurring” and to instead leverage these new technologies to drive real transformation in our health care system.

To meet this challenge, health care organizations will have to provide consumers with “some guidance as to how to tailor that journey,” Dr. Demaerschalk said. “It’s the responsibility of all of us to be creating that tailored and individual guidance for our patients.” By doing so, health care organizations ultimately can help consumers feel less overwhelmed.

Another strategy is to ensure that the use of technology promotes health equity. Mr. Osborne pointed out that events such as the pandemic and George Floyd’s murder have resulted in a “much more robust conversation around the need to address health inequities in America. I’ve also heard a lot of people say they believe that digital health solutions are the answer.”

As such, health care organizations need to ensure that digital innovations are leveraged to “fundamentally address the inequities that we’re facing today and support the care of all Americans,” Mr. Osborne noted.

To move in this direction, leaders need to address one glaring gap: “We talk all the time about fancy technology, like artificial intelligence. Most of my clients, they’re just trying to get basic Internet access at home,” Dr. McCann said. “So, there’s a technology challenge we first have to solve.”

Once this hurdle is overcome, however, digital technologies could pay off in spades, especially for consumers who struggle to access in-person services because they live 2 or 3 hours away from the hospital, are working two jobs, and have child care responsibilities, Dr. McCann noted.

Health care must also address staffing issues, said the panelists. Leaders need to create new career paths for clinicians as digital care delivery becomes more prominent.

Some health care organizations have already discovered that using digital technologies to support hospital-at-home programs can also enhance the work lives of clinicians.

When working in hospital-at-home programs, clinicians can “deliver care in the way that they have always wanted to but have never been able to within an acute inpatient facility. They’re able to go into patients’ homes and spend an hour with them, actually develop a proper relationship and look at social determinants of health and medications and do things in a way they’ve never been able to do before. And that has dramatically reduced rates of burnout,” Dr. McCann said.

While these strategies will help organizations support “this exciting digital ecosystem,” health care technology innovators need to “really study the costs and the health outcomes related to these digital health transactions in order to move the entire field and the science forward,” Dr. Demaerschalk concluded.

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

The American Medical Association estimates that physician burnout costs the country $4.6 billion annually, and that doesn’t include the cost for nurses and other clinicians. In addition, physicians note too many bureaucratic tasks as a main contributor to their daily stress.

Such revelations have prompted many in the health care industry to focus on clinician burnout, including a panel at the recent American Telemedicine Association annual conference in Boston.

Not surprisingly, the discussion quickly turned to the COVID-19 pandemic, commonly cited as an event that has exacerbated existing clinician burnout and caused what has become known as the “great resignation.”

Peter Yellowlees, MBBS, MD, professor of psychiatry and chief wellness officer at the University of California, Davis, said his health system has experienced a lot of its nursing staff resigning or moving to other employment, particularly from intensive care units and the emergency department.

“We actually haven’t had too many physicians go, but I have a funny feeling we’re going to see that over the next year or so because I think a lot of people have just put their head down during the pandemic and they’ve worked themselves hard,” he said. “They’re now sort of putting their heads up above the wall,” and could realize that they want a change.

In his role as the wellness officer at the academic medical center, Dr. Yellowlees is proactively addressing burnout among the organization’s 14,000 employees. For example, during the pandemic, he developed a peer responder program. Under this initiative, 600 staff members received training in “psychological first aid,” essentially utilizing staff to become therapists for peers.

For example, if a clinician is struggling emotionally while dealing with a patient who has had significant trauma, a peer responder could talk with the clinician, helping him or her to better deal with the situation.

Marlene McDermott, senior director of therapy services at Array Behavioral Care, a national telepsychiatry provider with offices in New Jersey and Illinois, noted that her organization also addresses burnout by creating opportunities for peer-to-peer support.

“We’ve got hundreds of clinicians and we’ll take 10 to 15 of them, put them in small treatment teams and they have a live chat, a one-off virtual meeting with each other to vent and to ask clinical questions. It’s all clinicians, there’s no administrative staff in there,” Ms. McDermott said. The clinicians have found value in these meetings, as they can share their concerns as well as “silly images or quotes, just to keep things light at times. That’s made a big difference.”
 

Retraining, technology can help curb administrative burdens

In addition to providing peer support, both Dr. Yellowlees and Ms. McDermott are addressing the significant administrative burden that plagues physicians.

This burden is especially onerous for physicians in the United States, according to a study that compared the number of keystrokes required to produce clinical notes among physicians in several countries.

“What [the study] discovered was that the American notes were three to five times longer than the notes of the Australian or U.K. physicians. I’ve worked in all three countries and I can promise you there’s no difference in the quality of the doctors across those places,” Dr. Yellowlees said.

To address this issue, Dr. Yellowlees is training physicians to reduce the length of their clinical documentation.

“I am trying to retrain physicians who for many years have been trained to be defensive in their documentation – to write absurd amounts just to justify billing,” Dr. Yellowlees said. “We are trying to go back in some respects to the way that we used to write notes 20 years ago ... so much shorter. This is a huge retraining exercise but it’s an exercise that is essential.”

Ms. McDermott also is tackling the administrative burden at her organization.

“We are trying to make the workflow as efficient as possible, doing some asynchronous work where consumers are completing information before a session ... so clinicians are essentially reconciling information instead of gathering all nonpertinent information. They can just work at the top of the license and not be burdened by some of the questions that don’t directly affect treatment,” Ms. McDermott noted.

Encouraging and training physicians in concurrent documentation also can help reduce administrative burden.

“Being proficient at remaining in session and documenting as much as you can during a session can help. So that at the end, you’re pressing the button, closing the encounter and you’ve finished documenting,” Ms. McDermott said. “It’s definitely possible to do that without losing the connection with the patient.”

To accomplish this, physicians need to leverage touch-typing – the practice of typing without looking at the keyboard. Fortunately, telehealth makes this mode of documentation easily achievable. Consider the following: During an online session, clinicians can place the patient’s picture “right underneath the camera and make it small. And then you type with the note floating behind it. So you’re actually staring at the note and the person all at the same time,” Ms. McDermott said.

The continued uptake of telehealth in general could also reduce stress for physicians, added Dr. Yellowlees.

“One of the interesting things about that is just how much time we save the physicians because it actually takes quite a lot of time to room patients,” Dr. Yellowlees concluded. “We are now doing about 20% of all our outpatient visits in all disciplines by video. We were higher than that midway through COVID. I’m hoping we’ll go back to being higher than that.”

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

The American Medical Association estimates that physician burnout costs the country $4.6 billion annually, and that doesn’t include the cost for nurses and other clinicians. In addition, physicians note too many bureaucratic tasks as a main contributor to their daily stress.

Such revelations have prompted many in the health care industry to focus on clinician burnout, including a panel at the recent American Telemedicine Association annual conference in Boston.

Not surprisingly, the discussion quickly turned to the COVID-19 pandemic, commonly cited as an event that has exacerbated existing clinician burnout and caused what has become known as the “great resignation.”

Peter Yellowlees, MBBS, MD, professor of psychiatry and chief wellness officer at the University of California, Davis, said his health system has experienced a lot of its nursing staff resigning or moving to other employment, particularly from intensive care units and the emergency department.

“We actually haven’t had too many physicians go, but I have a funny feeling we’re going to see that over the next year or so because I think a lot of people have just put their head down during the pandemic and they’ve worked themselves hard,” he said. “They’re now sort of putting their heads up above the wall,” and could realize that they want a change.

In his role as the wellness officer at the academic medical center, Dr. Yellowlees is proactively addressing burnout among the organization’s 14,000 employees. For example, during the pandemic, he developed a peer responder program. Under this initiative, 600 staff members received training in “psychological first aid,” essentially utilizing staff to become therapists for peers.

For example, if a clinician is struggling emotionally while dealing with a patient who has had significant trauma, a peer responder could talk with the clinician, helping him or her to better deal with the situation.

Marlene McDermott, senior director of therapy services at Array Behavioral Care, a national telepsychiatry provider with offices in New Jersey and Illinois, noted that her organization also addresses burnout by creating opportunities for peer-to-peer support.

“We’ve got hundreds of clinicians and we’ll take 10 to 15 of them, put them in small treatment teams and they have a live chat, a one-off virtual meeting with each other to vent and to ask clinical questions. It’s all clinicians, there’s no administrative staff in there,” Ms. McDermott said. The clinicians have found value in these meetings, as they can share their concerns as well as “silly images or quotes, just to keep things light at times. That’s made a big difference.”
 

Retraining, technology can help curb administrative burdens

In addition to providing peer support, both Dr. Yellowlees and Ms. McDermott are addressing the significant administrative burden that plagues physicians.

This burden is especially onerous for physicians in the United States, according to a study that compared the number of keystrokes required to produce clinical notes among physicians in several countries.

“What [the study] discovered was that the American notes were three to five times longer than the notes of the Australian or U.K. physicians. I’ve worked in all three countries and I can promise you there’s no difference in the quality of the doctors across those places,” Dr. Yellowlees said.

To address this issue, Dr. Yellowlees is training physicians to reduce the length of their clinical documentation.

“I am trying to retrain physicians who for many years have been trained to be defensive in their documentation – to write absurd amounts just to justify billing,” Dr. Yellowlees said. “We are trying to go back in some respects to the way that we used to write notes 20 years ago ... so much shorter. This is a huge retraining exercise but it’s an exercise that is essential.”

Ms. McDermott also is tackling the administrative burden at her organization.

“We are trying to make the workflow as efficient as possible, doing some asynchronous work where consumers are completing information before a session ... so clinicians are essentially reconciling information instead of gathering all nonpertinent information. They can just work at the top of the license and not be burdened by some of the questions that don’t directly affect treatment,” Ms. McDermott noted.

Encouraging and training physicians in concurrent documentation also can help reduce administrative burden.

“Being proficient at remaining in session and documenting as much as you can during a session can help. So that at the end, you’re pressing the button, closing the encounter and you’ve finished documenting,” Ms. McDermott said. “It’s definitely possible to do that without losing the connection with the patient.”

To accomplish this, physicians need to leverage touch-typing – the practice of typing without looking at the keyboard. Fortunately, telehealth makes this mode of documentation easily achievable. Consider the following: During an online session, clinicians can place the patient’s picture “right underneath the camera and make it small. And then you type with the note floating behind it. So you’re actually staring at the note and the person all at the same time,” Ms. McDermott said.

The continued uptake of telehealth in general could also reduce stress for physicians, added Dr. Yellowlees.

“One of the interesting things about that is just how much time we save the physicians because it actually takes quite a lot of time to room patients,” Dr. Yellowlees concluded. “We are now doing about 20% of all our outpatient visits in all disciplines by video. We were higher than that midway through COVID. I’m hoping we’ll go back to being higher than that.”

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

The American Medical Association estimates that physician burnout costs the country $4.6 billion annually, and that doesn’t include the cost for nurses and other clinicians. In addition, physicians note too many bureaucratic tasks as a main contributor to their daily stress.

Such revelations have prompted many in the health care industry to focus on clinician burnout, including a panel at the recent American Telemedicine Association annual conference in Boston.

Not surprisingly, the discussion quickly turned to the COVID-19 pandemic, commonly cited as an event that has exacerbated existing clinician burnout and caused what has become known as the “great resignation.”

Peter Yellowlees, MBBS, MD, professor of psychiatry and chief wellness officer at the University of California, Davis, said his health system has experienced a lot of its nursing staff resigning or moving to other employment, particularly from intensive care units and the emergency department.

“We actually haven’t had too many physicians go, but I have a funny feeling we’re going to see that over the next year or so because I think a lot of people have just put their head down during the pandemic and they’ve worked themselves hard,” he said. “They’re now sort of putting their heads up above the wall,” and could realize that they want a change.

In his role as the wellness officer at the academic medical center, Dr. Yellowlees is proactively addressing burnout among the organization’s 14,000 employees. For example, during the pandemic, he developed a peer responder program. Under this initiative, 600 staff members received training in “psychological first aid,” essentially utilizing staff to become therapists for peers.

For example, if a clinician is struggling emotionally while dealing with a patient who has had significant trauma, a peer responder could talk with the clinician, helping him or her to better deal with the situation.

Marlene McDermott, senior director of therapy services at Array Behavioral Care, a national telepsychiatry provider with offices in New Jersey and Illinois, noted that her organization also addresses burnout by creating opportunities for peer-to-peer support.

“We’ve got hundreds of clinicians and we’ll take 10 to 15 of them, put them in small treatment teams and they have a live chat, a one-off virtual meeting with each other to vent and to ask clinical questions. It’s all clinicians, there’s no administrative staff in there,” Ms. McDermott said. The clinicians have found value in these meetings, as they can share their concerns as well as “silly images or quotes, just to keep things light at times. That’s made a big difference.”
 

Retraining, technology can help curb administrative burdens

In addition to providing peer support, both Dr. Yellowlees and Ms. McDermott are addressing the significant administrative burden that plagues physicians.

This burden is especially onerous for physicians in the United States, according to a study that compared the number of keystrokes required to produce clinical notes among physicians in several countries.

“What [the study] discovered was that the American notes were three to five times longer than the notes of the Australian or U.K. physicians. I’ve worked in all three countries and I can promise you there’s no difference in the quality of the doctors across those places,” Dr. Yellowlees said.

To address this issue, Dr. Yellowlees is training physicians to reduce the length of their clinical documentation.

“I am trying to retrain physicians who for many years have been trained to be defensive in their documentation – to write absurd amounts just to justify billing,” Dr. Yellowlees said. “We are trying to go back in some respects to the way that we used to write notes 20 years ago ... so much shorter. This is a huge retraining exercise but it’s an exercise that is essential.”

Ms. McDermott also is tackling the administrative burden at her organization.

“We are trying to make the workflow as efficient as possible, doing some asynchronous work where consumers are completing information before a session ... so clinicians are essentially reconciling information instead of gathering all nonpertinent information. They can just work at the top of the license and not be burdened by some of the questions that don’t directly affect treatment,” Ms. McDermott noted.

Encouraging and training physicians in concurrent documentation also can help reduce administrative burden.

“Being proficient at remaining in session and documenting as much as you can during a session can help. So that at the end, you’re pressing the button, closing the encounter and you’ve finished documenting,” Ms. McDermott said. “It’s definitely possible to do that without losing the connection with the patient.”

To accomplish this, physicians need to leverage touch-typing – the practice of typing without looking at the keyboard. Fortunately, telehealth makes this mode of documentation easily achievable. Consider the following: During an online session, clinicians can place the patient’s picture “right underneath the camera and make it small. And then you type with the note floating behind it. So you’re actually staring at the note and the person all at the same time,” Ms. McDermott said.

The continued uptake of telehealth in general could also reduce stress for physicians, added Dr. Yellowlees.

“One of the interesting things about that is just how much time we save the physicians because it actually takes quite a lot of time to room patients,” Dr. Yellowlees concluded. “We are now doing about 20% of all our outpatient visits in all disciplines by video. We were higher than that midway through COVID. I’m hoping we’ll go back to being higher than that.”

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

MI. HTN. hx. Although these abbreviations might make it easier for physicians and other health care professionals to create and consume clinical documentation, the shorthand confuses patients, according to a study published in JAMA Network Open.

Researchers, who conducted clinical trials at three hospitals, found that expansion of 10 common medical abbreviations and acronyms in patient health records significantly increased overall comprehension.

Corresponding author Lisa Grossman Liu, PhD, MD, of Columbia University, New York, told this news organization that “comprehension of abbreviations was much lower than we expected and much lower than the clinicians who participated in this study expected.”

This discovery is particularly relevant in this era of digital care, where providers are now communicating with patients electronically more than ever before – and are required by rules emanating from the 21st Century Cures Act to provide online access to electronic health records.
 

Using elongated terms

Although the study found that expansion of medical abbreviations and acronyms can improve patient understanding, identifying all of the medical abbreviations that exist is difficult because the terms vary by specialty and geography. The fact that many abbreviations and acronyms have multiple meanings complicates matters even more. For example, the abbreviation PA has 128 possible meanings, Dr. Grossman Liu pointed out.

Technology, fortunately, has advanced in the last few years and is on the cusp of providing a solution. Artificial intelligence systems could help to develop large compendiums of abbreviations and acronyms and then machine learning could elongate the words.

“We’re almost to the point where we have these automated systems that can actually expand abbreviations pretty well and with a great degree of accuracy and ... where those can actually be used in medicine to help with patient communication,” Dr. Grossman Liu said.

Such intervention, however, is not a cure-all.

“There are abbreviations that are really hard to understand even after you expand them, such as MI for myocardial infarction, which is really a tough term all around. It means heart attack. So even if you tell patients, MI means myocardial infarction, they’re still not going to understand it,” Dr. Grossman Liu said.

On the flip side, patients are likely to understand some abbreviations such as hrs, which stands for hours, without elongating the words.
 

Moving from in-person to online communication

A look at the evolution of clinical documentation explains how this abbreviation problem came to fruition. Prior to this digital age where providers communicate with patients through portals, secure messaging, and other electronic methods, patients and providers would talk face to face. Now, however, electronic written communication is becoming the norm.

“We are not only seeing direct written communication through things like messaging systems or email, but also patients are now reading their medical records online and you can consider that as a form of communication,” Dr. Grossman Liu said. “It’s really interesting that the electronic health record itself has essentially become a medium for communication between patients and providers when previously it was only a way for providers to communicate with themselves and document patient care. So, clinicians use abbreviations because they aren’t intending for patients to see the records.”

Requiring physicians to use complete words in clinical documentation now that electronic records are relied on for patient communication, however, is not a practical solution.

“Abbreviations are so commonly used because they are more efficient to read and more efficient to write. We really shouldn’t be putting the onus on providers to spell out all the abbreviations in their notes. That’s realistically not going to work, because it compromises clinical efficiency,” Dr. Grossman Liu said.

While physicians should not be forced to use complete words in documentation, they should be wary of patients’ unfamiliarity with abbreviations as they communicate in person.

“I use terms like ED constantly when I talk to patients, and it turns out that only 67% of patients understand what you’re talking about when you say ED in reference to the emergency department. So it’s important to be mindful of that,” Dr. Grossman Liu concluded.

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

MI. HTN. hx. Although these abbreviations might make it easier for physicians and other health care professionals to create and consume clinical documentation, the shorthand confuses patients, according to a study published in JAMA Network Open.

Researchers, who conducted clinical trials at three hospitals, found that expansion of 10 common medical abbreviations and acronyms in patient health records significantly increased overall comprehension.

Corresponding author Lisa Grossman Liu, PhD, MD, of Columbia University, New York, told this news organization that “comprehension of abbreviations was much lower than we expected and much lower than the clinicians who participated in this study expected.”

This discovery is particularly relevant in this era of digital care, where providers are now communicating with patients electronically more than ever before – and are required by rules emanating from the 21st Century Cures Act to provide online access to electronic health records.
 

Using elongated terms

Although the study found that expansion of medical abbreviations and acronyms can improve patient understanding, identifying all of the medical abbreviations that exist is difficult because the terms vary by specialty and geography. The fact that many abbreviations and acronyms have multiple meanings complicates matters even more. For example, the abbreviation PA has 128 possible meanings, Dr. Grossman Liu pointed out.

Technology, fortunately, has advanced in the last few years and is on the cusp of providing a solution. Artificial intelligence systems could help to develop large compendiums of abbreviations and acronyms and then machine learning could elongate the words.

“We’re almost to the point where we have these automated systems that can actually expand abbreviations pretty well and with a great degree of accuracy and ... where those can actually be used in medicine to help with patient communication,” Dr. Grossman Liu said.

Such intervention, however, is not a cure-all.

“There are abbreviations that are really hard to understand even after you expand them, such as MI for myocardial infarction, which is really a tough term all around. It means heart attack. So even if you tell patients, MI means myocardial infarction, they’re still not going to understand it,” Dr. Grossman Liu said.

On the flip side, patients are likely to understand some abbreviations such as hrs, which stands for hours, without elongating the words.
 

Moving from in-person to online communication

A look at the evolution of clinical documentation explains how this abbreviation problem came to fruition. Prior to this digital age where providers communicate with patients through portals, secure messaging, and other electronic methods, patients and providers would talk face to face. Now, however, electronic written communication is becoming the norm.

“We are not only seeing direct written communication through things like messaging systems or email, but also patients are now reading their medical records online and you can consider that as a form of communication,” Dr. Grossman Liu said. “It’s really interesting that the electronic health record itself has essentially become a medium for communication between patients and providers when previously it was only a way for providers to communicate with themselves and document patient care. So, clinicians use abbreviations because they aren’t intending for patients to see the records.”

Requiring physicians to use complete words in clinical documentation now that electronic records are relied on for patient communication, however, is not a practical solution.

“Abbreviations are so commonly used because they are more efficient to read and more efficient to write. We really shouldn’t be putting the onus on providers to spell out all the abbreviations in their notes. That’s realistically not going to work, because it compromises clinical efficiency,” Dr. Grossman Liu said.

While physicians should not be forced to use complete words in documentation, they should be wary of patients’ unfamiliarity with abbreviations as they communicate in person.

“I use terms like ED constantly when I talk to patients, and it turns out that only 67% of patients understand what you’re talking about when you say ED in reference to the emergency department. So it’s important to be mindful of that,” Dr. Grossman Liu concluded.

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

MI. HTN. hx. Although these abbreviations might make it easier for physicians and other health care professionals to create and consume clinical documentation, the shorthand confuses patients, according to a study published in JAMA Network Open.

Researchers, who conducted clinical trials at three hospitals, found that expansion of 10 common medical abbreviations and acronyms in patient health records significantly increased overall comprehension.

Corresponding author Lisa Grossman Liu, PhD, MD, of Columbia University, New York, told this news organization that “comprehension of abbreviations was much lower than we expected and much lower than the clinicians who participated in this study expected.”

This discovery is particularly relevant in this era of digital care, where providers are now communicating with patients electronically more than ever before – and are required by rules emanating from the 21st Century Cures Act to provide online access to electronic health records.
 

Using elongated terms

Although the study found that expansion of medical abbreviations and acronyms can improve patient understanding, identifying all of the medical abbreviations that exist is difficult because the terms vary by specialty and geography. The fact that many abbreviations and acronyms have multiple meanings complicates matters even more. For example, the abbreviation PA has 128 possible meanings, Dr. Grossman Liu pointed out.

Technology, fortunately, has advanced in the last few years and is on the cusp of providing a solution. Artificial intelligence systems could help to develop large compendiums of abbreviations and acronyms and then machine learning could elongate the words.

“We’re almost to the point where we have these automated systems that can actually expand abbreviations pretty well and with a great degree of accuracy and ... where those can actually be used in medicine to help with patient communication,” Dr. Grossman Liu said.

Such intervention, however, is not a cure-all.

“There are abbreviations that are really hard to understand even after you expand them, such as MI for myocardial infarction, which is really a tough term all around. It means heart attack. So even if you tell patients, MI means myocardial infarction, they’re still not going to understand it,” Dr. Grossman Liu said.

On the flip side, patients are likely to understand some abbreviations such as hrs, which stands for hours, without elongating the words.
 

Moving from in-person to online communication

A look at the evolution of clinical documentation explains how this abbreviation problem came to fruition. Prior to this digital age where providers communicate with patients through portals, secure messaging, and other electronic methods, patients and providers would talk face to face. Now, however, electronic written communication is becoming the norm.

“We are not only seeing direct written communication through things like messaging systems or email, but also patients are now reading their medical records online and you can consider that as a form of communication,” Dr. Grossman Liu said. “It’s really interesting that the electronic health record itself has essentially become a medium for communication between patients and providers when previously it was only a way for providers to communicate with themselves and document patient care. So, clinicians use abbreviations because they aren’t intending for patients to see the records.”

Requiring physicians to use complete words in clinical documentation now that electronic records are relied on for patient communication, however, is not a practical solution.

“Abbreviations are so commonly used because they are more efficient to read and more efficient to write. We really shouldn’t be putting the onus on providers to spell out all the abbreviations in their notes. That’s realistically not going to work, because it compromises clinical efficiency,” Dr. Grossman Liu said.

While physicians should not be forced to use complete words in documentation, they should be wary of patients’ unfamiliarity with abbreviations as they communicate in person.

“I use terms like ED constantly when I talk to patients, and it turns out that only 67% of patients understand what you’re talking about when you say ED in reference to the emergency department. So it’s important to be mindful of that,” Dr. Grossman Liu concluded.

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

The latest increase in new child COVID-19 cases seems to be picking up steam, rising by 50% in the last week, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The new-case count was over 93,000 for the week of May 6-12, compared with 62,000 the previous week. That 50% week-to-week change follows increases of 17%, 44%, 12%, and 28% since the nationwide weekly total fell to its low point for the year (25,915) in the beginning of April, the AAP and CHA said in their weekly COVID report.

By comparison, the Centers for Disease Control and Prevention put the total number of cases in children aged 0-17 at 12.7 million, although that figure is based on a cumulative number of 73.4 million cases among all ages, which is well short of the reported total of almost 82.4 million as of May 16. COVID cases in children have led to 1,536 deaths so far, the CDC said.

The recent upward trend in new cases also can be seen in the CDC’s data, which show the weekly rate rising from 35 per 100,000 population on March 26 to 102 per 100,000 on May 7 in children aged 0-14 years, with commensurate increases seen among older children over the same period. In turn, the rate of new admissions for children aged 0-17 has gone from a low of 0.13 per 100,000 as late as April 10 up to 0.23 on May 13, the CDC said on its COVID Data Tracker.

One thing not going up these days is vaccinations among the youngest eligible children. The number of 5- to 11-year-olds receiving their initial dose was down to 40,000 for the week of May 5-11, the fewest since the vaccine was approved for that age group. For a change of pace, the number increased among children aged 12-17, as 37,000 got initial vaccinations that week, compared with 29,000 a week earlier, the AAP said in its weekly vaccination report.

[email protected]

The latest increase in new child COVID-19 cases seems to be picking up steam, rising by 50% in the last week, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The new-case count was over 93,000 for the week of May 6-12, compared with 62,000 the previous week. That 50% week-to-week change follows increases of 17%, 44%, 12%, and 28% since the nationwide weekly total fell to its low point for the year (25,915) in the beginning of April, the AAP and CHA said in their weekly COVID report.

By comparison, the Centers for Disease Control and Prevention put the total number of cases in children aged 0-17 at 12.7 million, although that figure is based on a cumulative number of 73.4 million cases among all ages, which is well short of the reported total of almost 82.4 million as of May 16. COVID cases in children have led to 1,536 deaths so far, the CDC said.

The recent upward trend in new cases also can be seen in the CDC’s data, which show the weekly rate rising from 35 per 100,000 population on March 26 to 102 per 100,000 on May 7 in children aged 0-14 years, with commensurate increases seen among older children over the same period. In turn, the rate of new admissions for children aged 0-17 has gone from a low of 0.13 per 100,000 as late as April 10 up to 0.23 on May 13, the CDC said on its COVID Data Tracker.

One thing not going up these days is vaccinations among the youngest eligible children. The number of 5- to 11-year-olds receiving their initial dose was down to 40,000 for the week of May 5-11, the fewest since the vaccine was approved for that age group. For a change of pace, the number increased among children aged 12-17, as 37,000 got initial vaccinations that week, compared with 29,000 a week earlier, the AAP said in its weekly vaccination report.

[email protected]

The latest increase in new child COVID-19 cases seems to be picking up steam, rising by 50% in the last week, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The new-case count was over 93,000 for the week of May 6-12, compared with 62,000 the previous week. That 50% week-to-week change follows increases of 17%, 44%, 12%, and 28% since the nationwide weekly total fell to its low point for the year (25,915) in the beginning of April, the AAP and CHA said in their weekly COVID report.

By comparison, the Centers for Disease Control and Prevention put the total number of cases in children aged 0-17 at 12.7 million, although that figure is based on a cumulative number of 73.4 million cases among all ages, which is well short of the reported total of almost 82.4 million as of May 16. COVID cases in children have led to 1,536 deaths so far, the CDC said.

The recent upward trend in new cases also can be seen in the CDC’s data, which show the weekly rate rising from 35 per 100,000 population on March 26 to 102 per 100,000 on May 7 in children aged 0-14 years, with commensurate increases seen among older children over the same period. In turn, the rate of new admissions for children aged 0-17 has gone from a low of 0.13 per 100,000 as late as April 10 up to 0.23 on May 13, the CDC said on its COVID Data Tracker.

One thing not going up these days is vaccinations among the youngest eligible children. The number of 5- to 11-year-olds receiving their initial dose was down to 40,000 for the week of May 5-11, the fewest since the vaccine was approved for that age group. For a change of pace, the number increased among children aged 12-17, as 37,000 got initial vaccinations that week, compared with 29,000 a week earlier, the AAP said in its weekly vaccination report.

[email protected]

Almost forgotten today, tuberculosis is still one of the deadliest infectious diseases in the world. In an interview with Coliquio, Ronald D. Gerste, MD, PhD, an ophthalmologist and historian, looked back on this disease’s eventful history, which encompasses outstanding discoveries and catastrophic failures in diagnosis and treatment from the Middle Ages to the present day.

Under different names, TB has affected mankind for millennia. One of these names was the “aesthetic disease,” because it led to weight loss and pallor in the younger patients that it often affected. This was considered the ideal of beauty in the Victorian era. Many celebrities suffered from the disease, including poets and artists such as Friedrich Schiller, Lord Byron, and the Bronte family. As recently as the early 1990s, the disease almost changed world history, because Nelson Mandela became ill before the negotiations that led to the end of apartheid in South Africa.

Today, the global community is still not on track to meet its self-imposed targets for controlling the infectious disease, as reported by the World Health Organization on World TB Day in late March. Children and young people are the leading victims. In 2020 alone, 1.1 million children and adolescents under age 15 years were infected with TB, and 226,000 died of the disease, according to the WHO.
 

Q: Nelson Mandela was ill with tuberculosis during his imprisonment. How did the disease manifest itself in the future Nobel Peace Prize winner, and what is known about the treatment?

Ronald D. Gerste: Nelson Mandela contracted tuberculosis in 1988. At that time, he was 70 years old and had been in prison for 26 years. The disease presented in him with the almost classic symptom: He was coughing up blood and was also increasingly fatigued and losing weight. After doctors initially suspected a viral infection, but then TB was proven, he was treated with medication, and fluid was also drained from his lungs. [Mr.] Mandela was hospitalized for six weeks at Tygerberg Hospital in Cape Town, the second largest hospital in South Africa. The therapy worked well, but [Mr.] Mandela’s lungs remained damaged. He was subsequently prone to pneumonia and was repeatedly hospitalized for pneumonia in 2012 and 2013.
 

Q: Mandela was lucky that the treatment worked for him. A few years later, the first antibiotic-resistant pathogen strains developed. How did medical research respond to this development?

Gerste: The emergence of multidrug resistant (MDR) strains of the pathogen prompted the WHO to declare a “global health emergency” in 1993. Three years later, World TB Day was proclaimed to raise awareness of the threat posed by this disease, which has been known since ancient times. It always takes place on March 24, the day in 1882 when Robert Koch gave his famous lecture in Berlin in which he announced the discovery of the pathogen Mycobacterium tuberculosis.

Medical research has introduced new drugs into TB therapy, such as bedaquiline and delamanid. But MDR tuberculosis therapy remains a global challenge and has diminished hopes of eradicating tuberculosis, as we did with smallpox some 40 years ago. Today, only 56% of all MDR-TB patients worldwide are successfully treated.
 

Q: As already mentioned, the TB pathogen was discovered by Robert Koch. How did this come about?

Gerste: Along with cholera, TB was a great epidemic of the 19th century. For an ambitious researcher like Robert Koch, who had made a name for himself with the discovery of anthrax in 1876, there was no more rewarding goal than to find the cause of this infectious disease, which claimed the lives of many famous people such as Kafka, Dostoevsky, and Schiller, as well as many whose names are forgotten today.

[Dr.] Koch worked with his cultures for several years; the method of staining with methylene blue that was developed by the young Paul Ehrlich represented a breakthrough. To this method, [Dr.] Koch added a second, brownish dye. After countless experiments, this allowed slightly curved bacilli to be identified in tuberculous material under the microscope.

On the evening of March 24, 1882, [Dr.] Koch gave a lecture at the Institute of Physiology in Berlin with the title “Etiology of TB,” which sounded less than sensational on the invitations. One or two dozen participants had been expected, but more than one hundred came; numerous listeners had to make do with standing room behind the rows of chairs in the lecture hall. After a rather dry presentation ([Dr.] Koch was not a great orator nor a self-promoter), he presented his results to those present.

His assistants had set up a series of microscopes in the lecture hall through which everyone could get a glimpse of this enemy of humanity: the tubercle bacillus. When [Dr.] Koch had finished his remarks, there was silence in the hall. There was no burst of applause; the audience was too deeply aware that they had witnessed a historic moment. Paul Ehrlich later said that this evening had been the most significant scientific experience of his life. Over the next few weeks, the newspapers made a national hero out of Robert Koch, and the Emperor appointed him a Privy Councilor of the Government. The country doctor from Pomerania was now the figurehead of science in the young German Empire.
 

Q: Shortly after his discovery, [Dr.] Koch advertised a vaccination against TB with the active ingredient tuberculin. Was he able to convince with that too?

Gerste: No, this was the big flop, almost the disaster of a remarkable scientific career. The preparation of attenuated tubercle bacilli with water and glycerin not only did not prevent infection at all, it proved fatal for numerous users. However, tuberculin has survived in a modified form: as a tuberculin test, in which a characteristic skin rash indicates that a tested person has already had contact with the Mycobacterium.
 

Q: How have diagnostic options and treatment of the disease evolved since Robert Koch’s lifetime?

Gerste: A very decisive advance was made in diagnostics. With the rather accidental discovery of the rays soon named after him by Wilhelm Conrad Röntgen in the last days of 1895, it became possible to visualize the lung changes that tuberculosis caused in an unexpected way on living patients; the serial examinations for TB by X-rays were the logical consequence. Both scientists received Nobel Prizes, which were still new at the time, within a few years of each other: [Dr.] Röntgen in 1901 for physics, and [Dr]. Koch in 1905 for medicine and physiology.

Effective drugs were practically unavailable toward the end of the 19th century. For those who could afford it, however, a whole new world of (hoped-for or perceived) healing from “consumption” opened up: the sanatorium, located high in the mountains, surrounded by “fresh air.” The most famous of these climatic health resorts is probably Davos. It is no disrespect to the Swiss Confederation, which I hold in high esteem, to point out that Switzerland owes its high status as a tourist destination and thus its prosperity in part to TB.
 

Q: Things were quite different in earlier times. Until 250 years ago, the hopes of many patients rested on the medieval healing method of the “royal touch.” What’s that all about?

Gerste: In the Middle Ages, a “healing method” emerged from which not only lepers and other seriously ill people but also those suffering from consumption expected to be saved: the “royal touch,” which was first described by the Frankish king Clovis in 496. This ceremony was based on the idea that the king or queen, anointed by God, could improve or even cure the ailment of a sick person through a brief touch.

With the transition from the Middle Ages to the early modern period, this act, during which thousands often gathered in front of the ruler’s residence, was practiced on a large scale. The sufferers passed by the anointed ruler as if in a procession and were briefly touched by him or her. The extremely few “successes” were of course exploited by royal propaganda to proclaim the blessing that the reign of the king or queen meant for the country. But on those who nevertheless fell victim to TB or another ailment, the chroniclers remained silent.

Charles II of England, who ruled from 1660 to 1685 during the Restoration after the English Civil War, is said to have touched 92,102 sick people during this period, according to contemporary counts. The record for a single day’s performance is probably held by Louis XVI of France, who is said to have touched a total of 2,400 sufferers on June 14, 1775. Some of them may have stood and cheered in the Paris crowd 18 years later as the king climbed the steps to the guillotine.
 

Q: Another invention associated with TB diagnosis is the stethoscope. How did it come about?

Gerste: A young physician named René-Théophile-Hyacinthe Laënnec had already experienced the importance of diagnosing TB in his student years. His teacher in Paris was Xavier Bichat, considered the founder of histology, who died of TB in [Dr.] Laënnec’s second year at the age of only 30. [Dr.] Laënnec was a devotee of auscultation and made it work with a massively overweight patient by rolling up a sheet of paper, then placing this on the woman’s thorax to listen to her heart sounds. He developed the idea further and built a hollow wooden tube with a metal earpiece. In 1818, he presented the device at the meeting of the Academy of Sciences in Paris; he called it a stethoscope. He used his new instrument primarily to auscultate the lungs of patients with TB and distinguished the sounds of TB cavities from those of other lung diseases such as pneumonia and emphysema.
 

Q: Back to the present day: The WHO wants to eradicate TB once and for all. What are the hopes and fears in the fight against this disease?

Gerste: There is no doubt that we are currently taking a step backwards in these efforts, and this is not only due to multiresistant pathogens. Especially in poorer countries particularly affected by TB, treatment and screening programs have been disrupted by lockdown measures targeting COVID-19. The WHO suspects that in the first pandemic year, 2020, about half a million additional people may have died from TB because they never received a diagnosis.

Dr. Gerste, born in 1957, is a physician and historian. Dr. Gerste has lived for many years as a correspondent and book author in Washington, D.C., where he writes primarily for the New Journal of Zürich, the FAS, Back Then, the German Medical Journal, and other academic journals.

This article was translated from Coliquio.

Almost forgotten today, tuberculosis is still one of the deadliest infectious diseases in the world. In an interview with Coliquio, Ronald D. Gerste, MD, PhD, an ophthalmologist and historian, looked back on this disease’s eventful history, which encompasses outstanding discoveries and catastrophic failures in diagnosis and treatment from the Middle Ages to the present day.

Under different names, TB has affected mankind for millennia. One of these names was the “aesthetic disease,” because it led to weight loss and pallor in the younger patients that it often affected. This was considered the ideal of beauty in the Victorian era. Many celebrities suffered from the disease, including poets and artists such as Friedrich Schiller, Lord Byron, and the Bronte family. As recently as the early 1990s, the disease almost changed world history, because Nelson Mandela became ill before the negotiations that led to the end of apartheid in South Africa.

Today, the global community is still not on track to meet its self-imposed targets for controlling the infectious disease, as reported by the World Health Organization on World TB Day in late March. Children and young people are the leading victims. In 2020 alone, 1.1 million children and adolescents under age 15 years were infected with TB, and 226,000 died of the disease, according to the WHO.
 

Q: Nelson Mandela was ill with tuberculosis during his imprisonment. How did the disease manifest itself in the future Nobel Peace Prize winner, and what is known about the treatment?

Ronald D. Gerste: Nelson Mandela contracted tuberculosis in 1988. At that time, he was 70 years old and had been in prison for 26 years. The disease presented in him with the almost classic symptom: He was coughing up blood and was also increasingly fatigued and losing weight. After doctors initially suspected a viral infection, but then TB was proven, he was treated with medication, and fluid was also drained from his lungs. [Mr.] Mandela was hospitalized for six weeks at Tygerberg Hospital in Cape Town, the second largest hospital in South Africa. The therapy worked well, but [Mr.] Mandela’s lungs remained damaged. He was subsequently prone to pneumonia and was repeatedly hospitalized for pneumonia in 2012 and 2013.
 

Q: Mandela was lucky that the treatment worked for him. A few years later, the first antibiotic-resistant pathogen strains developed. How did medical research respond to this development?

Gerste: The emergence of multidrug resistant (MDR) strains of the pathogen prompted the WHO to declare a “global health emergency” in 1993. Three years later, World TB Day was proclaimed to raise awareness of the threat posed by this disease, which has been known since ancient times. It always takes place on March 24, the day in 1882 when Robert Koch gave his famous lecture in Berlin in which he announced the discovery of the pathogen Mycobacterium tuberculosis.

Medical research has introduced new drugs into TB therapy, such as bedaquiline and delamanid. But MDR tuberculosis therapy remains a global challenge and has diminished hopes of eradicating tuberculosis, as we did with smallpox some 40 years ago. Today, only 56% of all MDR-TB patients worldwide are successfully treated.
 

Q: As already mentioned, the TB pathogen was discovered by Robert Koch. How did this come about?

Gerste: Along with cholera, TB was a great epidemic of the 19th century. For an ambitious researcher like Robert Koch, who had made a name for himself with the discovery of anthrax in 1876, there was no more rewarding goal than to find the cause of this infectious disease, which claimed the lives of many famous people such as Kafka, Dostoevsky, and Schiller, as well as many whose names are forgotten today.

[Dr.] Koch worked with his cultures for several years; the method of staining with methylene blue that was developed by the young Paul Ehrlich represented a breakthrough. To this method, [Dr.] Koch added a second, brownish dye. After countless experiments, this allowed slightly curved bacilli to be identified in tuberculous material under the microscope.

On the evening of March 24, 1882, [Dr.] Koch gave a lecture at the Institute of Physiology in Berlin with the title “Etiology of TB,” which sounded less than sensational on the invitations. One or two dozen participants had been expected, but more than one hundred came; numerous listeners had to make do with standing room behind the rows of chairs in the lecture hall. After a rather dry presentation ([Dr.] Koch was not a great orator nor a self-promoter), he presented his results to those present.

His assistants had set up a series of microscopes in the lecture hall through which everyone could get a glimpse of this enemy of humanity: the tubercle bacillus. When [Dr.] Koch had finished his remarks, there was silence in the hall. There was no burst of applause; the audience was too deeply aware that they had witnessed a historic moment. Paul Ehrlich later said that this evening had been the most significant scientific experience of his life. Over the next few weeks, the newspapers made a national hero out of Robert Koch, and the Emperor appointed him a Privy Councilor of the Government. The country doctor from Pomerania was now the figurehead of science in the young German Empire.
 

Q: Shortly after his discovery, [Dr.] Koch advertised a vaccination against TB with the active ingredient tuberculin. Was he able to convince with that too?

Gerste: No, this was the big flop, almost the disaster of a remarkable scientific career. The preparation of attenuated tubercle bacilli with water and glycerin not only did not prevent infection at all, it proved fatal for numerous users. However, tuberculin has survived in a modified form: as a tuberculin test, in which a characteristic skin rash indicates that a tested person has already had contact with the Mycobacterium.
 

Q: How have diagnostic options and treatment of the disease evolved since Robert Koch’s lifetime?

Gerste: A very decisive advance was made in diagnostics. With the rather accidental discovery of the rays soon named after him by Wilhelm Conrad Röntgen in the last days of 1895, it became possible to visualize the lung changes that tuberculosis caused in an unexpected way on living patients; the serial examinations for TB by X-rays were the logical consequence. Both scientists received Nobel Prizes, which were still new at the time, within a few years of each other: [Dr.] Röntgen in 1901 for physics, and [Dr]. Koch in 1905 for medicine and physiology.

Effective drugs were practically unavailable toward the end of the 19th century. For those who could afford it, however, a whole new world of (hoped-for or perceived) healing from “consumption” opened up: the sanatorium, located high in the mountains, surrounded by “fresh air.” The most famous of these climatic health resorts is probably Davos. It is no disrespect to the Swiss Confederation, which I hold in high esteem, to point out that Switzerland owes its high status as a tourist destination and thus its prosperity in part to TB.
 

Q: Things were quite different in earlier times. Until 250 years ago, the hopes of many patients rested on the medieval healing method of the “royal touch.” What’s that all about?

Gerste: In the Middle Ages, a “healing method” emerged from which not only lepers and other seriously ill people but also those suffering from consumption expected to be saved: the “royal touch,” which was first described by the Frankish king Clovis in 496. This ceremony was based on the idea that the king or queen, anointed by God, could improve or even cure the ailment of a sick person through a brief touch.

With the transition from the Middle Ages to the early modern period, this act, during which thousands often gathered in front of the ruler’s residence, was practiced on a large scale. The sufferers passed by the anointed ruler as if in a procession and were briefly touched by him or her. The extremely few “successes” were of course exploited by royal propaganda to proclaim the blessing that the reign of the king or queen meant for the country. But on those who nevertheless fell victim to TB or another ailment, the chroniclers remained silent.

Charles II of England, who ruled from 1660 to 1685 during the Restoration after the English Civil War, is said to have touched 92,102 sick people during this period, according to contemporary counts. The record for a single day’s performance is probably held by Louis XVI of France, who is said to have touched a total of 2,400 sufferers on June 14, 1775. Some of them may have stood and cheered in the Paris crowd 18 years later as the king climbed the steps to the guillotine.
 

Q: Another invention associated with TB diagnosis is the stethoscope. How did it come about?

Gerste: A young physician named René-Théophile-Hyacinthe Laënnec had already experienced the importance of diagnosing TB in his student years. His teacher in Paris was Xavier Bichat, considered the founder of histology, who died of TB in [Dr.] Laënnec’s second year at the age of only 30. [Dr.] Laënnec was a devotee of auscultation and made it work with a massively overweight patient by rolling up a sheet of paper, then placing this on the woman’s thorax to listen to her heart sounds. He developed the idea further and built a hollow wooden tube with a metal earpiece. In 1818, he presented the device at the meeting of the Academy of Sciences in Paris; he called it a stethoscope. He used his new instrument primarily to auscultate the lungs of patients with TB and distinguished the sounds of TB cavities from those of other lung diseases such as pneumonia and emphysema.
 

Q: Back to the present day: The WHO wants to eradicate TB once and for all. What are the hopes and fears in the fight against this disease?

Gerste: There is no doubt that we are currently taking a step backwards in these efforts, and this is not only due to multiresistant pathogens. Especially in poorer countries particularly affected by TB, treatment and screening programs have been disrupted by lockdown measures targeting COVID-19. The WHO suspects that in the first pandemic year, 2020, about half a million additional people may have died from TB because they never received a diagnosis.

Dr. Gerste, born in 1957, is a physician and historian. Dr. Gerste has lived for many years as a correspondent and book author in Washington, D.C., where he writes primarily for the New Journal of Zürich, the FAS, Back Then, the German Medical Journal, and other academic journals.

This article was translated from Coliquio.

Almost forgotten today, tuberculosis is still one of the deadliest infectious diseases in the world. In an interview with Coliquio, Ronald D. Gerste, MD, PhD, an ophthalmologist and historian, looked back on this disease’s eventful history, which encompasses outstanding discoveries and catastrophic failures in diagnosis and treatment from the Middle Ages to the present day.

Under different names, TB has affected mankind for millennia. One of these names was the “aesthetic disease,” because it led to weight loss and pallor in the younger patients that it often affected. This was considered the ideal of beauty in the Victorian era. Many celebrities suffered from the disease, including poets and artists such as Friedrich Schiller, Lord Byron, and the Bronte family. As recently as the early 1990s, the disease almost changed world history, because Nelson Mandela became ill before the negotiations that led to the end of apartheid in South Africa.

Today, the global community is still not on track to meet its self-imposed targets for controlling the infectious disease, as reported by the World Health Organization on World TB Day in late March. Children and young people are the leading victims. In 2020 alone, 1.1 million children and adolescents under age 15 years were infected with TB, and 226,000 died of the disease, according to the WHO.
 

Q: Nelson Mandela was ill with tuberculosis during his imprisonment. How did the disease manifest itself in the future Nobel Peace Prize winner, and what is known about the treatment?

Ronald D. Gerste: Nelson Mandela contracted tuberculosis in 1988. At that time, he was 70 years old and had been in prison for 26 years. The disease presented in him with the almost classic symptom: He was coughing up blood and was also increasingly fatigued and losing weight. After doctors initially suspected a viral infection, but then TB was proven, he was treated with medication, and fluid was also drained from his lungs. [Mr.] Mandela was hospitalized for six weeks at Tygerberg Hospital in Cape Town, the second largest hospital in South Africa. The therapy worked well, but [Mr.] Mandela’s lungs remained damaged. He was subsequently prone to pneumonia and was repeatedly hospitalized for pneumonia in 2012 and 2013.
 

Q: Mandela was lucky that the treatment worked for him. A few years later, the first antibiotic-resistant pathogen strains developed. How did medical research respond to this development?

Gerste: The emergence of multidrug resistant (MDR) strains of the pathogen prompted the WHO to declare a “global health emergency” in 1993. Three years later, World TB Day was proclaimed to raise awareness of the threat posed by this disease, which has been known since ancient times. It always takes place on March 24, the day in 1882 when Robert Koch gave his famous lecture in Berlin in which he announced the discovery of the pathogen Mycobacterium tuberculosis.

Medical research has introduced new drugs into TB therapy, such as bedaquiline and delamanid. But MDR tuberculosis therapy remains a global challenge and has diminished hopes of eradicating tuberculosis, as we did with smallpox some 40 years ago. Today, only 56% of all MDR-TB patients worldwide are successfully treated.
 

Q: As already mentioned, the TB pathogen was discovered by Robert Koch. How did this come about?

Gerste: Along with cholera, TB was a great epidemic of the 19th century. For an ambitious researcher like Robert Koch, who had made a name for himself with the discovery of anthrax in 1876, there was no more rewarding goal than to find the cause of this infectious disease, which claimed the lives of many famous people such as Kafka, Dostoevsky, and Schiller, as well as many whose names are forgotten today.

[Dr.] Koch worked with his cultures for several years; the method of staining with methylene blue that was developed by the young Paul Ehrlich represented a breakthrough. To this method, [Dr.] Koch added a second, brownish dye. After countless experiments, this allowed slightly curved bacilli to be identified in tuberculous material under the microscope.

On the evening of March 24, 1882, [Dr.] Koch gave a lecture at the Institute of Physiology in Berlin with the title “Etiology of TB,” which sounded less than sensational on the invitations. One or two dozen participants had been expected, but more than one hundred came; numerous listeners had to make do with standing room behind the rows of chairs in the lecture hall. After a rather dry presentation ([Dr.] Koch was not a great orator nor a self-promoter), he presented his results to those present.

His assistants had set up a series of microscopes in the lecture hall through which everyone could get a glimpse of this enemy of humanity: the tubercle bacillus. When [Dr.] Koch had finished his remarks, there was silence in the hall. There was no burst of applause; the audience was too deeply aware that they had witnessed a historic moment. Paul Ehrlich later said that this evening had been the most significant scientific experience of his life. Over the next few weeks, the newspapers made a national hero out of Robert Koch, and the Emperor appointed him a Privy Councilor of the Government. The country doctor from Pomerania was now the figurehead of science in the young German Empire.
 

Q: Shortly after his discovery, [Dr.] Koch advertised a vaccination against TB with the active ingredient tuberculin. Was he able to convince with that too?

Gerste: No, this was the big flop, almost the disaster of a remarkable scientific career. The preparation of attenuated tubercle bacilli with water and glycerin not only did not prevent infection at all, it proved fatal for numerous users. However, tuberculin has survived in a modified form: as a tuberculin test, in which a characteristic skin rash indicates that a tested person has already had contact with the Mycobacterium.
 

Q: How have diagnostic options and treatment of the disease evolved since Robert Koch’s lifetime?

Gerste: A very decisive advance was made in diagnostics. With the rather accidental discovery of the rays soon named after him by Wilhelm Conrad Röntgen in the last days of 1895, it became possible to visualize the lung changes that tuberculosis caused in an unexpected way on living patients; the serial examinations for TB by X-rays were the logical consequence. Both scientists received Nobel Prizes, which were still new at the time, within a few years of each other: [Dr.] Röntgen in 1901 for physics, and [Dr]. Koch in 1905 for medicine and physiology.

Effective drugs were practically unavailable toward the end of the 19th century. For those who could afford it, however, a whole new world of (hoped-for or perceived) healing from “consumption” opened up: the sanatorium, located high in the mountains, surrounded by “fresh air.” The most famous of these climatic health resorts is probably Davos. It is no disrespect to the Swiss Confederation, which I hold in high esteem, to point out that Switzerland owes its high status as a tourist destination and thus its prosperity in part to TB.
 

Q: Things were quite different in earlier times. Until 250 years ago, the hopes of many patients rested on the medieval healing method of the “royal touch.” What’s that all about?

Gerste: In the Middle Ages, a “healing method” emerged from which not only lepers and other seriously ill people but also those suffering from consumption expected to be saved: the “royal touch,” which was first described by the Frankish king Clovis in 496. This ceremony was based on the idea that the king or queen, anointed by God, could improve or even cure the ailment of a sick person through a brief touch.

With the transition from the Middle Ages to the early modern period, this act, during which thousands often gathered in front of the ruler’s residence, was practiced on a large scale. The sufferers passed by the anointed ruler as if in a procession and were briefly touched by him or her. The extremely few “successes” were of course exploited by royal propaganda to proclaim the blessing that the reign of the king or queen meant for the country. But on those who nevertheless fell victim to TB or another ailment, the chroniclers remained silent.

Charles II of England, who ruled from 1660 to 1685 during the Restoration after the English Civil War, is said to have touched 92,102 sick people during this period, according to contemporary counts. The record for a single day’s performance is probably held by Louis XVI of France, who is said to have touched a total of 2,400 sufferers on June 14, 1775. Some of them may have stood and cheered in the Paris crowd 18 years later as the king climbed the steps to the guillotine.
 

Q: Another invention associated with TB diagnosis is the stethoscope. How did it come about?

Gerste: A young physician named René-Théophile-Hyacinthe Laënnec had already experienced the importance of diagnosing TB in his student years. His teacher in Paris was Xavier Bichat, considered the founder of histology, who died of TB in [Dr.] Laënnec’s second year at the age of only 30. [Dr.] Laënnec was a devotee of auscultation and made it work with a massively overweight patient by rolling up a sheet of paper, then placing this on the woman’s thorax to listen to her heart sounds. He developed the idea further and built a hollow wooden tube with a metal earpiece. In 1818, he presented the device at the meeting of the Academy of Sciences in Paris; he called it a stethoscope. He used his new instrument primarily to auscultate the lungs of patients with TB and distinguished the sounds of TB cavities from those of other lung diseases such as pneumonia and emphysema.
 

Q: Back to the present day: The WHO wants to eradicate TB once and for all. What are the hopes and fears in the fight against this disease?

Gerste: There is no doubt that we are currently taking a step backwards in these efforts, and this is not only due to multiresistant pathogens. Especially in poorer countries particularly affected by TB, treatment and screening programs have been disrupted by lockdown measures targeting COVID-19. The WHO suspects that in the first pandemic year, 2020, about half a million additional people may have died from TB because they never received a diagnosis.

Dr. Gerste, born in 1957, is a physician and historian. Dr. Gerste has lived for many years as a correspondent and book author in Washington, D.C., where he writes primarily for the New Journal of Zürich, the FAS, Back Then, the German Medical Journal, and other academic journals.

This article was translated from Coliquio.

Imiquimod cream is a safe, effective, first-line alternative to surgery for the treatment of vulvar high-grade squamous intraepithelial lesions (vHSILs), suggest the results from the first randomized trial to compare the two approaches directly.

The findings provide women with human papillomavirus (HPV)–related precancerous lesions with a new treatment option that can circumvent drawbacks of surgery, according to first author Gerda Trutnovsky, MD, deputy head of the Division of Gynecology at the Medical University of Graz, Austria.

“Surgical removal of [vulvar intraepithelial neoplasia] can cause wound healing disorders, scarring, and even sexual complaints later on,” she explained in a press statement. Further, recurrences are common, and repeat surgeries are often necessary, she said.

The results from the trial show that “imiquimod cream was effective and well tolerated, and the rate of success of this treatment equaled that of surgery,” Dr. Trutnovsky said.

The study was published online in The Lancet.

The findings are of note because HPV vaccination rates remain low, and the incidence of both cervical and vulvar intraepithelial neoplasia has increased in recent years, particularly among younger women, the authors comment.
 

First head-to-head trial

For the trial, Dr. Trutnovsky and her colleagues randomly assigned 110 women with vHSIL to receive either imiquimod treatment or surgery between June 2013 and January 2020. Of these patients, 78% had unifocal lesions, and 22% had multifocal lesions.

The participants (aged 18-90 years) were recruited from six hospitals in Austria. All had histologically confirmed vHSIL with visible unifocal or multifocal lesions. Those with suspected invasive disease, a history of vulvar cancer or severe inflammatory dermatosis of the vulva, or who had undergone active treatment for vHSIL in the prior 3 months were excluded.

Imiquimod treatment was self-administered. The dose was slowly escalated to no more than three times per week for 4-6 months. Surgery involved either excision or ablation.

The team reports that 98 patients (of the 110 who were randomly assigned) completed the study: 46 in the imiquinod arm and 52 in the surgery arm.

Complete clinical response rates at 6 months were 80% with imiquimod versus 79% with surgery. No significant difference was observed between the groups with respect to HPV clearance, adverse events, and treatment satisfaction, the authors report.

“Long-term follow-up ... is ongoing and will assess the effect of treatment modality on recurrence rates,” the team comments.

Dr. Trutnovsky and colleagues recommend that patients with vHSIL be counseled regarding the potential benefits and risks of treatment options. “On the basis of our results, the oncological safety of imiquimod treatment can be assumed as long as regular clinical check-ups are carried out,” they write.

They also note that good patient compliance is important for treatment with imiquimod to be successful and that surgery might remain the treatment of choice for patients who may not be adherent to treatment.

“In all other women with vHSIL, imiquimod can be considered a first-line treatment option,” the authors conclude.

The study was funded by the Austrian Science Fund and Austrian Gynaecological Oncology group. The authors have disclosed no relevant financial relationships.

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

Imiquimod cream is a safe, effective, first-line alternative to surgery for the treatment of vulvar high-grade squamous intraepithelial lesions (vHSILs), suggest the results from the first randomized trial to compare the two approaches directly.

The findings provide women with human papillomavirus (HPV)–related precancerous lesions with a new treatment option that can circumvent drawbacks of surgery, according to first author Gerda Trutnovsky, MD, deputy head of the Division of Gynecology at the Medical University of Graz, Austria.

“Surgical removal of [vulvar intraepithelial neoplasia] can cause wound healing disorders, scarring, and even sexual complaints later on,” she explained in a press statement. Further, recurrences are common, and repeat surgeries are often necessary, she said.

The results from the trial show that “imiquimod cream was effective and well tolerated, and the rate of success of this treatment equaled that of surgery,” Dr. Trutnovsky said.

The study was published online in The Lancet.

The findings are of note because HPV vaccination rates remain low, and the incidence of both cervical and vulvar intraepithelial neoplasia has increased in recent years, particularly among younger women, the authors comment.
 

First head-to-head trial

For the trial, Dr. Trutnovsky and her colleagues randomly assigned 110 women with vHSIL to receive either imiquimod treatment or surgery between June 2013 and January 2020. Of these patients, 78% had unifocal lesions, and 22% had multifocal lesions.

The participants (aged 18-90 years) were recruited from six hospitals in Austria. All had histologically confirmed vHSIL with visible unifocal or multifocal lesions. Those with suspected invasive disease, a history of vulvar cancer or severe inflammatory dermatosis of the vulva, or who had undergone active treatment for vHSIL in the prior 3 months were excluded.

Imiquimod treatment was self-administered. The dose was slowly escalated to no more than three times per week for 4-6 months. Surgery involved either excision or ablation.

The team reports that 98 patients (of the 110 who were randomly assigned) completed the study: 46 in the imiquinod arm and 52 in the surgery arm.

Complete clinical response rates at 6 months were 80% with imiquimod versus 79% with surgery. No significant difference was observed between the groups with respect to HPV clearance, adverse events, and treatment satisfaction, the authors report.

“Long-term follow-up ... is ongoing and will assess the effect of treatment modality on recurrence rates,” the team comments.

Dr. Trutnovsky and colleagues recommend that patients with vHSIL be counseled regarding the potential benefits and risks of treatment options. “On the basis of our results, the oncological safety of imiquimod treatment can be assumed as long as regular clinical check-ups are carried out,” they write.

They also note that good patient compliance is important for treatment with imiquimod to be successful and that surgery might remain the treatment of choice for patients who may not be adherent to treatment.

“In all other women with vHSIL, imiquimod can be considered a first-line treatment option,” the authors conclude.

The study was funded by the Austrian Science Fund and Austrian Gynaecological Oncology group. The authors have disclosed no relevant financial relationships.

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

Imiquimod cream is a safe, effective, first-line alternative to surgery for the treatment of vulvar high-grade squamous intraepithelial lesions (vHSILs), suggest the results from the first randomized trial to compare the two approaches directly.

The findings provide women with human papillomavirus (HPV)–related precancerous lesions with a new treatment option that can circumvent drawbacks of surgery, according to first author Gerda Trutnovsky, MD, deputy head of the Division of Gynecology at the Medical University of Graz, Austria.

“Surgical removal of [vulvar intraepithelial neoplasia] can cause wound healing disorders, scarring, and even sexual complaints later on,” she explained in a press statement. Further, recurrences are common, and repeat surgeries are often necessary, she said.

The results from the trial show that “imiquimod cream was effective and well tolerated, and the rate of success of this treatment equaled that of surgery,” Dr. Trutnovsky said.

The study was published online in The Lancet.

The findings are of note because HPV vaccination rates remain low, and the incidence of both cervical and vulvar intraepithelial neoplasia has increased in recent years, particularly among younger women, the authors comment.
 

First head-to-head trial

For the trial, Dr. Trutnovsky and her colleagues randomly assigned 110 women with vHSIL to receive either imiquimod treatment or surgery between June 2013 and January 2020. Of these patients, 78% had unifocal lesions, and 22% had multifocal lesions.

The participants (aged 18-90 years) were recruited from six hospitals in Austria. All had histologically confirmed vHSIL with visible unifocal or multifocal lesions. Those with suspected invasive disease, a history of vulvar cancer or severe inflammatory dermatosis of the vulva, or who had undergone active treatment for vHSIL in the prior 3 months were excluded.

Imiquimod treatment was self-administered. The dose was slowly escalated to no more than three times per week for 4-6 months. Surgery involved either excision or ablation.

The team reports that 98 patients (of the 110 who were randomly assigned) completed the study: 46 in the imiquinod arm and 52 in the surgery arm.

Complete clinical response rates at 6 months were 80% with imiquimod versus 79% with surgery. No significant difference was observed between the groups with respect to HPV clearance, adverse events, and treatment satisfaction, the authors report.

“Long-term follow-up ... is ongoing and will assess the effect of treatment modality on recurrence rates,” the team comments.

Dr. Trutnovsky and colleagues recommend that patients with vHSIL be counseled regarding the potential benefits and risks of treatment options. “On the basis of our results, the oncological safety of imiquimod treatment can be assumed as long as regular clinical check-ups are carried out,” they write.

They also note that good patient compliance is important for treatment with imiquimod to be successful and that surgery might remain the treatment of choice for patients who may not be adherent to treatment.

“In all other women with vHSIL, imiquimod can be considered a first-line treatment option,” the authors conclude.

The study was funded by the Austrian Science Fund and Austrian Gynaecological Oncology group. The authors have disclosed no relevant financial relationships.

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