New world order: Reflecting on a year of COVID

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Changed
Thu, 08/26/2021 - 15:46

I remember sitting at the pool in San Diego. I had been there before many years prior – one of my first medical conferences. I remember the clinking of metal sail stays in the morning breeze.

Dr. Rebecca Jaffe

Flying out this time I packed a few surgical masks. I guiltily picked up an N95 from the hospital floors the day before leaving, but then left it at home thinking it overkill. I still have it in a ziplock bag a year later – it’s our emergency “what-if-we-have-to-care-for-one-another-with-COVID-in-this-tiny-house-full-of-kids” N95. Not that my husband has been fit tested. At the time, neither was I.

I returned after the conference to befuddlement over how we might fit test thousands of people, racing COVID to the front door. An overly complicated task, as we didn’t even know who was supposed to be responsible for orchestrating such an effort. We didn’t even know if we could spare the N95s.

Still in California, I sat by the pool wondering if anyone would acknowledge the impending new reality. At the conference we were told “don’t shake hands, don’t touch your face, wash your hands a lot.” I gave a workshop without a mask. I ate dinner in an actual restaurant worried only about gluten free soy sauce. I sat in a lecture hall with almost 5,000 people. I started to have a conversation with a friend from Seattle, but he needed to leave because they found a positive patient in his hospital. I listened to a prerecorded webinar by the pool from our chief safety officer saying there was a plan. I was not reassured.

When we flew home the world had already changed. There were patients in New York now. Masks had appeared in the airport news stand. Yet we breathed the air in the closed space of the red eye and forgot to be concerned. At work that Monday I asked my team – fist to 5, how worried are you about this? Brave faces and side eyes at each other and a lot of 1s or 2s held up in the air. My job this week, I told them, is to get you all to a 5.

I was working with a resident who 2 months prior I had told, as we worked together in the lounge, I don’t think you’re going to China on vacation. She hadn’t gone, of course. I wasn’t going on spring break either. On one of my last train rides a commuter friend (remember those?) told me we’ll all feel a lot better once we realize that none of us are going to get to do any of the things we want to do.

The med students were still there, helping the team and hanging onto their education. I told everyone not to see any patient with a respiratory complaint until we first discussed the case. On the third day of service I had to call infection control because a hypoxic febrile patient had come to the floor without isolation orders. “Are we testing?” No, I was informed, she hadn’t had exposures, hadn’t travelled. Speechless that we were screening for travel to Italy while living with one tiny state between us and the American epicenter, I can now recall thinking that our infection control officer did not sound well rested.

My N95 was still in a baggy at home. The PAPRS hadn’t appeared yet. Literally no one could agree what kind of mask the CDC or infection control or the ID consultant of the day recommended – today we are using surgical masks, I was told. Thursday will likely be different. “Anyway, she doesn’t sound like she has it.” I walked to the floors.

My med student started presenting our septic viral pneumonia patient including the very well done exam that I previously forbade him from obtaining. What happened to not seeing respiratory patients, I asked. Oh, they said, well night float said it didn’t sound like COVID. Insufficiently convinced by our second year resident’s unjustifiably overconfident, though ultimately correct, assessment – I held my head in my hands and give my first hallway COVID chalk talk of the new era. Complete with telling the team to question everything they thought they knew now including everything I said except “be careful.” That was about when Philadelphia ran out of toilet paper.

That weekend I sat in front of a bay of computers as our Medical Officer of the Day. Air traffic control for ED patients coming in for a landing on medical teams, I watched the new biohazard warnings line up indicating respiratory isolation patients waiting for a bed. I watched CRPs and D-dimers, and looked for leukopenia. I vowed I would follow up on tests to hone my COVID illness script. I soon realized that tests lie anyway.

By the end of that week we’d fallen through the looking glass. The old rules didn’t apply. We weren’t going to China, or Arizona; we didn’t know when the med students were coming back; the jobs we had were not the jobs we signed up for but were those that the world needed us to do; we couldn’t trust our intuition or our tests; we had no experts – and yet we started to grow the humble beginnings of expertise like spring garden sprouts.

In a chaotic world, seeds of order take shape and then scatter like a screensaver. The skills needed to manage chaos are different from those that leaders use in simple ordered times. Order cannot be pulled from chaos by force of will or cleverness, nor can it be delegated, cascaded, demanded, or launched. Order emerges when communities that are receptive to learning see patterns through noise, and slowly, lovingly, coax moments of stability into being.
 

Dr. Jaffe is division director for hospital medicine in the Department of Medicine at Thomas Jefferson University Hospital in Philadelphia.

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I remember sitting at the pool in San Diego. I had been there before many years prior – one of my first medical conferences. I remember the clinking of metal sail stays in the morning breeze.

Dr. Rebecca Jaffe

Flying out this time I packed a few surgical masks. I guiltily picked up an N95 from the hospital floors the day before leaving, but then left it at home thinking it overkill. I still have it in a ziplock bag a year later – it’s our emergency “what-if-we-have-to-care-for-one-another-with-COVID-in-this-tiny-house-full-of-kids” N95. Not that my husband has been fit tested. At the time, neither was I.

I returned after the conference to befuddlement over how we might fit test thousands of people, racing COVID to the front door. An overly complicated task, as we didn’t even know who was supposed to be responsible for orchestrating such an effort. We didn’t even know if we could spare the N95s.

Still in California, I sat by the pool wondering if anyone would acknowledge the impending new reality. At the conference we were told “don’t shake hands, don’t touch your face, wash your hands a lot.” I gave a workshop without a mask. I ate dinner in an actual restaurant worried only about gluten free soy sauce. I sat in a lecture hall with almost 5,000 people. I started to have a conversation with a friend from Seattle, but he needed to leave because they found a positive patient in his hospital. I listened to a prerecorded webinar by the pool from our chief safety officer saying there was a plan. I was not reassured.

When we flew home the world had already changed. There were patients in New York now. Masks had appeared in the airport news stand. Yet we breathed the air in the closed space of the red eye and forgot to be concerned. At work that Monday I asked my team – fist to 5, how worried are you about this? Brave faces and side eyes at each other and a lot of 1s or 2s held up in the air. My job this week, I told them, is to get you all to a 5.

I was working with a resident who 2 months prior I had told, as we worked together in the lounge, I don’t think you’re going to China on vacation. She hadn’t gone, of course. I wasn’t going on spring break either. On one of my last train rides a commuter friend (remember those?) told me we’ll all feel a lot better once we realize that none of us are going to get to do any of the things we want to do.

The med students were still there, helping the team and hanging onto their education. I told everyone not to see any patient with a respiratory complaint until we first discussed the case. On the third day of service I had to call infection control because a hypoxic febrile patient had come to the floor without isolation orders. “Are we testing?” No, I was informed, she hadn’t had exposures, hadn’t travelled. Speechless that we were screening for travel to Italy while living with one tiny state between us and the American epicenter, I can now recall thinking that our infection control officer did not sound well rested.

My N95 was still in a baggy at home. The PAPRS hadn’t appeared yet. Literally no one could agree what kind of mask the CDC or infection control or the ID consultant of the day recommended – today we are using surgical masks, I was told. Thursday will likely be different. “Anyway, she doesn’t sound like she has it.” I walked to the floors.

My med student started presenting our septic viral pneumonia patient including the very well done exam that I previously forbade him from obtaining. What happened to not seeing respiratory patients, I asked. Oh, they said, well night float said it didn’t sound like COVID. Insufficiently convinced by our second year resident’s unjustifiably overconfident, though ultimately correct, assessment – I held my head in my hands and give my first hallway COVID chalk talk of the new era. Complete with telling the team to question everything they thought they knew now including everything I said except “be careful.” That was about when Philadelphia ran out of toilet paper.

That weekend I sat in front of a bay of computers as our Medical Officer of the Day. Air traffic control for ED patients coming in for a landing on medical teams, I watched the new biohazard warnings line up indicating respiratory isolation patients waiting for a bed. I watched CRPs and D-dimers, and looked for leukopenia. I vowed I would follow up on tests to hone my COVID illness script. I soon realized that tests lie anyway.

By the end of that week we’d fallen through the looking glass. The old rules didn’t apply. We weren’t going to China, or Arizona; we didn’t know when the med students were coming back; the jobs we had were not the jobs we signed up for but were those that the world needed us to do; we couldn’t trust our intuition or our tests; we had no experts – and yet we started to grow the humble beginnings of expertise like spring garden sprouts.

In a chaotic world, seeds of order take shape and then scatter like a screensaver. The skills needed to manage chaos are different from those that leaders use in simple ordered times. Order cannot be pulled from chaos by force of will or cleverness, nor can it be delegated, cascaded, demanded, or launched. Order emerges when communities that are receptive to learning see patterns through noise, and slowly, lovingly, coax moments of stability into being.
 

Dr. Jaffe is division director for hospital medicine in the Department of Medicine at Thomas Jefferson University Hospital in Philadelphia.

I remember sitting at the pool in San Diego. I had been there before many years prior – one of my first medical conferences. I remember the clinking of metal sail stays in the morning breeze.

Dr. Rebecca Jaffe

Flying out this time I packed a few surgical masks. I guiltily picked up an N95 from the hospital floors the day before leaving, but then left it at home thinking it overkill. I still have it in a ziplock bag a year later – it’s our emergency “what-if-we-have-to-care-for-one-another-with-COVID-in-this-tiny-house-full-of-kids” N95. Not that my husband has been fit tested. At the time, neither was I.

I returned after the conference to befuddlement over how we might fit test thousands of people, racing COVID to the front door. An overly complicated task, as we didn’t even know who was supposed to be responsible for orchestrating such an effort. We didn’t even know if we could spare the N95s.

Still in California, I sat by the pool wondering if anyone would acknowledge the impending new reality. At the conference we were told “don’t shake hands, don’t touch your face, wash your hands a lot.” I gave a workshop without a mask. I ate dinner in an actual restaurant worried only about gluten free soy sauce. I sat in a lecture hall with almost 5,000 people. I started to have a conversation with a friend from Seattle, but he needed to leave because they found a positive patient in his hospital. I listened to a prerecorded webinar by the pool from our chief safety officer saying there was a plan. I was not reassured.

When we flew home the world had already changed. There were patients in New York now. Masks had appeared in the airport news stand. Yet we breathed the air in the closed space of the red eye and forgot to be concerned. At work that Monday I asked my team – fist to 5, how worried are you about this? Brave faces and side eyes at each other and a lot of 1s or 2s held up in the air. My job this week, I told them, is to get you all to a 5.

I was working with a resident who 2 months prior I had told, as we worked together in the lounge, I don’t think you’re going to China on vacation. She hadn’t gone, of course. I wasn’t going on spring break either. On one of my last train rides a commuter friend (remember those?) told me we’ll all feel a lot better once we realize that none of us are going to get to do any of the things we want to do.

The med students were still there, helping the team and hanging onto their education. I told everyone not to see any patient with a respiratory complaint until we first discussed the case. On the third day of service I had to call infection control because a hypoxic febrile patient had come to the floor without isolation orders. “Are we testing?” No, I was informed, she hadn’t had exposures, hadn’t travelled. Speechless that we were screening for travel to Italy while living with one tiny state between us and the American epicenter, I can now recall thinking that our infection control officer did not sound well rested.

My N95 was still in a baggy at home. The PAPRS hadn’t appeared yet. Literally no one could agree what kind of mask the CDC or infection control or the ID consultant of the day recommended – today we are using surgical masks, I was told. Thursday will likely be different. “Anyway, she doesn’t sound like she has it.” I walked to the floors.

My med student started presenting our septic viral pneumonia patient including the very well done exam that I previously forbade him from obtaining. What happened to not seeing respiratory patients, I asked. Oh, they said, well night float said it didn’t sound like COVID. Insufficiently convinced by our second year resident’s unjustifiably overconfident, though ultimately correct, assessment – I held my head in my hands and give my first hallway COVID chalk talk of the new era. Complete with telling the team to question everything they thought they knew now including everything I said except “be careful.” That was about when Philadelphia ran out of toilet paper.

That weekend I sat in front of a bay of computers as our Medical Officer of the Day. Air traffic control for ED patients coming in for a landing on medical teams, I watched the new biohazard warnings line up indicating respiratory isolation patients waiting for a bed. I watched CRPs and D-dimers, and looked for leukopenia. I vowed I would follow up on tests to hone my COVID illness script. I soon realized that tests lie anyway.

By the end of that week we’d fallen through the looking glass. The old rules didn’t apply. We weren’t going to China, or Arizona; we didn’t know when the med students were coming back; the jobs we had were not the jobs we signed up for but were those that the world needed us to do; we couldn’t trust our intuition or our tests; we had no experts – and yet we started to grow the humble beginnings of expertise like spring garden sprouts.

In a chaotic world, seeds of order take shape and then scatter like a screensaver. The skills needed to manage chaos are different from those that leaders use in simple ordered times. Order cannot be pulled from chaos by force of will or cleverness, nor can it be delegated, cascaded, demanded, or launched. Order emerges when communities that are receptive to learning see patterns through noise, and slowly, lovingly, coax moments of stability into being.
 

Dr. Jaffe is division director for hospital medicine in the Department of Medicine at Thomas Jefferson University Hospital in Philadelphia.

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Free U.K. tool could help guide COVID-19 care for cancer patients

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Changed
Thu, 09/09/2021 - 16:19

 

An online support tool for health care professionals that recommends whether to admit or discharge a cancer patient with COVID-19, based on their risk of a severe complication, has been developed by researchers from Manchester.

The team used machine learning on data from more than 900 cancer patients with COVID-19, conducting multiple analyses to arrive at a set of features that could accurately predict the need for admission or oxygen therapy, as well as the risk of death.

Dr. Rebecca Lee, The Christie NHS Foundation Trust, Manchester, and colleagues then developed thresholds to derive a score that recommended admission in 95% of patients who went on to need oxygen and an even greater proportion of those who later died.

The research was presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting on June 4.
 

CORONET

The resulting COVID-19 Risk in Oncology Evaluation Tool (CORONET) model “performs very well at predicting admission and severity of COVID-19 in patients with cancer,” Dr. Lee said. “We have set pragmatic and clinically relevant thresholds that focus on the safety regarding an admission versus discharge decision.”

To help health care professionals, the researchers have built a free online support tool that allows them to enter data and receive a recommendation “as to whether their patient should be considered for discharge, considered for admission, or is at high risk of having a severe outcome of coronavirus,” Dr. Lee explained.

“The health care professional can then explore the recommendation by seeing how their patient … compares with the rest of the cohort.”

The tool also includes a “diagram showing which features are most important to recommend a discharge decision versus an admission decision for each individual patient.”
 

Clinically intuitive

Dr. Alexi Wright, associate professor, Dana-Faber Cancer Institute, Boston, who was not involved in the study, commented that there were many things that were “really nice about the study.”

“First and foremost that they were establishing a tool to efficiently triage [patients] presenting with COVID,” she said, adding that it was “clinically intuitive” that the team made “pragmatic choices,” and the use of a random forest algorithm means the results are “very interpretable.”

However, Dr. Wright wondered whether the results can be replicated.

Alongside a lack of information on the deaths in the cohort, she pointed out that “ideally you have three data sets, with a training set, a testing set, and a validation set.”

The CORONET model was, however, trained and evaluated on the same dataset, “so it really needs external validation before it would be ready for direct clinical application.”

She continued that there is a “critical need to establish that studies can both be reproduced and replicated,” noting that a recent review showed that 85% of machine-learning studies that were used to detect COVID-19 using chest radiographs “failed fundamental reproducibility and quality checks.” 

 

Risk factors

Dr. Lee began her presentation by reminding the audience that cancer patients are at increased risk of severe COVID-19 and death, with older age, male sex, nosocomial infection, higher ECOG performance status, and active cancer among the risk factors for mortality.

“However, outcomes are very heterogeneous, ranging from patients without symptoms at all to cases with multi-organ failure and death,” she said.

It is consequently “very important for the treating clinician to determine which patients could be safely discharged to the community versus those who need additional support in being admitted to hospital.”

To develop a tool that could distinguish between those two groups of patients, the researchers collected data on 1,743 cancer patients, which was reduced down to 920 patients after excluding those without laboratory confirmed COVID-19 and those with missing data.

Using recursive feature elimination, they selected 10 key patient features associated with prognosis, then compared a lasso regression model with a random forest model, with the latter performing the best.

The team then divided their patients into four cohorts, with the model trained on three cohorts and tested on the fourth. This resulted in the CORONET score, with the final model determined by testing it against the entire patient population.

Next, thresholds were determined for assessing patients for admission versus discharge, as well as for severity of illness, giving the final CORONET model, from which the online tool was developed.
 

Checking performance

The results showed that the model was able to predict admission with an area under the receiver operating characteristics curve (AUROC) of 0.82 for admission, 0.85 for oxygen requirement, and 0.79 for death.

Further analysis revealed that the most important feature at the time of presentation for determining outcome was the National Early Warning Score 2 (NEWS2), “which is a composite score of heart rate, respiratory rate, saturations and confusion level,” Dr. Lee said.

In addition, C-reactive protein levels, albumin, age, and platelet counts “were also very important features,” she continued, “and these have also been shown in a number of different studies to be important at determining the outcome from coronavirus.”

To examine the performance of the CORONET score further, they applied it to a European hospital dataset, ESMO-CoCARE registry data, and a U.S. cohort, the COVID-19 and Cancer Consortium Registry (CCC19). They found that the score discriminated between patients, but it did so with some degree of heterogeneity.

This was largely driven by higher patient age among the U.S. patients, a higher NEWS2 score, and lower albumin levels, Dr. Lee said.

To ensure the score’s applicability to clinical practice, the team set pragmatic thresholds to determine whether or not a patient required admission or whether they were at risk of dying.

For admission, they set a sensitivity of 85% and a specificity of 56%, while for mortality they set a sensitivity of 43% and a specificity of 92%.

When this was converted into a decision support tool, the model recommended hospital admission for 95% of patients who eventually required oxygen and 97% of patients who died.

The study was funded by The Christie Charitable Foundation. Dr. Lee declares relationships with AstraZeneca and Bristol-Myers Squibb (Inst). Dr. Wright declares relationships with NCCN/AstraZeneca (Inst).

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

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An online support tool for health care professionals that recommends whether to admit or discharge a cancer patient with COVID-19, based on their risk of a severe complication, has been developed by researchers from Manchester.

The team used machine learning on data from more than 900 cancer patients with COVID-19, conducting multiple analyses to arrive at a set of features that could accurately predict the need for admission or oxygen therapy, as well as the risk of death.

Dr. Rebecca Lee, The Christie NHS Foundation Trust, Manchester, and colleagues then developed thresholds to derive a score that recommended admission in 95% of patients who went on to need oxygen and an even greater proportion of those who later died.

The research was presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting on June 4.
 

CORONET

The resulting COVID-19 Risk in Oncology Evaluation Tool (CORONET) model “performs very well at predicting admission and severity of COVID-19 in patients with cancer,” Dr. Lee said. “We have set pragmatic and clinically relevant thresholds that focus on the safety regarding an admission versus discharge decision.”

To help health care professionals, the researchers have built a free online support tool that allows them to enter data and receive a recommendation “as to whether their patient should be considered for discharge, considered for admission, or is at high risk of having a severe outcome of coronavirus,” Dr. Lee explained.

“The health care professional can then explore the recommendation by seeing how their patient … compares with the rest of the cohort.”

The tool also includes a “diagram showing which features are most important to recommend a discharge decision versus an admission decision for each individual patient.”
 

Clinically intuitive

Dr. Alexi Wright, associate professor, Dana-Faber Cancer Institute, Boston, who was not involved in the study, commented that there were many things that were “really nice about the study.”

“First and foremost that they were establishing a tool to efficiently triage [patients] presenting with COVID,” she said, adding that it was “clinically intuitive” that the team made “pragmatic choices,” and the use of a random forest algorithm means the results are “very interpretable.”

However, Dr. Wright wondered whether the results can be replicated.

Alongside a lack of information on the deaths in the cohort, she pointed out that “ideally you have three data sets, with a training set, a testing set, and a validation set.”

The CORONET model was, however, trained and evaluated on the same dataset, “so it really needs external validation before it would be ready for direct clinical application.”

She continued that there is a “critical need to establish that studies can both be reproduced and replicated,” noting that a recent review showed that 85% of machine-learning studies that were used to detect COVID-19 using chest radiographs “failed fundamental reproducibility and quality checks.” 

 

Risk factors

Dr. Lee began her presentation by reminding the audience that cancer patients are at increased risk of severe COVID-19 and death, with older age, male sex, nosocomial infection, higher ECOG performance status, and active cancer among the risk factors for mortality.

“However, outcomes are very heterogeneous, ranging from patients without symptoms at all to cases with multi-organ failure and death,” she said.

It is consequently “very important for the treating clinician to determine which patients could be safely discharged to the community versus those who need additional support in being admitted to hospital.”

To develop a tool that could distinguish between those two groups of patients, the researchers collected data on 1,743 cancer patients, which was reduced down to 920 patients after excluding those without laboratory confirmed COVID-19 and those with missing data.

Using recursive feature elimination, they selected 10 key patient features associated with prognosis, then compared a lasso regression model with a random forest model, with the latter performing the best.

The team then divided their patients into four cohorts, with the model trained on three cohorts and tested on the fourth. This resulted in the CORONET score, with the final model determined by testing it against the entire patient population.

Next, thresholds were determined for assessing patients for admission versus discharge, as well as for severity of illness, giving the final CORONET model, from which the online tool was developed.
 

Checking performance

The results showed that the model was able to predict admission with an area under the receiver operating characteristics curve (AUROC) of 0.82 for admission, 0.85 for oxygen requirement, and 0.79 for death.

Further analysis revealed that the most important feature at the time of presentation for determining outcome was the National Early Warning Score 2 (NEWS2), “which is a composite score of heart rate, respiratory rate, saturations and confusion level,” Dr. Lee said.

In addition, C-reactive protein levels, albumin, age, and platelet counts “were also very important features,” she continued, “and these have also been shown in a number of different studies to be important at determining the outcome from coronavirus.”

To examine the performance of the CORONET score further, they applied it to a European hospital dataset, ESMO-CoCARE registry data, and a U.S. cohort, the COVID-19 and Cancer Consortium Registry (CCC19). They found that the score discriminated between patients, but it did so with some degree of heterogeneity.

This was largely driven by higher patient age among the U.S. patients, a higher NEWS2 score, and lower albumin levels, Dr. Lee said.

To ensure the score’s applicability to clinical practice, the team set pragmatic thresholds to determine whether or not a patient required admission or whether they were at risk of dying.

For admission, they set a sensitivity of 85% and a specificity of 56%, while for mortality they set a sensitivity of 43% and a specificity of 92%.

When this was converted into a decision support tool, the model recommended hospital admission for 95% of patients who eventually required oxygen and 97% of patients who died.

The study was funded by The Christie Charitable Foundation. Dr. Lee declares relationships with AstraZeneca and Bristol-Myers Squibb (Inst). Dr. Wright declares relationships with NCCN/AstraZeneca (Inst).

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

 

An online support tool for health care professionals that recommends whether to admit or discharge a cancer patient with COVID-19, based on their risk of a severe complication, has been developed by researchers from Manchester.

The team used machine learning on data from more than 900 cancer patients with COVID-19, conducting multiple analyses to arrive at a set of features that could accurately predict the need for admission or oxygen therapy, as well as the risk of death.

Dr. Rebecca Lee, The Christie NHS Foundation Trust, Manchester, and colleagues then developed thresholds to derive a score that recommended admission in 95% of patients who went on to need oxygen and an even greater proportion of those who later died.

The research was presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting on June 4.
 

CORONET

The resulting COVID-19 Risk in Oncology Evaluation Tool (CORONET) model “performs very well at predicting admission and severity of COVID-19 in patients with cancer,” Dr. Lee said. “We have set pragmatic and clinically relevant thresholds that focus on the safety regarding an admission versus discharge decision.”

To help health care professionals, the researchers have built a free online support tool that allows them to enter data and receive a recommendation “as to whether their patient should be considered for discharge, considered for admission, or is at high risk of having a severe outcome of coronavirus,” Dr. Lee explained.

“The health care professional can then explore the recommendation by seeing how their patient … compares with the rest of the cohort.”

The tool also includes a “diagram showing which features are most important to recommend a discharge decision versus an admission decision for each individual patient.”
 

Clinically intuitive

Dr. Alexi Wright, associate professor, Dana-Faber Cancer Institute, Boston, who was not involved in the study, commented that there were many things that were “really nice about the study.”

“First and foremost that they were establishing a tool to efficiently triage [patients] presenting with COVID,” she said, adding that it was “clinically intuitive” that the team made “pragmatic choices,” and the use of a random forest algorithm means the results are “very interpretable.”

However, Dr. Wright wondered whether the results can be replicated.

Alongside a lack of information on the deaths in the cohort, she pointed out that “ideally you have three data sets, with a training set, a testing set, and a validation set.”

The CORONET model was, however, trained and evaluated on the same dataset, “so it really needs external validation before it would be ready for direct clinical application.”

She continued that there is a “critical need to establish that studies can both be reproduced and replicated,” noting that a recent review showed that 85% of machine-learning studies that were used to detect COVID-19 using chest radiographs “failed fundamental reproducibility and quality checks.” 

 

Risk factors

Dr. Lee began her presentation by reminding the audience that cancer patients are at increased risk of severe COVID-19 and death, with older age, male sex, nosocomial infection, higher ECOG performance status, and active cancer among the risk factors for mortality.

“However, outcomes are very heterogeneous, ranging from patients without symptoms at all to cases with multi-organ failure and death,” she said.

It is consequently “very important for the treating clinician to determine which patients could be safely discharged to the community versus those who need additional support in being admitted to hospital.”

To develop a tool that could distinguish between those two groups of patients, the researchers collected data on 1,743 cancer patients, which was reduced down to 920 patients after excluding those without laboratory confirmed COVID-19 and those with missing data.

Using recursive feature elimination, they selected 10 key patient features associated with prognosis, then compared a lasso regression model with a random forest model, with the latter performing the best.

The team then divided their patients into four cohorts, with the model trained on three cohorts and tested on the fourth. This resulted in the CORONET score, with the final model determined by testing it against the entire patient population.

Next, thresholds were determined for assessing patients for admission versus discharge, as well as for severity of illness, giving the final CORONET model, from which the online tool was developed.
 

Checking performance

The results showed that the model was able to predict admission with an area under the receiver operating characteristics curve (AUROC) of 0.82 for admission, 0.85 for oxygen requirement, and 0.79 for death.

Further analysis revealed that the most important feature at the time of presentation for determining outcome was the National Early Warning Score 2 (NEWS2), “which is a composite score of heart rate, respiratory rate, saturations and confusion level,” Dr. Lee said.

In addition, C-reactive protein levels, albumin, age, and platelet counts “were also very important features,” she continued, “and these have also been shown in a number of different studies to be important at determining the outcome from coronavirus.”

To examine the performance of the CORONET score further, they applied it to a European hospital dataset, ESMO-CoCARE registry data, and a U.S. cohort, the COVID-19 and Cancer Consortium Registry (CCC19). They found that the score discriminated between patients, but it did so with some degree of heterogeneity.

This was largely driven by higher patient age among the U.S. patients, a higher NEWS2 score, and lower albumin levels, Dr. Lee said.

To ensure the score’s applicability to clinical practice, the team set pragmatic thresholds to determine whether or not a patient required admission or whether they were at risk of dying.

For admission, they set a sensitivity of 85% and a specificity of 56%, while for mortality they set a sensitivity of 43% and a specificity of 92%.

When this was converted into a decision support tool, the model recommended hospital admission for 95% of patients who eventually required oxygen and 97% of patients who died.

The study was funded by The Christie Charitable Foundation. Dr. Lee declares relationships with AstraZeneca and Bristol-Myers Squibb (Inst). Dr. Wright declares relationships with NCCN/AstraZeneca (Inst).

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

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Mistrust and Mandates: COVID-19 Vaccination in the Military

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Changed
Thu, 08/26/2021 - 15:46

It is June and most of us are looking forward to a more normal summer than the one we had in 2020. Many Americans have been vaccinated and states are rolling back some (or all) masking requirements and restrictions on gatherings. In many sectors, including the US Department of Defense (DoD) and the US Department of Veterans Affairs (VA), worries from public health officials about vaccine supply and how to ethically allocate demand have given way to a new set of concerns: We have the shots, but for widespread protection we have to get them into arms.

The reluctance to roll up the sleeve is known as vaccine hesitancy. The National Academies of Science comments on vaccine hesitancy in its report on COVID-19 vaccination allocation. “Potential consequences of vaccine hesitancy—which the committee views as an attitude, preference, or motivational state—are the behaviors of vaccine refusal or delay.”2

On that count, there was encouraging albeit unexpected news in waning days of May. Media reported a sharp increase in the COVID-vaccination of military personnel. Unnamed DoD officials indicated, they had seen a 55% increase in the vaccination of active-duty service members over the previous month. This news represents a dramatic turnaround in a trend of vaccine hesitancy among military members that has persisted since the vaccine became available.3 Even last month, this would have been a very different column. The DoD has not disclosed the exact number of service members who have declined COVID-19 vaccination but multiple news outlets have documented that there was widespread and significant vaccine hesitancy among military personnel. In February, Military News reported that one-third of troops who were offered the vaccine declined it; and in April, USA Today stated that 40% of Marines had refused vaccination.4,5

Still, it is worth examining the data on vaccination among active duty service members. From December 2020 through March 2021, the military conducted the first study to evaluate rates of vaccine initiation and completion in the military in general and for service members from racial/ethnic minorities in particular. Black military personnel were 28% less likely than non-Hispanic White service members to initiate vaccination against coronavirus even after adjusting for other possible confounders. Just 29% of White, 25.5% of Hispanic, and 18.7% of Black service members had initiated the vaccine process in the survey.6

The authors suggest that in part, vaccine hesitancy explains the findings.4 Vaccine hesitancy among racial and ethnic minorities is even more tragic because these same already disadvantaged cohorts have disproportionately suffered from COVID-19 throughout the pandemic with higher rates of infection, serious illness requiring hospitalization, and infection-related morbidity.7

Vaccine hesitancy, delay, or refusal in Black Americans whether military or civilian often is attributed to the historical abuses like the Tuskegee syphilis experiments or the more recent example of cancer cell lines taken from Henrietta Lacks without consent.8 Such government sponsored betrayals no doubt are the soil in which hesitancy grows but recent commentators have opined that focusing solely on these infamous examples may ignore current systemic racism that is pervasively feeding Black Americans reluctance to consider or accept COVID-19 vaccination.9 Blaming infamous research also provides a convenient excuse for confronting contemporary racial discrimination in health care and taking responsibility as health care practitioners for reversing it. “Framing the conversation about distrust in COVID vaccines in terms of everyday racism rather than historical atrocities may increase underserved communities’ willingness to be vaccinated,” Bajaj and Stanford wrote in a recent recent New England Journal of Medicine commentary. “When we hyperfocus on Sims, Lacks, and Tuskegee, we ascribe the current Black health experience to past racism, rooting our present in immovable historical occurrences and undermining efforts to combat mistrust. Everyday racism, by contrast, can be tackled in the present.”9

The study of racial/ethnic disparities in COVID-19 vaccination in active-duty service members was a work product of the Armed Forces Health Surveillance Division. The authors underscore several factors that support the connection between discrimination and vaccine hesitancy in the military. Lack of access to and ability to obtain COVID-19 vaccination continues to be a major barrier that disadvantaged populations must overcome.10 The COVID-19 vaccine is widely available, easily obtained, and free of charge for all military personnel. Yet the vaccine hesitancy in the military parallels that of the civilian sector. This led the study authors to opine that, “forces external to the U.S. Military, such as interpersonal and societal factors also contribute to vaccine hesitancy among military service members.”6

Obviously, any unvaccinated active-duty service member reduces the combat readiness of the fighting force a consideration that led some in Congress to call for mandating vaccination. The vaccine is currently being administered under an emergency use authorization (EUA), which prevents even the military from mandating it.11 Even if President Joseph Biden obtained a waiver to make the vaccine mandatory, the implications of forcing service members who have volunteered to serve their country is ethically problematic. Those problems are exponentially amplified when applied to members of ethnic and racial minorities who have a past and present of health disparities and discrimination. Respecting the decision of those in uniform to decline COVID-19 vaccination is the first and perhaps most important step to rebuilding the trust that is the most promising means of reducing vaccine hesitancy.

Part of the accountability we all bear for health care inequity and racism is to continue the work of this landmark study to better understand vaccine hesitancy among military and veteran cohorts, develop counseling and education that target those attitudes, beliefs, and motivations with education, counseling, and support. All of us can in some small measure follow the ethical mandate “to dispel rumors and provide facts to people” of Secretary Austin, a Black retired 4-star Army general.1

References

1. Garmone J. Secretary of Defense Addresses Vaccine Hesitancy in the Military. Published February 25, 2021. Accessed May 26, 2021. https://www.defense.gov/Explore/News/Article/Article/2516511/secretary-of-defense-addresses-vaccine-hesitancy-in-military/

2. National Academies of Sciences, Engineering, and Medicine. Framework for Equitable Allocation of COVID-19 Vaccine . The National Academies of Science; 2020:188. doi:10.17226/25917

3. Liebermann O. US military sees 55% jump in COVID-19 vaccinations over last month. Published May 20, 2021. Accessed May 26, 2021. https://www.cnn.com/2021/05/20/politics/us-military-covid-vaccinations/index.html

4. Kime P. Almost one-third of us troops are refusing COVID-19 vaccines, officials Say. Published February 17, 2021. Accessed May 26, 2021. https://www.military.com/daily-news/2021/02/17/almost-one-third-of-us-troops-are-refusing-covid-vaccines-officials-say.html

5. Elbeshbishi S. Nearly 40% of Marines decline COVID-19 vaccine, prompting some Democrats to urge Biden to set mandate for the military. USA Today. April 10, 2021. Accessed May 26, 2021. https://www.usatoday.com/story/news/politics/2021/04/10/covid-vaccine-nearly-forty-percent-us-marines-decline/7173918002/

6. Lang MA, Stahlman S, Wells NY, et al. Disparities in COVID-19 vaccine initiation and completion among active component service members and health care personnel, 11 December 2020-12 March 2021. MSMR. 2021;28(4):2-9.

7. Webb Hooper M, Nápoles AM, Pérez-Stable EJ. COVID-19 and racial/ethnic disparities. JAMA . 2020;323(24):2466-2467. doi:10.1001/jama.2020.8598

8. Kum D. Fueled by a history of mistreatment, Black Americans distrust the new COVID-19 vaccines. TIME. December 8, 2020. Accessed May 26, 2021.https://time.com/5925074/black-americans-covid-19-vaccine-distrust/

9. Bajaj SS, Stanford FC. Beyond Tuskegee - Vaccine Distrust and Everyday Racism. N Engl J Med. 2021;384(5):e12. doi:10.1056/NEJMpv2035827

10. Feldman N. Why Black and Latino people still lag on COVID-19 vaccines-and how to fix it. NPR. April 26, 2021. Accessed May 26, 2021. https://www.npr.org/sections/health-shots/2021/04/26/989962041/why-black-and-latino-people-still-lag-on-covid-vaccines-and-how-to-fix-it

11. Kaufman E. Lawmakers ask Biden to issue waiver to make COVID-19 vaccination mandatory of members of the military. Updated March 24, 2021. Accessed May 26, 2021. https://www.cnn.com/2021/03/24/politics/congress-letter-military-vaccine/index.html

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The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner , Frontline Medical Communications Inc., the US Government, or any of its agencies.

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Related Articles

It is June and most of us are looking forward to a more normal summer than the one we had in 2020. Many Americans have been vaccinated and states are rolling back some (or all) masking requirements and restrictions on gatherings. In many sectors, including the US Department of Defense (DoD) and the US Department of Veterans Affairs (VA), worries from public health officials about vaccine supply and how to ethically allocate demand have given way to a new set of concerns: We have the shots, but for widespread protection we have to get them into arms.

The reluctance to roll up the sleeve is known as vaccine hesitancy. The National Academies of Science comments on vaccine hesitancy in its report on COVID-19 vaccination allocation. “Potential consequences of vaccine hesitancy—which the committee views as an attitude, preference, or motivational state—are the behaviors of vaccine refusal or delay.”2

On that count, there was encouraging albeit unexpected news in waning days of May. Media reported a sharp increase in the COVID-vaccination of military personnel. Unnamed DoD officials indicated, they had seen a 55% increase in the vaccination of active-duty service members over the previous month. This news represents a dramatic turnaround in a trend of vaccine hesitancy among military members that has persisted since the vaccine became available.3 Even last month, this would have been a very different column. The DoD has not disclosed the exact number of service members who have declined COVID-19 vaccination but multiple news outlets have documented that there was widespread and significant vaccine hesitancy among military personnel. In February, Military News reported that one-third of troops who were offered the vaccine declined it; and in April, USA Today stated that 40% of Marines had refused vaccination.4,5

Still, it is worth examining the data on vaccination among active duty service members. From December 2020 through March 2021, the military conducted the first study to evaluate rates of vaccine initiation and completion in the military in general and for service members from racial/ethnic minorities in particular. Black military personnel were 28% less likely than non-Hispanic White service members to initiate vaccination against coronavirus even after adjusting for other possible confounders. Just 29% of White, 25.5% of Hispanic, and 18.7% of Black service members had initiated the vaccine process in the survey.6

The authors suggest that in part, vaccine hesitancy explains the findings.4 Vaccine hesitancy among racial and ethnic minorities is even more tragic because these same already disadvantaged cohorts have disproportionately suffered from COVID-19 throughout the pandemic with higher rates of infection, serious illness requiring hospitalization, and infection-related morbidity.7

Vaccine hesitancy, delay, or refusal in Black Americans whether military or civilian often is attributed to the historical abuses like the Tuskegee syphilis experiments or the more recent example of cancer cell lines taken from Henrietta Lacks without consent.8 Such government sponsored betrayals no doubt are the soil in which hesitancy grows but recent commentators have opined that focusing solely on these infamous examples may ignore current systemic racism that is pervasively feeding Black Americans reluctance to consider or accept COVID-19 vaccination.9 Blaming infamous research also provides a convenient excuse for confronting contemporary racial discrimination in health care and taking responsibility as health care practitioners for reversing it. “Framing the conversation about distrust in COVID vaccines in terms of everyday racism rather than historical atrocities may increase underserved communities’ willingness to be vaccinated,” Bajaj and Stanford wrote in a recent recent New England Journal of Medicine commentary. “When we hyperfocus on Sims, Lacks, and Tuskegee, we ascribe the current Black health experience to past racism, rooting our present in immovable historical occurrences and undermining efforts to combat mistrust. Everyday racism, by contrast, can be tackled in the present.”9

The study of racial/ethnic disparities in COVID-19 vaccination in active-duty service members was a work product of the Armed Forces Health Surveillance Division. The authors underscore several factors that support the connection between discrimination and vaccine hesitancy in the military. Lack of access to and ability to obtain COVID-19 vaccination continues to be a major barrier that disadvantaged populations must overcome.10 The COVID-19 vaccine is widely available, easily obtained, and free of charge for all military personnel. Yet the vaccine hesitancy in the military parallels that of the civilian sector. This led the study authors to opine that, “forces external to the U.S. Military, such as interpersonal and societal factors also contribute to vaccine hesitancy among military service members.”6

Obviously, any unvaccinated active-duty service member reduces the combat readiness of the fighting force a consideration that led some in Congress to call for mandating vaccination. The vaccine is currently being administered under an emergency use authorization (EUA), which prevents even the military from mandating it.11 Even if President Joseph Biden obtained a waiver to make the vaccine mandatory, the implications of forcing service members who have volunteered to serve their country is ethically problematic. Those problems are exponentially amplified when applied to members of ethnic and racial minorities who have a past and present of health disparities and discrimination. Respecting the decision of those in uniform to decline COVID-19 vaccination is the first and perhaps most important step to rebuilding the trust that is the most promising means of reducing vaccine hesitancy.

Part of the accountability we all bear for health care inequity and racism is to continue the work of this landmark study to better understand vaccine hesitancy among military and veteran cohorts, develop counseling and education that target those attitudes, beliefs, and motivations with education, counseling, and support. All of us can in some small measure follow the ethical mandate “to dispel rumors and provide facts to people” of Secretary Austin, a Black retired 4-star Army general.1

It is June and most of us are looking forward to a more normal summer than the one we had in 2020. Many Americans have been vaccinated and states are rolling back some (or all) masking requirements and restrictions on gatherings. In many sectors, including the US Department of Defense (DoD) and the US Department of Veterans Affairs (VA), worries from public health officials about vaccine supply and how to ethically allocate demand have given way to a new set of concerns: We have the shots, but for widespread protection we have to get them into arms.

The reluctance to roll up the sleeve is known as vaccine hesitancy. The National Academies of Science comments on vaccine hesitancy in its report on COVID-19 vaccination allocation. “Potential consequences of vaccine hesitancy—which the committee views as an attitude, preference, or motivational state—are the behaviors of vaccine refusal or delay.”2

On that count, there was encouraging albeit unexpected news in waning days of May. Media reported a sharp increase in the COVID-vaccination of military personnel. Unnamed DoD officials indicated, they had seen a 55% increase in the vaccination of active-duty service members over the previous month. This news represents a dramatic turnaround in a trend of vaccine hesitancy among military members that has persisted since the vaccine became available.3 Even last month, this would have been a very different column. The DoD has not disclosed the exact number of service members who have declined COVID-19 vaccination but multiple news outlets have documented that there was widespread and significant vaccine hesitancy among military personnel. In February, Military News reported that one-third of troops who were offered the vaccine declined it; and in April, USA Today stated that 40% of Marines had refused vaccination.4,5

Still, it is worth examining the data on vaccination among active duty service members. From December 2020 through March 2021, the military conducted the first study to evaluate rates of vaccine initiation and completion in the military in general and for service members from racial/ethnic minorities in particular. Black military personnel were 28% less likely than non-Hispanic White service members to initiate vaccination against coronavirus even after adjusting for other possible confounders. Just 29% of White, 25.5% of Hispanic, and 18.7% of Black service members had initiated the vaccine process in the survey.6

The authors suggest that in part, vaccine hesitancy explains the findings.4 Vaccine hesitancy among racial and ethnic minorities is even more tragic because these same already disadvantaged cohorts have disproportionately suffered from COVID-19 throughout the pandemic with higher rates of infection, serious illness requiring hospitalization, and infection-related morbidity.7

Vaccine hesitancy, delay, or refusal in Black Americans whether military or civilian often is attributed to the historical abuses like the Tuskegee syphilis experiments or the more recent example of cancer cell lines taken from Henrietta Lacks without consent.8 Such government sponsored betrayals no doubt are the soil in which hesitancy grows but recent commentators have opined that focusing solely on these infamous examples may ignore current systemic racism that is pervasively feeding Black Americans reluctance to consider or accept COVID-19 vaccination.9 Blaming infamous research also provides a convenient excuse for confronting contemporary racial discrimination in health care and taking responsibility as health care practitioners for reversing it. “Framing the conversation about distrust in COVID vaccines in terms of everyday racism rather than historical atrocities may increase underserved communities’ willingness to be vaccinated,” Bajaj and Stanford wrote in a recent recent New England Journal of Medicine commentary. “When we hyperfocus on Sims, Lacks, and Tuskegee, we ascribe the current Black health experience to past racism, rooting our present in immovable historical occurrences and undermining efforts to combat mistrust. Everyday racism, by contrast, can be tackled in the present.”9

The study of racial/ethnic disparities in COVID-19 vaccination in active-duty service members was a work product of the Armed Forces Health Surveillance Division. The authors underscore several factors that support the connection between discrimination and vaccine hesitancy in the military. Lack of access to and ability to obtain COVID-19 vaccination continues to be a major barrier that disadvantaged populations must overcome.10 The COVID-19 vaccine is widely available, easily obtained, and free of charge for all military personnel. Yet the vaccine hesitancy in the military parallels that of the civilian sector. This led the study authors to opine that, “forces external to the U.S. Military, such as interpersonal and societal factors also contribute to vaccine hesitancy among military service members.”6

Obviously, any unvaccinated active-duty service member reduces the combat readiness of the fighting force a consideration that led some in Congress to call for mandating vaccination. The vaccine is currently being administered under an emergency use authorization (EUA), which prevents even the military from mandating it.11 Even if President Joseph Biden obtained a waiver to make the vaccine mandatory, the implications of forcing service members who have volunteered to serve their country is ethically problematic. Those problems are exponentially amplified when applied to members of ethnic and racial minorities who have a past and present of health disparities and discrimination. Respecting the decision of those in uniform to decline COVID-19 vaccination is the first and perhaps most important step to rebuilding the trust that is the most promising means of reducing vaccine hesitancy.

Part of the accountability we all bear for health care inequity and racism is to continue the work of this landmark study to better understand vaccine hesitancy among military and veteran cohorts, develop counseling and education that target those attitudes, beliefs, and motivations with education, counseling, and support. All of us can in some small measure follow the ethical mandate “to dispel rumors and provide facts to people” of Secretary Austin, a Black retired 4-star Army general.1

References

1. Garmone J. Secretary of Defense Addresses Vaccine Hesitancy in the Military. Published February 25, 2021. Accessed May 26, 2021. https://www.defense.gov/Explore/News/Article/Article/2516511/secretary-of-defense-addresses-vaccine-hesitancy-in-military/

2. National Academies of Sciences, Engineering, and Medicine. Framework for Equitable Allocation of COVID-19 Vaccine . The National Academies of Science; 2020:188. doi:10.17226/25917

3. Liebermann O. US military sees 55% jump in COVID-19 vaccinations over last month. Published May 20, 2021. Accessed May 26, 2021. https://www.cnn.com/2021/05/20/politics/us-military-covid-vaccinations/index.html

4. Kime P. Almost one-third of us troops are refusing COVID-19 vaccines, officials Say. Published February 17, 2021. Accessed May 26, 2021. https://www.military.com/daily-news/2021/02/17/almost-one-third-of-us-troops-are-refusing-covid-vaccines-officials-say.html

5. Elbeshbishi S. Nearly 40% of Marines decline COVID-19 vaccine, prompting some Democrats to urge Biden to set mandate for the military. USA Today. April 10, 2021. Accessed May 26, 2021. https://www.usatoday.com/story/news/politics/2021/04/10/covid-vaccine-nearly-forty-percent-us-marines-decline/7173918002/

6. Lang MA, Stahlman S, Wells NY, et al. Disparities in COVID-19 vaccine initiation and completion among active component service members and health care personnel, 11 December 2020-12 March 2021. MSMR. 2021;28(4):2-9.

7. Webb Hooper M, Nápoles AM, Pérez-Stable EJ. COVID-19 and racial/ethnic disparities. JAMA . 2020;323(24):2466-2467. doi:10.1001/jama.2020.8598

8. Kum D. Fueled by a history of mistreatment, Black Americans distrust the new COVID-19 vaccines. TIME. December 8, 2020. Accessed May 26, 2021.https://time.com/5925074/black-americans-covid-19-vaccine-distrust/

9. Bajaj SS, Stanford FC. Beyond Tuskegee - Vaccine Distrust and Everyday Racism. N Engl J Med. 2021;384(5):e12. doi:10.1056/NEJMpv2035827

10. Feldman N. Why Black and Latino people still lag on COVID-19 vaccines-and how to fix it. NPR. April 26, 2021. Accessed May 26, 2021. https://www.npr.org/sections/health-shots/2021/04/26/989962041/why-black-and-latino-people-still-lag-on-covid-vaccines-and-how-to-fix-it

11. Kaufman E. Lawmakers ask Biden to issue waiver to make COVID-19 vaccination mandatory of members of the military. Updated March 24, 2021. Accessed May 26, 2021. https://www.cnn.com/2021/03/24/politics/congress-letter-military-vaccine/index.html

References

1. Garmone J. Secretary of Defense Addresses Vaccine Hesitancy in the Military. Published February 25, 2021. Accessed May 26, 2021. https://www.defense.gov/Explore/News/Article/Article/2516511/secretary-of-defense-addresses-vaccine-hesitancy-in-military/

2. National Academies of Sciences, Engineering, and Medicine. Framework for Equitable Allocation of COVID-19 Vaccine . The National Academies of Science; 2020:188. doi:10.17226/25917

3. Liebermann O. US military sees 55% jump in COVID-19 vaccinations over last month. Published May 20, 2021. Accessed May 26, 2021. https://www.cnn.com/2021/05/20/politics/us-military-covid-vaccinations/index.html

4. Kime P. Almost one-third of us troops are refusing COVID-19 vaccines, officials Say. Published February 17, 2021. Accessed May 26, 2021. https://www.military.com/daily-news/2021/02/17/almost-one-third-of-us-troops-are-refusing-covid-vaccines-officials-say.html

5. Elbeshbishi S. Nearly 40% of Marines decline COVID-19 vaccine, prompting some Democrats to urge Biden to set mandate for the military. USA Today. April 10, 2021. Accessed May 26, 2021. https://www.usatoday.com/story/news/politics/2021/04/10/covid-vaccine-nearly-forty-percent-us-marines-decline/7173918002/

6. Lang MA, Stahlman S, Wells NY, et al. Disparities in COVID-19 vaccine initiation and completion among active component service members and health care personnel, 11 December 2020-12 March 2021. MSMR. 2021;28(4):2-9.

7. Webb Hooper M, Nápoles AM, Pérez-Stable EJ. COVID-19 and racial/ethnic disparities. JAMA . 2020;323(24):2466-2467. doi:10.1001/jama.2020.8598

8. Kum D. Fueled by a history of mistreatment, Black Americans distrust the new COVID-19 vaccines. TIME. December 8, 2020. Accessed May 26, 2021.https://time.com/5925074/black-americans-covid-19-vaccine-distrust/

9. Bajaj SS, Stanford FC. Beyond Tuskegee - Vaccine Distrust and Everyday Racism. N Engl J Med. 2021;384(5):e12. doi:10.1056/NEJMpv2035827

10. Feldman N. Why Black and Latino people still lag on COVID-19 vaccines-and how to fix it. NPR. April 26, 2021. Accessed May 26, 2021. https://www.npr.org/sections/health-shots/2021/04/26/989962041/why-black-and-latino-people-still-lag-on-covid-vaccines-and-how-to-fix-it

11. Kaufman E. Lawmakers ask Biden to issue waiver to make COVID-19 vaccination mandatory of members of the military. Updated March 24, 2021. Accessed May 26, 2021. https://www.cnn.com/2021/03/24/politics/congress-letter-military-vaccine/index.html

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By the numbers: Children and COVID-19 prevention

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Over 6.3 million doses of COVID-19 vaccine have been administered to children aged 12-17 years as of June 7, according to data from the Centers for Disease Control and Prevention.

The latest results from the CDC’s COVID Data Tracker show that 22.5% of all U.S. children aged 12-15 years have received at least one dose of a vaccine, compared with 38.1% of those aged 16-17, with the corresponding figures for vaccine completion coming in at 4.1% and 26.4%. Compared with a week earlier, those numbers are up by 15.4% (one dose) and 486% (completion) for the younger group and by 4.7% and 8.6%, respectively, for the older children.

Children aged 12-15 represented 17.9% of all persons who initiated vaccination in the last 14 days up to June 7, while children aged 16-17 made up 4.8% of vaccine initiation over that period. The 25- to 39-year-olds, at 23.7% of all vaccine initiators, were the only group ahead of those aged 12-15, and the 50- to 64-year-olds were just behind at 17.7%, the CDC data show.

Both groups of children were on the low side, however, when it came to vaccine completion in the last 14 days, with those aged 12-15 at 6.7% of the total and those aged 16-17 years at 4.3%. The only age groups lower than that were ≥75 at 3.5% and <12 at 0.2%, and the highest share of vaccine completion was 26.0% for those aged 25-39, which also happens to be the group with the largest share of the U.S. population (20.5%), the CDC said.

People considered fully vaccinated are those who have received the second dose of a two-dose series or one dose of a single-shot vaccine, but children under age 18 years are eligible only for the Pfizer-BioNTech version, the CDC noted.



Meanwhile, back on the incidence side of the COVID-19 pandemic, the number of new cases in U.S. children for the week ending June 3 was at its lowest point (16,281) since mid-June of 2020, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Cases among children now total 3.99 million, which represents 14.1% of cases among all ages, a proportion that hasn’t increased since mid-May, which hasn’t happened since the two groups started keeping track in mid-April of 2020 in the 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam that report such data by age.

Less encouraging was the CDC’s report that “COVID-19-associated hospitalization rates among adolescents ages 12-17 years increased during March and April, following declines in January and February 2021.”

Children have been experiencing much lower rates of severe disease than those of adults throughout the pandemic, the CDC pointed out, but “recent increases in COVID-19-associated hospitalization rates and the potential for severe disease in adolescents reinforce the importance of continued prevention strategies, including vaccination and the correct and consistent use of masks in those who are not yet fully vaccinated.”

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Over 6.3 million doses of COVID-19 vaccine have been administered to children aged 12-17 years as of June 7, according to data from the Centers for Disease Control and Prevention.

The latest results from the CDC’s COVID Data Tracker show that 22.5% of all U.S. children aged 12-15 years have received at least one dose of a vaccine, compared with 38.1% of those aged 16-17, with the corresponding figures for vaccine completion coming in at 4.1% and 26.4%. Compared with a week earlier, those numbers are up by 15.4% (one dose) and 486% (completion) for the younger group and by 4.7% and 8.6%, respectively, for the older children.

Children aged 12-15 represented 17.9% of all persons who initiated vaccination in the last 14 days up to June 7, while children aged 16-17 made up 4.8% of vaccine initiation over that period. The 25- to 39-year-olds, at 23.7% of all vaccine initiators, were the only group ahead of those aged 12-15, and the 50- to 64-year-olds were just behind at 17.7%, the CDC data show.

Both groups of children were on the low side, however, when it came to vaccine completion in the last 14 days, with those aged 12-15 at 6.7% of the total and those aged 16-17 years at 4.3%. The only age groups lower than that were ≥75 at 3.5% and <12 at 0.2%, and the highest share of vaccine completion was 26.0% for those aged 25-39, which also happens to be the group with the largest share of the U.S. population (20.5%), the CDC said.

People considered fully vaccinated are those who have received the second dose of a two-dose series or one dose of a single-shot vaccine, but children under age 18 years are eligible only for the Pfizer-BioNTech version, the CDC noted.



Meanwhile, back on the incidence side of the COVID-19 pandemic, the number of new cases in U.S. children for the week ending June 3 was at its lowest point (16,281) since mid-June of 2020, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Cases among children now total 3.99 million, which represents 14.1% of cases among all ages, a proportion that hasn’t increased since mid-May, which hasn’t happened since the two groups started keeping track in mid-April of 2020 in the 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam that report such data by age.

Less encouraging was the CDC’s report that “COVID-19-associated hospitalization rates among adolescents ages 12-17 years increased during March and April, following declines in January and February 2021.”

Children have been experiencing much lower rates of severe disease than those of adults throughout the pandemic, the CDC pointed out, but “recent increases in COVID-19-associated hospitalization rates and the potential for severe disease in adolescents reinforce the importance of continued prevention strategies, including vaccination and the correct and consistent use of masks in those who are not yet fully vaccinated.”

Over 6.3 million doses of COVID-19 vaccine have been administered to children aged 12-17 years as of June 7, according to data from the Centers for Disease Control and Prevention.

The latest results from the CDC’s COVID Data Tracker show that 22.5% of all U.S. children aged 12-15 years have received at least one dose of a vaccine, compared with 38.1% of those aged 16-17, with the corresponding figures for vaccine completion coming in at 4.1% and 26.4%. Compared with a week earlier, those numbers are up by 15.4% (one dose) and 486% (completion) for the younger group and by 4.7% and 8.6%, respectively, for the older children.

Children aged 12-15 represented 17.9% of all persons who initiated vaccination in the last 14 days up to June 7, while children aged 16-17 made up 4.8% of vaccine initiation over that period. The 25- to 39-year-olds, at 23.7% of all vaccine initiators, were the only group ahead of those aged 12-15, and the 50- to 64-year-olds were just behind at 17.7%, the CDC data show.

Both groups of children were on the low side, however, when it came to vaccine completion in the last 14 days, with those aged 12-15 at 6.7% of the total and those aged 16-17 years at 4.3%. The only age groups lower than that were ≥75 at 3.5% and <12 at 0.2%, and the highest share of vaccine completion was 26.0% for those aged 25-39, which also happens to be the group with the largest share of the U.S. population (20.5%), the CDC said.

People considered fully vaccinated are those who have received the second dose of a two-dose series or one dose of a single-shot vaccine, but children under age 18 years are eligible only for the Pfizer-BioNTech version, the CDC noted.



Meanwhile, back on the incidence side of the COVID-19 pandemic, the number of new cases in U.S. children for the week ending June 3 was at its lowest point (16,281) since mid-June of 2020, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Cases among children now total 3.99 million, which represents 14.1% of cases among all ages, a proportion that hasn’t increased since mid-May, which hasn’t happened since the two groups started keeping track in mid-April of 2020 in the 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam that report such data by age.

Less encouraging was the CDC’s report that “COVID-19-associated hospitalization rates among adolescents ages 12-17 years increased during March and April, following declines in January and February 2021.”

Children have been experiencing much lower rates of severe disease than those of adults throughout the pandemic, the CDC pointed out, but “recent increases in COVID-19-associated hospitalization rates and the potential for severe disease in adolescents reinforce the importance of continued prevention strategies, including vaccination and the correct and consistent use of masks in those who are not yet fully vaccinated.”

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CDC director cites rise in hospitalizations in urging teen vaccinations

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Thu, 08/26/2021 - 15:46

The CDC director is urging parents to vaccinate their teenagers against COVID-19, citing a study that shows increasing hospitalizations rates for adolescents.

“I am deeply concerned by the numbers of hospitalized adolescents and saddened to see the number of adolescents who required treatment in intensive care units or mechanical ventilation,” CDC Director Rochelle Walensky, MD, said in a statement.

While urging teenagers to wear masks and take precautions around others, she asked “parents, relatives, and close friends to join me and talk with teens about the importance of these prevention strategies and to encourage them to get vaccinated.”

Dr. Walensky referred to the CDC’s Morbidity and Mortality Weekly Report that showed adolescent hospitalizations peaked at 2.1 per 100,000 in early January 2021, then dropped to 0.6 per 100,000 in mid-March.

Alarmingly, hospitalizations rose to 1.3 per 100,000 in April, and a number of teens required serious interventions.

“Among hospitalized adolescents, nearly one-third required intensive care unit admission, and 5% required invasive mechanical ventilation,” the report said. No deaths occurred.

The study looked at 376 adolescents aged 12-17 who were hospitalized and tested positive for coronavirus. Of that group, 204 were hospitalized for COVID-19 and the other 172 were hospitalized for reasons not directly related to COVID-19.

Of the 204 hospitalized for COVID-19, 70.6% had an underlying medical condition such as obesity or chronic lung disease.

The study noted that children and teenagers have lower hospitalization rates and generally show less severe symptoms than do older people.

Possible causes for the rise in adolescent COVID-19 hospitalizations include the arrival of variants, the growing number of children returning to in-person education, and the changes in mask-wearing and other safety precautions, the study said.

The American Academy of Pediatrics said that as of May 27, 4 million children have tested positive for COVID-19 since the pandemic began, with about 34,500 new child cases reported for the week ending May 27.

The AAP said children have represented 14.1% of total cases since the pandemic began, but for the week ending May 27, children represented 24.3% of new reported weekly COVID-19 cases.

On May 10, the FDA granted emergency use authorization for the Pfizer coronavirus vaccine to be given to children aged 12-15 years. Previously, the FDA had authorized the Pfizer vaccine for people aged 16 years and up, whereas the Moderna and Johnson & Johnson vaccines are authorized for people aged 18 years and up.

“Vaccination is our way out of this pandemic,” Dr. Walensky said in her statement. “I continue to see promising signs in CDC data that we are nearing the end of this pandemic in this country; however, we all have to do our part and get vaccinated to cross the finish line.”
 

A version of this article was first published on WebMD.com.

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The CDC director is urging parents to vaccinate their teenagers against COVID-19, citing a study that shows increasing hospitalizations rates for adolescents.

“I am deeply concerned by the numbers of hospitalized adolescents and saddened to see the number of adolescents who required treatment in intensive care units or mechanical ventilation,” CDC Director Rochelle Walensky, MD, said in a statement.

While urging teenagers to wear masks and take precautions around others, she asked “parents, relatives, and close friends to join me and talk with teens about the importance of these prevention strategies and to encourage them to get vaccinated.”

Dr. Walensky referred to the CDC’s Morbidity and Mortality Weekly Report that showed adolescent hospitalizations peaked at 2.1 per 100,000 in early January 2021, then dropped to 0.6 per 100,000 in mid-March.

Alarmingly, hospitalizations rose to 1.3 per 100,000 in April, and a number of teens required serious interventions.

“Among hospitalized adolescents, nearly one-third required intensive care unit admission, and 5% required invasive mechanical ventilation,” the report said. No deaths occurred.

The study looked at 376 adolescents aged 12-17 who were hospitalized and tested positive for coronavirus. Of that group, 204 were hospitalized for COVID-19 and the other 172 were hospitalized for reasons not directly related to COVID-19.

Of the 204 hospitalized for COVID-19, 70.6% had an underlying medical condition such as obesity or chronic lung disease.

The study noted that children and teenagers have lower hospitalization rates and generally show less severe symptoms than do older people.

Possible causes for the rise in adolescent COVID-19 hospitalizations include the arrival of variants, the growing number of children returning to in-person education, and the changes in mask-wearing and other safety precautions, the study said.

The American Academy of Pediatrics said that as of May 27, 4 million children have tested positive for COVID-19 since the pandemic began, with about 34,500 new child cases reported for the week ending May 27.

The AAP said children have represented 14.1% of total cases since the pandemic began, but for the week ending May 27, children represented 24.3% of new reported weekly COVID-19 cases.

On May 10, the FDA granted emergency use authorization for the Pfizer coronavirus vaccine to be given to children aged 12-15 years. Previously, the FDA had authorized the Pfizer vaccine for people aged 16 years and up, whereas the Moderna and Johnson & Johnson vaccines are authorized for people aged 18 years and up.

“Vaccination is our way out of this pandemic,” Dr. Walensky said in her statement. “I continue to see promising signs in CDC data that we are nearing the end of this pandemic in this country; however, we all have to do our part and get vaccinated to cross the finish line.”
 

A version of this article was first published on WebMD.com.

The CDC director is urging parents to vaccinate their teenagers against COVID-19, citing a study that shows increasing hospitalizations rates for adolescents.

“I am deeply concerned by the numbers of hospitalized adolescents and saddened to see the number of adolescents who required treatment in intensive care units or mechanical ventilation,” CDC Director Rochelle Walensky, MD, said in a statement.

While urging teenagers to wear masks and take precautions around others, she asked “parents, relatives, and close friends to join me and talk with teens about the importance of these prevention strategies and to encourage them to get vaccinated.”

Dr. Walensky referred to the CDC’s Morbidity and Mortality Weekly Report that showed adolescent hospitalizations peaked at 2.1 per 100,000 in early January 2021, then dropped to 0.6 per 100,000 in mid-March.

Alarmingly, hospitalizations rose to 1.3 per 100,000 in April, and a number of teens required serious interventions.

“Among hospitalized adolescents, nearly one-third required intensive care unit admission, and 5% required invasive mechanical ventilation,” the report said. No deaths occurred.

The study looked at 376 adolescents aged 12-17 who were hospitalized and tested positive for coronavirus. Of that group, 204 were hospitalized for COVID-19 and the other 172 were hospitalized for reasons not directly related to COVID-19.

Of the 204 hospitalized for COVID-19, 70.6% had an underlying medical condition such as obesity or chronic lung disease.

The study noted that children and teenagers have lower hospitalization rates and generally show less severe symptoms than do older people.

Possible causes for the rise in adolescent COVID-19 hospitalizations include the arrival of variants, the growing number of children returning to in-person education, and the changes in mask-wearing and other safety precautions, the study said.

The American Academy of Pediatrics said that as of May 27, 4 million children have tested positive for COVID-19 since the pandemic began, with about 34,500 new child cases reported for the week ending May 27.

The AAP said children have represented 14.1% of total cases since the pandemic began, but for the week ending May 27, children represented 24.3% of new reported weekly COVID-19 cases.

On May 10, the FDA granted emergency use authorization for the Pfizer coronavirus vaccine to be given to children aged 12-15 years. Previously, the FDA had authorized the Pfizer vaccine for people aged 16 years and up, whereas the Moderna and Johnson & Johnson vaccines are authorized for people aged 18 years and up.

“Vaccination is our way out of this pandemic,” Dr. Walensky said in her statement. “I continue to see promising signs in CDC data that we are nearing the end of this pandemic in this country; however, we all have to do our part and get vaccinated to cross the finish line.”
 

A version of this article was first published on WebMD.com.

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Patients with RA on rituximab at risk for worse COVID-19 outcomes

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Thu, 09/09/2021 - 16:19

Patients with rheumatoid arthritis who were using rituximab at the time of COVID-19 onset had a fourfold higher risk of being hospitalized, needing mechanical ventilation, or dying, compared with patients taking a tumor necrosis factor inhibitor (TNFi), according to a report given at the annual European Congress of Rheumatology.

Dr. Jeffrey A. Sparks

The use of Janus kinase inhibitors (JAKi) also was associated with a twofold higher risk for these COVID-19 outcomes, said Jeffrey A. Sparks, MD, of Brigham and Women’s Hospital and Harvard Medical School, Boston, in presenting the analysis from the COVID-19 Global Rheumatology Alliance (GRA) Physician Registry.

“The strong association of rituximab and JAK inhibitor use with poor COVID-19 outcomes highlights the prioritization of risk mitigation strategies for these patients,” Dr. Sparks said at the meeting.

The full findings have now been published in Annals of the Rheumatic Diseases.
 

JAKi association questioned

These findings provide “an important understanding for the risk of our patients in times before vaccination,” said Hendrik Schulze-Koops, MD, of Ludwig Maximilian University of Munich, who chaired the session in which the study was presented.

Dr. Hendrik Schulze-Koops

However, “recently, baricitinib was licensed to prevent particular aspects of severe COVID. What’s the explanation for this discrepancy?” he asked.

“Certainly, the JAK inhibitor finding deserves further study,” Dr. Sparks acknowledged, adding that the data were analyzed by class rather than for individual drugs.

“One possible explanation could be when JAK inhibitors are used,” he suggested. “It might be different for patients who [have been] just infected – that might have different biologic effects – as opposed to choosing to treat patients right when there’s a hyperinflammatory cascade, or there’s oxygen need.”

Regarding the JAK inhibitor finding, Ronald van Vollenhoven, MD, PhD, of the University of Amsterdam, pointed out during the online Q&A that “JAKi have a very short half-life compared to biologics.”

Dr. Ronald van Vollenhoven

Dr. van Vollenhoven asked: “Could the practice of stopping these drugs upon COVID infection have a negative impact on the course?” To which Dr. Sparks responded: “The different half-life of drugs would be a promising avenue to look at, to see whether increases in disease activity might have imparted some of the effects we saw.”
 

Performing the analysis

As of April 12, 2021, the GRA Physician Registry contained the records of more than 15,000 patients. Dr. Sparks, collaborator Zachary Wallace, MD, of Massachusetts General Hospital, Boston, and associates limited their analysis to 2,869 patients with RA who had been treated with either a biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) at the time they were diagnosed with COVID-19.

“We wanted to limit it to a single disease and also limit it to drugs that are considered for that disease,” Dr. Sparks explained in an interview.

“Because patients with rheumatoid arthritis are often treated sequentially, we wanted to further limit the analysis to patients who were on advanced therapies so that they were at a similar disease state, and also had the opportunity to receive advanced therapies.”



This approach hopefully minimizes the possibility of confounding by indication, Dr. Sparks said.

Most of the patients included in the analysis had received a TNFi (n = 1,388), and they were used as the control arm of the analysis. Outcomes associated with treatment with the other b/tsDMARDs, which included abatacept (n = 237), rituximab (n = 364), interleukin-6 inhibitors (IL-6i; n = 317), and JAKi (n = 563), were then compared with TNFi.

Baseline characteristics of patients were broadly similar across the groups. The mean age was 56.7 years and 80.8% of the study population was female. There were a few expected differences among users of rituximab versus TNFi, notably a higher percentage of patients with interstitial lung disease (11% vs. 1.4% of TNFi users) or cancer (7.4% vs. 0.9%) among patients treated with rituximab since it is commonly used in these patients, Dr. Sparks said.

“We did perform a sensitivity analysis where we restricted the population to not having ILD or cancer and we actually found really similar findings,” he added.

 

 

Four COVID-19 outcomes assessed

The researchers used a four-point ordinal scale modeled after one set by the World Health Organization to assess four COVID-19 outcomes: not hospitalized, hospitalized without oxygenation, hospitalized with oxygenation or ventilation, and death.

Odds ratios (ORs) comparing rituximab to TNFi for these four COVID-19 outcomes were a respective 4.53, 2.87, 4.05, and 4.57. The ORs for JAKi versus TNFi were a respective 2.4, 1.55, 2.03, and 2.04.

“We found no consistent associations of abatacept or interleukin-6 inhibitors with COVID-19 severity, compared to TNF inhibitors,” which is reassuring, Dr. Sparks said.

ORs for the four COVID-19 outcomes with abatacept were a respective 1.18, 1.12, 1.41, and 1.46, and for IL-6i were 0.84, 0.72, 0.75, and 1.13.

Rituximab use in patients with RA who develop COVID-19

So, should rituximab be stopped in patients with RA if they develop COVID-19? “This is an important question and one that would be decided on a case-by-case basis,” Dr. Sparks said. “Of course, the drug has a very long half-life, so risk mitigation strategies are still of utmost importance,” he added.

“I think everyone’s a bit reticent to want to start rituximab in this environment, but it might also make me pause about starting a JAK inhibitor,” Dr. Sparks added. “Given that this is a first finding, I’m not sure I would necessarily change patients who are doing well on these medications. I think what it really makes me want to do is to try to obviously vaccinate the patients on JAK inhibitors as they do have a short half-life.”

More observational studies would be helpful, Dr. Sparks said, adding that “the most pressing need is to try to figure out how to protect our patients with rituximab.”

The COVID-19 Global Rheumatology Alliance Physician Registry is supported by the American College of Rheumatology and the European Alliance of Associations for Rheumatology. Dr. Sparks disclosed serving as a consultant for Bristol Myers Squibb, Gilead, Inova, Optum, and Pfizer for work unrelated to this study. Dr. Wallace disclosed receiving grant support from Bristol Myers Squibb and Principia/Sanofi and serving as a consultant for Viela Bio and Medpace for work unrelated to this study.

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Patients with rheumatoid arthritis who were using rituximab at the time of COVID-19 onset had a fourfold higher risk of being hospitalized, needing mechanical ventilation, or dying, compared with patients taking a tumor necrosis factor inhibitor (TNFi), according to a report given at the annual European Congress of Rheumatology.

Dr. Jeffrey A. Sparks

The use of Janus kinase inhibitors (JAKi) also was associated with a twofold higher risk for these COVID-19 outcomes, said Jeffrey A. Sparks, MD, of Brigham and Women’s Hospital and Harvard Medical School, Boston, in presenting the analysis from the COVID-19 Global Rheumatology Alliance (GRA) Physician Registry.

“The strong association of rituximab and JAK inhibitor use with poor COVID-19 outcomes highlights the prioritization of risk mitigation strategies for these patients,” Dr. Sparks said at the meeting.

The full findings have now been published in Annals of the Rheumatic Diseases.
 

JAKi association questioned

These findings provide “an important understanding for the risk of our patients in times before vaccination,” said Hendrik Schulze-Koops, MD, of Ludwig Maximilian University of Munich, who chaired the session in which the study was presented.

Dr. Hendrik Schulze-Koops

However, “recently, baricitinib was licensed to prevent particular aspects of severe COVID. What’s the explanation for this discrepancy?” he asked.

“Certainly, the JAK inhibitor finding deserves further study,” Dr. Sparks acknowledged, adding that the data were analyzed by class rather than for individual drugs.

“One possible explanation could be when JAK inhibitors are used,” he suggested. “It might be different for patients who [have been] just infected – that might have different biologic effects – as opposed to choosing to treat patients right when there’s a hyperinflammatory cascade, or there’s oxygen need.”

Regarding the JAK inhibitor finding, Ronald van Vollenhoven, MD, PhD, of the University of Amsterdam, pointed out during the online Q&A that “JAKi have a very short half-life compared to biologics.”

Dr. Ronald van Vollenhoven

Dr. van Vollenhoven asked: “Could the practice of stopping these drugs upon COVID infection have a negative impact on the course?” To which Dr. Sparks responded: “The different half-life of drugs would be a promising avenue to look at, to see whether increases in disease activity might have imparted some of the effects we saw.”
 

Performing the analysis

As of April 12, 2021, the GRA Physician Registry contained the records of more than 15,000 patients. Dr. Sparks, collaborator Zachary Wallace, MD, of Massachusetts General Hospital, Boston, and associates limited their analysis to 2,869 patients with RA who had been treated with either a biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) at the time they were diagnosed with COVID-19.

“We wanted to limit it to a single disease and also limit it to drugs that are considered for that disease,” Dr. Sparks explained in an interview.

“Because patients with rheumatoid arthritis are often treated sequentially, we wanted to further limit the analysis to patients who were on advanced therapies so that they were at a similar disease state, and also had the opportunity to receive advanced therapies.”



This approach hopefully minimizes the possibility of confounding by indication, Dr. Sparks said.

Most of the patients included in the analysis had received a TNFi (n = 1,388), and they were used as the control arm of the analysis. Outcomes associated with treatment with the other b/tsDMARDs, which included abatacept (n = 237), rituximab (n = 364), interleukin-6 inhibitors (IL-6i; n = 317), and JAKi (n = 563), were then compared with TNFi.

Baseline characteristics of patients were broadly similar across the groups. The mean age was 56.7 years and 80.8% of the study population was female. There were a few expected differences among users of rituximab versus TNFi, notably a higher percentage of patients with interstitial lung disease (11% vs. 1.4% of TNFi users) or cancer (7.4% vs. 0.9%) among patients treated with rituximab since it is commonly used in these patients, Dr. Sparks said.

“We did perform a sensitivity analysis where we restricted the population to not having ILD or cancer and we actually found really similar findings,” he added.

 

 

Four COVID-19 outcomes assessed

The researchers used a four-point ordinal scale modeled after one set by the World Health Organization to assess four COVID-19 outcomes: not hospitalized, hospitalized without oxygenation, hospitalized with oxygenation or ventilation, and death.

Odds ratios (ORs) comparing rituximab to TNFi for these four COVID-19 outcomes were a respective 4.53, 2.87, 4.05, and 4.57. The ORs for JAKi versus TNFi were a respective 2.4, 1.55, 2.03, and 2.04.

“We found no consistent associations of abatacept or interleukin-6 inhibitors with COVID-19 severity, compared to TNF inhibitors,” which is reassuring, Dr. Sparks said.

ORs for the four COVID-19 outcomes with abatacept were a respective 1.18, 1.12, 1.41, and 1.46, and for IL-6i were 0.84, 0.72, 0.75, and 1.13.

Rituximab use in patients with RA who develop COVID-19

So, should rituximab be stopped in patients with RA if they develop COVID-19? “This is an important question and one that would be decided on a case-by-case basis,” Dr. Sparks said. “Of course, the drug has a very long half-life, so risk mitigation strategies are still of utmost importance,” he added.

“I think everyone’s a bit reticent to want to start rituximab in this environment, but it might also make me pause about starting a JAK inhibitor,” Dr. Sparks added. “Given that this is a first finding, I’m not sure I would necessarily change patients who are doing well on these medications. I think what it really makes me want to do is to try to obviously vaccinate the patients on JAK inhibitors as they do have a short half-life.”

More observational studies would be helpful, Dr. Sparks said, adding that “the most pressing need is to try to figure out how to protect our patients with rituximab.”

The COVID-19 Global Rheumatology Alliance Physician Registry is supported by the American College of Rheumatology and the European Alliance of Associations for Rheumatology. Dr. Sparks disclosed serving as a consultant for Bristol Myers Squibb, Gilead, Inova, Optum, and Pfizer for work unrelated to this study. Dr. Wallace disclosed receiving grant support from Bristol Myers Squibb and Principia/Sanofi and serving as a consultant for Viela Bio and Medpace for work unrelated to this study.

Patients with rheumatoid arthritis who were using rituximab at the time of COVID-19 onset had a fourfold higher risk of being hospitalized, needing mechanical ventilation, or dying, compared with patients taking a tumor necrosis factor inhibitor (TNFi), according to a report given at the annual European Congress of Rheumatology.

Dr. Jeffrey A. Sparks

The use of Janus kinase inhibitors (JAKi) also was associated with a twofold higher risk for these COVID-19 outcomes, said Jeffrey A. Sparks, MD, of Brigham and Women’s Hospital and Harvard Medical School, Boston, in presenting the analysis from the COVID-19 Global Rheumatology Alliance (GRA) Physician Registry.

“The strong association of rituximab and JAK inhibitor use with poor COVID-19 outcomes highlights the prioritization of risk mitigation strategies for these patients,” Dr. Sparks said at the meeting.

The full findings have now been published in Annals of the Rheumatic Diseases.
 

JAKi association questioned

These findings provide “an important understanding for the risk of our patients in times before vaccination,” said Hendrik Schulze-Koops, MD, of Ludwig Maximilian University of Munich, who chaired the session in which the study was presented.

Dr. Hendrik Schulze-Koops

However, “recently, baricitinib was licensed to prevent particular aspects of severe COVID. What’s the explanation for this discrepancy?” he asked.

“Certainly, the JAK inhibitor finding deserves further study,” Dr. Sparks acknowledged, adding that the data were analyzed by class rather than for individual drugs.

“One possible explanation could be when JAK inhibitors are used,” he suggested. “It might be different for patients who [have been] just infected – that might have different biologic effects – as opposed to choosing to treat patients right when there’s a hyperinflammatory cascade, or there’s oxygen need.”

Regarding the JAK inhibitor finding, Ronald van Vollenhoven, MD, PhD, of the University of Amsterdam, pointed out during the online Q&A that “JAKi have a very short half-life compared to biologics.”

Dr. Ronald van Vollenhoven

Dr. van Vollenhoven asked: “Could the practice of stopping these drugs upon COVID infection have a negative impact on the course?” To which Dr. Sparks responded: “The different half-life of drugs would be a promising avenue to look at, to see whether increases in disease activity might have imparted some of the effects we saw.”
 

Performing the analysis

As of April 12, 2021, the GRA Physician Registry contained the records of more than 15,000 patients. Dr. Sparks, collaborator Zachary Wallace, MD, of Massachusetts General Hospital, Boston, and associates limited their analysis to 2,869 patients with RA who had been treated with either a biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) at the time they were diagnosed with COVID-19.

“We wanted to limit it to a single disease and also limit it to drugs that are considered for that disease,” Dr. Sparks explained in an interview.

“Because patients with rheumatoid arthritis are often treated sequentially, we wanted to further limit the analysis to patients who were on advanced therapies so that they were at a similar disease state, and also had the opportunity to receive advanced therapies.”



This approach hopefully minimizes the possibility of confounding by indication, Dr. Sparks said.

Most of the patients included in the analysis had received a TNFi (n = 1,388), and they were used as the control arm of the analysis. Outcomes associated with treatment with the other b/tsDMARDs, which included abatacept (n = 237), rituximab (n = 364), interleukin-6 inhibitors (IL-6i; n = 317), and JAKi (n = 563), were then compared with TNFi.

Baseline characteristics of patients were broadly similar across the groups. The mean age was 56.7 years and 80.8% of the study population was female. There were a few expected differences among users of rituximab versus TNFi, notably a higher percentage of patients with interstitial lung disease (11% vs. 1.4% of TNFi users) or cancer (7.4% vs. 0.9%) among patients treated with rituximab since it is commonly used in these patients, Dr. Sparks said.

“We did perform a sensitivity analysis where we restricted the population to not having ILD or cancer and we actually found really similar findings,” he added.

 

 

Four COVID-19 outcomes assessed

The researchers used a four-point ordinal scale modeled after one set by the World Health Organization to assess four COVID-19 outcomes: not hospitalized, hospitalized without oxygenation, hospitalized with oxygenation or ventilation, and death.

Odds ratios (ORs) comparing rituximab to TNFi for these four COVID-19 outcomes were a respective 4.53, 2.87, 4.05, and 4.57. The ORs for JAKi versus TNFi were a respective 2.4, 1.55, 2.03, and 2.04.

“We found no consistent associations of abatacept or interleukin-6 inhibitors with COVID-19 severity, compared to TNF inhibitors,” which is reassuring, Dr. Sparks said.

ORs for the four COVID-19 outcomes with abatacept were a respective 1.18, 1.12, 1.41, and 1.46, and for IL-6i were 0.84, 0.72, 0.75, and 1.13.

Rituximab use in patients with RA who develop COVID-19

So, should rituximab be stopped in patients with RA if they develop COVID-19? “This is an important question and one that would be decided on a case-by-case basis,” Dr. Sparks said. “Of course, the drug has a very long half-life, so risk mitigation strategies are still of utmost importance,” he added.

“I think everyone’s a bit reticent to want to start rituximab in this environment, but it might also make me pause about starting a JAK inhibitor,” Dr. Sparks added. “Given that this is a first finding, I’m not sure I would necessarily change patients who are doing well on these medications. I think what it really makes me want to do is to try to obviously vaccinate the patients on JAK inhibitors as they do have a short half-life.”

More observational studies would be helpful, Dr. Sparks said, adding that “the most pressing need is to try to figure out how to protect our patients with rituximab.”

The COVID-19 Global Rheumatology Alliance Physician Registry is supported by the American College of Rheumatology and the European Alliance of Associations for Rheumatology. Dr. Sparks disclosed serving as a consultant for Bristol Myers Squibb, Gilead, Inova, Optum, and Pfizer for work unrelated to this study. Dr. Wallace disclosed receiving grant support from Bristol Myers Squibb and Principia/Sanofi and serving as a consultant for Viela Bio and Medpace for work unrelated to this study.

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FROM THE EULAR 2021 CONGRESS

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A primer on COVID-19 in hospitalized children

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Changed
Thu, 08/26/2021 - 15:46

 

Converge 2021 session

COVID-19 in Children

Presenter

Philip Zachariah, MD, MPH

Session summary

Children have been less severely affected by COVID-19 than adults (hospitalization rates around 5%). However, once hospitalized, ICU admission rates in children have been similar to adults, around 30%. Mortality has been 1%-2%. Risk factors for more severe acute SARS CoV-2 infections include age extremes, minorities, obesity, medical complexity, immunocompromised pediatric patients, and asthma.

Dr. Philip Zachariah

Multisystem-inflammatory-syndrome-in-children (MIS-C) continues to present among persistently febrile children with multisystem findings and the history of acute COVID-19 infection in prior 3-6 weeks. There seems to be a link between the immunological defects in type I and II interferon production, as autoantibodies to type I interferon may predispose to severe disease. Dr. Zachariah of Columbia University Medical Center in New York, discussed the recent study exploring intravenous immunoglobulin (IVIG) alone versus IVIG and steroids as treatment options for MIS-C. So far, the failure rates in IVIG-alone group were higher (51%) versus IVIG and steroids (9%).

Besides MIS-C, many neurological manifestations of COVID-19 have been seen among children including GBS, seizures, encephalitis, cranial neuropathies, and demyelination cases. Diabetic ketoacidosis (DKA), secondary hemophagocytic lymphohistiocytosis (HLH), and pseudo-appendicitis have all been described in the literature, however, larger case control studied are needed.

In children, clinical vascular thrombotic events (VTEs) are rare. Anticoagulant thromboprophylaxis is suggested for hospitalized patients with COVID-19–related illness, whose D-dimer is >5 times upper limit of normal values and who have one or more non–COVID-19 related clinical risk factors for hospital acquired VTEs.

Dr. Mirna Giordano

Key takeaways

  • Once hospitalized, the ICU admission rates for children have been similar to those in adults, ~30%.
  • MIS-C is showing lower failure rates if treated with IVIG and steroids, and most reliable laboratory findings should be elevated C-reactive protein, lymphopenia, and elevated brain natriuretic peptide.
  • In hospitalized children with COVID-19, clinical VTEs are rare.

Dr. Giordano is an associate professor of pediatrics at Columbia University Medical Center in New York. She is a pediatric hospitalist with expertise in pediatric surgical comanagement

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Converge 2021 session

COVID-19 in Children

Presenter

Philip Zachariah, MD, MPH

Session summary

Children have been less severely affected by COVID-19 than adults (hospitalization rates around 5%). However, once hospitalized, ICU admission rates in children have been similar to adults, around 30%. Mortality has been 1%-2%. Risk factors for more severe acute SARS CoV-2 infections include age extremes, minorities, obesity, medical complexity, immunocompromised pediatric patients, and asthma.

Dr. Philip Zachariah

Multisystem-inflammatory-syndrome-in-children (MIS-C) continues to present among persistently febrile children with multisystem findings and the history of acute COVID-19 infection in prior 3-6 weeks. There seems to be a link between the immunological defects in type I and II interferon production, as autoantibodies to type I interferon may predispose to severe disease. Dr. Zachariah of Columbia University Medical Center in New York, discussed the recent study exploring intravenous immunoglobulin (IVIG) alone versus IVIG and steroids as treatment options for MIS-C. So far, the failure rates in IVIG-alone group were higher (51%) versus IVIG and steroids (9%).

Besides MIS-C, many neurological manifestations of COVID-19 have been seen among children including GBS, seizures, encephalitis, cranial neuropathies, and demyelination cases. Diabetic ketoacidosis (DKA), secondary hemophagocytic lymphohistiocytosis (HLH), and pseudo-appendicitis have all been described in the literature, however, larger case control studied are needed.

In children, clinical vascular thrombotic events (VTEs) are rare. Anticoagulant thromboprophylaxis is suggested for hospitalized patients with COVID-19–related illness, whose D-dimer is >5 times upper limit of normal values and who have one or more non–COVID-19 related clinical risk factors for hospital acquired VTEs.

Dr. Mirna Giordano

Key takeaways

  • Once hospitalized, the ICU admission rates for children have been similar to those in adults, ~30%.
  • MIS-C is showing lower failure rates if treated with IVIG and steroids, and most reliable laboratory findings should be elevated C-reactive protein, lymphopenia, and elevated brain natriuretic peptide.
  • In hospitalized children with COVID-19, clinical VTEs are rare.

Dr. Giordano is an associate professor of pediatrics at Columbia University Medical Center in New York. She is a pediatric hospitalist with expertise in pediatric surgical comanagement

 

Converge 2021 session

COVID-19 in Children

Presenter

Philip Zachariah, MD, MPH

Session summary

Children have been less severely affected by COVID-19 than adults (hospitalization rates around 5%). However, once hospitalized, ICU admission rates in children have been similar to adults, around 30%. Mortality has been 1%-2%. Risk factors for more severe acute SARS CoV-2 infections include age extremes, minorities, obesity, medical complexity, immunocompromised pediatric patients, and asthma.

Dr. Philip Zachariah

Multisystem-inflammatory-syndrome-in-children (MIS-C) continues to present among persistently febrile children with multisystem findings and the history of acute COVID-19 infection in prior 3-6 weeks. There seems to be a link between the immunological defects in type I and II interferon production, as autoantibodies to type I interferon may predispose to severe disease. Dr. Zachariah of Columbia University Medical Center in New York, discussed the recent study exploring intravenous immunoglobulin (IVIG) alone versus IVIG and steroids as treatment options for MIS-C. So far, the failure rates in IVIG-alone group were higher (51%) versus IVIG and steroids (9%).

Besides MIS-C, many neurological manifestations of COVID-19 have been seen among children including GBS, seizures, encephalitis, cranial neuropathies, and demyelination cases. Diabetic ketoacidosis (DKA), secondary hemophagocytic lymphohistiocytosis (HLH), and pseudo-appendicitis have all been described in the literature, however, larger case control studied are needed.

In children, clinical vascular thrombotic events (VTEs) are rare. Anticoagulant thromboprophylaxis is suggested for hospitalized patients with COVID-19–related illness, whose D-dimer is >5 times upper limit of normal values and who have one or more non–COVID-19 related clinical risk factors for hospital acquired VTEs.

Dr. Mirna Giordano

Key takeaways

  • Once hospitalized, the ICU admission rates for children have been similar to those in adults, ~30%.
  • MIS-C is showing lower failure rates if treated with IVIG and steroids, and most reliable laboratory findings should be elevated C-reactive protein, lymphopenia, and elevated brain natriuretic peptide.
  • In hospitalized children with COVID-19, clinical VTEs are rare.

Dr. Giordano is an associate professor of pediatrics at Columbia University Medical Center in New York. She is a pediatric hospitalist with expertise in pediatric surgical comanagement

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Texas hospital workers sue over vaccine mandates

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A group of 117 people who work at the Houston Methodist Health System has filed a lawsuit against the medical center, objecting to its policy of requiring employees and contractors to be vaccinated against COVID-19 or risk losing their jobs.

Plaintiffs include Jennifer Bridges, RN, a medical-surgical nurse at the hospital who has become the public face and voice of health care workers who object to mandatory vaccination, as well as Bob Nevens, the hospital’s director of corporate risk.

Mr. Nevens said the hospital was requiring him to be vaccinated even though he doesn’t treat patients and has been working from home for most of the past year.

“My civil rights and liberties have been trampled on,” he said in comments posted on an online petition. “My right to protect myself from unknown side effects of these vaccines has been placed below the optics of ‘leading medicine,’ “ he said.

Mr. Nevens says in his comments that he was fired on April 15, although the lawsuit says he is currently employed by the hospital’s corporate office.

The Texas attorney who filed the lawsuit, Jared Woodfill, is known to champion conservative causes. In March 2020, he challenged Harris County’s stay-at-home order, charging that it violated religious liberty. He was chairman of the Harris County Republican Party for more than a decade. His website says he is a frequent guest on the local Fox News affiliate.

The lawsuit hinges on a section of the federal law that authorizes emergency use of medical products – US Code 360bbb-3.

That law says that individuals to whom the product is administered should be informed “of the option to accept or refuse administration of the product, of the consequence, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”

Legal experts are split as to what the provision means for vaccination mandates. Courts have not yet weighed in with their interpretations of the law.

The petition also repeats a popular antivaccination argument that likens requiring a vaccine approved for emergency use to the kind of medical experimentation performed by Nazi doctors on Jewish prisoners in concentration camps. It says forcing people to choose between an experimental vaccine and a job is a violation of the Nuremberg Code, which says that people must voluntarily and knowingly consent to participating in research.

The vaccines have already been tested in clinical trials. People who are getting them now are not part of those studies, though vaccine manufacturers, regulators, and safety experts are still watching closely for any sign of problems tied to the new shots.

It is true, however, that the emergency use authorization granted by the U.S. Food and Drug Administraiton sped up the process of getting the vaccines onto market. Vaccine manufacturers are currently completing the process of submitting documentation required for a full biologics license application, the mechanism the FDA uses for full approval.

Houston Methodist sent an email to employees in April notifying them that they had until June 7 to start the vaccination process or apply for a medical or religious exemption. Those who decide not to will be terminated.

Marc Boom, MD, the health care system’s president and CEO, has explained that the policy is in place to protect patients and that it was the first hospital in the United States to require it. Since then, other hospitals, including the University of Pennsylvania Health System, have required COVID vaccines.

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

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A group of 117 people who work at the Houston Methodist Health System has filed a lawsuit against the medical center, objecting to its policy of requiring employees and contractors to be vaccinated against COVID-19 or risk losing their jobs.

Plaintiffs include Jennifer Bridges, RN, a medical-surgical nurse at the hospital who has become the public face and voice of health care workers who object to mandatory vaccination, as well as Bob Nevens, the hospital’s director of corporate risk.

Mr. Nevens said the hospital was requiring him to be vaccinated even though he doesn’t treat patients and has been working from home for most of the past year.

“My civil rights and liberties have been trampled on,” he said in comments posted on an online petition. “My right to protect myself from unknown side effects of these vaccines has been placed below the optics of ‘leading medicine,’ “ he said.

Mr. Nevens says in his comments that he was fired on April 15, although the lawsuit says he is currently employed by the hospital’s corporate office.

The Texas attorney who filed the lawsuit, Jared Woodfill, is known to champion conservative causes. In March 2020, he challenged Harris County’s stay-at-home order, charging that it violated religious liberty. He was chairman of the Harris County Republican Party for more than a decade. His website says he is a frequent guest on the local Fox News affiliate.

The lawsuit hinges on a section of the federal law that authorizes emergency use of medical products – US Code 360bbb-3.

That law says that individuals to whom the product is administered should be informed “of the option to accept or refuse administration of the product, of the consequence, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”

Legal experts are split as to what the provision means for vaccination mandates. Courts have not yet weighed in with their interpretations of the law.

The petition also repeats a popular antivaccination argument that likens requiring a vaccine approved for emergency use to the kind of medical experimentation performed by Nazi doctors on Jewish prisoners in concentration camps. It says forcing people to choose between an experimental vaccine and a job is a violation of the Nuremberg Code, which says that people must voluntarily and knowingly consent to participating in research.

The vaccines have already been tested in clinical trials. People who are getting them now are not part of those studies, though vaccine manufacturers, regulators, and safety experts are still watching closely for any sign of problems tied to the new shots.

It is true, however, that the emergency use authorization granted by the U.S. Food and Drug Administraiton sped up the process of getting the vaccines onto market. Vaccine manufacturers are currently completing the process of submitting documentation required for a full biologics license application, the mechanism the FDA uses for full approval.

Houston Methodist sent an email to employees in April notifying them that they had until June 7 to start the vaccination process or apply for a medical or religious exemption. Those who decide not to will be terminated.

Marc Boom, MD, the health care system’s president and CEO, has explained that the policy is in place to protect patients and that it was the first hospital in the United States to require it. Since then, other hospitals, including the University of Pennsylvania Health System, have required COVID vaccines.

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

 

A group of 117 people who work at the Houston Methodist Health System has filed a lawsuit against the medical center, objecting to its policy of requiring employees and contractors to be vaccinated against COVID-19 or risk losing their jobs.

Plaintiffs include Jennifer Bridges, RN, a medical-surgical nurse at the hospital who has become the public face and voice of health care workers who object to mandatory vaccination, as well as Bob Nevens, the hospital’s director of corporate risk.

Mr. Nevens said the hospital was requiring him to be vaccinated even though he doesn’t treat patients and has been working from home for most of the past year.

“My civil rights and liberties have been trampled on,” he said in comments posted on an online petition. “My right to protect myself from unknown side effects of these vaccines has been placed below the optics of ‘leading medicine,’ “ he said.

Mr. Nevens says in his comments that he was fired on April 15, although the lawsuit says he is currently employed by the hospital’s corporate office.

The Texas attorney who filed the lawsuit, Jared Woodfill, is known to champion conservative causes. In March 2020, he challenged Harris County’s stay-at-home order, charging that it violated religious liberty. He was chairman of the Harris County Republican Party for more than a decade. His website says he is a frequent guest on the local Fox News affiliate.

The lawsuit hinges on a section of the federal law that authorizes emergency use of medical products – US Code 360bbb-3.

That law says that individuals to whom the product is administered should be informed “of the option to accept or refuse administration of the product, of the consequence, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”

Legal experts are split as to what the provision means for vaccination mandates. Courts have not yet weighed in with their interpretations of the law.

The petition also repeats a popular antivaccination argument that likens requiring a vaccine approved for emergency use to the kind of medical experimentation performed by Nazi doctors on Jewish prisoners in concentration camps. It says forcing people to choose between an experimental vaccine and a job is a violation of the Nuremberg Code, which says that people must voluntarily and knowingly consent to participating in research.

The vaccines have already been tested in clinical trials. People who are getting them now are not part of those studies, though vaccine manufacturers, regulators, and safety experts are still watching closely for any sign of problems tied to the new shots.

It is true, however, that the emergency use authorization granted by the U.S. Food and Drug Administraiton sped up the process of getting the vaccines onto market. Vaccine manufacturers are currently completing the process of submitting documentation required for a full biologics license application, the mechanism the FDA uses for full approval.

Houston Methodist sent an email to employees in April notifying them that they had until June 7 to start the vaccination process or apply for a medical or religious exemption. Those who decide not to will be terminated.

Marc Boom, MD, the health care system’s president and CEO, has explained that the policy is in place to protect patients and that it was the first hospital in the United States to require it. Since then, other hospitals, including the University of Pennsylvania Health System, have required COVID vaccines.

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

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Concerts may be safe to attend with proper safety precautions: Study

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Researchers in Spain have shared heartening results from the first randomized controlled trial to assess risk for COVID-19 transmission at an indoor live music concert.
 

The study, published May 27 in The Lancet Infectious Diseases, led by virologist Boris Revollo, MD, from the Germans Trias i Pujol University Hospital in Barcelona, included comprehensive safety measures.

It was conducted on Dec. 12, 2020, at a time when local travel restrictions were in place, indoor meetings were limited to six people, and vaccines were not yet available.

All 465 event attendees got same-day SARS-CoV-2 screening with antigen-detecting rapid diagnostic tests before they entered, wore masks throughout, and followed crowd-control measures in the well-ventilated venue, which can hold up to 900 people.

The control group consisted of 495 participants randomly assigned to go home instead of attending the concert after the screening.

None of the attendees tested positive for SARS-CoV-2 infection by polymerase chain reaction (PCR) test 8 days after the 5-hour event, but two in the control group did.

In fact, the study showed that the risk for infection was no higher among those at the concert than it was for those who lived in the same community and did not attend.

The Bayesian estimate for the incidence between the test and control groups was –0.15% (95% confidence Interval, –0.72 to 0.44).

“Our findings pave the way to reactivate cultural activities halted during COVID-19, which could have important sociocultural and economic implications,” the authors wrote.
 

All wore masks throughout

Among the comprehensive safety measures were that, in addition to testing, all attendees had their temperature checked before gaining access and were given an N95 face mask, which had to be worn at all times inside.

Hand sanitizer was provided in multiple locations, access doors remained open to allow fresh air to circulate, and the coat room was closed to prevent clustering.

There was no mandated distancing, people could sing and dance, and alcohol was available in a bar located in a separate room – and drinks were allowed only in that space.

Rosanna W Peeling, PhD, professor and chair of diagnostic research at the London School of Hygiene and Tropical Medicine in the United Kingdom, and David L. Heymann, MD, of the department of infectious disease epidemiology there, said in an accompanying commentary that there is a great need for studies like this one to help build evidence for a return to normal gatherings.

“So many countries don’t have any policy or any way of doing this because they don’t have the evidence,” Dr. Peeling said in an interview.

The study was well done and a strength was the testing 8 days later, which can be hard to do for similar events when people disperse to locations outside the community where the event or gathering was held, she said.
 

Study prompts additional questions

Dr. Peeling and Dr. Heymann wrote that the work raises questions such as whether triple-layered masks would have been sufficient. Or how does rapid antigen testing at the entrance compare with molecular screening within 72 hours of entering? 

They noted that there are questions around whether existing rapid diagnostic tests are able to detect COVID-19 variants.

Dr. Peeling said that these kinds of results need to be shared and shared more quickly, “if we’re ever going to get out of this pandemic.”

Studies like this are also difficult, she noted, because they may involve non–health sector entities such as city governments and concert organizers working together with researchers.

In addition, the safety measures come at considerable expense and it’s unclear whether those could be employed routinely at such events.

“It’s not really sustainable at sports events with 20,000 people,” Dr. Peeling said.

Infectious disease expert William Schaffner, MD, of Vanderbilt University, Nashville, Tenn., told this news organization that the study results “come a little late to the party.”

If this study had been done in today’s era with authorized vaccines, “it would have been a moot issue,” he said. “The mask is a barrier to transmission, but we now have a much more solid barrier we could put in place, which is vaccination.

“That said, it does reinforce the fact that classical mask wearing does really offer protection even in a crowded venue,” Dr. Schaffner said.

He added that the study was relatively small and he’d like to see it replicated in larger concerts or group gatherings.

Dr. Peeling and Dr. Heymann report no relevant financial relationships. A coauthor is an employee and stockholder of Primavera Sound, sponsor of the study. All other authors declare no relevant financial relationships.
 

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

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Researchers in Spain have shared heartening results from the first randomized controlled trial to assess risk for COVID-19 transmission at an indoor live music concert.
 

The study, published May 27 in The Lancet Infectious Diseases, led by virologist Boris Revollo, MD, from the Germans Trias i Pujol University Hospital in Barcelona, included comprehensive safety measures.

It was conducted on Dec. 12, 2020, at a time when local travel restrictions were in place, indoor meetings were limited to six people, and vaccines were not yet available.

All 465 event attendees got same-day SARS-CoV-2 screening with antigen-detecting rapid diagnostic tests before they entered, wore masks throughout, and followed crowd-control measures in the well-ventilated venue, which can hold up to 900 people.

The control group consisted of 495 participants randomly assigned to go home instead of attending the concert after the screening.

None of the attendees tested positive for SARS-CoV-2 infection by polymerase chain reaction (PCR) test 8 days after the 5-hour event, but two in the control group did.

In fact, the study showed that the risk for infection was no higher among those at the concert than it was for those who lived in the same community and did not attend.

The Bayesian estimate for the incidence between the test and control groups was –0.15% (95% confidence Interval, –0.72 to 0.44).

“Our findings pave the way to reactivate cultural activities halted during COVID-19, which could have important sociocultural and economic implications,” the authors wrote.
 

All wore masks throughout

Among the comprehensive safety measures were that, in addition to testing, all attendees had their temperature checked before gaining access and were given an N95 face mask, which had to be worn at all times inside.

Hand sanitizer was provided in multiple locations, access doors remained open to allow fresh air to circulate, and the coat room was closed to prevent clustering.

There was no mandated distancing, people could sing and dance, and alcohol was available in a bar located in a separate room – and drinks were allowed only in that space.

Rosanna W Peeling, PhD, professor and chair of diagnostic research at the London School of Hygiene and Tropical Medicine in the United Kingdom, and David L. Heymann, MD, of the department of infectious disease epidemiology there, said in an accompanying commentary that there is a great need for studies like this one to help build evidence for a return to normal gatherings.

“So many countries don’t have any policy or any way of doing this because they don’t have the evidence,” Dr. Peeling said in an interview.

The study was well done and a strength was the testing 8 days later, which can be hard to do for similar events when people disperse to locations outside the community where the event or gathering was held, she said.
 

Study prompts additional questions

Dr. Peeling and Dr. Heymann wrote that the work raises questions such as whether triple-layered masks would have been sufficient. Or how does rapid antigen testing at the entrance compare with molecular screening within 72 hours of entering? 

They noted that there are questions around whether existing rapid diagnostic tests are able to detect COVID-19 variants.

Dr. Peeling said that these kinds of results need to be shared and shared more quickly, “if we’re ever going to get out of this pandemic.”

Studies like this are also difficult, she noted, because they may involve non–health sector entities such as city governments and concert organizers working together with researchers.

In addition, the safety measures come at considerable expense and it’s unclear whether those could be employed routinely at such events.

“It’s not really sustainable at sports events with 20,000 people,” Dr. Peeling said.

Infectious disease expert William Schaffner, MD, of Vanderbilt University, Nashville, Tenn., told this news organization that the study results “come a little late to the party.”

If this study had been done in today’s era with authorized vaccines, “it would have been a moot issue,” he said. “The mask is a barrier to transmission, but we now have a much more solid barrier we could put in place, which is vaccination.

“That said, it does reinforce the fact that classical mask wearing does really offer protection even in a crowded venue,” Dr. Schaffner said.

He added that the study was relatively small and he’d like to see it replicated in larger concerts or group gatherings.

Dr. Peeling and Dr. Heymann report no relevant financial relationships. A coauthor is an employee and stockholder of Primavera Sound, sponsor of the study. All other authors declare no relevant financial relationships.
 

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

Researchers in Spain have shared heartening results from the first randomized controlled trial to assess risk for COVID-19 transmission at an indoor live music concert.
 

The study, published May 27 in The Lancet Infectious Diseases, led by virologist Boris Revollo, MD, from the Germans Trias i Pujol University Hospital in Barcelona, included comprehensive safety measures.

It was conducted on Dec. 12, 2020, at a time when local travel restrictions were in place, indoor meetings were limited to six people, and vaccines were not yet available.

All 465 event attendees got same-day SARS-CoV-2 screening with antigen-detecting rapid diagnostic tests before they entered, wore masks throughout, and followed crowd-control measures in the well-ventilated venue, which can hold up to 900 people.

The control group consisted of 495 participants randomly assigned to go home instead of attending the concert after the screening.

None of the attendees tested positive for SARS-CoV-2 infection by polymerase chain reaction (PCR) test 8 days after the 5-hour event, but two in the control group did.

In fact, the study showed that the risk for infection was no higher among those at the concert than it was for those who lived in the same community and did not attend.

The Bayesian estimate for the incidence between the test and control groups was –0.15% (95% confidence Interval, –0.72 to 0.44).

“Our findings pave the way to reactivate cultural activities halted during COVID-19, which could have important sociocultural and economic implications,” the authors wrote.
 

All wore masks throughout

Among the comprehensive safety measures were that, in addition to testing, all attendees had their temperature checked before gaining access and were given an N95 face mask, which had to be worn at all times inside.

Hand sanitizer was provided in multiple locations, access doors remained open to allow fresh air to circulate, and the coat room was closed to prevent clustering.

There was no mandated distancing, people could sing and dance, and alcohol was available in a bar located in a separate room – and drinks were allowed only in that space.

Rosanna W Peeling, PhD, professor and chair of diagnostic research at the London School of Hygiene and Tropical Medicine in the United Kingdom, and David L. Heymann, MD, of the department of infectious disease epidemiology there, said in an accompanying commentary that there is a great need for studies like this one to help build evidence for a return to normal gatherings.

“So many countries don’t have any policy or any way of doing this because they don’t have the evidence,” Dr. Peeling said in an interview.

The study was well done and a strength was the testing 8 days later, which can be hard to do for similar events when people disperse to locations outside the community where the event or gathering was held, she said.
 

Study prompts additional questions

Dr. Peeling and Dr. Heymann wrote that the work raises questions such as whether triple-layered masks would have been sufficient. Or how does rapid antigen testing at the entrance compare with molecular screening within 72 hours of entering? 

They noted that there are questions around whether existing rapid diagnostic tests are able to detect COVID-19 variants.

Dr. Peeling said that these kinds of results need to be shared and shared more quickly, “if we’re ever going to get out of this pandemic.”

Studies like this are also difficult, she noted, because they may involve non–health sector entities such as city governments and concert organizers working together with researchers.

In addition, the safety measures come at considerable expense and it’s unclear whether those could be employed routinely at such events.

“It’s not really sustainable at sports events with 20,000 people,” Dr. Peeling said.

Infectious disease expert William Schaffner, MD, of Vanderbilt University, Nashville, Tenn., told this news organization that the study results “come a little late to the party.”

If this study had been done in today’s era with authorized vaccines, “it would have been a moot issue,” he said. “The mask is a barrier to transmission, but we now have a much more solid barrier we could put in place, which is vaccination.

“That said, it does reinforce the fact that classical mask wearing does really offer protection even in a crowded venue,” Dr. Schaffner said.

He added that the study was relatively small and he’d like to see it replicated in larger concerts or group gatherings.

Dr. Peeling and Dr. Heymann report no relevant financial relationships. A coauthor is an employee and stockholder of Primavera Sound, sponsor of the study. All other authors declare no relevant financial relationships.
 

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

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Child suicides drive Colorado hospital to declare state of emergency

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On May 25, Jena Hausmann, CEO of Children’s Hospital Colorado, Aurora, declared a state of emergency in youth mental health in response to an astronomical increase in pediatric mental health cases, including suicide, which has overwhelmed the institution.

Jena Hausmann

From April 2019 to April 2021, the demand for pediatric behavioral health treatment at the hospital system increased by 90%. In Colorado, suicide is now the number one cause of death among youth and occurs in children as young as 10 years of age.

“Now we are seeing our pediatric emergency departments and our inpatient units overrun with kids attempting suicide and suffering from other forms of major mental health illness,” Dr. Hausmann said in a press release.

“We had to draw attention to what we’re seeing in our hospital and our community on an everyday basis – an unprecedented number of suicidal children who need acute treatment for behavioral health problems – and when I say ‘unprecedented,’ I’m serious – I’ve been in pediatrics for two decades and have never seen anything like this before,” David Brumbaugh, MD, a pediatric gastroenterologist and chief medical officer for Children’s Colorado, told this news organization.

Christine Crawford, MD, associate medical director of the National Alliance on Mental Illness, stated in an interview that she “commends the CEO of the hospital for making this announcement, because it is outrageous to see what is happening with more and more children with significant psychiatric symptoms who are not getting adequate care.”

Jenna Glover, PhD, child psychologist and director of psychology training at Children’s Hospital, said that during the past decade, there has been a steady increase in depression, anxiety, and suicide among youth in Colorado. Suicide, she added, is now the number one cause of death in youth, “so we were already in a state of crisis.” She added that COVID-19 was “the straw that broke the camel’s back.”

“In January to April of this year, behavioral health ED visits to Children’s Hospital were 72% higher than they were 2 years ago at this time,” she said. “Colorado Springs had a 145% increase for ED behavioral health visits during the first 4 months of 2021, compared to the first 4 months of 2020.”
 

COVID’s impact

Other problems that have been “skyrocketing” in youth are self-harm, substance use, and eating disorders. Younger children are experiencing an increase in behavioral problems, including developmental regression, such as tantrums, and problems with sleeping, toileting, and eating, Dr. Glover noted.

Dr. Jenna Glover

The youth mental health crisis has mushroomed, although social distancing requirements are now beginning to ease and we are in the “home stretch of the pandemic,” Dr. Brumbaugh said.

One possible reason “is that we took kids out of their normal routines, social circles, friendships, etc., for 12 months, and that was the limit of their physiological or mental resistance, and they got to the end of their rope,” he speculated.

Dr. Glover said, “Kids are burned out, and although they’re asking to return to their life, they don’t feel they have the resources. They feel so behind; they don’t know how to catch up.”

Dr. Brumbaugh said that there are not enough child psychiatrists to provide outpatient services or enough inpatient beds for children in crisis.

“This is an unacceptable situation. We would never allow a child with leukemia or appendicitis to go several weeks without treatment,” he said.

Community donors have come forward, enabling an anticipated 50% increase in Children’s Hospital’s mental health outpatient, inpatient, and day services by March 2022.

“On a hospital level, we are continuing to do things to expand access to care, like opening units that provide different levels of care for patients with psychiatric problems, as well as expanding into areas that are more rural,” Dr. Glover said.

However, the “blueprint is not in action yet, and a lot of money still needs to be allocated. A workforce has to be created, because there are not enough clinicians to fill these roles,” she added.
 

 

 

Chronic underfunding

Dr. Brumbaugh said Colorado has always had a “relatively underfunded behavioral health system for kids.” A 2021 report by Mental Health America ranks Colorado among the lowest states in the country in terms of overall pediatric behavioral health funding.

Dr. David Brumbaugh

However, Dr. Glover noted that Colorado is “not exceptional.” The increased vulnerability to youth mental illness and suicide is characteristic of other mountain states, which have larger rural areas, less access to care, and increased access to guns, she said.

Mass shootings may have amped up stress levels. “For some kids, this is happening in their schools or towns, and they feel traumatized and unsafe,” Dr. Glover added.

Dr. Crawford, who is an assistant professor of psychiatry at Boston University, also pointed out that the mental health crisis in youth is not unique to Colorado.

“Throughout the country, we’ve seen these colliding pandemics – inadequate mental health resources for children and COVID-19, which exacerbated the existing mental health crisis,” she said.

“The pandemic led to an increase in telehealth services, making individual and group psychotherapy available to kids in areas that never had access to these before, which is a ‘silver lining’ of the pandemic,” Dr. Glover said.

Dr. Crawford is “encouraged that we are having more conversations about pediatric mental health, because the pandemic amplified what was already going on and made it impossible to ignore.”
 

Screening is essential

Screening for mental health problems should be at the top of the mind of pediatricians and other clinicians who work with children, Dr. Glover said.

“Pediatricians are in the best place to catch potentially suicidal kids, because they are more likely to see these kids than therapists,” she noted.

She suggested using a rapid screen for depression, such as the Patient Health Questionnaire-9 (PHQ-9) modified for adolescents. Parents can also fill out a PHQ-9 for younger children and even for themselves.

“Depression, anxiety, and suicidality affect the whole family, so screening for these conditions in adults will benefit the children too,” she said. Teachers should also “be aware of what depression and anxiety symptoms look like in kids, because sometimes they can manifest more as irritability,” Dr. Glover added.

Policymakers and insurers need to prioritize pediatric mental health when determining allocation of health care, said Dr. Crawford.

“Financial incentives should be provided for hospitals to want to reserve beds for psychiatric patients, and in the outpatient setting, we also need to look at the payment structure of psychiatric visits,” she added.

Many psychiatrists do not want to accept insurance because of the increased bureaucracy and low reimbursement rates of insurance companies, and families cannot afford to pay out of pocket, “so we really need to look at the insurance issue at a policy level,” Dr. Crawford said.

Dr. Brumbaugh, Dr. Glover, and Dr. Crawford have disclosed no relevant financial relationships.

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

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On May 25, Jena Hausmann, CEO of Children’s Hospital Colorado, Aurora, declared a state of emergency in youth mental health in response to an astronomical increase in pediatric mental health cases, including suicide, which has overwhelmed the institution.

Jena Hausmann

From April 2019 to April 2021, the demand for pediatric behavioral health treatment at the hospital system increased by 90%. In Colorado, suicide is now the number one cause of death among youth and occurs in children as young as 10 years of age.

“Now we are seeing our pediatric emergency departments and our inpatient units overrun with kids attempting suicide and suffering from other forms of major mental health illness,” Dr. Hausmann said in a press release.

“We had to draw attention to what we’re seeing in our hospital and our community on an everyday basis – an unprecedented number of suicidal children who need acute treatment for behavioral health problems – and when I say ‘unprecedented,’ I’m serious – I’ve been in pediatrics for two decades and have never seen anything like this before,” David Brumbaugh, MD, a pediatric gastroenterologist and chief medical officer for Children’s Colorado, told this news organization.

Christine Crawford, MD, associate medical director of the National Alliance on Mental Illness, stated in an interview that she “commends the CEO of the hospital for making this announcement, because it is outrageous to see what is happening with more and more children with significant psychiatric symptoms who are not getting adequate care.”

Jenna Glover, PhD, child psychologist and director of psychology training at Children’s Hospital, said that during the past decade, there has been a steady increase in depression, anxiety, and suicide among youth in Colorado. Suicide, she added, is now the number one cause of death in youth, “so we were already in a state of crisis.” She added that COVID-19 was “the straw that broke the camel’s back.”

“In January to April of this year, behavioral health ED visits to Children’s Hospital were 72% higher than they were 2 years ago at this time,” she said. “Colorado Springs had a 145% increase for ED behavioral health visits during the first 4 months of 2021, compared to the first 4 months of 2020.”
 

COVID’s impact

Other problems that have been “skyrocketing” in youth are self-harm, substance use, and eating disorders. Younger children are experiencing an increase in behavioral problems, including developmental regression, such as tantrums, and problems with sleeping, toileting, and eating, Dr. Glover noted.

Dr. Jenna Glover

The youth mental health crisis has mushroomed, although social distancing requirements are now beginning to ease and we are in the “home stretch of the pandemic,” Dr. Brumbaugh said.

One possible reason “is that we took kids out of their normal routines, social circles, friendships, etc., for 12 months, and that was the limit of their physiological or mental resistance, and they got to the end of their rope,” he speculated.

Dr. Glover said, “Kids are burned out, and although they’re asking to return to their life, they don’t feel they have the resources. They feel so behind; they don’t know how to catch up.”

Dr. Brumbaugh said that there are not enough child psychiatrists to provide outpatient services or enough inpatient beds for children in crisis.

“This is an unacceptable situation. We would never allow a child with leukemia or appendicitis to go several weeks without treatment,” he said.

Community donors have come forward, enabling an anticipated 50% increase in Children’s Hospital’s mental health outpatient, inpatient, and day services by March 2022.

“On a hospital level, we are continuing to do things to expand access to care, like opening units that provide different levels of care for patients with psychiatric problems, as well as expanding into areas that are more rural,” Dr. Glover said.

However, the “blueprint is not in action yet, and a lot of money still needs to be allocated. A workforce has to be created, because there are not enough clinicians to fill these roles,” she added.
 

 

 

Chronic underfunding

Dr. Brumbaugh said Colorado has always had a “relatively underfunded behavioral health system for kids.” A 2021 report by Mental Health America ranks Colorado among the lowest states in the country in terms of overall pediatric behavioral health funding.

Dr. David Brumbaugh

However, Dr. Glover noted that Colorado is “not exceptional.” The increased vulnerability to youth mental illness and suicide is characteristic of other mountain states, which have larger rural areas, less access to care, and increased access to guns, she said.

Mass shootings may have amped up stress levels. “For some kids, this is happening in their schools or towns, and they feel traumatized and unsafe,” Dr. Glover added.

Dr. Crawford, who is an assistant professor of psychiatry at Boston University, also pointed out that the mental health crisis in youth is not unique to Colorado.

“Throughout the country, we’ve seen these colliding pandemics – inadequate mental health resources for children and COVID-19, which exacerbated the existing mental health crisis,” she said.

“The pandemic led to an increase in telehealth services, making individual and group psychotherapy available to kids in areas that never had access to these before, which is a ‘silver lining’ of the pandemic,” Dr. Glover said.

Dr. Crawford is “encouraged that we are having more conversations about pediatric mental health, because the pandemic amplified what was already going on and made it impossible to ignore.”
 

Screening is essential

Screening for mental health problems should be at the top of the mind of pediatricians and other clinicians who work with children, Dr. Glover said.

“Pediatricians are in the best place to catch potentially suicidal kids, because they are more likely to see these kids than therapists,” she noted.

She suggested using a rapid screen for depression, such as the Patient Health Questionnaire-9 (PHQ-9) modified for adolescents. Parents can also fill out a PHQ-9 for younger children and even for themselves.

“Depression, anxiety, and suicidality affect the whole family, so screening for these conditions in adults will benefit the children too,” she said. Teachers should also “be aware of what depression and anxiety symptoms look like in kids, because sometimes they can manifest more as irritability,” Dr. Glover added.

Policymakers and insurers need to prioritize pediatric mental health when determining allocation of health care, said Dr. Crawford.

“Financial incentives should be provided for hospitals to want to reserve beds for psychiatric patients, and in the outpatient setting, we also need to look at the payment structure of psychiatric visits,” she added.

Many psychiatrists do not want to accept insurance because of the increased bureaucracy and low reimbursement rates of insurance companies, and families cannot afford to pay out of pocket, “so we really need to look at the insurance issue at a policy level,” Dr. Crawford said.

Dr. Brumbaugh, Dr. Glover, and Dr. Crawford have disclosed no relevant financial relationships.

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

On May 25, Jena Hausmann, CEO of Children’s Hospital Colorado, Aurora, declared a state of emergency in youth mental health in response to an astronomical increase in pediatric mental health cases, including suicide, which has overwhelmed the institution.

Jena Hausmann

From April 2019 to April 2021, the demand for pediatric behavioral health treatment at the hospital system increased by 90%. In Colorado, suicide is now the number one cause of death among youth and occurs in children as young as 10 years of age.

“Now we are seeing our pediatric emergency departments and our inpatient units overrun with kids attempting suicide and suffering from other forms of major mental health illness,” Dr. Hausmann said in a press release.

“We had to draw attention to what we’re seeing in our hospital and our community on an everyday basis – an unprecedented number of suicidal children who need acute treatment for behavioral health problems – and when I say ‘unprecedented,’ I’m serious – I’ve been in pediatrics for two decades and have never seen anything like this before,” David Brumbaugh, MD, a pediatric gastroenterologist and chief medical officer for Children’s Colorado, told this news organization.

Christine Crawford, MD, associate medical director of the National Alliance on Mental Illness, stated in an interview that she “commends the CEO of the hospital for making this announcement, because it is outrageous to see what is happening with more and more children with significant psychiatric symptoms who are not getting adequate care.”

Jenna Glover, PhD, child psychologist and director of psychology training at Children’s Hospital, said that during the past decade, there has been a steady increase in depression, anxiety, and suicide among youth in Colorado. Suicide, she added, is now the number one cause of death in youth, “so we were already in a state of crisis.” She added that COVID-19 was “the straw that broke the camel’s back.”

“In January to April of this year, behavioral health ED visits to Children’s Hospital were 72% higher than they were 2 years ago at this time,” she said. “Colorado Springs had a 145% increase for ED behavioral health visits during the first 4 months of 2021, compared to the first 4 months of 2020.”
 

COVID’s impact

Other problems that have been “skyrocketing” in youth are self-harm, substance use, and eating disorders. Younger children are experiencing an increase in behavioral problems, including developmental regression, such as tantrums, and problems with sleeping, toileting, and eating, Dr. Glover noted.

Dr. Jenna Glover

The youth mental health crisis has mushroomed, although social distancing requirements are now beginning to ease and we are in the “home stretch of the pandemic,” Dr. Brumbaugh said.

One possible reason “is that we took kids out of their normal routines, social circles, friendships, etc., for 12 months, and that was the limit of their physiological or mental resistance, and they got to the end of their rope,” he speculated.

Dr. Glover said, “Kids are burned out, and although they’re asking to return to their life, they don’t feel they have the resources. They feel so behind; they don’t know how to catch up.”

Dr. Brumbaugh said that there are not enough child psychiatrists to provide outpatient services or enough inpatient beds for children in crisis.

“This is an unacceptable situation. We would never allow a child with leukemia or appendicitis to go several weeks without treatment,” he said.

Community donors have come forward, enabling an anticipated 50% increase in Children’s Hospital’s mental health outpatient, inpatient, and day services by March 2022.

“On a hospital level, we are continuing to do things to expand access to care, like opening units that provide different levels of care for patients with psychiatric problems, as well as expanding into areas that are more rural,” Dr. Glover said.

However, the “blueprint is not in action yet, and a lot of money still needs to be allocated. A workforce has to be created, because there are not enough clinicians to fill these roles,” she added.
 

 

 

Chronic underfunding

Dr. Brumbaugh said Colorado has always had a “relatively underfunded behavioral health system for kids.” A 2021 report by Mental Health America ranks Colorado among the lowest states in the country in terms of overall pediatric behavioral health funding.

Dr. David Brumbaugh

However, Dr. Glover noted that Colorado is “not exceptional.” The increased vulnerability to youth mental illness and suicide is characteristic of other mountain states, which have larger rural areas, less access to care, and increased access to guns, she said.

Mass shootings may have amped up stress levels. “For some kids, this is happening in their schools or towns, and they feel traumatized and unsafe,” Dr. Glover added.

Dr. Crawford, who is an assistant professor of psychiatry at Boston University, also pointed out that the mental health crisis in youth is not unique to Colorado.

“Throughout the country, we’ve seen these colliding pandemics – inadequate mental health resources for children and COVID-19, which exacerbated the existing mental health crisis,” she said.

“The pandemic led to an increase in telehealth services, making individual and group psychotherapy available to kids in areas that never had access to these before, which is a ‘silver lining’ of the pandemic,” Dr. Glover said.

Dr. Crawford is “encouraged that we are having more conversations about pediatric mental health, because the pandemic amplified what was already going on and made it impossible to ignore.”
 

Screening is essential

Screening for mental health problems should be at the top of the mind of pediatricians and other clinicians who work with children, Dr. Glover said.

“Pediatricians are in the best place to catch potentially suicidal kids, because they are more likely to see these kids than therapists,” she noted.

She suggested using a rapid screen for depression, such as the Patient Health Questionnaire-9 (PHQ-9) modified for adolescents. Parents can also fill out a PHQ-9 for younger children and even for themselves.

“Depression, anxiety, and suicidality affect the whole family, so screening for these conditions in adults will benefit the children too,” she said. Teachers should also “be aware of what depression and anxiety symptoms look like in kids, because sometimes they can manifest more as irritability,” Dr. Glover added.

Policymakers and insurers need to prioritize pediatric mental health when determining allocation of health care, said Dr. Crawford.

“Financial incentives should be provided for hospitals to want to reserve beds for psychiatric patients, and in the outpatient setting, we also need to look at the payment structure of psychiatric visits,” she added.

Many psychiatrists do not want to accept insurance because of the increased bureaucracy and low reimbursement rates of insurance companies, and families cannot afford to pay out of pocket, “so we really need to look at the insurance issue at a policy level,” Dr. Crawford said.

Dr. Brumbaugh, Dr. Glover, and Dr. Crawford have disclosed no relevant financial relationships.

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

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