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The leading independent newspaper covering news and commentary in pediatrics.
Three ‘bad news’ payment changes coming soon for physicians
Physicians are bracing for upcoming changes in reimbursement that may start within a few months. As doctors gear up for another wave of COVID, payment trends may not be the top priority, but some “uh oh” announcements in the fall of 2021 could have far-reaching implications that could affect your future.
The Centers for Medicare & Medicaid Services issued a proposed rule in the summer covering key aspects of physician payment. Although the rule contained some small bright lights, the most important changes proposed were far from welcome.
Here’s what could be in store:
1. The highly anticipated Medicare Physician Fee Schedule ruling confirmed a sweeping payment cut. The drive to maintain budget neutrality forced the federal agency to reduce Medicare payments, on average, by nearly 4%. Many physicians are outraged at the proposed cut.
2. More bad news for 2022: Sequestration will be back. Sequestration is the mandatory, pesky, negative 2% adjustment on all Medicare payments. It had been put on hold and is set to return at the beginning of 2022.
Essentially, sequestration reduces what Medicare pays its providers for health services, but Medicare beneficiaries bear no responsibility for the cost difference. To prevent further debt, CMS imposes financially on hospitals, physicians, and other health care providers.
The Health Resources and Services Administration has funds remaining to reimburse for all COVID-related testing, treatment, and vaccines provided to uninsured individuals. You can apply and be reimbursed at Medicare rates for these services when COVID is the primary diagnosis (or secondary in the case of pregnancy). Patients need not be American citizens for you to get paid.
3. Down to a nail-biter: The final ruling is expected in early November. The situation smacks of earlier days when physicians clung to a precipice, waiting in anticipation for a legislative body to save them from the dreaded income plunge. Indeed, we are slipping back to the decade-long period when Congress kept coming to the rescue simply to maintain the status quo.
Many anticipate a last-minute Congressional intervention to save the day, particularly in the midst of another COVID spike. The promises of a stable reimbursement system made possible by the Medicare Access and CHIP Reauthorization Act have been far from realized, and there are signs that the payment landscape is in the midst of a fundamental transformation.
Other changes proposed in the 1,747-page ruling include:
Positive:
- More telehealth services will be covered by Medicare, including home visits.
- Tele–mental health services got a big boost; many restrictions were removed so that now the patient’s home is considered a permissible originating site. It also allows for audio-only (no visual required) encounters; the audio-only allowance will extend to opioid use disorder treatment services. Phone treatment is covered.
- Permanent adoption of G2252: The 11- to 20-minute virtual check-in code wasn’t just a one-time payment but will be reimbursed in perpetuity.
- Boosts in reimbursement for chronic care and principal care management codes, which range on the basis of service but indicate a commitment to pay for care coordination.
- Clarification of roles and billing opportunities for split/shared visits, which occur if a physician and advanced practice provider see the same patient on a particular day. Prepare for new coding rules to include a modifier. Previously, the rules for billing were muddled, so transparency helps guide payment opportunities.
- Delay of the appropriate use criteria for advanced imaging for 1 (more) year, a welcome postponement of the ruling that carries a significant administrative burden.
- Physician assistants will be able to bill Medicare directly, and referrals to be made to medical nutrition therapy by a nontreating physician.
- A new approach to patient cost-sharing for colorectal cancer screenings will be phased in. This area has caused problems in the past when the physician identifies a need for additional services (for example, polyp removal by a gastroenterologist during routine colonoscopy).
Not positive:
- Which specialties benefit and which get zapped? The anticipated impact by specialty ranges from hits to interventional radiologists (–9%) and vascular surgeons (–8%), to increases for family practitioners, hand surgeons, endocrinologists, and geriatricians, each estimated to gain a modest 2%. (The exception is portable x-ray supplier, with an estimated increase of 10%.) All other specialties fall in between.
- The proposed conversion factor for 2022 is $33.58, a 3.75% drop from the 2021 conversion factor of $34.89.
The proposed ruling also covered the Quality Payment Program, the overarching program of which the Merit-based Incentive Payment System (MIPS) is the main track for participation. The proposal incorporates additional episode-based cost measures as well as updates to quality indicators and improvement activities.
MIPS penalties. The stakes are higher now, with 9% penalties on the table for nonparticipants. The government offers physicians the ability to officially get out of the program in 2021 because of the COVID-19 pandemic, thereby staving off the steep penalty. The option, which is available through the end of the year, requires a simple application that can be completed on behalf of the entire practice. If you want out, now is the time to find and fill out that application.
Exempt from technology requirements. If the proposal is accepted, small practices – defined by CMS as 15 eligible clinicians or fewer – won’t have to file an annual application to reweight the “promoting interoperability” portion of the program. If acknowledged, small practices will automatically be exempt from the program’s technology section. That’s a big plus, as one of the many chief complaints from small practices is the onus of meeting the technology requirements, which include a security risk analysis, bi-directional health information exchange, public health reporting, and patient access to health information. Meeting the requirements is no small feat. That will only affect future years, so be sure to apply in 2021 if applicable for your practice.
Changes in MIPS. MIPS Value Pathways (MVPs) are anticipated for 2023, with the government releasing details about proposed models for heart disease, rheumatology, joint repair, and more. The MVPs are slated to take over the traditional MIPS by 2027.
The program will shift to 30% of your score coming from the “cost” category, which is based on the government’s analysis of a physician’s claims – and, if attributed, the claims of the patients for whom you care. This area is tricky to manage, but recognize that the costs under scrutiny are the expenses paid by Medicare on behalf of its patients.
In essence, Medicare is measuring the cost of your patients as compared with your colleagues’ costs (in the form of specialty-based benchmarks). Therefore, if you’re referring, or ordering, a more costly set of diagnostic tests, assessments, or interventions than your peers, you’ll be dinged.
However, physicians are more likely this year to flat out reject participation in the federal payment program. Payouts have been paltry and dismal to date, and the buzz is that physicians just don’t consider it worth the effort. Of course, clearing the threshold (which is proposed at 70 points next year) is a must to avoid the penalty, but don’t go crazy to get a perfect score as it won’t count for much. 2022 is the final year that there are any monies for exceptional performance.
Considering that the payouts for exceptional performance have been less than 2% for several years now, it’s hard to justify dedicating resources to achieve perfection. Experts believe that even exceptional performance will only be worth pennies in bonus payments.
The fear of the stick, therefore, may be the only motivation. And that is subjective, as physicians weigh the effort required versus just taking the hit on the penalty. But the penalty is substantial, and so even without the incentive, it’s important to participate at least at the threshold.
Fewer cost-sharing waivers. While the federal government’s payment policies have a major impact on reimbursement, other forces may have broader implications. Commercial payers have rolled back cost-sharing waivers, bringing to light the significant financial responsibility that patients have for their health care in the form of deductibles, coinsurance, and so forth.
More than a third of Americans had trouble paying their health care bills before the pandemic; as patients catch up with services that were postponed or delayed because of the pandemic, this may expose challenges for you. Patients with unpaid bills translate into your financial burden.
Virtual-first health plans. Patients may be seeking alternatives to avoid the frustrating cycle of unpaid medical bills. This may be a factor propelling another trend: Lower-cost virtual-first health plans such as Alignment Health have taken hold in the market. As the name implies, insurance coverage features telehealth that extends to in-person services if necessary.
These disruptors may have their hands at least somewhat tied, however. The market may not be able to fully embrace telemedicine until state licensure is addressed. Despite the federal regulatory relaxations, states still control the distribution of medical care through licensure requirements. Many are rolling back their pandemic-based emergency orders and only allowing licensed physicians to see patients in their state, even over telemedicine.
While seemingly frustrating for physicians who want to see patients over state lines, the delays imposed by states may actually have a welcome effect. If licensure migrates to the federal level, there are many implications. For the purposes of this article, the competitive landscape will become incredibly aggressive. You will need to compete with Amazon Care, Walmart, Cigna, and many other well-funded national players that would love nothing more than to launch a campaign to target the entire nation. Investors are eager to capture part of the nearly quarter-trillion-dollar market, with telemedicine at 38 times prepandemic levels and no signs of abating.
Increased competition for insurers. While the proposed drop in Medicare reimbursement is frustrating, keep a pulse on the fact that your patients may soon be lured by vendors like Amazon and others eager to gain access to physician payments. Instead of analyzing Federal Registers in the future, we may be assessing stock prices.
Consider, therefore, how to ensure that your digital front door is at least available, if not wide open, in the meantime. The nature of physician payments is surely changing.
Ms. Woodcock is president of Woodcock & Associates, Atlanta. She has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.
Physicians are bracing for upcoming changes in reimbursement that may start within a few months. As doctors gear up for another wave of COVID, payment trends may not be the top priority, but some “uh oh” announcements in the fall of 2021 could have far-reaching implications that could affect your future.
The Centers for Medicare & Medicaid Services issued a proposed rule in the summer covering key aspects of physician payment. Although the rule contained some small bright lights, the most important changes proposed were far from welcome.
Here’s what could be in store:
1. The highly anticipated Medicare Physician Fee Schedule ruling confirmed a sweeping payment cut. The drive to maintain budget neutrality forced the federal agency to reduce Medicare payments, on average, by nearly 4%. Many physicians are outraged at the proposed cut.
2. More bad news for 2022: Sequestration will be back. Sequestration is the mandatory, pesky, negative 2% adjustment on all Medicare payments. It had been put on hold and is set to return at the beginning of 2022.
Essentially, sequestration reduces what Medicare pays its providers for health services, but Medicare beneficiaries bear no responsibility for the cost difference. To prevent further debt, CMS imposes financially on hospitals, physicians, and other health care providers.
The Health Resources and Services Administration has funds remaining to reimburse for all COVID-related testing, treatment, and vaccines provided to uninsured individuals. You can apply and be reimbursed at Medicare rates for these services when COVID is the primary diagnosis (or secondary in the case of pregnancy). Patients need not be American citizens for you to get paid.
3. Down to a nail-biter: The final ruling is expected in early November. The situation smacks of earlier days when physicians clung to a precipice, waiting in anticipation for a legislative body to save them from the dreaded income plunge. Indeed, we are slipping back to the decade-long period when Congress kept coming to the rescue simply to maintain the status quo.
Many anticipate a last-minute Congressional intervention to save the day, particularly in the midst of another COVID spike. The promises of a stable reimbursement system made possible by the Medicare Access and CHIP Reauthorization Act have been far from realized, and there are signs that the payment landscape is in the midst of a fundamental transformation.
Other changes proposed in the 1,747-page ruling include:
Positive:
- More telehealth services will be covered by Medicare, including home visits.
- Tele–mental health services got a big boost; many restrictions were removed so that now the patient’s home is considered a permissible originating site. It also allows for audio-only (no visual required) encounters; the audio-only allowance will extend to opioid use disorder treatment services. Phone treatment is covered.
- Permanent adoption of G2252: The 11- to 20-minute virtual check-in code wasn’t just a one-time payment but will be reimbursed in perpetuity.
- Boosts in reimbursement for chronic care and principal care management codes, which range on the basis of service but indicate a commitment to pay for care coordination.
- Clarification of roles and billing opportunities for split/shared visits, which occur if a physician and advanced practice provider see the same patient on a particular day. Prepare for new coding rules to include a modifier. Previously, the rules for billing were muddled, so transparency helps guide payment opportunities.
- Delay of the appropriate use criteria for advanced imaging for 1 (more) year, a welcome postponement of the ruling that carries a significant administrative burden.
- Physician assistants will be able to bill Medicare directly, and referrals to be made to medical nutrition therapy by a nontreating physician.
- A new approach to patient cost-sharing for colorectal cancer screenings will be phased in. This area has caused problems in the past when the physician identifies a need for additional services (for example, polyp removal by a gastroenterologist during routine colonoscopy).
Not positive:
- Which specialties benefit and which get zapped? The anticipated impact by specialty ranges from hits to interventional radiologists (–9%) and vascular surgeons (–8%), to increases for family practitioners, hand surgeons, endocrinologists, and geriatricians, each estimated to gain a modest 2%. (The exception is portable x-ray supplier, with an estimated increase of 10%.) All other specialties fall in between.
- The proposed conversion factor for 2022 is $33.58, a 3.75% drop from the 2021 conversion factor of $34.89.
The proposed ruling also covered the Quality Payment Program, the overarching program of which the Merit-based Incentive Payment System (MIPS) is the main track for participation. The proposal incorporates additional episode-based cost measures as well as updates to quality indicators and improvement activities.
MIPS penalties. The stakes are higher now, with 9% penalties on the table for nonparticipants. The government offers physicians the ability to officially get out of the program in 2021 because of the COVID-19 pandemic, thereby staving off the steep penalty. The option, which is available through the end of the year, requires a simple application that can be completed on behalf of the entire practice. If you want out, now is the time to find and fill out that application.
Exempt from technology requirements. If the proposal is accepted, small practices – defined by CMS as 15 eligible clinicians or fewer – won’t have to file an annual application to reweight the “promoting interoperability” portion of the program. If acknowledged, small practices will automatically be exempt from the program’s technology section. That’s a big plus, as one of the many chief complaints from small practices is the onus of meeting the technology requirements, which include a security risk analysis, bi-directional health information exchange, public health reporting, and patient access to health information. Meeting the requirements is no small feat. That will only affect future years, so be sure to apply in 2021 if applicable for your practice.
Changes in MIPS. MIPS Value Pathways (MVPs) are anticipated for 2023, with the government releasing details about proposed models for heart disease, rheumatology, joint repair, and more. The MVPs are slated to take over the traditional MIPS by 2027.
The program will shift to 30% of your score coming from the “cost” category, which is based on the government’s analysis of a physician’s claims – and, if attributed, the claims of the patients for whom you care. This area is tricky to manage, but recognize that the costs under scrutiny are the expenses paid by Medicare on behalf of its patients.
In essence, Medicare is measuring the cost of your patients as compared with your colleagues’ costs (in the form of specialty-based benchmarks). Therefore, if you’re referring, or ordering, a more costly set of diagnostic tests, assessments, or interventions than your peers, you’ll be dinged.
However, physicians are more likely this year to flat out reject participation in the federal payment program. Payouts have been paltry and dismal to date, and the buzz is that physicians just don’t consider it worth the effort. Of course, clearing the threshold (which is proposed at 70 points next year) is a must to avoid the penalty, but don’t go crazy to get a perfect score as it won’t count for much. 2022 is the final year that there are any monies for exceptional performance.
Considering that the payouts for exceptional performance have been less than 2% for several years now, it’s hard to justify dedicating resources to achieve perfection. Experts believe that even exceptional performance will only be worth pennies in bonus payments.
The fear of the stick, therefore, may be the only motivation. And that is subjective, as physicians weigh the effort required versus just taking the hit on the penalty. But the penalty is substantial, and so even without the incentive, it’s important to participate at least at the threshold.
Fewer cost-sharing waivers. While the federal government’s payment policies have a major impact on reimbursement, other forces may have broader implications. Commercial payers have rolled back cost-sharing waivers, bringing to light the significant financial responsibility that patients have for their health care in the form of deductibles, coinsurance, and so forth.
More than a third of Americans had trouble paying their health care bills before the pandemic; as patients catch up with services that were postponed or delayed because of the pandemic, this may expose challenges for you. Patients with unpaid bills translate into your financial burden.
Virtual-first health plans. Patients may be seeking alternatives to avoid the frustrating cycle of unpaid medical bills. This may be a factor propelling another trend: Lower-cost virtual-first health plans such as Alignment Health have taken hold in the market. As the name implies, insurance coverage features telehealth that extends to in-person services if necessary.
These disruptors may have their hands at least somewhat tied, however. The market may not be able to fully embrace telemedicine until state licensure is addressed. Despite the federal regulatory relaxations, states still control the distribution of medical care through licensure requirements. Many are rolling back their pandemic-based emergency orders and only allowing licensed physicians to see patients in their state, even over telemedicine.
While seemingly frustrating for physicians who want to see patients over state lines, the delays imposed by states may actually have a welcome effect. If licensure migrates to the federal level, there are many implications. For the purposes of this article, the competitive landscape will become incredibly aggressive. You will need to compete with Amazon Care, Walmart, Cigna, and many other well-funded national players that would love nothing more than to launch a campaign to target the entire nation. Investors are eager to capture part of the nearly quarter-trillion-dollar market, with telemedicine at 38 times prepandemic levels and no signs of abating.
Increased competition for insurers. While the proposed drop in Medicare reimbursement is frustrating, keep a pulse on the fact that your patients may soon be lured by vendors like Amazon and others eager to gain access to physician payments. Instead of analyzing Federal Registers in the future, we may be assessing stock prices.
Consider, therefore, how to ensure that your digital front door is at least available, if not wide open, in the meantime. The nature of physician payments is surely changing.
Ms. Woodcock is president of Woodcock & Associates, Atlanta. She has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.
Physicians are bracing for upcoming changes in reimbursement that may start within a few months. As doctors gear up for another wave of COVID, payment trends may not be the top priority, but some “uh oh” announcements in the fall of 2021 could have far-reaching implications that could affect your future.
The Centers for Medicare & Medicaid Services issued a proposed rule in the summer covering key aspects of physician payment. Although the rule contained some small bright lights, the most important changes proposed were far from welcome.
Here’s what could be in store:
1. The highly anticipated Medicare Physician Fee Schedule ruling confirmed a sweeping payment cut. The drive to maintain budget neutrality forced the federal agency to reduce Medicare payments, on average, by nearly 4%. Many physicians are outraged at the proposed cut.
2. More bad news for 2022: Sequestration will be back. Sequestration is the mandatory, pesky, negative 2% adjustment on all Medicare payments. It had been put on hold and is set to return at the beginning of 2022.
Essentially, sequestration reduces what Medicare pays its providers for health services, but Medicare beneficiaries bear no responsibility for the cost difference. To prevent further debt, CMS imposes financially on hospitals, physicians, and other health care providers.
The Health Resources and Services Administration has funds remaining to reimburse for all COVID-related testing, treatment, and vaccines provided to uninsured individuals. You can apply and be reimbursed at Medicare rates for these services when COVID is the primary diagnosis (or secondary in the case of pregnancy). Patients need not be American citizens for you to get paid.
3. Down to a nail-biter: The final ruling is expected in early November. The situation smacks of earlier days when physicians clung to a precipice, waiting in anticipation for a legislative body to save them from the dreaded income plunge. Indeed, we are slipping back to the decade-long period when Congress kept coming to the rescue simply to maintain the status quo.
Many anticipate a last-minute Congressional intervention to save the day, particularly in the midst of another COVID spike. The promises of a stable reimbursement system made possible by the Medicare Access and CHIP Reauthorization Act have been far from realized, and there are signs that the payment landscape is in the midst of a fundamental transformation.
Other changes proposed in the 1,747-page ruling include:
Positive:
- More telehealth services will be covered by Medicare, including home visits.
- Tele–mental health services got a big boost; many restrictions were removed so that now the patient’s home is considered a permissible originating site. It also allows for audio-only (no visual required) encounters; the audio-only allowance will extend to opioid use disorder treatment services. Phone treatment is covered.
- Permanent adoption of G2252: The 11- to 20-minute virtual check-in code wasn’t just a one-time payment but will be reimbursed in perpetuity.
- Boosts in reimbursement for chronic care and principal care management codes, which range on the basis of service but indicate a commitment to pay for care coordination.
- Clarification of roles and billing opportunities for split/shared visits, which occur if a physician and advanced practice provider see the same patient on a particular day. Prepare for new coding rules to include a modifier. Previously, the rules for billing were muddled, so transparency helps guide payment opportunities.
- Delay of the appropriate use criteria for advanced imaging for 1 (more) year, a welcome postponement of the ruling that carries a significant administrative burden.
- Physician assistants will be able to bill Medicare directly, and referrals to be made to medical nutrition therapy by a nontreating physician.
- A new approach to patient cost-sharing for colorectal cancer screenings will be phased in. This area has caused problems in the past when the physician identifies a need for additional services (for example, polyp removal by a gastroenterologist during routine colonoscopy).
Not positive:
- Which specialties benefit and which get zapped? The anticipated impact by specialty ranges from hits to interventional radiologists (–9%) and vascular surgeons (–8%), to increases for family practitioners, hand surgeons, endocrinologists, and geriatricians, each estimated to gain a modest 2%. (The exception is portable x-ray supplier, with an estimated increase of 10%.) All other specialties fall in between.
- The proposed conversion factor for 2022 is $33.58, a 3.75% drop from the 2021 conversion factor of $34.89.
The proposed ruling also covered the Quality Payment Program, the overarching program of which the Merit-based Incentive Payment System (MIPS) is the main track for participation. The proposal incorporates additional episode-based cost measures as well as updates to quality indicators and improvement activities.
MIPS penalties. The stakes are higher now, with 9% penalties on the table for nonparticipants. The government offers physicians the ability to officially get out of the program in 2021 because of the COVID-19 pandemic, thereby staving off the steep penalty. The option, which is available through the end of the year, requires a simple application that can be completed on behalf of the entire practice. If you want out, now is the time to find and fill out that application.
Exempt from technology requirements. If the proposal is accepted, small practices – defined by CMS as 15 eligible clinicians or fewer – won’t have to file an annual application to reweight the “promoting interoperability” portion of the program. If acknowledged, small practices will automatically be exempt from the program’s technology section. That’s a big plus, as one of the many chief complaints from small practices is the onus of meeting the technology requirements, which include a security risk analysis, bi-directional health information exchange, public health reporting, and patient access to health information. Meeting the requirements is no small feat. That will only affect future years, so be sure to apply in 2021 if applicable for your practice.
Changes in MIPS. MIPS Value Pathways (MVPs) are anticipated for 2023, with the government releasing details about proposed models for heart disease, rheumatology, joint repair, and more. The MVPs are slated to take over the traditional MIPS by 2027.
The program will shift to 30% of your score coming from the “cost” category, which is based on the government’s analysis of a physician’s claims – and, if attributed, the claims of the patients for whom you care. This area is tricky to manage, but recognize that the costs under scrutiny are the expenses paid by Medicare on behalf of its patients.
In essence, Medicare is measuring the cost of your patients as compared with your colleagues’ costs (in the form of specialty-based benchmarks). Therefore, if you’re referring, or ordering, a more costly set of diagnostic tests, assessments, or interventions than your peers, you’ll be dinged.
However, physicians are more likely this year to flat out reject participation in the federal payment program. Payouts have been paltry and dismal to date, and the buzz is that physicians just don’t consider it worth the effort. Of course, clearing the threshold (which is proposed at 70 points next year) is a must to avoid the penalty, but don’t go crazy to get a perfect score as it won’t count for much. 2022 is the final year that there are any monies for exceptional performance.
Considering that the payouts for exceptional performance have been less than 2% for several years now, it’s hard to justify dedicating resources to achieve perfection. Experts believe that even exceptional performance will only be worth pennies in bonus payments.
The fear of the stick, therefore, may be the only motivation. And that is subjective, as physicians weigh the effort required versus just taking the hit on the penalty. But the penalty is substantial, and so even without the incentive, it’s important to participate at least at the threshold.
Fewer cost-sharing waivers. While the federal government’s payment policies have a major impact on reimbursement, other forces may have broader implications. Commercial payers have rolled back cost-sharing waivers, bringing to light the significant financial responsibility that patients have for their health care in the form of deductibles, coinsurance, and so forth.
More than a third of Americans had trouble paying their health care bills before the pandemic; as patients catch up with services that were postponed or delayed because of the pandemic, this may expose challenges for you. Patients with unpaid bills translate into your financial burden.
Virtual-first health plans. Patients may be seeking alternatives to avoid the frustrating cycle of unpaid medical bills. This may be a factor propelling another trend: Lower-cost virtual-first health plans such as Alignment Health have taken hold in the market. As the name implies, insurance coverage features telehealth that extends to in-person services if necessary.
These disruptors may have their hands at least somewhat tied, however. The market may not be able to fully embrace telemedicine until state licensure is addressed. Despite the federal regulatory relaxations, states still control the distribution of medical care through licensure requirements. Many are rolling back their pandemic-based emergency orders and only allowing licensed physicians to see patients in their state, even over telemedicine.
While seemingly frustrating for physicians who want to see patients over state lines, the delays imposed by states may actually have a welcome effect. If licensure migrates to the federal level, there are many implications. For the purposes of this article, the competitive landscape will become incredibly aggressive. You will need to compete with Amazon Care, Walmart, Cigna, and many other well-funded national players that would love nothing more than to launch a campaign to target the entire nation. Investors are eager to capture part of the nearly quarter-trillion-dollar market, with telemedicine at 38 times prepandemic levels and no signs of abating.
Increased competition for insurers. While the proposed drop in Medicare reimbursement is frustrating, keep a pulse on the fact that your patients may soon be lured by vendors like Amazon and others eager to gain access to physician payments. Instead of analyzing Federal Registers in the future, we may be assessing stock prices.
Consider, therefore, how to ensure that your digital front door is at least available, if not wide open, in the meantime. The nature of physician payments is surely changing.
Ms. Woodcock is president of Woodcock & Associates, Atlanta. She has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.
COVID wars, part nine: The rise of iodine
Onions and iodine and COVID, oh my!
As surely as the sun rises, anti-vaxxers will come up with some wacky and dangerous new idea to prevent COVID. While perhaps nothing will top horse medication, gargling iodine (or spraying it into the nose) is also not a great idea.
Multiple social media posts have extolled the virtues of gargling Betadine (povidone iodine), which is a TOPICAL disinfectant commonly used in EDs and operating rooms. One post cited a paper by a Bangladeshi plastic surgeon who hypothesized on the subject, and if that’s not a peer-reviewed, rigorously researched source, we don’t know what is.
Perhaps unsurprisingly, actual medical experts do not recommend using Betadine to prevent COVID. Ingesting it can cause iodine poisoning and plenty of nasty GI side effects; while Betadine does make a diluted product safe for gargling use (used for the treatment of sore throats), it has not shown any effectiveness against viruses or COVID in particular.
A New York ED doctor summed it up best in the Rolling Stone article when he was told anti-vaxxers were gargling iodine: He offered a choice four-letter expletive, then said, “Of course they are.”
But wait! We’ve got a two-for-one deal on dubious COVID cures this week. Health experts in Myanmar (Burma to all the “Seinfeld” fans) and Thailand have been combating social media posts claiming that onion fumes will cure COVID. All you need to do is slice an onion in half, sniff it for a while, then chew on a second onion, and your COVID will be cured!
In what is surely the most radical understatement of the year, a professor in the department of preventive and social medicine at Chulalongkorn University, Bangkok, said in the AFP article that there is “no solid evidence” to support onion sniffing from “any clinical research.”
We’re just going to assume the expletives that surely followed were kept off the record.
Pro-Trump state governor encourages vaccination
Clearly, the politics of COVID-19 have been working against the science of COVID-19. Politicians can’t, or won’t, agree on what to do about it, and many prominent Republicans have been actively resisting vaccine and mask mandates.
There is at least one Republican governor who has wholeheartedly encouraged vaccination in his pro-Trump state. We’re talking about Gov. Jim Justice of West Virginia, and not for the first time.
The Washington Post has detailed his efforts to promote the COVID vaccine, and we would like to share a couple of examples.
In June he suggested that people who didn’t get vaccinated were “entering the death drawing.” He followed that by saying, “If I knew for certain that there was going to be eight or nine people die by next Tuesday, and I could be one of them if I don’t take the vaccine ... What in the world do you think I would do? I mean, I would run over top of somebody.”
More recently, Gov. Justice took on vaccine conspiracy theories.
“For God’s sakes a livin’, how difficult is this to understand? Why in the world do we have to come up with these crazy ideas – and they’re crazy ideas – that the vaccine’s got something in it and it’s tracing people wherever they go? And the very same people that are saying that are carrying their cellphones around. I mean, come on. Come on.”
Nuff said.
Jet lag may be a gut feeling
After a week-long vacation halfway around the world, it’s time to go back to your usual routine and time zone. But don’t forget about that free souvenir, jet lag. A disrupted circadian rhythm can be a real bummer, but researchers may have found the fix in your belly.
In a study funded by the U.S. Navy, researchers at the University of Colorado, Boulder, looked into how the presence of a prebiotic in one’s diet can have on the disrupted biological clocks. They’re not the same as probiotics, which help you stay regular in another way. Prebiotics work as food to help the good gut bacteria you already have. An earlier study had suggested that prebiotics may have a positive effect on the brain.
To test the theory, the researchers gave one group of rats their regular food while another group received food with two different prebiotics. After manipulating the rats’ light-dark cycle for 8 weeks to give the illusion of traveling to a time zone 12 hours ahead every week, they found that the rats who ate the prebiotics were able to bounce back faster.
The possibility of ingesting something to keep your body clock regular sounds like a dream, but the researchers don’t really advise you to snatch all the supplements you can at your local pharmacy just yet.
“If you know you are going to come into a challenge, you could take a look at some of the prebiotics that are available. Just realize that they are not customized yet, so it might work for you but it won’t work for your neighbor,” said senior author Monika Fleshner.
Until there’s more conclusive research, just be good to your bacteria.
How to make stuff up and influence people
You’ve probably heard that we use only 10% of our brain. It’s right up there with “the Earth is flat” and “an apple a day keeps the doctor away.”
The idea that we use only 10% of our brains can probably be traced back to the early 1900s, suggests Discover magazine, when psychologist William James wrote, “Compared with what we ought to be, we are only half awake. Our fires are damped, our drafts are checked. We are making use of only a small part of our possible mental and physical resources.”
There are many different takes on it, but it is indeed a myth that we use only 10% of our brains. Dale Carnegie, the public speaking teacher, seems to be the one who put the specific number of 10% on James’ idea in his 1936 book, “How to Win Friends and Influence People.”
“We think that people are excited by this pseudo fact because it’s very optimistic,” neuroscientist Sandra Aamodt told Discover. “Wouldn’t we all love to think our brains had some giant pool of untapped potential that we’re not using?”
The reality is, we do use our whole brain. Functional MRI shows that different parts of the brain are used for different things such as language and memories. “Not all at the same time, of course. But every part of the brain has a job to do,” the Discover article explained.
There are many things we don’t know about how the brain works, but at least you know you use more than 10%. After all, a brain just told you so.
Onions and iodine and COVID, oh my!
As surely as the sun rises, anti-vaxxers will come up with some wacky and dangerous new idea to prevent COVID. While perhaps nothing will top horse medication, gargling iodine (or spraying it into the nose) is also not a great idea.
Multiple social media posts have extolled the virtues of gargling Betadine (povidone iodine), which is a TOPICAL disinfectant commonly used in EDs and operating rooms. One post cited a paper by a Bangladeshi plastic surgeon who hypothesized on the subject, and if that’s not a peer-reviewed, rigorously researched source, we don’t know what is.
Perhaps unsurprisingly, actual medical experts do not recommend using Betadine to prevent COVID. Ingesting it can cause iodine poisoning and plenty of nasty GI side effects; while Betadine does make a diluted product safe for gargling use (used for the treatment of sore throats), it has not shown any effectiveness against viruses or COVID in particular.
A New York ED doctor summed it up best in the Rolling Stone article when he was told anti-vaxxers were gargling iodine: He offered a choice four-letter expletive, then said, “Of course they are.”
But wait! We’ve got a two-for-one deal on dubious COVID cures this week. Health experts in Myanmar (Burma to all the “Seinfeld” fans) and Thailand have been combating social media posts claiming that onion fumes will cure COVID. All you need to do is slice an onion in half, sniff it for a while, then chew on a second onion, and your COVID will be cured!
In what is surely the most radical understatement of the year, a professor in the department of preventive and social medicine at Chulalongkorn University, Bangkok, said in the AFP article that there is “no solid evidence” to support onion sniffing from “any clinical research.”
We’re just going to assume the expletives that surely followed were kept off the record.
Pro-Trump state governor encourages vaccination
Clearly, the politics of COVID-19 have been working against the science of COVID-19. Politicians can’t, or won’t, agree on what to do about it, and many prominent Republicans have been actively resisting vaccine and mask mandates.
There is at least one Republican governor who has wholeheartedly encouraged vaccination in his pro-Trump state. We’re talking about Gov. Jim Justice of West Virginia, and not for the first time.
The Washington Post has detailed his efforts to promote the COVID vaccine, and we would like to share a couple of examples.
In June he suggested that people who didn’t get vaccinated were “entering the death drawing.” He followed that by saying, “If I knew for certain that there was going to be eight or nine people die by next Tuesday, and I could be one of them if I don’t take the vaccine ... What in the world do you think I would do? I mean, I would run over top of somebody.”
More recently, Gov. Justice took on vaccine conspiracy theories.
“For God’s sakes a livin’, how difficult is this to understand? Why in the world do we have to come up with these crazy ideas – and they’re crazy ideas – that the vaccine’s got something in it and it’s tracing people wherever they go? And the very same people that are saying that are carrying their cellphones around. I mean, come on. Come on.”
Nuff said.
Jet lag may be a gut feeling
After a week-long vacation halfway around the world, it’s time to go back to your usual routine and time zone. But don’t forget about that free souvenir, jet lag. A disrupted circadian rhythm can be a real bummer, but researchers may have found the fix in your belly.
In a study funded by the U.S. Navy, researchers at the University of Colorado, Boulder, looked into how the presence of a prebiotic in one’s diet can have on the disrupted biological clocks. They’re not the same as probiotics, which help you stay regular in another way. Prebiotics work as food to help the good gut bacteria you already have. An earlier study had suggested that prebiotics may have a positive effect on the brain.
To test the theory, the researchers gave one group of rats their regular food while another group received food with two different prebiotics. After manipulating the rats’ light-dark cycle for 8 weeks to give the illusion of traveling to a time zone 12 hours ahead every week, they found that the rats who ate the prebiotics were able to bounce back faster.
The possibility of ingesting something to keep your body clock regular sounds like a dream, but the researchers don’t really advise you to snatch all the supplements you can at your local pharmacy just yet.
“If you know you are going to come into a challenge, you could take a look at some of the prebiotics that are available. Just realize that they are not customized yet, so it might work for you but it won’t work for your neighbor,” said senior author Monika Fleshner.
Until there’s more conclusive research, just be good to your bacteria.
How to make stuff up and influence people
You’ve probably heard that we use only 10% of our brain. It’s right up there with “the Earth is flat” and “an apple a day keeps the doctor away.”
The idea that we use only 10% of our brains can probably be traced back to the early 1900s, suggests Discover magazine, when psychologist William James wrote, “Compared with what we ought to be, we are only half awake. Our fires are damped, our drafts are checked. We are making use of only a small part of our possible mental and physical resources.”
There are many different takes on it, but it is indeed a myth that we use only 10% of our brains. Dale Carnegie, the public speaking teacher, seems to be the one who put the specific number of 10% on James’ idea in his 1936 book, “How to Win Friends and Influence People.”
“We think that people are excited by this pseudo fact because it’s very optimistic,” neuroscientist Sandra Aamodt told Discover. “Wouldn’t we all love to think our brains had some giant pool of untapped potential that we’re not using?”
The reality is, we do use our whole brain. Functional MRI shows that different parts of the brain are used for different things such as language and memories. “Not all at the same time, of course. But every part of the brain has a job to do,” the Discover article explained.
There are many things we don’t know about how the brain works, but at least you know you use more than 10%. After all, a brain just told you so.
Onions and iodine and COVID, oh my!
As surely as the sun rises, anti-vaxxers will come up with some wacky and dangerous new idea to prevent COVID. While perhaps nothing will top horse medication, gargling iodine (or spraying it into the nose) is also not a great idea.
Multiple social media posts have extolled the virtues of gargling Betadine (povidone iodine), which is a TOPICAL disinfectant commonly used in EDs and operating rooms. One post cited a paper by a Bangladeshi plastic surgeon who hypothesized on the subject, and if that’s not a peer-reviewed, rigorously researched source, we don’t know what is.
Perhaps unsurprisingly, actual medical experts do not recommend using Betadine to prevent COVID. Ingesting it can cause iodine poisoning and plenty of nasty GI side effects; while Betadine does make a diluted product safe for gargling use (used for the treatment of sore throats), it has not shown any effectiveness against viruses or COVID in particular.
A New York ED doctor summed it up best in the Rolling Stone article when he was told anti-vaxxers were gargling iodine: He offered a choice four-letter expletive, then said, “Of course they are.”
But wait! We’ve got a two-for-one deal on dubious COVID cures this week. Health experts in Myanmar (Burma to all the “Seinfeld” fans) and Thailand have been combating social media posts claiming that onion fumes will cure COVID. All you need to do is slice an onion in half, sniff it for a while, then chew on a second onion, and your COVID will be cured!
In what is surely the most radical understatement of the year, a professor in the department of preventive and social medicine at Chulalongkorn University, Bangkok, said in the AFP article that there is “no solid evidence” to support onion sniffing from “any clinical research.”
We’re just going to assume the expletives that surely followed were kept off the record.
Pro-Trump state governor encourages vaccination
Clearly, the politics of COVID-19 have been working against the science of COVID-19. Politicians can’t, or won’t, agree on what to do about it, and many prominent Republicans have been actively resisting vaccine and mask mandates.
There is at least one Republican governor who has wholeheartedly encouraged vaccination in his pro-Trump state. We’re talking about Gov. Jim Justice of West Virginia, and not for the first time.
The Washington Post has detailed his efforts to promote the COVID vaccine, and we would like to share a couple of examples.
In June he suggested that people who didn’t get vaccinated were “entering the death drawing.” He followed that by saying, “If I knew for certain that there was going to be eight or nine people die by next Tuesday, and I could be one of them if I don’t take the vaccine ... What in the world do you think I would do? I mean, I would run over top of somebody.”
More recently, Gov. Justice took on vaccine conspiracy theories.
“For God’s sakes a livin’, how difficult is this to understand? Why in the world do we have to come up with these crazy ideas – and they’re crazy ideas – that the vaccine’s got something in it and it’s tracing people wherever they go? And the very same people that are saying that are carrying their cellphones around. I mean, come on. Come on.”
Nuff said.
Jet lag may be a gut feeling
After a week-long vacation halfway around the world, it’s time to go back to your usual routine and time zone. But don’t forget about that free souvenir, jet lag. A disrupted circadian rhythm can be a real bummer, but researchers may have found the fix in your belly.
In a study funded by the U.S. Navy, researchers at the University of Colorado, Boulder, looked into how the presence of a prebiotic in one’s diet can have on the disrupted biological clocks. They’re not the same as probiotics, which help you stay regular in another way. Prebiotics work as food to help the good gut bacteria you already have. An earlier study had suggested that prebiotics may have a positive effect on the brain.
To test the theory, the researchers gave one group of rats their regular food while another group received food with two different prebiotics. After manipulating the rats’ light-dark cycle for 8 weeks to give the illusion of traveling to a time zone 12 hours ahead every week, they found that the rats who ate the prebiotics were able to bounce back faster.
The possibility of ingesting something to keep your body clock regular sounds like a dream, but the researchers don’t really advise you to snatch all the supplements you can at your local pharmacy just yet.
“If you know you are going to come into a challenge, you could take a look at some of the prebiotics that are available. Just realize that they are not customized yet, so it might work for you but it won’t work for your neighbor,” said senior author Monika Fleshner.
Until there’s more conclusive research, just be good to your bacteria.
How to make stuff up and influence people
You’ve probably heard that we use only 10% of our brain. It’s right up there with “the Earth is flat” and “an apple a day keeps the doctor away.”
The idea that we use only 10% of our brains can probably be traced back to the early 1900s, suggests Discover magazine, when psychologist William James wrote, “Compared with what we ought to be, we are only half awake. Our fires are damped, our drafts are checked. We are making use of only a small part of our possible mental and physical resources.”
There are many different takes on it, but it is indeed a myth that we use only 10% of our brains. Dale Carnegie, the public speaking teacher, seems to be the one who put the specific number of 10% on James’ idea in his 1936 book, “How to Win Friends and Influence People.”
“We think that people are excited by this pseudo fact because it’s very optimistic,” neuroscientist Sandra Aamodt told Discover. “Wouldn’t we all love to think our brains had some giant pool of untapped potential that we’re not using?”
The reality is, we do use our whole brain. Functional MRI shows that different parts of the brain are used for different things such as language and memories. “Not all at the same time, of course. But every part of the brain has a job to do,” the Discover article explained.
There are many things we don’t know about how the brain works, but at least you know you use more than 10%. After all, a brain just told you so.
A boy went to a COVID-swamped ER. He waited for hours. Then his appendix burst.
Seth was finally diagnosed with appendicitis more than six hours after arriving at Cleveland Clinic Martin Health North Hospital in late July. Around midnight, he was taken by ambulance to a sister hospital about a half-hour away that was better equipped to perform pediatric emergency surgery, his father said.
But by the time the doctor operated in the early morning hours, Seth’s appendix had burst – a potentially fatal complication.
They, too, need emergency care, but the sheer number of COVID-19 cases is crowding them out. Treatment has often been delayed as ERs scramble to find a bed that may be hundreds of miles away.
Some health officials now worry about looming ethical decisions. Last week, Idaho activated a “crisis standard of care,” which one official described as a “last resort.” It allows overwhelmed hospitals to ration care, including “in rare cases, ventilator (breathing machines) or intensive care unit (ICU) beds may need to be used for those who are most likely to survive, while patients who are not likely to survive may not be able to receive one,” the state’s website said.
The federal government’s latest data shows Alabama is at 100% of its intensive care unit capacity, with Texas, Georgia, Mississippi and Arkansas at more than 90% ICU capacity. Florida is just under 90%.
It’s the COVID-19 cases that are dominating. In Georgia, 62% of the ICU beds are now filled with just COVID-19 patients. In Texas, the percentage is nearly half.
To have so many ICU beds pressed into service for a single diagnosis is “unheard of,” said Dr. Hasan Kakli, an emergency room physician at Bellville Medical Center in Bellville, Texas, about an hour from Houston. “It’s approaching apocalyptic.”
In Texas, state data released Monday showed there were only 319 adult and 104 pediatric staffed ICU beds available across a state of 29 million people.
Hospitals need to hold some ICU beds for other patients, such as those recovering from major surgery or other critical conditions such as stroke, trauma or heart failure.
“This is not just a COVID issue,” said Dr. Normaliz Rodriguez, pediatric emergency physician at Johns Hopkins All Children’s Hospital in St. Petersburg, Florida. “This is an everyone issue.”
While the latest hospital crisis echoes previous pandemic spikes, there are troubling differences this time around.
Before, localized COVID-19 hot spots led to bed shortages, but there were usually hospitals in the region not as affected that could accept a transfer.
Now, as the highly contagious delta variant envelops swaths of low-vaccination states all at once, it becomes harder to find nearby hospitals that are not slammed.
“Wait times can now be measured in days,” said Darrell Pile, CEO of the SouthEast Texas Regional Advisory Council, which helps coordinate patient transfers across a 25-county region.
Recently, Dr. Cedric Dark, a Houston emergency physician and assistant professor of emergency medicine at Baylor College of Medicine, said he saw a critically ill COVID-19 patient waiting in the emergency room for an ICU bed to open. The doctor worked eight hours, went home and came in the next day. The patient was still waiting.
Holding a seriously ill patient in an emergency room while waiting for an in-patient bed to open is known as boarding. The longer the wait, the more dangerous it can be for the patient, studies have found.
Not only do patients ultimately end up staying in the hospital or the ICU longer, some research suggests that long waits for a bed will worsen their condition and may increase the risk of in-hospital death.
That’s what happened last month in Texas.
On Aug. 21, around 11:30 a.m., Michelle Puget took her adult son, Daniel Wilkinson, to the Bellville Medical Center’s emergency room as a pain in his abdomen became unbearable. “Mama,” he said, “take me to the hospital.”
Wilkinson, a 46-year-old decorated Army veteran who did two tours of duty in Afghanistan, was ushered into an exam room about half an hour later. Kakli, the emergency room physician there, diagnosed gallstone pancreatitis, a serious but treatable condition that required a specialist to perform a surgical procedure and an ICU bed.
In other times, the transfer to a larger facility would be easy. But soon Kakli found himself on a frantic, six-hour quest to find a bed for his patient. Not only did he call hospitals across Texas, but he also tried Kansas, Missouri, Oklahoma and Colorado. It was like throwing darts at a map and hoping to get lucky, he told ProPublica. But no one could or would take the transfer.
By 2:30 p.m., Wilkinson’s condition was deteriorating. Kakli told Puget to come back to the hospital. “I have to tell you,” she said he told her, “Your son is a very, very sick man. If he doesn’t get this procedure he will die.” She began to weep.
Two hours later, Wilkinson’s blood pressure was dropping, signaling his organs were failing, she said.
Kakli went on Facebook and posted an all-caps plea to physician groups around the nation: “GETTING REJECTED BY ALL HOSPITALS IN TEXAS DUE TO NO ICU BEDS. PLEASE HELP. MESSAGE ME IF YOU HAVE A BED. PATIENT IS IN ER NOW. I AM THE ER DOC. WILL FLY ANYWHERE.”
The doctor tried Michael E. DeBakey VA Medical Center in Houston for a second time. This time he found a bed.
Around 7 p.m., Wilkinson, still conscious but in grave condition, was flown by helicopter to the hospital. He was put in a medically induced coma. Through the night and into the next morning, medical teams worked to stabilize him enough to perform the procedure. They could not.
Doctors told his family the internal damage was catastrophic. “We made the decision we had to let him go,” Puget said.
Time of death: 1:37 p.m. Aug. 22 – 26 hours after he first arrived in the emergency room.
The story was first reported by CBS News. Kakli told ProPublica last week he still sometimes does the math in his head: It should have been 40 minutes from diagnosis in Bellville to transfer to the ICU in Houston. “If he had 40 minutes to wait instead of six hours, I strongly believe he would have had a different outcome.”
Another difference with the latest surge is how it’s affecting children.
Last year, schools were closed, and children were more protected because they were mostly isolated at home. In fact, children’s hospitals were often so empty during previous spikes they opened beds to adult patients.
Now, families are out more. Schools have reopened, some with mask mandates, some without. Vaccines are not yet available to those under 12. Suddenly the numbers of hospitalized children are on the rise, setting up the same type of competition for resources between young COVID-19 patients and those with other illnesses such as new onset diabetes, trauma, pneumonia or appendicitis.
Dr. Rafael Santiago, a pediatric emergency physician in Central Florida, said at Lakeland Regional Health Medical Center, the average number of children coming into the emergency room is around 130 per day. During the lockdown last spring, that number dropped to 33. Last month – “the busiest month ever” – the average daily number of children in the emergency room was 160.
Pediatric transfers are not yet as fraught as adult ones, Santiago said, but it does take more calls than it once did to secure a bed.
Seth Osborn, the 12-year-old whose appendix burst after a long wait, spent five days and four nights in the hospital as doctors pumped his body full of antibiotics to stave off infection from the rupture. The typical hospitalization for a routine appendectomy is about 24 hours.
The initial hospital bill for the stay came to more than $48,000, Nathaniel Osborn said. Although insurance paid for most of it, he said the family still borrowed against its house to cover the more than $5,000 in out-of-pocket costs so far.
While the hospital system where Seth was treated declined to comment about his case because of patient privacy laws, it did email a statement about the strain the pandemic is creating.
“Since July 2021, we have seen a tremendous spike in COVID-19 patients needing care and hospitalization. In mid-August, we saw the highest number of patients hospitalized with COVID-19 across the Cleveland Clinic Florida region, a total of 395 COVID-19 patients in four hospitals. Those hospitals have approximately 1,000 total beds,” the email to ProPublica said. “We strongly encourage vaccination. Approximately 90% of our patients hospitalized due to COVID-19 are unvaccinated.”
On Sunday, The Washington Post reported that a hospital in Alabama called 43 others across three states before finding a bed for Ray DeMonia, a critically ill heart patient who later died. In his obituary his family wrote: “In honor of Ray, please get vaccinated if you have not, in an effort to free up resources for non COVID related emergencies. ... He would not want any other family to go through what his did.”
Today, Seth is mostly recovered. “Twelve-year-old boys bounce back,” his father said. Still, the experience has left Nathaniel Osborn shaken.
The high school history teacher said he likes to stay upbeat and apolitical in his social media musings, posting about Florida wildlife preservation and favorite books. But on Sept. 7, he tweeted: “My 12-year-old had appendicitis. The ER was overwhelmed with unvaccinated Covid patients and we had to wait 6+ hours. While waiting, his appendix ruptured and had to spend 5 days in hospital. ... So yeah, your decision to not vaccinate does affect others.”
It was retweeted 34,700 times, with 143,000 likes. Most comments were sympathetic and wished his child a speedy recovery. Some, though, went straight to hate, apparently triggered by his last line. He was attacked personally and accused of making up the story: “Good try with the guilt, jerk.”
Osborn, who is vaccinated, as are his wife and son, told ProPublica he only shared Seth’s story on Twitter to encourage vaccinations.
“I have no ill will towards the hospitals or the care received at either hospital,” he said this week, “but had these hospitals not been so crowded with COVID patients, we wouldn’t have had to wait so long and perhaps my son’s appendix would not have burst.”
This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive their biggest stories as soon as they’re published.
Seth was finally diagnosed with appendicitis more than six hours after arriving at Cleveland Clinic Martin Health North Hospital in late July. Around midnight, he was taken by ambulance to a sister hospital about a half-hour away that was better equipped to perform pediatric emergency surgery, his father said.
But by the time the doctor operated in the early morning hours, Seth’s appendix had burst – a potentially fatal complication.
They, too, need emergency care, but the sheer number of COVID-19 cases is crowding them out. Treatment has often been delayed as ERs scramble to find a bed that may be hundreds of miles away.
Some health officials now worry about looming ethical decisions. Last week, Idaho activated a “crisis standard of care,” which one official described as a “last resort.” It allows overwhelmed hospitals to ration care, including “in rare cases, ventilator (breathing machines) or intensive care unit (ICU) beds may need to be used for those who are most likely to survive, while patients who are not likely to survive may not be able to receive one,” the state’s website said.
The federal government’s latest data shows Alabama is at 100% of its intensive care unit capacity, with Texas, Georgia, Mississippi and Arkansas at more than 90% ICU capacity. Florida is just under 90%.
It’s the COVID-19 cases that are dominating. In Georgia, 62% of the ICU beds are now filled with just COVID-19 patients. In Texas, the percentage is nearly half.
To have so many ICU beds pressed into service for a single diagnosis is “unheard of,” said Dr. Hasan Kakli, an emergency room physician at Bellville Medical Center in Bellville, Texas, about an hour from Houston. “It’s approaching apocalyptic.”
In Texas, state data released Monday showed there were only 319 adult and 104 pediatric staffed ICU beds available across a state of 29 million people.
Hospitals need to hold some ICU beds for other patients, such as those recovering from major surgery or other critical conditions such as stroke, trauma or heart failure.
“This is not just a COVID issue,” said Dr. Normaliz Rodriguez, pediatric emergency physician at Johns Hopkins All Children’s Hospital in St. Petersburg, Florida. “This is an everyone issue.”
While the latest hospital crisis echoes previous pandemic spikes, there are troubling differences this time around.
Before, localized COVID-19 hot spots led to bed shortages, but there were usually hospitals in the region not as affected that could accept a transfer.
Now, as the highly contagious delta variant envelops swaths of low-vaccination states all at once, it becomes harder to find nearby hospitals that are not slammed.
“Wait times can now be measured in days,” said Darrell Pile, CEO of the SouthEast Texas Regional Advisory Council, which helps coordinate patient transfers across a 25-county region.
Recently, Dr. Cedric Dark, a Houston emergency physician and assistant professor of emergency medicine at Baylor College of Medicine, said he saw a critically ill COVID-19 patient waiting in the emergency room for an ICU bed to open. The doctor worked eight hours, went home and came in the next day. The patient was still waiting.
Holding a seriously ill patient in an emergency room while waiting for an in-patient bed to open is known as boarding. The longer the wait, the more dangerous it can be for the patient, studies have found.
Not only do patients ultimately end up staying in the hospital or the ICU longer, some research suggests that long waits for a bed will worsen their condition and may increase the risk of in-hospital death.
That’s what happened last month in Texas.
On Aug. 21, around 11:30 a.m., Michelle Puget took her adult son, Daniel Wilkinson, to the Bellville Medical Center’s emergency room as a pain in his abdomen became unbearable. “Mama,” he said, “take me to the hospital.”
Wilkinson, a 46-year-old decorated Army veteran who did two tours of duty in Afghanistan, was ushered into an exam room about half an hour later. Kakli, the emergency room physician there, diagnosed gallstone pancreatitis, a serious but treatable condition that required a specialist to perform a surgical procedure and an ICU bed.
In other times, the transfer to a larger facility would be easy. But soon Kakli found himself on a frantic, six-hour quest to find a bed for his patient. Not only did he call hospitals across Texas, but he also tried Kansas, Missouri, Oklahoma and Colorado. It was like throwing darts at a map and hoping to get lucky, he told ProPublica. But no one could or would take the transfer.
By 2:30 p.m., Wilkinson’s condition was deteriorating. Kakli told Puget to come back to the hospital. “I have to tell you,” she said he told her, “Your son is a very, very sick man. If he doesn’t get this procedure he will die.” She began to weep.
Two hours later, Wilkinson’s blood pressure was dropping, signaling his organs were failing, she said.
Kakli went on Facebook and posted an all-caps plea to physician groups around the nation: “GETTING REJECTED BY ALL HOSPITALS IN TEXAS DUE TO NO ICU BEDS. PLEASE HELP. MESSAGE ME IF YOU HAVE A BED. PATIENT IS IN ER NOW. I AM THE ER DOC. WILL FLY ANYWHERE.”
The doctor tried Michael E. DeBakey VA Medical Center in Houston for a second time. This time he found a bed.
Around 7 p.m., Wilkinson, still conscious but in grave condition, was flown by helicopter to the hospital. He was put in a medically induced coma. Through the night and into the next morning, medical teams worked to stabilize him enough to perform the procedure. They could not.
Doctors told his family the internal damage was catastrophic. “We made the decision we had to let him go,” Puget said.
Time of death: 1:37 p.m. Aug. 22 – 26 hours after he first arrived in the emergency room.
The story was first reported by CBS News. Kakli told ProPublica last week he still sometimes does the math in his head: It should have been 40 minutes from diagnosis in Bellville to transfer to the ICU in Houston. “If he had 40 minutes to wait instead of six hours, I strongly believe he would have had a different outcome.”
Another difference with the latest surge is how it’s affecting children.
Last year, schools were closed, and children were more protected because they were mostly isolated at home. In fact, children’s hospitals were often so empty during previous spikes they opened beds to adult patients.
Now, families are out more. Schools have reopened, some with mask mandates, some without. Vaccines are not yet available to those under 12. Suddenly the numbers of hospitalized children are on the rise, setting up the same type of competition for resources between young COVID-19 patients and those with other illnesses such as new onset diabetes, trauma, pneumonia or appendicitis.
Dr. Rafael Santiago, a pediatric emergency physician in Central Florida, said at Lakeland Regional Health Medical Center, the average number of children coming into the emergency room is around 130 per day. During the lockdown last spring, that number dropped to 33. Last month – “the busiest month ever” – the average daily number of children in the emergency room was 160.
Pediatric transfers are not yet as fraught as adult ones, Santiago said, but it does take more calls than it once did to secure a bed.
Seth Osborn, the 12-year-old whose appendix burst after a long wait, spent five days and four nights in the hospital as doctors pumped his body full of antibiotics to stave off infection from the rupture. The typical hospitalization for a routine appendectomy is about 24 hours.
The initial hospital bill for the stay came to more than $48,000, Nathaniel Osborn said. Although insurance paid for most of it, he said the family still borrowed against its house to cover the more than $5,000 in out-of-pocket costs so far.
While the hospital system where Seth was treated declined to comment about his case because of patient privacy laws, it did email a statement about the strain the pandemic is creating.
“Since July 2021, we have seen a tremendous spike in COVID-19 patients needing care and hospitalization. In mid-August, we saw the highest number of patients hospitalized with COVID-19 across the Cleveland Clinic Florida region, a total of 395 COVID-19 patients in four hospitals. Those hospitals have approximately 1,000 total beds,” the email to ProPublica said. “We strongly encourage vaccination. Approximately 90% of our patients hospitalized due to COVID-19 are unvaccinated.”
On Sunday, The Washington Post reported that a hospital in Alabama called 43 others across three states before finding a bed for Ray DeMonia, a critically ill heart patient who later died. In his obituary his family wrote: “In honor of Ray, please get vaccinated if you have not, in an effort to free up resources for non COVID related emergencies. ... He would not want any other family to go through what his did.”
Today, Seth is mostly recovered. “Twelve-year-old boys bounce back,” his father said. Still, the experience has left Nathaniel Osborn shaken.
The high school history teacher said he likes to stay upbeat and apolitical in his social media musings, posting about Florida wildlife preservation and favorite books. But on Sept. 7, he tweeted: “My 12-year-old had appendicitis. The ER was overwhelmed with unvaccinated Covid patients and we had to wait 6+ hours. While waiting, his appendix ruptured and had to spend 5 days in hospital. ... So yeah, your decision to not vaccinate does affect others.”
It was retweeted 34,700 times, with 143,000 likes. Most comments were sympathetic and wished his child a speedy recovery. Some, though, went straight to hate, apparently triggered by his last line. He was attacked personally and accused of making up the story: “Good try with the guilt, jerk.”
Osborn, who is vaccinated, as are his wife and son, told ProPublica he only shared Seth’s story on Twitter to encourage vaccinations.
“I have no ill will towards the hospitals or the care received at either hospital,” he said this week, “but had these hospitals not been so crowded with COVID patients, we wouldn’t have had to wait so long and perhaps my son’s appendix would not have burst.”
This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive their biggest stories as soon as they’re published.
Seth was finally diagnosed with appendicitis more than six hours after arriving at Cleveland Clinic Martin Health North Hospital in late July. Around midnight, he was taken by ambulance to a sister hospital about a half-hour away that was better equipped to perform pediatric emergency surgery, his father said.
But by the time the doctor operated in the early morning hours, Seth’s appendix had burst – a potentially fatal complication.
They, too, need emergency care, but the sheer number of COVID-19 cases is crowding them out. Treatment has often been delayed as ERs scramble to find a bed that may be hundreds of miles away.
Some health officials now worry about looming ethical decisions. Last week, Idaho activated a “crisis standard of care,” which one official described as a “last resort.” It allows overwhelmed hospitals to ration care, including “in rare cases, ventilator (breathing machines) or intensive care unit (ICU) beds may need to be used for those who are most likely to survive, while patients who are not likely to survive may not be able to receive one,” the state’s website said.
The federal government’s latest data shows Alabama is at 100% of its intensive care unit capacity, with Texas, Georgia, Mississippi and Arkansas at more than 90% ICU capacity. Florida is just under 90%.
It’s the COVID-19 cases that are dominating. In Georgia, 62% of the ICU beds are now filled with just COVID-19 patients. In Texas, the percentage is nearly half.
To have so many ICU beds pressed into service for a single diagnosis is “unheard of,” said Dr. Hasan Kakli, an emergency room physician at Bellville Medical Center in Bellville, Texas, about an hour from Houston. “It’s approaching apocalyptic.”
In Texas, state data released Monday showed there were only 319 adult and 104 pediatric staffed ICU beds available across a state of 29 million people.
Hospitals need to hold some ICU beds for other patients, such as those recovering from major surgery or other critical conditions such as stroke, trauma or heart failure.
“This is not just a COVID issue,” said Dr. Normaliz Rodriguez, pediatric emergency physician at Johns Hopkins All Children’s Hospital in St. Petersburg, Florida. “This is an everyone issue.”
While the latest hospital crisis echoes previous pandemic spikes, there are troubling differences this time around.
Before, localized COVID-19 hot spots led to bed shortages, but there were usually hospitals in the region not as affected that could accept a transfer.
Now, as the highly contagious delta variant envelops swaths of low-vaccination states all at once, it becomes harder to find nearby hospitals that are not slammed.
“Wait times can now be measured in days,” said Darrell Pile, CEO of the SouthEast Texas Regional Advisory Council, which helps coordinate patient transfers across a 25-county region.
Recently, Dr. Cedric Dark, a Houston emergency physician and assistant professor of emergency medicine at Baylor College of Medicine, said he saw a critically ill COVID-19 patient waiting in the emergency room for an ICU bed to open. The doctor worked eight hours, went home and came in the next day. The patient was still waiting.
Holding a seriously ill patient in an emergency room while waiting for an in-patient bed to open is known as boarding. The longer the wait, the more dangerous it can be for the patient, studies have found.
Not only do patients ultimately end up staying in the hospital or the ICU longer, some research suggests that long waits for a bed will worsen their condition and may increase the risk of in-hospital death.
That’s what happened last month in Texas.
On Aug. 21, around 11:30 a.m., Michelle Puget took her adult son, Daniel Wilkinson, to the Bellville Medical Center’s emergency room as a pain in his abdomen became unbearable. “Mama,” he said, “take me to the hospital.”
Wilkinson, a 46-year-old decorated Army veteran who did two tours of duty in Afghanistan, was ushered into an exam room about half an hour later. Kakli, the emergency room physician there, diagnosed gallstone pancreatitis, a serious but treatable condition that required a specialist to perform a surgical procedure and an ICU bed.
In other times, the transfer to a larger facility would be easy. But soon Kakli found himself on a frantic, six-hour quest to find a bed for his patient. Not only did he call hospitals across Texas, but he also tried Kansas, Missouri, Oklahoma and Colorado. It was like throwing darts at a map and hoping to get lucky, he told ProPublica. But no one could or would take the transfer.
By 2:30 p.m., Wilkinson’s condition was deteriorating. Kakli told Puget to come back to the hospital. “I have to tell you,” she said he told her, “Your son is a very, very sick man. If he doesn’t get this procedure he will die.” She began to weep.
Two hours later, Wilkinson’s blood pressure was dropping, signaling his organs were failing, she said.
Kakli went on Facebook and posted an all-caps plea to physician groups around the nation: “GETTING REJECTED BY ALL HOSPITALS IN TEXAS DUE TO NO ICU BEDS. PLEASE HELP. MESSAGE ME IF YOU HAVE A BED. PATIENT IS IN ER NOW. I AM THE ER DOC. WILL FLY ANYWHERE.”
The doctor tried Michael E. DeBakey VA Medical Center in Houston for a second time. This time he found a bed.
Around 7 p.m., Wilkinson, still conscious but in grave condition, was flown by helicopter to the hospital. He was put in a medically induced coma. Through the night and into the next morning, medical teams worked to stabilize him enough to perform the procedure. They could not.
Doctors told his family the internal damage was catastrophic. “We made the decision we had to let him go,” Puget said.
Time of death: 1:37 p.m. Aug. 22 – 26 hours after he first arrived in the emergency room.
The story was first reported by CBS News. Kakli told ProPublica last week he still sometimes does the math in his head: It should have been 40 minutes from diagnosis in Bellville to transfer to the ICU in Houston. “If he had 40 minutes to wait instead of six hours, I strongly believe he would have had a different outcome.”
Another difference with the latest surge is how it’s affecting children.
Last year, schools were closed, and children were more protected because they were mostly isolated at home. In fact, children’s hospitals were often so empty during previous spikes they opened beds to adult patients.
Now, families are out more. Schools have reopened, some with mask mandates, some without. Vaccines are not yet available to those under 12. Suddenly the numbers of hospitalized children are on the rise, setting up the same type of competition for resources between young COVID-19 patients and those with other illnesses such as new onset diabetes, trauma, pneumonia or appendicitis.
Dr. Rafael Santiago, a pediatric emergency physician in Central Florida, said at Lakeland Regional Health Medical Center, the average number of children coming into the emergency room is around 130 per day. During the lockdown last spring, that number dropped to 33. Last month – “the busiest month ever” – the average daily number of children in the emergency room was 160.
Pediatric transfers are not yet as fraught as adult ones, Santiago said, but it does take more calls than it once did to secure a bed.
Seth Osborn, the 12-year-old whose appendix burst after a long wait, spent five days and four nights in the hospital as doctors pumped his body full of antibiotics to stave off infection from the rupture. The typical hospitalization for a routine appendectomy is about 24 hours.
The initial hospital bill for the stay came to more than $48,000, Nathaniel Osborn said. Although insurance paid for most of it, he said the family still borrowed against its house to cover the more than $5,000 in out-of-pocket costs so far.
While the hospital system where Seth was treated declined to comment about his case because of patient privacy laws, it did email a statement about the strain the pandemic is creating.
“Since July 2021, we have seen a tremendous spike in COVID-19 patients needing care and hospitalization. In mid-August, we saw the highest number of patients hospitalized with COVID-19 across the Cleveland Clinic Florida region, a total of 395 COVID-19 patients in four hospitals. Those hospitals have approximately 1,000 total beds,” the email to ProPublica said. “We strongly encourage vaccination. Approximately 90% of our patients hospitalized due to COVID-19 are unvaccinated.”
On Sunday, The Washington Post reported that a hospital in Alabama called 43 others across three states before finding a bed for Ray DeMonia, a critically ill heart patient who later died. In his obituary his family wrote: “In honor of Ray, please get vaccinated if you have not, in an effort to free up resources for non COVID related emergencies. ... He would not want any other family to go through what his did.”
Today, Seth is mostly recovered. “Twelve-year-old boys bounce back,” his father said. Still, the experience has left Nathaniel Osborn shaken.
The high school history teacher said he likes to stay upbeat and apolitical in his social media musings, posting about Florida wildlife preservation and favorite books. But on Sept. 7, he tweeted: “My 12-year-old had appendicitis. The ER was overwhelmed with unvaccinated Covid patients and we had to wait 6+ hours. While waiting, his appendix ruptured and had to spend 5 days in hospital. ... So yeah, your decision to not vaccinate does affect others.”
It was retweeted 34,700 times, with 143,000 likes. Most comments were sympathetic and wished his child a speedy recovery. Some, though, went straight to hate, apparently triggered by his last line. He was attacked personally and accused of making up the story: “Good try with the guilt, jerk.”
Osborn, who is vaccinated, as are his wife and son, told ProPublica he only shared Seth’s story on Twitter to encourage vaccinations.
“I have no ill will towards the hospitals or the care received at either hospital,” he said this week, “but had these hospitals not been so crowded with COVID patients, we wouldn’t have had to wait so long and perhaps my son’s appendix would not have burst.”
This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive their biggest stories as soon as they’re published.
Children and COVID: New cases down slightly from record high
Weekly cases of COVID-19 in children dropped for the first time since June, and daily hospitalizations appear to be falling, even as the pace of vaccinations continues to slow among the youngest eligible recipients, according to new data.
Despite the 3.3% decline from the previous week’s record high, the new-case count still topped 243,000 for the week of Sept. 3-9, putting the total number of cases in children at almost 5.3 million since the pandemic began.
Hospitalizations seem to have peaked on Sept. 4, when the rate for children aged 0-17 years reached 0.51 per 100,000 population. The admission rate for confirmed COVID-19 has dropped steadily since then and was down to 0.45 per 100,000 on Sept. 11, the last day for which preliminary data from the Centers for Disease Control and Prevention were available.
On the prevention side, fully vaccinated children aged 12-17 years represented 5.5% of all Americans who had completed the vaccine regimen as of Sept. 13. Vaccine initiation, however, has dropped for 5 consecutive weeks in 12- to 15-year-olds and in 4 of the last 5 weeks among 16- and 17-year-olds, the CDC said on its COVID Data Tracker.
Just under 199,000 children aged 12-15 received their first dose of the COVID-19 vaccine during the week of Sept. 7-13. That’s down by 18.5% from the week before and by 51.6% since Aug. 9, the last week that vaccine initiation increased for the age group. Among 16- and 17-year-olds, the 83,000 new recipients that week was a decrease of 25.7% from the previous week and a decline of 47% since the summer peak of Aug. 9, the CDC data show.
Those newest recipients bring at-least-one-dose status to 52.0% of those aged 12-15 and 59.9% of the 16- and 17-year-olds, while 40.3% and 48.9% were fully vaccinated as of Sept. 13. Corresponding figures for some of the older groups are 61.6%/49.7% (age 18-24 years), 73.8%/63.1% (40-49 years), and 95.1%/84.5% (65-74 years), the CDC said.
Vaccine coverage for children at the state level deviates considerably from the national averages. The highest rates for children aged 12-17 are to be found in Vermont, where 76% have received at least one dose, the AAP reported in a separate analysis. Massachusetts is just below that but also comes in at 76% by virtue of a rounding error. The other states in the top five are Connecticut (74%), Hawaii (73%), and Rhode Island (71%).
The lowest vaccination rate for children comes from Wyoming (29%), which is preceded by North Dakota (33%), West Virginia (33%), Alabama (33%), and Mississippi (34%). the AAP said based on data from the CDC, which does not include Idaho.
In a bit of a side note, West Virginia’s Republican governor, Jim Justice, recently said this about vaccine reluctance in his state: “For God’s sakes a livin’, how difficult is this to understand? Why in the world do we have to come up with these crazy ideas – and they’re crazy ideas – that the vaccine’s got something in it and it’s tracing people wherever they go? And the same very people that are saying that are carrying their cellphones around. I mean, come on. Come on.”
Over the last 3 weeks, the District of Columbia has had the largest increase in children having received at least one dose: 10 percentage points, as it went from 58% to 68%. The next-largest improvement – 7 percentage points – occurred in Georgia (34% to 41%), New Mexico (61% to 68%), New York (55% to 62%), and Washington (57% to 64%), the AAP said in its weekly vaccination trends report.
Weekly cases of COVID-19 in children dropped for the first time since June, and daily hospitalizations appear to be falling, even as the pace of vaccinations continues to slow among the youngest eligible recipients, according to new data.
Despite the 3.3% decline from the previous week’s record high, the new-case count still topped 243,000 for the week of Sept. 3-9, putting the total number of cases in children at almost 5.3 million since the pandemic began.
Hospitalizations seem to have peaked on Sept. 4, when the rate for children aged 0-17 years reached 0.51 per 100,000 population. The admission rate for confirmed COVID-19 has dropped steadily since then and was down to 0.45 per 100,000 on Sept. 11, the last day for which preliminary data from the Centers for Disease Control and Prevention were available.
On the prevention side, fully vaccinated children aged 12-17 years represented 5.5% of all Americans who had completed the vaccine regimen as of Sept. 13. Vaccine initiation, however, has dropped for 5 consecutive weeks in 12- to 15-year-olds and in 4 of the last 5 weeks among 16- and 17-year-olds, the CDC said on its COVID Data Tracker.
Just under 199,000 children aged 12-15 received their first dose of the COVID-19 vaccine during the week of Sept. 7-13. That’s down by 18.5% from the week before and by 51.6% since Aug. 9, the last week that vaccine initiation increased for the age group. Among 16- and 17-year-olds, the 83,000 new recipients that week was a decrease of 25.7% from the previous week and a decline of 47% since the summer peak of Aug. 9, the CDC data show.
Those newest recipients bring at-least-one-dose status to 52.0% of those aged 12-15 and 59.9% of the 16- and 17-year-olds, while 40.3% and 48.9% were fully vaccinated as of Sept. 13. Corresponding figures for some of the older groups are 61.6%/49.7% (age 18-24 years), 73.8%/63.1% (40-49 years), and 95.1%/84.5% (65-74 years), the CDC said.
Vaccine coverage for children at the state level deviates considerably from the national averages. The highest rates for children aged 12-17 are to be found in Vermont, where 76% have received at least one dose, the AAP reported in a separate analysis. Massachusetts is just below that but also comes in at 76% by virtue of a rounding error. The other states in the top five are Connecticut (74%), Hawaii (73%), and Rhode Island (71%).
The lowest vaccination rate for children comes from Wyoming (29%), which is preceded by North Dakota (33%), West Virginia (33%), Alabama (33%), and Mississippi (34%). the AAP said based on data from the CDC, which does not include Idaho.
In a bit of a side note, West Virginia’s Republican governor, Jim Justice, recently said this about vaccine reluctance in his state: “For God’s sakes a livin’, how difficult is this to understand? Why in the world do we have to come up with these crazy ideas – and they’re crazy ideas – that the vaccine’s got something in it and it’s tracing people wherever they go? And the same very people that are saying that are carrying their cellphones around. I mean, come on. Come on.”
Over the last 3 weeks, the District of Columbia has had the largest increase in children having received at least one dose: 10 percentage points, as it went from 58% to 68%. The next-largest improvement – 7 percentage points – occurred in Georgia (34% to 41%), New Mexico (61% to 68%), New York (55% to 62%), and Washington (57% to 64%), the AAP said in its weekly vaccination trends report.
Weekly cases of COVID-19 in children dropped for the first time since June, and daily hospitalizations appear to be falling, even as the pace of vaccinations continues to slow among the youngest eligible recipients, according to new data.
Despite the 3.3% decline from the previous week’s record high, the new-case count still topped 243,000 for the week of Sept. 3-9, putting the total number of cases in children at almost 5.3 million since the pandemic began.
Hospitalizations seem to have peaked on Sept. 4, when the rate for children aged 0-17 years reached 0.51 per 100,000 population. The admission rate for confirmed COVID-19 has dropped steadily since then and was down to 0.45 per 100,000 on Sept. 11, the last day for which preliminary data from the Centers for Disease Control and Prevention were available.
On the prevention side, fully vaccinated children aged 12-17 years represented 5.5% of all Americans who had completed the vaccine regimen as of Sept. 13. Vaccine initiation, however, has dropped for 5 consecutive weeks in 12- to 15-year-olds and in 4 of the last 5 weeks among 16- and 17-year-olds, the CDC said on its COVID Data Tracker.
Just under 199,000 children aged 12-15 received their first dose of the COVID-19 vaccine during the week of Sept. 7-13. That’s down by 18.5% from the week before and by 51.6% since Aug. 9, the last week that vaccine initiation increased for the age group. Among 16- and 17-year-olds, the 83,000 new recipients that week was a decrease of 25.7% from the previous week and a decline of 47% since the summer peak of Aug. 9, the CDC data show.
Those newest recipients bring at-least-one-dose status to 52.0% of those aged 12-15 and 59.9% of the 16- and 17-year-olds, while 40.3% and 48.9% were fully vaccinated as of Sept. 13. Corresponding figures for some of the older groups are 61.6%/49.7% (age 18-24 years), 73.8%/63.1% (40-49 years), and 95.1%/84.5% (65-74 years), the CDC said.
Vaccine coverage for children at the state level deviates considerably from the national averages. The highest rates for children aged 12-17 are to be found in Vermont, where 76% have received at least one dose, the AAP reported in a separate analysis. Massachusetts is just below that but also comes in at 76% by virtue of a rounding error. The other states in the top five are Connecticut (74%), Hawaii (73%), and Rhode Island (71%).
The lowest vaccination rate for children comes from Wyoming (29%), which is preceded by North Dakota (33%), West Virginia (33%), Alabama (33%), and Mississippi (34%). the AAP said based on data from the CDC, which does not include Idaho.
In a bit of a side note, West Virginia’s Republican governor, Jim Justice, recently said this about vaccine reluctance in his state: “For God’s sakes a livin’, how difficult is this to understand? Why in the world do we have to come up with these crazy ideas – and they’re crazy ideas – that the vaccine’s got something in it and it’s tracing people wherever they go? And the same very people that are saying that are carrying their cellphones around. I mean, come on. Come on.”
Over the last 3 weeks, the District of Columbia has had the largest increase in children having received at least one dose: 10 percentage points, as it went from 58% to 68%. The next-largest improvement – 7 percentage points – occurred in Georgia (34% to 41%), New Mexico (61% to 68%), New York (55% to 62%), and Washington (57% to 64%), the AAP said in its weekly vaccination trends report.
Fewer inpatient work hours linked with worse patient outcomes
The number of physicians working part time in the United States has increased by nearly 11% since 1993, and as more physicians opt for part-time work, quality of care deserves further study, the investigators wrote in JAMA Internal Medicine. Most studies comparing outcomes for patients treated by full-timers and part-timers have focused on outpatient care settings, where mortality is low and the potential for confounding is high, according to the study authors Hirotaka Kato, PhD, of Keio University in Tokyo, and colleagues. The new study, in contrast, is based on data from nearly 400,000 hospitalizations.
The researchers conducted a cross-sectional analysis on a 20% random sample of Medicare patients aged 65 years and older who were treated by a hospitalist for an emergency medical condition between 2011 and 2016. They examined associations between the number of days per year worked by hospitalists and they 30-day mortality rates among the patients they treated. The researchers analyzed a total of 392,797 hospitalizations in which patients were treated by 19,170 hospitalists. The mean age of the hospitalists was 41 years; 39% were female. Clinician work days were divided into quartiles.
Overall, the 30-day mortality was significantly higher among patients treated by clinicians in the bottom quartile with the fewest number of days worked, compared with those treated by clinicians in the top quartile with the most days worked (10.5% vs. 9.6%). The rates were similar in the second and third quartiles (10.0% and 9.5%).
The average number of days worked clinically per year was 57.6 in the lowest quartile versus 163.3 in the highest quartile, a 65% difference. No significant associations were noted between days worked and patient outcomes with regard to physician age, gender, or hospital teaching status.
Hospital 30-day readmission rates were examined as a secondary outcome, but there was no association between patient readmission and the number of days worked by the clinician. The adjusted 30-day readmission rate for clinicians in the bottom quartile of days worked, compared with those in the top quartile, was 15.3% versus 15.2% (P = .61).
The researchers found no difference in patients’ severity of illness (defined by expected mortality) or reason for admission between physicians in the different quartiles of days worked. They eliminated confounding from hospital-level differences by comparing outcomes of patients between physicians in the same hospital.
Possible explanations for worse patient outcomes
“As the number of physicians who engage in part-time clinical work continues to increase, these findings should lead to careful consideration by health systems to reevaluate preventive measures to address potential unintended patient harm,” the researchers wrote.
The researchers proposed several reasons for the association between fewer clinical work days and worse patient outcomes. First, physicians putting in less clinical time may be less updated on the latest guidelines, their skills may decline with less frequent patient care, and they may be less familiar with the nurses, medical assistants, and support staff, which may contribute to poor teamwork. The researchers also stated that some part-time physicians may need to balance nonclinical responsibilities, such as research or administrative tasks, concurrently with inpatient care. “It is also possible that physicians with less clinical knowledge or skills select to become part-time physicians, whereas physicians with higher clinical performance decide to work full time,” they noted.
The study findings were limited by several factors including the observational design and potential for unmeasured confounding variables, and the results may not generalize to younger patients or surgical patients, the researchers noted. Also, the study did not include care by hospitalists that was not billed, days in which clinicians treated non-Medicare patients or patients not part of the Medicare sample, or information about the reasons for clinicians’ part-time work.
However, the results were strengthened by the large sample size, and suggest the need for better institutional support to maintain the clinical performance of physicians who may be balancing a range of obligations, they concluded.
Clinician work issues have renewed relevance
“The data in this paper are from 2016 and earlier, but it is possibly event more relevant today than then,” Eileen Barrett, MD, of the University of New Mexico, Albuquerque, said in an interview. “The pandemic has exacerbated stressors being experienced by physicians and other health care workers, including higher clinical workloads and burnout, and spotlighted gendered effects on women in the workforce, which is likely to drive more physicians to part-time work.
“Reporting these findings now is so important so they can contribute to a shared mental model of the challenges physicians and hospitals face as we seek solutions to deliver high-quality and high-value care with an engaged, professionally fulfilled workforce,” she emphasized.
Dr. Barrett said she was surprised that the study did not show differences in readmission rates depending on the number of shifts worked, and also that the results were not different when considering expected mortality.
“However unpopular it may be to say so, physicians and administrators should assume these results apply to their practice unless they have examined their own data and know it does not,” Dr. Barrett said. “With that in mind, hospitals, administrators, and regulatory bodies have an urgent need to examine and reduce the forces driving physicians to part-time clinical work. Some of these factors include the absence of childcare, excessive paperwork, burnout, administrative duties, and valued experiences such as teaching, leadership, and research that keep clinicians from the bedside.
“Additionally, steps should be taken to reduce the administrative complexity that makes providing the best care to patients difficult and requires hospitalists to create ‘workarounds,’ because those who work fewer clinical hours may not know how to do these, nor how to advocate for their patients,” Dr. Barrett emphasized.
“Additional research is needed to determine how mortality varies by number of clinical shifts for pediatric and obstetric patients who are infrequently covered by Medicare, also how the pandemic and increasing administrative complexity since the time the data was obtained affect patient care,” Dr. Barrett noted.
The study was supported by a grant from the Japan Society for the Promotion of Science to lead author Dr. Kato, who had no financial conflicts to disclose. Dr. Barrett, who serves on the editorial advisory board of Internal Medicine News, had no financial conflicts.
The number of physicians working part time in the United States has increased by nearly 11% since 1993, and as more physicians opt for part-time work, quality of care deserves further study, the investigators wrote in JAMA Internal Medicine. Most studies comparing outcomes for patients treated by full-timers and part-timers have focused on outpatient care settings, where mortality is low and the potential for confounding is high, according to the study authors Hirotaka Kato, PhD, of Keio University in Tokyo, and colleagues. The new study, in contrast, is based on data from nearly 400,000 hospitalizations.
The researchers conducted a cross-sectional analysis on a 20% random sample of Medicare patients aged 65 years and older who were treated by a hospitalist for an emergency medical condition between 2011 and 2016. They examined associations between the number of days per year worked by hospitalists and they 30-day mortality rates among the patients they treated. The researchers analyzed a total of 392,797 hospitalizations in which patients were treated by 19,170 hospitalists. The mean age of the hospitalists was 41 years; 39% were female. Clinician work days were divided into quartiles.
Overall, the 30-day mortality was significantly higher among patients treated by clinicians in the bottom quartile with the fewest number of days worked, compared with those treated by clinicians in the top quartile with the most days worked (10.5% vs. 9.6%). The rates were similar in the second and third quartiles (10.0% and 9.5%).
The average number of days worked clinically per year was 57.6 in the lowest quartile versus 163.3 in the highest quartile, a 65% difference. No significant associations were noted between days worked and patient outcomes with regard to physician age, gender, or hospital teaching status.
Hospital 30-day readmission rates were examined as a secondary outcome, but there was no association between patient readmission and the number of days worked by the clinician. The adjusted 30-day readmission rate for clinicians in the bottom quartile of days worked, compared with those in the top quartile, was 15.3% versus 15.2% (P = .61).
The researchers found no difference in patients’ severity of illness (defined by expected mortality) or reason for admission between physicians in the different quartiles of days worked. They eliminated confounding from hospital-level differences by comparing outcomes of patients between physicians in the same hospital.
Possible explanations for worse patient outcomes
“As the number of physicians who engage in part-time clinical work continues to increase, these findings should lead to careful consideration by health systems to reevaluate preventive measures to address potential unintended patient harm,” the researchers wrote.
The researchers proposed several reasons for the association between fewer clinical work days and worse patient outcomes. First, physicians putting in less clinical time may be less updated on the latest guidelines, their skills may decline with less frequent patient care, and they may be less familiar with the nurses, medical assistants, and support staff, which may contribute to poor teamwork. The researchers also stated that some part-time physicians may need to balance nonclinical responsibilities, such as research or administrative tasks, concurrently with inpatient care. “It is also possible that physicians with less clinical knowledge or skills select to become part-time physicians, whereas physicians with higher clinical performance decide to work full time,” they noted.
The study findings were limited by several factors including the observational design and potential for unmeasured confounding variables, and the results may not generalize to younger patients or surgical patients, the researchers noted. Also, the study did not include care by hospitalists that was not billed, days in which clinicians treated non-Medicare patients or patients not part of the Medicare sample, or information about the reasons for clinicians’ part-time work.
However, the results were strengthened by the large sample size, and suggest the need for better institutional support to maintain the clinical performance of physicians who may be balancing a range of obligations, they concluded.
Clinician work issues have renewed relevance
“The data in this paper are from 2016 and earlier, but it is possibly event more relevant today than then,” Eileen Barrett, MD, of the University of New Mexico, Albuquerque, said in an interview. “The pandemic has exacerbated stressors being experienced by physicians and other health care workers, including higher clinical workloads and burnout, and spotlighted gendered effects on women in the workforce, which is likely to drive more physicians to part-time work.
“Reporting these findings now is so important so they can contribute to a shared mental model of the challenges physicians and hospitals face as we seek solutions to deliver high-quality and high-value care with an engaged, professionally fulfilled workforce,” she emphasized.
Dr. Barrett said she was surprised that the study did not show differences in readmission rates depending on the number of shifts worked, and also that the results were not different when considering expected mortality.
“However unpopular it may be to say so, physicians and administrators should assume these results apply to their practice unless they have examined their own data and know it does not,” Dr. Barrett said. “With that in mind, hospitals, administrators, and regulatory bodies have an urgent need to examine and reduce the forces driving physicians to part-time clinical work. Some of these factors include the absence of childcare, excessive paperwork, burnout, administrative duties, and valued experiences such as teaching, leadership, and research that keep clinicians from the bedside.
“Additionally, steps should be taken to reduce the administrative complexity that makes providing the best care to patients difficult and requires hospitalists to create ‘workarounds,’ because those who work fewer clinical hours may not know how to do these, nor how to advocate for their patients,” Dr. Barrett emphasized.
“Additional research is needed to determine how mortality varies by number of clinical shifts for pediatric and obstetric patients who are infrequently covered by Medicare, also how the pandemic and increasing administrative complexity since the time the data was obtained affect patient care,” Dr. Barrett noted.
The study was supported by a grant from the Japan Society for the Promotion of Science to lead author Dr. Kato, who had no financial conflicts to disclose. Dr. Barrett, who serves on the editorial advisory board of Internal Medicine News, had no financial conflicts.
The number of physicians working part time in the United States has increased by nearly 11% since 1993, and as more physicians opt for part-time work, quality of care deserves further study, the investigators wrote in JAMA Internal Medicine. Most studies comparing outcomes for patients treated by full-timers and part-timers have focused on outpatient care settings, where mortality is low and the potential for confounding is high, according to the study authors Hirotaka Kato, PhD, of Keio University in Tokyo, and colleagues. The new study, in contrast, is based on data from nearly 400,000 hospitalizations.
The researchers conducted a cross-sectional analysis on a 20% random sample of Medicare patients aged 65 years and older who were treated by a hospitalist for an emergency medical condition between 2011 and 2016. They examined associations between the number of days per year worked by hospitalists and they 30-day mortality rates among the patients they treated. The researchers analyzed a total of 392,797 hospitalizations in which patients were treated by 19,170 hospitalists. The mean age of the hospitalists was 41 years; 39% were female. Clinician work days were divided into quartiles.
Overall, the 30-day mortality was significantly higher among patients treated by clinicians in the bottom quartile with the fewest number of days worked, compared with those treated by clinicians in the top quartile with the most days worked (10.5% vs. 9.6%). The rates were similar in the second and third quartiles (10.0% and 9.5%).
The average number of days worked clinically per year was 57.6 in the lowest quartile versus 163.3 in the highest quartile, a 65% difference. No significant associations were noted between days worked and patient outcomes with regard to physician age, gender, or hospital teaching status.
Hospital 30-day readmission rates were examined as a secondary outcome, but there was no association between patient readmission and the number of days worked by the clinician. The adjusted 30-day readmission rate for clinicians in the bottom quartile of days worked, compared with those in the top quartile, was 15.3% versus 15.2% (P = .61).
The researchers found no difference in patients’ severity of illness (defined by expected mortality) or reason for admission between physicians in the different quartiles of days worked. They eliminated confounding from hospital-level differences by comparing outcomes of patients between physicians in the same hospital.
Possible explanations for worse patient outcomes
“As the number of physicians who engage in part-time clinical work continues to increase, these findings should lead to careful consideration by health systems to reevaluate preventive measures to address potential unintended patient harm,” the researchers wrote.
The researchers proposed several reasons for the association between fewer clinical work days and worse patient outcomes. First, physicians putting in less clinical time may be less updated on the latest guidelines, their skills may decline with less frequent patient care, and they may be less familiar with the nurses, medical assistants, and support staff, which may contribute to poor teamwork. The researchers also stated that some part-time physicians may need to balance nonclinical responsibilities, such as research or administrative tasks, concurrently with inpatient care. “It is also possible that physicians with less clinical knowledge or skills select to become part-time physicians, whereas physicians with higher clinical performance decide to work full time,” they noted.
The study findings were limited by several factors including the observational design and potential for unmeasured confounding variables, and the results may not generalize to younger patients or surgical patients, the researchers noted. Also, the study did not include care by hospitalists that was not billed, days in which clinicians treated non-Medicare patients or patients not part of the Medicare sample, or information about the reasons for clinicians’ part-time work.
However, the results were strengthened by the large sample size, and suggest the need for better institutional support to maintain the clinical performance of physicians who may be balancing a range of obligations, they concluded.
Clinician work issues have renewed relevance
“The data in this paper are from 2016 and earlier, but it is possibly event more relevant today than then,” Eileen Barrett, MD, of the University of New Mexico, Albuquerque, said in an interview. “The pandemic has exacerbated stressors being experienced by physicians and other health care workers, including higher clinical workloads and burnout, and spotlighted gendered effects on women in the workforce, which is likely to drive more physicians to part-time work.
“Reporting these findings now is so important so they can contribute to a shared mental model of the challenges physicians and hospitals face as we seek solutions to deliver high-quality and high-value care with an engaged, professionally fulfilled workforce,” she emphasized.
Dr. Barrett said she was surprised that the study did not show differences in readmission rates depending on the number of shifts worked, and also that the results were not different when considering expected mortality.
“However unpopular it may be to say so, physicians and administrators should assume these results apply to their practice unless they have examined their own data and know it does not,” Dr. Barrett said. “With that in mind, hospitals, administrators, and regulatory bodies have an urgent need to examine and reduce the forces driving physicians to part-time clinical work. Some of these factors include the absence of childcare, excessive paperwork, burnout, administrative duties, and valued experiences such as teaching, leadership, and research that keep clinicians from the bedside.
“Additionally, steps should be taken to reduce the administrative complexity that makes providing the best care to patients difficult and requires hospitalists to create ‘workarounds,’ because those who work fewer clinical hours may not know how to do these, nor how to advocate for their patients,” Dr. Barrett emphasized.
“Additional research is needed to determine how mortality varies by number of clinical shifts for pediatric and obstetric patients who are infrequently covered by Medicare, also how the pandemic and increasing administrative complexity since the time the data was obtained affect patient care,” Dr. Barrett noted.
The study was supported by a grant from the Japan Society for the Promotion of Science to lead author Dr. Kato, who had no financial conflicts to disclose. Dr. Barrett, who serves on the editorial advisory board of Internal Medicine News, had no financial conflicts.
FROM JAMA INTERNAL MEDICINE
Obese children with asthma are resistant to ICS
Obese or overweight children with asthma could be using inhaled corticosteroids (ICS) to no avail, combined results from observational studies suggest.
Using Mendelian randomization, a method for reducing bias in observational studies, investigators from the University of Amsterdam Medical Center performed an analysis of data from four cross-sectional studies and one cohort study on a total of 1,511 children with asthma.
They showed that every 1-unit increase in the body mass index (BMI) z score was associated with a more than twofold higher odds ratio for exacerbation, reported Cristina Longo, PhD, a former postdoctoral fellow at AMC, and assistant professor of medicine at the University of Montreal.
“In this large, multicenter Mendelian randomization study, our findings support current evidence that children with higher BMI status respond inadequately to inhaled corticosteroids, and that this association is likely not explained by measured confounding or reverse causation,” she said in an oral abstract presentation during the European Respiratory Society International Congress.
Unmeasured confounding
The obese-asthma phenotype in children is characterized by reduced lung function, high symptom expression, poor response to ICS, and high health care utilization.
“While most observational studies suggest that weight status is associated with asthma exacerbations, despite using inhaled corticosteroids, it’s unclear whether these associations may be due to unmeasured confounding or reverse causation, which captures the idea that perhaps obesity is a consequence rather than a cause of uncontrolled severe asthma,” she said.
Traditional observational studies of the obesity-asthma link rely on comparing data on asthma in a target population and comparing nonobese patients with obese patients. The problem with this method, Dr. Longo contended, is that the exposure assignment – weight status – is not random, and could lead to bias from potential imbalance of confounders, leading to unintentionally biased results.
In contrast, Mendelian randomization uses genetic data to approximate random assignment of exposures, using a risk score for BMI based on genetic susceptibility. The score is based on the accumulation of genetic variants (single-nucleotide polymorphisms, or SNPs) that predispose individuals to obesity, with higher numbers of variants results in a higher risk score.
The scores are then used to determine the comparison groups for evaluating the obesity-asthma association.
Alphabet soup
Dr. Longo and colleagues analyzed data on a total 1,511 children enrolled in four observational studies (PACMAN, PAGES, HPR, CLARA) and one cohort study (ALSPAC).
They included children with an asthma diagnosis who used ICS and had available information on both BMI and genetics.
The Mendelian randomization analysis was based on a weighted allele score based on 97 SNPs predictive of BMI based on large-scale genomewide association studies. The exposure for the analysis was age- and sex-adjusted BMI z scores based on World Health Organization growth charts for children.
They found that using the Mendelian randomization approach, for each standard deviation increase in BMI, the OR for any parent-reported asthma exacerbations, including urgent care visits or use of oral corticosteroids, was 2.31 (95% confidence interval, 1.26-4.25).
In contrast, if the traditional observational model had been used, the OR would be a nonsignificant 1.10 (95% CI, 0.99-1.22).
“Treatment guidelines recommend steroids for children with asthma who have a higher-than-normal BMI,” Dr. Longo said in a statement. “Our research group felt that the one-size fits-all approach to treating children with asthma with inhaled steroids as their first-line treatment, particularly those with excess weight, warrants revision. At the very least, research identifying potential alternative treatments should be encouraged and prioritized, especially since 30% of children with asthma are also obese. With the childhood obesity epidemic rising, we expect this percentage to increase meaning this problem of poor control will be seen more frequently in routine clinical practice.”
Christopher E. Brightling, PhD, professor of respiratory medicine at the University of Leicester (England), commented that “this is very good and fascinating research with findings that are important and novel.
“It sheds light on the complex interplay between genes, weight, and response to inhaled corticosteroids, underscoring the need to combine drug treatments with lifestyle and diet modifications. Policy makers, health care providers and families need to do much more to tackle the growing obesity epidemic in young people,” he said.
Dr. Brightling was not involved in the study.
The study was supported by the ERS and the European Union’s H2020 research and innovation program. Dr. Longo was a Horizon 2020 Marie-Sklodowska Cure Respire-3 fellow. Dr. Brightling reported no relevant disclosures.
Obese or overweight children with asthma could be using inhaled corticosteroids (ICS) to no avail, combined results from observational studies suggest.
Using Mendelian randomization, a method for reducing bias in observational studies, investigators from the University of Amsterdam Medical Center performed an analysis of data from four cross-sectional studies and one cohort study on a total of 1,511 children with asthma.
They showed that every 1-unit increase in the body mass index (BMI) z score was associated with a more than twofold higher odds ratio for exacerbation, reported Cristina Longo, PhD, a former postdoctoral fellow at AMC, and assistant professor of medicine at the University of Montreal.
“In this large, multicenter Mendelian randomization study, our findings support current evidence that children with higher BMI status respond inadequately to inhaled corticosteroids, and that this association is likely not explained by measured confounding or reverse causation,” she said in an oral abstract presentation during the European Respiratory Society International Congress.
Unmeasured confounding
The obese-asthma phenotype in children is characterized by reduced lung function, high symptom expression, poor response to ICS, and high health care utilization.
“While most observational studies suggest that weight status is associated with asthma exacerbations, despite using inhaled corticosteroids, it’s unclear whether these associations may be due to unmeasured confounding or reverse causation, which captures the idea that perhaps obesity is a consequence rather than a cause of uncontrolled severe asthma,” she said.
Traditional observational studies of the obesity-asthma link rely on comparing data on asthma in a target population and comparing nonobese patients with obese patients. The problem with this method, Dr. Longo contended, is that the exposure assignment – weight status – is not random, and could lead to bias from potential imbalance of confounders, leading to unintentionally biased results.
In contrast, Mendelian randomization uses genetic data to approximate random assignment of exposures, using a risk score for BMI based on genetic susceptibility. The score is based on the accumulation of genetic variants (single-nucleotide polymorphisms, or SNPs) that predispose individuals to obesity, with higher numbers of variants results in a higher risk score.
The scores are then used to determine the comparison groups for evaluating the obesity-asthma association.
Alphabet soup
Dr. Longo and colleagues analyzed data on a total 1,511 children enrolled in four observational studies (PACMAN, PAGES, HPR, CLARA) and one cohort study (ALSPAC).
They included children with an asthma diagnosis who used ICS and had available information on both BMI and genetics.
The Mendelian randomization analysis was based on a weighted allele score based on 97 SNPs predictive of BMI based on large-scale genomewide association studies. The exposure for the analysis was age- and sex-adjusted BMI z scores based on World Health Organization growth charts for children.
They found that using the Mendelian randomization approach, for each standard deviation increase in BMI, the OR for any parent-reported asthma exacerbations, including urgent care visits or use of oral corticosteroids, was 2.31 (95% confidence interval, 1.26-4.25).
In contrast, if the traditional observational model had been used, the OR would be a nonsignificant 1.10 (95% CI, 0.99-1.22).
“Treatment guidelines recommend steroids for children with asthma who have a higher-than-normal BMI,” Dr. Longo said in a statement. “Our research group felt that the one-size fits-all approach to treating children with asthma with inhaled steroids as their first-line treatment, particularly those with excess weight, warrants revision. At the very least, research identifying potential alternative treatments should be encouraged and prioritized, especially since 30% of children with asthma are also obese. With the childhood obesity epidemic rising, we expect this percentage to increase meaning this problem of poor control will be seen more frequently in routine clinical practice.”
Christopher E. Brightling, PhD, professor of respiratory medicine at the University of Leicester (England), commented that “this is very good and fascinating research with findings that are important and novel.
“It sheds light on the complex interplay between genes, weight, and response to inhaled corticosteroids, underscoring the need to combine drug treatments with lifestyle and diet modifications. Policy makers, health care providers and families need to do much more to tackle the growing obesity epidemic in young people,” he said.
Dr. Brightling was not involved in the study.
The study was supported by the ERS and the European Union’s H2020 research and innovation program. Dr. Longo was a Horizon 2020 Marie-Sklodowska Cure Respire-3 fellow. Dr. Brightling reported no relevant disclosures.
Obese or overweight children with asthma could be using inhaled corticosteroids (ICS) to no avail, combined results from observational studies suggest.
Using Mendelian randomization, a method for reducing bias in observational studies, investigators from the University of Amsterdam Medical Center performed an analysis of data from four cross-sectional studies and one cohort study on a total of 1,511 children with asthma.
They showed that every 1-unit increase in the body mass index (BMI) z score was associated with a more than twofold higher odds ratio for exacerbation, reported Cristina Longo, PhD, a former postdoctoral fellow at AMC, and assistant professor of medicine at the University of Montreal.
“In this large, multicenter Mendelian randomization study, our findings support current evidence that children with higher BMI status respond inadequately to inhaled corticosteroids, and that this association is likely not explained by measured confounding or reverse causation,” she said in an oral abstract presentation during the European Respiratory Society International Congress.
Unmeasured confounding
The obese-asthma phenotype in children is characterized by reduced lung function, high symptom expression, poor response to ICS, and high health care utilization.
“While most observational studies suggest that weight status is associated with asthma exacerbations, despite using inhaled corticosteroids, it’s unclear whether these associations may be due to unmeasured confounding or reverse causation, which captures the idea that perhaps obesity is a consequence rather than a cause of uncontrolled severe asthma,” she said.
Traditional observational studies of the obesity-asthma link rely on comparing data on asthma in a target population and comparing nonobese patients with obese patients. The problem with this method, Dr. Longo contended, is that the exposure assignment – weight status – is not random, and could lead to bias from potential imbalance of confounders, leading to unintentionally biased results.
In contrast, Mendelian randomization uses genetic data to approximate random assignment of exposures, using a risk score for BMI based on genetic susceptibility. The score is based on the accumulation of genetic variants (single-nucleotide polymorphisms, or SNPs) that predispose individuals to obesity, with higher numbers of variants results in a higher risk score.
The scores are then used to determine the comparison groups for evaluating the obesity-asthma association.
Alphabet soup
Dr. Longo and colleagues analyzed data on a total 1,511 children enrolled in four observational studies (PACMAN, PAGES, HPR, CLARA) and one cohort study (ALSPAC).
They included children with an asthma diagnosis who used ICS and had available information on both BMI and genetics.
The Mendelian randomization analysis was based on a weighted allele score based on 97 SNPs predictive of BMI based on large-scale genomewide association studies. The exposure for the analysis was age- and sex-adjusted BMI z scores based on World Health Organization growth charts for children.
They found that using the Mendelian randomization approach, for each standard deviation increase in BMI, the OR for any parent-reported asthma exacerbations, including urgent care visits or use of oral corticosteroids, was 2.31 (95% confidence interval, 1.26-4.25).
In contrast, if the traditional observational model had been used, the OR would be a nonsignificant 1.10 (95% CI, 0.99-1.22).
“Treatment guidelines recommend steroids for children with asthma who have a higher-than-normal BMI,” Dr. Longo said in a statement. “Our research group felt that the one-size fits-all approach to treating children with asthma with inhaled steroids as their first-line treatment, particularly those with excess weight, warrants revision. At the very least, research identifying potential alternative treatments should be encouraged and prioritized, especially since 30% of children with asthma are also obese. With the childhood obesity epidemic rising, we expect this percentage to increase meaning this problem of poor control will be seen more frequently in routine clinical practice.”
Christopher E. Brightling, PhD, professor of respiratory medicine at the University of Leicester (England), commented that “this is very good and fascinating research with findings that are important and novel.
“It sheds light on the complex interplay between genes, weight, and response to inhaled corticosteroids, underscoring the need to combine drug treatments with lifestyle and diet modifications. Policy makers, health care providers and families need to do much more to tackle the growing obesity epidemic in young people,” he said.
Dr. Brightling was not involved in the study.
The study was supported by the ERS and the European Union’s H2020 research and innovation program. Dr. Longo was a Horizon 2020 Marie-Sklodowska Cure Respire-3 fellow. Dr. Brightling reported no relevant disclosures.
FROM ERS 2021
Study: Use urine sampling more broadly to rule out pediatric UTI
of diagnostic test accuracy studies in ambulatory care (Ann Fam Med 2021;19:437-46).
“Urine sampling is often restricted to children with clinical features such as pain while urinating, frequent urination or children presenting with fever without any abnormalities found on clinical examination,” said lead author Jan Y. Verbakel, MD, PhD, from the University of Leuven (Belgium) in an interview. “Our study findings suggest that, in children, pain while urinating or frequent urination are less accurate than in adults and increase the probability of UTI only moderately.”
Urine sampling “should be applied more broadly in ambulatory care, given that appropriate sampling techniques are available,” he and his coauthors advised in the paper.
Methods and results
The analysis included 35 studies, involving a total of 78,427 patients, which provided information on 58 clinical features and 6 prediction rules of UTI, compared with urine culture. For urine sampling, most studies used catheterization (n = 23), suprapubic aspiration (n = 17), or midstream catch (n = 14), and fewer studies used clean catch (n = 7), bag specimens (n = 5), or diaper pads (n = 2).
The study showed that only three features substantially decreased the likelihood of UTI: being circumcised, the presence of stridor, and the presence of diaper rash. “In febrile children, finding an apparent source of infection decreased the probability of UTI; however, this was not useful for ruling out UTI by itself,” the authors noted.
Additionally, they found that red flags for UTI were cloudy or malodorous urine, hematuria, no fluid intake, suprapubic tenderness, and loin tenderness.
Study implications
“We recommend to sample urine in children that have one or more features that increase the probability of UTI … and less so pain while urinating, frequent urination, urgency, bed wetting, or previous UTI history,” said Dr. Verbakel, who is also a researcher at the University of Oxford (England).
In terms of prediction rules, the analysis showed the Diagnosis of Urinary Tract Infection in Young Children (DUTY) score, Gorelick Scale score, and UTIcalc might be useful to identify which children should have urine sampling, the authors stated in the paper.
Specifically, a DUTY clean-catch score of less than one point was useful for ruling out UTI in children aged less than 5 years, and in girls aged less than 3 years with unexplained fever. The Gorelick Scale score was useful for ruling out UTI when less than two of five variables were present.
“The present meta-analyses confirm that few clinical features are useful for diagnosing or ruling out UTI without further urine analysis. Signs and symptoms combined in a clinical prediction rule, such as with the DUTY or UTIcalc score, might increase accuracy for ruling out UTI; however, these should be validated externally,” Dr. Verbakel said in an interview.
Is urine sampling guideline too broad?
Commenting on the new paper, Martin Koyle, MD, former division chief of urology at the Hospital for Sick Children and professor of surgery at the University of Toronto, expressed concern that unexplained fever is not included as a “differentiating” red flag.
“Many contemporary guidelines define fever as an important diagnostic symptom, as the goal truly is to differentiate lower urinary tract from actual kidney infection, the latter thought to be more important for severity of illness, and potential for developing kidney damage,” he said in an interview. “It begs the question as to which nonfebrile patients who don’t have symptoms related to the respiratory tract for instance [for example, stridor], should be under suspicion for an afebrile urinary tract infection, and have their urine sampled. This paper does not answer that question.”
Dr. Koyle added that an overly broad guideline for urine sampling could come at a cost, and he raised the following questions.
“Will there be an overdiagnosis based on urines alone? Will this lead to overtreatment, often unnecessary, just because there is a positive urine specimen or asymptomatic bacteriuria? Will overtreatment lead to resistant bacteria and side effects related to antibiotics? Will such treatment actually prevent clinical illness and/or renal damage?”
The study authors and Dr. Koyle reported no conflicts of interest.
of diagnostic test accuracy studies in ambulatory care (Ann Fam Med 2021;19:437-46).
“Urine sampling is often restricted to children with clinical features such as pain while urinating, frequent urination or children presenting with fever without any abnormalities found on clinical examination,” said lead author Jan Y. Verbakel, MD, PhD, from the University of Leuven (Belgium) in an interview. “Our study findings suggest that, in children, pain while urinating or frequent urination are less accurate than in adults and increase the probability of UTI only moderately.”
Urine sampling “should be applied more broadly in ambulatory care, given that appropriate sampling techniques are available,” he and his coauthors advised in the paper.
Methods and results
The analysis included 35 studies, involving a total of 78,427 patients, which provided information on 58 clinical features and 6 prediction rules of UTI, compared with urine culture. For urine sampling, most studies used catheterization (n = 23), suprapubic aspiration (n = 17), or midstream catch (n = 14), and fewer studies used clean catch (n = 7), bag specimens (n = 5), or diaper pads (n = 2).
The study showed that only three features substantially decreased the likelihood of UTI: being circumcised, the presence of stridor, and the presence of diaper rash. “In febrile children, finding an apparent source of infection decreased the probability of UTI; however, this was not useful for ruling out UTI by itself,” the authors noted.
Additionally, they found that red flags for UTI were cloudy or malodorous urine, hematuria, no fluid intake, suprapubic tenderness, and loin tenderness.
Study implications
“We recommend to sample urine in children that have one or more features that increase the probability of UTI … and less so pain while urinating, frequent urination, urgency, bed wetting, or previous UTI history,” said Dr. Verbakel, who is also a researcher at the University of Oxford (England).
In terms of prediction rules, the analysis showed the Diagnosis of Urinary Tract Infection in Young Children (DUTY) score, Gorelick Scale score, and UTIcalc might be useful to identify which children should have urine sampling, the authors stated in the paper.
Specifically, a DUTY clean-catch score of less than one point was useful for ruling out UTI in children aged less than 5 years, and in girls aged less than 3 years with unexplained fever. The Gorelick Scale score was useful for ruling out UTI when less than two of five variables were present.
“The present meta-analyses confirm that few clinical features are useful for diagnosing or ruling out UTI without further urine analysis. Signs and symptoms combined in a clinical prediction rule, such as with the DUTY or UTIcalc score, might increase accuracy for ruling out UTI; however, these should be validated externally,” Dr. Verbakel said in an interview.
Is urine sampling guideline too broad?
Commenting on the new paper, Martin Koyle, MD, former division chief of urology at the Hospital for Sick Children and professor of surgery at the University of Toronto, expressed concern that unexplained fever is not included as a “differentiating” red flag.
“Many contemporary guidelines define fever as an important diagnostic symptom, as the goal truly is to differentiate lower urinary tract from actual kidney infection, the latter thought to be more important for severity of illness, and potential for developing kidney damage,” he said in an interview. “It begs the question as to which nonfebrile patients who don’t have symptoms related to the respiratory tract for instance [for example, stridor], should be under suspicion for an afebrile urinary tract infection, and have their urine sampled. This paper does not answer that question.”
Dr. Koyle added that an overly broad guideline for urine sampling could come at a cost, and he raised the following questions.
“Will there be an overdiagnosis based on urines alone? Will this lead to overtreatment, often unnecessary, just because there is a positive urine specimen or asymptomatic bacteriuria? Will overtreatment lead to resistant bacteria and side effects related to antibiotics? Will such treatment actually prevent clinical illness and/or renal damage?”
The study authors and Dr. Koyle reported no conflicts of interest.
of diagnostic test accuracy studies in ambulatory care (Ann Fam Med 2021;19:437-46).
“Urine sampling is often restricted to children with clinical features such as pain while urinating, frequent urination or children presenting with fever without any abnormalities found on clinical examination,” said lead author Jan Y. Verbakel, MD, PhD, from the University of Leuven (Belgium) in an interview. “Our study findings suggest that, in children, pain while urinating or frequent urination are less accurate than in adults and increase the probability of UTI only moderately.”
Urine sampling “should be applied more broadly in ambulatory care, given that appropriate sampling techniques are available,” he and his coauthors advised in the paper.
Methods and results
The analysis included 35 studies, involving a total of 78,427 patients, which provided information on 58 clinical features and 6 prediction rules of UTI, compared with urine culture. For urine sampling, most studies used catheterization (n = 23), suprapubic aspiration (n = 17), or midstream catch (n = 14), and fewer studies used clean catch (n = 7), bag specimens (n = 5), or diaper pads (n = 2).
The study showed that only three features substantially decreased the likelihood of UTI: being circumcised, the presence of stridor, and the presence of diaper rash. “In febrile children, finding an apparent source of infection decreased the probability of UTI; however, this was not useful for ruling out UTI by itself,” the authors noted.
Additionally, they found that red flags for UTI were cloudy or malodorous urine, hematuria, no fluid intake, suprapubic tenderness, and loin tenderness.
Study implications
“We recommend to sample urine in children that have one or more features that increase the probability of UTI … and less so pain while urinating, frequent urination, urgency, bed wetting, or previous UTI history,” said Dr. Verbakel, who is also a researcher at the University of Oxford (England).
In terms of prediction rules, the analysis showed the Diagnosis of Urinary Tract Infection in Young Children (DUTY) score, Gorelick Scale score, and UTIcalc might be useful to identify which children should have urine sampling, the authors stated in the paper.
Specifically, a DUTY clean-catch score of less than one point was useful for ruling out UTI in children aged less than 5 years, and in girls aged less than 3 years with unexplained fever. The Gorelick Scale score was useful for ruling out UTI when less than two of five variables were present.
“The present meta-analyses confirm that few clinical features are useful for diagnosing or ruling out UTI without further urine analysis. Signs and symptoms combined in a clinical prediction rule, such as with the DUTY or UTIcalc score, might increase accuracy for ruling out UTI; however, these should be validated externally,” Dr. Verbakel said in an interview.
Is urine sampling guideline too broad?
Commenting on the new paper, Martin Koyle, MD, former division chief of urology at the Hospital for Sick Children and professor of surgery at the University of Toronto, expressed concern that unexplained fever is not included as a “differentiating” red flag.
“Many contemporary guidelines define fever as an important diagnostic symptom, as the goal truly is to differentiate lower urinary tract from actual kidney infection, the latter thought to be more important for severity of illness, and potential for developing kidney damage,” he said in an interview. “It begs the question as to which nonfebrile patients who don’t have symptoms related to the respiratory tract for instance [for example, stridor], should be under suspicion for an afebrile urinary tract infection, and have their urine sampled. This paper does not answer that question.”
Dr. Koyle added that an overly broad guideline for urine sampling could come at a cost, and he raised the following questions.
“Will there be an overdiagnosis based on urines alone? Will this lead to overtreatment, often unnecessary, just because there is a positive urine specimen or asymptomatic bacteriuria? Will overtreatment lead to resistant bacteria and side effects related to antibiotics? Will such treatment actually prevent clinical illness and/or renal damage?”
The study authors and Dr. Koyle reported no conflicts of interest.
Study gives bleeding risk estimates for VTE patients on anticoagulants
The meta-analysis of data from 27 studies with 17,202 patients was published in the Annals of Internal Medicine. According to two of the paper’s coauthors, Faizan Khan, MSc, and Marc A. Rodger, MD, it “provides best available estimates of long-term bleeding risk with different anticoagulants in patients with unprovoked VTE,” including subgroups at increased risk.
Patients at increased risk for major bleeding include those who are older; those using antiplatelet therapy; and patients with kidney disease, a history of bleeding, or anemia, noted the coauthors, who work for the Ottawa Hospital Research Institute.
The researchers focused on randomized controlled trials (RCTs) and prospective cohort studies that reported major bleeding among patients with a first unprovoked or weakly provoked VTE who received oral anticoagulation for at least 6 months beyond an initial anticoagulant treatment course of at least 3 months.
The investigators analyzed data from 14 RCTs and 13 cohort studies. In all, 9,982 patients received a vitamin K antagonist (VKA), and 7,220 received a direct oral anticoagulant (DOAC).
The incidence of major bleeding per 100 person-years was 1.7 events with VKAs, compared with 1.1 events with DOACs. The researchers estimated that the 5-year cumulative incidence of major bleeding with VKAs was 6.3%. The available data for DOACs were insufficient to estimate the incidence of major bleeding beyond 1 year.
“This information can help clinicians counsel patients and inform shared decision-making about extended therapy,” the researchers said.
Risks of serious bleeding ‘not trivial’
Margaret Fang, MD, with the University of California, San Francisco, agreed that the study can help clinicians and patients weigh the risks of extended anticoagulation for common types of VTE.
The study also “highlights that the risks of serious bleeding are not trivial” and points out gaps in the literature regarding the long-term use of DOACs for extended VTE therapy, Dr. Fang said.
Better ways to predict which patients will develop bleeding on anticoagulants are needed, Dr. Fang added. “It will also be important to establish which of the various therapies for preventing recurrent VTE – full dose versus lowered dose, or even aspirin – has the best balance of safety and efficacy,” she said.
‘Standardized approach’ for identifying high-risk patients lacking
Clinical practice guidelines recommend indefinite anticoagulation for an unprovoked VTE, except when patients are at high risk of bleeding, the authors noted. But clinicians lack a “standardized approach to identify patients at high risk of bleeding,” Mr. Khan and Dr. Rodger said. “Evidence from randomized trials on net long-term benefit of extended therapy is limited, and current guideline recommendations are largely based on expert consensus opinion. Major bleeding events are two to three times more likely to be fatal than recurrent VTE events, so extended therapy is not always associated with a net mortality benefit, particularly in patients at low risk of recurrent VTE or high risk of bleeding.”
The analysis indicates that there is “a clinically meaningful difference in long-term risk for anticoagulant-related major bleeding among patients with a first unprovoked VTE stratified according to presence or absence of the following risk factors: age older than 65 years, creatinine clearance less than 50 mL/min, history of bleeding, concomitant use of antiplatelet therapy, and hemoglobin level less than 100 g/L,” the authors said.
For example, the researchers found that the incidence of major bleeding was higher among those older than 65 years, compared with younger patients (incidence rate ratio, 1.84 with VKAs and 2.92 with DOACs), and among those with creatinine clearance less than 50 mL/min (IRR, 2.83 with VKAs and 3.71 with DOACs).
The case-fatality rate of major bleeding was 8.3% with VKAs and 9.7% with DOACs.
The study received funding from the Canadian Institutes of Health Research. Some of the coauthors are employees of or have financial ties to pharmaceutical companies. Mr. Khan, Dr. Rodger, and Dr. Fang had no relevant disclosures.
The meta-analysis of data from 27 studies with 17,202 patients was published in the Annals of Internal Medicine. According to two of the paper’s coauthors, Faizan Khan, MSc, and Marc A. Rodger, MD, it “provides best available estimates of long-term bleeding risk with different anticoagulants in patients with unprovoked VTE,” including subgroups at increased risk.
Patients at increased risk for major bleeding include those who are older; those using antiplatelet therapy; and patients with kidney disease, a history of bleeding, or anemia, noted the coauthors, who work for the Ottawa Hospital Research Institute.
The researchers focused on randomized controlled trials (RCTs) and prospective cohort studies that reported major bleeding among patients with a first unprovoked or weakly provoked VTE who received oral anticoagulation for at least 6 months beyond an initial anticoagulant treatment course of at least 3 months.
The investigators analyzed data from 14 RCTs and 13 cohort studies. In all, 9,982 patients received a vitamin K antagonist (VKA), and 7,220 received a direct oral anticoagulant (DOAC).
The incidence of major bleeding per 100 person-years was 1.7 events with VKAs, compared with 1.1 events with DOACs. The researchers estimated that the 5-year cumulative incidence of major bleeding with VKAs was 6.3%. The available data for DOACs were insufficient to estimate the incidence of major bleeding beyond 1 year.
“This information can help clinicians counsel patients and inform shared decision-making about extended therapy,” the researchers said.
Risks of serious bleeding ‘not trivial’
Margaret Fang, MD, with the University of California, San Francisco, agreed that the study can help clinicians and patients weigh the risks of extended anticoagulation for common types of VTE.
The study also “highlights that the risks of serious bleeding are not trivial” and points out gaps in the literature regarding the long-term use of DOACs for extended VTE therapy, Dr. Fang said.
Better ways to predict which patients will develop bleeding on anticoagulants are needed, Dr. Fang added. “It will also be important to establish which of the various therapies for preventing recurrent VTE – full dose versus lowered dose, or even aspirin – has the best balance of safety and efficacy,” she said.
‘Standardized approach’ for identifying high-risk patients lacking
Clinical practice guidelines recommend indefinite anticoagulation for an unprovoked VTE, except when patients are at high risk of bleeding, the authors noted. But clinicians lack a “standardized approach to identify patients at high risk of bleeding,” Mr. Khan and Dr. Rodger said. “Evidence from randomized trials on net long-term benefit of extended therapy is limited, and current guideline recommendations are largely based on expert consensus opinion. Major bleeding events are two to three times more likely to be fatal than recurrent VTE events, so extended therapy is not always associated with a net mortality benefit, particularly in patients at low risk of recurrent VTE or high risk of bleeding.”
The analysis indicates that there is “a clinically meaningful difference in long-term risk for anticoagulant-related major bleeding among patients with a first unprovoked VTE stratified according to presence or absence of the following risk factors: age older than 65 years, creatinine clearance less than 50 mL/min, history of bleeding, concomitant use of antiplatelet therapy, and hemoglobin level less than 100 g/L,” the authors said.
For example, the researchers found that the incidence of major bleeding was higher among those older than 65 years, compared with younger patients (incidence rate ratio, 1.84 with VKAs and 2.92 with DOACs), and among those with creatinine clearance less than 50 mL/min (IRR, 2.83 with VKAs and 3.71 with DOACs).
The case-fatality rate of major bleeding was 8.3% with VKAs and 9.7% with DOACs.
The study received funding from the Canadian Institutes of Health Research. Some of the coauthors are employees of or have financial ties to pharmaceutical companies. Mr. Khan, Dr. Rodger, and Dr. Fang had no relevant disclosures.
The meta-analysis of data from 27 studies with 17,202 patients was published in the Annals of Internal Medicine. According to two of the paper’s coauthors, Faizan Khan, MSc, and Marc A. Rodger, MD, it “provides best available estimates of long-term bleeding risk with different anticoagulants in patients with unprovoked VTE,” including subgroups at increased risk.
Patients at increased risk for major bleeding include those who are older; those using antiplatelet therapy; and patients with kidney disease, a history of bleeding, or anemia, noted the coauthors, who work for the Ottawa Hospital Research Institute.
The researchers focused on randomized controlled trials (RCTs) and prospective cohort studies that reported major bleeding among patients with a first unprovoked or weakly provoked VTE who received oral anticoagulation for at least 6 months beyond an initial anticoagulant treatment course of at least 3 months.
The investigators analyzed data from 14 RCTs and 13 cohort studies. In all, 9,982 patients received a vitamin K antagonist (VKA), and 7,220 received a direct oral anticoagulant (DOAC).
The incidence of major bleeding per 100 person-years was 1.7 events with VKAs, compared with 1.1 events with DOACs. The researchers estimated that the 5-year cumulative incidence of major bleeding with VKAs was 6.3%. The available data for DOACs were insufficient to estimate the incidence of major bleeding beyond 1 year.
“This information can help clinicians counsel patients and inform shared decision-making about extended therapy,” the researchers said.
Risks of serious bleeding ‘not trivial’
Margaret Fang, MD, with the University of California, San Francisco, agreed that the study can help clinicians and patients weigh the risks of extended anticoagulation for common types of VTE.
The study also “highlights that the risks of serious bleeding are not trivial” and points out gaps in the literature regarding the long-term use of DOACs for extended VTE therapy, Dr. Fang said.
Better ways to predict which patients will develop bleeding on anticoagulants are needed, Dr. Fang added. “It will also be important to establish which of the various therapies for preventing recurrent VTE – full dose versus lowered dose, or even aspirin – has the best balance of safety and efficacy,” she said.
‘Standardized approach’ for identifying high-risk patients lacking
Clinical practice guidelines recommend indefinite anticoagulation for an unprovoked VTE, except when patients are at high risk of bleeding, the authors noted. But clinicians lack a “standardized approach to identify patients at high risk of bleeding,” Mr. Khan and Dr. Rodger said. “Evidence from randomized trials on net long-term benefit of extended therapy is limited, and current guideline recommendations are largely based on expert consensus opinion. Major bleeding events are two to three times more likely to be fatal than recurrent VTE events, so extended therapy is not always associated with a net mortality benefit, particularly in patients at low risk of recurrent VTE or high risk of bleeding.”
The analysis indicates that there is “a clinically meaningful difference in long-term risk for anticoagulant-related major bleeding among patients with a first unprovoked VTE stratified according to presence or absence of the following risk factors: age older than 65 years, creatinine clearance less than 50 mL/min, history of bleeding, concomitant use of antiplatelet therapy, and hemoglobin level less than 100 g/L,” the authors said.
For example, the researchers found that the incidence of major bleeding was higher among those older than 65 years, compared with younger patients (incidence rate ratio, 1.84 with VKAs and 2.92 with DOACs), and among those with creatinine clearance less than 50 mL/min (IRR, 2.83 with VKAs and 3.71 with DOACs).
The case-fatality rate of major bleeding was 8.3% with VKAs and 9.7% with DOACs.
The study received funding from the Canadian Institutes of Health Research. Some of the coauthors are employees of or have financial ties to pharmaceutical companies. Mr. Khan, Dr. Rodger, and Dr. Fang had no relevant disclosures.
FROM ANNALS OF INTERNAL MEDICINE
FDA could authorize COVID-19 vaccine for ages 5-11 in October
The timeline is based on the expectation that Pfizer will have enough data from clinical trials to request Food and Drug Administration emergency use authorization for the age group near the end of September. Then the FDA would likely make a decision about the vaccine’s safety and effectiveness in children within about 3 weeks, two sources told Reuters.
Anthony Fauci, MD, chief medical adviser to President Joe Biden and director of the National Institute of Allergy and Infectious Diseases, spoke about the timeline during an online town hall meeting Friday, Reuters reported. The meeting was attended by thousands of staff members at the National Institutes of Health.
If Pfizer submits paperwork to the FDA by the end of September, the vaccine could be available for kids around mid-October, Dr. Fauci said, and approval for the Moderna vaccine could come in November. Moderna will take about 3 weeks longer to collect and analyze data for ages 5-11.
Pfizer has said it would have enough data for ages 5-11 in September and would submit its documentation for FDA authorization soon after. Moderna told investors on Sept. 9 that data for ages 6-11 would be available by the end of the year.
On Sept. 10, the FDA said it would work to approve COVID-19 vaccines for children quickly once companies submit their data, according to Reuters. The agency said it would consider applications for emergency use, which would allow for faster approval.
Pfizer’s vaccine is the only one to receive full FDA approval, but only for people ages 16 and older. Adolescents ages 12-15 can receive the Pfizer vaccine under the FDA’s emergency use authorization.
For emergency use authorization, companies must submit 2 months of safety data versus 6 months for full approval. The FDA said on Sept. 10 that children in clinical trials should be monitored for at least 2 months to observe side effects.
BioNTech, Pfizer’s vaccine manufacturing partner, told a news outlet in Germany that it plans to request authorization globally for ages 5-11 in coming weeks, according to Reuters.
“Already over the next few weeks, we will file the results of our trial in 5- to 11-year-olds with regulators across the world and will request approval of the vaccine in this age group, also here in Europe,” Oezlem Tuereci, MD, the chief medical officer for BioNTech, told Der Spiegel.
The company is completing the final production steps to make the vaccine at lower doses for the younger age group, she said. Pfizer and BioNTech will also seek vaccine approval for ages 6 months to 2 years later this year.
“Things are looking good, everything is going according to plan,” Ugur Sahin, MD, the CEO of BioNTech, told Der Spiegel.
A version of this article first appeared on WebMD.com.
The timeline is based on the expectation that Pfizer will have enough data from clinical trials to request Food and Drug Administration emergency use authorization for the age group near the end of September. Then the FDA would likely make a decision about the vaccine’s safety and effectiveness in children within about 3 weeks, two sources told Reuters.
Anthony Fauci, MD, chief medical adviser to President Joe Biden and director of the National Institute of Allergy and Infectious Diseases, spoke about the timeline during an online town hall meeting Friday, Reuters reported. The meeting was attended by thousands of staff members at the National Institutes of Health.
If Pfizer submits paperwork to the FDA by the end of September, the vaccine could be available for kids around mid-October, Dr. Fauci said, and approval for the Moderna vaccine could come in November. Moderna will take about 3 weeks longer to collect and analyze data for ages 5-11.
Pfizer has said it would have enough data for ages 5-11 in September and would submit its documentation for FDA authorization soon after. Moderna told investors on Sept. 9 that data for ages 6-11 would be available by the end of the year.
On Sept. 10, the FDA said it would work to approve COVID-19 vaccines for children quickly once companies submit their data, according to Reuters. The agency said it would consider applications for emergency use, which would allow for faster approval.
Pfizer’s vaccine is the only one to receive full FDA approval, but only for people ages 16 and older. Adolescents ages 12-15 can receive the Pfizer vaccine under the FDA’s emergency use authorization.
For emergency use authorization, companies must submit 2 months of safety data versus 6 months for full approval. The FDA said on Sept. 10 that children in clinical trials should be monitored for at least 2 months to observe side effects.
BioNTech, Pfizer’s vaccine manufacturing partner, told a news outlet in Germany that it plans to request authorization globally for ages 5-11 in coming weeks, according to Reuters.
“Already over the next few weeks, we will file the results of our trial in 5- to 11-year-olds with regulators across the world and will request approval of the vaccine in this age group, also here in Europe,” Oezlem Tuereci, MD, the chief medical officer for BioNTech, told Der Spiegel.
The company is completing the final production steps to make the vaccine at lower doses for the younger age group, she said. Pfizer and BioNTech will also seek vaccine approval for ages 6 months to 2 years later this year.
“Things are looking good, everything is going according to plan,” Ugur Sahin, MD, the CEO of BioNTech, told Der Spiegel.
A version of this article first appeared on WebMD.com.
The timeline is based on the expectation that Pfizer will have enough data from clinical trials to request Food and Drug Administration emergency use authorization for the age group near the end of September. Then the FDA would likely make a decision about the vaccine’s safety and effectiveness in children within about 3 weeks, two sources told Reuters.
Anthony Fauci, MD, chief medical adviser to President Joe Biden and director of the National Institute of Allergy and Infectious Diseases, spoke about the timeline during an online town hall meeting Friday, Reuters reported. The meeting was attended by thousands of staff members at the National Institutes of Health.
If Pfizer submits paperwork to the FDA by the end of September, the vaccine could be available for kids around mid-October, Dr. Fauci said, and approval for the Moderna vaccine could come in November. Moderna will take about 3 weeks longer to collect and analyze data for ages 5-11.
Pfizer has said it would have enough data for ages 5-11 in September and would submit its documentation for FDA authorization soon after. Moderna told investors on Sept. 9 that data for ages 6-11 would be available by the end of the year.
On Sept. 10, the FDA said it would work to approve COVID-19 vaccines for children quickly once companies submit their data, according to Reuters. The agency said it would consider applications for emergency use, which would allow for faster approval.
Pfizer’s vaccine is the only one to receive full FDA approval, but only for people ages 16 and older. Adolescents ages 12-15 can receive the Pfizer vaccine under the FDA’s emergency use authorization.
For emergency use authorization, companies must submit 2 months of safety data versus 6 months for full approval. The FDA said on Sept. 10 that children in clinical trials should be monitored for at least 2 months to observe side effects.
BioNTech, Pfizer’s vaccine manufacturing partner, told a news outlet in Germany that it plans to request authorization globally for ages 5-11 in coming weeks, according to Reuters.
“Already over the next few weeks, we will file the results of our trial in 5- to 11-year-olds with regulators across the world and will request approval of the vaccine in this age group, also here in Europe,” Oezlem Tuereci, MD, the chief medical officer for BioNTech, told Der Spiegel.
The company is completing the final production steps to make the vaccine at lower doses for the younger age group, she said. Pfizer and BioNTech will also seek vaccine approval for ages 6 months to 2 years later this year.
“Things are looking good, everything is going according to plan,” Ugur Sahin, MD, the CEO of BioNTech, told Der Spiegel.
A version of this article first appeared on WebMD.com.
Biden vaccine mandate rule could be ready within weeks
The emergency rule ordering large employers to require COVID-19 vaccines or weekly tests for their workers could be ready “within weeks,” officials said in a news briefing Sept. 10.
Labor Secretary Martin Walsh will oversee the Occupational Safety and Health Administration as the agency drafts what’s known as an emergency temporary standard, similar to the one that was issued a few months ago to protect health care workers during the pandemic.
The rule should be ready within weeks, said Jeff Zients, coordinator of the White House COVID-19 response team.
He said the ultimate goal of the president’s plan is to increase vaccinations as quickly as possible to keep schools open, the economy recovering, and to decrease hospitalizations and deaths from COVID.
Mr. Zients declined to set hard numbers around those goals, but other experts did.
“What we need to get to is 85% to 90% population immunity, and that’s going to be immunity both from vaccines and infections, before that really begins to have a substantial dampening effect on viral spread,” Ashish Jha, MD, dean of the Brown University School of Public Health, Providence, R.I., said on a call with reporters Sept. 9.
He said immunity needs to be that high because the Delta variant is so contagious.
Mandates are seen as the most effective way to increase immunity and do it quickly.
David Michaels, PhD, an epidemiologist and professor at George Washington University, Washington, says OSHA will have to work through a number of steps to develop the rule.
“OSHA will have to write a preamble explaining the standard, its justifications, its costs, and how it will be enforced,” says Dr. Michaels, who led OSHA for the Obama administration. After that, the rule will be reviewed by the White House. Then employers will have some time – typically 30 days – to comply.
In addition to drafting the standard, OSHA will oversee its enforcement.
Companies that refuse to follow the standard could be fined $13,600 per violation, Mr. Zients said.
Dr. Michaels said he doesn’t expect enforcement to be a big issue, and he said we’re likely to see the rule well before it is final.
“Most employers are law-abiding. When OSHA issues a standard, they try to meet whatever those requirements are, and generally that starts to happen when the rule is announced, even before it goes into effect,” he said.
The rule may face legal challenges as well. Several governors and state attorneys general, as well as the Republican National Committee, have promised lawsuits to stop the vaccine mandates.
Critics of the new mandates say they impinge on personal freedom and impose burdens on businesses.
But the president hit back at that notion Sept. 10.
“Look, I am so disappointed that, particularly some of the Republican governors, have been so cavalier with the health of these kids, so cavalier of the health of their communities,” President Biden told reporters.
“I don’t know of any scientist out there in this field who doesn’t think it makes considerable sense to do the six things I’ve suggested.”
Yet, others feel the new requirements didn’t go far enough.
“These are good steps in the right direction, but they’re not enough to get the job done,” said Leana Wen, MD, in an op-ed for The Washington Post.
Dr. Wen, an expert in public health, wondered why President Biden didn’t mandate vaccinations for plane and train travel. She was disappointed that children 12 and older weren’t required to be vaccinated, too.
“There are mandates for childhood immunizations in every state. The coronavirus vaccine should be no different,” she wrote.
Vaccines remain the cornerstone of U.S. plans to control the pandemic.
On Sept. 10, there was new research from the CDC and state health departments showing that the COVID-19 vaccines continue to be highly effective at preventing severe illness and death.
But the study also found that the vaccines became less effective in the United States after Delta became the dominant cause of infections here.
The study, which included more than 600,000 COVID-19 cases, analyzed breakthrough infections – cases where people got sick despite being fully vaccinated – in 13 jurisdictions in the United States between April 4 and July 17, 2021.
Epidemiologists compared breakthrough infections between two distinct points in time: Before and after the period when the Delta variant began causing most infections.
From April 4 to June 19, fully vaccinated people made up just 5% of cases, 7% of hospitalizations, and 8% of deaths. From June 20 to July 17, 18% of cases, 14% of hospitalizations, and 16% of deaths occurred in fully vaccinated people.
“After the week of June 20, 2021, when the SARS-CoV-2 Delta variant became predominant, the percentage of fully vaccinated persons among cases increased more than expected,” the study authors wrote.
Even after Delta swept the United States, fully vaccinated people were 5 times less likely to get a COVID-19 infection and more than 10 times less likely to be hospitalized or die from one.
“As we have shown in study after study, vaccination works,” CDC Director Rochelle Walensky, MD, said during the White House news briefing.
“We have the scientific tools we need to turn the corner on this pandemic. Vaccination works and will protect us from the severe complications of COVID-19,” she said.
A version of this article first appeared on WebMD.com.
The emergency rule ordering large employers to require COVID-19 vaccines or weekly tests for their workers could be ready “within weeks,” officials said in a news briefing Sept. 10.
Labor Secretary Martin Walsh will oversee the Occupational Safety and Health Administration as the agency drafts what’s known as an emergency temporary standard, similar to the one that was issued a few months ago to protect health care workers during the pandemic.
The rule should be ready within weeks, said Jeff Zients, coordinator of the White House COVID-19 response team.
He said the ultimate goal of the president’s plan is to increase vaccinations as quickly as possible to keep schools open, the economy recovering, and to decrease hospitalizations and deaths from COVID.
Mr. Zients declined to set hard numbers around those goals, but other experts did.
“What we need to get to is 85% to 90% population immunity, and that’s going to be immunity both from vaccines and infections, before that really begins to have a substantial dampening effect on viral spread,” Ashish Jha, MD, dean of the Brown University School of Public Health, Providence, R.I., said on a call with reporters Sept. 9.
He said immunity needs to be that high because the Delta variant is so contagious.
Mandates are seen as the most effective way to increase immunity and do it quickly.
David Michaels, PhD, an epidemiologist and professor at George Washington University, Washington, says OSHA will have to work through a number of steps to develop the rule.
“OSHA will have to write a preamble explaining the standard, its justifications, its costs, and how it will be enforced,” says Dr. Michaels, who led OSHA for the Obama administration. After that, the rule will be reviewed by the White House. Then employers will have some time – typically 30 days – to comply.
In addition to drafting the standard, OSHA will oversee its enforcement.
Companies that refuse to follow the standard could be fined $13,600 per violation, Mr. Zients said.
Dr. Michaels said he doesn’t expect enforcement to be a big issue, and he said we’re likely to see the rule well before it is final.
“Most employers are law-abiding. When OSHA issues a standard, they try to meet whatever those requirements are, and generally that starts to happen when the rule is announced, even before it goes into effect,” he said.
The rule may face legal challenges as well. Several governors and state attorneys general, as well as the Republican National Committee, have promised lawsuits to stop the vaccine mandates.
Critics of the new mandates say they impinge on personal freedom and impose burdens on businesses.
But the president hit back at that notion Sept. 10.
“Look, I am so disappointed that, particularly some of the Republican governors, have been so cavalier with the health of these kids, so cavalier of the health of their communities,” President Biden told reporters.
“I don’t know of any scientist out there in this field who doesn’t think it makes considerable sense to do the six things I’ve suggested.”
Yet, others feel the new requirements didn’t go far enough.
“These are good steps in the right direction, but they’re not enough to get the job done,” said Leana Wen, MD, in an op-ed for The Washington Post.
Dr. Wen, an expert in public health, wondered why President Biden didn’t mandate vaccinations for plane and train travel. She was disappointed that children 12 and older weren’t required to be vaccinated, too.
“There are mandates for childhood immunizations in every state. The coronavirus vaccine should be no different,” she wrote.
Vaccines remain the cornerstone of U.S. plans to control the pandemic.
On Sept. 10, there was new research from the CDC and state health departments showing that the COVID-19 vaccines continue to be highly effective at preventing severe illness and death.
But the study also found that the vaccines became less effective in the United States after Delta became the dominant cause of infections here.
The study, which included more than 600,000 COVID-19 cases, analyzed breakthrough infections – cases where people got sick despite being fully vaccinated – in 13 jurisdictions in the United States between April 4 and July 17, 2021.
Epidemiologists compared breakthrough infections between two distinct points in time: Before and after the period when the Delta variant began causing most infections.
From April 4 to June 19, fully vaccinated people made up just 5% of cases, 7% of hospitalizations, and 8% of deaths. From June 20 to July 17, 18% of cases, 14% of hospitalizations, and 16% of deaths occurred in fully vaccinated people.
“After the week of June 20, 2021, when the SARS-CoV-2 Delta variant became predominant, the percentage of fully vaccinated persons among cases increased more than expected,” the study authors wrote.
Even after Delta swept the United States, fully vaccinated people were 5 times less likely to get a COVID-19 infection and more than 10 times less likely to be hospitalized or die from one.
“As we have shown in study after study, vaccination works,” CDC Director Rochelle Walensky, MD, said during the White House news briefing.
“We have the scientific tools we need to turn the corner on this pandemic. Vaccination works and will protect us from the severe complications of COVID-19,” she said.
A version of this article first appeared on WebMD.com.
The emergency rule ordering large employers to require COVID-19 vaccines or weekly tests for their workers could be ready “within weeks,” officials said in a news briefing Sept. 10.
Labor Secretary Martin Walsh will oversee the Occupational Safety and Health Administration as the agency drafts what’s known as an emergency temporary standard, similar to the one that was issued a few months ago to protect health care workers during the pandemic.
The rule should be ready within weeks, said Jeff Zients, coordinator of the White House COVID-19 response team.
He said the ultimate goal of the president’s plan is to increase vaccinations as quickly as possible to keep schools open, the economy recovering, and to decrease hospitalizations and deaths from COVID.
Mr. Zients declined to set hard numbers around those goals, but other experts did.
“What we need to get to is 85% to 90% population immunity, and that’s going to be immunity both from vaccines and infections, before that really begins to have a substantial dampening effect on viral spread,” Ashish Jha, MD, dean of the Brown University School of Public Health, Providence, R.I., said on a call with reporters Sept. 9.
He said immunity needs to be that high because the Delta variant is so contagious.
Mandates are seen as the most effective way to increase immunity and do it quickly.
David Michaels, PhD, an epidemiologist and professor at George Washington University, Washington, says OSHA will have to work through a number of steps to develop the rule.
“OSHA will have to write a preamble explaining the standard, its justifications, its costs, and how it will be enforced,” says Dr. Michaels, who led OSHA for the Obama administration. After that, the rule will be reviewed by the White House. Then employers will have some time – typically 30 days – to comply.
In addition to drafting the standard, OSHA will oversee its enforcement.
Companies that refuse to follow the standard could be fined $13,600 per violation, Mr. Zients said.
Dr. Michaels said he doesn’t expect enforcement to be a big issue, and he said we’re likely to see the rule well before it is final.
“Most employers are law-abiding. When OSHA issues a standard, they try to meet whatever those requirements are, and generally that starts to happen when the rule is announced, even before it goes into effect,” he said.
The rule may face legal challenges as well. Several governors and state attorneys general, as well as the Republican National Committee, have promised lawsuits to stop the vaccine mandates.
Critics of the new mandates say they impinge on personal freedom and impose burdens on businesses.
But the president hit back at that notion Sept. 10.
“Look, I am so disappointed that, particularly some of the Republican governors, have been so cavalier with the health of these kids, so cavalier of the health of their communities,” President Biden told reporters.
“I don’t know of any scientist out there in this field who doesn’t think it makes considerable sense to do the six things I’ve suggested.”
Yet, others feel the new requirements didn’t go far enough.
“These are good steps in the right direction, but they’re not enough to get the job done,” said Leana Wen, MD, in an op-ed for The Washington Post.
Dr. Wen, an expert in public health, wondered why President Biden didn’t mandate vaccinations for plane and train travel. She was disappointed that children 12 and older weren’t required to be vaccinated, too.
“There are mandates for childhood immunizations in every state. The coronavirus vaccine should be no different,” she wrote.
Vaccines remain the cornerstone of U.S. plans to control the pandemic.
On Sept. 10, there was new research from the CDC and state health departments showing that the COVID-19 vaccines continue to be highly effective at preventing severe illness and death.
But the study also found that the vaccines became less effective in the United States after Delta became the dominant cause of infections here.
The study, which included more than 600,000 COVID-19 cases, analyzed breakthrough infections – cases where people got sick despite being fully vaccinated – in 13 jurisdictions in the United States between April 4 and July 17, 2021.
Epidemiologists compared breakthrough infections between two distinct points in time: Before and after the period when the Delta variant began causing most infections.
From April 4 to June 19, fully vaccinated people made up just 5% of cases, 7% of hospitalizations, and 8% of deaths. From June 20 to July 17, 18% of cases, 14% of hospitalizations, and 16% of deaths occurred in fully vaccinated people.
“After the week of June 20, 2021, when the SARS-CoV-2 Delta variant became predominant, the percentage of fully vaccinated persons among cases increased more than expected,” the study authors wrote.
Even after Delta swept the United States, fully vaccinated people were 5 times less likely to get a COVID-19 infection and more than 10 times less likely to be hospitalized or die from one.
“As we have shown in study after study, vaccination works,” CDC Director Rochelle Walensky, MD, said during the White House news briefing.
“We have the scientific tools we need to turn the corner on this pandemic. Vaccination works and will protect us from the severe complications of COVID-19,” she said.
A version of this article first appeared on WebMD.com.