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COVID spikes exacerbate health worker shortages in Rocky Mountains, Great Plains

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Thu, 08/26/2021 - 15:58

COVID-19 cases are surging in rural places across the Mountain States and Midwest, and when it hits health care workers, ready reinforcements aren’t easy to find.

In Montana, pandemic-induced staffing shortages have shuttered a clinic in the state’s capital, led a northwestern regional hospital to ask employees exposed to COVID-19 to continue to work and emptied a health department 400 miles to the east.

“Just one more person out and we wouldn’t be able to keep the surgeries going,” said Dr. Shelly Harkins, MD, chief medical officer of St. Peter’s Health in Helena, a city of roughly 32,000 where cases continue to spread. “When the virus is just all around you, it’s almost impossible to not be deemed a contact at some point. One case can take out a whole team of people in a blink of an eye.”

In North Dakota, where cases per resident are growing faster than any other state, hospitals may once again curtail elective surgeries and possibly seek government aid to hire more nurses if the situation gets worse, North Dakota Hospital Association President Tim Blasl said.

“How long can we run at this rate with the workforce that we have?” Blasl said. “You can have all the licensed beds you want, but if you don’t have anybody to staff those beds, it doesn’t do you any good.”

The northern Rocky Mountains, Great Plains and Upper Midwest are seeing the highest surge of COVID-19 cases in the nation, as some residents have ignored recommendations for curtailing the virus, such as wearing masks and avoiding large gatherings. Montana, Idaho, Utah, Wyoming, North Dakota, South Dakota, Nebraska, Iowa, and Wisconsin have recently ranked among the top 10 U.S. states in confirmed cases per 100,000 residents over a 7-day period, according to an analysis  by the New York Times.

Such coronavirus infections – and the quarantines that occur because of them – are exacerbating the health care worker shortage that existed in these states well before the pandemic. Unlike in the nation’s metropolitan hubs, these outbreaks are scattered across hundreds of miles. And even in these states’ biggest cities, the ranks of medical professionals are in short supply. Specialists and registered nurses are sometimes harder to track down than ventilators, N95 masks or hospital beds. Without enough care providers, patients may not be able to get the medical attention they need.

Hospitals have asked staffers to cover extra shifts and learn new skills. They have brought in temporary workers from other parts of the country and transferred some patients to less-crowded hospitals. But, at St. Peter’s Health, if the hospital’s one kidney doctor gets sick or is told to quarantine, Dr. Harkins doesn’t expect to find a backup.

“We make a point to not have excessive staff because we have an obligation to keep the cost of health care down for a community – we just don’t have a lot of slack in our rope,” Dr. Harkins said. “What we don’t account for is a mass exodus of staff for 14 days.”

Some hospitals are already at patient capacity or are nearly there. That’s not just because of the growing number of COVID-19 patients. Elective surgeries have resumed, and medical emergencies don’t pause for a pandemic.

Some Montana hospitals formed agreements with local affiliates early in the pandemic to share staff if one came up short. But now that the disease is spreading fast – and widely – the hope is that their needs don’t peak all at once.

Montana state officials keep a list of primarily in-state volunteer workers ready to travel to towns with shortages of contact tracers, nurses and more. But during a press conference on Oct. 15, Democratic Gov. Steve Bullock said the state had exhausted that database, and its nationwide request for National Guard medical staffing hadn’t brought in new workers.

“If you are a registered nurse, licensed practical nurse, paramedic, EMT, CNA or contact tracer, and are able to join our workforce, please do consider joining our team,” Gov. Bullock said.

This month, Kalispell Regional Medical Center in northwestern Montana even stopped quarantining COVID-exposed staff who remain asymptomatic, a change allowed by Centers for Disease Control and Prevention guidelines for health facilities facing staffing shortages.

“That’s very telling for what staffing is going through right now,” said Andrea Lueck, a registered nurse at the center. “We’re so tight that employees are called off of quarantine.”

Financial pressure early in the pandemic led the hospital to furlough staff, but it had to bring most of them back to work because it needs those bodies more than ever. The regional hub is based in Flathead County, which has recorded the state’s second-highest number of active COVID-19 cases.

Mellody Sharpton, a hospital spokesperson, said hospital workers who are exposed to someone infected with the virus are tested within three to five days and monitored for symptoms. The hospital is also pulling in new workers, with 25 traveling health professionals on hand and another 25 temporary ones on the way.

But Ms. Sharpton said the best way to conserve the hospital’s workforce is to stop the disease surge in the community.

Earlier in the pandemic, Central Montana Medical Center in Lewistown, a town of fewer than 6,000, experienced an exodus of part-time workers or those close to retirement who decided their jobs weren’t worth the risk. The facility recently secured two traveling workers, but both backed out because they couldn’t find housing. And, so far, roughly 40 of the hospital’s 322 employees have missed work for reasons connected to COVID-19.

“We’re at a critical staffing shortage and have been since the beginning of COVID,” said Joanie Slaybaugh, Central Montana Medical Center’s director of human resources. “We’re small enough, everybody feels an obligation to protect themselves and to protect each other. But it doesn’t take much to take out our staff.”

Roosevelt County, where roughly 11,000 live on the northeastern edge of Montana, had one of the nation’s highest rates of new cases as of Oct. 15. But by the end of the month, the county health department will lose half of its registered nurses as one person is about to retire and another was hired through a grant that’s ending. That leaves only one registered nurse aside from its director, Patty Presser. The health department already had to close earlier during the pandemic because of COVID exposure and not enough staffers to cover the gap. Now, if Ms. Presser can’t find nurse replacements in time, she hopes volunteers will step in, though she added they typically stay for only a few weeks.

“I need someone to do immunizations for my community, and you don’t become an immunization nurse in 14 days,” she said. “We don’t have the workforce here to deal with this virus, not even right now, and then I’m going to have my best two people go.”

Back in Helena, Dr. Harkins said St. Peter’s Health had to close a specialty outpatient clinic that treats chronic diseases for two weeks at the end of September because the entire staff had to quarantine.

Now the hospital is considering having doctors take turns spending a week working from home, so that if another wave of quarantines hits in the hospital, at least one untainted person can be brought back to work. But that won’t help for some specialties, like the hospital’s sole kidney doctor.

Every time Dr. Harkins’ phone rings, she said, she takes a breath and hopes it’s not another case that will force a whole division to close.

“Because I think immediately of the hundreds of people that need that service and won’t have it for 14 days,” she said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

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COVID-19 cases are surging in rural places across the Mountain States and Midwest, and when it hits health care workers, ready reinforcements aren’t easy to find.

In Montana, pandemic-induced staffing shortages have shuttered a clinic in the state’s capital, led a northwestern regional hospital to ask employees exposed to COVID-19 to continue to work and emptied a health department 400 miles to the east.

“Just one more person out and we wouldn’t be able to keep the surgeries going,” said Dr. Shelly Harkins, MD, chief medical officer of St. Peter’s Health in Helena, a city of roughly 32,000 where cases continue to spread. “When the virus is just all around you, it’s almost impossible to not be deemed a contact at some point. One case can take out a whole team of people in a blink of an eye.”

In North Dakota, where cases per resident are growing faster than any other state, hospitals may once again curtail elective surgeries and possibly seek government aid to hire more nurses if the situation gets worse, North Dakota Hospital Association President Tim Blasl said.

“How long can we run at this rate with the workforce that we have?” Blasl said. “You can have all the licensed beds you want, but if you don’t have anybody to staff those beds, it doesn’t do you any good.”

The northern Rocky Mountains, Great Plains and Upper Midwest are seeing the highest surge of COVID-19 cases in the nation, as some residents have ignored recommendations for curtailing the virus, such as wearing masks and avoiding large gatherings. Montana, Idaho, Utah, Wyoming, North Dakota, South Dakota, Nebraska, Iowa, and Wisconsin have recently ranked among the top 10 U.S. states in confirmed cases per 100,000 residents over a 7-day period, according to an analysis  by the New York Times.

Such coronavirus infections – and the quarantines that occur because of them – are exacerbating the health care worker shortage that existed in these states well before the pandemic. Unlike in the nation’s metropolitan hubs, these outbreaks are scattered across hundreds of miles. And even in these states’ biggest cities, the ranks of medical professionals are in short supply. Specialists and registered nurses are sometimes harder to track down than ventilators, N95 masks or hospital beds. Without enough care providers, patients may not be able to get the medical attention they need.

Hospitals have asked staffers to cover extra shifts and learn new skills. They have brought in temporary workers from other parts of the country and transferred some patients to less-crowded hospitals. But, at St. Peter’s Health, if the hospital’s one kidney doctor gets sick or is told to quarantine, Dr. Harkins doesn’t expect to find a backup.

“We make a point to not have excessive staff because we have an obligation to keep the cost of health care down for a community – we just don’t have a lot of slack in our rope,” Dr. Harkins said. “What we don’t account for is a mass exodus of staff for 14 days.”

Some hospitals are already at patient capacity or are nearly there. That’s not just because of the growing number of COVID-19 patients. Elective surgeries have resumed, and medical emergencies don’t pause for a pandemic.

Some Montana hospitals formed agreements with local affiliates early in the pandemic to share staff if one came up short. But now that the disease is spreading fast – and widely – the hope is that their needs don’t peak all at once.

Montana state officials keep a list of primarily in-state volunteer workers ready to travel to towns with shortages of contact tracers, nurses and more. But during a press conference on Oct. 15, Democratic Gov. Steve Bullock said the state had exhausted that database, and its nationwide request for National Guard medical staffing hadn’t brought in new workers.

“If you are a registered nurse, licensed practical nurse, paramedic, EMT, CNA or contact tracer, and are able to join our workforce, please do consider joining our team,” Gov. Bullock said.

This month, Kalispell Regional Medical Center in northwestern Montana even stopped quarantining COVID-exposed staff who remain asymptomatic, a change allowed by Centers for Disease Control and Prevention guidelines for health facilities facing staffing shortages.

“That’s very telling for what staffing is going through right now,” said Andrea Lueck, a registered nurse at the center. “We’re so tight that employees are called off of quarantine.”

Financial pressure early in the pandemic led the hospital to furlough staff, but it had to bring most of them back to work because it needs those bodies more than ever. The regional hub is based in Flathead County, which has recorded the state’s second-highest number of active COVID-19 cases.

Mellody Sharpton, a hospital spokesperson, said hospital workers who are exposed to someone infected with the virus are tested within three to five days and monitored for symptoms. The hospital is also pulling in new workers, with 25 traveling health professionals on hand and another 25 temporary ones on the way.

But Ms. Sharpton said the best way to conserve the hospital’s workforce is to stop the disease surge in the community.

Earlier in the pandemic, Central Montana Medical Center in Lewistown, a town of fewer than 6,000, experienced an exodus of part-time workers or those close to retirement who decided their jobs weren’t worth the risk. The facility recently secured two traveling workers, but both backed out because they couldn’t find housing. And, so far, roughly 40 of the hospital’s 322 employees have missed work for reasons connected to COVID-19.

“We’re at a critical staffing shortage and have been since the beginning of COVID,” said Joanie Slaybaugh, Central Montana Medical Center’s director of human resources. “We’re small enough, everybody feels an obligation to protect themselves and to protect each other. But it doesn’t take much to take out our staff.”

Roosevelt County, where roughly 11,000 live on the northeastern edge of Montana, had one of the nation’s highest rates of new cases as of Oct. 15. But by the end of the month, the county health department will lose half of its registered nurses as one person is about to retire and another was hired through a grant that’s ending. That leaves only one registered nurse aside from its director, Patty Presser. The health department already had to close earlier during the pandemic because of COVID exposure and not enough staffers to cover the gap. Now, if Ms. Presser can’t find nurse replacements in time, she hopes volunteers will step in, though she added they typically stay for only a few weeks.

“I need someone to do immunizations for my community, and you don’t become an immunization nurse in 14 days,” she said. “We don’t have the workforce here to deal with this virus, not even right now, and then I’m going to have my best two people go.”

Back in Helena, Dr. Harkins said St. Peter’s Health had to close a specialty outpatient clinic that treats chronic diseases for two weeks at the end of September because the entire staff had to quarantine.

Now the hospital is considering having doctors take turns spending a week working from home, so that if another wave of quarantines hits in the hospital, at least one untainted person can be brought back to work. But that won’t help for some specialties, like the hospital’s sole kidney doctor.

Every time Dr. Harkins’ phone rings, she said, she takes a breath and hopes it’s not another case that will force a whole division to close.

“Because I think immediately of the hundreds of people that need that service and won’t have it for 14 days,” she said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

COVID-19 cases are surging in rural places across the Mountain States and Midwest, and when it hits health care workers, ready reinforcements aren’t easy to find.

In Montana, pandemic-induced staffing shortages have shuttered a clinic in the state’s capital, led a northwestern regional hospital to ask employees exposed to COVID-19 to continue to work and emptied a health department 400 miles to the east.

“Just one more person out and we wouldn’t be able to keep the surgeries going,” said Dr. Shelly Harkins, MD, chief medical officer of St. Peter’s Health in Helena, a city of roughly 32,000 where cases continue to spread. “When the virus is just all around you, it’s almost impossible to not be deemed a contact at some point. One case can take out a whole team of people in a blink of an eye.”

In North Dakota, where cases per resident are growing faster than any other state, hospitals may once again curtail elective surgeries and possibly seek government aid to hire more nurses if the situation gets worse, North Dakota Hospital Association President Tim Blasl said.

“How long can we run at this rate with the workforce that we have?” Blasl said. “You can have all the licensed beds you want, but if you don’t have anybody to staff those beds, it doesn’t do you any good.”

The northern Rocky Mountains, Great Plains and Upper Midwest are seeing the highest surge of COVID-19 cases in the nation, as some residents have ignored recommendations for curtailing the virus, such as wearing masks and avoiding large gatherings. Montana, Idaho, Utah, Wyoming, North Dakota, South Dakota, Nebraska, Iowa, and Wisconsin have recently ranked among the top 10 U.S. states in confirmed cases per 100,000 residents over a 7-day period, according to an analysis  by the New York Times.

Such coronavirus infections – and the quarantines that occur because of them – are exacerbating the health care worker shortage that existed in these states well before the pandemic. Unlike in the nation’s metropolitan hubs, these outbreaks are scattered across hundreds of miles. And even in these states’ biggest cities, the ranks of medical professionals are in short supply. Specialists and registered nurses are sometimes harder to track down than ventilators, N95 masks or hospital beds. Without enough care providers, patients may not be able to get the medical attention they need.

Hospitals have asked staffers to cover extra shifts and learn new skills. They have brought in temporary workers from other parts of the country and transferred some patients to less-crowded hospitals. But, at St. Peter’s Health, if the hospital’s one kidney doctor gets sick or is told to quarantine, Dr. Harkins doesn’t expect to find a backup.

“We make a point to not have excessive staff because we have an obligation to keep the cost of health care down for a community – we just don’t have a lot of slack in our rope,” Dr. Harkins said. “What we don’t account for is a mass exodus of staff for 14 days.”

Some hospitals are already at patient capacity or are nearly there. That’s not just because of the growing number of COVID-19 patients. Elective surgeries have resumed, and medical emergencies don’t pause for a pandemic.

Some Montana hospitals formed agreements with local affiliates early in the pandemic to share staff if one came up short. But now that the disease is spreading fast – and widely – the hope is that their needs don’t peak all at once.

Montana state officials keep a list of primarily in-state volunteer workers ready to travel to towns with shortages of contact tracers, nurses and more. But during a press conference on Oct. 15, Democratic Gov. Steve Bullock said the state had exhausted that database, and its nationwide request for National Guard medical staffing hadn’t brought in new workers.

“If you are a registered nurse, licensed practical nurse, paramedic, EMT, CNA or contact tracer, and are able to join our workforce, please do consider joining our team,” Gov. Bullock said.

This month, Kalispell Regional Medical Center in northwestern Montana even stopped quarantining COVID-exposed staff who remain asymptomatic, a change allowed by Centers for Disease Control and Prevention guidelines for health facilities facing staffing shortages.

“That’s very telling for what staffing is going through right now,” said Andrea Lueck, a registered nurse at the center. “We’re so tight that employees are called off of quarantine.”

Financial pressure early in the pandemic led the hospital to furlough staff, but it had to bring most of them back to work because it needs those bodies more than ever. The regional hub is based in Flathead County, which has recorded the state’s second-highest number of active COVID-19 cases.

Mellody Sharpton, a hospital spokesperson, said hospital workers who are exposed to someone infected with the virus are tested within three to five days and monitored for symptoms. The hospital is also pulling in new workers, with 25 traveling health professionals on hand and another 25 temporary ones on the way.

But Ms. Sharpton said the best way to conserve the hospital’s workforce is to stop the disease surge in the community.

Earlier in the pandemic, Central Montana Medical Center in Lewistown, a town of fewer than 6,000, experienced an exodus of part-time workers or those close to retirement who decided their jobs weren’t worth the risk. The facility recently secured two traveling workers, but both backed out because they couldn’t find housing. And, so far, roughly 40 of the hospital’s 322 employees have missed work for reasons connected to COVID-19.

“We’re at a critical staffing shortage and have been since the beginning of COVID,” said Joanie Slaybaugh, Central Montana Medical Center’s director of human resources. “We’re small enough, everybody feels an obligation to protect themselves and to protect each other. But it doesn’t take much to take out our staff.”

Roosevelt County, where roughly 11,000 live on the northeastern edge of Montana, had one of the nation’s highest rates of new cases as of Oct. 15. But by the end of the month, the county health department will lose half of its registered nurses as one person is about to retire and another was hired through a grant that’s ending. That leaves only one registered nurse aside from its director, Patty Presser. The health department already had to close earlier during the pandemic because of COVID exposure and not enough staffers to cover the gap. Now, if Ms. Presser can’t find nurse replacements in time, she hopes volunteers will step in, though she added they typically stay for only a few weeks.

“I need someone to do immunizations for my community, and you don’t become an immunization nurse in 14 days,” she said. “We don’t have the workforce here to deal with this virus, not even right now, and then I’m going to have my best two people go.”

Back in Helena, Dr. Harkins said St. Peter’s Health had to close a specialty outpatient clinic that treats chronic diseases for two weeks at the end of September because the entire staff had to quarantine.

Now the hospital is considering having doctors take turns spending a week working from home, so that if another wave of quarantines hits in the hospital, at least one untainted person can be brought back to work. But that won’t help for some specialties, like the hospital’s sole kidney doctor.

Every time Dr. Harkins’ phone rings, she said, she takes a breath and hopes it’s not another case that will force a whole division to close.

“Because I think immediately of the hundreds of people that need that service and won’t have it for 14 days,” she said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

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Twelve end-of-year tax tips: How COVID-19 could lower your tax bite

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Mon, 10/26/2020 - 08:15

COVID-19 has had a huge impact on every aspect of physicians’ medical practice, incomes, and business. Although this will probably not end soon, there are some key tax strategies that can help your financial position if you take some important actions by the end of the year.

Some of the ways in which physicians were hard hit include:

  • Physicians who are self-employed are facing increased costs for personal protective equipment, cleaning protocols, and new telehealth infrastructure. Many are also facing staffing shortages as employees fall to part-time work or take time off work to care for family members.
  • Even physicians working for large hospitals are not isolated from the financial impact of the virus. A recent survey conducted by Medscape concluded that over 60% of physicians in the United States have experienced a decrease in income since the start of the pandemic.
  • Saving and investing have been affected: Physicians may expect to see that companies in which they are invested are cutting dividends. Interest rates (CDs, bonds) are lower, and capital gains distributions are reduced this year. Overall, that makes for a fairly grim financial picture.

While taxable income this year has mostly declined, the applicable tax rates overall are low. However, federal, state, and local budget deficits have been skyrocketing owing to the demands of the pandemic. That means, in all likelihood, there will be tax increases in the coming years to cover spending. However, this year’s financial challenges could lend themselves to a unique tax planning scenario that could potentially benefit physicians as they make long-term plans for their investments.

Given these circumstances, these 12 tips can help you to lessen your tax bite this tax season. Many of these tips entail actions that you need to take before Dec. 31, 2020.
 

1. Coronavirus stimulus rebates

If you have significantly depressed income this year or have lost your job, you may find that you qualify for an Economic Impact Payment, a refundable tax credit on the 2020 tax return. The credit is $1,200 for individuals or $2,400 for joint filers, plus an additional $500 for each qualifying child aged 16 years or younger. You begin to phase out of the credit at an adjusted gross income (AGI) of $75,000 for individuals and $150,000 for joint filers. People who had AGI below these thresholds in 2019 already would have received the credit in advance, but those who now find themselves qualifying will receive the credit when they file their 2020 tax return. No action is needed on your part; your tax preparer will calculate whether you are eligible for the credit when filing your return.

2. Look to accelerate income at lower brackets

With reduced earned income, many physicians will find themselves in significantly lower tax brackets this year. Once you fall below $200,000 for individuals or $250,000 for joint filers, you no longer trigger two additional surcharge taxes. The first is the additional Medicare tax, which is a further 0.9% applied to earned income above those thresholds, on top of ordinary income tax brackets. The second is the Net Investment Income Tax (NIIT), which is an additional 3.8% applied to your investment income on top of capital gains tax brackets.

 

 

If you are someone to whom the additional Medicare tax or NIIT no longer applies for 2020, you might consider generating income this year in order to realize the lower tax rates. You could consider selling highly appreciated investments in your taxable portfolio and reinvest the proceeds by repurchasing the same securities, thereby receiving a step-up in cost basis. Remember, when you go to sell securities in retirement, you are only taxed on the gain on the security over your cost basis. By bringing the cost basis up to today’s fair market value, you could be greatly reducing the future tax applied on a sale.

For those with IRA or inherited IRA accounts who also have required minimum distributions (RMDs), you might consider making voluntary withdrawals this year and then reinvesting the proceeds into a savings or taxable account for when you need it. Keep in mind that under the CARES Act, you are no longer required to take RMDs for 2020. However, this action would help avoid being forced to withdraw the amount when you may be at a higher tax bracket. You would need to do this before Dec. 31.
 

3. Build Roth assets strategies

With reduced incomes and lower marginal tax rates applying to the last dollar of income this year, physicians should carefully consider how to take advantage of current tax rates by building Roth assets. There are a few strategies, including switching 401(k) or 457 contributions from pretax to Roth or performing a backdoor Roth IRA contribution. However, neither is as powerful as converting IRA assets to Roth assets because there is no restriction on conversion amount or income cutoffs.

The goal is to convert enough assets to fill up lower applicable marginal tax brackets while avoiding tax surcharges, where possible. Roth IRA conversions can get you in trouble if you don’t know what to expect, so it’s best to work with a financial advisor or tax professional to give you guidance. For example, Roth conversions can trigger some tax surprises, such as the phaseout for the 199A qualified business income deduction, increased taxation on your Social Security benefits, or higher Income-Related Monthly Adjustment Amount surcharges on Medicare Part B and Part D premiums.

Bear in mind that Roth conversions generate taxable income and cannot be undone once completed. However, paying the lower marginal tax rate today may be a big win when RMDs could push physicians into tax brackets as high as or higher than during their working years.
 

4. Coronavirus-related distributions

New this year is a penalty-free way to withdraw qualified retirement plan funds for those who are not yet eligible to make penalty-free withdrawals.

Congress introduced the Coronavirus-Related Distribution under the CARES Act. It allows individuals who have been affected by the pandemic to withdraw up to $100,000 before Dec. 31, 2020, without paying the 10% early withdrawal penalty. If you are considering an early retirement because of the pandemic, it may make sense to take this withdrawal while the option lasts and keep the cash available to help fund the gap before the remainder of your retirement plan assets are available penalty free. Keep in mind that this withdrawal generates taxable ordinary income, even though the early withdrawal penalty does not apply. Taking this withdrawal can boost your taxable income bracket, so calculate carefully before you do this.
 

 

 

5. Charitable donations for 2020

There is no shortage of people in need owing to the pandemic. For those who continue to be charitable-minded, a decrease in income may mean you have more opportunity for your regularly recurring charitable donations to decrease your taxes this year. Normally, charitable donations for itemizers are limited to 60% of AGI. However, the CARES Act increased the charitable deduction limit to 100% of AGI for 2020. Even those who claim the standard deduction can take advantage of a new “above-the-line” deduction worth $300 for individuals and $600 for joint filers by making qualified cash donations in 2020. Take special note that the contributions do not apply to donor-advised funds or nonoperating private foundations.

6. Noncash charitable donations

Many physicians are working longer and harder than ever, and for many, that means vacation plans have been placed on hold for the remainder of the year. Don’t let your paid-time-off days go to waste! The IRS now permits leave-based donation programs, which allow employers to make deductible charitable donations for the relief of victims of the COVID-19 pandemic on the basis of the value of the sick, vacation, or personal leave that employees voluntarily forgo. The value of the donation will not be treated as compensation for the employee and will be free of any otherwise applicable Federal Insurance Contributions Act (FICA) taxes, and the employer can deduct the donation as ordinary and necessary business expenses if they meet certain requirements.

7. Claiming 2020 losses on prior tax returns

For self-employed physicians, a wealth of tax planning strategies are available. One of the most significant may be the new provisions under the CARES Act that allow 100% of net operating losses (NOLs) for 3 calendar years of losses – namely 2018, 2019, and 2020 – to be carried back to the prior 5 tax years. Using these NOLs, you may be able to claim a refund for tax returns from prior tax years when there was otherwise a limit on NOLs at 80% of taxable income. If you think this applies to you, it’s wise to meet with your accountant or financial professional to discuss this.

8. Delay payroll taxes where possible

For physicians with employees looking for some cash flow relief, a new payroll tax deferral is available to you this year. Under the CARES Act, employers can delay payment of their 2020 employer payroll tax, namely the 6.2% Social Security tax, with 50% not due until Dec. 31, 2021, and the remainder due Dec. 31, 2022. The deferral will not incur any interest or penalties and is also available to those who are self-employed.

On top of that, a new payroll tax credit was created under the Families First Coronavirus Response Act. Eligible employers can receive this tax credit for the amount of wages they pay to eligible employees who are taking pandemic-related paid family leave or paid sick leave this year. The credit is also available to those who are self-employed. If you think this credit may be applicable to you, it’s worth speaking with your tax preparer about it.
 

 

 

9. Increased business property deductions

The nature of many physician business operations has drastically changed this year. For physicians who already have invested in and implemented new telehealth infrastructure, this can create valuable tax deductions to offset their ordinary income. Businesses may take 100% bonus depreciation on the cost of qualified property both acquired and placed in service after Sept. 27, 2017, and before Jan. 1, 2023. In general, during the last quarter of the year, you should look to decelerate business purchases until after Jan. 1, 2021, to get a deduction in 2021 at a higher marginal tax bracket.

10. Switch to cash accounting instead of accrual accounting

With higher expenses and lower profits, some large practice groups may take a second look to see whether they qualify to switch to cash accounting from accrual accounting to defer taxes. This rule change was adopted back in 2017 to allow small-business taxpayers with average annual gross receipts of $25 million or less in the prior 3 years to use the cash method of accounting. Ultimately, this switch should allow practices to owe the IRS money only after invoices were paid.

11. Physicians looking to sell their unprofitable practices

For physicians looking to make a quick exit from their practice in response to the pandemic, there is some tax relief in the event of a sale at a loss. Certain business owners who sell failed businesses will be able to use up to $50,000 of net losses as individuals or $100,000 as joint filers from the sale to offset ordinary income, current or future, under Internal Revenue Code (IRC) Section 1244. Remember that ordinary income tax rates are much higher than capital gains rates, so you could see some tax relief through a sale. The provision covers shareholders of domestic small-business corporations, both C or S corporations, but not partnerships. You would have to sell the business before Dec. 31 to get this deduction in 2020.

12. Physicians looking to sell their profitable practices

Even self-employed physicians who have managed to maintain profitable practices may be looking for early retirement after the exhaustion of the pandemic. If you own stock in a C corporation engaged in an active trade or business that has not had assets of more than $50 million at any time, you can take advantage of the IRC Section 1202 exemption. Section 1202 provides an exclusion from gain from the sale of stock of either $10 million or 10 times the adjusted basis of the stock, owned at least 5 years, in corporations regarded as “qualified small businesses.” This means you may be able to sell your practice at a gain with a handsome tax shield. Again, to get this tax benefit for April’s tax return, you’d have to engage in this activity before year end.

Regardless of whether the pandemic has placed financial constraints on you this year, tax-savvy opportunities are available to capitalize on your reduced income and lower tax rates. It’s always important to keep in mind not just your taxes in any one given year, but your lifetime tax obligations. Financial advisors and tax planners can perform multiyear tax calculations and recommend ways to manage your tax bracket and help lower your overall lifetime tax obligations.
 

 

 

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

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COVID-19 has had a huge impact on every aspect of physicians’ medical practice, incomes, and business. Although this will probably not end soon, there are some key tax strategies that can help your financial position if you take some important actions by the end of the year.

Some of the ways in which physicians were hard hit include:

  • Physicians who are self-employed are facing increased costs for personal protective equipment, cleaning protocols, and new telehealth infrastructure. Many are also facing staffing shortages as employees fall to part-time work or take time off work to care for family members.
  • Even physicians working for large hospitals are not isolated from the financial impact of the virus. A recent survey conducted by Medscape concluded that over 60% of physicians in the United States have experienced a decrease in income since the start of the pandemic.
  • Saving and investing have been affected: Physicians may expect to see that companies in which they are invested are cutting dividends. Interest rates (CDs, bonds) are lower, and capital gains distributions are reduced this year. Overall, that makes for a fairly grim financial picture.

While taxable income this year has mostly declined, the applicable tax rates overall are low. However, federal, state, and local budget deficits have been skyrocketing owing to the demands of the pandemic. That means, in all likelihood, there will be tax increases in the coming years to cover spending. However, this year’s financial challenges could lend themselves to a unique tax planning scenario that could potentially benefit physicians as they make long-term plans for their investments.

Given these circumstances, these 12 tips can help you to lessen your tax bite this tax season. Many of these tips entail actions that you need to take before Dec. 31, 2020.
 

1. Coronavirus stimulus rebates

If you have significantly depressed income this year or have lost your job, you may find that you qualify for an Economic Impact Payment, a refundable tax credit on the 2020 tax return. The credit is $1,200 for individuals or $2,400 for joint filers, plus an additional $500 for each qualifying child aged 16 years or younger. You begin to phase out of the credit at an adjusted gross income (AGI) of $75,000 for individuals and $150,000 for joint filers. People who had AGI below these thresholds in 2019 already would have received the credit in advance, but those who now find themselves qualifying will receive the credit when they file their 2020 tax return. No action is needed on your part; your tax preparer will calculate whether you are eligible for the credit when filing your return.

2. Look to accelerate income at lower brackets

With reduced earned income, many physicians will find themselves in significantly lower tax brackets this year. Once you fall below $200,000 for individuals or $250,000 for joint filers, you no longer trigger two additional surcharge taxes. The first is the additional Medicare tax, which is a further 0.9% applied to earned income above those thresholds, on top of ordinary income tax brackets. The second is the Net Investment Income Tax (NIIT), which is an additional 3.8% applied to your investment income on top of capital gains tax brackets.

 

 

If you are someone to whom the additional Medicare tax or NIIT no longer applies for 2020, you might consider generating income this year in order to realize the lower tax rates. You could consider selling highly appreciated investments in your taxable portfolio and reinvest the proceeds by repurchasing the same securities, thereby receiving a step-up in cost basis. Remember, when you go to sell securities in retirement, you are only taxed on the gain on the security over your cost basis. By bringing the cost basis up to today’s fair market value, you could be greatly reducing the future tax applied on a sale.

For those with IRA or inherited IRA accounts who also have required minimum distributions (RMDs), you might consider making voluntary withdrawals this year and then reinvesting the proceeds into a savings or taxable account for when you need it. Keep in mind that under the CARES Act, you are no longer required to take RMDs for 2020. However, this action would help avoid being forced to withdraw the amount when you may be at a higher tax bracket. You would need to do this before Dec. 31.
 

3. Build Roth assets strategies

With reduced incomes and lower marginal tax rates applying to the last dollar of income this year, physicians should carefully consider how to take advantage of current tax rates by building Roth assets. There are a few strategies, including switching 401(k) or 457 contributions from pretax to Roth or performing a backdoor Roth IRA contribution. However, neither is as powerful as converting IRA assets to Roth assets because there is no restriction on conversion amount or income cutoffs.

The goal is to convert enough assets to fill up lower applicable marginal tax brackets while avoiding tax surcharges, where possible. Roth IRA conversions can get you in trouble if you don’t know what to expect, so it’s best to work with a financial advisor or tax professional to give you guidance. For example, Roth conversions can trigger some tax surprises, such as the phaseout for the 199A qualified business income deduction, increased taxation on your Social Security benefits, or higher Income-Related Monthly Adjustment Amount surcharges on Medicare Part B and Part D premiums.

Bear in mind that Roth conversions generate taxable income and cannot be undone once completed. However, paying the lower marginal tax rate today may be a big win when RMDs could push physicians into tax brackets as high as or higher than during their working years.
 

4. Coronavirus-related distributions

New this year is a penalty-free way to withdraw qualified retirement plan funds for those who are not yet eligible to make penalty-free withdrawals.

Congress introduced the Coronavirus-Related Distribution under the CARES Act. It allows individuals who have been affected by the pandemic to withdraw up to $100,000 before Dec. 31, 2020, without paying the 10% early withdrawal penalty. If you are considering an early retirement because of the pandemic, it may make sense to take this withdrawal while the option lasts and keep the cash available to help fund the gap before the remainder of your retirement plan assets are available penalty free. Keep in mind that this withdrawal generates taxable ordinary income, even though the early withdrawal penalty does not apply. Taking this withdrawal can boost your taxable income bracket, so calculate carefully before you do this.
 

 

 

5. Charitable donations for 2020

There is no shortage of people in need owing to the pandemic. For those who continue to be charitable-minded, a decrease in income may mean you have more opportunity for your regularly recurring charitable donations to decrease your taxes this year. Normally, charitable donations for itemizers are limited to 60% of AGI. However, the CARES Act increased the charitable deduction limit to 100% of AGI for 2020. Even those who claim the standard deduction can take advantage of a new “above-the-line” deduction worth $300 for individuals and $600 for joint filers by making qualified cash donations in 2020. Take special note that the contributions do not apply to donor-advised funds or nonoperating private foundations.

6. Noncash charitable donations

Many physicians are working longer and harder than ever, and for many, that means vacation plans have been placed on hold for the remainder of the year. Don’t let your paid-time-off days go to waste! The IRS now permits leave-based donation programs, which allow employers to make deductible charitable donations for the relief of victims of the COVID-19 pandemic on the basis of the value of the sick, vacation, or personal leave that employees voluntarily forgo. The value of the donation will not be treated as compensation for the employee and will be free of any otherwise applicable Federal Insurance Contributions Act (FICA) taxes, and the employer can deduct the donation as ordinary and necessary business expenses if they meet certain requirements.

7. Claiming 2020 losses on prior tax returns

For self-employed physicians, a wealth of tax planning strategies are available. One of the most significant may be the new provisions under the CARES Act that allow 100% of net operating losses (NOLs) for 3 calendar years of losses – namely 2018, 2019, and 2020 – to be carried back to the prior 5 tax years. Using these NOLs, you may be able to claim a refund for tax returns from prior tax years when there was otherwise a limit on NOLs at 80% of taxable income. If you think this applies to you, it’s wise to meet with your accountant or financial professional to discuss this.

8. Delay payroll taxes where possible

For physicians with employees looking for some cash flow relief, a new payroll tax deferral is available to you this year. Under the CARES Act, employers can delay payment of their 2020 employer payroll tax, namely the 6.2% Social Security tax, with 50% not due until Dec. 31, 2021, and the remainder due Dec. 31, 2022. The deferral will not incur any interest or penalties and is also available to those who are self-employed.

On top of that, a new payroll tax credit was created under the Families First Coronavirus Response Act. Eligible employers can receive this tax credit for the amount of wages they pay to eligible employees who are taking pandemic-related paid family leave or paid sick leave this year. The credit is also available to those who are self-employed. If you think this credit may be applicable to you, it’s worth speaking with your tax preparer about it.
 

 

 

9. Increased business property deductions

The nature of many physician business operations has drastically changed this year. For physicians who already have invested in and implemented new telehealth infrastructure, this can create valuable tax deductions to offset their ordinary income. Businesses may take 100% bonus depreciation on the cost of qualified property both acquired and placed in service after Sept. 27, 2017, and before Jan. 1, 2023. In general, during the last quarter of the year, you should look to decelerate business purchases until after Jan. 1, 2021, to get a deduction in 2021 at a higher marginal tax bracket.

10. Switch to cash accounting instead of accrual accounting

With higher expenses and lower profits, some large practice groups may take a second look to see whether they qualify to switch to cash accounting from accrual accounting to defer taxes. This rule change was adopted back in 2017 to allow small-business taxpayers with average annual gross receipts of $25 million or less in the prior 3 years to use the cash method of accounting. Ultimately, this switch should allow practices to owe the IRS money only after invoices were paid.

11. Physicians looking to sell their unprofitable practices

For physicians looking to make a quick exit from their practice in response to the pandemic, there is some tax relief in the event of a sale at a loss. Certain business owners who sell failed businesses will be able to use up to $50,000 of net losses as individuals or $100,000 as joint filers from the sale to offset ordinary income, current or future, under Internal Revenue Code (IRC) Section 1244. Remember that ordinary income tax rates are much higher than capital gains rates, so you could see some tax relief through a sale. The provision covers shareholders of domestic small-business corporations, both C or S corporations, but not partnerships. You would have to sell the business before Dec. 31 to get this deduction in 2020.

12. Physicians looking to sell their profitable practices

Even self-employed physicians who have managed to maintain profitable practices may be looking for early retirement after the exhaustion of the pandemic. If you own stock in a C corporation engaged in an active trade or business that has not had assets of more than $50 million at any time, you can take advantage of the IRC Section 1202 exemption. Section 1202 provides an exclusion from gain from the sale of stock of either $10 million or 10 times the adjusted basis of the stock, owned at least 5 years, in corporations regarded as “qualified small businesses.” This means you may be able to sell your practice at a gain with a handsome tax shield. Again, to get this tax benefit for April’s tax return, you’d have to engage in this activity before year end.

Regardless of whether the pandemic has placed financial constraints on you this year, tax-savvy opportunities are available to capitalize on your reduced income and lower tax rates. It’s always important to keep in mind not just your taxes in any one given year, but your lifetime tax obligations. Financial advisors and tax planners can perform multiyear tax calculations and recommend ways to manage your tax bracket and help lower your overall lifetime tax obligations.
 

 

 

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

COVID-19 has had a huge impact on every aspect of physicians’ medical practice, incomes, and business. Although this will probably not end soon, there are some key tax strategies that can help your financial position if you take some important actions by the end of the year.

Some of the ways in which physicians were hard hit include:

  • Physicians who are self-employed are facing increased costs for personal protective equipment, cleaning protocols, and new telehealth infrastructure. Many are also facing staffing shortages as employees fall to part-time work or take time off work to care for family members.
  • Even physicians working for large hospitals are not isolated from the financial impact of the virus. A recent survey conducted by Medscape concluded that over 60% of physicians in the United States have experienced a decrease in income since the start of the pandemic.
  • Saving and investing have been affected: Physicians may expect to see that companies in which they are invested are cutting dividends. Interest rates (CDs, bonds) are lower, and capital gains distributions are reduced this year. Overall, that makes for a fairly grim financial picture.

While taxable income this year has mostly declined, the applicable tax rates overall are low. However, federal, state, and local budget deficits have been skyrocketing owing to the demands of the pandemic. That means, in all likelihood, there will be tax increases in the coming years to cover spending. However, this year’s financial challenges could lend themselves to a unique tax planning scenario that could potentially benefit physicians as they make long-term plans for their investments.

Given these circumstances, these 12 tips can help you to lessen your tax bite this tax season. Many of these tips entail actions that you need to take before Dec. 31, 2020.
 

1. Coronavirus stimulus rebates

If you have significantly depressed income this year or have lost your job, you may find that you qualify for an Economic Impact Payment, a refundable tax credit on the 2020 tax return. The credit is $1,200 for individuals or $2,400 for joint filers, plus an additional $500 for each qualifying child aged 16 years or younger. You begin to phase out of the credit at an adjusted gross income (AGI) of $75,000 for individuals and $150,000 for joint filers. People who had AGI below these thresholds in 2019 already would have received the credit in advance, but those who now find themselves qualifying will receive the credit when they file their 2020 tax return. No action is needed on your part; your tax preparer will calculate whether you are eligible for the credit when filing your return.

2. Look to accelerate income at lower brackets

With reduced earned income, many physicians will find themselves in significantly lower tax brackets this year. Once you fall below $200,000 for individuals or $250,000 for joint filers, you no longer trigger two additional surcharge taxes. The first is the additional Medicare tax, which is a further 0.9% applied to earned income above those thresholds, on top of ordinary income tax brackets. The second is the Net Investment Income Tax (NIIT), which is an additional 3.8% applied to your investment income on top of capital gains tax brackets.

 

 

If you are someone to whom the additional Medicare tax or NIIT no longer applies for 2020, you might consider generating income this year in order to realize the lower tax rates. You could consider selling highly appreciated investments in your taxable portfolio and reinvest the proceeds by repurchasing the same securities, thereby receiving a step-up in cost basis. Remember, when you go to sell securities in retirement, you are only taxed on the gain on the security over your cost basis. By bringing the cost basis up to today’s fair market value, you could be greatly reducing the future tax applied on a sale.

For those with IRA or inherited IRA accounts who also have required minimum distributions (RMDs), you might consider making voluntary withdrawals this year and then reinvesting the proceeds into a savings or taxable account for when you need it. Keep in mind that under the CARES Act, you are no longer required to take RMDs for 2020. However, this action would help avoid being forced to withdraw the amount when you may be at a higher tax bracket. You would need to do this before Dec. 31.
 

3. Build Roth assets strategies

With reduced incomes and lower marginal tax rates applying to the last dollar of income this year, physicians should carefully consider how to take advantage of current tax rates by building Roth assets. There are a few strategies, including switching 401(k) or 457 contributions from pretax to Roth or performing a backdoor Roth IRA contribution. However, neither is as powerful as converting IRA assets to Roth assets because there is no restriction on conversion amount or income cutoffs.

The goal is to convert enough assets to fill up lower applicable marginal tax brackets while avoiding tax surcharges, where possible. Roth IRA conversions can get you in trouble if you don’t know what to expect, so it’s best to work with a financial advisor or tax professional to give you guidance. For example, Roth conversions can trigger some tax surprises, such as the phaseout for the 199A qualified business income deduction, increased taxation on your Social Security benefits, or higher Income-Related Monthly Adjustment Amount surcharges on Medicare Part B and Part D premiums.

Bear in mind that Roth conversions generate taxable income and cannot be undone once completed. However, paying the lower marginal tax rate today may be a big win when RMDs could push physicians into tax brackets as high as or higher than during their working years.
 

4. Coronavirus-related distributions

New this year is a penalty-free way to withdraw qualified retirement plan funds for those who are not yet eligible to make penalty-free withdrawals.

Congress introduced the Coronavirus-Related Distribution under the CARES Act. It allows individuals who have been affected by the pandemic to withdraw up to $100,000 before Dec. 31, 2020, without paying the 10% early withdrawal penalty. If you are considering an early retirement because of the pandemic, it may make sense to take this withdrawal while the option lasts and keep the cash available to help fund the gap before the remainder of your retirement plan assets are available penalty free. Keep in mind that this withdrawal generates taxable ordinary income, even though the early withdrawal penalty does not apply. Taking this withdrawal can boost your taxable income bracket, so calculate carefully before you do this.
 

 

 

5. Charitable donations for 2020

There is no shortage of people in need owing to the pandemic. For those who continue to be charitable-minded, a decrease in income may mean you have more opportunity for your regularly recurring charitable donations to decrease your taxes this year. Normally, charitable donations for itemizers are limited to 60% of AGI. However, the CARES Act increased the charitable deduction limit to 100% of AGI for 2020. Even those who claim the standard deduction can take advantage of a new “above-the-line” deduction worth $300 for individuals and $600 for joint filers by making qualified cash donations in 2020. Take special note that the contributions do not apply to donor-advised funds or nonoperating private foundations.

6. Noncash charitable donations

Many physicians are working longer and harder than ever, and for many, that means vacation plans have been placed on hold for the remainder of the year. Don’t let your paid-time-off days go to waste! The IRS now permits leave-based donation programs, which allow employers to make deductible charitable donations for the relief of victims of the COVID-19 pandemic on the basis of the value of the sick, vacation, or personal leave that employees voluntarily forgo. The value of the donation will not be treated as compensation for the employee and will be free of any otherwise applicable Federal Insurance Contributions Act (FICA) taxes, and the employer can deduct the donation as ordinary and necessary business expenses if they meet certain requirements.

7. Claiming 2020 losses on prior tax returns

For self-employed physicians, a wealth of tax planning strategies are available. One of the most significant may be the new provisions under the CARES Act that allow 100% of net operating losses (NOLs) for 3 calendar years of losses – namely 2018, 2019, and 2020 – to be carried back to the prior 5 tax years. Using these NOLs, you may be able to claim a refund for tax returns from prior tax years when there was otherwise a limit on NOLs at 80% of taxable income. If you think this applies to you, it’s wise to meet with your accountant or financial professional to discuss this.

8. Delay payroll taxes where possible

For physicians with employees looking for some cash flow relief, a new payroll tax deferral is available to you this year. Under the CARES Act, employers can delay payment of their 2020 employer payroll tax, namely the 6.2% Social Security tax, with 50% not due until Dec. 31, 2021, and the remainder due Dec. 31, 2022. The deferral will not incur any interest or penalties and is also available to those who are self-employed.

On top of that, a new payroll tax credit was created under the Families First Coronavirus Response Act. Eligible employers can receive this tax credit for the amount of wages they pay to eligible employees who are taking pandemic-related paid family leave or paid sick leave this year. The credit is also available to those who are self-employed. If you think this credit may be applicable to you, it’s worth speaking with your tax preparer about it.
 

 

 

9. Increased business property deductions

The nature of many physician business operations has drastically changed this year. For physicians who already have invested in and implemented new telehealth infrastructure, this can create valuable tax deductions to offset their ordinary income. Businesses may take 100% bonus depreciation on the cost of qualified property both acquired and placed in service after Sept. 27, 2017, and before Jan. 1, 2023. In general, during the last quarter of the year, you should look to decelerate business purchases until after Jan. 1, 2021, to get a deduction in 2021 at a higher marginal tax bracket.

10. Switch to cash accounting instead of accrual accounting

With higher expenses and lower profits, some large practice groups may take a second look to see whether they qualify to switch to cash accounting from accrual accounting to defer taxes. This rule change was adopted back in 2017 to allow small-business taxpayers with average annual gross receipts of $25 million or less in the prior 3 years to use the cash method of accounting. Ultimately, this switch should allow practices to owe the IRS money only after invoices were paid.

11. Physicians looking to sell their unprofitable practices

For physicians looking to make a quick exit from their practice in response to the pandemic, there is some tax relief in the event of a sale at a loss. Certain business owners who sell failed businesses will be able to use up to $50,000 of net losses as individuals or $100,000 as joint filers from the sale to offset ordinary income, current or future, under Internal Revenue Code (IRC) Section 1244. Remember that ordinary income tax rates are much higher than capital gains rates, so you could see some tax relief through a sale. The provision covers shareholders of domestic small-business corporations, both C or S corporations, but not partnerships. You would have to sell the business before Dec. 31 to get this deduction in 2020.

12. Physicians looking to sell their profitable practices

Even self-employed physicians who have managed to maintain profitable practices may be looking for early retirement after the exhaustion of the pandemic. If you own stock in a C corporation engaged in an active trade or business that has not had assets of more than $50 million at any time, you can take advantage of the IRC Section 1202 exemption. Section 1202 provides an exclusion from gain from the sale of stock of either $10 million or 10 times the adjusted basis of the stock, owned at least 5 years, in corporations regarded as “qualified small businesses.” This means you may be able to sell your practice at a gain with a handsome tax shield. Again, to get this tax benefit for April’s tax return, you’d have to engage in this activity before year end.

Regardless of whether the pandemic has placed financial constraints on you this year, tax-savvy opportunities are available to capitalize on your reduced income and lower tax rates. It’s always important to keep in mind not just your taxes in any one given year, but your lifetime tax obligations. Financial advisors and tax planners can perform multiyear tax calculations and recommend ways to manage your tax bracket and help lower your overall lifetime tax obligations.
 

 

 

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

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When should students resume sports after a COVID-19 diagnosis?

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Many student athletes who test positive for COVID-19 likely can have an uneventful return to their sports after they have rested for 2 weeks in quarantine, doctors suggest.

A teenager wears a face mask
Canberk Sezer/Getty Images

There are reasons for caution, however, especially when a patient has symptoms that indicate possible cardiac involvement. In these cases, patients should undergo cardiac testing before a physician clears them to return to play, according to guidance from professional associations. Reports of myocarditis in college athletes who tested positive for SARS-CoV-2 but were asymptomatic are among the reasons for concern. Myocarditis may increase the risk of sudden death during exercise.

“The thing that you need to keep in mind is that this is not just a respiratory illness,” David T. Bernhardt, MD, professor of pediatrics, orthopedics, and rehabilitation at the University of Wisconsin in Madison, said in a presentation at the annual meeting of the American Academy of Pediatrics, held virtually this year. High school and college athletes have had cardiac, neurologic, hematologic, and renal problems that “can complicate their recovery and their return to sport.”

Still, children who test positive for COVID-19 tend to have mild illness and often are asymptomatic. “It is more than likely going to be safe for the majority of the student athletes who are in the elementary and middle school age to return to sport,” said Dr. Bernhardt. Given that 18-year-old college freshmen have had cardiac complications, there may be reason for more caution with high school students.
 

Limited data

Dr. Susannah Briskin

The AAP has released interim guidance on returning to sports and recommends that primary care physicians clear all patients with COVID-19 before they resume training. Physicians should screen for cardiac symptoms such as chest pain, shortness of breath, fatigue, palpitations, or syncope.

Those with severe illness should be restricted from exercise and participation for 3-6 months. Primary care physicians, preferably in consultation with pediatric cardiologists, should clear athletes who experience severe illness.

“Most of the recommendations come from the fact that we simply do not know what we do not know with COVID-19,” Susannah Briskin, MD, a coauthor of the interim guidance, said in an interview. “We have to be cautious in returning individuals to play and closely monitor them as we learn more about the disease process and its effect on kids.”

Patients with severe illness could include those who were hospitalized and experienced hypotension or arrhythmias, required intubation or extracorporeal membrane oxygenation (ECMO) support, had kidney or cardiac failure, or developed multisystem inflammatory syndrome in children (MIS-C), said Dr. Briskin, a specialist in pediatric sports medicine at Case Western Reserve University, Cleveland.

“The majority of COVID-19 cases will not present like this in kids. We have no idea how common myocarditis is in kids post infection. We do know that, if anyone has chest pain, shortness of breath, excessive fatigue, syncope [passing out], or arrhythmia [feeling of their heart skipping beats], they should undergo further evaluation for myocarditis,” Dr. Briskin said.

Patients who are asymptomatic or have mild symptoms should rest for 14 days after their positive test. After their infectious period has passed, a doctor should assess for any concerning cardiac symptoms. “Anyone with prolonged fever or moderate symptoms should see their pediatrician and have an EKG performed, at a minimum, prior to return to sports,” Dr. Briskin said. “Anyone with an abnormal EKG or concerning signs or symptoms should be referred on to pediatric cardiology for a further assessment.”

Most patients who Dr. Briskin has seen have been asymptomatic or mildly symptomatic. “They have done well with a gradual return to physical activity,” she said. “We recommend a gradual return so individuals can be monitored for any signs or symptoms concerning for myocarditis. The far majority of individuals likely have an uneventful return to play.”

 

 



Mitigating risk

Dr. David T. Bernhardt

COVID-19 adds elements of uncertainty and complexity to the usual process of mitigating risk in sports, Dr. Bernhardt noted in his lecture. “You are dealing with an infection that we do not know a lot about,” he said. “And we are trying to mitigate risk not only for the individual who may or may not have underlying health problems, but you are also trying to mitigate risk for anybody else involved with the sport, including athletic trainers and team physicians, coaches, spectators, custodial staff, people working at a snack shack, and all the other people that can be involved in a typical sporting type of atmosphere.”

When patients do return to play after an illness, they should gradually increase the training load to avoid injury. In addition, clinicians should screen for depression and anxiety using tools such as the Four-Item Patient Health Questionnaire (PHQ-4) when they see patients. “The pandemic has been quite stressful for everybody, including our high school student athletes,” Dr. Bernhardt said. “Giving everybody a PHQ-4 when they come into clinic right now probably makes sense in terms of the stress levels that all of us are experiencing.”

If a patient screens positive, take additional history and refer for more in-depth mental health evaluation and treatment if warranted. Sharing breathing and relaxation exercises, promoting healthy behaviors, and paying attention to unhealthy strategies also may help, Dr. Bernhardt suggested.

Ultimately, determining when an athlete with COVID-19 can be medically cleared to return to play may be a challenge. There are limited data on epidemiology and clinical presentations that could help identify cardiac injury related to the disease, Dr. Bernhardt said. Guidance from the American College of Cardiology provides a framework for evaluating athletes for return to play, and pediatric cardiologists have discussed how the guidance relates to a pediatric population. Cardiac assessments may include measures of biomarkers such as troponin, B-type natriuretic peptide, and sedimentation rate, along with electrocardiograms, echocardiograms, and cardiac MRI.

Beyond return-to-play decisions, encourage the use of cloth face coverings on the sidelines and away from the playing field, and stress proper quarantining, Dr. Briskin added. Too often, she hears about children not quarantining properly. “Individuals with a known exposure should be quarantined in their house – ideally in a separate room from everyone else. ... When they come out of their room, they should wash their hands well and wear a cloth face covering. They should not be eating with other people.”

Dr. Bernhardt had no relevant disclosures.

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Many student athletes who test positive for COVID-19 likely can have an uneventful return to their sports after they have rested for 2 weeks in quarantine, doctors suggest.

A teenager wears a face mask
Canberk Sezer/Getty Images

There are reasons for caution, however, especially when a patient has symptoms that indicate possible cardiac involvement. In these cases, patients should undergo cardiac testing before a physician clears them to return to play, according to guidance from professional associations. Reports of myocarditis in college athletes who tested positive for SARS-CoV-2 but were asymptomatic are among the reasons for concern. Myocarditis may increase the risk of sudden death during exercise.

“The thing that you need to keep in mind is that this is not just a respiratory illness,” David T. Bernhardt, MD, professor of pediatrics, orthopedics, and rehabilitation at the University of Wisconsin in Madison, said in a presentation at the annual meeting of the American Academy of Pediatrics, held virtually this year. High school and college athletes have had cardiac, neurologic, hematologic, and renal problems that “can complicate their recovery and their return to sport.”

Still, children who test positive for COVID-19 tend to have mild illness and often are asymptomatic. “It is more than likely going to be safe for the majority of the student athletes who are in the elementary and middle school age to return to sport,” said Dr. Bernhardt. Given that 18-year-old college freshmen have had cardiac complications, there may be reason for more caution with high school students.
 

Limited data

Dr. Susannah Briskin

The AAP has released interim guidance on returning to sports and recommends that primary care physicians clear all patients with COVID-19 before they resume training. Physicians should screen for cardiac symptoms such as chest pain, shortness of breath, fatigue, palpitations, or syncope.

Those with severe illness should be restricted from exercise and participation for 3-6 months. Primary care physicians, preferably in consultation with pediatric cardiologists, should clear athletes who experience severe illness.

“Most of the recommendations come from the fact that we simply do not know what we do not know with COVID-19,” Susannah Briskin, MD, a coauthor of the interim guidance, said in an interview. “We have to be cautious in returning individuals to play and closely monitor them as we learn more about the disease process and its effect on kids.”

Patients with severe illness could include those who were hospitalized and experienced hypotension or arrhythmias, required intubation or extracorporeal membrane oxygenation (ECMO) support, had kidney or cardiac failure, or developed multisystem inflammatory syndrome in children (MIS-C), said Dr. Briskin, a specialist in pediatric sports medicine at Case Western Reserve University, Cleveland.

“The majority of COVID-19 cases will not present like this in kids. We have no idea how common myocarditis is in kids post infection. We do know that, if anyone has chest pain, shortness of breath, excessive fatigue, syncope [passing out], or arrhythmia [feeling of their heart skipping beats], they should undergo further evaluation for myocarditis,” Dr. Briskin said.

Patients who are asymptomatic or have mild symptoms should rest for 14 days after their positive test. After their infectious period has passed, a doctor should assess for any concerning cardiac symptoms. “Anyone with prolonged fever or moderate symptoms should see their pediatrician and have an EKG performed, at a minimum, prior to return to sports,” Dr. Briskin said. “Anyone with an abnormal EKG or concerning signs or symptoms should be referred on to pediatric cardiology for a further assessment.”

Most patients who Dr. Briskin has seen have been asymptomatic or mildly symptomatic. “They have done well with a gradual return to physical activity,” she said. “We recommend a gradual return so individuals can be monitored for any signs or symptoms concerning for myocarditis. The far majority of individuals likely have an uneventful return to play.”

 

 



Mitigating risk

Dr. David T. Bernhardt

COVID-19 adds elements of uncertainty and complexity to the usual process of mitigating risk in sports, Dr. Bernhardt noted in his lecture. “You are dealing with an infection that we do not know a lot about,” he said. “And we are trying to mitigate risk not only for the individual who may or may not have underlying health problems, but you are also trying to mitigate risk for anybody else involved with the sport, including athletic trainers and team physicians, coaches, spectators, custodial staff, people working at a snack shack, and all the other people that can be involved in a typical sporting type of atmosphere.”

When patients do return to play after an illness, they should gradually increase the training load to avoid injury. In addition, clinicians should screen for depression and anxiety using tools such as the Four-Item Patient Health Questionnaire (PHQ-4) when they see patients. “The pandemic has been quite stressful for everybody, including our high school student athletes,” Dr. Bernhardt said. “Giving everybody a PHQ-4 when they come into clinic right now probably makes sense in terms of the stress levels that all of us are experiencing.”

If a patient screens positive, take additional history and refer for more in-depth mental health evaluation and treatment if warranted. Sharing breathing and relaxation exercises, promoting healthy behaviors, and paying attention to unhealthy strategies also may help, Dr. Bernhardt suggested.

Ultimately, determining when an athlete with COVID-19 can be medically cleared to return to play may be a challenge. There are limited data on epidemiology and clinical presentations that could help identify cardiac injury related to the disease, Dr. Bernhardt said. Guidance from the American College of Cardiology provides a framework for evaluating athletes for return to play, and pediatric cardiologists have discussed how the guidance relates to a pediatric population. Cardiac assessments may include measures of biomarkers such as troponin, B-type natriuretic peptide, and sedimentation rate, along with electrocardiograms, echocardiograms, and cardiac MRI.

Beyond return-to-play decisions, encourage the use of cloth face coverings on the sidelines and away from the playing field, and stress proper quarantining, Dr. Briskin added. Too often, she hears about children not quarantining properly. “Individuals with a known exposure should be quarantined in their house – ideally in a separate room from everyone else. ... When they come out of their room, they should wash their hands well and wear a cloth face covering. They should not be eating with other people.”

Dr. Bernhardt had no relevant disclosures.

Many student athletes who test positive for COVID-19 likely can have an uneventful return to their sports after they have rested for 2 weeks in quarantine, doctors suggest.

A teenager wears a face mask
Canberk Sezer/Getty Images

There are reasons for caution, however, especially when a patient has symptoms that indicate possible cardiac involvement. In these cases, patients should undergo cardiac testing before a physician clears them to return to play, according to guidance from professional associations. Reports of myocarditis in college athletes who tested positive for SARS-CoV-2 but were asymptomatic are among the reasons for concern. Myocarditis may increase the risk of sudden death during exercise.

“The thing that you need to keep in mind is that this is not just a respiratory illness,” David T. Bernhardt, MD, professor of pediatrics, orthopedics, and rehabilitation at the University of Wisconsin in Madison, said in a presentation at the annual meeting of the American Academy of Pediatrics, held virtually this year. High school and college athletes have had cardiac, neurologic, hematologic, and renal problems that “can complicate their recovery and their return to sport.”

Still, children who test positive for COVID-19 tend to have mild illness and often are asymptomatic. “It is more than likely going to be safe for the majority of the student athletes who are in the elementary and middle school age to return to sport,” said Dr. Bernhardt. Given that 18-year-old college freshmen have had cardiac complications, there may be reason for more caution with high school students.
 

Limited data

Dr. Susannah Briskin

The AAP has released interim guidance on returning to sports and recommends that primary care physicians clear all patients with COVID-19 before they resume training. Physicians should screen for cardiac symptoms such as chest pain, shortness of breath, fatigue, palpitations, or syncope.

Those with severe illness should be restricted from exercise and participation for 3-6 months. Primary care physicians, preferably in consultation with pediatric cardiologists, should clear athletes who experience severe illness.

“Most of the recommendations come from the fact that we simply do not know what we do not know with COVID-19,” Susannah Briskin, MD, a coauthor of the interim guidance, said in an interview. “We have to be cautious in returning individuals to play and closely monitor them as we learn more about the disease process and its effect on kids.”

Patients with severe illness could include those who were hospitalized and experienced hypotension or arrhythmias, required intubation or extracorporeal membrane oxygenation (ECMO) support, had kidney or cardiac failure, or developed multisystem inflammatory syndrome in children (MIS-C), said Dr. Briskin, a specialist in pediatric sports medicine at Case Western Reserve University, Cleveland.

“The majority of COVID-19 cases will not present like this in kids. We have no idea how common myocarditis is in kids post infection. We do know that, if anyone has chest pain, shortness of breath, excessive fatigue, syncope [passing out], or arrhythmia [feeling of their heart skipping beats], they should undergo further evaluation for myocarditis,” Dr. Briskin said.

Patients who are asymptomatic or have mild symptoms should rest for 14 days after their positive test. After their infectious period has passed, a doctor should assess for any concerning cardiac symptoms. “Anyone with prolonged fever or moderate symptoms should see their pediatrician and have an EKG performed, at a minimum, prior to return to sports,” Dr. Briskin said. “Anyone with an abnormal EKG or concerning signs or symptoms should be referred on to pediatric cardiology for a further assessment.”

Most patients who Dr. Briskin has seen have been asymptomatic or mildly symptomatic. “They have done well with a gradual return to physical activity,” she said. “We recommend a gradual return so individuals can be monitored for any signs or symptoms concerning for myocarditis. The far majority of individuals likely have an uneventful return to play.”

 

 



Mitigating risk

Dr. David T. Bernhardt

COVID-19 adds elements of uncertainty and complexity to the usual process of mitigating risk in sports, Dr. Bernhardt noted in his lecture. “You are dealing with an infection that we do not know a lot about,” he said. “And we are trying to mitigate risk not only for the individual who may or may not have underlying health problems, but you are also trying to mitigate risk for anybody else involved with the sport, including athletic trainers and team physicians, coaches, spectators, custodial staff, people working at a snack shack, and all the other people that can be involved in a typical sporting type of atmosphere.”

When patients do return to play after an illness, they should gradually increase the training load to avoid injury. In addition, clinicians should screen for depression and anxiety using tools such as the Four-Item Patient Health Questionnaire (PHQ-4) when they see patients. “The pandemic has been quite stressful for everybody, including our high school student athletes,” Dr. Bernhardt said. “Giving everybody a PHQ-4 when they come into clinic right now probably makes sense in terms of the stress levels that all of us are experiencing.”

If a patient screens positive, take additional history and refer for more in-depth mental health evaluation and treatment if warranted. Sharing breathing and relaxation exercises, promoting healthy behaviors, and paying attention to unhealthy strategies also may help, Dr. Bernhardt suggested.

Ultimately, determining when an athlete with COVID-19 can be medically cleared to return to play may be a challenge. There are limited data on epidemiology and clinical presentations that could help identify cardiac injury related to the disease, Dr. Bernhardt said. Guidance from the American College of Cardiology provides a framework for evaluating athletes for return to play, and pediatric cardiologists have discussed how the guidance relates to a pediatric population. Cardiac assessments may include measures of biomarkers such as troponin, B-type natriuretic peptide, and sedimentation rate, along with electrocardiograms, echocardiograms, and cardiac MRI.

Beyond return-to-play decisions, encourage the use of cloth face coverings on the sidelines and away from the playing field, and stress proper quarantining, Dr. Briskin added. Too often, she hears about children not quarantining properly. “Individuals with a known exposure should be quarantined in their house – ideally in a separate room from everyone else. ... When they come out of their room, they should wash their hands well and wear a cloth face covering. They should not be eating with other people.”

Dr. Bernhardt had no relevant disclosures.

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COVID-19 vaccine standards questioned at FDA advisory meeting

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Researchers and several medical groups on Oct. 23 pressed for changes to the US Food and Drug Administration’s (FDA) current plans for deciding how to eventually clear vaccines for COVID-19, arguing tougher standards would help bolster confidence in these critical medicines.

The FDA’s Vaccines and Related Biological Products Advisory Committee met for a wide-ranging discussion beginning around 10 am. The FDA did not ask the panel to weigh in on any particular vaccine. Instead, the FDA asked for the panel’s feedback on a series of questions, including considerations for continuing phase 3 trials if a product were to get an interim clearance known as an emergency use authorization (EUA).

Speakers at the hearing made a variety of requests, including asking for data showing COVID-19 vaccines can prevent serious illness and urging transparency about the agency’s deliberations for each product to be considered.

FDA staff are closely tracking the crop of experimental vaccines that have made it into advanced stages of testing, including products from Pfizer Inc, AstraZeneca, Johnson & Johnson, and Moderna.
 

‘Time for a reset’

Among the speakers at the public hearing was Peter Lurie, MD, who served as an FDA associate commissioner from 2014 to 2017. Now the president of the Center for Science in the Public Interest, Lurie was among the speakers who asked the agency to make its independence clear.

President Donald Trump has for months been making predictions about COVID-19 vaccine approvals that have been overly optimistic. In one example, the president, who is seeking re-election on November 3, last month spoke about being able to begin distributing a vaccine in October.

“Until now the process of developing candidate vaccines has been inappropriately politicized with an eye on the election calendar, rather than the deliberate timeframe science requires,” Lurie told the FDA advisory panel. “Now is the time for a reset. This committee has a unique opportunity to set a new tone for vaccine deliberations going forward.”

Lurie asked the panel to press the FDA to commit to hold an advisory committee meeting on requests by drugmakers for EUAs. He also asked the panel to demand that informed consent forms and minutes from institutional review board (IRB) discussions of COVID-19 vaccines trials be made public.

Also among the speakers at the public hearing was Peter Doshi, PhD, an associate professor at the University of Maryland School of Pharmacy, who argued that the current trials won’t answer the right questions about the COVID-19 vaccines.

“We could end up with approved vaccines that reduce the risk of mild infection, but do not decrease the risk of hospitalization, ICU use, or death — either at all or by a clinically relevant amount,” Doshi told the panel.

In his presentation, he reiterated points he had made previously, including in an October 21 article in the BMJ, for which he is an associate editor. Doshi also raised these concerns in a September opinion article in The New York Times, co-authored with Eric Topol, MD, director of the Scripps Research Translational Institute and editor-in-chief of Medscape.
 

Risks of a ‘rushed vaccine’

Other complaints about the FDA’s approach included criticism of a 2-month follow-up time after vaccination, which was seen as too short. ECRI, a nonprofit organization that seeks to improve the safety, quality, and cost-effectiveness of medicines, has argued that approving a weak COVID-19 vaccine might worsen the pandemic.

In an October 21 statement, ECRI noted the risk of a partially effective vaccine, which could be welcomed as a means of slowing transmission of the virus. But public response and attitudes over the past 9 months in the United States suggest that people would relax their precautions as soon as a vaccine is available.

“Resulting infections may offset the vaccine’s impact and end up increasing the mortality and morbidity burden,” ECRI said in the brief.

“The risks and consequences of a rushed vaccine could be very severe if the review is anything shy of thorough,” ECRI Chief Executive Officer Marcus Schabacker, MD, PhD, said in a statement prepared for the hearing.

This article first appeared on Medscape.com.

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Researchers and several medical groups on Oct. 23 pressed for changes to the US Food and Drug Administration’s (FDA) current plans for deciding how to eventually clear vaccines for COVID-19, arguing tougher standards would help bolster confidence in these critical medicines.

The FDA’s Vaccines and Related Biological Products Advisory Committee met for a wide-ranging discussion beginning around 10 am. The FDA did not ask the panel to weigh in on any particular vaccine. Instead, the FDA asked for the panel’s feedback on a series of questions, including considerations for continuing phase 3 trials if a product were to get an interim clearance known as an emergency use authorization (EUA).

Speakers at the hearing made a variety of requests, including asking for data showing COVID-19 vaccines can prevent serious illness and urging transparency about the agency’s deliberations for each product to be considered.

FDA staff are closely tracking the crop of experimental vaccines that have made it into advanced stages of testing, including products from Pfizer Inc, AstraZeneca, Johnson & Johnson, and Moderna.
 

‘Time for a reset’

Among the speakers at the public hearing was Peter Lurie, MD, who served as an FDA associate commissioner from 2014 to 2017. Now the president of the Center for Science in the Public Interest, Lurie was among the speakers who asked the agency to make its independence clear.

President Donald Trump has for months been making predictions about COVID-19 vaccine approvals that have been overly optimistic. In one example, the president, who is seeking re-election on November 3, last month spoke about being able to begin distributing a vaccine in October.

“Until now the process of developing candidate vaccines has been inappropriately politicized with an eye on the election calendar, rather than the deliberate timeframe science requires,” Lurie told the FDA advisory panel. “Now is the time for a reset. This committee has a unique opportunity to set a new tone for vaccine deliberations going forward.”

Lurie asked the panel to press the FDA to commit to hold an advisory committee meeting on requests by drugmakers for EUAs. He also asked the panel to demand that informed consent forms and minutes from institutional review board (IRB) discussions of COVID-19 vaccines trials be made public.

Also among the speakers at the public hearing was Peter Doshi, PhD, an associate professor at the University of Maryland School of Pharmacy, who argued that the current trials won’t answer the right questions about the COVID-19 vaccines.

“We could end up with approved vaccines that reduce the risk of mild infection, but do not decrease the risk of hospitalization, ICU use, or death — either at all or by a clinically relevant amount,” Doshi told the panel.

In his presentation, he reiterated points he had made previously, including in an October 21 article in the BMJ, for which he is an associate editor. Doshi also raised these concerns in a September opinion article in The New York Times, co-authored with Eric Topol, MD, director of the Scripps Research Translational Institute and editor-in-chief of Medscape.
 

Risks of a ‘rushed vaccine’

Other complaints about the FDA’s approach included criticism of a 2-month follow-up time after vaccination, which was seen as too short. ECRI, a nonprofit organization that seeks to improve the safety, quality, and cost-effectiveness of medicines, has argued that approving a weak COVID-19 vaccine might worsen the pandemic.

In an October 21 statement, ECRI noted the risk of a partially effective vaccine, which could be welcomed as a means of slowing transmission of the virus. But public response and attitudes over the past 9 months in the United States suggest that people would relax their precautions as soon as a vaccine is available.

“Resulting infections may offset the vaccine’s impact and end up increasing the mortality and morbidity burden,” ECRI said in the brief.

“The risks and consequences of a rushed vaccine could be very severe if the review is anything shy of thorough,” ECRI Chief Executive Officer Marcus Schabacker, MD, PhD, said in a statement prepared for the hearing.

This article first appeared on Medscape.com.

Researchers and several medical groups on Oct. 23 pressed for changes to the US Food and Drug Administration’s (FDA) current plans for deciding how to eventually clear vaccines for COVID-19, arguing tougher standards would help bolster confidence in these critical medicines.

The FDA’s Vaccines and Related Biological Products Advisory Committee met for a wide-ranging discussion beginning around 10 am. The FDA did not ask the panel to weigh in on any particular vaccine. Instead, the FDA asked for the panel’s feedback on a series of questions, including considerations for continuing phase 3 trials if a product were to get an interim clearance known as an emergency use authorization (EUA).

Speakers at the hearing made a variety of requests, including asking for data showing COVID-19 vaccines can prevent serious illness and urging transparency about the agency’s deliberations for each product to be considered.

FDA staff are closely tracking the crop of experimental vaccines that have made it into advanced stages of testing, including products from Pfizer Inc, AstraZeneca, Johnson & Johnson, and Moderna.
 

‘Time for a reset’

Among the speakers at the public hearing was Peter Lurie, MD, who served as an FDA associate commissioner from 2014 to 2017. Now the president of the Center for Science in the Public Interest, Lurie was among the speakers who asked the agency to make its independence clear.

President Donald Trump has for months been making predictions about COVID-19 vaccine approvals that have been overly optimistic. In one example, the president, who is seeking re-election on November 3, last month spoke about being able to begin distributing a vaccine in October.

“Until now the process of developing candidate vaccines has been inappropriately politicized with an eye on the election calendar, rather than the deliberate timeframe science requires,” Lurie told the FDA advisory panel. “Now is the time for a reset. This committee has a unique opportunity to set a new tone for vaccine deliberations going forward.”

Lurie asked the panel to press the FDA to commit to hold an advisory committee meeting on requests by drugmakers for EUAs. He also asked the panel to demand that informed consent forms and minutes from institutional review board (IRB) discussions of COVID-19 vaccines trials be made public.

Also among the speakers at the public hearing was Peter Doshi, PhD, an associate professor at the University of Maryland School of Pharmacy, who argued that the current trials won’t answer the right questions about the COVID-19 vaccines.

“We could end up with approved vaccines that reduce the risk of mild infection, but do not decrease the risk of hospitalization, ICU use, or death — either at all or by a clinically relevant amount,” Doshi told the panel.

In his presentation, he reiterated points he had made previously, including in an October 21 article in the BMJ, for which he is an associate editor. Doshi also raised these concerns in a September opinion article in The New York Times, co-authored with Eric Topol, MD, director of the Scripps Research Translational Institute and editor-in-chief of Medscape.
 

Risks of a ‘rushed vaccine’

Other complaints about the FDA’s approach included criticism of a 2-month follow-up time after vaccination, which was seen as too short. ECRI, a nonprofit organization that seeks to improve the safety, quality, and cost-effectiveness of medicines, has argued that approving a weak COVID-19 vaccine might worsen the pandemic.

In an October 21 statement, ECRI noted the risk of a partially effective vaccine, which could be welcomed as a means of slowing transmission of the virus. But public response and attitudes over the past 9 months in the United States suggest that people would relax their precautions as soon as a vaccine is available.

“Resulting infections may offset the vaccine’s impact and end up increasing the mortality and morbidity burden,” ECRI said in the brief.

“The risks and consequences of a rushed vaccine could be very severe if the review is anything shy of thorough,” ECRI Chief Executive Officer Marcus Schabacker, MD, PhD, said in a statement prepared for the hearing.

This article first appeared on Medscape.com.

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Data on potential risks of COVID-19 in psoriasis patients limited, but reassuring

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Tue, 02/07/2023 - 16:48

The available data suggest that the risks posed by COVID-19 infection to patients with psoriasis, including those on therapies that affect immune function, are modest at most, according to a summary of published studies and expert opinions summarized at the annual Coastal Dermatology Symposium, held virtually.

Dr. Kristina C. Duffin

For patients with psoriasis concerned about their outcome if infected with COVID-19, “there is no evidence to support stopping biologics or systemic agents, so I am asking my patients to continue,” Kristina C. Duffin, MD, professor and chair of dermatology at the University of Utah, Salt Lake City, said at the meeting.

The National Psoriasis Foundation, which created a COVID-19 task force and maintains a COVID-19 Resource Center on its website, has provided similar advice. Many statements are phrased cautiously and clinicians are encouraged to practice shared decision-making, but the NPF guidance supports continuing effective therapy – or, in newly diagnosed patients, starting effective therapy – among those who are not infected with SARS-CoV2.

Patients with a new diagnosis of psoriasis “should be aware that untreated psoriatic disease is associated with serious impact on physical and emotional health, and in the case of psoriatic arthritis, can lead to permanent joint damage and disability,” according to the NPF guidance.

Overall, the “existing data generally suggest” that most treatments for psoriasis and psoriatic arthritis “do not meaningfully alter the risks of contracting SARS-CoV2 or having a worse course of COVID-19 illness,” the current guidance states. Yet, because of limited data this “is not known with certainty.”

Chronic systemic steroids are an exception. In a review of recently published studies evaluating whether psoriasis or its therapies increase risk of adverse outcomes in patients with COVID-19 infection, Dr. Duffin pointed to several that associated systemic steroids with hospitalization or other markers of severe disease.

The NPF guidance also recommends avoiding chronic systemic steroids in patients with psoriasis during the current COVID-19 era “if possible.” In patients with psoriatic arthritis who require systemic steroids, the guidance recommends “the lowest dose necessary to achieve the desired therapeutic effect.”

This is not necessarily true in patients with psoriasis and COVID-19 infection. Based on the potential for systemic steroids to improve outcomes in hospitalized COVID-19 patients requiring oxygen, steroids “should not be withheld” even when the justification is concern about the potential risk of flares with withdrawal, according to the NPF guidance statement.



The NPF guidance specifically cautions against use of hydroxychloroquine or chloroquine for prevention or treatment of COVID-19. In addition to an uncertain benefit, these antimalarial drugs have been associated previously with flares of psoriasis.

Dr. Duffin agreed and went on to warn that COVID-19 infection itself is a potential trigger for flares. She cited two published case reports of flares associated with psoriasis. Although one patient had also been exposed to hydroxychloroquine, she said the risk of psoriasis-induced flare “makes sense” based on previous associations made between flares and other viral infections and stress.

In patients with psoriasis who contract COVID-19 infection, Dr. Duffin concurred with the NPF guidance that management decisions should be made on a “case-by-case basis.” Although the NPF guidance states that “most patients can restart psoriasis and/or psoriatic arthritis treatments after complete resolution of COVID-19 symptoms,” no specific advice was offered on the decision to stop treatments.

For protecting psoriasis patients from infection and managing COVID-19 in those who become infected, much of the NPF advice is consistent with that offered to patients without psoriasis. This involves practicing infection control that reduces risk of transmission. Both the NPF guidance and Dr. Duffin suggested telemedicine is appropriate for limiting in-patient visits under pandemic conditions.

Although patients with psoriasis are more likely than the general population to have the comorbidities associated with bad COVID-19 infection outcomes, according to the NPF guidance, Dr. Duffin called the overall data evaluating susceptibility among psoriasis patients “reassuring.” She cautioned that the data are still limited, but the evidence so far suggests that neither psoriasis nor biologics are independent risk factors for acquiring COVID-19 or having a worse outcome if infected.

Yet, more definitive data are needed, and Dr. Duffin advised clinicians and patients to consult the NPF website for updates. “More up-to-date information will certainly be added as we go forward,” she said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.

Dr. Joel Gelfand

This NPF task force on COVID-19 is meeting every 2 weeks, according to Joel M. Gelfand, MD, professor of dermatology, University of Pennsylvania, Philadelphia, and cochair of the task force. Dr. Gelfand reported that updates are based on a discussion of the available data.

“We will be releasing additional recommendations as necessary based on the developments,” he said in an interview. Updates are not necessarily required at this frequency but can be if appropriate. The goal is to keep recommendations current and evidence-based.

Dr. Duffin reported financial relationships with Amgen, AbbVie, Bristol-Myers Squibb, Boehringer-Ingelheim, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Siena, and UCB. Dr. Gelfand reported financial relationships with AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Lilly, Pfizer, Roche, and UCB.

This publication and Global Academy for Medical Education are owned by the same parent company.
 

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The available data suggest that the risks posed by COVID-19 infection to patients with psoriasis, including those on therapies that affect immune function, are modest at most, according to a summary of published studies and expert opinions summarized at the annual Coastal Dermatology Symposium, held virtually.

Dr. Kristina C. Duffin

For patients with psoriasis concerned about their outcome if infected with COVID-19, “there is no evidence to support stopping biologics or systemic agents, so I am asking my patients to continue,” Kristina C. Duffin, MD, professor and chair of dermatology at the University of Utah, Salt Lake City, said at the meeting.

The National Psoriasis Foundation, which created a COVID-19 task force and maintains a COVID-19 Resource Center on its website, has provided similar advice. Many statements are phrased cautiously and clinicians are encouraged to practice shared decision-making, but the NPF guidance supports continuing effective therapy – or, in newly diagnosed patients, starting effective therapy – among those who are not infected with SARS-CoV2.

Patients with a new diagnosis of psoriasis “should be aware that untreated psoriatic disease is associated with serious impact on physical and emotional health, and in the case of psoriatic arthritis, can lead to permanent joint damage and disability,” according to the NPF guidance.

Overall, the “existing data generally suggest” that most treatments for psoriasis and psoriatic arthritis “do not meaningfully alter the risks of contracting SARS-CoV2 or having a worse course of COVID-19 illness,” the current guidance states. Yet, because of limited data this “is not known with certainty.”

Chronic systemic steroids are an exception. In a review of recently published studies evaluating whether psoriasis or its therapies increase risk of adverse outcomes in patients with COVID-19 infection, Dr. Duffin pointed to several that associated systemic steroids with hospitalization or other markers of severe disease.

The NPF guidance also recommends avoiding chronic systemic steroids in patients with psoriasis during the current COVID-19 era “if possible.” In patients with psoriatic arthritis who require systemic steroids, the guidance recommends “the lowest dose necessary to achieve the desired therapeutic effect.”

This is not necessarily true in patients with psoriasis and COVID-19 infection. Based on the potential for systemic steroids to improve outcomes in hospitalized COVID-19 patients requiring oxygen, steroids “should not be withheld” even when the justification is concern about the potential risk of flares with withdrawal, according to the NPF guidance statement.



The NPF guidance specifically cautions against use of hydroxychloroquine or chloroquine for prevention or treatment of COVID-19. In addition to an uncertain benefit, these antimalarial drugs have been associated previously with flares of psoriasis.

Dr. Duffin agreed and went on to warn that COVID-19 infection itself is a potential trigger for flares. She cited two published case reports of flares associated with psoriasis. Although one patient had also been exposed to hydroxychloroquine, she said the risk of psoriasis-induced flare “makes sense” based on previous associations made between flares and other viral infections and stress.

In patients with psoriasis who contract COVID-19 infection, Dr. Duffin concurred with the NPF guidance that management decisions should be made on a “case-by-case basis.” Although the NPF guidance states that “most patients can restart psoriasis and/or psoriatic arthritis treatments after complete resolution of COVID-19 symptoms,” no specific advice was offered on the decision to stop treatments.

For protecting psoriasis patients from infection and managing COVID-19 in those who become infected, much of the NPF advice is consistent with that offered to patients without psoriasis. This involves practicing infection control that reduces risk of transmission. Both the NPF guidance and Dr. Duffin suggested telemedicine is appropriate for limiting in-patient visits under pandemic conditions.

Although patients with psoriasis are more likely than the general population to have the comorbidities associated with bad COVID-19 infection outcomes, according to the NPF guidance, Dr. Duffin called the overall data evaluating susceptibility among psoriasis patients “reassuring.” She cautioned that the data are still limited, but the evidence so far suggests that neither psoriasis nor biologics are independent risk factors for acquiring COVID-19 or having a worse outcome if infected.

Yet, more definitive data are needed, and Dr. Duffin advised clinicians and patients to consult the NPF website for updates. “More up-to-date information will certainly be added as we go forward,” she said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.

Dr. Joel Gelfand

This NPF task force on COVID-19 is meeting every 2 weeks, according to Joel M. Gelfand, MD, professor of dermatology, University of Pennsylvania, Philadelphia, and cochair of the task force. Dr. Gelfand reported that updates are based on a discussion of the available data.

“We will be releasing additional recommendations as necessary based on the developments,” he said in an interview. Updates are not necessarily required at this frequency but can be if appropriate. The goal is to keep recommendations current and evidence-based.

Dr. Duffin reported financial relationships with Amgen, AbbVie, Bristol-Myers Squibb, Boehringer-Ingelheim, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Siena, and UCB. Dr. Gelfand reported financial relationships with AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Lilly, Pfizer, Roche, and UCB.

This publication and Global Academy for Medical Education are owned by the same parent company.
 

The available data suggest that the risks posed by COVID-19 infection to patients with psoriasis, including those on therapies that affect immune function, are modest at most, according to a summary of published studies and expert opinions summarized at the annual Coastal Dermatology Symposium, held virtually.

Dr. Kristina C. Duffin

For patients with psoriasis concerned about their outcome if infected with COVID-19, “there is no evidence to support stopping biologics or systemic agents, so I am asking my patients to continue,” Kristina C. Duffin, MD, professor and chair of dermatology at the University of Utah, Salt Lake City, said at the meeting.

The National Psoriasis Foundation, which created a COVID-19 task force and maintains a COVID-19 Resource Center on its website, has provided similar advice. Many statements are phrased cautiously and clinicians are encouraged to practice shared decision-making, but the NPF guidance supports continuing effective therapy – or, in newly diagnosed patients, starting effective therapy – among those who are not infected with SARS-CoV2.

Patients with a new diagnosis of psoriasis “should be aware that untreated psoriatic disease is associated with serious impact on physical and emotional health, and in the case of psoriatic arthritis, can lead to permanent joint damage and disability,” according to the NPF guidance.

Overall, the “existing data generally suggest” that most treatments for psoriasis and psoriatic arthritis “do not meaningfully alter the risks of contracting SARS-CoV2 or having a worse course of COVID-19 illness,” the current guidance states. Yet, because of limited data this “is not known with certainty.”

Chronic systemic steroids are an exception. In a review of recently published studies evaluating whether psoriasis or its therapies increase risk of adverse outcomes in patients with COVID-19 infection, Dr. Duffin pointed to several that associated systemic steroids with hospitalization or other markers of severe disease.

The NPF guidance also recommends avoiding chronic systemic steroids in patients with psoriasis during the current COVID-19 era “if possible.” In patients with psoriatic arthritis who require systemic steroids, the guidance recommends “the lowest dose necessary to achieve the desired therapeutic effect.”

This is not necessarily true in patients with psoriasis and COVID-19 infection. Based on the potential for systemic steroids to improve outcomes in hospitalized COVID-19 patients requiring oxygen, steroids “should not be withheld” even when the justification is concern about the potential risk of flares with withdrawal, according to the NPF guidance statement.



The NPF guidance specifically cautions against use of hydroxychloroquine or chloroquine for prevention or treatment of COVID-19. In addition to an uncertain benefit, these antimalarial drugs have been associated previously with flares of psoriasis.

Dr. Duffin agreed and went on to warn that COVID-19 infection itself is a potential trigger for flares. She cited two published case reports of flares associated with psoriasis. Although one patient had also been exposed to hydroxychloroquine, she said the risk of psoriasis-induced flare “makes sense” based on previous associations made between flares and other viral infections and stress.

In patients with psoriasis who contract COVID-19 infection, Dr. Duffin concurred with the NPF guidance that management decisions should be made on a “case-by-case basis.” Although the NPF guidance states that “most patients can restart psoriasis and/or psoriatic arthritis treatments after complete resolution of COVID-19 symptoms,” no specific advice was offered on the decision to stop treatments.

For protecting psoriasis patients from infection and managing COVID-19 in those who become infected, much of the NPF advice is consistent with that offered to patients without psoriasis. This involves practicing infection control that reduces risk of transmission. Both the NPF guidance and Dr. Duffin suggested telemedicine is appropriate for limiting in-patient visits under pandemic conditions.

Although patients with psoriasis are more likely than the general population to have the comorbidities associated with bad COVID-19 infection outcomes, according to the NPF guidance, Dr. Duffin called the overall data evaluating susceptibility among psoriasis patients “reassuring.” She cautioned that the data are still limited, but the evidence so far suggests that neither psoriasis nor biologics are independent risk factors for acquiring COVID-19 or having a worse outcome if infected.

Yet, more definitive data are needed, and Dr. Duffin advised clinicians and patients to consult the NPF website for updates. “More up-to-date information will certainly be added as we go forward,” she said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.

Dr. Joel Gelfand

This NPF task force on COVID-19 is meeting every 2 weeks, according to Joel M. Gelfand, MD, professor of dermatology, University of Pennsylvania, Philadelphia, and cochair of the task force. Dr. Gelfand reported that updates are based on a discussion of the available data.

“We will be releasing additional recommendations as necessary based on the developments,” he said in an interview. Updates are not necessarily required at this frequency but can be if appropriate. The goal is to keep recommendations current and evidence-based.

Dr. Duffin reported financial relationships with Amgen, AbbVie, Bristol-Myers Squibb, Boehringer-Ingelheim, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Siena, and UCB. Dr. Gelfand reported financial relationships with AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Lilly, Pfizer, Roche, and UCB.

This publication and Global Academy for Medical Education are owned by the same parent company.
 

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CDC expands definition of COVID-19 exposure from ‘close contact’

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The Centers for Disease Control and Prevention updated its recommendations for likely person-to-person spread of SARS-CoV-2 to warn about the risk of multiple, brief, “close contact” encounters with others who are positive for COVID-19.

New data suggest each close encounter – coming within 6 feet of an infected person – can increase the risk for transmission, CDC director Robert Redfield, MD, said during a media briefing.

“As we get more data and understand the science of COVID, we’re going to continue to incorporate that in our recommendations,” Dr. Redfield said in response to a reporter’s question about a recent study.

Previously, the CDC cautioned against spending 15 minutes or longer in close proximity to an infected person, particularly in enclosed indoor spaces.

In a new report published online Oct. 21 in Morbidity and Mortality Weekly Report, however, investigators “determined that an individual who had a series of shorter contacts that over time added up to more than 15 minutes became infected.”
 

Beware of brief encounters?

On July 28, a 20-year-old male correctional officer in Vermont had multiple brief encounters with six transferred incarcerated or detained people while their SARS-CoV-2 test results were pending. The six were asymptomatic at the time and were housed in a quarantine unit, reported CDC researcher Julia Pringle, PhD, and colleagues.

The following day, all six inmates tested polymerase chain reaction (PCR) positive for COVID-19. The correctional officer did not spend 15 minutes or more within 6 feet of any of the inmates, according to video surveillance footage, and he continued to work.

On Aug. 4, however, he developed symptoms that included loss of smell and taste, myalgia, runny nose, cough, shortness of breath, headache, loss of appetite, and gastrointestinal symptoms. He stayed home starting the next day and tested PCR positive for COVID-19 on Aug. 11.

Further review of the surveillance video showed that the officer had numerous brief encounters of approximately 1 minute each that cumulatively exceeded 15 minutes over a 24-hour period, the researchers reported.

During all the interactions with inmates, the correctional officer wore a cloth mask, gown, and eye protection. The inmates wore masks while in their cells but did not have them on during brief cell doorway interactions or in the recreation room, according to the report.
 

No interaction is 100% safe

“We know that every activity that involves interacting with others has some degree of risk right now,” said Jay Butler, MD, CDC deputy director for infectious diseases.

“Unfortunately, we’re seeing a distressing trend here in the United States with COVID-19 cases increasing in nearly 75% of the country,” he said. “We’ve confirmed 8.1 million cases and, sadly, over 220,000 deaths since January.

“I know these are numbers, but these are also people,” Dr. Butler added.

“The pandemic is not over,” Dr. Redfield said. “Earlier this week, COVID virus cases reached over 40 million globally. Here in the United States we are approaching a critical phase.”

Four factors associated with higher risk for transmission are the proximity of each encounter, its duration, whether an interaction takes place indoors or outdoors, and the number of people encountered, Dr. Butler said.

Dr. Butler acknowledged widespread fatigue with adherence to personal protection measures, but added that social distancing, mask-wearing, and other measures are more important now than ever. He noted that more Americans will be spending time indoors with the onset of cooler weather and the upcoming holidays.
 

A note of optimism

Dr. Redfield remains optimistic about the limited availability of a vaccine or vaccines by year’s end but added that “it’s important for all of us to remain diligent in our efforts to defeat this virus.”

“There is hope on the way, in the form of safe and effective vaccines in a matter of weeks or months. To bridge to that next phase, we have to take steps to keep ourselves, our families, and our communities safe,” said Alex Azar, secretary of the Department of Health & Human Services.

“I know it’s been a difficult year for Americans, but we are going to come through this on the other side,” Dr. Redfield said.

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The Centers for Disease Control and Prevention updated its recommendations for likely person-to-person spread of SARS-CoV-2 to warn about the risk of multiple, brief, “close contact” encounters with others who are positive for COVID-19.

New data suggest each close encounter – coming within 6 feet of an infected person – can increase the risk for transmission, CDC director Robert Redfield, MD, said during a media briefing.

“As we get more data and understand the science of COVID, we’re going to continue to incorporate that in our recommendations,” Dr. Redfield said in response to a reporter’s question about a recent study.

Previously, the CDC cautioned against spending 15 minutes or longer in close proximity to an infected person, particularly in enclosed indoor spaces.

In a new report published online Oct. 21 in Morbidity and Mortality Weekly Report, however, investigators “determined that an individual who had a series of shorter contacts that over time added up to more than 15 minutes became infected.”
 

Beware of brief encounters?

On July 28, a 20-year-old male correctional officer in Vermont had multiple brief encounters with six transferred incarcerated or detained people while their SARS-CoV-2 test results were pending. The six were asymptomatic at the time and were housed in a quarantine unit, reported CDC researcher Julia Pringle, PhD, and colleagues.

The following day, all six inmates tested polymerase chain reaction (PCR) positive for COVID-19. The correctional officer did not spend 15 minutes or more within 6 feet of any of the inmates, according to video surveillance footage, and he continued to work.

On Aug. 4, however, he developed symptoms that included loss of smell and taste, myalgia, runny nose, cough, shortness of breath, headache, loss of appetite, and gastrointestinal symptoms. He stayed home starting the next day and tested PCR positive for COVID-19 on Aug. 11.

Further review of the surveillance video showed that the officer had numerous brief encounters of approximately 1 minute each that cumulatively exceeded 15 minutes over a 24-hour period, the researchers reported.

During all the interactions with inmates, the correctional officer wore a cloth mask, gown, and eye protection. The inmates wore masks while in their cells but did not have them on during brief cell doorway interactions or in the recreation room, according to the report.
 

No interaction is 100% safe

“We know that every activity that involves interacting with others has some degree of risk right now,” said Jay Butler, MD, CDC deputy director for infectious diseases.

“Unfortunately, we’re seeing a distressing trend here in the United States with COVID-19 cases increasing in nearly 75% of the country,” he said. “We’ve confirmed 8.1 million cases and, sadly, over 220,000 deaths since January.

“I know these are numbers, but these are also people,” Dr. Butler added.

“The pandemic is not over,” Dr. Redfield said. “Earlier this week, COVID virus cases reached over 40 million globally. Here in the United States we are approaching a critical phase.”

Four factors associated with higher risk for transmission are the proximity of each encounter, its duration, whether an interaction takes place indoors or outdoors, and the number of people encountered, Dr. Butler said.

Dr. Butler acknowledged widespread fatigue with adherence to personal protection measures, but added that social distancing, mask-wearing, and other measures are more important now than ever. He noted that more Americans will be spending time indoors with the onset of cooler weather and the upcoming holidays.
 

A note of optimism

Dr. Redfield remains optimistic about the limited availability of a vaccine or vaccines by year’s end but added that “it’s important for all of us to remain diligent in our efforts to defeat this virus.”

“There is hope on the way, in the form of safe and effective vaccines in a matter of weeks or months. To bridge to that next phase, we have to take steps to keep ourselves, our families, and our communities safe,” said Alex Azar, secretary of the Department of Health & Human Services.

“I know it’s been a difficult year for Americans, but we are going to come through this on the other side,” Dr. Redfield said.

The Centers for Disease Control and Prevention updated its recommendations for likely person-to-person spread of SARS-CoV-2 to warn about the risk of multiple, brief, “close contact” encounters with others who are positive for COVID-19.

New data suggest each close encounter – coming within 6 feet of an infected person – can increase the risk for transmission, CDC director Robert Redfield, MD, said during a media briefing.

“As we get more data and understand the science of COVID, we’re going to continue to incorporate that in our recommendations,” Dr. Redfield said in response to a reporter’s question about a recent study.

Previously, the CDC cautioned against spending 15 minutes or longer in close proximity to an infected person, particularly in enclosed indoor spaces.

In a new report published online Oct. 21 in Morbidity and Mortality Weekly Report, however, investigators “determined that an individual who had a series of shorter contacts that over time added up to more than 15 minutes became infected.”
 

Beware of brief encounters?

On July 28, a 20-year-old male correctional officer in Vermont had multiple brief encounters with six transferred incarcerated or detained people while their SARS-CoV-2 test results were pending. The six were asymptomatic at the time and were housed in a quarantine unit, reported CDC researcher Julia Pringle, PhD, and colleagues.

The following day, all six inmates tested polymerase chain reaction (PCR) positive for COVID-19. The correctional officer did not spend 15 minutes or more within 6 feet of any of the inmates, according to video surveillance footage, and he continued to work.

On Aug. 4, however, he developed symptoms that included loss of smell and taste, myalgia, runny nose, cough, shortness of breath, headache, loss of appetite, and gastrointestinal symptoms. He stayed home starting the next day and tested PCR positive for COVID-19 on Aug. 11.

Further review of the surveillance video showed that the officer had numerous brief encounters of approximately 1 minute each that cumulatively exceeded 15 minutes over a 24-hour period, the researchers reported.

During all the interactions with inmates, the correctional officer wore a cloth mask, gown, and eye protection. The inmates wore masks while in their cells but did not have them on during brief cell doorway interactions or in the recreation room, according to the report.
 

No interaction is 100% safe

“We know that every activity that involves interacting with others has some degree of risk right now,” said Jay Butler, MD, CDC deputy director for infectious diseases.

“Unfortunately, we’re seeing a distressing trend here in the United States with COVID-19 cases increasing in nearly 75% of the country,” he said. “We’ve confirmed 8.1 million cases and, sadly, over 220,000 deaths since January.

“I know these are numbers, but these are also people,” Dr. Butler added.

“The pandemic is not over,” Dr. Redfield said. “Earlier this week, COVID virus cases reached over 40 million globally. Here in the United States we are approaching a critical phase.”

Four factors associated with higher risk for transmission are the proximity of each encounter, its duration, whether an interaction takes place indoors or outdoors, and the number of people encountered, Dr. Butler said.

Dr. Butler acknowledged widespread fatigue with adherence to personal protection measures, but added that social distancing, mask-wearing, and other measures are more important now than ever. He noted that more Americans will be spending time indoors with the onset of cooler weather and the upcoming holidays.
 

A note of optimism

Dr. Redfield remains optimistic about the limited availability of a vaccine or vaccines by year’s end but added that “it’s important for all of us to remain diligent in our efforts to defeat this virus.”

“There is hope on the way, in the form of safe and effective vaccines in a matter of weeks or months. To bridge to that next phase, we have to take steps to keep ourselves, our families, and our communities safe,” said Alex Azar, secretary of the Department of Health & Human Services.

“I know it’s been a difficult year for Americans, but we are going to come through this on the other side,” Dr. Redfield said.

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FDA approves remdesivir, first treatment for COVID-19

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The U.S. Food and Drug Administration approved remdesivir (Veklury) Oct. 22 as a treatment for hospitalized COVID-19 patients aged 12 and up, making it the first and only approved treatment for COVID-19, according to a release from drug manufacturer Gilead Sciences.

The FDA’s initial Emergency Use Authorization (EUA) of the antiviral, issued in May, allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who needed oxygen therapy or mechanical ventilation.

An August EUA expanded treatment to include all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease. The FDA also issued a new EUA for remdesivir Oct. 22 allowing treatment of hospitalized pediatric patients younger than 12 weighing at least 3.5 kg.

Today’s approval is based on three randomized controlled trials, according to Gilead.

Final trial results from one of them, the National Institute of Allergy and Infectious Disease–funded ACTT-1 trial, published earlier in October, showed that hospitalized patients with COVID-19 who received remdesivir had a shorter median recovery time than those who received a placebo – 10 days versus 15 days.

This difference and some related secondary endpoints were statistically significant in the randomized trial, but there was not a statistically significant difference in mortality between the treatment and placebo groups.

The other two trials used for the approval, the SIMPLE trials, were open-label phase 3 trials conducted in countries with a high prevalence of COVID-19 infections, according to Gilead.

The SIMPLE-Severe trial was a randomized, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing plus standard of care in 397 hospitalized adult patients with severe COVID-19. The primary endpoint was clinical status on day 14 assessed on a 7-point ordinal scale, according to Gilead.

The trial found that a 5-day or a 10-day treatment course of Veklury achieved similar clinical outcomes to the ACTT-1 trial (odds ratio, 0.75; 95% confidence interval, 0.51-1.12).

The SIMPLE-Moderate trial was a randomized, controlled, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing durations of Veklury plus standard of care, compared with standard of care alone in 600 hospitalized adult patients with moderate COVID-19, Gilead stated in its release.

The primary endpoint was clinical status on day 11 assessed on a 7-point ordinal scale.

The results showed statistically improved clinical outcomes with a 5-day treatment course of Veklury, compared with standard of care (OR, 1.65; 95% CI, 1.0-2.48; P = .017), according to Gilead.

This article first appeared on Medscape.com.

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The U.S. Food and Drug Administration approved remdesivir (Veklury) Oct. 22 as a treatment for hospitalized COVID-19 patients aged 12 and up, making it the first and only approved treatment for COVID-19, according to a release from drug manufacturer Gilead Sciences.

The FDA’s initial Emergency Use Authorization (EUA) of the antiviral, issued in May, allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who needed oxygen therapy or mechanical ventilation.

An August EUA expanded treatment to include all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease. The FDA also issued a new EUA for remdesivir Oct. 22 allowing treatment of hospitalized pediatric patients younger than 12 weighing at least 3.5 kg.

Today’s approval is based on three randomized controlled trials, according to Gilead.

Final trial results from one of them, the National Institute of Allergy and Infectious Disease–funded ACTT-1 trial, published earlier in October, showed that hospitalized patients with COVID-19 who received remdesivir had a shorter median recovery time than those who received a placebo – 10 days versus 15 days.

This difference and some related secondary endpoints were statistically significant in the randomized trial, but there was not a statistically significant difference in mortality between the treatment and placebo groups.

The other two trials used for the approval, the SIMPLE trials, were open-label phase 3 trials conducted in countries with a high prevalence of COVID-19 infections, according to Gilead.

The SIMPLE-Severe trial was a randomized, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing plus standard of care in 397 hospitalized adult patients with severe COVID-19. The primary endpoint was clinical status on day 14 assessed on a 7-point ordinal scale, according to Gilead.

The trial found that a 5-day or a 10-day treatment course of Veklury achieved similar clinical outcomes to the ACTT-1 trial (odds ratio, 0.75; 95% confidence interval, 0.51-1.12).

The SIMPLE-Moderate trial was a randomized, controlled, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing durations of Veklury plus standard of care, compared with standard of care alone in 600 hospitalized adult patients with moderate COVID-19, Gilead stated in its release.

The primary endpoint was clinical status on day 11 assessed on a 7-point ordinal scale.

The results showed statistically improved clinical outcomes with a 5-day treatment course of Veklury, compared with standard of care (OR, 1.65; 95% CI, 1.0-2.48; P = .017), according to Gilead.

This article first appeared on Medscape.com.

 

The U.S. Food and Drug Administration approved remdesivir (Veklury) Oct. 22 as a treatment for hospitalized COVID-19 patients aged 12 and up, making it the first and only approved treatment for COVID-19, according to a release from drug manufacturer Gilead Sciences.

The FDA’s initial Emergency Use Authorization (EUA) of the antiviral, issued in May, allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who needed oxygen therapy or mechanical ventilation.

An August EUA expanded treatment to include all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease. The FDA also issued a new EUA for remdesivir Oct. 22 allowing treatment of hospitalized pediatric patients younger than 12 weighing at least 3.5 kg.

Today’s approval is based on three randomized controlled trials, according to Gilead.

Final trial results from one of them, the National Institute of Allergy and Infectious Disease–funded ACTT-1 trial, published earlier in October, showed that hospitalized patients with COVID-19 who received remdesivir had a shorter median recovery time than those who received a placebo – 10 days versus 15 days.

This difference and some related secondary endpoints were statistically significant in the randomized trial, but there was not a statistically significant difference in mortality between the treatment and placebo groups.

The other two trials used for the approval, the SIMPLE trials, were open-label phase 3 trials conducted in countries with a high prevalence of COVID-19 infections, according to Gilead.

The SIMPLE-Severe trial was a randomized, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing plus standard of care in 397 hospitalized adult patients with severe COVID-19. The primary endpoint was clinical status on day 14 assessed on a 7-point ordinal scale, according to Gilead.

The trial found that a 5-day or a 10-day treatment course of Veklury achieved similar clinical outcomes to the ACTT-1 trial (odds ratio, 0.75; 95% confidence interval, 0.51-1.12).

The SIMPLE-Moderate trial was a randomized, controlled, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing durations of Veklury plus standard of care, compared with standard of care alone in 600 hospitalized adult patients with moderate COVID-19, Gilead stated in its release.

The primary endpoint was clinical status on day 11 assessed on a 7-point ordinal scale.

The results showed statistically improved clinical outcomes with a 5-day treatment course of Veklury, compared with standard of care (OR, 1.65; 95% CI, 1.0-2.48; P = .017), according to Gilead.

This article first appeared on Medscape.com.

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Rinse and repeat? Mouthwash might mitigate COVID-19 spread

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Multiple mouthwash and oral rinse products wiped out a human coronavirus closely related to the SARS-CoV-2 virus in a laboratory comparison study.

Listerine Antiseptic led the list of most effective mouthwashes for inactivating the coronavirus. Interestingly, a 1% nasal rinse solution of Johnson’s Baby Shampoo also worked, eliminating up to 99.9% of the viral load in the in vitro experiments.

In contrast, use of a neti pot nasal solution yielded no decrease in virus levels.

The study was published in the Journal of Medical Virology.

Because the mouthwash and hydrogen peroxide oral rinses in the study are widely available and easy to use, “I would recommend the use of the rinses on top of wearing mask and social distancing. This could add a layer of protection for yourself and others,” lead study author Craig Meyers, PhD, professor of microbiology and immunology and obstetrics and gynecology, Penn State College of Medicine in Hershey, Pennsylvania, told Medscape Medical News.

Meyers and colleagues found that efficacy aligned with duration of time the cell cultures were exposed to each mouthwash or rinse product. Although it varied, the products required at least 30 seconds to kill most of the virus. Waiting 1 or 2 minutes tended to fortify results.

“This study adds to and further confirms the recently published evidence from virologists in Germany that mouthwashes can inactivate the virus that causes COVID-19 in a test tube,” Valerie O’Donnell, PhD, co-director of the Systems Immunity Research Institute of Cardiff University, Cardiff, Wales, said when asked to comment on the study.

“While this is great to see, what is still lacking is in vivo evidence, since we know the virus will be continually shed in the mouth,” O’Donnell said. “So, the question now becomes, by how much could mouthwashes reduce viral load in the oropharynx of infected people, and if so, then for how long?”

Meyers noted that studies of people positive for COVID-19 using each product would be informative. It remains unknown, for example, if swishing, gargling, and/or spitting out mouthwash would add or decrease the efficacy demonstrated in the lab.

The investigators used the human coronavirus HCoV‐229e as a surrogate for SARS-CoV-2. They noted HCoV-229e is analogous, and SARS-CoV-2 would have been more expensive, less available, and would have required biosafety level 3 laboratory conditions.
 

Listerine Antiseptic leads the way

“Surprisingly, we found that several of these common products had strong virucidal properties, inactivating from 2 log10 [or 99%] to greater than 4 log10 [or 99.99%] of infectious human coronavirus,” the researchers note.



The researchers added a small amount of organic material (extra protein) to each product to more closely mimic physiologic conditions in the nasopharynx.

Listerine Antiseptic “historically has claimed numerous antimicrobial properties,” the researchers note. Although the label currently only claims to kill germs that cause bad breath, “our tests show that it is highly effective at inactivating human coronavirus in solution. Even at the lowest contact time of 30 seconds, it inactivated greater than 99.99% of human coronavirus.”

Interestingly, the mouthwashes that contained the same active ingredients as Listerine Antiseptic — Listerine Ultra, Equate Antiseptic, and CVS Antiseptic Mouth Wash — were less efficacious. Meyers said the reason remains unclear, but he and colleagues found the same result when they repeated the comparisons.
 

Timing of the essence?

Meyers and colleagues also tested a nasal rinse solution of 1% baby shampoo because it is sometimes used to treat people with chronic rhinosinusitis. They found 30 seconds led to < 90% to < 99.99% effectiveness, but that, by 2 minutes, efficacy climbed to > 99.9% to > 99.99%.

“Thirty seconds for some products just was not enough time for the efficacy to be observed,” Meyers said. “Whereas, after a minute or two the active ingredient had enough time to work. Thirty seconds may be at the border to see full efficacy.” More research is needed to confirm the timing and determine which active ingredients are driving the findings.

A future trial could test the efficacy of mouthwash products to reduce the viral load in people with COVID-19. “If we are able to get funding to continue, I would like to see a small clinical trial as the next step,” Meyers said.

Meyers and O’Donnell disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

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Multiple mouthwash and oral rinse products wiped out a human coronavirus closely related to the SARS-CoV-2 virus in a laboratory comparison study.

Listerine Antiseptic led the list of most effective mouthwashes for inactivating the coronavirus. Interestingly, a 1% nasal rinse solution of Johnson’s Baby Shampoo also worked, eliminating up to 99.9% of the viral load in the in vitro experiments.

In contrast, use of a neti pot nasal solution yielded no decrease in virus levels.

The study was published in the Journal of Medical Virology.

Because the mouthwash and hydrogen peroxide oral rinses in the study are widely available and easy to use, “I would recommend the use of the rinses on top of wearing mask and social distancing. This could add a layer of protection for yourself and others,” lead study author Craig Meyers, PhD, professor of microbiology and immunology and obstetrics and gynecology, Penn State College of Medicine in Hershey, Pennsylvania, told Medscape Medical News.

Meyers and colleagues found that efficacy aligned with duration of time the cell cultures were exposed to each mouthwash or rinse product. Although it varied, the products required at least 30 seconds to kill most of the virus. Waiting 1 or 2 minutes tended to fortify results.

“This study adds to and further confirms the recently published evidence from virologists in Germany that mouthwashes can inactivate the virus that causes COVID-19 in a test tube,” Valerie O’Donnell, PhD, co-director of the Systems Immunity Research Institute of Cardiff University, Cardiff, Wales, said when asked to comment on the study.

“While this is great to see, what is still lacking is in vivo evidence, since we know the virus will be continually shed in the mouth,” O’Donnell said. “So, the question now becomes, by how much could mouthwashes reduce viral load in the oropharynx of infected people, and if so, then for how long?”

Meyers noted that studies of people positive for COVID-19 using each product would be informative. It remains unknown, for example, if swishing, gargling, and/or spitting out mouthwash would add or decrease the efficacy demonstrated in the lab.

The investigators used the human coronavirus HCoV‐229e as a surrogate for SARS-CoV-2. They noted HCoV-229e is analogous, and SARS-CoV-2 would have been more expensive, less available, and would have required biosafety level 3 laboratory conditions.
 

Listerine Antiseptic leads the way

“Surprisingly, we found that several of these common products had strong virucidal properties, inactivating from 2 log10 [or 99%] to greater than 4 log10 [or 99.99%] of infectious human coronavirus,” the researchers note.



The researchers added a small amount of organic material (extra protein) to each product to more closely mimic physiologic conditions in the nasopharynx.

Listerine Antiseptic “historically has claimed numerous antimicrobial properties,” the researchers note. Although the label currently only claims to kill germs that cause bad breath, “our tests show that it is highly effective at inactivating human coronavirus in solution. Even at the lowest contact time of 30 seconds, it inactivated greater than 99.99% of human coronavirus.”

Interestingly, the mouthwashes that contained the same active ingredients as Listerine Antiseptic — Listerine Ultra, Equate Antiseptic, and CVS Antiseptic Mouth Wash — were less efficacious. Meyers said the reason remains unclear, but he and colleagues found the same result when they repeated the comparisons.
 

Timing of the essence?

Meyers and colleagues also tested a nasal rinse solution of 1% baby shampoo because it is sometimes used to treat people with chronic rhinosinusitis. They found 30 seconds led to < 90% to < 99.99% effectiveness, but that, by 2 minutes, efficacy climbed to > 99.9% to > 99.99%.

“Thirty seconds for some products just was not enough time for the efficacy to be observed,” Meyers said. “Whereas, after a minute or two the active ingredient had enough time to work. Thirty seconds may be at the border to see full efficacy.” More research is needed to confirm the timing and determine which active ingredients are driving the findings.

A future trial could test the efficacy of mouthwash products to reduce the viral load in people with COVID-19. “If we are able to get funding to continue, I would like to see a small clinical trial as the next step,” Meyers said.

Meyers and O’Donnell disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Multiple mouthwash and oral rinse products wiped out a human coronavirus closely related to the SARS-CoV-2 virus in a laboratory comparison study.

Listerine Antiseptic led the list of most effective mouthwashes for inactivating the coronavirus. Interestingly, a 1% nasal rinse solution of Johnson’s Baby Shampoo also worked, eliminating up to 99.9% of the viral load in the in vitro experiments.

In contrast, use of a neti pot nasal solution yielded no decrease in virus levels.

The study was published in the Journal of Medical Virology.

Because the mouthwash and hydrogen peroxide oral rinses in the study are widely available and easy to use, “I would recommend the use of the rinses on top of wearing mask and social distancing. This could add a layer of protection for yourself and others,” lead study author Craig Meyers, PhD, professor of microbiology and immunology and obstetrics and gynecology, Penn State College of Medicine in Hershey, Pennsylvania, told Medscape Medical News.

Meyers and colleagues found that efficacy aligned with duration of time the cell cultures were exposed to each mouthwash or rinse product. Although it varied, the products required at least 30 seconds to kill most of the virus. Waiting 1 or 2 minutes tended to fortify results.

“This study adds to and further confirms the recently published evidence from virologists in Germany that mouthwashes can inactivate the virus that causes COVID-19 in a test tube,” Valerie O’Donnell, PhD, co-director of the Systems Immunity Research Institute of Cardiff University, Cardiff, Wales, said when asked to comment on the study.

“While this is great to see, what is still lacking is in vivo evidence, since we know the virus will be continually shed in the mouth,” O’Donnell said. “So, the question now becomes, by how much could mouthwashes reduce viral load in the oropharynx of infected people, and if so, then for how long?”

Meyers noted that studies of people positive for COVID-19 using each product would be informative. It remains unknown, for example, if swishing, gargling, and/or spitting out mouthwash would add or decrease the efficacy demonstrated in the lab.

The investigators used the human coronavirus HCoV‐229e as a surrogate for SARS-CoV-2. They noted HCoV-229e is analogous, and SARS-CoV-2 would have been more expensive, less available, and would have required biosafety level 3 laboratory conditions.
 

Listerine Antiseptic leads the way

“Surprisingly, we found that several of these common products had strong virucidal properties, inactivating from 2 log10 [or 99%] to greater than 4 log10 [or 99.99%] of infectious human coronavirus,” the researchers note.



The researchers added a small amount of organic material (extra protein) to each product to more closely mimic physiologic conditions in the nasopharynx.

Listerine Antiseptic “historically has claimed numerous antimicrobial properties,” the researchers note. Although the label currently only claims to kill germs that cause bad breath, “our tests show that it is highly effective at inactivating human coronavirus in solution. Even at the lowest contact time of 30 seconds, it inactivated greater than 99.99% of human coronavirus.”

Interestingly, the mouthwashes that contained the same active ingredients as Listerine Antiseptic — Listerine Ultra, Equate Antiseptic, and CVS Antiseptic Mouth Wash — were less efficacious. Meyers said the reason remains unclear, but he and colleagues found the same result when they repeated the comparisons.
 

Timing of the essence?

Meyers and colleagues also tested a nasal rinse solution of 1% baby shampoo because it is sometimes used to treat people with chronic rhinosinusitis. They found 30 seconds led to < 90% to < 99.99% effectiveness, but that, by 2 minutes, efficacy climbed to > 99.9% to > 99.99%.

“Thirty seconds for some products just was not enough time for the efficacy to be observed,” Meyers said. “Whereas, after a minute or two the active ingredient had enough time to work. Thirty seconds may be at the border to see full efficacy.” More research is needed to confirm the timing and determine which active ingredients are driving the findings.

A future trial could test the efficacy of mouthwash products to reduce the viral load in people with COVID-19. “If we are able to get funding to continue, I would like to see a small clinical trial as the next step,” Meyers said.

Meyers and O’Donnell disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

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Is ‘Med Ed’ changing for better or worse?

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Wed, 07/12/2023 - 12:37

 

Although medical education is constantly evolving, unique and rapid developments in recent years have sparked controversy. The next generation of physicians is learning much differently from how established doctors once did. Training has shifted from an acute focus on disease to a wider approach that considers patients within the larger context of their community and society. Although many, like myself, see this as progress, others have expressed doubts about this and many other changes.

Amid the madness that is the year 2020, I’m grateful to have a moment to reflect on this subject. Five years ago, in celebration of Medscape’s 20th anniversary, I spoke with various leaders in medical education to learn how med ed had evolved since they were in school. Since then, I’ve gone from student to faculty. This year, for Medscape’s 25th anniversary, I reached out to current medical trainees to reflect on how much things have changed in such a short time.

From adjustments forced on us by COVID-19 to trends that predated the pandemic – including an increased emphasis on social justice and a decreased emphasis on other material – becoming a doctor no longer looks like it did just a half-decade ago.
 

Social justice is now in the curricula

More than ever, medical training has shifted toward humanism, population health, and social justice. Students are now being shown not only how to treat the patient in front of them but how to “treat” the larger communities they serve. Research skills around social drivers of health, such as structural racism, are increasingly becoming status quo.

In reflecting on her current experience, Emily Kahoud, a third-year medical student at New Jersey Medical School, Newark, told me about a course she took that was devoted to health equity. She applauded how her professors have incorporated this education into their courses. “It’s so nice and refreshing to be in a community that appreciates that.”

I, too, have seen this change firsthand. In addition to caring for patients and teaching at the University of North Carolina at Chapel Hill, I work with a team that develops curricula around social justice. We strive to integrate this material into existing courses and rotations. I believe that this is not only the right thing to teach trainees in order to help their future patients, but that it also reduces harm that many students experience. The “hidden curriculum” of medical school has long marginalized anyone who isn’t White and/or male.

Children, women, and the elderly were often referred to as “special populations” during my training. Even now, content about social and structural drivers of health is still most often relegated to separate courses rather than integrated into existing material. I hope to help improve this at my institution and that others are doing the same elsewhere.

If the current students I spoke with are any indication, further integration will be a welcomed change. Travis Benson, a third-year medical student at Harvard Medical School, Boston, appreciates where medical training is headed. Specifically, he is interested in inequities in the care of transgender patients. He says he has loved what his school has done with education on issues not previously considered part of med ed. “In the first week of school, we go on tours and spend time in community health centers and learn about the ‘Family Van,’ a mobile health care clinic that offers free care. I even had an opportunity to have a longitudinal clinic experience at a jail.”

While some critics argue that this learning goes too far, others argue that it has not gone far enough fast enough. In general, I consider the progress made in this area since my time in med school to be a very good thing. Medical students are now being taught to think about the science of medicine in the context of the larger human condition.
 

 

 

More technology, less preclinical time and cost

Beyond evolution in curricular content, technical and logistical changes have dramatically reshaped med ed. Since I started my training in 2012, most medical schools now no longer formally require students to attend lectures. Instead, they make them available online for students to view on demand. This undoubtedly makes schedules more flexible, allows students to learn at their own pace, and helps accommodate students with different needs.

Another big change: Preclinical years may now be as short as 1.5 years or less. This is a big draw for some students. Most choose to go to medical school to take care of patients. Shortening the preclinical years means students have more time immersed in patient care and less time dealing with medical minutiae.

That also means that they can spend more time thinking about professional development. Ramie Fathy, a fourth-year student, told me, “I came to Penn [University of Pennsylvania in Philadelphia] because of the shortened preclinical curriculum. That allowed more time on the back end to explore different specialties.” Although some established doctors worry about what scientific details may be left out, providing more hands-on experience sure seems like a good thing to me. Learning from textbooks can only take you so far in this profession.

Another, and more expected, development is the use of ever-advancing technology. Some schools now offer 3D virtual modeling for the study of anatomy, as well as a myriad of electronic visual aids for subjects like pathology and microbiology. Adapting to technological changes can be challenging, however, especially because more nontraditional students are being admitted to medical school each year.

Kahoud is one such nontraditional – older – student. She had some concerns about reliance on newer resources going in. “It [medical school] has become increasingly dependent on technology, even before COVID,” she said. “When you are not well versed in these tools it can definitely be a struggle.”

Thanks to the pandemic, remote learning is now the name of the game for many. As a result, instructors have had to amend their teaching styles to suit distance education, various untested applications and programs have been integrated into the curriculum, and students and administrators alike have had to find alternative ways to build a sense of community.

Is this a glimpse at the future for med ed? And if so, what may be lost or gained from this transition? Tino Delamerced, a third-year student at the Brown University, Providence, R.I., shared a likely very widely held hope: “If the preclinical years can be totally remote permanently, then can tuition be cheaper?”

Med ed debt keeps growing and remains a huge deterrent for potential students, especially those who are the first in their family to pursue medicine, come from a disadvantaged background, or have other people for whom they are financially responsible. Is it possible that the restrictions of COVID-19 could finally lead to cost cutting?

A bigger solution – free medical school – predated the pandemic. Institutions such as New York University have completely eliminated tuition, whereas others such as the Icahn School of Medicine at Mount Sinai (my alma mater) have limited the amount of debt with which a student graduates. You can imagine my frustration that the debt limit policy was enacted after I graduated.

Still, as optimistic as some have been at this movement that developed in the past 5 years, many think this specific evolution is little more than a “pipe dream.”
 

 

 

Current students score big with USMLE change

Beyond med school cost, another universally despised part of medical training that has seen a dramatic change is the licensing examination. My dedicated study period for the United States Medical Licensing Examination (USMLE) Step 1 was my worst time of medical school. Well, it was second to holding a retractor in the operating room for hours at a time.

Like everyone, I suspected that Step 1 would not be an accurate indicator of my ability to actually care for patients. As a practicing physician, I can now tell you for sure that this is the case. How lucky for the next generation, then, that the test is going to a pass/fail grading system.

Step 1 has always been important, as residency programs rely on the score to weed out applicants. Even if that screening emphasis simply gets shifted to scores on other examinations, this change still feels like progress. As Fathy told me, “There will likely be more emphasis on USMLE Step 2. But I think, based on practice questions I’ve done, that is more relevant to clinical abilities.” From my new vantage point, I can confirm that.

Not everyone is excited, though. Delamerced told me that he fears that the pass/fail Step 1 score may disparately affect students outside of allopathic medical schools. He said that the new scoring system “does not allow students to distinguish themselves via a standardized test score. That may hurt IMGs or DO students.”

Even then, Delamerced conceded that the change has some clear benefits. “For med students’ mental health, it’s probably a good thing.” From a population-based perspective, a medical student’s mental health often declines throughout school. Standardized exams are not the only cause, but we all know that it is a big contributor. The Step 1 switch can only help with that.
 

Finish faster or learn more?

In addition to evolution in the content and methods used to teach and assess current med students, the duration of med ed has also changed. Today’s students can choose to complete medical school in less than 4 years.

At the school where I work, the Fully Integrated Readiness for Service Training (FIRST) program allows certain students to complete their education in just 3 years. This program is for students who already know early on that they want to pursue a specialty included on our curated list. The goal of the program is to ultimately train physicians in family medicine, psychiatry, pediatrics, or general surgery in order to provide crucial care to those who need it most in our state.

Other medical schools offer accelerated MD programs for students based on various admissions criteria and specialty interest. The benefit of these programs is that shortening training time cuts down on debt for students.

Accelerated MD programs also aim to quickly increase the number of practicing physicians. This is especially important for primary care, which expects to see a growing gap in the years to come. That aim has come under some criticism, as some believe that the 4-year program was the standard for a reason. But when I reflect on it, I often wonder whether my fourth year was really worth $60,000. I spent a lot of that year traveling for residency interviews and watching Netflix between clinic electives.

Instead of finishing medical school faster, some students now have an opportunity to integrate additional training and education. Benson told me that, at Harvard, many students take a year off to pursue other opportunities. He said, “About 40% of students end up taking a fifth year to do either a master’s degree, global health, or research.” Benson said the additional learning opportunities are broad. “Some classmates even go to other schools altogether to get additional education.” Widened areas of learning are likely to produce better doctors, in my opinion.

This chance to look back on medical education has shown me that the ways in which it has changed rapidly in just the past few years are largely positive. Although COVID-19 has been an unwanted bane, it has also forced schools to integrate new technology and has placed an even brighter spotlight on health inequities and other areas in which education further improved. I hope that, when I look back on med ed in another 5 years, it has grown even more flexible and nimble in meeting the ever-changing needs of students and patients alike.

Alexa Mieses Malchuk, MD, MPH, was born and raised in Queens, New York. Social justice is what drew her to family medicine. As an academic physician at the University of North Carolina, she practices inpatient and outpatient medicine and serves as a medical educator for students and residents.
 

This article first appeared on Medscape.com.

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Although medical education is constantly evolving, unique and rapid developments in recent years have sparked controversy. The next generation of physicians is learning much differently from how established doctors once did. Training has shifted from an acute focus on disease to a wider approach that considers patients within the larger context of their community and society. Although many, like myself, see this as progress, others have expressed doubts about this and many other changes.

Amid the madness that is the year 2020, I’m grateful to have a moment to reflect on this subject. Five years ago, in celebration of Medscape’s 20th anniversary, I spoke with various leaders in medical education to learn how med ed had evolved since they were in school. Since then, I’ve gone from student to faculty. This year, for Medscape’s 25th anniversary, I reached out to current medical trainees to reflect on how much things have changed in such a short time.

From adjustments forced on us by COVID-19 to trends that predated the pandemic – including an increased emphasis on social justice and a decreased emphasis on other material – becoming a doctor no longer looks like it did just a half-decade ago.
 

Social justice is now in the curricula

More than ever, medical training has shifted toward humanism, population health, and social justice. Students are now being shown not only how to treat the patient in front of them but how to “treat” the larger communities they serve. Research skills around social drivers of health, such as structural racism, are increasingly becoming status quo.

In reflecting on her current experience, Emily Kahoud, a third-year medical student at New Jersey Medical School, Newark, told me about a course she took that was devoted to health equity. She applauded how her professors have incorporated this education into their courses. “It’s so nice and refreshing to be in a community that appreciates that.”

I, too, have seen this change firsthand. In addition to caring for patients and teaching at the University of North Carolina at Chapel Hill, I work with a team that develops curricula around social justice. We strive to integrate this material into existing courses and rotations. I believe that this is not only the right thing to teach trainees in order to help their future patients, but that it also reduces harm that many students experience. The “hidden curriculum” of medical school has long marginalized anyone who isn’t White and/or male.

Children, women, and the elderly were often referred to as “special populations” during my training. Even now, content about social and structural drivers of health is still most often relegated to separate courses rather than integrated into existing material. I hope to help improve this at my institution and that others are doing the same elsewhere.

If the current students I spoke with are any indication, further integration will be a welcomed change. Travis Benson, a third-year medical student at Harvard Medical School, Boston, appreciates where medical training is headed. Specifically, he is interested in inequities in the care of transgender patients. He says he has loved what his school has done with education on issues not previously considered part of med ed. “In the first week of school, we go on tours and spend time in community health centers and learn about the ‘Family Van,’ a mobile health care clinic that offers free care. I even had an opportunity to have a longitudinal clinic experience at a jail.”

While some critics argue that this learning goes too far, others argue that it has not gone far enough fast enough. In general, I consider the progress made in this area since my time in med school to be a very good thing. Medical students are now being taught to think about the science of medicine in the context of the larger human condition.
 

 

 

More technology, less preclinical time and cost

Beyond evolution in curricular content, technical and logistical changes have dramatically reshaped med ed. Since I started my training in 2012, most medical schools now no longer formally require students to attend lectures. Instead, they make them available online for students to view on demand. This undoubtedly makes schedules more flexible, allows students to learn at their own pace, and helps accommodate students with different needs.

Another big change: Preclinical years may now be as short as 1.5 years or less. This is a big draw for some students. Most choose to go to medical school to take care of patients. Shortening the preclinical years means students have more time immersed in patient care and less time dealing with medical minutiae.

That also means that they can spend more time thinking about professional development. Ramie Fathy, a fourth-year student, told me, “I came to Penn [University of Pennsylvania in Philadelphia] because of the shortened preclinical curriculum. That allowed more time on the back end to explore different specialties.” Although some established doctors worry about what scientific details may be left out, providing more hands-on experience sure seems like a good thing to me. Learning from textbooks can only take you so far in this profession.

Another, and more expected, development is the use of ever-advancing technology. Some schools now offer 3D virtual modeling for the study of anatomy, as well as a myriad of electronic visual aids for subjects like pathology and microbiology. Adapting to technological changes can be challenging, however, especially because more nontraditional students are being admitted to medical school each year.

Kahoud is one such nontraditional – older – student. She had some concerns about reliance on newer resources going in. “It [medical school] has become increasingly dependent on technology, even before COVID,” she said. “When you are not well versed in these tools it can definitely be a struggle.”

Thanks to the pandemic, remote learning is now the name of the game for many. As a result, instructors have had to amend their teaching styles to suit distance education, various untested applications and programs have been integrated into the curriculum, and students and administrators alike have had to find alternative ways to build a sense of community.

Is this a glimpse at the future for med ed? And if so, what may be lost or gained from this transition? Tino Delamerced, a third-year student at the Brown University, Providence, R.I., shared a likely very widely held hope: “If the preclinical years can be totally remote permanently, then can tuition be cheaper?”

Med ed debt keeps growing and remains a huge deterrent for potential students, especially those who are the first in their family to pursue medicine, come from a disadvantaged background, or have other people for whom they are financially responsible. Is it possible that the restrictions of COVID-19 could finally lead to cost cutting?

A bigger solution – free medical school – predated the pandemic. Institutions such as New York University have completely eliminated tuition, whereas others such as the Icahn School of Medicine at Mount Sinai (my alma mater) have limited the amount of debt with which a student graduates. You can imagine my frustration that the debt limit policy was enacted after I graduated.

Still, as optimistic as some have been at this movement that developed in the past 5 years, many think this specific evolution is little more than a “pipe dream.”
 

 

 

Current students score big with USMLE change

Beyond med school cost, another universally despised part of medical training that has seen a dramatic change is the licensing examination. My dedicated study period for the United States Medical Licensing Examination (USMLE) Step 1 was my worst time of medical school. Well, it was second to holding a retractor in the operating room for hours at a time.

Like everyone, I suspected that Step 1 would not be an accurate indicator of my ability to actually care for patients. As a practicing physician, I can now tell you for sure that this is the case. How lucky for the next generation, then, that the test is going to a pass/fail grading system.

Step 1 has always been important, as residency programs rely on the score to weed out applicants. Even if that screening emphasis simply gets shifted to scores on other examinations, this change still feels like progress. As Fathy told me, “There will likely be more emphasis on USMLE Step 2. But I think, based on practice questions I’ve done, that is more relevant to clinical abilities.” From my new vantage point, I can confirm that.

Not everyone is excited, though. Delamerced told me that he fears that the pass/fail Step 1 score may disparately affect students outside of allopathic medical schools. He said that the new scoring system “does not allow students to distinguish themselves via a standardized test score. That may hurt IMGs or DO students.”

Even then, Delamerced conceded that the change has some clear benefits. “For med students’ mental health, it’s probably a good thing.” From a population-based perspective, a medical student’s mental health often declines throughout school. Standardized exams are not the only cause, but we all know that it is a big contributor. The Step 1 switch can only help with that.
 

Finish faster or learn more?

In addition to evolution in the content and methods used to teach and assess current med students, the duration of med ed has also changed. Today’s students can choose to complete medical school in less than 4 years.

At the school where I work, the Fully Integrated Readiness for Service Training (FIRST) program allows certain students to complete their education in just 3 years. This program is for students who already know early on that they want to pursue a specialty included on our curated list. The goal of the program is to ultimately train physicians in family medicine, psychiatry, pediatrics, or general surgery in order to provide crucial care to those who need it most in our state.

Other medical schools offer accelerated MD programs for students based on various admissions criteria and specialty interest. The benefit of these programs is that shortening training time cuts down on debt for students.

Accelerated MD programs also aim to quickly increase the number of practicing physicians. This is especially important for primary care, which expects to see a growing gap in the years to come. That aim has come under some criticism, as some believe that the 4-year program was the standard for a reason. But when I reflect on it, I often wonder whether my fourth year was really worth $60,000. I spent a lot of that year traveling for residency interviews and watching Netflix between clinic electives.

Instead of finishing medical school faster, some students now have an opportunity to integrate additional training and education. Benson told me that, at Harvard, many students take a year off to pursue other opportunities. He said, “About 40% of students end up taking a fifth year to do either a master’s degree, global health, or research.” Benson said the additional learning opportunities are broad. “Some classmates even go to other schools altogether to get additional education.” Widened areas of learning are likely to produce better doctors, in my opinion.

This chance to look back on medical education has shown me that the ways in which it has changed rapidly in just the past few years are largely positive. Although COVID-19 has been an unwanted bane, it has also forced schools to integrate new technology and has placed an even brighter spotlight on health inequities and other areas in which education further improved. I hope that, when I look back on med ed in another 5 years, it has grown even more flexible and nimble in meeting the ever-changing needs of students and patients alike.

Alexa Mieses Malchuk, MD, MPH, was born and raised in Queens, New York. Social justice is what drew her to family medicine. As an academic physician at the University of North Carolina, she practices inpatient and outpatient medicine and serves as a medical educator for students and residents.
 

This article first appeared on Medscape.com.

 

Although medical education is constantly evolving, unique and rapid developments in recent years have sparked controversy. The next generation of physicians is learning much differently from how established doctors once did. Training has shifted from an acute focus on disease to a wider approach that considers patients within the larger context of their community and society. Although many, like myself, see this as progress, others have expressed doubts about this and many other changes.

Amid the madness that is the year 2020, I’m grateful to have a moment to reflect on this subject. Five years ago, in celebration of Medscape’s 20th anniversary, I spoke with various leaders in medical education to learn how med ed had evolved since they were in school. Since then, I’ve gone from student to faculty. This year, for Medscape’s 25th anniversary, I reached out to current medical trainees to reflect on how much things have changed in such a short time.

From adjustments forced on us by COVID-19 to trends that predated the pandemic – including an increased emphasis on social justice and a decreased emphasis on other material – becoming a doctor no longer looks like it did just a half-decade ago.
 

Social justice is now in the curricula

More than ever, medical training has shifted toward humanism, population health, and social justice. Students are now being shown not only how to treat the patient in front of them but how to “treat” the larger communities they serve. Research skills around social drivers of health, such as structural racism, are increasingly becoming status quo.

In reflecting on her current experience, Emily Kahoud, a third-year medical student at New Jersey Medical School, Newark, told me about a course she took that was devoted to health equity. She applauded how her professors have incorporated this education into their courses. “It’s so nice and refreshing to be in a community that appreciates that.”

I, too, have seen this change firsthand. In addition to caring for patients and teaching at the University of North Carolina at Chapel Hill, I work with a team that develops curricula around social justice. We strive to integrate this material into existing courses and rotations. I believe that this is not only the right thing to teach trainees in order to help their future patients, but that it also reduces harm that many students experience. The “hidden curriculum” of medical school has long marginalized anyone who isn’t White and/or male.

Children, women, and the elderly were often referred to as “special populations” during my training. Even now, content about social and structural drivers of health is still most often relegated to separate courses rather than integrated into existing material. I hope to help improve this at my institution and that others are doing the same elsewhere.

If the current students I spoke with are any indication, further integration will be a welcomed change. Travis Benson, a third-year medical student at Harvard Medical School, Boston, appreciates where medical training is headed. Specifically, he is interested in inequities in the care of transgender patients. He says he has loved what his school has done with education on issues not previously considered part of med ed. “In the first week of school, we go on tours and spend time in community health centers and learn about the ‘Family Van,’ a mobile health care clinic that offers free care. I even had an opportunity to have a longitudinal clinic experience at a jail.”

While some critics argue that this learning goes too far, others argue that it has not gone far enough fast enough. In general, I consider the progress made in this area since my time in med school to be a very good thing. Medical students are now being taught to think about the science of medicine in the context of the larger human condition.
 

 

 

More technology, less preclinical time and cost

Beyond evolution in curricular content, technical and logistical changes have dramatically reshaped med ed. Since I started my training in 2012, most medical schools now no longer formally require students to attend lectures. Instead, they make them available online for students to view on demand. This undoubtedly makes schedules more flexible, allows students to learn at their own pace, and helps accommodate students with different needs.

Another big change: Preclinical years may now be as short as 1.5 years or less. This is a big draw for some students. Most choose to go to medical school to take care of patients. Shortening the preclinical years means students have more time immersed in patient care and less time dealing with medical minutiae.

That also means that they can spend more time thinking about professional development. Ramie Fathy, a fourth-year student, told me, “I came to Penn [University of Pennsylvania in Philadelphia] because of the shortened preclinical curriculum. That allowed more time on the back end to explore different specialties.” Although some established doctors worry about what scientific details may be left out, providing more hands-on experience sure seems like a good thing to me. Learning from textbooks can only take you so far in this profession.

Another, and more expected, development is the use of ever-advancing technology. Some schools now offer 3D virtual modeling for the study of anatomy, as well as a myriad of electronic visual aids for subjects like pathology and microbiology. Adapting to technological changes can be challenging, however, especially because more nontraditional students are being admitted to medical school each year.

Kahoud is one such nontraditional – older – student. She had some concerns about reliance on newer resources going in. “It [medical school] has become increasingly dependent on technology, even before COVID,” she said. “When you are not well versed in these tools it can definitely be a struggle.”

Thanks to the pandemic, remote learning is now the name of the game for many. As a result, instructors have had to amend their teaching styles to suit distance education, various untested applications and programs have been integrated into the curriculum, and students and administrators alike have had to find alternative ways to build a sense of community.

Is this a glimpse at the future for med ed? And if so, what may be lost or gained from this transition? Tino Delamerced, a third-year student at the Brown University, Providence, R.I., shared a likely very widely held hope: “If the preclinical years can be totally remote permanently, then can tuition be cheaper?”

Med ed debt keeps growing and remains a huge deterrent for potential students, especially those who are the first in their family to pursue medicine, come from a disadvantaged background, or have other people for whom they are financially responsible. Is it possible that the restrictions of COVID-19 could finally lead to cost cutting?

A bigger solution – free medical school – predated the pandemic. Institutions such as New York University have completely eliminated tuition, whereas others such as the Icahn School of Medicine at Mount Sinai (my alma mater) have limited the amount of debt with which a student graduates. You can imagine my frustration that the debt limit policy was enacted after I graduated.

Still, as optimistic as some have been at this movement that developed in the past 5 years, many think this specific evolution is little more than a “pipe dream.”
 

 

 

Current students score big with USMLE change

Beyond med school cost, another universally despised part of medical training that has seen a dramatic change is the licensing examination. My dedicated study period for the United States Medical Licensing Examination (USMLE) Step 1 was my worst time of medical school. Well, it was second to holding a retractor in the operating room for hours at a time.

Like everyone, I suspected that Step 1 would not be an accurate indicator of my ability to actually care for patients. As a practicing physician, I can now tell you for sure that this is the case. How lucky for the next generation, then, that the test is going to a pass/fail grading system.

Step 1 has always been important, as residency programs rely on the score to weed out applicants. Even if that screening emphasis simply gets shifted to scores on other examinations, this change still feels like progress. As Fathy told me, “There will likely be more emphasis on USMLE Step 2. But I think, based on practice questions I’ve done, that is more relevant to clinical abilities.” From my new vantage point, I can confirm that.

Not everyone is excited, though. Delamerced told me that he fears that the pass/fail Step 1 score may disparately affect students outside of allopathic medical schools. He said that the new scoring system “does not allow students to distinguish themselves via a standardized test score. That may hurt IMGs or DO students.”

Even then, Delamerced conceded that the change has some clear benefits. “For med students’ mental health, it’s probably a good thing.” From a population-based perspective, a medical student’s mental health often declines throughout school. Standardized exams are not the only cause, but we all know that it is a big contributor. The Step 1 switch can only help with that.
 

Finish faster or learn more?

In addition to evolution in the content and methods used to teach and assess current med students, the duration of med ed has also changed. Today’s students can choose to complete medical school in less than 4 years.

At the school where I work, the Fully Integrated Readiness for Service Training (FIRST) program allows certain students to complete their education in just 3 years. This program is for students who already know early on that they want to pursue a specialty included on our curated list. The goal of the program is to ultimately train physicians in family medicine, psychiatry, pediatrics, or general surgery in order to provide crucial care to those who need it most in our state.

Other medical schools offer accelerated MD programs for students based on various admissions criteria and specialty interest. The benefit of these programs is that shortening training time cuts down on debt for students.

Accelerated MD programs also aim to quickly increase the number of practicing physicians. This is especially important for primary care, which expects to see a growing gap in the years to come. That aim has come under some criticism, as some believe that the 4-year program was the standard for a reason. But when I reflect on it, I often wonder whether my fourth year was really worth $60,000. I spent a lot of that year traveling for residency interviews and watching Netflix between clinic electives.

Instead of finishing medical school faster, some students now have an opportunity to integrate additional training and education. Benson told me that, at Harvard, many students take a year off to pursue other opportunities. He said, “About 40% of students end up taking a fifth year to do either a master’s degree, global health, or research.” Benson said the additional learning opportunities are broad. “Some classmates even go to other schools altogether to get additional education.” Widened areas of learning are likely to produce better doctors, in my opinion.

This chance to look back on medical education has shown me that the ways in which it has changed rapidly in just the past few years are largely positive. Although COVID-19 has been an unwanted bane, it has also forced schools to integrate new technology and has placed an even brighter spotlight on health inequities and other areas in which education further improved. I hope that, when I look back on med ed in another 5 years, it has grown even more flexible and nimble in meeting the ever-changing needs of students and patients alike.

Alexa Mieses Malchuk, MD, MPH, was born and raised in Queens, New York. Social justice is what drew her to family medicine. As an academic physician at the University of North Carolina, she practices inpatient and outpatient medicine and serves as a medical educator for students and residents.
 

This article first appeared on Medscape.com.

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Patients can read your clinical notes starting Nov. 2

Article Type
Changed
Mon, 10/26/2020 - 11:44

Starting Nov. 2, all patients in the United States will have immediate access to clinical notes and thus will be able to read their doctors’ writings, as well as test results and reports from pathology and imaging.

FG Trade/iStock/Getty Images Plus

The 21st Century Cures Act mandates that patients have fast, electronic access to the following types of notes: consultations, discharge summaries, history, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes.

But this federal mandate, called “open notes” by many, is potentially confusing and frightening for patients, say some physicians. Others worry that the change will increase workload as clinicians tailor notes for patients and answer related questions.

The law means that inpatient and outpatient notes will be released immediately and that patients will have immediate access to testing and imaging results, including results from sexually transmitted disease tests, Pap tests, cancer biopsies, CT and PET scans, fetal ultrasounds, pneumonia cultures, and mammograms.

Such notes could contain sensitive information, and there is concern that patients could be shocked, confused, or annoyed by what they read, even with more run-of-the-mill notes.

Champions of open notes say that the benefits, including better provider-patient communication, greatly outweigh such risks.

“This is about convenience – a bit like online banking,” commented Charlotte Blease, PhD, resident scholar at OpenNotes, an advocacy nonprofit organization headquartered at the Beth Israel–Deaconess Medical Center in Boston. “But it’s a culture shift for doctors,” she said in an interview.

“It turns physician paternalism on its head,” said C. T. Lin, MD, chief medical information officer, UCHealth, Denver. The change requires “some letting go of old traditions” in medicine, he wrote in an August blog post, referring to the fact that a computer screen – and not a physician – may tell patients about a new health problem.

Dr. Lin summarized the experience at the University of Colorado Cancer Center, which has allowed patients to have access to oncology notes for the past 5 years: “No issues and highly appreciated by patients. We have nothing to fear but fear itself.”
 

A new audience

Other institutions have also been voluntarily implementing open notes.

UC Davis Health in Sacramento, Calif., has run an optional program for the past year. However, only about two dozen of approximately 1,000 staff physicians opted in to the program.

“This illustrates the point that it’s a new thing that physicians aren’t used to doing. They’ve traditionally written notes for the benefit of their colleagues, for billing, for their own reference,” Scott MacDonald, MD, an internist and electronic health record medical director at UC Davis Health, told this news organization.

“They’ve never –until recently – had the patient as one of the audiences for a note,” he said.

Liam Keating, MD, an otolaryngologist in Martinez, Calif., recalls that he once wrote “globus hystericus,” and the patient wanted to sue him for saying that the patient was hysterical. “I now just code ‘Globus’ (if I don’t jump straight to LPD [lateral pharyngeal diverticulum]),” he commented in response to a commentary on open notes.

Sensitive information occurs more often in certain specialties, for example, psychiatry, genetics, adolescent medicine, and oncology, experts say.

“Cancer is an area that is highly charged for patients and doctors alike,” Dr. MacDonald pointed out. When reading pathology or imaging notes, patients may learn that they have been diagnosed with cancer or that they have a recurrence “without the physician being able to contextualize it and explain things – that’s just new and scary,” he said.

California law dictates that providers cannot post cancer test results without talking with the patient first, said Dr. MacDonald, but not all states have such laws.
 

 

 

Adjustments needed – or not – with open notes

At UCHealth in Aurora, Colo., Robert Breeze, MD, vice-chair of neurosurgery, said he has adjusted his practice to accommodate open notes and to anticipate trouble spots.*

“When I order imaging or send pathology specimens, I have already discussed with the patient the possibilities, including cancer, and what we will do next. Patients deeply appreciate these discussions, before they see the results,” he commented in an institutional white paper issued in anticipation of the changes on Nov. 2.

This is called precounseling, said Trent Rosenbloom, MD, MPH, director of patient portals at Vanderbilt University Medical Center, Nashville, Tenn., which has been a pioneer in information sharing with patients. Their system does delay the release of information in the case of “complicated” results, such as from cancer biopsies, he said in an interview.

However, Christiaan Hoff, MD, PhD, a surgeon at the Medical Center Leeuwarden (the Netherlands), wonders how important it is for the physician to be present when the patient receives bad news, including news about cancer. “We may overestimate our added value in these situations,” he suggested.

“Our empathy may not outweigh” the disadvantages of the situation, and the “finer points of our explanation will often go unnoticed” by the stressed patient, he commented. Dr. Hoff was also responding to the commentary about open notes.

In that commentary, Jack West, MD, a medical oncologist at City of Hope Cancer Center, Duarte, Calif., was concerned about misunderstandings. Oncology is complex, and patients can struggle to understand their prognosis and planned treatment efficacy, especially in cases of metastatic disease, he wrote.

This concern is somewhat refuted by a study published Oct. 5 in Cancer Cell. Responses to two surveys involving 96 oncology clinicians at three U.S. centers found that almost half (44%) believed that their patients “would be confused” by open notes.

However, only 4% of the 3,418 cancer patients from the same surveys reported being confused by open notes. (A majority of participants had more than a high school education, and English was their primary language.)

“Patient and clinician views about open notes in oncology are not aligned, with patients expressing considerably more enthusiasm,” wrote the authors, led by Liz Salmi, senior strategist at OpenNotes, who has been treated for brain cancer.

“All clinicians are anxious at first,” Ms. Salmi told this news organization. “Those patients who have more serious or chronic conditions … are more likely to read their notes.”

The survey results echo the early experience reported from Sweden, where open notes was launched in 2012. “Patients have loved it from the beginning,” said Maria Haggland, PhD, of Uppsala MedTech Science Innovation Center.

However, when the scheme first launched, it was considered to be “very controversial,” and “there were a lot of complaints, from health care professionals, especially,” she added.

Over time, clinicians have embraced open notes, and the program has 7.2 million patient accounts in a country of 10 million people, she observed during an Oct. 5 webinar on open notes.
 

More work for already overworked clinicians?

An outstanding concern about open notes is that it will cause more work for health care professionals.

Traditionally, doctors have written notes using medical lexicon, including a lot of abbreviations and jargon for efficiency’s sake. Now that patients will read the notes, will clinicians have to spell out things in lay terms, alter their writing so as not to offend, and generally do more work?

William Harvey, MD, chief medical information officer, Tufts Medical Center, Boston, acknowledged that that may be the case.

In a forthcoming note to staff about the Nov. 2 start of open notes, Dr. Harvey will include a reminder to accommodate the patient as a reader. But that may or may not mean an increase in work volume, depending on the provider. “Clinical note writing is highly personal. There’s an art to it,” he said in an interview. “So it’s hard to give standard advice.”

Steven Reidbord, MD, a psychiatrist in private practice in San Francisco and a lecturer at California Pacific Medical Center, is particularly concerned about the impact of open notes on progress notes, which he calls a tool to develop strategies and make observations while working with a patient.

By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” he told this news organization.

“These notes serve many masters already,” he said, referring to purposes such as utilization review and billing. “The more masters they serve, the less useful they are to get medical work done.”

Dr. MacDonald, the medical information officer, said the new law doesn’t mandate a change in writing style.

In a study published last year, researchers analyzed notes written by oncologists before and after adoption of open notes. They found that, on average, clinicians did not change their note writing. The investigators analyzed more than 100,000 clinical notes written by 35 oncologists at a single center.

Advocates for open notes emphasize that there are benefits for clinicians.

“Doctors are overworked. They’re overburdened. But empowered patients can help the doctor,” said OpenNotes’ Dr. Blease. She cited survey data that show that patients better understand their treatment plan and medication, which can cut down on physician workload.

Open notes are “what you make of it,” said Marlene Millen, MD, an internist at UC San Diego Health, which has had a pilot program for 3 years. Each day, Dr. Millen discusses a shared note with two or three patients. “I actually end all of my appointments with, ‘Don’t forget to read your note later,’ ” she told this news organization.

“I was a little afraid of this initially,” she said, but within the first 3 months of the pilot, about 15 patients gave her direct feedback on how much they appreciated her notes. “It seemed to really reassure them that they were getting good care.”

The persons quoted in this article have disclosed no relevant financial relationships.
 

Correction, 10/23/20: An earlier version of this article misstated the campus' location. 

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

Publications
Topics
Sections

Starting Nov. 2, all patients in the United States will have immediate access to clinical notes and thus will be able to read their doctors’ writings, as well as test results and reports from pathology and imaging.

FG Trade/iStock/Getty Images Plus

The 21st Century Cures Act mandates that patients have fast, electronic access to the following types of notes: consultations, discharge summaries, history, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes.

But this federal mandate, called “open notes” by many, is potentially confusing and frightening for patients, say some physicians. Others worry that the change will increase workload as clinicians tailor notes for patients and answer related questions.

The law means that inpatient and outpatient notes will be released immediately and that patients will have immediate access to testing and imaging results, including results from sexually transmitted disease tests, Pap tests, cancer biopsies, CT and PET scans, fetal ultrasounds, pneumonia cultures, and mammograms.

Such notes could contain sensitive information, and there is concern that patients could be shocked, confused, or annoyed by what they read, even with more run-of-the-mill notes.

Champions of open notes say that the benefits, including better provider-patient communication, greatly outweigh such risks.

“This is about convenience – a bit like online banking,” commented Charlotte Blease, PhD, resident scholar at OpenNotes, an advocacy nonprofit organization headquartered at the Beth Israel–Deaconess Medical Center in Boston. “But it’s a culture shift for doctors,” she said in an interview.

“It turns physician paternalism on its head,” said C. T. Lin, MD, chief medical information officer, UCHealth, Denver. The change requires “some letting go of old traditions” in medicine, he wrote in an August blog post, referring to the fact that a computer screen – and not a physician – may tell patients about a new health problem.

Dr. Lin summarized the experience at the University of Colorado Cancer Center, which has allowed patients to have access to oncology notes for the past 5 years: “No issues and highly appreciated by patients. We have nothing to fear but fear itself.”
 

A new audience

Other institutions have also been voluntarily implementing open notes.

UC Davis Health in Sacramento, Calif., has run an optional program for the past year. However, only about two dozen of approximately 1,000 staff physicians opted in to the program.

“This illustrates the point that it’s a new thing that physicians aren’t used to doing. They’ve traditionally written notes for the benefit of their colleagues, for billing, for their own reference,” Scott MacDonald, MD, an internist and electronic health record medical director at UC Davis Health, told this news organization.

“They’ve never –until recently – had the patient as one of the audiences for a note,” he said.

Liam Keating, MD, an otolaryngologist in Martinez, Calif., recalls that he once wrote “globus hystericus,” and the patient wanted to sue him for saying that the patient was hysterical. “I now just code ‘Globus’ (if I don’t jump straight to LPD [lateral pharyngeal diverticulum]),” he commented in response to a commentary on open notes.

Sensitive information occurs more often in certain specialties, for example, psychiatry, genetics, adolescent medicine, and oncology, experts say.

“Cancer is an area that is highly charged for patients and doctors alike,” Dr. MacDonald pointed out. When reading pathology or imaging notes, patients may learn that they have been diagnosed with cancer or that they have a recurrence “without the physician being able to contextualize it and explain things – that’s just new and scary,” he said.

California law dictates that providers cannot post cancer test results without talking with the patient first, said Dr. MacDonald, but not all states have such laws.
 

 

 

Adjustments needed – or not – with open notes

At UCHealth in Aurora, Colo., Robert Breeze, MD, vice-chair of neurosurgery, said he has adjusted his practice to accommodate open notes and to anticipate trouble spots.*

“When I order imaging or send pathology specimens, I have already discussed with the patient the possibilities, including cancer, and what we will do next. Patients deeply appreciate these discussions, before they see the results,” he commented in an institutional white paper issued in anticipation of the changes on Nov. 2.

This is called precounseling, said Trent Rosenbloom, MD, MPH, director of patient portals at Vanderbilt University Medical Center, Nashville, Tenn., which has been a pioneer in information sharing with patients. Their system does delay the release of information in the case of “complicated” results, such as from cancer biopsies, he said in an interview.

However, Christiaan Hoff, MD, PhD, a surgeon at the Medical Center Leeuwarden (the Netherlands), wonders how important it is for the physician to be present when the patient receives bad news, including news about cancer. “We may overestimate our added value in these situations,” he suggested.

“Our empathy may not outweigh” the disadvantages of the situation, and the “finer points of our explanation will often go unnoticed” by the stressed patient, he commented. Dr. Hoff was also responding to the commentary about open notes.

In that commentary, Jack West, MD, a medical oncologist at City of Hope Cancer Center, Duarte, Calif., was concerned about misunderstandings. Oncology is complex, and patients can struggle to understand their prognosis and planned treatment efficacy, especially in cases of metastatic disease, he wrote.

This concern is somewhat refuted by a study published Oct. 5 in Cancer Cell. Responses to two surveys involving 96 oncology clinicians at three U.S. centers found that almost half (44%) believed that their patients “would be confused” by open notes.

However, only 4% of the 3,418 cancer patients from the same surveys reported being confused by open notes. (A majority of participants had more than a high school education, and English was their primary language.)

“Patient and clinician views about open notes in oncology are not aligned, with patients expressing considerably more enthusiasm,” wrote the authors, led by Liz Salmi, senior strategist at OpenNotes, who has been treated for brain cancer.

“All clinicians are anxious at first,” Ms. Salmi told this news organization. “Those patients who have more serious or chronic conditions … are more likely to read their notes.”

The survey results echo the early experience reported from Sweden, where open notes was launched in 2012. “Patients have loved it from the beginning,” said Maria Haggland, PhD, of Uppsala MedTech Science Innovation Center.

However, when the scheme first launched, it was considered to be “very controversial,” and “there were a lot of complaints, from health care professionals, especially,” she added.

Over time, clinicians have embraced open notes, and the program has 7.2 million patient accounts in a country of 10 million people, she observed during an Oct. 5 webinar on open notes.
 

More work for already overworked clinicians?

An outstanding concern about open notes is that it will cause more work for health care professionals.

Traditionally, doctors have written notes using medical lexicon, including a lot of abbreviations and jargon for efficiency’s sake. Now that patients will read the notes, will clinicians have to spell out things in lay terms, alter their writing so as not to offend, and generally do more work?

William Harvey, MD, chief medical information officer, Tufts Medical Center, Boston, acknowledged that that may be the case.

In a forthcoming note to staff about the Nov. 2 start of open notes, Dr. Harvey will include a reminder to accommodate the patient as a reader. But that may or may not mean an increase in work volume, depending on the provider. “Clinical note writing is highly personal. There’s an art to it,” he said in an interview. “So it’s hard to give standard advice.”

Steven Reidbord, MD, a psychiatrist in private practice in San Francisco and a lecturer at California Pacific Medical Center, is particularly concerned about the impact of open notes on progress notes, which he calls a tool to develop strategies and make observations while working with a patient.

By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” he told this news organization.

“These notes serve many masters already,” he said, referring to purposes such as utilization review and billing. “The more masters they serve, the less useful they are to get medical work done.”

Dr. MacDonald, the medical information officer, said the new law doesn’t mandate a change in writing style.

In a study published last year, researchers analyzed notes written by oncologists before and after adoption of open notes. They found that, on average, clinicians did not change their note writing. The investigators analyzed more than 100,000 clinical notes written by 35 oncologists at a single center.

Advocates for open notes emphasize that there are benefits for clinicians.

“Doctors are overworked. They’re overburdened. But empowered patients can help the doctor,” said OpenNotes’ Dr. Blease. She cited survey data that show that patients better understand their treatment plan and medication, which can cut down on physician workload.

Open notes are “what you make of it,” said Marlene Millen, MD, an internist at UC San Diego Health, which has had a pilot program for 3 years. Each day, Dr. Millen discusses a shared note with two or three patients. “I actually end all of my appointments with, ‘Don’t forget to read your note later,’ ” she told this news organization.

“I was a little afraid of this initially,” she said, but within the first 3 months of the pilot, about 15 patients gave her direct feedback on how much they appreciated her notes. “It seemed to really reassure them that they were getting good care.”

The persons quoted in this article have disclosed no relevant financial relationships.
 

Correction, 10/23/20: An earlier version of this article misstated the campus' location. 

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

Starting Nov. 2, all patients in the United States will have immediate access to clinical notes and thus will be able to read their doctors’ writings, as well as test results and reports from pathology and imaging.

FG Trade/iStock/Getty Images Plus

The 21st Century Cures Act mandates that patients have fast, electronic access to the following types of notes: consultations, discharge summaries, history, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes.

But this federal mandate, called “open notes” by many, is potentially confusing and frightening for patients, say some physicians. Others worry that the change will increase workload as clinicians tailor notes for patients and answer related questions.

The law means that inpatient and outpatient notes will be released immediately and that patients will have immediate access to testing and imaging results, including results from sexually transmitted disease tests, Pap tests, cancer biopsies, CT and PET scans, fetal ultrasounds, pneumonia cultures, and mammograms.

Such notes could contain sensitive information, and there is concern that patients could be shocked, confused, or annoyed by what they read, even with more run-of-the-mill notes.

Champions of open notes say that the benefits, including better provider-patient communication, greatly outweigh such risks.

“This is about convenience – a bit like online banking,” commented Charlotte Blease, PhD, resident scholar at OpenNotes, an advocacy nonprofit organization headquartered at the Beth Israel–Deaconess Medical Center in Boston. “But it’s a culture shift for doctors,” she said in an interview.

“It turns physician paternalism on its head,” said C. T. Lin, MD, chief medical information officer, UCHealth, Denver. The change requires “some letting go of old traditions” in medicine, he wrote in an August blog post, referring to the fact that a computer screen – and not a physician – may tell patients about a new health problem.

Dr. Lin summarized the experience at the University of Colorado Cancer Center, which has allowed patients to have access to oncology notes for the past 5 years: “No issues and highly appreciated by patients. We have nothing to fear but fear itself.”
 

A new audience

Other institutions have also been voluntarily implementing open notes.

UC Davis Health in Sacramento, Calif., has run an optional program for the past year. However, only about two dozen of approximately 1,000 staff physicians opted in to the program.

“This illustrates the point that it’s a new thing that physicians aren’t used to doing. They’ve traditionally written notes for the benefit of their colleagues, for billing, for their own reference,” Scott MacDonald, MD, an internist and electronic health record medical director at UC Davis Health, told this news organization.

“They’ve never –until recently – had the patient as one of the audiences for a note,” he said.

Liam Keating, MD, an otolaryngologist in Martinez, Calif., recalls that he once wrote “globus hystericus,” and the patient wanted to sue him for saying that the patient was hysterical. “I now just code ‘Globus’ (if I don’t jump straight to LPD [lateral pharyngeal diverticulum]),” he commented in response to a commentary on open notes.

Sensitive information occurs more often in certain specialties, for example, psychiatry, genetics, adolescent medicine, and oncology, experts say.

“Cancer is an area that is highly charged for patients and doctors alike,” Dr. MacDonald pointed out. When reading pathology or imaging notes, patients may learn that they have been diagnosed with cancer or that they have a recurrence “without the physician being able to contextualize it and explain things – that’s just new and scary,” he said.

California law dictates that providers cannot post cancer test results without talking with the patient first, said Dr. MacDonald, but not all states have such laws.
 

 

 

Adjustments needed – or not – with open notes

At UCHealth in Aurora, Colo., Robert Breeze, MD, vice-chair of neurosurgery, said he has adjusted his practice to accommodate open notes and to anticipate trouble spots.*

“When I order imaging or send pathology specimens, I have already discussed with the patient the possibilities, including cancer, and what we will do next. Patients deeply appreciate these discussions, before they see the results,” he commented in an institutional white paper issued in anticipation of the changes on Nov. 2.

This is called precounseling, said Trent Rosenbloom, MD, MPH, director of patient portals at Vanderbilt University Medical Center, Nashville, Tenn., which has been a pioneer in information sharing with patients. Their system does delay the release of information in the case of “complicated” results, such as from cancer biopsies, he said in an interview.

However, Christiaan Hoff, MD, PhD, a surgeon at the Medical Center Leeuwarden (the Netherlands), wonders how important it is for the physician to be present when the patient receives bad news, including news about cancer. “We may overestimate our added value in these situations,” he suggested.

“Our empathy may not outweigh” the disadvantages of the situation, and the “finer points of our explanation will often go unnoticed” by the stressed patient, he commented. Dr. Hoff was also responding to the commentary about open notes.

In that commentary, Jack West, MD, a medical oncologist at City of Hope Cancer Center, Duarte, Calif., was concerned about misunderstandings. Oncology is complex, and patients can struggle to understand their prognosis and planned treatment efficacy, especially in cases of metastatic disease, he wrote.

This concern is somewhat refuted by a study published Oct. 5 in Cancer Cell. Responses to two surveys involving 96 oncology clinicians at three U.S. centers found that almost half (44%) believed that their patients “would be confused” by open notes.

However, only 4% of the 3,418 cancer patients from the same surveys reported being confused by open notes. (A majority of participants had more than a high school education, and English was their primary language.)

“Patient and clinician views about open notes in oncology are not aligned, with patients expressing considerably more enthusiasm,” wrote the authors, led by Liz Salmi, senior strategist at OpenNotes, who has been treated for brain cancer.

“All clinicians are anxious at first,” Ms. Salmi told this news organization. “Those patients who have more serious or chronic conditions … are more likely to read their notes.”

The survey results echo the early experience reported from Sweden, where open notes was launched in 2012. “Patients have loved it from the beginning,” said Maria Haggland, PhD, of Uppsala MedTech Science Innovation Center.

However, when the scheme first launched, it was considered to be “very controversial,” and “there were a lot of complaints, from health care professionals, especially,” she added.

Over time, clinicians have embraced open notes, and the program has 7.2 million patient accounts in a country of 10 million people, she observed during an Oct. 5 webinar on open notes.
 

More work for already overworked clinicians?

An outstanding concern about open notes is that it will cause more work for health care professionals.

Traditionally, doctors have written notes using medical lexicon, including a lot of abbreviations and jargon for efficiency’s sake. Now that patients will read the notes, will clinicians have to spell out things in lay terms, alter their writing so as not to offend, and generally do more work?

William Harvey, MD, chief medical information officer, Tufts Medical Center, Boston, acknowledged that that may be the case.

In a forthcoming note to staff about the Nov. 2 start of open notes, Dr. Harvey will include a reminder to accommodate the patient as a reader. But that may or may not mean an increase in work volume, depending on the provider. “Clinical note writing is highly personal. There’s an art to it,” he said in an interview. “So it’s hard to give standard advice.”

Steven Reidbord, MD, a psychiatrist in private practice in San Francisco and a lecturer at California Pacific Medical Center, is particularly concerned about the impact of open notes on progress notes, which he calls a tool to develop strategies and make observations while working with a patient.

By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” he told this news organization.

“These notes serve many masters already,” he said, referring to purposes such as utilization review and billing. “The more masters they serve, the less useful they are to get medical work done.”

Dr. MacDonald, the medical information officer, said the new law doesn’t mandate a change in writing style.

In a study published last year, researchers analyzed notes written by oncologists before and after adoption of open notes. They found that, on average, clinicians did not change their note writing. The investigators analyzed more than 100,000 clinical notes written by 35 oncologists at a single center.

Advocates for open notes emphasize that there are benefits for clinicians.

“Doctors are overworked. They’re overburdened. But empowered patients can help the doctor,” said OpenNotes’ Dr. Blease. She cited survey data that show that patients better understand their treatment plan and medication, which can cut down on physician workload.

Open notes are “what you make of it,” said Marlene Millen, MD, an internist at UC San Diego Health, which has had a pilot program for 3 years. Each day, Dr. Millen discusses a shared note with two or three patients. “I actually end all of my appointments with, ‘Don’t forget to read your note later,’ ” she told this news organization.

“I was a little afraid of this initially,” she said, but within the first 3 months of the pilot, about 15 patients gave her direct feedback on how much they appreciated her notes. “It seemed to really reassure them that they were getting good care.”

The persons quoted in this article have disclosed no relevant financial relationships.
 

Correction, 10/23/20: An earlier version of this article misstated the campus' location. 

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

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