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As the COVID-19 crisis pandemic continues, many physicians are not only battling the medical challenges it has wrought but they’re also dealing with its financial ramifications at home.

“Some of our physician clients have seen their income decrease by as much as 50%,” says Joel Greenwald, MD, CEO of Greenwald Wealth Management in St. Louis Park, Minnesota. “Many physicians had previously figured that whatever financial obligations they had wouldn’t be a problem because whatever amount they were making would continue, and if there were a decline it would be gradual.” However, assumption is now creating financial strain for many doctors.

Vikram Tarugu, MD, a gastroenterologist and CEO of Detox of South Florida in Okeechobee, Florida, says he has watched his budget for years, but has become even more careful with his spending in the past few months.

“It has helped me a lot to adjust to the new normal when it comes to the financial side of things,” Dr. Tarugu said. “Patients aren’t coming in as much as they used to, so my income has really been affected.”

Primary care physicians have seen a 55% decrease in revenue and a 20%-30% decrease in patient volume as a result of COVID-19. The impact has been even more severe for specialists. Even for physicians whose practices remain busy and whose family members haven’t lost their jobs or income, broader concerns about the economy may be reason enough for physicians to adopt cost-cutting measures.

In Medscape’s Physician Compensation Report 2020, we asked physicians to share their best cost-cutting tips. Many illustrate the lengths to which physicians are going to conserve money.  

Here’s a look at some of the advice they shared, along with guidance from experts on how to make it work for you:
 

1. Create a written budget, even if you think it’s pointless.

Physicians said their most important piece of advice includes the following: “Use a formal budget to track progress,” “write out a budget,” “plan intermittent/large expenses in advance,” “Make sure all expenses are paid before you spend on leisure.”

Nearly 7 in 10 physicians say they have a budget for personal expenses, yet only one-quarter of those who do have a formal, written budget. Writing out a spending plan is key to being intentional about your spending, making sure that you’re living within your means, and identifying areas in which you may be able to cut back.

“Financial planning is all about cash flow, and everybody should know the amount of money coming in, how much is going out, and the difference between the two,” says Amy Guerich, a partner with Stepp & Rothwell, a Kansas City–based financial planning firm. “That’s important in good times, but it’s even more important now when we see physicians taking pay cuts.”

Many physicians have found that budget apps or software programs are easier to work with than anticipated; some even walk you through the process of creating a budget. To get the most out of the apps, you’ll need to check them regularly and make changes based on their data.

“Sometimes there’s this false belief that just by signing up, you are automatically going to be better at budgeting,” says Scott Snider, CFP, a certified financial planner and partner with Mellen Money Management in Ponte Vedra Beach, Florida. “Basically, these apps are a great way to identify problem areas of spending. We have a tendency as humans to underestimate how much we spend on things like Starbucks, dining out, and Amazon shopping.”

One of the doctors’ tips that requires the most willpower is to “pay all expenses before spending on leisure.” That’s because we live in an instant gratification world, and want everything right away, Ms. Guerich said.

“I also think there’s an element of ‘keeping up with the Joneses’ and pressure associated with this profession,” she said. “The stereotype is that physicians are high-income earners so ‘We should be able to do that’ or ‘Mom and dad are doctors, so they can afford it.’ “

Creating and then revisiting your budget progress on a monthly or quarterly basis can give you a feeling of accomplishment and keep you motivated to stay with it.  

Keep in mind that budgeting is a continual process rather than a singular event, and you’ll likely adjust it over time as your income and goals change. 
 

2. Save more as you earn more.

Respondents to our Physician Compensation Report gave the following recommendations: “Pay yourself first,” “I put half of my bonus into an investment account no matter how much it is,” “I allocate extra money and put it into a savings account.”

Dr. Greenwald said, “I have a rule that every client needs to be saving 20% of their gross income toward retirement, including whatever the employer is putting in.”

Putting a portion of every paycheck into savings is key to making progress toward financial goals. Start by building an emergency fund with at least 3-6 months’ worth of expenses in it and making sure you’re saving at least enough for retirement to get any potential employer match.

Mr. Snider suggests increasing the percentage you save every time you get a raise.

“The thought behind that strategy is that when a doctor receives a pay raise – even if it’s just a cost-of-living raise of 3% – an extra 1% saved doesn’t reduce their take-home pay year-over-year,” he says. “In fact, they still take home more money, and they save more money. Win-win.”
 

3. Focus on paying down your debt.

Physicians told us how they were working to pay down debt with the following recommendations:  “Accelerate debt reduction,” “I make additional principal payment to our home mortgage,” “We are aggressively attacking our remaining student loans.”

Reducing or eliminating debt is key to increasing cash flow, which can make it easier to meet all of your other financial goals. One-quarter of physicians have credit card debt, which typically carries interest rates higher than other types of debt, making it far more expensive. Focus on paying off such high-interest debt first, before moving on to other types of debt such as auto loans, student loans, or a mortgage.

“Credit card debt and any unsecured debt should be paid before anything else,” Mr. Snider says. “Getting rid of those high interest rates should be a priority. And that type of debt has less flexible terms than student debt.”
 

4. Great opportunity to take advantage of record-low interest rates.

Physicians said that, to save money, they are recommending the following: “Consolidating student debt into our mortgage,” “Accelerating payments of the principle on our mortgage,” “Making sure we have an affordable mortgage.”

With interest rates at an all-time low, even those who’ve recently refinanced might see significant savings by refinancing again. Given the associated fees, it typically makes sense to refinance if you can reduce your mortgage rate by at least a point, and you’re planning to stay in the home for at least 5 years.

“Depending on how much lower your rate is, refinancing can make a big difference in your monthly payments,” Ms. Guerich said. “For physicians who might need an emergency reserve but don’t have cash on hand, a HELOC [Home Equity Line of Credit] is a great way to accomplish that.”
 

5. Be wary of credit cards dangers; use cards wisely.

Physician respondents recommended the following:  “Use 0% interest offers on credit cards,” “Only have one card and pay it off every month,” “Never carry over balance.”

Nearly 80% of physicians have three or more credit cards, with 18% reporting that they have seven or more. When used wisely, credit cards can be an important tool for managing finances. Many credit cards come with tools that can help with budgeting, and credit cards rewards and perks can offer real value to users. That said, rewards typically are not valuable enough to offset the cost of interest on balances (or the associated damage to your credit score) that aren’t paid off each month.

“If you’re paying a high rate on credit card balances that carry over every month, regardless of your income, that could be a symptom that you may be spending more than you should,” says Dan Keady, a CFP and chief financial planning strategist at financial services firm TIAA.

6. Give less to Uncle Sam: Keep it for yourself.

Physicians said that they do the following: “Maximize tax-free/deferred savings (401k, HSA, etc.),” “Give to charity to reduce tax,” “Use pre-tax dollars for childcare and healthcare.”

Not only does saving in workplace retirement accounts help you build your nest egg, but it also reduces the amount that you have to pay in taxes in a given year. Physicians should also take advantage of other ways to reduce their income for tax purposes, such as saving money in a health savings account or flexible savings account.

The 401(k) or 403(b) contribution limit for this year is $19,500 ($26,000) for those age 50 years and older. Self-employed physicians can save even more money via a Simplified Employee Pension (SEP) IRA, says Ms. Guerich said. They can save up to 25% of compensation, up to $57,000 in 2020.
 

7. Automate everything and spare yourself the headache.

Physicians said the following: “Designate money from your paycheck directly to tax deferred and taxable accounts automatically,” “Use automatic payment for credit card balance monthly,” “Automate your savings.”

You probably already automate your 401(k) contributions, but you can also automate bill payments, emergency savings contributions and other financial tasks. For busy physicians, this can make it easier to stick to your financial plan and achieve your goals.

“The older you get, the busier you get, said Mr. Snider says. “Automation can definitely help with that. But make sure you are checking in quarterly to make sure that everything is still in line with your plan. The problem with automation is when you forget about it completely and just let everything sit there.”
 

8. Save separately for big purchases.

Sometimes it’s the big major expenses that can start to derail a budget. Physicians told us the following tactics for large purchases:  “We buy affordable cars and take budget vacations,” “I buy used cars,” “We save in advance for new cars and only buy cars with cash.”

The decision of which car to purchase or where to go on a family vacation is a personal one, and some physicians take great enjoyment and pride in driving a luxury vehicle or traveling to exotic locales. The key, experts say, is to factor the cost of that car into the rest of your budget, and make sure that it’s not preventing you from achieving other financial goals.

“I don’t like to judge or tell clients how they should spend their money,” said Andrew Musbach, a certified financial planner and cofounder of MD Wealth Management in Chelsea, Mich. “Some people like cars, we have clients that have two planes, others want a second house or like to travel. Each person has their own interest where they may spend more relative to other people, but as long as they are meeting their savings targets, I encourage them to spend their money and enjoy what they enjoy most, guilt free.”

Mr. Snider suggests setting up a savings account separate from emergency or retirement accounts to set aside money if you have a goal for a large future purchase, such as a boat or a second home.

“That way, the funds don’t get commingled, and it’s explicitly clear whether or not the doctor is on target,” he says. “It also prevents them from treating their emergency savings account as an ATM machine.”
 

9. Start saving for college when the kids are little.  

Respondents said the following: “We are buying less to save for the kids’ college education,” “We set up direct deposit into college and retirement savings plans,” “We have a 529 account for college savings.”

Helping pay for their children’s college education is an important financial goal for many physicians. The earlier that you start saving, the less you’ll have to save overall, thanks to compound interest. State 529 accounts are often a good place to start, especially if your state offers a tax incentive for doing so.

Mr. Snider recommends that physicians start small, with an initial investment of $1,000 per month and $100 per month contributions. Assuming a 7% rate of return and 17 years’ worth of savings, this would generate just over $42,000. (Note, current typical rates of return are less than 7%).

“Ideally, as other goals are accomplished and personal debt gets paid off, the doctor is ramping up their savings to have at least 50% of college expenses covered from their 529 college savings,” he says.
 

10. Watch out for the temptation of impulse purchases.

Physicians said the following: “Avoid impulse purchases,” “Avoid impulse shopping, make a list for the store and stick to it,” “Wait to buy things on sale.”

Nothing wrecks a budget like an impulse buy. More than half (54%) of U.S. shoppers have admitted to spending $100 or more on an impulse purchase. And 20% of shoppers have spent at least $1,000 on an impulse buy. Avoid buyers’ remorse by waiting a few days to make large purchase decisions or by limiting your unplanned spending to a certain dollar amount within your budget.

Online shopping may be a particular temptation. Dr. Tarugu, the Florida gastroenterologist, has focused on reducing those impulse buys as well, deleting all online shopping apps from his and his family’s phones.

“You won’t notice how much you have ordered online until it arrives at your doorstep,” he said. “It’s really important to keep it at bay.”

Mr. Keady, the TIAA chief planning strategist, recommended this tactic: Calculate the number of patients (or hours) you’d need to see in order to earn the cash required to make the purchase.

“Then, in a mindful way, figure out the amount of value derived from the purchase,” he said.
 

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

As the COVID-19 crisis pandemic continues, many physicians are not only battling the medical challenges it has wrought but they’re also dealing with its financial ramifications at home.

“Some of our physician clients have seen their income decrease by as much as 50%,” says Joel Greenwald, MD, CEO of Greenwald Wealth Management in St. Louis Park, Minnesota. “Many physicians had previously figured that whatever financial obligations they had wouldn’t be a problem because whatever amount they were making would continue, and if there were a decline it would be gradual.” However, assumption is now creating financial strain for many doctors.

Vikram Tarugu, MD, a gastroenterologist and CEO of Detox of South Florida in Okeechobee, Florida, says he has watched his budget for years, but has become even more careful with his spending in the past few months.

“It has helped me a lot to adjust to the new normal when it comes to the financial side of things,” Dr. Tarugu said. “Patients aren’t coming in as much as they used to, so my income has really been affected.”

Primary care physicians have seen a 55% decrease in revenue and a 20%-30% decrease in patient volume as a result of COVID-19. The impact has been even more severe for specialists. Even for physicians whose practices remain busy and whose family members haven’t lost their jobs or income, broader concerns about the economy may be reason enough for physicians to adopt cost-cutting measures.

In Medscape’s Physician Compensation Report 2020, we asked physicians to share their best cost-cutting tips. Many illustrate the lengths to which physicians are going to conserve money.  

Here’s a look at some of the advice they shared, along with guidance from experts on how to make it work for you:
 

1. Create a written budget, even if you think it’s pointless.

Physicians said their most important piece of advice includes the following: “Use a formal budget to track progress,” “write out a budget,” “plan intermittent/large expenses in advance,” “Make sure all expenses are paid before you spend on leisure.”

Nearly 7 in 10 physicians say they have a budget for personal expenses, yet only one-quarter of those who do have a formal, written budget. Writing out a spending plan is key to being intentional about your spending, making sure that you’re living within your means, and identifying areas in which you may be able to cut back.

“Financial planning is all about cash flow, and everybody should know the amount of money coming in, how much is going out, and the difference between the two,” says Amy Guerich, a partner with Stepp & Rothwell, a Kansas City–based financial planning firm. “That’s important in good times, but it’s even more important now when we see physicians taking pay cuts.”

Many physicians have found that budget apps or software programs are easier to work with than anticipated; some even walk you through the process of creating a budget. To get the most out of the apps, you’ll need to check them regularly and make changes based on their data.

“Sometimes there’s this false belief that just by signing up, you are automatically going to be better at budgeting,” says Scott Snider, CFP, a certified financial planner and partner with Mellen Money Management in Ponte Vedra Beach, Florida. “Basically, these apps are a great way to identify problem areas of spending. We have a tendency as humans to underestimate how much we spend on things like Starbucks, dining out, and Amazon shopping.”

One of the doctors’ tips that requires the most willpower is to “pay all expenses before spending on leisure.” That’s because we live in an instant gratification world, and want everything right away, Ms. Guerich said.

“I also think there’s an element of ‘keeping up with the Joneses’ and pressure associated with this profession,” she said. “The stereotype is that physicians are high-income earners so ‘We should be able to do that’ or ‘Mom and dad are doctors, so they can afford it.’ “

Creating and then revisiting your budget progress on a monthly or quarterly basis can give you a feeling of accomplishment and keep you motivated to stay with it.  

Keep in mind that budgeting is a continual process rather than a singular event, and you’ll likely adjust it over time as your income and goals change. 
 

2. Save more as you earn more.

Respondents to our Physician Compensation Report gave the following recommendations: “Pay yourself first,” “I put half of my bonus into an investment account no matter how much it is,” “I allocate extra money and put it into a savings account.”

Dr. Greenwald said, “I have a rule that every client needs to be saving 20% of their gross income toward retirement, including whatever the employer is putting in.”

Putting a portion of every paycheck into savings is key to making progress toward financial goals. Start by building an emergency fund with at least 3-6 months’ worth of expenses in it and making sure you’re saving at least enough for retirement to get any potential employer match.

Mr. Snider suggests increasing the percentage you save every time you get a raise.

“The thought behind that strategy is that when a doctor receives a pay raise – even if it’s just a cost-of-living raise of 3% – an extra 1% saved doesn’t reduce their take-home pay year-over-year,” he says. “In fact, they still take home more money, and they save more money. Win-win.”
 

3. Focus on paying down your debt.

Physicians told us how they were working to pay down debt with the following recommendations:  “Accelerate debt reduction,” “I make additional principal payment to our home mortgage,” “We are aggressively attacking our remaining student loans.”

Reducing or eliminating debt is key to increasing cash flow, which can make it easier to meet all of your other financial goals. One-quarter of physicians have credit card debt, which typically carries interest rates higher than other types of debt, making it far more expensive. Focus on paying off such high-interest debt first, before moving on to other types of debt such as auto loans, student loans, or a mortgage.

“Credit card debt and any unsecured debt should be paid before anything else,” Mr. Snider says. “Getting rid of those high interest rates should be a priority. And that type of debt has less flexible terms than student debt.”
 

4. Great opportunity to take advantage of record-low interest rates.

Physicians said that, to save money, they are recommending the following: “Consolidating student debt into our mortgage,” “Accelerating payments of the principle on our mortgage,” “Making sure we have an affordable mortgage.”

With interest rates at an all-time low, even those who’ve recently refinanced might see significant savings by refinancing again. Given the associated fees, it typically makes sense to refinance if you can reduce your mortgage rate by at least a point, and you’re planning to stay in the home for at least 5 years.

“Depending on how much lower your rate is, refinancing can make a big difference in your monthly payments,” Ms. Guerich said. “For physicians who might need an emergency reserve but don’t have cash on hand, a HELOC [Home Equity Line of Credit] is a great way to accomplish that.”
 

5. Be wary of credit cards dangers; use cards wisely.

Physician respondents recommended the following:  “Use 0% interest offers on credit cards,” “Only have one card and pay it off every month,” “Never carry over balance.”

Nearly 80% of physicians have three or more credit cards, with 18% reporting that they have seven or more. When used wisely, credit cards can be an important tool for managing finances. Many credit cards come with tools that can help with budgeting, and credit cards rewards and perks can offer real value to users. That said, rewards typically are not valuable enough to offset the cost of interest on balances (or the associated damage to your credit score) that aren’t paid off each month.

“If you’re paying a high rate on credit card balances that carry over every month, regardless of your income, that could be a symptom that you may be spending more than you should,” says Dan Keady, a CFP and chief financial planning strategist at financial services firm TIAA.

6. Give less to Uncle Sam: Keep it for yourself.

Physicians said that they do the following: “Maximize tax-free/deferred savings (401k, HSA, etc.),” “Give to charity to reduce tax,” “Use pre-tax dollars for childcare and healthcare.”

Not only does saving in workplace retirement accounts help you build your nest egg, but it also reduces the amount that you have to pay in taxes in a given year. Physicians should also take advantage of other ways to reduce their income for tax purposes, such as saving money in a health savings account or flexible savings account.

The 401(k) or 403(b) contribution limit for this year is $19,500 ($26,000) for those age 50 years and older. Self-employed physicians can save even more money via a Simplified Employee Pension (SEP) IRA, says Ms. Guerich said. They can save up to 25% of compensation, up to $57,000 in 2020.
 

7. Automate everything and spare yourself the headache.

Physicians said the following: “Designate money from your paycheck directly to tax deferred and taxable accounts automatically,” “Use automatic payment for credit card balance monthly,” “Automate your savings.”

You probably already automate your 401(k) contributions, but you can also automate bill payments, emergency savings contributions and other financial tasks. For busy physicians, this can make it easier to stick to your financial plan and achieve your goals.

“The older you get, the busier you get, said Mr. Snider says. “Automation can definitely help with that. But make sure you are checking in quarterly to make sure that everything is still in line with your plan. The problem with automation is when you forget about it completely and just let everything sit there.”
 

8. Save separately for big purchases.

Sometimes it’s the big major expenses that can start to derail a budget. Physicians told us the following tactics for large purchases:  “We buy affordable cars and take budget vacations,” “I buy used cars,” “We save in advance for new cars and only buy cars with cash.”

The decision of which car to purchase or where to go on a family vacation is a personal one, and some physicians take great enjoyment and pride in driving a luxury vehicle or traveling to exotic locales. The key, experts say, is to factor the cost of that car into the rest of your budget, and make sure that it’s not preventing you from achieving other financial goals.

“I don’t like to judge or tell clients how they should spend their money,” said Andrew Musbach, a certified financial planner and cofounder of MD Wealth Management in Chelsea, Mich. “Some people like cars, we have clients that have two planes, others want a second house or like to travel. Each person has their own interest where they may spend more relative to other people, but as long as they are meeting their savings targets, I encourage them to spend their money and enjoy what they enjoy most, guilt free.”

Mr. Snider suggests setting up a savings account separate from emergency or retirement accounts to set aside money if you have a goal for a large future purchase, such as a boat or a second home.

“That way, the funds don’t get commingled, and it’s explicitly clear whether or not the doctor is on target,” he says. “It also prevents them from treating their emergency savings account as an ATM machine.”
 

9. Start saving for college when the kids are little.  

Respondents said the following: “We are buying less to save for the kids’ college education,” “We set up direct deposit into college and retirement savings plans,” “We have a 529 account for college savings.”

Helping pay for their children’s college education is an important financial goal for many physicians. The earlier that you start saving, the less you’ll have to save overall, thanks to compound interest. State 529 accounts are often a good place to start, especially if your state offers a tax incentive for doing so.

Mr. Snider recommends that physicians start small, with an initial investment of $1,000 per month and $100 per month contributions. Assuming a 7% rate of return and 17 years’ worth of savings, this would generate just over $42,000. (Note, current typical rates of return are less than 7%).

“Ideally, as other goals are accomplished and personal debt gets paid off, the doctor is ramping up their savings to have at least 50% of college expenses covered from their 529 college savings,” he says.
 

10. Watch out for the temptation of impulse purchases.

Physicians said the following: “Avoid impulse purchases,” “Avoid impulse shopping, make a list for the store and stick to it,” “Wait to buy things on sale.”

Nothing wrecks a budget like an impulse buy. More than half (54%) of U.S. shoppers have admitted to spending $100 or more on an impulse purchase. And 20% of shoppers have spent at least $1,000 on an impulse buy. Avoid buyers’ remorse by waiting a few days to make large purchase decisions or by limiting your unplanned spending to a certain dollar amount within your budget.

Online shopping may be a particular temptation. Dr. Tarugu, the Florida gastroenterologist, has focused on reducing those impulse buys as well, deleting all online shopping apps from his and his family’s phones.

“You won’t notice how much you have ordered online until it arrives at your doorstep,” he said. “It’s really important to keep it at bay.”

Mr. Keady, the TIAA chief planning strategist, recommended this tactic: Calculate the number of patients (or hours) you’d need to see in order to earn the cash required to make the purchase.

“Then, in a mindful way, figure out the amount of value derived from the purchase,” he said.
 

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

As the COVID-19 crisis pandemic continues, many physicians are not only battling the medical challenges it has wrought but they’re also dealing with its financial ramifications at home.

“Some of our physician clients have seen their income decrease by as much as 50%,” says Joel Greenwald, MD, CEO of Greenwald Wealth Management in St. Louis Park, Minnesota. “Many physicians had previously figured that whatever financial obligations they had wouldn’t be a problem because whatever amount they were making would continue, and if there were a decline it would be gradual.” However, assumption is now creating financial strain for many doctors.

Vikram Tarugu, MD, a gastroenterologist and CEO of Detox of South Florida in Okeechobee, Florida, says he has watched his budget for years, but has become even more careful with his spending in the past few months.

“It has helped me a lot to adjust to the new normal when it comes to the financial side of things,” Dr. Tarugu said. “Patients aren’t coming in as much as they used to, so my income has really been affected.”

Primary care physicians have seen a 55% decrease in revenue and a 20%-30% decrease in patient volume as a result of COVID-19. The impact has been even more severe for specialists. Even for physicians whose practices remain busy and whose family members haven’t lost their jobs or income, broader concerns about the economy may be reason enough for physicians to adopt cost-cutting measures.

In Medscape’s Physician Compensation Report 2020, we asked physicians to share their best cost-cutting tips. Many illustrate the lengths to which physicians are going to conserve money.  

Here’s a look at some of the advice they shared, along with guidance from experts on how to make it work for you:
 

1. Create a written budget, even if you think it’s pointless.

Physicians said their most important piece of advice includes the following: “Use a formal budget to track progress,” “write out a budget,” “plan intermittent/large expenses in advance,” “Make sure all expenses are paid before you spend on leisure.”

Nearly 7 in 10 physicians say they have a budget for personal expenses, yet only one-quarter of those who do have a formal, written budget. Writing out a spending plan is key to being intentional about your spending, making sure that you’re living within your means, and identifying areas in which you may be able to cut back.

“Financial planning is all about cash flow, and everybody should know the amount of money coming in, how much is going out, and the difference between the two,” says Amy Guerich, a partner with Stepp & Rothwell, a Kansas City–based financial planning firm. “That’s important in good times, but it’s even more important now when we see physicians taking pay cuts.”

Many physicians have found that budget apps or software programs are easier to work with than anticipated; some even walk you through the process of creating a budget. To get the most out of the apps, you’ll need to check them regularly and make changes based on their data.

“Sometimes there’s this false belief that just by signing up, you are automatically going to be better at budgeting,” says Scott Snider, CFP, a certified financial planner and partner with Mellen Money Management in Ponte Vedra Beach, Florida. “Basically, these apps are a great way to identify problem areas of spending. We have a tendency as humans to underestimate how much we spend on things like Starbucks, dining out, and Amazon shopping.”

One of the doctors’ tips that requires the most willpower is to “pay all expenses before spending on leisure.” That’s because we live in an instant gratification world, and want everything right away, Ms. Guerich said.

“I also think there’s an element of ‘keeping up with the Joneses’ and pressure associated with this profession,” she said. “The stereotype is that physicians are high-income earners so ‘We should be able to do that’ or ‘Mom and dad are doctors, so they can afford it.’ “

Creating and then revisiting your budget progress on a monthly or quarterly basis can give you a feeling of accomplishment and keep you motivated to stay with it.  

Keep in mind that budgeting is a continual process rather than a singular event, and you’ll likely adjust it over time as your income and goals change. 
 

2. Save more as you earn more.

Respondents to our Physician Compensation Report gave the following recommendations: “Pay yourself first,” “I put half of my bonus into an investment account no matter how much it is,” “I allocate extra money and put it into a savings account.”

Dr. Greenwald said, “I have a rule that every client needs to be saving 20% of their gross income toward retirement, including whatever the employer is putting in.”

Putting a portion of every paycheck into savings is key to making progress toward financial goals. Start by building an emergency fund with at least 3-6 months’ worth of expenses in it and making sure you’re saving at least enough for retirement to get any potential employer match.

Mr. Snider suggests increasing the percentage you save every time you get a raise.

“The thought behind that strategy is that when a doctor receives a pay raise – even if it’s just a cost-of-living raise of 3% – an extra 1% saved doesn’t reduce their take-home pay year-over-year,” he says. “In fact, they still take home more money, and they save more money. Win-win.”
 

3. Focus on paying down your debt.

Physicians told us how they were working to pay down debt with the following recommendations:  “Accelerate debt reduction,” “I make additional principal payment to our home mortgage,” “We are aggressively attacking our remaining student loans.”

Reducing or eliminating debt is key to increasing cash flow, which can make it easier to meet all of your other financial goals. One-quarter of physicians have credit card debt, which typically carries interest rates higher than other types of debt, making it far more expensive. Focus on paying off such high-interest debt first, before moving on to other types of debt such as auto loans, student loans, or a mortgage.

“Credit card debt and any unsecured debt should be paid before anything else,” Mr. Snider says. “Getting rid of those high interest rates should be a priority. And that type of debt has less flexible terms than student debt.”
 

4. Great opportunity to take advantage of record-low interest rates.

Physicians said that, to save money, they are recommending the following: “Consolidating student debt into our mortgage,” “Accelerating payments of the principle on our mortgage,” “Making sure we have an affordable mortgage.”

With interest rates at an all-time low, even those who’ve recently refinanced might see significant savings by refinancing again. Given the associated fees, it typically makes sense to refinance if you can reduce your mortgage rate by at least a point, and you’re planning to stay in the home for at least 5 years.

“Depending on how much lower your rate is, refinancing can make a big difference in your monthly payments,” Ms. Guerich said. “For physicians who might need an emergency reserve but don’t have cash on hand, a HELOC [Home Equity Line of Credit] is a great way to accomplish that.”
 

5. Be wary of credit cards dangers; use cards wisely.

Physician respondents recommended the following:  “Use 0% interest offers on credit cards,” “Only have one card and pay it off every month,” “Never carry over balance.”

Nearly 80% of physicians have three or more credit cards, with 18% reporting that they have seven or more. When used wisely, credit cards can be an important tool for managing finances. Many credit cards come with tools that can help with budgeting, and credit cards rewards and perks can offer real value to users. That said, rewards typically are not valuable enough to offset the cost of interest on balances (or the associated damage to your credit score) that aren’t paid off each month.

“If you’re paying a high rate on credit card balances that carry over every month, regardless of your income, that could be a symptom that you may be spending more than you should,” says Dan Keady, a CFP and chief financial planning strategist at financial services firm TIAA.

6. Give less to Uncle Sam: Keep it for yourself.

Physicians said that they do the following: “Maximize tax-free/deferred savings (401k, HSA, etc.),” “Give to charity to reduce tax,” “Use pre-tax dollars for childcare and healthcare.”

Not only does saving in workplace retirement accounts help you build your nest egg, but it also reduces the amount that you have to pay in taxes in a given year. Physicians should also take advantage of other ways to reduce their income for tax purposes, such as saving money in a health savings account or flexible savings account.

The 401(k) or 403(b) contribution limit for this year is $19,500 ($26,000) for those age 50 years and older. Self-employed physicians can save even more money via a Simplified Employee Pension (SEP) IRA, says Ms. Guerich said. They can save up to 25% of compensation, up to $57,000 in 2020.
 

7. Automate everything and spare yourself the headache.

Physicians said the following: “Designate money from your paycheck directly to tax deferred and taxable accounts automatically,” “Use automatic payment for credit card balance monthly,” “Automate your savings.”

You probably already automate your 401(k) contributions, but you can also automate bill payments, emergency savings contributions and other financial tasks. For busy physicians, this can make it easier to stick to your financial plan and achieve your goals.

“The older you get, the busier you get, said Mr. Snider says. “Automation can definitely help with that. But make sure you are checking in quarterly to make sure that everything is still in line with your plan. The problem with automation is when you forget about it completely and just let everything sit there.”
 

8. Save separately for big purchases.

Sometimes it’s the big major expenses that can start to derail a budget. Physicians told us the following tactics for large purchases:  “We buy affordable cars and take budget vacations,” “I buy used cars,” “We save in advance for new cars and only buy cars with cash.”

The decision of which car to purchase or where to go on a family vacation is a personal one, and some physicians take great enjoyment and pride in driving a luxury vehicle or traveling to exotic locales. The key, experts say, is to factor the cost of that car into the rest of your budget, and make sure that it’s not preventing you from achieving other financial goals.

“I don’t like to judge or tell clients how they should spend their money,” said Andrew Musbach, a certified financial planner and cofounder of MD Wealth Management in Chelsea, Mich. “Some people like cars, we have clients that have two planes, others want a second house or like to travel. Each person has their own interest where they may spend more relative to other people, but as long as they are meeting their savings targets, I encourage them to spend their money and enjoy what they enjoy most, guilt free.”

Mr. Snider suggests setting up a savings account separate from emergency or retirement accounts to set aside money if you have a goal for a large future purchase, such as a boat or a second home.

“That way, the funds don’t get commingled, and it’s explicitly clear whether or not the doctor is on target,” he says. “It also prevents them from treating their emergency savings account as an ATM machine.”
 

9. Start saving for college when the kids are little.  

Respondents said the following: “We are buying less to save for the kids’ college education,” “We set up direct deposit into college and retirement savings plans,” “We have a 529 account for college savings.”

Helping pay for their children’s college education is an important financial goal for many physicians. The earlier that you start saving, the less you’ll have to save overall, thanks to compound interest. State 529 accounts are often a good place to start, especially if your state offers a tax incentive for doing so.

Mr. Snider recommends that physicians start small, with an initial investment of $1,000 per month and $100 per month contributions. Assuming a 7% rate of return and 17 years’ worth of savings, this would generate just over $42,000. (Note, current typical rates of return are less than 7%).

“Ideally, as other goals are accomplished and personal debt gets paid off, the doctor is ramping up their savings to have at least 50% of college expenses covered from their 529 college savings,” he says.
 

10. Watch out for the temptation of impulse purchases.

Physicians said the following: “Avoid impulse purchases,” “Avoid impulse shopping, make a list for the store and stick to it,” “Wait to buy things on sale.”

Nothing wrecks a budget like an impulse buy. More than half (54%) of U.S. shoppers have admitted to spending $100 or more on an impulse purchase. And 20% of shoppers have spent at least $1,000 on an impulse buy. Avoid buyers’ remorse by waiting a few days to make large purchase decisions or by limiting your unplanned spending to a certain dollar amount within your budget.

Online shopping may be a particular temptation. Dr. Tarugu, the Florida gastroenterologist, has focused on reducing those impulse buys as well, deleting all online shopping apps from his and his family’s phones.

“You won’t notice how much you have ordered online until it arrives at your doorstep,” he said. “It’s really important to keep it at bay.”

Mr. Keady, the TIAA chief planning strategist, recommended this tactic: Calculate the number of patients (or hours) you’d need to see in order to earn the cash required to make the purchase.

“Then, in a mindful way, figure out the amount of value derived from the purchase,” he said.
 

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

When an ovarian mass is anticipated or known, following evaluation of a patient’s history and physician examination, imaging via transvaginal and often abdominal ultrasound is the very next step. This evaluation likely will include both gray-scale and color Doppler examination. The initial concern always must be to identify ovarian malignancy.

Despite morphological scoring systems as well as the use of Doppler ultrasonography, there remains a lack of agreement and acceptance. In a 2008 multicenter study, Timmerman and colleagues evaluated 1,066 patients with 1,233 persistent adnexal tumors via transvaginal grayscale and Doppler ultrasound; 73% were benign tumors, and 27% were malignant tumors. Information on 42 gray-scale ultrasound variables and 6 Doppler variables was collected and evaluated to determine which variables had the highest positive predictive value for a malignant tumor and for a benign mass (Ultrasound Obstet Gynecol. 2008 Jun. doi: 10.1002/uog.5365).

Five simple rules were selected that best predict malignancy (M-rules), as follows:

• Irregular solid tumor.
• Ascites.
• At least four papillary projections.
• Irregular multilocular-solid tumor with a greatest diameter greater than or equal to 10 cm.
• Very high color content on Doppler exam.

The following five simple rules suggested that a mass is benign (B-rules):

• Unilocular cyst.
• Largest solid component less than 7 mm.
• Acoustic shadows.
• Smooth multilocular tumor less than 10 cm.
• No detectable blood flow with Doppler exam.

Unfortunately, despite a sensitivity of 93% and specificity of 90%, and a positive and negative predictive value of 80% and 97%, these 10 simple rules were applicable to only 76% of tumors.

To assist those of us who are not gynecologic oncologists and who are often faced with having to determine whether surgery is recommended, I have elicited the expertise of Jubilee Brown, MD, professor and associate director of gynecologic oncology at the Levine Cancer Institute, Carolinas HealthCare System, in Charlotte, N.C., and the current president of the AAGL, to lead us in a review of evaluating an ovarian mass.
 

Dr. Miller is professor of obstetrics & gynecology in the department of clinical sciences, Rosalind Franklin University, North Chicago, Ill., and director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, both in Illinois. Email him at [email protected].

When an ovarian mass is anticipated or known, following evaluation of a patient’s history and physician examination, imaging via transvaginal and often abdominal ultrasound is the very next step. This evaluation likely will include both gray-scale and color Doppler examination. The initial concern always must be to identify ovarian malignancy.

Despite morphological scoring systems as well as the use of Doppler ultrasonography, there remains a lack of agreement and acceptance. In a 2008 multicenter study, Timmerman and colleagues evaluated 1,066 patients with 1,233 persistent adnexal tumors via transvaginal grayscale and Doppler ultrasound; 73% were benign tumors, and 27% were malignant tumors. Information on 42 gray-scale ultrasound variables and 6 Doppler variables was collected and evaluated to determine which variables had the highest positive predictive value for a malignant tumor and for a benign mass (Ultrasound Obstet Gynecol. 2008 Jun. doi: 10.1002/uog.5365).

Five simple rules were selected that best predict malignancy (M-rules), as follows:

• Irregular solid tumor.
• Ascites.
• At least four papillary projections.
• Irregular multilocular-solid tumor with a greatest diameter greater than or equal to 10 cm.
• Very high color content on Doppler exam.

The following five simple rules suggested that a mass is benign (B-rules):

• Unilocular cyst.
• Largest solid component less than 7 mm.
• Acoustic shadows.
• Smooth multilocular tumor less than 10 cm.
• No detectable blood flow with Doppler exam.

Unfortunately, despite a sensitivity of 93% and specificity of 90%, and a positive and negative predictive value of 80% and 97%, these 10 simple rules were applicable to only 76% of tumors.

To assist those of us who are not gynecologic oncologists and who are often faced with having to determine whether surgery is recommended, I have elicited the expertise of Jubilee Brown, MD, professor and associate director of gynecologic oncology at the Levine Cancer Institute, Carolinas HealthCare System, in Charlotte, N.C., and the current president of the AAGL, to lead us in a review of evaluating an ovarian mass.
 

Dr. Miller is professor of obstetrics & gynecology in the department of clinical sciences, Rosalind Franklin University, North Chicago, Ill., and director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, both in Illinois. Email him at [email protected].

When an ovarian mass is anticipated or known, following evaluation of a patient’s history and physician examination, imaging via transvaginal and often abdominal ultrasound is the very next step. This evaluation likely will include both gray-scale and color Doppler examination. The initial concern always must be to identify ovarian malignancy.

Despite morphological scoring systems as well as the use of Doppler ultrasonography, there remains a lack of agreement and acceptance. In a 2008 multicenter study, Timmerman and colleagues evaluated 1,066 patients with 1,233 persistent adnexal tumors via transvaginal grayscale and Doppler ultrasound; 73% were benign tumors, and 27% were malignant tumors. Information on 42 gray-scale ultrasound variables and 6 Doppler variables was collected and evaluated to determine which variables had the highest positive predictive value for a malignant tumor and for a benign mass (Ultrasound Obstet Gynecol. 2008 Jun. doi: 10.1002/uog.5365).

Five simple rules were selected that best predict malignancy (M-rules), as follows:

• Irregular solid tumor.
• Ascites.
• At least four papillary projections.
• Irregular multilocular-solid tumor with a greatest diameter greater than or equal to 10 cm.
• Very high color content on Doppler exam.

The following five simple rules suggested that a mass is benign (B-rules):

• Unilocular cyst.
• Largest solid component less than 7 mm.
• Acoustic shadows.
• Smooth multilocular tumor less than 10 cm.
• No detectable blood flow with Doppler exam.

Unfortunately, despite a sensitivity of 93% and specificity of 90%, and a positive and negative predictive value of 80% and 97%, these 10 simple rules were applicable to only 76% of tumors.

To assist those of us who are not gynecologic oncologists and who are often faced with having to determine whether surgery is recommended, I have elicited the expertise of Jubilee Brown, MD, professor and associate director of gynecologic oncology at the Levine Cancer Institute, Carolinas HealthCare System, in Charlotte, N.C., and the current president of the AAGL, to lead us in a review of evaluating an ovarian mass.
 

Dr. Miller is professor of obstetrics & gynecology in the department of clinical sciences, Rosalind Franklin University, North Chicago, Ill., and director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, both in Illinois. Email him at [email protected].

Ovarian masses are common in women of all ages. It is important not to miss even one ovarian cancer, but we must also identify masses that will resolve on their own over time to avoid overtreatment. These concurrent goals of excluding malignancy while not overtreating patients are the basis for management of the pelvic mass. Additionally, fertility preservation is important when surgery is performed in a reproductive-aged woman.

An ovarian mass may be anything from a simple functional or physiologic cyst to an endometrioma to an epithelial carcinoma, a germ-cell tumor, or a stromal tumor (the latter three of which may metastasize). Across the general population, women have a 5%-10% lifetime risk of needing surgery for a suspected ovarian mass and a 1.4% (1 in 70) risk that this mass is cancerous. The majority of ovarian cysts or masses therefore are benign.

A thorough history – including family history – and physical examination with appropriate laboratory testing and directed imaging are important first steps for the ob.gyn. Fortunately, we have guidelines and criteria governing not only when observation or surgery is warranted but also when patients should be referred to a gynecologic oncologist. By following these guidelines,¹ we are able to achieve the best outcomes.
 

Transvaginal ultrasound

A 2007 groundbreaking study led by Barbara Goff, MD, demonstrated that there are warning signs for ovarian cancer – symptoms that are significantly associated with malignancy. Dr. Goff and her coinvestigators evaluated the charts of hundreds of patients, including about 150 with ovarian cancer, and found that pelvic/abdominal pressure or pain, bloating, increase in abdominal size, and difficulty eating or feeling full were significantly and independently associated with cancer if these symptoms were present for less than a year and occurred at least 12 times per month.²

A pelvic examination is an integral part of evaluating every patient who has such concerns. That said, pelvic exams have limited ability to identify adnexal masses, especially in women who are obese – and that’s where imaging becomes especially important.

Masses generally can be considered simple or complex based on their appearance. A simple cyst is fluid-filled with thin, smooth walls and the absence of solid components or septations; it is significantly more likely to resolve on its own and is less likely to imply malignancy than a complex cyst, especially in a premenopausal woman. A complex cyst is multiseptated and/or solid – possibly with papillary projections – and is more concerning, especially if there is increased, new vascularity. Making this distinction helps us determine the risk of malignancy.

Transvaginal ultrasound (TVUS) is the preferred method for imaging, and our threshold for obtaining a TVUS should be very low. Women who have symptoms or concerns that can’t be attributed to a particular condition, and women in whom a mass can be palpated (even if asymptomatic) should have a TVUS. The imaging modality is cost effective and well tolerated by patients, does not expose the patient to ionizing radiation, and should generally be considered first-line imaging.^3,4

Size is not predictive of malignancy, but it is important for determining whether surgery is warranted. In our experience, a mass of 8-10 cm or larger on TVUS is at risk of torsion and is unlikely to resolve on its own, even in a premenopausal woman. While large masses generally require surgery, patients of any age who have simple cysts smaller than 8-10 cm generally can be followed with serial exams and ultrasound; spontaneous regression is common.

Doppler ultrasonography is useful for evaluating blood flow in and around an ovarian mass and can be helpful for confirming suspected characteristics of a mass.

Recent studies from the radiology community have looked at the utility of the resistive index – a measure of the impedance and velocity of blood flow – as a predictor of ovarian malignancy. However, we caution against using Doppler to determine whether a mass is benign or malignant, or to determine the necessity of surgery. An abnormal ovary may have what is considered to be a normal resistive index, and the resistive index of a normal ovary may fall within the abnormal range. Doppler flow can be helpful, but it must be combined with other predictive features, like solid components with flow or papillary projections within a cyst, to define a decision about surgery.^4,5

Magnetic resonance imaging can be useful in differentiating a fibroid from an ovarian mass, and a CT scan can be helpful in looking for disseminated disease when ovarian cancer is suspected based on ultrasound imaging, physical and history, and serum markers. A CT is useful, for instance, in a patient whose ovary is distended with ascites or who has upper abdominal complaints and a complex cyst. CT, PET, and MRI are not recommended in the initial evaluation of an ovarian mass.

The utility of serum biomarkers

Cancer antigen 125 (CA-125) testing may be helpful – in combination with other findings – for decision-making regarding the likelihood of malignancy and the need to refer patients. CA-125 is like Doppler in that a normal CA-125 cannot eliminate the possibility of cancer, and an abnormal CA-125 does not in and of itself imply malignancy. It’s far from a perfect cancer screening test.

CA-125 is a protein associated with epithelial ovarian malignancies, the type of ovarian cancer most commonly seen in postmenopausal women with genetic predispositions. Its specificity and positive predictive value are much higher in postmenopausal women than in average-risk premenopausal women (those without a family history or a known mutation that predisposes them to ovarian cancer). Levels of the marker are elevated in association with many nonmalignant conditions in premenopausal women – endometriosis, fibroids, and various inflammatory conditions, for instance – so the marker’s utility in this population is limited.

For women who have a family history of ovarian cancer or a known breast cancer gene 1 (BRCA1) or BRCA2 mutation, there are some data that suggest that monitoring with CA-125 measurements and TVUS may be a good approach to following patients prior to the age at which risk-reducing surgery can best be performed.

In an adolescent girl or a woman of reproductive age, we think less about epithelial cancer and more about germ-cell and stromal tumors. When a solid mass is palpated or visualized on imaging, we therefore will utilize a different set of markers; alpha-fetoprotein, L-lactate dehydrogenase, and beta-HCG, for instance, have much higher specificity than CA-125 does for germ-cell tumors in this age group and may be helpful in the evaluation. Similarly, in cases of a very large mass resembling a mucinous tumor, a carcinoembryonic antigen may be helpful.

A number of proprietary profiling technologies have been developed to determine the risk of a diagnosed mass being malignant. For instance, the OVA1 assay looks at five serum markers and scores the results, and the Risk of Ovarian Malignancy Algorithm (ROMA) combines the results of three serum markers with menopausal status into a numerical score. Both have Food and Drug Administration approval for use in women in whom surgery has been deemed necessary. These panels can be fairly predictive of risk and may be helpful – especially in rural areas – in determining which women should be referred to a gynecologic oncologist for surgery.

It is important to appreciate that an ovarian cyst or mass should never be biopsied or aspirated lest a malignant tumor confined to one ovary be potentially spread to the peritoneum.
 

Referral to a gynecologic oncologist

Postmenopausal women with a CA-125 greater than 35 U/mL should be referred, as should postmenopausal women with ascites, those with a nodular or fixed pelvic mass, and those with suspected abdominal or distant metastases (per a CT scan, for instance).

In premenopausal women, ascites, a nodular or fixed mass, and evidence of metastases also are reasons for referral to a gynecologic oncologist. CA-125, again, is much more likely to be elevated for reasons other than malignancy and therefore is not as strong a driver for referral as in postmenopausal women. Patients with markedly elevated levels, however, should probably be referred – particularly when other clinical factors also suggest the need for consultation. While there is no evidence-based threshold for CA-125 in premenopausal women, a CA-125 greater than 200 U/mL is a good cutoff for referral.

For any patient, family history of breast and/or ovarian cancer – especially in a first-degree relative – raises the risk of malignancy and should figure prominently into decision-making regarding referral. Criteria for referral are among the points discussed in the ACOG 2016 Practice Bulletin on Evaluation and Management of Adnexal Masses.¹

A note on BRCA mutations

As the American College of Obstetricians and Gynecologists says in its practice bulletin, the most important personal risk factor for ovarian cancer is a strong family history of breast or ovarian cancer. Women with such a family history can undergo genetic testing for BRCA mutations and have the opportunity to prevent ovarian cancers when mutations are detected. This simple blood test can save lives.

A modeling study we recently completed – not yet published – shows that it actually would be cost effective to do population screening with BRCA testing performed on every woman at age 30 years.

According to the National Cancer Institute website (last review: 2018), it is estimated that about 44% of women who inherit a BRCA1 mutation, and about 17% of those who inherit a BRAC2 mutation, will develop ovarian cancer by the age of 80 years. By identifying those mutations, women may undergo risk-reducing surgery at designated ages after childbearing is complete and bring their risk down to under 5%.

An international take on managing adnexal masses

• Pelvic ultrasound should include the transvaginal approach. Use Doppler imaging as indicated.
• Although simple ovarian cysts are not precursor lesions to a malignant ovarian cancer, perform a high-quality examination to make sure there are no solid/papillary structures before classifying a cyst as a simple cyst. The risk of progression to malignancy is extremely low, but some follow-up is prudent.
• The most accurate method of characterizing an ovarian mass currently is real-time pattern recognition sonography in the hands of an experienced imager.
• Pattern recognition sonography or a risk model such as the International Ovarian Tumor Analysis (IOTA) Simple Rules can be used to initially characterize an ovarian mass.
• When an ovarian lesion is classified as benign, the patient may be followed conservatively, or if indicated, surgery can be performed by a general gynecologist.
• Serial sonography can be beneficial, but there are limited prospective data to support an exact interval and duration.
• Fewer surgical interventions may result in an increase in sonographic surveillance.
• When an ovarian lesion is considered indeterminate on initial sonography, and after appropriate clinical evaluation, a “second-step” evaluation may include referral to an expert sonologist, serial sonography, application of established risk-prediction models, correlation with serum biomarkers, correlation with MRI, or referral to a gynecologic oncologist for further evaluation.

From the First International Consensus Report on Adnexal Masses: Management Recommendations

Source: Glanc P et al. J Ultrasound Med. 2017 May;36(5):849-63.

Dr. Brown reported that she had received an earlier grant from Aspira Labs, the company that developed the OVA1 assay. Dr. Miller reported that he has no relevant financial disclosures.

References

1. Obstet Gynecol. 2016 Nov. doi: 10.1097/AOG.0000000000001768.

2. Cancer. 2007 Jan 15. doi: 10.1002/cncr.22371.

3. Clin Obstet Gynecol. 2015 Mar. doi: 10.1097/GRF.0000000000000083.

4. Ultrasound Q. 2013 Mar. doi: 10.1097/RUQ.0b013e3182814d9b.

5. Ultrasound Obstet Gynecol. 2008 Jun. doi: 10.1002/uog.5365.

Ovarian masses are common in women of all ages. It is important not to miss even one ovarian cancer, but we must also identify masses that will resolve on their own over time to avoid overtreatment. These concurrent goals of excluding malignancy while not overtreating patients are the basis for management of the pelvic mass. Additionally, fertility preservation is important when surgery is performed in a reproductive-aged woman.

An ovarian mass may be anything from a simple functional or physiologic cyst to an endometrioma to an epithelial carcinoma, a germ-cell tumor, or a stromal tumor (the latter three of which may metastasize). Across the general population, women have a 5%-10% lifetime risk of needing surgery for a suspected ovarian mass and a 1.4% (1 in 70) risk that this mass is cancerous. The majority of ovarian cysts or masses therefore are benign.

A thorough history – including family history – and physical examination with appropriate laboratory testing and directed imaging are important first steps for the ob.gyn. Fortunately, we have guidelines and criteria governing not only when observation or surgery is warranted but also when patients should be referred to a gynecologic oncologist. By following these guidelines,¹ we are able to achieve the best outcomes.
 

Transvaginal ultrasound

A 2007 groundbreaking study led by Barbara Goff, MD, demonstrated that there are warning signs for ovarian cancer – symptoms that are significantly associated with malignancy. Dr. Goff and her coinvestigators evaluated the charts of hundreds of patients, including about 150 with ovarian cancer, and found that pelvic/abdominal pressure or pain, bloating, increase in abdominal size, and difficulty eating or feeling full were significantly and independently associated with cancer if these symptoms were present for less than a year and occurred at least 12 times per month.²

A pelvic examination is an integral part of evaluating every patient who has such concerns. That said, pelvic exams have limited ability to identify adnexal masses, especially in women who are obese – and that’s where imaging becomes especially important.

Masses generally can be considered simple or complex based on their appearance. A simple cyst is fluid-filled with thin, smooth walls and the absence of solid components or septations; it is significantly more likely to resolve on its own and is less likely to imply malignancy than a complex cyst, especially in a premenopausal woman. A complex cyst is multiseptated and/or solid – possibly with papillary projections – and is more concerning, especially if there is increased, new vascularity. Making this distinction helps us determine the risk of malignancy.

Transvaginal ultrasound (TVUS) is the preferred method for imaging, and our threshold for obtaining a TVUS should be very low. Women who have symptoms or concerns that can’t be attributed to a particular condition, and women in whom a mass can be palpated (even if asymptomatic) should have a TVUS. The imaging modality is cost effective and well tolerated by patients, does not expose the patient to ionizing radiation, and should generally be considered first-line imaging.^3,4

Size is not predictive of malignancy, but it is important for determining whether surgery is warranted. In our experience, a mass of 8-10 cm or larger on TVUS is at risk of torsion and is unlikely to resolve on its own, even in a premenopausal woman. While large masses generally require surgery, patients of any age who have simple cysts smaller than 8-10 cm generally can be followed with serial exams and ultrasound; spontaneous regression is common.

Doppler ultrasonography is useful for evaluating blood flow in and around an ovarian mass and can be helpful for confirming suspected characteristics of a mass.

Recent studies from the radiology community have looked at the utility of the resistive index – a measure of the impedance and velocity of blood flow – as a predictor of ovarian malignancy. However, we caution against using Doppler to determine whether a mass is benign or malignant, or to determine the necessity of surgery. An abnormal ovary may have what is considered to be a normal resistive index, and the resistive index of a normal ovary may fall within the abnormal range. Doppler flow can be helpful, but it must be combined with other predictive features, like solid components with flow or papillary projections within a cyst, to define a decision about surgery.^4,5

Magnetic resonance imaging can be useful in differentiating a fibroid from an ovarian mass, and a CT scan can be helpful in looking for disseminated disease when ovarian cancer is suspected based on ultrasound imaging, physical and history, and serum markers. A CT is useful, for instance, in a patient whose ovary is distended with ascites or who has upper abdominal complaints and a complex cyst. CT, PET, and MRI are not recommended in the initial evaluation of an ovarian mass.

The utility of serum biomarkers

Cancer antigen 125 (CA-125) testing may be helpful – in combination with other findings – for decision-making regarding the likelihood of malignancy and the need to refer patients. CA-125 is like Doppler in that a normal CA-125 cannot eliminate the possibility of cancer, and an abnormal CA-125 does not in and of itself imply malignancy. It’s far from a perfect cancer screening test.

CA-125 is a protein associated with epithelial ovarian malignancies, the type of ovarian cancer most commonly seen in postmenopausal women with genetic predispositions. Its specificity and positive predictive value are much higher in postmenopausal women than in average-risk premenopausal women (those without a family history or a known mutation that predisposes them to ovarian cancer). Levels of the marker are elevated in association with many nonmalignant conditions in premenopausal women – endometriosis, fibroids, and various inflammatory conditions, for instance – so the marker’s utility in this population is limited.

For women who have a family history of ovarian cancer or a known breast cancer gene 1 (BRCA1) or BRCA2 mutation, there are some data that suggest that monitoring with CA-125 measurements and TVUS may be a good approach to following patients prior to the age at which risk-reducing surgery can best be performed.

In an adolescent girl or a woman of reproductive age, we think less about epithelial cancer and more about germ-cell and stromal tumors. When a solid mass is palpated or visualized on imaging, we therefore will utilize a different set of markers; alpha-fetoprotein, L-lactate dehydrogenase, and beta-HCG, for instance, have much higher specificity than CA-125 does for germ-cell tumors in this age group and may be helpful in the evaluation. Similarly, in cases of a very large mass resembling a mucinous tumor, a carcinoembryonic antigen may be helpful.

A number of proprietary profiling technologies have been developed to determine the risk of a diagnosed mass being malignant. For instance, the OVA1 assay looks at five serum markers and scores the results, and the Risk of Ovarian Malignancy Algorithm (ROMA) combines the results of three serum markers with menopausal status into a numerical score. Both have Food and Drug Administration approval for use in women in whom surgery has been deemed necessary. These panels can be fairly predictive of risk and may be helpful – especially in rural areas – in determining which women should be referred to a gynecologic oncologist for surgery.

It is important to appreciate that an ovarian cyst or mass should never be biopsied or aspirated lest a malignant tumor confined to one ovary be potentially spread to the peritoneum.
 

Referral to a gynecologic oncologist

Postmenopausal women with a CA-125 greater than 35 U/mL should be referred, as should postmenopausal women with ascites, those with a nodular or fixed pelvic mass, and those with suspected abdominal or distant metastases (per a CT scan, for instance).

In premenopausal women, ascites, a nodular or fixed mass, and evidence of metastases also are reasons for referral to a gynecologic oncologist. CA-125, again, is much more likely to be elevated for reasons other than malignancy and therefore is not as strong a driver for referral as in postmenopausal women. Patients with markedly elevated levels, however, should probably be referred – particularly when other clinical factors also suggest the need for consultation. While there is no evidence-based threshold for CA-125 in premenopausal women, a CA-125 greater than 200 U/mL is a good cutoff for referral.

For any patient, family history of breast and/or ovarian cancer – especially in a first-degree relative – raises the risk of malignancy and should figure prominently into decision-making regarding referral. Criteria for referral are among the points discussed in the ACOG 2016 Practice Bulletin on Evaluation and Management of Adnexal Masses.¹

A note on BRCA mutations

As the American College of Obstetricians and Gynecologists says in its practice bulletin, the most important personal risk factor for ovarian cancer is a strong family history of breast or ovarian cancer. Women with such a family history can undergo genetic testing for BRCA mutations and have the opportunity to prevent ovarian cancers when mutations are detected. This simple blood test can save lives.

A modeling study we recently completed – not yet published – shows that it actually would be cost effective to do population screening with BRCA testing performed on every woman at age 30 years.

According to the National Cancer Institute website (last review: 2018), it is estimated that about 44% of women who inherit a BRCA1 mutation, and about 17% of those who inherit a BRAC2 mutation, will develop ovarian cancer by the age of 80 years. By identifying those mutations, women may undergo risk-reducing surgery at designated ages after childbearing is complete and bring their risk down to under 5%.

An international take on managing adnexal masses

• Pelvic ultrasound should include the transvaginal approach. Use Doppler imaging as indicated.
• Although simple ovarian cysts are not precursor lesions to a malignant ovarian cancer, perform a high-quality examination to make sure there are no solid/papillary structures before classifying a cyst as a simple cyst. The risk of progression to malignancy is extremely low, but some follow-up is prudent.
• The most accurate method of characterizing an ovarian mass currently is real-time pattern recognition sonography in the hands of an experienced imager.
• Pattern recognition sonography or a risk model such as the International Ovarian Tumor Analysis (IOTA) Simple Rules can be used to initially characterize an ovarian mass.
• When an ovarian lesion is classified as benign, the patient may be followed conservatively, or if indicated, surgery can be performed by a general gynecologist.
• Serial sonography can be beneficial, but there are limited prospective data to support an exact interval and duration.
• Fewer surgical interventions may result in an increase in sonographic surveillance.
• When an ovarian lesion is considered indeterminate on initial sonography, and after appropriate clinical evaluation, a “second-step” evaluation may include referral to an expert sonologist, serial sonography, application of established risk-prediction models, correlation with serum biomarkers, correlation with MRI, or referral to a gynecologic oncologist for further evaluation.

From the First International Consensus Report on Adnexal Masses: Management Recommendations

Source: Glanc P et al. J Ultrasound Med. 2017 May;36(5):849-63.

Dr. Brown reported that she had received an earlier grant from Aspira Labs, the company that developed the OVA1 assay. Dr. Miller reported that he has no relevant financial disclosures.

References

1. Obstet Gynecol. 2016 Nov. doi: 10.1097/AOG.0000000000001768.

2. Cancer. 2007 Jan 15. doi: 10.1002/cncr.22371.

3. Clin Obstet Gynecol. 2015 Mar. doi: 10.1097/GRF.0000000000000083.

4. Ultrasound Q. 2013 Mar. doi: 10.1097/RUQ.0b013e3182814d9b.

5. Ultrasound Obstet Gynecol. 2008 Jun. doi: 10.1002/uog.5365.

Ovarian masses are common in women of all ages. It is important not to miss even one ovarian cancer, but we must also identify masses that will resolve on their own over time to avoid overtreatment. These concurrent goals of excluding malignancy while not overtreating patients are the basis for management of the pelvic mass. Additionally, fertility preservation is important when surgery is performed in a reproductive-aged woman.

An ovarian mass may be anything from a simple functional or physiologic cyst to an endometrioma to an epithelial carcinoma, a germ-cell tumor, or a stromal tumor (the latter three of which may metastasize). Across the general population, women have a 5%-10% lifetime risk of needing surgery for a suspected ovarian mass and a 1.4% (1 in 70) risk that this mass is cancerous. The majority of ovarian cysts or masses therefore are benign.

A thorough history – including family history – and physical examination with appropriate laboratory testing and directed imaging are important first steps for the ob.gyn. Fortunately, we have guidelines and criteria governing not only when observation or surgery is warranted but also when patients should be referred to a gynecologic oncologist. By following these guidelines,¹ we are able to achieve the best outcomes.
 

Transvaginal ultrasound

A 2007 groundbreaking study led by Barbara Goff, MD, demonstrated that there are warning signs for ovarian cancer – symptoms that are significantly associated with malignancy. Dr. Goff and her coinvestigators evaluated the charts of hundreds of patients, including about 150 with ovarian cancer, and found that pelvic/abdominal pressure or pain, bloating, increase in abdominal size, and difficulty eating or feeling full were significantly and independently associated with cancer if these symptoms were present for less than a year and occurred at least 12 times per month.²

A pelvic examination is an integral part of evaluating every patient who has such concerns. That said, pelvic exams have limited ability to identify adnexal masses, especially in women who are obese – and that’s where imaging becomes especially important.

Masses generally can be considered simple or complex based on their appearance. A simple cyst is fluid-filled with thin, smooth walls and the absence of solid components or septations; it is significantly more likely to resolve on its own and is less likely to imply malignancy than a complex cyst, especially in a premenopausal woman. A complex cyst is multiseptated and/or solid – possibly with papillary projections – and is more concerning, especially if there is increased, new vascularity. Making this distinction helps us determine the risk of malignancy.

Transvaginal ultrasound (TVUS) is the preferred method for imaging, and our threshold for obtaining a TVUS should be very low. Women who have symptoms or concerns that can’t be attributed to a particular condition, and women in whom a mass can be palpated (even if asymptomatic) should have a TVUS. The imaging modality is cost effective and well tolerated by patients, does not expose the patient to ionizing radiation, and should generally be considered first-line imaging.^3,4

Size is not predictive of malignancy, but it is important for determining whether surgery is warranted. In our experience, a mass of 8-10 cm or larger on TVUS is at risk of torsion and is unlikely to resolve on its own, even in a premenopausal woman. While large masses generally require surgery, patients of any age who have simple cysts smaller than 8-10 cm generally can be followed with serial exams and ultrasound; spontaneous regression is common.

Doppler ultrasonography is useful for evaluating blood flow in and around an ovarian mass and can be helpful for confirming suspected characteristics of a mass.

Recent studies from the radiology community have looked at the utility of the resistive index – a measure of the impedance and velocity of blood flow – as a predictor of ovarian malignancy. However, we caution against using Doppler to determine whether a mass is benign or malignant, or to determine the necessity of surgery. An abnormal ovary may have what is considered to be a normal resistive index, and the resistive index of a normal ovary may fall within the abnormal range. Doppler flow can be helpful, but it must be combined with other predictive features, like solid components with flow or papillary projections within a cyst, to define a decision about surgery.^4,5

Magnetic resonance imaging can be useful in differentiating a fibroid from an ovarian mass, and a CT scan can be helpful in looking for disseminated disease when ovarian cancer is suspected based on ultrasound imaging, physical and history, and serum markers. A CT is useful, for instance, in a patient whose ovary is distended with ascites or who has upper abdominal complaints and a complex cyst. CT, PET, and MRI are not recommended in the initial evaluation of an ovarian mass.

The utility of serum biomarkers

Cancer antigen 125 (CA-125) testing may be helpful – in combination with other findings – for decision-making regarding the likelihood of malignancy and the need to refer patients. CA-125 is like Doppler in that a normal CA-125 cannot eliminate the possibility of cancer, and an abnormal CA-125 does not in and of itself imply malignancy. It’s far from a perfect cancer screening test.

CA-125 is a protein associated with epithelial ovarian malignancies, the type of ovarian cancer most commonly seen in postmenopausal women with genetic predispositions. Its specificity and positive predictive value are much higher in postmenopausal women than in average-risk premenopausal women (those without a family history or a known mutation that predisposes them to ovarian cancer). Levels of the marker are elevated in association with many nonmalignant conditions in premenopausal women – endometriosis, fibroids, and various inflammatory conditions, for instance – so the marker’s utility in this population is limited.

For women who have a family history of ovarian cancer or a known breast cancer gene 1 (BRCA1) or BRCA2 mutation, there are some data that suggest that monitoring with CA-125 measurements and TVUS may be a good approach to following patients prior to the age at which risk-reducing surgery can best be performed.

In an adolescent girl or a woman of reproductive age, we think less about epithelial cancer and more about germ-cell and stromal tumors. When a solid mass is palpated or visualized on imaging, we therefore will utilize a different set of markers; alpha-fetoprotein, L-lactate dehydrogenase, and beta-HCG, for instance, have much higher specificity than CA-125 does for germ-cell tumors in this age group and may be helpful in the evaluation. Similarly, in cases of a very large mass resembling a mucinous tumor, a carcinoembryonic antigen may be helpful.

A number of proprietary profiling technologies have been developed to determine the risk of a diagnosed mass being malignant. For instance, the OVA1 assay looks at five serum markers and scores the results, and the Risk of Ovarian Malignancy Algorithm (ROMA) combines the results of three serum markers with menopausal status into a numerical score. Both have Food and Drug Administration approval for use in women in whom surgery has been deemed necessary. These panels can be fairly predictive of risk and may be helpful – especially in rural areas – in determining which women should be referred to a gynecologic oncologist for surgery.

It is important to appreciate that an ovarian cyst or mass should never be biopsied or aspirated lest a malignant tumor confined to one ovary be potentially spread to the peritoneum.
 

Referral to a gynecologic oncologist

Postmenopausal women with a CA-125 greater than 35 U/mL should be referred, as should postmenopausal women with ascites, those with a nodular or fixed pelvic mass, and those with suspected abdominal or distant metastases (per a CT scan, for instance).

In premenopausal women, ascites, a nodular or fixed mass, and evidence of metastases also are reasons for referral to a gynecologic oncologist. CA-125, again, is much more likely to be elevated for reasons other than malignancy and therefore is not as strong a driver for referral as in postmenopausal women. Patients with markedly elevated levels, however, should probably be referred – particularly when other clinical factors also suggest the need for consultation. While there is no evidence-based threshold for CA-125 in premenopausal women, a CA-125 greater than 200 U/mL is a good cutoff for referral.

For any patient, family history of breast and/or ovarian cancer – especially in a first-degree relative – raises the risk of malignancy and should figure prominently into decision-making regarding referral. Criteria for referral are among the points discussed in the ACOG 2016 Practice Bulletin on Evaluation and Management of Adnexal Masses.¹

A note on BRCA mutations

As the American College of Obstetricians and Gynecologists says in its practice bulletin, the most important personal risk factor for ovarian cancer is a strong family history of breast or ovarian cancer. Women with such a family history can undergo genetic testing for BRCA mutations and have the opportunity to prevent ovarian cancers when mutations are detected. This simple blood test can save lives.

A modeling study we recently completed – not yet published – shows that it actually would be cost effective to do population screening with BRCA testing performed on every woman at age 30 years.

According to the National Cancer Institute website (last review: 2018), it is estimated that about 44% of women who inherit a BRCA1 mutation, and about 17% of those who inherit a BRAC2 mutation, will develop ovarian cancer by the age of 80 years. By identifying those mutations, women may undergo risk-reducing surgery at designated ages after childbearing is complete and bring their risk down to under 5%.

An international take on managing adnexal masses

• Pelvic ultrasound should include the transvaginal approach. Use Doppler imaging as indicated.
• Although simple ovarian cysts are not precursor lesions to a malignant ovarian cancer, perform a high-quality examination to make sure there are no solid/papillary structures before classifying a cyst as a simple cyst. The risk of progression to malignancy is extremely low, but some follow-up is prudent.
• The most accurate method of characterizing an ovarian mass currently is real-time pattern recognition sonography in the hands of an experienced imager.
• Pattern recognition sonography or a risk model such as the International Ovarian Tumor Analysis (IOTA) Simple Rules can be used to initially characterize an ovarian mass.
• When an ovarian lesion is classified as benign, the patient may be followed conservatively, or if indicated, surgery can be performed by a general gynecologist.
• Serial sonography can be beneficial, but there are limited prospective data to support an exact interval and duration.
• Fewer surgical interventions may result in an increase in sonographic surveillance.
• When an ovarian lesion is considered indeterminate on initial sonography, and after appropriate clinical evaluation, a “second-step” evaluation may include referral to an expert sonologist, serial sonography, application of established risk-prediction models, correlation with serum biomarkers, correlation with MRI, or referral to a gynecologic oncologist for further evaluation.

From the First International Consensus Report on Adnexal Masses: Management Recommendations

Source: Glanc P et al. J Ultrasound Med. 2017 May;36(5):849-63.

Dr. Brown reported that she had received an earlier grant from Aspira Labs, the company that developed the OVA1 assay. Dr. Miller reported that he has no relevant financial disclosures.

References

1. Obstet Gynecol. 2016 Nov. doi: 10.1097/AOG.0000000000001768.

2. Cancer. 2007 Jan 15. doi: 10.1002/cncr.22371.

3. Clin Obstet Gynecol. 2015 Mar. doi: 10.1097/GRF.0000000000000083.

4. Ultrasound Q. 2013 Mar. doi: 10.1097/RUQ.0b013e3182814d9b.

5. Ultrasound Obstet Gynecol. 2008 Jun. doi: 10.1002/uog.5365.

About 22% of children with COVID-19 infections were asymptomatic, and 66% of the symptomatic children had unrecognized symptoms at the time of diagnosis, based on data from a case series of 91 confirmed cases.

South_agency/Getty Images

Although recent reports suggest that COVID-19 infections in children are generally mild, data on the full spectrum of illness and duration of viral RNA in children are limited, wrote Mi Seon Han, MD, PhD, of Seoul (South Korea) Metropolitan Government–Seoul National University Boramae Medical Center, and colleagues.

To examine the full clinical course and duration of COVID-19 RNA detectability in children with confirmed infections, the researchers reviewed data from 91 individuals with confirmed infections. The children ranged in age from 27 days to 18 years, and 58% were male. The children were monitored at 20 hospitals and 2 isolation facilities for a mean 21.9 days. The findings were published in JAMA Pediatrics.

Overall, COVID-19 viral RNA was present in the study population for a mean 17.6 days, with testing done at a median interval of 3 days. A total of 20 children (22%) were asymptomatic throughout the study period. In these children, viral RNA was detected for a mean 14 days.

“The major hurdle implicated in this study in diagnosing and treating children with COVID-19 is that a considerable number of children are asymptomatic, and even if symptoms are present, they are unrecognized and overlooked before COVID-19 is diagnosed,” the researchers noted.

Of the 71 symptomatic children, 47 (66%) had unrecognized symptoms prior to diagnosis, 18 (25%) developed symptoms after diagnosis, and 6 (9%) were diagnosed at the time of symptom onset. The symptomatic children were symptomatic for a median of 11 days; 43 (61%) remained symptomatic at 7 days’ follow-up after the study period, 27 (38%) were symptomatic at 14 days, and 7 (10%) were symptomatic at 21 days.

A total of 41 children had upper respiratory infections (58%) and 22 children (24%) had lower respiratory tract infections. No difference in the duration of virus RNA was detected between children with upper respiratory tract infections and lower respiratory tract infections (average, 18.7 days vs. 19.9 days).

Among the symptomatic children, 46 (65%) had mild cases and 20 (28%) had moderate cases.

For treatment, 14 children (15%) received lopinavir-ritonavir and/or hydroxychloroquine. Two patients had severe illness and received oxygen via nasal prong, without the need for mechanical ventilation. All the children in the case series recovered from their infections with no fatalities.

The study’s main limitation was the inability to analyze the transmission potential of the children because of the quarantine and isolation policies in Korea, the researchers noted. In addition, the researchers did not perform follow-up testing at consistent intervals, so the duration of COVID-19 RNA detection may be inexact.

However, the results suggest “that suspecting and diagnosing COVID-19 in children based on their symptoms without epidemiologic information and virus testing is very challenging,” the researchers emphasized.

“Most of the children with COVID-19 have silent disease, but SARS-CoV-2 RNA can still be detected in the respiratory tract for a prolonged period,” they wrote. More research is needed to explore the potential for disease transmission by children in the community, and increased surveillance with laboratory screening can help identify children with unrecognized infections.

The study is the first known to focus on the frequency of asymptomatic infection in children and the duration of symptoms in both asymptomatic and symptomatic children, Roberta L. DeBiasi, MD, and Meghan Delaney, DO, both affiliated with Children’s National Hospital and Research Institute, Washington, and George Washington University, Washington, wrote in an accompanying editorial. The structure of the Korean public health system “allowed for the sequential observation, testing (median testing interval of every 3 days), and comparison of 91 asymptomatic, presymptomatic, and symptomatic children with mild to moderate upper and lower respiratory tract infection, identified primarily by contact tracing from laboratory-proven cases.”

Two take-home points from the study are that not all infected children are symptomatic, and the duration of symptoms in those who are varies widely, they noted. “Interestingly, this study aligns with adult data in which up to 40% of adults may remain asymptomatic in the face of infection.”

However, “The third and most important take-home point from this study relates to the duration of viral shedding in infected pediatric patients,” Dr. DeBiasi and Dr. Delaney said (JAMA Pediatr. 2020 Aug 28. doi: 10.1001/jamapediatrics.2020.3996).

“Fully half of symptomatic children with both upper and lower tract disease were still shedding virus at 21 days. These are striking data, particularly since 86 of 88 diagnosed children (98%) either had no symptoms or mild or moderate disease,” they explained. The results highlight the need for improvements in qualitative molecular testing and formal studies to identify differences in results from different testing scenarios, such as hospital entry, preprocedure screening, and symptomatic testing. In addition, “these findings are highly relevant to the development of public health strategies to mitigate and contain spread within communities, particularly as affected communities begin their recovery phases.”

The study is important because “schools are opening, and we don’t know what is going to happen,” Michael E. Pichichero, MD, of Rochester General Hospital, N.Y., said in an interview.

“Clinicians, parents, students, school administrators and politicians are worried,” he said. “This study adds to others recently published, bringing into focus the challenges to several suppositions that existed when the COVID-19 pandemic began and over the summer.”

“This study of 91 Korean children tells us that taking a child’s temperature as a screening tool to decide if they may enter school will not be a highly successful strategy,” he said. “Many children are without fever and asymptomatic when infected and contagious. The notion that children shed less virus or shed it for shorter lengths of time we keep learning from this type of research is not true. In another recent study the authors found that children shed as much of the SARS-CoV-2 virus as an adult in the ICU on a ventilator.”

Dr. Pichichero said he was not surprised by the study findings. “A similar paper was published last week in the Journal of Pediatrics from Massachusetts General Hospital, so the findings in the JAMA paper are similar to what has been reported in the United States.”

“Availability of testing will continue to be a challenge in some communities,” said Dr. Pichichero. “Here in the Rochester, New York, area we will use a screening questionnaire based on the CDC [Centers for Disease Control and Prevention] symptom criteria of SARS-CoV-2 infections to decide whom to test.”

As for additional research, “We have so much more to learn about SARS-CoV-2 in children,” he emphasized. “The focus has been on adults because the morbidity and mortality has been greatest in adults, especially the elderly and those with compromised health.”

“The National Institutes of Health has issued a call for more research in children to characterize the spectrum of SARS-CoV-2 illness, including the multisystem inflammatory syndrome in children [MIS-C] and try to identify biomarkers and/or biosignatures for a prognostic algorithm to predict the longitudinal risk of disease severity after a child is exposed to and may be infected with SARS-CoV-2,” said Dr. Pichichero. “NIH has asked researchers to answer the following questions.”

• Why do children have milder illness?
• Are there differences in childhood biology (e.g., gender, puberty, etc.) that contribute to illness severity?
• Are there genetic host differences associated with different disease severity phenotypes, including MIS-C?
• Are there innate mucosal, humoral, cellular and other adaptive immune profiles that are associated with reduced or increased risk of progressive disease, including previous coronavirus infections?
• Will SARS-CoV-2 reinfection cause worse disease as seen with antibody-dependent enhancement (ADE) in other viral infections (e.g., dengue)? Will future vaccines carry a risk of the ADE phenomenon?
• Does substance use (e.g., nicotine, marijuana) exacerbate or trigger MIS-C through immune activation?

“We have no knowledge yet about SARS-CoV-2 vaccination of children, especially young children,” Dr. Pichichero emphasized. “There are different types of vaccines – messenger RNA, adenovirus vector and purified spike proteins of the virus – among others, but questions remain: Will the vaccines work in children? What about side effects? Will the antibodies and cellular immunity protect partially or completely?”

The researchers and editorialists had no financial conflicts to disclose. Dr. Pichichero had no financial conflicts to disclose.

SOURCE: Han MS et al. JAMA Pediatr. 2020 Aug 28. doi:10.1001/jamapediatrics.2020.3988.

About 22% of children with COVID-19 infections were asymptomatic, and 66% of the symptomatic children had unrecognized symptoms at the time of diagnosis, based on data from a case series of 91 confirmed cases.

South_agency/Getty Images

Although recent reports suggest that COVID-19 infections in children are generally mild, data on the full spectrum of illness and duration of viral RNA in children are limited, wrote Mi Seon Han, MD, PhD, of Seoul (South Korea) Metropolitan Government–Seoul National University Boramae Medical Center, and colleagues.

To examine the full clinical course and duration of COVID-19 RNA detectability in children with confirmed infections, the researchers reviewed data from 91 individuals with confirmed infections. The children ranged in age from 27 days to 18 years, and 58% were male. The children were monitored at 20 hospitals and 2 isolation facilities for a mean 21.9 days. The findings were published in JAMA Pediatrics.

Overall, COVID-19 viral RNA was present in the study population for a mean 17.6 days, with testing done at a median interval of 3 days. A total of 20 children (22%) were asymptomatic throughout the study period. In these children, viral RNA was detected for a mean 14 days.

“The major hurdle implicated in this study in diagnosing and treating children with COVID-19 is that a considerable number of children are asymptomatic, and even if symptoms are present, they are unrecognized and overlooked before COVID-19 is diagnosed,” the researchers noted.

Of the 71 symptomatic children, 47 (66%) had unrecognized symptoms prior to diagnosis, 18 (25%) developed symptoms after diagnosis, and 6 (9%) were diagnosed at the time of symptom onset. The symptomatic children were symptomatic for a median of 11 days; 43 (61%) remained symptomatic at 7 days’ follow-up after the study period, 27 (38%) were symptomatic at 14 days, and 7 (10%) were symptomatic at 21 days.

A total of 41 children had upper respiratory infections (58%) and 22 children (24%) had lower respiratory tract infections. No difference in the duration of virus RNA was detected between children with upper respiratory tract infections and lower respiratory tract infections (average, 18.7 days vs. 19.9 days).

Among the symptomatic children, 46 (65%) had mild cases and 20 (28%) had moderate cases.

For treatment, 14 children (15%) received lopinavir-ritonavir and/or hydroxychloroquine. Two patients had severe illness and received oxygen via nasal prong, without the need for mechanical ventilation. All the children in the case series recovered from their infections with no fatalities.

The study’s main limitation was the inability to analyze the transmission potential of the children because of the quarantine and isolation policies in Korea, the researchers noted. In addition, the researchers did not perform follow-up testing at consistent intervals, so the duration of COVID-19 RNA detection may be inexact.

However, the results suggest “that suspecting and diagnosing COVID-19 in children based on their symptoms without epidemiologic information and virus testing is very challenging,” the researchers emphasized.

“Most of the children with COVID-19 have silent disease, but SARS-CoV-2 RNA can still be detected in the respiratory tract for a prolonged period,” they wrote. More research is needed to explore the potential for disease transmission by children in the community, and increased surveillance with laboratory screening can help identify children with unrecognized infections.

The study is the first known to focus on the frequency of asymptomatic infection in children and the duration of symptoms in both asymptomatic and symptomatic children, Roberta L. DeBiasi, MD, and Meghan Delaney, DO, both affiliated with Children’s National Hospital and Research Institute, Washington, and George Washington University, Washington, wrote in an accompanying editorial. The structure of the Korean public health system “allowed for the sequential observation, testing (median testing interval of every 3 days), and comparison of 91 asymptomatic, presymptomatic, and symptomatic children with mild to moderate upper and lower respiratory tract infection, identified primarily by contact tracing from laboratory-proven cases.”

Two take-home points from the study are that not all infected children are symptomatic, and the duration of symptoms in those who are varies widely, they noted. “Interestingly, this study aligns with adult data in which up to 40% of adults may remain asymptomatic in the face of infection.”

However, “The third and most important take-home point from this study relates to the duration of viral shedding in infected pediatric patients,” Dr. DeBiasi and Dr. Delaney said (JAMA Pediatr. 2020 Aug 28. doi: 10.1001/jamapediatrics.2020.3996).

“Fully half of symptomatic children with both upper and lower tract disease were still shedding virus at 21 days. These are striking data, particularly since 86 of 88 diagnosed children (98%) either had no symptoms or mild or moderate disease,” they explained. The results highlight the need for improvements in qualitative molecular testing and formal studies to identify differences in results from different testing scenarios, such as hospital entry, preprocedure screening, and symptomatic testing. In addition, “these findings are highly relevant to the development of public health strategies to mitigate and contain spread within communities, particularly as affected communities begin their recovery phases.”

The study is important because “schools are opening, and we don’t know what is going to happen,” Michael E. Pichichero, MD, of Rochester General Hospital, N.Y., said in an interview.

“Clinicians, parents, students, school administrators and politicians are worried,” he said. “This study adds to others recently published, bringing into focus the challenges to several suppositions that existed when the COVID-19 pandemic began and over the summer.”

“This study of 91 Korean children tells us that taking a child’s temperature as a screening tool to decide if they may enter school will not be a highly successful strategy,” he said. “Many children are without fever and asymptomatic when infected and contagious. The notion that children shed less virus or shed it for shorter lengths of time we keep learning from this type of research is not true. In another recent study the authors found that children shed as much of the SARS-CoV-2 virus as an adult in the ICU on a ventilator.”

Dr. Pichichero said he was not surprised by the study findings. “A similar paper was published last week in the Journal of Pediatrics from Massachusetts General Hospital, so the findings in the JAMA paper are similar to what has been reported in the United States.”

“Availability of testing will continue to be a challenge in some communities,” said Dr. Pichichero. “Here in the Rochester, New York, area we will use a screening questionnaire based on the CDC [Centers for Disease Control and Prevention] symptom criteria of SARS-CoV-2 infections to decide whom to test.”

As for additional research, “We have so much more to learn about SARS-CoV-2 in children,” he emphasized. “The focus has been on adults because the morbidity and mortality has been greatest in adults, especially the elderly and those with compromised health.”

“The National Institutes of Health has issued a call for more research in children to characterize the spectrum of SARS-CoV-2 illness, including the multisystem inflammatory syndrome in children [MIS-C] and try to identify biomarkers and/or biosignatures for a prognostic algorithm to predict the longitudinal risk of disease severity after a child is exposed to and may be infected with SARS-CoV-2,” said Dr. Pichichero. “NIH has asked researchers to answer the following questions.”

• Why do children have milder illness?
• Are there differences in childhood biology (e.g., gender, puberty, etc.) that contribute to illness severity?
• Are there genetic host differences associated with different disease severity phenotypes, including MIS-C?
• Are there innate mucosal, humoral, cellular and other adaptive immune profiles that are associated with reduced or increased risk of progressive disease, including previous coronavirus infections?
• Will SARS-CoV-2 reinfection cause worse disease as seen with antibody-dependent enhancement (ADE) in other viral infections (e.g., dengue)? Will future vaccines carry a risk of the ADE phenomenon?
• Does substance use (e.g., nicotine, marijuana) exacerbate or trigger MIS-C through immune activation?

“We have no knowledge yet about SARS-CoV-2 vaccination of children, especially young children,” Dr. Pichichero emphasized. “There are different types of vaccines – messenger RNA, adenovirus vector and purified spike proteins of the virus – among others, but questions remain: Will the vaccines work in children? What about side effects? Will the antibodies and cellular immunity protect partially or completely?”

The researchers and editorialists had no financial conflicts to disclose. Dr. Pichichero had no financial conflicts to disclose.

SOURCE: Han MS et al. JAMA Pediatr. 2020 Aug 28. doi:10.1001/jamapediatrics.2020.3988.

About 22% of children with COVID-19 infections were asymptomatic, and 66% of the symptomatic children had unrecognized symptoms at the time of diagnosis, based on data from a case series of 91 confirmed cases.

South_agency/Getty Images

Although recent reports suggest that COVID-19 infections in children are generally mild, data on the full spectrum of illness and duration of viral RNA in children are limited, wrote Mi Seon Han, MD, PhD, of Seoul (South Korea) Metropolitan Government–Seoul National University Boramae Medical Center, and colleagues.

To examine the full clinical course and duration of COVID-19 RNA detectability in children with confirmed infections, the researchers reviewed data from 91 individuals with confirmed infections. The children ranged in age from 27 days to 18 years, and 58% were male. The children were monitored at 20 hospitals and 2 isolation facilities for a mean 21.9 days. The findings were published in JAMA Pediatrics.

Overall, COVID-19 viral RNA was present in the study population for a mean 17.6 days, with testing done at a median interval of 3 days. A total of 20 children (22%) were asymptomatic throughout the study period. In these children, viral RNA was detected for a mean 14 days.

“The major hurdle implicated in this study in diagnosing and treating children with COVID-19 is that a considerable number of children are asymptomatic, and even if symptoms are present, they are unrecognized and overlooked before COVID-19 is diagnosed,” the researchers noted.

Of the 71 symptomatic children, 47 (66%) had unrecognized symptoms prior to diagnosis, 18 (25%) developed symptoms after diagnosis, and 6 (9%) were diagnosed at the time of symptom onset. The symptomatic children were symptomatic for a median of 11 days; 43 (61%) remained symptomatic at 7 days’ follow-up after the study period, 27 (38%) were symptomatic at 14 days, and 7 (10%) were symptomatic at 21 days.

A total of 41 children had upper respiratory infections (58%) and 22 children (24%) had lower respiratory tract infections. No difference in the duration of virus RNA was detected between children with upper respiratory tract infections and lower respiratory tract infections (average, 18.7 days vs. 19.9 days).

Among the symptomatic children, 46 (65%) had mild cases and 20 (28%) had moderate cases.

For treatment, 14 children (15%) received lopinavir-ritonavir and/or hydroxychloroquine. Two patients had severe illness and received oxygen via nasal prong, without the need for mechanical ventilation. All the children in the case series recovered from their infections with no fatalities.

The study’s main limitation was the inability to analyze the transmission potential of the children because of the quarantine and isolation policies in Korea, the researchers noted. In addition, the researchers did not perform follow-up testing at consistent intervals, so the duration of COVID-19 RNA detection may be inexact.

However, the results suggest “that suspecting and diagnosing COVID-19 in children based on their symptoms without epidemiologic information and virus testing is very challenging,” the researchers emphasized.

“Most of the children with COVID-19 have silent disease, but SARS-CoV-2 RNA can still be detected in the respiratory tract for a prolonged period,” they wrote. More research is needed to explore the potential for disease transmission by children in the community, and increased surveillance with laboratory screening can help identify children with unrecognized infections.

The study is the first known to focus on the frequency of asymptomatic infection in children and the duration of symptoms in both asymptomatic and symptomatic children, Roberta L. DeBiasi, MD, and Meghan Delaney, DO, both affiliated with Children’s National Hospital and Research Institute, Washington, and George Washington University, Washington, wrote in an accompanying editorial. The structure of the Korean public health system “allowed for the sequential observation, testing (median testing interval of every 3 days), and comparison of 91 asymptomatic, presymptomatic, and symptomatic children with mild to moderate upper and lower respiratory tract infection, identified primarily by contact tracing from laboratory-proven cases.”

Two take-home points from the study are that not all infected children are symptomatic, and the duration of symptoms in those who are varies widely, they noted. “Interestingly, this study aligns with adult data in which up to 40% of adults may remain asymptomatic in the face of infection.”

However, “The third and most important take-home point from this study relates to the duration of viral shedding in infected pediatric patients,” Dr. DeBiasi and Dr. Delaney said (JAMA Pediatr. 2020 Aug 28. doi: 10.1001/jamapediatrics.2020.3996).

“Fully half of symptomatic children with both upper and lower tract disease were still shedding virus at 21 days. These are striking data, particularly since 86 of 88 diagnosed children (98%) either had no symptoms or mild or moderate disease,” they explained. The results highlight the need for improvements in qualitative molecular testing and formal studies to identify differences in results from different testing scenarios, such as hospital entry, preprocedure screening, and symptomatic testing. In addition, “these findings are highly relevant to the development of public health strategies to mitigate and contain spread within communities, particularly as affected communities begin their recovery phases.”

The study is important because “schools are opening, and we don’t know what is going to happen,” Michael E. Pichichero, MD, of Rochester General Hospital, N.Y., said in an interview.

“Clinicians, parents, students, school administrators and politicians are worried,” he said. “This study adds to others recently published, bringing into focus the challenges to several suppositions that existed when the COVID-19 pandemic began and over the summer.”

“This study of 91 Korean children tells us that taking a child’s temperature as a screening tool to decide if they may enter school will not be a highly successful strategy,” he said. “Many children are without fever and asymptomatic when infected and contagious. The notion that children shed less virus or shed it for shorter lengths of time we keep learning from this type of research is not true. In another recent study the authors found that children shed as much of the SARS-CoV-2 virus as an adult in the ICU on a ventilator.”

Dr. Pichichero said he was not surprised by the study findings. “A similar paper was published last week in the Journal of Pediatrics from Massachusetts General Hospital, so the findings in the JAMA paper are similar to what has been reported in the United States.”

“Availability of testing will continue to be a challenge in some communities,” said Dr. Pichichero. “Here in the Rochester, New York, area we will use a screening questionnaire based on the CDC [Centers for Disease Control and Prevention] symptom criteria of SARS-CoV-2 infections to decide whom to test.”

As for additional research, “We have so much more to learn about SARS-CoV-2 in children,” he emphasized. “The focus has been on adults because the morbidity and mortality has been greatest in adults, especially the elderly and those with compromised health.”

“The National Institutes of Health has issued a call for more research in children to characterize the spectrum of SARS-CoV-2 illness, including the multisystem inflammatory syndrome in children [MIS-C] and try to identify biomarkers and/or biosignatures for a prognostic algorithm to predict the longitudinal risk of disease severity after a child is exposed to and may be infected with SARS-CoV-2,” said Dr. Pichichero. “NIH has asked researchers to answer the following questions.”

• Why do children have milder illness?
• Are there differences in childhood biology (e.g., gender, puberty, etc.) that contribute to illness severity?
• Are there genetic host differences associated with different disease severity phenotypes, including MIS-C?
• Are there innate mucosal, humoral, cellular and other adaptive immune profiles that are associated with reduced or increased risk of progressive disease, including previous coronavirus infections?
• Will SARS-CoV-2 reinfection cause worse disease as seen with antibody-dependent enhancement (ADE) in other viral infections (e.g., dengue)? Will future vaccines carry a risk of the ADE phenomenon?
• Does substance use (e.g., nicotine, marijuana) exacerbate or trigger MIS-C through immune activation?

“We have no knowledge yet about SARS-CoV-2 vaccination of children, especially young children,” Dr. Pichichero emphasized. “There are different types of vaccines – messenger RNA, adenovirus vector and purified spike proteins of the virus – among others, but questions remain: Will the vaccines work in children? What about side effects? Will the antibodies and cellular immunity protect partially or completely?”

The researchers and editorialists had no financial conflicts to disclose. Dr. Pichichero had no financial conflicts to disclose.

SOURCE: Han MS et al. JAMA Pediatr. 2020 Aug 28. doi:10.1001/jamapediatrics.2020.3988.

Self-employed physicians have the highest salaries, largest homes, and greatest wealth – yet they feel the least fairly compensated, according to an analysis of data from over 17,000 physicians.

A new examination of survey responses from the Medscape Physician Compensation Report 2020, which included information about income, job satisfaction, and more, compared responses from self-employed physicians, independent contractors, and employed physicians.

Income and wealth, benefits, and job satisfaction were compared. From the results of the questionnaire, self-employed physicians stand out among their peers across all categories: They enjoy greater income, wealth, and benefits and appear to be more satisfied by their choice of practice.

“The survey confirms that self-employed is the most satisfying, although the trend in health care is to take employed positions,” said Robert Scroggins, JD, CPA, certified health care business consultant with ScrogginsGreer, Cincinnati. “Doctors who become employees primarily do that to escape the management responsibilities for the practice. It seems to be more a decision to get away from something than to go toward something.”
 

The financial and work picture for self-employed physicians

Self-employed physicians reported the largest salaries for 2019 (average, $360,752), followed by independent contractors ($336,005). Employees reported the lowest average salary ($297,332).

The largest percentage of self-employed physicians (46%) work in an office-based group practice, followed by those in office-based solo practices (30%). Almost two-thirds of self-employed respondents are owners and 37% are partners.

Self-employed physicians are more likely to be older than 45 years; 79% fall into that age bracket, compared with 57% of employees and 70% of independent contractors.

Self-employed physicians reported the highest levels of wealth among their peers. About 44% of self-employed respondents declared a net wealth of over $2 million, compared with 25% of employees. Only 6% of contractors and employed physicians reported a net wealth of over $5 million, compared with 13% of self-employed physicians.

Self-employed physicians also managed their personal expenses slightly differently. They were more likely to pool their income with their spouse in a common account used for bills and expenses, regardless of how much they each earned (63% of self-employed respondents, compared with 58% of employees and 50% of independent contractors).

Perhaps unsurprisingly, self-employed physicians also reported having the largest homes, with an average square footage of 3,629 square feet, compared with 3,023 square feet for employees and 2,984 square feet for independent contractors. Self-employed physicians’ mortgages (average, $240,389) were similar to those of employed physicians’ mortgages but were higher than those of independent contractors’ mortgages (average, $213,740).

Self-employed physicians were also most likely to highly appraise their own performance: Half of all self-employed respondents felt “very satisfied” with their job performance, compared with 40% of employees and 44% of independent contractors.

When asked what they consider to be the most rewarding aspect of their job, self-employed physicians were more likely to choose gratitude and patient relationships than their peers (32%, compared with 26% of employees and 19% of independent contractors).

Despite their higher net wealth and larger salaries, self-employed physicians were least likely to feel fairly compensated; 49% of self-employed physicians said they did not feel fairly compensated for their work, compared with 40% of employees and 40% of independent contractors.

“Self-employed physicians may be better compensated than others of the same specialty who are employees, so some of that may be perception,” said Mr. Scroggins. “Or they feel they should be compensated to a far greater degree than those who are employed.”

Self-employed physicians were also more likely to respond that they would choose the same practice setting again, though across all three categories, fewer than 50% of respondents would do so: 34% of self-employed physicians, compared with 29% of employees and 28% of independent contractors.
 

The financial and work picture for employed physicians

About a third (32%) of employed physician respondents work in hospitals; 28% work in private practices.

Employed physicians were most likely to report a salary increase from 2018 to 2019: 74%, compared with 45% of self-employed and 52% of independent contractors.

As for declines in income, self-employed physicians and independent contractors suffered a comparable loss, with 13% and 12% of them, respectively, reporting salary cuts greater than 10%. Decreases of up to 10% were felt mostly by the self-employed, with 17% experiencing such cuts, compared with 7% of employees and 10% of independent contractors.

In contrast, employees were the least likely of the three categories to have incurred large financial losses over the past year: 77% of employed respondents indicated that they had not experienced any significant financial losses in the past year, compared with 63% of self-employed physicians and 63% of independent contractors. They were also least likely to have made any investments at all over the past year – 21% of employees reported having made none at all in 2019, compared to 11% of self-employed physicians and 16% of independent contractors.
 

The financial and work picture for independent contractors

Just over half (52%) of all independent contractors who responded to our questionnaire work in hospitals, 15% work in group practices, 9% work in outpatient clinics, and just 2% work in solo practices.

Independent contractors were less likely than their peers to have received employment benefits such as health insurance, malpractice coverage, and paid time off. They were also less likely to be saving for retirement. Almost half (45%) of independent contractors said they received no employment benefits at all, compared to 20% of self-employed physicians and just 8% of employees.

What’s more, 27% of independent contractors do not currently put money into a 401(k) retirement account or tax-deferred college savings account on a regular basis, compared with 16% of self-employed physicians and 8% of employees. Similarly, they were less likely to put money into a taxable savings account (39% responded that they do not, compared with 32% of self-employed physicians and 27% of employees).

“Net worth and retirement funding findings do line up with what I’ve observed,” said Mr. Scroggins. “Those who have independent practices as opposed to working for a hospital do tend to more heavily fund retirement plan accounts, which is typically the biggest driver of building net worth.”

Despite the lack of retirement planning, independent contractors were more likely than their peers to derive satisfaction from making money at a job they like (18%, compared with 12% of employees and 11% of self-employed physicians). They’re also far more likely to be in emergency medicine (22% of independent contractors, compared with 3% of self-employed and 5% of employees) or psychiatry (11% of independent contractors, compared with 5% of self-employed and 6% of employees).

Among the three categories of physicians, independent contractors were least likely to say that they would choose the same practice setting again. Across all three categories, fewer than 50% of respondents would do so: 34% of self-employed physicians, compared with 29% of employees and 28% of independent contractors.

Physicians who are considering leaving their own practice for a hospital setting should do so with caution and fully understand what they are getting into, said Mr. Scroggins. “If they’re just looking at compensation, they also should be looking very carefully at retirement plan benefits. If that’s their main method of saving and building net worth, then that’s a dramatic difference.”

And of course, there’s always the intangible value of feeling connected to a practice and its patients: “Physicians got into this line of work to treat patients and help people become healthier, and in hospitals they end up being more disconnected from their patients,” Mr. Scroggins said. “That’s a big factor as well.”

Editor’s note: Only differences that are statistically significant at a 95% confidence level between categories of employment have been included. Of the 13,893 responses included in this analysis, 3,860 physicians identified as self-employed, 9,262 as employees, and 772 as independent contractors.

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

Self-employed physicians have the highest salaries, largest homes, and greatest wealth – yet they feel the least fairly compensated, according to an analysis of data from over 17,000 physicians.

A new examination of survey responses from the Medscape Physician Compensation Report 2020, which included information about income, job satisfaction, and more, compared responses from self-employed physicians, independent contractors, and employed physicians.

Income and wealth, benefits, and job satisfaction were compared. From the results of the questionnaire, self-employed physicians stand out among their peers across all categories: They enjoy greater income, wealth, and benefits and appear to be more satisfied by their choice of practice.

“The survey confirms that self-employed is the most satisfying, although the trend in health care is to take employed positions,” said Robert Scroggins, JD, CPA, certified health care business consultant with ScrogginsGreer, Cincinnati. “Doctors who become employees primarily do that to escape the management responsibilities for the practice. It seems to be more a decision to get away from something than to go toward something.”
 

The financial and work picture for self-employed physicians

Self-employed physicians reported the largest salaries for 2019 (average, $360,752), followed by independent contractors ($336,005). Employees reported the lowest average salary ($297,332).

The largest percentage of self-employed physicians (46%) work in an office-based group practice, followed by those in office-based solo practices (30%). Almost two-thirds of self-employed respondents are owners and 37% are partners.

Self-employed physicians are more likely to be older than 45 years; 79% fall into that age bracket, compared with 57% of employees and 70% of independent contractors.

Self-employed physicians reported the highest levels of wealth among their peers. About 44% of self-employed respondents declared a net wealth of over $2 million, compared with 25% of employees. Only 6% of contractors and employed physicians reported a net wealth of over $5 million, compared with 13% of self-employed physicians.

Self-employed physicians also managed their personal expenses slightly differently. They were more likely to pool their income with their spouse in a common account used for bills and expenses, regardless of how much they each earned (63% of self-employed respondents, compared with 58% of employees and 50% of independent contractors).

Perhaps unsurprisingly, self-employed physicians also reported having the largest homes, with an average square footage of 3,629 square feet, compared with 3,023 square feet for employees and 2,984 square feet for independent contractors. Self-employed physicians’ mortgages (average, $240,389) were similar to those of employed physicians’ mortgages but were higher than those of independent contractors’ mortgages (average, $213,740).

Self-employed physicians were also most likely to highly appraise their own performance: Half of all self-employed respondents felt “very satisfied” with their job performance, compared with 40% of employees and 44% of independent contractors.

When asked what they consider to be the most rewarding aspect of their job, self-employed physicians were more likely to choose gratitude and patient relationships than their peers (32%, compared with 26% of employees and 19% of independent contractors).

Despite their higher net wealth and larger salaries, self-employed physicians were least likely to feel fairly compensated; 49% of self-employed physicians said they did not feel fairly compensated for their work, compared with 40% of employees and 40% of independent contractors.

“Self-employed physicians may be better compensated than others of the same specialty who are employees, so some of that may be perception,” said Mr. Scroggins. “Or they feel they should be compensated to a far greater degree than those who are employed.”

Self-employed physicians were also more likely to respond that they would choose the same practice setting again, though across all three categories, fewer than 50% of respondents would do so: 34% of self-employed physicians, compared with 29% of employees and 28% of independent contractors.
 

The financial and work picture for employed physicians

About a third (32%) of employed physician respondents work in hospitals; 28% work in private practices.

Employed physicians were most likely to report a salary increase from 2018 to 2019: 74%, compared with 45% of self-employed and 52% of independent contractors.

As for declines in income, self-employed physicians and independent contractors suffered a comparable loss, with 13% and 12% of them, respectively, reporting salary cuts greater than 10%. Decreases of up to 10% were felt mostly by the self-employed, with 17% experiencing such cuts, compared with 7% of employees and 10% of independent contractors.

In contrast, employees were the least likely of the three categories to have incurred large financial losses over the past year: 77% of employed respondents indicated that they had not experienced any significant financial losses in the past year, compared with 63% of self-employed physicians and 63% of independent contractors. They were also least likely to have made any investments at all over the past year – 21% of employees reported having made none at all in 2019, compared to 11% of self-employed physicians and 16% of independent contractors.
 

The financial and work picture for independent contractors

Just over half (52%) of all independent contractors who responded to our questionnaire work in hospitals, 15% work in group practices, 9% work in outpatient clinics, and just 2% work in solo practices.

Independent contractors were less likely than their peers to have received employment benefits such as health insurance, malpractice coverage, and paid time off. They were also less likely to be saving for retirement. Almost half (45%) of independent contractors said they received no employment benefits at all, compared to 20% of self-employed physicians and just 8% of employees.

What’s more, 27% of independent contractors do not currently put money into a 401(k) retirement account or tax-deferred college savings account on a regular basis, compared with 16% of self-employed physicians and 8% of employees. Similarly, they were less likely to put money into a taxable savings account (39% responded that they do not, compared with 32% of self-employed physicians and 27% of employees).

“Net worth and retirement funding findings do line up with what I’ve observed,” said Mr. Scroggins. “Those who have independent practices as opposed to working for a hospital do tend to more heavily fund retirement plan accounts, which is typically the biggest driver of building net worth.”

Despite the lack of retirement planning, independent contractors were more likely than their peers to derive satisfaction from making money at a job they like (18%, compared with 12% of employees and 11% of self-employed physicians). They’re also far more likely to be in emergency medicine (22% of independent contractors, compared with 3% of self-employed and 5% of employees) or psychiatry (11% of independent contractors, compared with 5% of self-employed and 6% of employees).

Among the three categories of physicians, independent contractors were least likely to say that they would choose the same practice setting again. Across all three categories, fewer than 50% of respondents would do so: 34% of self-employed physicians, compared with 29% of employees and 28% of independent contractors.

Physicians who are considering leaving their own practice for a hospital setting should do so with caution and fully understand what they are getting into, said Mr. Scroggins. “If they’re just looking at compensation, they also should be looking very carefully at retirement plan benefits. If that’s their main method of saving and building net worth, then that’s a dramatic difference.”

And of course, there’s always the intangible value of feeling connected to a practice and its patients: “Physicians got into this line of work to treat patients and help people become healthier, and in hospitals they end up being more disconnected from their patients,” Mr. Scroggins said. “That’s a big factor as well.”

Editor’s note: Only differences that are statistically significant at a 95% confidence level between categories of employment have been included. Of the 13,893 responses included in this analysis, 3,860 physicians identified as self-employed, 9,262 as employees, and 772 as independent contractors.

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

Self-employed physicians have the highest salaries, largest homes, and greatest wealth – yet they feel the least fairly compensated, according to an analysis of data from over 17,000 physicians.

A new examination of survey responses from the Medscape Physician Compensation Report 2020, which included information about income, job satisfaction, and more, compared responses from self-employed physicians, independent contractors, and employed physicians.

Income and wealth, benefits, and job satisfaction were compared. From the results of the questionnaire, self-employed physicians stand out among their peers across all categories: They enjoy greater income, wealth, and benefits and appear to be more satisfied by their choice of practice.

“The survey confirms that self-employed is the most satisfying, although the trend in health care is to take employed positions,” said Robert Scroggins, JD, CPA, certified health care business consultant with ScrogginsGreer, Cincinnati. “Doctors who become employees primarily do that to escape the management responsibilities for the practice. It seems to be more a decision to get away from something than to go toward something.”
 

The financial and work picture for self-employed physicians

Self-employed physicians reported the largest salaries for 2019 (average, $360,752), followed by independent contractors ($336,005). Employees reported the lowest average salary ($297,332).

The largest percentage of self-employed physicians (46%) work in an office-based group practice, followed by those in office-based solo practices (30%). Almost two-thirds of self-employed respondents are owners and 37% are partners.

Self-employed physicians are more likely to be older than 45 years; 79% fall into that age bracket, compared with 57% of employees and 70% of independent contractors.

Self-employed physicians reported the highest levels of wealth among their peers. About 44% of self-employed respondents declared a net wealth of over $2 million, compared with 25% of employees. Only 6% of contractors and employed physicians reported a net wealth of over $5 million, compared with 13% of self-employed physicians.

Self-employed physicians also managed their personal expenses slightly differently. They were more likely to pool their income with their spouse in a common account used for bills and expenses, regardless of how much they each earned (63% of self-employed respondents, compared with 58% of employees and 50% of independent contractors).

Perhaps unsurprisingly, self-employed physicians also reported having the largest homes, with an average square footage of 3,629 square feet, compared with 3,023 square feet for employees and 2,984 square feet for independent contractors. Self-employed physicians’ mortgages (average, $240,389) were similar to those of employed physicians’ mortgages but were higher than those of independent contractors’ mortgages (average, $213,740).

Self-employed physicians were also most likely to highly appraise their own performance: Half of all self-employed respondents felt “very satisfied” with their job performance, compared with 40% of employees and 44% of independent contractors.

When asked what they consider to be the most rewarding aspect of their job, self-employed physicians were more likely to choose gratitude and patient relationships than their peers (32%, compared with 26% of employees and 19% of independent contractors).

Despite their higher net wealth and larger salaries, self-employed physicians were least likely to feel fairly compensated; 49% of self-employed physicians said they did not feel fairly compensated for their work, compared with 40% of employees and 40% of independent contractors.

“Self-employed physicians may be better compensated than others of the same specialty who are employees, so some of that may be perception,” said Mr. Scroggins. “Or they feel they should be compensated to a far greater degree than those who are employed.”

Self-employed physicians were also more likely to respond that they would choose the same practice setting again, though across all three categories, fewer than 50% of respondents would do so: 34% of self-employed physicians, compared with 29% of employees and 28% of independent contractors.
 

The financial and work picture for employed physicians

About a third (32%) of employed physician respondents work in hospitals; 28% work in private practices.

Employed physicians were most likely to report a salary increase from 2018 to 2019: 74%, compared with 45% of self-employed and 52% of independent contractors.

As for declines in income, self-employed physicians and independent contractors suffered a comparable loss, with 13% and 12% of them, respectively, reporting salary cuts greater than 10%. Decreases of up to 10% were felt mostly by the self-employed, with 17% experiencing such cuts, compared with 7% of employees and 10% of independent contractors.

In contrast, employees were the least likely of the three categories to have incurred large financial losses over the past year: 77% of employed respondents indicated that they had not experienced any significant financial losses in the past year, compared with 63% of self-employed physicians and 63% of independent contractors. They were also least likely to have made any investments at all over the past year – 21% of employees reported having made none at all in 2019, compared to 11% of self-employed physicians and 16% of independent contractors.
 

The financial and work picture for independent contractors

Just over half (52%) of all independent contractors who responded to our questionnaire work in hospitals, 15% work in group practices, 9% work in outpatient clinics, and just 2% work in solo practices.

Independent contractors were less likely than their peers to have received employment benefits such as health insurance, malpractice coverage, and paid time off. They were also less likely to be saving for retirement. Almost half (45%) of independent contractors said they received no employment benefits at all, compared to 20% of self-employed physicians and just 8% of employees.

What’s more, 27% of independent contractors do not currently put money into a 401(k) retirement account or tax-deferred college savings account on a regular basis, compared with 16% of self-employed physicians and 8% of employees. Similarly, they were less likely to put money into a taxable savings account (39% responded that they do not, compared with 32% of self-employed physicians and 27% of employees).

“Net worth and retirement funding findings do line up with what I’ve observed,” said Mr. Scroggins. “Those who have independent practices as opposed to working for a hospital do tend to more heavily fund retirement plan accounts, which is typically the biggest driver of building net worth.”

Despite the lack of retirement planning, independent contractors were more likely than their peers to derive satisfaction from making money at a job they like (18%, compared with 12% of employees and 11% of self-employed physicians). They’re also far more likely to be in emergency medicine (22% of independent contractors, compared with 3% of self-employed and 5% of employees) or psychiatry (11% of independent contractors, compared with 5% of self-employed and 6% of employees).

Among the three categories of physicians, independent contractors were least likely to say that they would choose the same practice setting again. Across all three categories, fewer than 50% of respondents would do so: 34% of self-employed physicians, compared with 29% of employees and 28% of independent contractors.

Physicians who are considering leaving their own practice for a hospital setting should do so with caution and fully understand what they are getting into, said Mr. Scroggins. “If they’re just looking at compensation, they also should be looking very carefully at retirement plan benefits. If that’s their main method of saving and building net worth, then that’s a dramatic difference.”

And of course, there’s always the intangible value of feeling connected to a practice and its patients: “Physicians got into this line of work to treat patients and help people become healthier, and in hospitals they end up being more disconnected from their patients,” Mr. Scroggins said. “That’s a big factor as well.”

Editor’s note: Only differences that are statistically significant at a 95% confidence level between categories of employment have been included. Of the 13,893 responses included in this analysis, 3,860 physicians identified as self-employed, 9,262 as employees, and 772 as independent contractors.

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

Voiding trials after female pelvic floor surgery may detect similar rates of voiding dysfunction regardless of whether voiding occurs spontaneously or after the bladder is retrograde-filled with saline, according to a randomized study.

Nevertheless, patients may prefer the more common retrograde-fill approach.

In the study of 109 patients, those who underwent retrograde fill reported significantly greater satisfaction with their method of voiding evaluation, compared with patients whose voiding trials occurred spontaneously. The increased satisfaction could relate to the fact that retrograde-fill trials take less time, study investigator Patrick Popiel, MD, of Yale University, New Haven, Conn., suggested at the virtual annual scientific meeting of the Society of Gynecologic Surgeons. The exact reasons are unclear, however.

Voiding trials help identify patients who cannot sufficiently empty their bladder after surgery. Prior research has indicated that the incidence of voiding dysfunction after pelvic floor surgery is about 25%-35%. “Patients with voiding dysfunction are generally managed with an indwelling Foley catheter or clean intermittent self-catheterization,” Dr. Popiel said. “Catheterization increases the risk of urinary tract infection, increases anxiety, and decreases patient satisfaction. A large proportion of patients who are discharged home with a Foley catheter state that the catheter was the worst aspect of their experience.”

Dr. Popiel and colleagues conducted a randomized, prospective study to examine the rate of failed voiding trials that necessitate discharge home with an indwelling Foley catheter using spontaneous and retrograde-fill approaches. The study included women who required a voiding trial after surgery for pelvic organ prolapse or urinary incontinence. Patients who required prolonged catheterization after surgery, such as those with a urinary tract infection, bowel injury, or large amount of blood loss, were excluded.

Researchers analyzed data from 55 patients who were randomly assigned to the retrograde-fill group and 54 patients who were randomly assigned to the spontaneous trial group.

In the spontaneous group, patients were required to void at least 150 mL at one time within 6 hours of catheter removal to successfully complete the voiding trial.

In the retrograde-fill group, the bladder was filled in the postanesthesia care unit with 300 mL of saline or until the maximum volume tolerated by the patient (not exceeding 300 mL ) was reached. Patients in this group had to void at least 150 mL or 50% of the instilled volume at one time within 60 minutes of catheter removal to pass the trial.

The researchers documented postvoid residual (PVR) but did not use this measure to determine voiding function.

The baseline demographics of the two groups were similar, although prior hysterectomy was more common in the retrograde-fill group than in the spontaneous group (32.7% vs. 14.8%). The average age was 58.5 years in the retrograde-fill group and 61 years in the spontaneous group.

“There was no significant difference in our primary outcome,” Dr. Popiel said. “There was a 12.7% rate of failed voiding trial in the retrograde group versus 7.7% in the spontaneous group.”

No patients had urinary retention after initially passing their voiding trial. Force of stream did not differ between groups, and about 15% in each group had a postoperative urinary tract infection.

The study demonstrates that voiding assessment based on a spontaneous minimum void of 150 mL is safe and has similar pass rates, compared with the more commonly performed retrograde void trial, Dr. Popiel said. “If the voided amount is at least 150 mL, PVR is not critical to obtain. The study adds to the body of literature that supports less stringent criteria for evaluating voiding function and can limit postoperative urinary recatheterization.”

The investigators allowed patients with PVRs as high as 575 mL to return home without an alternative way to empty the bladder, C. Sage Claydon, MD, a urogynecologist who was not involved in the study, noted during a discussion after the presentation. In all, 6 patients who met the passing criteria for the spontaneous voiding trial had a PVR greater than 200 mL, with volumes ranging from 205-575 mL.

The patients received standardized counseling about postoperative voiding problems, said Dr. Popiel. “This is similar to the work done by Ingber et al. from 2011, where patients who reached a certain force of stream, greater than 5 out of 10, were discharged home regardless of PVR.”

Dr. Popiel had no relevant disclosures. Two coinvestigators disclosed ties to BlossomMed, Renovia, and ArmadaHealth.

[email protected]

SOURCE: Popiel P et al. SGS 2020, Abstract 14.

Voiding trials after female pelvic floor surgery may detect similar rates of voiding dysfunction regardless of whether voiding occurs spontaneously or after the bladder is retrograde-filled with saline, according to a randomized study.

Nevertheless, patients may prefer the more common retrograde-fill approach.

In the study of 109 patients, those who underwent retrograde fill reported significantly greater satisfaction with their method of voiding evaluation, compared with patients whose voiding trials occurred spontaneously. The increased satisfaction could relate to the fact that retrograde-fill trials take less time, study investigator Patrick Popiel, MD, of Yale University, New Haven, Conn., suggested at the virtual annual scientific meeting of the Society of Gynecologic Surgeons. The exact reasons are unclear, however.

Voiding trials help identify patients who cannot sufficiently empty their bladder after surgery. Prior research has indicated that the incidence of voiding dysfunction after pelvic floor surgery is about 25%-35%. “Patients with voiding dysfunction are generally managed with an indwelling Foley catheter or clean intermittent self-catheterization,” Dr. Popiel said. “Catheterization increases the risk of urinary tract infection, increases anxiety, and decreases patient satisfaction. A large proportion of patients who are discharged home with a Foley catheter state that the catheter was the worst aspect of their experience.”

Dr. Popiel and colleagues conducted a randomized, prospective study to examine the rate of failed voiding trials that necessitate discharge home with an indwelling Foley catheter using spontaneous and retrograde-fill approaches. The study included women who required a voiding trial after surgery for pelvic organ prolapse or urinary incontinence. Patients who required prolonged catheterization after surgery, such as those with a urinary tract infection, bowel injury, or large amount of blood loss, were excluded.

Researchers analyzed data from 55 patients who were randomly assigned to the retrograde-fill group and 54 patients who were randomly assigned to the spontaneous trial group.

In the spontaneous group, patients were required to void at least 150 mL at one time within 6 hours of catheter removal to successfully complete the voiding trial.

In the retrograde-fill group, the bladder was filled in the postanesthesia care unit with 300 mL of saline or until the maximum volume tolerated by the patient (not exceeding 300 mL ) was reached. Patients in this group had to void at least 150 mL or 50% of the instilled volume at one time within 60 minutes of catheter removal to pass the trial.

The researchers documented postvoid residual (PVR) but did not use this measure to determine voiding function.

The baseline demographics of the two groups were similar, although prior hysterectomy was more common in the retrograde-fill group than in the spontaneous group (32.7% vs. 14.8%). The average age was 58.5 years in the retrograde-fill group and 61 years in the spontaneous group.

“There was no significant difference in our primary outcome,” Dr. Popiel said. “There was a 12.7% rate of failed voiding trial in the retrograde group versus 7.7% in the spontaneous group.”

No patients had urinary retention after initially passing their voiding trial. Force of stream did not differ between groups, and about 15% in each group had a postoperative urinary tract infection.

The study demonstrates that voiding assessment based on a spontaneous minimum void of 150 mL is safe and has similar pass rates, compared with the more commonly performed retrograde void trial, Dr. Popiel said. “If the voided amount is at least 150 mL, PVR is not critical to obtain. The study adds to the body of literature that supports less stringent criteria for evaluating voiding function and can limit postoperative urinary recatheterization.”

The investigators allowed patients with PVRs as high as 575 mL to return home without an alternative way to empty the bladder, C. Sage Claydon, MD, a urogynecologist who was not involved in the study, noted during a discussion after the presentation. In all, 6 patients who met the passing criteria for the spontaneous voiding trial had a PVR greater than 200 mL, with volumes ranging from 205-575 mL.

The patients received standardized counseling about postoperative voiding problems, said Dr. Popiel. “This is similar to the work done by Ingber et al. from 2011, where patients who reached a certain force of stream, greater than 5 out of 10, were discharged home regardless of PVR.”

Dr. Popiel had no relevant disclosures. Two coinvestigators disclosed ties to BlossomMed, Renovia, and ArmadaHealth.

[email protected]

SOURCE: Popiel P et al. SGS 2020, Abstract 14.

Voiding trials after female pelvic floor surgery may detect similar rates of voiding dysfunction regardless of whether voiding occurs spontaneously or after the bladder is retrograde-filled with saline, according to a randomized study.

Nevertheless, patients may prefer the more common retrograde-fill approach.

In the study of 109 patients, those who underwent retrograde fill reported significantly greater satisfaction with their method of voiding evaluation, compared with patients whose voiding trials occurred spontaneously. The increased satisfaction could relate to the fact that retrograde-fill trials take less time, study investigator Patrick Popiel, MD, of Yale University, New Haven, Conn., suggested at the virtual annual scientific meeting of the Society of Gynecologic Surgeons. The exact reasons are unclear, however.

Voiding trials help identify patients who cannot sufficiently empty their bladder after surgery. Prior research has indicated that the incidence of voiding dysfunction after pelvic floor surgery is about 25%-35%. “Patients with voiding dysfunction are generally managed with an indwelling Foley catheter or clean intermittent self-catheterization,” Dr. Popiel said. “Catheterization increases the risk of urinary tract infection, increases anxiety, and decreases patient satisfaction. A large proportion of patients who are discharged home with a Foley catheter state that the catheter was the worst aspect of their experience.”

Dr. Popiel and colleagues conducted a randomized, prospective study to examine the rate of failed voiding trials that necessitate discharge home with an indwelling Foley catheter using spontaneous and retrograde-fill approaches. The study included women who required a voiding trial after surgery for pelvic organ prolapse or urinary incontinence. Patients who required prolonged catheterization after surgery, such as those with a urinary tract infection, bowel injury, or large amount of blood loss, were excluded.

Researchers analyzed data from 55 patients who were randomly assigned to the retrograde-fill group and 54 patients who were randomly assigned to the spontaneous trial group.

In the spontaneous group, patients were required to void at least 150 mL at one time within 6 hours of catheter removal to successfully complete the voiding trial.

In the retrograde-fill group, the bladder was filled in the postanesthesia care unit with 300 mL of saline or until the maximum volume tolerated by the patient (not exceeding 300 mL ) was reached. Patients in this group had to void at least 150 mL or 50% of the instilled volume at one time within 60 minutes of catheter removal to pass the trial.

The researchers documented postvoid residual (PVR) but did not use this measure to determine voiding function.

The baseline demographics of the two groups were similar, although prior hysterectomy was more common in the retrograde-fill group than in the spontaneous group (32.7% vs. 14.8%). The average age was 58.5 years in the retrograde-fill group and 61 years in the spontaneous group.

“There was no significant difference in our primary outcome,” Dr. Popiel said. “There was a 12.7% rate of failed voiding trial in the retrograde group versus 7.7% in the spontaneous group.”

No patients had urinary retention after initially passing their voiding trial. Force of stream did not differ between groups, and about 15% in each group had a postoperative urinary tract infection.

The study demonstrates that voiding assessment based on a spontaneous minimum void of 150 mL is safe and has similar pass rates, compared with the more commonly performed retrograde void trial, Dr. Popiel said. “If the voided amount is at least 150 mL, PVR is not critical to obtain. The study adds to the body of literature that supports less stringent criteria for evaluating voiding function and can limit postoperative urinary recatheterization.”

The investigators allowed patients with PVRs as high as 575 mL to return home without an alternative way to empty the bladder, C. Sage Claydon, MD, a urogynecologist who was not involved in the study, noted during a discussion after the presentation. In all, 6 patients who met the passing criteria for the spontaneous voiding trial had a PVR greater than 200 mL, with volumes ranging from 205-575 mL.

The patients received standardized counseling about postoperative voiding problems, said Dr. Popiel. “This is similar to the work done by Ingber et al. from 2011, where patients who reached a certain force of stream, greater than 5 out of 10, were discharged home regardless of PVR.”

Dr. Popiel had no relevant disclosures. Two coinvestigators disclosed ties to BlossomMed, Renovia, and ArmadaHealth.

[email protected]

SOURCE: Popiel P et al. SGS 2020, Abstract 14.

Factors including older age and certain comorbidities have been linked to more serious COVID-19 outcomes in previous research, and now a large dataset collected from hundreds of hospitals nationwide provides more detailed data regarding risk for mechanical ventilation and death.

Comorbidities such as cardiovascular disease, chronic kidney disease, and obesity also were associated with more severe COVID-19 outcomes in this observational study of 11,721 adults. History of pulmonary disease or smoking, interestingly, were not.

One expert urges caution when interpreting the results, however. Although the study found a number of risk factors for ventilation and mortality, she says the dataset lacks information on race and disease severity, and the sample may not be nationally representative. 

The investigators hope their level of granularity will further assist researchers searching for effective treatments and clinicians seeking to triage patients during the COVID-19 pandemic.

The study was published online August 28 in Clinical Infectious Diseases.
 

COVID-19 and comorbidities

“What I found most illuminating was this whole concept of comorbid conditions. This provides suggestive data about who we need to worry about most and who we may need to worry about less,” study author Robert S. Brown Jr, MD, MPH, told Medscape Medical News.

Comorbid conditions included hypertension in 47% of patients, diabetes in 28%, and cardiovascular disease in 19%. Another 16% were obese and 12% had chronic kidney disease. People with comorbid obesity, chronic kidney disease, and cardiovascular disease were more likely to receive mechanical ventilation compared to those without a history of these conditions in an adjusted, multivariable logistic analysis.

With the exception of obesity, the same factors were associated with risk for death during hospitalization.

In contrast, hypertension, history of smoking, and history of pulmonary disease were associated with a lower risk of needing mechanical ventilation and/or lower risk for mortality.

Furthermore, people with liver disease, gastrointestinal diseases, and even autoimmune diseases – which are likely associated with immunosuppression – “are not at that much of an increased risk that we noticed it in our data,” Brown said.

“As I tell many of my patients who have mild liver disease, for example, I would rather have mild liver disease and be on immunosuppressant therapy than be an older, obese male,” he added.

Assessing data for people in 38 U.S. states, and not limiting outcomes to patients in a particular COVID-19 hot spot, was a unique aspect of the research, said Brown, clinical chief of the Division of Gastroenterology and Hepatology at Weill Cornell Medicine in New York City.

Brown, lead author Michael W. Fried, MD, from TARGET PharmaSolutions in Durham, North Carolina, and colleagues studied adults from a commercially available Target Real-World Evidence (RWE) dataset of nearly 70,000 patients. They examined hospital chargemaster data and ICD-10 codes for COVID-19 inpatients between February 15 and April 20.

This population tended to be older, with 60% older than 60 years. A little more than half of participants, 53%, were men.
 

Key findings

A total of 21% of patients died after a median hospital length of stay of 8 days.

Older patients were significantly more likely to die, particularly those older than 60 years (P < .0001).

“This confirms some of the things we know about age and its impact on outcome,” Brown said.

The risk for mortality among patients older than 60 years was 7.2 times that of patients between 18 and 40 years in an adjusted multivariate analysis. The risk for death for those between 41 and 60 years of age was lower (odds ratio [OR], 2.6), compared with the youngest cohort.  

Men were more likely to die than women (OR, 1.5).

When asked if he was surprised by the high mortality rates, Brown said, “Having worked here in New York? No, I was not.”
 

Mechanical ventilation and mortality

Male sex, age older than 40 years, obesity, and presence of cardiovascular or chronic kidney disease were risk factors for mechanical ventilation.

Among the nearly 2,000 hospitalized adults requiring mechanical ventilation in the current report, only 27% were discharged alive. “The outcomes of people who are mechanically ventilated are really quite sobering,” Brown said.

People who ever required mechanical ventilation were 32 times more likely to die compared with others whose highest level of oxygenation was low-flow, high-flow, or no-oxygen therapy in an analysis that controlled for demographics and comorbidities.

Furthermore, patients placed on mechanical ventilation earlier – within 24 hours of admission – tended to experience better outcomes.
 

COVID-19 therapies?

Brown and colleagues also evaluated outcomes in patients who were taking either remdesivir or hydroxychloroquine. A total of 48 people were treated with remdesivir.

The four individuals receiving remdesivir who died were among 11 who were taking remdesivir and also on mechanical ventilation.

“The data for remdesivir is very encouraging,” Brown said.

Many more participants were treated with hydroxychloroquine, more than 4,200 or 36% of the total study population.

A higher proportion of people treated with hydroxychloroquine received mechanical ventilation, at 25%, versus 12% not treated with hydroxychloroquine.

The unadjusted mortality rate was also higher among those treated with the agent, at 25%, compared to 20% not receiving hydroxychloroquine.

The data with hydroxychloroquine can lead to two conclusions, Brown said: “One, it doesn’t work. Or two, it doesn’t work in the way that we use it.”

The researchers cautioned that their hydroxychloroquine findings must be interpreted carefully because those treated with the agent were also more likely to have comorbidities and greater COVID-19 disease severity.

“This study greatly contributes to understanding the natural course of COVID-19 infection by describing characteristics and outcomes of patients with COVID-19 hospitalized throughout the US,” the investigators note. “It identified categories of patients at greatest risk for poor outcomes, which should be used to prioritize prevention and treatment strategies in the future.”
 

Some limitations

“The findings that patients with hypertension and who were smokers had lower ventilation rates, and patients with hypertension, pulmonary disease, who were smokers had lower mortality risks was very surprising,” Ninez A. Ponce, PhD, MPP, told Medscape Medical News when asked to comment on the study.

Although the study identified multiple risk factors for ventilation and mortality, “unfortunately the dataset did not have race available or disease severity,” said Ponce, director of the UCLA Center for Health Policy Research and professor in the Department of Health Policy and Management at the UCLA Fielding School of Public Health.

“These omitted variables could have a considerable effect on the significance, magnitude, and direction of point estimates provided, so I would be cautious in interpreting the results as a picture of a nationally representative sample,” she said.

On a positive note, the study and dataset could illuminate the utility of medications used to treat COVID-19, Ponce said. In addition, as the authors note, “the data will expand over time.” 

Brown has reported receiving grants and consulting for Gilead. Ponce has disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Factors including older age and certain comorbidities have been linked to more serious COVID-19 outcomes in previous research, and now a large dataset collected from hundreds of hospitals nationwide provides more detailed data regarding risk for mechanical ventilation and death.

Comorbidities such as cardiovascular disease, chronic kidney disease, and obesity also were associated with more severe COVID-19 outcomes in this observational study of 11,721 adults. History of pulmonary disease or smoking, interestingly, were not.

One expert urges caution when interpreting the results, however. Although the study found a number of risk factors for ventilation and mortality, she says the dataset lacks information on race and disease severity, and the sample may not be nationally representative. 

The investigators hope their level of granularity will further assist researchers searching for effective treatments and clinicians seeking to triage patients during the COVID-19 pandemic.

The study was published online August 28 in Clinical Infectious Diseases.
 

COVID-19 and comorbidities

“What I found most illuminating was this whole concept of comorbid conditions. This provides suggestive data about who we need to worry about most and who we may need to worry about less,” study author Robert S. Brown Jr, MD, MPH, told Medscape Medical News.

Comorbid conditions included hypertension in 47% of patients, diabetes in 28%, and cardiovascular disease in 19%. Another 16% were obese and 12% had chronic kidney disease. People with comorbid obesity, chronic kidney disease, and cardiovascular disease were more likely to receive mechanical ventilation compared to those without a history of these conditions in an adjusted, multivariable logistic analysis.

With the exception of obesity, the same factors were associated with risk for death during hospitalization.

In contrast, hypertension, history of smoking, and history of pulmonary disease were associated with a lower risk of needing mechanical ventilation and/or lower risk for mortality.

Furthermore, people with liver disease, gastrointestinal diseases, and even autoimmune diseases – which are likely associated with immunosuppression – “are not at that much of an increased risk that we noticed it in our data,” Brown said.

“As I tell many of my patients who have mild liver disease, for example, I would rather have mild liver disease and be on immunosuppressant therapy than be an older, obese male,” he added.

Assessing data for people in 38 U.S. states, and not limiting outcomes to patients in a particular COVID-19 hot spot, was a unique aspect of the research, said Brown, clinical chief of the Division of Gastroenterology and Hepatology at Weill Cornell Medicine in New York City.

Brown, lead author Michael W. Fried, MD, from TARGET PharmaSolutions in Durham, North Carolina, and colleagues studied adults from a commercially available Target Real-World Evidence (RWE) dataset of nearly 70,000 patients. They examined hospital chargemaster data and ICD-10 codes for COVID-19 inpatients between February 15 and April 20.

This population tended to be older, with 60% older than 60 years. A little more than half of participants, 53%, were men.
 

Key findings

A total of 21% of patients died after a median hospital length of stay of 8 days.

Older patients were significantly more likely to die, particularly those older than 60 years (P < .0001).

“This confirms some of the things we know about age and its impact on outcome,” Brown said.

The risk for mortality among patients older than 60 years was 7.2 times that of patients between 18 and 40 years in an adjusted multivariate analysis. The risk for death for those between 41 and 60 years of age was lower (odds ratio [OR], 2.6), compared with the youngest cohort.  

Men were more likely to die than women (OR, 1.5).

When asked if he was surprised by the high mortality rates, Brown said, “Having worked here in New York? No, I was not.”
 

Mechanical ventilation and mortality

Male sex, age older than 40 years, obesity, and presence of cardiovascular or chronic kidney disease were risk factors for mechanical ventilation.

Among the nearly 2,000 hospitalized adults requiring mechanical ventilation in the current report, only 27% were discharged alive. “The outcomes of people who are mechanically ventilated are really quite sobering,” Brown said.

People who ever required mechanical ventilation were 32 times more likely to die compared with others whose highest level of oxygenation was low-flow, high-flow, or no-oxygen therapy in an analysis that controlled for demographics and comorbidities.

Furthermore, patients placed on mechanical ventilation earlier – within 24 hours of admission – tended to experience better outcomes.
 

COVID-19 therapies?

Brown and colleagues also evaluated outcomes in patients who were taking either remdesivir or hydroxychloroquine. A total of 48 people were treated with remdesivir.

The four individuals receiving remdesivir who died were among 11 who were taking remdesivir and also on mechanical ventilation.

“The data for remdesivir is very encouraging,” Brown said.

Many more participants were treated with hydroxychloroquine, more than 4,200 or 36% of the total study population.

A higher proportion of people treated with hydroxychloroquine received mechanical ventilation, at 25%, versus 12% not treated with hydroxychloroquine.

The unadjusted mortality rate was also higher among those treated with the agent, at 25%, compared to 20% not receiving hydroxychloroquine.

The data with hydroxychloroquine can lead to two conclusions, Brown said: “One, it doesn’t work. Or two, it doesn’t work in the way that we use it.”

The researchers cautioned that their hydroxychloroquine findings must be interpreted carefully because those treated with the agent were also more likely to have comorbidities and greater COVID-19 disease severity.

“This study greatly contributes to understanding the natural course of COVID-19 infection by describing characteristics and outcomes of patients with COVID-19 hospitalized throughout the US,” the investigators note. “It identified categories of patients at greatest risk for poor outcomes, which should be used to prioritize prevention and treatment strategies in the future.”
 

Some limitations

“The findings that patients with hypertension and who were smokers had lower ventilation rates, and patients with hypertension, pulmonary disease, who were smokers had lower mortality risks was very surprising,” Ninez A. Ponce, PhD, MPP, told Medscape Medical News when asked to comment on the study.

Although the study identified multiple risk factors for ventilation and mortality, “unfortunately the dataset did not have race available or disease severity,” said Ponce, director of the UCLA Center for Health Policy Research and professor in the Department of Health Policy and Management at the UCLA Fielding School of Public Health.

“These omitted variables could have a considerable effect on the significance, magnitude, and direction of point estimates provided, so I would be cautious in interpreting the results as a picture of a nationally representative sample,” she said.

On a positive note, the study and dataset could illuminate the utility of medications used to treat COVID-19, Ponce said. In addition, as the authors note, “the data will expand over time.” 

Brown has reported receiving grants and consulting for Gilead. Ponce has disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Factors including older age and certain comorbidities have been linked to more serious COVID-19 outcomes in previous research, and now a large dataset collected from hundreds of hospitals nationwide provides more detailed data regarding risk for mechanical ventilation and death.

Comorbidities such as cardiovascular disease, chronic kidney disease, and obesity also were associated with more severe COVID-19 outcomes in this observational study of 11,721 adults. History of pulmonary disease or smoking, interestingly, were not.

One expert urges caution when interpreting the results, however. Although the study found a number of risk factors for ventilation and mortality, she says the dataset lacks information on race and disease severity, and the sample may not be nationally representative. 

The investigators hope their level of granularity will further assist researchers searching for effective treatments and clinicians seeking to triage patients during the COVID-19 pandemic.

The study was published online August 28 in Clinical Infectious Diseases.
 

COVID-19 and comorbidities

“What I found most illuminating was this whole concept of comorbid conditions. This provides suggestive data about who we need to worry about most and who we may need to worry about less,” study author Robert S. Brown Jr, MD, MPH, told Medscape Medical News.

Comorbid conditions included hypertension in 47% of patients, diabetes in 28%, and cardiovascular disease in 19%. Another 16% were obese and 12% had chronic kidney disease. People with comorbid obesity, chronic kidney disease, and cardiovascular disease were more likely to receive mechanical ventilation compared to those without a history of these conditions in an adjusted, multivariable logistic analysis.

With the exception of obesity, the same factors were associated with risk for death during hospitalization.

In contrast, hypertension, history of smoking, and history of pulmonary disease were associated with a lower risk of needing mechanical ventilation and/or lower risk for mortality.

Furthermore, people with liver disease, gastrointestinal diseases, and even autoimmune diseases – which are likely associated with immunosuppression – “are not at that much of an increased risk that we noticed it in our data,” Brown said.

“As I tell many of my patients who have mild liver disease, for example, I would rather have mild liver disease and be on immunosuppressant therapy than be an older, obese male,” he added.

Assessing data for people in 38 U.S. states, and not limiting outcomes to patients in a particular COVID-19 hot spot, was a unique aspect of the research, said Brown, clinical chief of the Division of Gastroenterology and Hepatology at Weill Cornell Medicine in New York City.

Brown, lead author Michael W. Fried, MD, from TARGET PharmaSolutions in Durham, North Carolina, and colleagues studied adults from a commercially available Target Real-World Evidence (RWE) dataset of nearly 70,000 patients. They examined hospital chargemaster data and ICD-10 codes for COVID-19 inpatients between February 15 and April 20.

This population tended to be older, with 60% older than 60 years. A little more than half of participants, 53%, were men.
 

Key findings

A total of 21% of patients died after a median hospital length of stay of 8 days.

Older patients were significantly more likely to die, particularly those older than 60 years (P < .0001).

“This confirms some of the things we know about age and its impact on outcome,” Brown said.

The risk for mortality among patients older than 60 years was 7.2 times that of patients between 18 and 40 years in an adjusted multivariate analysis. The risk for death for those between 41 and 60 years of age was lower (odds ratio [OR], 2.6), compared with the youngest cohort.  

Men were more likely to die than women (OR, 1.5).

When asked if he was surprised by the high mortality rates, Brown said, “Having worked here in New York? No, I was not.”
 

Mechanical ventilation and mortality

Male sex, age older than 40 years, obesity, and presence of cardiovascular or chronic kidney disease were risk factors for mechanical ventilation.

Among the nearly 2,000 hospitalized adults requiring mechanical ventilation in the current report, only 27% were discharged alive. “The outcomes of people who are mechanically ventilated are really quite sobering,” Brown said.

People who ever required mechanical ventilation were 32 times more likely to die compared with others whose highest level of oxygenation was low-flow, high-flow, or no-oxygen therapy in an analysis that controlled for demographics and comorbidities.

Furthermore, patients placed on mechanical ventilation earlier – within 24 hours of admission – tended to experience better outcomes.
 

COVID-19 therapies?

Brown and colleagues also evaluated outcomes in patients who were taking either remdesivir or hydroxychloroquine. A total of 48 people were treated with remdesivir.

The four individuals receiving remdesivir who died were among 11 who were taking remdesivir and also on mechanical ventilation.

“The data for remdesivir is very encouraging,” Brown said.

Many more participants were treated with hydroxychloroquine, more than 4,200 or 36% of the total study population.

A higher proportion of people treated with hydroxychloroquine received mechanical ventilation, at 25%, versus 12% not treated with hydroxychloroquine.

The unadjusted mortality rate was also higher among those treated with the agent, at 25%, compared to 20% not receiving hydroxychloroquine.

The data with hydroxychloroquine can lead to two conclusions, Brown said: “One, it doesn’t work. Or two, it doesn’t work in the way that we use it.”

The researchers cautioned that their hydroxychloroquine findings must be interpreted carefully because those treated with the agent were also more likely to have comorbidities and greater COVID-19 disease severity.

“This study greatly contributes to understanding the natural course of COVID-19 infection by describing characteristics and outcomes of patients with COVID-19 hospitalized throughout the US,” the investigators note. “It identified categories of patients at greatest risk for poor outcomes, which should be used to prioritize prevention and treatment strategies in the future.”
 

Some limitations

“The findings that patients with hypertension and who were smokers had lower ventilation rates, and patients with hypertension, pulmonary disease, who were smokers had lower mortality risks was very surprising,” Ninez A. Ponce, PhD, MPP, told Medscape Medical News when asked to comment on the study.

Although the study identified multiple risk factors for ventilation and mortality, “unfortunately the dataset did not have race available or disease severity,” said Ponce, director of the UCLA Center for Health Policy Research and professor in the Department of Health Policy and Management at the UCLA Fielding School of Public Health.

“These omitted variables could have a considerable effect on the significance, magnitude, and direction of point estimates provided, so I would be cautious in interpreting the results as a picture of a nationally representative sample,” she said.

On a positive note, the study and dataset could illuminate the utility of medications used to treat COVID-19, Ponce said. In addition, as the authors note, “the data will expand over time.” 

Brown has reported receiving grants and consulting for Gilead. Ponce has disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Uterine papillary serous carcinoma (UPSC) is an infrequent but deadly form of endometrial cancer comprising 10% of cases but contributing 40% of deaths from the disease. Recurrence rates are high for this disease. Five-year survival is 55% for all patients and only 70% for stage I disease.¹ Patterns of recurrence tend to be distant (extrapelvic and extraabdominal) as frequently as they are localized to the pelvis, and metastases and recurrences are unrelated to the extent of uterine disease (such as myometrial invasion). It is for these reasons that the recommended course of adjuvant therapy for this disease is systemic therapy (typically six doses of carboplatin and paclitaxel chemotherapy) with consideration for radiation to the vagina or pelvis to consolidate pelvic and vaginal control.² This differs from early-stage high/intermediate–risk endometrioid adenocarcinomas, for which adjuvant chemotherapy has not been found to be helpful.

Dr Joshua Kish

Because of the lower incidence of UPSC, it frequently has been studied alongside endometrioid cell types in clinical trials which explore novel adjuvant therapies. However, UPSC is biologically distinct from endometrioid endometrial cancers, which likely results in inferior clinical responses to conventional interventions. Fortunately we are beginning to better understand UPSC at a molecular level, and advancements are being made in the targeted therapies for these patients that are unique, compared with those applied to other cancer subtypes.

As discussed above, UPSC is a particularly aggressive form of uterine cancer. Histologically it is characterized by a precursor lesion of endometrial glandular dysplasia progressing to endometrial intraepithelial neoplasia (EIC). Histologically it presents with a highly atypical slit-like glandular configuration, which appears similar to serous carcinomas of the fallopian tube and ovary. Molecularly these tumors commonly manifest mutations in tumor protein p53 (TP53) and phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA), which are both genes associated with oncogenic potential.¹ While most UPSC tumors have loss of expression in hormone receptors such as estrogen and progesterone, 25%-30% of cases overexpress the tyrosine kinase receptor human epidermal growth factor receptor 2 (HER2).^3-5 This has proven to provide an exciting target for therapeutic interventions.
 

A target for therapeutic intervention

HER2 is a transmembrane receptor which, when activated, signals complex downstream pathways responsible for cellular proliferation, dedifferentiation, and metastasis. In a recent multi-institutional analysis of early-stage UPSC, HER2 overexpression was identified among 25% of cases.⁴ Approximately 30% of cases of advanced disease manifest overexpression of this biomarker.⁵ HER2 overexpression (HER2-positive status) is significantly associated with higher rates of recurrence and mortality, even among patients treated with conventional therapies.³ Thus HER2-positive status is obviously an indicator of particularly aggressive disease.

Fortunately this particular biomarker is one for which we have established and developing therapeutics. The humanized monoclonal antibody, trastuzumab, has been highly effective in improving survival for HER2-positive breast cancer.⁶ More recently, it was studied in a phase 2 trial with carboplatin and paclitaxel chemotherapy for advanced or recurrent HER2-positive UPSC.⁵ This trial showed that the addition of this targeted therapy to conventional chemotherapy improved recurrence-free survival from 8 months to 12 months, and improved overall survival from 24.4 months to 29.6 months.⁵
 

^{One discovery leads to another treatment}

This discovery led to the approval of trastuzumab to be used in addition to chemotherapy for advanced or recurrent disease.² The most significant effects appear to be among those who have not received prior therapies, with a doubling of progression-free survival among these patients, and a more modest response among patients treated for recurrent, mostly pretreated disease.

Work currently is underway to explore an array of antibody or small-molecule blockades of HER2 in addition to vaccines against the protein or treatment with conjugate compounds in which an antibody to HER2 is paired with a cytotoxic drug able to be internalized into HER2-expressing cells.⁷ This represents a form of personalized medicine referred to as biomarker-driven targeted therapy, in which therapies are prescribed based on the expression of specific molecular markers (such as HER2 expression) typically in combination with other clinical markers such as surgical staging results, race, age, etc. These approaches can be very effective strategies in rare tumor subtypes with distinct molecular and clinical behaviors.

As previously mentioned, the targeting of HER2 overexpression with trastuzumab has been shown to be highly effective in the treatment of HER2-positive breast cancers where even patients with early-stage disease receive a multimodal therapy approach including antibody, chemotherapy, surgical, and often radiation treatments.⁶ We are moving towards a similar multimodal comprehensive treatment strategy for UPSC. If it is as successful as it is in breast cancer, it will be long overdue, and desperately necessary given the poor prognosis of this disease for all stages because of the inadequacies of current treatments strategies.

Routine testing of UPSC for HER2 expression is now a part of routine molecular substaging of uterine cancers in the same way we have embraced testing for microsatellite instability and hormone-receptor status. While a diagnosis of HER2 overexpression in UPSC portends a poor prognosis, patients can be reassured that treatment strategies exist that can target this malignant mechanism in advanced disease and more are under further development for early-stage disease.
 

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no relevant financial disclosures. Email her at [email protected].

References

1. Curr Opin Obstet Gynecol. 2010 Feb. doi: 10.1097/GCO.0b013e328334d8a3.

2. National Comprehensive Cancer Network. Uterine Neoplasms (version 2.2020).

3. Cancer 2005 Oct 1. doi: 10.1002/cncr.21308.

4. Gynecol Oncol 2020 doi: 10.1016/j.ygyno.2020.07.016.

5. J Clin Oncol 2018. doi: 10.1200/JCO.2017.76.5966.

6. N Engl J Med 2011. doi: 10.1056/NEJMoa0910383.

7. Discov Med. 2016 Apr;21(116):293-303.

Uterine papillary serous carcinoma (UPSC) is an infrequent but deadly form of endometrial cancer comprising 10% of cases but contributing 40% of deaths from the disease. Recurrence rates are high for this disease. Five-year survival is 55% for all patients and only 70% for stage I disease.¹ Patterns of recurrence tend to be distant (extrapelvic and extraabdominal) as frequently as they are localized to the pelvis, and metastases and recurrences are unrelated to the extent of uterine disease (such as myometrial invasion). It is for these reasons that the recommended course of adjuvant therapy for this disease is systemic therapy (typically six doses of carboplatin and paclitaxel chemotherapy) with consideration for radiation to the vagina or pelvis to consolidate pelvic and vaginal control.² This differs from early-stage high/intermediate–risk endometrioid adenocarcinomas, for which adjuvant chemotherapy has not been found to be helpful.

Dr Joshua Kish

Because of the lower incidence of UPSC, it frequently has been studied alongside endometrioid cell types in clinical trials which explore novel adjuvant therapies. However, UPSC is biologically distinct from endometrioid endometrial cancers, which likely results in inferior clinical responses to conventional interventions. Fortunately we are beginning to better understand UPSC at a molecular level, and advancements are being made in the targeted therapies for these patients that are unique, compared with those applied to other cancer subtypes.

As discussed above, UPSC is a particularly aggressive form of uterine cancer. Histologically it is characterized by a precursor lesion of endometrial glandular dysplasia progressing to endometrial intraepithelial neoplasia (EIC). Histologically it presents with a highly atypical slit-like glandular configuration, which appears similar to serous carcinomas of the fallopian tube and ovary. Molecularly these tumors commonly manifest mutations in tumor protein p53 (TP53) and phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA), which are both genes associated with oncogenic potential.¹ While most UPSC tumors have loss of expression in hormone receptors such as estrogen and progesterone, 25%-30% of cases overexpress the tyrosine kinase receptor human epidermal growth factor receptor 2 (HER2).^3-5 This has proven to provide an exciting target for therapeutic interventions.
 

A target for therapeutic intervention

HER2 is a transmembrane receptor which, when activated, signals complex downstream pathways responsible for cellular proliferation, dedifferentiation, and metastasis. In a recent multi-institutional analysis of early-stage UPSC, HER2 overexpression was identified among 25% of cases.⁴ Approximately 30% of cases of advanced disease manifest overexpression of this biomarker.⁵ HER2 overexpression (HER2-positive status) is significantly associated with higher rates of recurrence and mortality, even among patients treated with conventional therapies.³ Thus HER2-positive status is obviously an indicator of particularly aggressive disease.

Fortunately this particular biomarker is one for which we have established and developing therapeutics. The humanized monoclonal antibody, trastuzumab, has been highly effective in improving survival for HER2-positive breast cancer.⁶ More recently, it was studied in a phase 2 trial with carboplatin and paclitaxel chemotherapy for advanced or recurrent HER2-positive UPSC.⁵ This trial showed that the addition of this targeted therapy to conventional chemotherapy improved recurrence-free survival from 8 months to 12 months, and improved overall survival from 24.4 months to 29.6 months.⁵
 

^{One discovery leads to another treatment}

This discovery led to the approval of trastuzumab to be used in addition to chemotherapy for advanced or recurrent disease.² The most significant effects appear to be among those who have not received prior therapies, with a doubling of progression-free survival among these patients, and a more modest response among patients treated for recurrent, mostly pretreated disease.

Work currently is underway to explore an array of antibody or small-molecule blockades of HER2 in addition to vaccines against the protein or treatment with conjugate compounds in which an antibody to HER2 is paired with a cytotoxic drug able to be internalized into HER2-expressing cells.⁷ This represents a form of personalized medicine referred to as biomarker-driven targeted therapy, in which therapies are prescribed based on the expression of specific molecular markers (such as HER2 expression) typically in combination with other clinical markers such as surgical staging results, race, age, etc. These approaches can be very effective strategies in rare tumor subtypes with distinct molecular and clinical behaviors.

As previously mentioned, the targeting of HER2 overexpression with trastuzumab has been shown to be highly effective in the treatment of HER2-positive breast cancers where even patients with early-stage disease receive a multimodal therapy approach including antibody, chemotherapy, surgical, and often radiation treatments.⁶ We are moving towards a similar multimodal comprehensive treatment strategy for UPSC. If it is as successful as it is in breast cancer, it will be long overdue, and desperately necessary given the poor prognosis of this disease for all stages because of the inadequacies of current treatments strategies.

Routine testing of UPSC for HER2 expression is now a part of routine molecular substaging of uterine cancers in the same way we have embraced testing for microsatellite instability and hormone-receptor status. While a diagnosis of HER2 overexpression in UPSC portends a poor prognosis, patients can be reassured that treatment strategies exist that can target this malignant mechanism in advanced disease and more are under further development for early-stage disease.
 

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no relevant financial disclosures. Email her at [email protected].

References

1. Curr Opin Obstet Gynecol. 2010 Feb. doi: 10.1097/GCO.0b013e328334d8a3.

2. National Comprehensive Cancer Network. Uterine Neoplasms (version 2.2020).

3. Cancer 2005 Oct 1. doi: 10.1002/cncr.21308.

4. Gynecol Oncol 2020 doi: 10.1016/j.ygyno.2020.07.016.

5. J Clin Oncol 2018. doi: 10.1200/JCO.2017.76.5966.

6. N Engl J Med 2011. doi: 10.1056/NEJMoa0910383.

7. Discov Med. 2016 Apr;21(116):293-303.

Uterine papillary serous carcinoma (UPSC) is an infrequent but deadly form of endometrial cancer comprising 10% of cases but contributing 40% of deaths from the disease. Recurrence rates are high for this disease. Five-year survival is 55% for all patients and only 70% for stage I disease.¹ Patterns of recurrence tend to be distant (extrapelvic and extraabdominal) as frequently as they are localized to the pelvis, and metastases and recurrences are unrelated to the extent of uterine disease (such as myometrial invasion). It is for these reasons that the recommended course of adjuvant therapy for this disease is systemic therapy (typically six doses of carboplatin and paclitaxel chemotherapy) with consideration for radiation to the vagina or pelvis to consolidate pelvic and vaginal control.² This differs from early-stage high/intermediate–risk endometrioid adenocarcinomas, for which adjuvant chemotherapy has not been found to be helpful.

Dr Joshua Kish

Because of the lower incidence of UPSC, it frequently has been studied alongside endometrioid cell types in clinical trials which explore novel adjuvant therapies. However, UPSC is biologically distinct from endometrioid endometrial cancers, which likely results in inferior clinical responses to conventional interventions. Fortunately we are beginning to better understand UPSC at a molecular level, and advancements are being made in the targeted therapies for these patients that are unique, compared with those applied to other cancer subtypes.

As discussed above, UPSC is a particularly aggressive form of uterine cancer. Histologically it is characterized by a precursor lesion of endometrial glandular dysplasia progressing to endometrial intraepithelial neoplasia (EIC). Histologically it presents with a highly atypical slit-like glandular configuration, which appears similar to serous carcinomas of the fallopian tube and ovary. Molecularly these tumors commonly manifest mutations in tumor protein p53 (TP53) and phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA), which are both genes associated with oncogenic potential.¹ While most UPSC tumors have loss of expression in hormone receptors such as estrogen and progesterone, 25%-30% of cases overexpress the tyrosine kinase receptor human epidermal growth factor receptor 2 (HER2).^3-5 This has proven to provide an exciting target for therapeutic interventions.
 

A target for therapeutic intervention

HER2 is a transmembrane receptor which, when activated, signals complex downstream pathways responsible for cellular proliferation, dedifferentiation, and metastasis. In a recent multi-institutional analysis of early-stage UPSC, HER2 overexpression was identified among 25% of cases.⁴ Approximately 30% of cases of advanced disease manifest overexpression of this biomarker.⁵ HER2 overexpression (HER2-positive status) is significantly associated with higher rates of recurrence and mortality, even among patients treated with conventional therapies.³ Thus HER2-positive status is obviously an indicator of particularly aggressive disease.

Fortunately this particular biomarker is one for which we have established and developing therapeutics. The humanized monoclonal antibody, trastuzumab, has been highly effective in improving survival for HER2-positive breast cancer.⁶ More recently, it was studied in a phase 2 trial with carboplatin and paclitaxel chemotherapy for advanced or recurrent HER2-positive UPSC.⁵ This trial showed that the addition of this targeted therapy to conventional chemotherapy improved recurrence-free survival from 8 months to 12 months, and improved overall survival from 24.4 months to 29.6 months.⁵
 

^{One discovery leads to another treatment}

This discovery led to the approval of trastuzumab to be used in addition to chemotherapy for advanced or recurrent disease.² The most significant effects appear to be among those who have not received prior therapies, with a doubling of progression-free survival among these patients, and a more modest response among patients treated for recurrent, mostly pretreated disease.

Work currently is underway to explore an array of antibody or small-molecule blockades of HER2 in addition to vaccines against the protein or treatment with conjugate compounds in which an antibody to HER2 is paired with a cytotoxic drug able to be internalized into HER2-expressing cells.⁷ This represents a form of personalized medicine referred to as biomarker-driven targeted therapy, in which therapies are prescribed based on the expression of specific molecular markers (such as HER2 expression) typically in combination with other clinical markers such as surgical staging results, race, age, etc. These approaches can be very effective strategies in rare tumor subtypes with distinct molecular and clinical behaviors.

As previously mentioned, the targeting of HER2 overexpression with trastuzumab has been shown to be highly effective in the treatment of HER2-positive breast cancers where even patients with early-stage disease receive a multimodal therapy approach including antibody, chemotherapy, surgical, and often radiation treatments.⁶ We are moving towards a similar multimodal comprehensive treatment strategy for UPSC. If it is as successful as it is in breast cancer, it will be long overdue, and desperately necessary given the poor prognosis of this disease for all stages because of the inadequacies of current treatments strategies.

Routine testing of UPSC for HER2 expression is now a part of routine molecular substaging of uterine cancers in the same way we have embraced testing for microsatellite instability and hormone-receptor status. While a diagnosis of HER2 overexpression in UPSC portends a poor prognosis, patients can be reassured that treatment strategies exist that can target this malignant mechanism in advanced disease and more are under further development for early-stage disease.
 

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no relevant financial disclosures. Email her at [email protected].

References

1. Curr Opin Obstet Gynecol. 2010 Feb. doi: 10.1097/GCO.0b013e328334d8a3.

2. National Comprehensive Cancer Network. Uterine Neoplasms (version 2.2020).

3. Cancer 2005 Oct 1. doi: 10.1002/cncr.21308.

4. Gynecol Oncol 2020 doi: 10.1016/j.ygyno.2020.07.016.

5. J Clin Oncol 2018. doi: 10.1200/JCO.2017.76.5966.

6. N Engl J Med 2011. doi: 10.1056/NEJMoa0910383.

7. Discov Med. 2016 Apr;21(116):293-303.

During a telemedicine visit with his physician, a 62-year-old obese patient with an ankle injury reported new swelling of his leg. Three weeks had passed since the man visited an emergency department, where he underwent surgery and had a cast applied to the wound. The physician, during the telemedicine visit, advised the patient to elevate his leg and see an orthopedist within 24 hours. A Doppler ultrasound was ordered for 12:30 p.m. that same day.

The patient never made it to the appointment. He became unresponsive and went into full arrest hours later. His death fueled a lawsuit by his family that claimed failure to diagnose and treat deep venous thrombosis. The family contended the providers involved should have referred the patient to care immediately during the video visit.  

The case, which comes from the claims database of national medical liability insurer The Doctors Company, illustrates the legal risks that can stem from video visits with patients, says Richard Cahill, JD, vice president and associate general counsel for The Doctors Company.

“By evaluating the patient remotely, the physician failed to appreciate the often subtle nuances of the clinical presentation, which undoubtedly could have been more accurately assessed in the office setting, and would probably have led to more urgent evaluation and intervention, thereby likely preventing the unfortunate and otherwise avoidable result,” said Mr. Cahill.

According to a Harris poll, 42% of Americans reported using video visits during the pandemic, a trend that is likely to continue as practices reopen and virtual care becomes the norm. But as physicians conduct more video visits, so grows their risk for lawsuits associated with the technology. 

“We probably will see more malpractice suits filed the more telehealth is used,” said Mei Wa Kwong, JD, executive director of the Center for Connected Health Policy. “It’s a numbers game. The more it’s used, the higher likelihood that lawsuits occur.”
 

Three problems in not being able to touch the patient

1. The primary challenge with video visits “is the inability to directly observe and lay hands on the patient,” says Jonathan Einbinder, MD, assistant vice president of analytics for CRICO, a medical liability insurer based in Boston.

“While you can see them via video, it can be hard to get a full sense of how sick the patient is and whether other things might be going on than what they are reporting,” said Dr. Einbinder, a practicing internist. 

Such incomplete pictures can lead to diagnostic errors and the potential for lawsuits, as demonstrated by a recent CRICO analysis. Of 106 telemedicine-related claims from 2014 to 2018, 66% were diagnosis related, according to the analysis of claims from CRICO’s national database. Twelve percent of the telemedicine-related claims were associated with surgical treatment, 11% were related to medical treatment, and 5% were associated with medication issues. A smaller number of claims resulted from patient monitoring, ob.gyn. care, and safety and security.

Another analysis by The Doctors Company similarly determined that diagnostic errors are the most common allegation in telemedicine-related claims. In the study of 28 telemedicine-related claims from The Doctors’ database, 71% were diagnosis related, 11% were associated with mismanagement of treatment, and 7% were related to improper management of a surgical patient. Other allegations included improper performance of treatment or procedure and improper performance of surgery.

“Because a ‘typical’ exam can’t be done, there is the potential to miss things,” said David L. Feldman, MD, chief medical officer for The Doctors Company Group. “A subtlety, perhaps a lump that can’t be seen but only felt, and only by an experienced examiner, for example, may be missed.” 

2. Documentation dangers also loom, said William Sullivan, DO, JD, an emergency physician and an attorney who specializes in health care. The legal risk lies in documenting a video visit in the same way the doctor would document an in-person visit, he explained.

“Investigation into a potential lawsuit begins when there is some type of bad outcome related to medical care,” Dr. Sullivan explained. “To determine whether the lawsuit has merit, patients/attorneys review the medical records to retrospectively determine the potential cause of the bad outcome. If the documentation reflects an examination that could not have been performed, a lawyer might be more likely to pursue a case, and it would be more difficult to defend the care provided.”

Dr. Sullivan provided this example: During a video visit, a patient complains of acute onset weakness. The physician documents that the patient’s heart has a “regular rate and rhythm,” and “muscle strength is equal bilaterally.” The following day, the patient’s weakness continues, and the patient goes to the emergency department where he is diagnosed with stroke. An EKG in the ED shows that the patient is in atrial fibrillation.

“The telehealth provider would have a difficult time explaining how it was determined that the patient had normal muscle strength and a normal heart rhythm over a video visit the day before,” Dr. Sullivan said. “A lawyer in a subsequent malpractice case would present the provider as careless and would argue that if the provider had only sent the patient to the emergency department after the telehealth visit instead of documenting exam findings that couldn’t have been performed, the patient could have been successfully treated for the stroke.”

3. Poorly executed informed consent can also give rise to a lawsuit. This includes informed consent regarding the use of telehealth as the accepted modality for the visit rather than traditional on-site evaluations, as well as preprocedure informed consent.

“Inadequate and/or poorly documented informed consent can result in a claim for medical battery,” Mr. Cahill said.

A medical battery allegation refers to the alleged treatment or touching of a patient’s body without that person’s consent. As the AMA Journal of Ethics explains, a patient’s consent must be given, either expressly or implicitly, before a physician may legally “interfere” with the physical body of the patient.

Ideally, the informed consent process is undertaken during a first in-person visit, before virtual visits begin, Dr. Feldman said.

“There is a lot that a patient has to understand when a visit is done virtually, which is part of the informed consent process,” Dr. Feldman said. “The pandemic has forced some physicians to do their first visit virtually, and this makes the process of informing patients more onerous. It is not a simple matter of converting an in-person office practice to a remote office practice. The work flows are different, so there are definitely legal concerns as it relates to privacy and cybersecurity to name a few.”
 

Waivers may be weak protection

Since the pandemic started, a number of states have enacted emergency malpractice protections to shield health professionals from lawsuits. Some protections, such as those in Massachusetts, offer immunity to health professionals who provide general care to patients during the COVID-19 emergency, in addition to treatment of COVID-19 patients. Other protections, like those in Connecticut, apply specifically to care provided in support of the state’s pandemic response.

Whether that immunity applies both to in-person visits and video visits during the pandemic is not certain, said J. Richard Moore, JD, a medical liability defense attorney based in Indianapolis. Indiana’s immunity statute for example, does not make a specific provision for telehealth, he said.

“My best prediction is that if considered by the courts, the immunity would be applied to telehealth services, so long as they are being provided ‘in response to the emergency,’ which is the scope of the immunity,” he said. “I would not consider telehealth physicians to be either more or less protected than in-person providers.”

Regulatory scrutiny for telehealth providers has also been relaxed in response to COVID-19, but experts warn not to rely on the temporary shields for ultimate protection.

In March, the U.S. Department of Health and Human Service’s Office of Civil Rights (OCR) eased enforcement actions for noncompliance with Health Insurance Portability and Accountability Act requirements in connection with the good faith provision of telehealth during the COVID-19 health crisis. Under the notice, health providers can use popular applications such as Apple FaceTime, Facebook Messenger, Zoom, or Google Hangouts, to offer telehealth care without risk that OCR will impose fines or penalties for HIPAA violations.

But once the current health care emergency is mitigated, the waivers will likely be withdrawn, and enforcement actions will probably resume, Mr. Cahill said.

“It is recommended that, to avoid potential problems going forward, practitioners use due diligence and undertake best efforts to obey existing privacy and security requirements, including the use of technology that satisfies compliance regulations, despite the waiver by OCR,” he said.

In addition, a majority of states have relaxed state-specific rules for practicing telehealth and loosened licensure requirements during the pandemic. At least 47 states have issued waivers to alter in-state licensure requirements for telemedicine in response to COVID-19, according to the Federation of State Medical Boards. Most of the waivers allow physicians licensed in other states to provide care in states where they do not hold licenses, and some enable doctors to treat patients without first having had an in-person evaluation.

But at least for now, these are temporary changes, reminds Amy Lerman, JD, a health care attorney based in Washington, who specializes in telehealth and corporate compliance. Given the current pandemic environment, a significant concern is that physicians new to the telemedicine space are reacting only to the most recent rules established in the context of the pandemic, Ms. Lerman said.

“As previously noted, the recent developments are temporary in nature – states and various federal agencies have been pretty clear in setting this temporal boundary,” she said. “It is not advisable for providers to build telepractice models around temporary sets of rules. 

“Furthermore, the recent developments are not necessarily comprehensive relative to all of the state-specific and other requirements that telemedicine providers are otherwise expected to follow, so relying only on the most recent guidance may cause providers to create telepractice models that have key gaps with respect to regulatory compliance.”
 

How you can avoid a lawsuit

As businesses reopen and practices resume treatments, physicians should weigh the choice between in-person care and video visits very carefully, said Joseph Kvedar, MD, president of the American Telemedicine Association and a dermatology professor at Harvard Medical School, Boston.

“We have to be very thoughtful about quality in this current phase, where we are doing what I call a hybrid model,” he said. “Some services are offered by telehealth and some require patients to come into the doctor’s office. We have to be very thoughtful about what types of care we determine to be appropriate for telehealth, and that has to be based on clinical quality. And if it is, it should follow that we’ll have low incidence of liability claims.”

Data should be at the center of that conclusion, Dr. Kvedar advises.

“Think about what data is needed to make a therapeutic or diagnostic decision,” he said. “If a health care provider can gather the information needed without touching the patient, then the provider is probably on safe, solid ground making that decision via a telehealth interaction. If the patient can come into the doctor’s office, and the provider deems it necessary to see the patient in person and touch the patient in order to make that clinical decision, then the patient should come in.”

An important step to preventing liability is also having strong telehealth systems and protocols in place and the necessary support to carry them out, said Dr. Einbinder of medical liability insurer CRICO.

For example, Dr. Einbinder, who practices in a 12-doctor internal medicine group, said when he finishes a virtual visit, he enters any orders into the electronic health record. Some of the orders will result in notifications to Dr. Einbinder if they are not executed, such as a referral appointment or a procedure that was not completed. 

“I also can forward my orders to a front desk pool that is responsible for making sure things get done,” he said. “And, in our hospital system, we have good case management for complex patients and population management for a variety of chronic conditions. These represent additional safety nets.” 

Another liability safeguard is sending patients a “visit summary” after each virtual visit, Dr. Sullivan said. This could be in the form of an email or a text that includes a brief template including items such as diagnosis, recommendations, follow-up, and a reminder to contact the doctor or go to the emergency department if symptoms worsen or new problems develop.

“Patients tend to remember about half of what physicians tell them and half of the information patients do remember is incorrect,” he said. “Consider a few sentences in an e-mail or text message as a substitute for the after-visit instructions from an office visit to enhance patient understanding. There are several inexpensive programs/services that allow text messages to be sent from a computer using a separate dedicated phone number and pretty much every patient has a cell phone to receive the instructions.”

Dr. Sullivan suggests having a documentation template specifically for telehealth visits. He also recommends the inclusion an “informed refusal of care” in the record when necessary. Dr. Sullivan’s wife, a family physician, has encountered several patients who fear contracting COVID-19 and who have refused her recommendations for in-person visits, he said. In such cases, he said it’s a good idea to document that the patient decided to forgo the recommendations given.

“If a patient suffers a bad outcome because of a failure to seek an in-person exam, a short note in the patient’s chart would help to establish that the lack of a follow-up physical exam was the patient’s informed decision, not due to some alleged negligence of the medical provider,” he said.

Concerning informed consent, Dr. Feldman says at a minimum physicians should discuss the following with patients:

• Names and credentials of staff participating.
• The right to stop or refuse treatment by telemedicine.
• Technology that will be used.
• Privacy and security risks.
• Technology-specific risks and permission to bill.
• Alternative care in case of an emergency or technology malfunction.
• Any state-specific requirements.

“Physicians can ensure they have a strong informed consent process during video visits by taking the time to cover these points at the beginning of the first visit, and being sure the patient understands and agrees to these,” Dr. Sullivan explained. “Ideally, this conversation can be recorded for future reference if necessary or at a minimum documented in the medical record.”
 

Consider these extra precautions

Mr. Cahill advises that practitioners be especially mindful of their “web-side manner” and the setting in which they are communicating with virtual patients to promote confidentiality, professionalism, and uninterrupted interactions.

“Use of a headset in a quiet home office is advisable,” he said. “Physicians must also be cognizant of their physical appearance and the background behind them when the visit includes both audio and visual capability. For ‘face-to-face’ telehealth encounters, it is recommended that a white lab jacket be worn as the appropriate attire; coat and tie are unnecessary.”

Some patients may need to be reminded of the need for confidentiality during a video visit, Mr. Moore added. Physicians are typically in a position to ensure confidentiality, but some patients may not understand how to protect their privacy on their end. 

“If the physician sees on the screen or hears from an audio connection that there are other people around who may be able to overhear what is communicated, the physician probably has some responsibility to remind the patient that she or he may want to go to a more private place, close the door, etc.,” he said. “While I think a claim against a physician on this basis would be pretty weak, it is still a good practice for the physician to be cognizant of those kinds of concerns even if the patient is not.”

Finally, for physicians who set up telehealth operability during the pandemic – possibly in a hurry – consider using your actual case data to take a look backward, said Ms. Lerman, the Washington-based health care attorney. Reviewing the data can help determine whether you’re in compliance with relevant state laws, she said. 

“If, for example, a provider set up telehealth operations during the pandemic and can see that most of [the] patients are based in a single state, or a small group of states, it is worthwhile to take [the] time and become familiar with the telemedicine laws in those states,” she said. “If there are modifications that need to be made, it may be easier to make them incrementally before the telehealth operations grow any larger in scope.” 

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

During a telemedicine visit with his physician, a 62-year-old obese patient with an ankle injury reported new swelling of his leg. Three weeks had passed since the man visited an emergency department, where he underwent surgery and had a cast applied to the wound. The physician, during the telemedicine visit, advised the patient to elevate his leg and see an orthopedist within 24 hours. A Doppler ultrasound was ordered for 12:30 p.m. that same day.

The patient never made it to the appointment. He became unresponsive and went into full arrest hours later. His death fueled a lawsuit by his family that claimed failure to diagnose and treat deep venous thrombosis. The family contended the providers involved should have referred the patient to care immediately during the video visit.  

The case, which comes from the claims database of national medical liability insurer The Doctors Company, illustrates the legal risks that can stem from video visits with patients, says Richard Cahill, JD, vice president and associate general counsel for The Doctors Company.

“By evaluating the patient remotely, the physician failed to appreciate the often subtle nuances of the clinical presentation, which undoubtedly could have been more accurately assessed in the office setting, and would probably have led to more urgent evaluation and intervention, thereby likely preventing the unfortunate and otherwise avoidable result,” said Mr. Cahill.

According to a Harris poll, 42% of Americans reported using video visits during the pandemic, a trend that is likely to continue as practices reopen and virtual care becomes the norm. But as physicians conduct more video visits, so grows their risk for lawsuits associated with the technology. 

“We probably will see more malpractice suits filed the more telehealth is used,” said Mei Wa Kwong, JD, executive director of the Center for Connected Health Policy. “It’s a numbers game. The more it’s used, the higher likelihood that lawsuits occur.”
 

Three problems in not being able to touch the patient

1. The primary challenge with video visits “is the inability to directly observe and lay hands on the patient,” says Jonathan Einbinder, MD, assistant vice president of analytics for CRICO, a medical liability insurer based in Boston.

“While you can see them via video, it can be hard to get a full sense of how sick the patient is and whether other things might be going on than what they are reporting,” said Dr. Einbinder, a practicing internist. 

Such incomplete pictures can lead to diagnostic errors and the potential for lawsuits, as demonstrated by a recent CRICO analysis. Of 106 telemedicine-related claims from 2014 to 2018, 66% were diagnosis related, according to the analysis of claims from CRICO’s national database. Twelve percent of the telemedicine-related claims were associated with surgical treatment, 11% were related to medical treatment, and 5% were associated with medication issues. A smaller number of claims resulted from patient monitoring, ob.gyn. care, and safety and security.

Another analysis by The Doctors Company similarly determined that diagnostic errors are the most common allegation in telemedicine-related claims. In the study of 28 telemedicine-related claims from The Doctors’ database, 71% were diagnosis related, 11% were associated with mismanagement of treatment, and 7% were related to improper management of a surgical patient. Other allegations included improper performance of treatment or procedure and improper performance of surgery.

“Because a ‘typical’ exam can’t be done, there is the potential to miss things,” said David L. Feldman, MD, chief medical officer for The Doctors Company Group. “A subtlety, perhaps a lump that can’t be seen but only felt, and only by an experienced examiner, for example, may be missed.” 

2. Documentation dangers also loom, said William Sullivan, DO, JD, an emergency physician and an attorney who specializes in health care. The legal risk lies in documenting a video visit in the same way the doctor would document an in-person visit, he explained.

“Investigation into a potential lawsuit begins when there is some type of bad outcome related to medical care,” Dr. Sullivan explained. “To determine whether the lawsuit has merit, patients/attorneys review the medical records to retrospectively determine the potential cause of the bad outcome. If the documentation reflects an examination that could not have been performed, a lawyer might be more likely to pursue a case, and it would be more difficult to defend the care provided.”

Dr. Sullivan provided this example: During a video visit, a patient complains of acute onset weakness. The physician documents that the patient’s heart has a “regular rate and rhythm,” and “muscle strength is equal bilaterally.” The following day, the patient’s weakness continues, and the patient goes to the emergency department where he is diagnosed with stroke. An EKG in the ED shows that the patient is in atrial fibrillation.

“The telehealth provider would have a difficult time explaining how it was determined that the patient had normal muscle strength and a normal heart rhythm over a video visit the day before,” Dr. Sullivan said. “A lawyer in a subsequent malpractice case would present the provider as careless and would argue that if the provider had only sent the patient to the emergency department after the telehealth visit instead of documenting exam findings that couldn’t have been performed, the patient could have been successfully treated for the stroke.”

3. Poorly executed informed consent can also give rise to a lawsuit. This includes informed consent regarding the use of telehealth as the accepted modality for the visit rather than traditional on-site evaluations, as well as preprocedure informed consent.

“Inadequate and/or poorly documented informed consent can result in a claim for medical battery,” Mr. Cahill said.

A medical battery allegation refers to the alleged treatment or touching of a patient’s body without that person’s consent. As the AMA Journal of Ethics explains, a patient’s consent must be given, either expressly or implicitly, before a physician may legally “interfere” with the physical body of the patient.

Ideally, the informed consent process is undertaken during a first in-person visit, before virtual visits begin, Dr. Feldman said.

“There is a lot that a patient has to understand when a visit is done virtually, which is part of the informed consent process,” Dr. Feldman said. “The pandemic has forced some physicians to do their first visit virtually, and this makes the process of informing patients more onerous. It is not a simple matter of converting an in-person office practice to a remote office practice. The work flows are different, so there are definitely legal concerns as it relates to privacy and cybersecurity to name a few.”
 

Waivers may be weak protection

Since the pandemic started, a number of states have enacted emergency malpractice protections to shield health professionals from lawsuits. Some protections, such as those in Massachusetts, offer immunity to health professionals who provide general care to patients during the COVID-19 emergency, in addition to treatment of COVID-19 patients. Other protections, like those in Connecticut, apply specifically to care provided in support of the state’s pandemic response.

Whether that immunity applies both to in-person visits and video visits during the pandemic is not certain, said J. Richard Moore, JD, a medical liability defense attorney based in Indianapolis. Indiana’s immunity statute for example, does not make a specific provision for telehealth, he said.

“My best prediction is that if considered by the courts, the immunity would be applied to telehealth services, so long as they are being provided ‘in response to the emergency,’ which is the scope of the immunity,” he said. “I would not consider telehealth physicians to be either more or less protected than in-person providers.”

Regulatory scrutiny for telehealth providers has also been relaxed in response to COVID-19, but experts warn not to rely on the temporary shields for ultimate protection.

In March, the U.S. Department of Health and Human Service’s Office of Civil Rights (OCR) eased enforcement actions for noncompliance with Health Insurance Portability and Accountability Act requirements in connection with the good faith provision of telehealth during the COVID-19 health crisis. Under the notice, health providers can use popular applications such as Apple FaceTime, Facebook Messenger, Zoom, or Google Hangouts, to offer telehealth care without risk that OCR will impose fines or penalties for HIPAA violations.

But once the current health care emergency is mitigated, the waivers will likely be withdrawn, and enforcement actions will probably resume, Mr. Cahill said.

“It is recommended that, to avoid potential problems going forward, practitioners use due diligence and undertake best efforts to obey existing privacy and security requirements, including the use of technology that satisfies compliance regulations, despite the waiver by OCR,” he said.

In addition, a majority of states have relaxed state-specific rules for practicing telehealth and loosened licensure requirements during the pandemic. At least 47 states have issued waivers to alter in-state licensure requirements for telemedicine in response to COVID-19, according to the Federation of State Medical Boards. Most of the waivers allow physicians licensed in other states to provide care in states where they do not hold licenses, and some enable doctors to treat patients without first having had an in-person evaluation.

But at least for now, these are temporary changes, reminds Amy Lerman, JD, a health care attorney based in Washington, who specializes in telehealth and corporate compliance. Given the current pandemic environment, a significant concern is that physicians new to the telemedicine space are reacting only to the most recent rules established in the context of the pandemic, Ms. Lerman said.

“As previously noted, the recent developments are temporary in nature – states and various federal agencies have been pretty clear in setting this temporal boundary,” she said. “It is not advisable for providers to build telepractice models around temporary sets of rules. 

“Furthermore, the recent developments are not necessarily comprehensive relative to all of the state-specific and other requirements that telemedicine providers are otherwise expected to follow, so relying only on the most recent guidance may cause providers to create telepractice models that have key gaps with respect to regulatory compliance.”
 

How you can avoid a lawsuit

As businesses reopen and practices resume treatments, physicians should weigh the choice between in-person care and video visits very carefully, said Joseph Kvedar, MD, president of the American Telemedicine Association and a dermatology professor at Harvard Medical School, Boston.

“We have to be very thoughtful about quality in this current phase, where we are doing what I call a hybrid model,” he said. “Some services are offered by telehealth and some require patients to come into the doctor’s office. We have to be very thoughtful about what types of care we determine to be appropriate for telehealth, and that has to be based on clinical quality. And if it is, it should follow that we’ll have low incidence of liability claims.”

Data should be at the center of that conclusion, Dr. Kvedar advises.

“Think about what data is needed to make a therapeutic or diagnostic decision,” he said. “If a health care provider can gather the information needed without touching the patient, then the provider is probably on safe, solid ground making that decision via a telehealth interaction. If the patient can come into the doctor’s office, and the provider deems it necessary to see the patient in person and touch the patient in order to make that clinical decision, then the patient should come in.”

An important step to preventing liability is also having strong telehealth systems and protocols in place and the necessary support to carry them out, said Dr. Einbinder of medical liability insurer CRICO.

For example, Dr. Einbinder, who practices in a 12-doctor internal medicine group, said when he finishes a virtual visit, he enters any orders into the electronic health record. Some of the orders will result in notifications to Dr. Einbinder if they are not executed, such as a referral appointment or a procedure that was not completed. 

“I also can forward my orders to a front desk pool that is responsible for making sure things get done,” he said. “And, in our hospital system, we have good case management for complex patients and population management for a variety of chronic conditions. These represent additional safety nets.” 

Another liability safeguard is sending patients a “visit summary” after each virtual visit, Dr. Sullivan said. This could be in the form of an email or a text that includes a brief template including items such as diagnosis, recommendations, follow-up, and a reminder to contact the doctor or go to the emergency department if symptoms worsen or new problems develop.

“Patients tend to remember about half of what physicians tell them and half of the information patients do remember is incorrect,” he said. “Consider a few sentences in an e-mail or text message as a substitute for the after-visit instructions from an office visit to enhance patient understanding. There are several inexpensive programs/services that allow text messages to be sent from a computer using a separate dedicated phone number and pretty much every patient has a cell phone to receive the instructions.”

Dr. Sullivan suggests having a documentation template specifically for telehealth visits. He also recommends the inclusion an “informed refusal of care” in the record when necessary. Dr. Sullivan’s wife, a family physician, has encountered several patients who fear contracting COVID-19 and who have refused her recommendations for in-person visits, he said. In such cases, he said it’s a good idea to document that the patient decided to forgo the recommendations given.

“If a patient suffers a bad outcome because of a failure to seek an in-person exam, a short note in the patient’s chart would help to establish that the lack of a follow-up physical exam was the patient’s informed decision, not due to some alleged negligence of the medical provider,” he said.

Concerning informed consent, Dr. Feldman says at a minimum physicians should discuss the following with patients:

• Names and credentials of staff participating.
• The right to stop or refuse treatment by telemedicine.
• Technology that will be used.
• Privacy and security risks.
• Technology-specific risks and permission to bill.
• Alternative care in case of an emergency or technology malfunction.
• Any state-specific requirements.

“Physicians can ensure they have a strong informed consent process during video visits by taking the time to cover these points at the beginning of the first visit, and being sure the patient understands and agrees to these,” Dr. Sullivan explained. “Ideally, this conversation can be recorded for future reference if necessary or at a minimum documented in the medical record.”
 

Consider these extra precautions

Mr. Cahill advises that practitioners be especially mindful of their “web-side manner” and the setting in which they are communicating with virtual patients to promote confidentiality, professionalism, and uninterrupted interactions.

“Use of a headset in a quiet home office is advisable,” he said. “Physicians must also be cognizant of their physical appearance and the background behind them when the visit includes both audio and visual capability. For ‘face-to-face’ telehealth encounters, it is recommended that a white lab jacket be worn as the appropriate attire; coat and tie are unnecessary.”

Some patients may need to be reminded of the need for confidentiality during a video visit, Mr. Moore added. Physicians are typically in a position to ensure confidentiality, but some patients may not understand how to protect their privacy on their end. 

“If the physician sees on the screen or hears from an audio connection that there are other people around who may be able to overhear what is communicated, the physician probably has some responsibility to remind the patient that she or he may want to go to a more private place, close the door, etc.,” he said. “While I think a claim against a physician on this basis would be pretty weak, it is still a good practice for the physician to be cognizant of those kinds of concerns even if the patient is not.”

Finally, for physicians who set up telehealth operability during the pandemic – possibly in a hurry – consider using your actual case data to take a look backward, said Ms. Lerman, the Washington-based health care attorney. Reviewing the data can help determine whether you’re in compliance with relevant state laws, she said. 

“If, for example, a provider set up telehealth operations during the pandemic and can see that most of [the] patients are based in a single state, or a small group of states, it is worthwhile to take [the] time and become familiar with the telemedicine laws in those states,” she said. “If there are modifications that need to be made, it may be easier to make them incrementally before the telehealth operations grow any larger in scope.” 

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

During a telemedicine visit with his physician, a 62-year-old obese patient with an ankle injury reported new swelling of his leg. Three weeks had passed since the man visited an emergency department, where he underwent surgery and had a cast applied to the wound. The physician, during the telemedicine visit, advised the patient to elevate his leg and see an orthopedist within 24 hours. A Doppler ultrasound was ordered for 12:30 p.m. that same day.

The patient never made it to the appointment. He became unresponsive and went into full arrest hours later. His death fueled a lawsuit by his family that claimed failure to diagnose and treat deep venous thrombosis. The family contended the providers involved should have referred the patient to care immediately during the video visit.  

The case, which comes from the claims database of national medical liability insurer The Doctors Company, illustrates the legal risks that can stem from video visits with patients, says Richard Cahill, JD, vice president and associate general counsel for The Doctors Company.

“By evaluating the patient remotely, the physician failed to appreciate the often subtle nuances of the clinical presentation, which undoubtedly could have been more accurately assessed in the office setting, and would probably have led to more urgent evaluation and intervention, thereby likely preventing the unfortunate and otherwise avoidable result,” said Mr. Cahill.

According to a Harris poll, 42% of Americans reported using video visits during the pandemic, a trend that is likely to continue as practices reopen and virtual care becomes the norm. But as physicians conduct more video visits, so grows their risk for lawsuits associated with the technology. 

“We probably will see more malpractice suits filed the more telehealth is used,” said Mei Wa Kwong, JD, executive director of the Center for Connected Health Policy. “It’s a numbers game. The more it’s used, the higher likelihood that lawsuits occur.”
 

Three problems in not being able to touch the patient

1. The primary challenge with video visits “is the inability to directly observe and lay hands on the patient,” says Jonathan Einbinder, MD, assistant vice president of analytics for CRICO, a medical liability insurer based in Boston.

“While you can see them via video, it can be hard to get a full sense of how sick the patient is and whether other things might be going on than what they are reporting,” said Dr. Einbinder, a practicing internist. 

Such incomplete pictures can lead to diagnostic errors and the potential for lawsuits, as demonstrated by a recent CRICO analysis. Of 106 telemedicine-related claims from 2014 to 2018, 66% were diagnosis related, according to the analysis of claims from CRICO’s national database. Twelve percent of the telemedicine-related claims were associated with surgical treatment, 11% were related to medical treatment, and 5% were associated with medication issues. A smaller number of claims resulted from patient monitoring, ob.gyn. care, and safety and security.

Another analysis by The Doctors Company similarly determined that diagnostic errors are the most common allegation in telemedicine-related claims. In the study of 28 telemedicine-related claims from The Doctors’ database, 71% were diagnosis related, 11% were associated with mismanagement of treatment, and 7% were related to improper management of a surgical patient. Other allegations included improper performance of treatment or procedure and improper performance of surgery.

“Because a ‘typical’ exam can’t be done, there is the potential to miss things,” said David L. Feldman, MD, chief medical officer for The Doctors Company Group. “A subtlety, perhaps a lump that can’t be seen but only felt, and only by an experienced examiner, for example, may be missed.” 

2. Documentation dangers also loom, said William Sullivan, DO, JD, an emergency physician and an attorney who specializes in health care. The legal risk lies in documenting a video visit in the same way the doctor would document an in-person visit, he explained.

“Investigation into a potential lawsuit begins when there is some type of bad outcome related to medical care,” Dr. Sullivan explained. “To determine whether the lawsuit has merit, patients/attorneys review the medical records to retrospectively determine the potential cause of the bad outcome. If the documentation reflects an examination that could not have been performed, a lawyer might be more likely to pursue a case, and it would be more difficult to defend the care provided.”

Dr. Sullivan provided this example: During a video visit, a patient complains of acute onset weakness. The physician documents that the patient’s heart has a “regular rate and rhythm,” and “muscle strength is equal bilaterally.” The following day, the patient’s weakness continues, and the patient goes to the emergency department where he is diagnosed with stroke. An EKG in the ED shows that the patient is in atrial fibrillation.

“The telehealth provider would have a difficult time explaining how it was determined that the patient had normal muscle strength and a normal heart rhythm over a video visit the day before,” Dr. Sullivan said. “A lawyer in a subsequent malpractice case would present the provider as careless and would argue that if the provider had only sent the patient to the emergency department after the telehealth visit instead of documenting exam findings that couldn’t have been performed, the patient could have been successfully treated for the stroke.”

3. Poorly executed informed consent can also give rise to a lawsuit. This includes informed consent regarding the use of telehealth as the accepted modality for the visit rather than traditional on-site evaluations, as well as preprocedure informed consent.

“Inadequate and/or poorly documented informed consent can result in a claim for medical battery,” Mr. Cahill said.

A medical battery allegation refers to the alleged treatment or touching of a patient’s body without that person’s consent. As the AMA Journal of Ethics explains, a patient’s consent must be given, either expressly or implicitly, before a physician may legally “interfere” with the physical body of the patient.

Ideally, the informed consent process is undertaken during a first in-person visit, before virtual visits begin, Dr. Feldman said.

“There is a lot that a patient has to understand when a visit is done virtually, which is part of the informed consent process,” Dr. Feldman said. “The pandemic has forced some physicians to do their first visit virtually, and this makes the process of informing patients more onerous. It is not a simple matter of converting an in-person office practice to a remote office practice. The work flows are different, so there are definitely legal concerns as it relates to privacy and cybersecurity to name a few.”
 

Waivers may be weak protection

Since the pandemic started, a number of states have enacted emergency malpractice protections to shield health professionals from lawsuits. Some protections, such as those in Massachusetts, offer immunity to health professionals who provide general care to patients during the COVID-19 emergency, in addition to treatment of COVID-19 patients. Other protections, like those in Connecticut, apply specifically to care provided in support of the state’s pandemic response.

Whether that immunity applies both to in-person visits and video visits during the pandemic is not certain, said J. Richard Moore, JD, a medical liability defense attorney based in Indianapolis. Indiana’s immunity statute for example, does not make a specific provision for telehealth, he said.

“My best prediction is that if considered by the courts, the immunity would be applied to telehealth services, so long as they are being provided ‘in response to the emergency,’ which is the scope of the immunity,” he said. “I would not consider telehealth physicians to be either more or less protected than in-person providers.”

Regulatory scrutiny for telehealth providers has also been relaxed in response to COVID-19, but experts warn not to rely on the temporary shields for ultimate protection.

In March, the U.S. Department of Health and Human Service’s Office of Civil Rights (OCR) eased enforcement actions for noncompliance with Health Insurance Portability and Accountability Act requirements in connection with the good faith provision of telehealth during the COVID-19 health crisis. Under the notice, health providers can use popular applications such as Apple FaceTime, Facebook Messenger, Zoom, or Google Hangouts, to offer telehealth care without risk that OCR will impose fines or penalties for HIPAA violations.

But once the current health care emergency is mitigated, the waivers will likely be withdrawn, and enforcement actions will probably resume, Mr. Cahill said.

“It is recommended that, to avoid potential problems going forward, practitioners use due diligence and undertake best efforts to obey existing privacy and security requirements, including the use of technology that satisfies compliance regulations, despite the waiver by OCR,” he said.

In addition, a majority of states have relaxed state-specific rules for practicing telehealth and loosened licensure requirements during the pandemic. At least 47 states have issued waivers to alter in-state licensure requirements for telemedicine in response to COVID-19, according to the Federation of State Medical Boards. Most of the waivers allow physicians licensed in other states to provide care in states where they do not hold licenses, and some enable doctors to treat patients without first having had an in-person evaluation.

But at least for now, these are temporary changes, reminds Amy Lerman, JD, a health care attorney based in Washington, who specializes in telehealth and corporate compliance. Given the current pandemic environment, a significant concern is that physicians new to the telemedicine space are reacting only to the most recent rules established in the context of the pandemic, Ms. Lerman said.

“As previously noted, the recent developments are temporary in nature – states and various federal agencies have been pretty clear in setting this temporal boundary,” she said. “It is not advisable for providers to build telepractice models around temporary sets of rules. 

“Furthermore, the recent developments are not necessarily comprehensive relative to all of the state-specific and other requirements that telemedicine providers are otherwise expected to follow, so relying only on the most recent guidance may cause providers to create telepractice models that have key gaps with respect to regulatory compliance.”
 

How you can avoid a lawsuit

As businesses reopen and practices resume treatments, physicians should weigh the choice between in-person care and video visits very carefully, said Joseph Kvedar, MD, president of the American Telemedicine Association and a dermatology professor at Harvard Medical School, Boston.

“We have to be very thoughtful about quality in this current phase, where we are doing what I call a hybrid model,” he said. “Some services are offered by telehealth and some require patients to come into the doctor’s office. We have to be very thoughtful about what types of care we determine to be appropriate for telehealth, and that has to be based on clinical quality. And if it is, it should follow that we’ll have low incidence of liability claims.”

Data should be at the center of that conclusion, Dr. Kvedar advises.

“Think about what data is needed to make a therapeutic or diagnostic decision,” he said. “If a health care provider can gather the information needed without touching the patient, then the provider is probably on safe, solid ground making that decision via a telehealth interaction. If the patient can come into the doctor’s office, and the provider deems it necessary to see the patient in person and touch the patient in order to make that clinical decision, then the patient should come in.”

An important step to preventing liability is also having strong telehealth systems and protocols in place and the necessary support to carry them out, said Dr. Einbinder of medical liability insurer CRICO.

For example, Dr. Einbinder, who practices in a 12-doctor internal medicine group, said when he finishes a virtual visit, he enters any orders into the electronic health record. Some of the orders will result in notifications to Dr. Einbinder if they are not executed, such as a referral appointment or a procedure that was not completed. 

“I also can forward my orders to a front desk pool that is responsible for making sure things get done,” he said. “And, in our hospital system, we have good case management for complex patients and population management for a variety of chronic conditions. These represent additional safety nets.” 

Another liability safeguard is sending patients a “visit summary” after each virtual visit, Dr. Sullivan said. This could be in the form of an email or a text that includes a brief template including items such as diagnosis, recommendations, follow-up, and a reminder to contact the doctor or go to the emergency department if symptoms worsen or new problems develop.

“Patients tend to remember about half of what physicians tell them and half of the information patients do remember is incorrect,” he said. “Consider a few sentences in an e-mail or text message as a substitute for the after-visit instructions from an office visit to enhance patient understanding. There are several inexpensive programs/services that allow text messages to be sent from a computer using a separate dedicated phone number and pretty much every patient has a cell phone to receive the instructions.”

Dr. Sullivan suggests having a documentation template specifically for telehealth visits. He also recommends the inclusion an “informed refusal of care” in the record when necessary. Dr. Sullivan’s wife, a family physician, has encountered several patients who fear contracting COVID-19 and who have refused her recommendations for in-person visits, he said. In such cases, he said it’s a good idea to document that the patient decided to forgo the recommendations given.

“If a patient suffers a bad outcome because of a failure to seek an in-person exam, a short note in the patient’s chart would help to establish that the lack of a follow-up physical exam was the patient’s informed decision, not due to some alleged negligence of the medical provider,” he said.

Concerning informed consent, Dr. Feldman says at a minimum physicians should discuss the following with patients:

• Names and credentials of staff participating.
• The right to stop or refuse treatment by telemedicine.
• Technology that will be used.
• Privacy and security risks.
• Technology-specific risks and permission to bill.
• Alternative care in case of an emergency or technology malfunction.
• Any state-specific requirements.

“Physicians can ensure they have a strong informed consent process during video visits by taking the time to cover these points at the beginning of the first visit, and being sure the patient understands and agrees to these,” Dr. Sullivan explained. “Ideally, this conversation can be recorded for future reference if necessary or at a minimum documented in the medical record.”
 

Consider these extra precautions

Mr. Cahill advises that practitioners be especially mindful of their “web-side manner” and the setting in which they are communicating with virtual patients to promote confidentiality, professionalism, and uninterrupted interactions.

“Use of a headset in a quiet home office is advisable,” he said. “Physicians must also be cognizant of their physical appearance and the background behind them when the visit includes both audio and visual capability. For ‘face-to-face’ telehealth encounters, it is recommended that a white lab jacket be worn as the appropriate attire; coat and tie are unnecessary.”

Some patients may need to be reminded of the need for confidentiality during a video visit, Mr. Moore added. Physicians are typically in a position to ensure confidentiality, but some patients may not understand how to protect their privacy on their end. 

“If the physician sees on the screen or hears from an audio connection that there are other people around who may be able to overhear what is communicated, the physician probably has some responsibility to remind the patient that she or he may want to go to a more private place, close the door, etc.,” he said. “While I think a claim against a physician on this basis would be pretty weak, it is still a good practice for the physician to be cognizant of those kinds of concerns even if the patient is not.”

Finally, for physicians who set up telehealth operability during the pandemic – possibly in a hurry – consider using your actual case data to take a look backward, said Ms. Lerman, the Washington-based health care attorney. Reviewing the data can help determine whether you’re in compliance with relevant state laws, she said. 

“If, for example, a provider set up telehealth operations during the pandemic and can see that most of [the] patients are based in a single state, or a small group of states, it is worthwhile to take [the] time and become familiar with the telemedicine laws in those states,” she said. “If there are modifications that need to be made, it may be easier to make them incrementally before the telehealth operations grow any larger in scope.” 

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

The US Food and Drug Administration on Aug. 28 expanded its emergency use authorization (EUA) of remdesivir (Veklury) to include treatment of all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease.

An EUA of remdesivir 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 need oxygen therapy or mechanical ventilation.

“Today, based on the Agency’s ongoing review of the EUA, including its review of the totality of scientific information now available, the FDA has determined that it is reasonable to believe Veklury may be effective for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients,” the FDA news release about the expanded EUA said. “The Agency’s review has also concluded that the known and potential benefits of Veklury outweigh the known and potential risks for these uses.”
 

‘Further evaluation’ needed

The EUA expansion is partially based on the results of a randomized, open-label trial that Gilead Sciences, remdesivir’s manufacturer, conducted at multiple sites.

The trial showed that a 5-day course of remdesivir was associated with statistically significant improvement among patients hospitalized with moderate COVID-19 in comparison with those receiving standard care. However, patients who were randomly assigned to a receive longer, 10-day remdesivir course had not improved significantly 11 days after treatment started, compared with those who received standard care.

Results with remdesivir in this trial and in two previously reported randomized trials varied, “raising the question of whether the discrepancies are artifacts of study design choices, including patient populations, or whether the drug is less efficacious than hoped,” wrote Erin K. McCreary, PharmD, and Derek C. Angus, MD, MPH, with the University of Pittsburgh School of Medicine, in an editorial that accompanied publication of the trials in JAMA.

Angus previously expressed concern that expanding remdesivir’s EUA could “interrupt or thwart efforts to execute the needed RCTs [randomized controlled trials].

“We think there really needs to be further evaluation of remdesivir in large-scale RCTs adequately powered to understand in which patients, at which dose, given at which point in the course of illness leads to what concrete and tangible improvement in clinical outcomes,” he told Medscape Medical News.

“At this point, remdesivir definitely holds promise, but given the cost to produce and distribute the drug, it seems crucial to know with more certainty how best to use it,” Angus said.

The EUA expansion is also partially based on results from a randomized, double-blind, placebo-controlled clinical trial that the National Institutes of Allergy and Infectious Diseases conducted. In that trial, there was a statistically significant reduction in median recovery time and higher odds of clinical improvement after 2 weeks for hospitalized patients who received remdesivir.

For hospitalized patients with mild to moderate disease, the results were consistent with the overall study results but were not statistically significant.
 

This article first appeared on Medscape.com.

The US Food and Drug Administration on Aug. 28 expanded its emergency use authorization (EUA) of remdesivir (Veklury) to include treatment of all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease.

An EUA of remdesivir 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 need oxygen therapy or mechanical ventilation.

“Today, based on the Agency’s ongoing review of the EUA, including its review of the totality of scientific information now available, the FDA has determined that it is reasonable to believe Veklury may be effective for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients,” the FDA news release about the expanded EUA said. “The Agency’s review has also concluded that the known and potential benefits of Veklury outweigh the known and potential risks for these uses.”
 

‘Further evaluation’ needed

The EUA expansion is partially based on the results of a randomized, open-label trial that Gilead Sciences, remdesivir’s manufacturer, conducted at multiple sites.

The trial showed that a 5-day course of remdesivir was associated with statistically significant improvement among patients hospitalized with moderate COVID-19 in comparison with those receiving standard care. However, patients who were randomly assigned to a receive longer, 10-day remdesivir course had not improved significantly 11 days after treatment started, compared with those who received standard care.

Results with remdesivir in this trial and in two previously reported randomized trials varied, “raising the question of whether the discrepancies are artifacts of study design choices, including patient populations, or whether the drug is less efficacious than hoped,” wrote Erin K. McCreary, PharmD, and Derek C. Angus, MD, MPH, with the University of Pittsburgh School of Medicine, in an editorial that accompanied publication of the trials in JAMA.

Angus previously expressed concern that expanding remdesivir’s EUA could “interrupt or thwart efforts to execute the needed RCTs [randomized controlled trials].

“We think there really needs to be further evaluation of remdesivir in large-scale RCTs adequately powered to understand in which patients, at which dose, given at which point in the course of illness leads to what concrete and tangible improvement in clinical outcomes,” he told Medscape Medical News.

“At this point, remdesivir definitely holds promise, but given the cost to produce and distribute the drug, it seems crucial to know with more certainty how best to use it,” Angus said.

The EUA expansion is also partially based on results from a randomized, double-blind, placebo-controlled clinical trial that the National Institutes of Allergy and Infectious Diseases conducted. In that trial, there was a statistically significant reduction in median recovery time and higher odds of clinical improvement after 2 weeks for hospitalized patients who received remdesivir.

For hospitalized patients with mild to moderate disease, the results were consistent with the overall study results but were not statistically significant.
 

This article first appeared on Medscape.com.

The US Food and Drug Administration on Aug. 28 expanded its emergency use authorization (EUA) of remdesivir (Veklury) to include treatment of all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease.

An EUA of remdesivir 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 need oxygen therapy or mechanical ventilation.

“Today, based on the Agency’s ongoing review of the EUA, including its review of the totality of scientific information now available, the FDA has determined that it is reasonable to believe Veklury may be effective for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients,” the FDA news release about the expanded EUA said. “The Agency’s review has also concluded that the known and potential benefits of Veklury outweigh the known and potential risks for these uses.”
 

‘Further evaluation’ needed

The EUA expansion is partially based on the results of a randomized, open-label trial that Gilead Sciences, remdesivir’s manufacturer, conducted at multiple sites.

The trial showed that a 5-day course of remdesivir was associated with statistically significant improvement among patients hospitalized with moderate COVID-19 in comparison with those receiving standard care. However, patients who were randomly assigned to a receive longer, 10-day remdesivir course had not improved significantly 11 days after treatment started, compared with those who received standard care.

Results with remdesivir in this trial and in two previously reported randomized trials varied, “raising the question of whether the discrepancies are artifacts of study design choices, including patient populations, or whether the drug is less efficacious than hoped,” wrote Erin K. McCreary, PharmD, and Derek C. Angus, MD, MPH, with the University of Pittsburgh School of Medicine, in an editorial that accompanied publication of the trials in JAMA.

Angus previously expressed concern that expanding remdesivir’s EUA could “interrupt or thwart efforts to execute the needed RCTs [randomized controlled trials].

“We think there really needs to be further evaluation of remdesivir in large-scale RCTs adequately powered to understand in which patients, at which dose, given at which point in the course of illness leads to what concrete and tangible improvement in clinical outcomes,” he told Medscape Medical News.

“At this point, remdesivir definitely holds promise, but given the cost to produce and distribute the drug, it seems crucial to know with more certainty how best to use it,” Angus said.

The EUA expansion is also partially based on results from a randomized, double-blind, placebo-controlled clinical trial that the National Institutes of Allergy and Infectious Diseases conducted. In that trial, there was a statistically significant reduction in median recovery time and higher odds of clinical improvement after 2 weeks for hospitalized patients who received remdesivir.

For hospitalized patients with mild to moderate disease, the results were consistent with the overall study results but were not statistically significant.
 

This article first appeared on Medscape.com.