Study Overview

Objective. To evaluate the efficacy of maintenance avelumab in patients with advanced urothelial carcinoma who had received first-line platinum-based chemotherapy.

Design. International, open-label, randomized, phase 3 trial.

Intervention. Patients were randomized in a 1:1 ratio to receive either maintenance therapy with avelumab 10 mg/kg plus best supportive care (BSC) or BSC alone, per local practice. Randomization was stratified according to best response to first-line chemotherapy and metastatic site (visceral vs nonvisceral). Treatment was continued until progression, unacceptable toxicities, or patient withdrawal occurred.

Setting and participants. A total of 700 patients were enrolled at 197 sites (350 in the avelumab group and 350 in the BSC group). All patients had histologically confirmed unresectable or metastatic urothelial carcinoma. Patients received 4 to 6 cycles of chemotherapy with either gemcitabine plus cisplatin or carboplatin and had no evidence of progression after completion. Patients had a treatment-free interval of 4 to 10 weeks prior to starting maintenance therapy. Patients who received neoadjuvant or adjuvant platinum-based therapy within the prior 12 months were excluded.

Main outcome measures. The primary endpoint was overall survival (OS) assessed in both the overall population and PD-L1–positive population. Secondary endpoints included progression-free survival (PFS), objective response, time to response, duration of response, and disease control. PD-L1 expression was determined via the Ventana PD-L1 assay (SP263), and patients were classified as PD-L1 positive if they met 1 of the following: (1) at least 25% of tumor cells were positive for PD-L1; (2) at least 25% of immune cells were positive for PD-L1 if more than 1% of the tumor area contained immune cells; and (3) 100% of immune cells stained for PD-L1 if no more than 1% of the tumor area contained immune cells.

Results. The baseline characteristics were well balanced between the groups. A total of 51.1% of patients had PD-L1–positive tumors (57.6% in the avelumab group and 56.3% in the control group). At the time of analysis, 24% of patients in the avelumab group were still receiving therapy compared with only 7% in the BSC group. The most common reason for discontinuation of therapy was disease progression; 43.7% of patients in the control group received anti-PD-1 or anti-PD-L1 therapy at progression. The median follow-up was 19 months. OS at 1 year was 71.3% in the avelumab group and 58.4% in the control group. The median OS was 21.4 months in the avelumab group compared with 14.3 months in the control group (hazard ratio [HR] for death, 0.69; confidence interval [CI], 0.56-0.86, P = 0.001). In the PD-L1–positive population, OS was also significantly longer in the avelumab group (NE vs 17.1 months, HR, 0.56; CI, 0.40-0.79; P < 0.001). In the PD-L1–negative population, median OS was 18.8 months in the avelumab group versus 13.7 months in the control group (HR, 0.85). PFS was longer in the avelumab group than in the control group, with a median PFS of 3.7 months versus 2 months, respectively. The median PFS was 5.7 months in the avelumab group and 2.1 months in the control group in the PD-L1–positive population.

Adverse events (AEs) of any grade occurred in 98% of patients in the avelumab group and 77% in the control group. Grade 3 or higher AEs occurred in 47.4% of patients in the avelumab group. AEs led to discontinuation in 11.9% of patients in the avelumab group. Two patients died in the avelumab group as a result of toxicity (urinary tract infection with sepsis and ischemic stroke). Immune-related adverse events occurred in 29.4% of patients in the avelumab group. Of those, 7% were grade 3 in nature, and there were no grade 4 or 5 immune-related AEs. The most commonly seen immune-related AEs were thyroid disorders.

Conclusion. Avelumab maintenance significantly improved OS compared with BSC in patients with advanced/metastatic urothelial carcinoma whose disease did not progress after first-line platinum-based chemotherapy.

Commentary

In summary, the JAVELIN Bladder 100 trial showed significantly longer OS with the use of maintenance avelumab following first-line platinum-based chemotherapy. This survival benefit was seen in all subgroups, including those who received cisplatin or carboplatin therapy, as well as those with stable disease, partial response, or complete response to initial chemotherapy. Furthermore, the survival benefit was seen in both the overall population as well as in the PD-L1–positive population. There did not appear to be any new safety concerns noted in this trial. Based on these findings, avelumab maintenance in those who do not progress on first-line platinum-based therapy certainly represents a potentially new standard of care in this patient population. While the results of this study are promising and potentially practice changing, whether this “switch maintenance” approach is superior to treatment at progression (ie, use of checkpoint inhibition in the second-line setting) remains debatable. Nevertheless, for most patients, this appears to be the preferred approach given the notable longer OS and improved PFS, which is meaningful, particularly if the progression event is symptomatic. Furthermore, a portion of patients will not proceed to second-line therapy for a variety of reasons, and thus will not be exposed to checkpoint inhibitors if one takes a treatment break approach.

In the previous KEYNOTE-45 study evaluating pembrolizumab versus chemotherapy in the second-line setting after progression on previous platinum therapy, the median OS was just 10 months in the pembrolizumab arm.¹ This is markedly different from the 21.4-month median OS noted in the current study. While there are many limitations to this comparison, it does appear that switch maintenance leads to meaningful improvements in patient outcomes. It should be noted, however, that a portion of patients will have a durable response to platinum-based therapy, and thus there may be a portion of patients who would be “overtreated” with such an approach.

A similar approach has been explored in a randomized phase 2 trial looking at maintenance pembrolizumab after first-line chemotherapy (HCRN GU14-182).² This trial similarly showed improvement in PFS; however, OS was not yet mature at the time of data analysis. It should be noted that crossover was permitted in the HCRN study, while this was not allowed in the current Javelin 100 study. Certainly, this crossover effect influenced OS data in that trial. Thus, the current study is the first and only to show an OS benefit with such an approach in this population. Numerous ongoing studies are seeking to evaluate the efficacy of immune checkpoint inhibitors in the first-line setting for advanced urothelial carcinoma, and the results of these studies will help shed additional light regarding the efficacy of this approach.

Applications for Clinical Practice

First-line maintenance avelumab in patients who do not progress on platinum-based chemotherapy improves both progression-free and overall survival. This approach is certainly practice-changing and represents a new standard of care in this patient population. Careful discussion with each patient about the benefits and risks of a switch maintenance approach is warranted.

Daniel Isaac, DO, MS

Study Overview

Objective. To evaluate the efficacy of maintenance avelumab in patients with advanced urothelial carcinoma who had received first-line platinum-based chemotherapy.

Design. International, open-label, randomized, phase 3 trial.

Intervention. Patients were randomized in a 1:1 ratio to receive either maintenance therapy with avelumab 10 mg/kg plus best supportive care (BSC) or BSC alone, per local practice. Randomization was stratified according to best response to first-line chemotherapy and metastatic site (visceral vs nonvisceral). Treatment was continued until progression, unacceptable toxicities, or patient withdrawal occurred.

Setting and participants. A total of 700 patients were enrolled at 197 sites (350 in the avelumab group and 350 in the BSC group). All patients had histologically confirmed unresectable or metastatic urothelial carcinoma. Patients received 4 to 6 cycles of chemotherapy with either gemcitabine plus cisplatin or carboplatin and had no evidence of progression after completion. Patients had a treatment-free interval of 4 to 10 weeks prior to starting maintenance therapy. Patients who received neoadjuvant or adjuvant platinum-based therapy within the prior 12 months were excluded.

Main outcome measures. The primary endpoint was overall survival (OS) assessed in both the overall population and PD-L1–positive population. Secondary endpoints included progression-free survival (PFS), objective response, time to response, duration of response, and disease control. PD-L1 expression was determined via the Ventana PD-L1 assay (SP263), and patients were classified as PD-L1 positive if they met 1 of the following: (1) at least 25% of tumor cells were positive for PD-L1; (2) at least 25% of immune cells were positive for PD-L1 if more than 1% of the tumor area contained immune cells; and (3) 100% of immune cells stained for PD-L1 if no more than 1% of the tumor area contained immune cells.

Results. The baseline characteristics were well balanced between the groups. A total of 51.1% of patients had PD-L1–positive tumors (57.6% in the avelumab group and 56.3% in the control group). At the time of analysis, 24% of patients in the avelumab group were still receiving therapy compared with only 7% in the BSC group. The most common reason for discontinuation of therapy was disease progression; 43.7% of patients in the control group received anti-PD-1 or anti-PD-L1 therapy at progression. The median follow-up was 19 months. OS at 1 year was 71.3% in the avelumab group and 58.4% in the control group. The median OS was 21.4 months in the avelumab group compared with 14.3 months in the control group (hazard ratio [HR] for death, 0.69; confidence interval [CI], 0.56-0.86, P = 0.001). In the PD-L1–positive population, OS was also significantly longer in the avelumab group (NE vs 17.1 months, HR, 0.56; CI, 0.40-0.79; P < 0.001). In the PD-L1–negative population, median OS was 18.8 months in the avelumab group versus 13.7 months in the control group (HR, 0.85). PFS was longer in the avelumab group than in the control group, with a median PFS of 3.7 months versus 2 months, respectively. The median PFS was 5.7 months in the avelumab group and 2.1 months in the control group in the PD-L1–positive population.

Adverse events (AEs) of any grade occurred in 98% of patients in the avelumab group and 77% in the control group. Grade 3 or higher AEs occurred in 47.4% of patients in the avelumab group. AEs led to discontinuation in 11.9% of patients in the avelumab group. Two patients died in the avelumab group as a result of toxicity (urinary tract infection with sepsis and ischemic stroke). Immune-related adverse events occurred in 29.4% of patients in the avelumab group. Of those, 7% were grade 3 in nature, and there were no grade 4 or 5 immune-related AEs. The most commonly seen immune-related AEs were thyroid disorders.

Conclusion. Avelumab maintenance significantly improved OS compared with BSC in patients with advanced/metastatic urothelial carcinoma whose disease did not progress after first-line platinum-based chemotherapy.

Commentary

In summary, the JAVELIN Bladder 100 trial showed significantly longer OS with the use of maintenance avelumab following first-line platinum-based chemotherapy. This survival benefit was seen in all subgroups, including those who received cisplatin or carboplatin therapy, as well as those with stable disease, partial response, or complete response to initial chemotherapy. Furthermore, the survival benefit was seen in both the overall population as well as in the PD-L1–positive population. There did not appear to be any new safety concerns noted in this trial. Based on these findings, avelumab maintenance in those who do not progress on first-line platinum-based therapy certainly represents a potentially new standard of care in this patient population. While the results of this study are promising and potentially practice changing, whether this “switch maintenance” approach is superior to treatment at progression (ie, use of checkpoint inhibition in the second-line setting) remains debatable. Nevertheless, for most patients, this appears to be the preferred approach given the notable longer OS and improved PFS, which is meaningful, particularly if the progression event is symptomatic. Furthermore, a portion of patients will not proceed to second-line therapy for a variety of reasons, and thus will not be exposed to checkpoint inhibitors if one takes a treatment break approach.

In the previous KEYNOTE-45 study evaluating pembrolizumab versus chemotherapy in the second-line setting after progression on previous platinum therapy, the median OS was just 10 months in the pembrolizumab arm.¹ This is markedly different from the 21.4-month median OS noted in the current study. While there are many limitations to this comparison, it does appear that switch maintenance leads to meaningful improvements in patient outcomes. It should be noted, however, that a portion of patients will have a durable response to platinum-based therapy, and thus there may be a portion of patients who would be “overtreated” with such an approach.

A similar approach has been explored in a randomized phase 2 trial looking at maintenance pembrolizumab after first-line chemotherapy (HCRN GU14-182).² This trial similarly showed improvement in PFS; however, OS was not yet mature at the time of data analysis. It should be noted that crossover was permitted in the HCRN study, while this was not allowed in the current Javelin 100 study. Certainly, this crossover effect influenced OS data in that trial. Thus, the current study is the first and only to show an OS benefit with such an approach in this population. Numerous ongoing studies are seeking to evaluate the efficacy of immune checkpoint inhibitors in the first-line setting for advanced urothelial carcinoma, and the results of these studies will help shed additional light regarding the efficacy of this approach.

Applications for Clinical Practice

First-line maintenance avelumab in patients who do not progress on platinum-based chemotherapy improves both progression-free and overall survival. This approach is certainly practice-changing and represents a new standard of care in this patient population. Careful discussion with each patient about the benefits and risks of a switch maintenance approach is warranted.

Daniel Isaac, DO, MS

Study Overview

Objective. To evaluate the efficacy of maintenance avelumab in patients with advanced urothelial carcinoma who had received first-line platinum-based chemotherapy.

Design. International, open-label, randomized, phase 3 trial.

Intervention. Patients were randomized in a 1:1 ratio to receive either maintenance therapy with avelumab 10 mg/kg plus best supportive care (BSC) or BSC alone, per local practice. Randomization was stratified according to best response to first-line chemotherapy and metastatic site (visceral vs nonvisceral). Treatment was continued until progression, unacceptable toxicities, or patient withdrawal occurred.

Setting and participants. A total of 700 patients were enrolled at 197 sites (350 in the avelumab group and 350 in the BSC group). All patients had histologically confirmed unresectable or metastatic urothelial carcinoma. Patients received 4 to 6 cycles of chemotherapy with either gemcitabine plus cisplatin or carboplatin and had no evidence of progression after completion. Patients had a treatment-free interval of 4 to 10 weeks prior to starting maintenance therapy. Patients who received neoadjuvant or adjuvant platinum-based therapy within the prior 12 months were excluded.

Main outcome measures. The primary endpoint was overall survival (OS) assessed in both the overall population and PD-L1–positive population. Secondary endpoints included progression-free survival (PFS), objective response, time to response, duration of response, and disease control. PD-L1 expression was determined via the Ventana PD-L1 assay (SP263), and patients were classified as PD-L1 positive if they met 1 of the following: (1) at least 25% of tumor cells were positive for PD-L1; (2) at least 25% of immune cells were positive for PD-L1 if more than 1% of the tumor area contained immune cells; and (3) 100% of immune cells stained for PD-L1 if no more than 1% of the tumor area contained immune cells.

Results. The baseline characteristics were well balanced between the groups. A total of 51.1% of patients had PD-L1–positive tumors (57.6% in the avelumab group and 56.3% in the control group). At the time of analysis, 24% of patients in the avelumab group were still receiving therapy compared with only 7% in the BSC group. The most common reason for discontinuation of therapy was disease progression; 43.7% of patients in the control group received anti-PD-1 or anti-PD-L1 therapy at progression. The median follow-up was 19 months. OS at 1 year was 71.3% in the avelumab group and 58.4% in the control group. The median OS was 21.4 months in the avelumab group compared with 14.3 months in the control group (hazard ratio [HR] for death, 0.69; confidence interval [CI], 0.56-0.86, P = 0.001). In the PD-L1–positive population, OS was also significantly longer in the avelumab group (NE vs 17.1 months, HR, 0.56; CI, 0.40-0.79; P < 0.001). In the PD-L1–negative population, median OS was 18.8 months in the avelumab group versus 13.7 months in the control group (HR, 0.85). PFS was longer in the avelumab group than in the control group, with a median PFS of 3.7 months versus 2 months, respectively. The median PFS was 5.7 months in the avelumab group and 2.1 months in the control group in the PD-L1–positive population.

Adverse events (AEs) of any grade occurred in 98% of patients in the avelumab group and 77% in the control group. Grade 3 or higher AEs occurred in 47.4% of patients in the avelumab group. AEs led to discontinuation in 11.9% of patients in the avelumab group. Two patients died in the avelumab group as a result of toxicity (urinary tract infection with sepsis and ischemic stroke). Immune-related adverse events occurred in 29.4% of patients in the avelumab group. Of those, 7% were grade 3 in nature, and there were no grade 4 or 5 immune-related AEs. The most commonly seen immune-related AEs were thyroid disorders.

Conclusion. Avelumab maintenance significantly improved OS compared with BSC in patients with advanced/metastatic urothelial carcinoma whose disease did not progress after first-line platinum-based chemotherapy.

Commentary

In summary, the JAVELIN Bladder 100 trial showed significantly longer OS with the use of maintenance avelumab following first-line platinum-based chemotherapy. This survival benefit was seen in all subgroups, including those who received cisplatin or carboplatin therapy, as well as those with stable disease, partial response, or complete response to initial chemotherapy. Furthermore, the survival benefit was seen in both the overall population as well as in the PD-L1–positive population. There did not appear to be any new safety concerns noted in this trial. Based on these findings, avelumab maintenance in those who do not progress on first-line platinum-based therapy certainly represents a potentially new standard of care in this patient population. While the results of this study are promising and potentially practice changing, whether this “switch maintenance” approach is superior to treatment at progression (ie, use of checkpoint inhibition in the second-line setting) remains debatable. Nevertheless, for most patients, this appears to be the preferred approach given the notable longer OS and improved PFS, which is meaningful, particularly if the progression event is symptomatic. Furthermore, a portion of patients will not proceed to second-line therapy for a variety of reasons, and thus will not be exposed to checkpoint inhibitors if one takes a treatment break approach.

In the previous KEYNOTE-45 study evaluating pembrolizumab versus chemotherapy in the second-line setting after progression on previous platinum therapy, the median OS was just 10 months in the pembrolizumab arm.¹ This is markedly different from the 21.4-month median OS noted in the current study. While there are many limitations to this comparison, it does appear that switch maintenance leads to meaningful improvements in patient outcomes. It should be noted, however, that a portion of patients will have a durable response to platinum-based therapy, and thus there may be a portion of patients who would be “overtreated” with such an approach.

A similar approach has been explored in a randomized phase 2 trial looking at maintenance pembrolizumab after first-line chemotherapy (HCRN GU14-182).² This trial similarly showed improvement in PFS; however, OS was not yet mature at the time of data analysis. It should be noted that crossover was permitted in the HCRN study, while this was not allowed in the current Javelin 100 study. Certainly, this crossover effect influenced OS data in that trial. Thus, the current study is the first and only to show an OS benefit with such an approach in this population. Numerous ongoing studies are seeking to evaluate the efficacy of immune checkpoint inhibitors in the first-line setting for advanced urothelial carcinoma, and the results of these studies will help shed additional light regarding the efficacy of this approach.

Applications for Clinical Practice

First-line maintenance avelumab in patients who do not progress on platinum-based chemotherapy improves both progression-free and overall survival. This approach is certainly practice-changing and represents a new standard of care in this patient population. Careful discussion with each patient about the benefits and risks of a switch maintenance approach is warranted.

Daniel Isaac, DO, MS

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

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

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

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

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

1. Coronavirus stimulus rebates

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

2. Look to accelerate income at lower brackets

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

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

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

3. Build Roth assets strategies

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

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

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

4. Coronavirus-related distributions

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

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

5. Charitable donations for 2020

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

6. Noncash charitable donations

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

7. Claiming 2020 losses on prior tax returns

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

8. Delay payroll taxes where possible

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

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

9. Increased business property deductions

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

10. Switch to cash accounting instead of accrual accounting

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

11. Physicians looking to sell their unprofitable practices

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

12. Physicians looking to sell their profitable practices

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

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

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

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

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

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

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

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

1. Coronavirus stimulus rebates

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

2. Look to accelerate income at lower brackets

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

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

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

3. Build Roth assets strategies

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

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

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

4. Coronavirus-related distributions

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

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

5. Charitable donations for 2020

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

6. Noncash charitable donations

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

7. Claiming 2020 losses on prior tax returns

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

8. Delay payroll taxes where possible

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

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

9. Increased business property deductions

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

10. Switch to cash accounting instead of accrual accounting

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

11. Physicians looking to sell their unprofitable practices

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

12. Physicians looking to sell their profitable practices

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

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

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

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

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

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

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

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

1. Coronavirus stimulus rebates

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

2. Look to accelerate income at lower brackets

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

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

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

3. Build Roth assets strategies

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

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

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

4. Coronavirus-related distributions

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

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

5. Charitable donations for 2020

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

6. Noncash charitable donations

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

7. Claiming 2020 losses on prior tax returns

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

8. Delay payroll taxes where possible

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

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

9. Increased business property deductions

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

10. Switch to cash accounting instead of accrual accounting

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

11. Physicians looking to sell their unprofitable practices

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

12. Physicians looking to sell their profitable practices

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

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

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

In patients with intermediate-risk pulmonary arterial hypertension (PAH) who are not at treatment goal on standard therapy, switching to riociguat is a promising strategy across a broad range of patient subgroups, an investigator said at the annual meeting of the American College of Chest Physicians, held virtually this year.

Patients switching to riociguat in the REPLACE study more frequently met the primary efficacy endpoint, compared with patients who remained on a phosphodiesterase-5 (PDE5) inhibitor, said Marius M. Hoeper, MD, of the Clinic for Respiratory Medicine at Hannover (Germany) Medical School.

That clinical benefit of switching to riociguat, a soluble guanylate cyclase (sGC) stimulator, was relatively consistent across patient subgroups including age, sex, PAH subtype, according to Dr. Hoeper.

“At the end of the day, we believe that switching from a PDE5 inhibitor to riociguat can benefit patients with PAH at intermediate risk and may serve as a new strategic option for treatment escalation,” he said in a live virtual presentation of the study results.

About 40% of patients switching to riociguat met the primary endpoint of clinical improvement in absence of clinical worsening versus just 20% of patients who stayed on a PDE5 inhibitor, according to top-line results of the phase 4 REPLACE study, which were reported Sept. 7 at the annual meeting of the European Respiratory Society.

Results of REPLACE presented at the CHEST meeting show a benefit across most patient subgroups, including PAH subtype and whether patients came from monotherapy or combination treatment to riociguat. Some groups did not appear to respond quite as well to switching, including elderly patients, patients with a 6-minute walk distance (6MWD) of less than 320 meters at baseline, and patients switching from tadalafil as opposed to sildenafil. However, these findings were not statistically significant and may have been chance findings, according to Dr. Hoeper.

These results of REPLACE suggest the efficacy of riociguat “across the board” for intermediate-risk PAH patients with inadequate response to standard therapy, said Vijay Balasubramanian, MD, FCCP, clinical professor of medicine at the University of California San Francisco, Fresno.

Based on REPLACE results, switching from a PDE5 inhibitor to riociguat is now a “strong potential option” beyond adding a third drug such as selexipag or an inhaled prostacyclin to usual treatment with a PDE5 inhibitor plus an endothelin receptor antagonist, Dr. Balasubramanian said in an interview.

“We now have an evidence-based option where you can stay on a two-drug regimen and see whether the switch would work just as well,” said Dr. Balasubramanian, vice chair of the Pulmonary Vascular Disease Steering Committee for the American College of Chest Physicians.

REPLACE is a randomized phase 4 study including 226 patients with PAH considered to be at intermediate risk according to World Health Organization functional class III or 6MWD of 165-440 meters. The composite primary endpoint was defined as no clinical worsening (death, disease progression, or hospitalization for worsening PAH) plus clinical improvement on at least two measures including an improvement in 6MWD, achieving WHO functional class I/II, or a decrease in N-terminal pro-brain natriuretic peptide (NT-proBNP).

The primary endpoint of REPLACE was met, showing that 45 patients (41%) who switched to riociguat had clinical improvement without clinical worsening versus 22 patient (20%) who stayed on the PDE5 inhibitor (odds ratio, 2.78; 95% confidence interval, 1.53-5.06; P = .0007), Dr. Hoeper reported.

The benefit appeared consistent across PAH subgroups, according to Dr. Hoeper. In patients with idiopathic, heritable, or drug- and toxin-induced PAH, the primary endpoint favored riociguat over PDE5 inhibitor, at 45% and 23%, respectively. Similarly, a higher proportion of patients with PAH associated with congenital heart disease or portal hypertension achieved the primary endpoint (46% vs. 8%), as did patients with PAH associated with connective tissue disease (25% vs. 16%).

Adverse events were seen in 71% of riociguat-treated patients and 66% of PDE5 inhibitor–treated patients, according to Dr. Hoeper, who said severe adverse events were more frequent with PDE5-inhibitor treatment, at 17% versus 7% for riociguat. There were three clinical worsening events in the PDE5 inhibitor group leading to death, while a fourth patient died in safety follow-up, according to the reported results, whereas there were no deaths reported with riociguat.

The REPLACE study was cofunded by Bayer AG and Merck Sharpe & Dohme, a subsidiary of Merck & Co. Dr. Hoeper reported receiving fees for consultations or lectures from Acceleron, Actelion, Bayer AG, Janssen, MSD, and Pfizer.

SOURCE: Hoeper MM. CHEST 2020, Abstract A2156-A2159.

In patients with intermediate-risk pulmonary arterial hypertension (PAH) who are not at treatment goal on standard therapy, switching to riociguat is a promising strategy across a broad range of patient subgroups, an investigator said at the annual meeting of the American College of Chest Physicians, held virtually this year.

Patients switching to riociguat in the REPLACE study more frequently met the primary efficacy endpoint, compared with patients who remained on a phosphodiesterase-5 (PDE5) inhibitor, said Marius M. Hoeper, MD, of the Clinic for Respiratory Medicine at Hannover (Germany) Medical School.

That clinical benefit of switching to riociguat, a soluble guanylate cyclase (sGC) stimulator, was relatively consistent across patient subgroups including age, sex, PAH subtype, according to Dr. Hoeper.

“At the end of the day, we believe that switching from a PDE5 inhibitor to riociguat can benefit patients with PAH at intermediate risk and may serve as a new strategic option for treatment escalation,” he said in a live virtual presentation of the study results.

About 40% of patients switching to riociguat met the primary endpoint of clinical improvement in absence of clinical worsening versus just 20% of patients who stayed on a PDE5 inhibitor, according to top-line results of the phase 4 REPLACE study, which were reported Sept. 7 at the annual meeting of the European Respiratory Society.

Results of REPLACE presented at the CHEST meeting show a benefit across most patient subgroups, including PAH subtype and whether patients came from monotherapy or combination treatment to riociguat. Some groups did not appear to respond quite as well to switching, including elderly patients, patients with a 6-minute walk distance (6MWD) of less than 320 meters at baseline, and patients switching from tadalafil as opposed to sildenafil. However, these findings were not statistically significant and may have been chance findings, according to Dr. Hoeper.

These results of REPLACE suggest the efficacy of riociguat “across the board” for intermediate-risk PAH patients with inadequate response to standard therapy, said Vijay Balasubramanian, MD, FCCP, clinical professor of medicine at the University of California San Francisco, Fresno.

Based on REPLACE results, switching from a PDE5 inhibitor to riociguat is now a “strong potential option” beyond adding a third drug such as selexipag or an inhaled prostacyclin to usual treatment with a PDE5 inhibitor plus an endothelin receptor antagonist, Dr. Balasubramanian said in an interview.

“We now have an evidence-based option where you can stay on a two-drug regimen and see whether the switch would work just as well,” said Dr. Balasubramanian, vice chair of the Pulmonary Vascular Disease Steering Committee for the American College of Chest Physicians.

REPLACE is a randomized phase 4 study including 226 patients with PAH considered to be at intermediate risk according to World Health Organization functional class III or 6MWD of 165-440 meters. The composite primary endpoint was defined as no clinical worsening (death, disease progression, or hospitalization for worsening PAH) plus clinical improvement on at least two measures including an improvement in 6MWD, achieving WHO functional class I/II, or a decrease in N-terminal pro-brain natriuretic peptide (NT-proBNP).

The primary endpoint of REPLACE was met, showing that 45 patients (41%) who switched to riociguat had clinical improvement without clinical worsening versus 22 patient (20%) who stayed on the PDE5 inhibitor (odds ratio, 2.78; 95% confidence interval, 1.53-5.06; P = .0007), Dr. Hoeper reported.

The benefit appeared consistent across PAH subgroups, according to Dr. Hoeper. In patients with idiopathic, heritable, or drug- and toxin-induced PAH, the primary endpoint favored riociguat over PDE5 inhibitor, at 45% and 23%, respectively. Similarly, a higher proportion of patients with PAH associated with congenital heart disease or portal hypertension achieved the primary endpoint (46% vs. 8%), as did patients with PAH associated with connective tissue disease (25% vs. 16%).

Adverse events were seen in 71% of riociguat-treated patients and 66% of PDE5 inhibitor–treated patients, according to Dr. Hoeper, who said severe adverse events were more frequent with PDE5-inhibitor treatment, at 17% versus 7% for riociguat. There were three clinical worsening events in the PDE5 inhibitor group leading to death, while a fourth patient died in safety follow-up, according to the reported results, whereas there were no deaths reported with riociguat.

The REPLACE study was cofunded by Bayer AG and Merck Sharpe & Dohme, a subsidiary of Merck & Co. Dr. Hoeper reported receiving fees for consultations or lectures from Acceleron, Actelion, Bayer AG, Janssen, MSD, and Pfizer.

SOURCE: Hoeper MM. CHEST 2020, Abstract A2156-A2159.

In patients with intermediate-risk pulmonary arterial hypertension (PAH) who are not at treatment goal on standard therapy, switching to riociguat is a promising strategy across a broad range of patient subgroups, an investigator said at the annual meeting of the American College of Chest Physicians, held virtually this year.

Patients switching to riociguat in the REPLACE study more frequently met the primary efficacy endpoint, compared with patients who remained on a phosphodiesterase-5 (PDE5) inhibitor, said Marius M. Hoeper, MD, of the Clinic for Respiratory Medicine at Hannover (Germany) Medical School.

That clinical benefit of switching to riociguat, a soluble guanylate cyclase (sGC) stimulator, was relatively consistent across patient subgroups including age, sex, PAH subtype, according to Dr. Hoeper.

“At the end of the day, we believe that switching from a PDE5 inhibitor to riociguat can benefit patients with PAH at intermediate risk and may serve as a new strategic option for treatment escalation,” he said in a live virtual presentation of the study results.

About 40% of patients switching to riociguat met the primary endpoint of clinical improvement in absence of clinical worsening versus just 20% of patients who stayed on a PDE5 inhibitor, according to top-line results of the phase 4 REPLACE study, which were reported Sept. 7 at the annual meeting of the European Respiratory Society.

Results of REPLACE presented at the CHEST meeting show a benefit across most patient subgroups, including PAH subtype and whether patients came from monotherapy or combination treatment to riociguat. Some groups did not appear to respond quite as well to switching, including elderly patients, patients with a 6-minute walk distance (6MWD) of less than 320 meters at baseline, and patients switching from tadalafil as opposed to sildenafil. However, these findings were not statistically significant and may have been chance findings, according to Dr. Hoeper.

These results of REPLACE suggest the efficacy of riociguat “across the board” for intermediate-risk PAH patients with inadequate response to standard therapy, said Vijay Balasubramanian, MD, FCCP, clinical professor of medicine at the University of California San Francisco, Fresno.

Based on REPLACE results, switching from a PDE5 inhibitor to riociguat is now a “strong potential option” beyond adding a third drug such as selexipag or an inhaled prostacyclin to usual treatment with a PDE5 inhibitor plus an endothelin receptor antagonist, Dr. Balasubramanian said in an interview.

“We now have an evidence-based option where you can stay on a two-drug regimen and see whether the switch would work just as well,” said Dr. Balasubramanian, vice chair of the Pulmonary Vascular Disease Steering Committee for the American College of Chest Physicians.

REPLACE is a randomized phase 4 study including 226 patients with PAH considered to be at intermediate risk according to World Health Organization functional class III or 6MWD of 165-440 meters. The composite primary endpoint was defined as no clinical worsening (death, disease progression, or hospitalization for worsening PAH) plus clinical improvement on at least two measures including an improvement in 6MWD, achieving WHO functional class I/II, or a decrease in N-terminal pro-brain natriuretic peptide (NT-proBNP).

The primary endpoint of REPLACE was met, showing that 45 patients (41%) who switched to riociguat had clinical improvement without clinical worsening versus 22 patient (20%) who stayed on the PDE5 inhibitor (odds ratio, 2.78; 95% confidence interval, 1.53-5.06; P = .0007), Dr. Hoeper reported.

The benefit appeared consistent across PAH subgroups, according to Dr. Hoeper. In patients with idiopathic, heritable, or drug- and toxin-induced PAH, the primary endpoint favored riociguat over PDE5 inhibitor, at 45% and 23%, respectively. Similarly, a higher proportion of patients with PAH associated with congenital heart disease or portal hypertension achieved the primary endpoint (46% vs. 8%), as did patients with PAH associated with connective tissue disease (25% vs. 16%).

Adverse events were seen in 71% of riociguat-treated patients and 66% of PDE5 inhibitor–treated patients, according to Dr. Hoeper, who said severe adverse events were more frequent with PDE5-inhibitor treatment, at 17% versus 7% for riociguat. There were three clinical worsening events in the PDE5 inhibitor group leading to death, while a fourth patient died in safety follow-up, according to the reported results, whereas there were no deaths reported with riociguat.

The REPLACE study was cofunded by Bayer AG and Merck Sharpe & Dohme, a subsidiary of Merck & Co. Dr. Hoeper reported receiving fees for consultations or lectures from Acceleron, Actelion, Bayer AG, Janssen, MSD, and Pfizer.

SOURCE: Hoeper MM. CHEST 2020, Abstract A2156-A2159.

A new scoring system can predict whether COVID-19 patients will require invasive mechanical ventilation, researchers report.

The score uses three variables to predict future risk: heart rate; the ratio of oxygen saturation (SpO₂) to fraction of inspired oxygen (FiO₂); and a positive troponin I level.

“What excites us is it’s a really benign tool,” said Muhtadi Alnababteh, MD, from the Medstar Washington (D.C.) Hospital Center. “For the first two variables you only need to look at vital signs, no labs or invasive diagnostics.”

“The third part is a simple lab, which is performed universally and can be done in any hospital,” he told this news organization. “We know that even rural hospitals can do this.”

For their retrospective analysis, Dr. Alnababteh and his colleagues assessed 265 adults with confirmed COVID-19 infection who were admitted to a single tertiary care center in March and April. They looked at demographic characteristics, lab results, and clinical and outcome information.

Ultimately, 54 of these patients required invasive mechanical ventilation.

On multiple-regression analysis, the researchers determined that three variables independently predicted the need for invasive mechanical ventilation.

Existing scores evaluated for COVID-19 outcome prediction

The MuLBSTA score can also be used to predict outcomes in patients with COVID-19.

A retrospective evaluation of 163 patients was presented at CHEST 2020 by Jurgena Tusha, MD, from Wayne State University in Detroit.

Patients who survived their illness had a mean MuLBSTA score of 8.67, whereas patients who died had a mean score of 13.60.

The score “correlated significantly with mortality, ventilator support, and length of stay, which may be used to provide guidance to screen patients and make further clinical decisions,” Dr. Tusha said in a press release.

“Further studies are required to validate this study in larger patient cohorts,” she added.

The three-variable scoring system is easier to use than the MuLBSTA, and more specific, said Dr. Alnababteh.

“The main difference between our study and the MuLBSTA study is that we came up with a novel score for COVID-19 patients,” he said. “Our study score doesn’t require chest x-rays or blood cultures, and the outcome is need for invasive mechanical ventilation, not mortality.”

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

A new scoring system can predict whether COVID-19 patients will require invasive mechanical ventilation, researchers report.

The score uses three variables to predict future risk: heart rate; the ratio of oxygen saturation (SpO₂) to fraction of inspired oxygen (FiO₂); and a positive troponin I level.

“What excites us is it’s a really benign tool,” said Muhtadi Alnababteh, MD, from the Medstar Washington (D.C.) Hospital Center. “For the first two variables you only need to look at vital signs, no labs or invasive diagnostics.”

“The third part is a simple lab, which is performed universally and can be done in any hospital,” he told this news organization. “We know that even rural hospitals can do this.”

For their retrospective analysis, Dr. Alnababteh and his colleagues assessed 265 adults with confirmed COVID-19 infection who were admitted to a single tertiary care center in March and April. They looked at demographic characteristics, lab results, and clinical and outcome information.

Ultimately, 54 of these patients required invasive mechanical ventilation.

On multiple-regression analysis, the researchers determined that three variables independently predicted the need for invasive mechanical ventilation.

Existing scores evaluated for COVID-19 outcome prediction

The MuLBSTA score can also be used to predict outcomes in patients with COVID-19.

A retrospective evaluation of 163 patients was presented at CHEST 2020 by Jurgena Tusha, MD, from Wayne State University in Detroit.

Patients who survived their illness had a mean MuLBSTA score of 8.67, whereas patients who died had a mean score of 13.60.

The score “correlated significantly with mortality, ventilator support, and length of stay, which may be used to provide guidance to screen patients and make further clinical decisions,” Dr. Tusha said in a press release.

“Further studies are required to validate this study in larger patient cohorts,” she added.

The three-variable scoring system is easier to use than the MuLBSTA, and more specific, said Dr. Alnababteh.

“The main difference between our study and the MuLBSTA study is that we came up with a novel score for COVID-19 patients,” he said. “Our study score doesn’t require chest x-rays or blood cultures, and the outcome is need for invasive mechanical ventilation, not mortality.”

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

A new scoring system can predict whether COVID-19 patients will require invasive mechanical ventilation, researchers report.

The score uses three variables to predict future risk: heart rate; the ratio of oxygen saturation (SpO₂) to fraction of inspired oxygen (FiO₂); and a positive troponin I level.

“What excites us is it’s a really benign tool,” said Muhtadi Alnababteh, MD, from the Medstar Washington (D.C.) Hospital Center. “For the first two variables you only need to look at vital signs, no labs or invasive diagnostics.”

“The third part is a simple lab, which is performed universally and can be done in any hospital,” he told this news organization. “We know that even rural hospitals can do this.”

For their retrospective analysis, Dr. Alnababteh and his colleagues assessed 265 adults with confirmed COVID-19 infection who were admitted to a single tertiary care center in March and April. They looked at demographic characteristics, lab results, and clinical and outcome information.

Ultimately, 54 of these patients required invasive mechanical ventilation.

On multiple-regression analysis, the researchers determined that three variables independently predicted the need for invasive mechanical ventilation.

Existing scores evaluated for COVID-19 outcome prediction

The MuLBSTA score can also be used to predict outcomes in patients with COVID-19.

A retrospective evaluation of 163 patients was presented at CHEST 2020 by Jurgena Tusha, MD, from Wayne State University in Detroit.

Patients who survived their illness had a mean MuLBSTA score of 8.67, whereas patients who died had a mean score of 13.60.

The score “correlated significantly with mortality, ventilator support, and length of stay, which may be used to provide guidance to screen patients and make further clinical decisions,” Dr. Tusha said in a press release.

“Further studies are required to validate this study in larger patient cohorts,” she added.

The three-variable scoring system is easier to use than the MuLBSTA, and more specific, said Dr. Alnababteh.

“The main difference between our study and the MuLBSTA study is that we came up with a novel score for COVID-19 patients,” he said. “Our study score doesn’t require chest x-rays or blood cultures, and the outcome is need for invasive mechanical ventilation, not mortality.”

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

The COVID-19 pandemic figured prominently in the final debate between President Donald Trump and former Vice President Joe Biden when they met on stage for a 90-minute debate in Nashville, Tennessee, Thursday evening.

The adequacy of the COVID-19 response to date, the likely timeline for vaccine availability, and how to reopen businesses while keeping Americans safe were among the points on which the two candidates disagreed. The two candidates also sparred over the value of the Affordable Care Act (ACA) and the future of healthcare in the United States.

Trump and Biden also differed on whether or not the country is facing a “dark winter” because of the pandemic.

Moderator Kristen Welker, NBC News White House correspondent, asked Trump to comment on the fact that 40,000 people are in the hospital on debate night with COVID-19 and that 16,000 have died since the last presidential debate.

Trump said, “2.2 million people modeled out were expected to die.” He said COVID-19 is a worldwide disease that does not only affect the United States.

“The mortality rate is down 85%, and the excess mortality is also down,” he added. He pointed out that previous spikes in Florida, Texas, and Arizona are now gone, and “spikes and surges in other places will soon be gone.

“It will go away, we are rounding the corner,” Trump said. “From personal experience, I was in the hospital, I had it, and they gave me a therapeutic, some would call it a cure...and now they say I’m immune. Whether it’s for a month or lifetime, nobody has been able to say that, but I’m immune.”

Biden countered by saying that “220,000 people are dead. If you hear nothing else I say tonight, hear this: Anyone who’s responsible for that many deaths should not remain president of the United States of America.”

Biden said there are a thousand deaths a day now and that there are over 70K new cases per day. “The expectation is we will have another 200,000 people down before the end of this year. If we just all wore these masks, we could save 100,000.”

“The New England Journal of Medicine said the way the president has handled this is absolutely tragic,” Biden added.

Vaccine timeline

Welker asked Trump if he could guarantee that there will be a COVID-19 vaccine within weeks.

“I can’t guarantee that, but it will be by end of the year. It will be distributed very quickly,” Trump said. He added that three leading vaccine developers, Johnson & Johnson, Moderna, and Pfizer, “are doing very well.”

“We’re about to go into a dark winter and he has no clear plan,” Biden said. “There is no prospect there will be a vaccine for most Americans by middle of next year.”

“It will not be a dark winter,” Trump responded.

Reopening the economy

Trump and Biden disagreed on how aggressively the economy should be reopened in light of the pandemic.

“I want to open the schools. We can’t keep this country closed,” Trump said. “This is a massive country with a massive economy.” He pointed out that rates of depression and suicide have risen because of the economic shutdown. “The cure cannot be worse than the problem.

“His Democrat governors...shut down so tight, and they’re dying,” the president added, gesturing toward Biden. “We are not going to shut down. We are going to open the schools.” As an example of the resiliency of young people, he mentioned that his son Barron tested positive for COVID-19 and recovered.

“I would shut down the virus, not the country,” Biden said. “It’s his ineptitude that caused so many schools and businesses to close in large part. Instead of being in a sand trap playing golf, he should have been negotiating with Nancy Pelosi.”

“He says we’re learning to live with it,” the former vice president said, but instead, “people are learning to die with it.”

Biden added that reopening the economy and minimizing transmission of COVID-19 are not mutually exclusive. “We can walk and chew gum at the same time.”

Divergence over the ACA

The fate of the ACA also garnered considerable attention. The discussion underlined a vast difference of opinion between the two candidates on the US healthcare system.

The moderator asked Trump what he would do for the 20 million Americans who get their healthcare through the ACA if it’s taken away.

“Through the legislature, I terminated the individual mandate, the worst part of Obamacare,” Trump said. “And now it’s in court because Obamacare is no good.

“Preexisting conditions will stay,” Trump added.

“I want to terminate Obamacare, and I want to come up with a beautiful healthcare [plan],” Trump added, turning the discussion toward private health insurance. “One thing that is very important is we have 180 million out there who have great private healthcare. Joe Biden will terminate all of their healthcare.”

Trump described Biden’s plan as “socialized medicine.” He also emphasized that protections for people with preexisting conditions “will stay.”

The Trump administration is supporting a lawsuit to overturn the ACA. The suit was filed by 18 Republican-led states. Arguments before the US Supreme Court on the constitutionality of the ACA are scheduled for November 10.

The moderator asked what Biden plans to do if the ACA is struck down. “I will pass Obamacare with a public option ― that will be ‘Bidencare.’ “ He said his plan will reduce premiums and drug prices. “I support private insurance. No one lost their private insurance under Obamacare.

“There is no way he can protect preexisting conditions,” Biden said. He added that 10 million people have already lost their private healthcare through unemployment during the pandemic.

Muting the mic

Following what many described as a chaotic first debate at the Cleveland Clinic in Ohio on September 29, the Commission on Presidential Debate opted to allow the muting of the microphone during the first 2 minutes of remarks made by each candidate during each debate segment.

The muting of the microphones appeared to prevent crosstalk during the beginning of each segment of the debate. The candidates did manage to talk over and interrupt each other, as well as the moderator, during portions of the debate.

This article first appeared on Medscape.com.

The COVID-19 pandemic figured prominently in the final debate between President Donald Trump and former Vice President Joe Biden when they met on stage for a 90-minute debate in Nashville, Tennessee, Thursday evening.

The adequacy of the COVID-19 response to date, the likely timeline for vaccine availability, and how to reopen businesses while keeping Americans safe were among the points on which the two candidates disagreed. The two candidates also sparred over the value of the Affordable Care Act (ACA) and the future of healthcare in the United States.

Trump and Biden also differed on whether or not the country is facing a “dark winter” because of the pandemic.

Moderator Kristen Welker, NBC News White House correspondent, asked Trump to comment on the fact that 40,000 people are in the hospital on debate night with COVID-19 and that 16,000 have died since the last presidential debate.

Trump said, “2.2 million people modeled out were expected to die.” He said COVID-19 is a worldwide disease that does not only affect the United States.

“The mortality rate is down 85%, and the excess mortality is also down,” he added. He pointed out that previous spikes in Florida, Texas, and Arizona are now gone, and “spikes and surges in other places will soon be gone.

“It will go away, we are rounding the corner,” Trump said. “From personal experience, I was in the hospital, I had it, and they gave me a therapeutic, some would call it a cure...and now they say I’m immune. Whether it’s for a month or lifetime, nobody has been able to say that, but I’m immune.”

Biden countered by saying that “220,000 people are dead. If you hear nothing else I say tonight, hear this: Anyone who’s responsible for that many deaths should not remain president of the United States of America.”

Biden said there are a thousand deaths a day now and that there are over 70K new cases per day. “The expectation is we will have another 200,000 people down before the end of this year. If we just all wore these masks, we could save 100,000.”

“The New England Journal of Medicine said the way the president has handled this is absolutely tragic,” Biden added.

Vaccine timeline

Welker asked Trump if he could guarantee that there will be a COVID-19 vaccine within weeks.

“I can’t guarantee that, but it will be by end of the year. It will be distributed very quickly,” Trump said. He added that three leading vaccine developers, Johnson & Johnson, Moderna, and Pfizer, “are doing very well.”

“We’re about to go into a dark winter and he has no clear plan,” Biden said. “There is no prospect there will be a vaccine for most Americans by middle of next year.”

“It will not be a dark winter,” Trump responded.

Reopening the economy

Trump and Biden disagreed on how aggressively the economy should be reopened in light of the pandemic.

“I want to open the schools. We can’t keep this country closed,” Trump said. “This is a massive country with a massive economy.” He pointed out that rates of depression and suicide have risen because of the economic shutdown. “The cure cannot be worse than the problem.

“His Democrat governors...shut down so tight, and they’re dying,” the president added, gesturing toward Biden. “We are not going to shut down. We are going to open the schools.” As an example of the resiliency of young people, he mentioned that his son Barron tested positive for COVID-19 and recovered.

“I would shut down the virus, not the country,” Biden said. “It’s his ineptitude that caused so many schools and businesses to close in large part. Instead of being in a sand trap playing golf, he should have been negotiating with Nancy Pelosi.”

“He says we’re learning to live with it,” the former vice president said, but instead, “people are learning to die with it.”

Biden added that reopening the economy and minimizing transmission of COVID-19 are not mutually exclusive. “We can walk and chew gum at the same time.”

Divergence over the ACA

The fate of the ACA also garnered considerable attention. The discussion underlined a vast difference of opinion between the two candidates on the US healthcare system.

The moderator asked Trump what he would do for the 20 million Americans who get their healthcare through the ACA if it’s taken away.

“Through the legislature, I terminated the individual mandate, the worst part of Obamacare,” Trump said. “And now it’s in court because Obamacare is no good.

“Preexisting conditions will stay,” Trump added.

“I want to terminate Obamacare, and I want to come up with a beautiful healthcare [plan],” Trump added, turning the discussion toward private health insurance. “One thing that is very important is we have 180 million out there who have great private healthcare. Joe Biden will terminate all of their healthcare.”

Trump described Biden’s plan as “socialized medicine.” He also emphasized that protections for people with preexisting conditions “will stay.”

The Trump administration is supporting a lawsuit to overturn the ACA. The suit was filed by 18 Republican-led states. Arguments before the US Supreme Court on the constitutionality of the ACA are scheduled for November 10.

The moderator asked what Biden plans to do if the ACA is struck down. “I will pass Obamacare with a public option ― that will be ‘Bidencare.’ “ He said his plan will reduce premiums and drug prices. “I support private insurance. No one lost their private insurance under Obamacare.

“There is no way he can protect preexisting conditions,” Biden said. He added that 10 million people have already lost their private healthcare through unemployment during the pandemic.

Muting the mic

Following what many described as a chaotic first debate at the Cleveland Clinic in Ohio on September 29, the Commission on Presidential Debate opted to allow the muting of the microphone during the first 2 minutes of remarks made by each candidate during each debate segment.

The muting of the microphones appeared to prevent crosstalk during the beginning of each segment of the debate. The candidates did manage to talk over and interrupt each other, as well as the moderator, during portions of the debate.

This article first appeared on Medscape.com.

The COVID-19 pandemic figured prominently in the final debate between President Donald Trump and former Vice President Joe Biden when they met on stage for a 90-minute debate in Nashville, Tennessee, Thursday evening.

The adequacy of the COVID-19 response to date, the likely timeline for vaccine availability, and how to reopen businesses while keeping Americans safe were among the points on which the two candidates disagreed. The two candidates also sparred over the value of the Affordable Care Act (ACA) and the future of healthcare in the United States.

Trump and Biden also differed on whether or not the country is facing a “dark winter” because of the pandemic.

Moderator Kristen Welker, NBC News White House correspondent, asked Trump to comment on the fact that 40,000 people are in the hospital on debate night with COVID-19 and that 16,000 have died since the last presidential debate.

Trump said, “2.2 million people modeled out were expected to die.” He said COVID-19 is a worldwide disease that does not only affect the United States.

“The mortality rate is down 85%, and the excess mortality is also down,” he added. He pointed out that previous spikes in Florida, Texas, and Arizona are now gone, and “spikes and surges in other places will soon be gone.

“It will go away, we are rounding the corner,” Trump said. “From personal experience, I was in the hospital, I had it, and they gave me a therapeutic, some would call it a cure...and now they say I’m immune. Whether it’s for a month or lifetime, nobody has been able to say that, but I’m immune.”

Biden countered by saying that “220,000 people are dead. If you hear nothing else I say tonight, hear this: Anyone who’s responsible for that many deaths should not remain president of the United States of America.”

Biden said there are a thousand deaths a day now and that there are over 70K new cases per day. “The expectation is we will have another 200,000 people down before the end of this year. If we just all wore these masks, we could save 100,000.”

“The New England Journal of Medicine said the way the president has handled this is absolutely tragic,” Biden added.

Vaccine timeline

Welker asked Trump if he could guarantee that there will be a COVID-19 vaccine within weeks.

“I can’t guarantee that, but it will be by end of the year. It will be distributed very quickly,” Trump said. He added that three leading vaccine developers, Johnson & Johnson, Moderna, and Pfizer, “are doing very well.”

“We’re about to go into a dark winter and he has no clear plan,” Biden said. “There is no prospect there will be a vaccine for most Americans by middle of next year.”

“It will not be a dark winter,” Trump responded.

Reopening the economy

Trump and Biden disagreed on how aggressively the economy should be reopened in light of the pandemic.

“I want to open the schools. We can’t keep this country closed,” Trump said. “This is a massive country with a massive economy.” He pointed out that rates of depression and suicide have risen because of the economic shutdown. “The cure cannot be worse than the problem.

“His Democrat governors...shut down so tight, and they’re dying,” the president added, gesturing toward Biden. “We are not going to shut down. We are going to open the schools.” As an example of the resiliency of young people, he mentioned that his son Barron tested positive for COVID-19 and recovered.

“I would shut down the virus, not the country,” Biden said. “It’s his ineptitude that caused so many schools and businesses to close in large part. Instead of being in a sand trap playing golf, he should have been negotiating with Nancy Pelosi.”

“He says we’re learning to live with it,” the former vice president said, but instead, “people are learning to die with it.”

Biden added that reopening the economy and minimizing transmission of COVID-19 are not mutually exclusive. “We can walk and chew gum at the same time.”

Divergence over the ACA

The fate of the ACA also garnered considerable attention. The discussion underlined a vast difference of opinion between the two candidates on the US healthcare system.

The moderator asked Trump what he would do for the 20 million Americans who get their healthcare through the ACA if it’s taken away.

“Through the legislature, I terminated the individual mandate, the worst part of Obamacare,” Trump said. “And now it’s in court because Obamacare is no good.

“Preexisting conditions will stay,” Trump added.

“I want to terminate Obamacare, and I want to come up with a beautiful healthcare [plan],” Trump added, turning the discussion toward private health insurance. “One thing that is very important is we have 180 million out there who have great private healthcare. Joe Biden will terminate all of their healthcare.”

Trump described Biden’s plan as “socialized medicine.” He also emphasized that protections for people with preexisting conditions “will stay.”

The Trump administration is supporting a lawsuit to overturn the ACA. The suit was filed by 18 Republican-led states. Arguments before the US Supreme Court on the constitutionality of the ACA are scheduled for November 10.

The moderator asked what Biden plans to do if the ACA is struck down. “I will pass Obamacare with a public option ― that will be ‘Bidencare.’ “ He said his plan will reduce premiums and drug prices. “I support private insurance. No one lost their private insurance under Obamacare.

“There is no way he can protect preexisting conditions,” Biden said. He added that 10 million people have already lost their private healthcare through unemployment during the pandemic.

Muting the mic

Following what many described as a chaotic first debate at the Cleveland Clinic in Ohio on September 29, the Commission on Presidential Debate opted to allow the muting of the microphone during the first 2 minutes of remarks made by each candidate during each debate segment.

The muting of the microphones appeared to prevent crosstalk during the beginning of each segment of the debate. The candidates did manage to talk over and interrupt each other, as well as the moderator, during portions of the debate.

This article first appeared on Medscape.com.

The ongoing COVID-19 pandemic poses clear threats to mental well-being, but an increase in suicide is not inevitable if appropriate action is taken, one expert says.

“Increases in suicide rates should not be a foregone conclusion, even with the negative effects of the pandemic. If the lessons of suicide prevention research are heeded during and after the pandemic, this potential for increased risk could be substantially mitigated,” writes Christine Moutier, MD, chief medical officer of the American Foundation for Suicide Prevention, in an invited communication in JAMA Psychiatry.

“This is a moment in history when suicide prevention must be prioritized as a serious public health concern,” she writes.

Mitigating suicide risk

Although evidence from the first 6 months of the pandemic reveal specific effects on suicide risk, real-time data on suicide deaths are not available in most regions of the world. From emerging data from several countries, there is no evidence of increased suicide rates during the pandemic thus far, Moutier notes.

Still, a number of pandemic-related risk factors could increase individual and population suicide risk.

They include deterioration or recurrence of serious mental illness; increased isolation, loneliness, and bereavement; increased use of drugs and alcohol; job loss and other financial stressors; and increases in domestic violence.

There are mitigating strategies for each of these “threats to suicide risk.” The science is “very clear,” Moutier told Medscape Medical News.

“Suicide risk is never a situation of inevitability. It’s dynamic, with multiple forces at play in each individual and in the population. Lives can be saved simply by making people feel more connected to each other, that they are part of a larger community,” she added.

The political will

Moutier notes that prior to the pandemic, four countries ― Finland, Norway, Sweden, and Australia ― had fully implemented national suicide prevention plans and had achieved reductions in their national suicide rates. However, in the United States, the suicide rate has been steadily increasing since 1999.

A Centers for Disease Control and Prevention survey released in August 2020 found that 40% of US adults reported symptoms of depression, anxiety, or increased substance use during COVID-19 and that about 11% reported suicidal ideation in the past month, all increases from prior surveys.

COVID-19 presents a “new and urgent opportunity” to focus political will, federal investments, and the global community on suicide prevention, Moutier writes.

“The political will to address suicide has actually moved in the right direction during COVID, as evidenced by a number of pieces of legislation that have suddenly found their way to passing that we’ve been working on for years,” she said in an interview.

One example, she said, is the National Suicide Hotline Designation Act, signed into law earlier this month by President Donald Trump.

As previously reported, under the law, beginning in July 2022, Americans experiencing a mental health crisis will be able to dial 9-8-8 and be connected to the services and counselors at the National Suicide Prevention Lifeline.

Moutier reports no relevant financial relationships.

This article first appeared on Medscape.com.

The ongoing COVID-19 pandemic poses clear threats to mental well-being, but an increase in suicide is not inevitable if appropriate action is taken, one expert says.

“Increases in suicide rates should not be a foregone conclusion, even with the negative effects of the pandemic. If the lessons of suicide prevention research are heeded during and after the pandemic, this potential for increased risk could be substantially mitigated,” writes Christine Moutier, MD, chief medical officer of the American Foundation for Suicide Prevention, in an invited communication in JAMA Psychiatry.

“This is a moment in history when suicide prevention must be prioritized as a serious public health concern,” she writes.

Mitigating suicide risk

Although evidence from the first 6 months of the pandemic reveal specific effects on suicide risk, real-time data on suicide deaths are not available in most regions of the world. From emerging data from several countries, there is no evidence of increased suicide rates during the pandemic thus far, Moutier notes.

Still, a number of pandemic-related risk factors could increase individual and population suicide risk.

They include deterioration or recurrence of serious mental illness; increased isolation, loneliness, and bereavement; increased use of drugs and alcohol; job loss and other financial stressors; and increases in domestic violence.

There are mitigating strategies for each of these “threats to suicide risk.” The science is “very clear,” Moutier told Medscape Medical News.

“Suicide risk is never a situation of inevitability. It’s dynamic, with multiple forces at play in each individual and in the population. Lives can be saved simply by making people feel more connected to each other, that they are part of a larger community,” she added.

The political will

Moutier notes that prior to the pandemic, four countries ― Finland, Norway, Sweden, and Australia ― had fully implemented national suicide prevention plans and had achieved reductions in their national suicide rates. However, in the United States, the suicide rate has been steadily increasing since 1999.

A Centers for Disease Control and Prevention survey released in August 2020 found that 40% of US adults reported symptoms of depression, anxiety, or increased substance use during COVID-19 and that about 11% reported suicidal ideation in the past month, all increases from prior surveys.

COVID-19 presents a “new and urgent opportunity” to focus political will, federal investments, and the global community on suicide prevention, Moutier writes.

“The political will to address suicide has actually moved in the right direction during COVID, as evidenced by a number of pieces of legislation that have suddenly found their way to passing that we’ve been working on for years,” she said in an interview.

One example, she said, is the National Suicide Hotline Designation Act, signed into law earlier this month by President Donald Trump.

As previously reported, under the law, beginning in July 2022, Americans experiencing a mental health crisis will be able to dial 9-8-8 and be connected to the services and counselors at the National Suicide Prevention Lifeline.

Moutier reports no relevant financial relationships.

This article first appeared on Medscape.com.

The ongoing COVID-19 pandemic poses clear threats to mental well-being, but an increase in suicide is not inevitable if appropriate action is taken, one expert says.

“Increases in suicide rates should not be a foregone conclusion, even with the negative effects of the pandemic. If the lessons of suicide prevention research are heeded during and after the pandemic, this potential for increased risk could be substantially mitigated,” writes Christine Moutier, MD, chief medical officer of the American Foundation for Suicide Prevention, in an invited communication in JAMA Psychiatry.

“This is a moment in history when suicide prevention must be prioritized as a serious public health concern,” she writes.

Mitigating suicide risk

Although evidence from the first 6 months of the pandemic reveal specific effects on suicide risk, real-time data on suicide deaths are not available in most regions of the world. From emerging data from several countries, there is no evidence of increased suicide rates during the pandemic thus far, Moutier notes.

Still, a number of pandemic-related risk factors could increase individual and population suicide risk.

They include deterioration or recurrence of serious mental illness; increased isolation, loneliness, and bereavement; increased use of drugs and alcohol; job loss and other financial stressors; and increases in domestic violence.

There are mitigating strategies for each of these “threats to suicide risk.” The science is “very clear,” Moutier told Medscape Medical News.

“Suicide risk is never a situation of inevitability. It’s dynamic, with multiple forces at play in each individual and in the population. Lives can be saved simply by making people feel more connected to each other, that they are part of a larger community,” she added.

The political will

Moutier notes that prior to the pandemic, four countries ― Finland, Norway, Sweden, and Australia ― had fully implemented national suicide prevention plans and had achieved reductions in their national suicide rates. However, in the United States, the suicide rate has been steadily increasing since 1999.

A Centers for Disease Control and Prevention survey released in August 2020 found that 40% of US adults reported symptoms of depression, anxiety, or increased substance use during COVID-19 and that about 11% reported suicidal ideation in the past month, all increases from prior surveys.

COVID-19 presents a “new and urgent opportunity” to focus political will, federal investments, and the global community on suicide prevention, Moutier writes.

“The political will to address suicide has actually moved in the right direction during COVID, as evidenced by a number of pieces of legislation that have suddenly found their way to passing that we’ve been working on for years,” she said in an interview.

One example, she said, is the National Suicide Hotline Designation Act, signed into law earlier this month by President Donald Trump.

As previously reported, under the law, beginning in July 2022, Americans experiencing a mental health crisis will be able to dial 9-8-8 and be connected to the services and counselors at the National Suicide Prevention Lifeline.

Moutier reports no relevant financial relationships.

This article first appeared on Medscape.com.

The Florida Department of Health will investigate the state’s 16,000 coronavirus deaths due to questions about the integrity of the data, according to an announcement issued Wednesday.

State health department officials said the “fatality data reported to the state consistently presents confusion and warrants a rigorous review.” The review is meant to “ensure data integrity.”

“During a pandemic, the public must be able to rely on accurate public health data to make informed decisions,” Scott Rivkees, the surgeon general for Florida, said in the statement.

Among the 95 deaths reported Wednesday for instance, 16 had more than a 2-month separation between the time of testing positive for COVID-19 and passing away, and 5 cases had a 3-month gap. In addition, 11 of the deaths occurred more than a month ago.

The health department then listed data for all 95 cases, including the age, gender, county and the dates of test positivity and death. Palm Beach County had 50 of the COVID-19 deaths.

“To ensure the accuracy of COVID-19 related deaths, the department will be performing additional reviews of all deaths,” Rivkees said. “Timely and accurate data remains a top priority of the Department of Health.”

Last week, Jose Oliva, speaker of the Florida House of Representatives, said medical examiner reports were “often lacking in rigor.” House Democrats then said Republicans were trying to “downplay the death toll,” according to the South Florida Sun Sentinel .

Fred Piccolo Jr., a spokesman for Florida Gov. Ron DeSantis, told the newspaper Wednesday that officials have struggled to obtain timely data. Labs sometimes report test results from weeks before, he added.

“It’s really one of those things that you gotta know if someone is dying of COVID or if they’re not,” Piccolo said. “Then you can legitimately say, here are the numbers.”

Sources

Florida Department of Health, “Florida Surgeon General Implements Additional Review Process for Fatalities Attributed to COVID-19 to Ensure Data Integrity.”

South Florida Sun Sentinel, “Florida to investigate all COVID-19 deaths after questions about ‘integrity’ of data.”

WebMD Health News © 2020 

This article first appeared on Medscape.com.

The Florida Department of Health will investigate the state’s 16,000 coronavirus deaths due to questions about the integrity of the data, according to an announcement issued Wednesday.

State health department officials said the “fatality data reported to the state consistently presents confusion and warrants a rigorous review.” The review is meant to “ensure data integrity.”

“During a pandemic, the public must be able to rely on accurate public health data to make informed decisions,” Scott Rivkees, the surgeon general for Florida, said in the statement.

Among the 95 deaths reported Wednesday for instance, 16 had more than a 2-month separation between the time of testing positive for COVID-19 and passing away, and 5 cases had a 3-month gap. In addition, 11 of the deaths occurred more than a month ago.

The health department then listed data for all 95 cases, including the age, gender, county and the dates of test positivity and death. Palm Beach County had 50 of the COVID-19 deaths.

“To ensure the accuracy of COVID-19 related deaths, the department will be performing additional reviews of all deaths,” Rivkees said. “Timely and accurate data remains a top priority of the Department of Health.”

Last week, Jose Oliva, speaker of the Florida House of Representatives, said medical examiner reports were “often lacking in rigor.” House Democrats then said Republicans were trying to “downplay the death toll,” according to the South Florida Sun Sentinel .

Fred Piccolo Jr., a spokesman for Florida Gov. Ron DeSantis, told the newspaper Wednesday that officials have struggled to obtain timely data. Labs sometimes report test results from weeks before, he added.

“It’s really one of those things that you gotta know if someone is dying of COVID or if they’re not,” Piccolo said. “Then you can legitimately say, here are the numbers.”

Sources

Florida Department of Health, “Florida Surgeon General Implements Additional Review Process for Fatalities Attributed to COVID-19 to Ensure Data Integrity.”

South Florida Sun Sentinel, “Florida to investigate all COVID-19 deaths after questions about ‘integrity’ of data.”

WebMD Health News © 2020 

This article first appeared on Medscape.com.

The Florida Department of Health will investigate the state’s 16,000 coronavirus deaths due to questions about the integrity of the data, according to an announcement issued Wednesday.

State health department officials said the “fatality data reported to the state consistently presents confusion and warrants a rigorous review.” The review is meant to “ensure data integrity.”

“During a pandemic, the public must be able to rely on accurate public health data to make informed decisions,” Scott Rivkees, the surgeon general for Florida, said in the statement.

Among the 95 deaths reported Wednesday for instance, 16 had more than a 2-month separation between the time of testing positive for COVID-19 and passing away, and 5 cases had a 3-month gap. In addition, 11 of the deaths occurred more than a month ago.

The health department then listed data for all 95 cases, including the age, gender, county and the dates of test positivity and death. Palm Beach County had 50 of the COVID-19 deaths.

“To ensure the accuracy of COVID-19 related deaths, the department will be performing additional reviews of all deaths,” Rivkees said. “Timely and accurate data remains a top priority of the Department of Health.”

Last week, Jose Oliva, speaker of the Florida House of Representatives, said medical examiner reports were “often lacking in rigor.” House Democrats then said Republicans were trying to “downplay the death toll,” according to the South Florida Sun Sentinel .

Fred Piccolo Jr., a spokesman for Florida Gov. Ron DeSantis, told the newspaper Wednesday that officials have struggled to obtain timely data. Labs sometimes report test results from weeks before, he added.

“It’s really one of those things that you gotta know if someone is dying of COVID or if they’re not,” Piccolo said. “Then you can legitimately say, here are the numbers.”

Sources

Florida Department of Health, “Florida Surgeon General Implements Additional Review Process for Fatalities Attributed to COVID-19 to Ensure Data Integrity.”

South Florida Sun Sentinel, “Florida to investigate all COVID-19 deaths after questions about ‘integrity’ of data.”

WebMD Health News © 2020 

This article first appeared on Medscape.com.

A novel urine-based assay improved detection of urothelial carcinoma when compared with conventional urine cytology in a prospective, observational study.

The study authors developed a low-coverage whole-genome sequencing technique, called “Urine Exfoliated Cells Copy Number Aberration Detector” (UroCAD), to detect copy number variants in urine-exfoliated cells.

The team then tested whether UroCAD could detect urothelial carcinomas in a single-blinded trial.

Shuxiong Zeng, MD, PhD, of Naval Medical University, Shanghai, China, and colleagues described this work in Clinical Cancer Research.
 

Study details and results

The researchers first tested UroCAD on urine samples from a discovery cohort of 190 patients – 126 with urothelial carcinoma and 64 noncancer controls. In this group, UroCAD detected urothelial carcinoma with a sensitivity of 82.5% and a specificity of 96.9%.

The researchers also analyzed samples from a validation cohort of 95 patients – 56 with urothelial carcinoma and 39 noncancer controls.

In this cohort, UroCAD had significantly higher sensitivity than urine cytology (80.4% and 33.9%, respectively; P < .001) but similar specificity (94.9% and 100%, respectively; P = .49) for the detection of urothelial carcinoma.

Among seven patients with pTa tumors, UroCAD had a sensitivity of 71.4%, while urine cytology had a sensitivity of 0%.

UroCAD’s sensitivity was greater for high-grade than low-grade urothelial carcinomas (86.7% and 60.0%, respectively). The assay was also more sensitive for larger tumors, with sensitivities of 66.7% for tumors measuring 1 cm or less, 72% for tumors between 1 cm and 3 cm, and 95.5% for tumors larger than 3 cm.

“The relatively lower sensitivity of UroCAD for the detection of lower-grade or smaller tumors is not unexpected, as these tumors are less likely to have abundant chromosomal alterations,” study author Chuan-Liang Xu, MD, PhD, of the Changhai Hospital in Shanghai, explained in a press release. “Ultimately, we believe that our assay could help to reduce the frequency of cystoscopy examination but not to replace it.”

The researchers noted that UroCAD positivity was associated with microscopic epithelial cells in cancer patients, and this suggests that insufficient exfoliative cells “might be the major technique limitation.”
 

Conclusions and next steps

“In summary, UroCAD could be a highly specific, robust, and noninvasive urothelial carcinoma diagnostic method with improved sensitivity and similar specificity as compared with cytology tests,” the researchers concluded.

“Within the next 5 years, we can see UroCAD in a variety of commercial formats available to the global markets, including the USA,” Dr. Xu commented in an interview. “We see UroCAD as a disruptive technology in diagnosing and monitoring patients with urothelial carcinoma.

“In America, given the COVID-19 pandemic, we also envision UroCAD becoming commercially available in the form of a mailed, at-home collection kit for high-risk patients, which may also be purchased off the shelf at commercial pharmacies,” Dr. Xu added. “We hope UroCAD will make a positive clinical impact to the urology field.”

In a follow-up trial (NCT04432909), researchers are evaluating the utility of UroCAD in the surveillance of urothelial carcinoma.

The current research was supported by various funding sources in China. The authors reported having no conflicts of interest.

SOURCE: Zeng S et al. Clin Cancer Res. 2020 Oct 9. doi: 10.1158/1078-0432.CCR-20-0401.

A novel urine-based assay improved detection of urothelial carcinoma when compared with conventional urine cytology in a prospective, observational study.

The study authors developed a low-coverage whole-genome sequencing technique, called “Urine Exfoliated Cells Copy Number Aberration Detector” (UroCAD), to detect copy number variants in urine-exfoliated cells.

The team then tested whether UroCAD could detect urothelial carcinomas in a single-blinded trial.

Shuxiong Zeng, MD, PhD, of Naval Medical University, Shanghai, China, and colleagues described this work in Clinical Cancer Research.
 

Study details and results

The researchers first tested UroCAD on urine samples from a discovery cohort of 190 patients – 126 with urothelial carcinoma and 64 noncancer controls. In this group, UroCAD detected urothelial carcinoma with a sensitivity of 82.5% and a specificity of 96.9%.

The researchers also analyzed samples from a validation cohort of 95 patients – 56 with urothelial carcinoma and 39 noncancer controls.

In this cohort, UroCAD had significantly higher sensitivity than urine cytology (80.4% and 33.9%, respectively; P < .001) but similar specificity (94.9% and 100%, respectively; P = .49) for the detection of urothelial carcinoma.

Among seven patients with pTa tumors, UroCAD had a sensitivity of 71.4%, while urine cytology had a sensitivity of 0%.

UroCAD’s sensitivity was greater for high-grade than low-grade urothelial carcinomas (86.7% and 60.0%, respectively). The assay was also more sensitive for larger tumors, with sensitivities of 66.7% for tumors measuring 1 cm or less, 72% for tumors between 1 cm and 3 cm, and 95.5% for tumors larger than 3 cm.

“The relatively lower sensitivity of UroCAD for the detection of lower-grade or smaller tumors is not unexpected, as these tumors are less likely to have abundant chromosomal alterations,” study author Chuan-Liang Xu, MD, PhD, of the Changhai Hospital in Shanghai, explained in a press release. “Ultimately, we believe that our assay could help to reduce the frequency of cystoscopy examination but not to replace it.”

The researchers noted that UroCAD positivity was associated with microscopic epithelial cells in cancer patients, and this suggests that insufficient exfoliative cells “might be the major technique limitation.”
 

Conclusions and next steps

“In summary, UroCAD could be a highly specific, robust, and noninvasive urothelial carcinoma diagnostic method with improved sensitivity and similar specificity as compared with cytology tests,” the researchers concluded.

“Within the next 5 years, we can see UroCAD in a variety of commercial formats available to the global markets, including the USA,” Dr. Xu commented in an interview. “We see UroCAD as a disruptive technology in diagnosing and monitoring patients with urothelial carcinoma.

“In America, given the COVID-19 pandemic, we also envision UroCAD becoming commercially available in the form of a mailed, at-home collection kit for high-risk patients, which may also be purchased off the shelf at commercial pharmacies,” Dr. Xu added. “We hope UroCAD will make a positive clinical impact to the urology field.”

In a follow-up trial (NCT04432909), researchers are evaluating the utility of UroCAD in the surveillance of urothelial carcinoma.

The current research was supported by various funding sources in China. The authors reported having no conflicts of interest.

SOURCE: Zeng S et al. Clin Cancer Res. 2020 Oct 9. doi: 10.1158/1078-0432.CCR-20-0401.

A novel urine-based assay improved detection of urothelial carcinoma when compared with conventional urine cytology in a prospective, observational study.

The study authors developed a low-coverage whole-genome sequencing technique, called “Urine Exfoliated Cells Copy Number Aberration Detector” (UroCAD), to detect copy number variants in urine-exfoliated cells.

The team then tested whether UroCAD could detect urothelial carcinomas in a single-blinded trial.

Shuxiong Zeng, MD, PhD, of Naval Medical University, Shanghai, China, and colleagues described this work in Clinical Cancer Research.
 

Study details and results

The researchers first tested UroCAD on urine samples from a discovery cohort of 190 patients – 126 with urothelial carcinoma and 64 noncancer controls. In this group, UroCAD detected urothelial carcinoma with a sensitivity of 82.5% and a specificity of 96.9%.

The researchers also analyzed samples from a validation cohort of 95 patients – 56 with urothelial carcinoma and 39 noncancer controls.

In this cohort, UroCAD had significantly higher sensitivity than urine cytology (80.4% and 33.9%, respectively; P < .001) but similar specificity (94.9% and 100%, respectively; P = .49) for the detection of urothelial carcinoma.

Among seven patients with pTa tumors, UroCAD had a sensitivity of 71.4%, while urine cytology had a sensitivity of 0%.

UroCAD’s sensitivity was greater for high-grade than low-grade urothelial carcinomas (86.7% and 60.0%, respectively). The assay was also more sensitive for larger tumors, with sensitivities of 66.7% for tumors measuring 1 cm or less, 72% for tumors between 1 cm and 3 cm, and 95.5% for tumors larger than 3 cm.

“The relatively lower sensitivity of UroCAD for the detection of lower-grade or smaller tumors is not unexpected, as these tumors are less likely to have abundant chromosomal alterations,” study author Chuan-Liang Xu, MD, PhD, of the Changhai Hospital in Shanghai, explained in a press release. “Ultimately, we believe that our assay could help to reduce the frequency of cystoscopy examination but not to replace it.”

The researchers noted that UroCAD positivity was associated with microscopic epithelial cells in cancer patients, and this suggests that insufficient exfoliative cells “might be the major technique limitation.”
 

Conclusions and next steps

“In summary, UroCAD could be a highly specific, robust, and noninvasive urothelial carcinoma diagnostic method with improved sensitivity and similar specificity as compared with cytology tests,” the researchers concluded.

“Within the next 5 years, we can see UroCAD in a variety of commercial formats available to the global markets, including the USA,” Dr. Xu commented in an interview. “We see UroCAD as a disruptive technology in diagnosing and monitoring patients with urothelial carcinoma.

“In America, given the COVID-19 pandemic, we also envision UroCAD becoming commercially available in the form of a mailed, at-home collection kit for high-risk patients, which may also be purchased off the shelf at commercial pharmacies,” Dr. Xu added. “We hope UroCAD will make a positive clinical impact to the urology field.”

In a follow-up trial (NCT04432909), researchers are evaluating the utility of UroCAD in the surveillance of urothelial carcinoma.

The current research was supported by various funding sources in China. The authors reported having no conflicts of interest.

SOURCE: Zeng S et al. Clin Cancer Res. 2020 Oct 9. doi: 10.1158/1078-0432.CCR-20-0401.

The effort to increase use of sun protection among Black individuals and others with relatively dark skin is likely to require tailoring of strategies to address barriers and alter perceptions, according to a review of racial differences in the approach to photoprotection, presented at the virtual Skin of Color Update 2020.

“Using photoprotection is not second nature to people of color,” said Amy McMichael, MD, chair, department of dermatology, Wake Forest University, Winston-Salem, N.C. “It is important to understand the complexity of perception in photoprotection patients with skin of color,” she added.

One obstacle is appearance. For instance, some products appear chalky on dark skin.

“Consider cosmesis,” advised Dr. McMichael. As an alternative to oxybenzone and other organic sunscreen filters, she specifically recommended inorganic sunscreens with tint. Currently, zinc oxide and titanium dioxide are the only Food and Drug Administration–approved inorganic filters, she noted. The nanoparticle formulations are less than 100 nm in size. Tinted products blocking visible light of different shades have been developed for individuals of all Fitzpatrick skin types.

Many patients with dark skin will need convincing that sun protection offers benefits and does not impose significant risks. In one survey cited by Dr. McMichael, Blacks reported the lowest level of sunscreen use when compared with Whites, Asians, or Latinos. While the increased melanin content in the skin of people of color does provide natural photoprotection, it does not fully eliminate the many adverse consequences of excess sun exposure.

“Photoprotection is essential to minimize acute and chronic effects of exposure to UV light that includes erythema, pigment darkening, photoaging, and photocarcinogenesis,” Dr. McMichael noted.

Among Black people who do employ sun protection, a large proportion do so to reduce the risk or prevent exacerbation of dyschromias such as vitiligo, melasma, and postinflammatory hyperpigmentation, according to Dr. McMichael. However, there appears to be inadequate use of sunscreens even for these concerns.

According to a study she cited, dermatologists prescribed sunscreens to Black patients in only 1.8% of office visits. Yet, 5% of all dermatologist consultations by Black patients are made to address a dyschromia. After acne, generalized forms of dermatitis, seborrheic dermatitis, and atopic dermatitis, dyschromias are the fifth most common reason for Blacks to consult a dermatologist.

“We cannot know from the data what the provider was seeing, but we can see that sunscreens are not the first medication that providers are reaching for,” Dr. McMichael said.

There are some concerns about the use of sunscreen that can be dispelled. The risk of vitamin D deficiency is one. Dr. McMichael, citing National Health and Nutrition Examination Survey data, said there appears to be a low risk in Whites and essentially no risk in Blacks.

The potential for sunscreens to induce frontal fibrosing alopecia (FFA) is another concern, but Dr. McMichael sees several problems with the surveys that have associated sunscreens with FFA, including recall bias, temporal ambiguity regarding sunscreen exposure and FFA onset, and cases of FFA in areas of the world where sunscreen is not used.

For sunscreens and FFA, “there is no direct evidence of causation,” she said. For concerned patients, she does acknowledge that there are data supporting an association, but she explains that this “connection is very loose at best.”

When encouraging sun protection, Dr. McMichael discusses alternatives to sunscreens, including hats and clothing that are photoprotective, wrap-around sunglasses, and sun avoidance. For patients with dyschromias, it makes particular sense to employ multiple sun protection strategies, but Dr. McMichael suggested that everybody, including individuals with skin of color, should be considering how to reduce excess sun exposure. She indicated that messages should to be tailored for the Black population.

“It is important to understand the complexity of the perception in photoprotection in patients with skin of color,” she said. Success with increasing uptake of sunscreens in patients with darker skin might depend on allaying fears and directing patients to agents that are cosmetically acceptable.

Others have delivered the same or related messages in the past. Natasha Buchanan Lunsford, PhD, a researcher in the Division of Cancer Prevention and Control at the Centers for Disease Control and Prevention, led a study on perceptions about skin cancer among Blacks and Hispanics.

“Most participants perceived themselves to be at low skin cancer risk due to their darker skin tone,” reported Dr. Lundsford and her coinvestigators, a finding based on data collected from 18 focus groups with Black and Hispanic participants aged 18 through 44 years.

In this study, Hispanics reported sun protection behavior more often than Blacks, but the minority of both groups used sunscreen or other sun avoidance measures routinely. For those who did use sunscreens, skin darkening and photoaging, rather than prevention of skin cancer, was the most common motivation to do so.

One problem is that “while general skin cancer prevention messaging exists, tailored and culturally sensitive messaging is limited,” Dr. Lundsford and coauthors wrote.

Dr. McMichael has financial relationships with multiple pharmaceutical companies, including those that make skin care products.

The effort to increase use of sun protection among Black individuals and others with relatively dark skin is likely to require tailoring of strategies to address barriers and alter perceptions, according to a review of racial differences in the approach to photoprotection, presented at the virtual Skin of Color Update 2020.

“Using photoprotection is not second nature to people of color,” said Amy McMichael, MD, chair, department of dermatology, Wake Forest University, Winston-Salem, N.C. “It is important to understand the complexity of perception in photoprotection patients with skin of color,” she added.

One obstacle is appearance. For instance, some products appear chalky on dark skin.

“Consider cosmesis,” advised Dr. McMichael. As an alternative to oxybenzone and other organic sunscreen filters, she specifically recommended inorganic sunscreens with tint. Currently, zinc oxide and titanium dioxide are the only Food and Drug Administration–approved inorganic filters, she noted. The nanoparticle formulations are less than 100 nm in size. Tinted products blocking visible light of different shades have been developed for individuals of all Fitzpatrick skin types.

Many patients with dark skin will need convincing that sun protection offers benefits and does not impose significant risks. In one survey cited by Dr. McMichael, Blacks reported the lowest level of sunscreen use when compared with Whites, Asians, or Latinos. While the increased melanin content in the skin of people of color does provide natural photoprotection, it does not fully eliminate the many adverse consequences of excess sun exposure.

“Photoprotection is essential to minimize acute and chronic effects of exposure to UV light that includes erythema, pigment darkening, photoaging, and photocarcinogenesis,” Dr. McMichael noted.

Among Black people who do employ sun protection, a large proportion do so to reduce the risk or prevent exacerbation of dyschromias such as vitiligo, melasma, and postinflammatory hyperpigmentation, according to Dr. McMichael. However, there appears to be inadequate use of sunscreens even for these concerns.

According to a study she cited, dermatologists prescribed sunscreens to Black patients in only 1.8% of office visits. Yet, 5% of all dermatologist consultations by Black patients are made to address a dyschromia. After acne, generalized forms of dermatitis, seborrheic dermatitis, and atopic dermatitis, dyschromias are the fifth most common reason for Blacks to consult a dermatologist.

“We cannot know from the data what the provider was seeing, but we can see that sunscreens are not the first medication that providers are reaching for,” Dr. McMichael said.

There are some concerns about the use of sunscreen that can be dispelled. The risk of vitamin D deficiency is one. Dr. McMichael, citing National Health and Nutrition Examination Survey data, said there appears to be a low risk in Whites and essentially no risk in Blacks.

The potential for sunscreens to induce frontal fibrosing alopecia (FFA) is another concern, but Dr. McMichael sees several problems with the surveys that have associated sunscreens with FFA, including recall bias, temporal ambiguity regarding sunscreen exposure and FFA onset, and cases of FFA in areas of the world where sunscreen is not used.

For sunscreens and FFA, “there is no direct evidence of causation,” she said. For concerned patients, she does acknowledge that there are data supporting an association, but she explains that this “connection is very loose at best.”

When encouraging sun protection, Dr. McMichael discusses alternatives to sunscreens, including hats and clothing that are photoprotective, wrap-around sunglasses, and sun avoidance. For patients with dyschromias, it makes particular sense to employ multiple sun protection strategies, but Dr. McMichael suggested that everybody, including individuals with skin of color, should be considering how to reduce excess sun exposure. She indicated that messages should to be tailored for the Black population.

“It is important to understand the complexity of the perception in photoprotection in patients with skin of color,” she said. Success with increasing uptake of sunscreens in patients with darker skin might depend on allaying fears and directing patients to agents that are cosmetically acceptable.

Others have delivered the same or related messages in the past. Natasha Buchanan Lunsford, PhD, a researcher in the Division of Cancer Prevention and Control at the Centers for Disease Control and Prevention, led a study on perceptions about skin cancer among Blacks and Hispanics.

“Most participants perceived themselves to be at low skin cancer risk due to their darker skin tone,” reported Dr. Lundsford and her coinvestigators, a finding based on data collected from 18 focus groups with Black and Hispanic participants aged 18 through 44 years.

In this study, Hispanics reported sun protection behavior more often than Blacks, but the minority of both groups used sunscreen or other sun avoidance measures routinely. For those who did use sunscreens, skin darkening and photoaging, rather than prevention of skin cancer, was the most common motivation to do so.

One problem is that “while general skin cancer prevention messaging exists, tailored and culturally sensitive messaging is limited,” Dr. Lundsford and coauthors wrote.

Dr. McMichael has financial relationships with multiple pharmaceutical companies, including those that make skin care products.

The effort to increase use of sun protection among Black individuals and others with relatively dark skin is likely to require tailoring of strategies to address barriers and alter perceptions, according to a review of racial differences in the approach to photoprotection, presented at the virtual Skin of Color Update 2020.

“Using photoprotection is not second nature to people of color,” said Amy McMichael, MD, chair, department of dermatology, Wake Forest University, Winston-Salem, N.C. “It is important to understand the complexity of perception in photoprotection patients with skin of color,” she added.

One obstacle is appearance. For instance, some products appear chalky on dark skin.

“Consider cosmesis,” advised Dr. McMichael. As an alternative to oxybenzone and other organic sunscreen filters, she specifically recommended inorganic sunscreens with tint. Currently, zinc oxide and titanium dioxide are the only Food and Drug Administration–approved inorganic filters, she noted. The nanoparticle formulations are less than 100 nm in size. Tinted products blocking visible light of different shades have been developed for individuals of all Fitzpatrick skin types.

Many patients with dark skin will need convincing that sun protection offers benefits and does not impose significant risks. In one survey cited by Dr. McMichael, Blacks reported the lowest level of sunscreen use when compared with Whites, Asians, or Latinos. While the increased melanin content in the skin of people of color does provide natural photoprotection, it does not fully eliminate the many adverse consequences of excess sun exposure.

“Photoprotection is essential to minimize acute and chronic effects of exposure to UV light that includes erythema, pigment darkening, photoaging, and photocarcinogenesis,” Dr. McMichael noted.

Among Black people who do employ sun protection, a large proportion do so to reduce the risk or prevent exacerbation of dyschromias such as vitiligo, melasma, and postinflammatory hyperpigmentation, according to Dr. McMichael. However, there appears to be inadequate use of sunscreens even for these concerns.

According to a study she cited, dermatologists prescribed sunscreens to Black patients in only 1.8% of office visits. Yet, 5% of all dermatologist consultations by Black patients are made to address a dyschromia. After acne, generalized forms of dermatitis, seborrheic dermatitis, and atopic dermatitis, dyschromias are the fifth most common reason for Blacks to consult a dermatologist.

“We cannot know from the data what the provider was seeing, but we can see that sunscreens are not the first medication that providers are reaching for,” Dr. McMichael said.

There are some concerns about the use of sunscreen that can be dispelled. The risk of vitamin D deficiency is one. Dr. McMichael, citing National Health and Nutrition Examination Survey data, said there appears to be a low risk in Whites and essentially no risk in Blacks.

The potential for sunscreens to induce frontal fibrosing alopecia (FFA) is another concern, but Dr. McMichael sees several problems with the surveys that have associated sunscreens with FFA, including recall bias, temporal ambiguity regarding sunscreen exposure and FFA onset, and cases of FFA in areas of the world where sunscreen is not used.

For sunscreens and FFA, “there is no direct evidence of causation,” she said. For concerned patients, she does acknowledge that there are data supporting an association, but she explains that this “connection is very loose at best.”

When encouraging sun protection, Dr. McMichael discusses alternatives to sunscreens, including hats and clothing that are photoprotective, wrap-around sunglasses, and sun avoidance. For patients with dyschromias, it makes particular sense to employ multiple sun protection strategies, but Dr. McMichael suggested that everybody, including individuals with skin of color, should be considering how to reduce excess sun exposure. She indicated that messages should to be tailored for the Black population.

“It is important to understand the complexity of the perception in photoprotection in patients with skin of color,” she said. Success with increasing uptake of sunscreens in patients with darker skin might depend on allaying fears and directing patients to agents that are cosmetically acceptable.

Others have delivered the same or related messages in the past. Natasha Buchanan Lunsford, PhD, a researcher in the Division of Cancer Prevention and Control at the Centers for Disease Control and Prevention, led a study on perceptions about skin cancer among Blacks and Hispanics.

“Most participants perceived themselves to be at low skin cancer risk due to their darker skin tone,” reported Dr. Lundsford and her coinvestigators, a finding based on data collected from 18 focus groups with Black and Hispanic participants aged 18 through 44 years.

In this study, Hispanics reported sun protection behavior more often than Blacks, but the minority of both groups used sunscreen or other sun avoidance measures routinely. For those who did use sunscreens, skin darkening and photoaging, rather than prevention of skin cancer, was the most common motivation to do so.

One problem is that “while general skin cancer prevention messaging exists, tailored and culturally sensitive messaging is limited,” Dr. Lundsford and coauthors wrote.

Dr. McMichael has financial relationships with multiple pharmaceutical companies, including those that make skin care products.

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

Canberk Sezer/Getty Images

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

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

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

Limited data

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

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

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

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

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

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

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

Mitigating risk

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

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

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

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

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

Dr. Bernhardt had no relevant disclosures.

[email protected]

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

Canberk Sezer/Getty Images

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

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

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

Limited data

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

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

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

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

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

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

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

Mitigating risk

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

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

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

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

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

Dr. Bernhardt had no relevant disclosures.

[email protected]

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

Canberk Sezer/Getty Images

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

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

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

Limited data

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

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

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

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

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

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

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

Mitigating risk

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

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

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

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

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

Dr. Bernhardt had no relevant disclosures.

[email protected]