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COVID-19 fears tied to dangerous drop in child vaccinations
The social distancing and sheltering in place mandated because of the COVID-19 pandemic are keeping parents and kids out of their doctors’ offices, and that has prompted a steep decline in recommended routine vaccinations for U.S. children, according to Centers for Disease Control and Prevention researchers.
Pediatric vaccinations dropped sharply after the national emergency was declared on March 13, suggesting that some children may be at increased risk for other serious infectious diseases, such as measles.
The researchers compared weekly orders for federally funded vaccines from Jan. 6 to April 19, 2020, with those during the same period in 2019.
They noted that, by the end of the study period, there was a cumulative COVID-19–related decline of 2.5 million doses in orders for routine noninfluenza pediatric childhood vaccines recommended by the Advisory Committee on Immunization Practices, as well as a cumulative decline in orders of 250,000 doses of measles vaccines.
Although the overall decrease in vaccinations during the study period was larger, according to CDC spokesperson Richard Quartarone, the above figures represent declines clearly associated with the pandemic.
The weekly number of measles vaccines ordered for children aged 24 months or older fell dramatically to about 500 during the week beginning March 16, 2020, and fell further to approximately 250 during the week beginning March 23. It stayed at that level until the week beginning April 13. By comparison, more than 2,500 were ordered during the week starting March 2, before the emergency was declared.
The decline was notably less for children younger than 2 years. For those children, orders dropped to about 750 during the week starting March 23 and climbed slightly for 3 weeks. By comparison, during the week of March 2, about 2,000 vaccines were ordered.
The findings, which were published in the CDC’s Morbidity and Mortality Weekly Report, stem from an analysis of ordering data from the federal Vaccines for Children (VFC) Program, as well as from vaccine administration data from the CDC’s Vaccine Tracking System and the collaborative Vaccine Safety Datalink (VSD).
The VFC provides federally purchased vaccines at no cost to about half of persons aged 18 years or younger. The VSD collaborates on vaccine coverage with the CDC’s Immunization Safety Office and eight large health care organizations across the country. Vaccination coverage is the usual metric for assessing vaccine usage; providers’ orders and the number of doses administered are two proxy measures, the authors explained.
“The substantial reduction in VFC-funded pediatric vaccine ordering after the COVID-19 emergency declaration is consistent with changes in vaccine administration among children in the VSD population receiving care through eight large U.S. health care organizations,” wrote Jeanne M. Santoli, MD, and colleagues, of the immunization services division at the National Center for Immunization and Respiratory Diseases. “The smaller decline in measles-containing vaccine administration among children aged ≤24 months suggests that system-level strategies to prioritize well child care and immunization for this age group are being implemented.”
Dr. Santoli, who is an Atlanta-based pediatrician, and associates stressed the importance of maintaining regular vaccinations during the pandemic. “The identified declines in routine pediatric vaccine ordering and doses administered might indicate that U.S. children and their communities face increased risks for outbreaks of vaccine-preventable diseases,” they wrote. “Parental concerns about potentially exposing their children to COVID-19 during well child visits might contribute to the declines observed.” Parents should therefore be reminded of the necessity of protecting their children against vaccine-preventable diseases.
In 2019, a Gallup survey reported that overall support for vaccination continued to decline in the United States.
The researchers predicted that, as social distancing relaxes, unvaccinated children will be more susceptible to other serious diseases. “In response, continued coordinated efforts between health care providers and public health officials at the local, state, and federal levels will be necessary to achieve rapid catch-up vaccination,” they concluded.
The authors disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
The social distancing and sheltering in place mandated because of the COVID-19 pandemic are keeping parents and kids out of their doctors’ offices, and that has prompted a steep decline in recommended routine vaccinations for U.S. children, according to Centers for Disease Control and Prevention researchers.
Pediatric vaccinations dropped sharply after the national emergency was declared on March 13, suggesting that some children may be at increased risk for other serious infectious diseases, such as measles.
The researchers compared weekly orders for federally funded vaccines from Jan. 6 to April 19, 2020, with those during the same period in 2019.
They noted that, by the end of the study period, there was a cumulative COVID-19–related decline of 2.5 million doses in orders for routine noninfluenza pediatric childhood vaccines recommended by the Advisory Committee on Immunization Practices, as well as a cumulative decline in orders of 250,000 doses of measles vaccines.
Although the overall decrease in vaccinations during the study period was larger, according to CDC spokesperson Richard Quartarone, the above figures represent declines clearly associated with the pandemic.
The weekly number of measles vaccines ordered for children aged 24 months or older fell dramatically to about 500 during the week beginning March 16, 2020, and fell further to approximately 250 during the week beginning March 23. It stayed at that level until the week beginning April 13. By comparison, more than 2,500 were ordered during the week starting March 2, before the emergency was declared.
The decline was notably less for children younger than 2 years. For those children, orders dropped to about 750 during the week starting March 23 and climbed slightly for 3 weeks. By comparison, during the week of March 2, about 2,000 vaccines were ordered.
The findings, which were published in the CDC’s Morbidity and Mortality Weekly Report, stem from an analysis of ordering data from the federal Vaccines for Children (VFC) Program, as well as from vaccine administration data from the CDC’s Vaccine Tracking System and the collaborative Vaccine Safety Datalink (VSD).
The VFC provides federally purchased vaccines at no cost to about half of persons aged 18 years or younger. The VSD collaborates on vaccine coverage with the CDC’s Immunization Safety Office and eight large health care organizations across the country. Vaccination coverage is the usual metric for assessing vaccine usage; providers’ orders and the number of doses administered are two proxy measures, the authors explained.
“The substantial reduction in VFC-funded pediatric vaccine ordering after the COVID-19 emergency declaration is consistent with changes in vaccine administration among children in the VSD population receiving care through eight large U.S. health care organizations,” wrote Jeanne M. Santoli, MD, and colleagues, of the immunization services division at the National Center for Immunization and Respiratory Diseases. “The smaller decline in measles-containing vaccine administration among children aged ≤24 months suggests that system-level strategies to prioritize well child care and immunization for this age group are being implemented.”
Dr. Santoli, who is an Atlanta-based pediatrician, and associates stressed the importance of maintaining regular vaccinations during the pandemic. “The identified declines in routine pediatric vaccine ordering and doses administered might indicate that U.S. children and their communities face increased risks for outbreaks of vaccine-preventable diseases,” they wrote. “Parental concerns about potentially exposing their children to COVID-19 during well child visits might contribute to the declines observed.” Parents should therefore be reminded of the necessity of protecting their children against vaccine-preventable diseases.
In 2019, a Gallup survey reported that overall support for vaccination continued to decline in the United States.
The researchers predicted that, as social distancing relaxes, unvaccinated children will be more susceptible to other serious diseases. “In response, continued coordinated efforts between health care providers and public health officials at the local, state, and federal levels will be necessary to achieve rapid catch-up vaccination,” they concluded.
The authors disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
The social distancing and sheltering in place mandated because of the COVID-19 pandemic are keeping parents and kids out of their doctors’ offices, and that has prompted a steep decline in recommended routine vaccinations for U.S. children, according to Centers for Disease Control and Prevention researchers.
Pediatric vaccinations dropped sharply after the national emergency was declared on March 13, suggesting that some children may be at increased risk for other serious infectious diseases, such as measles.
The researchers compared weekly orders for federally funded vaccines from Jan. 6 to April 19, 2020, with those during the same period in 2019.
They noted that, by the end of the study period, there was a cumulative COVID-19–related decline of 2.5 million doses in orders for routine noninfluenza pediatric childhood vaccines recommended by the Advisory Committee on Immunization Practices, as well as a cumulative decline in orders of 250,000 doses of measles vaccines.
Although the overall decrease in vaccinations during the study period was larger, according to CDC spokesperson Richard Quartarone, the above figures represent declines clearly associated with the pandemic.
The weekly number of measles vaccines ordered for children aged 24 months or older fell dramatically to about 500 during the week beginning March 16, 2020, and fell further to approximately 250 during the week beginning March 23. It stayed at that level until the week beginning April 13. By comparison, more than 2,500 were ordered during the week starting March 2, before the emergency was declared.
The decline was notably less for children younger than 2 years. For those children, orders dropped to about 750 during the week starting March 23 and climbed slightly for 3 weeks. By comparison, during the week of March 2, about 2,000 vaccines were ordered.
The findings, which were published in the CDC’s Morbidity and Mortality Weekly Report, stem from an analysis of ordering data from the federal Vaccines for Children (VFC) Program, as well as from vaccine administration data from the CDC’s Vaccine Tracking System and the collaborative Vaccine Safety Datalink (VSD).
The VFC provides federally purchased vaccines at no cost to about half of persons aged 18 years or younger. The VSD collaborates on vaccine coverage with the CDC’s Immunization Safety Office and eight large health care organizations across the country. Vaccination coverage is the usual metric for assessing vaccine usage; providers’ orders and the number of doses administered are two proxy measures, the authors explained.
“The substantial reduction in VFC-funded pediatric vaccine ordering after the COVID-19 emergency declaration is consistent with changes in vaccine administration among children in the VSD population receiving care through eight large U.S. health care organizations,” wrote Jeanne M. Santoli, MD, and colleagues, of the immunization services division at the National Center for Immunization and Respiratory Diseases. “The smaller decline in measles-containing vaccine administration among children aged ≤24 months suggests that system-level strategies to prioritize well child care and immunization for this age group are being implemented.”
Dr. Santoli, who is an Atlanta-based pediatrician, and associates stressed the importance of maintaining regular vaccinations during the pandemic. “The identified declines in routine pediatric vaccine ordering and doses administered might indicate that U.S. children and their communities face increased risks for outbreaks of vaccine-preventable diseases,” they wrote. “Parental concerns about potentially exposing their children to COVID-19 during well child visits might contribute to the declines observed.” Parents should therefore be reminded of the necessity of protecting their children against vaccine-preventable diseases.
In 2019, a Gallup survey reported that overall support for vaccination continued to decline in the United States.
The researchers predicted that, as social distancing relaxes, unvaccinated children will be more susceptible to other serious diseases. “In response, continued coordinated efforts between health care providers and public health officials at the local, state, and federal levels will be necessary to achieve rapid catch-up vaccination,” they concluded.
The authors disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
COVID-19: What will happen to physician income this year?
“At a combined system and hospital board meeting yesterday, there was a financial presentation,” said a cardiologist in Minnesota, who declined to be named. “We have ‘salary support’ through May 16, which means we will be receiving base pay at our 2019 level. After May 16, I think it’s fairly certain salaries will be decreased.”
A general internist in the same area added: “The system has decided to pay physicians and other employees for 8 weeks, until May 15, and they are borrowing about $150 million to do this. We don’t know what will happen after May 15, but we are supposed to have an update in early May.”
Physician income is of huge interest, and many aspects of it are discussed in Medscape’s Physician Compensation Report 2020, just released.
The worst may be yet to come
Of all the categories of physicians, “I am worried about private practices the most,” said Travis Singleton, senior vice president at Merritt Hawkins, a physician search firm. “They don’t have a financial cushion, and will start seeing big drops in revenue at the end of May.”
“A lot of the A/R [accounts receivables] for practices come within 30 days, and very little comes in after 90 days,” said Terrence R. McWilliams, MD, chief clinical consultant at HSG Advisors, a consultancy for not-for-profit hospitals and their employed physician networks around the country. “So private practices are reaching the point where prior A/R will start to dwindle and they will start feeling the decline in new claims submissions.”
Large practices may have a bigger financial cushion, but in many cases, they also have more liabilities. “We don’t know the financial loss yet, but I think it’s been devastating,” said Paul M. Yonover, MD, a urologist at UroPartners, a large single-specialty practice in Chicago with 62 urologists. “In fact, the financial loss may well be larger than our loss in volume, because we have to support our own surgery center, pathology lab, radiation center, and other in-house services.”
Employed physicians in limbo
In contrast to physicians in private practices, many employed physicians at hospitals and health systems have been shielded from the impact of COVID-19 – at least for now.
“The experiences of employed physicians are very mixed,” said Mr. Singleton at Merritt Hawkins. “Some health systems have reduced physicians’ pay by 20%, but other systems have been putting off any reductions.”
Hospitals and health systems are struggling. “Stopping elective surgeries deeply affected hospitals,” said Ryan Inman, founder of Physician Wealth Services in San Diego. “With fewer elective surgeries, they have much less income coming in. Some big hospitals that are pillars of their community are under great financial stress.”
“Hospitals’ patient volumes have fallen by 50%-90%,” Mr. McWilliams reported. “Lower volume means lower pay for employed physicians, who are paid by straight productivity or other models that require high volumes. However, some health systems have intervened to make sure these physicians get some money.”
Base pay is often safe for now, but quarterly bonuses are on the chopping block. “Employed physicians are often getting a guaranteed salary for a month or two, but no bonuses or extra distributions,” said Joel Greenwald, MD, a financial adviser for physicians in St. Louis Park, Minn., a state mecca for physician employment. “They’ve been told that they will continue to get their base salary but forget about the quarterly bonuses. This amounts to salary reductions of 10%-30%.”
Ensuring payment for these doctors means lowering their productivity benchmarks, but the benchmarks might still be too high for these times. An internist at a large health system in Minneapolis–St. Paul reports that, at a lunch meeting, employed doctors learned that payment benchmarks will be reduced to 70% of their 2019 monthly average.
“I am seeing nowhere near 70% of what I was seeing last year,” he said in an interview, asking that his name not be used. “Given how slow things have been, I am probably closer to 30%, but have not been given any data on this, so I am guessing at this point.”
Adapting to a brave new world
Even as they face a dark financial future, physicians have had to completely revamp the way they practice medicine – a cumbersome process that, in itself, incurred some financial losses. They had to obtain masks and other PPE, reposition or even close down their waiting rooms, cut back on unneeded staff, and adapt to telemedicine.
“It’s been an incredibly challenging time,” said Dr. Yonover, the Chicago urologist. “As a doctor. I cannot avoid contact, and it’s not totally clear yet how the virus spreads. But I don’t have the option of closing the door. As a practice owner, you’re responsible for the health and well-being of employees, patients, and the business.”
“A practice’s daily routine is somewhat slower and costlier,” said David N. Gans, MSHA, senior fellow at the Medical Group Management Association (MGMA), which represents group practices. “Between each patient, you have to clean a lot more than previously, and you have to stock up on PPE such as masks and gowns. PPE used to be limited to infectious patients, but now it’s universal.”
At PA Clinical Network, a clinically integrated network in Pennsylvania, volume fell 40%-50% and income fell 30%-50% from late March to late April, according to Jaan Sidorov, MD, an internist who is CEO of the network, which has 158 physicians in a variety of specialties working in 54 practices around the state.
“Revenue went down but it didn’t crash,” he said. “And our physicians pivoted very quickly. They adapted to telehealth and applied for the federal loan programs. They didn’t use waiting rooms. In some cases, staff was out in the parking lot, putting stethoscopes through patients’ windows.”
“None of the practices closed, not even temporarily,” Dr. Sidorov said. “But clearly this cannot go forever without having serious consequences.”
How much can telemedicine help?
Telemedicine has been a lifeline for many struggling practices. “As much as 20%-40% of a practice’s losses can be recouped through telemedicine, depending on variables like patients’ attitudes,” said Mr. Singleton at Merritt Hawkins.
The rise in telemedicine was made possible by a temporary relaxation of the limits on telemedicine payments by Medicare and many private payers. Medicare is currently paying the same rates for telemedicine as it does for in-office visits.
In a recent MGMA Stat survey, 97% of practices reported that they had taken up telemedicine, according to Mr. Gans. He estimates that 80% of primary care could be converted to telemedicine, including medication refills, ongoing care of chronic patients, and recording patients’ vital signs from home.
Some primary care physicians are now using telemedicine for 100% of their visits. “I voluntarily closed my practice weeks ago except for virtual visits due to the risk of exposure for my patients,” a doctor in South Carolina told the Primary Care Collaborative in mid-April. “I continue to pay my staff out of pocket but have reduced hours and am not receiving any income myself.”
However, Mr. Inman of Physician Wealth Services said family medicine clients using telemedicine for all of their patients are earning less per visit, even though the Medicare reimbursement is the same as for an office visit. “They earn less because they cannot charge for any ancillaries, such as labs or imaging,” he said.
“Telemedicine has its limits,” Mr. Singleton said. It cannot replace elective surgeries, and even in primary care practices, “there is a lot of work for which patients have to come in, such as physicals or providing vaccines,” he said. “I know of one doctor who has refrigerator full of vaccines to give out. That pays his bills.”
In many cases, “telemedicine” simply means using the phone, with no video. Many patients can only use the phone, and Medicare now reimburses for some kinds of phone visits. In a mid-April survey of primary care providers, 44% were using the telephone for the majority of their visits, and 14% were not using video at all. Medicare recently decided to pay physicians the same amount for telephone visits as in-person visits.
Financial boosts will run out soon
Many private practices are surviving only because they have managed to tap into new federal programs that can finance them for the short-term. Here are the main examples:
Receiving advance Medicare payments. Through the Medicare Accelerated and Advance Payment Program, physicians can be paid up to 3 months of their average Medicare reimbursement in advance. However, repayment starts 120 days after receiving the money and must be completed within 210 days.
Obtaining a federal loan. Under the Paycheck Protection Program (PPP), which is available to all kinds of small businesses, practices can apply for up to 2.5 times their average monthly payroll costs.
PPP money can be used for payroll, rent, mortgage interest, or utility payments for up to 8 weeks. The loan will be entirely forgiven as long as the rules are followed. For example, three quarters of the money must go to payroll, and laid-off employees must be rehired by June 30.
There was such a rush for the first round of PPP loans that many physicians failed to get the loan. “Many of my physician clients applied for the loan as soon as they could, but none of them got it,” said Mr. Inman, the San Diego financial adviser. “We are hoping that the next round of funding will provide them some relief.” The second round started on April 27.
Physicians who have already obtained the PPP loan are very relieved. “This loan made it possible for us to pay our employees,” said George W. Monks, MD, a dermatologist in Tulsa, Okla., and president of the Oklahoma Medical Association.
Staff benefiting from higher unemployment payments. Many practices and hospitals are laying off their staff so that they can collect unemployment benefits. This is a good time to do that because the federal government has boosted unemployment payments by $600 a week, creating a total benefit that is greater than many people earned at their regular jobs.
This extra boost ends in July, but practices with PPP loans will have to rehire their laid-off workers a month before that. Getting laid-off staffers to come back in is going to be critical, and some practices are already having a hard time convincing them to come back, said Michael La Penna, a physician practice manager in Grand Rapids, Mich.
“They are finding that those people don’t want to come back in yet,” he said. “In many cases they have to care for children at home or have been getting generous unemployment checks.”
The problem with all these temporary financial boosts is that they will disappear within weeks or months from now. Mr. La Penna is concerned that the sudden loss of this support could send some practices spinning into bankruptcy. “Unless volume gets better very soon, time is running out for a lot of practices,” he said.
Hospitals, which also have been depending on federal assistance, may run out of money, too. Daniel Wrenne, a financial planner for physicians in Lexington, Ky., said smaller hospitals are particularly vulnerable because they lack the capital. He said a friend who is an attorney for hospitals predicted that 25% of small regional hospitals “won’t make it through this.”
Such financial turmoil might prompt many physicians to retire or find a new job, said Gary Price, MD, a plastic surgeon in New Haven, Conn., and president of the Physicians Foundation, an advocacy group for the profession. In a survey of doctors by the Physicians Foundation and Merritt Hawkins, released on April 21, 18% planned to retire, temporarily close their practices, or opt out of patient care, and another 14%, presumably employed physicians, planned to change jobs.
Is recovery around the corner?
In early May, practices in many parts of the country were seeing the possibility of a return to normal business – or at least what could pass for normal in these unusual times.
“From mid-March to mid-April, hospitals and practices were in panic mode,” said MGMA’s Mr. Gans. “They were focusing on the here and now. But from mid-April to mid-May, they could begin looking at the big picture and decide how they will get back into business.”
Surgeons devastated by bans on elective surgeries might see a bounce in cases, as the backlog of patients comes back in. By late April, 10 states reinstituted elective surgeries, including California, Arizona, Georgia, Indiana, Colorado, and Oklahoma, and New York has reinstituted elective surgeries for some counties.
Dr. Price said he hopes to reopen his plastic surgery practice by the end of June. “If it takes longer than that, I’m not sure that the practice will survive.” His PPP loan would have run out and he would have to lay off his staff. “At that point, ongoing viability of practice would become a real question.”
Dr. Monks said he hopes a lot more patients will come to his dermatology practice. As of the end of April, “we’re starting to see an uptick in the number of patients wanting to come in,” he said. “They seem to be more comfortable with the new world we’re living in.
“Viewing the backlog of cases that haven’t been attended to,” Dr. Monks added, “I think we’ll be really busy for a while.”
But Mr. La Penna said he thinks the expected backlog of elective patients will be more like a trickle than a flood. “Many patients aren’t going to want to return that fast,” he said. “They may have a condition that makes exposure to COVID-19 more risky, like diabetes or high blood pressure, or they’re elderly, or they live in a household with one of these risk groups.”
Andrew Musbach, cofounder of MD Wealth Management in Chelsea, Mich., said he expects a slow recovery for primary care physicians as well. “Even when the lockdowns are over, not everyone is going to feel comfortable coming to a hospital or visiting a doctor’s office unless it’s absolutely necessary,” he said.
Getting back to normal patient volumes will involve finding better ways to protect patients and staff from COVID-19, Dr. Yonover said. At his urology practice, “we take all the usual precautions, but nothing yet has made it dramatically easier to protect patients and staff,” he said. “Rapid, accurate testing for COVID-19 would change the landscape, but I have no idea when that will come.”
Mr. Wrenne advises his physician clients that a financial recovery will take months. “I tell them to plan for 6 months, until October, before income returns to pre–COVID-19 levels. Reimbursement lags appointments by as much as 3 months, plus it will probably take the economy 2-3 months more to get back to normal.”
“We are facing a recession, and how long it will last is anyone’s guess,” said Alex Kilian, a physician wealth manager at Aldrich Wealth in San Diego. “The federal government’s efforts to stimulate the economy is keeping it from crashing, but there are no real signs that it will actually pick up. It may take years for the travel and entertainment industries to come back.”
A recession means patients will have less spending power, and health care sectors like laser eye surgery may be damaged for years to come, said John B. Pinto, an ophthalmology practice management consultant in San Diego. “[That kind of surgery] is purely elective and relatively costly,” he said. “When people get back to work, they are going to be building up their savings and avoiding new debt. They won’t be having [laser eye surgery].”
“There won’t be any quick return to normal for me,” said Dr. Price, the Connecticut plastic surgeon. “The damage this time will probably be worse than in the Great Recession. Back then, plastic surgery was off by 20%, but this time you have the extra problem of patients reluctant to come into medical offices.”
“To get patients to come in, facilities are going to have to convince patients that they are safe,” Mr. Singleton said. “That may mean undertaking some marketing and promotion, and hospitals tend to be much better at that than practices.”
What a new wave of COVID-19 would mean
Some states have begun reopening public places, which could signal patients to return to doctors’ offices even though doctors’ offices were never officially closed. Oklahoma, for example, reopened restaurants, movie theaters, and sports venues on May 1.
Dr. Monks, president of the Oklahoma Medical Association, said his group opposes states reopening. “The governor’s order is too hasty and overly ambitious,” he said. “Oklahoma has seen an ongoing growth in the number of cases, hospitalizations, and deaths in the past week alone [in late April].”
The concern is that opening up public places too soon would create a new wave of COVID-19, which would not only be a public health disaster, but also a financial disaster for physicians. Doctors would be back where they were in March, but unlike in March, they would not benefit from revenues from previously busy times.
Mr. Pinto said the number of COVID-19 cases will rise and fall in the next 2 years, forcing states to reenact new bans on public gatherings and on elective surgeries until the numbers subside again.
Mr. Pinto said authorities in Singapore have successfully handled such waves of the disease through short bans that are tantamount to tapping the brakes of a car. “As the car gathers speed down the hill, you tap the brake,” he said. “I suspect we’ll be seeing a lot of brake-tapping until a vaccine can be developed and distributed.”
Gary LeRoy, MD, president of the American Academy of Family Physicians, recalled the worldwide Spanish Flu pandemic a century ago. “People were allowed out of their houses after 2 months, and the flu spiked up again,” he said. “I hope we don’t make that mistake this time.”
Dr. LeRoy said it’s not possible to predict how the COVID-19 crisis will play out. “What will the future be like? I don’t know the answer,” he said. “The information we learn in next hours, days, or months will probably change everything.”
A version of this article originally appeared on Medscape.com.
“At a combined system and hospital board meeting yesterday, there was a financial presentation,” said a cardiologist in Minnesota, who declined to be named. “We have ‘salary support’ through May 16, which means we will be receiving base pay at our 2019 level. After May 16, I think it’s fairly certain salaries will be decreased.”
A general internist in the same area added: “The system has decided to pay physicians and other employees for 8 weeks, until May 15, and they are borrowing about $150 million to do this. We don’t know what will happen after May 15, but we are supposed to have an update in early May.”
Physician income is of huge interest, and many aspects of it are discussed in Medscape’s Physician Compensation Report 2020, just released.
The worst may be yet to come
Of all the categories of physicians, “I am worried about private practices the most,” said Travis Singleton, senior vice president at Merritt Hawkins, a physician search firm. “They don’t have a financial cushion, and will start seeing big drops in revenue at the end of May.”
“A lot of the A/R [accounts receivables] for practices come within 30 days, and very little comes in after 90 days,” said Terrence R. McWilliams, MD, chief clinical consultant at HSG Advisors, a consultancy for not-for-profit hospitals and their employed physician networks around the country. “So private practices are reaching the point where prior A/R will start to dwindle and they will start feeling the decline in new claims submissions.”
Large practices may have a bigger financial cushion, but in many cases, they also have more liabilities. “We don’t know the financial loss yet, but I think it’s been devastating,” said Paul M. Yonover, MD, a urologist at UroPartners, a large single-specialty practice in Chicago with 62 urologists. “In fact, the financial loss may well be larger than our loss in volume, because we have to support our own surgery center, pathology lab, radiation center, and other in-house services.”
Employed physicians in limbo
In contrast to physicians in private practices, many employed physicians at hospitals and health systems have been shielded from the impact of COVID-19 – at least for now.
“The experiences of employed physicians are very mixed,” said Mr. Singleton at Merritt Hawkins. “Some health systems have reduced physicians’ pay by 20%, but other systems have been putting off any reductions.”
Hospitals and health systems are struggling. “Stopping elective surgeries deeply affected hospitals,” said Ryan Inman, founder of Physician Wealth Services in San Diego. “With fewer elective surgeries, they have much less income coming in. Some big hospitals that are pillars of their community are under great financial stress.”
“Hospitals’ patient volumes have fallen by 50%-90%,” Mr. McWilliams reported. “Lower volume means lower pay for employed physicians, who are paid by straight productivity or other models that require high volumes. However, some health systems have intervened to make sure these physicians get some money.”
Base pay is often safe for now, but quarterly bonuses are on the chopping block. “Employed physicians are often getting a guaranteed salary for a month or two, but no bonuses or extra distributions,” said Joel Greenwald, MD, a financial adviser for physicians in St. Louis Park, Minn., a state mecca for physician employment. “They’ve been told that they will continue to get their base salary but forget about the quarterly bonuses. This amounts to salary reductions of 10%-30%.”
Ensuring payment for these doctors means lowering their productivity benchmarks, but the benchmarks might still be too high for these times. An internist at a large health system in Minneapolis–St. Paul reports that, at a lunch meeting, employed doctors learned that payment benchmarks will be reduced to 70% of their 2019 monthly average.
“I am seeing nowhere near 70% of what I was seeing last year,” he said in an interview, asking that his name not be used. “Given how slow things have been, I am probably closer to 30%, but have not been given any data on this, so I am guessing at this point.”
Adapting to a brave new world
Even as they face a dark financial future, physicians have had to completely revamp the way they practice medicine – a cumbersome process that, in itself, incurred some financial losses. They had to obtain masks and other PPE, reposition or even close down their waiting rooms, cut back on unneeded staff, and adapt to telemedicine.
“It’s been an incredibly challenging time,” said Dr. Yonover, the Chicago urologist. “As a doctor. I cannot avoid contact, and it’s not totally clear yet how the virus spreads. But I don’t have the option of closing the door. As a practice owner, you’re responsible for the health and well-being of employees, patients, and the business.”
“A practice’s daily routine is somewhat slower and costlier,” said David N. Gans, MSHA, senior fellow at the Medical Group Management Association (MGMA), which represents group practices. “Between each patient, you have to clean a lot more than previously, and you have to stock up on PPE such as masks and gowns. PPE used to be limited to infectious patients, but now it’s universal.”
At PA Clinical Network, a clinically integrated network in Pennsylvania, volume fell 40%-50% and income fell 30%-50% from late March to late April, according to Jaan Sidorov, MD, an internist who is CEO of the network, which has 158 physicians in a variety of specialties working in 54 practices around the state.
“Revenue went down but it didn’t crash,” he said. “And our physicians pivoted very quickly. They adapted to telehealth and applied for the federal loan programs. They didn’t use waiting rooms. In some cases, staff was out in the parking lot, putting stethoscopes through patients’ windows.”
“None of the practices closed, not even temporarily,” Dr. Sidorov said. “But clearly this cannot go forever without having serious consequences.”
How much can telemedicine help?
Telemedicine has been a lifeline for many struggling practices. “As much as 20%-40% of a practice’s losses can be recouped through telemedicine, depending on variables like patients’ attitudes,” said Mr. Singleton at Merritt Hawkins.
The rise in telemedicine was made possible by a temporary relaxation of the limits on telemedicine payments by Medicare and many private payers. Medicare is currently paying the same rates for telemedicine as it does for in-office visits.
In a recent MGMA Stat survey, 97% of practices reported that they had taken up telemedicine, according to Mr. Gans. He estimates that 80% of primary care could be converted to telemedicine, including medication refills, ongoing care of chronic patients, and recording patients’ vital signs from home.
Some primary care physicians are now using telemedicine for 100% of their visits. “I voluntarily closed my practice weeks ago except for virtual visits due to the risk of exposure for my patients,” a doctor in South Carolina told the Primary Care Collaborative in mid-April. “I continue to pay my staff out of pocket but have reduced hours and am not receiving any income myself.”
However, Mr. Inman of Physician Wealth Services said family medicine clients using telemedicine for all of their patients are earning less per visit, even though the Medicare reimbursement is the same as for an office visit. “They earn less because they cannot charge for any ancillaries, such as labs or imaging,” he said.
“Telemedicine has its limits,” Mr. Singleton said. It cannot replace elective surgeries, and even in primary care practices, “there is a lot of work for which patients have to come in, such as physicals or providing vaccines,” he said. “I know of one doctor who has refrigerator full of vaccines to give out. That pays his bills.”
In many cases, “telemedicine” simply means using the phone, with no video. Many patients can only use the phone, and Medicare now reimburses for some kinds of phone visits. In a mid-April survey of primary care providers, 44% were using the telephone for the majority of their visits, and 14% were not using video at all. Medicare recently decided to pay physicians the same amount for telephone visits as in-person visits.
Financial boosts will run out soon
Many private practices are surviving only because they have managed to tap into new federal programs that can finance them for the short-term. Here are the main examples:
Receiving advance Medicare payments. Through the Medicare Accelerated and Advance Payment Program, physicians can be paid up to 3 months of their average Medicare reimbursement in advance. However, repayment starts 120 days after receiving the money and must be completed within 210 days.
Obtaining a federal loan. Under the Paycheck Protection Program (PPP), which is available to all kinds of small businesses, practices can apply for up to 2.5 times their average monthly payroll costs.
PPP money can be used for payroll, rent, mortgage interest, or utility payments for up to 8 weeks. The loan will be entirely forgiven as long as the rules are followed. For example, three quarters of the money must go to payroll, and laid-off employees must be rehired by June 30.
There was such a rush for the first round of PPP loans that many physicians failed to get the loan. “Many of my physician clients applied for the loan as soon as they could, but none of them got it,” said Mr. Inman, the San Diego financial adviser. “We are hoping that the next round of funding will provide them some relief.” The second round started on April 27.
Physicians who have already obtained the PPP loan are very relieved. “This loan made it possible for us to pay our employees,” said George W. Monks, MD, a dermatologist in Tulsa, Okla., and president of the Oklahoma Medical Association.
Staff benefiting from higher unemployment payments. Many practices and hospitals are laying off their staff so that they can collect unemployment benefits. This is a good time to do that because the federal government has boosted unemployment payments by $600 a week, creating a total benefit that is greater than many people earned at their regular jobs.
This extra boost ends in July, but practices with PPP loans will have to rehire their laid-off workers a month before that. Getting laid-off staffers to come back in is going to be critical, and some practices are already having a hard time convincing them to come back, said Michael La Penna, a physician practice manager in Grand Rapids, Mich.
“They are finding that those people don’t want to come back in yet,” he said. “In many cases they have to care for children at home or have been getting generous unemployment checks.”
The problem with all these temporary financial boosts is that they will disappear within weeks or months from now. Mr. La Penna is concerned that the sudden loss of this support could send some practices spinning into bankruptcy. “Unless volume gets better very soon, time is running out for a lot of practices,” he said.
Hospitals, which also have been depending on federal assistance, may run out of money, too. Daniel Wrenne, a financial planner for physicians in Lexington, Ky., said smaller hospitals are particularly vulnerable because they lack the capital. He said a friend who is an attorney for hospitals predicted that 25% of small regional hospitals “won’t make it through this.”
Such financial turmoil might prompt many physicians to retire or find a new job, said Gary Price, MD, a plastic surgeon in New Haven, Conn., and president of the Physicians Foundation, an advocacy group for the profession. In a survey of doctors by the Physicians Foundation and Merritt Hawkins, released on April 21, 18% planned to retire, temporarily close their practices, or opt out of patient care, and another 14%, presumably employed physicians, planned to change jobs.
Is recovery around the corner?
In early May, practices in many parts of the country were seeing the possibility of a return to normal business – or at least what could pass for normal in these unusual times.
“From mid-March to mid-April, hospitals and practices were in panic mode,” said MGMA’s Mr. Gans. “They were focusing on the here and now. But from mid-April to mid-May, they could begin looking at the big picture and decide how they will get back into business.”
Surgeons devastated by bans on elective surgeries might see a bounce in cases, as the backlog of patients comes back in. By late April, 10 states reinstituted elective surgeries, including California, Arizona, Georgia, Indiana, Colorado, and Oklahoma, and New York has reinstituted elective surgeries for some counties.
Dr. Price said he hopes to reopen his plastic surgery practice by the end of June. “If it takes longer than that, I’m not sure that the practice will survive.” His PPP loan would have run out and he would have to lay off his staff. “At that point, ongoing viability of practice would become a real question.”
Dr. Monks said he hopes a lot more patients will come to his dermatology practice. As of the end of April, “we’re starting to see an uptick in the number of patients wanting to come in,” he said. “They seem to be more comfortable with the new world we’re living in.
“Viewing the backlog of cases that haven’t been attended to,” Dr. Monks added, “I think we’ll be really busy for a while.”
But Mr. La Penna said he thinks the expected backlog of elective patients will be more like a trickle than a flood. “Many patients aren’t going to want to return that fast,” he said. “They may have a condition that makes exposure to COVID-19 more risky, like diabetes or high blood pressure, or they’re elderly, or they live in a household with one of these risk groups.”
Andrew Musbach, cofounder of MD Wealth Management in Chelsea, Mich., said he expects a slow recovery for primary care physicians as well. “Even when the lockdowns are over, not everyone is going to feel comfortable coming to a hospital or visiting a doctor’s office unless it’s absolutely necessary,” he said.
Getting back to normal patient volumes will involve finding better ways to protect patients and staff from COVID-19, Dr. Yonover said. At his urology practice, “we take all the usual precautions, but nothing yet has made it dramatically easier to protect patients and staff,” he said. “Rapid, accurate testing for COVID-19 would change the landscape, but I have no idea when that will come.”
Mr. Wrenne advises his physician clients that a financial recovery will take months. “I tell them to plan for 6 months, until October, before income returns to pre–COVID-19 levels. Reimbursement lags appointments by as much as 3 months, plus it will probably take the economy 2-3 months more to get back to normal.”
“We are facing a recession, and how long it will last is anyone’s guess,” said Alex Kilian, a physician wealth manager at Aldrich Wealth in San Diego. “The federal government’s efforts to stimulate the economy is keeping it from crashing, but there are no real signs that it will actually pick up. It may take years for the travel and entertainment industries to come back.”
A recession means patients will have less spending power, and health care sectors like laser eye surgery may be damaged for years to come, said John B. Pinto, an ophthalmology practice management consultant in San Diego. “[That kind of surgery] is purely elective and relatively costly,” he said. “When people get back to work, they are going to be building up their savings and avoiding new debt. They won’t be having [laser eye surgery].”
“There won’t be any quick return to normal for me,” said Dr. Price, the Connecticut plastic surgeon. “The damage this time will probably be worse than in the Great Recession. Back then, plastic surgery was off by 20%, but this time you have the extra problem of patients reluctant to come into medical offices.”
“To get patients to come in, facilities are going to have to convince patients that they are safe,” Mr. Singleton said. “That may mean undertaking some marketing and promotion, and hospitals tend to be much better at that than practices.”
What a new wave of COVID-19 would mean
Some states have begun reopening public places, which could signal patients to return to doctors’ offices even though doctors’ offices were never officially closed. Oklahoma, for example, reopened restaurants, movie theaters, and sports venues on May 1.
Dr. Monks, president of the Oklahoma Medical Association, said his group opposes states reopening. “The governor’s order is too hasty and overly ambitious,” he said. “Oklahoma has seen an ongoing growth in the number of cases, hospitalizations, and deaths in the past week alone [in late April].”
The concern is that opening up public places too soon would create a new wave of COVID-19, which would not only be a public health disaster, but also a financial disaster for physicians. Doctors would be back where they were in March, but unlike in March, they would not benefit from revenues from previously busy times.
Mr. Pinto said the number of COVID-19 cases will rise and fall in the next 2 years, forcing states to reenact new bans on public gatherings and on elective surgeries until the numbers subside again.
Mr. Pinto said authorities in Singapore have successfully handled such waves of the disease through short bans that are tantamount to tapping the brakes of a car. “As the car gathers speed down the hill, you tap the brake,” he said. “I suspect we’ll be seeing a lot of brake-tapping until a vaccine can be developed and distributed.”
Gary LeRoy, MD, president of the American Academy of Family Physicians, recalled the worldwide Spanish Flu pandemic a century ago. “People were allowed out of their houses after 2 months, and the flu spiked up again,” he said. “I hope we don’t make that mistake this time.”
Dr. LeRoy said it’s not possible to predict how the COVID-19 crisis will play out. “What will the future be like? I don’t know the answer,” he said. “The information we learn in next hours, days, or months will probably change everything.”
A version of this article originally appeared on Medscape.com.
“At a combined system and hospital board meeting yesterday, there was a financial presentation,” said a cardiologist in Minnesota, who declined to be named. “We have ‘salary support’ through May 16, which means we will be receiving base pay at our 2019 level. After May 16, I think it’s fairly certain salaries will be decreased.”
A general internist in the same area added: “The system has decided to pay physicians and other employees for 8 weeks, until May 15, and they are borrowing about $150 million to do this. We don’t know what will happen after May 15, but we are supposed to have an update in early May.”
Physician income is of huge interest, and many aspects of it are discussed in Medscape’s Physician Compensation Report 2020, just released.
The worst may be yet to come
Of all the categories of physicians, “I am worried about private practices the most,” said Travis Singleton, senior vice president at Merritt Hawkins, a physician search firm. “They don’t have a financial cushion, and will start seeing big drops in revenue at the end of May.”
“A lot of the A/R [accounts receivables] for practices come within 30 days, and very little comes in after 90 days,” said Terrence R. McWilliams, MD, chief clinical consultant at HSG Advisors, a consultancy for not-for-profit hospitals and their employed physician networks around the country. “So private practices are reaching the point where prior A/R will start to dwindle and they will start feeling the decline in new claims submissions.”
Large practices may have a bigger financial cushion, but in many cases, they also have more liabilities. “We don’t know the financial loss yet, but I think it’s been devastating,” said Paul M. Yonover, MD, a urologist at UroPartners, a large single-specialty practice in Chicago with 62 urologists. “In fact, the financial loss may well be larger than our loss in volume, because we have to support our own surgery center, pathology lab, radiation center, and other in-house services.”
Employed physicians in limbo
In contrast to physicians in private practices, many employed physicians at hospitals and health systems have been shielded from the impact of COVID-19 – at least for now.
“The experiences of employed physicians are very mixed,” said Mr. Singleton at Merritt Hawkins. “Some health systems have reduced physicians’ pay by 20%, but other systems have been putting off any reductions.”
Hospitals and health systems are struggling. “Stopping elective surgeries deeply affected hospitals,” said Ryan Inman, founder of Physician Wealth Services in San Diego. “With fewer elective surgeries, they have much less income coming in. Some big hospitals that are pillars of their community are under great financial stress.”
“Hospitals’ patient volumes have fallen by 50%-90%,” Mr. McWilliams reported. “Lower volume means lower pay for employed physicians, who are paid by straight productivity or other models that require high volumes. However, some health systems have intervened to make sure these physicians get some money.”
Base pay is often safe for now, but quarterly bonuses are on the chopping block. “Employed physicians are often getting a guaranteed salary for a month or two, but no bonuses or extra distributions,” said Joel Greenwald, MD, a financial adviser for physicians in St. Louis Park, Minn., a state mecca for physician employment. “They’ve been told that they will continue to get their base salary but forget about the quarterly bonuses. This amounts to salary reductions of 10%-30%.”
Ensuring payment for these doctors means lowering their productivity benchmarks, but the benchmarks might still be too high for these times. An internist at a large health system in Minneapolis–St. Paul reports that, at a lunch meeting, employed doctors learned that payment benchmarks will be reduced to 70% of their 2019 monthly average.
“I am seeing nowhere near 70% of what I was seeing last year,” he said in an interview, asking that his name not be used. “Given how slow things have been, I am probably closer to 30%, but have not been given any data on this, so I am guessing at this point.”
Adapting to a brave new world
Even as they face a dark financial future, physicians have had to completely revamp the way they practice medicine – a cumbersome process that, in itself, incurred some financial losses. They had to obtain masks and other PPE, reposition or even close down their waiting rooms, cut back on unneeded staff, and adapt to telemedicine.
“It’s been an incredibly challenging time,” said Dr. Yonover, the Chicago urologist. “As a doctor. I cannot avoid contact, and it’s not totally clear yet how the virus spreads. But I don’t have the option of closing the door. As a practice owner, you’re responsible for the health and well-being of employees, patients, and the business.”
“A practice’s daily routine is somewhat slower and costlier,” said David N. Gans, MSHA, senior fellow at the Medical Group Management Association (MGMA), which represents group practices. “Between each patient, you have to clean a lot more than previously, and you have to stock up on PPE such as masks and gowns. PPE used to be limited to infectious patients, but now it’s universal.”
At PA Clinical Network, a clinically integrated network in Pennsylvania, volume fell 40%-50% and income fell 30%-50% from late March to late April, according to Jaan Sidorov, MD, an internist who is CEO of the network, which has 158 physicians in a variety of specialties working in 54 practices around the state.
“Revenue went down but it didn’t crash,” he said. “And our physicians pivoted very quickly. They adapted to telehealth and applied for the federal loan programs. They didn’t use waiting rooms. In some cases, staff was out in the parking lot, putting stethoscopes through patients’ windows.”
“None of the practices closed, not even temporarily,” Dr. Sidorov said. “But clearly this cannot go forever without having serious consequences.”
How much can telemedicine help?
Telemedicine has been a lifeline for many struggling practices. “As much as 20%-40% of a practice’s losses can be recouped through telemedicine, depending on variables like patients’ attitudes,” said Mr. Singleton at Merritt Hawkins.
The rise in telemedicine was made possible by a temporary relaxation of the limits on telemedicine payments by Medicare and many private payers. Medicare is currently paying the same rates for telemedicine as it does for in-office visits.
In a recent MGMA Stat survey, 97% of practices reported that they had taken up telemedicine, according to Mr. Gans. He estimates that 80% of primary care could be converted to telemedicine, including medication refills, ongoing care of chronic patients, and recording patients’ vital signs from home.
Some primary care physicians are now using telemedicine for 100% of their visits. “I voluntarily closed my practice weeks ago except for virtual visits due to the risk of exposure for my patients,” a doctor in South Carolina told the Primary Care Collaborative in mid-April. “I continue to pay my staff out of pocket but have reduced hours and am not receiving any income myself.”
However, Mr. Inman of Physician Wealth Services said family medicine clients using telemedicine for all of their patients are earning less per visit, even though the Medicare reimbursement is the same as for an office visit. “They earn less because they cannot charge for any ancillaries, such as labs or imaging,” he said.
“Telemedicine has its limits,” Mr. Singleton said. It cannot replace elective surgeries, and even in primary care practices, “there is a lot of work for which patients have to come in, such as physicals or providing vaccines,” he said. “I know of one doctor who has refrigerator full of vaccines to give out. That pays his bills.”
In many cases, “telemedicine” simply means using the phone, with no video. Many patients can only use the phone, and Medicare now reimburses for some kinds of phone visits. In a mid-April survey of primary care providers, 44% were using the telephone for the majority of their visits, and 14% were not using video at all. Medicare recently decided to pay physicians the same amount for telephone visits as in-person visits.
Financial boosts will run out soon
Many private practices are surviving only because they have managed to tap into new federal programs that can finance them for the short-term. Here are the main examples:
Receiving advance Medicare payments. Through the Medicare Accelerated and Advance Payment Program, physicians can be paid up to 3 months of their average Medicare reimbursement in advance. However, repayment starts 120 days after receiving the money and must be completed within 210 days.
Obtaining a federal loan. Under the Paycheck Protection Program (PPP), which is available to all kinds of small businesses, practices can apply for up to 2.5 times their average monthly payroll costs.
PPP money can be used for payroll, rent, mortgage interest, or utility payments for up to 8 weeks. The loan will be entirely forgiven as long as the rules are followed. For example, three quarters of the money must go to payroll, and laid-off employees must be rehired by June 30.
There was such a rush for the first round of PPP loans that many physicians failed to get the loan. “Many of my physician clients applied for the loan as soon as they could, but none of them got it,” said Mr. Inman, the San Diego financial adviser. “We are hoping that the next round of funding will provide them some relief.” The second round started on April 27.
Physicians who have already obtained the PPP loan are very relieved. “This loan made it possible for us to pay our employees,” said George W. Monks, MD, a dermatologist in Tulsa, Okla., and president of the Oklahoma Medical Association.
Staff benefiting from higher unemployment payments. Many practices and hospitals are laying off their staff so that they can collect unemployment benefits. This is a good time to do that because the federal government has boosted unemployment payments by $600 a week, creating a total benefit that is greater than many people earned at their regular jobs.
This extra boost ends in July, but practices with PPP loans will have to rehire their laid-off workers a month before that. Getting laid-off staffers to come back in is going to be critical, and some practices are already having a hard time convincing them to come back, said Michael La Penna, a physician practice manager in Grand Rapids, Mich.
“They are finding that those people don’t want to come back in yet,” he said. “In many cases they have to care for children at home or have been getting generous unemployment checks.”
The problem with all these temporary financial boosts is that they will disappear within weeks or months from now. Mr. La Penna is concerned that the sudden loss of this support could send some practices spinning into bankruptcy. “Unless volume gets better very soon, time is running out for a lot of practices,” he said.
Hospitals, which also have been depending on federal assistance, may run out of money, too. Daniel Wrenne, a financial planner for physicians in Lexington, Ky., said smaller hospitals are particularly vulnerable because they lack the capital. He said a friend who is an attorney for hospitals predicted that 25% of small regional hospitals “won’t make it through this.”
Such financial turmoil might prompt many physicians to retire or find a new job, said Gary Price, MD, a plastic surgeon in New Haven, Conn., and president of the Physicians Foundation, an advocacy group for the profession. In a survey of doctors by the Physicians Foundation and Merritt Hawkins, released on April 21, 18% planned to retire, temporarily close their practices, or opt out of patient care, and another 14%, presumably employed physicians, planned to change jobs.
Is recovery around the corner?
In early May, practices in many parts of the country were seeing the possibility of a return to normal business – or at least what could pass for normal in these unusual times.
“From mid-March to mid-April, hospitals and practices were in panic mode,” said MGMA’s Mr. Gans. “They were focusing on the here and now. But from mid-April to mid-May, they could begin looking at the big picture and decide how they will get back into business.”
Surgeons devastated by bans on elective surgeries might see a bounce in cases, as the backlog of patients comes back in. By late April, 10 states reinstituted elective surgeries, including California, Arizona, Georgia, Indiana, Colorado, and Oklahoma, and New York has reinstituted elective surgeries for some counties.
Dr. Price said he hopes to reopen his plastic surgery practice by the end of June. “If it takes longer than that, I’m not sure that the practice will survive.” His PPP loan would have run out and he would have to lay off his staff. “At that point, ongoing viability of practice would become a real question.”
Dr. Monks said he hopes a lot more patients will come to his dermatology practice. As of the end of April, “we’re starting to see an uptick in the number of patients wanting to come in,” he said. “They seem to be more comfortable with the new world we’re living in.
“Viewing the backlog of cases that haven’t been attended to,” Dr. Monks added, “I think we’ll be really busy for a while.”
But Mr. La Penna said he thinks the expected backlog of elective patients will be more like a trickle than a flood. “Many patients aren’t going to want to return that fast,” he said. “They may have a condition that makes exposure to COVID-19 more risky, like diabetes or high blood pressure, or they’re elderly, or they live in a household with one of these risk groups.”
Andrew Musbach, cofounder of MD Wealth Management in Chelsea, Mich., said he expects a slow recovery for primary care physicians as well. “Even when the lockdowns are over, not everyone is going to feel comfortable coming to a hospital or visiting a doctor’s office unless it’s absolutely necessary,” he said.
Getting back to normal patient volumes will involve finding better ways to protect patients and staff from COVID-19, Dr. Yonover said. At his urology practice, “we take all the usual precautions, but nothing yet has made it dramatically easier to protect patients and staff,” he said. “Rapid, accurate testing for COVID-19 would change the landscape, but I have no idea when that will come.”
Mr. Wrenne advises his physician clients that a financial recovery will take months. “I tell them to plan for 6 months, until October, before income returns to pre–COVID-19 levels. Reimbursement lags appointments by as much as 3 months, plus it will probably take the economy 2-3 months more to get back to normal.”
“We are facing a recession, and how long it will last is anyone’s guess,” said Alex Kilian, a physician wealth manager at Aldrich Wealth in San Diego. “The federal government’s efforts to stimulate the economy is keeping it from crashing, but there are no real signs that it will actually pick up. It may take years for the travel and entertainment industries to come back.”
A recession means patients will have less spending power, and health care sectors like laser eye surgery may be damaged for years to come, said John B. Pinto, an ophthalmology practice management consultant in San Diego. “[That kind of surgery] is purely elective and relatively costly,” he said. “When people get back to work, they are going to be building up their savings and avoiding new debt. They won’t be having [laser eye surgery].”
“There won’t be any quick return to normal for me,” said Dr. Price, the Connecticut plastic surgeon. “The damage this time will probably be worse than in the Great Recession. Back then, plastic surgery was off by 20%, but this time you have the extra problem of patients reluctant to come into medical offices.”
“To get patients to come in, facilities are going to have to convince patients that they are safe,” Mr. Singleton said. “That may mean undertaking some marketing and promotion, and hospitals tend to be much better at that than practices.”
What a new wave of COVID-19 would mean
Some states have begun reopening public places, which could signal patients to return to doctors’ offices even though doctors’ offices were never officially closed. Oklahoma, for example, reopened restaurants, movie theaters, and sports venues on May 1.
Dr. Monks, president of the Oklahoma Medical Association, said his group opposes states reopening. “The governor’s order is too hasty and overly ambitious,” he said. “Oklahoma has seen an ongoing growth in the number of cases, hospitalizations, and deaths in the past week alone [in late April].”
The concern is that opening up public places too soon would create a new wave of COVID-19, which would not only be a public health disaster, but also a financial disaster for physicians. Doctors would be back where they were in March, but unlike in March, they would not benefit from revenues from previously busy times.
Mr. Pinto said the number of COVID-19 cases will rise and fall in the next 2 years, forcing states to reenact new bans on public gatherings and on elective surgeries until the numbers subside again.
Mr. Pinto said authorities in Singapore have successfully handled such waves of the disease through short bans that are tantamount to tapping the brakes of a car. “As the car gathers speed down the hill, you tap the brake,” he said. “I suspect we’ll be seeing a lot of brake-tapping until a vaccine can be developed and distributed.”
Gary LeRoy, MD, president of the American Academy of Family Physicians, recalled the worldwide Spanish Flu pandemic a century ago. “People were allowed out of their houses after 2 months, and the flu spiked up again,” he said. “I hope we don’t make that mistake this time.”
Dr. LeRoy said it’s not possible to predict how the COVID-19 crisis will play out. “What will the future be like? I don’t know the answer,” he said. “The information we learn in next hours, days, or months will probably change everything.”
A version of this article originally appeared on Medscape.com.
The third surge: Are we prepared for the non-COVID crisis?
Over the last several weeks, hospitals and health systems have focused on the COVID-19 epidemic, preparing and expanding bed capacities for the surge of admissions both in intensive care and medical units. An indirect impact of this has been the reduction in outpatient staffing and resources, with the shifting of staff for inpatient care. Many areas seem to have passed the peak in the number of cases and are now seeing a plateau or downward trend in the admissions to acute care facilities.
During this period, there has been a noticeable downtrend in patients being evaluated in the ED, or admitted for decompensation of chronic conditions like heart failure, COPD and diabetes mellitus, or such acute conditions as stroke and MI. Studies from Italy and Spain, and closer to home from Atlanta and Boston, point to a significant decrease in numbers of ST-elevation myocardial infarction (STEMI) admissions.1 Duke Health saw a decrease in stroke admissions in their hospitals by 34%.2
One could argue that these patients are in fact presenting with COVID-19 or similar symptoms as is evidenced by the studies linking the severity of SARS-Co-V2 infection to chronic conditions like diabetes mellitus and obesity.2 On the other hand, the message of social isolation and avoidance of nonurgent visits could lead to delays in care resulting in patients presenting sicker and in advanced stages.3 Also, this has not been limited to the adult population. For example, reports indicate that visits to WakeMed’s pediatric emergency rooms in Wake County, N.C., were down by 60%.2
We could well be seeing a calm before the storm. While it is anticipated that there may be a second surge of COVID-19 cases, health systems would do well to be prepared for the “third surge,” consisting of patients coming in with chronic medical conditions for which they have been, so far, avoiding follow-up and managing at home, and acute medical conditions with delayed diagnoses. The impact could likely be more in the subset of patients with limited access to health care, including medications and follow-up, resulting in a disproportionate burden on safety-net hospitals.
Compounding this issue would be the economic impact of the current crisis on health systems, their staffing, and resources. Several major organizations have already proposed budget cuts and reduction of the workforce, raising significant concerns about the future of health care workers who put their lives at risk during this pandemic.4 There is no guarantee that the federal funding provided by the stimulus packages will save jobs in the health care industry. This problem needs new leadership thinking, and every organization that puts employees over profits margins will have a long-term impact on communities.
Another area of concern is a shift in resources and workflow from ambulatory to inpatient settings for the COVID-19 pandemic, and the need for revamping the ambulatory services with reshifting the workforce. As COVID-19 cases plateau, the resurgence of non-COVID–related admissions will require additional help in inpatient settings. Prioritizing the ambulatory services based on financial benefits versus patient outcomes is also a major challenge to leadership.5
Lastly, the current health care crisis has led to significant stress, both emotional and physical, among frontline caregivers, increasing the risk of burnout.6 How leadership helps health care workers to cope with these stressors, and the resources they provide, is going to play a key role in long term retention of their talent, and will reflect on the organizational culture. Though it might seem trivial, posttraumatic stress disorder related to this is already obvious, and health care leadership needs to put every effort in providing the resources to help prevent burnout, in partnership with national organizations like the Society of Hospital Medicine and the American College of Physicians.
The expansion of telemedicine has provided a unique opportunity to address several of these issues while maintaining the nonpharmacologic interventions to fight the epidemic, and keeping the cost curve as low as possible.7 Extension of these services to all ambulatory service lines, including home health and therapy, is the next big step in the new health care era. Virtual check-ins by physicians, advance practice clinicians, and home care nurses could help alleviate the concerns regarding delays in care of patients with chronic conditions, and help identify those at risk. This would also be of help with staffing shortages, and possibly provide much needed support to frontline providers.
Dr. Prasad is currently medical director of care management and a hospitalist at Advocate Aurora Health in Milwaukee. He was previously quality and utilization officer and chief of the medical staff at Aurora Sinai Medical Center. Dr. Prasad is cochair of SHM’s IT Special Interest Group, sits on the HQPS Committee, and is president of SHM’s Wisconsin Chapter. Dr. Palabindala is the medical director, utilization management and physician advisory services, at the University of Mississippi Medical Center, Jackson. He is an associate professor of medicine and academic hospitalist in the UMMC School of Medicine.
References
1. Wood S. TCTMD. 2020 Apr 2. “The mystery of the missing STEMIs during the COVID-19 pandemic.”
2. Stradling R. The News & Observer. 2020 Apr 21. “Fewer people are going to Triangle [N.C.] emergency rooms, and that could be a bad thing.”
3. Kasanagottu K. USA Today. 2020 Apr 15. “Don’t delay care for chronic illness over coronavirus. It’s bad for you and for hospitals.”
4. Snowbeck C. The Star Tribune. 2020 Apr 11. “Mayo Clinic cutting pay for more than 20,000 workers.”
5. LaPointe J. RevCycle Intelligence. 2020 Mar 31. “How much will the COVID-19 pandemic cost hospitals?”
6. Gavidia M. AJMC. 2020 Mar 31. “Sleep, physician burnout linked amid COVID-19 pandemic.”
7. Hollander JE and Carr BG. N Engl J Med. 2020 Apr 30;382(18):1679-81. “Virtually perfect? Telemedicine for COVID-19.”
Over the last several weeks, hospitals and health systems have focused on the COVID-19 epidemic, preparing and expanding bed capacities for the surge of admissions both in intensive care and medical units. An indirect impact of this has been the reduction in outpatient staffing and resources, with the shifting of staff for inpatient care. Many areas seem to have passed the peak in the number of cases and are now seeing a plateau or downward trend in the admissions to acute care facilities.
During this period, there has been a noticeable downtrend in patients being evaluated in the ED, or admitted for decompensation of chronic conditions like heart failure, COPD and diabetes mellitus, or such acute conditions as stroke and MI. Studies from Italy and Spain, and closer to home from Atlanta and Boston, point to a significant decrease in numbers of ST-elevation myocardial infarction (STEMI) admissions.1 Duke Health saw a decrease in stroke admissions in their hospitals by 34%.2
One could argue that these patients are in fact presenting with COVID-19 or similar symptoms as is evidenced by the studies linking the severity of SARS-Co-V2 infection to chronic conditions like diabetes mellitus and obesity.2 On the other hand, the message of social isolation and avoidance of nonurgent visits could lead to delays in care resulting in patients presenting sicker and in advanced stages.3 Also, this has not been limited to the adult population. For example, reports indicate that visits to WakeMed’s pediatric emergency rooms in Wake County, N.C., were down by 60%.2
We could well be seeing a calm before the storm. While it is anticipated that there may be a second surge of COVID-19 cases, health systems would do well to be prepared for the “third surge,” consisting of patients coming in with chronic medical conditions for which they have been, so far, avoiding follow-up and managing at home, and acute medical conditions with delayed diagnoses. The impact could likely be more in the subset of patients with limited access to health care, including medications and follow-up, resulting in a disproportionate burden on safety-net hospitals.
Compounding this issue would be the economic impact of the current crisis on health systems, their staffing, and resources. Several major organizations have already proposed budget cuts and reduction of the workforce, raising significant concerns about the future of health care workers who put their lives at risk during this pandemic.4 There is no guarantee that the federal funding provided by the stimulus packages will save jobs in the health care industry. This problem needs new leadership thinking, and every organization that puts employees over profits margins will have a long-term impact on communities.
Another area of concern is a shift in resources and workflow from ambulatory to inpatient settings for the COVID-19 pandemic, and the need for revamping the ambulatory services with reshifting the workforce. As COVID-19 cases plateau, the resurgence of non-COVID–related admissions will require additional help in inpatient settings. Prioritizing the ambulatory services based on financial benefits versus patient outcomes is also a major challenge to leadership.5
Lastly, the current health care crisis has led to significant stress, both emotional and physical, among frontline caregivers, increasing the risk of burnout.6 How leadership helps health care workers to cope with these stressors, and the resources they provide, is going to play a key role in long term retention of their talent, and will reflect on the organizational culture. Though it might seem trivial, posttraumatic stress disorder related to this is already obvious, and health care leadership needs to put every effort in providing the resources to help prevent burnout, in partnership with national organizations like the Society of Hospital Medicine and the American College of Physicians.
The expansion of telemedicine has provided a unique opportunity to address several of these issues while maintaining the nonpharmacologic interventions to fight the epidemic, and keeping the cost curve as low as possible.7 Extension of these services to all ambulatory service lines, including home health and therapy, is the next big step in the new health care era. Virtual check-ins by physicians, advance practice clinicians, and home care nurses could help alleviate the concerns regarding delays in care of patients with chronic conditions, and help identify those at risk. This would also be of help with staffing shortages, and possibly provide much needed support to frontline providers.
Dr. Prasad is currently medical director of care management and a hospitalist at Advocate Aurora Health in Milwaukee. He was previously quality and utilization officer and chief of the medical staff at Aurora Sinai Medical Center. Dr. Prasad is cochair of SHM’s IT Special Interest Group, sits on the HQPS Committee, and is president of SHM’s Wisconsin Chapter. Dr. Palabindala is the medical director, utilization management and physician advisory services, at the University of Mississippi Medical Center, Jackson. He is an associate professor of medicine and academic hospitalist in the UMMC School of Medicine.
References
1. Wood S. TCTMD. 2020 Apr 2. “The mystery of the missing STEMIs during the COVID-19 pandemic.”
2. Stradling R. The News & Observer. 2020 Apr 21. “Fewer people are going to Triangle [N.C.] emergency rooms, and that could be a bad thing.”
3. Kasanagottu K. USA Today. 2020 Apr 15. “Don’t delay care for chronic illness over coronavirus. It’s bad for you and for hospitals.”
4. Snowbeck C. The Star Tribune. 2020 Apr 11. “Mayo Clinic cutting pay for more than 20,000 workers.”
5. LaPointe J. RevCycle Intelligence. 2020 Mar 31. “How much will the COVID-19 pandemic cost hospitals?”
6. Gavidia M. AJMC. 2020 Mar 31. “Sleep, physician burnout linked amid COVID-19 pandemic.”
7. Hollander JE and Carr BG. N Engl J Med. 2020 Apr 30;382(18):1679-81. “Virtually perfect? Telemedicine for COVID-19.”
Over the last several weeks, hospitals and health systems have focused on the COVID-19 epidemic, preparing and expanding bed capacities for the surge of admissions both in intensive care and medical units. An indirect impact of this has been the reduction in outpatient staffing and resources, with the shifting of staff for inpatient care. Many areas seem to have passed the peak in the number of cases and are now seeing a plateau or downward trend in the admissions to acute care facilities.
During this period, there has been a noticeable downtrend in patients being evaluated in the ED, or admitted for decompensation of chronic conditions like heart failure, COPD and diabetes mellitus, or such acute conditions as stroke and MI. Studies from Italy and Spain, and closer to home from Atlanta and Boston, point to a significant decrease in numbers of ST-elevation myocardial infarction (STEMI) admissions.1 Duke Health saw a decrease in stroke admissions in their hospitals by 34%.2
One could argue that these patients are in fact presenting with COVID-19 or similar symptoms as is evidenced by the studies linking the severity of SARS-Co-V2 infection to chronic conditions like diabetes mellitus and obesity.2 On the other hand, the message of social isolation and avoidance of nonurgent visits could lead to delays in care resulting in patients presenting sicker and in advanced stages.3 Also, this has not been limited to the adult population. For example, reports indicate that visits to WakeMed’s pediatric emergency rooms in Wake County, N.C., were down by 60%.2
We could well be seeing a calm before the storm. While it is anticipated that there may be a second surge of COVID-19 cases, health systems would do well to be prepared for the “third surge,” consisting of patients coming in with chronic medical conditions for which they have been, so far, avoiding follow-up and managing at home, and acute medical conditions with delayed diagnoses. The impact could likely be more in the subset of patients with limited access to health care, including medications and follow-up, resulting in a disproportionate burden on safety-net hospitals.
Compounding this issue would be the economic impact of the current crisis on health systems, their staffing, and resources. Several major organizations have already proposed budget cuts and reduction of the workforce, raising significant concerns about the future of health care workers who put their lives at risk during this pandemic.4 There is no guarantee that the federal funding provided by the stimulus packages will save jobs in the health care industry. This problem needs new leadership thinking, and every organization that puts employees over profits margins will have a long-term impact on communities.
Another area of concern is a shift in resources and workflow from ambulatory to inpatient settings for the COVID-19 pandemic, and the need for revamping the ambulatory services with reshifting the workforce. As COVID-19 cases plateau, the resurgence of non-COVID–related admissions will require additional help in inpatient settings. Prioritizing the ambulatory services based on financial benefits versus patient outcomes is also a major challenge to leadership.5
Lastly, the current health care crisis has led to significant stress, both emotional and physical, among frontline caregivers, increasing the risk of burnout.6 How leadership helps health care workers to cope with these stressors, and the resources they provide, is going to play a key role in long term retention of their talent, and will reflect on the organizational culture. Though it might seem trivial, posttraumatic stress disorder related to this is already obvious, and health care leadership needs to put every effort in providing the resources to help prevent burnout, in partnership with national organizations like the Society of Hospital Medicine and the American College of Physicians.
The expansion of telemedicine has provided a unique opportunity to address several of these issues while maintaining the nonpharmacologic interventions to fight the epidemic, and keeping the cost curve as low as possible.7 Extension of these services to all ambulatory service lines, including home health and therapy, is the next big step in the new health care era. Virtual check-ins by physicians, advance practice clinicians, and home care nurses could help alleviate the concerns regarding delays in care of patients with chronic conditions, and help identify those at risk. This would also be of help with staffing shortages, and possibly provide much needed support to frontline providers.
Dr. Prasad is currently medical director of care management and a hospitalist at Advocate Aurora Health in Milwaukee. He was previously quality and utilization officer and chief of the medical staff at Aurora Sinai Medical Center. Dr. Prasad is cochair of SHM’s IT Special Interest Group, sits on the HQPS Committee, and is president of SHM’s Wisconsin Chapter. Dr. Palabindala is the medical director, utilization management and physician advisory services, at the University of Mississippi Medical Center, Jackson. He is an associate professor of medicine and academic hospitalist in the UMMC School of Medicine.
References
1. Wood S. TCTMD. 2020 Apr 2. “The mystery of the missing STEMIs during the COVID-19 pandemic.”
2. Stradling R. The News & Observer. 2020 Apr 21. “Fewer people are going to Triangle [N.C.] emergency rooms, and that could be a bad thing.”
3. Kasanagottu K. USA Today. 2020 Apr 15. “Don’t delay care for chronic illness over coronavirus. It’s bad for you and for hospitals.”
4. Snowbeck C. The Star Tribune. 2020 Apr 11. “Mayo Clinic cutting pay for more than 20,000 workers.”
5. LaPointe J. RevCycle Intelligence. 2020 Mar 31. “How much will the COVID-19 pandemic cost hospitals?”
6. Gavidia M. AJMC. 2020 Mar 31. “Sleep, physician burnout linked amid COVID-19 pandemic.”
7. Hollander JE and Carr BG. N Engl J Med. 2020 Apr 30;382(18):1679-81. “Virtually perfect? Telemedicine for COVID-19.”
COVID-19 experiences from the pediatrician front line
As the COVID-19 pandemic continues to spread across the United States, several members of the Pediatric News Editorial Advisory Board shared how practices have been adapting to the pandemic, especially in terms of immunization.
Karalyn Kinsella, MD, a member of a four-pediatrician private practice in Cheshire, Conn., said in an interview that “we have been seeing only children under age 2 years for their well visits to keep them up to date on their vaccinations” as recommended by infectious disease departments at nearby hospitals such as Connecticut Children’s Medical Center. “We also are seeing the 4- and 5-year-old children for vaccinations.”
Dr. Kinsella explained that, in case parents don’t want to bring their children into the office, her staff is offering to give the vaccinations in the parking lot. But most families are coming into the office.
“We are only seeing well babies and take the parent and child back to a room as soon as they come in the office to avoid having patients sit in the waiting room. At this point, both parents and office staff are wearing masks; we are cleaning the rooms between patients,” Dr. Kinsella said.
“Most of our patients are coming in for their vaccines, so I don’t anticipate a lot of kids being behind. However, we will have a surge of all the physicals that need to be done prior to school in the fall. We have thought about opening up for the weekends for physicals to accommodate this. We also may need to start the day earlier and end later. I have heard some schools may be postponing the date the physicals are due.”
Because of a lack of full personal protective equipment, the practice has not been seeing sick visits in the office, but they have been doing a lot of telehealth visits. “We have been using doxy.me for that, which is free, incredibly easy to use, and Health Insurance Portability and Accountability Act (HIPAA)–compliant,” she said. “I am finding some visits, such as ADHD follow-ups and mental health follow-ups, very amenable to telehealth.”
“The hardest part – as I am sure is for most pediatricians – is the financial strain to a small business,” Dr. Kinsella noted. “We are down about 70% in revenue from this time last year. We have had to lay-off half our staff, and those who are working have much-reduced hours. We did not get the first round of funding for the paycheck protection program loan from the government and are waiting on the second round. We are trying to recoup some business by doing telehealth, but [the insurance companies] are only paying about 75%-80%. We also are charging for phone calls over 5 minutes. It will take a long time once we are up and running to recoup the losses.
“When this is all over, I’m hoping that we will be able to continue to incorporate telehealth into our schedules as I think it is convenient for families. I also am hoping that pediatricians continue to bill for phone calls as we have been giving out a lot of free care prior to this. I hope the American Academy of Pediatrics and all pediatricians work together to advocate for payment of these modalities,” she said.
J. Howard Smart, MD, who is chairman of the department of pediatrics at Sharp Rees-Stealy Medical Group in San Diego, said in an interview, “We have been bringing all of the infants and toddlers in for checkups and vaccines up to age 18 months.” These visits are scheduled in the morning, and sick patients are scheduled in the afternoon. “Well-child visits for older ages are being done by video, and the kindergarten and adolescent vaccines can be done by quick nurse visits. We will have some catching up to do once restrictions are lifted.”
“A fair amount of discussion went into these decisions. Is a video checkup better than no checkup? There is no clear-cut answer. Important things can be addressed by video: lifestyle, diet, exercise, family coping with stay-at-home orders, maintaining healthy childhood relationships, Internet use, ongoing education, among others. We know that we may miss things that can only be picked up by physical examination: hypertension, heart murmurs, abnormal growth, sexual development, abdominal masses, subtle strabismus. This is why we need to bring these children back for the physical exam later,” Dr. Smart emphasized.
“One possible negative result of doing the ‘well-child check’ by video would be if the parent assumed that the ‘checkup’ was done, never brought the child back for the exam, and something was missed that needed intervention. It will be important to get the message across that the return visit is needed. The American Academy of Pediatrics made this a part of their recommendations. It is going to be important for payers to realize that we need to do both visits – and to pay accordingly,” he concluded.
Francis E. Rushton Jr., MD, of Birmingham, Ala., described in an interview how the pediatricians in his former practice are looking for new ways to encourage shot administration in a timely manner during the COVID-19 pandemic, as well as exploring ways to partner with home visitors in encouraging timely infant and toddler vaccinations.
At South Carolina’s Beaufort Pediatrics, Joseph Floyd, MD, described a multipronged initiative. The practice’s well-child visit reminder system is being reprogrammed to check for lapses in vaccinations rather than just well-child visit attendance. For the most part, Dr. Floyd stated parents appreciate the reminders and accept the need for vaccination: “In the absence of immunizations for coronavirus, families seem to be more cognizant of the value of the vaccines we do have.” Beaufort Pediatrics is also partnering with their local hospital on a publicity campaign stressing the importance of staying up to date with currently available and recommended vaccines.
Other child-service organizations are concerned as well. Dr. Francis E. Rushton Jr., as faculty with the Education Development Center’s Health Resources and Services Administration–funded home-visiting quality improvement collaborative (HV CoIIN 2.0), described efforts with home visitors in Alabama and other states. “Home visitors understand the importance of immunizations to the health and welfare of the infants they care for. They’re looking for opportunities to improve compliance with vaccination regimens.” Some of these home-visiting agencies are employing quality improvement technique to improve compliance. One idea they are working on is documenting annual training on updated vaccines for the home visitors. They are working on protocols for linking their clients with primary health care providers, referral relations, and relationship development with local pediatric offices. Motivational interviewing techniques for home visitors focused on immunizations are being considered. For families who are hesitant, home visitors are considering accompanying the family when they come to the doctor’s office while paying attention to COVID-19 social distancing policies at medical facilities.
As the COVID-19 pandemic continues to spread across the United States, several members of the Pediatric News Editorial Advisory Board shared how practices have been adapting to the pandemic, especially in terms of immunization.
Karalyn Kinsella, MD, a member of a four-pediatrician private practice in Cheshire, Conn., said in an interview that “we have been seeing only children under age 2 years for their well visits to keep them up to date on their vaccinations” as recommended by infectious disease departments at nearby hospitals such as Connecticut Children’s Medical Center. “We also are seeing the 4- and 5-year-old children for vaccinations.”
Dr. Kinsella explained that, in case parents don’t want to bring their children into the office, her staff is offering to give the vaccinations in the parking lot. But most families are coming into the office.
“We are only seeing well babies and take the parent and child back to a room as soon as they come in the office to avoid having patients sit in the waiting room. At this point, both parents and office staff are wearing masks; we are cleaning the rooms between patients,” Dr. Kinsella said.
“Most of our patients are coming in for their vaccines, so I don’t anticipate a lot of kids being behind. However, we will have a surge of all the physicals that need to be done prior to school in the fall. We have thought about opening up for the weekends for physicals to accommodate this. We also may need to start the day earlier and end later. I have heard some schools may be postponing the date the physicals are due.”
Because of a lack of full personal protective equipment, the practice has not been seeing sick visits in the office, but they have been doing a lot of telehealth visits. “We have been using doxy.me for that, which is free, incredibly easy to use, and Health Insurance Portability and Accountability Act (HIPAA)–compliant,” she said. “I am finding some visits, such as ADHD follow-ups and mental health follow-ups, very amenable to telehealth.”
“The hardest part – as I am sure is for most pediatricians – is the financial strain to a small business,” Dr. Kinsella noted. “We are down about 70% in revenue from this time last year. We have had to lay-off half our staff, and those who are working have much-reduced hours. We did not get the first round of funding for the paycheck protection program loan from the government and are waiting on the second round. We are trying to recoup some business by doing telehealth, but [the insurance companies] are only paying about 75%-80%. We also are charging for phone calls over 5 minutes. It will take a long time once we are up and running to recoup the losses.
“When this is all over, I’m hoping that we will be able to continue to incorporate telehealth into our schedules as I think it is convenient for families. I also am hoping that pediatricians continue to bill for phone calls as we have been giving out a lot of free care prior to this. I hope the American Academy of Pediatrics and all pediatricians work together to advocate for payment of these modalities,” she said.
J. Howard Smart, MD, who is chairman of the department of pediatrics at Sharp Rees-Stealy Medical Group in San Diego, said in an interview, “We have been bringing all of the infants and toddlers in for checkups and vaccines up to age 18 months.” These visits are scheduled in the morning, and sick patients are scheduled in the afternoon. “Well-child visits for older ages are being done by video, and the kindergarten and adolescent vaccines can be done by quick nurse visits. We will have some catching up to do once restrictions are lifted.”
“A fair amount of discussion went into these decisions. Is a video checkup better than no checkup? There is no clear-cut answer. Important things can be addressed by video: lifestyle, diet, exercise, family coping with stay-at-home orders, maintaining healthy childhood relationships, Internet use, ongoing education, among others. We know that we may miss things that can only be picked up by physical examination: hypertension, heart murmurs, abnormal growth, sexual development, abdominal masses, subtle strabismus. This is why we need to bring these children back for the physical exam later,” Dr. Smart emphasized.
“One possible negative result of doing the ‘well-child check’ by video would be if the parent assumed that the ‘checkup’ was done, never brought the child back for the exam, and something was missed that needed intervention. It will be important to get the message across that the return visit is needed. The American Academy of Pediatrics made this a part of their recommendations. It is going to be important for payers to realize that we need to do both visits – and to pay accordingly,” he concluded.
Francis E. Rushton Jr., MD, of Birmingham, Ala., described in an interview how the pediatricians in his former practice are looking for new ways to encourage shot administration in a timely manner during the COVID-19 pandemic, as well as exploring ways to partner with home visitors in encouraging timely infant and toddler vaccinations.
At South Carolina’s Beaufort Pediatrics, Joseph Floyd, MD, described a multipronged initiative. The practice’s well-child visit reminder system is being reprogrammed to check for lapses in vaccinations rather than just well-child visit attendance. For the most part, Dr. Floyd stated parents appreciate the reminders and accept the need for vaccination: “In the absence of immunizations for coronavirus, families seem to be more cognizant of the value of the vaccines we do have.” Beaufort Pediatrics is also partnering with their local hospital on a publicity campaign stressing the importance of staying up to date with currently available and recommended vaccines.
Other child-service organizations are concerned as well. Dr. Francis E. Rushton Jr., as faculty with the Education Development Center’s Health Resources and Services Administration–funded home-visiting quality improvement collaborative (HV CoIIN 2.0), described efforts with home visitors in Alabama and other states. “Home visitors understand the importance of immunizations to the health and welfare of the infants they care for. They’re looking for opportunities to improve compliance with vaccination regimens.” Some of these home-visiting agencies are employing quality improvement technique to improve compliance. One idea they are working on is documenting annual training on updated vaccines for the home visitors. They are working on protocols for linking their clients with primary health care providers, referral relations, and relationship development with local pediatric offices. Motivational interviewing techniques for home visitors focused on immunizations are being considered. For families who are hesitant, home visitors are considering accompanying the family when they come to the doctor’s office while paying attention to COVID-19 social distancing policies at medical facilities.
As the COVID-19 pandemic continues to spread across the United States, several members of the Pediatric News Editorial Advisory Board shared how practices have been adapting to the pandemic, especially in terms of immunization.
Karalyn Kinsella, MD, a member of a four-pediatrician private practice in Cheshire, Conn., said in an interview that “we have been seeing only children under age 2 years for their well visits to keep them up to date on their vaccinations” as recommended by infectious disease departments at nearby hospitals such as Connecticut Children’s Medical Center. “We also are seeing the 4- and 5-year-old children for vaccinations.”
Dr. Kinsella explained that, in case parents don’t want to bring their children into the office, her staff is offering to give the vaccinations in the parking lot. But most families are coming into the office.
“We are only seeing well babies and take the parent and child back to a room as soon as they come in the office to avoid having patients sit in the waiting room. At this point, both parents and office staff are wearing masks; we are cleaning the rooms between patients,” Dr. Kinsella said.
“Most of our patients are coming in for their vaccines, so I don’t anticipate a lot of kids being behind. However, we will have a surge of all the physicals that need to be done prior to school in the fall. We have thought about opening up for the weekends for physicals to accommodate this. We also may need to start the day earlier and end later. I have heard some schools may be postponing the date the physicals are due.”
Because of a lack of full personal protective equipment, the practice has not been seeing sick visits in the office, but they have been doing a lot of telehealth visits. “We have been using doxy.me for that, which is free, incredibly easy to use, and Health Insurance Portability and Accountability Act (HIPAA)–compliant,” she said. “I am finding some visits, such as ADHD follow-ups and mental health follow-ups, very amenable to telehealth.”
“The hardest part – as I am sure is for most pediatricians – is the financial strain to a small business,” Dr. Kinsella noted. “We are down about 70% in revenue from this time last year. We have had to lay-off half our staff, and those who are working have much-reduced hours. We did not get the first round of funding for the paycheck protection program loan from the government and are waiting on the second round. We are trying to recoup some business by doing telehealth, but [the insurance companies] are only paying about 75%-80%. We also are charging for phone calls over 5 minutes. It will take a long time once we are up and running to recoup the losses.
“When this is all over, I’m hoping that we will be able to continue to incorporate telehealth into our schedules as I think it is convenient for families. I also am hoping that pediatricians continue to bill for phone calls as we have been giving out a lot of free care prior to this. I hope the American Academy of Pediatrics and all pediatricians work together to advocate for payment of these modalities,” she said.
J. Howard Smart, MD, who is chairman of the department of pediatrics at Sharp Rees-Stealy Medical Group in San Diego, said in an interview, “We have been bringing all of the infants and toddlers in for checkups and vaccines up to age 18 months.” These visits are scheduled in the morning, and sick patients are scheduled in the afternoon. “Well-child visits for older ages are being done by video, and the kindergarten and adolescent vaccines can be done by quick nurse visits. We will have some catching up to do once restrictions are lifted.”
“A fair amount of discussion went into these decisions. Is a video checkup better than no checkup? There is no clear-cut answer. Important things can be addressed by video: lifestyle, diet, exercise, family coping with stay-at-home orders, maintaining healthy childhood relationships, Internet use, ongoing education, among others. We know that we may miss things that can only be picked up by physical examination: hypertension, heart murmurs, abnormal growth, sexual development, abdominal masses, subtle strabismus. This is why we need to bring these children back for the physical exam later,” Dr. Smart emphasized.
“One possible negative result of doing the ‘well-child check’ by video would be if the parent assumed that the ‘checkup’ was done, never brought the child back for the exam, and something was missed that needed intervention. It will be important to get the message across that the return visit is needed. The American Academy of Pediatrics made this a part of their recommendations. It is going to be important for payers to realize that we need to do both visits – and to pay accordingly,” he concluded.
Francis E. Rushton Jr., MD, of Birmingham, Ala., described in an interview how the pediatricians in his former practice are looking for new ways to encourage shot administration in a timely manner during the COVID-19 pandemic, as well as exploring ways to partner with home visitors in encouraging timely infant and toddler vaccinations.
At South Carolina’s Beaufort Pediatrics, Joseph Floyd, MD, described a multipronged initiative. The practice’s well-child visit reminder system is being reprogrammed to check for lapses in vaccinations rather than just well-child visit attendance. For the most part, Dr. Floyd stated parents appreciate the reminders and accept the need for vaccination: “In the absence of immunizations for coronavirus, families seem to be more cognizant of the value of the vaccines we do have.” Beaufort Pediatrics is also partnering with their local hospital on a publicity campaign stressing the importance of staying up to date with currently available and recommended vaccines.
Other child-service organizations are concerned as well. Dr. Francis E. Rushton Jr., as faculty with the Education Development Center’s Health Resources and Services Administration–funded home-visiting quality improvement collaborative (HV CoIIN 2.0), described efforts with home visitors in Alabama and other states. “Home visitors understand the importance of immunizations to the health and welfare of the infants they care for. They’re looking for opportunities to improve compliance with vaccination regimens.” Some of these home-visiting agencies are employing quality improvement technique to improve compliance. One idea they are working on is documenting annual training on updated vaccines for the home visitors. They are working on protocols for linking their clients with primary health care providers, referral relations, and relationship development with local pediatric offices. Motivational interviewing techniques for home visitors focused on immunizations are being considered. For families who are hesitant, home visitors are considering accompanying the family when they come to the doctor’s office while paying attention to COVID-19 social distancing policies at medical facilities.
MRD surveillance can detect relapse before imaging in early-stage NSCLC
, according to findings from the TRACERx study.
The findings pave the way for clinical trials of MRD-driven treatment escalation, Chris Abbosh, MD, of University College London, reported during a presentation at the AACR virtual meeting I. Data in the presentation were updated from the abstract.
Dr. Abbosh and colleagues used phylogenetic circulating tumor DNA (ctDNA) profiling to assess MRD and predict relapse in patients from the TRACERx study who underwent surgery for stage I-III NSCLC.
“The approach we take is technically termed a ‘tumor-informed, personalized cell-free DNA-enrichment approach,’” Dr. Abbosh explained. “We take out the primary tumor from the patient, we multiregion sample that tumor, and submit each region for deep whole-exome sequencing.”
The researchers prioritize variants for MRD tracking based on clonality/subclonality, high copy number status, and low background sequencing noise. The researchers then construct an anchored-multiplex PCR panel against the positions of interest, which is applied to cell-free DNA in the pre- and postoperative setting.
“We’ve developed an MRD caller to go alongside this chemistry,” Dr. Abbosh said. “The main premise behind the MRD caller is that it can calculate intralibrary error rates to inform the MRD pool.”
Sensitivity and specificity
To validate their approach, Dr. Abbosh and colleagues tested the assay with low DNA input (5 ng, 10 ng) and high DNA input (30 ng, 60 ng). They found the assay to be more sensitive with higher DNA input, and variant fractions were detected down to 0.003%.
The researchers also assessed how sensitivity and specificity scale with an increasing number of variants – 50, 100, or 200 variants. When tracking 200 variants, the assay was powered to detect lower ctDNA fractions than when tracking 50 variants. On the other hand, specificity was higher with 50 variants (99.8%) than with 200 variants (99.4%).
Next, Dr. Abbosh and colleagues analyzed postoperative cell-free DNA collected at 271 time points from 37 NSCLC patients who did not relapse. This included 11 patients who developed proven second primary malignancies.
Of the 271 time points when MRD negativity was expected, MRD was not detected at 269 time points, which translates to 99.3% specificity for the assay.
Shedding, relapse, and disease-free survival
Dr. Abbosh and colleagues also found that non-adenocarcinoma histology is associated with preoperative ctDNA shedding in NSCLC. The researchers analyzed 88 early-stage preoperative samples from NSCLC patients. ctDNA was detected preoperatively in 49% of lung adenocarcinomas and 100% of lung squamous cell carcinomas.
“This finding is important when it comes to interpreting our non–small cell lung cancer relapse data from 53 TRACERx patients,” Dr. Abbosh said.
Of the 53 patients who relapsed, 42 had ctDNA detected prior to surgery and were thus considered shedders, while 11 were nonshedders. ctDNA was detectable at or before relapse in 91% (38/42) of shedders and 64% (7/11) of nonshedders.
The median time from ctDNA detection to clinical relapse was 164 days in shedders and 22 days in nonshedders. The median disease-free survival was 362 days and 640 days, respectively.
“So what these data suggest is that preoperative ctDNA detection status will be a proxy of the potential utility of ctDNA as an MRD biomarker in a clinical setting,” Dr. Abbosh explained.
Standard-of-care imaging findings in the 53 patients who relapsed further demonstrated the utility of ctDNA in this setting, Dr. Abbosh said.
All scans were divided into three categories: those showing unequivocal relapse, those with a new equivocal change (relapse, inflammation, or a nonspecific finding), and those with no evidence of relapse. Each was further categorized by preimaging MRD status.
Relapse occurred in 9 of 10 patients who were MRD positive but had a scan showing no evidence of relapse. Relapse occurred in 15 of 16 patients who were MRD positive and had scans showing new equivocal changes.
Patients with unequivocal evidence of relapse who were MRD negative at or before the scan were more likely to have a second primary cancer than to have NSCLC relapse (52% vs. 48%), which is a reflection of the specificity of the MRD assay to the primary tumor, Dr. Abbosh said.
Implications of the findings
The researchers’ findings are important because establishing an MRD-driven approach to treating early-stage NSCLC would facilitate escalation of standard-of-care treatment only for those patients at high risk for relapse, thereby overcoming a key challenge in conventional adjuvant drug-trial design, Dr. Abbosh said.
“If we take a patient population with high-risk early-stage disease who have undergone potentially curative resection of their cancer and we offer these patients adjuvant chemotherapy or adjuvant chemoradiation therapy, then we can improve 5-year survival outcomes in this population,” Dr. Abbosh said. “This is striking because, if we give the same treatment in the metastatic setting, we only see a progression-free survival benefit of a short number of months.”
This suggests a potential “vulnerability of low-burden residual cancer to systemic treatment following surgery,” he added. “So if we want to improve outcomes further in non–small cell lung cancer, we really need to focus on innovation in the early-stage space.”
Dr. Abbosh said he and colleagues demonstrated that “personalized cell-free DNA enrichment can detect low-frequency variant DNA in an accurate manner.
“We’ve shown that preoperative ctDNA shedding is associated with utility of ctDNA as an MRD biomarker and that MRD surveillance can lead to detection of relapse in advance of standard-of-care-imaging,” he said. “We feel that the field is now ready for MRD-driven adjuvant trials.”
Questions to be answered
Invited discussant Corey J. Langer, MD, of Penn Medicine in Philadelphia, outlined “fundamental questions” raised by the findings.
“We need more information on the staging and demographics of those who were MRD positive versus MRD negative,” he said.
Dr. Langer also asked about the findings for shedders versus nonshedders.
“Does this mean nonshedders fare better? This needs to addressed formally,” he said.
Another question is whether the assay “simply enables us to detect relapse sooner and increase anxiety,” or if the trajectory and outcomes in those who prove MRD positive ahead of radiographic manifestations can actually be altered.
A study comparing standard observation with early immunotherapy or chemoimmunotherapy in patients with MRD-positive radiographically occult relapse or progression – using progression-free and overall survival, along with time without symptoms of disease or relapse – would be useful, Dr. Langer said.
“A hazard ratio of 0.8 or less would be meaningful,” he added. “In this regard, there are trials looking at enhanced adjuvant treatment both in colorectal and breast cancer, and trials planned in advanced non–small cell [lung cancer].”
Dr. Langer also said it would be interesting to know if the assay can be used as an adjunct to diagnosis in frailer patients with inaccessible tumors or equivocal biopsy results or to avoid invasive procedures in patients who are stereotactic radiation candidates.
“The jury is still out on this,” he said.
TRACERx is funded by University College London in collaboration with Cancer Research UK. Dr. Abbosh disclosed relationships with AstraZeneca, Novartis, Roche Diagnostics, Bristol Myers Squibb, Achilles Therapeutics, and Archer Diagnostics. Dr. Langer reported grant/research support and/or scientific advisory work for multiple companies.
SOURCE: Abbosh C et al. AACR 2020, Abstract CT023.
, according to findings from the TRACERx study.
The findings pave the way for clinical trials of MRD-driven treatment escalation, Chris Abbosh, MD, of University College London, reported during a presentation at the AACR virtual meeting I. Data in the presentation were updated from the abstract.
Dr. Abbosh and colleagues used phylogenetic circulating tumor DNA (ctDNA) profiling to assess MRD and predict relapse in patients from the TRACERx study who underwent surgery for stage I-III NSCLC.
“The approach we take is technically termed a ‘tumor-informed, personalized cell-free DNA-enrichment approach,’” Dr. Abbosh explained. “We take out the primary tumor from the patient, we multiregion sample that tumor, and submit each region for deep whole-exome sequencing.”
The researchers prioritize variants for MRD tracking based on clonality/subclonality, high copy number status, and low background sequencing noise. The researchers then construct an anchored-multiplex PCR panel against the positions of interest, which is applied to cell-free DNA in the pre- and postoperative setting.
“We’ve developed an MRD caller to go alongside this chemistry,” Dr. Abbosh said. “The main premise behind the MRD caller is that it can calculate intralibrary error rates to inform the MRD pool.”
Sensitivity and specificity
To validate their approach, Dr. Abbosh and colleagues tested the assay with low DNA input (5 ng, 10 ng) and high DNA input (30 ng, 60 ng). They found the assay to be more sensitive with higher DNA input, and variant fractions were detected down to 0.003%.
The researchers also assessed how sensitivity and specificity scale with an increasing number of variants – 50, 100, or 200 variants. When tracking 200 variants, the assay was powered to detect lower ctDNA fractions than when tracking 50 variants. On the other hand, specificity was higher with 50 variants (99.8%) than with 200 variants (99.4%).
Next, Dr. Abbosh and colleagues analyzed postoperative cell-free DNA collected at 271 time points from 37 NSCLC patients who did not relapse. This included 11 patients who developed proven second primary malignancies.
Of the 271 time points when MRD negativity was expected, MRD was not detected at 269 time points, which translates to 99.3% specificity for the assay.
Shedding, relapse, and disease-free survival
Dr. Abbosh and colleagues also found that non-adenocarcinoma histology is associated with preoperative ctDNA shedding in NSCLC. The researchers analyzed 88 early-stage preoperative samples from NSCLC patients. ctDNA was detected preoperatively in 49% of lung adenocarcinomas and 100% of lung squamous cell carcinomas.
“This finding is important when it comes to interpreting our non–small cell lung cancer relapse data from 53 TRACERx patients,” Dr. Abbosh said.
Of the 53 patients who relapsed, 42 had ctDNA detected prior to surgery and were thus considered shedders, while 11 were nonshedders. ctDNA was detectable at or before relapse in 91% (38/42) of shedders and 64% (7/11) of nonshedders.
The median time from ctDNA detection to clinical relapse was 164 days in shedders and 22 days in nonshedders. The median disease-free survival was 362 days and 640 days, respectively.
“So what these data suggest is that preoperative ctDNA detection status will be a proxy of the potential utility of ctDNA as an MRD biomarker in a clinical setting,” Dr. Abbosh explained.
Standard-of-care imaging findings in the 53 patients who relapsed further demonstrated the utility of ctDNA in this setting, Dr. Abbosh said.
All scans were divided into three categories: those showing unequivocal relapse, those with a new equivocal change (relapse, inflammation, or a nonspecific finding), and those with no evidence of relapse. Each was further categorized by preimaging MRD status.
Relapse occurred in 9 of 10 patients who were MRD positive but had a scan showing no evidence of relapse. Relapse occurred in 15 of 16 patients who were MRD positive and had scans showing new equivocal changes.
Patients with unequivocal evidence of relapse who were MRD negative at or before the scan were more likely to have a second primary cancer than to have NSCLC relapse (52% vs. 48%), which is a reflection of the specificity of the MRD assay to the primary tumor, Dr. Abbosh said.
Implications of the findings
The researchers’ findings are important because establishing an MRD-driven approach to treating early-stage NSCLC would facilitate escalation of standard-of-care treatment only for those patients at high risk for relapse, thereby overcoming a key challenge in conventional adjuvant drug-trial design, Dr. Abbosh said.
“If we take a patient population with high-risk early-stage disease who have undergone potentially curative resection of their cancer and we offer these patients adjuvant chemotherapy or adjuvant chemoradiation therapy, then we can improve 5-year survival outcomes in this population,” Dr. Abbosh said. “This is striking because, if we give the same treatment in the metastatic setting, we only see a progression-free survival benefit of a short number of months.”
This suggests a potential “vulnerability of low-burden residual cancer to systemic treatment following surgery,” he added. “So if we want to improve outcomes further in non–small cell lung cancer, we really need to focus on innovation in the early-stage space.”
Dr. Abbosh said he and colleagues demonstrated that “personalized cell-free DNA enrichment can detect low-frequency variant DNA in an accurate manner.
“We’ve shown that preoperative ctDNA shedding is associated with utility of ctDNA as an MRD biomarker and that MRD surveillance can lead to detection of relapse in advance of standard-of-care-imaging,” he said. “We feel that the field is now ready for MRD-driven adjuvant trials.”
Questions to be answered
Invited discussant Corey J. Langer, MD, of Penn Medicine in Philadelphia, outlined “fundamental questions” raised by the findings.
“We need more information on the staging and demographics of those who were MRD positive versus MRD negative,” he said.
Dr. Langer also asked about the findings for shedders versus nonshedders.
“Does this mean nonshedders fare better? This needs to addressed formally,” he said.
Another question is whether the assay “simply enables us to detect relapse sooner and increase anxiety,” or if the trajectory and outcomes in those who prove MRD positive ahead of radiographic manifestations can actually be altered.
A study comparing standard observation with early immunotherapy or chemoimmunotherapy in patients with MRD-positive radiographically occult relapse or progression – using progression-free and overall survival, along with time without symptoms of disease or relapse – would be useful, Dr. Langer said.
“A hazard ratio of 0.8 or less would be meaningful,” he added. “In this regard, there are trials looking at enhanced adjuvant treatment both in colorectal and breast cancer, and trials planned in advanced non–small cell [lung cancer].”
Dr. Langer also said it would be interesting to know if the assay can be used as an adjunct to diagnosis in frailer patients with inaccessible tumors or equivocal biopsy results or to avoid invasive procedures in patients who are stereotactic radiation candidates.
“The jury is still out on this,” he said.
TRACERx is funded by University College London in collaboration with Cancer Research UK. Dr. Abbosh disclosed relationships with AstraZeneca, Novartis, Roche Diagnostics, Bristol Myers Squibb, Achilles Therapeutics, and Archer Diagnostics. Dr. Langer reported grant/research support and/or scientific advisory work for multiple companies.
SOURCE: Abbosh C et al. AACR 2020, Abstract CT023.
, according to findings from the TRACERx study.
The findings pave the way for clinical trials of MRD-driven treatment escalation, Chris Abbosh, MD, of University College London, reported during a presentation at the AACR virtual meeting I. Data in the presentation were updated from the abstract.
Dr. Abbosh and colleagues used phylogenetic circulating tumor DNA (ctDNA) profiling to assess MRD and predict relapse in patients from the TRACERx study who underwent surgery for stage I-III NSCLC.
“The approach we take is technically termed a ‘tumor-informed, personalized cell-free DNA-enrichment approach,’” Dr. Abbosh explained. “We take out the primary tumor from the patient, we multiregion sample that tumor, and submit each region for deep whole-exome sequencing.”
The researchers prioritize variants for MRD tracking based on clonality/subclonality, high copy number status, and low background sequencing noise. The researchers then construct an anchored-multiplex PCR panel against the positions of interest, which is applied to cell-free DNA in the pre- and postoperative setting.
“We’ve developed an MRD caller to go alongside this chemistry,” Dr. Abbosh said. “The main premise behind the MRD caller is that it can calculate intralibrary error rates to inform the MRD pool.”
Sensitivity and specificity
To validate their approach, Dr. Abbosh and colleagues tested the assay with low DNA input (5 ng, 10 ng) and high DNA input (30 ng, 60 ng). They found the assay to be more sensitive with higher DNA input, and variant fractions were detected down to 0.003%.
The researchers also assessed how sensitivity and specificity scale with an increasing number of variants – 50, 100, or 200 variants. When tracking 200 variants, the assay was powered to detect lower ctDNA fractions than when tracking 50 variants. On the other hand, specificity was higher with 50 variants (99.8%) than with 200 variants (99.4%).
Next, Dr. Abbosh and colleagues analyzed postoperative cell-free DNA collected at 271 time points from 37 NSCLC patients who did not relapse. This included 11 patients who developed proven second primary malignancies.
Of the 271 time points when MRD negativity was expected, MRD was not detected at 269 time points, which translates to 99.3% specificity for the assay.
Shedding, relapse, and disease-free survival
Dr. Abbosh and colleagues also found that non-adenocarcinoma histology is associated with preoperative ctDNA shedding in NSCLC. The researchers analyzed 88 early-stage preoperative samples from NSCLC patients. ctDNA was detected preoperatively in 49% of lung adenocarcinomas and 100% of lung squamous cell carcinomas.
“This finding is important when it comes to interpreting our non–small cell lung cancer relapse data from 53 TRACERx patients,” Dr. Abbosh said.
Of the 53 patients who relapsed, 42 had ctDNA detected prior to surgery and were thus considered shedders, while 11 were nonshedders. ctDNA was detectable at or before relapse in 91% (38/42) of shedders and 64% (7/11) of nonshedders.
The median time from ctDNA detection to clinical relapse was 164 days in shedders and 22 days in nonshedders. The median disease-free survival was 362 days and 640 days, respectively.
“So what these data suggest is that preoperative ctDNA detection status will be a proxy of the potential utility of ctDNA as an MRD biomarker in a clinical setting,” Dr. Abbosh explained.
Standard-of-care imaging findings in the 53 patients who relapsed further demonstrated the utility of ctDNA in this setting, Dr. Abbosh said.
All scans were divided into three categories: those showing unequivocal relapse, those with a new equivocal change (relapse, inflammation, or a nonspecific finding), and those with no evidence of relapse. Each was further categorized by preimaging MRD status.
Relapse occurred in 9 of 10 patients who were MRD positive but had a scan showing no evidence of relapse. Relapse occurred in 15 of 16 patients who were MRD positive and had scans showing new equivocal changes.
Patients with unequivocal evidence of relapse who were MRD negative at or before the scan were more likely to have a second primary cancer than to have NSCLC relapse (52% vs. 48%), which is a reflection of the specificity of the MRD assay to the primary tumor, Dr. Abbosh said.
Implications of the findings
The researchers’ findings are important because establishing an MRD-driven approach to treating early-stage NSCLC would facilitate escalation of standard-of-care treatment only for those patients at high risk for relapse, thereby overcoming a key challenge in conventional adjuvant drug-trial design, Dr. Abbosh said.
“If we take a patient population with high-risk early-stage disease who have undergone potentially curative resection of their cancer and we offer these patients adjuvant chemotherapy or adjuvant chemoradiation therapy, then we can improve 5-year survival outcomes in this population,” Dr. Abbosh said. “This is striking because, if we give the same treatment in the metastatic setting, we only see a progression-free survival benefit of a short number of months.”
This suggests a potential “vulnerability of low-burden residual cancer to systemic treatment following surgery,” he added. “So if we want to improve outcomes further in non–small cell lung cancer, we really need to focus on innovation in the early-stage space.”
Dr. Abbosh said he and colleagues demonstrated that “personalized cell-free DNA enrichment can detect low-frequency variant DNA in an accurate manner.
“We’ve shown that preoperative ctDNA shedding is associated with utility of ctDNA as an MRD biomarker and that MRD surveillance can lead to detection of relapse in advance of standard-of-care-imaging,” he said. “We feel that the field is now ready for MRD-driven adjuvant trials.”
Questions to be answered
Invited discussant Corey J. Langer, MD, of Penn Medicine in Philadelphia, outlined “fundamental questions” raised by the findings.
“We need more information on the staging and demographics of those who were MRD positive versus MRD negative,” he said.
Dr. Langer also asked about the findings for shedders versus nonshedders.
“Does this mean nonshedders fare better? This needs to addressed formally,” he said.
Another question is whether the assay “simply enables us to detect relapse sooner and increase anxiety,” or if the trajectory and outcomes in those who prove MRD positive ahead of radiographic manifestations can actually be altered.
A study comparing standard observation with early immunotherapy or chemoimmunotherapy in patients with MRD-positive radiographically occult relapse or progression – using progression-free and overall survival, along with time without symptoms of disease or relapse – would be useful, Dr. Langer said.
“A hazard ratio of 0.8 or less would be meaningful,” he added. “In this regard, there are trials looking at enhanced adjuvant treatment both in colorectal and breast cancer, and trials planned in advanced non–small cell [lung cancer].”
Dr. Langer also said it would be interesting to know if the assay can be used as an adjunct to diagnosis in frailer patients with inaccessible tumors or equivocal biopsy results or to avoid invasive procedures in patients who are stereotactic radiation candidates.
“The jury is still out on this,” he said.
TRACERx is funded by University College London in collaboration with Cancer Research UK. Dr. Abbosh disclosed relationships with AstraZeneca, Novartis, Roche Diagnostics, Bristol Myers Squibb, Achilles Therapeutics, and Archer Diagnostics. Dr. Langer reported grant/research support and/or scientific advisory work for multiple companies.
SOURCE: Abbosh C et al. AACR 2020, Abstract CT023.
FROM AACR 2020
Inhaled nitric oxide explored for COVID-19 oxygenation
The successful treatment of a patient with pulmonary arterial hypertension who contracted COVID-19 with self-administered inhaled nitrous oxide from a tankless device at home has caught the imagination of researchers investigating treatments for other patients.
It is not clear whether the team was treating the COVID or “some manifestation of her pulmonary hypertension exacerbation,” said Roham Zamanian, MD, a pulmonologist at Stanford Health in Palo Alto, California.
This is why a clinical trial is needed, he told Medscape Medical News.
“In this case, the COVID-19 respiratory infection led to a pulmonary hypertension exacerbation,” he explained. And the 34-year-old woman, who is also a physician, had demonstrated a response to nitric oxide before contracting the COVID-19 virus.
Zamanian and his colleagues describe the case in a letter published online in the American Journal of Respiratory and Critical Care. It will be discussed at the upcoming American Thoracic Society 2020 International Conference.
COVID-19 was confirmed in the patient, who had stable vasoreactive idiopathic pulmonary arterial hypertension, after she returned from a trip to Egypt. She did not want to travel the 350 miles from her home to the hospital for treatment, potentially infecting others, unless it was absolutely necessary.
“We had to make sure we were doing the right thing treating her at home, and we had to do it quickly,” Zamanian said. The patient was put on a remote routine – with vital monitoring in place – that included 6-minute walk tests twice daily and video conferencing. She also completed the EmPHasis-10 questionnaire, which is used to assess the status of patients with pulmonary hypertension.
The care team filed an Emergency Investigational New Drug application for the off-label at-home use of the tankless inhaled nitric oxide system (GENOSYL DS, VERO Biotech), which was approved by the US Food and Drug Administration. The system has so far been approved only for the treatment of newborns with persistent pulmonary hypertension.
Off-label inhaled nitric oxide has never been used in an outpatient setting. “That’s where this case is unique,” Zamanian explained.
“This case was very specific. We knew she was vasoreactive, and she knew how to use the device,” he said. “And we know nitric oxide is a quick-acting medication when it works, showing results in minutes, if not seconds.”
Within 24 hours of approval, the tankless system arrived at her home.
The patient’s therapy consisted of nitric oxide at a dose of 20 ppm plus supplemental oxygen delivered by nasal cannula at a dose of 2 L/min for 12 to 14 hours a day. After symptomatic improvement, a stepwise reduction in nitric oxide was implemented from day 13 to 17, with the dose dropping to 10 ppm, 5 ppm, and then 0 ppm.
“We quickly knew she was responding and feeling better. Without the medication, she would very likely have needed to be hospitalized,” Zamanian said.
“The real novelty of this case is demonstrating use in an outpatient system,” he pointed out. “My perspective is that this particular case was very specific, in a person who had been formally evaluated and known to be responsive to this treatment.”
The team is now preparing to launch a clinical trial of inhaled nitric oxide in COVID-19 patients without pulmonary hypertension, Zamanian reported.
Treating other patients
Nitric oxide could be useful for patients who come in with pulmonary hypertension, but “we have to test and figure that out. It could also be that patients with other underlying lung diseases could be helped with nitric oxide as well,” Zamanian said.
To treat on an outpatient basis, “we would need to make sure patients have established and reliable communications with an investigator or physician.” In addition, a protocol will have to be established that outlines how to administer the nitric oxide treatment and how to connect the nasal cannula.
“We envision patients being prescribed a certain dose and then working with either their healthcare provider or respiratory therapist to follow the standards we set,” he explained.
Although it is not a cure, nitric oxide could improve oxygenation for COIVD-19 patients in respiratory distress who have a component of abnormal pulmonary vascular function “largely driven” by ventilation perfusion – or V/Q – mismatch, he explained.
It is widely known that the gas, because it is a selective pulmonary vasodilator, can be used as rescue therapy in patients with refractory hypoxemia due to acute respiratory distress syndrome (ARDS).
“There is justification for studying it in both pulmonary hypertension and nonpulmonary hypertension patients,” Zamanian added. “The idea is that there is a component of pulmonary function and constriction with COVID-19 that may be at play here, which is not typical of regular ARDS.”
Several trials underway
In early April, an investigation into the use of high-dose nitric oxide therapy for the treatment of patients infected with SARS-CoV-2 who suffer lung complications was approved by the Therapeutic Products Directorate of Health Canada.
The NONTM – Inhaled Gaseous Nitric Oxide Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections – trial will test the use of Thiolanox, a high-concentration, 5000 ppm nitric oxide canister (Mallinckrodt Pharmaceuticals) administered with the INODD delivery device (Novoteris), at Vancouver Coastal Health Authority facilities. The open-label safety study will look at whether nitric oxide can reduce the bacterial load in the lungs of adults and adolescents.
Last week, two randomized multicenter clinical trials — also focused on the potential therapeutic benefits of nitric oxide in patients with COVID-19 in a hospital setting — were launched by teams at the Massachusetts General Hospital in Boston.
The NoCovid trial will look at nitric oxide for mild to moderate COVID-19 in 240 patients treated with a noninvasive CPAP system or a nonrebreathing mask system.
The NOSARSCOVID trial will look at the use of the INOmax (Mallinckrodt) nitric oxide inhalation system in 200 COVID-19 patients with severe acute respiratory syndrome.
“Data suggest that inhaled nitric oxide may have an important role in helping patients with acute respiratory distress syndrome (ARDS) to achieve normal oxygen levels in the blood,” Lorenzo Berra, MD, from Massachusetts General Hospital, said in a news release from Mallinckrodt announcing NOSARSCOVID.
“The trial we are conducting will help us gain critical insights into the potential effectiveness of INOmax in treating ARDS in critically ill COVID-19 patients,” Berra explains.
INOmax has already been used to treat COVID-19 patients in more than 170 hospitals in the United States, according to the news release.
Still, for COVID-19 treatment, “it’s still all hypothetical, as it hasn’t been proven,” said Alex Stenzler, founder and president of Novoteris.
We’ve demonstrated that we are able to get more oxygen to the blood and that there are some pro- and anti-inflammatory properties, “but there’s no randomized evidence, and the numbers are small,” he told Medscape Medical News.
And if there is a response or benefit, “we won’t know the reason for that benefit – if it’s anti-inflammatory, antiviral, or a vascular effect,” he pointed out.
“Nitric oxide is one of the most important signaling molecules in the human body. Our own body uses it to kill organisms and cells, heal wounds,” he explained, but “we’re a long way off from knowing” whether it can help ARDS patients.
COVID-19 Ventilation Clinical Practice Guidelines, issued by the European Society of Intensive Care Medicine and the Society of Critical Care, warn that “in patients with ARDS who are on mechanical ventilation, routine use of inhaled nitric oxide is not recommended,” as reported by Medscape.
Antimicrobial, antiviral properties
Previous studies of nitric oxide have shown that it has antiviral and antimicrobial properties.
Nitric oxide was shown to reduce H1N1 in vitro in Madin-Darby canine kidney (MDCK) epithelial cells in a 2013 study conducted by Chris Miller, PhD, from the University of British Columbia in Vancouver, and colleagues. Miller is currently involved in the NONTM trial.
This could be an added benefit of treatment. “Nitric oxide has been shown to have antiviral properties,” Zamanian said. “We need to investigate it further to see how it can help us avoid negative outcomes.”
This article first appeared on Medscape.com.
The successful treatment of a patient with pulmonary arterial hypertension who contracted COVID-19 with self-administered inhaled nitrous oxide from a tankless device at home has caught the imagination of researchers investigating treatments for other patients.
It is not clear whether the team was treating the COVID or “some manifestation of her pulmonary hypertension exacerbation,” said Roham Zamanian, MD, a pulmonologist at Stanford Health in Palo Alto, California.
This is why a clinical trial is needed, he told Medscape Medical News.
“In this case, the COVID-19 respiratory infection led to a pulmonary hypertension exacerbation,” he explained. And the 34-year-old woman, who is also a physician, had demonstrated a response to nitric oxide before contracting the COVID-19 virus.
Zamanian and his colleagues describe the case in a letter published online in the American Journal of Respiratory and Critical Care. It will be discussed at the upcoming American Thoracic Society 2020 International Conference.
COVID-19 was confirmed in the patient, who had stable vasoreactive idiopathic pulmonary arterial hypertension, after she returned from a trip to Egypt. She did not want to travel the 350 miles from her home to the hospital for treatment, potentially infecting others, unless it was absolutely necessary.
“We had to make sure we were doing the right thing treating her at home, and we had to do it quickly,” Zamanian said. The patient was put on a remote routine – with vital monitoring in place – that included 6-minute walk tests twice daily and video conferencing. She also completed the EmPHasis-10 questionnaire, which is used to assess the status of patients with pulmonary hypertension.
The care team filed an Emergency Investigational New Drug application for the off-label at-home use of the tankless inhaled nitric oxide system (GENOSYL DS, VERO Biotech), which was approved by the US Food and Drug Administration. The system has so far been approved only for the treatment of newborns with persistent pulmonary hypertension.
Off-label inhaled nitric oxide has never been used in an outpatient setting. “That’s where this case is unique,” Zamanian explained.
“This case was very specific. We knew she was vasoreactive, and she knew how to use the device,” he said. “And we know nitric oxide is a quick-acting medication when it works, showing results in minutes, if not seconds.”
Within 24 hours of approval, the tankless system arrived at her home.
The patient’s therapy consisted of nitric oxide at a dose of 20 ppm plus supplemental oxygen delivered by nasal cannula at a dose of 2 L/min for 12 to 14 hours a day. After symptomatic improvement, a stepwise reduction in nitric oxide was implemented from day 13 to 17, with the dose dropping to 10 ppm, 5 ppm, and then 0 ppm.
“We quickly knew she was responding and feeling better. Without the medication, she would very likely have needed to be hospitalized,” Zamanian said.
“The real novelty of this case is demonstrating use in an outpatient system,” he pointed out. “My perspective is that this particular case was very specific, in a person who had been formally evaluated and known to be responsive to this treatment.”
The team is now preparing to launch a clinical trial of inhaled nitric oxide in COVID-19 patients without pulmonary hypertension, Zamanian reported.
Treating other patients
Nitric oxide could be useful for patients who come in with pulmonary hypertension, but “we have to test and figure that out. It could also be that patients with other underlying lung diseases could be helped with nitric oxide as well,” Zamanian said.
To treat on an outpatient basis, “we would need to make sure patients have established and reliable communications with an investigator or physician.” In addition, a protocol will have to be established that outlines how to administer the nitric oxide treatment and how to connect the nasal cannula.
“We envision patients being prescribed a certain dose and then working with either their healthcare provider or respiratory therapist to follow the standards we set,” he explained.
Although it is not a cure, nitric oxide could improve oxygenation for COIVD-19 patients in respiratory distress who have a component of abnormal pulmonary vascular function “largely driven” by ventilation perfusion – or V/Q – mismatch, he explained.
It is widely known that the gas, because it is a selective pulmonary vasodilator, can be used as rescue therapy in patients with refractory hypoxemia due to acute respiratory distress syndrome (ARDS).
“There is justification for studying it in both pulmonary hypertension and nonpulmonary hypertension patients,” Zamanian added. “The idea is that there is a component of pulmonary function and constriction with COVID-19 that may be at play here, which is not typical of regular ARDS.”
Several trials underway
In early April, an investigation into the use of high-dose nitric oxide therapy for the treatment of patients infected with SARS-CoV-2 who suffer lung complications was approved by the Therapeutic Products Directorate of Health Canada.
The NONTM – Inhaled Gaseous Nitric Oxide Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections – trial will test the use of Thiolanox, a high-concentration, 5000 ppm nitric oxide canister (Mallinckrodt Pharmaceuticals) administered with the INODD delivery device (Novoteris), at Vancouver Coastal Health Authority facilities. The open-label safety study will look at whether nitric oxide can reduce the bacterial load in the lungs of adults and adolescents.
Last week, two randomized multicenter clinical trials — also focused on the potential therapeutic benefits of nitric oxide in patients with COVID-19 in a hospital setting — were launched by teams at the Massachusetts General Hospital in Boston.
The NoCovid trial will look at nitric oxide for mild to moderate COVID-19 in 240 patients treated with a noninvasive CPAP system or a nonrebreathing mask system.
The NOSARSCOVID trial will look at the use of the INOmax (Mallinckrodt) nitric oxide inhalation system in 200 COVID-19 patients with severe acute respiratory syndrome.
“Data suggest that inhaled nitric oxide may have an important role in helping patients with acute respiratory distress syndrome (ARDS) to achieve normal oxygen levels in the blood,” Lorenzo Berra, MD, from Massachusetts General Hospital, said in a news release from Mallinckrodt announcing NOSARSCOVID.
“The trial we are conducting will help us gain critical insights into the potential effectiveness of INOmax in treating ARDS in critically ill COVID-19 patients,” Berra explains.
INOmax has already been used to treat COVID-19 patients in more than 170 hospitals in the United States, according to the news release.
Still, for COVID-19 treatment, “it’s still all hypothetical, as it hasn’t been proven,” said Alex Stenzler, founder and president of Novoteris.
We’ve demonstrated that we are able to get more oxygen to the blood and that there are some pro- and anti-inflammatory properties, “but there’s no randomized evidence, and the numbers are small,” he told Medscape Medical News.
And if there is a response or benefit, “we won’t know the reason for that benefit – if it’s anti-inflammatory, antiviral, or a vascular effect,” he pointed out.
“Nitric oxide is one of the most important signaling molecules in the human body. Our own body uses it to kill organisms and cells, heal wounds,” he explained, but “we’re a long way off from knowing” whether it can help ARDS patients.
COVID-19 Ventilation Clinical Practice Guidelines, issued by the European Society of Intensive Care Medicine and the Society of Critical Care, warn that “in patients with ARDS who are on mechanical ventilation, routine use of inhaled nitric oxide is not recommended,” as reported by Medscape.
Antimicrobial, antiviral properties
Previous studies of nitric oxide have shown that it has antiviral and antimicrobial properties.
Nitric oxide was shown to reduce H1N1 in vitro in Madin-Darby canine kidney (MDCK) epithelial cells in a 2013 study conducted by Chris Miller, PhD, from the University of British Columbia in Vancouver, and colleagues. Miller is currently involved in the NONTM trial.
This could be an added benefit of treatment. “Nitric oxide has been shown to have antiviral properties,” Zamanian said. “We need to investigate it further to see how it can help us avoid negative outcomes.”
This article first appeared on Medscape.com.
The successful treatment of a patient with pulmonary arterial hypertension who contracted COVID-19 with self-administered inhaled nitrous oxide from a tankless device at home has caught the imagination of researchers investigating treatments for other patients.
It is not clear whether the team was treating the COVID or “some manifestation of her pulmonary hypertension exacerbation,” said Roham Zamanian, MD, a pulmonologist at Stanford Health in Palo Alto, California.
This is why a clinical trial is needed, he told Medscape Medical News.
“In this case, the COVID-19 respiratory infection led to a pulmonary hypertension exacerbation,” he explained. And the 34-year-old woman, who is also a physician, had demonstrated a response to nitric oxide before contracting the COVID-19 virus.
Zamanian and his colleagues describe the case in a letter published online in the American Journal of Respiratory and Critical Care. It will be discussed at the upcoming American Thoracic Society 2020 International Conference.
COVID-19 was confirmed in the patient, who had stable vasoreactive idiopathic pulmonary arterial hypertension, after she returned from a trip to Egypt. She did not want to travel the 350 miles from her home to the hospital for treatment, potentially infecting others, unless it was absolutely necessary.
“We had to make sure we were doing the right thing treating her at home, and we had to do it quickly,” Zamanian said. The patient was put on a remote routine – with vital monitoring in place – that included 6-minute walk tests twice daily and video conferencing. She also completed the EmPHasis-10 questionnaire, which is used to assess the status of patients with pulmonary hypertension.
The care team filed an Emergency Investigational New Drug application for the off-label at-home use of the tankless inhaled nitric oxide system (GENOSYL DS, VERO Biotech), which was approved by the US Food and Drug Administration. The system has so far been approved only for the treatment of newborns with persistent pulmonary hypertension.
Off-label inhaled nitric oxide has never been used in an outpatient setting. “That’s where this case is unique,” Zamanian explained.
“This case was very specific. We knew she was vasoreactive, and she knew how to use the device,” he said. “And we know nitric oxide is a quick-acting medication when it works, showing results in minutes, if not seconds.”
Within 24 hours of approval, the tankless system arrived at her home.
The patient’s therapy consisted of nitric oxide at a dose of 20 ppm plus supplemental oxygen delivered by nasal cannula at a dose of 2 L/min for 12 to 14 hours a day. After symptomatic improvement, a stepwise reduction in nitric oxide was implemented from day 13 to 17, with the dose dropping to 10 ppm, 5 ppm, and then 0 ppm.
“We quickly knew she was responding and feeling better. Without the medication, she would very likely have needed to be hospitalized,” Zamanian said.
“The real novelty of this case is demonstrating use in an outpatient system,” he pointed out. “My perspective is that this particular case was very specific, in a person who had been formally evaluated and known to be responsive to this treatment.”
The team is now preparing to launch a clinical trial of inhaled nitric oxide in COVID-19 patients without pulmonary hypertension, Zamanian reported.
Treating other patients
Nitric oxide could be useful for patients who come in with pulmonary hypertension, but “we have to test and figure that out. It could also be that patients with other underlying lung diseases could be helped with nitric oxide as well,” Zamanian said.
To treat on an outpatient basis, “we would need to make sure patients have established and reliable communications with an investigator or physician.” In addition, a protocol will have to be established that outlines how to administer the nitric oxide treatment and how to connect the nasal cannula.
“We envision patients being prescribed a certain dose and then working with either their healthcare provider or respiratory therapist to follow the standards we set,” he explained.
Although it is not a cure, nitric oxide could improve oxygenation for COIVD-19 patients in respiratory distress who have a component of abnormal pulmonary vascular function “largely driven” by ventilation perfusion – or V/Q – mismatch, he explained.
It is widely known that the gas, because it is a selective pulmonary vasodilator, can be used as rescue therapy in patients with refractory hypoxemia due to acute respiratory distress syndrome (ARDS).
“There is justification for studying it in both pulmonary hypertension and nonpulmonary hypertension patients,” Zamanian added. “The idea is that there is a component of pulmonary function and constriction with COVID-19 that may be at play here, which is not typical of regular ARDS.”
Several trials underway
In early April, an investigation into the use of high-dose nitric oxide therapy for the treatment of patients infected with SARS-CoV-2 who suffer lung complications was approved by the Therapeutic Products Directorate of Health Canada.
The NONTM – Inhaled Gaseous Nitric Oxide Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections – trial will test the use of Thiolanox, a high-concentration, 5000 ppm nitric oxide canister (Mallinckrodt Pharmaceuticals) administered with the INODD delivery device (Novoteris), at Vancouver Coastal Health Authority facilities. The open-label safety study will look at whether nitric oxide can reduce the bacterial load in the lungs of adults and adolescents.
Last week, two randomized multicenter clinical trials — also focused on the potential therapeutic benefits of nitric oxide in patients with COVID-19 in a hospital setting — were launched by teams at the Massachusetts General Hospital in Boston.
The NoCovid trial will look at nitric oxide for mild to moderate COVID-19 in 240 patients treated with a noninvasive CPAP system or a nonrebreathing mask system.
The NOSARSCOVID trial will look at the use of the INOmax (Mallinckrodt) nitric oxide inhalation system in 200 COVID-19 patients with severe acute respiratory syndrome.
“Data suggest that inhaled nitric oxide may have an important role in helping patients with acute respiratory distress syndrome (ARDS) to achieve normal oxygen levels in the blood,” Lorenzo Berra, MD, from Massachusetts General Hospital, said in a news release from Mallinckrodt announcing NOSARSCOVID.
“The trial we are conducting will help us gain critical insights into the potential effectiveness of INOmax in treating ARDS in critically ill COVID-19 patients,” Berra explains.
INOmax has already been used to treat COVID-19 patients in more than 170 hospitals in the United States, according to the news release.
Still, for COVID-19 treatment, “it’s still all hypothetical, as it hasn’t been proven,” said Alex Stenzler, founder and president of Novoteris.
We’ve demonstrated that we are able to get more oxygen to the blood and that there are some pro- and anti-inflammatory properties, “but there’s no randomized evidence, and the numbers are small,” he told Medscape Medical News.
And if there is a response or benefit, “we won’t know the reason for that benefit – if it’s anti-inflammatory, antiviral, or a vascular effect,” he pointed out.
“Nitric oxide is one of the most important signaling molecules in the human body. Our own body uses it to kill organisms and cells, heal wounds,” he explained, but “we’re a long way off from knowing” whether it can help ARDS patients.
COVID-19 Ventilation Clinical Practice Guidelines, issued by the European Society of Intensive Care Medicine and the Society of Critical Care, warn that “in patients with ARDS who are on mechanical ventilation, routine use of inhaled nitric oxide is not recommended,” as reported by Medscape.
Antimicrobial, antiviral properties
Previous studies of nitric oxide have shown that it has antiviral and antimicrobial properties.
Nitric oxide was shown to reduce H1N1 in vitro in Madin-Darby canine kidney (MDCK) epithelial cells in a 2013 study conducted by Chris Miller, PhD, from the University of British Columbia in Vancouver, and colleagues. Miller is currently involved in the NONTM trial.
This could be an added benefit of treatment. “Nitric oxide has been shown to have antiviral properties,” Zamanian said. “We need to investigate it further to see how it can help us avoid negative outcomes.”
This article first appeared on Medscape.com.
Advice on treating rheumatic diseases from a COVID-19 epicenter
The COVID-19 pandemic continues to pose an unprecedented challenge to health care systems worldwide. In addition to the direct impact of the disease itself, there is a growing concern related to ensuring adequate health care utilization and addressing the needs of vulnerable populations, such as those with chronic illness.
Emanuel et al. have advocated a framework of fair allocation of resources, led by the principles of equity, maximizing benefits, and prioritizing the vulnerable. In these uncertain times, patients with rheumatic diseases represent a vulnerable population whose health and wellness are particularly threatened, not only by the risk of COVID-19, but also by reduced access to usual medical care (e.g., in-person clinic visits), potential treatment interruptions (e.g., planned infusion therapies), and the ongoing shortage of hydroxychloroquine, to name a few.
As rheumatologists, we are now tasked with the development of best practices for caring for patients with rheumatic conditions in this uncertain, evolving, and nearly data-free landscape. We also must maintain an active role as advocates for our patients to help them navigate this pandemic. Herein, we discuss our approach to caring for patients with rheumatic diseases within our practice in New York City, an epicenter of the COVID-19 pandemic.
Communication with patients
Maintaining an open line of communication with our patients (by phone, patient portal, telemedicine, and so on) has become more essential than ever. It is through these communications that we best understand our patients’ concerns and provide support and personalized treatment decisions. The most common questions we have received during recent weeks are:
- Should I stop my medication to lower my risk for infection?
- Are my current symptoms caused by coronavirus, and what should I do next?
- Where can I fill my hydroxychloroquine prescription?
The American College of Rheumatology has deployed a number of task forces aimed at advocating for rheumatologists and patients with rheumatic diseases and is doing an exemplary job guiding us. For patients, several other organizations (e.g., CreakyJoints, Arthritis Foundation, Lupus Research Alliance, Vasculitis Foundation, and Scleroderma Foundation) are also providing accurate information regarding hygiene practices, social distancing, management of medications, and other guidance related to specific rheumatic diseases. In line with ACR recommendations, we encourage a personalized, shared decision-making process with each of our patients.
Patients with rheumatic disease at risk for COVID-19 infection
First, for rheumatology patients who have no COVID-19 symptoms, our management approach is individualized. For patients who are able to maintain social distancing, we have not routinely stopped immunosuppressive medications, including disease-modifying antirheumatic drugs (DMARDs) and biologic agents. However, we discuss the risks and benefits of continuing immunosuppressive therapy during this time with all of our patients.
In certain cases of stable, non–life-threatening disease, we may consider spacing or temporarily interrupting immunosuppressive therapy, using individualized, shared decision making. Yet, it is important to recognize that, for some patients, achieving adequate disease control can require a substantial amount of time.
Furthermore, it is important to acknowledge that disease flares requiring steroid therapy may increase the risk for infection even more, keeping in mind that, in some rheumatic diseases, high disease activity itself can increase infection risk. We advise patients who are continuing therapy to maintain at least a 1-month supply of their medications.
Decisions regarding infusions in the hospital and outpatient settings are similarly made on an individual basis, weighing the risk for virus exposure against that of disease flare. The more limited availability of appropriately distanced infusion chairs in some already overburdened systems must be considered in this discussion. We agree with the ACR, whose infusion guidance recommends that “possible changes might include temporary interruption of therapy, temporary initiation of a bridge therapy such as a less potent anti-inflammatory or immune-modulating agent, or temporary change to an alternative therapy.”
We also reinforce recommended behaviors for preventing infection, including social distancing, frequent handwashing, and avoiding touching one’s face.
Patients with rheumatic disease and confirmed or suspected COVID-19 infection
With the worldwide spread of COVID-19, patients with rheumatic diseases will undoubtedly be among those exposed and infected. Though current data are limited, within a cohort from China, 1% had an autoimmune disease. Testing recommendations to confirm COVID-19 and decision guidelines for outpatient versus inpatient management are evolving, and we consult the most up-to-date, local information regarding testing as individual potential cases arise.
For patients who develop COVID-19 and are currently taking DMARDs and biologics, we recommend that they discontinue these medications, with the exception of hydroxychloroquine (HCQ). HCQ may be continued because its mechanism is not expected to worsen infection, and it plays a key role in the management of patients with systemic lupus erythematosus (SLE). In addition, in vitro antiviral effects have been reported and there is growing interest for its use in the management of COVID-19. However, there are conflicting data and methodological concerns about the nonrandomized human studies that suggest a benefit of HCQ against COVID-19.
The decision regarding management of glucocorticoids in the setting of new COVID-19 infection is challenging and should be individualized. At present, expert panels recommend against the use of glucocorticoids among individuals with COVID-19 who do not have acute respiratory distress syndrome. However, adrenal insufficiency must be considered among patients with COVID-19 who are treated with chronic glucocorticoids. Again, these decisions should be made on an individual, case-by-case basis.
Implications of a hydroxychloroquine shortage
The use of HCQ in rheumatology is supported by years of research. Particularly in SLE, HCQ has been shown to reduce disease activity and damage and to improve survival. Furthermore, for pregnant patients with SLE, numerous studies have demonstrated the safety and benefit of HCQ for both the mother and fetus; thus, it is strongly recommended. By contrast, despite the growing interest for HCQ in patients with COVID-19, the evidence is inconclusive and limited.
The ACR suggests that decisions regarding HCQ dose reductions to extend individual patients supplies should be tailored to each patient’s need and risk in the unfortunate setting of medication shortages. Even in patients with stable SLE, however, disease flares at 6 months are more common among individuals who discontinue HCQ. Of note, these flares may incorporate novel and severe disease manifestations.
Unfortunately, other therapeutic options for SLE are associated with more adverse effects (including increased susceptibility to infection) or are largely unavailable (e.g., quinacrine). Thus, we strive to continue standard dosing of HCQ for patients who are currently flaring or recently flared, and we make shared, individualized decisions for those patients with stable disease as the HCQ shortage evolves.
Future research on COVID-19 and rheumatic disease
While we might expect that an underlying rheumatic disease and associated treatments may predispose individuals to developing COVID-19, current data do not indicate which, if any, rheumatic diseases and associated therapies convey the greatest risk.
To address this uncertainty, the rheumatology community created the COVID-19 Global Rheumatology Alliance, an international effort to initiate and maintain a deidentified patient registry for individuals with rheumatic disease who develop COVID-19. These efforts will allow us to gain essential insights regarding which patient demographics, underlying diseases, and medications are most common among patients who develop COVID-19.
This alliance encourages rheumatologists and those caring for patients with rheumatic diseases to report their patient cases to this registry. As we are confronted with making management decisions with a scarcity of supporting data, efforts like these will improve our ability to make individualized treatment recommendations.
The COVID-19 pandemic has presented us all with unprecedented challenges. As rheumatologists, it is our duty to lead our patients through this uncharted territory with close communication, information, advocacy, and personalized treatment decisions. Each of these is central to the management of rheumatology patients during the COVID-19 pandemic.
With the growing interest in immunomodulatory therapies for the complications of this infection, we have the unique opportunity to share our expertise, recommendations, and caution with our colleagues. As clinicians and scientists, we must advocate for data collection and studies that will allow us to develop novel, data-driven disease management approaches while providing the best care possible for our patients.
Stephen Paget, MD, is physician in chief emeritus for the Center for Rheumatology at Hospital for Special Surgery in New York. Kimberly Showalter, MD, is a third-year rheumatology fellow at Hospital for Special Surgery. Sebastian E. Sattui, MD, is a third-year rheumatology and 1-year vasculitis fellow at Hospital for Special Surgery.
A version of this article originally appeared on Medscape.com.
The COVID-19 pandemic continues to pose an unprecedented challenge to health care systems worldwide. In addition to the direct impact of the disease itself, there is a growing concern related to ensuring adequate health care utilization and addressing the needs of vulnerable populations, such as those with chronic illness.
Emanuel et al. have advocated a framework of fair allocation of resources, led by the principles of equity, maximizing benefits, and prioritizing the vulnerable. In these uncertain times, patients with rheumatic diseases represent a vulnerable population whose health and wellness are particularly threatened, not only by the risk of COVID-19, but also by reduced access to usual medical care (e.g., in-person clinic visits), potential treatment interruptions (e.g., planned infusion therapies), and the ongoing shortage of hydroxychloroquine, to name a few.
As rheumatologists, we are now tasked with the development of best practices for caring for patients with rheumatic conditions in this uncertain, evolving, and nearly data-free landscape. We also must maintain an active role as advocates for our patients to help them navigate this pandemic. Herein, we discuss our approach to caring for patients with rheumatic diseases within our practice in New York City, an epicenter of the COVID-19 pandemic.
Communication with patients
Maintaining an open line of communication with our patients (by phone, patient portal, telemedicine, and so on) has become more essential than ever. It is through these communications that we best understand our patients’ concerns and provide support and personalized treatment decisions. The most common questions we have received during recent weeks are:
- Should I stop my medication to lower my risk for infection?
- Are my current symptoms caused by coronavirus, and what should I do next?
- Where can I fill my hydroxychloroquine prescription?
The American College of Rheumatology has deployed a number of task forces aimed at advocating for rheumatologists and patients with rheumatic diseases and is doing an exemplary job guiding us. For patients, several other organizations (e.g., CreakyJoints, Arthritis Foundation, Lupus Research Alliance, Vasculitis Foundation, and Scleroderma Foundation) are also providing accurate information regarding hygiene practices, social distancing, management of medications, and other guidance related to specific rheumatic diseases. In line with ACR recommendations, we encourage a personalized, shared decision-making process with each of our patients.
Patients with rheumatic disease at risk for COVID-19 infection
First, for rheumatology patients who have no COVID-19 symptoms, our management approach is individualized. For patients who are able to maintain social distancing, we have not routinely stopped immunosuppressive medications, including disease-modifying antirheumatic drugs (DMARDs) and biologic agents. However, we discuss the risks and benefits of continuing immunosuppressive therapy during this time with all of our patients.
In certain cases of stable, non–life-threatening disease, we may consider spacing or temporarily interrupting immunosuppressive therapy, using individualized, shared decision making. Yet, it is important to recognize that, for some patients, achieving adequate disease control can require a substantial amount of time.
Furthermore, it is important to acknowledge that disease flares requiring steroid therapy may increase the risk for infection even more, keeping in mind that, in some rheumatic diseases, high disease activity itself can increase infection risk. We advise patients who are continuing therapy to maintain at least a 1-month supply of their medications.
Decisions regarding infusions in the hospital and outpatient settings are similarly made on an individual basis, weighing the risk for virus exposure against that of disease flare. The more limited availability of appropriately distanced infusion chairs in some already overburdened systems must be considered in this discussion. We agree with the ACR, whose infusion guidance recommends that “possible changes might include temporary interruption of therapy, temporary initiation of a bridge therapy such as a less potent anti-inflammatory or immune-modulating agent, or temporary change to an alternative therapy.”
We also reinforce recommended behaviors for preventing infection, including social distancing, frequent handwashing, and avoiding touching one’s face.
Patients with rheumatic disease and confirmed or suspected COVID-19 infection
With the worldwide spread of COVID-19, patients with rheumatic diseases will undoubtedly be among those exposed and infected. Though current data are limited, within a cohort from China, 1% had an autoimmune disease. Testing recommendations to confirm COVID-19 and decision guidelines for outpatient versus inpatient management are evolving, and we consult the most up-to-date, local information regarding testing as individual potential cases arise.
For patients who develop COVID-19 and are currently taking DMARDs and biologics, we recommend that they discontinue these medications, with the exception of hydroxychloroquine (HCQ). HCQ may be continued because its mechanism is not expected to worsen infection, and it plays a key role in the management of patients with systemic lupus erythematosus (SLE). In addition, in vitro antiviral effects have been reported and there is growing interest for its use in the management of COVID-19. However, there are conflicting data and methodological concerns about the nonrandomized human studies that suggest a benefit of HCQ against COVID-19.
The decision regarding management of glucocorticoids in the setting of new COVID-19 infection is challenging and should be individualized. At present, expert panels recommend against the use of glucocorticoids among individuals with COVID-19 who do not have acute respiratory distress syndrome. However, adrenal insufficiency must be considered among patients with COVID-19 who are treated with chronic glucocorticoids. Again, these decisions should be made on an individual, case-by-case basis.
Implications of a hydroxychloroquine shortage
The use of HCQ in rheumatology is supported by years of research. Particularly in SLE, HCQ has been shown to reduce disease activity and damage and to improve survival. Furthermore, for pregnant patients with SLE, numerous studies have demonstrated the safety and benefit of HCQ for both the mother and fetus; thus, it is strongly recommended. By contrast, despite the growing interest for HCQ in patients with COVID-19, the evidence is inconclusive and limited.
The ACR suggests that decisions regarding HCQ dose reductions to extend individual patients supplies should be tailored to each patient’s need and risk in the unfortunate setting of medication shortages. Even in patients with stable SLE, however, disease flares at 6 months are more common among individuals who discontinue HCQ. Of note, these flares may incorporate novel and severe disease manifestations.
Unfortunately, other therapeutic options for SLE are associated with more adverse effects (including increased susceptibility to infection) or are largely unavailable (e.g., quinacrine). Thus, we strive to continue standard dosing of HCQ for patients who are currently flaring or recently flared, and we make shared, individualized decisions for those patients with stable disease as the HCQ shortage evolves.
Future research on COVID-19 and rheumatic disease
While we might expect that an underlying rheumatic disease and associated treatments may predispose individuals to developing COVID-19, current data do not indicate which, if any, rheumatic diseases and associated therapies convey the greatest risk.
To address this uncertainty, the rheumatology community created the COVID-19 Global Rheumatology Alliance, an international effort to initiate and maintain a deidentified patient registry for individuals with rheumatic disease who develop COVID-19. These efforts will allow us to gain essential insights regarding which patient demographics, underlying diseases, and medications are most common among patients who develop COVID-19.
This alliance encourages rheumatologists and those caring for patients with rheumatic diseases to report their patient cases to this registry. As we are confronted with making management decisions with a scarcity of supporting data, efforts like these will improve our ability to make individualized treatment recommendations.
The COVID-19 pandemic has presented us all with unprecedented challenges. As rheumatologists, it is our duty to lead our patients through this uncharted territory with close communication, information, advocacy, and personalized treatment decisions. Each of these is central to the management of rheumatology patients during the COVID-19 pandemic.
With the growing interest in immunomodulatory therapies for the complications of this infection, we have the unique opportunity to share our expertise, recommendations, and caution with our colleagues. As clinicians and scientists, we must advocate for data collection and studies that will allow us to develop novel, data-driven disease management approaches while providing the best care possible for our patients.
Stephen Paget, MD, is physician in chief emeritus for the Center for Rheumatology at Hospital for Special Surgery in New York. Kimberly Showalter, MD, is a third-year rheumatology fellow at Hospital for Special Surgery. Sebastian E. Sattui, MD, is a third-year rheumatology and 1-year vasculitis fellow at Hospital for Special Surgery.
A version of this article originally appeared on Medscape.com.
The COVID-19 pandemic continues to pose an unprecedented challenge to health care systems worldwide. In addition to the direct impact of the disease itself, there is a growing concern related to ensuring adequate health care utilization and addressing the needs of vulnerable populations, such as those with chronic illness.
Emanuel et al. have advocated a framework of fair allocation of resources, led by the principles of equity, maximizing benefits, and prioritizing the vulnerable. In these uncertain times, patients with rheumatic diseases represent a vulnerable population whose health and wellness are particularly threatened, not only by the risk of COVID-19, but also by reduced access to usual medical care (e.g., in-person clinic visits), potential treatment interruptions (e.g., planned infusion therapies), and the ongoing shortage of hydroxychloroquine, to name a few.
As rheumatologists, we are now tasked with the development of best practices for caring for patients with rheumatic conditions in this uncertain, evolving, and nearly data-free landscape. We also must maintain an active role as advocates for our patients to help them navigate this pandemic. Herein, we discuss our approach to caring for patients with rheumatic diseases within our practice in New York City, an epicenter of the COVID-19 pandemic.
Communication with patients
Maintaining an open line of communication with our patients (by phone, patient portal, telemedicine, and so on) has become more essential than ever. It is through these communications that we best understand our patients’ concerns and provide support and personalized treatment decisions. The most common questions we have received during recent weeks are:
- Should I stop my medication to lower my risk for infection?
- Are my current symptoms caused by coronavirus, and what should I do next?
- Where can I fill my hydroxychloroquine prescription?
The American College of Rheumatology has deployed a number of task forces aimed at advocating for rheumatologists and patients with rheumatic diseases and is doing an exemplary job guiding us. For patients, several other organizations (e.g., CreakyJoints, Arthritis Foundation, Lupus Research Alliance, Vasculitis Foundation, and Scleroderma Foundation) are also providing accurate information regarding hygiene practices, social distancing, management of medications, and other guidance related to specific rheumatic diseases. In line with ACR recommendations, we encourage a personalized, shared decision-making process with each of our patients.
Patients with rheumatic disease at risk for COVID-19 infection
First, for rheumatology patients who have no COVID-19 symptoms, our management approach is individualized. For patients who are able to maintain social distancing, we have not routinely stopped immunosuppressive medications, including disease-modifying antirheumatic drugs (DMARDs) and biologic agents. However, we discuss the risks and benefits of continuing immunosuppressive therapy during this time with all of our patients.
In certain cases of stable, non–life-threatening disease, we may consider spacing or temporarily interrupting immunosuppressive therapy, using individualized, shared decision making. Yet, it is important to recognize that, for some patients, achieving adequate disease control can require a substantial amount of time.
Furthermore, it is important to acknowledge that disease flares requiring steroid therapy may increase the risk for infection even more, keeping in mind that, in some rheumatic diseases, high disease activity itself can increase infection risk. We advise patients who are continuing therapy to maintain at least a 1-month supply of their medications.
Decisions regarding infusions in the hospital and outpatient settings are similarly made on an individual basis, weighing the risk for virus exposure against that of disease flare. The more limited availability of appropriately distanced infusion chairs in some already overburdened systems must be considered in this discussion. We agree with the ACR, whose infusion guidance recommends that “possible changes might include temporary interruption of therapy, temporary initiation of a bridge therapy such as a less potent anti-inflammatory or immune-modulating agent, or temporary change to an alternative therapy.”
We also reinforce recommended behaviors for preventing infection, including social distancing, frequent handwashing, and avoiding touching one’s face.
Patients with rheumatic disease and confirmed or suspected COVID-19 infection
With the worldwide spread of COVID-19, patients with rheumatic diseases will undoubtedly be among those exposed and infected. Though current data are limited, within a cohort from China, 1% had an autoimmune disease. Testing recommendations to confirm COVID-19 and decision guidelines for outpatient versus inpatient management are evolving, and we consult the most up-to-date, local information regarding testing as individual potential cases arise.
For patients who develop COVID-19 and are currently taking DMARDs and biologics, we recommend that they discontinue these medications, with the exception of hydroxychloroquine (HCQ). HCQ may be continued because its mechanism is not expected to worsen infection, and it plays a key role in the management of patients with systemic lupus erythematosus (SLE). In addition, in vitro antiviral effects have been reported and there is growing interest for its use in the management of COVID-19. However, there are conflicting data and methodological concerns about the nonrandomized human studies that suggest a benefit of HCQ against COVID-19.
The decision regarding management of glucocorticoids in the setting of new COVID-19 infection is challenging and should be individualized. At present, expert panels recommend against the use of glucocorticoids among individuals with COVID-19 who do not have acute respiratory distress syndrome. However, adrenal insufficiency must be considered among patients with COVID-19 who are treated with chronic glucocorticoids. Again, these decisions should be made on an individual, case-by-case basis.
Implications of a hydroxychloroquine shortage
The use of HCQ in rheumatology is supported by years of research. Particularly in SLE, HCQ has been shown to reduce disease activity and damage and to improve survival. Furthermore, for pregnant patients with SLE, numerous studies have demonstrated the safety and benefit of HCQ for both the mother and fetus; thus, it is strongly recommended. By contrast, despite the growing interest for HCQ in patients with COVID-19, the evidence is inconclusive and limited.
The ACR suggests that decisions regarding HCQ dose reductions to extend individual patients supplies should be tailored to each patient’s need and risk in the unfortunate setting of medication shortages. Even in patients with stable SLE, however, disease flares at 6 months are more common among individuals who discontinue HCQ. Of note, these flares may incorporate novel and severe disease manifestations.
Unfortunately, other therapeutic options for SLE are associated with more adverse effects (including increased susceptibility to infection) or are largely unavailable (e.g., quinacrine). Thus, we strive to continue standard dosing of HCQ for patients who are currently flaring or recently flared, and we make shared, individualized decisions for those patients with stable disease as the HCQ shortage evolves.
Future research on COVID-19 and rheumatic disease
While we might expect that an underlying rheumatic disease and associated treatments may predispose individuals to developing COVID-19, current data do not indicate which, if any, rheumatic diseases and associated therapies convey the greatest risk.
To address this uncertainty, the rheumatology community created the COVID-19 Global Rheumatology Alliance, an international effort to initiate and maintain a deidentified patient registry for individuals with rheumatic disease who develop COVID-19. These efforts will allow us to gain essential insights regarding which patient demographics, underlying diseases, and medications are most common among patients who develop COVID-19.
This alliance encourages rheumatologists and those caring for patients with rheumatic diseases to report their patient cases to this registry. As we are confronted with making management decisions with a scarcity of supporting data, efforts like these will improve our ability to make individualized treatment recommendations.
The COVID-19 pandemic has presented us all with unprecedented challenges. As rheumatologists, it is our duty to lead our patients through this uncharted territory with close communication, information, advocacy, and personalized treatment decisions. Each of these is central to the management of rheumatology patients during the COVID-19 pandemic.
With the growing interest in immunomodulatory therapies for the complications of this infection, we have the unique opportunity to share our expertise, recommendations, and caution with our colleagues. As clinicians and scientists, we must advocate for data collection and studies that will allow us to develop novel, data-driven disease management approaches while providing the best care possible for our patients.
Stephen Paget, MD, is physician in chief emeritus for the Center for Rheumatology at Hospital for Special Surgery in New York. Kimberly Showalter, MD, is a third-year rheumatology fellow at Hospital for Special Surgery. Sebastian E. Sattui, MD, is a third-year rheumatology and 1-year vasculitis fellow at Hospital for Special Surgery.
A version of this article originally appeared on Medscape.com.
COVID fatigue is setting in
The slow-moving game of viral roulette is wearing on everyone. Eventually, we may all become fatigued and say, “well, let’s just take our chances,” the isolation being worse than the disease. I must say, however, the sight of the local funeral director loading lumber into his van at the hardware store last week made me snug up my mask a bit. We have had a surge of COVID-19 deaths in local nursing homes and I heard refrigerated space is tight. Who knows, though, maybe he just needed more shelf space in his garage.
The most exasperating thing is not knowing who has had the virus and who hasn’t, and what medicine might or might not work. My son, quartered in the sardine-tin bunks of an aircraft carrier has “it,” as do all his mates, is in total isolation except for fever checks once a day, and is having a tough time. His eagerness to receive our phone calls was sweet at first, but is now starting to worry me. Today, I received a letter from him, which I dutifully steam-microwaved for 5 minutes and am letting dry in the sun. He is asymptomatic by the way. This was not the case for one of my buddies in New York. He suffered through 10 days of shaking chills so bad he thought he had chipped his teeth, and weeks later he still has no sense of smell.
My practice has been completely disrupted, but we are open a couple of days a week. I have kept all my employees, doing busy things mostly. There will be long hours for everyone because of widely spaced appointments and a certain amount of friction with patients who miss appointments. My fellow is going to take a long trip in July. Who knows when he will have a month off again? I wonder where he plans to go.
We have rearranged the waiting room furniture, so everyone is 6 feet apart, though I am not confident this makes a difference. We all have masks, and use alcohol gel before and after patient encounters, and spritz all fixtures and handles with alcohol after encounters. I have a large exhaust fan in the lab that creates a negative pressure gradient in the office. Somehow, I don’t think it is quite the same as in the hospital.
One slick trick we’ve enacted is running an ozone generator in the office at night, which will kill all things on all surfaces and in the air. It also is probably eroding the insides of my computers, but hey, the insects and burglars hate it too.
We heard the fighter jets fly over today saluting the frontline health care workers, but did not go out and wave. I feel a little guilt about this. Treating cancer is important, but we are not in the ICU or ED immersed in virus. That is who the jets are for.
My daughter, a high school senior, is taking the loss of graduation, prom, and pomp and circumstance quite well. I am relieved I don’t have to worry about the after-prom parties. She is gearing up for college, I just hope they allow classes to start.
The future is cloudy and uncertain, despite this beautiful spring day as I write this column. Surely the way we practice medicine is going to change, and for a long while. I am thinking of taking a part-time job out of town for a year or so, and my wife is considering closing her practice altogether. If we were a few years older, there is little doubt we would just move it down the line and retire.
Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. He has no disclosures. Write to him at [email protected].
The slow-moving game of viral roulette is wearing on everyone. Eventually, we may all become fatigued and say, “well, let’s just take our chances,” the isolation being worse than the disease. I must say, however, the sight of the local funeral director loading lumber into his van at the hardware store last week made me snug up my mask a bit. We have had a surge of COVID-19 deaths in local nursing homes and I heard refrigerated space is tight. Who knows, though, maybe he just needed more shelf space in his garage.
The most exasperating thing is not knowing who has had the virus and who hasn’t, and what medicine might or might not work. My son, quartered in the sardine-tin bunks of an aircraft carrier has “it,” as do all his mates, is in total isolation except for fever checks once a day, and is having a tough time. His eagerness to receive our phone calls was sweet at first, but is now starting to worry me. Today, I received a letter from him, which I dutifully steam-microwaved for 5 minutes and am letting dry in the sun. He is asymptomatic by the way. This was not the case for one of my buddies in New York. He suffered through 10 days of shaking chills so bad he thought he had chipped his teeth, and weeks later he still has no sense of smell.
My practice has been completely disrupted, but we are open a couple of days a week. I have kept all my employees, doing busy things mostly. There will be long hours for everyone because of widely spaced appointments and a certain amount of friction with patients who miss appointments. My fellow is going to take a long trip in July. Who knows when he will have a month off again? I wonder where he plans to go.
We have rearranged the waiting room furniture, so everyone is 6 feet apart, though I am not confident this makes a difference. We all have masks, and use alcohol gel before and after patient encounters, and spritz all fixtures and handles with alcohol after encounters. I have a large exhaust fan in the lab that creates a negative pressure gradient in the office. Somehow, I don’t think it is quite the same as in the hospital.
One slick trick we’ve enacted is running an ozone generator in the office at night, which will kill all things on all surfaces and in the air. It also is probably eroding the insides of my computers, but hey, the insects and burglars hate it too.
We heard the fighter jets fly over today saluting the frontline health care workers, but did not go out and wave. I feel a little guilt about this. Treating cancer is important, but we are not in the ICU or ED immersed in virus. That is who the jets are for.
My daughter, a high school senior, is taking the loss of graduation, prom, and pomp and circumstance quite well. I am relieved I don’t have to worry about the after-prom parties. She is gearing up for college, I just hope they allow classes to start.
The future is cloudy and uncertain, despite this beautiful spring day as I write this column. Surely the way we practice medicine is going to change, and for a long while. I am thinking of taking a part-time job out of town for a year or so, and my wife is considering closing her practice altogether. If we were a few years older, there is little doubt we would just move it down the line and retire.
Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. He has no disclosures. Write to him at [email protected].
The slow-moving game of viral roulette is wearing on everyone. Eventually, we may all become fatigued and say, “well, let’s just take our chances,” the isolation being worse than the disease. I must say, however, the sight of the local funeral director loading lumber into his van at the hardware store last week made me snug up my mask a bit. We have had a surge of COVID-19 deaths in local nursing homes and I heard refrigerated space is tight. Who knows, though, maybe he just needed more shelf space in his garage.
The most exasperating thing is not knowing who has had the virus and who hasn’t, and what medicine might or might not work. My son, quartered in the sardine-tin bunks of an aircraft carrier has “it,” as do all his mates, is in total isolation except for fever checks once a day, and is having a tough time. His eagerness to receive our phone calls was sweet at first, but is now starting to worry me. Today, I received a letter from him, which I dutifully steam-microwaved for 5 minutes and am letting dry in the sun. He is asymptomatic by the way. This was not the case for one of my buddies in New York. He suffered through 10 days of shaking chills so bad he thought he had chipped his teeth, and weeks later he still has no sense of smell.
My practice has been completely disrupted, but we are open a couple of days a week. I have kept all my employees, doing busy things mostly. There will be long hours for everyone because of widely spaced appointments and a certain amount of friction with patients who miss appointments. My fellow is going to take a long trip in July. Who knows when he will have a month off again? I wonder where he plans to go.
We have rearranged the waiting room furniture, so everyone is 6 feet apart, though I am not confident this makes a difference. We all have masks, and use alcohol gel before and after patient encounters, and spritz all fixtures and handles with alcohol after encounters. I have a large exhaust fan in the lab that creates a negative pressure gradient in the office. Somehow, I don’t think it is quite the same as in the hospital.
One slick trick we’ve enacted is running an ozone generator in the office at night, which will kill all things on all surfaces and in the air. It also is probably eroding the insides of my computers, but hey, the insects and burglars hate it too.
We heard the fighter jets fly over today saluting the frontline health care workers, but did not go out and wave. I feel a little guilt about this. Treating cancer is important, but we are not in the ICU or ED immersed in virus. That is who the jets are for.
My daughter, a high school senior, is taking the loss of graduation, prom, and pomp and circumstance quite well. I am relieved I don’t have to worry about the after-prom parties. She is gearing up for college, I just hope they allow classes to start.
The future is cloudy and uncertain, despite this beautiful spring day as I write this column. Surely the way we practice medicine is going to change, and for a long while. I am thinking of taking a part-time job out of town for a year or so, and my wife is considering closing her practice altogether. If we were a few years older, there is little doubt we would just move it down the line and retire.
Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. He has no disclosures. Write to him at [email protected].
A surge in PTSD may be the ‘new normal’
The prolonged and unique stresses imparted by the COVID-19 pandemic has many predicting a significant rise in mental health issues in the weeks, months, and years ahead.
To understand how health care workers can best get ahead of this emerging crisis within a crisis, Medscape Psychiatry editorial director Bret Stetka, MD, spoke with Sheila Rauch, PhD, who’s with the Department of Psychiatry and Behavioral Sciences at the Emory University, Atlanta. The director of Mental Health Research and Program Evaluation at the Atlanta VA Medical Center, Dr. Rauch has studied the effects of and best treatments for posttraumatic stress disorder (PTSD) and anxiety disorders over the past 20 years.
Are we going to see a PTSD or anxiety epidemic as a result of the pandemic?
First, I think it’s really important that we prepare for the worst but hope for the best. But I would expect that, given the high levels of stress, the impact on resources, and other factors, we are going to see a pretty significant mental health impact over time. This could be the new normal for a while. Some of that will be PTSD, but there will also be other things. I would suspect that the resulting increase in rates of depression, traumatic grief, and loss is probably going to be a significant issue for years to come.
What will the anxiety we see as a result of COVID-19 look like compared with that seen in past disasters, like 9/11?
Most disasters in recent history, like 9/11, are single incidents. Something horrible happened, it impacted people at different levels, and we were able to start putting the pieces back together right away. The prolonged nature of this pandemic makes it even more variable given that the impact is going to be extended over time.
We’re also going to see a lot more people with compound impact – people who’ve lost their jobs, loved ones, maybe even their homes. All of those financial and resource losses put people in a higher risk category for negative mental health outcomes.
Is this analogous to the prolonged trauma that can occur with military service during war?
There is some similarity there. Combat is kind of an overarching context in which people experience trauma and, much like this pandemic, may or may not have traumatic exposures during it.
We’re asking health care workers to actually be in a role similar to what we ask of our military: going into danger, sometimes even without proper protective equipment, in order to save the lives of others. That’s also something we need to be factoring in as we plan to support those people and their families.
This is an ongoing incident, but is there a time window we need to be particularly worried about for seeing spikes in anxiety and PTSD?
I think we’re going to see variability on that. PTSD is a disorder that’s related to a specific incident or a couple of incidents that are similar. It’s a memory that’s haunting you.
For instance, typically if you have a combat veteran who has PTSD, they’ve been exposed to the overarching context of combat but then they have specific memories that are stuck. If they don’t have PTSD about 3-6 months after those incidents happen, then we would expect that they will not develop it, or it’s much less common that they would.
Depression has a very different course. It’s more prolonged and tends to grow with time.
Are you already seeing increased symptoms in your patients?
This is pretty similar to what we see in combat veterans. They’ll often be unhappy with the leadership decisions that were made as they were being deployed.
We’re also seeing lots more anger, sadness, and isolation now. Especially over the past couple of weeks, we’ve seen a rise in things like people reaching out for help in our intakes because we’re still open and doing phone assessments and telehealth with veterans and the veterans program.
In terms of interventions for this, what should psychiatrists, psychologists, and other clinicians be thinking about?
Right now, the best thing that we can do as mental health providers for people affected by the trauma is provide crisis intervention for those saying they are a danger to themselves and others. That means providing coping strategies and support. It also means making sure people are taking breaks and taking care of themselves, taking that little bit of time off so that they can go back, fully recharged, to their jobs and really stay there.
As we move forward, it will be clearer whether people are going to naturally recover, which most people will. For those who are going to have ongoing problems with time, we need to be getting ready as a system and as a country for those long-term mental health issues that are going to be coming up. And when I say long-term, it means the next 1-3 months. We want to be providing preventive interventions, versions of prolonged exposure, and other things that have shown some help in preventing PTSD. Psychological first aid is helpful.
There’s also an app called COVID Coach that the National Center for PTSD has created. That features a lot of positive coping resources together in one source.
Then when we get to the middle of that point and beyond it, we need to be ready to provide those evidence-based interventions for PTSD, depression, panic disorder, and other issues that are going to come out of this current situation.
But we were already short-staffed as far as mental health resources in general across the country, and especially in rural areas. So that means finding ways to efficiently use what we have through potentially briefer versions of interventions, through primary care, mental health, and other staff.
In what ways can primary care providers help?
There are versions of prolonged exposure therapy for primary care. That’s one of my big areas of research – increasing access. That would be something that we need to be building, by training and embedding mental health providers in primary care settings so that they can help to accommodate the increased need for access that’s going to be showing up for the next, I would suspect, several years with the pandemic.
Is there evidence that a prior episode of PTSD or traumatic experience like combat influences a subsequent reaction to a trauma like this?
It depends on how they manage. Research suggests that veterans or other people who have experienced trauma and naturally recovered, or who have gotten good treatment and remitted from that issue, are probably at no higher risk. But people who have subsyndromal PTSD or depression, or who are still experiencing symptoms from a history of trauma exposure, are maybe at a higher risk of having problems over time.
Do you have any guidance for healthcare providers on how to approach the pandemic with their patients, and also on how they can look after their own mental health?
In talking to patients, make sure that they have what they need. Ask if they’ve thought through how they’re going to cope if things get harder for them.
For people who have preexisting mental health issues, I’m talking with them about whether things have gotten worse. If they’re at high risk for suicide, I’m checking in to make sure that they’ve got new plans and ways to connect with people to reduce isolation, keeping in mind the social distancing that we’re asked to engage in so that they can do that safely.
It’s important to check and see if they have had any losses, whether it’s a financial loss or a personal loss of people that they care about. Also have them think through ways to stay entertained, which tends to help manage their own anxiety.
Every coping strategy we outline for patients also applies to mental health professionals. However, you would add to it the real need to take time to recharge, to take breaks, time off. It can feel overwhelming and like you need to just keep going. But the more that you get stuck in that mode of overdoing it, the less effective you’re going to be in helping people and also the more likely that you’ll be at risk of perhaps being one of the people that needs help.
It’s also important to make sure you’re staying connected with family and friends virtually, in whatever ways you can safely do that with social distancing.
So take a break to watch some Netflix now and then?
Yes!
A version of this article originally appeared on Medscape.com.
The prolonged and unique stresses imparted by the COVID-19 pandemic has many predicting a significant rise in mental health issues in the weeks, months, and years ahead.
To understand how health care workers can best get ahead of this emerging crisis within a crisis, Medscape Psychiatry editorial director Bret Stetka, MD, spoke with Sheila Rauch, PhD, who’s with the Department of Psychiatry and Behavioral Sciences at the Emory University, Atlanta. The director of Mental Health Research and Program Evaluation at the Atlanta VA Medical Center, Dr. Rauch has studied the effects of and best treatments for posttraumatic stress disorder (PTSD) and anxiety disorders over the past 20 years.
Are we going to see a PTSD or anxiety epidemic as a result of the pandemic?
First, I think it’s really important that we prepare for the worst but hope for the best. But I would expect that, given the high levels of stress, the impact on resources, and other factors, we are going to see a pretty significant mental health impact over time. This could be the new normal for a while. Some of that will be PTSD, but there will also be other things. I would suspect that the resulting increase in rates of depression, traumatic grief, and loss is probably going to be a significant issue for years to come.
What will the anxiety we see as a result of COVID-19 look like compared with that seen in past disasters, like 9/11?
Most disasters in recent history, like 9/11, are single incidents. Something horrible happened, it impacted people at different levels, and we were able to start putting the pieces back together right away. The prolonged nature of this pandemic makes it even more variable given that the impact is going to be extended over time.
We’re also going to see a lot more people with compound impact – people who’ve lost their jobs, loved ones, maybe even their homes. All of those financial and resource losses put people in a higher risk category for negative mental health outcomes.
Is this analogous to the prolonged trauma that can occur with military service during war?
There is some similarity there. Combat is kind of an overarching context in which people experience trauma and, much like this pandemic, may or may not have traumatic exposures during it.
We’re asking health care workers to actually be in a role similar to what we ask of our military: going into danger, sometimes even without proper protective equipment, in order to save the lives of others. That’s also something we need to be factoring in as we plan to support those people and their families.
This is an ongoing incident, but is there a time window we need to be particularly worried about for seeing spikes in anxiety and PTSD?
I think we’re going to see variability on that. PTSD is a disorder that’s related to a specific incident or a couple of incidents that are similar. It’s a memory that’s haunting you.
For instance, typically if you have a combat veteran who has PTSD, they’ve been exposed to the overarching context of combat but then they have specific memories that are stuck. If they don’t have PTSD about 3-6 months after those incidents happen, then we would expect that they will not develop it, or it’s much less common that they would.
Depression has a very different course. It’s more prolonged and tends to grow with time.
Are you already seeing increased symptoms in your patients?
This is pretty similar to what we see in combat veterans. They’ll often be unhappy with the leadership decisions that were made as they were being deployed.
We’re also seeing lots more anger, sadness, and isolation now. Especially over the past couple of weeks, we’ve seen a rise in things like people reaching out for help in our intakes because we’re still open and doing phone assessments and telehealth with veterans and the veterans program.
In terms of interventions for this, what should psychiatrists, psychologists, and other clinicians be thinking about?
Right now, the best thing that we can do as mental health providers for people affected by the trauma is provide crisis intervention for those saying they are a danger to themselves and others. That means providing coping strategies and support. It also means making sure people are taking breaks and taking care of themselves, taking that little bit of time off so that they can go back, fully recharged, to their jobs and really stay there.
As we move forward, it will be clearer whether people are going to naturally recover, which most people will. For those who are going to have ongoing problems with time, we need to be getting ready as a system and as a country for those long-term mental health issues that are going to be coming up. And when I say long-term, it means the next 1-3 months. We want to be providing preventive interventions, versions of prolonged exposure, and other things that have shown some help in preventing PTSD. Psychological first aid is helpful.
There’s also an app called COVID Coach that the National Center for PTSD has created. That features a lot of positive coping resources together in one source.
Then when we get to the middle of that point and beyond it, we need to be ready to provide those evidence-based interventions for PTSD, depression, panic disorder, and other issues that are going to come out of this current situation.
But we were already short-staffed as far as mental health resources in general across the country, and especially in rural areas. So that means finding ways to efficiently use what we have through potentially briefer versions of interventions, through primary care, mental health, and other staff.
In what ways can primary care providers help?
There are versions of prolonged exposure therapy for primary care. That’s one of my big areas of research – increasing access. That would be something that we need to be building, by training and embedding mental health providers in primary care settings so that they can help to accommodate the increased need for access that’s going to be showing up for the next, I would suspect, several years with the pandemic.
Is there evidence that a prior episode of PTSD or traumatic experience like combat influences a subsequent reaction to a trauma like this?
It depends on how they manage. Research suggests that veterans or other people who have experienced trauma and naturally recovered, or who have gotten good treatment and remitted from that issue, are probably at no higher risk. But people who have subsyndromal PTSD or depression, or who are still experiencing symptoms from a history of trauma exposure, are maybe at a higher risk of having problems over time.
Do you have any guidance for healthcare providers on how to approach the pandemic with their patients, and also on how they can look after their own mental health?
In talking to patients, make sure that they have what they need. Ask if they’ve thought through how they’re going to cope if things get harder for them.
For people who have preexisting mental health issues, I’m talking with them about whether things have gotten worse. If they’re at high risk for suicide, I’m checking in to make sure that they’ve got new plans and ways to connect with people to reduce isolation, keeping in mind the social distancing that we’re asked to engage in so that they can do that safely.
It’s important to check and see if they have had any losses, whether it’s a financial loss or a personal loss of people that they care about. Also have them think through ways to stay entertained, which tends to help manage their own anxiety.
Every coping strategy we outline for patients also applies to mental health professionals. However, you would add to it the real need to take time to recharge, to take breaks, time off. It can feel overwhelming and like you need to just keep going. But the more that you get stuck in that mode of overdoing it, the less effective you’re going to be in helping people and also the more likely that you’ll be at risk of perhaps being one of the people that needs help.
It’s also important to make sure you’re staying connected with family and friends virtually, in whatever ways you can safely do that with social distancing.
So take a break to watch some Netflix now and then?
Yes!
A version of this article originally appeared on Medscape.com.
The prolonged and unique stresses imparted by the COVID-19 pandemic has many predicting a significant rise in mental health issues in the weeks, months, and years ahead.
To understand how health care workers can best get ahead of this emerging crisis within a crisis, Medscape Psychiatry editorial director Bret Stetka, MD, spoke with Sheila Rauch, PhD, who’s with the Department of Psychiatry and Behavioral Sciences at the Emory University, Atlanta. The director of Mental Health Research and Program Evaluation at the Atlanta VA Medical Center, Dr. Rauch has studied the effects of and best treatments for posttraumatic stress disorder (PTSD) and anxiety disorders over the past 20 years.
Are we going to see a PTSD or anxiety epidemic as a result of the pandemic?
First, I think it’s really important that we prepare for the worst but hope for the best. But I would expect that, given the high levels of stress, the impact on resources, and other factors, we are going to see a pretty significant mental health impact over time. This could be the new normal for a while. Some of that will be PTSD, but there will also be other things. I would suspect that the resulting increase in rates of depression, traumatic grief, and loss is probably going to be a significant issue for years to come.
What will the anxiety we see as a result of COVID-19 look like compared with that seen in past disasters, like 9/11?
Most disasters in recent history, like 9/11, are single incidents. Something horrible happened, it impacted people at different levels, and we were able to start putting the pieces back together right away. The prolonged nature of this pandemic makes it even more variable given that the impact is going to be extended over time.
We’re also going to see a lot more people with compound impact – people who’ve lost their jobs, loved ones, maybe even their homes. All of those financial and resource losses put people in a higher risk category for negative mental health outcomes.
Is this analogous to the prolonged trauma that can occur with military service during war?
There is some similarity there. Combat is kind of an overarching context in which people experience trauma and, much like this pandemic, may or may not have traumatic exposures during it.
We’re asking health care workers to actually be in a role similar to what we ask of our military: going into danger, sometimes even without proper protective equipment, in order to save the lives of others. That’s also something we need to be factoring in as we plan to support those people and their families.
This is an ongoing incident, but is there a time window we need to be particularly worried about for seeing spikes in anxiety and PTSD?
I think we’re going to see variability on that. PTSD is a disorder that’s related to a specific incident or a couple of incidents that are similar. It’s a memory that’s haunting you.
For instance, typically if you have a combat veteran who has PTSD, they’ve been exposed to the overarching context of combat but then they have specific memories that are stuck. If they don’t have PTSD about 3-6 months after those incidents happen, then we would expect that they will not develop it, or it’s much less common that they would.
Depression has a very different course. It’s more prolonged and tends to grow with time.
Are you already seeing increased symptoms in your patients?
This is pretty similar to what we see in combat veterans. They’ll often be unhappy with the leadership decisions that were made as they were being deployed.
We’re also seeing lots more anger, sadness, and isolation now. Especially over the past couple of weeks, we’ve seen a rise in things like people reaching out for help in our intakes because we’re still open and doing phone assessments and telehealth with veterans and the veterans program.
In terms of interventions for this, what should psychiatrists, psychologists, and other clinicians be thinking about?
Right now, the best thing that we can do as mental health providers for people affected by the trauma is provide crisis intervention for those saying they are a danger to themselves and others. That means providing coping strategies and support. It also means making sure people are taking breaks and taking care of themselves, taking that little bit of time off so that they can go back, fully recharged, to their jobs and really stay there.
As we move forward, it will be clearer whether people are going to naturally recover, which most people will. For those who are going to have ongoing problems with time, we need to be getting ready as a system and as a country for those long-term mental health issues that are going to be coming up. And when I say long-term, it means the next 1-3 months. We want to be providing preventive interventions, versions of prolonged exposure, and other things that have shown some help in preventing PTSD. Psychological first aid is helpful.
There’s also an app called COVID Coach that the National Center for PTSD has created. That features a lot of positive coping resources together in one source.
Then when we get to the middle of that point and beyond it, we need to be ready to provide those evidence-based interventions for PTSD, depression, panic disorder, and other issues that are going to come out of this current situation.
But we were already short-staffed as far as mental health resources in general across the country, and especially in rural areas. So that means finding ways to efficiently use what we have through potentially briefer versions of interventions, through primary care, mental health, and other staff.
In what ways can primary care providers help?
There are versions of prolonged exposure therapy for primary care. That’s one of my big areas of research – increasing access. That would be something that we need to be building, by training and embedding mental health providers in primary care settings so that they can help to accommodate the increased need for access that’s going to be showing up for the next, I would suspect, several years with the pandemic.
Is there evidence that a prior episode of PTSD or traumatic experience like combat influences a subsequent reaction to a trauma like this?
It depends on how they manage. Research suggests that veterans or other people who have experienced trauma and naturally recovered, or who have gotten good treatment and remitted from that issue, are probably at no higher risk. But people who have subsyndromal PTSD or depression, or who are still experiencing symptoms from a history of trauma exposure, are maybe at a higher risk of having problems over time.
Do you have any guidance for healthcare providers on how to approach the pandemic with their patients, and also on how they can look after their own mental health?
In talking to patients, make sure that they have what they need. Ask if they’ve thought through how they’re going to cope if things get harder for them.
For people who have preexisting mental health issues, I’m talking with them about whether things have gotten worse. If they’re at high risk for suicide, I’m checking in to make sure that they’ve got new plans and ways to connect with people to reduce isolation, keeping in mind the social distancing that we’re asked to engage in so that they can do that safely.
It’s important to check and see if they have had any losses, whether it’s a financial loss or a personal loss of people that they care about. Also have them think through ways to stay entertained, which tends to help manage their own anxiety.
Every coping strategy we outline for patients also applies to mental health professionals. However, you would add to it the real need to take time to recharge, to take breaks, time off. It can feel overwhelming and like you need to just keep going. But the more that you get stuck in that mode of overdoing it, the less effective you’re going to be in helping people and also the more likely that you’ll be at risk of perhaps being one of the people that needs help.
It’s also important to make sure you’re staying connected with family and friends virtually, in whatever ways you can safely do that with social distancing.
So take a break to watch some Netflix now and then?
Yes!
A version of this article originally appeared on Medscape.com.
Modify risk factors to manage ICU delirium in patients with COVID-19
Several factors can contribute to an increased risk of ICU delirium in COVID-19 patients, wrote Katarzyna Kotfis, MD, of Pomeranian Medical University, Szczecin, Poland, and colleagues.
“In patients with COVID-19, delirium may be a manifestation of direct central nervous system invasion, induction of CNS inflammatory mediators, a secondary effect of other organ system failure, an effect of sedative strategies, prolonged mechanical ventilation time, or environmental factors, including social isolation,” they said.
Delirium in the context of COVID-19 can mean an early sign of infection, so patients should be screened using dedicated psychometric tools, the researchers wrote. Also, COVID-19 has been shown to cause pneumonia in elderly patients, who are at high risk for severe pulmonary disease related to COVID-19 and for ICU delirium generally, they said.
In addition, don’t underestimate the impact of social isolation created by quarantines, the researchers said.
“What is needed now, is not only high-quality ICU care, concentrated on providing adequate respiratory support to critically ill patients, but an identification of the source and degree of mental and spiritual suffering of patients as well as their families to provide the most ethical and person-centered care during this humanitarian crisis,” they emphasized. However, they acknowledged that nonpharmacologic interventions such as mobility outside the ICU room and interactions with family members are limited by the COVID-19 situation.
The researchers noted several mechanisms by which the COVID-19 virus may cause brain damage, including through the dysfunction of the renin-angiotensin system.
“Inflammatory response of the CNS to viral infection seems to be another important reason for poor neurological outcome and occurrence of delirium,” in COVID-19 patients, they said.
As for risk-reduction strategies, the researchers noted that “delirium in mechanically ventilated patients can be reduced dramatically to 50% using a culture of lighter sedation and mobilization via the implementation of the safety bundle called the ABCDEFs promoted by the Society of Critical Care Medicine in their ICU Liberation Collaborative,” although COVID-19 isolation is a barrier, they said.
The ABCDEF bundle consists of Assessment of pain, Both spontaneous awakening trials and spontaneous breathing trials, Choice of sedation, Delirium (hyperactive or hypoactive), Early mobility, and Family presence; all of which are challenging in the COVID-19 environment, the researchers said.
They advised implementing easy screening methods for delirium to reduce the burden on medical staff, and emphasized the importance of regular patient orientation, despite social separation from family and caregivers.
“No drugs can be recommended for the prevention or treatment of ICU delirium other than avoidance of overuse of potent psychoactive agents like sedatives and neuromuscular blockers (NMB) unless patients absolutely require such management,” they added.
“Delirium is so common and so hard to manage in the COVID-19 population,” Mangala Narasimhan, DO, of Northwell Health in New Hyde Park, N.Y., said in an interview. Delirium is impacted by many sources including a viral encephalopathy, the amount and duration of sedation medications, and prolonged intubation and hypoxemia, she said. “Managing the delirium allows you to wake the patient up successfully and without a lot of discoordination. This will help with weaning,” she noted. Barriers to delirium management for COVID-19 patients include the length of time on a ventilator, as well as amount of sedatives and paralytics, and the added issues of renal insufficiency, she noted. “How they can be addressed is thoughtful plans on the addition of long-term sedation for withdrawal symptoms, and anxiolytics for the profound anxiety associated with arousal from this type of sedation on ventilators, she said. The take-home message for clinicians is the need to perform weaning trials to manage delirium in the ICU. “We have to combat this delirium in order to be successful in taking these patients off of ventilators,” she said. Dr. Narasimhan added that more research is needed on areas including drug-to-drug interactions, duration of efficacy of various drugs, and how the virus affects the brain.
“Adherence to the ABCDEF bundle can reduce the incidence of delirium, from approximately 75% of mechanically ventilated patients to 50% or less,” David L. Bowton, MD, of Wake Forest Baptist Health in Winston-Salem, N.C., said in an interview.
“Importantly, in most studies, bundle adherence reduces mortality and ICU length of stay and lowers the total cost of care. However, isolation of patients and protection of staff, visitor restrictions, and potentially stressed staffing will likely alter how most institutions approach bundle compliance,” he said. “Gathering input from infection control clinicians and bedside providers from multiple disciplines that consider these factors to critically examine current bundle procedures and workflow will be essential to the creation and/or revision of bundle processes of care that maintain the integrity of the ABCDEF bundle yet preserve staff, patient, and family safety,” he said.
“We did not have strong evidence to suggest an optimal approach to treating delirium before the advent of the COVID-19 pandemic, so I do not believe we know what the best approach is in the current environment,” Dr. Bowton added. “Further, vigilance will be necessary to ensure that altered consciousness or cognition is ICU delirium and not attributable to another cause such as drug withdrawal, drug adverse effect, or primary central nervous system infection or immune response that mandates specific therapy,” he emphasized.
For clinicians, “this study reminds us of the importance of the ABCDEF bundle to improve outcomes of critical illness,” said Dr. Bowton. “It highlights the difficulties of providing frequent reassessment of pain, comfort, reassurance, and reorientation to critically ill patients. To me, it underscores the importance of each institution critically examining staffing needs and staffing roles to mitigate these difficulties and to explore novel methods of maintaining staff-patient and family-patient interactions to enhance compliance with all elements of the ABCDEF bundle while maintaining the safety of staff and families.”
Dr. Bowton added, “When necessary, explicit modifications to existing ABCDEF bundles should be developed and disseminated to provide realistic, readily understood guidance to achieve the best possible compliance with each bundle element. One potentially underrecognized issue will be the large, hopefully temporary, number of people requiring post–critical illness rehabilitation and mental health services,” he said. “In many regions these services are already underfunded and ill-equipped to handle an increased demand for these services,” he noted.
Additional research is needed in many areas, said Dr. Bowton. “While compliance with the ABCDEF bundle decreases the incidence and duration of delirium, decreases ICU length of stay, decreases duration of mechanical ventilation, and improves mortality, many questions remain. Individual elements of the bundle have been inconsistently associated with improved outcomes,” he said. “What is the relative importance of specific elements and what are the mechanisms by which they improve outcomes?” he asked. “We still do not know how to best achieve physical/functional recovery following critical illness, which, in light of these authors’ studies relating persisting physical debility to depression (Lancet Respir Med. 2014; 2[5]:369-79), may be a key component to improving long-term outcomes,” he said.
The study received no specific funding, although several coauthors disclosed grants from agencies including the National Center for Advancing Translational Sciences, National Institute of General Medical Sciences, National Heart, Lung, and Blood Institute, and National Institute on Aging. Dr. Narasimhan and Dr. Bowton had no financial conflicts to disclose.
SOURCE: Kotfis K et al. Critical Care. 2020 Apr 28. doi: 10.1186/s13054-020-02882-x.
Several factors can contribute to an increased risk of ICU delirium in COVID-19 patients, wrote Katarzyna Kotfis, MD, of Pomeranian Medical University, Szczecin, Poland, and colleagues.
“In patients with COVID-19, delirium may be a manifestation of direct central nervous system invasion, induction of CNS inflammatory mediators, a secondary effect of other organ system failure, an effect of sedative strategies, prolonged mechanical ventilation time, or environmental factors, including social isolation,” they said.
Delirium in the context of COVID-19 can mean an early sign of infection, so patients should be screened using dedicated psychometric tools, the researchers wrote. Also, COVID-19 has been shown to cause pneumonia in elderly patients, who are at high risk for severe pulmonary disease related to COVID-19 and for ICU delirium generally, they said.
In addition, don’t underestimate the impact of social isolation created by quarantines, the researchers said.
“What is needed now, is not only high-quality ICU care, concentrated on providing adequate respiratory support to critically ill patients, but an identification of the source and degree of mental and spiritual suffering of patients as well as their families to provide the most ethical and person-centered care during this humanitarian crisis,” they emphasized. However, they acknowledged that nonpharmacologic interventions such as mobility outside the ICU room and interactions with family members are limited by the COVID-19 situation.
The researchers noted several mechanisms by which the COVID-19 virus may cause brain damage, including through the dysfunction of the renin-angiotensin system.
“Inflammatory response of the CNS to viral infection seems to be another important reason for poor neurological outcome and occurrence of delirium,” in COVID-19 patients, they said.
As for risk-reduction strategies, the researchers noted that “delirium in mechanically ventilated patients can be reduced dramatically to 50% using a culture of lighter sedation and mobilization via the implementation of the safety bundle called the ABCDEFs promoted by the Society of Critical Care Medicine in their ICU Liberation Collaborative,” although COVID-19 isolation is a barrier, they said.
The ABCDEF bundle consists of Assessment of pain, Both spontaneous awakening trials and spontaneous breathing trials, Choice of sedation, Delirium (hyperactive or hypoactive), Early mobility, and Family presence; all of which are challenging in the COVID-19 environment, the researchers said.
They advised implementing easy screening methods for delirium to reduce the burden on medical staff, and emphasized the importance of regular patient orientation, despite social separation from family and caregivers.
“No drugs can be recommended for the prevention or treatment of ICU delirium other than avoidance of overuse of potent psychoactive agents like sedatives and neuromuscular blockers (NMB) unless patients absolutely require such management,” they added.
“Delirium is so common and so hard to manage in the COVID-19 population,” Mangala Narasimhan, DO, of Northwell Health in New Hyde Park, N.Y., said in an interview. Delirium is impacted by many sources including a viral encephalopathy, the amount and duration of sedation medications, and prolonged intubation and hypoxemia, she said. “Managing the delirium allows you to wake the patient up successfully and without a lot of discoordination. This will help with weaning,” she noted. Barriers to delirium management for COVID-19 patients include the length of time on a ventilator, as well as amount of sedatives and paralytics, and the added issues of renal insufficiency, she noted. “How they can be addressed is thoughtful plans on the addition of long-term sedation for withdrawal symptoms, and anxiolytics for the profound anxiety associated with arousal from this type of sedation on ventilators, she said. The take-home message for clinicians is the need to perform weaning trials to manage delirium in the ICU. “We have to combat this delirium in order to be successful in taking these patients off of ventilators,” she said. Dr. Narasimhan added that more research is needed on areas including drug-to-drug interactions, duration of efficacy of various drugs, and how the virus affects the brain.
“Adherence to the ABCDEF bundle can reduce the incidence of delirium, from approximately 75% of mechanically ventilated patients to 50% or less,” David L. Bowton, MD, of Wake Forest Baptist Health in Winston-Salem, N.C., said in an interview.
“Importantly, in most studies, bundle adherence reduces mortality and ICU length of stay and lowers the total cost of care. However, isolation of patients and protection of staff, visitor restrictions, and potentially stressed staffing will likely alter how most institutions approach bundle compliance,” he said. “Gathering input from infection control clinicians and bedside providers from multiple disciplines that consider these factors to critically examine current bundle procedures and workflow will be essential to the creation and/or revision of bundle processes of care that maintain the integrity of the ABCDEF bundle yet preserve staff, patient, and family safety,” he said.
“We did not have strong evidence to suggest an optimal approach to treating delirium before the advent of the COVID-19 pandemic, so I do not believe we know what the best approach is in the current environment,” Dr. Bowton added. “Further, vigilance will be necessary to ensure that altered consciousness or cognition is ICU delirium and not attributable to another cause such as drug withdrawal, drug adverse effect, or primary central nervous system infection or immune response that mandates specific therapy,” he emphasized.
For clinicians, “this study reminds us of the importance of the ABCDEF bundle to improve outcomes of critical illness,” said Dr. Bowton. “It highlights the difficulties of providing frequent reassessment of pain, comfort, reassurance, and reorientation to critically ill patients. To me, it underscores the importance of each institution critically examining staffing needs and staffing roles to mitigate these difficulties and to explore novel methods of maintaining staff-patient and family-patient interactions to enhance compliance with all elements of the ABCDEF bundle while maintaining the safety of staff and families.”
Dr. Bowton added, “When necessary, explicit modifications to existing ABCDEF bundles should be developed and disseminated to provide realistic, readily understood guidance to achieve the best possible compliance with each bundle element. One potentially underrecognized issue will be the large, hopefully temporary, number of people requiring post–critical illness rehabilitation and mental health services,” he said. “In many regions these services are already underfunded and ill-equipped to handle an increased demand for these services,” he noted.
Additional research is needed in many areas, said Dr. Bowton. “While compliance with the ABCDEF bundle decreases the incidence and duration of delirium, decreases ICU length of stay, decreases duration of mechanical ventilation, and improves mortality, many questions remain. Individual elements of the bundle have been inconsistently associated with improved outcomes,” he said. “What is the relative importance of specific elements and what are the mechanisms by which they improve outcomes?” he asked. “We still do not know how to best achieve physical/functional recovery following critical illness, which, in light of these authors’ studies relating persisting physical debility to depression (Lancet Respir Med. 2014; 2[5]:369-79), may be a key component to improving long-term outcomes,” he said.
The study received no specific funding, although several coauthors disclosed grants from agencies including the National Center for Advancing Translational Sciences, National Institute of General Medical Sciences, National Heart, Lung, and Blood Institute, and National Institute on Aging. Dr. Narasimhan and Dr. Bowton had no financial conflicts to disclose.
SOURCE: Kotfis K et al. Critical Care. 2020 Apr 28. doi: 10.1186/s13054-020-02882-x.
Several factors can contribute to an increased risk of ICU delirium in COVID-19 patients, wrote Katarzyna Kotfis, MD, of Pomeranian Medical University, Szczecin, Poland, and colleagues.
“In patients with COVID-19, delirium may be a manifestation of direct central nervous system invasion, induction of CNS inflammatory mediators, a secondary effect of other organ system failure, an effect of sedative strategies, prolonged mechanical ventilation time, or environmental factors, including social isolation,” they said.
Delirium in the context of COVID-19 can mean an early sign of infection, so patients should be screened using dedicated psychometric tools, the researchers wrote. Also, COVID-19 has been shown to cause pneumonia in elderly patients, who are at high risk for severe pulmonary disease related to COVID-19 and for ICU delirium generally, they said.
In addition, don’t underestimate the impact of social isolation created by quarantines, the researchers said.
“What is needed now, is not only high-quality ICU care, concentrated on providing adequate respiratory support to critically ill patients, but an identification of the source and degree of mental and spiritual suffering of patients as well as their families to provide the most ethical and person-centered care during this humanitarian crisis,” they emphasized. However, they acknowledged that nonpharmacologic interventions such as mobility outside the ICU room and interactions with family members are limited by the COVID-19 situation.
The researchers noted several mechanisms by which the COVID-19 virus may cause brain damage, including through the dysfunction of the renin-angiotensin system.
“Inflammatory response of the CNS to viral infection seems to be another important reason for poor neurological outcome and occurrence of delirium,” in COVID-19 patients, they said.
As for risk-reduction strategies, the researchers noted that “delirium in mechanically ventilated patients can be reduced dramatically to 50% using a culture of lighter sedation and mobilization via the implementation of the safety bundle called the ABCDEFs promoted by the Society of Critical Care Medicine in their ICU Liberation Collaborative,” although COVID-19 isolation is a barrier, they said.
The ABCDEF bundle consists of Assessment of pain, Both spontaneous awakening trials and spontaneous breathing trials, Choice of sedation, Delirium (hyperactive or hypoactive), Early mobility, and Family presence; all of which are challenging in the COVID-19 environment, the researchers said.
They advised implementing easy screening methods for delirium to reduce the burden on medical staff, and emphasized the importance of regular patient orientation, despite social separation from family and caregivers.
“No drugs can be recommended for the prevention or treatment of ICU delirium other than avoidance of overuse of potent psychoactive agents like sedatives and neuromuscular blockers (NMB) unless patients absolutely require such management,” they added.
“Delirium is so common and so hard to manage in the COVID-19 population,” Mangala Narasimhan, DO, of Northwell Health in New Hyde Park, N.Y., said in an interview. Delirium is impacted by many sources including a viral encephalopathy, the amount and duration of sedation medications, and prolonged intubation and hypoxemia, she said. “Managing the delirium allows you to wake the patient up successfully and without a lot of discoordination. This will help with weaning,” she noted. Barriers to delirium management for COVID-19 patients include the length of time on a ventilator, as well as amount of sedatives and paralytics, and the added issues of renal insufficiency, she noted. “How they can be addressed is thoughtful plans on the addition of long-term sedation for withdrawal symptoms, and anxiolytics for the profound anxiety associated with arousal from this type of sedation on ventilators, she said. The take-home message for clinicians is the need to perform weaning trials to manage delirium in the ICU. “We have to combat this delirium in order to be successful in taking these patients off of ventilators,” she said. Dr. Narasimhan added that more research is needed on areas including drug-to-drug interactions, duration of efficacy of various drugs, and how the virus affects the brain.
“Adherence to the ABCDEF bundle can reduce the incidence of delirium, from approximately 75% of mechanically ventilated patients to 50% or less,” David L. Bowton, MD, of Wake Forest Baptist Health in Winston-Salem, N.C., said in an interview.
“Importantly, in most studies, bundle adherence reduces mortality and ICU length of stay and lowers the total cost of care. However, isolation of patients and protection of staff, visitor restrictions, and potentially stressed staffing will likely alter how most institutions approach bundle compliance,” he said. “Gathering input from infection control clinicians and bedside providers from multiple disciplines that consider these factors to critically examine current bundle procedures and workflow will be essential to the creation and/or revision of bundle processes of care that maintain the integrity of the ABCDEF bundle yet preserve staff, patient, and family safety,” he said.
“We did not have strong evidence to suggest an optimal approach to treating delirium before the advent of the COVID-19 pandemic, so I do not believe we know what the best approach is in the current environment,” Dr. Bowton added. “Further, vigilance will be necessary to ensure that altered consciousness or cognition is ICU delirium and not attributable to another cause such as drug withdrawal, drug adverse effect, or primary central nervous system infection or immune response that mandates specific therapy,” he emphasized.
For clinicians, “this study reminds us of the importance of the ABCDEF bundle to improve outcomes of critical illness,” said Dr. Bowton. “It highlights the difficulties of providing frequent reassessment of pain, comfort, reassurance, and reorientation to critically ill patients. To me, it underscores the importance of each institution critically examining staffing needs and staffing roles to mitigate these difficulties and to explore novel methods of maintaining staff-patient and family-patient interactions to enhance compliance with all elements of the ABCDEF bundle while maintaining the safety of staff and families.”
Dr. Bowton added, “When necessary, explicit modifications to existing ABCDEF bundles should be developed and disseminated to provide realistic, readily understood guidance to achieve the best possible compliance with each bundle element. One potentially underrecognized issue will be the large, hopefully temporary, number of people requiring post–critical illness rehabilitation and mental health services,” he said. “In many regions these services are already underfunded and ill-equipped to handle an increased demand for these services,” he noted.
Additional research is needed in many areas, said Dr. Bowton. “While compliance with the ABCDEF bundle decreases the incidence and duration of delirium, decreases ICU length of stay, decreases duration of mechanical ventilation, and improves mortality, many questions remain. Individual elements of the bundle have been inconsistently associated with improved outcomes,” he said. “What is the relative importance of specific elements and what are the mechanisms by which they improve outcomes?” he asked. “We still do not know how to best achieve physical/functional recovery following critical illness, which, in light of these authors’ studies relating persisting physical debility to depression (Lancet Respir Med. 2014; 2[5]:369-79), may be a key component to improving long-term outcomes,” he said.
The study received no specific funding, although several coauthors disclosed grants from agencies including the National Center for Advancing Translational Sciences, National Institute of General Medical Sciences, National Heart, Lung, and Blood Institute, and National Institute on Aging. Dr. Narasimhan and Dr. Bowton had no financial conflicts to disclose.
SOURCE: Kotfis K et al. Critical Care. 2020 Apr 28. doi: 10.1186/s13054-020-02882-x.
FROM CRITICAL CARE