Covid ICYMI

Hospitalists nationwide have put in longer hours, played new clinical roles, and stretched beyond their medical specialty and comfort level to meet their hospital’s COVID-19 care demands. Can they expect some kind of financial recognition – perhaps in the form of “hazard pay” for going above and beyond – even though their institutions are experiencing negative financial fallout from the crisis?

Hospitals in regions experiencing a COVID-19 surge have limited elective procedures, discouraged non–COVID-19 admissions, and essentially entered crisis management mode. Other facilities in less hard-hit communities are also standing by, with reduced hospital census, smaller caseloads and less work to do, while trying to prepare their bottom lines for lower demand.

“This crisis has put most hospitals in financial jeopardy and that is likely to trickle down to all employees – including hospitalists,” said Ron Greeno, MD, FCCP, MHM, a past president of SHM and the society’s current senior advisor for government affairs. “But it’s not like hospitals could or would forgo an effective hospitalist program today. Hospitalists will be important players in defining the hospital’s future direction post crisis.”

That doesn’t mean tighter financials, caps on annual salary increases, or higher productivity expectations won’t be part of future conversations between hospital administrators and their hospitalists, Dr. Greeno said. Administrators are starting to look ahead to the post–COVID-19 era even as numbers of cases and rates of growth continue to rise in various regions, and Dr. Greeno sees a lot of uncertainty ahead.

Even prior to the crisis, he noted, hospital margins had been falling, while the cost of labor, including hospitalist labor, was going up. That was pointing toward an inevitable collision, which has only intensified with the new financial crisis facing hospitals – created by SARS-CoV-2 and by policies such as shutting down elective surgeries in anticipation of a COVID-19 patient surge that, for some institutions, may never come.

Brian Harte, MD, MHM, president of Cleveland Clinic Akron General and a past president of SHM, said that the Cleveland Clinic system has been planning since January its response to the coming crisis. “Governor Mike DeWine and the state Department of Health led the way in flattening the curve in Ohio. We engaged our hospitalists in brainstorming solutions. They have been excellent partners,” he said.

Approaching the crisis with a sense of urgency from the outset, the Cleveland Clinic built a COVID-19 surge team and incident command structure, with nursing, infectious diseases, critical care and hospital medicine represented. “We used that time to get ready for what was coming. We worked on streamlining consultant work flows.”

But utilization numbers are off in almost every service line, Dr. Harte said. “It has forced us to look at things we’ve always talked about, including greater use of telemedicine and exploring other ways of caring for patients, such as increased use of evening hours.”

Cleveland Clinic contracts with Sound Physicians of Tacoma, Wash., for its hospitalist coverage. “We have an excellent working relationship with Sound at the local, regional, and national levels, with common goals for quality and utilization. We tried to involve our hospitalists as early as possible in planning. We needed them to step in and role model and lead the way,” Dr. Harte said, for everybody’s anxiety levels.

“We’re still in the process of understanding the long-term financial impact of the epidemic,” Dr. Harte added. “But at this point I see no reason to think our relationship with our hospitalists needs to change. We’re the stewards of long-term finances. We’ll need to keep a close eye on this. But we’re committed to working through this together.”

Hazard pay for frontline health care workers was included in the COVID-19 relief package assembled in mid-May by Democrats in the House of Representatives. The $3 trillion HEROES Act includes $200 billion to award hazard pay to essential workers, including those in the health field, but Senate Majority Leader Mitch McConnell (R-Ky.) declared the legislation “dead on arrival” in the Senate.

Supplementary hazard payments made by hospitals to their hospitalists as a reward for sacrifices they made in the crisis is an interesting question, Dr. Greeno noted, and it’s definitely on the table at some hospitals. “But I think it is going to be a tough ask in these times.”

Dr. Harte said he has not offered nor been asked about hazard pay for hospitalists. Cleveland Clinic Akron General made a strategic decision that hazard pay was not going to be part of its response to the pandemic. Other hospital administrators interviewed for this article concur.

Hospitals respond to the fiscal crisis

Hospitals in other parts of the country also report significant fiscal fallout from the COVID-19 crisis, with predictions that 100 or more hospitals may be forced to close. Jeff Dye, president of the New Mexico Hospital Association, told the Albuquerque Journal on May 1 that hospitals in his state have been squeezed on all sides by increased costs, patients delaying routine care, and public health orders restricting elective surgeries. New Mexico hospitals, especially in rural areas, face incredible financial strain.

The University of Virginia Medical Center, Charlottesville, recently announced 20% reductions in total compensation for its providers through July 31, along with suspension of retirement contributions. Those changes won’t affect team members caring for COVID-19 patients. And the Spectrum Health Medical Group of 15 hospitals in western Michigan, according to Michigan Public Radio, told its doctors they either needed to sign “contract addendums” giving the system more control over their hours – or face a 25% pay cut, or worse.

Cheyenne (Wyo.) Regional Medical Center issued a statement April 24 that it expected losses of $10 million for the month of April. “CRMC, like every other hospital in Wyoming, is certainly feeling the financial impact that COVID-19 is having,” CEO Tim Thornell told the Cowboy State Daily on April 24. That includes a 30% reduction in inpatient care and 50% reduction in outpatient care, while the hospital has only had a handful of COVID-19 patients at any time. Capital projects are now on hold, overtime is limited, and a hiring freeze is in effect.

“We’re certainly prepared for a larger surge, which hasn’t come yet,” Mr. Thornell said in an interview. CRMC’s ICU was split to create a nine-bed dedicated COVID-19 unit. Intensivists see most of the critical care patients, while the hospital’s 15 directly-employed hospitalists are treating all of the non-ICU COVID-19 patients. “Among themselves, the hospitalists volunteered who would work on the unit. We’ve been fortunate enough to have enough volunteers and enough PPE [personal protective equipment],” he said.

Preparing for the COVID-19 pandemic has strengthened the medical center’s relationship with its hospitalists, Mr. Thornell explained. “Hospitalists are key to our operations, involved in so much that happens here. We’re trying to staff to volume with decreased utilization. We’ve scaled back, which only makes fiscal sense. Now, how do we reinfuse patients back into the mix? Our hospitalists are paid by the number of shifts, and as you distribute shift reductions over 15 providers, it shouldn’t be an intolerable burden.” But two open hospitalist positions have not been filled, he noted.

CRMC is trying to approach these changes with a Lean perspective, Mr. Thornell said. “We had already adopted a Lean program, but this has been a chance to go through a life-altering circumstance using the tools of Lean planning and applying them instantaneously.”
 

Providers step up

At Emory Healthcare in Atlanta, a major center for COVID-19 cases, communication has been essential in the crisis, said Bryce Gartland, MD, SFHM, Emory’s hospital group president and cochief of clinical operations. “Our group was prepared for a significant influx of patients. Like every other institution, we made the decision to postpone elective care, with a resulting plummet in volume,” he said.

As COVID-19 patients entered the Emory system, frontline hospitalists stepped up to care for those patients. “We’ve had ample providers in terms of clinical care. We guaranteed our physicians’ base compensation. They have flexed teams up and down as needed.” Advanced practice professionals also stepped up to bridge gaps.

With regard to the return of volumes of non–COVID-19 patients, the jury’s still out, Dr. Gartland said. “None of us has a crystal ball, and there are tremendous variables and decision points that will have significant impact. We have started to see numbers of time-sensitive and essential cases increase as of the first week of May.”

What lies ahead will likely include some rightsizing to future volumes. On top of that, the broader economic pressures on hospitals from high rates of unemployment, uninsured patients, bad debt, and charity care will push health care systems to significantly address costs and infrastructure, he said. “We’re still early in planning, and striving to maintain flexibility and nimbleness, given the uncertainties to this early understanding of our new normal. No hospital is immune from the financial impact. We’ll see and hear about more of these conversations in the months ahead.”

But the experience has also generated some positives, Dr. Gartland noted. “Things like telehealth, which we’ve been talking about for years but previously faced barriers to widespread adoption.” Now with COVID-19, the federal government issued waivers, and barriers – both internal and external – came down. “With telehealth, what will the role and deployment of hospitalists look like in this new model? How will traditional productivity expectations change, or the numbers and types of providers? This will make the relationship and partnership between hospitalist groups and hospital administrators ever more important as we consider the evolution toward new care models.”

Dr. Gartland said that “one of the great things about hospital medicine as a field is its flexibility and adaptability. Where there have been gaps, hospitalists were quick to step in. As long as hospital medicine continues to embrace those kinds of behaviors, it will be successful.” But if the conversation with hospitals is just about money, it will be harder, he acknowledged. “Where there is this kind of disruption in our usual way of doing things, there are also tremendous opportunities for care model innovation. I would encourage hospitalist groups to try to be true value partners.”

Command center mode

Like other physicians in hospital C-suites, Chad Whelan MD, FACP, SFHM, chief executive officer of Banner–University Medicine in Tucson, Ariz., led his two hospitals into command center mode when the crisis hit, planning for a surge of COVID-19 cases that could overwhelm hospital capacity.

“In terms of our hospitalists, we leaned in to them hard in the beginning, preparing them to supervise other physicians who came in to help if needed,” he said. “Our [non–COVID-19] census is down, revenues are down, and the implications are enormous – like nothing we’ve ever seen before.”

“We’re fortunate that we’re part of the Banner health system. We made a decision that we would essentially keep our physicians financially protected through this crisis,” Dr. Whelan said. “In return, we called on them to step up and be on the front lines and to put in enormous hours for planning. We asked them to consider: How could you contribute if the surge comes?”

He affirmed that hospital medicine has been a major part of his medical center’s planning and implementation. “I’ve been overwhelmed by the degree to which the entire delivery team has rallied around the pandemic, with everybody saying they want to keep people safe and be part of the solution. We have always had hospitalist leaders at the table as we’ve planned our response and as decisions were made,” said Dr. Whelan, a practicing hospitalist and teaching service attending since 2000 until he assumed his current executive position in Arizona 18 months ago.

“While we have kept people whole during the immediate crisis, we have acknowledged that we don’t know what our recovery will look like. What if [non–COVID-19] volume doesn’t return? That keeps me awake at night,” he said. “I have talked to our physician leadership in hospital medicine and more broadly. We need to ask ourselves many questions, including: do we have the right levels of staffing? Is this the time to consider alternate models of staffing, for example, advanced practice providers? And does the compensation plan need adjustments?”

Dr. Whelan thinks that the COVID-19 crisis is an opportunity for hospital medicine to more rapidly explore different models and to ask what additional value hospitalists can bring to the care model. “For example, what would it mean to redefine the hospitalist’s scope of practice as an acute medicine specialist, not defined by the hospital’s four walls?” he noted.

“One of the reasons our smaller hospital reached capacity with COVID-19 patients was the skilled nursing facility located a few hundred feet away that turned into a hot spot. If we had imported the hospital medicine model virtually into that SNF early on, could there have been a different scenario? Have we thought through what that would have even looked like?” Dr. Whelan asked.

He challenges the hospital medicine field, once it gets to the other side of this crisis, to not fall back on old way of doing things. “Instead, let’s use this time to create a better model today,” he said. “That’s what we’re trying to do at a system level at Banner, with our hospital medicine groups partnering with the hospital. I want to see our hospitalists create and thrive in that new model.”

Hospitalists nationwide have put in longer hours, played new clinical roles, and stretched beyond their medical specialty and comfort level to meet their hospital’s COVID-19 care demands. Can they expect some kind of financial recognition – perhaps in the form of “hazard pay” for going above and beyond – even though their institutions are experiencing negative financial fallout from the crisis?

Hospitals in regions experiencing a COVID-19 surge have limited elective procedures, discouraged non–COVID-19 admissions, and essentially entered crisis management mode. Other facilities in less hard-hit communities are also standing by, with reduced hospital census, smaller caseloads and less work to do, while trying to prepare their bottom lines for lower demand.

“This crisis has put most hospitals in financial jeopardy and that is likely to trickle down to all employees – including hospitalists,” said Ron Greeno, MD, FCCP, MHM, a past president of SHM and the society’s current senior advisor for government affairs. “But it’s not like hospitals could or would forgo an effective hospitalist program today. Hospitalists will be important players in defining the hospital’s future direction post crisis.”

That doesn’t mean tighter financials, caps on annual salary increases, or higher productivity expectations won’t be part of future conversations between hospital administrators and their hospitalists, Dr. Greeno said. Administrators are starting to look ahead to the post–COVID-19 era even as numbers of cases and rates of growth continue to rise in various regions, and Dr. Greeno sees a lot of uncertainty ahead.

Even prior to the crisis, he noted, hospital margins had been falling, while the cost of labor, including hospitalist labor, was going up. That was pointing toward an inevitable collision, which has only intensified with the new financial crisis facing hospitals – created by SARS-CoV-2 and by policies such as shutting down elective surgeries in anticipation of a COVID-19 patient surge that, for some institutions, may never come.

Brian Harte, MD, MHM, president of Cleveland Clinic Akron General and a past president of SHM, said that the Cleveland Clinic system has been planning since January its response to the coming crisis. “Governor Mike DeWine and the state Department of Health led the way in flattening the curve in Ohio. We engaged our hospitalists in brainstorming solutions. They have been excellent partners,” he said.

Approaching the crisis with a sense of urgency from the outset, the Cleveland Clinic built a COVID-19 surge team and incident command structure, with nursing, infectious diseases, critical care and hospital medicine represented. “We used that time to get ready for what was coming. We worked on streamlining consultant work flows.”

But utilization numbers are off in almost every service line, Dr. Harte said. “It has forced us to look at things we’ve always talked about, including greater use of telemedicine and exploring other ways of caring for patients, such as increased use of evening hours.”

Cleveland Clinic contracts with Sound Physicians of Tacoma, Wash., for its hospitalist coverage. “We have an excellent working relationship with Sound at the local, regional, and national levels, with common goals for quality and utilization. We tried to involve our hospitalists as early as possible in planning. We needed them to step in and role model and lead the way,” Dr. Harte said, for everybody’s anxiety levels.

“We’re still in the process of understanding the long-term financial impact of the epidemic,” Dr. Harte added. “But at this point I see no reason to think our relationship with our hospitalists needs to change. We’re the stewards of long-term finances. We’ll need to keep a close eye on this. But we’re committed to working through this together.”

Hazard pay for frontline health care workers was included in the COVID-19 relief package assembled in mid-May by Democrats in the House of Representatives. The $3 trillion HEROES Act includes $200 billion to award hazard pay to essential workers, including those in the health field, but Senate Majority Leader Mitch McConnell (R-Ky.) declared the legislation “dead on arrival” in the Senate.

Supplementary hazard payments made by hospitals to their hospitalists as a reward for sacrifices they made in the crisis is an interesting question, Dr. Greeno noted, and it’s definitely on the table at some hospitals. “But I think it is going to be a tough ask in these times.”

Dr. Harte said he has not offered nor been asked about hazard pay for hospitalists. Cleveland Clinic Akron General made a strategic decision that hazard pay was not going to be part of its response to the pandemic. Other hospital administrators interviewed for this article concur.

Hospitals respond to the fiscal crisis

Hospitals in other parts of the country also report significant fiscal fallout from the COVID-19 crisis, with predictions that 100 or more hospitals may be forced to close. Jeff Dye, president of the New Mexico Hospital Association, told the Albuquerque Journal on May 1 that hospitals in his state have been squeezed on all sides by increased costs, patients delaying routine care, and public health orders restricting elective surgeries. New Mexico hospitals, especially in rural areas, face incredible financial strain.

The University of Virginia Medical Center, Charlottesville, recently announced 20% reductions in total compensation for its providers through July 31, along with suspension of retirement contributions. Those changes won’t affect team members caring for COVID-19 patients. And the Spectrum Health Medical Group of 15 hospitals in western Michigan, according to Michigan Public Radio, told its doctors they either needed to sign “contract addendums” giving the system more control over their hours – or face a 25% pay cut, or worse.

Cheyenne (Wyo.) Regional Medical Center issued a statement April 24 that it expected losses of $10 million for the month of April. “CRMC, like every other hospital in Wyoming, is certainly feeling the financial impact that COVID-19 is having,” CEO Tim Thornell told the Cowboy State Daily on April 24. That includes a 30% reduction in inpatient care and 50% reduction in outpatient care, while the hospital has only had a handful of COVID-19 patients at any time. Capital projects are now on hold, overtime is limited, and a hiring freeze is in effect.

“We’re certainly prepared for a larger surge, which hasn’t come yet,” Mr. Thornell said in an interview. CRMC’s ICU was split to create a nine-bed dedicated COVID-19 unit. Intensivists see most of the critical care patients, while the hospital’s 15 directly-employed hospitalists are treating all of the non-ICU COVID-19 patients. “Among themselves, the hospitalists volunteered who would work on the unit. We’ve been fortunate enough to have enough volunteers and enough PPE [personal protective equipment],” he said.

Preparing for the COVID-19 pandemic has strengthened the medical center’s relationship with its hospitalists, Mr. Thornell explained. “Hospitalists are key to our operations, involved in so much that happens here. We’re trying to staff to volume with decreased utilization. We’ve scaled back, which only makes fiscal sense. Now, how do we reinfuse patients back into the mix? Our hospitalists are paid by the number of shifts, and as you distribute shift reductions over 15 providers, it shouldn’t be an intolerable burden.” But two open hospitalist positions have not been filled, he noted.

CRMC is trying to approach these changes with a Lean perspective, Mr. Thornell said. “We had already adopted a Lean program, but this has been a chance to go through a life-altering circumstance using the tools of Lean planning and applying them instantaneously.”
 

Providers step up

At Emory Healthcare in Atlanta, a major center for COVID-19 cases, communication has been essential in the crisis, said Bryce Gartland, MD, SFHM, Emory’s hospital group president and cochief of clinical operations. “Our group was prepared for a significant influx of patients. Like every other institution, we made the decision to postpone elective care, with a resulting plummet in volume,” he said.

As COVID-19 patients entered the Emory system, frontline hospitalists stepped up to care for those patients. “We’ve had ample providers in terms of clinical care. We guaranteed our physicians’ base compensation. They have flexed teams up and down as needed.” Advanced practice professionals also stepped up to bridge gaps.

With regard to the return of volumes of non–COVID-19 patients, the jury’s still out, Dr. Gartland said. “None of us has a crystal ball, and there are tremendous variables and decision points that will have significant impact. We have started to see numbers of time-sensitive and essential cases increase as of the first week of May.”

What lies ahead will likely include some rightsizing to future volumes. On top of that, the broader economic pressures on hospitals from high rates of unemployment, uninsured patients, bad debt, and charity care will push health care systems to significantly address costs and infrastructure, he said. “We’re still early in planning, and striving to maintain flexibility and nimbleness, given the uncertainties to this early understanding of our new normal. No hospital is immune from the financial impact. We’ll see and hear about more of these conversations in the months ahead.”

But the experience has also generated some positives, Dr. Gartland noted. “Things like telehealth, which we’ve been talking about for years but previously faced barriers to widespread adoption.” Now with COVID-19, the federal government issued waivers, and barriers – both internal and external – came down. “With telehealth, what will the role and deployment of hospitalists look like in this new model? How will traditional productivity expectations change, or the numbers and types of providers? This will make the relationship and partnership between hospitalist groups and hospital administrators ever more important as we consider the evolution toward new care models.”

Dr. Gartland said that “one of the great things about hospital medicine as a field is its flexibility and adaptability. Where there have been gaps, hospitalists were quick to step in. As long as hospital medicine continues to embrace those kinds of behaviors, it will be successful.” But if the conversation with hospitals is just about money, it will be harder, he acknowledged. “Where there is this kind of disruption in our usual way of doing things, there are also tremendous opportunities for care model innovation. I would encourage hospitalist groups to try to be true value partners.”

Command center mode

Like other physicians in hospital C-suites, Chad Whelan MD, FACP, SFHM, chief executive officer of Banner–University Medicine in Tucson, Ariz., led his two hospitals into command center mode when the crisis hit, planning for a surge of COVID-19 cases that could overwhelm hospital capacity.

“In terms of our hospitalists, we leaned in to them hard in the beginning, preparing them to supervise other physicians who came in to help if needed,” he said. “Our [non–COVID-19] census is down, revenues are down, and the implications are enormous – like nothing we’ve ever seen before.”

“We’re fortunate that we’re part of the Banner health system. We made a decision that we would essentially keep our physicians financially protected through this crisis,” Dr. Whelan said. “In return, we called on them to step up and be on the front lines and to put in enormous hours for planning. We asked them to consider: How could you contribute if the surge comes?”

He affirmed that hospital medicine has been a major part of his medical center’s planning and implementation. “I’ve been overwhelmed by the degree to which the entire delivery team has rallied around the pandemic, with everybody saying they want to keep people safe and be part of the solution. We have always had hospitalist leaders at the table as we’ve planned our response and as decisions were made,” said Dr. Whelan, a practicing hospitalist and teaching service attending since 2000 until he assumed his current executive position in Arizona 18 months ago.

“While we have kept people whole during the immediate crisis, we have acknowledged that we don’t know what our recovery will look like. What if [non–COVID-19] volume doesn’t return? That keeps me awake at night,” he said. “I have talked to our physician leadership in hospital medicine and more broadly. We need to ask ourselves many questions, including: do we have the right levels of staffing? Is this the time to consider alternate models of staffing, for example, advanced practice providers? And does the compensation plan need adjustments?”

Dr. Whelan thinks that the COVID-19 crisis is an opportunity for hospital medicine to more rapidly explore different models and to ask what additional value hospitalists can bring to the care model. “For example, what would it mean to redefine the hospitalist’s scope of practice as an acute medicine specialist, not defined by the hospital’s four walls?” he noted.

“One of the reasons our smaller hospital reached capacity with COVID-19 patients was the skilled nursing facility located a few hundred feet away that turned into a hot spot. If we had imported the hospital medicine model virtually into that SNF early on, could there have been a different scenario? Have we thought through what that would have even looked like?” Dr. Whelan asked.

He challenges the hospital medicine field, once it gets to the other side of this crisis, to not fall back on old way of doing things. “Instead, let’s use this time to create a better model today,” he said. “That’s what we’re trying to do at a system level at Banner, with our hospital medicine groups partnering with the hospital. I want to see our hospitalists create and thrive in that new model.”

Hospitalists nationwide have put in longer hours, played new clinical roles, and stretched beyond their medical specialty and comfort level to meet their hospital’s COVID-19 care demands. Can they expect some kind of financial recognition – perhaps in the form of “hazard pay” for going above and beyond – even though their institutions are experiencing negative financial fallout from the crisis?

Hospitals in regions experiencing a COVID-19 surge have limited elective procedures, discouraged non–COVID-19 admissions, and essentially entered crisis management mode. Other facilities in less hard-hit communities are also standing by, with reduced hospital census, smaller caseloads and less work to do, while trying to prepare their bottom lines for lower demand.

“This crisis has put most hospitals in financial jeopardy and that is likely to trickle down to all employees – including hospitalists,” said Ron Greeno, MD, FCCP, MHM, a past president of SHM and the society’s current senior advisor for government affairs. “But it’s not like hospitals could or would forgo an effective hospitalist program today. Hospitalists will be important players in defining the hospital’s future direction post crisis.”

That doesn’t mean tighter financials, caps on annual salary increases, or higher productivity expectations won’t be part of future conversations between hospital administrators and their hospitalists, Dr. Greeno said. Administrators are starting to look ahead to the post–COVID-19 era even as numbers of cases and rates of growth continue to rise in various regions, and Dr. Greeno sees a lot of uncertainty ahead.

Even prior to the crisis, he noted, hospital margins had been falling, while the cost of labor, including hospitalist labor, was going up. That was pointing toward an inevitable collision, which has only intensified with the new financial crisis facing hospitals – created by SARS-CoV-2 and by policies such as shutting down elective surgeries in anticipation of a COVID-19 patient surge that, for some institutions, may never come.

Brian Harte, MD, MHM, president of Cleveland Clinic Akron General and a past president of SHM, said that the Cleveland Clinic system has been planning since January its response to the coming crisis. “Governor Mike DeWine and the state Department of Health led the way in flattening the curve in Ohio. We engaged our hospitalists in brainstorming solutions. They have been excellent partners,” he said.

Approaching the crisis with a sense of urgency from the outset, the Cleveland Clinic built a COVID-19 surge team and incident command structure, with nursing, infectious diseases, critical care and hospital medicine represented. “We used that time to get ready for what was coming. We worked on streamlining consultant work flows.”

But utilization numbers are off in almost every service line, Dr. Harte said. “It has forced us to look at things we’ve always talked about, including greater use of telemedicine and exploring other ways of caring for patients, such as increased use of evening hours.”

Cleveland Clinic contracts with Sound Physicians of Tacoma, Wash., for its hospitalist coverage. “We have an excellent working relationship with Sound at the local, regional, and national levels, with common goals for quality and utilization. We tried to involve our hospitalists as early as possible in planning. We needed them to step in and role model and lead the way,” Dr. Harte said, for everybody’s anxiety levels.

“We’re still in the process of understanding the long-term financial impact of the epidemic,” Dr. Harte added. “But at this point I see no reason to think our relationship with our hospitalists needs to change. We’re the stewards of long-term finances. We’ll need to keep a close eye on this. But we’re committed to working through this together.”

Hazard pay for frontline health care workers was included in the COVID-19 relief package assembled in mid-May by Democrats in the House of Representatives. The $3 trillion HEROES Act includes $200 billion to award hazard pay to essential workers, including those in the health field, but Senate Majority Leader Mitch McConnell (R-Ky.) declared the legislation “dead on arrival” in the Senate.

Supplementary hazard payments made by hospitals to their hospitalists as a reward for sacrifices they made in the crisis is an interesting question, Dr. Greeno noted, and it’s definitely on the table at some hospitals. “But I think it is going to be a tough ask in these times.”

Dr. Harte said he has not offered nor been asked about hazard pay for hospitalists. Cleveland Clinic Akron General made a strategic decision that hazard pay was not going to be part of its response to the pandemic. Other hospital administrators interviewed for this article concur.

Hospitals respond to the fiscal crisis

Hospitals in other parts of the country also report significant fiscal fallout from the COVID-19 crisis, with predictions that 100 or more hospitals may be forced to close. Jeff Dye, president of the New Mexico Hospital Association, told the Albuquerque Journal on May 1 that hospitals in his state have been squeezed on all sides by increased costs, patients delaying routine care, and public health orders restricting elective surgeries. New Mexico hospitals, especially in rural areas, face incredible financial strain.

The University of Virginia Medical Center, Charlottesville, recently announced 20% reductions in total compensation for its providers through July 31, along with suspension of retirement contributions. Those changes won’t affect team members caring for COVID-19 patients. And the Spectrum Health Medical Group of 15 hospitals in western Michigan, according to Michigan Public Radio, told its doctors they either needed to sign “contract addendums” giving the system more control over their hours – or face a 25% pay cut, or worse.

Cheyenne (Wyo.) Regional Medical Center issued a statement April 24 that it expected losses of $10 million for the month of April. “CRMC, like every other hospital in Wyoming, is certainly feeling the financial impact that COVID-19 is having,” CEO Tim Thornell told the Cowboy State Daily on April 24. That includes a 30% reduction in inpatient care and 50% reduction in outpatient care, while the hospital has only had a handful of COVID-19 patients at any time. Capital projects are now on hold, overtime is limited, and a hiring freeze is in effect.

“We’re certainly prepared for a larger surge, which hasn’t come yet,” Mr. Thornell said in an interview. CRMC’s ICU was split to create a nine-bed dedicated COVID-19 unit. Intensivists see most of the critical care patients, while the hospital’s 15 directly-employed hospitalists are treating all of the non-ICU COVID-19 patients. “Among themselves, the hospitalists volunteered who would work on the unit. We’ve been fortunate enough to have enough volunteers and enough PPE [personal protective equipment],” he said.

Preparing for the COVID-19 pandemic has strengthened the medical center’s relationship with its hospitalists, Mr. Thornell explained. “Hospitalists are key to our operations, involved in so much that happens here. We’re trying to staff to volume with decreased utilization. We’ve scaled back, which only makes fiscal sense. Now, how do we reinfuse patients back into the mix? Our hospitalists are paid by the number of shifts, and as you distribute shift reductions over 15 providers, it shouldn’t be an intolerable burden.” But two open hospitalist positions have not been filled, he noted.

CRMC is trying to approach these changes with a Lean perspective, Mr. Thornell said. “We had already adopted a Lean program, but this has been a chance to go through a life-altering circumstance using the tools of Lean planning and applying them instantaneously.”
 

Providers step up

At Emory Healthcare in Atlanta, a major center for COVID-19 cases, communication has been essential in the crisis, said Bryce Gartland, MD, SFHM, Emory’s hospital group president and cochief of clinical operations. “Our group was prepared for a significant influx of patients. Like every other institution, we made the decision to postpone elective care, with a resulting plummet in volume,” he said.

As COVID-19 patients entered the Emory system, frontline hospitalists stepped up to care for those patients. “We’ve had ample providers in terms of clinical care. We guaranteed our physicians’ base compensation. They have flexed teams up and down as needed.” Advanced practice professionals also stepped up to bridge gaps.

With regard to the return of volumes of non–COVID-19 patients, the jury’s still out, Dr. Gartland said. “None of us has a crystal ball, and there are tremendous variables and decision points that will have significant impact. We have started to see numbers of time-sensitive and essential cases increase as of the first week of May.”

What lies ahead will likely include some rightsizing to future volumes. On top of that, the broader economic pressures on hospitals from high rates of unemployment, uninsured patients, bad debt, and charity care will push health care systems to significantly address costs and infrastructure, he said. “We’re still early in planning, and striving to maintain flexibility and nimbleness, given the uncertainties to this early understanding of our new normal. No hospital is immune from the financial impact. We’ll see and hear about more of these conversations in the months ahead.”

But the experience has also generated some positives, Dr. Gartland noted. “Things like telehealth, which we’ve been talking about for years but previously faced barriers to widespread adoption.” Now with COVID-19, the federal government issued waivers, and barriers – both internal and external – came down. “With telehealth, what will the role and deployment of hospitalists look like in this new model? How will traditional productivity expectations change, or the numbers and types of providers? This will make the relationship and partnership between hospitalist groups and hospital administrators ever more important as we consider the evolution toward new care models.”

Dr. Gartland said that “one of the great things about hospital medicine as a field is its flexibility and adaptability. Where there have been gaps, hospitalists were quick to step in. As long as hospital medicine continues to embrace those kinds of behaviors, it will be successful.” But if the conversation with hospitals is just about money, it will be harder, he acknowledged. “Where there is this kind of disruption in our usual way of doing things, there are also tremendous opportunities for care model innovation. I would encourage hospitalist groups to try to be true value partners.”

Command center mode

Like other physicians in hospital C-suites, Chad Whelan MD, FACP, SFHM, chief executive officer of Banner–University Medicine in Tucson, Ariz., led his two hospitals into command center mode when the crisis hit, planning for a surge of COVID-19 cases that could overwhelm hospital capacity.

“In terms of our hospitalists, we leaned in to them hard in the beginning, preparing them to supervise other physicians who came in to help if needed,” he said. “Our [non–COVID-19] census is down, revenues are down, and the implications are enormous – like nothing we’ve ever seen before.”

“We’re fortunate that we’re part of the Banner health system. We made a decision that we would essentially keep our physicians financially protected through this crisis,” Dr. Whelan said. “In return, we called on them to step up and be on the front lines and to put in enormous hours for planning. We asked them to consider: How could you contribute if the surge comes?”

He affirmed that hospital medicine has been a major part of his medical center’s planning and implementation. “I’ve been overwhelmed by the degree to which the entire delivery team has rallied around the pandemic, with everybody saying they want to keep people safe and be part of the solution. We have always had hospitalist leaders at the table as we’ve planned our response and as decisions were made,” said Dr. Whelan, a practicing hospitalist and teaching service attending since 2000 until he assumed his current executive position in Arizona 18 months ago.

“While we have kept people whole during the immediate crisis, we have acknowledged that we don’t know what our recovery will look like. What if [non–COVID-19] volume doesn’t return? That keeps me awake at night,” he said. “I have talked to our physician leadership in hospital medicine and more broadly. We need to ask ourselves many questions, including: do we have the right levels of staffing? Is this the time to consider alternate models of staffing, for example, advanced practice providers? And does the compensation plan need adjustments?”

Dr. Whelan thinks that the COVID-19 crisis is an opportunity for hospital medicine to more rapidly explore different models and to ask what additional value hospitalists can bring to the care model. “For example, what would it mean to redefine the hospitalist’s scope of practice as an acute medicine specialist, not defined by the hospital’s four walls?” he noted.

“One of the reasons our smaller hospital reached capacity with COVID-19 patients was the skilled nursing facility located a few hundred feet away that turned into a hot spot. If we had imported the hospital medicine model virtually into that SNF early on, could there have been a different scenario? Have we thought through what that would have even looked like?” Dr. Whelan asked.

He challenges the hospital medicine field, once it gets to the other side of this crisis, to not fall back on old way of doing things. “Instead, let’s use this time to create a better model today,” he said. “That’s what we’re trying to do at a system level at Banner, with our hospital medicine groups partnering with the hospital. I want to see our hospitalists create and thrive in that new model.”

When I was preparing for the recent birth of my baby, I anticipated a period of transition for myself. As a reproductive psychiatrist, I have treated many women during the perinatal and postpartum periods, and have a unique appreciation for the life changes that accompany birth. What I did not expect, however, was the world transitioning with me.

“The new normal” is an economic phrase that describes the COVID-19 era. The pandemic has engendered economic instability, collapsed industries, challenged health care systems, and has led to many deaths worldwide. The COVID-19 pandemic also has been associated with overall increases in anxiety and depression.¹ Emerging research suggests that frontline medical workers are especially at risk for developing psychological distress.²

COVID-19 has also created immense challenges for families. Because of concern for the spread of the virus, schools have been suspended, older grandparents isolated, and many parents continue to work remotely. For families in psychiatric care, this time has also been a time of change. Telepsychiatry might be more accessible, but the transition has been an adjustment for patients and clinicians.

As psychiatrists, how do we best treat families during this time? What are some ways to support our psychiatric colleagues? How do we ensure our own emotional well-being amid the tremendous changes occurring around us?
 

Background of interpersonal psychotherapy

Interpersonal psychotherapy (IPT) is a form of psychotherapy designed to treat depression following periods of transition. Its main goals include improving interpersonal connection and reducing psychological distress. Originally developed in the 1970s by Gerald Klerman, MD; Myrna Weissman, PhD; and Eugene Paykel, MD, IPT is a structured, time-limited form of psychotherapy.³

Conceptualizing depression as a treatable illness, Pim Cuijpers, PhD, and associates summarized the division of IPT into three phases.⁴ The initial phase involves history taking, forming an alliance, and choosing an interpersonal focus for treatment. The middle phase focuses on applying interpersonal problem-specific therapeutic techniques. The concluding phase of treatment involves consolidation of gains as well as formulating contingency plans for relapse of symptoms. Over the course of treatment, an IPT clinician focuses on life transitions and emphasizes that isolation and antagonistic relationships increase an individual’s vulnerability for a depressive episode.³

Randomized, controlled trials support IPT’s efficacy as a treatment for depression. Research also suggests it can possibly prevent the development of depression.⁴ Although IPT initially was designed as an individual form of psychotherapy, it has been adapted to both family and group contexts.^5,6 IPT is also an empirically valid form of psychotherapy for postpartum depression.⁷

Interpersonal psychotherapy for families

Given IPT’s role for treating depression following times of transition, clinicians should consider adapting interpersonal psychotherapy to family treatment during this time. Addressing social isolation, managing complex family relationships, and monitoring the family’s overall emotional health should be prioritized. Families under quarantine or who are grieving the death of family members may especially benefit from improved interpersonal connection. Consistent with the IPT model, contingency plans for the family should also be explored to prepare for potential future waves of the pandemic.

In addition to supporting and strengthening families, psychiatrists can use IPT themes to identify positive changes for families tied to COVID-19. Despite its difficulties, the stay-at-home order provided some families a unique chance to slow down and adapt a more relaxed routine. Busy families were suddenly given the opportunity to spend more time with one another. Although many older grandparents were isolated, creative uses of technology provided a chance for grandparents to remain an integral part of family life. Psychiatrists can assist families in transitioning back to previous schedules, while also exploring ways to incorporate the positive changes gained during this time.
 

Interpersonal psychotherapy for psychiatrists

An interpersonal focus could also be helpful for clinicians to adapt to changes in psychiatric practice. Many clinicians have been thrust into telepsychiatry practice, some with little to no preparation. Because of the trauma associated with frontline work, some psychiatrists have expanded their patient panel to treat physician colleagues. For consult-liaison psychiatrists, the possible neuropsychiatric effects of COVID-19 are new symptoms to consider when evaluating patients in a medical hospital setting.⁸ Fundamentally, modern day psychiatrists have never encountered a pandemic nor attempted to treat its psychological implications. Prioritizing seeking support from colleagues and caring for one’s personal relationships are helpful tools for clinicians to maintain their own emotional health during this challenging period.

Personal reflection

When I reflect on my baby’s recent birth, I recognize the importance of interpersonal relationships. COVID-19 developed shortly after I gave birth, during the initial haze of the newborn period. Initially, I felt overwhelmed by the many transitions and emotions that were occurring simultaneously. However, as I began to prioritize socialization for myself and my family (albeit creatively at times while socially distancing), I witnessed its positive effects on my emotional well-being and recognized its value in managing times of transition.
 

Using IPT for families, colleagues, and ourselves

As general psychiatrists, there are several ways to utilize IPT-related themes during this time:

• Connect with families: Although families may recognize they are struggling emotionally, some may find it difficult to navigate the sea of mental health resources. This is particularly true when a family’s financial situation is also stressed. Reaching out to local religious services and community medical resources or inquiring about the mental health of other family members are ways for psychiatrists to engage more families in mental health treatment.
• Reach out to colleagues: Psychiatrists are not immune to developing psychiatric disorders,and it is important to support each other.⁹ This is also an unusual time when psychiatrists are treating symptoms in patients that they themselves may be also experiencing. Supporting help groups and hot lines, reaching out to colleagues who appear to be struggling and addressing interpersonal conflicts within one’s practice are crucial practices for psychiatrists during this time.
• Explore within ourselves: Evaluating our own interpersonal relationships as well as areas for improvement are critical skills to maintain our own emotional well-being. Setting aside time to connect with friends in a nonclinical setting and prioritizing our family connections are helpful tools. In addition, exploring our reactions to past life transitions could improve our own level of insight into our response to COVID-19.

Conclusion

Conceptualizing COVID-19 as a period of transition and using IPT themes are helpful tools to mitigate the potential adverse psychological effects of COVID-19 on families. Similarly, they can also be helpful in supporting our colleagues and helping ourselves cope during this difficult period.

References

1. Qiu J et al. Gen Psychiatr. 2020 Mar 6;33(2):e100213.

2. Gautam M et al. Psychosomatics. 2020 Apr 20. doi: 10.1016/j.psym.2020.04.009.

3. Markowitz JC, Weissman MM. Clin Psychol Psychother. 2012 Mar-Apr;19(2):99-105.

4. Cuijpers P et al. Am J Psychiatry. 2016 Jul;173(7):680-7.

5. Dietz LJ et al. J Am Acad Child Adolesc Psychiatry. 2015 Mar;54(3):191-9.

6. Verdeli H et al. Child Adolesc Psychiatr Clin N Am. 2008 Jul;17(3):605-24.

7. Stuart S. Clin Psychol Psychother. 2012 Mar-Apr;19(2):134-40.

8. Rogers JP et al. Lancet Psychiatry. 2020 Jul;7(7):611-27.

9. Korkeila JA et al. Scand J Public Health. 2003;31(2):85-91.
 

Dr. Reinstein is a psychiatry attending at Zucker Hillside Hospital, New York. Her clinical interests include reproductive psychiatry and family therapy, with a specific focus on maternal mental health. She is one of the recipients of the 4th Annual Resident Recognition Award for Excellence in Family Oriented Care. Dr. Reinstein has no conflicts of interest. Alison M. Heru, MD, the Families in Psychiatry columnist, invited Dr. Reinstein to address this topic.

When I was preparing for the recent birth of my baby, I anticipated a period of transition for myself. As a reproductive psychiatrist, I have treated many women during the perinatal and postpartum periods, and have a unique appreciation for the life changes that accompany birth. What I did not expect, however, was the world transitioning with me.

“The new normal” is an economic phrase that describes the COVID-19 era. The pandemic has engendered economic instability, collapsed industries, challenged health care systems, and has led to many deaths worldwide. The COVID-19 pandemic also has been associated with overall increases in anxiety and depression.¹ Emerging research suggests that frontline medical workers are especially at risk for developing psychological distress.²

COVID-19 has also created immense challenges for families. Because of concern for the spread of the virus, schools have been suspended, older grandparents isolated, and many parents continue to work remotely. For families in psychiatric care, this time has also been a time of change. Telepsychiatry might be more accessible, but the transition has been an adjustment for patients and clinicians.

As psychiatrists, how do we best treat families during this time? What are some ways to support our psychiatric colleagues? How do we ensure our own emotional well-being amid the tremendous changes occurring around us?
 

Background of interpersonal psychotherapy

Interpersonal psychotherapy (IPT) is a form of psychotherapy designed to treat depression following periods of transition. Its main goals include improving interpersonal connection and reducing psychological distress. Originally developed in the 1970s by Gerald Klerman, MD; Myrna Weissman, PhD; and Eugene Paykel, MD, IPT is a structured, time-limited form of psychotherapy.³

Conceptualizing depression as a treatable illness, Pim Cuijpers, PhD, and associates summarized the division of IPT into three phases.⁴ The initial phase involves history taking, forming an alliance, and choosing an interpersonal focus for treatment. The middle phase focuses on applying interpersonal problem-specific therapeutic techniques. The concluding phase of treatment involves consolidation of gains as well as formulating contingency plans for relapse of symptoms. Over the course of treatment, an IPT clinician focuses on life transitions and emphasizes that isolation and antagonistic relationships increase an individual’s vulnerability for a depressive episode.³

Randomized, controlled trials support IPT’s efficacy as a treatment for depression. Research also suggests it can possibly prevent the development of depression.⁴ Although IPT initially was designed as an individual form of psychotherapy, it has been adapted to both family and group contexts.^5,6 IPT is also an empirically valid form of psychotherapy for postpartum depression.⁷

Interpersonal psychotherapy for families

Given IPT’s role for treating depression following times of transition, clinicians should consider adapting interpersonal psychotherapy to family treatment during this time. Addressing social isolation, managing complex family relationships, and monitoring the family’s overall emotional health should be prioritized. Families under quarantine or who are grieving the death of family members may especially benefit from improved interpersonal connection. Consistent with the IPT model, contingency plans for the family should also be explored to prepare for potential future waves of the pandemic.

In addition to supporting and strengthening families, psychiatrists can use IPT themes to identify positive changes for families tied to COVID-19. Despite its difficulties, the stay-at-home order provided some families a unique chance to slow down and adapt a more relaxed routine. Busy families were suddenly given the opportunity to spend more time with one another. Although many older grandparents were isolated, creative uses of technology provided a chance for grandparents to remain an integral part of family life. Psychiatrists can assist families in transitioning back to previous schedules, while also exploring ways to incorporate the positive changes gained during this time.
 

Interpersonal psychotherapy for psychiatrists

An interpersonal focus could also be helpful for clinicians to adapt to changes in psychiatric practice. Many clinicians have been thrust into telepsychiatry practice, some with little to no preparation. Because of the trauma associated with frontline work, some psychiatrists have expanded their patient panel to treat physician colleagues. For consult-liaison psychiatrists, the possible neuropsychiatric effects of COVID-19 are new symptoms to consider when evaluating patients in a medical hospital setting.⁸ Fundamentally, modern day psychiatrists have never encountered a pandemic nor attempted to treat its psychological implications. Prioritizing seeking support from colleagues and caring for one’s personal relationships are helpful tools for clinicians to maintain their own emotional health during this challenging period.

Personal reflection

When I reflect on my baby’s recent birth, I recognize the importance of interpersonal relationships. COVID-19 developed shortly after I gave birth, during the initial haze of the newborn period. Initially, I felt overwhelmed by the many transitions and emotions that were occurring simultaneously. However, as I began to prioritize socialization for myself and my family (albeit creatively at times while socially distancing), I witnessed its positive effects on my emotional well-being and recognized its value in managing times of transition.
 

Using IPT for families, colleagues, and ourselves

As general psychiatrists, there are several ways to utilize IPT-related themes during this time:

• Connect with families: Although families may recognize they are struggling emotionally, some may find it difficult to navigate the sea of mental health resources. This is particularly true when a family’s financial situation is also stressed. Reaching out to local religious services and community medical resources or inquiring about the mental health of other family members are ways for psychiatrists to engage more families in mental health treatment.
• Reach out to colleagues: Psychiatrists are not immune to developing psychiatric disorders,and it is important to support each other.⁹ This is also an unusual time when psychiatrists are treating symptoms in patients that they themselves may be also experiencing. Supporting help groups and hot lines, reaching out to colleagues who appear to be struggling and addressing interpersonal conflicts within one’s practice are crucial practices for psychiatrists during this time.
• Explore within ourselves: Evaluating our own interpersonal relationships as well as areas for improvement are critical skills to maintain our own emotional well-being. Setting aside time to connect with friends in a nonclinical setting and prioritizing our family connections are helpful tools. In addition, exploring our reactions to past life transitions could improve our own level of insight into our response to COVID-19.

Conclusion

Conceptualizing COVID-19 as a period of transition and using IPT themes are helpful tools to mitigate the potential adverse psychological effects of COVID-19 on families. Similarly, they can also be helpful in supporting our colleagues and helping ourselves cope during this difficult period.

References

1. Qiu J et al. Gen Psychiatr. 2020 Mar 6;33(2):e100213.

2. Gautam M et al. Psychosomatics. 2020 Apr 20. doi: 10.1016/j.psym.2020.04.009.

3. Markowitz JC, Weissman MM. Clin Psychol Psychother. 2012 Mar-Apr;19(2):99-105.

4. Cuijpers P et al. Am J Psychiatry. 2016 Jul;173(7):680-7.

5. Dietz LJ et al. J Am Acad Child Adolesc Psychiatry. 2015 Mar;54(3):191-9.

6. Verdeli H et al. Child Adolesc Psychiatr Clin N Am. 2008 Jul;17(3):605-24.

7. Stuart S. Clin Psychol Psychother. 2012 Mar-Apr;19(2):134-40.

8. Rogers JP et al. Lancet Psychiatry. 2020 Jul;7(7):611-27.

9. Korkeila JA et al. Scand J Public Health. 2003;31(2):85-91.
 

Dr. Reinstein is a psychiatry attending at Zucker Hillside Hospital, New York. Her clinical interests include reproductive psychiatry and family therapy, with a specific focus on maternal mental health. She is one of the recipients of the 4th Annual Resident Recognition Award for Excellence in Family Oriented Care. Dr. Reinstein has no conflicts of interest. Alison M. Heru, MD, the Families in Psychiatry columnist, invited Dr. Reinstein to address this topic.

When I was preparing for the recent birth of my baby, I anticipated a period of transition for myself. As a reproductive psychiatrist, I have treated many women during the perinatal and postpartum periods, and have a unique appreciation for the life changes that accompany birth. What I did not expect, however, was the world transitioning with me.

“The new normal” is an economic phrase that describes the COVID-19 era. The pandemic has engendered economic instability, collapsed industries, challenged health care systems, and has led to many deaths worldwide. The COVID-19 pandemic also has been associated with overall increases in anxiety and depression.¹ Emerging research suggests that frontline medical workers are especially at risk for developing psychological distress.²

COVID-19 has also created immense challenges for families. Because of concern for the spread of the virus, schools have been suspended, older grandparents isolated, and many parents continue to work remotely. For families in psychiatric care, this time has also been a time of change. Telepsychiatry might be more accessible, but the transition has been an adjustment for patients and clinicians.

As psychiatrists, how do we best treat families during this time? What are some ways to support our psychiatric colleagues? How do we ensure our own emotional well-being amid the tremendous changes occurring around us?
 

Background of interpersonal psychotherapy

Interpersonal psychotherapy (IPT) is a form of psychotherapy designed to treat depression following periods of transition. Its main goals include improving interpersonal connection and reducing psychological distress. Originally developed in the 1970s by Gerald Klerman, MD; Myrna Weissman, PhD; and Eugene Paykel, MD, IPT is a structured, time-limited form of psychotherapy.³

Conceptualizing depression as a treatable illness, Pim Cuijpers, PhD, and associates summarized the division of IPT into three phases.⁴ The initial phase involves history taking, forming an alliance, and choosing an interpersonal focus for treatment. The middle phase focuses on applying interpersonal problem-specific therapeutic techniques. The concluding phase of treatment involves consolidation of gains as well as formulating contingency plans for relapse of symptoms. Over the course of treatment, an IPT clinician focuses on life transitions and emphasizes that isolation and antagonistic relationships increase an individual’s vulnerability for a depressive episode.³

Randomized, controlled trials support IPT’s efficacy as a treatment for depression. Research also suggests it can possibly prevent the development of depression.⁴ Although IPT initially was designed as an individual form of psychotherapy, it has been adapted to both family and group contexts.^5,6 IPT is also an empirically valid form of psychotherapy for postpartum depression.⁷

Interpersonal psychotherapy for families

Given IPT’s role for treating depression following times of transition, clinicians should consider adapting interpersonal psychotherapy to family treatment during this time. Addressing social isolation, managing complex family relationships, and monitoring the family’s overall emotional health should be prioritized. Families under quarantine or who are grieving the death of family members may especially benefit from improved interpersonal connection. Consistent with the IPT model, contingency plans for the family should also be explored to prepare for potential future waves of the pandemic.

In addition to supporting and strengthening families, psychiatrists can use IPT themes to identify positive changes for families tied to COVID-19. Despite its difficulties, the stay-at-home order provided some families a unique chance to slow down and adapt a more relaxed routine. Busy families were suddenly given the opportunity to spend more time with one another. Although many older grandparents were isolated, creative uses of technology provided a chance for grandparents to remain an integral part of family life. Psychiatrists can assist families in transitioning back to previous schedules, while also exploring ways to incorporate the positive changes gained during this time.
 

Interpersonal psychotherapy for psychiatrists

An interpersonal focus could also be helpful for clinicians to adapt to changes in psychiatric practice. Many clinicians have been thrust into telepsychiatry practice, some with little to no preparation. Because of the trauma associated with frontline work, some psychiatrists have expanded their patient panel to treat physician colleagues. For consult-liaison psychiatrists, the possible neuropsychiatric effects of COVID-19 are new symptoms to consider when evaluating patients in a medical hospital setting.⁸ Fundamentally, modern day psychiatrists have never encountered a pandemic nor attempted to treat its psychological implications. Prioritizing seeking support from colleagues and caring for one’s personal relationships are helpful tools for clinicians to maintain their own emotional health during this challenging period.

Personal reflection

When I reflect on my baby’s recent birth, I recognize the importance of interpersonal relationships. COVID-19 developed shortly after I gave birth, during the initial haze of the newborn period. Initially, I felt overwhelmed by the many transitions and emotions that were occurring simultaneously. However, as I began to prioritize socialization for myself and my family (albeit creatively at times while socially distancing), I witnessed its positive effects on my emotional well-being and recognized its value in managing times of transition.
 

Using IPT for families, colleagues, and ourselves

As general psychiatrists, there are several ways to utilize IPT-related themes during this time:

• Connect with families: Although families may recognize they are struggling emotionally, some may find it difficult to navigate the sea of mental health resources. This is particularly true when a family’s financial situation is also stressed. Reaching out to local religious services and community medical resources or inquiring about the mental health of other family members are ways for psychiatrists to engage more families in mental health treatment.
• Reach out to colleagues: Psychiatrists are not immune to developing psychiatric disorders,and it is important to support each other.⁹ This is also an unusual time when psychiatrists are treating symptoms in patients that they themselves may be also experiencing. Supporting help groups and hot lines, reaching out to colleagues who appear to be struggling and addressing interpersonal conflicts within one’s practice are crucial practices for psychiatrists during this time.
• Explore within ourselves: Evaluating our own interpersonal relationships as well as areas for improvement are critical skills to maintain our own emotional well-being. Setting aside time to connect with friends in a nonclinical setting and prioritizing our family connections are helpful tools. In addition, exploring our reactions to past life transitions could improve our own level of insight into our response to COVID-19.

Conclusion

Conceptualizing COVID-19 as a period of transition and using IPT themes are helpful tools to mitigate the potential adverse psychological effects of COVID-19 on families. Similarly, they can also be helpful in supporting our colleagues and helping ourselves cope during this difficult period.

References

1. Qiu J et al. Gen Psychiatr. 2020 Mar 6;33(2):e100213.

2. Gautam M et al. Psychosomatics. 2020 Apr 20. doi: 10.1016/j.psym.2020.04.009.

3. Markowitz JC, Weissman MM. Clin Psychol Psychother. 2012 Mar-Apr;19(2):99-105.

4. Cuijpers P et al. Am J Psychiatry. 2016 Jul;173(7):680-7.

5. Dietz LJ et al. J Am Acad Child Adolesc Psychiatry. 2015 Mar;54(3):191-9.

6. Verdeli H et al. Child Adolesc Psychiatr Clin N Am. 2008 Jul;17(3):605-24.

7. Stuart S. Clin Psychol Psychother. 2012 Mar-Apr;19(2):134-40.

8. Rogers JP et al. Lancet Psychiatry. 2020 Jul;7(7):611-27.

9. Korkeila JA et al. Scand J Public Health. 2003;31(2):85-91.
 

Dr. Reinstein is a psychiatry attending at Zucker Hillside Hospital, New York. Her clinical interests include reproductive psychiatry and family therapy, with a specific focus on maternal mental health. She is one of the recipients of the 4th Annual Resident Recognition Award for Excellence in Family Oriented Care. Dr. Reinstein has no conflicts of interest. Alison M. Heru, MD, the Families in Psychiatry columnist, invited Dr. Reinstein to address this topic.

Oleandrin, a toxic cardiac glycoside found in the poisonous oleander plant, is making headlines as a potential treatment for COVID-19, raising concerns that uninformed people may eat the leaves of the plant and become ill or die.

CANCER CIFTCI/Getty Images

“Though renowned for its beauty and use in landscaping, this Mediterranean shrub is responsible for cases of accidental poisoning across the globe. All parts of the plant are poisonous,” Cassandra Quave, PhD, ethnobotanist and herbarium curator at Emory University, Atlanta, cautioned in an article in The Conversation, an independent, not-for-profit publication.

Oleandrin has properties similar to digoxin; the onset of toxicity occurs several hours after consumption.

The first symptoms of oleandrin poisoning may be gastrointestinal, such as nausea, vomiting, abdominal pain, diarrhea (which may contain blood), and loss of appetite.

After these first symptoms, the heart may be affected by tachyarrhythmia, bradyarrhythmia, premature ventricular contractions, or atrioventricular blockage. Xanthopsia (yellow vision), a burning sensation in the eyes, paralysis of the gastrointestinal tract, and respiratory symptoms may also occur.

Oleandrin poisoning may affect the central nervous system, as evidenced by drowsiness, tremors, seizures, collapse, and coma leading to death. When applied to the skin, oleander sap can cause skin irritations and allergic reactions characterized by dermatitis.

Diagnosis of oleandrin poisoning is mainly made on the basis of a description of the plant, how much of it was ingested, how much time has elapsed since ingestion, and symptoms. Confirmation of oleandrin in blood involves fluorescence polarization immunoassay, digoxin immunoassay, or liquid chromatography-electrospray tandem mass spectrometry.

Neither oleander nor oleandrin is approved by regulatory agencies as a prescription drug or dietary supplement.
 

In vitro study

Oleandrin for COVID-19 made headlines after President Trump met in the Oval Office with Andrew Whitney, vice chairman and director of Phoenix Biotechnology, along with Housing and Urban Development Secretary Ben Carson, MD, and MyPillow founder/CEO Mike Lindell, a strong supporter of Trump and an investor in the biotech company, to learn about oleandrin, which Whitney called a “cure” for COVID-19, Axios reported.

In an in vitro study, researchers from Phoenix Biotechnology and the University of Texas Medical Branch, Galveston, tested oleandrin against SARS-CoV-2 in cultured Vero cells.

“When administered both before and after virus infection, nanogram doses of oleandrin significantly inhibited replication by 45 to 3000-fold,” the researchers said in an article posted on bioRxiv, a free online archive and distribution service for unpublished preprints in the life sciences. The study has not been peer reviewed.

On the basis of these in vitro findings, the researchers said the plant extract has “potential to prevent disease and virus spread in persons recently exposed to SARS-CoV-2, as well as to prevent severe disease in persons at high risk.”

But it’s a far cry from test tube to human, one expert cautioned.

“This is an understatement: Care must be taken when inferring potential therapeutic benefits from in vitro antiviral effects,” Harlan Krumholz, MD, cardiologist and director, Yale New Haven Hospital Center for Outcomes Research and Evaluation, New Haven, Connecticut, told Medscape Medical News.

“There is a chasm between a single in vitro study and any use in humans outside of a protocol. People should be cautioned about that distance and the need [to] avoid such remedies unless part of a credible research project,” said Krumholz.

Yet Lindell told Axios that, in the Oval Office meeting, Trump expressed enthusiasm for the Food and Drug Administration to allow oleandrin to be marketed as a dietary supplement or approved for COVID-19.

“This is really just nonsense and a distraction,” Jonathan Reiner, MD, of George Washington University Medical Center, Washington, DC, said on CNN.

This article first appeared on Medscape.com.

Oleandrin, a toxic cardiac glycoside found in the poisonous oleander plant, is making headlines as a potential treatment for COVID-19, raising concerns that uninformed people may eat the leaves of the plant and become ill or die.

CANCER CIFTCI/Getty Images

“Though renowned for its beauty and use in landscaping, this Mediterranean shrub is responsible for cases of accidental poisoning across the globe. All parts of the plant are poisonous,” Cassandra Quave, PhD, ethnobotanist and herbarium curator at Emory University, Atlanta, cautioned in an article in The Conversation, an independent, not-for-profit publication.

Oleandrin has properties similar to digoxin; the onset of toxicity occurs several hours after consumption.

The first symptoms of oleandrin poisoning may be gastrointestinal, such as nausea, vomiting, abdominal pain, diarrhea (which may contain blood), and loss of appetite.

After these first symptoms, the heart may be affected by tachyarrhythmia, bradyarrhythmia, premature ventricular contractions, or atrioventricular blockage. Xanthopsia (yellow vision), a burning sensation in the eyes, paralysis of the gastrointestinal tract, and respiratory symptoms may also occur.

Oleandrin poisoning may affect the central nervous system, as evidenced by drowsiness, tremors, seizures, collapse, and coma leading to death. When applied to the skin, oleander sap can cause skin irritations and allergic reactions characterized by dermatitis.

Diagnosis of oleandrin poisoning is mainly made on the basis of a description of the plant, how much of it was ingested, how much time has elapsed since ingestion, and symptoms. Confirmation of oleandrin in blood involves fluorescence polarization immunoassay, digoxin immunoassay, or liquid chromatography-electrospray tandem mass spectrometry.

Neither oleander nor oleandrin is approved by regulatory agencies as a prescription drug or dietary supplement.
 

In vitro study

Oleandrin for COVID-19 made headlines after President Trump met in the Oval Office with Andrew Whitney, vice chairman and director of Phoenix Biotechnology, along with Housing and Urban Development Secretary Ben Carson, MD, and MyPillow founder/CEO Mike Lindell, a strong supporter of Trump and an investor in the biotech company, to learn about oleandrin, which Whitney called a “cure” for COVID-19, Axios reported.

In an in vitro study, researchers from Phoenix Biotechnology and the University of Texas Medical Branch, Galveston, tested oleandrin against SARS-CoV-2 in cultured Vero cells.

“When administered both before and after virus infection, nanogram doses of oleandrin significantly inhibited replication by 45 to 3000-fold,” the researchers said in an article posted on bioRxiv, a free online archive and distribution service for unpublished preprints in the life sciences. The study has not been peer reviewed.

On the basis of these in vitro findings, the researchers said the plant extract has “potential to prevent disease and virus spread in persons recently exposed to SARS-CoV-2, as well as to prevent severe disease in persons at high risk.”

But it’s a far cry from test tube to human, one expert cautioned.

“This is an understatement: Care must be taken when inferring potential therapeutic benefits from in vitro antiviral effects,” Harlan Krumholz, MD, cardiologist and director, Yale New Haven Hospital Center for Outcomes Research and Evaluation, New Haven, Connecticut, told Medscape Medical News.

“There is a chasm between a single in vitro study and any use in humans outside of a protocol. People should be cautioned about that distance and the need [to] avoid such remedies unless part of a credible research project,” said Krumholz.

Yet Lindell told Axios that, in the Oval Office meeting, Trump expressed enthusiasm for the Food and Drug Administration to allow oleandrin to be marketed as a dietary supplement or approved for COVID-19.

“This is really just nonsense and a distraction,” Jonathan Reiner, MD, of George Washington University Medical Center, Washington, DC, said on CNN.

This article first appeared on Medscape.com.

Oleandrin, a toxic cardiac glycoside found in the poisonous oleander plant, is making headlines as a potential treatment for COVID-19, raising concerns that uninformed people may eat the leaves of the plant and become ill or die.

CANCER CIFTCI/Getty Images

“Though renowned for its beauty and use in landscaping, this Mediterranean shrub is responsible for cases of accidental poisoning across the globe. All parts of the plant are poisonous,” Cassandra Quave, PhD, ethnobotanist and herbarium curator at Emory University, Atlanta, cautioned in an article in The Conversation, an independent, not-for-profit publication.

Oleandrin has properties similar to digoxin; the onset of toxicity occurs several hours after consumption.

The first symptoms of oleandrin poisoning may be gastrointestinal, such as nausea, vomiting, abdominal pain, diarrhea (which may contain blood), and loss of appetite.

After these first symptoms, the heart may be affected by tachyarrhythmia, bradyarrhythmia, premature ventricular contractions, or atrioventricular blockage. Xanthopsia (yellow vision), a burning sensation in the eyes, paralysis of the gastrointestinal tract, and respiratory symptoms may also occur.

Oleandrin poisoning may affect the central nervous system, as evidenced by drowsiness, tremors, seizures, collapse, and coma leading to death. When applied to the skin, oleander sap can cause skin irritations and allergic reactions characterized by dermatitis.

Diagnosis of oleandrin poisoning is mainly made on the basis of a description of the plant, how much of it was ingested, how much time has elapsed since ingestion, and symptoms. Confirmation of oleandrin in blood involves fluorescence polarization immunoassay, digoxin immunoassay, or liquid chromatography-electrospray tandem mass spectrometry.

Neither oleander nor oleandrin is approved by regulatory agencies as a prescription drug or dietary supplement.
 

In vitro study

Oleandrin for COVID-19 made headlines after President Trump met in the Oval Office with Andrew Whitney, vice chairman and director of Phoenix Biotechnology, along with Housing and Urban Development Secretary Ben Carson, MD, and MyPillow founder/CEO Mike Lindell, a strong supporter of Trump and an investor in the biotech company, to learn about oleandrin, which Whitney called a “cure” for COVID-19, Axios reported.

In an in vitro study, researchers from Phoenix Biotechnology and the University of Texas Medical Branch, Galveston, tested oleandrin against SARS-CoV-2 in cultured Vero cells.

“When administered both before and after virus infection, nanogram doses of oleandrin significantly inhibited replication by 45 to 3000-fold,” the researchers said in an article posted on bioRxiv, a free online archive and distribution service for unpublished preprints in the life sciences. The study has not been peer reviewed.

On the basis of these in vitro findings, the researchers said the plant extract has “potential to prevent disease and virus spread in persons recently exposed to SARS-CoV-2, as well as to prevent severe disease in persons at high risk.”

But it’s a far cry from test tube to human, one expert cautioned.

“This is an understatement: Care must be taken when inferring potential therapeutic benefits from in vitro antiviral effects,” Harlan Krumholz, MD, cardiologist and director, Yale New Haven Hospital Center for Outcomes Research and Evaluation, New Haven, Connecticut, told Medscape Medical News.

“There is a chasm between a single in vitro study and any use in humans outside of a protocol. People should be cautioned about that distance and the need [to] avoid such remedies unless part of a credible research project,” said Krumholz.

Yet Lindell told Axios that, in the Oval Office meeting, Trump expressed enthusiasm for the Food and Drug Administration to allow oleandrin to be marketed as a dietary supplement or approved for COVID-19.

“This is really just nonsense and a distraction,” Jonathan Reiner, MD, of George Washington University Medical Center, Washington, DC, said on CNN.

This article first appeared on Medscape.com.

The cumulative number of reported COVID-19 cases among children in the United States stood at 406,109 as of Aug. 13, an increase of 6.8% over the previous week, according to a new report from the American Academy of Pediatrics and the Children’s Hospital Association.

The 406,000 children who have tested positive for COVID-19 represent 9.1% of all cases reported so far by 49 states (New York does not provide age distribution), New York City, the District of Columbia, Puerto Rico, and Guam. Since the proportion of child cases also was 9.1% on Aug. 6, the most recent week is the first without an increase since tracking began in mid-April, the report shows.

State-level data show that Wyoming has the highest percentage of child cases (16.6%) after Alabama changed its “definition of child case from 0-24 to 0-17 years, resulting in a downward revision of cumulative child cases,” the AAP and the CHA said. Alabama’s proportion of such cases dropped from 22.5% to 9.0%.

New Jersey had the lowest rate (3.1%) again this week, along with New York City, but both were up slightly from the week before, when New Jersey was at 2.9% and N.Y.C. was 3.0%. The only states, other than Alabama, that saw declines over the last week were Arkansas, Massachusetts, Mississippi, South Dakota, Texas, and West Virginia. Texas, however, has reported age for only 8% of its confirmed cases, the report noted.

The overall rate of child COVID-19 cases as of Aug. 13 was 538 per 100,000 children, up from 500.7 per 100,000 a week earlier. Arizona was again highest among the states with a rate of 1,254 per 100,000 (up from 1,206) and Vermont was lowest at 121, although Puerto Rico (114) and Guam (88) were lower still, the AAP/CHA data indicate.

For the nine states that report testing information for children, Arizona has the highest positivity rate at 18.3% and West Virginia has the lowest at 3.6%. Data on hospitalizations – available from 21 states and N.Y.C. – show that 3,849 children have been admitted, with rates varying from 0.2% of children in Hawaii to 8.8% in the Big Apple, according to the report.

More specific information on child cases, such as symptoms or underlying conditions, is not being provided by states at this time, the AAP and CHA pointed out.

rfranki@mdedge.com

The cumulative number of reported COVID-19 cases among children in the United States stood at 406,109 as of Aug. 13, an increase of 6.8% over the previous week, according to a new report from the American Academy of Pediatrics and the Children’s Hospital Association.

The 406,000 children who have tested positive for COVID-19 represent 9.1% of all cases reported so far by 49 states (New York does not provide age distribution), New York City, the District of Columbia, Puerto Rico, and Guam. Since the proportion of child cases also was 9.1% on Aug. 6, the most recent week is the first without an increase since tracking began in mid-April, the report shows.

State-level data show that Wyoming has the highest percentage of child cases (16.6%) after Alabama changed its “definition of child case from 0-24 to 0-17 years, resulting in a downward revision of cumulative child cases,” the AAP and the CHA said. Alabama’s proportion of such cases dropped from 22.5% to 9.0%.

New Jersey had the lowest rate (3.1%) again this week, along with New York City, but both were up slightly from the week before, when New Jersey was at 2.9% and N.Y.C. was 3.0%. The only states, other than Alabama, that saw declines over the last week were Arkansas, Massachusetts, Mississippi, South Dakota, Texas, and West Virginia. Texas, however, has reported age for only 8% of its confirmed cases, the report noted.

The overall rate of child COVID-19 cases as of Aug. 13 was 538 per 100,000 children, up from 500.7 per 100,000 a week earlier. Arizona was again highest among the states with a rate of 1,254 per 100,000 (up from 1,206) and Vermont was lowest at 121, although Puerto Rico (114) and Guam (88) were lower still, the AAP/CHA data indicate.

For the nine states that report testing information for children, Arizona has the highest positivity rate at 18.3% and West Virginia has the lowest at 3.6%. Data on hospitalizations – available from 21 states and N.Y.C. – show that 3,849 children have been admitted, with rates varying from 0.2% of children in Hawaii to 8.8% in the Big Apple, according to the report.

More specific information on child cases, such as symptoms or underlying conditions, is not being provided by states at this time, the AAP and CHA pointed out.

rfranki@mdedge.com

The cumulative number of reported COVID-19 cases among children in the United States stood at 406,109 as of Aug. 13, an increase of 6.8% over the previous week, according to a new report from the American Academy of Pediatrics and the Children’s Hospital Association.

The 406,000 children who have tested positive for COVID-19 represent 9.1% of all cases reported so far by 49 states (New York does not provide age distribution), New York City, the District of Columbia, Puerto Rico, and Guam. Since the proportion of child cases also was 9.1% on Aug. 6, the most recent week is the first without an increase since tracking began in mid-April, the report shows.

State-level data show that Wyoming has the highest percentage of child cases (16.6%) after Alabama changed its “definition of child case from 0-24 to 0-17 years, resulting in a downward revision of cumulative child cases,” the AAP and the CHA said. Alabama’s proportion of such cases dropped from 22.5% to 9.0%.

New Jersey had the lowest rate (3.1%) again this week, along with New York City, but both were up slightly from the week before, when New Jersey was at 2.9% and N.Y.C. was 3.0%. The only states, other than Alabama, that saw declines over the last week were Arkansas, Massachusetts, Mississippi, South Dakota, Texas, and West Virginia. Texas, however, has reported age for only 8% of its confirmed cases, the report noted.

The overall rate of child COVID-19 cases as of Aug. 13 was 538 per 100,000 children, up from 500.7 per 100,000 a week earlier. Arizona was again highest among the states with a rate of 1,254 per 100,000 (up from 1,206) and Vermont was lowest at 121, although Puerto Rico (114) and Guam (88) were lower still, the AAP/CHA data indicate.

For the nine states that report testing information for children, Arizona has the highest positivity rate at 18.3% and West Virginia has the lowest at 3.6%. Data on hospitalizations – available from 21 states and N.Y.C. – show that 3,849 children have been admitted, with rates varying from 0.2% of children in Hawaii to 8.8% in the Big Apple, according to the report.

More specific information on child cases, such as symptoms or underlying conditions, is not being provided by states at this time, the AAP and CHA pointed out.

rfranki@mdedge.com

Rates of thyrotoxicosis are significantly higher among patients who are critically ill with COVID-19 than among patients who are critically ill but who do not not have COVID-19, suggesting an atypical form of thyroiditis related to the novel coronavirus infection, according to new research.

“We suggest routine assessment of thyroid function in patients with COVID-19 requiring high-intensity care because they frequently present with thyrotoxicosis due to a form of subacute thyroiditis related to SARS-CoV-2,” the authors wrote in correspondence published online in The Lancet Diabetes and Endocrinology.

However, notably, the study – which compared critically ill ICU patients who had COVID-19 with those who did not have COVID-19 or who had milder cases of COVID-19 – indicates that thyroid disorders do not appear to increase the risk of developing COVID-19, first author Ilaria Muller, MD, PhD, of the department of endocrinology, IRCCS Fondazione Ca’ Granda Ospedale Maggiore Policlinico, Milan, said in an interview.

“It is important to highlight that we did not find an increased prevalence of preexisting thyroid disorders in COVID-19 patients (contrary to early media reports),” she said. “So far, clinical observations do not support this fear, and we need to reassure people with thyroid disorders, since such disorders are very common among the general population.”

Yet the findings add to emerging evidence of a COVID-19/thyroid relationship, Angela M. Leung, MD, said in an interview.

“Given the health care impacts of the current COVID-19 pandemic worldwide, this study provides some insight on the potential systemic inflammation, as well as thyroid-specific inflammation, of the SARS-Cov-2 virus that is described in some emerging reports,” she said.

“This study joins at least six others that have reported a clinical presentation resembling subacute thyroiditis in critically ill patients with COVID-19,” noted Dr. Leung, of the division of endocrinology, diabetes, and metabolism in the department of medicine at the University of California, Los Angeles.
 

Thyroid function analysis in those with severe COVID-19

Dr. Muller explained that preliminary data from her institution showed thyroid abnormalities in patients who were severely ill with COVID-19. She and her team extended the evaluation to include thyroid data and other data on 93 patients with COVID-19 who were admitted to high-intensity care units (HICUs) in Italy during the 2020 pandemic.

Those data were compared with data on 101 critically ill patients admitted to the same HICUs in 2019 who did not have COVID-19. A third group of 52 patients with COVID-19 who were admitted to low-intensity care units (LICUs) in Italy in 2020 were also included in the analysis.

The mean age of the patients in the HICU 2020 group was 65.3 years; in the HICU 2019 group, it was 73 years; and in the LICU group, it was 70 years (P = .001). In addition, the HICU 2020 group included more men than the other two groups (69% vs. 56% and 48%; P = .03).

Of note, only 9% of patients in the HICU 2020 group had preexisting thyroid disorders, compared with 21% in the LICU group and 23% in the HICU 2019 group (P = .017).

These findings suggest that “such conditions are not a risk factor for SARS-CoV-2 infection or severity of COVID-19,” the authors wrote.

The patients with the preexisting thyroid conditions were excluded from the thyroid function analysis.

A significantly higher proportion of patients in the HICU 2020 group (13; 15%) were thyrotoxic upon admission, compared with just 1 (1%) of 78 patients in the HICU 2019 group (P = .002) and one (2%) of 41 patients in the LICU group (P = .025).

Among the 14 patients in the two COVID-19 groups who had thyrotoxicosis, the majority were male (9; 64%)

Among those in the HICU 2020 group, serum thyroid-stimulating hormone concentrations were lower than in either of the other two groups (P = .018), and serum free thyroxine (free T4) concentrations were higher than in the LICU group (P = .016) but not the HICU 2019 group.
 

Differences compared with other infection-related thyroiditis

Although thyrotoxicosis relating to subacute viral thyroiditis can result from a wide variety of viral infections, there are some key differences with COVID-19, Dr. Muller said.

“Thyroid dysfunction related to SARS-CoV-2 seems to be milder than that of classic subacute thyroiditis due to other viruses,” she explained. Furthermore, thyroid dysfunction associated with other viral infections is more common in women, whereas there were more male patients with the COVID-19–related atypical thyroiditis.

In addition, the thyroid effects developed early with COVID-19, whereas they usually emerge after the infections by other viruses.

Patients did not demonstrate the neck pain that is common with classic viral thyroiditis, and the thyroid abnormalities appear to correlate with the severity of COVID-19, whereas they are seen even in patients with mild symptoms when other viral infections are the cause.

In addition to the risk for subacute viral thyroiditis, critically ill patients in general are at risk of developing nonthyroidal illness syndrome, with alterations in thyroid function. However, thyroid hormone measures in the patients severely ill with COVID-19 were not consistent with that syndrome.

A subanalysis of eight HICU 2020 patients with thyroid dysfunction who were followed for 55 days after discharge showed that two experienced hyperthyroidism but likely not from COVID-19; in the remaining six, thyroid function normalized.

Muller speculated that, when ill with COVID-19, the patients likely had a combination of SARS-CoV-2–related atypical thyroiditis and nonthyroidal illness syndrome, known as T4 toxicosis.
 

Will there be any long-term effects?

Importantly, it remains unknown whether the novel coronavirus has longer-term effects on the thyroid, Dr. Muller said.

“We cannot predict what will be the long-lasting thyroid effects after COVID-19,” she said.

With classic subacute viral thyroiditis, “After a few years ... 5%-20% of patients develop permanent hypothyroidism, [and] the same might happen in COVID-19 patients,” she hypothesized. “We will follow our patients long term to answer this question – this study is already ongoing.”

In the meantime, diagnosis of thyroid dysfunction in patients with COVID-19 is important, inasmuch as it could worsen the already critical conditions of patients, Muller stressed.

“The gold-standard treatment for thyroiditis is steroids, so the presence of thyroid dysfunction might represent an additional indication to such treatment in COVID-19 patients, to be verified in properly designed clinical trials,” she advised.
 

ACE2 cell receptors highly expressed in thyroid

Dr. Muller and colleagues also noted recent research showing that ACE2 – demonstrated to be a key host-cell entry receptor for both SARS-CoV and SARS-CoV-2 – is expressed in even higher levels in the thyroid than the lungs, where it causes COVID-19’s notorious pulmonary effects.

Dr. Muller said the implications of ACE2 expression in the thyroid remain to be elucidated.

“If ACE2 is confirmed to be expressed at higher levels, compared with the lungs in the thyroid gland and other tissues, i.e., small intestine, testis, kidney, heart, etc, dedicated studies will be needed to correlate ACE2 expression with the organs’ susceptibility to SARS-CoV-2 reflected by clinical presentation,” she said.

Dr. Leung added that, as a take-home message from these and the other thyroid/COVID-19 studies, “data are starting to show us that COVID-19 infection may cause thyrotoxicosis that is possibly related to thyroid and systemic inflammation. However, the serum thyroid function test abnormalities seen in COVID-19 patients with subacute thyroiditis are also likely exacerbated to a substantial extent by nonthyroidal illness physiology.”

The authors have disclosed no relevant financial relationships. Dr. Leung is on the advisory board of Medscape Diabetes and Endocrinology.

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

Rates of thyrotoxicosis are significantly higher among patients who are critically ill with COVID-19 than among patients who are critically ill but who do not not have COVID-19, suggesting an atypical form of thyroiditis related to the novel coronavirus infection, according to new research.

“We suggest routine assessment of thyroid function in patients with COVID-19 requiring high-intensity care because they frequently present with thyrotoxicosis due to a form of subacute thyroiditis related to SARS-CoV-2,” the authors wrote in correspondence published online in The Lancet Diabetes and Endocrinology.

However, notably, the study – which compared critically ill ICU patients who had COVID-19 with those who did not have COVID-19 or who had milder cases of COVID-19 – indicates that thyroid disorders do not appear to increase the risk of developing COVID-19, first author Ilaria Muller, MD, PhD, of the department of endocrinology, IRCCS Fondazione Ca’ Granda Ospedale Maggiore Policlinico, Milan, said in an interview.

“It is important to highlight that we did not find an increased prevalence of preexisting thyroid disorders in COVID-19 patients (contrary to early media reports),” she said. “So far, clinical observations do not support this fear, and we need to reassure people with thyroid disorders, since such disorders are very common among the general population.”

Yet the findings add to emerging evidence of a COVID-19/thyroid relationship, Angela M. Leung, MD, said in an interview.

“Given the health care impacts of the current COVID-19 pandemic worldwide, this study provides some insight on the potential systemic inflammation, as well as thyroid-specific inflammation, of the SARS-Cov-2 virus that is described in some emerging reports,” she said.

“This study joins at least six others that have reported a clinical presentation resembling subacute thyroiditis in critically ill patients with COVID-19,” noted Dr. Leung, of the division of endocrinology, diabetes, and metabolism in the department of medicine at the University of California, Los Angeles.
 

Thyroid function analysis in those with severe COVID-19

Dr. Muller explained that preliminary data from her institution showed thyroid abnormalities in patients who were severely ill with COVID-19. She and her team extended the evaluation to include thyroid data and other data on 93 patients with COVID-19 who were admitted to high-intensity care units (HICUs) in Italy during the 2020 pandemic.

Those data were compared with data on 101 critically ill patients admitted to the same HICUs in 2019 who did not have COVID-19. A third group of 52 patients with COVID-19 who were admitted to low-intensity care units (LICUs) in Italy in 2020 were also included in the analysis.

The mean age of the patients in the HICU 2020 group was 65.3 years; in the HICU 2019 group, it was 73 years; and in the LICU group, it was 70 years (P = .001). In addition, the HICU 2020 group included more men than the other two groups (69% vs. 56% and 48%; P = .03).

Of note, only 9% of patients in the HICU 2020 group had preexisting thyroid disorders, compared with 21% in the LICU group and 23% in the HICU 2019 group (P = .017).

These findings suggest that “such conditions are not a risk factor for SARS-CoV-2 infection or severity of COVID-19,” the authors wrote.

The patients with the preexisting thyroid conditions were excluded from the thyroid function analysis.

A significantly higher proportion of patients in the HICU 2020 group (13; 15%) were thyrotoxic upon admission, compared with just 1 (1%) of 78 patients in the HICU 2019 group (P = .002) and one (2%) of 41 patients in the LICU group (P = .025).

Among the 14 patients in the two COVID-19 groups who had thyrotoxicosis, the majority were male (9; 64%)

Among those in the HICU 2020 group, serum thyroid-stimulating hormone concentrations were lower than in either of the other two groups (P = .018), and serum free thyroxine (free T4) concentrations were higher than in the LICU group (P = .016) but not the HICU 2019 group.
 

Differences compared with other infection-related thyroiditis

Although thyrotoxicosis relating to subacute viral thyroiditis can result from a wide variety of viral infections, there are some key differences with COVID-19, Dr. Muller said.

“Thyroid dysfunction related to SARS-CoV-2 seems to be milder than that of classic subacute thyroiditis due to other viruses,” she explained. Furthermore, thyroid dysfunction associated with other viral infections is more common in women, whereas there were more male patients with the COVID-19–related atypical thyroiditis.

In addition, the thyroid effects developed early with COVID-19, whereas they usually emerge after the infections by other viruses.

Patients did not demonstrate the neck pain that is common with classic viral thyroiditis, and the thyroid abnormalities appear to correlate with the severity of COVID-19, whereas they are seen even in patients with mild symptoms when other viral infections are the cause.

In addition to the risk for subacute viral thyroiditis, critically ill patients in general are at risk of developing nonthyroidal illness syndrome, with alterations in thyroid function. However, thyroid hormone measures in the patients severely ill with COVID-19 were not consistent with that syndrome.

A subanalysis of eight HICU 2020 patients with thyroid dysfunction who were followed for 55 days after discharge showed that two experienced hyperthyroidism but likely not from COVID-19; in the remaining six, thyroid function normalized.

Muller speculated that, when ill with COVID-19, the patients likely had a combination of SARS-CoV-2–related atypical thyroiditis and nonthyroidal illness syndrome, known as T4 toxicosis.
 

Will there be any long-term effects?

Importantly, it remains unknown whether the novel coronavirus has longer-term effects on the thyroid, Dr. Muller said.

“We cannot predict what will be the long-lasting thyroid effects after COVID-19,” she said.

With classic subacute viral thyroiditis, “After a few years ... 5%-20% of patients develop permanent hypothyroidism, [and] the same might happen in COVID-19 patients,” she hypothesized. “We will follow our patients long term to answer this question – this study is already ongoing.”

In the meantime, diagnosis of thyroid dysfunction in patients with COVID-19 is important, inasmuch as it could worsen the already critical conditions of patients, Muller stressed.

“The gold-standard treatment for thyroiditis is steroids, so the presence of thyroid dysfunction might represent an additional indication to such treatment in COVID-19 patients, to be verified in properly designed clinical trials,” she advised.
 

ACE2 cell receptors highly expressed in thyroid

Dr. Muller and colleagues also noted recent research showing that ACE2 – demonstrated to be a key host-cell entry receptor for both SARS-CoV and SARS-CoV-2 – is expressed in even higher levels in the thyroid than the lungs, where it causes COVID-19’s notorious pulmonary effects.

Dr. Muller said the implications of ACE2 expression in the thyroid remain to be elucidated.

“If ACE2 is confirmed to be expressed at higher levels, compared with the lungs in the thyroid gland and other tissues, i.e., small intestine, testis, kidney, heart, etc, dedicated studies will be needed to correlate ACE2 expression with the organs’ susceptibility to SARS-CoV-2 reflected by clinical presentation,” she said.

Dr. Leung added that, as a take-home message from these and the other thyroid/COVID-19 studies, “data are starting to show us that COVID-19 infection may cause thyrotoxicosis that is possibly related to thyroid and systemic inflammation. However, the serum thyroid function test abnormalities seen in COVID-19 patients with subacute thyroiditis are also likely exacerbated to a substantial extent by nonthyroidal illness physiology.”

The authors have disclosed no relevant financial relationships. Dr. Leung is on the advisory board of Medscape Diabetes and Endocrinology.

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

Rates of thyrotoxicosis are significantly higher among patients who are critically ill with COVID-19 than among patients who are critically ill but who do not not have COVID-19, suggesting an atypical form of thyroiditis related to the novel coronavirus infection, according to new research.

“We suggest routine assessment of thyroid function in patients with COVID-19 requiring high-intensity care because they frequently present with thyrotoxicosis due to a form of subacute thyroiditis related to SARS-CoV-2,” the authors wrote in correspondence published online in The Lancet Diabetes and Endocrinology.

However, notably, the study – which compared critically ill ICU patients who had COVID-19 with those who did not have COVID-19 or who had milder cases of COVID-19 – indicates that thyroid disorders do not appear to increase the risk of developing COVID-19, first author Ilaria Muller, MD, PhD, of the department of endocrinology, IRCCS Fondazione Ca’ Granda Ospedale Maggiore Policlinico, Milan, said in an interview.

“It is important to highlight that we did not find an increased prevalence of preexisting thyroid disorders in COVID-19 patients (contrary to early media reports),” she said. “So far, clinical observations do not support this fear, and we need to reassure people with thyroid disorders, since such disorders are very common among the general population.”

Yet the findings add to emerging evidence of a COVID-19/thyroid relationship, Angela M. Leung, MD, said in an interview.

“Given the health care impacts of the current COVID-19 pandemic worldwide, this study provides some insight on the potential systemic inflammation, as well as thyroid-specific inflammation, of the SARS-Cov-2 virus that is described in some emerging reports,” she said.

“This study joins at least six others that have reported a clinical presentation resembling subacute thyroiditis in critically ill patients with COVID-19,” noted Dr. Leung, of the division of endocrinology, diabetes, and metabolism in the department of medicine at the University of California, Los Angeles.
 

Thyroid function analysis in those with severe COVID-19

Dr. Muller explained that preliminary data from her institution showed thyroid abnormalities in patients who were severely ill with COVID-19. She and her team extended the evaluation to include thyroid data and other data on 93 patients with COVID-19 who were admitted to high-intensity care units (HICUs) in Italy during the 2020 pandemic.

Those data were compared with data on 101 critically ill patients admitted to the same HICUs in 2019 who did not have COVID-19. A third group of 52 patients with COVID-19 who were admitted to low-intensity care units (LICUs) in Italy in 2020 were also included in the analysis.

The mean age of the patients in the HICU 2020 group was 65.3 years; in the HICU 2019 group, it was 73 years; and in the LICU group, it was 70 years (P = .001). In addition, the HICU 2020 group included more men than the other two groups (69% vs. 56% and 48%; P = .03).

Of note, only 9% of patients in the HICU 2020 group had preexisting thyroid disorders, compared with 21% in the LICU group and 23% in the HICU 2019 group (P = .017).

These findings suggest that “such conditions are not a risk factor for SARS-CoV-2 infection or severity of COVID-19,” the authors wrote.

The patients with the preexisting thyroid conditions were excluded from the thyroid function analysis.

A significantly higher proportion of patients in the HICU 2020 group (13; 15%) were thyrotoxic upon admission, compared with just 1 (1%) of 78 patients in the HICU 2019 group (P = .002) and one (2%) of 41 patients in the LICU group (P = .025).

Among the 14 patients in the two COVID-19 groups who had thyrotoxicosis, the majority were male (9; 64%)

Among those in the HICU 2020 group, serum thyroid-stimulating hormone concentrations were lower than in either of the other two groups (P = .018), and serum free thyroxine (free T4) concentrations were higher than in the LICU group (P = .016) but not the HICU 2019 group.
 

Differences compared with other infection-related thyroiditis

Although thyrotoxicosis relating to subacute viral thyroiditis can result from a wide variety of viral infections, there are some key differences with COVID-19, Dr. Muller said.

“Thyroid dysfunction related to SARS-CoV-2 seems to be milder than that of classic subacute thyroiditis due to other viruses,” she explained. Furthermore, thyroid dysfunction associated with other viral infections is more common in women, whereas there were more male patients with the COVID-19–related atypical thyroiditis.

In addition, the thyroid effects developed early with COVID-19, whereas they usually emerge after the infections by other viruses.

Patients did not demonstrate the neck pain that is common with classic viral thyroiditis, and the thyroid abnormalities appear to correlate with the severity of COVID-19, whereas they are seen even in patients with mild symptoms when other viral infections are the cause.

In addition to the risk for subacute viral thyroiditis, critically ill patients in general are at risk of developing nonthyroidal illness syndrome, with alterations in thyroid function. However, thyroid hormone measures in the patients severely ill with COVID-19 were not consistent with that syndrome.

A subanalysis of eight HICU 2020 patients with thyroid dysfunction who were followed for 55 days after discharge showed that two experienced hyperthyroidism but likely not from COVID-19; in the remaining six, thyroid function normalized.

Muller speculated that, when ill with COVID-19, the patients likely had a combination of SARS-CoV-2–related atypical thyroiditis and nonthyroidal illness syndrome, known as T4 toxicosis.
 

Will there be any long-term effects?

Importantly, it remains unknown whether the novel coronavirus has longer-term effects on the thyroid, Dr. Muller said.

“We cannot predict what will be the long-lasting thyroid effects after COVID-19,” she said.

With classic subacute viral thyroiditis, “After a few years ... 5%-20% of patients develop permanent hypothyroidism, [and] the same might happen in COVID-19 patients,” she hypothesized. “We will follow our patients long term to answer this question – this study is already ongoing.”

In the meantime, diagnosis of thyroid dysfunction in patients with COVID-19 is important, inasmuch as it could worsen the already critical conditions of patients, Muller stressed.

“The gold-standard treatment for thyroiditis is steroids, so the presence of thyroid dysfunction might represent an additional indication to such treatment in COVID-19 patients, to be verified in properly designed clinical trials,” she advised.
 

ACE2 cell receptors highly expressed in thyroid

Dr. Muller and colleagues also noted recent research showing that ACE2 – demonstrated to be a key host-cell entry receptor for both SARS-CoV and SARS-CoV-2 – is expressed in even higher levels in the thyroid than the lungs, where it causes COVID-19’s notorious pulmonary effects.

Dr. Muller said the implications of ACE2 expression in the thyroid remain to be elucidated.

“If ACE2 is confirmed to be expressed at higher levels, compared with the lungs in the thyroid gland and other tissues, i.e., small intestine, testis, kidney, heart, etc, dedicated studies will be needed to correlate ACE2 expression with the organs’ susceptibility to SARS-CoV-2 reflected by clinical presentation,” she said.

Dr. Leung added that, as a take-home message from these and the other thyroid/COVID-19 studies, “data are starting to show us that COVID-19 infection may cause thyrotoxicosis that is possibly related to thyroid and systemic inflammation. However, the serum thyroid function test abnormalities seen in COVID-19 patients with subacute thyroiditis are also likely exacerbated to a substantial extent by nonthyroidal illness physiology.”

The authors have disclosed no relevant financial relationships. Dr. Leung is on the advisory board of Medscape Diabetes and Endocrinology.

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

The COVID-19 pandemic has created unique and unprecedented challenges for the clinical research world, with potentially long-lasting consequences.

A new analysis of the extent of disruption shows that the average rate of stopped trials nearly doubled during the first 5 months of 2020, compared with the 2 previous years.

“Typically, clinical research precedes clinical practice by several years, so this disruption we’re seeing now will be felt for many years to come,” said Mario Guadino, MD, of Weill Cornell Medicine, New York.

The analysis was published online July 31 in the Journal of the American College of Cardiology.

The researchers used Python software to query meta-data from all trials reported on ClinicalTrials.gov. Of 321,218 non-COVID-19 trials queried, 28,672 (8.9%) were reported as stopped, defined as a switch in trial status from “recruiting” to “active and not recruiting,” “completed,” “suspended,” “terminated,” or “withdrawn.”

The average rate of discontinuation was 638 trials/month from January 2017 to December 2019, rising to 1,147 trials/month between January 2020 and May 2020 (P < .001 for trend).

Once stopped (as opposed to paused), restarting a trial is a tricky prospect, said Dr. Guadino. “You can’t stop and restart a trial because it creates a lot of issues, so we should expect many of these stopped trials to never be completed.”

He said these figures likely represent an underestimate of the true impact of the pandemic because there is typically a delay in the updating of the status of a trial on ClinicalTrials.gov.

“We are likely looking only at the tip of the iceberg,” he added. “My impression is that the number of trials that will be affected and even canceled will be very high.”

As for cardiology trials, one of the report’s authors, Deepak Bhatt, MD, Brigham and Women’s Hospital, Boston, without naming specific trials, had this to say: “Several cardiovascular trials were paused, and some were permanently discontinued. It may be a while before we fully appreciate just how much information was lost and how much might be salvaged.”

He’s not worried, however, that upcoming cardiology meetings, which have moved online for the foreseeable future, might get a bit boring. “Fortunately, there is enough good work going on in the cardiovascular and cardiometabolic space that I believe there will still be ample randomized and observational data of high quality to present at the major meetings,” Dr. Bhatt said in an email.

The researchers found a weak correlation between the national population-adjusted numbers of COVID-19 cases and the proportion of non-COVID-19 trials stopped by country.

Even for trials that stopped recruiting for a period of time but are continuing, there are myriad issues involving compliance, data integrity, statistical interpretability, etc.

“Even if there is just a temporary disruption, that will most likely lead to reduced enrollment, missing follow-up visits, and protocol deviations, all things that would be red flags during normal times and impact the quality of the clinical trial,” said Dr. Guadino.

“And if your outcome of interest is mortality, well, how exactly do you measure that during a pandemic?” he added.
 

Stopped for lack of funding

Besides the logistical issues, another reason trials may be in jeopardy is funding. A warning early in the pandemic from the research community in Canada that funding was quickly drying up, leaving both jobs and data at risk, led to an aid package from the government to keep the lights on.

The National Institutes of Health (NIH), the Canadian Institutes of Health Research, and similar groups “have devoted large sums of money to research in COVID, which is of course very appropriate, but that clearly reduces the amount of funding that is available for other researchers,” said Dr. Guadino.

Some funding agencies around the world have canceled or put on hold all non-COVID-19 clinical trials still at the design state, Dr. Guadino said in an interview.

The NIH, he stressed, has not canceled funding and has been “extremely open and cooperative” in trying to help trialists navigate the many COVID-generated issues. They’ve even issued guidance on how to manage trials during COVID-19.

Of note, in the survey, the majority of the trials stopped (95.4%) had nongovernmental funding.

“The data are not very granular, so we’re only able to make some very simple, descriptive comments, but it does seem like the more fragile trials – those that are smaller and industry-funded – are the ones more likely to be disrupted,” said Dr. Guadino.

In some cases, he said, priorities have shifted to COVID-19. “If a small company is sponsoring a trial and they decide they want to sponsor something related to COVID, or they realize that because of the slow enrollment, the trial becomes too expensive to complete, they may opt to just abandon it,” said Dr. Guadino.

At what cost? It will take years to sort that out, he said.

This study received no funding. Dr. Guadino and Dr. Bhatt are both active trialists, participating in both industry- and government-sponsored clinical research.
 

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

The COVID-19 pandemic has created unique and unprecedented challenges for the clinical research world, with potentially long-lasting consequences.

A new analysis of the extent of disruption shows that the average rate of stopped trials nearly doubled during the first 5 months of 2020, compared with the 2 previous years.

“Typically, clinical research precedes clinical practice by several years, so this disruption we’re seeing now will be felt for many years to come,” said Mario Guadino, MD, of Weill Cornell Medicine, New York.

The analysis was published online July 31 in the Journal of the American College of Cardiology.

The researchers used Python software to query meta-data from all trials reported on ClinicalTrials.gov. Of 321,218 non-COVID-19 trials queried, 28,672 (8.9%) were reported as stopped, defined as a switch in trial status from “recruiting” to “active and not recruiting,” “completed,” “suspended,” “terminated,” or “withdrawn.”

The average rate of discontinuation was 638 trials/month from January 2017 to December 2019, rising to 1,147 trials/month between January 2020 and May 2020 (P < .001 for trend).

Once stopped (as opposed to paused), restarting a trial is a tricky prospect, said Dr. Guadino. “You can’t stop and restart a trial because it creates a lot of issues, so we should expect many of these stopped trials to never be completed.”

He said these figures likely represent an underestimate of the true impact of the pandemic because there is typically a delay in the updating of the status of a trial on ClinicalTrials.gov.

“We are likely looking only at the tip of the iceberg,” he added. “My impression is that the number of trials that will be affected and even canceled will be very high.”

As for cardiology trials, one of the report’s authors, Deepak Bhatt, MD, Brigham and Women’s Hospital, Boston, without naming specific trials, had this to say: “Several cardiovascular trials were paused, and some were permanently discontinued. It may be a while before we fully appreciate just how much information was lost and how much might be salvaged.”

He’s not worried, however, that upcoming cardiology meetings, which have moved online for the foreseeable future, might get a bit boring. “Fortunately, there is enough good work going on in the cardiovascular and cardiometabolic space that I believe there will still be ample randomized and observational data of high quality to present at the major meetings,” Dr. Bhatt said in an email.

The researchers found a weak correlation between the national population-adjusted numbers of COVID-19 cases and the proportion of non-COVID-19 trials stopped by country.

Even for trials that stopped recruiting for a period of time but are continuing, there are myriad issues involving compliance, data integrity, statistical interpretability, etc.

“Even if there is just a temporary disruption, that will most likely lead to reduced enrollment, missing follow-up visits, and protocol deviations, all things that would be red flags during normal times and impact the quality of the clinical trial,” said Dr. Guadino.

“And if your outcome of interest is mortality, well, how exactly do you measure that during a pandemic?” he added.
 

Stopped for lack of funding

Besides the logistical issues, another reason trials may be in jeopardy is funding. A warning early in the pandemic from the research community in Canada that funding was quickly drying up, leaving both jobs and data at risk, led to an aid package from the government to keep the lights on.

The National Institutes of Health (NIH), the Canadian Institutes of Health Research, and similar groups “have devoted large sums of money to research in COVID, which is of course very appropriate, but that clearly reduces the amount of funding that is available for other researchers,” said Dr. Guadino.

Some funding agencies around the world have canceled or put on hold all non-COVID-19 clinical trials still at the design state, Dr. Guadino said in an interview.

The NIH, he stressed, has not canceled funding and has been “extremely open and cooperative” in trying to help trialists navigate the many COVID-generated issues. They’ve even issued guidance on how to manage trials during COVID-19.

Of note, in the survey, the majority of the trials stopped (95.4%) had nongovernmental funding.

“The data are not very granular, so we’re only able to make some very simple, descriptive comments, but it does seem like the more fragile trials – those that are smaller and industry-funded – are the ones more likely to be disrupted,” said Dr. Guadino.

In some cases, he said, priorities have shifted to COVID-19. “If a small company is sponsoring a trial and they decide they want to sponsor something related to COVID, or they realize that because of the slow enrollment, the trial becomes too expensive to complete, they may opt to just abandon it,” said Dr. Guadino.

At what cost? It will take years to sort that out, he said.

This study received no funding. Dr. Guadino and Dr. Bhatt are both active trialists, participating in both industry- and government-sponsored clinical research.
 

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

The COVID-19 pandemic has created unique and unprecedented challenges for the clinical research world, with potentially long-lasting consequences.

A new analysis of the extent of disruption shows that the average rate of stopped trials nearly doubled during the first 5 months of 2020, compared with the 2 previous years.

“Typically, clinical research precedes clinical practice by several years, so this disruption we’re seeing now will be felt for many years to come,” said Mario Guadino, MD, of Weill Cornell Medicine, New York.

The analysis was published online July 31 in the Journal of the American College of Cardiology.

The researchers used Python software to query meta-data from all trials reported on ClinicalTrials.gov. Of 321,218 non-COVID-19 trials queried, 28,672 (8.9%) were reported as stopped, defined as a switch in trial status from “recruiting” to “active and not recruiting,” “completed,” “suspended,” “terminated,” or “withdrawn.”

The average rate of discontinuation was 638 trials/month from January 2017 to December 2019, rising to 1,147 trials/month between January 2020 and May 2020 (P < .001 for trend).

Once stopped (as opposed to paused), restarting a trial is a tricky prospect, said Dr. Guadino. “You can’t stop and restart a trial because it creates a lot of issues, so we should expect many of these stopped trials to never be completed.”

He said these figures likely represent an underestimate of the true impact of the pandemic because there is typically a delay in the updating of the status of a trial on ClinicalTrials.gov.

“We are likely looking only at the tip of the iceberg,” he added. “My impression is that the number of trials that will be affected and even canceled will be very high.”

As for cardiology trials, one of the report’s authors, Deepak Bhatt, MD, Brigham and Women’s Hospital, Boston, without naming specific trials, had this to say: “Several cardiovascular trials were paused, and some were permanently discontinued. It may be a while before we fully appreciate just how much information was lost and how much might be salvaged.”

He’s not worried, however, that upcoming cardiology meetings, which have moved online for the foreseeable future, might get a bit boring. “Fortunately, there is enough good work going on in the cardiovascular and cardiometabolic space that I believe there will still be ample randomized and observational data of high quality to present at the major meetings,” Dr. Bhatt said in an email.

The researchers found a weak correlation between the national population-adjusted numbers of COVID-19 cases and the proportion of non-COVID-19 trials stopped by country.

Even for trials that stopped recruiting for a period of time but are continuing, there are myriad issues involving compliance, data integrity, statistical interpretability, etc.

“Even if there is just a temporary disruption, that will most likely lead to reduced enrollment, missing follow-up visits, and protocol deviations, all things that would be red flags during normal times and impact the quality of the clinical trial,” said Dr. Guadino.

“And if your outcome of interest is mortality, well, how exactly do you measure that during a pandemic?” he added.
 

Stopped for lack of funding

Besides the logistical issues, another reason trials may be in jeopardy is funding. A warning early in the pandemic from the research community in Canada that funding was quickly drying up, leaving both jobs and data at risk, led to an aid package from the government to keep the lights on.

The National Institutes of Health (NIH), the Canadian Institutes of Health Research, and similar groups “have devoted large sums of money to research in COVID, which is of course very appropriate, but that clearly reduces the amount of funding that is available for other researchers,” said Dr. Guadino.

Some funding agencies around the world have canceled or put on hold all non-COVID-19 clinical trials still at the design state, Dr. Guadino said in an interview.

The NIH, he stressed, has not canceled funding and has been “extremely open and cooperative” in trying to help trialists navigate the many COVID-generated issues. They’ve even issued guidance on how to manage trials during COVID-19.

Of note, in the survey, the majority of the trials stopped (95.4%) had nongovernmental funding.

“The data are not very granular, so we’re only able to make some very simple, descriptive comments, but it does seem like the more fragile trials – those that are smaller and industry-funded – are the ones more likely to be disrupted,” said Dr. Guadino.

In some cases, he said, priorities have shifted to COVID-19. “If a small company is sponsoring a trial and they decide they want to sponsor something related to COVID, or they realize that because of the slow enrollment, the trial becomes too expensive to complete, they may opt to just abandon it,” said Dr. Guadino.

At what cost? It will take years to sort that out, he said.

This study received no funding. Dr. Guadino and Dr. Bhatt are both active trialists, participating in both industry- and government-sponsored clinical research.
 

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

The abrupt transition to online learning for American children in kindergarten through 12th grade has left educators and parents unprepared, but virtual learning can be a successful part of education going forward, according to a viewpoint published in JAMA Pediatrics. However, schools also can reopen safely if precautions are taken, and students would benefit in many ways, according to a second viewpoint.

monkeybusinessimages/Thinkstock

“As policy makers, health care professionals, and parents prepare for the fall semester and as public and private schools grapple with how to make that possible, a better understanding of K-12 virtual learning options and outcomes may facilitate those difficult decisions,” wrote Erik Black, PhD, of the University of Florida, Gainesville; Richard Ferdig, PhD, of Kent State University, Ohio; and Lindsay A. Thompson, MD, of the University of Florida, Gainesville.

“Importantly, K-12 virtual schooling is not suited for all students or all families.”

In a viewpoint published in JAMA Pediatrics, the authors noted that virtual schooling has existed in the United States in various forms for some time. “Just like the myriad options that are available for face-to-face schooling in the U.S., virtual schooling exists in a complex landscape of for-profit, charter, and public options.”
 

Not all virtual schools are equal

Consequently, not all virtual schools are created equal, they emphasized. Virtual education can be successful for many students when presented by trained online instructors using a curriculum designed to be effective in an online venue.

“Parents need to seek reviews and ask for educational outcomes from each virtual school system to assess the quality of the provided education,” Dr. Black, Dr. Ferdig, and Dr. Thompson emphasized.

Key questions for parents to consider when faced with online learning include the type of technology needed to participate; whether their child can maintain a study schedule and complete assignments with limited supervision; whether their child could ask for help and communicate with teachers through technology including phone, text, email, or video; and whether their child has the basic reading, math, and computer literacy skills to engage in online learning, the authors said. Other questions include the school’s expectations for parents and caregivers, how student information may be shared, and how the virtual school lines up with state standards for K-12 educators (in the case of options outside the public school system).

“The COVID-19 pandemic offers a unique challenge for educators, policymakers, and health care professionals to partner with parents to make the best local and individual decisions for children,” Dr. Black, Dr. Ferdig, and Dr. Thompson concluded.
 

Schools may be able to open safely

Children continue to make up a low percentage of COVID-19 cases and appear less likely to experience illness, wrote C. Jason Wang, MD, PhD, and Henry Bair, BS, of Stanford (Calif.) University in a second viewpoint also published in JAMA Pediatrics. The impact of long-term school closures extends beyond education and can “exacerbate socioeconomic disparities, amplify existing educational inequalities, and aggravate food insecurity, domestic violence, and mental health disorders,” they wrote.

Dr. Wang and Mr. Bair proposed that school districts “engage key stakeholders to establish a COVID-19 task force, composed of the superintendent, members of the school board, teachers, parents, and health care professionals to develop policies and procedures,” that would allow schools to open safely.

The authors outlined strategies including adapting teaching spaces to accommodate physical distance, with the addition of temporary modular buildings if needed. They advised assigned seating on school buses, and acknowledged the need for the availability of protective equipment, including hand sanitizer and masks, as well as the possible use of transparent barriers on the sides of student desks.

“As the AAP [American Academy of Pediatrics] guidance suggests, teachers who must work closely with students with special needs or with students who are unable to wear masks should wear N95 masks if possible or wear face shields in addition to surgical masks,” Dr. Wang and Mr. Bair noted. Other elements of the AAP guidance include the creation of fixed cohorts of students and teachers to limit virus exposure.

“Even with all the precautions in place, COVID-19 outbreaks within schools are still likely,” they said. “Therefore, schools will need to remain flexible and consider temporary closures if there is an outbreak involving multiple students and/or staff and be ready to transition to online education.”

The AAP guidance does not address operational approaches to identifying signs and symptoms of COVID-19, the authors noted. “To address this, we recommend that schools implement multilevel screening for students and staff.”

“In summary, to maximize health and educational outcomes, school districts should adopt some or all of the measures of the AAP guidance and prioritize them after considering local COVID-19 incidence, key stakeholder input, and budgetary constraints,” Dr. Wang and Mr. Bair concluded.
 

Schools opening is a regional decision

“The mission of the AAP is to attain optimal physical, mental, and social health and well-being for all infants, children, adolescents, and young adults,” Howard Smart, MD, said in an interview. The question of school reopening “is of national importance, and the AAP has a national role in making recommendations regarding national policy affecting the health of the children.”

“The decision to open schools will be made regionally, but it is important for a nonpolitical national voice to make expert recommendations,” he emphasized.

“Many of the recommendations are ideal goals,” noted Dr. Smart, chairman of the department of pediatrics at the Sharp Rees-Stealy Medical Group in San Diego. “It will be difficult, for example, to implement symptom screening every day before school, no matter where it is performed. Some of the measures may be quite costly, and take time to implement, or require expansion of school staff, for which there may be no budget.”

In addition, “[n]ot all students are likely to comply with masking, distance, and hand-washing recommendations. One student who is noncompliant will be able to infect many other students and staff, as has been seen in other countries.” Also, parental attitudes toward control measures are likely to affect student attitudes, he noted.

“I have interviewed many families at recent checkups, and most have felt that the rush to remote learning that occurred at the end of the last school year resulted in fairly disorganized instruction,” Dr. Smart said. “They are hoping that, having had the summer to plan ahead, the remote teaching will be handled better. Remote learning will certainly work best for self-motivated, organized students with good family support, as noted in the Black, Ferdig, and Thompson article,” he said.

Pediatricians can support the schools by being a source of evidence-based information for parents, Dr. Smart said. “Pediatricians with time and energy might want to volunteer to hold informational video conferences for parents and/or school personnel if they feel they are up to date on current COVID-19 science and want to handle potentially contentious questions.”

The decision parents make to send their children back to school comes down to a risk-benefit calculation. “In some communities this may be left to parents, while in other communities this will a public health decision,” he said. “It is still not clear whether having students attend school in person will result in increased spread of COVID-19 among the students, or in their communities. Although some evidence from early in the pandemic suggests that children may not spread the virus as much as adults, more recent evidence suggests that children 10 years and older do transmit the virus at least as much as adults.”

“The risk to the students and the community, therefore, is unknown,” and difficult to compare with the benefit of in-person schooling, Dr. Smart noted.

“We will learn quite a bit from communities where students do go back to in-person class, as we follow the progression of COVID-19 over the weeks following the resumption of instruction.” Ultimately, advice to parents will need to be tailored to the current conditions of COVID-19 transmission in the community, he concluded.
 

It’s not just about education

“The AAP released its guidance to ensure that as school districts were contemplating reopening they were considering the full array of risks for children and adolescents. These risks included not only those related to COVID-19, but also those related to the impact of not reopening in-person,” Nathaniel Beers, MD, president of the HSC Health Care System in Washington, said in an interview.

“Students and families are dependent on schools for much more than just an education, and those [elements] need to be factored into the decisions to reopen,” the pediatrician said.

However, “[t]he major barrier for schools is resources to safely reopen,” said Dr. Beers. “The additional staffing and supplies will require additional funding. There are increased demands regardless of whether students are learning in-person or virtually or through hybrid models.”

“Another significant barrier is ensuring that parents and staff are actively engaged in planning for the type of model being used,” he said.

“All of the models require buy-in by staff and parents. This will require significant outreach and strong communication plans. Schools also need to ensure they are planning not just for how to return students to schools, but what will happen when staff or students test positive for COVID-19. Students, families, and staff all will need to know what these plans are up front to feel confident in returning to school,” he emphasized.

“There are students who can thrive in a virtual learning environment,” Dr. Beers said. “There are also students who benefit from the virtual learning environment because of their own risk, or because of a family member’s risk for COVID-19 or the complications from it.”

“However, many children with disabilities have struggled in a virtual environment,” he said. “These students struggle to access the educational services without the adequate supports at home. They often receive additional services in school, such as speech, occupational therapy or physical therapy, or nursing services, that may not have transitioned to home but are critical for their health and development. Many students with disabilities are dependent on family members to successfully access the educational services they need.”

“Pediatricians can play a role in providing feedback on recommendations related to physical distancing and face coverings in particular,” said Dr. Beers. “In addition, they can be helpful in developing plans for children with disabilities as well as what the response plan should be for students who become sick during the school day.”

The Centers for Disease Control and Prevention released a decision tool for parents who are considering whether to send their child to in-person school, and pediatricians can help parents walk through these questions, Dr. Beers noted. “In addition, pediatricians play an important role in helping patients and families think about the risks of COVID for the patient and other family members, and this can be helpful in addressing the anxiety that parents and patients may be experiencing.”

Further information can be found in Return to School During COVID-19, which can be located at HealthyChildren.org, by the American Academy of Pediatrics.

The authors of the viewpoints had no relevant financial disclosures. Dr. Smart, a member of the Pediatric News editorial advisory board, had no relevant financial disclosures. Dr. Beers has served on the editorial advisory board of Pediatric News in the past, but had no relevant financial disclosures.

SOURCES: Black E, Ferdig R, Thompson LA. JAMA Pediatr. 2020 Aug 11. doi: 10.1001/jamapediatrics.2020.3800. Wang CJ and Bair H. JAMA Pediatr. Aug 11. doi: 10.1001/jamapediatrics.2020.3871.
 

The abrupt transition to online learning for American children in kindergarten through 12th grade has left educators and parents unprepared, but virtual learning can be a successful part of education going forward, according to a viewpoint published in JAMA Pediatrics. However, schools also can reopen safely if precautions are taken, and students would benefit in many ways, according to a second viewpoint.

monkeybusinessimages/Thinkstock

“As policy makers, health care professionals, and parents prepare for the fall semester and as public and private schools grapple with how to make that possible, a better understanding of K-12 virtual learning options and outcomes may facilitate those difficult decisions,” wrote Erik Black, PhD, of the University of Florida, Gainesville; Richard Ferdig, PhD, of Kent State University, Ohio; and Lindsay A. Thompson, MD, of the University of Florida, Gainesville.

“Importantly, K-12 virtual schooling is not suited for all students or all families.”

In a viewpoint published in JAMA Pediatrics, the authors noted that virtual schooling has existed in the United States in various forms for some time. “Just like the myriad options that are available for face-to-face schooling in the U.S., virtual schooling exists in a complex landscape of for-profit, charter, and public options.”
 

Not all virtual schools are equal

Consequently, not all virtual schools are created equal, they emphasized. Virtual education can be successful for many students when presented by trained online instructors using a curriculum designed to be effective in an online venue.

“Parents need to seek reviews and ask for educational outcomes from each virtual school system to assess the quality of the provided education,” Dr. Black, Dr. Ferdig, and Dr. Thompson emphasized.

Key questions for parents to consider when faced with online learning include the type of technology needed to participate; whether their child can maintain a study schedule and complete assignments with limited supervision; whether their child could ask for help and communicate with teachers through technology including phone, text, email, or video; and whether their child has the basic reading, math, and computer literacy skills to engage in online learning, the authors said. Other questions include the school’s expectations for parents and caregivers, how student information may be shared, and how the virtual school lines up with state standards for K-12 educators (in the case of options outside the public school system).

“The COVID-19 pandemic offers a unique challenge for educators, policymakers, and health care professionals to partner with parents to make the best local and individual decisions for children,” Dr. Black, Dr. Ferdig, and Dr. Thompson concluded.
 

Schools may be able to open safely

Children continue to make up a low percentage of COVID-19 cases and appear less likely to experience illness, wrote C. Jason Wang, MD, PhD, and Henry Bair, BS, of Stanford (Calif.) University in a second viewpoint also published in JAMA Pediatrics. The impact of long-term school closures extends beyond education and can “exacerbate socioeconomic disparities, amplify existing educational inequalities, and aggravate food insecurity, domestic violence, and mental health disorders,” they wrote.

Dr. Wang and Mr. Bair proposed that school districts “engage key stakeholders to establish a COVID-19 task force, composed of the superintendent, members of the school board, teachers, parents, and health care professionals to develop policies and procedures,” that would allow schools to open safely.

The authors outlined strategies including adapting teaching spaces to accommodate physical distance, with the addition of temporary modular buildings if needed. They advised assigned seating on school buses, and acknowledged the need for the availability of protective equipment, including hand sanitizer and masks, as well as the possible use of transparent barriers on the sides of student desks.

“As the AAP [American Academy of Pediatrics] guidance suggests, teachers who must work closely with students with special needs or with students who are unable to wear masks should wear N95 masks if possible or wear face shields in addition to surgical masks,” Dr. Wang and Mr. Bair noted. Other elements of the AAP guidance include the creation of fixed cohorts of students and teachers to limit virus exposure.

“Even with all the precautions in place, COVID-19 outbreaks within schools are still likely,” they said. “Therefore, schools will need to remain flexible and consider temporary closures if there is an outbreak involving multiple students and/or staff and be ready to transition to online education.”

The AAP guidance does not address operational approaches to identifying signs and symptoms of COVID-19, the authors noted. “To address this, we recommend that schools implement multilevel screening for students and staff.”

“In summary, to maximize health and educational outcomes, school districts should adopt some or all of the measures of the AAP guidance and prioritize them after considering local COVID-19 incidence, key stakeholder input, and budgetary constraints,” Dr. Wang and Mr. Bair concluded.
 

Schools opening is a regional decision

“The mission of the AAP is to attain optimal physical, mental, and social health and well-being for all infants, children, adolescents, and young adults,” Howard Smart, MD, said in an interview. The question of school reopening “is of national importance, and the AAP has a national role in making recommendations regarding national policy affecting the health of the children.”

“The decision to open schools will be made regionally, but it is important for a nonpolitical national voice to make expert recommendations,” he emphasized.

“Many of the recommendations are ideal goals,” noted Dr. Smart, chairman of the department of pediatrics at the Sharp Rees-Stealy Medical Group in San Diego. “It will be difficult, for example, to implement symptom screening every day before school, no matter where it is performed. Some of the measures may be quite costly, and take time to implement, or require expansion of school staff, for which there may be no budget.”

In addition, “[n]ot all students are likely to comply with masking, distance, and hand-washing recommendations. One student who is noncompliant will be able to infect many other students and staff, as has been seen in other countries.” Also, parental attitudes toward control measures are likely to affect student attitudes, he noted.

“I have interviewed many families at recent checkups, and most have felt that the rush to remote learning that occurred at the end of the last school year resulted in fairly disorganized instruction,” Dr. Smart said. “They are hoping that, having had the summer to plan ahead, the remote teaching will be handled better. Remote learning will certainly work best for self-motivated, organized students with good family support, as noted in the Black, Ferdig, and Thompson article,” he said.

Pediatricians can support the schools by being a source of evidence-based information for parents, Dr. Smart said. “Pediatricians with time and energy might want to volunteer to hold informational video conferences for parents and/or school personnel if they feel they are up to date on current COVID-19 science and want to handle potentially contentious questions.”

The decision parents make to send their children back to school comes down to a risk-benefit calculation. “In some communities this may be left to parents, while in other communities this will a public health decision,” he said. “It is still not clear whether having students attend school in person will result in increased spread of COVID-19 among the students, or in their communities. Although some evidence from early in the pandemic suggests that children may not spread the virus as much as adults, more recent evidence suggests that children 10 years and older do transmit the virus at least as much as adults.”

“The risk to the students and the community, therefore, is unknown,” and difficult to compare with the benefit of in-person schooling, Dr. Smart noted.

“We will learn quite a bit from communities where students do go back to in-person class, as we follow the progression of COVID-19 over the weeks following the resumption of instruction.” Ultimately, advice to parents will need to be tailored to the current conditions of COVID-19 transmission in the community, he concluded.
 

It’s not just about education

“The AAP released its guidance to ensure that as school districts were contemplating reopening they were considering the full array of risks for children and adolescents. These risks included not only those related to COVID-19, but also those related to the impact of not reopening in-person,” Nathaniel Beers, MD, president of the HSC Health Care System in Washington, said in an interview.

“Students and families are dependent on schools for much more than just an education, and those [elements] need to be factored into the decisions to reopen,” the pediatrician said.

However, “[t]he major barrier for schools is resources to safely reopen,” said Dr. Beers. “The additional staffing and supplies will require additional funding. There are increased demands regardless of whether students are learning in-person or virtually or through hybrid models.”

“Another significant barrier is ensuring that parents and staff are actively engaged in planning for the type of model being used,” he said.

“All of the models require buy-in by staff and parents. This will require significant outreach and strong communication plans. Schools also need to ensure they are planning not just for how to return students to schools, but what will happen when staff or students test positive for COVID-19. Students, families, and staff all will need to know what these plans are up front to feel confident in returning to school,” he emphasized.

“There are students who can thrive in a virtual learning environment,” Dr. Beers said. “There are also students who benefit from the virtual learning environment because of their own risk, or because of a family member’s risk for COVID-19 or the complications from it.”

“However, many children with disabilities have struggled in a virtual environment,” he said. “These students struggle to access the educational services without the adequate supports at home. They often receive additional services in school, such as speech, occupational therapy or physical therapy, or nursing services, that may not have transitioned to home but are critical for their health and development. Many students with disabilities are dependent on family members to successfully access the educational services they need.”

“Pediatricians can play a role in providing feedback on recommendations related to physical distancing and face coverings in particular,” said Dr. Beers. “In addition, they can be helpful in developing plans for children with disabilities as well as what the response plan should be for students who become sick during the school day.”

The Centers for Disease Control and Prevention released a decision tool for parents who are considering whether to send their child to in-person school, and pediatricians can help parents walk through these questions, Dr. Beers noted. “In addition, pediatricians play an important role in helping patients and families think about the risks of COVID for the patient and other family members, and this can be helpful in addressing the anxiety that parents and patients may be experiencing.”

Further information can be found in Return to School During COVID-19, which can be located at HealthyChildren.org, by the American Academy of Pediatrics.

The authors of the viewpoints had no relevant financial disclosures. Dr. Smart, a member of the Pediatric News editorial advisory board, had no relevant financial disclosures. Dr. Beers has served on the editorial advisory board of Pediatric News in the past, but had no relevant financial disclosures.

SOURCES: Black E, Ferdig R, Thompson LA. JAMA Pediatr. 2020 Aug 11. doi: 10.1001/jamapediatrics.2020.3800. Wang CJ and Bair H. JAMA Pediatr. Aug 11. doi: 10.1001/jamapediatrics.2020.3871.
 

The abrupt transition to online learning for American children in kindergarten through 12th grade has left educators and parents unprepared, but virtual learning can be a successful part of education going forward, according to a viewpoint published in JAMA Pediatrics. However, schools also can reopen safely if precautions are taken, and students would benefit in many ways, according to a second viewpoint.

monkeybusinessimages/Thinkstock

“As policy makers, health care professionals, and parents prepare for the fall semester and as public and private schools grapple with how to make that possible, a better understanding of K-12 virtual learning options and outcomes may facilitate those difficult decisions,” wrote Erik Black, PhD, of the University of Florida, Gainesville; Richard Ferdig, PhD, of Kent State University, Ohio; and Lindsay A. Thompson, MD, of the University of Florida, Gainesville.

“Importantly, K-12 virtual schooling is not suited for all students or all families.”

In a viewpoint published in JAMA Pediatrics, the authors noted that virtual schooling has existed in the United States in various forms for some time. “Just like the myriad options that are available for face-to-face schooling in the U.S., virtual schooling exists in a complex landscape of for-profit, charter, and public options.”
 

Not all virtual schools are equal

Consequently, not all virtual schools are created equal, they emphasized. Virtual education can be successful for many students when presented by trained online instructors using a curriculum designed to be effective in an online venue.

“Parents need to seek reviews and ask for educational outcomes from each virtual school system to assess the quality of the provided education,” Dr. Black, Dr. Ferdig, and Dr. Thompson emphasized.

Key questions for parents to consider when faced with online learning include the type of technology needed to participate; whether their child can maintain a study schedule and complete assignments with limited supervision; whether their child could ask for help and communicate with teachers through technology including phone, text, email, or video; and whether their child has the basic reading, math, and computer literacy skills to engage in online learning, the authors said. Other questions include the school’s expectations for parents and caregivers, how student information may be shared, and how the virtual school lines up with state standards for K-12 educators (in the case of options outside the public school system).

“The COVID-19 pandemic offers a unique challenge for educators, policymakers, and health care professionals to partner with parents to make the best local and individual decisions for children,” Dr. Black, Dr. Ferdig, and Dr. Thompson concluded.
 

Schools may be able to open safely

Children continue to make up a low percentage of COVID-19 cases and appear less likely to experience illness, wrote C. Jason Wang, MD, PhD, and Henry Bair, BS, of Stanford (Calif.) University in a second viewpoint also published in JAMA Pediatrics. The impact of long-term school closures extends beyond education and can “exacerbate socioeconomic disparities, amplify existing educational inequalities, and aggravate food insecurity, domestic violence, and mental health disorders,” they wrote.

Dr. Wang and Mr. Bair proposed that school districts “engage key stakeholders to establish a COVID-19 task force, composed of the superintendent, members of the school board, teachers, parents, and health care professionals to develop policies and procedures,” that would allow schools to open safely.

The authors outlined strategies including adapting teaching spaces to accommodate physical distance, with the addition of temporary modular buildings if needed. They advised assigned seating on school buses, and acknowledged the need for the availability of protective equipment, including hand sanitizer and masks, as well as the possible use of transparent barriers on the sides of student desks.

“As the AAP [American Academy of Pediatrics] guidance suggests, teachers who must work closely with students with special needs or with students who are unable to wear masks should wear N95 masks if possible or wear face shields in addition to surgical masks,” Dr. Wang and Mr. Bair noted. Other elements of the AAP guidance include the creation of fixed cohorts of students and teachers to limit virus exposure.

“Even with all the precautions in place, COVID-19 outbreaks within schools are still likely,” they said. “Therefore, schools will need to remain flexible and consider temporary closures if there is an outbreak involving multiple students and/or staff and be ready to transition to online education.”

The AAP guidance does not address operational approaches to identifying signs and symptoms of COVID-19, the authors noted. “To address this, we recommend that schools implement multilevel screening for students and staff.”

“In summary, to maximize health and educational outcomes, school districts should adopt some or all of the measures of the AAP guidance and prioritize them after considering local COVID-19 incidence, key stakeholder input, and budgetary constraints,” Dr. Wang and Mr. Bair concluded.
 

Schools opening is a regional decision

“The mission of the AAP is to attain optimal physical, mental, and social health and well-being for all infants, children, adolescents, and young adults,” Howard Smart, MD, said in an interview. The question of school reopening “is of national importance, and the AAP has a national role in making recommendations regarding national policy affecting the health of the children.”

“The decision to open schools will be made regionally, but it is important for a nonpolitical national voice to make expert recommendations,” he emphasized.

“Many of the recommendations are ideal goals,” noted Dr. Smart, chairman of the department of pediatrics at the Sharp Rees-Stealy Medical Group in San Diego. “It will be difficult, for example, to implement symptom screening every day before school, no matter where it is performed. Some of the measures may be quite costly, and take time to implement, or require expansion of school staff, for which there may be no budget.”

In addition, “[n]ot all students are likely to comply with masking, distance, and hand-washing recommendations. One student who is noncompliant will be able to infect many other students and staff, as has been seen in other countries.” Also, parental attitudes toward control measures are likely to affect student attitudes, he noted.

“I have interviewed many families at recent checkups, and most have felt that the rush to remote learning that occurred at the end of the last school year resulted in fairly disorganized instruction,” Dr. Smart said. “They are hoping that, having had the summer to plan ahead, the remote teaching will be handled better. Remote learning will certainly work best for self-motivated, organized students with good family support, as noted in the Black, Ferdig, and Thompson article,” he said.

Pediatricians can support the schools by being a source of evidence-based information for parents, Dr. Smart said. “Pediatricians with time and energy might want to volunteer to hold informational video conferences for parents and/or school personnel if they feel they are up to date on current COVID-19 science and want to handle potentially contentious questions.”

The decision parents make to send their children back to school comes down to a risk-benefit calculation. “In some communities this may be left to parents, while in other communities this will a public health decision,” he said. “It is still not clear whether having students attend school in person will result in increased spread of COVID-19 among the students, or in their communities. Although some evidence from early in the pandemic suggests that children may not spread the virus as much as adults, more recent evidence suggests that children 10 years and older do transmit the virus at least as much as adults.”

“The risk to the students and the community, therefore, is unknown,” and difficult to compare with the benefit of in-person schooling, Dr. Smart noted.

“We will learn quite a bit from communities where students do go back to in-person class, as we follow the progression of COVID-19 over the weeks following the resumption of instruction.” Ultimately, advice to parents will need to be tailored to the current conditions of COVID-19 transmission in the community, he concluded.
 

It’s not just about education

“The AAP released its guidance to ensure that as school districts were contemplating reopening they were considering the full array of risks for children and adolescents. These risks included not only those related to COVID-19, but also those related to the impact of not reopening in-person,” Nathaniel Beers, MD, president of the HSC Health Care System in Washington, said in an interview.

“Students and families are dependent on schools for much more than just an education, and those [elements] need to be factored into the decisions to reopen,” the pediatrician said.

However, “[t]he major barrier for schools is resources to safely reopen,” said Dr. Beers. “The additional staffing and supplies will require additional funding. There are increased demands regardless of whether students are learning in-person or virtually or through hybrid models.”

“Another significant barrier is ensuring that parents and staff are actively engaged in planning for the type of model being used,” he said.

“All of the models require buy-in by staff and parents. This will require significant outreach and strong communication plans. Schools also need to ensure they are planning not just for how to return students to schools, but what will happen when staff or students test positive for COVID-19. Students, families, and staff all will need to know what these plans are up front to feel confident in returning to school,” he emphasized.

“There are students who can thrive in a virtual learning environment,” Dr. Beers said. “There are also students who benefit from the virtual learning environment because of their own risk, or because of a family member’s risk for COVID-19 or the complications from it.”

“However, many children with disabilities have struggled in a virtual environment,” he said. “These students struggle to access the educational services without the adequate supports at home. They often receive additional services in school, such as speech, occupational therapy or physical therapy, or nursing services, that may not have transitioned to home but are critical for their health and development. Many students with disabilities are dependent on family members to successfully access the educational services they need.”

“Pediatricians can play a role in providing feedback on recommendations related to physical distancing and face coverings in particular,” said Dr. Beers. “In addition, they can be helpful in developing plans for children with disabilities as well as what the response plan should be for students who become sick during the school day.”

The Centers for Disease Control and Prevention released a decision tool for parents who are considering whether to send their child to in-person school, and pediatricians can help parents walk through these questions, Dr. Beers noted. “In addition, pediatricians play an important role in helping patients and families think about the risks of COVID for the patient and other family members, and this can be helpful in addressing the anxiety that parents and patients may be experiencing.”

Further information can be found in Return to School During COVID-19, which can be located at HealthyChildren.org, by the American Academy of Pediatrics.

The authors of the viewpoints had no relevant financial disclosures. Dr. Smart, a member of the Pediatric News editorial advisory board, had no relevant financial disclosures. Dr. Beers has served on the editorial advisory board of Pediatric News in the past, but had no relevant financial disclosures.

SOURCES: Black E, Ferdig R, Thompson LA. JAMA Pediatr. 2020 Aug 11. doi: 10.1001/jamapediatrics.2020.3800. Wang CJ and Bair H. JAMA Pediatr. Aug 11. doi: 10.1001/jamapediatrics.2020.3871.
 

The 1918 H1N1 influenza pandemic was the most severe pandemic in recent history. Fifty to 100 million individuals died worldwide, with approximately 675,000 deaths in the United States.^1-3 The fatality rate was approximately 2% and was highest during the second and third waves of the disease.⁴ At that time, there were no diagnostic tests for influenza infection, influenza vaccines, antiviral drugs, antibiotics to treat secondary bacterial infections, or mechanical ventilation. Some cities decided to close schools, limit public gatherings, self-isolate, and issue quarantine orders; the federal government took no central role.

The 1918 influenza pandemic seems far away in history, but my mother often tells me stories about her own grandmother who disliked shaking anyone’s hands and would worry when people coughed or sneezed around her. It sounded like she was overreacting. Now, we can better relate to her concerns. Life has changed dramatically.

In mid-February 2020, news spread that the coronavirus disease 2019 (COVID-19) had spread from Wuhan, China, to a number of countries in Asia and the Middle East. I was following the news with great sadness for those affected countries, especially for Iran, my country of origin, which had become an epicenter of COVID-19. We were not worried for ourselves in the United States. These infections seemed far away. However, once Italy became the new epicenter of COVID-19 with alarmingly high death rates, I grasped the inevitable reality: The novel coronavirus would not spare the United States and would not spare New York.

Then the virus arrived in New York City. On March 10, 2020, our hospital recommended using teledermatology instead of in-person visits in an attempt to keep patients safe in their own homes. Cases of COVID-19 were escalating, hospitals were filling up, health care workers were falling ill, and there was a shortage of health care staff and personal protective equipment (PPE). Dermatologists at various hospitals were asked to retrain to help care for COVID-19 patients.

On March 13, flights from Europe to the United States were suspended. A statewide stay-at-home order subsequently went into effect on March 22. It felt surreal. From March 23 on, various specialty physicians and nurses in our hospital volunteered to work as frontline staff in the newly prepared annex where patients with possible COVID-19 would arrive. My dermatology co-residents and I started working as frontline physicians. Everything we had heard from the countries affected first had become our reality. Our hospital, part of the largest public health care system in the nation, became a dedicated COVID-19 treatment center.

Large numbers of scared patients with symptoms of COVID-19 flooded the annex. We sent the majority of them home, unable to offer them even a diagnostic test, and advised them to stay isolated. We only had the capacity to test those who required hospital admission.

It broke my heart even more when my colleagues became patients. We often felt helpless, not being able to help every patient and not being able to help our infected colleagues.

Elective surgeries were suspended. Inpatient beds, including specialized intensive care unit beds, rapidly filled up with COVID-19 patients. To help with the surge of patients, our hospital added medical and intensive care unit beds. The hospital became surreal, the corridors eerily empty and silent while every bed was filled, and health care workers were rushing around the inpatient units.

Life quickly became filled with fears—worries about how sick the patients would be, how much we would be able to help them, whether we would have enough PPE, who among our friends or family might be infected next, and whether we might ourselves be next. As PPE became scarce, I desperately searched for some form of protective equipment. I hunted for protective masks, face shields, eye protection, and gowns. We had to reuse disposable N95 masks and face shields multiple times and disinfect them as best we could. Our attendings ordered any protective gear they could find for us. Nearly everything was sold out; the very few items remaining would not for arrive for months. I could have never imagined that I would be afraid of going to work, of not having the appropriate protective gear, and that any day might be my last because of my profession.

New York City had become the epicenter of COVID-19. The city, the country, and the world were in chaos. Hospitals were overflowing, and makeshift morgues were appearing outside of hospitals. Those who could fled the city. Despite warnings from experts, we were not prepared. The number of deaths was climbing rapidly. There was no clarity on who could be tested or how to get it done. It felt like a nightmare.

Social distancing was in place, nonessential businesses were shut down, street vendors disappeared, and people were advised to wear face coverings. People were afraid of each other, afraid of getting too close and catching the virus. New York City—The City That Never Sleeps—went into deep sleep. Every day brought ever greater numbers of infected patients and more deaths.

Every day at 7:00 pm, people in New York City started clapping from their windows to salute health care workers, bringing tears to my eyes—tears for the gratitude of people mixed with tears of fear for my life and the lives of my patients and colleagues. I made arrangements for the event of falling ill, including a list of names and contact details of my family and close friends so they could be reached in case I ended up in intensive care or died.

After around 2 months of lockdown, New York City passed its peak, and the epicenter moved on. The current death toll (ie, confirmed deaths due to COVID-19) in New York stands at 18,836, while the reported death toll in the United States is 143,868, according to the Centers for Disease Control and Prevention. New York City has started a phased reopening to a new normal. Elective care has resumed, and people are leaving their homes again, eager to bring some sense of normalcy back into their lives.

I fear for those who will contract the virus in the next wave. I wonder what we will have learned.

Acknowledgment
The author wishes to thank Steven R. Feldman, MD, PhD (Winston-Salem, North Carolina), for his friendship and invaluable assistance with the conception and editing of this manuscript.

The 1918 H1N1 influenza pandemic was the most severe pandemic in recent history. Fifty to 100 million individuals died worldwide, with approximately 675,000 deaths in the United States.^1-3 The fatality rate was approximately 2% and was highest during the second and third waves of the disease.⁴ At that time, there were no diagnostic tests for influenza infection, influenza vaccines, antiviral drugs, antibiotics to treat secondary bacterial infections, or mechanical ventilation. Some cities decided to close schools, limit public gatherings, self-isolate, and issue quarantine orders; the federal government took no central role.

The 1918 influenza pandemic seems far away in history, but my mother often tells me stories about her own grandmother who disliked shaking anyone’s hands and would worry when people coughed or sneezed around her. It sounded like she was overreacting. Now, we can better relate to her concerns. Life has changed dramatically.

In mid-February 2020, news spread that the coronavirus disease 2019 (COVID-19) had spread from Wuhan, China, to a number of countries in Asia and the Middle East. I was following the news with great sadness for those affected countries, especially for Iran, my country of origin, which had become an epicenter of COVID-19. We were not worried for ourselves in the United States. These infections seemed far away. However, once Italy became the new epicenter of COVID-19 with alarmingly high death rates, I grasped the inevitable reality: The novel coronavirus would not spare the United States and would not spare New York.

Then the virus arrived in New York City. On March 10, 2020, our hospital recommended using teledermatology instead of in-person visits in an attempt to keep patients safe in their own homes. Cases of COVID-19 were escalating, hospitals were filling up, health care workers were falling ill, and there was a shortage of health care staff and personal protective equipment (PPE). Dermatologists at various hospitals were asked to retrain to help care for COVID-19 patients.

On March 13, flights from Europe to the United States were suspended. A statewide stay-at-home order subsequently went into effect on March 22. It felt surreal. From March 23 on, various specialty physicians and nurses in our hospital volunteered to work as frontline staff in the newly prepared annex where patients with possible COVID-19 would arrive. My dermatology co-residents and I started working as frontline physicians. Everything we had heard from the countries affected first had become our reality. Our hospital, part of the largest public health care system in the nation, became a dedicated COVID-19 treatment center.

Large numbers of scared patients with symptoms of COVID-19 flooded the annex. We sent the majority of them home, unable to offer them even a diagnostic test, and advised them to stay isolated. We only had the capacity to test those who required hospital admission.

It broke my heart even more when my colleagues became patients. We often felt helpless, not being able to help every patient and not being able to help our infected colleagues.

Elective surgeries were suspended. Inpatient beds, including specialized intensive care unit beds, rapidly filled up with COVID-19 patients. To help with the surge of patients, our hospital added medical and intensive care unit beds. The hospital became surreal, the corridors eerily empty and silent while every bed was filled, and health care workers were rushing around the inpatient units.

Life quickly became filled with fears—worries about how sick the patients would be, how much we would be able to help them, whether we would have enough PPE, who among our friends or family might be infected next, and whether we might ourselves be next. As PPE became scarce, I desperately searched for some form of protective equipment. I hunted for protective masks, face shields, eye protection, and gowns. We had to reuse disposable N95 masks and face shields multiple times and disinfect them as best we could. Our attendings ordered any protective gear they could find for us. Nearly everything was sold out; the very few items remaining would not for arrive for months. I could have never imagined that I would be afraid of going to work, of not having the appropriate protective gear, and that any day might be my last because of my profession.

New York City had become the epicenter of COVID-19. The city, the country, and the world were in chaos. Hospitals were overflowing, and makeshift morgues were appearing outside of hospitals. Those who could fled the city. Despite warnings from experts, we were not prepared. The number of deaths was climbing rapidly. There was no clarity on who could be tested or how to get it done. It felt like a nightmare.

Social distancing was in place, nonessential businesses were shut down, street vendors disappeared, and people were advised to wear face coverings. People were afraid of each other, afraid of getting too close and catching the virus. New York City—The City That Never Sleeps—went into deep sleep. Every day brought ever greater numbers of infected patients and more deaths.

Every day at 7:00 pm, people in New York City started clapping from their windows to salute health care workers, bringing tears to my eyes—tears for the gratitude of people mixed with tears of fear for my life and the lives of my patients and colleagues. I made arrangements for the event of falling ill, including a list of names and contact details of my family and close friends so they could be reached in case I ended up in intensive care or died.

After around 2 months of lockdown, New York City passed its peak, and the epicenter moved on. The current death toll (ie, confirmed deaths due to COVID-19) in New York stands at 18,836, while the reported death toll in the United States is 143,868, according to the Centers for Disease Control and Prevention. New York City has started a phased reopening to a new normal. Elective care has resumed, and people are leaving their homes again, eager to bring some sense of normalcy back into their lives.

I fear for those who will contract the virus in the next wave. I wonder what we will have learned.

Acknowledgment
The author wishes to thank Steven R. Feldman, MD, PhD (Winston-Salem, North Carolina), for his friendship and invaluable assistance with the conception and editing of this manuscript.

The 1918 H1N1 influenza pandemic was the most severe pandemic in recent history. Fifty to 100 million individuals died worldwide, with approximately 675,000 deaths in the United States.^1-3 The fatality rate was approximately 2% and was highest during the second and third waves of the disease.⁴ At that time, there were no diagnostic tests for influenza infection, influenza vaccines, antiviral drugs, antibiotics to treat secondary bacterial infections, or mechanical ventilation. Some cities decided to close schools, limit public gatherings, self-isolate, and issue quarantine orders; the federal government took no central role.

The 1918 influenza pandemic seems far away in history, but my mother often tells me stories about her own grandmother who disliked shaking anyone’s hands and would worry when people coughed or sneezed around her. It sounded like she was overreacting. Now, we can better relate to her concerns. Life has changed dramatically.

In mid-February 2020, news spread that the coronavirus disease 2019 (COVID-19) had spread from Wuhan, China, to a number of countries in Asia and the Middle East. I was following the news with great sadness for those affected countries, especially for Iran, my country of origin, which had become an epicenter of COVID-19. We were not worried for ourselves in the United States. These infections seemed far away. However, once Italy became the new epicenter of COVID-19 with alarmingly high death rates, I grasped the inevitable reality: The novel coronavirus would not spare the United States and would not spare New York.

Then the virus arrived in New York City. On March 10, 2020, our hospital recommended using teledermatology instead of in-person visits in an attempt to keep patients safe in their own homes. Cases of COVID-19 were escalating, hospitals were filling up, health care workers were falling ill, and there was a shortage of health care staff and personal protective equipment (PPE). Dermatologists at various hospitals were asked to retrain to help care for COVID-19 patients.

On March 13, flights from Europe to the United States were suspended. A statewide stay-at-home order subsequently went into effect on March 22. It felt surreal. From March 23 on, various specialty physicians and nurses in our hospital volunteered to work as frontline staff in the newly prepared annex where patients with possible COVID-19 would arrive. My dermatology co-residents and I started working as frontline physicians. Everything we had heard from the countries affected first had become our reality. Our hospital, part of the largest public health care system in the nation, became a dedicated COVID-19 treatment center.

Large numbers of scared patients with symptoms of COVID-19 flooded the annex. We sent the majority of them home, unable to offer them even a diagnostic test, and advised them to stay isolated. We only had the capacity to test those who required hospital admission.

It broke my heart even more when my colleagues became patients. We often felt helpless, not being able to help every patient and not being able to help our infected colleagues.

Elective surgeries were suspended. Inpatient beds, including specialized intensive care unit beds, rapidly filled up with COVID-19 patients. To help with the surge of patients, our hospital added medical and intensive care unit beds. The hospital became surreal, the corridors eerily empty and silent while every bed was filled, and health care workers were rushing around the inpatient units.

Life quickly became filled with fears—worries about how sick the patients would be, how much we would be able to help them, whether we would have enough PPE, who among our friends or family might be infected next, and whether we might ourselves be next. As PPE became scarce, I desperately searched for some form of protective equipment. I hunted for protective masks, face shields, eye protection, and gowns. We had to reuse disposable N95 masks and face shields multiple times and disinfect them as best we could. Our attendings ordered any protective gear they could find for us. Nearly everything was sold out; the very few items remaining would not for arrive for months. I could have never imagined that I would be afraid of going to work, of not having the appropriate protective gear, and that any day might be my last because of my profession.

New York City had become the epicenter of COVID-19. The city, the country, and the world were in chaos. Hospitals were overflowing, and makeshift morgues were appearing outside of hospitals. Those who could fled the city. Despite warnings from experts, we were not prepared. The number of deaths was climbing rapidly. There was no clarity on who could be tested or how to get it done. It felt like a nightmare.

Social distancing was in place, nonessential businesses were shut down, street vendors disappeared, and people were advised to wear face coverings. People were afraid of each other, afraid of getting too close and catching the virus. New York City—The City That Never Sleeps—went into deep sleep. Every day brought ever greater numbers of infected patients and more deaths.

Every day at 7:00 pm, people in New York City started clapping from their windows to salute health care workers, bringing tears to my eyes—tears for the gratitude of people mixed with tears of fear for my life and the lives of my patients and colleagues. I made arrangements for the event of falling ill, including a list of names and contact details of my family and close friends so they could be reached in case I ended up in intensive care or died.

After around 2 months of lockdown, New York City passed its peak, and the epicenter moved on. The current death toll (ie, confirmed deaths due to COVID-19) in New York stands at 18,836, while the reported death toll in the United States is 143,868, according to the Centers for Disease Control and Prevention. New York City has started a phased reopening to a new normal. Elective care has resumed, and people are leaving their homes again, eager to bring some sense of normalcy back into their lives.

I fear for those who will contract the virus in the next wave. I wonder what we will have learned.

Acknowledgment
The author wishes to thank Steven R. Feldman, MD, PhD (Winston-Salem, North Carolina), for his friendship and invaluable assistance with the conception and editing of this manuscript.

In a large California health care plan, among patients with COVID-19, men aged 60 years and younger had a much higher risk of dying within 3 weeks of diagnosis if they had severe obesity as opposed to being of normal weight, independently of other risk factors.

The research shows that “obesity plays a profound role in risk for death from COVID-19, particularly in male patients and younger populations,” reported Sara Y. Tartof, PhD, MPH, Kaiser Permanente Southern California, Pasadena, Calif., and coauthors.

The data “highlight the leading role of severe obesity over correlated risk factors, providing a target for early intervention,” they concluded in an article published online Aug. 12 in Annals of Internal Medicine.

This work adds to nearly 300 articles that have shown that severe obesity is associated with an increased risk for morbidity and mortality from COVID-19.

In an accompanying editorial, David A. Kass, MD, said: “Consistency of this new study and prior research should put to rest the contention that obesity is common in severe COVID-19 because it is common in the population.”

Rather, these findings show that “obesity is an important independent risk factor for serious COVID-19 disease,” he pointed out.

On the basis of this evidence, “arguably the hardest question to answer is: What is to be done?” wondered Kass, of Johns Hopkins University, Baltimore.

Although data consistently show that a body mass index >35 kg/m² is predictive of major health risks, “weight reduction at that level of obesity is difficult and certainly is not achieved rapidly,” Dr. Kass stressed.

“Therefore ... social distancing; altering behaviors to reduce viral exposure and transmission, such as wearing masks; and instituting policies and health care approaches that recognize the potential effects of obesity should be implemented,” he emphasized. “These actions should help and are certainly doable.”

Similarly, Dr. Tartof and colleagues said their “findings also reveal the distressing collision of two pandemics: COVID-19 and obesity.

“As COVID-19 continues to spread unabated, we must focus our immediate efforts on containing the crisis at hand,” they urged.

However, the findings also “underscore the need for future collective efforts to combat the equally devastating, and potentially synergistic, force of the obesity epidemic.”
 

COVID-19 pandemic collides with obesity epidemic

Previous studies of obesity and COVID-19 were small, did not adjust for multiple confounders, or did not include nonhospitalized patients, Dr. Tartof and coauthors wrote.

Their study included 6,916 members of the Kaiser Permanente Southern California health care plan who were diagnosed with COVID-19 from Feb. 13 to May 2, 2020.

The researchers calculated the risk for death at 21 days after a COVID-19 diagnosis; findings were corrected for age, sex, race/ethnicity, smoking, myocardial infarction, heart failure, peripheral vascular disease, cerebrovascular disease, chronic pulmonary disease, renal disease, metastatic tumor or malignancy, other immune disease, hyperlipidemia, hypertension, asthma, organ transplant, and diabetes status.

On the basis of BMI, the patients were classified as being underweight, of normal weight, overweight, or as having class 1, 2, or 3 obesity. BMI of 18.5 to 24 kg/m² is defined as normal weight.

Class 3 obesity, also called severe obesity, included moderately severe obesity (BMI, 40-44 kg/m²) and extremely severe obesity (≥45 kg/m²).

A little more than half of the patients were women (55%), and more than 50% were Hispanic (54%).

A total of 206 patients (3%) died within 21 days of being diagnosed with COVID-19; of these, 67% had been hospitalized, and 43% had been intubated.

Overall, the COVID-19 patients with moderately severe or extremely severe obesity had a 2.7-fold and 4.2-fold increased risk for death, respectively, within 3 weeks compared with patients of normal weight.

Patients in the other BMI categories did not have a significantly higher risk of dying during follow-up.

However, each decade of increasing age after age 40 was associated with a stepwise increased risk for death within 3 weeks of the COVID-19 diagnosis.
 

Risk stratified by age and sex

Further analysis showed that, “most strikingly,” among patients aged 60 and younger, those with moderately severe obesity and extremely severe obesity had significant 17-fold and 12-fold higher risks of dying during follow-up, respectively, compared with patients of normal weight, the researchers reported.

In patients older than 60, moderately severe obesity did not confer a significant increased risk for imminent death from COVID-19; extremely severe obesity conferred a smaller, threefold increased risk for this.

“Our finding that severe obesity, particularly among younger patients, eclipses the mortality risk posed by other obesity-related conditions, such as history of myocardial infarction (MI), diabetes, hypertension, or hyperlipidemia, suggests a significant pathophysiologic link between excess adiposity and severe COVID-19 illness,” the researchers noted.

This independent increased risk for death with severe obesity was seen in men but not in women.

Men with moderately severe and extremely severe obesity had significant 4.8-fold and 10-fold higher risks of dying within 3 weeks, respectively, compared with men of normal weight.

“That the risks are higher in younger patients is probably not because obesity is particularly damaging in this age group; it is more likely that other serious comorbidities that evolve later in life take over as dominant risk factors,” Dr. Kass suggested in his editorial.

“That males are particularly affected may reflect their greater visceral adiposity over females, given that this fat is notably proinflammatory and contributes to metabolic and vascular disease,” he added.

“As a cardiologist who studies heart failure,” Dr. Kass wrote, “I am struck by how many of the mechanisms that are mentioned in reviews of obesity risk and heart disease are also mentioned in reviews of obesity and COVID-19.”

The study was funded by Roche-Genentech. Kass has disclosed no relevant financial relationships. Disclosures of the authors are listed in the article.
 

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

In a large California health care plan, among patients with COVID-19, men aged 60 years and younger had a much higher risk of dying within 3 weeks of diagnosis if they had severe obesity as opposed to being of normal weight, independently of other risk factors.

The research shows that “obesity plays a profound role in risk for death from COVID-19, particularly in male patients and younger populations,” reported Sara Y. Tartof, PhD, MPH, Kaiser Permanente Southern California, Pasadena, Calif., and coauthors.

The data “highlight the leading role of severe obesity over correlated risk factors, providing a target for early intervention,” they concluded in an article published online Aug. 12 in Annals of Internal Medicine.

This work adds to nearly 300 articles that have shown that severe obesity is associated with an increased risk for morbidity and mortality from COVID-19.

In an accompanying editorial, David A. Kass, MD, said: “Consistency of this new study and prior research should put to rest the contention that obesity is common in severe COVID-19 because it is common in the population.”

Rather, these findings show that “obesity is an important independent risk factor for serious COVID-19 disease,” he pointed out.

On the basis of this evidence, “arguably the hardest question to answer is: What is to be done?” wondered Kass, of Johns Hopkins University, Baltimore.

Although data consistently show that a body mass index >35 kg/m² is predictive of major health risks, “weight reduction at that level of obesity is difficult and certainly is not achieved rapidly,” Dr. Kass stressed.

“Therefore ... social distancing; altering behaviors to reduce viral exposure and transmission, such as wearing masks; and instituting policies and health care approaches that recognize the potential effects of obesity should be implemented,” he emphasized. “These actions should help and are certainly doable.”

Similarly, Dr. Tartof and colleagues said their “findings also reveal the distressing collision of two pandemics: COVID-19 and obesity.

“As COVID-19 continues to spread unabated, we must focus our immediate efforts on containing the crisis at hand,” they urged.

However, the findings also “underscore the need for future collective efforts to combat the equally devastating, and potentially synergistic, force of the obesity epidemic.”
 

COVID-19 pandemic collides with obesity epidemic

Previous studies of obesity and COVID-19 were small, did not adjust for multiple confounders, or did not include nonhospitalized patients, Dr. Tartof and coauthors wrote.

Their study included 6,916 members of the Kaiser Permanente Southern California health care plan who were diagnosed with COVID-19 from Feb. 13 to May 2, 2020.

The researchers calculated the risk for death at 21 days after a COVID-19 diagnosis; findings were corrected for age, sex, race/ethnicity, smoking, myocardial infarction, heart failure, peripheral vascular disease, cerebrovascular disease, chronic pulmonary disease, renal disease, metastatic tumor or malignancy, other immune disease, hyperlipidemia, hypertension, asthma, organ transplant, and diabetes status.

On the basis of BMI, the patients were classified as being underweight, of normal weight, overweight, or as having class 1, 2, or 3 obesity. BMI of 18.5 to 24 kg/m² is defined as normal weight.

Class 3 obesity, also called severe obesity, included moderately severe obesity (BMI, 40-44 kg/m²) and extremely severe obesity (≥45 kg/m²).

A little more than half of the patients were women (55%), and more than 50% were Hispanic (54%).

A total of 206 patients (3%) died within 21 days of being diagnosed with COVID-19; of these, 67% had been hospitalized, and 43% had been intubated.

Overall, the COVID-19 patients with moderately severe or extremely severe obesity had a 2.7-fold and 4.2-fold increased risk for death, respectively, within 3 weeks compared with patients of normal weight.

Patients in the other BMI categories did not have a significantly higher risk of dying during follow-up.

However, each decade of increasing age after age 40 was associated with a stepwise increased risk for death within 3 weeks of the COVID-19 diagnosis.
 

Risk stratified by age and sex

Further analysis showed that, “most strikingly,” among patients aged 60 and younger, those with moderately severe obesity and extremely severe obesity had significant 17-fold and 12-fold higher risks of dying during follow-up, respectively, compared with patients of normal weight, the researchers reported.

In patients older than 60, moderately severe obesity did not confer a significant increased risk for imminent death from COVID-19; extremely severe obesity conferred a smaller, threefold increased risk for this.

“Our finding that severe obesity, particularly among younger patients, eclipses the mortality risk posed by other obesity-related conditions, such as history of myocardial infarction (MI), diabetes, hypertension, or hyperlipidemia, suggests a significant pathophysiologic link between excess adiposity and severe COVID-19 illness,” the researchers noted.

This independent increased risk for death with severe obesity was seen in men but not in women.

Men with moderately severe and extremely severe obesity had significant 4.8-fold and 10-fold higher risks of dying within 3 weeks, respectively, compared with men of normal weight.

“That the risks are higher in younger patients is probably not because obesity is particularly damaging in this age group; it is more likely that other serious comorbidities that evolve later in life take over as dominant risk factors,” Dr. Kass suggested in his editorial.

“That males are particularly affected may reflect their greater visceral adiposity over females, given that this fat is notably proinflammatory and contributes to metabolic and vascular disease,” he added.

“As a cardiologist who studies heart failure,” Dr. Kass wrote, “I am struck by how many of the mechanisms that are mentioned in reviews of obesity risk and heart disease are also mentioned in reviews of obesity and COVID-19.”

The study was funded by Roche-Genentech. Kass has disclosed no relevant financial relationships. Disclosures of the authors are listed in the article.
 

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

In a large California health care plan, among patients with COVID-19, men aged 60 years and younger had a much higher risk of dying within 3 weeks of diagnosis if they had severe obesity as opposed to being of normal weight, independently of other risk factors.

The research shows that “obesity plays a profound role in risk for death from COVID-19, particularly in male patients and younger populations,” reported Sara Y. Tartof, PhD, MPH, Kaiser Permanente Southern California, Pasadena, Calif., and coauthors.

The data “highlight the leading role of severe obesity over correlated risk factors, providing a target for early intervention,” they concluded in an article published online Aug. 12 in Annals of Internal Medicine.

This work adds to nearly 300 articles that have shown that severe obesity is associated with an increased risk for morbidity and mortality from COVID-19.

In an accompanying editorial, David A. Kass, MD, said: “Consistency of this new study and prior research should put to rest the contention that obesity is common in severe COVID-19 because it is common in the population.”

Rather, these findings show that “obesity is an important independent risk factor for serious COVID-19 disease,” he pointed out.

On the basis of this evidence, “arguably the hardest question to answer is: What is to be done?” wondered Kass, of Johns Hopkins University, Baltimore.

Although data consistently show that a body mass index >35 kg/m² is predictive of major health risks, “weight reduction at that level of obesity is difficult and certainly is not achieved rapidly,” Dr. Kass stressed.

“Therefore ... social distancing; altering behaviors to reduce viral exposure and transmission, such as wearing masks; and instituting policies and health care approaches that recognize the potential effects of obesity should be implemented,” he emphasized. “These actions should help and are certainly doable.”

Similarly, Dr. Tartof and colleagues said their “findings also reveal the distressing collision of two pandemics: COVID-19 and obesity.

“As COVID-19 continues to spread unabated, we must focus our immediate efforts on containing the crisis at hand,” they urged.

However, the findings also “underscore the need for future collective efforts to combat the equally devastating, and potentially synergistic, force of the obesity epidemic.”
 

COVID-19 pandemic collides with obesity epidemic

Previous studies of obesity and COVID-19 were small, did not adjust for multiple confounders, or did not include nonhospitalized patients, Dr. Tartof and coauthors wrote.

Their study included 6,916 members of the Kaiser Permanente Southern California health care plan who were diagnosed with COVID-19 from Feb. 13 to May 2, 2020.

The researchers calculated the risk for death at 21 days after a COVID-19 diagnosis; findings were corrected for age, sex, race/ethnicity, smoking, myocardial infarction, heart failure, peripheral vascular disease, cerebrovascular disease, chronic pulmonary disease, renal disease, metastatic tumor or malignancy, other immune disease, hyperlipidemia, hypertension, asthma, organ transplant, and diabetes status.

On the basis of BMI, the patients were classified as being underweight, of normal weight, overweight, or as having class 1, 2, or 3 obesity. BMI of 18.5 to 24 kg/m² is defined as normal weight.

Class 3 obesity, also called severe obesity, included moderately severe obesity (BMI, 40-44 kg/m²) and extremely severe obesity (≥45 kg/m²).

A little more than half of the patients were women (55%), and more than 50% were Hispanic (54%).

A total of 206 patients (3%) died within 21 days of being diagnosed with COVID-19; of these, 67% had been hospitalized, and 43% had been intubated.

Overall, the COVID-19 patients with moderately severe or extremely severe obesity had a 2.7-fold and 4.2-fold increased risk for death, respectively, within 3 weeks compared with patients of normal weight.

Patients in the other BMI categories did not have a significantly higher risk of dying during follow-up.

However, each decade of increasing age after age 40 was associated with a stepwise increased risk for death within 3 weeks of the COVID-19 diagnosis.
 

Risk stratified by age and sex

Further analysis showed that, “most strikingly,” among patients aged 60 and younger, those with moderately severe obesity and extremely severe obesity had significant 17-fold and 12-fold higher risks of dying during follow-up, respectively, compared with patients of normal weight, the researchers reported.

In patients older than 60, moderately severe obesity did not confer a significant increased risk for imminent death from COVID-19; extremely severe obesity conferred a smaller, threefold increased risk for this.

“Our finding that severe obesity, particularly among younger patients, eclipses the mortality risk posed by other obesity-related conditions, such as history of myocardial infarction (MI), diabetes, hypertension, or hyperlipidemia, suggests a significant pathophysiologic link between excess adiposity and severe COVID-19 illness,” the researchers noted.

This independent increased risk for death with severe obesity was seen in men but not in women.

Men with moderately severe and extremely severe obesity had significant 4.8-fold and 10-fold higher risks of dying within 3 weeks, respectively, compared with men of normal weight.

“That the risks are higher in younger patients is probably not because obesity is particularly damaging in this age group; it is more likely that other serious comorbidities that evolve later in life take over as dominant risk factors,” Dr. Kass suggested in his editorial.

“That males are particularly affected may reflect their greater visceral adiposity over females, given that this fat is notably proinflammatory and contributes to metabolic and vascular disease,” he added.

“As a cardiologist who studies heart failure,” Dr. Kass wrote, “I am struck by how many of the mechanisms that are mentioned in reviews of obesity risk and heart disease are also mentioned in reviews of obesity and COVID-19.”

The study was funded by Roche-Genentech. Kass has disclosed no relevant financial relationships. Disclosures of the authors are listed in the article.
 

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

Recently, OBG Management convened an expert panel of clinicians and thought leaders to discuss the changes needed in health care delivery—and in health care policy—that have risen to the forefront of consciousness as a result of the global COVID-19 pandemic. Here is that stimulating exchange moderated by Editorial Board member Dr. Barbara Levy.

Barbara Levy, MD: The disruption of the COVID-19 pandemic has given us an opportunity to consider how we would recraft the delivery of health care for women if we could. My goal for this discussion is to talk about that and see if we can incentivize people to make changes.

Cindy, what are women looking for in health care that they are not getting now?

What women want in health care

Cynthia A. Pearson: Women, like men, want a sense of assurance that health care can be provided in a safe way, and that can’t be given completely right now.

Aside from that, women want a personal connection, ideally with the same provider. Many women are embracing telehealth, which came about because of this disruptive time, and that has potential that we can possibly mobilize around. One thing women don’t always find is consistency and contact, and they would like that.

Scott D. Hayworth, MD: Women want to be listened to, and they want their doctors to take a holistic and individualized approach to their care. In-person visits are the ideal setting for this, but during the pandemic we have had to adapt to new modalities for delivering care: government regulations restricting services, and the necessity to limit the flow of patients into offices, has meant that we have had to rely on remote visits. CareMount Medical has been in the forefront of telehealth with our “Virtual Visit” technology, so we were well prepared, and our patients have embraced this truly vital option. We’ve ramped up capabilities significantly to deal with the surge in volume.

While our practice has been able to provide consistent and convenient access to care, this isn’t the case in all areas of the country. Even before the pandemic, the cost of malpractice insurance has led to shortages of ObGyns; this deficit has been compounded by the closing of hospitals due to restrictions on services imposed to try to stem the spread of COVID-19. The affordability of care has also been jeopardized by job losses and therefore of employer-provided insurance, following months of lockdowns.

Continue to: Dr. Levy...

Dr. Levy: To balance that long-term relationship with access and cost, clearly we are not delivering what is needed. Janice, at UnitedHealth you have experimented with some products and some different ways of delivering care. What are beneficiaries looking for?

Janice Huckaby, MD: There is a real thirst for digital content—everybody consults with Dr. Google. They are looking for reliable sources of clinical content. Ideally, that comes from their physician, but people access it in other ways as well.

I agree that women desire a personalized relationship. That is why we are seeing more communities of women, such as virtual pregnancy support groups, that have cropped up in the age of COVID-19. Women are not content with the idea of “I’m going to see my doctor, get my tummy measured, listen to the heartbeat, and go home.” That model is done. Patients will look for practices that are accessible at convenient times and that can give them the personalized experience to make them feel well cared for and that offer them a long-term relationship.

One concern is that as more obstetric groups use laborists to do their deliveries at the hospital, I wonder whether we do a good job of forming that relationship on the front end, and when it comes to the delivery, will we drop the ball? The jury is out, but it’s worth watching.

Dr. Levy: How do we as obstetrician-gynecologists get patients to consider that we are providing reliable information? There is so much disinformation out there.

Errol R. Norwitz, MD, PhD, MBA: I echo the sentiments discussed and I’ll add that many women want care that is convenient, close to home, coordinated, and integrated—not fragmented. They want their providers and their office to anticipate and know who they are even before they arrive, to be prepared for the visit. And it’s not only care for them, but also care for their families. Women are the gatekeepers to the health care system. They want a health care system in place that will care not just for each member separately but also for the family as an integrated whole.

To answer your question, Barbara, we have all been overwhelmed with the amount of data coming at us, both providers and patients. Teaching providers how to synthesize and integrate the data and then present it to patients is quite a challenge. We have to instill this skill in our trainees, teach them how to absorb and present the data.

Consensus bodies can help in this regard, and ACOG (American College of Obstetricians and Gynecologists) has led the way in providing guidance around the management of pregnancy in the setting of COVID-19. Another reliable site for my trainees is UpToDate, which is easy to access. If a scientific paper comes out today, it will be covered in UpToDate tomorrow. Patients need someone who can synthesize the data and give it to them in little pieces, and keep it current.

Dr. Levy: We need to be a reliable source not only for medical information but also for referral to resources in the community for families and for women.

Continue to: ObGyn services...

 

 

ObGyn services: Primary care or specialty?

Dr. Norwitz: That begs the question, who are we? Are we primary care providers or are we a subspecialty, or are we both?

Ms. Pearson: Women, particularly in their younger, middle reproductive years, see their ObGyn as a primary care provider. The way forward for the profession is to embrace the call that Barbara articulated, to know what other referral sources are available beyond other clinicians. We need to be aware of the social determinants of health—that there are times when the primary care provider needs to know the community well enough to know what is available that would make a difference for that person and her family.

Dr. Levy: Scott, how do you manage that?

Dr. Hayworth: As reimbursement models move rapidly toward value, practices that can undertake risk are in the best position to thrive; specialty providers relying solely on fee-for-service may well be unable to survive. The key for any ObGyn practice is to be of sufficient size and scope that it can manage the primary care for a panel of patients, the more numerous the better; being in charge of those dollars allows maximum control. ObGyns who subspecialize should seek to become members of larger groups, whether comprehensive women’s health practices or multispecialty groups like ours at CareMount Medical, that manage the spectrum of care for their patients.

Dr. Levy: Janice, fill us in on some of the structures that exist now for ObGyns that they may be able to participate in—payment structures like the Women’s Medical Home. Does UnitedHealth have anything like that?

Dr. Huckaby: Probably 3 or 4 exist now, but I agree that risk arrangements are perhaps a wave of the future. Right now, UnitedHealth has accountable care organizations (ACOs) that include ObGyns, a number of them in the Northeast. We also rolled out bundled payment programs.

Our hospital contracts have always had metrics around infection rates and elective deliveries before 39 weeks, and we will probably start seeing some of that put into the provider contracts as well.

There is a desire to move people into a risk-sharing model for payment, but part of the concern there is the infrastructure, because if you are going to manage risk, you need to have staff that can do care coordination. Care coordinators can ensure, for example, that people have transportation to their appointments, and thus address some of the social determinants in ways that historically have not been done in obstetrics.

The ACOs sometimes have given seed money for practices to hire additional staff to do those kinds of things, and that can help get practices started. Probably the people best positioned are in large multispecialty groups that can leverage case management and maybe support other specialties.

I do think we are going to see a move to risk in the future. Obstetrics has moved at a slower pace than we have seen in internal medicine and some other specialties.

Dr. Hayworth: The value model for reimbursement can only be managed via care coordination, maximizing efficacy and efficiency at every level for every patient. Fortunately for ObGyns, we are familiar with the value concept via bundling for obstetrical services covering prenatal to postpartum, including delivery. ObGyn practices need to prepare for a future in which insurers will pay for patient panels in which providers take on the risk for the entirety of care.

At CareMount Medical, we have embraced the value model as one of 40 Next Generation Medicare Accountable Care Organizations across the country. We’ve put in place the infrastructure, from front desk through back office, to optimize resource utilization. Our team approach includes both patient advocates and care coordinators who extend the capabilities of our physicians and ensure that our patients’ needs, including well care, are met comprehensively.

Dr. Huckaby: One area that we sometimes leave out, whether we are talking about payment or a patient-centered medical home, is integration with behavioral health. Anxiety and depression are fairly rampant, fairly underdiagnosed, and woefully undertreated. I hope that our ObGyn practices of the future—and maybe this is the broadening into primary care—will engage and take the lead in addressing some of those issues, because women suffer. We need to embrace the behavioral aspect of care for the whole person more than we have.

Continue to: Physician training issues...

 

 

Physician training issues

Dr. Levy: I could not agree more. We have trained physicians to do illness care, not wellness care, and to be physician and practice centered, not patient centered. While we train medical students in hospital settings and in acute care, there’s not much training in how to manage people or in the factors that determine whether someone is truly well, such as housing security and food security. We are not training physicians in nutrition or in mental health.

Errol, how do we help an ObGyn or women’s health trainee to prepare for the ideal world we are trying to create?

Dr. Norwitz: It’s a challenging question. I like to reference a remarkable piece by Atul Gawande in The New Yorker, in which he interviewed the CEO of the Cheesecake Factory restaurant chain, who in effect said that we’ve got it all wrong; there’s no health in health care.¹ We don’t manage health; we wait until people get sick and then we treat them. We have to put the health back into health care.

It has always been my passion to focus on preventative care. We need to reclaim our identity—I have never particularly liked the name “ObGyn,” the term “women’s health” may be more appropriate and help us focus on disease prevention—and we need to stand up for training programs that separate the O from the G.

Low-volume surgeons, who may do only 1 or 2 hysterectomies per year, can’t maintain their proficiency, and many don’t do enough cases to maintain their robotics privileges. I can foresee a time where labor and delivery units are like ICUs, where the people who work there do nothing but manage labor and perform deliveries using standardized bundles of practice. Such an approach will decrease variability in management and lead to improved outcomes.

We need to completely reframe how we train our pipeline providers to provide care in women’s health. It would be difficult, take a lot of effort, and there would be pushback, I suspect, but that’s where the field needs to go.

The ideal system redesign

Dr. Levy: Cindy, if you could start from scratch and design an ideal comprehensive system to better deliver care for women of all ages, what would that look like?

Ms. Pearson: I would design a system in which people at any life stage met with providers who were less trained in dealing with disease and more trained in the holistic approach to maintaining health. That might be a nurse practitioner or maybe a version of what Errol describes as a new way of training ObGyns. That’s the initial interaction, and the person could be with someone for decades and deepen the relationship in that wonderful way. It would also have an avenue for the times when disease needed to be treated or when more specialized care would be provided. And the financing would be worked out to support consistency.

Dr. Norwitz: We can learn from other countries. Singapore, with only 5.5 million people, has the best health care system in the world. They have a great model. Costa Rica and Cuba have completely redesigned their health care systems. You go through medical school in 2 or 3 years, and then you get embedded in the community. So you have doctors living in the community responsible for the health of their neighbors. They get to know people in the context in which they live and refer them on only when they need more than basic care. These countries have vastly superior outcome measures, and they spend less money on health care.

Dr. Levy: My dream, as we reinvent things, is that we could create a comprehensive Women’s Medical Home where there’s a hub and an opportunity to be centered on patients so they could reach us when needed.

Ideally we could create a structure with a central contact person—a nurse practi­tioner, a midwife, someone in family medicine or internal medicine—someone focused on women’s health who has researched how inequities apply to women and women’s health and the areas where research doesn’t necessarily apply to women as just “smaller men.” Then we would have the hub, and the spokes—those would be mental health care providers, surgeons, and people to provide additional services when needed.

The only way I can figure how to make that work from a payment perspective is with a prospective payment system, a per member, per month capitated payment structure. That way, ancillary and other services would be available, and overtesting and such would be disincentivized.

Continue to: The question of payment...

 

 

The question of payment

Dr. Hayworth: I agree. For every practice, the two key considerations in addressing the challenges of capitation are, first, that the team approach is essential, and, second, that providers appreciate that everything they do for their patients is reimbursed in a global payment.

At CareMount Medical, our team system embeds advanced practice professionals in our primary care and ObGyn offices. Everyone—physicians, midwives, nurse practi­tioners—practices at the top of their license. Our care coordinators ensure that our patients’ health journeys are optimized from well care through specialized needs, engaging every member of the care team effectively.

To optimize our success in a risk model, we recognize that tasks and services that went without direct reimbursement in a fee-for-service arrangement are integral to producing the best outcomes for our patients. We examine everything we do from the perspective of how to provide the most advanced care in the most efficient manner. For example, we drive toward moving procedures from the hospital to the outpatient setting, and from the ambulatory surgical center to the office. This allows us maximal control of both quality and cost, with savings benefiting our group as well as the payers with whom we have contracts.

Dr. Norwitz: I have been fortunate to have trained and worked in 5 different countries on 3 continents. There’s no question there are better health care systems out there. Some form of capitation is needed, whether it’s value-based care or a risk-sharing arrangement. But how do you do it without a single payer? I don’t think you can, but I’m ready to listen.

Dr. Hayworth: You can have capitation without a single payer; in fact, it’s far better to have many payers compete to offer the greatest flexibility to both patients and providers. CareMount Medical has 650,000 patients who rely on us to provide their care with the utmost quality and affordability. In our Next Generation ACO, our Medicare patients have the benefit of care coordination in a team approach that saves our government money, and we are incentivized to do our best because some of those savings return to us.

The needs of Medicare patients, of course, are different from those in other age groups, and our contracts with other payers will reflect that distinction. There’s no inherent reason why capitation has to equal “single payer.” The benefits of the risk model are magnified by incentivizing all participants to provide maximum value.

Continue to: Ms. Pearson...

Ms. Pearson: I am going to comment on capitated care because I think educated consumers are well aware of the benefits of moving away from fee-for-service and bringing in some more sensible system. However, given the historical racial inequities and injustices, and lack of access and disparate treatment, capitation raises fear in the hearts of people whose communities have not gotten the care that they need.

The answer is not to avoid capitation, but to find a way for the profession to be seen more visibly as reflecting who they serve, and we know we can’t change the profession’s racial makeup overnight. That’s a generation-long effort.

Dr. Levy: For capitation to work, there has to be value, you have to meet the quality metrics. Having served on the National Quality Forum on multiple different committees, I am convinced that we measure what is easy to measure, and we are not measuring what really matters to people. My thought is to embrace the communities that have been underserved to help us design the metrics for a capitated system that is meaningful to the people that we serve.

Ms. Pearson: On the West Coast, some people are leading efforts to create patient-centered metrics for respectful maternity care led by Black, indigenous, and people of color communities that are validated with solid research tools.

Algorithms for care

Dr. Norwitz: Artificial intelligence (AI) may have a role to play. For example, I think we do a terrible job of caring for women in the postpartum period. We focus almost all of our care in the antepartum period and not postpartum. I am working with a group with a finance and banking background to try and risk-adjust patients in the antepartum, intrapartum, and postpartum period. We are developing algorithms using AI and deep learning technologies to risk-stratify patients and say, “This patient is low risk so can safely get obstetric care with a family medicine doctor or midwife. That patient requires consultation with a maternal-fetal medicine subspecialist or a general internist,” and so on.

Ms. Pearson: As policy advocates, we are trying to get Medicaid postpartum coverage expanded to 12 months. Too many women fall into a coverage gap shortly after delivery; continued coverage would help improve postpartum outcomes. I am curious how an algorithm might help take better care of women postpartum.

Dr. Norwitz: Postpartum care is one of the greatest areas of need. I love the Dutch model. In the Netherlands, when a woman goes home after giving birth, a designated nurse comes home with her, teaches her how to breastfeed and how to bathe the baby, and assists with routine activities such as cooking and washing. And the nurse remains engaged for a prolonged period of time, paid for by the government. There are also other social welfare packages, such as a full 4-year or more maternity leave.

The solution is part political and part medical. We need to rethink our care model, and I don’t think we provide enough postpartum care.

Continue to: Dr. Hayworth...

Dr. Hayworth: Errol made an excellent point about AI. There is a product that’s being used in Europe and in some other parts of the world that can provide 85% of care through an algorithm without a patient even having to speak to a nurse or doctor. The company that offers the product claims a high level of patient satisfaction and a very low error rate.

We are a long way from the point at which—and I don’t anticipate that we’ll ever get there—AI fully replaces human providers, but there’s enormous and growing potential for data aggregation and machine learning to enhance, exponentially, the capabilities and capacity of care teams.

The most immediate applications for AI in the United States are in diagnostics, pathology, and the mapping of protocols for patients with cancer who will benefit from access to investigational interventions and clinical trials. As we gain experience in those areas, acceptance and confidence will lead steadily to broader deployment of AI, enhancing the quality of care and the efficiency of delivery and saving costs.

Dr. Norwitz: AI is a tool to assist providers. It is not going to replace us, which is the fear.

Ms. Pearson: From the consumer perspective, again, there is concern that if not enough data are available from Black, indigenous, and people of color, the levels won’t start out in a good place. The criticism over mammography randomized controlled trials (RCTs) has existed for a long time. The big trials that got all the way out to mortality did not include enough women of color; and so women of color rightly say, “Why should we believe these guidelines developed on results of the RCTs?” My point is that because of historical inequity, logical solutions such as algorithms do not always work for communities that were previously excluded or mistreated.

Dr. Levy: Your point is incredibly well taken. That means that those of us researching and working with AI need to ensure that the data going in are representative, that we are not embedding implicit biases into the AI algorithms, which clearly has sometimes already happened. We have to be careful to embrace input from multiple sources that we have not thought of before.

As we look at an algorithm for managing a postpartum patient or a postoperative patient, have we thought about how she’s managing her children at home after she goes home? What else is happening in her life? How can we impact her recovery in a positive way? We need to hear the voices of the people that we are trying to serve as we develop those algorithms.

Perspectives on future health care delivery

Dr. Levy: To summarize so far, we are thinking about a Woman’s Medical Home, a capitated model of comprehensive care for women that includes mental health, social determinants, and home care. There are different models, but a payment structure where we would have the capital to invest in community services and in things that we think may make a difference.

Dr. Norwitz: I think the health care system of the future is not going to be based in large academic medical centers. It’s going to be in community hospitals close to home. It’s going to be in the home. And it will be provided by different types of practitioners, whose performances are tracked using more appropriate outcome metrics.

Dr. Levy: I also think we will have community health workers. While we haven’t talked about rural health and access to care, there are some structural things we can do to reach rural communities with really excellent care, such as training community health workers and using telemedicine. It does require thinking through a different payment structure, though, because there really isn’t money in the system to do that currently, at least to my knowledge.

Janice, do we have enough motivation to take care of women? Women are so underrepresented when we look at care models.

Dr. Huckaby: I do think there is hope, but it will truly take a village. While CMS (Centers for Medicare and Medicaid Services) has its innovation center in the Medicaid space, it’s almost like we have to have the payers, the government, the specialty societies, and so on say that we need to do something better. I mention the government because it is not only a payer but also a regulator. They can help create some of these things.

There are opportunities with payers to say, “Let’s move to this kind of model for that.” But still, we are implementing change but on a fairly minor scale.

We could have the people who care about issues, help deliver the care, pay the bills, and so on say, “This is what we want to do,” and then we could pilot them. It may be one type of pilot in a rural area and one type of pilot in an urban area, because they are going to differ, and do it that way and then scale it.

Telemedicine, or telehealth, is part of creating access. Even some nontraditional settings, such as retail store clinics, may work.

Continue to: Dr. Levy...

Dr. Levy: Cindy, is there any last thing you wanted to comment on?

Ms. Pearson: All the changes we have talked about require public policy change. Physicians become physicians to take care of people, not because they want to be policy wonks like us. We love policy because we see how it can benefit. To our readers I say be part of making this generational change in the profession and women’s health care, get involved in policy, because these things can’t happen without the policy changes.

Dr. Norwitz: That is so important. In most developed countries around the world, you get trained in medical school, the cost of training is subsidized, and in return you owe 2 years of service. In this country, if we subsidized the training of doctors and in return they owed us 2 years of primary care service based in the community or in an underserved area, they would get valuable clinical experience and wouldn’t have so many loans to pay back. I think it is a policy that could work and could profoundly change the health care landscape in time.

Dr. Levy: And it would save a great deal of money. The reality is that if we subsidize medical education and in return required service in a national public health service, we would move providers out into rural areas. That would to some extent solve our rural problem. We would train people to think about diagnostic options when the resources are not unlimited, so that they will perhaps not order quite so many tests.

That policy change would foundationally allow for more minority students to become physicians and health care workers. If there were one thing we could do to begin to drive this change, that would be it.

Who would have thought a disruptive pandemic could affect the way people receive care, in bad and good ways? Some carriers, for example, are now paying for telehealth visits who previously did not.

Final thoughts

Dr. Hayworth: It’s an exciting time to be in medicine and women’s health: We are ushering in a new era in which we can fulfill the vision of comprehensive care, patient-focused and seamlessly delivered by teams whose capabilities are optimized by ever-improving technology. ObGyns, with our foundation in the continuum of care, have the experience and the sensibilities to adapt to the challenges of the value model, in which our success will depend on fully embracing our role as primary care providers.

Dr. Levy: Circling back to the beginning of our discussion, we talked about relationships, and developing deep relationships with patients is the internal reward and the piece that prevents us from burnout. It makes you feel good at the end of the day—or sometimes bad at the end of the day when something didn’t go well. Restructuring the system in a way that gets us back to personalized relationship-centered care will benefit ObGyns and our patients.

I thank you all for participating in this thoughtful discussion. ●

Recently, OBG Management convened an expert panel of clinicians and thought leaders to discuss the changes needed in health care delivery—and in health care policy—that have risen to the forefront of consciousness as a result of the global COVID-19 pandemic. Here is that stimulating exchange moderated by Editorial Board member Dr. Barbara Levy.

Barbara Levy, MD: The disruption of the COVID-19 pandemic has given us an opportunity to consider how we would recraft the delivery of health care for women if we could. My goal for this discussion is to talk about that and see if we can incentivize people to make changes.

Cindy, what are women looking for in health care that they are not getting now?

What women want in health care

Cynthia A. Pearson: Women, like men, want a sense of assurance that health care can be provided in a safe way, and that can’t be given completely right now.

Aside from that, women want a personal connection, ideally with the same provider. Many women are embracing telehealth, which came about because of this disruptive time, and that has potential that we can possibly mobilize around. One thing women don’t always find is consistency and contact, and they would like that.

Scott D. Hayworth, MD: Women want to be listened to, and they want their doctors to take a holistic and individualized approach to their care. In-person visits are the ideal setting for this, but during the pandemic we have had to adapt to new modalities for delivering care: government regulations restricting services, and the necessity to limit the flow of patients into offices, has meant that we have had to rely on remote visits. CareMount Medical has been in the forefront of telehealth with our “Virtual Visit” technology, so we were well prepared, and our patients have embraced this truly vital option. We’ve ramped up capabilities significantly to deal with the surge in volume.

While our practice has been able to provide consistent and convenient access to care, this isn’t the case in all areas of the country. Even before the pandemic, the cost of malpractice insurance has led to shortages of ObGyns; this deficit has been compounded by the closing of hospitals due to restrictions on services imposed to try to stem the spread of COVID-19. The affordability of care has also been jeopardized by job losses and therefore of employer-provided insurance, following months of lockdowns.

Continue to: Dr. Levy...

Dr. Levy: To balance that long-term relationship with access and cost, clearly we are not delivering what is needed. Janice, at UnitedHealth you have experimented with some products and some different ways of delivering care. What are beneficiaries looking for?

Janice Huckaby, MD: There is a real thirst for digital content—everybody consults with Dr. Google. They are looking for reliable sources of clinical content. Ideally, that comes from their physician, but people access it in other ways as well.

I agree that women desire a personalized relationship. That is why we are seeing more communities of women, such as virtual pregnancy support groups, that have cropped up in the age of COVID-19. Women are not content with the idea of “I’m going to see my doctor, get my tummy measured, listen to the heartbeat, and go home.” That model is done. Patients will look for practices that are accessible at convenient times and that can give them the personalized experience to make them feel well cared for and that offer them a long-term relationship.

One concern is that as more obstetric groups use laborists to do their deliveries at the hospital, I wonder whether we do a good job of forming that relationship on the front end, and when it comes to the delivery, will we drop the ball? The jury is out, but it’s worth watching.

Dr. Levy: How do we as obstetrician-gynecologists get patients to consider that we are providing reliable information? There is so much disinformation out there.

Errol R. Norwitz, MD, PhD, MBA: I echo the sentiments discussed and I’ll add that many women want care that is convenient, close to home, coordinated, and integrated—not fragmented. They want their providers and their office to anticipate and know who they are even before they arrive, to be prepared for the visit. And it’s not only care for them, but also care for their families. Women are the gatekeepers to the health care system. They want a health care system in place that will care not just for each member separately but also for the family as an integrated whole.

To answer your question, Barbara, we have all been overwhelmed with the amount of data coming at us, both providers and patients. Teaching providers how to synthesize and integrate the data and then present it to patients is quite a challenge. We have to instill this skill in our trainees, teach them how to absorb and present the data.

Consensus bodies can help in this regard, and ACOG (American College of Obstetricians and Gynecologists) has led the way in providing guidance around the management of pregnancy in the setting of COVID-19. Another reliable site for my trainees is UpToDate, which is easy to access. If a scientific paper comes out today, it will be covered in UpToDate tomorrow. Patients need someone who can synthesize the data and give it to them in little pieces, and keep it current.

Dr. Levy: We need to be a reliable source not only for medical information but also for referral to resources in the community for families and for women.

Continue to: ObGyn services...

 

 

ObGyn services: Primary care or specialty?

Dr. Norwitz: That begs the question, who are we? Are we primary care providers or are we a subspecialty, or are we both?

Ms. Pearson: Women, particularly in their younger, middle reproductive years, see their ObGyn as a primary care provider. The way forward for the profession is to embrace the call that Barbara articulated, to know what other referral sources are available beyond other clinicians. We need to be aware of the social determinants of health—that there are times when the primary care provider needs to know the community well enough to know what is available that would make a difference for that person and her family.

Dr. Levy: Scott, how do you manage that?

Dr. Hayworth: As reimbursement models move rapidly toward value, practices that can undertake risk are in the best position to thrive; specialty providers relying solely on fee-for-service may well be unable to survive. The key for any ObGyn practice is to be of sufficient size and scope that it can manage the primary care for a panel of patients, the more numerous the better; being in charge of those dollars allows maximum control. ObGyns who subspecialize should seek to become members of larger groups, whether comprehensive women’s health practices or multispecialty groups like ours at CareMount Medical, that manage the spectrum of care for their patients.

Dr. Levy: Janice, fill us in on some of the structures that exist now for ObGyns that they may be able to participate in—payment structures like the Women’s Medical Home. Does UnitedHealth have anything like that?

Dr. Huckaby: Probably 3 or 4 exist now, but I agree that risk arrangements are perhaps a wave of the future. Right now, UnitedHealth has accountable care organizations (ACOs) that include ObGyns, a number of them in the Northeast. We also rolled out bundled payment programs.

Our hospital contracts have always had metrics around infection rates and elective deliveries before 39 weeks, and we will probably start seeing some of that put into the provider contracts as well.

There is a desire to move people into a risk-sharing model for payment, but part of the concern there is the infrastructure, because if you are going to manage risk, you need to have staff that can do care coordination. Care coordinators can ensure, for example, that people have transportation to their appointments, and thus address some of the social determinants in ways that historically have not been done in obstetrics.

The ACOs sometimes have given seed money for practices to hire additional staff to do those kinds of things, and that can help get practices started. Probably the people best positioned are in large multispecialty groups that can leverage case management and maybe support other specialties.

I do think we are going to see a move to risk in the future. Obstetrics has moved at a slower pace than we have seen in internal medicine and some other specialties.

Dr. Hayworth: The value model for reimbursement can only be managed via care coordination, maximizing efficacy and efficiency at every level for every patient. Fortunately for ObGyns, we are familiar with the value concept via bundling for obstetrical services covering prenatal to postpartum, including delivery. ObGyn practices need to prepare for a future in which insurers will pay for patient panels in which providers take on the risk for the entirety of care.

At CareMount Medical, we have embraced the value model as one of 40 Next Generation Medicare Accountable Care Organizations across the country. We’ve put in place the infrastructure, from front desk through back office, to optimize resource utilization. Our team approach includes both patient advocates and care coordinators who extend the capabilities of our physicians and ensure that our patients’ needs, including well care, are met comprehensively.

Dr. Huckaby: One area that we sometimes leave out, whether we are talking about payment or a patient-centered medical home, is integration with behavioral health. Anxiety and depression are fairly rampant, fairly underdiagnosed, and woefully undertreated. I hope that our ObGyn practices of the future—and maybe this is the broadening into primary care—will engage and take the lead in addressing some of those issues, because women suffer. We need to embrace the behavioral aspect of care for the whole person more than we have.

Continue to: Physician training issues...

 

 

Physician training issues

Dr. Levy: I could not agree more. We have trained physicians to do illness care, not wellness care, and to be physician and practice centered, not patient centered. While we train medical students in hospital settings and in acute care, there’s not much training in how to manage people or in the factors that determine whether someone is truly well, such as housing security and food security. We are not training physicians in nutrition or in mental health.

Errol, how do we help an ObGyn or women’s health trainee to prepare for the ideal world we are trying to create?

Dr. Norwitz: It’s a challenging question. I like to reference a remarkable piece by Atul Gawande in The New Yorker, in which he interviewed the CEO of the Cheesecake Factory restaurant chain, who in effect said that we’ve got it all wrong; there’s no health in health care.¹ We don’t manage health; we wait until people get sick and then we treat them. We have to put the health back into health care.

It has always been my passion to focus on preventative care. We need to reclaim our identity—I have never particularly liked the name “ObGyn,” the term “women’s health” may be more appropriate and help us focus on disease prevention—and we need to stand up for training programs that separate the O from the G.

Low-volume surgeons, who may do only 1 or 2 hysterectomies per year, can’t maintain their proficiency, and many don’t do enough cases to maintain their robotics privileges. I can foresee a time where labor and delivery units are like ICUs, where the people who work there do nothing but manage labor and perform deliveries using standardized bundles of practice. Such an approach will decrease variability in management and lead to improved outcomes.

We need to completely reframe how we train our pipeline providers to provide care in women’s health. It would be difficult, take a lot of effort, and there would be pushback, I suspect, but that’s where the field needs to go.

The ideal system redesign

Dr. Levy: Cindy, if you could start from scratch and design an ideal comprehensive system to better deliver care for women of all ages, what would that look like?

Ms. Pearson: I would design a system in which people at any life stage met with providers who were less trained in dealing with disease and more trained in the holistic approach to maintaining health. That might be a nurse practitioner or maybe a version of what Errol describes as a new way of training ObGyns. That’s the initial interaction, and the person could be with someone for decades and deepen the relationship in that wonderful way. It would also have an avenue for the times when disease needed to be treated or when more specialized care would be provided. And the financing would be worked out to support consistency.

Dr. Norwitz: We can learn from other countries. Singapore, with only 5.5 million people, has the best health care system in the world. They have a great model. Costa Rica and Cuba have completely redesigned their health care systems. You go through medical school in 2 or 3 years, and then you get embedded in the community. So you have doctors living in the community responsible for the health of their neighbors. They get to know people in the context in which they live and refer them on only when they need more than basic care. These countries have vastly superior outcome measures, and they spend less money on health care.

Dr. Levy: My dream, as we reinvent things, is that we could create a comprehensive Women’s Medical Home where there’s a hub and an opportunity to be centered on patients so they could reach us when needed.

Ideally we could create a structure with a central contact person—a nurse practi­tioner, a midwife, someone in family medicine or internal medicine—someone focused on women’s health who has researched how inequities apply to women and women’s health and the areas where research doesn’t necessarily apply to women as just “smaller men.” Then we would have the hub, and the spokes—those would be mental health care providers, surgeons, and people to provide additional services when needed.

The only way I can figure how to make that work from a payment perspective is with a prospective payment system, a per member, per month capitated payment structure. That way, ancillary and other services would be available, and overtesting and such would be disincentivized.

Continue to: The question of payment...

 

 

The question of payment

Dr. Hayworth: I agree. For every practice, the two key considerations in addressing the challenges of capitation are, first, that the team approach is essential, and, second, that providers appreciate that everything they do for their patients is reimbursed in a global payment.

At CareMount Medical, our team system embeds advanced practice professionals in our primary care and ObGyn offices. Everyone—physicians, midwives, nurse practi­tioners—practices at the top of their license. Our care coordinators ensure that our patients’ health journeys are optimized from well care through specialized needs, engaging every member of the care team effectively.

To optimize our success in a risk model, we recognize that tasks and services that went without direct reimbursement in a fee-for-service arrangement are integral to producing the best outcomes for our patients. We examine everything we do from the perspective of how to provide the most advanced care in the most efficient manner. For example, we drive toward moving procedures from the hospital to the outpatient setting, and from the ambulatory surgical center to the office. This allows us maximal control of both quality and cost, with savings benefiting our group as well as the payers with whom we have contracts.

Dr. Norwitz: I have been fortunate to have trained and worked in 5 different countries on 3 continents. There’s no question there are better health care systems out there. Some form of capitation is needed, whether it’s value-based care or a risk-sharing arrangement. But how do you do it without a single payer? I don’t think you can, but I’m ready to listen.

Dr. Hayworth: You can have capitation without a single payer; in fact, it’s far better to have many payers compete to offer the greatest flexibility to both patients and providers. CareMount Medical has 650,000 patients who rely on us to provide their care with the utmost quality and affordability. In our Next Generation ACO, our Medicare patients have the benefit of care coordination in a team approach that saves our government money, and we are incentivized to do our best because some of those savings return to us.

The needs of Medicare patients, of course, are different from those in other age groups, and our contracts with other payers will reflect that distinction. There’s no inherent reason why capitation has to equal “single payer.” The benefits of the risk model are magnified by incentivizing all participants to provide maximum value.

Continue to: Ms. Pearson...

Ms. Pearson: I am going to comment on capitated care because I think educated consumers are well aware of the benefits of moving away from fee-for-service and bringing in some more sensible system. However, given the historical racial inequities and injustices, and lack of access and disparate treatment, capitation raises fear in the hearts of people whose communities have not gotten the care that they need.

The answer is not to avoid capitation, but to find a way for the profession to be seen more visibly as reflecting who they serve, and we know we can’t change the profession’s racial makeup overnight. That’s a generation-long effort.

Dr. Levy: For capitation to work, there has to be value, you have to meet the quality metrics. Having served on the National Quality Forum on multiple different committees, I am convinced that we measure what is easy to measure, and we are not measuring what really matters to people. My thought is to embrace the communities that have been underserved to help us design the metrics for a capitated system that is meaningful to the people that we serve.

Ms. Pearson: On the West Coast, some people are leading efforts to create patient-centered metrics for respectful maternity care led by Black, indigenous, and people of color communities that are validated with solid research tools.

Algorithms for care

Dr. Norwitz: Artificial intelligence (AI) may have a role to play. For example, I think we do a terrible job of caring for women in the postpartum period. We focus almost all of our care in the antepartum period and not postpartum. I am working with a group with a finance and banking background to try and risk-adjust patients in the antepartum, intrapartum, and postpartum period. We are developing algorithms using AI and deep learning technologies to risk-stratify patients and say, “This patient is low risk so can safely get obstetric care with a family medicine doctor or midwife. That patient requires consultation with a maternal-fetal medicine subspecialist or a general internist,” and so on.

Ms. Pearson: As policy advocates, we are trying to get Medicaid postpartum coverage expanded to 12 months. Too many women fall into a coverage gap shortly after delivery; continued coverage would help improve postpartum outcomes. I am curious how an algorithm might help take better care of women postpartum.

Dr. Norwitz: Postpartum care is one of the greatest areas of need. I love the Dutch model. In the Netherlands, when a woman goes home after giving birth, a designated nurse comes home with her, teaches her how to breastfeed and how to bathe the baby, and assists with routine activities such as cooking and washing. And the nurse remains engaged for a prolonged period of time, paid for by the government. There are also other social welfare packages, such as a full 4-year or more maternity leave.

The solution is part political and part medical. We need to rethink our care model, and I don’t think we provide enough postpartum care.

Continue to: Dr. Hayworth...

Dr. Hayworth: Errol made an excellent point about AI. There is a product that’s being used in Europe and in some other parts of the world that can provide 85% of care through an algorithm without a patient even having to speak to a nurse or doctor. The company that offers the product claims a high level of patient satisfaction and a very low error rate.

We are a long way from the point at which—and I don’t anticipate that we’ll ever get there—AI fully replaces human providers, but there’s enormous and growing potential for data aggregation and machine learning to enhance, exponentially, the capabilities and capacity of care teams.

The most immediate applications for AI in the United States are in diagnostics, pathology, and the mapping of protocols for patients with cancer who will benefit from access to investigational interventions and clinical trials. As we gain experience in those areas, acceptance and confidence will lead steadily to broader deployment of AI, enhancing the quality of care and the efficiency of delivery and saving costs.

Dr. Norwitz: AI is a tool to assist providers. It is not going to replace us, which is the fear.

Ms. Pearson: From the consumer perspective, again, there is concern that if not enough data are available from Black, indigenous, and people of color, the levels won’t start out in a good place. The criticism over mammography randomized controlled trials (RCTs) has existed for a long time. The big trials that got all the way out to mortality did not include enough women of color; and so women of color rightly say, “Why should we believe these guidelines developed on results of the RCTs?” My point is that because of historical inequity, logical solutions such as algorithms do not always work for communities that were previously excluded or mistreated.

Dr. Levy: Your point is incredibly well taken. That means that those of us researching and working with AI need to ensure that the data going in are representative, that we are not embedding implicit biases into the AI algorithms, which clearly has sometimes already happened. We have to be careful to embrace input from multiple sources that we have not thought of before.

As we look at an algorithm for managing a postpartum patient or a postoperative patient, have we thought about how she’s managing her children at home after she goes home? What else is happening in her life? How can we impact her recovery in a positive way? We need to hear the voices of the people that we are trying to serve as we develop those algorithms.

Perspectives on future health care delivery

Dr. Levy: To summarize so far, we are thinking about a Woman’s Medical Home, a capitated model of comprehensive care for women that includes mental health, social determinants, and home care. There are different models, but a payment structure where we would have the capital to invest in community services and in things that we think may make a difference.

Dr. Norwitz: I think the health care system of the future is not going to be based in large academic medical centers. It’s going to be in community hospitals close to home. It’s going to be in the home. And it will be provided by different types of practitioners, whose performances are tracked using more appropriate outcome metrics.

Dr. Levy: I also think we will have community health workers. While we haven’t talked about rural health and access to care, there are some structural things we can do to reach rural communities with really excellent care, such as training community health workers and using telemedicine. It does require thinking through a different payment structure, though, because there really isn’t money in the system to do that currently, at least to my knowledge.

Janice, do we have enough motivation to take care of women? Women are so underrepresented when we look at care models.

Dr. Huckaby: I do think there is hope, but it will truly take a village. While CMS (Centers for Medicare and Medicaid Services) has its innovation center in the Medicaid space, it’s almost like we have to have the payers, the government, the specialty societies, and so on say that we need to do something better. I mention the government because it is not only a payer but also a regulator. They can help create some of these things.

There are opportunities with payers to say, “Let’s move to this kind of model for that.” But still, we are implementing change but on a fairly minor scale.

We could have the people who care about issues, help deliver the care, pay the bills, and so on say, “This is what we want to do,” and then we could pilot them. It may be one type of pilot in a rural area and one type of pilot in an urban area, because they are going to differ, and do it that way and then scale it.

Telemedicine, or telehealth, is part of creating access. Even some nontraditional settings, such as retail store clinics, may work.

Continue to: Dr. Levy...

Dr. Levy: Cindy, is there any last thing you wanted to comment on?

Ms. Pearson: All the changes we have talked about require public policy change. Physicians become physicians to take care of people, not because they want to be policy wonks like us. We love policy because we see how it can benefit. To our readers I say be part of making this generational change in the profession and women’s health care, get involved in policy, because these things can’t happen without the policy changes.

Dr. Norwitz: That is so important. In most developed countries around the world, you get trained in medical school, the cost of training is subsidized, and in return you owe 2 years of service. In this country, if we subsidized the training of doctors and in return they owed us 2 years of primary care service based in the community or in an underserved area, they would get valuable clinical experience and wouldn’t have so many loans to pay back. I think it is a policy that could work and could profoundly change the health care landscape in time.

Dr. Levy: And it would save a great deal of money. The reality is that if we subsidize medical education and in return required service in a national public health service, we would move providers out into rural areas. That would to some extent solve our rural problem. We would train people to think about diagnostic options when the resources are not unlimited, so that they will perhaps not order quite so many tests.

That policy change would foundationally allow for more minority students to become physicians and health care workers. If there were one thing we could do to begin to drive this change, that would be it.

Who would have thought a disruptive pandemic could affect the way people receive care, in bad and good ways? Some carriers, for example, are now paying for telehealth visits who previously did not.

Final thoughts

Dr. Hayworth: It’s an exciting time to be in medicine and women’s health: We are ushering in a new era in which we can fulfill the vision of comprehensive care, patient-focused and seamlessly delivered by teams whose capabilities are optimized by ever-improving technology. ObGyns, with our foundation in the continuum of care, have the experience and the sensibilities to adapt to the challenges of the value model, in which our success will depend on fully embracing our role as primary care providers.

Dr. Levy: Circling back to the beginning of our discussion, we talked about relationships, and developing deep relationships with patients is the internal reward and the piece that prevents us from burnout. It makes you feel good at the end of the day—or sometimes bad at the end of the day when something didn’t go well. Restructuring the system in a way that gets us back to personalized relationship-centered care will benefit ObGyns and our patients.

I thank you all for participating in this thoughtful discussion. ●

Recently, OBG Management convened an expert panel of clinicians and thought leaders to discuss the changes needed in health care delivery—and in health care policy—that have risen to the forefront of consciousness as a result of the global COVID-19 pandemic. Here is that stimulating exchange moderated by Editorial Board member Dr. Barbara Levy.

Barbara Levy, MD: The disruption of the COVID-19 pandemic has given us an opportunity to consider how we would recraft the delivery of health care for women if we could. My goal for this discussion is to talk about that and see if we can incentivize people to make changes.

Cindy, what are women looking for in health care that they are not getting now?

What women want in health care

Cynthia A. Pearson: Women, like men, want a sense of assurance that health care can be provided in a safe way, and that can’t be given completely right now.

Aside from that, women want a personal connection, ideally with the same provider. Many women are embracing telehealth, which came about because of this disruptive time, and that has potential that we can possibly mobilize around. One thing women don’t always find is consistency and contact, and they would like that.

Scott D. Hayworth, MD: Women want to be listened to, and they want their doctors to take a holistic and individualized approach to their care. In-person visits are the ideal setting for this, but during the pandemic we have had to adapt to new modalities for delivering care: government regulations restricting services, and the necessity to limit the flow of patients into offices, has meant that we have had to rely on remote visits. CareMount Medical has been in the forefront of telehealth with our “Virtual Visit” technology, so we were well prepared, and our patients have embraced this truly vital option. We’ve ramped up capabilities significantly to deal with the surge in volume.

While our practice has been able to provide consistent and convenient access to care, this isn’t the case in all areas of the country. Even before the pandemic, the cost of malpractice insurance has led to shortages of ObGyns; this deficit has been compounded by the closing of hospitals due to restrictions on services imposed to try to stem the spread of COVID-19. The affordability of care has also been jeopardized by job losses and therefore of employer-provided insurance, following months of lockdowns.

Continue to: Dr. Levy...

Dr. Levy: To balance that long-term relationship with access and cost, clearly we are not delivering what is needed. Janice, at UnitedHealth you have experimented with some products and some different ways of delivering care. What are beneficiaries looking for?

Janice Huckaby, MD: There is a real thirst for digital content—everybody consults with Dr. Google. They are looking for reliable sources of clinical content. Ideally, that comes from their physician, but people access it in other ways as well.

I agree that women desire a personalized relationship. That is why we are seeing more communities of women, such as virtual pregnancy support groups, that have cropped up in the age of COVID-19. Women are not content with the idea of “I’m going to see my doctor, get my tummy measured, listen to the heartbeat, and go home.” That model is done. Patients will look for practices that are accessible at convenient times and that can give them the personalized experience to make them feel well cared for and that offer them a long-term relationship.

One concern is that as more obstetric groups use laborists to do their deliveries at the hospital, I wonder whether we do a good job of forming that relationship on the front end, and when it comes to the delivery, will we drop the ball? The jury is out, but it’s worth watching.

Dr. Levy: How do we as obstetrician-gynecologists get patients to consider that we are providing reliable information? There is so much disinformation out there.

Errol R. Norwitz, MD, PhD, MBA: I echo the sentiments discussed and I’ll add that many women want care that is convenient, close to home, coordinated, and integrated—not fragmented. They want their providers and their office to anticipate and know who they are even before they arrive, to be prepared for the visit. And it’s not only care for them, but also care for their families. Women are the gatekeepers to the health care system. They want a health care system in place that will care not just for each member separately but also for the family as an integrated whole.

To answer your question, Barbara, we have all been overwhelmed with the amount of data coming at us, both providers and patients. Teaching providers how to synthesize and integrate the data and then present it to patients is quite a challenge. We have to instill this skill in our trainees, teach them how to absorb and present the data.

Consensus bodies can help in this regard, and ACOG (American College of Obstetricians and Gynecologists) has led the way in providing guidance around the management of pregnancy in the setting of COVID-19. Another reliable site for my trainees is UpToDate, which is easy to access. If a scientific paper comes out today, it will be covered in UpToDate tomorrow. Patients need someone who can synthesize the data and give it to them in little pieces, and keep it current.

Dr. Levy: We need to be a reliable source not only for medical information but also for referral to resources in the community for families and for women.

Continue to: ObGyn services...

 

 

ObGyn services: Primary care or specialty?

Dr. Norwitz: That begs the question, who are we? Are we primary care providers or are we a subspecialty, or are we both?

Ms. Pearson: Women, particularly in their younger, middle reproductive years, see their ObGyn as a primary care provider. The way forward for the profession is to embrace the call that Barbara articulated, to know what other referral sources are available beyond other clinicians. We need to be aware of the social determinants of health—that there are times when the primary care provider needs to know the community well enough to know what is available that would make a difference for that person and her family.

Dr. Levy: Scott, how do you manage that?

Dr. Hayworth: As reimbursement models move rapidly toward value, practices that can undertake risk are in the best position to thrive; specialty providers relying solely on fee-for-service may well be unable to survive. The key for any ObGyn practice is to be of sufficient size and scope that it can manage the primary care for a panel of patients, the more numerous the better; being in charge of those dollars allows maximum control. ObGyns who subspecialize should seek to become members of larger groups, whether comprehensive women’s health practices or multispecialty groups like ours at CareMount Medical, that manage the spectrum of care for their patients.

Dr. Levy: Janice, fill us in on some of the structures that exist now for ObGyns that they may be able to participate in—payment structures like the Women’s Medical Home. Does UnitedHealth have anything like that?

Dr. Huckaby: Probably 3 or 4 exist now, but I agree that risk arrangements are perhaps a wave of the future. Right now, UnitedHealth has accountable care organizations (ACOs) that include ObGyns, a number of them in the Northeast. We also rolled out bundled payment programs.

Our hospital contracts have always had metrics around infection rates and elective deliveries before 39 weeks, and we will probably start seeing some of that put into the provider contracts as well.

There is a desire to move people into a risk-sharing model for payment, but part of the concern there is the infrastructure, because if you are going to manage risk, you need to have staff that can do care coordination. Care coordinators can ensure, for example, that people have transportation to their appointments, and thus address some of the social determinants in ways that historically have not been done in obstetrics.

The ACOs sometimes have given seed money for practices to hire additional staff to do those kinds of things, and that can help get practices started. Probably the people best positioned are in large multispecialty groups that can leverage case management and maybe support other specialties.

I do think we are going to see a move to risk in the future. Obstetrics has moved at a slower pace than we have seen in internal medicine and some other specialties.

Dr. Hayworth: The value model for reimbursement can only be managed via care coordination, maximizing efficacy and efficiency at every level for every patient. Fortunately for ObGyns, we are familiar with the value concept via bundling for obstetrical services covering prenatal to postpartum, including delivery. ObGyn practices need to prepare for a future in which insurers will pay for patient panels in which providers take on the risk for the entirety of care.

At CareMount Medical, we have embraced the value model as one of 40 Next Generation Medicare Accountable Care Organizations across the country. We’ve put in place the infrastructure, from front desk through back office, to optimize resource utilization. Our team approach includes both patient advocates and care coordinators who extend the capabilities of our physicians and ensure that our patients’ needs, including well care, are met comprehensively.

Dr. Huckaby: One area that we sometimes leave out, whether we are talking about payment or a patient-centered medical home, is integration with behavioral health. Anxiety and depression are fairly rampant, fairly underdiagnosed, and woefully undertreated. I hope that our ObGyn practices of the future—and maybe this is the broadening into primary care—will engage and take the lead in addressing some of those issues, because women suffer. We need to embrace the behavioral aspect of care for the whole person more than we have.

Continue to: Physician training issues...

 

 

Physician training issues

Dr. Levy: I could not agree more. We have trained physicians to do illness care, not wellness care, and to be physician and practice centered, not patient centered. While we train medical students in hospital settings and in acute care, there’s not much training in how to manage people or in the factors that determine whether someone is truly well, such as housing security and food security. We are not training physicians in nutrition or in mental health.

Errol, how do we help an ObGyn or women’s health trainee to prepare for the ideal world we are trying to create?

Dr. Norwitz: It’s a challenging question. I like to reference a remarkable piece by Atul Gawande in The New Yorker, in which he interviewed the CEO of the Cheesecake Factory restaurant chain, who in effect said that we’ve got it all wrong; there’s no health in health care.¹ We don’t manage health; we wait until people get sick and then we treat them. We have to put the health back into health care.

It has always been my passion to focus on preventative care. We need to reclaim our identity—I have never particularly liked the name “ObGyn,” the term “women’s health” may be more appropriate and help us focus on disease prevention—and we need to stand up for training programs that separate the O from the G.

Low-volume surgeons, who may do only 1 or 2 hysterectomies per year, can’t maintain their proficiency, and many don’t do enough cases to maintain their robotics privileges. I can foresee a time where labor and delivery units are like ICUs, where the people who work there do nothing but manage labor and perform deliveries using standardized bundles of practice. Such an approach will decrease variability in management and lead to improved outcomes.

We need to completely reframe how we train our pipeline providers to provide care in women’s health. It would be difficult, take a lot of effort, and there would be pushback, I suspect, but that’s where the field needs to go.

The ideal system redesign

Dr. Levy: Cindy, if you could start from scratch and design an ideal comprehensive system to better deliver care for women of all ages, what would that look like?

Ms. Pearson: I would design a system in which people at any life stage met with providers who were less trained in dealing with disease and more trained in the holistic approach to maintaining health. That might be a nurse practitioner or maybe a version of what Errol describes as a new way of training ObGyns. That’s the initial interaction, and the person could be with someone for decades and deepen the relationship in that wonderful way. It would also have an avenue for the times when disease needed to be treated or when more specialized care would be provided. And the financing would be worked out to support consistency.

Dr. Norwitz: We can learn from other countries. Singapore, with only 5.5 million people, has the best health care system in the world. They have a great model. Costa Rica and Cuba have completely redesigned their health care systems. You go through medical school in 2 or 3 years, and then you get embedded in the community. So you have doctors living in the community responsible for the health of their neighbors. They get to know people in the context in which they live and refer them on only when they need more than basic care. These countries have vastly superior outcome measures, and they spend less money on health care.

Dr. Levy: My dream, as we reinvent things, is that we could create a comprehensive Women’s Medical Home where there’s a hub and an opportunity to be centered on patients so they could reach us when needed.

Ideally we could create a structure with a central contact person—a nurse practi­tioner, a midwife, someone in family medicine or internal medicine—someone focused on women’s health who has researched how inequities apply to women and women’s health and the areas where research doesn’t necessarily apply to women as just “smaller men.” Then we would have the hub, and the spokes—those would be mental health care providers, surgeons, and people to provide additional services when needed.

The only way I can figure how to make that work from a payment perspective is with a prospective payment system, a per member, per month capitated payment structure. That way, ancillary and other services would be available, and overtesting and such would be disincentivized.

Continue to: The question of payment...

 

 

The question of payment

Dr. Hayworth: I agree. For every practice, the two key considerations in addressing the challenges of capitation are, first, that the team approach is essential, and, second, that providers appreciate that everything they do for their patients is reimbursed in a global payment.

At CareMount Medical, our team system embeds advanced practice professionals in our primary care and ObGyn offices. Everyone—physicians, midwives, nurse practi­tioners—practices at the top of their license. Our care coordinators ensure that our patients’ health journeys are optimized from well care through specialized needs, engaging every member of the care team effectively.

To optimize our success in a risk model, we recognize that tasks and services that went without direct reimbursement in a fee-for-service arrangement are integral to producing the best outcomes for our patients. We examine everything we do from the perspective of how to provide the most advanced care in the most efficient manner. For example, we drive toward moving procedures from the hospital to the outpatient setting, and from the ambulatory surgical center to the office. This allows us maximal control of both quality and cost, with savings benefiting our group as well as the payers with whom we have contracts.

Dr. Norwitz: I have been fortunate to have trained and worked in 5 different countries on 3 continents. There’s no question there are better health care systems out there. Some form of capitation is needed, whether it’s value-based care or a risk-sharing arrangement. But how do you do it without a single payer? I don’t think you can, but I’m ready to listen.

Dr. Hayworth: You can have capitation without a single payer; in fact, it’s far better to have many payers compete to offer the greatest flexibility to both patients and providers. CareMount Medical has 650,000 patients who rely on us to provide their care with the utmost quality and affordability. In our Next Generation ACO, our Medicare patients have the benefit of care coordination in a team approach that saves our government money, and we are incentivized to do our best because some of those savings return to us.

The needs of Medicare patients, of course, are different from those in other age groups, and our contracts with other payers will reflect that distinction. There’s no inherent reason why capitation has to equal “single payer.” The benefits of the risk model are magnified by incentivizing all participants to provide maximum value.

Continue to: Ms. Pearson...

Ms. Pearson: I am going to comment on capitated care because I think educated consumers are well aware of the benefits of moving away from fee-for-service and bringing in some more sensible system. However, given the historical racial inequities and injustices, and lack of access and disparate treatment, capitation raises fear in the hearts of people whose communities have not gotten the care that they need.

The answer is not to avoid capitation, but to find a way for the profession to be seen more visibly as reflecting who they serve, and we know we can’t change the profession’s racial makeup overnight. That’s a generation-long effort.

Dr. Levy: For capitation to work, there has to be value, you have to meet the quality metrics. Having served on the National Quality Forum on multiple different committees, I am convinced that we measure what is easy to measure, and we are not measuring what really matters to people. My thought is to embrace the communities that have been underserved to help us design the metrics for a capitated system that is meaningful to the people that we serve.

Ms. Pearson: On the West Coast, some people are leading efforts to create patient-centered metrics for respectful maternity care led by Black, indigenous, and people of color communities that are validated with solid research tools.

Algorithms for care

Dr. Norwitz: Artificial intelligence (AI) may have a role to play. For example, I think we do a terrible job of caring for women in the postpartum period. We focus almost all of our care in the antepartum period and not postpartum. I am working with a group with a finance and banking background to try and risk-adjust patients in the antepartum, intrapartum, and postpartum period. We are developing algorithms using AI and deep learning technologies to risk-stratify patients and say, “This patient is low risk so can safely get obstetric care with a family medicine doctor or midwife. That patient requires consultation with a maternal-fetal medicine subspecialist or a general internist,” and so on.

Ms. Pearson: As policy advocates, we are trying to get Medicaid postpartum coverage expanded to 12 months. Too many women fall into a coverage gap shortly after delivery; continued coverage would help improve postpartum outcomes. I am curious how an algorithm might help take better care of women postpartum.

Dr. Norwitz: Postpartum care is one of the greatest areas of need. I love the Dutch model. In the Netherlands, when a woman goes home after giving birth, a designated nurse comes home with her, teaches her how to breastfeed and how to bathe the baby, and assists with routine activities such as cooking and washing. And the nurse remains engaged for a prolonged period of time, paid for by the government. There are also other social welfare packages, such as a full 4-year or more maternity leave.

The solution is part political and part medical. We need to rethink our care model, and I don’t think we provide enough postpartum care.

Continue to: Dr. Hayworth...

Dr. Hayworth: Errol made an excellent point about AI. There is a product that’s being used in Europe and in some other parts of the world that can provide 85% of care through an algorithm without a patient even having to speak to a nurse or doctor. The company that offers the product claims a high level of patient satisfaction and a very low error rate.

We are a long way from the point at which—and I don’t anticipate that we’ll ever get there—AI fully replaces human providers, but there’s enormous and growing potential for data aggregation and machine learning to enhance, exponentially, the capabilities and capacity of care teams.

The most immediate applications for AI in the United States are in diagnostics, pathology, and the mapping of protocols for patients with cancer who will benefit from access to investigational interventions and clinical trials. As we gain experience in those areas, acceptance and confidence will lead steadily to broader deployment of AI, enhancing the quality of care and the efficiency of delivery and saving costs.

Dr. Norwitz: AI is a tool to assist providers. It is not going to replace us, which is the fear.

Ms. Pearson: From the consumer perspective, again, there is concern that if not enough data are available from Black, indigenous, and people of color, the levels won’t start out in a good place. The criticism over mammography randomized controlled trials (RCTs) has existed for a long time. The big trials that got all the way out to mortality did not include enough women of color; and so women of color rightly say, “Why should we believe these guidelines developed on results of the RCTs?” My point is that because of historical inequity, logical solutions such as algorithms do not always work for communities that were previously excluded or mistreated.

Dr. Levy: Your point is incredibly well taken. That means that those of us researching and working with AI need to ensure that the data going in are representative, that we are not embedding implicit biases into the AI algorithms, which clearly has sometimes already happened. We have to be careful to embrace input from multiple sources that we have not thought of before.

As we look at an algorithm for managing a postpartum patient or a postoperative patient, have we thought about how she’s managing her children at home after she goes home? What else is happening in her life? How can we impact her recovery in a positive way? We need to hear the voices of the people that we are trying to serve as we develop those algorithms.

Perspectives on future health care delivery

Dr. Levy: To summarize so far, we are thinking about a Woman’s Medical Home, a capitated model of comprehensive care for women that includes mental health, social determinants, and home care. There are different models, but a payment structure where we would have the capital to invest in community services and in things that we think may make a difference.

Dr. Norwitz: I think the health care system of the future is not going to be based in large academic medical centers. It’s going to be in community hospitals close to home. It’s going to be in the home. And it will be provided by different types of practitioners, whose performances are tracked using more appropriate outcome metrics.

Dr. Levy: I also think we will have community health workers. While we haven’t talked about rural health and access to care, there are some structural things we can do to reach rural communities with really excellent care, such as training community health workers and using telemedicine. It does require thinking through a different payment structure, though, because there really isn’t money in the system to do that currently, at least to my knowledge.

Janice, do we have enough motivation to take care of women? Women are so underrepresented when we look at care models.

Dr. Huckaby: I do think there is hope, but it will truly take a village. While CMS (Centers for Medicare and Medicaid Services) has its innovation center in the Medicaid space, it’s almost like we have to have the payers, the government, the specialty societies, and so on say that we need to do something better. I mention the government because it is not only a payer but also a regulator. They can help create some of these things.

There are opportunities with payers to say, “Let’s move to this kind of model for that.” But still, we are implementing change but on a fairly minor scale.

We could have the people who care about issues, help deliver the care, pay the bills, and so on say, “This is what we want to do,” and then we could pilot them. It may be one type of pilot in a rural area and one type of pilot in an urban area, because they are going to differ, and do it that way and then scale it.

Telemedicine, or telehealth, is part of creating access. Even some nontraditional settings, such as retail store clinics, may work.

Continue to: Dr. Levy...

Dr. Levy: Cindy, is there any last thing you wanted to comment on?

Ms. Pearson: All the changes we have talked about require public policy change. Physicians become physicians to take care of people, not because they want to be policy wonks like us. We love policy because we see how it can benefit. To our readers I say be part of making this generational change in the profession and women’s health care, get involved in policy, because these things can’t happen without the policy changes.

Dr. Norwitz: That is so important. In most developed countries around the world, you get trained in medical school, the cost of training is subsidized, and in return you owe 2 years of service. In this country, if we subsidized the training of doctors and in return they owed us 2 years of primary care service based in the community or in an underserved area, they would get valuable clinical experience and wouldn’t have so many loans to pay back. I think it is a policy that could work and could profoundly change the health care landscape in time.

Dr. Levy: And it would save a great deal of money. The reality is that if we subsidize medical education and in return required service in a national public health service, we would move providers out into rural areas. That would to some extent solve our rural problem. We would train people to think about diagnostic options when the resources are not unlimited, so that they will perhaps not order quite so many tests.

That policy change would foundationally allow for more minority students to become physicians and health care workers. If there were one thing we could do to begin to drive this change, that would be it.

Who would have thought a disruptive pandemic could affect the way people receive care, in bad and good ways? Some carriers, for example, are now paying for telehealth visits who previously did not.

Final thoughts

Dr. Hayworth: It’s an exciting time to be in medicine and women’s health: We are ushering in a new era in which we can fulfill the vision of comprehensive care, patient-focused and seamlessly delivered by teams whose capabilities are optimized by ever-improving technology. ObGyns, with our foundation in the continuum of care, have the experience and the sensibilities to adapt to the challenges of the value model, in which our success will depend on fully embracing our role as primary care providers.

Dr. Levy: Circling back to the beginning of our discussion, we talked about relationships, and developing deep relationships with patients is the internal reward and the piece that prevents us from burnout. It makes you feel good at the end of the day—or sometimes bad at the end of the day when something didn’t go well. Restructuring the system in a way that gets us back to personalized relationship-centered care will benefit ObGyns and our patients.

I thank you all for participating in this thoughtful discussion. ●