Bringing you the latest news, research and reviews, exclusive interviews, podcasts, quizzes, and more.

Theme
medstat_ph
phh

Powered by CHEST Physician, Clinician Reviews, MDedge Family Medicine, Internal Medicine News, and The Journal of Clinical Outcomes Management.

Main menu
PHH Main Menu
Unpublish
Altmetric
DSM Affiliated
Display in offset block
Enable Disqus
Display Author and Disclosure Link
Publication Type
News
Slot System
Top 25
Disable Sticky Ads
Disable Ad Block Mitigation
Featured Buckets Admin
Show Ads on this Publication's Homepage
Consolidated Pub
Show Article Page Numbers on TOC
Use larger logo size
Off
publication_blueconic_enabled
Off
Show More Destinations Menu
Disable Adhesion on Publication
Off
Restore Menu Label on Mobile Navigation
Disable Facebook Pixel from Publication
Exclude this publication from publication selection on articles and quiz
Gating Strategy
First Peek Free
Challenge Center
Disable Inline Native ads

COVID-19 plans put to test as firefighters crowd camps for peak wildfire season

Article Type
Changed
Thu, 08/26/2021 - 16:01

Jon Paul was leery entering his first wildfire camp of the year late last month to fight three lightning-caused fires scorching parts of a Northern California forest that hadn’t burned in 40 years.

Courtesy of U.S. Forest Service
Firefighters wear face masks at a morning briefing on the Bighorn Fire, north of Tucson, Ariz., on June 22, 2020. COVID-prevention protocols – based on guidelines from the Centers for Disease Control and Prevention – are recommended for wildfire camps.

The 54-year-old engine captain from southern Oregon knew from experience that these crowded, grimy camps can be breeding grounds for norovirus and a respiratory illness that firefighters call the “camp crud” in a normal year. He wondered what the coronavirus would do in the tent cities where hundreds of men and women eat, sleep, wash, and spend their downtime between shifts.

Mr. Paul thought about his immunocompromised wife and his 84-year-old mother back home. Then he joined the approximately 1,300 people spread across the Modoc National Forest who would provide a major test for the COVID-prevention measures that had been developed for wildland firefighters.

“We’re still first responders and we have that responsibility to go and deal with these emergencies,” he said in a recent interview. “I don’t scare easy, but I’m very wary and concerned about my surroundings. I’m still going to work and do my job.”

Mr. Paul is one of thousands of firefighters from across the United States battling dozens of wildfires burning throughout the West. It’s an inherently dangerous job that now carries the additional risk of COVID-19 transmission. Any outbreak that ripples through a camp could easily sideline crews and spread the virus across multiple fires – and back to communities across the country – as personnel transfer in and out of “hot zones” and return home.

Though most firefighters are young and fit, some will inevitably fall ill in these remote makeshift communities of shared showers and portable toilets, where medical care can be limited. The pollutants in the smoke they breathe daily also make them more susceptible to COVID-19 and can worsen the effects of the disease, according to the Centers for Disease Control and Prevention.

Also, one suspected or positive case in a camp will mean many other firefighters will need to be quarantined, unable to work. The worst-case scenario is that multiple outbreaks could hamstring the nation’s ability to respond as wildfire season peaks in August, the hottest and driest month of the year in the western United States.

The number of acres burned so far this year is below the 10-year average, but the fire outlook for August is above average in nine states, according to the National Interagency Fire Center. Twenty-two large fires were ignited on Monday alone after lightning storms passed through the Northwest.

A study published this month by researchers at Colorado State University and the U.S. Forest Service’s Rocky Mountain Research Station concluded that COVID outbreaks “could be a serious threat to the firefighting mission” and urged vigilant social distancing and screening measures in the camps.

“If simultaneous fires incurred outbreaks, the entire wildland response system could be stressed substantially, with a large portion of the workforce quarantined,” the study’s authors wrote.

This spring, the National Wildfire Coordinating Group’s Fire Management Board wrote – and has since been updating – protocols to prevent the spread of COVID-19 in fire camps, based on CDC guidelines. Though they can be adapted by managers at different fires and even by individual team, they center on some key recommendations, including the following:

  • Firefighters should be screened for fever and other COVID symptoms when they arrive at camp.
  • Every crew should insulate itself as a “module of one” for the fire season and limit interactions with other crews.
  • Firefighters should maintain social distancing and wear face coverings when social distancing isn’t possible. Smaller satellite camps, known as spike camps, can be built to ensure enough space.
  • Shared areas should be regularly cleaned and disinfected, and sharing tools and radios should be minimized.

The guidance does not include routine testing of newly arrived firefighters – a practice used for athletes at training camps and students returning to college campuses.

The Fire Management Board’s Wildland Fire Medical and Public Health Advisory Team wrote in a July 2 memo that it “does not recommend utilizing universal COVID-19 laboratory testing as a standalone risk mitigation or screening measure among wildland firefighters.” Rather, the group recommends testing an individual and directly exposed coworkers, saying that approach is in line with CDC guidance.

The lack of testing capacity and long turnaround times are factors, according to Forest Service spokesperson Dan Hottle.

The exception is Alaska, where firefighters are tested upon arrival at the airport and are quarantined in a hotel while awaiting results, which come within 24 hours, Mr. Hottle said.

Fire crews responding to early-season fires in the spring had some problems adjusting to the new protocols, according to assessments written by fire leaders and compiled by the Wildland Fire Lessons Learned Center.

Shawn Faiella, superintendent of the interagency “hotshot crew” – so named because they work the most challenging or “hottest” parts of wildfires – based at Montana’s Lolo National Forest, questioned the need to wear masks inside vehicles and the safety of bringing extra vehicles to space out firefighters traveling to a blaze. Parking extra vehicles at the scene of a fire is difficult in tight dirt roads – and would be dangerous if evacuations are necessary, he wrote.

“It’s damn tough to take these practices to the fire line,” Mr. Faiella wrote after his team responded to a 40-acre Montana fire in April.

One recommendation that fire managers say has been particularly effective is the “module of one” concept requiring crews to eat and sleep together in isolation for the entire fire season.

“Whoever came up with it, it is working,” said Mike Goicoechea, the Montana-based incident commander for the Forest Service’s Northern Region Type 1 team, which manages the nation’s largest and most complex wildfires and natural disasters. “Somebody may test positive, and you end up having to take that module out of service for 14 days. But the nice part is you’re not taking out a whole camp. ... It’s just that module.”

The total number of positive COVID cases among wildland firefighters among the various federal, state, local, and tribal agencies is not being tracked. Each fire agency has its own system for tracking and reporting COVID-19, said Jessica Gardetto, a spokesperson for the Bureau of Land Management (BLM) and the National Interagency Fire Center in Idaho.

The largest wildland firefighting agency is the Department of Agriculture’s Forest Service, with 10,000 firefighters. Another major agency is the Department of the Interior, which BLM is part of and which had more than 3,500 full-time fire employees last year. As of the first week of August, 111 Forest Service firefighters and 40 BLM firefighters (who work underneath the broader Interior Department agency) had tested positive for COVID-19, according to officials for the respective agencies.

“Considering we’ve now been experiencing fire activity for several months, this number is surprisingly low if you think about the thousands of fire personnel who’ve been suppressing wildfires this summer,” Ms. Gardetto said.

Mr. Goicoechea and his Montana team traveled north of Tucson, Arizona, on June 22 to manage a rapidly spreading fire in the Santa Catalina Mountains that required 1,200 responders at its peak. Within 2 days of the team’s arrival, his managers were overwhelmed by calls from firefighters worried or with questions about preventing the spread of COVID-19 or carrying the virus home to their families.

In an unusual move, Mr. Goicoechea called upon Montana physician – and former National Park Service ranger with wildfire experience – Harry Sibold, MD, to join the team. Physicians are rarely, if ever, part of a wildfire camp’s medical team, Mr. Goicoechea said.

Dr. Sibold gave regular coronavirus updates during morning briefings, consulted with local health officials, soothed firefighters worried about bringing the virus home to their families, and advised fire managers on how to handle scenarios that might come up.

But Dr. Sibold said he wasn’t optimistic at the beginning about keeping the coronavirus in check in a large camp in Pima County, which has the second-highest number of confirmed cases in Arizona, at the time a national COVID-19 hot spot. “I quite firmly expected that we might have two or three outbreaks,” he said.

There were no positive cases during the team’s 2-week deployment, just three or four cases in which a firefighter showed symptoms but tested negative for the virus. After the Montana team returned home, nine firefighters at the Arizona fire from other units tested positive, Mr. Goicoechea said. Contact tracers notified the Montana team, some of whom were tested. All tests returned negative.

“I can’t say enough about having that doctor to help,” Mr. Goicoechea said, suggesting other teams might consider doing the same. “We’re not the experts in a pandemic. We’re the experts with fire.”

That early success will be tested as the number of fires increases across the West, along with the number of firefighters responding to them. There were more than 15,000 firefighters and support personnel assigned to fires across the nation as of mid-August, and the success of those COVID-19 prevention protocols depend largely on them.

Mr. Paul, the Oregon firefighter, said that the guidelines were followed closely in camp, but less so out on the fire line. It also appeared to him that younger firefighters were less likely to follow the masking and social-distancing rules than the veterans like him. That worried him as he realized it wouldn’t take much to spark an outbreak that could sideline crews and cripple the ability to respond to a fire.

“We’re outside, so it definitely helps with mitigation and makes it simpler to social distance,” Mr. Paul said. “But I think if there’s a mistake made, it could happen.”

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

Publications
Topics
Sections

Jon Paul was leery entering his first wildfire camp of the year late last month to fight three lightning-caused fires scorching parts of a Northern California forest that hadn’t burned in 40 years.

Courtesy of U.S. Forest Service
Firefighters wear face masks at a morning briefing on the Bighorn Fire, north of Tucson, Ariz., on June 22, 2020. COVID-prevention protocols – based on guidelines from the Centers for Disease Control and Prevention – are recommended for wildfire camps.

The 54-year-old engine captain from southern Oregon knew from experience that these crowded, grimy camps can be breeding grounds for norovirus and a respiratory illness that firefighters call the “camp crud” in a normal year. He wondered what the coronavirus would do in the tent cities where hundreds of men and women eat, sleep, wash, and spend their downtime between shifts.

Mr. Paul thought about his immunocompromised wife and his 84-year-old mother back home. Then he joined the approximately 1,300 people spread across the Modoc National Forest who would provide a major test for the COVID-prevention measures that had been developed for wildland firefighters.

“We’re still first responders and we have that responsibility to go and deal with these emergencies,” he said in a recent interview. “I don’t scare easy, but I’m very wary and concerned about my surroundings. I’m still going to work and do my job.”

Mr. Paul is one of thousands of firefighters from across the United States battling dozens of wildfires burning throughout the West. It’s an inherently dangerous job that now carries the additional risk of COVID-19 transmission. Any outbreak that ripples through a camp could easily sideline crews and spread the virus across multiple fires – and back to communities across the country – as personnel transfer in and out of “hot zones” and return home.

Though most firefighters are young and fit, some will inevitably fall ill in these remote makeshift communities of shared showers and portable toilets, where medical care can be limited. The pollutants in the smoke they breathe daily also make them more susceptible to COVID-19 and can worsen the effects of the disease, according to the Centers for Disease Control and Prevention.

Also, one suspected or positive case in a camp will mean many other firefighters will need to be quarantined, unable to work. The worst-case scenario is that multiple outbreaks could hamstring the nation’s ability to respond as wildfire season peaks in August, the hottest and driest month of the year in the western United States.

The number of acres burned so far this year is below the 10-year average, but the fire outlook for August is above average in nine states, according to the National Interagency Fire Center. Twenty-two large fires were ignited on Monday alone after lightning storms passed through the Northwest.

A study published this month by researchers at Colorado State University and the U.S. Forest Service’s Rocky Mountain Research Station concluded that COVID outbreaks “could be a serious threat to the firefighting mission” and urged vigilant social distancing and screening measures in the camps.

“If simultaneous fires incurred outbreaks, the entire wildland response system could be stressed substantially, with a large portion of the workforce quarantined,” the study’s authors wrote.

This spring, the National Wildfire Coordinating Group’s Fire Management Board wrote – and has since been updating – protocols to prevent the spread of COVID-19 in fire camps, based on CDC guidelines. Though they can be adapted by managers at different fires and even by individual team, they center on some key recommendations, including the following:

  • Firefighters should be screened for fever and other COVID symptoms when they arrive at camp.
  • Every crew should insulate itself as a “module of one” for the fire season and limit interactions with other crews.
  • Firefighters should maintain social distancing and wear face coverings when social distancing isn’t possible. Smaller satellite camps, known as spike camps, can be built to ensure enough space.
  • Shared areas should be regularly cleaned and disinfected, and sharing tools and radios should be minimized.

The guidance does not include routine testing of newly arrived firefighters – a practice used for athletes at training camps and students returning to college campuses.

The Fire Management Board’s Wildland Fire Medical and Public Health Advisory Team wrote in a July 2 memo that it “does not recommend utilizing universal COVID-19 laboratory testing as a standalone risk mitigation or screening measure among wildland firefighters.” Rather, the group recommends testing an individual and directly exposed coworkers, saying that approach is in line with CDC guidance.

The lack of testing capacity and long turnaround times are factors, according to Forest Service spokesperson Dan Hottle.

The exception is Alaska, where firefighters are tested upon arrival at the airport and are quarantined in a hotel while awaiting results, which come within 24 hours, Mr. Hottle said.

Fire crews responding to early-season fires in the spring had some problems adjusting to the new protocols, according to assessments written by fire leaders and compiled by the Wildland Fire Lessons Learned Center.

Shawn Faiella, superintendent of the interagency “hotshot crew” – so named because they work the most challenging or “hottest” parts of wildfires – based at Montana’s Lolo National Forest, questioned the need to wear masks inside vehicles and the safety of bringing extra vehicles to space out firefighters traveling to a blaze. Parking extra vehicles at the scene of a fire is difficult in tight dirt roads – and would be dangerous if evacuations are necessary, he wrote.

“It’s damn tough to take these practices to the fire line,” Mr. Faiella wrote after his team responded to a 40-acre Montana fire in April.

One recommendation that fire managers say has been particularly effective is the “module of one” concept requiring crews to eat and sleep together in isolation for the entire fire season.

“Whoever came up with it, it is working,” said Mike Goicoechea, the Montana-based incident commander for the Forest Service’s Northern Region Type 1 team, which manages the nation’s largest and most complex wildfires and natural disasters. “Somebody may test positive, and you end up having to take that module out of service for 14 days. But the nice part is you’re not taking out a whole camp. ... It’s just that module.”

The total number of positive COVID cases among wildland firefighters among the various federal, state, local, and tribal agencies is not being tracked. Each fire agency has its own system for tracking and reporting COVID-19, said Jessica Gardetto, a spokesperson for the Bureau of Land Management (BLM) and the National Interagency Fire Center in Idaho.

The largest wildland firefighting agency is the Department of Agriculture’s Forest Service, with 10,000 firefighters. Another major agency is the Department of the Interior, which BLM is part of and which had more than 3,500 full-time fire employees last year. As of the first week of August, 111 Forest Service firefighters and 40 BLM firefighters (who work underneath the broader Interior Department agency) had tested positive for COVID-19, according to officials for the respective agencies.

“Considering we’ve now been experiencing fire activity for several months, this number is surprisingly low if you think about the thousands of fire personnel who’ve been suppressing wildfires this summer,” Ms. Gardetto said.

Mr. Goicoechea and his Montana team traveled north of Tucson, Arizona, on June 22 to manage a rapidly spreading fire in the Santa Catalina Mountains that required 1,200 responders at its peak. Within 2 days of the team’s arrival, his managers were overwhelmed by calls from firefighters worried or with questions about preventing the spread of COVID-19 or carrying the virus home to their families.

In an unusual move, Mr. Goicoechea called upon Montana physician – and former National Park Service ranger with wildfire experience – Harry Sibold, MD, to join the team. Physicians are rarely, if ever, part of a wildfire camp’s medical team, Mr. Goicoechea said.

Dr. Sibold gave regular coronavirus updates during morning briefings, consulted with local health officials, soothed firefighters worried about bringing the virus home to their families, and advised fire managers on how to handle scenarios that might come up.

But Dr. Sibold said he wasn’t optimistic at the beginning about keeping the coronavirus in check in a large camp in Pima County, which has the second-highest number of confirmed cases in Arizona, at the time a national COVID-19 hot spot. “I quite firmly expected that we might have two or three outbreaks,” he said.

There were no positive cases during the team’s 2-week deployment, just three or four cases in which a firefighter showed symptoms but tested negative for the virus. After the Montana team returned home, nine firefighters at the Arizona fire from other units tested positive, Mr. Goicoechea said. Contact tracers notified the Montana team, some of whom were tested. All tests returned negative.

“I can’t say enough about having that doctor to help,” Mr. Goicoechea said, suggesting other teams might consider doing the same. “We’re not the experts in a pandemic. We’re the experts with fire.”

That early success will be tested as the number of fires increases across the West, along with the number of firefighters responding to them. There were more than 15,000 firefighters and support personnel assigned to fires across the nation as of mid-August, and the success of those COVID-19 prevention protocols depend largely on them.

Mr. Paul, the Oregon firefighter, said that the guidelines were followed closely in camp, but less so out on the fire line. It also appeared to him that younger firefighters were less likely to follow the masking and social-distancing rules than the veterans like him. That worried him as he realized it wouldn’t take much to spark an outbreak that could sideline crews and cripple the ability to respond to a fire.

“We’re outside, so it definitely helps with mitigation and makes it simpler to social distance,” Mr. Paul said. “But I think if there’s a mistake made, it could happen.”

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

Jon Paul was leery entering his first wildfire camp of the year late last month to fight three lightning-caused fires scorching parts of a Northern California forest that hadn’t burned in 40 years.

Courtesy of U.S. Forest Service
Firefighters wear face masks at a morning briefing on the Bighorn Fire, north of Tucson, Ariz., on June 22, 2020. COVID-prevention protocols – based on guidelines from the Centers for Disease Control and Prevention – are recommended for wildfire camps.

The 54-year-old engine captain from southern Oregon knew from experience that these crowded, grimy camps can be breeding grounds for norovirus and a respiratory illness that firefighters call the “camp crud” in a normal year. He wondered what the coronavirus would do in the tent cities where hundreds of men and women eat, sleep, wash, and spend their downtime between shifts.

Mr. Paul thought about his immunocompromised wife and his 84-year-old mother back home. Then he joined the approximately 1,300 people spread across the Modoc National Forest who would provide a major test for the COVID-prevention measures that had been developed for wildland firefighters.

“We’re still first responders and we have that responsibility to go and deal with these emergencies,” he said in a recent interview. “I don’t scare easy, but I’m very wary and concerned about my surroundings. I’m still going to work and do my job.”

Mr. Paul is one of thousands of firefighters from across the United States battling dozens of wildfires burning throughout the West. It’s an inherently dangerous job that now carries the additional risk of COVID-19 transmission. Any outbreak that ripples through a camp could easily sideline crews and spread the virus across multiple fires – and back to communities across the country – as personnel transfer in and out of “hot zones” and return home.

Though most firefighters are young and fit, some will inevitably fall ill in these remote makeshift communities of shared showers and portable toilets, where medical care can be limited. The pollutants in the smoke they breathe daily also make them more susceptible to COVID-19 and can worsen the effects of the disease, according to the Centers for Disease Control and Prevention.

Also, one suspected or positive case in a camp will mean many other firefighters will need to be quarantined, unable to work. The worst-case scenario is that multiple outbreaks could hamstring the nation’s ability to respond as wildfire season peaks in August, the hottest and driest month of the year in the western United States.

The number of acres burned so far this year is below the 10-year average, but the fire outlook for August is above average in nine states, according to the National Interagency Fire Center. Twenty-two large fires were ignited on Monday alone after lightning storms passed through the Northwest.

A study published this month by researchers at Colorado State University and the U.S. Forest Service’s Rocky Mountain Research Station concluded that COVID outbreaks “could be a serious threat to the firefighting mission” and urged vigilant social distancing and screening measures in the camps.

“If simultaneous fires incurred outbreaks, the entire wildland response system could be stressed substantially, with a large portion of the workforce quarantined,” the study’s authors wrote.

This spring, the National Wildfire Coordinating Group’s Fire Management Board wrote – and has since been updating – protocols to prevent the spread of COVID-19 in fire camps, based on CDC guidelines. Though they can be adapted by managers at different fires and even by individual team, they center on some key recommendations, including the following:

  • Firefighters should be screened for fever and other COVID symptoms when they arrive at camp.
  • Every crew should insulate itself as a “module of one” for the fire season and limit interactions with other crews.
  • Firefighters should maintain social distancing and wear face coverings when social distancing isn’t possible. Smaller satellite camps, known as spike camps, can be built to ensure enough space.
  • Shared areas should be regularly cleaned and disinfected, and sharing tools and radios should be minimized.

The guidance does not include routine testing of newly arrived firefighters – a practice used for athletes at training camps and students returning to college campuses.

The Fire Management Board’s Wildland Fire Medical and Public Health Advisory Team wrote in a July 2 memo that it “does not recommend utilizing universal COVID-19 laboratory testing as a standalone risk mitigation or screening measure among wildland firefighters.” Rather, the group recommends testing an individual and directly exposed coworkers, saying that approach is in line with CDC guidance.

The lack of testing capacity and long turnaround times are factors, according to Forest Service spokesperson Dan Hottle.

The exception is Alaska, where firefighters are tested upon arrival at the airport and are quarantined in a hotel while awaiting results, which come within 24 hours, Mr. Hottle said.

Fire crews responding to early-season fires in the spring had some problems adjusting to the new protocols, according to assessments written by fire leaders and compiled by the Wildland Fire Lessons Learned Center.

Shawn Faiella, superintendent of the interagency “hotshot crew” – so named because they work the most challenging or “hottest” parts of wildfires – based at Montana’s Lolo National Forest, questioned the need to wear masks inside vehicles and the safety of bringing extra vehicles to space out firefighters traveling to a blaze. Parking extra vehicles at the scene of a fire is difficult in tight dirt roads – and would be dangerous if evacuations are necessary, he wrote.

“It’s damn tough to take these practices to the fire line,” Mr. Faiella wrote after his team responded to a 40-acre Montana fire in April.

One recommendation that fire managers say has been particularly effective is the “module of one” concept requiring crews to eat and sleep together in isolation for the entire fire season.

“Whoever came up with it, it is working,” said Mike Goicoechea, the Montana-based incident commander for the Forest Service’s Northern Region Type 1 team, which manages the nation’s largest and most complex wildfires and natural disasters. “Somebody may test positive, and you end up having to take that module out of service for 14 days. But the nice part is you’re not taking out a whole camp. ... It’s just that module.”

The total number of positive COVID cases among wildland firefighters among the various federal, state, local, and tribal agencies is not being tracked. Each fire agency has its own system for tracking and reporting COVID-19, said Jessica Gardetto, a spokesperson for the Bureau of Land Management (BLM) and the National Interagency Fire Center in Idaho.

The largest wildland firefighting agency is the Department of Agriculture’s Forest Service, with 10,000 firefighters. Another major agency is the Department of the Interior, which BLM is part of and which had more than 3,500 full-time fire employees last year. As of the first week of August, 111 Forest Service firefighters and 40 BLM firefighters (who work underneath the broader Interior Department agency) had tested positive for COVID-19, according to officials for the respective agencies.

“Considering we’ve now been experiencing fire activity for several months, this number is surprisingly low if you think about the thousands of fire personnel who’ve been suppressing wildfires this summer,” Ms. Gardetto said.

Mr. Goicoechea and his Montana team traveled north of Tucson, Arizona, on June 22 to manage a rapidly spreading fire in the Santa Catalina Mountains that required 1,200 responders at its peak. Within 2 days of the team’s arrival, his managers were overwhelmed by calls from firefighters worried or with questions about preventing the spread of COVID-19 or carrying the virus home to their families.

In an unusual move, Mr. Goicoechea called upon Montana physician – and former National Park Service ranger with wildfire experience – Harry Sibold, MD, to join the team. Physicians are rarely, if ever, part of a wildfire camp’s medical team, Mr. Goicoechea said.

Dr. Sibold gave regular coronavirus updates during morning briefings, consulted with local health officials, soothed firefighters worried about bringing the virus home to their families, and advised fire managers on how to handle scenarios that might come up.

But Dr. Sibold said he wasn’t optimistic at the beginning about keeping the coronavirus in check in a large camp in Pima County, which has the second-highest number of confirmed cases in Arizona, at the time a national COVID-19 hot spot. “I quite firmly expected that we might have two or three outbreaks,” he said.

There were no positive cases during the team’s 2-week deployment, just three or four cases in which a firefighter showed symptoms but tested negative for the virus. After the Montana team returned home, nine firefighters at the Arizona fire from other units tested positive, Mr. Goicoechea said. Contact tracers notified the Montana team, some of whom were tested. All tests returned negative.

“I can’t say enough about having that doctor to help,” Mr. Goicoechea said, suggesting other teams might consider doing the same. “We’re not the experts in a pandemic. We’re the experts with fire.”

That early success will be tested as the number of fires increases across the West, along with the number of firefighters responding to them. There were more than 15,000 firefighters and support personnel assigned to fires across the nation as of mid-August, and the success of those COVID-19 prevention protocols depend largely on them.

Mr. Paul, the Oregon firefighter, said that the guidelines were followed closely in camp, but less so out on the fire line. It also appeared to him that younger firefighters were less likely to follow the masking and social-distancing rules than the veterans like him. That worried him as he realized it wouldn’t take much to spark an outbreak that could sideline crews and cripple the ability to respond to a fire.

“We’re outside, so it definitely helps with mitigation and makes it simpler to social distance,” Mr. Paul said. “But I think if there’s a mistake made, it could happen.”

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article

Hospitalists confront administrative, financial challenges of COVID-19 crisis

Article Type
Changed
Thu, 08/26/2021 - 16:01

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?

Dr. Ron Greeno

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.

Dr. Brian Harte

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.

Dr. Bryce Gartland

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.

Dr. Chad T. Whelan

“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.”

Publications
Topics
Sections

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?

Dr. Ron Greeno

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.

Dr. Brian Harte

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.

Dr. Bryce Gartland

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.

Dr. Chad T. Whelan

“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?

Dr. Ron Greeno

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.

Dr. Brian Harte

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.

Dr. Bryce Gartland

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.

Dr. Chad T. Whelan

“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.”

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article

Oleander extract for COVID-19? That’s a hard ‘no’ experts say

Article Type
Changed
Thu, 08/26/2021 - 16:01

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.

Publications
Topics
Sections

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.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article

Pulmonary artery denervation eases PAH after endarterectomy

Article Type
Changed
Thu, 08/20/2020 - 11:58

Pulmonary artery denervation (PADN) provides persistent and clinically significant hemodynamic improvements in patients with persistent chronic thromboembolic hypertension (CTEPH) after pulmonary endarterectomy (PEA), according to a randomized, sham-controlled trial.

“PADN in patients with CTEPH after PEA was safe and effective,” according to an investigating team led by Alexander Romanov, MD, PhD.

The mean reduction in pulmonary vascular resistance (PVR) was 258 dyn/sec per cm–5 for those randomized to PADN versus 149 dyn/sec per cm–5 (P = .001) for those randomized to the sham procedure, according to the newly published findings.

For the 6-minute walk test (6MWT), the mean distance was 470 m for the experimental group versus 399 m (P = .03) for the controls.

Several secondary endpoints measuring hemodynamics also favored PADN relative to the sham procedure at 12 months. This included the relative increase in tricuspid annular systolic excursion (P = .03) and the increase in the right ventricular fraction area (P < .001).

A total of 50 patients with residual CTEPH for at least 6 months after PEA despite medical therapy were enrolled and randomized. Entry criteria included a mean pulmonary artery pressure (PAP) of 25 mm Hg or greater or PVR greater than 400 dyn/sec per cm–5 on right heart catheterization. Patients with comorbidities associated with a life expectancy of less than 1 year were excluded.

Those randomized to the sham group were treated with riociguat over the course of follow-up. This therapy was not offered to patients in the PADN group, but all patients were blinded to the procedure and told that riociguat might or might not be administered.

Following the procedure, participating clinicians, who were also blinded to the procedure, were instructed to provide standard therapies for heart failure, such beta-blockers, diuretics, or digoxin, as needed. All patients were placed on an oral anticoagulant.

At 12 months the mean PAP (26 vs. 35 mm Hg; P < .001) and the mean systolic PAP (46 vs. 54 mm Hg; P = .01) were significantly lower in the PADN group versus those who underwent a sham procedure.

About 52% of the PADN group versus 12% of the sham group were classified as responders by the definition of a PVR reduction of at least 150 dyn/sec per cm–5 and 6MWT improvement of at least 20%, compared with baseline, reported Dr. Romanov, of the E. Meshalkin National Medical Research Center, ministry of health, Novosibirsk, Russia, and coinvestigators.

Of the three deaths caused by heart failure over the course of follow-up, two occurred in the sham group. Of the eight hospitalizations for heart failure, seven (29% of the sham group) occurred among controls versus one in those treated with PADN (4% of this group; P = .049).

There was one groin hematoma at the puncture site in each group. Both resolved without any consequences prior to hospital discharge. There were no other significant procedure-related complications in either group.



Larger multicenter trials are needed to confirm these findings, according to both the trial investigators and Marius M. Hoeper, MD, who is charge of the pulmonary hypertension program at the Hannover (Germany) Medical School.

In an editorial that accompanied publication of these findings, Dr. Hoeper identified the small sample size of this study as one of its limitations, but he said the results are consistent with several other small studies associating pulmonary artery denervation with benefit in pulmonary hypertension.

“It appears as if we are currently witnessing the emergence of a new treatment option for various forms of pulmonary hypertension,” Dr. Hoeper wrote. In his critique of the study, he suggested that it would have been “more informative” if both groups were on background riociguat, but the data from this and other studies so far indicates that ablation to achieve denervation “is safe and feasible.”

The PADN technique used in this study might be relevant to the results. Dr. Hoeper noted that the investigators employed catheter tip–based electroanatomic mapping with a novel remote navigation system with three-dimensional imaging of the right ventricle and central pulmonary arteries.

“Apparently, this approach minimizes radiation exposure and provides precise location of ablation sites,” Dr. Hoeper observed. However, he called for direct comparisons of this tool to the guidance systems used in other studies.

In an interview, Dr. Hoeper acknowledged that it is not yet clear that a large-scale trial of pulmonary artery denervation for the indication evaluated in this study is coming. He noted several strategies in CTEPH are widely used without trials confirming a reduction in clinical events.

“Balloon pulmonary angioplasty for CTEPH has become an established treatment around the world without any randomized, controlled trial and without demonstration of improved outcomes. A couple of well-conducted observational trials might be sufficient to convince physicians to introduce PADN as well,” he said. If such studies associated PADN with “improvements in hemodynamics, exercise capacity, and patient-reported outcomes, it might be sufficient.”

Currently, Dr. Hoeper is most concerned about obtaining further evidence of safety, which he characterized as a “major issue.”

If a multicenter trial is conducted “the primary endpoint should be focused on clinical events,” according to Dr. Romanov, who was asked to comment on the next steps in validating PADN for the treatment of CTEPH-associated pulmonary hypertension persisting after endarterectomy.

“The mortality rate during 1-year long-term follow-up is not so high, but heart failure progression is a problem. So in my view, the primary endpoint should be a composite of death and heart failure hospitalization,” he said. He called for follow-up duration of 2-3 years.

Jonathan Steinberg, MD, director of cardiac clinical trials and education, Summit Medical Group, Montclair, N.J., also called a trial with hard endpoints, such as death, the ideal.

In the meantime, hemodynamic and functional measures “are still quite valuable and move the ball forward for this intervention,” he said in an interview. Senior author of this trial and principle investigator of the recent ERADICATE-AF trial, which evaluated renal denervation in preventing recurrence of atrial fibrillation (JAMA. 2020;323:248-55), Dr. Steinberg predicted, “I do indeed suspect we will see trials that are more accomplishable [than a large-scale, randomized, controlled trial] in the not too distant future.”

Dr. Romanov received funding from Biosense Webster. Dr. Hoeper has received fees for lectures and/or consultations from Acceleron, Actelion, Bayer, Janssen, Merck Sharp & Dohme, and Pfizer.

SOURCE: Romanov A et al. J Am Coll Cardiol. 2020 Aug 17;76:916-26.

Publications
Topics
Sections

Pulmonary artery denervation (PADN) provides persistent and clinically significant hemodynamic improvements in patients with persistent chronic thromboembolic hypertension (CTEPH) after pulmonary endarterectomy (PEA), according to a randomized, sham-controlled trial.

“PADN in patients with CTEPH after PEA was safe and effective,” according to an investigating team led by Alexander Romanov, MD, PhD.

The mean reduction in pulmonary vascular resistance (PVR) was 258 dyn/sec per cm–5 for those randomized to PADN versus 149 dyn/sec per cm–5 (P = .001) for those randomized to the sham procedure, according to the newly published findings.

For the 6-minute walk test (6MWT), the mean distance was 470 m for the experimental group versus 399 m (P = .03) for the controls.

Several secondary endpoints measuring hemodynamics also favored PADN relative to the sham procedure at 12 months. This included the relative increase in tricuspid annular systolic excursion (P = .03) and the increase in the right ventricular fraction area (P < .001).

A total of 50 patients with residual CTEPH for at least 6 months after PEA despite medical therapy were enrolled and randomized. Entry criteria included a mean pulmonary artery pressure (PAP) of 25 mm Hg or greater or PVR greater than 400 dyn/sec per cm–5 on right heart catheterization. Patients with comorbidities associated with a life expectancy of less than 1 year were excluded.

Those randomized to the sham group were treated with riociguat over the course of follow-up. This therapy was not offered to patients in the PADN group, but all patients were blinded to the procedure and told that riociguat might or might not be administered.

Following the procedure, participating clinicians, who were also blinded to the procedure, were instructed to provide standard therapies for heart failure, such beta-blockers, diuretics, or digoxin, as needed. All patients were placed on an oral anticoagulant.

At 12 months the mean PAP (26 vs. 35 mm Hg; P < .001) and the mean systolic PAP (46 vs. 54 mm Hg; P = .01) were significantly lower in the PADN group versus those who underwent a sham procedure.

About 52% of the PADN group versus 12% of the sham group were classified as responders by the definition of a PVR reduction of at least 150 dyn/sec per cm–5 and 6MWT improvement of at least 20%, compared with baseline, reported Dr. Romanov, of the E. Meshalkin National Medical Research Center, ministry of health, Novosibirsk, Russia, and coinvestigators.

Of the three deaths caused by heart failure over the course of follow-up, two occurred in the sham group. Of the eight hospitalizations for heart failure, seven (29% of the sham group) occurred among controls versus one in those treated with PADN (4% of this group; P = .049).

There was one groin hematoma at the puncture site in each group. Both resolved without any consequences prior to hospital discharge. There were no other significant procedure-related complications in either group.



Larger multicenter trials are needed to confirm these findings, according to both the trial investigators and Marius M. Hoeper, MD, who is charge of the pulmonary hypertension program at the Hannover (Germany) Medical School.

In an editorial that accompanied publication of these findings, Dr. Hoeper identified the small sample size of this study as one of its limitations, but he said the results are consistent with several other small studies associating pulmonary artery denervation with benefit in pulmonary hypertension.

“It appears as if we are currently witnessing the emergence of a new treatment option for various forms of pulmonary hypertension,” Dr. Hoeper wrote. In his critique of the study, he suggested that it would have been “more informative” if both groups were on background riociguat, but the data from this and other studies so far indicates that ablation to achieve denervation “is safe and feasible.”

The PADN technique used in this study might be relevant to the results. Dr. Hoeper noted that the investigators employed catheter tip–based electroanatomic mapping with a novel remote navigation system with three-dimensional imaging of the right ventricle and central pulmonary arteries.

“Apparently, this approach minimizes radiation exposure and provides precise location of ablation sites,” Dr. Hoeper observed. However, he called for direct comparisons of this tool to the guidance systems used in other studies.

In an interview, Dr. Hoeper acknowledged that it is not yet clear that a large-scale trial of pulmonary artery denervation for the indication evaluated in this study is coming. He noted several strategies in CTEPH are widely used without trials confirming a reduction in clinical events.

“Balloon pulmonary angioplasty for CTEPH has become an established treatment around the world without any randomized, controlled trial and without demonstration of improved outcomes. A couple of well-conducted observational trials might be sufficient to convince physicians to introduce PADN as well,” he said. If such studies associated PADN with “improvements in hemodynamics, exercise capacity, and patient-reported outcomes, it might be sufficient.”

Currently, Dr. Hoeper is most concerned about obtaining further evidence of safety, which he characterized as a “major issue.”

If a multicenter trial is conducted “the primary endpoint should be focused on clinical events,” according to Dr. Romanov, who was asked to comment on the next steps in validating PADN for the treatment of CTEPH-associated pulmonary hypertension persisting after endarterectomy.

“The mortality rate during 1-year long-term follow-up is not so high, but heart failure progression is a problem. So in my view, the primary endpoint should be a composite of death and heart failure hospitalization,” he said. He called for follow-up duration of 2-3 years.

Jonathan Steinberg, MD, director of cardiac clinical trials and education, Summit Medical Group, Montclair, N.J., also called a trial with hard endpoints, such as death, the ideal.

In the meantime, hemodynamic and functional measures “are still quite valuable and move the ball forward for this intervention,” he said in an interview. Senior author of this trial and principle investigator of the recent ERADICATE-AF trial, which evaluated renal denervation in preventing recurrence of atrial fibrillation (JAMA. 2020;323:248-55), Dr. Steinberg predicted, “I do indeed suspect we will see trials that are more accomplishable [than a large-scale, randomized, controlled trial] in the not too distant future.”

Dr. Romanov received funding from Biosense Webster. Dr. Hoeper has received fees for lectures and/or consultations from Acceleron, Actelion, Bayer, Janssen, Merck Sharp & Dohme, and Pfizer.

SOURCE: Romanov A et al. J Am Coll Cardiol. 2020 Aug 17;76:916-26.

Pulmonary artery denervation (PADN) provides persistent and clinically significant hemodynamic improvements in patients with persistent chronic thromboembolic hypertension (CTEPH) after pulmonary endarterectomy (PEA), according to a randomized, sham-controlled trial.

“PADN in patients with CTEPH after PEA was safe and effective,” according to an investigating team led by Alexander Romanov, MD, PhD.

The mean reduction in pulmonary vascular resistance (PVR) was 258 dyn/sec per cm–5 for those randomized to PADN versus 149 dyn/sec per cm–5 (P = .001) for those randomized to the sham procedure, according to the newly published findings.

For the 6-minute walk test (6MWT), the mean distance was 470 m for the experimental group versus 399 m (P = .03) for the controls.

Several secondary endpoints measuring hemodynamics also favored PADN relative to the sham procedure at 12 months. This included the relative increase in tricuspid annular systolic excursion (P = .03) and the increase in the right ventricular fraction area (P < .001).

A total of 50 patients with residual CTEPH for at least 6 months after PEA despite medical therapy were enrolled and randomized. Entry criteria included a mean pulmonary artery pressure (PAP) of 25 mm Hg or greater or PVR greater than 400 dyn/sec per cm–5 on right heart catheterization. Patients with comorbidities associated with a life expectancy of less than 1 year were excluded.

Those randomized to the sham group were treated with riociguat over the course of follow-up. This therapy was not offered to patients in the PADN group, but all patients were blinded to the procedure and told that riociguat might or might not be administered.

Following the procedure, participating clinicians, who were also blinded to the procedure, were instructed to provide standard therapies for heart failure, such beta-blockers, diuretics, or digoxin, as needed. All patients were placed on an oral anticoagulant.

At 12 months the mean PAP (26 vs. 35 mm Hg; P < .001) and the mean systolic PAP (46 vs. 54 mm Hg; P = .01) were significantly lower in the PADN group versus those who underwent a sham procedure.

About 52% of the PADN group versus 12% of the sham group were classified as responders by the definition of a PVR reduction of at least 150 dyn/sec per cm–5 and 6MWT improvement of at least 20%, compared with baseline, reported Dr. Romanov, of the E. Meshalkin National Medical Research Center, ministry of health, Novosibirsk, Russia, and coinvestigators.

Of the three deaths caused by heart failure over the course of follow-up, two occurred in the sham group. Of the eight hospitalizations for heart failure, seven (29% of the sham group) occurred among controls versus one in those treated with PADN (4% of this group; P = .049).

There was one groin hematoma at the puncture site in each group. Both resolved without any consequences prior to hospital discharge. There were no other significant procedure-related complications in either group.



Larger multicenter trials are needed to confirm these findings, according to both the trial investigators and Marius M. Hoeper, MD, who is charge of the pulmonary hypertension program at the Hannover (Germany) Medical School.

In an editorial that accompanied publication of these findings, Dr. Hoeper identified the small sample size of this study as one of its limitations, but he said the results are consistent with several other small studies associating pulmonary artery denervation with benefit in pulmonary hypertension.

“It appears as if we are currently witnessing the emergence of a new treatment option for various forms of pulmonary hypertension,” Dr. Hoeper wrote. In his critique of the study, he suggested that it would have been “more informative” if both groups were on background riociguat, but the data from this and other studies so far indicates that ablation to achieve denervation “is safe and feasible.”

The PADN technique used in this study might be relevant to the results. Dr. Hoeper noted that the investigators employed catheter tip–based electroanatomic mapping with a novel remote navigation system with three-dimensional imaging of the right ventricle and central pulmonary arteries.

“Apparently, this approach minimizes radiation exposure and provides precise location of ablation sites,” Dr. Hoeper observed. However, he called for direct comparisons of this tool to the guidance systems used in other studies.

In an interview, Dr. Hoeper acknowledged that it is not yet clear that a large-scale trial of pulmonary artery denervation for the indication evaluated in this study is coming. He noted several strategies in CTEPH are widely used without trials confirming a reduction in clinical events.

“Balloon pulmonary angioplasty for CTEPH has become an established treatment around the world without any randomized, controlled trial and without demonstration of improved outcomes. A couple of well-conducted observational trials might be sufficient to convince physicians to introduce PADN as well,” he said. If such studies associated PADN with “improvements in hemodynamics, exercise capacity, and patient-reported outcomes, it might be sufficient.”

Currently, Dr. Hoeper is most concerned about obtaining further evidence of safety, which he characterized as a “major issue.”

If a multicenter trial is conducted “the primary endpoint should be focused on clinical events,” according to Dr. Romanov, who was asked to comment on the next steps in validating PADN for the treatment of CTEPH-associated pulmonary hypertension persisting after endarterectomy.

“The mortality rate during 1-year long-term follow-up is not so high, but heart failure progression is a problem. So in my view, the primary endpoint should be a composite of death and heart failure hospitalization,” he said. He called for follow-up duration of 2-3 years.

Jonathan Steinberg, MD, director of cardiac clinical trials and education, Summit Medical Group, Montclair, N.J., also called a trial with hard endpoints, such as death, the ideal.

In the meantime, hemodynamic and functional measures “are still quite valuable and move the ball forward for this intervention,” he said in an interview. Senior author of this trial and principle investigator of the recent ERADICATE-AF trial, which evaluated renal denervation in preventing recurrence of atrial fibrillation (JAMA. 2020;323:248-55), Dr. Steinberg predicted, “I do indeed suspect we will see trials that are more accomplishable [than a large-scale, randomized, controlled trial] in the not too distant future.”

Dr. Romanov received funding from Biosense Webster. Dr. Hoeper has received fees for lectures and/or consultations from Acceleron, Actelion, Bayer, Janssen, Merck Sharp & Dohme, and Pfizer.

SOURCE: Romanov A et al. J Am Coll Cardiol. 2020 Aug 17;76:916-26.

Publications
Publications
Topics
Article Type
Sections
Inside the Article

FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article

Pulmonary rehab reduces COPD readmissions

Article Type
Changed
Mon, 03/22/2021 - 14:08

Pulmonary rehabilitation reduces the likelihood that patients with chronic obstructive pulmonary disease (COPD) will be readmitted to the hospital in the year after discharge by 33%, new research shows, but few patients participate in those programs.

In fact, in a retrospective cohort of 197,376 patients from 4446 hospitals, only 1.5% of patients initiated pulmonary rehabilitation in the 90 days after hospital discharge.

“This is a striking finding,” said Mihaela Stefan, PhD, from the University of Massachusetts Medical School–Baystate in Springfield. “Our study demonstrates that we need to increase access to rehabilitation to reduce the risk of readmissions.”

Not enough patients are initiating rehabilitation, but the onus is not only on them; the system is failing them. “We wanted to understand how much pulmonary rehabilitation lowers the readmission rate,” Stefan told Medscape Medical News.

So she and her colleagues examined the records of patients who were hospitalized for COPD in 2014 to see whether they had begun rehabilitation in the 90 days after discharge and whether they were readmitted to the hospital in the subsequent 12 months.

Patients who were unlikely to initiate pulmonary rehabilitation — such as those with dementia or metastatic cancer and those discharged to hospice care or a nursing home — were excluded from the analysis, Stefan said during her presentation at the study results at the virtual American Thoracic Society (ATS) 2020 International Conference.

The risk analysis was complex because many patients died before the year was out, and “a patient who dies has no risk of being readmitted,” she explained. Selection bias was also a factor because patients who do pulmonary rehab tend to be in better shape.

The researchers used propensity score matching and Anderson–Gill models of cumulative rehospitalizations or death at 1 year with time-varying exposure to pulmonary rehabilitation to account for clustering of individual events and adjust for covariates. “It was a complicated risk analysis,” she said.

In the year after discharge, 130,660 patients (66%) were readmitted to the hospital. The rate of rehospitalization was lower for those who initiated rehabilitation than for those who did not (59% vs 66%), as was the mean number of readmissions per patient (1.4 vs 1.8).

Rehabilitation was associated with a lower risk for readmission or death (hazard ratio, 0.67; 95% CI, 0.66 - 0.69).

“We know the referral rates are low and that pulmonary rehabilitation is effective in clinical trials,” said Stefan, and now “we see that pulmonary rehabilitation is effective when you look at patients in real life.”

From a provider perspective, “we need to make sure that hospitals get more money for pulmonary rehabilitation. Cardiac rehabilitation is paid for,” she explained. "But pulmonary rehab is not a lucrative business. I don›t know why the CMS pays more for cardiac."

A rehabilitation program generally consists of 36 sessions, held two or three times a week, and many patients can’t afford that on their own, she noted. Transportation is another huge issue.

recent study in which semi-structured interviews were conducted with 15 COPD patients showed that the main barriers to enrollment in a pulmonary rehabilitation program are lack of awareness, family obligations, transportation, and lack of motivation, said Stefan, who was involved in that research.

Telehealth rehabilitation programs might become more available in the near future, given the COVID pandemic. But “currently, Medicare doesn’t pay for telerehab,” she said. Virtual sessions might attract more patients, but lack of computer access and training could present another barrier for some.

 

 

PAH rehab

Uptake for pulmonary rehabilitation is as low for patients with pulmonary arterial hypertension (PAH) as it is for those with COPD, according to another study presented at the virtual ATS meeting.

An examination of the electronic health records of 111,356 veterans who experienced incident PAH from 2010 to 2016 showed that only 1,737 (1.6%) followed through on pulmonary rehabilitation.

“Exercise therapy is safe and effective at improving outcomes,” lead author Thomas Cascino, MD, from the University of Michigan in Ann Arbor, said in an ATS press release. “Recognizing that it is being underutilized is a necessary first step in working toward increasing patient access to rehab.

His group is currently working on a trial for home-based rehabilitation “using wearable technology as a means to expand access for people unable to come to center-based rehab for a variety of reasons,” he explained.

“The goal of all our treatments is to help people feel better and live longer,” Cascino added.

Stefan and Cascino have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Publications
Topics
Sections

Pulmonary rehabilitation reduces the likelihood that patients with chronic obstructive pulmonary disease (COPD) will be readmitted to the hospital in the year after discharge by 33%, new research shows, but few patients participate in those programs.

In fact, in a retrospective cohort of 197,376 patients from 4446 hospitals, only 1.5% of patients initiated pulmonary rehabilitation in the 90 days after hospital discharge.

“This is a striking finding,” said Mihaela Stefan, PhD, from the University of Massachusetts Medical School–Baystate in Springfield. “Our study demonstrates that we need to increase access to rehabilitation to reduce the risk of readmissions.”

Not enough patients are initiating rehabilitation, but the onus is not only on them; the system is failing them. “We wanted to understand how much pulmonary rehabilitation lowers the readmission rate,” Stefan told Medscape Medical News.

So she and her colleagues examined the records of patients who were hospitalized for COPD in 2014 to see whether they had begun rehabilitation in the 90 days after discharge and whether they were readmitted to the hospital in the subsequent 12 months.

Patients who were unlikely to initiate pulmonary rehabilitation — such as those with dementia or metastatic cancer and those discharged to hospice care or a nursing home — were excluded from the analysis, Stefan said during her presentation at the study results at the virtual American Thoracic Society (ATS) 2020 International Conference.

The risk analysis was complex because many patients died before the year was out, and “a patient who dies has no risk of being readmitted,” she explained. Selection bias was also a factor because patients who do pulmonary rehab tend to be in better shape.

The researchers used propensity score matching and Anderson–Gill models of cumulative rehospitalizations or death at 1 year with time-varying exposure to pulmonary rehabilitation to account for clustering of individual events and adjust for covariates. “It was a complicated risk analysis,” she said.

In the year after discharge, 130,660 patients (66%) were readmitted to the hospital. The rate of rehospitalization was lower for those who initiated rehabilitation than for those who did not (59% vs 66%), as was the mean number of readmissions per patient (1.4 vs 1.8).

Rehabilitation was associated with a lower risk for readmission or death (hazard ratio, 0.67; 95% CI, 0.66 - 0.69).

“We know the referral rates are low and that pulmonary rehabilitation is effective in clinical trials,” said Stefan, and now “we see that pulmonary rehabilitation is effective when you look at patients in real life.”

From a provider perspective, “we need to make sure that hospitals get more money for pulmonary rehabilitation. Cardiac rehabilitation is paid for,” she explained. "But pulmonary rehab is not a lucrative business. I don›t know why the CMS pays more for cardiac."

A rehabilitation program generally consists of 36 sessions, held two or three times a week, and many patients can’t afford that on their own, she noted. Transportation is another huge issue.

recent study in which semi-structured interviews were conducted with 15 COPD patients showed that the main barriers to enrollment in a pulmonary rehabilitation program are lack of awareness, family obligations, transportation, and lack of motivation, said Stefan, who was involved in that research.

Telehealth rehabilitation programs might become more available in the near future, given the COVID pandemic. But “currently, Medicare doesn’t pay for telerehab,” she said. Virtual sessions might attract more patients, but lack of computer access and training could present another barrier for some.

 

 

PAH rehab

Uptake for pulmonary rehabilitation is as low for patients with pulmonary arterial hypertension (PAH) as it is for those with COPD, according to another study presented at the virtual ATS meeting.

An examination of the electronic health records of 111,356 veterans who experienced incident PAH from 2010 to 2016 showed that only 1,737 (1.6%) followed through on pulmonary rehabilitation.

“Exercise therapy is safe and effective at improving outcomes,” lead author Thomas Cascino, MD, from the University of Michigan in Ann Arbor, said in an ATS press release. “Recognizing that it is being underutilized is a necessary first step in working toward increasing patient access to rehab.

His group is currently working on a trial for home-based rehabilitation “using wearable technology as a means to expand access for people unable to come to center-based rehab for a variety of reasons,” he explained.

“The goal of all our treatments is to help people feel better and live longer,” Cascino added.

Stefan and Cascino have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Pulmonary rehabilitation reduces the likelihood that patients with chronic obstructive pulmonary disease (COPD) will be readmitted to the hospital in the year after discharge by 33%, new research shows, but few patients participate in those programs.

In fact, in a retrospective cohort of 197,376 patients from 4446 hospitals, only 1.5% of patients initiated pulmonary rehabilitation in the 90 days after hospital discharge.

“This is a striking finding,” said Mihaela Stefan, PhD, from the University of Massachusetts Medical School–Baystate in Springfield. “Our study demonstrates that we need to increase access to rehabilitation to reduce the risk of readmissions.”

Not enough patients are initiating rehabilitation, but the onus is not only on them; the system is failing them. “We wanted to understand how much pulmonary rehabilitation lowers the readmission rate,” Stefan told Medscape Medical News.

So she and her colleagues examined the records of patients who were hospitalized for COPD in 2014 to see whether they had begun rehabilitation in the 90 days after discharge and whether they were readmitted to the hospital in the subsequent 12 months.

Patients who were unlikely to initiate pulmonary rehabilitation — such as those with dementia or metastatic cancer and those discharged to hospice care or a nursing home — were excluded from the analysis, Stefan said during her presentation at the study results at the virtual American Thoracic Society (ATS) 2020 International Conference.

The risk analysis was complex because many patients died before the year was out, and “a patient who dies has no risk of being readmitted,” she explained. Selection bias was also a factor because patients who do pulmonary rehab tend to be in better shape.

The researchers used propensity score matching and Anderson–Gill models of cumulative rehospitalizations or death at 1 year with time-varying exposure to pulmonary rehabilitation to account for clustering of individual events and adjust for covariates. “It was a complicated risk analysis,” she said.

In the year after discharge, 130,660 patients (66%) were readmitted to the hospital. The rate of rehospitalization was lower for those who initiated rehabilitation than for those who did not (59% vs 66%), as was the mean number of readmissions per patient (1.4 vs 1.8).

Rehabilitation was associated with a lower risk for readmission or death (hazard ratio, 0.67; 95% CI, 0.66 - 0.69).

“We know the referral rates are low and that pulmonary rehabilitation is effective in clinical trials,” said Stefan, and now “we see that pulmonary rehabilitation is effective when you look at patients in real life.”

From a provider perspective, “we need to make sure that hospitals get more money for pulmonary rehabilitation. Cardiac rehabilitation is paid for,” she explained. "But pulmonary rehab is not a lucrative business. I don›t know why the CMS pays more for cardiac."

A rehabilitation program generally consists of 36 sessions, held two or three times a week, and many patients can’t afford that on their own, she noted. Transportation is another huge issue.

recent study in which semi-structured interviews were conducted with 15 COPD patients showed that the main barriers to enrollment in a pulmonary rehabilitation program are lack of awareness, family obligations, transportation, and lack of motivation, said Stefan, who was involved in that research.

Telehealth rehabilitation programs might become more available in the near future, given the COVID pandemic. But “currently, Medicare doesn’t pay for telerehab,” she said. Virtual sessions might attract more patients, but lack of computer access and training could present another barrier for some.

 

 

PAH rehab

Uptake for pulmonary rehabilitation is as low for patients with pulmonary arterial hypertension (PAH) as it is for those with COPD, according to another study presented at the virtual ATS meeting.

An examination of the electronic health records of 111,356 veterans who experienced incident PAH from 2010 to 2016 showed that only 1,737 (1.6%) followed through on pulmonary rehabilitation.

“Exercise therapy is safe and effective at improving outcomes,” lead author Thomas Cascino, MD, from the University of Michigan in Ann Arbor, said in an ATS press release. “Recognizing that it is being underutilized is a necessary first step in working toward increasing patient access to rehab.

His group is currently working on a trial for home-based rehabilitation “using wearable technology as a means to expand access for people unable to come to center-based rehab for a variety of reasons,” he explained.

“The goal of all our treatments is to help people feel better and live longer,” Cascino added.

Stefan and Cascino have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article

HFNC more comfortable for posthypercapnic patients with COPD

Article Type
Changed
Wed, 08/19/2020 - 12:36

Following invasive ventilation for severe hypercapnic respiratory failure, patients with chronic obstructive pulmonary disease had similar levels of treatment failure if they received high-flow nasal cannula oxygen therapy or noninvasive ventilation, recent research in Critical Care has suggested.

However, for patients with COPD weaned off invasive ventilation, high-flow nasal cannula (HFNC) oxygen therapy was “more comfortable and better tolerated,” compared with noninvasive ventilation (NIV). In addition, “airway care interventions and the incidence of nasofacial skin breakdown associated with HFNC were significantly lower than in NIV,” according to Dingyu Tan of the Clinical Medical College of Yangzhou (China) University, Northern Jiangsu People’s Hospital, and colleagues. “HFNC appears to be an effective means of respiratory support for COPD patients extubated after severe hypercapnic respiratory failure,” they said.

The investigators screened patients with COPD and hypercapnic respiratory failure for enrollment, including those who met Global Initiative for Obstructive Lung Disease (GOLD) criteria, were 85 years old or younger and caring for themselves, had bronchopulmonary infection–induced respiratory failure, and had achieved pulmonary infection control criteria. Exclusion criteria were:

  • Patients under age 18 years.
  • Presence of oral or facial trauma.
  • Poor sputum excretion ability.
  • Hemodynamic instability that would contraindicate use of NIV.
  • Poor cough during PIC window.
  • Poor short-term prognosis.
  • Failure of the heart, brain, liver or kidney.
  • Patients who could not consent to treatment.

Patients were determined to have failed treatment if they returned to invasive mechanical ventilation or switched from one treatment to another (HFNC to NIV or NIV to HFNC). Investigators also performed an arterial blood gas analysis, recorded the number of duration of airway care interventions, and monitored vital signs at 1 hour, 24 hours, and 48 hours after extubation as secondary analyses.

Overall, 44 patients randomized to receive HFNC and 42 patients randomized for NIV were available for analysis. The investigators found 22.7% of patients in the HFNC group and 28.6% in the NIV group experienced treatment failure (risk difference, –5.8%; 95% confidence interval, −23.8 to 12.4%; P = .535), with patients in the HFNC group experiencing a significantly lower level of treatment intolerance, compared with patients in the NIV group (risk difference, ­–50.0%; 95% CI, −74.6 to −12.9%; P = .015). There were no significant differences between either group regarding intubation (−0.65%; 95% CI, −16.01 to 14.46%), while rate of switching treatments was lower in the HFNC group but not significant (−5.2%; 95% CI, −19.82 to 9.05%).

Patients in both the HFNC and NIV groups had faster mean respiratory rates 1 hour after extubation (P < .050). After 24 hours, the NIV group had higher-than-baseline respiratory rates, compared with the HFNC group, which had returned to normal (20 vs. 24.5 breaths per minute; P < .050). Both groups had returned to baseline by 48 hours after extubation. At 1 hour after extubation, patients in the HFNC group had lower PaO2/FiO2 (P < .050) and pH values (P < .050), and higher PaCO2 values (P less than .050), compared with baseline. There were no statistically significant differences in PaO2/FiO2, pH, and PaCO2 values in either group at 24 hours or 48 hours after extubation.

Daily airway care interventions were significantly higher on average in the NIV group, compared with the HFNC group (7 vs. 6; P = .0006), and the HFNC group also had significantly better comfort scores (7 vs. 5; P < .001) as measured by a modified visual analog scale, as well as incidence of nasal and facial skin breakdown (0 vs. 9.6%; P = .027), compared with the NIV group.
 

 

 

Results difficult to apply to North American patients

David L. Bowton, MD, FCCP, a professor specializing in critical care at Wake Forest University, Winston-Salem, N.C., said in an interview the results of this trial may not be applicable for patients with infection-related respiratory failure and COPD in North America “due to the differences in common weaning practices between North America and China.”

Dr. David L. Bowton

For example, the trial used the pulmonary infection control (PIC) window criteria for extubation, which requires a significant decrease in radiographic infiltrates, improvement in quality and quantity of sputum, normalizing of leukocyte count, a synchronized intermittent mandatory ventilation (SIMV) rate of 10-12 breaths per minute, and pressure support less than 10-12 cm/H2O (Int J Chron Obstruct Pulmon Dis. 2017;12:1255-67).

“The process used to achieve these measures is not standardized. In North America, daily awakening and screening for spontaneous breathing trials would be usual, but this was not reported in the current trial,” he explained.

Differences in patient population also make the application of the results difficult, Dr. Bowton said. “Only 60% of the patients had spirometrically confirmed COPD and fewer than half were on at least dual inhaled therapy prior to hospitalization with only one-third taking beta agonists or anticholinergic agents,” he noted. “The cause of respiratory failure was infectious, requiring an infiltrate on chest radiograph; thus, patients with hypercarbic respiratory failure without a new infiltrate were excluded from the study. On average, patients were hypercarbic, yet alkalemic at the time of extubation; the PaCO2 and pH at the time of intubation were not reported.

“This study suggests that in some patients with COPD and respiratory failure requiring invasive mechanical ventilation, HFO [high-flow oxygen] may be better tolerated and equally effective as NIPPV [noninvasive positive-pressure ventilation] at mitigating the need for reintubation following extubation. In this patient population where hypoxemia prior to extubation was not severe, the mechanisms by which HFO is beneficial remain speculative,” he said.

This study was funded by the Rui E special fund for emergency medicine research and the Yangzhou Science and Technology Development Plan. The authors report no relevant conflicts of interest. Dr. Bowton reports no relevant conflicts of interest.

SOURCE: Tan D et al. Crit Care. 2020 Aug 6. doi: 10.1186/s13054-020-03214-9.

Publications
Topics
Sections

Following invasive ventilation for severe hypercapnic respiratory failure, patients with chronic obstructive pulmonary disease had similar levels of treatment failure if they received high-flow nasal cannula oxygen therapy or noninvasive ventilation, recent research in Critical Care has suggested.

However, for patients with COPD weaned off invasive ventilation, high-flow nasal cannula (HFNC) oxygen therapy was “more comfortable and better tolerated,” compared with noninvasive ventilation (NIV). In addition, “airway care interventions and the incidence of nasofacial skin breakdown associated with HFNC were significantly lower than in NIV,” according to Dingyu Tan of the Clinical Medical College of Yangzhou (China) University, Northern Jiangsu People’s Hospital, and colleagues. “HFNC appears to be an effective means of respiratory support for COPD patients extubated after severe hypercapnic respiratory failure,” they said.

The investigators screened patients with COPD and hypercapnic respiratory failure for enrollment, including those who met Global Initiative for Obstructive Lung Disease (GOLD) criteria, were 85 years old or younger and caring for themselves, had bronchopulmonary infection–induced respiratory failure, and had achieved pulmonary infection control criteria. Exclusion criteria were:

  • Patients under age 18 years.
  • Presence of oral or facial trauma.
  • Poor sputum excretion ability.
  • Hemodynamic instability that would contraindicate use of NIV.
  • Poor cough during PIC window.
  • Poor short-term prognosis.
  • Failure of the heart, brain, liver or kidney.
  • Patients who could not consent to treatment.

Patients were determined to have failed treatment if they returned to invasive mechanical ventilation or switched from one treatment to another (HFNC to NIV or NIV to HFNC). Investigators also performed an arterial blood gas analysis, recorded the number of duration of airway care interventions, and monitored vital signs at 1 hour, 24 hours, and 48 hours after extubation as secondary analyses.

Overall, 44 patients randomized to receive HFNC and 42 patients randomized for NIV were available for analysis. The investigators found 22.7% of patients in the HFNC group and 28.6% in the NIV group experienced treatment failure (risk difference, –5.8%; 95% confidence interval, −23.8 to 12.4%; P = .535), with patients in the HFNC group experiencing a significantly lower level of treatment intolerance, compared with patients in the NIV group (risk difference, ­–50.0%; 95% CI, −74.6 to −12.9%; P = .015). There were no significant differences between either group regarding intubation (−0.65%; 95% CI, −16.01 to 14.46%), while rate of switching treatments was lower in the HFNC group but not significant (−5.2%; 95% CI, −19.82 to 9.05%).

Patients in both the HFNC and NIV groups had faster mean respiratory rates 1 hour after extubation (P < .050). After 24 hours, the NIV group had higher-than-baseline respiratory rates, compared with the HFNC group, which had returned to normal (20 vs. 24.5 breaths per minute; P < .050). Both groups had returned to baseline by 48 hours after extubation. At 1 hour after extubation, patients in the HFNC group had lower PaO2/FiO2 (P < .050) and pH values (P < .050), and higher PaCO2 values (P less than .050), compared with baseline. There were no statistically significant differences in PaO2/FiO2, pH, and PaCO2 values in either group at 24 hours or 48 hours after extubation.

Daily airway care interventions were significantly higher on average in the NIV group, compared with the HFNC group (7 vs. 6; P = .0006), and the HFNC group also had significantly better comfort scores (7 vs. 5; P < .001) as measured by a modified visual analog scale, as well as incidence of nasal and facial skin breakdown (0 vs. 9.6%; P = .027), compared with the NIV group.
 

 

 

Results difficult to apply to North American patients

David L. Bowton, MD, FCCP, a professor specializing in critical care at Wake Forest University, Winston-Salem, N.C., said in an interview the results of this trial may not be applicable for patients with infection-related respiratory failure and COPD in North America “due to the differences in common weaning practices between North America and China.”

Dr. David L. Bowton

For example, the trial used the pulmonary infection control (PIC) window criteria for extubation, which requires a significant decrease in radiographic infiltrates, improvement in quality and quantity of sputum, normalizing of leukocyte count, a synchronized intermittent mandatory ventilation (SIMV) rate of 10-12 breaths per minute, and pressure support less than 10-12 cm/H2O (Int J Chron Obstruct Pulmon Dis. 2017;12:1255-67).

“The process used to achieve these measures is not standardized. In North America, daily awakening and screening for spontaneous breathing trials would be usual, but this was not reported in the current trial,” he explained.

Differences in patient population also make the application of the results difficult, Dr. Bowton said. “Only 60% of the patients had spirometrically confirmed COPD and fewer than half were on at least dual inhaled therapy prior to hospitalization with only one-third taking beta agonists or anticholinergic agents,” he noted. “The cause of respiratory failure was infectious, requiring an infiltrate on chest radiograph; thus, patients with hypercarbic respiratory failure without a new infiltrate were excluded from the study. On average, patients were hypercarbic, yet alkalemic at the time of extubation; the PaCO2 and pH at the time of intubation were not reported.

“This study suggests that in some patients with COPD and respiratory failure requiring invasive mechanical ventilation, HFO [high-flow oxygen] may be better tolerated and equally effective as NIPPV [noninvasive positive-pressure ventilation] at mitigating the need for reintubation following extubation. In this patient population where hypoxemia prior to extubation was not severe, the mechanisms by which HFO is beneficial remain speculative,” he said.

This study was funded by the Rui E special fund for emergency medicine research and the Yangzhou Science and Technology Development Plan. The authors report no relevant conflicts of interest. Dr. Bowton reports no relevant conflicts of interest.

SOURCE: Tan D et al. Crit Care. 2020 Aug 6. doi: 10.1186/s13054-020-03214-9.

Following invasive ventilation for severe hypercapnic respiratory failure, patients with chronic obstructive pulmonary disease had similar levels of treatment failure if they received high-flow nasal cannula oxygen therapy or noninvasive ventilation, recent research in Critical Care has suggested.

However, for patients with COPD weaned off invasive ventilation, high-flow nasal cannula (HFNC) oxygen therapy was “more comfortable and better tolerated,” compared with noninvasive ventilation (NIV). In addition, “airway care interventions and the incidence of nasofacial skin breakdown associated with HFNC were significantly lower than in NIV,” according to Dingyu Tan of the Clinical Medical College of Yangzhou (China) University, Northern Jiangsu People’s Hospital, and colleagues. “HFNC appears to be an effective means of respiratory support for COPD patients extubated after severe hypercapnic respiratory failure,” they said.

The investigators screened patients with COPD and hypercapnic respiratory failure for enrollment, including those who met Global Initiative for Obstructive Lung Disease (GOLD) criteria, were 85 years old or younger and caring for themselves, had bronchopulmonary infection–induced respiratory failure, and had achieved pulmonary infection control criteria. Exclusion criteria were:

  • Patients under age 18 years.
  • Presence of oral or facial trauma.
  • Poor sputum excretion ability.
  • Hemodynamic instability that would contraindicate use of NIV.
  • Poor cough during PIC window.
  • Poor short-term prognosis.
  • Failure of the heart, brain, liver or kidney.
  • Patients who could not consent to treatment.

Patients were determined to have failed treatment if they returned to invasive mechanical ventilation or switched from one treatment to another (HFNC to NIV or NIV to HFNC). Investigators also performed an arterial blood gas analysis, recorded the number of duration of airway care interventions, and monitored vital signs at 1 hour, 24 hours, and 48 hours after extubation as secondary analyses.

Overall, 44 patients randomized to receive HFNC and 42 patients randomized for NIV were available for analysis. The investigators found 22.7% of patients in the HFNC group and 28.6% in the NIV group experienced treatment failure (risk difference, –5.8%; 95% confidence interval, −23.8 to 12.4%; P = .535), with patients in the HFNC group experiencing a significantly lower level of treatment intolerance, compared with patients in the NIV group (risk difference, ­–50.0%; 95% CI, −74.6 to −12.9%; P = .015). There were no significant differences between either group regarding intubation (−0.65%; 95% CI, −16.01 to 14.46%), while rate of switching treatments was lower in the HFNC group but not significant (−5.2%; 95% CI, −19.82 to 9.05%).

Patients in both the HFNC and NIV groups had faster mean respiratory rates 1 hour after extubation (P < .050). After 24 hours, the NIV group had higher-than-baseline respiratory rates, compared with the HFNC group, which had returned to normal (20 vs. 24.5 breaths per minute; P < .050). Both groups had returned to baseline by 48 hours after extubation. At 1 hour after extubation, patients in the HFNC group had lower PaO2/FiO2 (P < .050) and pH values (P < .050), and higher PaCO2 values (P less than .050), compared with baseline. There were no statistically significant differences in PaO2/FiO2, pH, and PaCO2 values in either group at 24 hours or 48 hours after extubation.

Daily airway care interventions were significantly higher on average in the NIV group, compared with the HFNC group (7 vs. 6; P = .0006), and the HFNC group also had significantly better comfort scores (7 vs. 5; P < .001) as measured by a modified visual analog scale, as well as incidence of nasal and facial skin breakdown (0 vs. 9.6%; P = .027), compared with the NIV group.
 

 

 

Results difficult to apply to North American patients

David L. Bowton, MD, FCCP, a professor specializing in critical care at Wake Forest University, Winston-Salem, N.C., said in an interview the results of this trial may not be applicable for patients with infection-related respiratory failure and COPD in North America “due to the differences in common weaning practices between North America and China.”

Dr. David L. Bowton

For example, the trial used the pulmonary infection control (PIC) window criteria for extubation, which requires a significant decrease in radiographic infiltrates, improvement in quality and quantity of sputum, normalizing of leukocyte count, a synchronized intermittent mandatory ventilation (SIMV) rate of 10-12 breaths per minute, and pressure support less than 10-12 cm/H2O (Int J Chron Obstruct Pulmon Dis. 2017;12:1255-67).

“The process used to achieve these measures is not standardized. In North America, daily awakening and screening for spontaneous breathing trials would be usual, but this was not reported in the current trial,” he explained.

Differences in patient population also make the application of the results difficult, Dr. Bowton said. “Only 60% of the patients had spirometrically confirmed COPD and fewer than half were on at least dual inhaled therapy prior to hospitalization with only one-third taking beta agonists or anticholinergic agents,” he noted. “The cause of respiratory failure was infectious, requiring an infiltrate on chest radiograph; thus, patients with hypercarbic respiratory failure without a new infiltrate were excluded from the study. On average, patients were hypercarbic, yet alkalemic at the time of extubation; the PaCO2 and pH at the time of intubation were not reported.

“This study suggests that in some patients with COPD and respiratory failure requiring invasive mechanical ventilation, HFO [high-flow oxygen] may be better tolerated and equally effective as NIPPV [noninvasive positive-pressure ventilation] at mitigating the need for reintubation following extubation. In this patient population where hypoxemia prior to extubation was not severe, the mechanisms by which HFO is beneficial remain speculative,” he said.

This study was funded by the Rui E special fund for emergency medicine research and the Yangzhou Science and Technology Development Plan. The authors report no relevant conflicts of interest. Dr. Bowton reports no relevant conflicts of interest.

SOURCE: Tan D et al. Crit Care. 2020 Aug 6. doi: 10.1186/s13054-020-03214-9.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM CRITICAL CARE

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article

Non-COVID-19 clinical trials grind to a halt during pandemic

Article Type
Changed
Thu, 08/26/2021 - 16:01

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.

Publications
Topics
Sections

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.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article

Send kids to school safely if possible, supplement virtually

Article Type
Changed
Tue, 02/14/2023 - 13:00

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

Dr. Howard Smart

“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

Dr. Nathaniel Savio Beers

“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.
 

Publications
Topics
Sections

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

Dr. Howard Smart

“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

Dr. Nathaniel Savio Beers

“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

Dr. Howard Smart

“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

Dr. Nathaniel Savio Beers

“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.
 

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM JAMA PEDIATRICS

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article

Severe obesity ups risk for death in younger men with COVID-19

Article Type
Changed
Thu, 08/26/2021 - 16:01

 

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 infarctionheart failureperipheral vascular disease, cerebrovascular disease, chronic pulmonary disease, renal disease, metastatic tumor or malignancy, other immune disease, hyperlipidemia, hypertensionasthma, 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.

Publications
Topics
Sections

 

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 infarctionheart failureperipheral vascular disease, cerebrovascular disease, chronic pulmonary disease, renal disease, metastatic tumor or malignancy, other immune disease, hyperlipidemia, hypertensionasthma, 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 infarctionheart failureperipheral vascular disease, cerebrovascular disease, chronic pulmonary disease, renal disease, metastatic tumor or malignancy, other immune disease, hyperlipidemia, hypertensionasthma, 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.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article

Financial planning in the COVID-19 era

Article Type
Changed
Thu, 08/26/2021 - 16:01

Less than a year ago, I wrote a column on retirement strategies; but that was before COVID-19 took down the economy, putting millions out of work and shuttering many of our offices. Add extraordinary racial tensions and an election year like no other, and 2020 has generated fear and uncertainty on an unprecedented level.

Dr. Joseph S. Eastern

Not surprisingly, my e-mail has been dominated for months by questions about the short- and long-term financial consequences of this annus horribilis on our practices and retirement plans. Most physicians have felt the downturn acutely, of course. Revenues have declined, non-COVID-19-related hospital visits plunged, and only recently have we seen hospitals resuming elective procedures. As I write this, my practice is approaching its prepandemic volume; but many patients have been avoiding hospitals and doctors’ offices for fear of COVID-19 exposure. With no real end in sight, who can say when this trend will finally correct itself?

Long term, the outlook is not nearly so grim. I have always written that downturns – even steep ones – are inevitable; and rather than fear them, you should expect them and plan for them. Younger physicians with riskier investments have plenty of time to rebound. Physicians nearing retirement, if they have done everything right, probably have the least to lose. Ideally, they will be at or near their savings target and will have transitioned to less vulnerable assets. And remember, you don’t need to have 100% of your retirement money to retire; a sound retirement plan will continue to generate investment returns as you move through retirement.

In short, the essentials of postpandemic financial planning remain the same as before: Make a plan and stick to it.

By way of a brief review, the basics of a good plan are a budget, an emergency fund, disability insurance, and retiring your debt as quickly as possible. All of these have been covered individually in previous columns.

An essential component of your plan should be a list of long-term goals – and it should be more specific than simply accumulating a pile of cash. What do you plan to accomplish with the money? If it’s travel, helping your grandkids with college expenses, hobbies, or something else, make a list. Review it regularly, and modify it if your goals change.

Time to trot out another hoary old cliché: Saving for retirement is a marathon, not a sprint. If the pandemic has temporarily derailed your retirement strategy – forcing you, for example, to make retirement account withdrawals to cover expenses, or raid your emergency fund – no worries! When things have stabilized, it’s time to recommit to your retirement plan. Once again, with so many other issues to deal with, retaining the services of a qualified financial professional is usually a far better strategy than going it alone.

Many readers have expressed the fear that their retirement savings would never recover from the COVID-19 hit – but my own financial adviser pointed out that as I write this, in August, conservative portfolio values are about level with similar portfolios on Jan. 1, 2020. “Good plans are built to withstand difficult times,” she said. “Sometimes staying the course is the most difficult, disciplined course of action.”

“If your gut tells you that things will only get worse,” writes Kimberly Lankford in AARP’s magazine, “know that your gut is a terrible economic forecaster.” The University of Michigan’s Index of Consumer Sentiment hit rock bottom in 2008, during the Great Recession; yet only 4 months later, the U.S. economy began its longest expansion in modern history. The point is that it is important to maintain a long-term approach, and not make changes based on short-term events.

COVID-19 (or whatever else comes along) then becomes a matter of statement pain, not long-term financial pain. The key to recovery has nothing to do with a financial change, an investment strategy change, or a holding change, and everything to do with realigning your long-term goals.

So, moving on from COVID-19 is actually quite simple: Fill your retirement plan to its legal limit and let it grow, tax-deferred. Then invest for the long term, with your target amount in mind. And once again, the earlier you start and the longer you stick with it, the better.

 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Publications
Topics
Sections

Less than a year ago, I wrote a column on retirement strategies; but that was before COVID-19 took down the economy, putting millions out of work and shuttering many of our offices. Add extraordinary racial tensions and an election year like no other, and 2020 has generated fear and uncertainty on an unprecedented level.

Dr. Joseph S. Eastern

Not surprisingly, my e-mail has been dominated for months by questions about the short- and long-term financial consequences of this annus horribilis on our practices and retirement plans. Most physicians have felt the downturn acutely, of course. Revenues have declined, non-COVID-19-related hospital visits plunged, and only recently have we seen hospitals resuming elective procedures. As I write this, my practice is approaching its prepandemic volume; but many patients have been avoiding hospitals and doctors’ offices for fear of COVID-19 exposure. With no real end in sight, who can say when this trend will finally correct itself?

Long term, the outlook is not nearly so grim. I have always written that downturns – even steep ones – are inevitable; and rather than fear them, you should expect them and plan for them. Younger physicians with riskier investments have plenty of time to rebound. Physicians nearing retirement, if they have done everything right, probably have the least to lose. Ideally, they will be at or near their savings target and will have transitioned to less vulnerable assets. And remember, you don’t need to have 100% of your retirement money to retire; a sound retirement plan will continue to generate investment returns as you move through retirement.

In short, the essentials of postpandemic financial planning remain the same as before: Make a plan and stick to it.

By way of a brief review, the basics of a good plan are a budget, an emergency fund, disability insurance, and retiring your debt as quickly as possible. All of these have been covered individually in previous columns.

An essential component of your plan should be a list of long-term goals – and it should be more specific than simply accumulating a pile of cash. What do you plan to accomplish with the money? If it’s travel, helping your grandkids with college expenses, hobbies, or something else, make a list. Review it regularly, and modify it if your goals change.

Time to trot out another hoary old cliché: Saving for retirement is a marathon, not a sprint. If the pandemic has temporarily derailed your retirement strategy – forcing you, for example, to make retirement account withdrawals to cover expenses, or raid your emergency fund – no worries! When things have stabilized, it’s time to recommit to your retirement plan. Once again, with so many other issues to deal with, retaining the services of a qualified financial professional is usually a far better strategy than going it alone.

Many readers have expressed the fear that their retirement savings would never recover from the COVID-19 hit – but my own financial adviser pointed out that as I write this, in August, conservative portfolio values are about level with similar portfolios on Jan. 1, 2020. “Good plans are built to withstand difficult times,” she said. “Sometimes staying the course is the most difficult, disciplined course of action.”

“If your gut tells you that things will only get worse,” writes Kimberly Lankford in AARP’s magazine, “know that your gut is a terrible economic forecaster.” The University of Michigan’s Index of Consumer Sentiment hit rock bottom in 2008, during the Great Recession; yet only 4 months later, the U.S. economy began its longest expansion in modern history. The point is that it is important to maintain a long-term approach, and not make changes based on short-term events.

COVID-19 (or whatever else comes along) then becomes a matter of statement pain, not long-term financial pain. The key to recovery has nothing to do with a financial change, an investment strategy change, or a holding change, and everything to do with realigning your long-term goals.

So, moving on from COVID-19 is actually quite simple: Fill your retirement plan to its legal limit and let it grow, tax-deferred. Then invest for the long term, with your target amount in mind. And once again, the earlier you start and the longer you stick with it, the better.

 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Less than a year ago, I wrote a column on retirement strategies; but that was before COVID-19 took down the economy, putting millions out of work and shuttering many of our offices. Add extraordinary racial tensions and an election year like no other, and 2020 has generated fear and uncertainty on an unprecedented level.

Dr. Joseph S. Eastern

Not surprisingly, my e-mail has been dominated for months by questions about the short- and long-term financial consequences of this annus horribilis on our practices and retirement plans. Most physicians have felt the downturn acutely, of course. Revenues have declined, non-COVID-19-related hospital visits plunged, and only recently have we seen hospitals resuming elective procedures. As I write this, my practice is approaching its prepandemic volume; but many patients have been avoiding hospitals and doctors’ offices for fear of COVID-19 exposure. With no real end in sight, who can say when this trend will finally correct itself?

Long term, the outlook is not nearly so grim. I have always written that downturns – even steep ones – are inevitable; and rather than fear them, you should expect them and plan for them. Younger physicians with riskier investments have plenty of time to rebound. Physicians nearing retirement, if they have done everything right, probably have the least to lose. Ideally, they will be at or near their savings target and will have transitioned to less vulnerable assets. And remember, you don’t need to have 100% of your retirement money to retire; a sound retirement plan will continue to generate investment returns as you move through retirement.

In short, the essentials of postpandemic financial planning remain the same as before: Make a plan and stick to it.

By way of a brief review, the basics of a good plan are a budget, an emergency fund, disability insurance, and retiring your debt as quickly as possible. All of these have been covered individually in previous columns.

An essential component of your plan should be a list of long-term goals – and it should be more specific than simply accumulating a pile of cash. What do you plan to accomplish with the money? If it’s travel, helping your grandkids with college expenses, hobbies, or something else, make a list. Review it regularly, and modify it if your goals change.

Time to trot out another hoary old cliché: Saving for retirement is a marathon, not a sprint. If the pandemic has temporarily derailed your retirement strategy – forcing you, for example, to make retirement account withdrawals to cover expenses, or raid your emergency fund – no worries! When things have stabilized, it’s time to recommit to your retirement plan. Once again, with so many other issues to deal with, retaining the services of a qualified financial professional is usually a far better strategy than going it alone.

Many readers have expressed the fear that their retirement savings would never recover from the COVID-19 hit – but my own financial adviser pointed out that as I write this, in August, conservative portfolio values are about level with similar portfolios on Jan. 1, 2020. “Good plans are built to withstand difficult times,” she said. “Sometimes staying the course is the most difficult, disciplined course of action.”

“If your gut tells you that things will only get worse,” writes Kimberly Lankford in AARP’s magazine, “know that your gut is a terrible economic forecaster.” The University of Michigan’s Index of Consumer Sentiment hit rock bottom in 2008, during the Great Recession; yet only 4 months later, the U.S. economy began its longest expansion in modern history. The point is that it is important to maintain a long-term approach, and not make changes based on short-term events.

COVID-19 (or whatever else comes along) then becomes a matter of statement pain, not long-term financial pain. The key to recovery has nothing to do with a financial change, an investment strategy change, or a holding change, and everything to do with realigning your long-term goals.

So, moving on from COVID-19 is actually quite simple: Fill your retirement plan to its legal limit and let it grow, tax-deferred. Then invest for the long term, with your target amount in mind. And once again, the earlier you start and the longer you stick with it, the better.

 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article