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Rural hospitalists confront COVID-19
Unique demands of patient care in small hospitals
In 2018, Atashi Mandal, MD, a hospitalist residing in Orange County, Calif., was recruited along with several other doctors to fill hospitalist positions in rural Bishop, Calif. She has since driven 600 miles round trip every month for a week of hospital medicine shifts at Northern Inyo Hospital.
Dr. Mandal said she has really enjoyed her time at the small rural hospital and found it professionally fulfilling to participate so fully in the health of its local community. She was building personal bonds and calling the experience the pinnacle of her career when the COVID-19 pandemic swept across America and the world, even reaching up into Bishop, population 3,760, in the isolated Owens Valley.
The 25-bed hospital has seen at least 100 COVID patients in the past year and some months. Responsibility for taking care of these patients has been both humbling and gratifying, Dr. Mandal said. The facility’s hospitalists made a commitment to keep working through the pandemic. “We were able to come together (around COVID) as a team and our teamwork really made a difference,” she said.
“One of the advantages in a smaller hospital is you can have greater cohesiveness and your communication can be tighter. That played a big role in how we were able to accomplish so much with fewer resources as a rural hospital.” But staffing shortages, recruitment, and retention remain a perennial challenge for rural hospitals. “And COVID only exacerbated the problems,” she said. “I’ve had my challenges trying to make proper treatment plans without access to specialists.”
It was also difficult to witness so many patients severely ill or dying from COVID, Dr. Mandal said, especially since patients were not allowed family visitors – even though that was for a good reason, to minimize the virus’s spread.
HM in rural communities
Hospital medicine continues to extend into rural communities and small rural hospitals. In 2018, 35.7% of all rural counties in America had hospitals staffed with hospitalists, and 63.3% of rural hospitals had hospitalist programs (compared with 79.2% of urban hospitals). These numbers come from Medicare resources files from the Department of Health & Human Services, analyzed by Peiyin Hung, PhD, assistant professor of health services management and policy at the University of South Carolina, Columbia.1 Hospitalist penetration rates rose steadily from 2011 to 2017, with a slight dip in 2018, Dr. Hung said in an interview.
A total of 138 rural hospitals have closed since 2010, according to the Cecil G. Sheps Center for Health Services Research in Chapel Hill, N.C. Nineteen rural hospitals closed in 2020 alone, although many of those were caused by factors predating the pandemic. Only one has closed so far in 2021. But financial pressures, including low patient volumes and loss of revenue from canceled routine services like elective surgeries during the pandemic, have added to hospitals’ difficulties. Pandemic relief funding may have helped some hospitals stay open, but that support eventually will go away.
Experts emphasize the diversity of rural America and its health care systems. Rural economies are volatile and more diverse than is often appreciated. The hospital may be a cornerstone of the local economy; when one closes, it can devastate the community. Workforce is one of the chief components of a hospital’s ability to meet its strategic vision, and hospitalists are a big part in that. But while hospitalists are valued and appreciated, if the hospital is suffering severe financial problems, that will impact its doctors’ jobs and livelihoods.
“Bandwidth” varies widely for rural hospitalists and their hospitalist groups, said Ken Simone, DO, SFHM, executive chair of SHM’s Rural Special Interest Group and founder and principal of KGS Consultants, a Hospital Medicine and Primary Care Practice Management Consulting company. They may face scarce resources, scarce clinical staffing, lack of support staff to help operations run smoothly, lack of access to specialists locally, and lack of technology. While practicing in a rural setting presents various challenges, it can be rewarding for those clinicians who embrace its autonomy and broad scope of services, Dr. Simone said.
SHM’s Rural SIG focuses on the unique needs of rural hospitalists, providing them with an opportunity to share their concerns, challenges and solutions through roundtable discussions every other month and a special interest forum held in conjunction with the SHM Converge annual conference, Dr. Simone said. (The next SHM Converge will be April 7-10, 2022, in Nashville, Tenn.) The Rural SIG also collaborates with other hospital medicine SIGs and committees and is working on a white paper, “Key Principles and Characteristics of an Effective Rural Hospital Medicine Group.” It is also looking to develop a rural mentorship exchange program.
COVID reaches rural America
Early COVID caseloads tended to be in urban areas, but subsequent surges of infections have spread to many rural areas. Some rural settings became epicenters for the pandemic in November and December 2020. More recent troubling rises in COVID cases, particularly in areas with lower vaccination rates – suggest that the challenges of the pandemic are still not behind us.
“By no means is the crisis done in rural America,” said Alan Morgan, CEO of the National Rural Health Association, in a Virtual Rural Health Journalism workshop on rural health care sponsored by the Association of Health Care Journalists.2
Mr. Morgan’s colleague, Brock Slabach, NRHA’s chief operations officer, said in an interview that, while 453 of the 1,800 hospitals in rural areas fit NRHA’s criteria as being vulnerable to closure, the rest are not, and are fulfilling their missions for their communities. Hospitalists are becoming more common in these hospitals, he said, and rural hospitalists can be an important asset in attracting primary care physicians – who might not appreciate being perpetually on call for their hospitalized patients – to rural communities.
In many cases, traveling doctors like Dr. Mandal or telemedicine backup, particularly for after-hours coverage or ICU beds, are important pieces of the puzzle for smaller hospitals. There are different ways to use the spectrum of telemedicine services to interact with a hospital’s daytime and night routines. In some isolated locations, nurse practitioners or physician assistants provide on-the-ground coverage with virtual backup. Rural hospitals often affiliate with telemedicine networks within health systems – or else contract with independent specialized providers of telemedicine consultation.
Mr. Slabach said another alternative for staffing hospitals with smaller ED and inpatient volumes is to have one doctor on duty who can cover both departments simultaneously. Meanwhile, the new federal Rural Emergency Hospital Program proposes to allow rural hospitals to become essentially freestanding EDs – starting Jan. 1, 2023 – that can manage patients for a maximum of 24 hours.3
Community connections and proactive staffing
Lisa Kaufmann, MD, works as a hospitalist for a two-hospital system in North Carolina, Appalachian Regional Health Care. She practices at Watauga Medical Center, with 100 licensed beds in Boone, and at Cannon Memorial Hospital, a critical access hospital in unincorporated Linville. “We are proud of what we have been able to accomplish during the pandemic,” she said.
A former critical care unit at Watauga had been shut down, but its wiring remained intact. “We turned it into a COVID unit in three days. Then we opened another COVID unit with 18 beds, but that still wasn’t enough. We converted half of our med/surg capacity into a COVID unit. At one point almost half of all of our acute beds were for COVID patients. We made plans for what we would do if it got worse, since we had almost run out of beds,” she said. Demand peaked at the end of January 2021.
“The biggest barrier for us was if someone needed to be transferred, for example, if they needed ECMO [extracorporeal membrane oxygenation], and we couldn’t find another hospital to provide that technology.” In ARHC’s mountainous region – known as the “High Country” – weather can also make it difficult to transport patients. “Sometimes the ambulance can’t make it off the mountain, and half of the time the medical helicopter can’t fly. So we have to be prepared to keep people who we might think ought to be transferred,” she said.
Like many rural communities, the High Country is tightly knit, and its hospitals are really connected to their communities, Dr. Kaufmann said. The health system already had a lot of community connections beyond acute care, and that meant the pandemic wasn’t experienced as severely as it was in some other rural communities. “But without hospitalists in our hospitals, it would have been much more difficult.”
Proactive supply fulfillment meant that her hospitals never ran out of personal protective equipment. “Staffing was a challenge, but we were proactive in getting traveling doctors to come here. We also utilized extra doctors from the local community,” she said. Another key was well-established disaster planning, with regular drills, and a robust incident command structure, which just needed to be activated in the crisis. “Small hospitals need to be prepared for disaster,” Dr. Kaufmann said.
For Dale Wiersma, MD, a hospitalist with Spectrum Health, a 14-hospital system in western Michigan, telemedicine services are coordinated across 8 rural regional hospitals. “We don’t tend to use it for direct hospitalist work during daytime hours, unless a facility is swamped, in which case we can cross-cover. We do more telemedicine at night. But during daytime hours we have access to stroke neurology, cardiology, psychiatry, critical care and infectious disease specialists who are able to offer virtual consults,” Dr. Wiersma said. A virtual critical care team of doctor and nurse is often the only intensivist service covering Spectrum’s rural hospitals.
“In our system, the pandemic accelerated the adoption of telemedicine,” Dr. Wiersma said. “We had been working on the tele-ICU program, trying to get it rolled out. When the pandemic hit, we launched it in just 6 weeks.”
There have been several COVID surges in Michigan, he said. “We were stretched pretty close to our limit several times, but never to the breaking point. For our physicians, it was the protracted nature of the pandemic that was fatiguing for everyone involved. Our system worked hard to staff up as well as it could, to make sure our people didn’t go over the edge.” It was also hard for hospitals that typically might see one or two deaths in a month to suddenly have five in a week.
Another Spectrum hospitalist, Christopher Skinner, MD, works at two rural Michigan hospitals 15 minutes apart in Big Rapids and Reed City. “I prefer working in rural areas. I’ve never had an ambition to be a top dog. I like the style of practice where you don’t have all of the medical subspecialties on site. It frees you up to use all your skills,” Dr. Skinner said.
But that approach was put to the test by the pandemic, since it was harder to transfer those patients who normally would not have stayed at these rural hospitals. “We had to make do,” he said, although virtual backup and second opinions from Spectrum’s virtual critical care team helped.
“It was a great collaboration, which helped us to handle critical care cases that we hadn’t had to manage pre-COVID. We’ve gotten used to it, with the backup, so I expect we’ll still be taking care of these kind of sick ventilator patients even after the pandemic ends,” Dr. Skinner said. “We’ve gotten pretty good at it.”
Sukhbir Pannu, MD, a hospitalist in Denver and CEO and founder of Rural Physicians Group, said the pandemic was highly impactful, operationally and logistically, for his firm, which contracts with 54 hospitals to provide their hospitalist staffing. “There was no preparation. Everything had to be done on the fly. Initially, it was felt that rural areas weren’t at as great a risk for COVID, but that proved not to be true. Many experienced a sudden increase in very sick patients. We set up a task force to manage daily census in all of our contracted facilities.”
How did Rural Physicians Group manage through the crisis? “The short answer is telemedicine,” he said. “We had physicians on the ground in these hospitals. But we needed intensivists at the other end of the line to support them.” A lot of conversations about telemedicine were already going on in the company, but the pandemic provided the impetus to launch its network, which has grown to include rheumatologists, pulmonologists, cardiologists, infection medicine, neurology, and psychiatry, all reachable through a central command structure.
Telemedicine is not a cure-all, Dr. Pannu said. It doesn’t work in a vacuum. It requires both a provider on the ground and specialists available remotely. “But it can be a massive multiplier.”
Critical medicine
Other hospitals, including small and rural ones, have reported taking on the challenge of covering critical care with nonintensivist physicians because the pandemic demanded it. David Aymond, MD, a hospitalist at 60-bed Byrd Regional Hospital in Leesville, La., population 6,612, has advocated for years for expanded training and credentialing opportunities in intensive care medicine beyond the traditional path of becoming a board-certified intensivist. Some rural hospitalists were already experienced in providing critical care for ICU patients even before the pandemic hit.
“What COVID did was to highlight the problem that there aren’t enough intensivists in this country, particular for smaller hospitals,” Dr. Aymond said. Some hospitalists who stepped into crisis roles in ICUs during COVID surges showed that they could take care of COVID patients very well.
Dr. Aymond, who is a fellowship-trained hospitalist with primary training in family medicine, has used his ICU experience in both fellowship and practice to make a thorough study of critical care medicine, which he put to good use when the seven-bed ICU at Byrd Memorial filled with COVID patients. “Early on, we were managing multiple ventilators throughout the hospital,” he said. “But we were having good outcomes. Our COVID patients were surviving.” That led to Dr. Aymond being interviewed by local news media, which led to other patients across the state asking to be transferred to “the COVID specialist who practices at Byrd.”
Dr. Aymond would like to see opportunities for abbreviated 1-year critical care fellowships for hospitalists who have amassed enough ICU experience in practice or in residency, and to make room for family medicine physicians in such programs. He is also working through SHM with the Society of Critical Care Medicine to generate educational ICU content. SHM now has a critical care lecture series at: www.hospitalmedicine.org/clinical-topics/critical-care/.
Dr. Mandal, who also works as a pediatric hospitalist, said that experience gave her more familiarity with using noninvasive methods for delivering respiratory therapies like high-flow oxygen. “When I saw a COVID patient who had hypoxia but was still able to talk, I didn’t hesitate to deliver oxygen through noninvasive means.” Eventually hospital practice generally for COVID caught up with this approach.
But she ran into personal difficulties because N95 face masks didn’t fit her face. Instead, she had to wear a portable respirator, which made it hard to hear what her patients were saying. “I formulated a lot of workarounds, such as interviewing the patient over the phone before going into the room for the physical exam.”
Throughout the pandemic, she never wavered in her commitment to rural hospital medicine and its opportunities for working in a small and wonderful community, where she could practice at the top of her license, with a degree of autonomy not granted in other settings. For doctors who want that kind of practice, she said, “the rewards will be paid back in spades. That’s been my experience.”
For more information on SHM’s Rural SIG and its supports for rural hospitalists, contact its executive chair, Kenneth Simone, DO, at ksimone911@gmail.com.
References
1. Personal communication from Peiyin Hung, June 2021.
2. Association of Health Care Journalists. Rural Health Journalism Workshop 2021. June 21, 2021. https://healthjournalism.org/calendar-details.php?id=2369.
3. Congress Establishes New Medicare Provider Category and Reimbursement for Rural Emergency Hospitals. National Law Review. Jan. 5, 2021. https://www.natlawreview.com/article/congress-establishes-new-medicare-provider-category-and-reimbursement-rural.
Unique demands of patient care in small hospitals
Unique demands of patient care in small hospitals
In 2018, Atashi Mandal, MD, a hospitalist residing in Orange County, Calif., was recruited along with several other doctors to fill hospitalist positions in rural Bishop, Calif. She has since driven 600 miles round trip every month for a week of hospital medicine shifts at Northern Inyo Hospital.
Dr. Mandal said she has really enjoyed her time at the small rural hospital and found it professionally fulfilling to participate so fully in the health of its local community. She was building personal bonds and calling the experience the pinnacle of her career when the COVID-19 pandemic swept across America and the world, even reaching up into Bishop, population 3,760, in the isolated Owens Valley.
The 25-bed hospital has seen at least 100 COVID patients in the past year and some months. Responsibility for taking care of these patients has been both humbling and gratifying, Dr. Mandal said. The facility’s hospitalists made a commitment to keep working through the pandemic. “We were able to come together (around COVID) as a team and our teamwork really made a difference,” she said.
“One of the advantages in a smaller hospital is you can have greater cohesiveness and your communication can be tighter. That played a big role in how we were able to accomplish so much with fewer resources as a rural hospital.” But staffing shortages, recruitment, and retention remain a perennial challenge for rural hospitals. “And COVID only exacerbated the problems,” she said. “I’ve had my challenges trying to make proper treatment plans without access to specialists.”
It was also difficult to witness so many patients severely ill or dying from COVID, Dr. Mandal said, especially since patients were not allowed family visitors – even though that was for a good reason, to minimize the virus’s spread.
HM in rural communities
Hospital medicine continues to extend into rural communities and small rural hospitals. In 2018, 35.7% of all rural counties in America had hospitals staffed with hospitalists, and 63.3% of rural hospitals had hospitalist programs (compared with 79.2% of urban hospitals). These numbers come from Medicare resources files from the Department of Health & Human Services, analyzed by Peiyin Hung, PhD, assistant professor of health services management and policy at the University of South Carolina, Columbia.1 Hospitalist penetration rates rose steadily from 2011 to 2017, with a slight dip in 2018, Dr. Hung said in an interview.
A total of 138 rural hospitals have closed since 2010, according to the Cecil G. Sheps Center for Health Services Research in Chapel Hill, N.C. Nineteen rural hospitals closed in 2020 alone, although many of those were caused by factors predating the pandemic. Only one has closed so far in 2021. But financial pressures, including low patient volumes and loss of revenue from canceled routine services like elective surgeries during the pandemic, have added to hospitals’ difficulties. Pandemic relief funding may have helped some hospitals stay open, but that support eventually will go away.
Experts emphasize the diversity of rural America and its health care systems. Rural economies are volatile and more diverse than is often appreciated. The hospital may be a cornerstone of the local economy; when one closes, it can devastate the community. Workforce is one of the chief components of a hospital’s ability to meet its strategic vision, and hospitalists are a big part in that. But while hospitalists are valued and appreciated, if the hospital is suffering severe financial problems, that will impact its doctors’ jobs and livelihoods.
“Bandwidth” varies widely for rural hospitalists and their hospitalist groups, said Ken Simone, DO, SFHM, executive chair of SHM’s Rural Special Interest Group and founder and principal of KGS Consultants, a Hospital Medicine and Primary Care Practice Management Consulting company. They may face scarce resources, scarce clinical staffing, lack of support staff to help operations run smoothly, lack of access to specialists locally, and lack of technology. While practicing in a rural setting presents various challenges, it can be rewarding for those clinicians who embrace its autonomy and broad scope of services, Dr. Simone said.
SHM’s Rural SIG focuses on the unique needs of rural hospitalists, providing them with an opportunity to share their concerns, challenges and solutions through roundtable discussions every other month and a special interest forum held in conjunction with the SHM Converge annual conference, Dr. Simone said. (The next SHM Converge will be April 7-10, 2022, in Nashville, Tenn.) The Rural SIG also collaborates with other hospital medicine SIGs and committees and is working on a white paper, “Key Principles and Characteristics of an Effective Rural Hospital Medicine Group.” It is also looking to develop a rural mentorship exchange program.
COVID reaches rural America
Early COVID caseloads tended to be in urban areas, but subsequent surges of infections have spread to many rural areas. Some rural settings became epicenters for the pandemic in November and December 2020. More recent troubling rises in COVID cases, particularly in areas with lower vaccination rates – suggest that the challenges of the pandemic are still not behind us.
“By no means is the crisis done in rural America,” said Alan Morgan, CEO of the National Rural Health Association, in a Virtual Rural Health Journalism workshop on rural health care sponsored by the Association of Health Care Journalists.2
Mr. Morgan’s colleague, Brock Slabach, NRHA’s chief operations officer, said in an interview that, while 453 of the 1,800 hospitals in rural areas fit NRHA’s criteria as being vulnerable to closure, the rest are not, and are fulfilling their missions for their communities. Hospitalists are becoming more common in these hospitals, he said, and rural hospitalists can be an important asset in attracting primary care physicians – who might not appreciate being perpetually on call for their hospitalized patients – to rural communities.
In many cases, traveling doctors like Dr. Mandal or telemedicine backup, particularly for after-hours coverage or ICU beds, are important pieces of the puzzle for smaller hospitals. There are different ways to use the spectrum of telemedicine services to interact with a hospital’s daytime and night routines. In some isolated locations, nurse practitioners or physician assistants provide on-the-ground coverage with virtual backup. Rural hospitals often affiliate with telemedicine networks within health systems – or else contract with independent specialized providers of telemedicine consultation.
Mr. Slabach said another alternative for staffing hospitals with smaller ED and inpatient volumes is to have one doctor on duty who can cover both departments simultaneously. Meanwhile, the new federal Rural Emergency Hospital Program proposes to allow rural hospitals to become essentially freestanding EDs – starting Jan. 1, 2023 – that can manage patients for a maximum of 24 hours.3
Community connections and proactive staffing
Lisa Kaufmann, MD, works as a hospitalist for a two-hospital system in North Carolina, Appalachian Regional Health Care. She practices at Watauga Medical Center, with 100 licensed beds in Boone, and at Cannon Memorial Hospital, a critical access hospital in unincorporated Linville. “We are proud of what we have been able to accomplish during the pandemic,” she said.
A former critical care unit at Watauga had been shut down, but its wiring remained intact. “We turned it into a COVID unit in three days. Then we opened another COVID unit with 18 beds, but that still wasn’t enough. We converted half of our med/surg capacity into a COVID unit. At one point almost half of all of our acute beds were for COVID patients. We made plans for what we would do if it got worse, since we had almost run out of beds,” she said. Demand peaked at the end of January 2021.
“The biggest barrier for us was if someone needed to be transferred, for example, if they needed ECMO [extracorporeal membrane oxygenation], and we couldn’t find another hospital to provide that technology.” In ARHC’s mountainous region – known as the “High Country” – weather can also make it difficult to transport patients. “Sometimes the ambulance can’t make it off the mountain, and half of the time the medical helicopter can’t fly. So we have to be prepared to keep people who we might think ought to be transferred,” she said.
Like many rural communities, the High Country is tightly knit, and its hospitals are really connected to their communities, Dr. Kaufmann said. The health system already had a lot of community connections beyond acute care, and that meant the pandemic wasn’t experienced as severely as it was in some other rural communities. “But without hospitalists in our hospitals, it would have been much more difficult.”
Proactive supply fulfillment meant that her hospitals never ran out of personal protective equipment. “Staffing was a challenge, but we were proactive in getting traveling doctors to come here. We also utilized extra doctors from the local community,” she said. Another key was well-established disaster planning, with regular drills, and a robust incident command structure, which just needed to be activated in the crisis. “Small hospitals need to be prepared for disaster,” Dr. Kaufmann said.
For Dale Wiersma, MD, a hospitalist with Spectrum Health, a 14-hospital system in western Michigan, telemedicine services are coordinated across 8 rural regional hospitals. “We don’t tend to use it for direct hospitalist work during daytime hours, unless a facility is swamped, in which case we can cross-cover. We do more telemedicine at night. But during daytime hours we have access to stroke neurology, cardiology, psychiatry, critical care and infectious disease specialists who are able to offer virtual consults,” Dr. Wiersma said. A virtual critical care team of doctor and nurse is often the only intensivist service covering Spectrum’s rural hospitals.
“In our system, the pandemic accelerated the adoption of telemedicine,” Dr. Wiersma said. “We had been working on the tele-ICU program, trying to get it rolled out. When the pandemic hit, we launched it in just 6 weeks.”
There have been several COVID surges in Michigan, he said. “We were stretched pretty close to our limit several times, but never to the breaking point. For our physicians, it was the protracted nature of the pandemic that was fatiguing for everyone involved. Our system worked hard to staff up as well as it could, to make sure our people didn’t go over the edge.” It was also hard for hospitals that typically might see one or two deaths in a month to suddenly have five in a week.
Another Spectrum hospitalist, Christopher Skinner, MD, works at two rural Michigan hospitals 15 minutes apart in Big Rapids and Reed City. “I prefer working in rural areas. I’ve never had an ambition to be a top dog. I like the style of practice where you don’t have all of the medical subspecialties on site. It frees you up to use all your skills,” Dr. Skinner said.
But that approach was put to the test by the pandemic, since it was harder to transfer those patients who normally would not have stayed at these rural hospitals. “We had to make do,” he said, although virtual backup and second opinions from Spectrum’s virtual critical care team helped.
“It was a great collaboration, which helped us to handle critical care cases that we hadn’t had to manage pre-COVID. We’ve gotten used to it, with the backup, so I expect we’ll still be taking care of these kind of sick ventilator patients even after the pandemic ends,” Dr. Skinner said. “We’ve gotten pretty good at it.”
Sukhbir Pannu, MD, a hospitalist in Denver and CEO and founder of Rural Physicians Group, said the pandemic was highly impactful, operationally and logistically, for his firm, which contracts with 54 hospitals to provide their hospitalist staffing. “There was no preparation. Everything had to be done on the fly. Initially, it was felt that rural areas weren’t at as great a risk for COVID, but that proved not to be true. Many experienced a sudden increase in very sick patients. We set up a task force to manage daily census in all of our contracted facilities.”
How did Rural Physicians Group manage through the crisis? “The short answer is telemedicine,” he said. “We had physicians on the ground in these hospitals. But we needed intensivists at the other end of the line to support them.” A lot of conversations about telemedicine were already going on in the company, but the pandemic provided the impetus to launch its network, which has grown to include rheumatologists, pulmonologists, cardiologists, infection medicine, neurology, and psychiatry, all reachable through a central command structure.
Telemedicine is not a cure-all, Dr. Pannu said. It doesn’t work in a vacuum. It requires both a provider on the ground and specialists available remotely. “But it can be a massive multiplier.”
Critical medicine
Other hospitals, including small and rural ones, have reported taking on the challenge of covering critical care with nonintensivist physicians because the pandemic demanded it. David Aymond, MD, a hospitalist at 60-bed Byrd Regional Hospital in Leesville, La., population 6,612, has advocated for years for expanded training and credentialing opportunities in intensive care medicine beyond the traditional path of becoming a board-certified intensivist. Some rural hospitalists were already experienced in providing critical care for ICU patients even before the pandemic hit.
“What COVID did was to highlight the problem that there aren’t enough intensivists in this country, particular for smaller hospitals,” Dr. Aymond said. Some hospitalists who stepped into crisis roles in ICUs during COVID surges showed that they could take care of COVID patients very well.
Dr. Aymond, who is a fellowship-trained hospitalist with primary training in family medicine, has used his ICU experience in both fellowship and practice to make a thorough study of critical care medicine, which he put to good use when the seven-bed ICU at Byrd Memorial filled with COVID patients. “Early on, we were managing multiple ventilators throughout the hospital,” he said. “But we were having good outcomes. Our COVID patients were surviving.” That led to Dr. Aymond being interviewed by local news media, which led to other patients across the state asking to be transferred to “the COVID specialist who practices at Byrd.”
Dr. Aymond would like to see opportunities for abbreviated 1-year critical care fellowships for hospitalists who have amassed enough ICU experience in practice or in residency, and to make room for family medicine physicians in such programs. He is also working through SHM with the Society of Critical Care Medicine to generate educational ICU content. SHM now has a critical care lecture series at: www.hospitalmedicine.org/clinical-topics/critical-care/.
Dr. Mandal, who also works as a pediatric hospitalist, said that experience gave her more familiarity with using noninvasive methods for delivering respiratory therapies like high-flow oxygen. “When I saw a COVID patient who had hypoxia but was still able to talk, I didn’t hesitate to deliver oxygen through noninvasive means.” Eventually hospital practice generally for COVID caught up with this approach.
But she ran into personal difficulties because N95 face masks didn’t fit her face. Instead, she had to wear a portable respirator, which made it hard to hear what her patients were saying. “I formulated a lot of workarounds, such as interviewing the patient over the phone before going into the room for the physical exam.”
Throughout the pandemic, she never wavered in her commitment to rural hospital medicine and its opportunities for working in a small and wonderful community, where she could practice at the top of her license, with a degree of autonomy not granted in other settings. For doctors who want that kind of practice, she said, “the rewards will be paid back in spades. That’s been my experience.”
For more information on SHM’s Rural SIG and its supports for rural hospitalists, contact its executive chair, Kenneth Simone, DO, at ksimone911@gmail.com.
References
1. Personal communication from Peiyin Hung, June 2021.
2. Association of Health Care Journalists. Rural Health Journalism Workshop 2021. June 21, 2021. https://healthjournalism.org/calendar-details.php?id=2369.
3. Congress Establishes New Medicare Provider Category and Reimbursement for Rural Emergency Hospitals. National Law Review. Jan. 5, 2021. https://www.natlawreview.com/article/congress-establishes-new-medicare-provider-category-and-reimbursement-rural.
In 2018, Atashi Mandal, MD, a hospitalist residing in Orange County, Calif., was recruited along with several other doctors to fill hospitalist positions in rural Bishop, Calif. She has since driven 600 miles round trip every month for a week of hospital medicine shifts at Northern Inyo Hospital.
Dr. Mandal said she has really enjoyed her time at the small rural hospital and found it professionally fulfilling to participate so fully in the health of its local community. She was building personal bonds and calling the experience the pinnacle of her career when the COVID-19 pandemic swept across America and the world, even reaching up into Bishop, population 3,760, in the isolated Owens Valley.
The 25-bed hospital has seen at least 100 COVID patients in the past year and some months. Responsibility for taking care of these patients has been both humbling and gratifying, Dr. Mandal said. The facility’s hospitalists made a commitment to keep working through the pandemic. “We were able to come together (around COVID) as a team and our teamwork really made a difference,” she said.
“One of the advantages in a smaller hospital is you can have greater cohesiveness and your communication can be tighter. That played a big role in how we were able to accomplish so much with fewer resources as a rural hospital.” But staffing shortages, recruitment, and retention remain a perennial challenge for rural hospitals. “And COVID only exacerbated the problems,” she said. “I’ve had my challenges trying to make proper treatment plans without access to specialists.”
It was also difficult to witness so many patients severely ill or dying from COVID, Dr. Mandal said, especially since patients were not allowed family visitors – even though that was for a good reason, to minimize the virus’s spread.
HM in rural communities
Hospital medicine continues to extend into rural communities and small rural hospitals. In 2018, 35.7% of all rural counties in America had hospitals staffed with hospitalists, and 63.3% of rural hospitals had hospitalist programs (compared with 79.2% of urban hospitals). These numbers come from Medicare resources files from the Department of Health & Human Services, analyzed by Peiyin Hung, PhD, assistant professor of health services management and policy at the University of South Carolina, Columbia.1 Hospitalist penetration rates rose steadily from 2011 to 2017, with a slight dip in 2018, Dr. Hung said in an interview.
A total of 138 rural hospitals have closed since 2010, according to the Cecil G. Sheps Center for Health Services Research in Chapel Hill, N.C. Nineteen rural hospitals closed in 2020 alone, although many of those were caused by factors predating the pandemic. Only one has closed so far in 2021. But financial pressures, including low patient volumes and loss of revenue from canceled routine services like elective surgeries during the pandemic, have added to hospitals’ difficulties. Pandemic relief funding may have helped some hospitals stay open, but that support eventually will go away.
Experts emphasize the diversity of rural America and its health care systems. Rural economies are volatile and more diverse than is often appreciated. The hospital may be a cornerstone of the local economy; when one closes, it can devastate the community. Workforce is one of the chief components of a hospital’s ability to meet its strategic vision, and hospitalists are a big part in that. But while hospitalists are valued and appreciated, if the hospital is suffering severe financial problems, that will impact its doctors’ jobs and livelihoods.
“Bandwidth” varies widely for rural hospitalists and their hospitalist groups, said Ken Simone, DO, SFHM, executive chair of SHM’s Rural Special Interest Group and founder and principal of KGS Consultants, a Hospital Medicine and Primary Care Practice Management Consulting company. They may face scarce resources, scarce clinical staffing, lack of support staff to help operations run smoothly, lack of access to specialists locally, and lack of technology. While practicing in a rural setting presents various challenges, it can be rewarding for those clinicians who embrace its autonomy and broad scope of services, Dr. Simone said.
SHM’s Rural SIG focuses on the unique needs of rural hospitalists, providing them with an opportunity to share their concerns, challenges and solutions through roundtable discussions every other month and a special interest forum held in conjunction with the SHM Converge annual conference, Dr. Simone said. (The next SHM Converge will be April 7-10, 2022, in Nashville, Tenn.) The Rural SIG also collaborates with other hospital medicine SIGs and committees and is working on a white paper, “Key Principles and Characteristics of an Effective Rural Hospital Medicine Group.” It is also looking to develop a rural mentorship exchange program.
COVID reaches rural America
Early COVID caseloads tended to be in urban areas, but subsequent surges of infections have spread to many rural areas. Some rural settings became epicenters for the pandemic in November and December 2020. More recent troubling rises in COVID cases, particularly in areas with lower vaccination rates – suggest that the challenges of the pandemic are still not behind us.
“By no means is the crisis done in rural America,” said Alan Morgan, CEO of the National Rural Health Association, in a Virtual Rural Health Journalism workshop on rural health care sponsored by the Association of Health Care Journalists.2
Mr. Morgan’s colleague, Brock Slabach, NRHA’s chief operations officer, said in an interview that, while 453 of the 1,800 hospitals in rural areas fit NRHA’s criteria as being vulnerable to closure, the rest are not, and are fulfilling their missions for their communities. Hospitalists are becoming more common in these hospitals, he said, and rural hospitalists can be an important asset in attracting primary care physicians – who might not appreciate being perpetually on call for their hospitalized patients – to rural communities.
In many cases, traveling doctors like Dr. Mandal or telemedicine backup, particularly for after-hours coverage or ICU beds, are important pieces of the puzzle for smaller hospitals. There are different ways to use the spectrum of telemedicine services to interact with a hospital’s daytime and night routines. In some isolated locations, nurse practitioners or physician assistants provide on-the-ground coverage with virtual backup. Rural hospitals often affiliate with telemedicine networks within health systems – or else contract with independent specialized providers of telemedicine consultation.
Mr. Slabach said another alternative for staffing hospitals with smaller ED and inpatient volumes is to have one doctor on duty who can cover both departments simultaneously. Meanwhile, the new federal Rural Emergency Hospital Program proposes to allow rural hospitals to become essentially freestanding EDs – starting Jan. 1, 2023 – that can manage patients for a maximum of 24 hours.3
Community connections and proactive staffing
Lisa Kaufmann, MD, works as a hospitalist for a two-hospital system in North Carolina, Appalachian Regional Health Care. She practices at Watauga Medical Center, with 100 licensed beds in Boone, and at Cannon Memorial Hospital, a critical access hospital in unincorporated Linville. “We are proud of what we have been able to accomplish during the pandemic,” she said.
A former critical care unit at Watauga had been shut down, but its wiring remained intact. “We turned it into a COVID unit in three days. Then we opened another COVID unit with 18 beds, but that still wasn’t enough. We converted half of our med/surg capacity into a COVID unit. At one point almost half of all of our acute beds were for COVID patients. We made plans for what we would do if it got worse, since we had almost run out of beds,” she said. Demand peaked at the end of January 2021.
“The biggest barrier for us was if someone needed to be transferred, for example, if they needed ECMO [extracorporeal membrane oxygenation], and we couldn’t find another hospital to provide that technology.” In ARHC’s mountainous region – known as the “High Country” – weather can also make it difficult to transport patients. “Sometimes the ambulance can’t make it off the mountain, and half of the time the medical helicopter can’t fly. So we have to be prepared to keep people who we might think ought to be transferred,” she said.
Like many rural communities, the High Country is tightly knit, and its hospitals are really connected to their communities, Dr. Kaufmann said. The health system already had a lot of community connections beyond acute care, and that meant the pandemic wasn’t experienced as severely as it was in some other rural communities. “But without hospitalists in our hospitals, it would have been much more difficult.”
Proactive supply fulfillment meant that her hospitals never ran out of personal protective equipment. “Staffing was a challenge, but we were proactive in getting traveling doctors to come here. We also utilized extra doctors from the local community,” she said. Another key was well-established disaster planning, with regular drills, and a robust incident command structure, which just needed to be activated in the crisis. “Small hospitals need to be prepared for disaster,” Dr. Kaufmann said.
For Dale Wiersma, MD, a hospitalist with Spectrum Health, a 14-hospital system in western Michigan, telemedicine services are coordinated across 8 rural regional hospitals. “We don’t tend to use it for direct hospitalist work during daytime hours, unless a facility is swamped, in which case we can cross-cover. We do more telemedicine at night. But during daytime hours we have access to stroke neurology, cardiology, psychiatry, critical care and infectious disease specialists who are able to offer virtual consults,” Dr. Wiersma said. A virtual critical care team of doctor and nurse is often the only intensivist service covering Spectrum’s rural hospitals.
“In our system, the pandemic accelerated the adoption of telemedicine,” Dr. Wiersma said. “We had been working on the tele-ICU program, trying to get it rolled out. When the pandemic hit, we launched it in just 6 weeks.”
There have been several COVID surges in Michigan, he said. “We were stretched pretty close to our limit several times, but never to the breaking point. For our physicians, it was the protracted nature of the pandemic that was fatiguing for everyone involved. Our system worked hard to staff up as well as it could, to make sure our people didn’t go over the edge.” It was also hard for hospitals that typically might see one or two deaths in a month to suddenly have five in a week.
Another Spectrum hospitalist, Christopher Skinner, MD, works at two rural Michigan hospitals 15 minutes apart in Big Rapids and Reed City. “I prefer working in rural areas. I’ve never had an ambition to be a top dog. I like the style of practice where you don’t have all of the medical subspecialties on site. It frees you up to use all your skills,” Dr. Skinner said.
But that approach was put to the test by the pandemic, since it was harder to transfer those patients who normally would not have stayed at these rural hospitals. “We had to make do,” he said, although virtual backup and second opinions from Spectrum’s virtual critical care team helped.
“It was a great collaboration, which helped us to handle critical care cases that we hadn’t had to manage pre-COVID. We’ve gotten used to it, with the backup, so I expect we’ll still be taking care of these kind of sick ventilator patients even after the pandemic ends,” Dr. Skinner said. “We’ve gotten pretty good at it.”
Sukhbir Pannu, MD, a hospitalist in Denver and CEO and founder of Rural Physicians Group, said the pandemic was highly impactful, operationally and logistically, for his firm, which contracts with 54 hospitals to provide their hospitalist staffing. “There was no preparation. Everything had to be done on the fly. Initially, it was felt that rural areas weren’t at as great a risk for COVID, but that proved not to be true. Many experienced a sudden increase in very sick patients. We set up a task force to manage daily census in all of our contracted facilities.”
How did Rural Physicians Group manage through the crisis? “The short answer is telemedicine,” he said. “We had physicians on the ground in these hospitals. But we needed intensivists at the other end of the line to support them.” A lot of conversations about telemedicine were already going on in the company, but the pandemic provided the impetus to launch its network, which has grown to include rheumatologists, pulmonologists, cardiologists, infection medicine, neurology, and psychiatry, all reachable through a central command structure.
Telemedicine is not a cure-all, Dr. Pannu said. It doesn’t work in a vacuum. It requires both a provider on the ground and specialists available remotely. “But it can be a massive multiplier.”
Critical medicine
Other hospitals, including small and rural ones, have reported taking on the challenge of covering critical care with nonintensivist physicians because the pandemic demanded it. David Aymond, MD, a hospitalist at 60-bed Byrd Regional Hospital in Leesville, La., population 6,612, has advocated for years for expanded training and credentialing opportunities in intensive care medicine beyond the traditional path of becoming a board-certified intensivist. Some rural hospitalists were already experienced in providing critical care for ICU patients even before the pandemic hit.
“What COVID did was to highlight the problem that there aren’t enough intensivists in this country, particular for smaller hospitals,” Dr. Aymond said. Some hospitalists who stepped into crisis roles in ICUs during COVID surges showed that they could take care of COVID patients very well.
Dr. Aymond, who is a fellowship-trained hospitalist with primary training in family medicine, has used his ICU experience in both fellowship and practice to make a thorough study of critical care medicine, which he put to good use when the seven-bed ICU at Byrd Memorial filled with COVID patients. “Early on, we were managing multiple ventilators throughout the hospital,” he said. “But we were having good outcomes. Our COVID patients were surviving.” That led to Dr. Aymond being interviewed by local news media, which led to other patients across the state asking to be transferred to “the COVID specialist who practices at Byrd.”
Dr. Aymond would like to see opportunities for abbreviated 1-year critical care fellowships for hospitalists who have amassed enough ICU experience in practice or in residency, and to make room for family medicine physicians in such programs. He is also working through SHM with the Society of Critical Care Medicine to generate educational ICU content. SHM now has a critical care lecture series at: www.hospitalmedicine.org/clinical-topics/critical-care/.
Dr. Mandal, who also works as a pediatric hospitalist, said that experience gave her more familiarity with using noninvasive methods for delivering respiratory therapies like high-flow oxygen. “When I saw a COVID patient who had hypoxia but was still able to talk, I didn’t hesitate to deliver oxygen through noninvasive means.” Eventually hospital practice generally for COVID caught up with this approach.
But she ran into personal difficulties because N95 face masks didn’t fit her face. Instead, she had to wear a portable respirator, which made it hard to hear what her patients were saying. “I formulated a lot of workarounds, such as interviewing the patient over the phone before going into the room for the physical exam.”
Throughout the pandemic, she never wavered in her commitment to rural hospital medicine and its opportunities for working in a small and wonderful community, where she could practice at the top of her license, with a degree of autonomy not granted in other settings. For doctors who want that kind of practice, she said, “the rewards will be paid back in spades. That’s been my experience.”
For more information on SHM’s Rural SIG and its supports for rural hospitalists, contact its executive chair, Kenneth Simone, DO, at ksimone911@gmail.com.
References
1. Personal communication from Peiyin Hung, June 2021.
2. Association of Health Care Journalists. Rural Health Journalism Workshop 2021. June 21, 2021. https://healthjournalism.org/calendar-details.php?id=2369.
3. Congress Establishes New Medicare Provider Category and Reimbursement for Rural Emergency Hospitals. National Law Review. Jan. 5, 2021. https://www.natlawreview.com/article/congress-establishes-new-medicare-provider-category-and-reimbursement-rural.
Droperidol/midazolam combo curbs agitation in ED patients
a study involving 86 adult patients at a single tertiary medical care center.
Patients with acute agitation present significant safety concerns in the emergency department, according to Jessica Javed, MD, of the University of Louisville (Ky.) and colleagues.
A combination of haloperidol and lorazepam has been widely used to curb agitation in these patients, but droperidol and midazolam could be more effective, owing to faster onset of action, Dr. Javed noted in a presentation at the annual meeting of the American College of Emergency Physicians.
Dr. Javed and colleagues conducted a prospective study to compare time to adequate sedation in agitated patients in the ED. In the trial, 43 patients received droperidol 5 mg plus midazolam 5 mg, and 43 patients received haloperidol plus lorazepam 2 mg. The average age of the patients in the droperidol/midazolam group was 34 years; the average age of the patients in the haloperidol/lorazepam group was 38 years. Baseline demographics, including height, weight, body mass index, and baseline Sedation Assessment Tool (SAT) scores, were similar between the groups.
The SAT score scale ranges from +3 (combative, violent, or out of control) to –3 (no response to stimulation); zero indicates being awake and calm/cooperative. The median baseline SAT score was 3 for both treatment groups.
The primary outcome was the proportion of patients with adequate sedation (defined as SAT scores of ≤0) 10 min after treatment.
Significantly more patients in the droperidol/midazolam group met this outcome, compared with the patients in the haloperidol/lorazepam group (51.2% vs. 7%). Also, significantly more patients in the droperidol/midazolam group achieved adequate sedation at 5, 10, 15, and 30 min than in the haloperidol/lorazepam group.
Fewer patients in the haloperidol/lorazepam group required supplemental oxygen, compared with the droperidol/midazolam group (9.3% vs. 25.6%). However, none of the droperidol/midazolam patients required rescue sedation, compared with 16.3% of the haloperidol/lorazepam patients, Dr. Javed noted. None of the patients required endotracheal intubation or experienced extrapyramidal symptoms, she said.
The study was limited by the small sample size and inclusion of data from only a single center.
The results suggest that droperidol/midazolam is superior to intramuscular haloperidol/lorazepam for producing adequate sedation after 10 min in agitated patients, Dr. Javed concluded.
The study received no outside funding. The researchers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
a study involving 86 adult patients at a single tertiary medical care center.
Patients with acute agitation present significant safety concerns in the emergency department, according to Jessica Javed, MD, of the University of Louisville (Ky.) and colleagues.
A combination of haloperidol and lorazepam has been widely used to curb agitation in these patients, but droperidol and midazolam could be more effective, owing to faster onset of action, Dr. Javed noted in a presentation at the annual meeting of the American College of Emergency Physicians.
Dr. Javed and colleagues conducted a prospective study to compare time to adequate sedation in agitated patients in the ED. In the trial, 43 patients received droperidol 5 mg plus midazolam 5 mg, and 43 patients received haloperidol plus lorazepam 2 mg. The average age of the patients in the droperidol/midazolam group was 34 years; the average age of the patients in the haloperidol/lorazepam group was 38 years. Baseline demographics, including height, weight, body mass index, and baseline Sedation Assessment Tool (SAT) scores, were similar between the groups.
The SAT score scale ranges from +3 (combative, violent, or out of control) to –3 (no response to stimulation); zero indicates being awake and calm/cooperative. The median baseline SAT score was 3 for both treatment groups.
The primary outcome was the proportion of patients with adequate sedation (defined as SAT scores of ≤0) 10 min after treatment.
Significantly more patients in the droperidol/midazolam group met this outcome, compared with the patients in the haloperidol/lorazepam group (51.2% vs. 7%). Also, significantly more patients in the droperidol/midazolam group achieved adequate sedation at 5, 10, 15, and 30 min than in the haloperidol/lorazepam group.
Fewer patients in the haloperidol/lorazepam group required supplemental oxygen, compared with the droperidol/midazolam group (9.3% vs. 25.6%). However, none of the droperidol/midazolam patients required rescue sedation, compared with 16.3% of the haloperidol/lorazepam patients, Dr. Javed noted. None of the patients required endotracheal intubation or experienced extrapyramidal symptoms, she said.
The study was limited by the small sample size and inclusion of data from only a single center.
The results suggest that droperidol/midazolam is superior to intramuscular haloperidol/lorazepam for producing adequate sedation after 10 min in agitated patients, Dr. Javed concluded.
The study received no outside funding. The researchers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
a study involving 86 adult patients at a single tertiary medical care center.
Patients with acute agitation present significant safety concerns in the emergency department, according to Jessica Javed, MD, of the University of Louisville (Ky.) and colleagues.
A combination of haloperidol and lorazepam has been widely used to curb agitation in these patients, but droperidol and midazolam could be more effective, owing to faster onset of action, Dr. Javed noted in a presentation at the annual meeting of the American College of Emergency Physicians.
Dr. Javed and colleagues conducted a prospective study to compare time to adequate sedation in agitated patients in the ED. In the trial, 43 patients received droperidol 5 mg plus midazolam 5 mg, and 43 patients received haloperidol plus lorazepam 2 mg. The average age of the patients in the droperidol/midazolam group was 34 years; the average age of the patients in the haloperidol/lorazepam group was 38 years. Baseline demographics, including height, weight, body mass index, and baseline Sedation Assessment Tool (SAT) scores, were similar between the groups.
The SAT score scale ranges from +3 (combative, violent, or out of control) to –3 (no response to stimulation); zero indicates being awake and calm/cooperative. The median baseline SAT score was 3 for both treatment groups.
The primary outcome was the proportion of patients with adequate sedation (defined as SAT scores of ≤0) 10 min after treatment.
Significantly more patients in the droperidol/midazolam group met this outcome, compared with the patients in the haloperidol/lorazepam group (51.2% vs. 7%). Also, significantly more patients in the droperidol/midazolam group achieved adequate sedation at 5, 10, 15, and 30 min than in the haloperidol/lorazepam group.
Fewer patients in the haloperidol/lorazepam group required supplemental oxygen, compared with the droperidol/midazolam group (9.3% vs. 25.6%). However, none of the droperidol/midazolam patients required rescue sedation, compared with 16.3% of the haloperidol/lorazepam patients, Dr. Javed noted. None of the patients required endotracheal intubation or experienced extrapyramidal symptoms, she said.
The study was limited by the small sample size and inclusion of data from only a single center.
The results suggest that droperidol/midazolam is superior to intramuscular haloperidol/lorazepam for producing adequate sedation after 10 min in agitated patients, Dr. Javed concluded.
The study received no outside funding. The researchers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
ASNC rejects new chest pain guideline it helped create
It was Oct. 28 when the two big North American cardiology societies issued a joint practice guideline on evaluating and managing chest pain that was endorsed by five other subspecialty groups. The next day, another group that had taken part in the document’s genesis explained why it wasn’t one of those five.
Although the American Society of Nuclear Cardiology (ASNC) was “actively engaged at every stage of the guideline-writing and review process,” the society “could not endorse the guideline,” the society announced in a statement released to clinicians and the media. The most prominent cited reason: It doesn’t adequately “support the principle of Patient First Imaging.”
The guideline was published in Circulation and the Journal of the American College of Cardiology, flagship journals of the American Heart Association and American College of Cardiology, respectively.
The document notes at least two clinicians represented ASNC as peer reviewers, and another was on the writing committee, but the organization does not appear in the list of societies endorsing the document.
“We believe that the document fails to provide unbiased guidance to health care professionals on the optimal evaluation of patients with chest pain,” contends an editorial ASNC board members have scheduled for the Jan. 10 issue of the Journal of Nuclear Medicine but is available now on an open-access preprint server.
“Despite the many important and helpful recommendations in the new guideline, there are several recommendations that we could not support,” it states.
“The ASNC board of directors reviewed the document twice during the endorsement process,” and the society “offered substantive comments after the first endorsement review, several of which were addressed,” Randall C. Thompson, MD, St. Luke’s Mid America Heart Institute and University of Missouri–Kansas City, said in an interview.
“However, some of the board’s concerns went unresolved. It was after the board’s second review, when the document had been declared finalized, that they voted not to endorse,” said Dr. Thompson, who is ASNC president.
“When we gather multiple organizations together to review and summarize the evidence, we work collaboratively to interpret the extensive catalog of peer-reviewed, published literature and create clinical practice recommendations,” Guideline Writing Committee Chair Martha Gulati, MD, University of Arizona, Phoenix, told this news organization in a prepared statement.
“The ASNC had a representative on the writing committee who is a coauthor on the paper and actively participated throughout the writing process the past 4 years,” she said. “The final guideline reflects the latest evidence-based recommendations for the evaluation and diagnosis of chest pain, as agreed by the seven endorsing organizations.”
The document does not clearly note that an ASNC representative was on the writing committee. However, ASNC confirmed that Renee Bullock-Palmer, MD, Deborah Heart and Lung Center, Browns Mills, N.J., is a fellow of the ASNC and had represented the group as one of the coauthors. Two “official reviewers” of the document, however, are listed as ASNC representatives.
Points of contention
“The decision about which test to order can be a nuanced one, and cardiac imaging tests tend to be complementary,” elaborates the editorial on the issue of patient-centered management.
Careful patient selection for different tests is important, “and physician and technical local expertise, availability, quality of equipment, and patient preference are extremely important factors to consider. There is not enough emphasis on this important point,” contend the authors. “This is an important limitation of the guideline.”
Other issues of concern include “lack of balance in the document’s presentation of the science on FFR-CT [fractional flow reserve assessment with computed tomography] and its inappropriately prominent endorsement,” the editorial states.
The U.S. Food and Drug Administration–recognized “limitations and contraindications” to FFR-CT tend to be glossed over in the document, Dr. Thompson said. And most ASNC board members were “concerned with the prominent location of the recommendations for FFR-CT in various tables – especially since there was minimal-to-no discussion of the fact that it is currently provided by only one company, that it is not widely available nor covered routinely by health insurance carriers, and [that] the accuracy in the most relevant population is disputed.”
In other concerns, the document “inadequately discusses the benefit” of combining coronary artery calcium (CAC) scores with functional testing, which ASNC said it supports. For example, adding CAC scores to myocardial perfusion imaging improves its diagnostic accuracy and prognostic power.
Functional vs. anatomic testing?
Moreover, “it is no longer appropriate to bundle all types of stress testing together. All stress imaging tests have their unique advantages and limitations.” Yet, “the concept of the dichotomy of functional testing versus anatomic testing is a common theme in the guideline in many important patient groups,” the editorial states. That could overemphasize CT angiography and thus “blur distinction between different types of functional tests.”
Such concerns about “imbalance” in the portrayals of the two kinds of tests were “amplified by the problem of health insurance companies and radiologic benefits managers inappropriately substituting a test that was ordered by a physician with a different test,” Dr. Thompson elaborated. “There is the impression that some of them ‘cherry-pick’ certain guidelines and that this practice is harmful to patients.”
The ASNC currently does not plan its own corresponding guideline, he said. But the editorial says that “over the coming weeks and months ASNC will offer a series of webinars and other programs that address specific patient populations and dilemmas.” Also, “we will enhance our focus on programs to address quality and efficiency to support a patient-first approach to imaging.”
The five subspecialty groups that have endorsed the document are the American Society of Echocardiography, American College of Chest Physicians, Society for Academic Emergency Medicine, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance.
Dr. Thompson has reported no relevant financial relationships. Statements of disclosure for the other editorial writers are listed in the publication.
A version of this article first appeared on Medscape.com.
It was Oct. 28 when the two big North American cardiology societies issued a joint practice guideline on evaluating and managing chest pain that was endorsed by five other subspecialty groups. The next day, another group that had taken part in the document’s genesis explained why it wasn’t one of those five.
Although the American Society of Nuclear Cardiology (ASNC) was “actively engaged at every stage of the guideline-writing and review process,” the society “could not endorse the guideline,” the society announced in a statement released to clinicians and the media. The most prominent cited reason: It doesn’t adequately “support the principle of Patient First Imaging.”
The guideline was published in Circulation and the Journal of the American College of Cardiology, flagship journals of the American Heart Association and American College of Cardiology, respectively.
The document notes at least two clinicians represented ASNC as peer reviewers, and another was on the writing committee, but the organization does not appear in the list of societies endorsing the document.
“We believe that the document fails to provide unbiased guidance to health care professionals on the optimal evaluation of patients with chest pain,” contends an editorial ASNC board members have scheduled for the Jan. 10 issue of the Journal of Nuclear Medicine but is available now on an open-access preprint server.
“Despite the many important and helpful recommendations in the new guideline, there are several recommendations that we could not support,” it states.
“The ASNC board of directors reviewed the document twice during the endorsement process,” and the society “offered substantive comments after the first endorsement review, several of which were addressed,” Randall C. Thompson, MD, St. Luke’s Mid America Heart Institute and University of Missouri–Kansas City, said in an interview.
“However, some of the board’s concerns went unresolved. It was after the board’s second review, when the document had been declared finalized, that they voted not to endorse,” said Dr. Thompson, who is ASNC president.
“When we gather multiple organizations together to review and summarize the evidence, we work collaboratively to interpret the extensive catalog of peer-reviewed, published literature and create clinical practice recommendations,” Guideline Writing Committee Chair Martha Gulati, MD, University of Arizona, Phoenix, told this news organization in a prepared statement.
“The ASNC had a representative on the writing committee who is a coauthor on the paper and actively participated throughout the writing process the past 4 years,” she said. “The final guideline reflects the latest evidence-based recommendations for the evaluation and diagnosis of chest pain, as agreed by the seven endorsing organizations.”
The document does not clearly note that an ASNC representative was on the writing committee. However, ASNC confirmed that Renee Bullock-Palmer, MD, Deborah Heart and Lung Center, Browns Mills, N.J., is a fellow of the ASNC and had represented the group as one of the coauthors. Two “official reviewers” of the document, however, are listed as ASNC representatives.
Points of contention
“The decision about which test to order can be a nuanced one, and cardiac imaging tests tend to be complementary,” elaborates the editorial on the issue of patient-centered management.
Careful patient selection for different tests is important, “and physician and technical local expertise, availability, quality of equipment, and patient preference are extremely important factors to consider. There is not enough emphasis on this important point,” contend the authors. “This is an important limitation of the guideline.”
Other issues of concern include “lack of balance in the document’s presentation of the science on FFR-CT [fractional flow reserve assessment with computed tomography] and its inappropriately prominent endorsement,” the editorial states.
The U.S. Food and Drug Administration–recognized “limitations and contraindications” to FFR-CT tend to be glossed over in the document, Dr. Thompson said. And most ASNC board members were “concerned with the prominent location of the recommendations for FFR-CT in various tables – especially since there was minimal-to-no discussion of the fact that it is currently provided by only one company, that it is not widely available nor covered routinely by health insurance carriers, and [that] the accuracy in the most relevant population is disputed.”
In other concerns, the document “inadequately discusses the benefit” of combining coronary artery calcium (CAC) scores with functional testing, which ASNC said it supports. For example, adding CAC scores to myocardial perfusion imaging improves its diagnostic accuracy and prognostic power.
Functional vs. anatomic testing?
Moreover, “it is no longer appropriate to bundle all types of stress testing together. All stress imaging tests have their unique advantages and limitations.” Yet, “the concept of the dichotomy of functional testing versus anatomic testing is a common theme in the guideline in many important patient groups,” the editorial states. That could overemphasize CT angiography and thus “blur distinction between different types of functional tests.”
Such concerns about “imbalance” in the portrayals of the two kinds of tests were “amplified by the problem of health insurance companies and radiologic benefits managers inappropriately substituting a test that was ordered by a physician with a different test,” Dr. Thompson elaborated. “There is the impression that some of them ‘cherry-pick’ certain guidelines and that this practice is harmful to patients.”
The ASNC currently does not plan its own corresponding guideline, he said. But the editorial says that “over the coming weeks and months ASNC will offer a series of webinars and other programs that address specific patient populations and dilemmas.” Also, “we will enhance our focus on programs to address quality and efficiency to support a patient-first approach to imaging.”
The five subspecialty groups that have endorsed the document are the American Society of Echocardiography, American College of Chest Physicians, Society for Academic Emergency Medicine, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance.
Dr. Thompson has reported no relevant financial relationships. Statements of disclosure for the other editorial writers are listed in the publication.
A version of this article first appeared on Medscape.com.
It was Oct. 28 when the two big North American cardiology societies issued a joint practice guideline on evaluating and managing chest pain that was endorsed by five other subspecialty groups. The next day, another group that had taken part in the document’s genesis explained why it wasn’t one of those five.
Although the American Society of Nuclear Cardiology (ASNC) was “actively engaged at every stage of the guideline-writing and review process,” the society “could not endorse the guideline,” the society announced in a statement released to clinicians and the media. The most prominent cited reason: It doesn’t adequately “support the principle of Patient First Imaging.”
The guideline was published in Circulation and the Journal of the American College of Cardiology, flagship journals of the American Heart Association and American College of Cardiology, respectively.
The document notes at least two clinicians represented ASNC as peer reviewers, and another was on the writing committee, but the organization does not appear in the list of societies endorsing the document.
“We believe that the document fails to provide unbiased guidance to health care professionals on the optimal evaluation of patients with chest pain,” contends an editorial ASNC board members have scheduled for the Jan. 10 issue of the Journal of Nuclear Medicine but is available now on an open-access preprint server.
“Despite the many important and helpful recommendations in the new guideline, there are several recommendations that we could not support,” it states.
“The ASNC board of directors reviewed the document twice during the endorsement process,” and the society “offered substantive comments after the first endorsement review, several of which were addressed,” Randall C. Thompson, MD, St. Luke’s Mid America Heart Institute and University of Missouri–Kansas City, said in an interview.
“However, some of the board’s concerns went unresolved. It was after the board’s second review, when the document had been declared finalized, that they voted not to endorse,” said Dr. Thompson, who is ASNC president.
“When we gather multiple organizations together to review and summarize the evidence, we work collaboratively to interpret the extensive catalog of peer-reviewed, published literature and create clinical practice recommendations,” Guideline Writing Committee Chair Martha Gulati, MD, University of Arizona, Phoenix, told this news organization in a prepared statement.
“The ASNC had a representative on the writing committee who is a coauthor on the paper and actively participated throughout the writing process the past 4 years,” she said. “The final guideline reflects the latest evidence-based recommendations for the evaluation and diagnosis of chest pain, as agreed by the seven endorsing organizations.”
The document does not clearly note that an ASNC representative was on the writing committee. However, ASNC confirmed that Renee Bullock-Palmer, MD, Deborah Heart and Lung Center, Browns Mills, N.J., is a fellow of the ASNC and had represented the group as one of the coauthors. Two “official reviewers” of the document, however, are listed as ASNC representatives.
Points of contention
“The decision about which test to order can be a nuanced one, and cardiac imaging tests tend to be complementary,” elaborates the editorial on the issue of patient-centered management.
Careful patient selection for different tests is important, “and physician and technical local expertise, availability, quality of equipment, and patient preference are extremely important factors to consider. There is not enough emphasis on this important point,” contend the authors. “This is an important limitation of the guideline.”
Other issues of concern include “lack of balance in the document’s presentation of the science on FFR-CT [fractional flow reserve assessment with computed tomography] and its inappropriately prominent endorsement,” the editorial states.
The U.S. Food and Drug Administration–recognized “limitations and contraindications” to FFR-CT tend to be glossed over in the document, Dr. Thompson said. And most ASNC board members were “concerned with the prominent location of the recommendations for FFR-CT in various tables – especially since there was minimal-to-no discussion of the fact that it is currently provided by only one company, that it is not widely available nor covered routinely by health insurance carriers, and [that] the accuracy in the most relevant population is disputed.”
In other concerns, the document “inadequately discusses the benefit” of combining coronary artery calcium (CAC) scores with functional testing, which ASNC said it supports. For example, adding CAC scores to myocardial perfusion imaging improves its diagnostic accuracy and prognostic power.
Functional vs. anatomic testing?
Moreover, “it is no longer appropriate to bundle all types of stress testing together. All stress imaging tests have their unique advantages and limitations.” Yet, “the concept of the dichotomy of functional testing versus anatomic testing is a common theme in the guideline in many important patient groups,” the editorial states. That could overemphasize CT angiography and thus “blur distinction between different types of functional tests.”
Such concerns about “imbalance” in the portrayals of the two kinds of tests were “amplified by the problem of health insurance companies and radiologic benefits managers inappropriately substituting a test that was ordered by a physician with a different test,” Dr. Thompson elaborated. “There is the impression that some of them ‘cherry-pick’ certain guidelines and that this practice is harmful to patients.”
The ASNC currently does not plan its own corresponding guideline, he said. But the editorial says that “over the coming weeks and months ASNC will offer a series of webinars and other programs that address specific patient populations and dilemmas.” Also, “we will enhance our focus on programs to address quality and efficiency to support a patient-first approach to imaging.”
The five subspecialty groups that have endorsed the document are the American Society of Echocardiography, American College of Chest Physicians, Society for Academic Emergency Medicine, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance.
Dr. Thompson has reported no relevant financial relationships. Statements of disclosure for the other editorial writers are listed in the publication.
A version of this article first appeared on Medscape.com.
COVID-19 vaccines provide 5 times the protection of natural immunity, CDC study says
new study published recently in the CDC’s Morbidity and Mortality Weekly Report.
, according to aThe research team concluded that vaccination can provide a higher, stronger, and more consistent level of immunity against COVID-19 hospitalization than infection alone for at least six months.
“We now have additional evidence that reaffirms the importance of COVID-19 vaccines, even if you have had prior infection,” Rochelle Walensky, MD, director of the CDC, said in a statement.
“This study adds more to the body of knowledge demonstrating the protection of vaccines against severe disease from COVID-19,” she said. “The best way to stop COVID-19, including the emergence of variants, is with widespread COVID-19 vaccination and with disease prevention actions such as mask wearing, washing hands often, physical distancing and staying home when sick.”
Researchers looked at data from the VISION Network, which included more than 201,000 hospitalizations for COVID-like illness at 187 hospitals across nine states between Jan. 1 to Sept. 2. Among those, more than 94,000 had rapid testing for the coronavirus, and 7,300 had a lab-confirmed test for COVID-19.
The research team found that unvaccinated people with a prior infection within 3 to 6 months were about 5-1/2 times more likely to have laboratory-confirmed COVID-19 than those who were fully vaccinated within 3 to 6 months with the Pfizer or Moderna shots. They found similar results when looking at the months that the Delta variant was the dominant strain of the coronavirus.
Protection from the Moderna vaccine “appeared to be higher” than for the Pfizer vaccine, the study authors wrote. The boost in protection also “trended higher” among older adults, as compared to those under age 65.
Importantly, the research team noted, these estimates may change over time as immunity wanes. Future studies should consider infection-induced and vaccine-induced immunity as time passes during the pandemic, they wrote.
Additional research is also needed for the Johnson & Johnson vaccine, they wrote. Those who have received the Johnson & Johnson vaccine are currently recommended to receive a booster shot at least two months after the first shot.
Overall, “all eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected,” the research team concluded.
A version of this article first appeared on WebMD.com.
new study published recently in the CDC’s Morbidity and Mortality Weekly Report.
, according to aThe research team concluded that vaccination can provide a higher, stronger, and more consistent level of immunity against COVID-19 hospitalization than infection alone for at least six months.
“We now have additional evidence that reaffirms the importance of COVID-19 vaccines, even if you have had prior infection,” Rochelle Walensky, MD, director of the CDC, said in a statement.
“This study adds more to the body of knowledge demonstrating the protection of vaccines against severe disease from COVID-19,” she said. “The best way to stop COVID-19, including the emergence of variants, is with widespread COVID-19 vaccination and with disease prevention actions such as mask wearing, washing hands often, physical distancing and staying home when sick.”
Researchers looked at data from the VISION Network, which included more than 201,000 hospitalizations for COVID-like illness at 187 hospitals across nine states between Jan. 1 to Sept. 2. Among those, more than 94,000 had rapid testing for the coronavirus, and 7,300 had a lab-confirmed test for COVID-19.
The research team found that unvaccinated people with a prior infection within 3 to 6 months were about 5-1/2 times more likely to have laboratory-confirmed COVID-19 than those who were fully vaccinated within 3 to 6 months with the Pfizer or Moderna shots. They found similar results when looking at the months that the Delta variant was the dominant strain of the coronavirus.
Protection from the Moderna vaccine “appeared to be higher” than for the Pfizer vaccine, the study authors wrote. The boost in protection also “trended higher” among older adults, as compared to those under age 65.
Importantly, the research team noted, these estimates may change over time as immunity wanes. Future studies should consider infection-induced and vaccine-induced immunity as time passes during the pandemic, they wrote.
Additional research is also needed for the Johnson & Johnson vaccine, they wrote. Those who have received the Johnson & Johnson vaccine are currently recommended to receive a booster shot at least two months after the first shot.
Overall, “all eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected,” the research team concluded.
A version of this article first appeared on WebMD.com.
new study published recently in the CDC’s Morbidity and Mortality Weekly Report.
, according to aThe research team concluded that vaccination can provide a higher, stronger, and more consistent level of immunity against COVID-19 hospitalization than infection alone for at least six months.
“We now have additional evidence that reaffirms the importance of COVID-19 vaccines, even if you have had prior infection,” Rochelle Walensky, MD, director of the CDC, said in a statement.
“This study adds more to the body of knowledge demonstrating the protection of vaccines against severe disease from COVID-19,” she said. “The best way to stop COVID-19, including the emergence of variants, is with widespread COVID-19 vaccination and with disease prevention actions such as mask wearing, washing hands often, physical distancing and staying home when sick.”
Researchers looked at data from the VISION Network, which included more than 201,000 hospitalizations for COVID-like illness at 187 hospitals across nine states between Jan. 1 to Sept. 2. Among those, more than 94,000 had rapid testing for the coronavirus, and 7,300 had a lab-confirmed test for COVID-19.
The research team found that unvaccinated people with a prior infection within 3 to 6 months were about 5-1/2 times more likely to have laboratory-confirmed COVID-19 than those who were fully vaccinated within 3 to 6 months with the Pfizer or Moderna shots. They found similar results when looking at the months that the Delta variant was the dominant strain of the coronavirus.
Protection from the Moderna vaccine “appeared to be higher” than for the Pfizer vaccine, the study authors wrote. The boost in protection also “trended higher” among older adults, as compared to those under age 65.
Importantly, the research team noted, these estimates may change over time as immunity wanes. Future studies should consider infection-induced and vaccine-induced immunity as time passes during the pandemic, they wrote.
Additional research is also needed for the Johnson & Johnson vaccine, they wrote. Those who have received the Johnson & Johnson vaccine are currently recommended to receive a booster shot at least two months after the first shot.
Overall, “all eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected,” the research team concluded.
A version of this article first appeared on WebMD.com.
ERs are swamped with seriously ill patients, although many don’t have COVID
Inside the emergency department at Sparrow Hospital in Lansing, Mich., staff members are struggling to care for patients showing up much sicker than they’ve ever seen.
Tiffani Dusang, the ER’s nursing director, practically vibrates with pent-up anxiety, looking at patients lying on a long line of stretchers pushed up against the beige walls of the hospital hallways. “It’s hard to watch,” she said in a warm Texas twang.
But there’s nothing she can do. The ER’s 72 rooms are already filled.
“I always feel very, very bad when I walk down the hallway and see that people are in pain, or needing to sleep, or needing quiet. But they have to be in the hallway with, as you can see, 10 or 15 people walking by every minute,” Ms. Dusang said.
The scene is a stark contrast to where this emergency department — and thousands of others — were at the start of the pandemic. Except for initial hot spots like New York City, in spring 2020 many ERs across the country were often eerily empty. Terrified of contracting COVID-19, people who were sick with other things did their best to stay away from hospitals. Visits to emergency rooms dropped to half their typical levels, according to the Epic Health Research Network, and didn’t fully rebound until this summer.
But now, they’re too full.
Months of treatment delays have exacerbated chronic conditions and worsened symptoms. Doctors and nurses say the severity of illness ranges widely and includes abdominal pain, respiratory problems, blood clots, heart conditions and suicide attempts, among other conditions.
But they can hardly be accommodated. Emergency departments, ideally, are meant to be brief ports in a storm, with patients staying just long enough to be sent home with instructions to follow up with primary care physicians, or sufficiently stabilized to be transferred “upstairs” to inpatient or intensive care units.
Except now those long-term care floors are full too, with a mix of covid and non-covid patients. People coming to the ER get warehoused for hours, even days, forcing ER staffers to perform long-term care roles they weren’t trained to do.
At Sparrow, space is a valuable commodity in the ER: A separate section of the hospital was turned into an overflow unit. Stretchers stack up in halls. A row of brown reclining chairs lines a wall, intended for patients who aren’t sick enough for a stretcher but are too sick to stay in the main waiting room.
Forget privacy, Alejos Perrientoz learned when he arrived. He came to the ER because his arm had been tingling and painful for over a week. He couldn’t hold a cup of coffee. A nurse gave him a full physical exam in a brown recliner, which made him self-conscious about having his shirt lifted in front of strangers. “I felt a little uncomfortable,” he whispered. “But I have no choice, you know? I’m in the hallway. There’s no rooms.
“We could have done the physical in the parking lot,” he added, managing a laugh.
Even patients who arrive by ambulance are not guaranteed a room: One nurse runs triage, screening those who absolutely need a bed, and those who can be put in the waiting area.
“I hate that we even have to make that determination,” MS. Dusang said. Lately, staff members have been pulling out some patients already in the ER’s rooms when others arrive who are more critically ill. “No one likes to take someone out of the privacy of their room and say, ‘We’re going to put you in a hallway because we need to get care to someone else.’”
ER patients have grown sicker
“We are hearing from members in every part of the country,” said Dr. Lisa Moreno, president of the American Academy of Emergency Medicine. “The Midwest, the South, the Northeast, the West … they are seeing this exact same phenomenon.”
Although the number of ER visits returned to pre-COVID levels this summer, admission rates, from the ER to the hospital’s inpatient floors, are still almost 20% higher. That’s according to the most recent analysis by the Epic Health Research Network, which pulls data from more than 120 million patients across the country.
“It’s an early indicator that what’s happening in the ED is that we’re seeing more acute cases than we were pre-pandemic,” said Caleb Cox, a data scientist at Epic.
Less acute cases, such as people with health issues like rashes or conjunctivitis, still aren’t going to the ER as much as they used to. Instead, they may be opting for an urgent care center or their primary care doctor, Mr. Cox explained. Meanwhile, there has been an increase in people coming to the ER with more serious conditions, like strokes and heart attacks.
So, even though the total number of patients coming to ERs is about the same as before the pandemic, “that’s absolutely going to feel like [if I’m an ER doctor or nurse] I’m seeing more patients and I’m seeing more acute patients,” Mr. Cox said.
Dr. Moreno, the AAEM president, works at an emergency department in New Orleans. She said the level of illness, and the inability to admit patients quickly and move them to beds upstairs, has created a level of chaos she described as “not even humane.”
At the beginning of a recent shift, she heard a patient crying nearby and went to investigate. It was a paraplegic man who’d recently had surgery for colon cancer. His large post-operative wound was sealed with a device called a wound vac, which pulls fluid from the wound into a drainage tube attached to a portable vacuum pump.
But the wound vac had malfunctioned, which is why he had come to the ER. Staffers were so busy, however, that by the time Dr. Moreno came in, the fluid from his wound was leaking everywhere.
“When I went in, the bed was covered,” she recalled. “I mean, he was lying in a puddle of secretions from this wound. And he was crying, because he said to me, ‘I’m paralyzed. I can’t move to get away from all these secretions, and I know I’m going to end up getting an infection. I know I’m going to end up getting an ulcer. I’ve been laying in this for, like, eight or nine hours.’”
The nurse in charge of his care told Dr. Moreno she simply hadn’t had time to help this patient yet. “She said, ‘I’ve had so many patients to take care of, and so many critical patients. I started [an IV] drip on this person. This person is on a cardiac monitor. I just didn’t have time to get in there.’”
“This is not humane care,” Dr. Moreno said. “This is horrible care.”
But it’s what can happen when emergency department staffers don’t have the resources they need to deal with the onslaught of competing demands.
“All the nurses and doctors had the highest level of intent to do the right thing for the person,” Dr. Moreno said. “But because of the high acuity of … a large number of patients, the staffing ratio of nurse to patient, even the staffing ratio of doctor to patient, this guy did not get the care that he deserved to get, just as a human being.”
The instance of unintended neglect that Dr. Moreno saw is extreme, and not the experience of most patients who arrive at ERs these days. But the problem is not new: Even before the pandemic, ER overcrowding had been a “widespread problem and a source of patient harm, according to a recent commentary in NEJM Catalyst Innovations in Care Delivery.
“ED crowding is not an issue of inconvenience,” the authors wrote. “There is incontrovertible evidence that ED crowding leads to significant patient harm, including morbidity and mortality related to consequential delays of treatment for both high- and low-acuity patients.”
And already-overwhelmed staffers are burning out.
Burnout feeds staffing shortages, and vice versa
Every morning, Tiffani Dusang wakes up and checks her Sparrow email with one singular hope: that she will not see yet another nurse resignation letter in her inbox.
“I cannot tell you how many of them [the nurses] tell me they went home crying” after their shifts, she said.
Despite Ms. Dusang’s best efforts to support her staffers, they’re leaving too fast to be replaced, either to take higher-paying gigs as a travel nurse, to try a less-stressful type of nursing, or simply walking away from the profession entirely.
Kelly Spitz has been an emergency department nurse at Sparrow for 10 years. But, lately, she has also fantasized about leaving. “It has crossed my mind several times,” she said, and yet she continues to come back. “Because I have a team here. And I love what I do.” But then she started to cry. The issue is not the hard work, or even the stress. She struggles with not being able to give her patients the kind of care and attention she wants to give them, and that they need and deserve, she said.
She often thinks about a patient whose test results revealed terminal cancer, she said. Ms. Spitz spent all day working the phones, hustling case managers, trying to get hospice care set up in the man’s home. He was going to die, and she just didn’t want him to have to die in the hospital, where only one visitor was allowed. She wanted to get him home, and back with his family.
Finally, after many hours, they found an ambulance to take him home.
Three days later, the man’s family members called Ms. Spitz: He had died surrounded by family. They were calling to thank her.
“I felt like I did my job there, because I got him home,” she said. But that’s a rare feeling these days. “I just hope it gets better. I hope it gets better soon.”
Around 4 p.m. at Sparrow Hospital as one shift approached its end, Ms. Dusang faced a new crisis: The overnight shift was more short-staffed than usual.
“Can we get two inpatient nurses?” she asked, hoping to borrow two nurses from one of the hospital floors upstairs.
“Already tried,” replied nurse Troy Latunski.
Without more staff, it’s going to be hard to care for new patients who come in overnight — from car crashes to seizures or other emergencies.
But Mr. Latunski had a plan: He would go home, snatch a few hours of sleep and return at 11 p.m. to work the overnight shift in the ER’s overflow unit. That meant he would be largely caring for eight patients, alone. On just a few short hours of sleep. But lately that seemed to be their only, and best, option.
Ms. Dusang considered for a moment, took a deep breath and nodded. “OK,” she said.
“Go home. Get some sleep. Thank you,” she added, shooting Mr. Latunski a grateful smile. And then she pivoted, because another nurse was approaching with an urgent question. On to the next crisis.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation. This story is part of a partnership that includes Michigan Radio, NPR and KHN.
Inside the emergency department at Sparrow Hospital in Lansing, Mich., staff members are struggling to care for patients showing up much sicker than they’ve ever seen.
Tiffani Dusang, the ER’s nursing director, practically vibrates with pent-up anxiety, looking at patients lying on a long line of stretchers pushed up against the beige walls of the hospital hallways. “It’s hard to watch,” she said in a warm Texas twang.
But there’s nothing she can do. The ER’s 72 rooms are already filled.
“I always feel very, very bad when I walk down the hallway and see that people are in pain, or needing to sleep, or needing quiet. But they have to be in the hallway with, as you can see, 10 or 15 people walking by every minute,” Ms. Dusang said.
The scene is a stark contrast to where this emergency department — and thousands of others — were at the start of the pandemic. Except for initial hot spots like New York City, in spring 2020 many ERs across the country were often eerily empty. Terrified of contracting COVID-19, people who were sick with other things did their best to stay away from hospitals. Visits to emergency rooms dropped to half their typical levels, according to the Epic Health Research Network, and didn’t fully rebound until this summer.
But now, they’re too full.
Months of treatment delays have exacerbated chronic conditions and worsened symptoms. Doctors and nurses say the severity of illness ranges widely and includes abdominal pain, respiratory problems, blood clots, heart conditions and suicide attempts, among other conditions.
But they can hardly be accommodated. Emergency departments, ideally, are meant to be brief ports in a storm, with patients staying just long enough to be sent home with instructions to follow up with primary care physicians, or sufficiently stabilized to be transferred “upstairs” to inpatient or intensive care units.
Except now those long-term care floors are full too, with a mix of covid and non-covid patients. People coming to the ER get warehoused for hours, even days, forcing ER staffers to perform long-term care roles they weren’t trained to do.
At Sparrow, space is a valuable commodity in the ER: A separate section of the hospital was turned into an overflow unit. Stretchers stack up in halls. A row of brown reclining chairs lines a wall, intended for patients who aren’t sick enough for a stretcher but are too sick to stay in the main waiting room.
Forget privacy, Alejos Perrientoz learned when he arrived. He came to the ER because his arm had been tingling and painful for over a week. He couldn’t hold a cup of coffee. A nurse gave him a full physical exam in a brown recliner, which made him self-conscious about having his shirt lifted in front of strangers. “I felt a little uncomfortable,” he whispered. “But I have no choice, you know? I’m in the hallway. There’s no rooms.
“We could have done the physical in the parking lot,” he added, managing a laugh.
Even patients who arrive by ambulance are not guaranteed a room: One nurse runs triage, screening those who absolutely need a bed, and those who can be put in the waiting area.
“I hate that we even have to make that determination,” MS. Dusang said. Lately, staff members have been pulling out some patients already in the ER’s rooms when others arrive who are more critically ill. “No one likes to take someone out of the privacy of their room and say, ‘We’re going to put you in a hallway because we need to get care to someone else.’”
ER patients have grown sicker
“We are hearing from members in every part of the country,” said Dr. Lisa Moreno, president of the American Academy of Emergency Medicine. “The Midwest, the South, the Northeast, the West … they are seeing this exact same phenomenon.”
Although the number of ER visits returned to pre-COVID levels this summer, admission rates, from the ER to the hospital’s inpatient floors, are still almost 20% higher. That’s according to the most recent analysis by the Epic Health Research Network, which pulls data from more than 120 million patients across the country.
“It’s an early indicator that what’s happening in the ED is that we’re seeing more acute cases than we were pre-pandemic,” said Caleb Cox, a data scientist at Epic.
Less acute cases, such as people with health issues like rashes or conjunctivitis, still aren’t going to the ER as much as they used to. Instead, they may be opting for an urgent care center or their primary care doctor, Mr. Cox explained. Meanwhile, there has been an increase in people coming to the ER with more serious conditions, like strokes and heart attacks.
So, even though the total number of patients coming to ERs is about the same as before the pandemic, “that’s absolutely going to feel like [if I’m an ER doctor or nurse] I’m seeing more patients and I’m seeing more acute patients,” Mr. Cox said.
Dr. Moreno, the AAEM president, works at an emergency department in New Orleans. She said the level of illness, and the inability to admit patients quickly and move them to beds upstairs, has created a level of chaos she described as “not even humane.”
At the beginning of a recent shift, she heard a patient crying nearby and went to investigate. It was a paraplegic man who’d recently had surgery for colon cancer. His large post-operative wound was sealed with a device called a wound vac, which pulls fluid from the wound into a drainage tube attached to a portable vacuum pump.
But the wound vac had malfunctioned, which is why he had come to the ER. Staffers were so busy, however, that by the time Dr. Moreno came in, the fluid from his wound was leaking everywhere.
“When I went in, the bed was covered,” she recalled. “I mean, he was lying in a puddle of secretions from this wound. And he was crying, because he said to me, ‘I’m paralyzed. I can’t move to get away from all these secretions, and I know I’m going to end up getting an infection. I know I’m going to end up getting an ulcer. I’ve been laying in this for, like, eight or nine hours.’”
The nurse in charge of his care told Dr. Moreno she simply hadn’t had time to help this patient yet. “She said, ‘I’ve had so many patients to take care of, and so many critical patients. I started [an IV] drip on this person. This person is on a cardiac monitor. I just didn’t have time to get in there.’”
“This is not humane care,” Dr. Moreno said. “This is horrible care.”
But it’s what can happen when emergency department staffers don’t have the resources they need to deal with the onslaught of competing demands.
“All the nurses and doctors had the highest level of intent to do the right thing for the person,” Dr. Moreno said. “But because of the high acuity of … a large number of patients, the staffing ratio of nurse to patient, even the staffing ratio of doctor to patient, this guy did not get the care that he deserved to get, just as a human being.”
The instance of unintended neglect that Dr. Moreno saw is extreme, and not the experience of most patients who arrive at ERs these days. But the problem is not new: Even before the pandemic, ER overcrowding had been a “widespread problem and a source of patient harm, according to a recent commentary in NEJM Catalyst Innovations in Care Delivery.
“ED crowding is not an issue of inconvenience,” the authors wrote. “There is incontrovertible evidence that ED crowding leads to significant patient harm, including morbidity and mortality related to consequential delays of treatment for both high- and low-acuity patients.”
And already-overwhelmed staffers are burning out.
Burnout feeds staffing shortages, and vice versa
Every morning, Tiffani Dusang wakes up and checks her Sparrow email with one singular hope: that she will not see yet another nurse resignation letter in her inbox.
“I cannot tell you how many of them [the nurses] tell me they went home crying” after their shifts, she said.
Despite Ms. Dusang’s best efforts to support her staffers, they’re leaving too fast to be replaced, either to take higher-paying gigs as a travel nurse, to try a less-stressful type of nursing, or simply walking away from the profession entirely.
Kelly Spitz has been an emergency department nurse at Sparrow for 10 years. But, lately, she has also fantasized about leaving. “It has crossed my mind several times,” she said, and yet she continues to come back. “Because I have a team here. And I love what I do.” But then she started to cry. The issue is not the hard work, or even the stress. She struggles with not being able to give her patients the kind of care and attention she wants to give them, and that they need and deserve, she said.
She often thinks about a patient whose test results revealed terminal cancer, she said. Ms. Spitz spent all day working the phones, hustling case managers, trying to get hospice care set up in the man’s home. He was going to die, and she just didn’t want him to have to die in the hospital, where only one visitor was allowed. She wanted to get him home, and back with his family.
Finally, after many hours, they found an ambulance to take him home.
Three days later, the man’s family members called Ms. Spitz: He had died surrounded by family. They were calling to thank her.
“I felt like I did my job there, because I got him home,” she said. But that’s a rare feeling these days. “I just hope it gets better. I hope it gets better soon.”
Around 4 p.m. at Sparrow Hospital as one shift approached its end, Ms. Dusang faced a new crisis: The overnight shift was more short-staffed than usual.
“Can we get two inpatient nurses?” she asked, hoping to borrow two nurses from one of the hospital floors upstairs.
“Already tried,” replied nurse Troy Latunski.
Without more staff, it’s going to be hard to care for new patients who come in overnight — from car crashes to seizures or other emergencies.
But Mr. Latunski had a plan: He would go home, snatch a few hours of sleep and return at 11 p.m. to work the overnight shift in the ER’s overflow unit. That meant he would be largely caring for eight patients, alone. On just a few short hours of sleep. But lately that seemed to be their only, and best, option.
Ms. Dusang considered for a moment, took a deep breath and nodded. “OK,” she said.
“Go home. Get some sleep. Thank you,” she added, shooting Mr. Latunski a grateful smile. And then she pivoted, because another nurse was approaching with an urgent question. On to the next crisis.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation. This story is part of a partnership that includes Michigan Radio, NPR and KHN.
Inside the emergency department at Sparrow Hospital in Lansing, Mich., staff members are struggling to care for patients showing up much sicker than they’ve ever seen.
Tiffani Dusang, the ER’s nursing director, practically vibrates with pent-up anxiety, looking at patients lying on a long line of stretchers pushed up against the beige walls of the hospital hallways. “It’s hard to watch,” she said in a warm Texas twang.
But there’s nothing she can do. The ER’s 72 rooms are already filled.
“I always feel very, very bad when I walk down the hallway and see that people are in pain, or needing to sleep, or needing quiet. But they have to be in the hallway with, as you can see, 10 or 15 people walking by every minute,” Ms. Dusang said.
The scene is a stark contrast to where this emergency department — and thousands of others — were at the start of the pandemic. Except for initial hot spots like New York City, in spring 2020 many ERs across the country were often eerily empty. Terrified of contracting COVID-19, people who were sick with other things did their best to stay away from hospitals. Visits to emergency rooms dropped to half their typical levels, according to the Epic Health Research Network, and didn’t fully rebound until this summer.
But now, they’re too full.
Months of treatment delays have exacerbated chronic conditions and worsened symptoms. Doctors and nurses say the severity of illness ranges widely and includes abdominal pain, respiratory problems, blood clots, heart conditions and suicide attempts, among other conditions.
But they can hardly be accommodated. Emergency departments, ideally, are meant to be brief ports in a storm, with patients staying just long enough to be sent home with instructions to follow up with primary care physicians, or sufficiently stabilized to be transferred “upstairs” to inpatient or intensive care units.
Except now those long-term care floors are full too, with a mix of covid and non-covid patients. People coming to the ER get warehoused for hours, even days, forcing ER staffers to perform long-term care roles they weren’t trained to do.
At Sparrow, space is a valuable commodity in the ER: A separate section of the hospital was turned into an overflow unit. Stretchers stack up in halls. A row of brown reclining chairs lines a wall, intended for patients who aren’t sick enough for a stretcher but are too sick to stay in the main waiting room.
Forget privacy, Alejos Perrientoz learned when he arrived. He came to the ER because his arm had been tingling and painful for over a week. He couldn’t hold a cup of coffee. A nurse gave him a full physical exam in a brown recliner, which made him self-conscious about having his shirt lifted in front of strangers. “I felt a little uncomfortable,” he whispered. “But I have no choice, you know? I’m in the hallway. There’s no rooms.
“We could have done the physical in the parking lot,” he added, managing a laugh.
Even patients who arrive by ambulance are not guaranteed a room: One nurse runs triage, screening those who absolutely need a bed, and those who can be put in the waiting area.
“I hate that we even have to make that determination,” MS. Dusang said. Lately, staff members have been pulling out some patients already in the ER’s rooms when others arrive who are more critically ill. “No one likes to take someone out of the privacy of their room and say, ‘We’re going to put you in a hallway because we need to get care to someone else.’”
ER patients have grown sicker
“We are hearing from members in every part of the country,” said Dr. Lisa Moreno, president of the American Academy of Emergency Medicine. “The Midwest, the South, the Northeast, the West … they are seeing this exact same phenomenon.”
Although the number of ER visits returned to pre-COVID levels this summer, admission rates, from the ER to the hospital’s inpatient floors, are still almost 20% higher. That’s according to the most recent analysis by the Epic Health Research Network, which pulls data from more than 120 million patients across the country.
“It’s an early indicator that what’s happening in the ED is that we’re seeing more acute cases than we were pre-pandemic,” said Caleb Cox, a data scientist at Epic.
Less acute cases, such as people with health issues like rashes or conjunctivitis, still aren’t going to the ER as much as they used to. Instead, they may be opting for an urgent care center or their primary care doctor, Mr. Cox explained. Meanwhile, there has been an increase in people coming to the ER with more serious conditions, like strokes and heart attacks.
So, even though the total number of patients coming to ERs is about the same as before the pandemic, “that’s absolutely going to feel like [if I’m an ER doctor or nurse] I’m seeing more patients and I’m seeing more acute patients,” Mr. Cox said.
Dr. Moreno, the AAEM president, works at an emergency department in New Orleans. She said the level of illness, and the inability to admit patients quickly and move them to beds upstairs, has created a level of chaos she described as “not even humane.”
At the beginning of a recent shift, she heard a patient crying nearby and went to investigate. It was a paraplegic man who’d recently had surgery for colon cancer. His large post-operative wound was sealed with a device called a wound vac, which pulls fluid from the wound into a drainage tube attached to a portable vacuum pump.
But the wound vac had malfunctioned, which is why he had come to the ER. Staffers were so busy, however, that by the time Dr. Moreno came in, the fluid from his wound was leaking everywhere.
“When I went in, the bed was covered,” she recalled. “I mean, he was lying in a puddle of secretions from this wound. And he was crying, because he said to me, ‘I’m paralyzed. I can’t move to get away from all these secretions, and I know I’m going to end up getting an infection. I know I’m going to end up getting an ulcer. I’ve been laying in this for, like, eight or nine hours.’”
The nurse in charge of his care told Dr. Moreno she simply hadn’t had time to help this patient yet. “She said, ‘I’ve had so many patients to take care of, and so many critical patients. I started [an IV] drip on this person. This person is on a cardiac monitor. I just didn’t have time to get in there.’”
“This is not humane care,” Dr. Moreno said. “This is horrible care.”
But it’s what can happen when emergency department staffers don’t have the resources they need to deal with the onslaught of competing demands.
“All the nurses and doctors had the highest level of intent to do the right thing for the person,” Dr. Moreno said. “But because of the high acuity of … a large number of patients, the staffing ratio of nurse to patient, even the staffing ratio of doctor to patient, this guy did not get the care that he deserved to get, just as a human being.”
The instance of unintended neglect that Dr. Moreno saw is extreme, and not the experience of most patients who arrive at ERs these days. But the problem is not new: Even before the pandemic, ER overcrowding had been a “widespread problem and a source of patient harm, according to a recent commentary in NEJM Catalyst Innovations in Care Delivery.
“ED crowding is not an issue of inconvenience,” the authors wrote. “There is incontrovertible evidence that ED crowding leads to significant patient harm, including morbidity and mortality related to consequential delays of treatment for both high- and low-acuity patients.”
And already-overwhelmed staffers are burning out.
Burnout feeds staffing shortages, and vice versa
Every morning, Tiffani Dusang wakes up and checks her Sparrow email with one singular hope: that she will not see yet another nurse resignation letter in her inbox.
“I cannot tell you how many of them [the nurses] tell me they went home crying” after their shifts, she said.
Despite Ms. Dusang’s best efforts to support her staffers, they’re leaving too fast to be replaced, either to take higher-paying gigs as a travel nurse, to try a less-stressful type of nursing, or simply walking away from the profession entirely.
Kelly Spitz has been an emergency department nurse at Sparrow for 10 years. But, lately, she has also fantasized about leaving. “It has crossed my mind several times,” she said, and yet she continues to come back. “Because I have a team here. And I love what I do.” But then she started to cry. The issue is not the hard work, or even the stress. She struggles with not being able to give her patients the kind of care and attention she wants to give them, and that they need and deserve, she said.
She often thinks about a patient whose test results revealed terminal cancer, she said. Ms. Spitz spent all day working the phones, hustling case managers, trying to get hospice care set up in the man’s home. He was going to die, and she just didn’t want him to have to die in the hospital, where only one visitor was allowed. She wanted to get him home, and back with his family.
Finally, after many hours, they found an ambulance to take him home.
Three days later, the man’s family members called Ms. Spitz: He had died surrounded by family. They were calling to thank her.
“I felt like I did my job there, because I got him home,” she said. But that’s a rare feeling these days. “I just hope it gets better. I hope it gets better soon.”
Around 4 p.m. at Sparrow Hospital as one shift approached its end, Ms. Dusang faced a new crisis: The overnight shift was more short-staffed than usual.
“Can we get two inpatient nurses?” she asked, hoping to borrow two nurses from one of the hospital floors upstairs.
“Already tried,” replied nurse Troy Latunski.
Without more staff, it’s going to be hard to care for new patients who come in overnight — from car crashes to seizures or other emergencies.
But Mr. Latunski had a plan: He would go home, snatch a few hours of sleep and return at 11 p.m. to work the overnight shift in the ER’s overflow unit. That meant he would be largely caring for eight patients, alone. On just a few short hours of sleep. But lately that seemed to be their only, and best, option.
Ms. Dusang considered for a moment, took a deep breath and nodded. “OK,” she said.
“Go home. Get some sleep. Thank you,” she added, shooting Mr. Latunski a grateful smile. And then she pivoted, because another nurse was approaching with an urgent question. On to the next crisis.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation. This story is part of a partnership that includes Michigan Radio, NPR and KHN.
FDA authorizes Pfizer’s COVID-19 vaccine for kids
The move brings families with young children a step closer to resuming their normal activities, and it should help further slow transmission of the coronavirus virus in the United States.
States have already placed their orders for initial doses of the vaccines. The Oct. 29 FDA authorization triggers the shipment of millions of doses to pediatricians, family practice doctors, children’s hospitals, community health centers, and pharmacies.
Next, a panel of experts known as the Advisory Committee on Immunization Practices, or ACIP, will meet Nov. 2 to vote on recommendations for use of the vaccine.
As soon as the Centers for Disease Control and Prevention’s director signs off on those recommendations, children can get the shots, perhaps as early as Nov. 3.
Pfizer’s vaccine for children is 10 micrograms, or one-third of the dose given to teens and adults. Kids get two doses of the vaccine 3 weeks apart. In clinical trials, the most common side effects were pain at the injection site, fatigue, and headache. These side effects were mild and disappeared quickly. There were no serious adverse events detected in the studies, which included about 3,100 children. In one study, the vaccine was 90% effective at preventing COVID-19 infections with symptoms in younger children.
There are about 28 million children in the United States between the ages of 5 and 12.
“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” Acting FDA Commissioner Janet Woodcock, MD, said in an FDA news release.
“Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards,” she said.
A version of this article first appeared on WebMD.com.
The move brings families with young children a step closer to resuming their normal activities, and it should help further slow transmission of the coronavirus virus in the United States.
States have already placed their orders for initial doses of the vaccines. The Oct. 29 FDA authorization triggers the shipment of millions of doses to pediatricians, family practice doctors, children’s hospitals, community health centers, and pharmacies.
Next, a panel of experts known as the Advisory Committee on Immunization Practices, or ACIP, will meet Nov. 2 to vote on recommendations for use of the vaccine.
As soon as the Centers for Disease Control and Prevention’s director signs off on those recommendations, children can get the shots, perhaps as early as Nov. 3.
Pfizer’s vaccine for children is 10 micrograms, or one-third of the dose given to teens and adults. Kids get two doses of the vaccine 3 weeks apart. In clinical trials, the most common side effects were pain at the injection site, fatigue, and headache. These side effects were mild and disappeared quickly. There were no serious adverse events detected in the studies, which included about 3,100 children. In one study, the vaccine was 90% effective at preventing COVID-19 infections with symptoms in younger children.
There are about 28 million children in the United States between the ages of 5 and 12.
“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” Acting FDA Commissioner Janet Woodcock, MD, said in an FDA news release.
“Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards,” she said.
A version of this article first appeared on WebMD.com.
The move brings families with young children a step closer to resuming their normal activities, and it should help further slow transmission of the coronavirus virus in the United States.
States have already placed their orders for initial doses of the vaccines. The Oct. 29 FDA authorization triggers the shipment of millions of doses to pediatricians, family practice doctors, children’s hospitals, community health centers, and pharmacies.
Next, a panel of experts known as the Advisory Committee on Immunization Practices, or ACIP, will meet Nov. 2 to vote on recommendations for use of the vaccine.
As soon as the Centers for Disease Control and Prevention’s director signs off on those recommendations, children can get the shots, perhaps as early as Nov. 3.
Pfizer’s vaccine for children is 10 micrograms, or one-third of the dose given to teens and adults. Kids get two doses of the vaccine 3 weeks apart. In clinical trials, the most common side effects were pain at the injection site, fatigue, and headache. These side effects were mild and disappeared quickly. There were no serious adverse events detected in the studies, which included about 3,100 children. In one study, the vaccine was 90% effective at preventing COVID-19 infections with symptoms in younger children.
There are about 28 million children in the United States between the ages of 5 and 12.
“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” Acting FDA Commissioner Janet Woodcock, MD, said in an FDA news release.
“Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards,” she said.
A version of this article first appeared on WebMD.com.
Antidepressant may cut COVID-19–related hospitalization, mortality: TOGETHER
The antidepressant fluvoxamine (Luvox) may prevent hospitalization and death in outpatients with COVID-19, new research suggests.
Results from the placebo-controlled, multisite, phase 3 TOGETHER trial showed that in COVID-19 outpatients at high risk for complications, hospitalizations were cut by 66% and deaths were reduced by 91% in those who tolerated fluvoxamine.
“Our trial has found that fluvoxamine, an inexpensive existing drug, reduces the need for advanced disease care in this high-risk population,” wrote the investigators, led by Gilmar Reis, MD, PhD, research division, Cardresearch, Belo Horizonte, Brazil.
The findings were published online Oct. 27 in The Lancet Global Health.
Alternative mechanisms
Fluvoxamine, a selective serotonin reuptake inhibitor (SSRI), is an antidepressant commonly prescribed for obsessive-compulsive disorder.
Besides its known effects on serotonin, the drug acts in other molecular pathways to dampen the production of inflammatory cytokines. Those alternative mechanisms are the ones believed to help patients with COVID-19, said coinvestigator Angela Reiersen, MD, child psychiatrist at Washington University, St. Louis.
Based on cell culture and mouse studies showing effects of the molecule’s binding to the sigma-1 receptor in the endoplasmic reticulum, Dr. Reiersen came up with the idea of testing if fluvoxamine could keep COVID-19 from progressing in newly infected patients.
Dr. Reiersen and psychiatrist Eric Lenze, MD, also from Washington University, led the phase 2 trial that initially suggested fluvoxamine’s promise as an outpatient medication. They are coinvestigators on the new phase 3 adaptive platform trial called TOGETHER, which was conducted by an international team of investigators in Brazil, Canada, and the United States.
For this latest study, researchers at McMaster University, Hamilton, Ont., partnered with the research clinic Cardresearch in Brazil to recruit unvaccinated, high-risk adults within 7 days of developing flu-like symptoms from COVID-19. They analyzed 1,497 newly symptomatic COVID-19 patients at 11 clinical sites in Brazil.
Patients entered the trial between January and August 2021 and were assigned to receive 100 mg fluvoxamine or placebo pills twice a day for 10 days. Investigators monitored participants through 28 days post treatment, noting whether complications developed requiring hospitalization or more than 6 hours of emergency care.
In the placebo group, 119 of 756 patients (15.7%) worsened to this extent. In comparison, 79 of 741 (10.7%) fluvoxamine-treated patients met these primary criteria. This represented a 32% reduction in hospitalizations and emergency visits.
Additional analysis requested
As Lancet Global Health reviewed these findings from the submitted manuscript, journal reviewers requested an additional “pre-protocol analysis” that was not specified in the trial’s original protocol. The request was to examine the subgroup of patients with good adherence (74% of treated group, 82% of placebo group).
Among these three quarters of patients who took at least 80% of their doses, benefits were better.
Fluvoxamine cut serious complications in this group by 66% and reduced mortality by 91%. In the placebo group, 12 people died compared with one who received the study drug.
from complications of the infection.
However, clinicians should note that the drug can cause side effects such as nausea, dizziness, and insomnia, she added. In addition, because it prevents the body from metabolizing caffeine, patients should limit their daily intake to half of a small cup of coffee or one can of soda or one tea while taking the drug.
Previous research has shown that fluvoxamine affects the metabolism of some drugs, such as theophylline, clozapine, olanzapine, and tizanidine.
Despite huge challenges with studying generic drugs as early COVID-19 treatment, the TOGETHER trial shows it is possible to produce quality evidence during a pandemic on a shoestring budget, noted co-principal investigator Edward Mills, PhD, professor in the department of health research methods, evidence, and impact at McMaster University.
To screen more than 12,000 patients and enroll 4,000 to test nine interventions, “our total budget was less than $8 million,” Dr. Mills said. The trial was funded by Fast Grants and the Rainwater Charitable Foundation.
‘A $10 medicine’
Commenting on the findings, David Boulware, MD, MPH, an infectious disease physician-researcher at the University of Minnesota in Minneapolis, noted fluvoxamine is “a $10 medicine that’s available and has a very good safety record.”
By comparison, a 5-day course of Merck’s antiviral molnupiravir, another oral drug that the company says can cut hospitalizations in COVID-19 outpatients, costs $700. However, the data have not been peer reviewed – and molnupiravir is not currently available and has unknown long-term safety implications, Dr. Boulware said.
Pharmaceutical companies typically spend tens of thousands of dollars on a trial evaluating a single drug, he noted.
In addition, the National Institutes of Health’s ACTIV-6 study, a nationwide trial on the effect of fluvoxamine and other repurposed generic drugs on thousands of COVID-19 outpatients, is a $110 million effort, according to Dr. Boulware, who cochairs its steering committee.
ACTIV-6 is currently enrolling outpatients with COVID-19 to test a lower dose of fluvoxamine, at 50 mg twice daily instead of the 100-mg dose used in the TOGETHER trial, as well as ivermectin and inhaled fluticasone. The COVID-OUT trial is also recruiting newly diagnosed COVID-19 patients to test various combinations of fluvoxamine, ivermectin, and the diabetes drug metformin.
Unanswered safety, efficacy questions
In an accompanying editorial in The Lancet Global Health, Otavio Berwanger, MD, cardiologist and clinical trialist, Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo, Brazil, commends the investigators for rapidly generating evidence during the COVID-19 pandemic.
However, despite the important findings, “some questions related to efficacy and safety of fluvoxamine for patients with COVID-19 remain open,” Dr. Berwanger wrote.
The effects of the drug on reducing both mortality and hospitalizations also “still need addressing,” he noted.
“In addition, it remains to be established whether fluvoxamine has an additive effect to other therapies such as monoclonal antibodies and budesonide, and what is the optimal fluvoxamine therapeutic scheme,” wrote Dr. Berwanger.
In an interview, he noted that 74% of the Brazil population have currently received at least one dose of a COVID-19 vaccine and 52% have received two doses. In addition, deaths have gone down from 4,000 per day during the March-April second wave to about 400 per day. “That is still unfortunate and far from ideal,” he said. In total, they have had about 600,000 deaths because of COVID-19.
Asked whether public health authorities are now recommending fluvoxamine as an early treatment for COVID-19 based on the TOGETHER trial data, Dr. Berwanger answered, “Not yet.
“I believe medical and scientific societies will need to critically appraise the manuscript in order to inform their decisions and recommendations. This interesting trial adds another important piece of information in this regard,” he said.
Dr. Reiersen and Dr. Lenze are inventors on a patent application related to methods for treating COVID-19, which was filed by Washington University. Dr. Mills reports no relevant financial relationships, as does Dr. Boulware – except that the TOGETHER trial funders are also funding the University of Minnesota COVID-OUT trial. Dr. Berwanger reports having received research grants outside of the submitted work that were paid to his institution by AstraZeneca, Bayer, Amgen, Servier, Novartis, Pfizer, and Boehringer Ingelheim.
A version of this article first appeared on Medscape.com.
The antidepressant fluvoxamine (Luvox) may prevent hospitalization and death in outpatients with COVID-19, new research suggests.
Results from the placebo-controlled, multisite, phase 3 TOGETHER trial showed that in COVID-19 outpatients at high risk for complications, hospitalizations were cut by 66% and deaths were reduced by 91% in those who tolerated fluvoxamine.
“Our trial has found that fluvoxamine, an inexpensive existing drug, reduces the need for advanced disease care in this high-risk population,” wrote the investigators, led by Gilmar Reis, MD, PhD, research division, Cardresearch, Belo Horizonte, Brazil.
The findings were published online Oct. 27 in The Lancet Global Health.
Alternative mechanisms
Fluvoxamine, a selective serotonin reuptake inhibitor (SSRI), is an antidepressant commonly prescribed for obsessive-compulsive disorder.
Besides its known effects on serotonin, the drug acts in other molecular pathways to dampen the production of inflammatory cytokines. Those alternative mechanisms are the ones believed to help patients with COVID-19, said coinvestigator Angela Reiersen, MD, child psychiatrist at Washington University, St. Louis.
Based on cell culture and mouse studies showing effects of the molecule’s binding to the sigma-1 receptor in the endoplasmic reticulum, Dr. Reiersen came up with the idea of testing if fluvoxamine could keep COVID-19 from progressing in newly infected patients.
Dr. Reiersen and psychiatrist Eric Lenze, MD, also from Washington University, led the phase 2 trial that initially suggested fluvoxamine’s promise as an outpatient medication. They are coinvestigators on the new phase 3 adaptive platform trial called TOGETHER, which was conducted by an international team of investigators in Brazil, Canada, and the United States.
For this latest study, researchers at McMaster University, Hamilton, Ont., partnered with the research clinic Cardresearch in Brazil to recruit unvaccinated, high-risk adults within 7 days of developing flu-like symptoms from COVID-19. They analyzed 1,497 newly symptomatic COVID-19 patients at 11 clinical sites in Brazil.
Patients entered the trial between January and August 2021 and were assigned to receive 100 mg fluvoxamine or placebo pills twice a day for 10 days. Investigators monitored participants through 28 days post treatment, noting whether complications developed requiring hospitalization or more than 6 hours of emergency care.
In the placebo group, 119 of 756 patients (15.7%) worsened to this extent. In comparison, 79 of 741 (10.7%) fluvoxamine-treated patients met these primary criteria. This represented a 32% reduction in hospitalizations and emergency visits.
Additional analysis requested
As Lancet Global Health reviewed these findings from the submitted manuscript, journal reviewers requested an additional “pre-protocol analysis” that was not specified in the trial’s original protocol. The request was to examine the subgroup of patients with good adherence (74% of treated group, 82% of placebo group).
Among these three quarters of patients who took at least 80% of their doses, benefits were better.
Fluvoxamine cut serious complications in this group by 66% and reduced mortality by 91%. In the placebo group, 12 people died compared with one who received the study drug.
from complications of the infection.
However, clinicians should note that the drug can cause side effects such as nausea, dizziness, and insomnia, she added. In addition, because it prevents the body from metabolizing caffeine, patients should limit their daily intake to half of a small cup of coffee or one can of soda or one tea while taking the drug.
Previous research has shown that fluvoxamine affects the metabolism of some drugs, such as theophylline, clozapine, olanzapine, and tizanidine.
Despite huge challenges with studying generic drugs as early COVID-19 treatment, the TOGETHER trial shows it is possible to produce quality evidence during a pandemic on a shoestring budget, noted co-principal investigator Edward Mills, PhD, professor in the department of health research methods, evidence, and impact at McMaster University.
To screen more than 12,000 patients and enroll 4,000 to test nine interventions, “our total budget was less than $8 million,” Dr. Mills said. The trial was funded by Fast Grants and the Rainwater Charitable Foundation.
‘A $10 medicine’
Commenting on the findings, David Boulware, MD, MPH, an infectious disease physician-researcher at the University of Minnesota in Minneapolis, noted fluvoxamine is “a $10 medicine that’s available and has a very good safety record.”
By comparison, a 5-day course of Merck’s antiviral molnupiravir, another oral drug that the company says can cut hospitalizations in COVID-19 outpatients, costs $700. However, the data have not been peer reviewed – and molnupiravir is not currently available and has unknown long-term safety implications, Dr. Boulware said.
Pharmaceutical companies typically spend tens of thousands of dollars on a trial evaluating a single drug, he noted.
In addition, the National Institutes of Health’s ACTIV-6 study, a nationwide trial on the effect of fluvoxamine and other repurposed generic drugs on thousands of COVID-19 outpatients, is a $110 million effort, according to Dr. Boulware, who cochairs its steering committee.
ACTIV-6 is currently enrolling outpatients with COVID-19 to test a lower dose of fluvoxamine, at 50 mg twice daily instead of the 100-mg dose used in the TOGETHER trial, as well as ivermectin and inhaled fluticasone. The COVID-OUT trial is also recruiting newly diagnosed COVID-19 patients to test various combinations of fluvoxamine, ivermectin, and the diabetes drug metformin.
Unanswered safety, efficacy questions
In an accompanying editorial in The Lancet Global Health, Otavio Berwanger, MD, cardiologist and clinical trialist, Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo, Brazil, commends the investigators for rapidly generating evidence during the COVID-19 pandemic.
However, despite the important findings, “some questions related to efficacy and safety of fluvoxamine for patients with COVID-19 remain open,” Dr. Berwanger wrote.
The effects of the drug on reducing both mortality and hospitalizations also “still need addressing,” he noted.
“In addition, it remains to be established whether fluvoxamine has an additive effect to other therapies such as monoclonal antibodies and budesonide, and what is the optimal fluvoxamine therapeutic scheme,” wrote Dr. Berwanger.
In an interview, he noted that 74% of the Brazil population have currently received at least one dose of a COVID-19 vaccine and 52% have received two doses. In addition, deaths have gone down from 4,000 per day during the March-April second wave to about 400 per day. “That is still unfortunate and far from ideal,” he said. In total, they have had about 600,000 deaths because of COVID-19.
Asked whether public health authorities are now recommending fluvoxamine as an early treatment for COVID-19 based on the TOGETHER trial data, Dr. Berwanger answered, “Not yet.
“I believe medical and scientific societies will need to critically appraise the manuscript in order to inform their decisions and recommendations. This interesting trial adds another important piece of information in this regard,” he said.
Dr. Reiersen and Dr. Lenze are inventors on a patent application related to methods for treating COVID-19, which was filed by Washington University. Dr. Mills reports no relevant financial relationships, as does Dr. Boulware – except that the TOGETHER trial funders are also funding the University of Minnesota COVID-OUT trial. Dr. Berwanger reports having received research grants outside of the submitted work that were paid to his institution by AstraZeneca, Bayer, Amgen, Servier, Novartis, Pfizer, and Boehringer Ingelheim.
A version of this article first appeared on Medscape.com.
The antidepressant fluvoxamine (Luvox) may prevent hospitalization and death in outpatients with COVID-19, new research suggests.
Results from the placebo-controlled, multisite, phase 3 TOGETHER trial showed that in COVID-19 outpatients at high risk for complications, hospitalizations were cut by 66% and deaths were reduced by 91% in those who tolerated fluvoxamine.
“Our trial has found that fluvoxamine, an inexpensive existing drug, reduces the need for advanced disease care in this high-risk population,” wrote the investigators, led by Gilmar Reis, MD, PhD, research division, Cardresearch, Belo Horizonte, Brazil.
The findings were published online Oct. 27 in The Lancet Global Health.
Alternative mechanisms
Fluvoxamine, a selective serotonin reuptake inhibitor (SSRI), is an antidepressant commonly prescribed for obsessive-compulsive disorder.
Besides its known effects on serotonin, the drug acts in other molecular pathways to dampen the production of inflammatory cytokines. Those alternative mechanisms are the ones believed to help patients with COVID-19, said coinvestigator Angela Reiersen, MD, child psychiatrist at Washington University, St. Louis.
Based on cell culture and mouse studies showing effects of the molecule’s binding to the sigma-1 receptor in the endoplasmic reticulum, Dr. Reiersen came up with the idea of testing if fluvoxamine could keep COVID-19 from progressing in newly infected patients.
Dr. Reiersen and psychiatrist Eric Lenze, MD, also from Washington University, led the phase 2 trial that initially suggested fluvoxamine’s promise as an outpatient medication. They are coinvestigators on the new phase 3 adaptive platform trial called TOGETHER, which was conducted by an international team of investigators in Brazil, Canada, and the United States.
For this latest study, researchers at McMaster University, Hamilton, Ont., partnered with the research clinic Cardresearch in Brazil to recruit unvaccinated, high-risk adults within 7 days of developing flu-like symptoms from COVID-19. They analyzed 1,497 newly symptomatic COVID-19 patients at 11 clinical sites in Brazil.
Patients entered the trial between January and August 2021 and were assigned to receive 100 mg fluvoxamine or placebo pills twice a day for 10 days. Investigators monitored participants through 28 days post treatment, noting whether complications developed requiring hospitalization or more than 6 hours of emergency care.
In the placebo group, 119 of 756 patients (15.7%) worsened to this extent. In comparison, 79 of 741 (10.7%) fluvoxamine-treated patients met these primary criteria. This represented a 32% reduction in hospitalizations and emergency visits.
Additional analysis requested
As Lancet Global Health reviewed these findings from the submitted manuscript, journal reviewers requested an additional “pre-protocol analysis” that was not specified in the trial’s original protocol. The request was to examine the subgroup of patients with good adherence (74% of treated group, 82% of placebo group).
Among these three quarters of patients who took at least 80% of their doses, benefits were better.
Fluvoxamine cut serious complications in this group by 66% and reduced mortality by 91%. In the placebo group, 12 people died compared with one who received the study drug.
from complications of the infection.
However, clinicians should note that the drug can cause side effects such as nausea, dizziness, and insomnia, she added. In addition, because it prevents the body from metabolizing caffeine, patients should limit their daily intake to half of a small cup of coffee or one can of soda or one tea while taking the drug.
Previous research has shown that fluvoxamine affects the metabolism of some drugs, such as theophylline, clozapine, olanzapine, and tizanidine.
Despite huge challenges with studying generic drugs as early COVID-19 treatment, the TOGETHER trial shows it is possible to produce quality evidence during a pandemic on a shoestring budget, noted co-principal investigator Edward Mills, PhD, professor in the department of health research methods, evidence, and impact at McMaster University.
To screen more than 12,000 patients and enroll 4,000 to test nine interventions, “our total budget was less than $8 million,” Dr. Mills said. The trial was funded by Fast Grants and the Rainwater Charitable Foundation.
‘A $10 medicine’
Commenting on the findings, David Boulware, MD, MPH, an infectious disease physician-researcher at the University of Minnesota in Minneapolis, noted fluvoxamine is “a $10 medicine that’s available and has a very good safety record.”
By comparison, a 5-day course of Merck’s antiviral molnupiravir, another oral drug that the company says can cut hospitalizations in COVID-19 outpatients, costs $700. However, the data have not been peer reviewed – and molnupiravir is not currently available and has unknown long-term safety implications, Dr. Boulware said.
Pharmaceutical companies typically spend tens of thousands of dollars on a trial evaluating a single drug, he noted.
In addition, the National Institutes of Health’s ACTIV-6 study, a nationwide trial on the effect of fluvoxamine and other repurposed generic drugs on thousands of COVID-19 outpatients, is a $110 million effort, according to Dr. Boulware, who cochairs its steering committee.
ACTIV-6 is currently enrolling outpatients with COVID-19 to test a lower dose of fluvoxamine, at 50 mg twice daily instead of the 100-mg dose used in the TOGETHER trial, as well as ivermectin and inhaled fluticasone. The COVID-OUT trial is also recruiting newly diagnosed COVID-19 patients to test various combinations of fluvoxamine, ivermectin, and the diabetes drug metformin.
Unanswered safety, efficacy questions
In an accompanying editorial in The Lancet Global Health, Otavio Berwanger, MD, cardiologist and clinical trialist, Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo, Brazil, commends the investigators for rapidly generating evidence during the COVID-19 pandemic.
However, despite the important findings, “some questions related to efficacy and safety of fluvoxamine for patients with COVID-19 remain open,” Dr. Berwanger wrote.
The effects of the drug on reducing both mortality and hospitalizations also “still need addressing,” he noted.
“In addition, it remains to be established whether fluvoxamine has an additive effect to other therapies such as monoclonal antibodies and budesonide, and what is the optimal fluvoxamine therapeutic scheme,” wrote Dr. Berwanger.
In an interview, he noted that 74% of the Brazil population have currently received at least one dose of a COVID-19 vaccine and 52% have received two doses. In addition, deaths have gone down from 4,000 per day during the March-April second wave to about 400 per day. “That is still unfortunate and far from ideal,” he said. In total, they have had about 600,000 deaths because of COVID-19.
Asked whether public health authorities are now recommending fluvoxamine as an early treatment for COVID-19 based on the TOGETHER trial data, Dr. Berwanger answered, “Not yet.
“I believe medical and scientific societies will need to critically appraise the manuscript in order to inform their decisions and recommendations. This interesting trial adds another important piece of information in this regard,” he said.
Dr. Reiersen and Dr. Lenze are inventors on a patent application related to methods for treating COVID-19, which was filed by Washington University. Dr. Mills reports no relevant financial relationships, as does Dr. Boulware – except that the TOGETHER trial funders are also funding the University of Minnesota COVID-OUT trial. Dr. Berwanger reports having received research grants outside of the submitted work that were paid to his institution by AstraZeneca, Bayer, Amgen, Servier, Novartis, Pfizer, and Boehringer Ingelheim.
A version of this article first appeared on Medscape.com.
In and out surgeries become the norm during pandemic
Urologist Ronney Abaza, MD, a robotic surgery specialist in Dublin, Ohio, and colleagues, reviewed robotic surgeries at their hospital during COVID-19 restrictions on surgery in Ohio between March 17 and June 5, 2020, and compared them with robotic procedures before COVID-19 and after restrictions were lifted. They published their results in Urology.
Since 2016, the hospital has offered the option of same-day discharge (SDD) to all robotic urologic surgery patients, regardless of procedure or patient-specific factors.
Among patients who had surgery during COVID-19 restrictions, 98% (87/89 patients) opted for SDD versus 52% in the group having surgery before the restrictions (P < .00001). After the COVID-19 surgery restrictions were lifted, the higher rate of SDD remained at 98%.
“There were no differences in 30-day complications or readmissions between SDD and overnight patients,” the authors write.
The right patient, the right motivation for successful surgery
Brian Lane, MD, PhD, a urologic oncologist with Spectrum Health in Grand Rapids, Michigan, told this news organization that, for nephrectomies, uptake of same-day discharge will continue to be slow.
“You have to have the right patient, the right patient motivation, and the surgery has to go smoothly,” he said. “If you start sending everyone home the same day, you will certainly see readmissions,” he said.
Dr. Lane is part of the Michigan Urologic Surgery Improvement Collaborative and he said the group recently looked at same-day discharge outcomes after robotic prostatectomies with SDD as compared with 1-2 nights in the hospital.
The work has not yet been published but, “There was a slight signal that there were increased readmissions with same-day discharge vs. 0-1 day,” he said.
A paper on outcomes of same-day discharge in total knee arthroplasty in the Journal of Bone & Joint Surgery found a higher risk of perioperative complications “including component failure, surgical site infection, knee stiffness, and deep vein thrombosis.” Researchers compared outcomes between 4,391 patients who underwent outpatient TKA and 128,951 patients who underwent inpatient TKA.
But for other many surgeries, same-day discharge numbers are increasing without worsening outcomes.
A paper in the Journal of Robotic Surgery found that same-day discharge following robotic-assisted endometrial cancer staging is “safe and feasible.”
Stephen Bradley, MD, MPH, with the Minneapolis Heart Institute in Minneapolis, and colleagues write in the Journal of the American College of Cardiology: Cardiovascular Interventions that they found a large increase in the use of same-day discharge after elective percutaneous coronary intervention (PCI) was not associated with worse 30-day mortality rates or readmission.
In that study, 114,461 patients were discharged the same day they underwent PCI. The proportion of patients who had a same-day discharge increased from 4.5% in 2009 to 28.6% in the fourth quarter of 2017.
Risk-adjusted 30-day mortality did not change in that time, while risk-adjusted rehospitalization decreased over time and more quickly when patients had same-day discharge.
Deepak L. Bhatt, MD, MPH, and Jonathan G. Sung, MBCHB, both of Brigham and Women’s Hospital Heart & Vascular Center, Harvard Medical School, Boston, wrote in an accompanying article that, “Advances in the devices and techniques of PCI have improved the safety and efficacy of the procedure. In selected patients, same-day discharge has become possible, and overnight in-hospital observation can be avoided. By reducing unnecessary hospital stays, both patients and hospitals could benefit.”
Evan Garden, a medical student at Icahn School of Medicine at Mount Sinai in New York, presented findings at the American Urological Association 2021 annual meeting that show patients selected for same-day discharge after partial or radical nephrectomy did not have increased rates of postoperative complications or readmissions in the immediate postoperative period, compared with standard discharge of 1-3 days.
Case studies in nephrectomy
While several case studies have looked at the feasibility and safety of performing partial and radical nephrectomy with same-day discharge in select cases, “this topic has not been addressed on a national level,” Mr. Garden said.
Few patients who have partial or radical nephrectomies have same-day discharges. The researchers found that fewer than 1% of patients who have either procedure in the sample studied were discharged the same day.
Researchers used the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database, a nationally representative deidentified database that prospectively tracks patient characteristics and 30-day perioperative outcomes for major inpatient and outpatient surgical procedures at more than 700 hospitals.
They extracted all minimally invasive partial and radical nephrectomies from 2012 to 2019 and refined the cohort to 28,140 patients who were theoretically eligible for same-day discharge: Of those, 237 (0.8%) had SSD, and 27,903 (99.2%) had a standard-length discharge (SLD).
The team found that there were no differences in 30-day complications or readmissions between same-day discharge (Clavien-Dindo [CD] I/II, 4.22%; CD III, 0%; CD IV, 1.27%; readmission, 4.64%); and SLD (CD I/II, 4.11%; CD III, 0.95%; CD IV, 0.79%; readmission, 3.90%; all P > .05).
Controlling for demographic and clinical variables, SDD was not associated with greater risk of 30-day complications or readmissions (CD I/II: odds ratio, 1.08; 95% confidence interval, 0.57-2.048; P = .813; CD IV: OR 1.699; 95% CI, 0.537-5.375; P = .367; readmission: OR, 1.254; 95% CI, 0.681-2.31; P = .467).
Mr. Garden and coauthors report no relevant financial relationships.
Dr. Lane reports no relevant financial relationships.
Urologist Ronney Abaza, MD, a robotic surgery specialist in Dublin, Ohio, and colleagues, reviewed robotic surgeries at their hospital during COVID-19 restrictions on surgery in Ohio between March 17 and June 5, 2020, and compared them with robotic procedures before COVID-19 and after restrictions were lifted. They published their results in Urology.
Since 2016, the hospital has offered the option of same-day discharge (SDD) to all robotic urologic surgery patients, regardless of procedure or patient-specific factors.
Among patients who had surgery during COVID-19 restrictions, 98% (87/89 patients) opted for SDD versus 52% in the group having surgery before the restrictions (P < .00001). After the COVID-19 surgery restrictions were lifted, the higher rate of SDD remained at 98%.
“There were no differences in 30-day complications or readmissions between SDD and overnight patients,” the authors write.
The right patient, the right motivation for successful surgery
Brian Lane, MD, PhD, a urologic oncologist with Spectrum Health in Grand Rapids, Michigan, told this news organization that, for nephrectomies, uptake of same-day discharge will continue to be slow.
“You have to have the right patient, the right patient motivation, and the surgery has to go smoothly,” he said. “If you start sending everyone home the same day, you will certainly see readmissions,” he said.
Dr. Lane is part of the Michigan Urologic Surgery Improvement Collaborative and he said the group recently looked at same-day discharge outcomes after robotic prostatectomies with SDD as compared with 1-2 nights in the hospital.
The work has not yet been published but, “There was a slight signal that there were increased readmissions with same-day discharge vs. 0-1 day,” he said.
A paper on outcomes of same-day discharge in total knee arthroplasty in the Journal of Bone & Joint Surgery found a higher risk of perioperative complications “including component failure, surgical site infection, knee stiffness, and deep vein thrombosis.” Researchers compared outcomes between 4,391 patients who underwent outpatient TKA and 128,951 patients who underwent inpatient TKA.
But for other many surgeries, same-day discharge numbers are increasing without worsening outcomes.
A paper in the Journal of Robotic Surgery found that same-day discharge following robotic-assisted endometrial cancer staging is “safe and feasible.”
Stephen Bradley, MD, MPH, with the Minneapolis Heart Institute in Minneapolis, and colleagues write in the Journal of the American College of Cardiology: Cardiovascular Interventions that they found a large increase in the use of same-day discharge after elective percutaneous coronary intervention (PCI) was not associated with worse 30-day mortality rates or readmission.
In that study, 114,461 patients were discharged the same day they underwent PCI. The proportion of patients who had a same-day discharge increased from 4.5% in 2009 to 28.6% in the fourth quarter of 2017.
Risk-adjusted 30-day mortality did not change in that time, while risk-adjusted rehospitalization decreased over time and more quickly when patients had same-day discharge.
Deepak L. Bhatt, MD, MPH, and Jonathan G. Sung, MBCHB, both of Brigham and Women’s Hospital Heart & Vascular Center, Harvard Medical School, Boston, wrote in an accompanying article that, “Advances in the devices and techniques of PCI have improved the safety and efficacy of the procedure. In selected patients, same-day discharge has become possible, and overnight in-hospital observation can be avoided. By reducing unnecessary hospital stays, both patients and hospitals could benefit.”
Evan Garden, a medical student at Icahn School of Medicine at Mount Sinai in New York, presented findings at the American Urological Association 2021 annual meeting that show patients selected for same-day discharge after partial or radical nephrectomy did not have increased rates of postoperative complications or readmissions in the immediate postoperative period, compared with standard discharge of 1-3 days.
Case studies in nephrectomy
While several case studies have looked at the feasibility and safety of performing partial and radical nephrectomy with same-day discharge in select cases, “this topic has not been addressed on a national level,” Mr. Garden said.
Few patients who have partial or radical nephrectomies have same-day discharges. The researchers found that fewer than 1% of patients who have either procedure in the sample studied were discharged the same day.
Researchers used the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database, a nationally representative deidentified database that prospectively tracks patient characteristics and 30-day perioperative outcomes for major inpatient and outpatient surgical procedures at more than 700 hospitals.
They extracted all minimally invasive partial and radical nephrectomies from 2012 to 2019 and refined the cohort to 28,140 patients who were theoretically eligible for same-day discharge: Of those, 237 (0.8%) had SSD, and 27,903 (99.2%) had a standard-length discharge (SLD).
The team found that there were no differences in 30-day complications or readmissions between same-day discharge (Clavien-Dindo [CD] I/II, 4.22%; CD III, 0%; CD IV, 1.27%; readmission, 4.64%); and SLD (CD I/II, 4.11%; CD III, 0.95%; CD IV, 0.79%; readmission, 3.90%; all P > .05).
Controlling for demographic and clinical variables, SDD was not associated with greater risk of 30-day complications or readmissions (CD I/II: odds ratio, 1.08; 95% confidence interval, 0.57-2.048; P = .813; CD IV: OR 1.699; 95% CI, 0.537-5.375; P = .367; readmission: OR, 1.254; 95% CI, 0.681-2.31; P = .467).
Mr. Garden and coauthors report no relevant financial relationships.
Dr. Lane reports no relevant financial relationships.
Urologist Ronney Abaza, MD, a robotic surgery specialist in Dublin, Ohio, and colleagues, reviewed robotic surgeries at their hospital during COVID-19 restrictions on surgery in Ohio between March 17 and June 5, 2020, and compared them with robotic procedures before COVID-19 and after restrictions were lifted. They published their results in Urology.
Since 2016, the hospital has offered the option of same-day discharge (SDD) to all robotic urologic surgery patients, regardless of procedure or patient-specific factors.
Among patients who had surgery during COVID-19 restrictions, 98% (87/89 patients) opted for SDD versus 52% in the group having surgery before the restrictions (P < .00001). After the COVID-19 surgery restrictions were lifted, the higher rate of SDD remained at 98%.
“There were no differences in 30-day complications or readmissions between SDD and overnight patients,” the authors write.
The right patient, the right motivation for successful surgery
Brian Lane, MD, PhD, a urologic oncologist with Spectrum Health in Grand Rapids, Michigan, told this news organization that, for nephrectomies, uptake of same-day discharge will continue to be slow.
“You have to have the right patient, the right patient motivation, and the surgery has to go smoothly,” he said. “If you start sending everyone home the same day, you will certainly see readmissions,” he said.
Dr. Lane is part of the Michigan Urologic Surgery Improvement Collaborative and he said the group recently looked at same-day discharge outcomes after robotic prostatectomies with SDD as compared with 1-2 nights in the hospital.
The work has not yet been published but, “There was a slight signal that there were increased readmissions with same-day discharge vs. 0-1 day,” he said.
A paper on outcomes of same-day discharge in total knee arthroplasty in the Journal of Bone & Joint Surgery found a higher risk of perioperative complications “including component failure, surgical site infection, knee stiffness, and deep vein thrombosis.” Researchers compared outcomes between 4,391 patients who underwent outpatient TKA and 128,951 patients who underwent inpatient TKA.
But for other many surgeries, same-day discharge numbers are increasing without worsening outcomes.
A paper in the Journal of Robotic Surgery found that same-day discharge following robotic-assisted endometrial cancer staging is “safe and feasible.”
Stephen Bradley, MD, MPH, with the Minneapolis Heart Institute in Minneapolis, and colleagues write in the Journal of the American College of Cardiology: Cardiovascular Interventions that they found a large increase in the use of same-day discharge after elective percutaneous coronary intervention (PCI) was not associated with worse 30-day mortality rates or readmission.
In that study, 114,461 patients were discharged the same day they underwent PCI. The proportion of patients who had a same-day discharge increased from 4.5% in 2009 to 28.6% in the fourth quarter of 2017.
Risk-adjusted 30-day mortality did not change in that time, while risk-adjusted rehospitalization decreased over time and more quickly when patients had same-day discharge.
Deepak L. Bhatt, MD, MPH, and Jonathan G. Sung, MBCHB, both of Brigham and Women’s Hospital Heart & Vascular Center, Harvard Medical School, Boston, wrote in an accompanying article that, “Advances in the devices and techniques of PCI have improved the safety and efficacy of the procedure. In selected patients, same-day discharge has become possible, and overnight in-hospital observation can be avoided. By reducing unnecessary hospital stays, both patients and hospitals could benefit.”
Evan Garden, a medical student at Icahn School of Medicine at Mount Sinai in New York, presented findings at the American Urological Association 2021 annual meeting that show patients selected for same-day discharge after partial or radical nephrectomy did not have increased rates of postoperative complications or readmissions in the immediate postoperative period, compared with standard discharge of 1-3 days.
Case studies in nephrectomy
While several case studies have looked at the feasibility and safety of performing partial and radical nephrectomy with same-day discharge in select cases, “this topic has not been addressed on a national level,” Mr. Garden said.
Few patients who have partial or radical nephrectomies have same-day discharges. The researchers found that fewer than 1% of patients who have either procedure in the sample studied were discharged the same day.
Researchers used the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database, a nationally representative deidentified database that prospectively tracks patient characteristics and 30-day perioperative outcomes for major inpatient and outpatient surgical procedures at more than 700 hospitals.
They extracted all minimally invasive partial and radical nephrectomies from 2012 to 2019 and refined the cohort to 28,140 patients who were theoretically eligible for same-day discharge: Of those, 237 (0.8%) had SSD, and 27,903 (99.2%) had a standard-length discharge (SLD).
The team found that there were no differences in 30-day complications or readmissions between same-day discharge (Clavien-Dindo [CD] I/II, 4.22%; CD III, 0%; CD IV, 1.27%; readmission, 4.64%); and SLD (CD I/II, 4.11%; CD III, 0.95%; CD IV, 0.79%; readmission, 3.90%; all P > .05).
Controlling for demographic and clinical variables, SDD was not associated with greater risk of 30-day complications or readmissions (CD I/II: odds ratio, 1.08; 95% confidence interval, 0.57-2.048; P = .813; CD IV: OR 1.699; 95% CI, 0.537-5.375; P = .367; readmission: OR, 1.254; 95% CI, 0.681-2.31; P = .467).
Mr. Garden and coauthors report no relevant financial relationships.
Dr. Lane reports no relevant financial relationships.
AHA/ACC issues first comprehensive guidance on chest pain
Clinicians should use standardized risk assessments, clinical pathways, and tools to evaluate and communicate with patients who present with chest pain (angina), advises a joint clinical practice guideline released by American Heart Association and American College of Cardiology.
While evaluation of chest pain has been covered in previous guidelines, this is the first comprehensive guideline from the AHA and ACC focused exclusively on the evaluation and diagnosis of chest pain.
“As our imaging technologies have evolved, we needed a contemporary approach to which patients need further testing, and which do not, in addition to what testing is effective,” Martha Gulati, MD, University of Arizona, Phoenix, and chair of the guideline writing group, said in an interview.
“Our hope is that we have provided an evidence-based approach to evaluating patients that will assist all of us who manage, diagnose, and treat patients who experience chest pain,” said Dr. Gulati, who is also president-elect of the American Society for Preventive Cardiology.
The guideline was simultaneously published online Oct. 28, 2021, in Circulation and the Journal of the American College of Cardiology.
‘Atypical’ is out, ‘noncardiac’ is in
Each year, chest pain sends more than 6.5 million adults to the ED and more than 4 million to outpatient clinics in the United States.
Yet, among all patients who come to the ED, only 5% will have acute coronary syndrome (ACS). More than half will ultimately have a noncardiac reason for their chest pain, including respiratory, musculoskeletal, gastrointestinal, psychological, or other causes.
The guideline says evaluating the severity and the cause of chest pain is essential and advises using standard risk assessments to determine if a patient is at low, intermediate, or high risk for having a cardiac event.
“I hope clinicians take from our guidelines the understanding that low-risk patients often do not need additional testing. And if we communicate this effectively with our patients – incorporating shared decision-making into our practice – we can reduce ‘overtesting’ in low-risk patients,” Dr. Gulati said in an interview.
The guideline notes that women are unique when presenting with ACS symptoms. While chest pain is the dominant and most common symptom for both men and women, women may be more likely to also have symptoms such as nausea and shortness of breath.
The guideline also encourages using the term “noncardiac” if heart disease is not suspected in a patient with angina and says the term “atypical” is a “misleading” descriptor of chest pain and should not be used.
“Words matter, and we need to move away from describing chest pain as ‘atypical’ because it has resulted in confusion when these words are used,” Dr. Gulati stressed.
“Rather than meaning a different way of presenting, it has taken on a meaning to imply it is not cardiac. It is more useful to talk about the probability of the pain being cardiac vs noncardiac,” Dr. Gulati explained.
No one best test for everyone
There is also a focus on evaluation of patients with chest pain who present to the ED. The initial goals of ED physicians should be to identify if there are life-threatening causes and to determine if there is a need for hospital admission or testing, the guideline states.
Thorough screening in the ED may help determine who is at high risk versus intermediate or low risk for a cardiac event. An individual deemed to be at low risk may be referred for additional evaluation in an outpatient setting rather than being admitted to the hospital, the authors wrote.
High-sensitivity cardiac troponins are the “preferred standard” for establishing a biomarker diagnosis of acute myocardial infarction, allowing for more accurate detection and exclusion of myocardial injury, they added.
“While there is no one ‘best test’ for every patient, the guideline emphasizes the tests that may be most appropriate, depending on the individual situation, and which ones won’t provide additional information; therefore, these tests should not be done just for the sake of doing them,” Dr. Gulati said in a news release.
“Appropriate testing is also dependent upon the technology and screening devices that are available at the hospital or healthcare center where the patient is receiving care. All imaging modalities highlighted in the guideline have an important role in the assessment of chest pain to help determine the underlying cause, with the goal of preventing a serious cardiac event,” Dr. Gulati added.
The guideline was prepared on behalf of and approved by the AHA and ACC Joint Committee on Clinical Practice Guidelines.
Five other partnering organizations participated in and approved the guideline: the American Society of Echocardiography, the American College of Chest Physicians, the Society for Academic Emergency Medicine, the Society of Cardiovascular Computed Tomography, and the Society for Cardiovascular Magnetic Resonance.
The writing group included representatives from each of the partnering organizations and experts in the field (cardiac intensivists, cardiac interventionalists, cardiac surgeons, cardiologists, emergency physicians, and epidemiologists), as well as a lay/patient representative.
The research had no commercial funding.
A version of this article first appeared on Medscape.com.
Clinicians should use standardized risk assessments, clinical pathways, and tools to evaluate and communicate with patients who present with chest pain (angina), advises a joint clinical practice guideline released by American Heart Association and American College of Cardiology.
While evaluation of chest pain has been covered in previous guidelines, this is the first comprehensive guideline from the AHA and ACC focused exclusively on the evaluation and diagnosis of chest pain.
“As our imaging technologies have evolved, we needed a contemporary approach to which patients need further testing, and which do not, in addition to what testing is effective,” Martha Gulati, MD, University of Arizona, Phoenix, and chair of the guideline writing group, said in an interview.
“Our hope is that we have provided an evidence-based approach to evaluating patients that will assist all of us who manage, diagnose, and treat patients who experience chest pain,” said Dr. Gulati, who is also president-elect of the American Society for Preventive Cardiology.
The guideline was simultaneously published online Oct. 28, 2021, in Circulation and the Journal of the American College of Cardiology.
‘Atypical’ is out, ‘noncardiac’ is in
Each year, chest pain sends more than 6.5 million adults to the ED and more than 4 million to outpatient clinics in the United States.
Yet, among all patients who come to the ED, only 5% will have acute coronary syndrome (ACS). More than half will ultimately have a noncardiac reason for their chest pain, including respiratory, musculoskeletal, gastrointestinal, psychological, or other causes.
The guideline says evaluating the severity and the cause of chest pain is essential and advises using standard risk assessments to determine if a patient is at low, intermediate, or high risk for having a cardiac event.
“I hope clinicians take from our guidelines the understanding that low-risk patients often do not need additional testing. And if we communicate this effectively with our patients – incorporating shared decision-making into our practice – we can reduce ‘overtesting’ in low-risk patients,” Dr. Gulati said in an interview.
The guideline notes that women are unique when presenting with ACS symptoms. While chest pain is the dominant and most common symptom for both men and women, women may be more likely to also have symptoms such as nausea and shortness of breath.
The guideline also encourages using the term “noncardiac” if heart disease is not suspected in a patient with angina and says the term “atypical” is a “misleading” descriptor of chest pain and should not be used.
“Words matter, and we need to move away from describing chest pain as ‘atypical’ because it has resulted in confusion when these words are used,” Dr. Gulati stressed.
“Rather than meaning a different way of presenting, it has taken on a meaning to imply it is not cardiac. It is more useful to talk about the probability of the pain being cardiac vs noncardiac,” Dr. Gulati explained.
No one best test for everyone
There is also a focus on evaluation of patients with chest pain who present to the ED. The initial goals of ED physicians should be to identify if there are life-threatening causes and to determine if there is a need for hospital admission or testing, the guideline states.
Thorough screening in the ED may help determine who is at high risk versus intermediate or low risk for a cardiac event. An individual deemed to be at low risk may be referred for additional evaluation in an outpatient setting rather than being admitted to the hospital, the authors wrote.
High-sensitivity cardiac troponins are the “preferred standard” for establishing a biomarker diagnosis of acute myocardial infarction, allowing for more accurate detection and exclusion of myocardial injury, they added.
“While there is no one ‘best test’ for every patient, the guideline emphasizes the tests that may be most appropriate, depending on the individual situation, and which ones won’t provide additional information; therefore, these tests should not be done just for the sake of doing them,” Dr. Gulati said in a news release.
“Appropriate testing is also dependent upon the technology and screening devices that are available at the hospital or healthcare center where the patient is receiving care. All imaging modalities highlighted in the guideline have an important role in the assessment of chest pain to help determine the underlying cause, with the goal of preventing a serious cardiac event,” Dr. Gulati added.
The guideline was prepared on behalf of and approved by the AHA and ACC Joint Committee on Clinical Practice Guidelines.
Five other partnering organizations participated in and approved the guideline: the American Society of Echocardiography, the American College of Chest Physicians, the Society for Academic Emergency Medicine, the Society of Cardiovascular Computed Tomography, and the Society for Cardiovascular Magnetic Resonance.
The writing group included representatives from each of the partnering organizations and experts in the field (cardiac intensivists, cardiac interventionalists, cardiac surgeons, cardiologists, emergency physicians, and epidemiologists), as well as a lay/patient representative.
The research had no commercial funding.
A version of this article first appeared on Medscape.com.
Clinicians should use standardized risk assessments, clinical pathways, and tools to evaluate and communicate with patients who present with chest pain (angina), advises a joint clinical practice guideline released by American Heart Association and American College of Cardiology.
While evaluation of chest pain has been covered in previous guidelines, this is the first comprehensive guideline from the AHA and ACC focused exclusively on the evaluation and diagnosis of chest pain.
“As our imaging technologies have evolved, we needed a contemporary approach to which patients need further testing, and which do not, in addition to what testing is effective,” Martha Gulati, MD, University of Arizona, Phoenix, and chair of the guideline writing group, said in an interview.
“Our hope is that we have provided an evidence-based approach to evaluating patients that will assist all of us who manage, diagnose, and treat patients who experience chest pain,” said Dr. Gulati, who is also president-elect of the American Society for Preventive Cardiology.
The guideline was simultaneously published online Oct. 28, 2021, in Circulation and the Journal of the American College of Cardiology.
‘Atypical’ is out, ‘noncardiac’ is in
Each year, chest pain sends more than 6.5 million adults to the ED and more than 4 million to outpatient clinics in the United States.
Yet, among all patients who come to the ED, only 5% will have acute coronary syndrome (ACS). More than half will ultimately have a noncardiac reason for their chest pain, including respiratory, musculoskeletal, gastrointestinal, psychological, or other causes.
The guideline says evaluating the severity and the cause of chest pain is essential and advises using standard risk assessments to determine if a patient is at low, intermediate, or high risk for having a cardiac event.
“I hope clinicians take from our guidelines the understanding that low-risk patients often do not need additional testing. And if we communicate this effectively with our patients – incorporating shared decision-making into our practice – we can reduce ‘overtesting’ in low-risk patients,” Dr. Gulati said in an interview.
The guideline notes that women are unique when presenting with ACS symptoms. While chest pain is the dominant and most common symptom for both men and women, women may be more likely to also have symptoms such as nausea and shortness of breath.
The guideline also encourages using the term “noncardiac” if heart disease is not suspected in a patient with angina and says the term “atypical” is a “misleading” descriptor of chest pain and should not be used.
“Words matter, and we need to move away from describing chest pain as ‘atypical’ because it has resulted in confusion when these words are used,” Dr. Gulati stressed.
“Rather than meaning a different way of presenting, it has taken on a meaning to imply it is not cardiac. It is more useful to talk about the probability of the pain being cardiac vs noncardiac,” Dr. Gulati explained.
No one best test for everyone
There is also a focus on evaluation of patients with chest pain who present to the ED. The initial goals of ED physicians should be to identify if there are life-threatening causes and to determine if there is a need for hospital admission or testing, the guideline states.
Thorough screening in the ED may help determine who is at high risk versus intermediate or low risk for a cardiac event. An individual deemed to be at low risk may be referred for additional evaluation in an outpatient setting rather than being admitted to the hospital, the authors wrote.
High-sensitivity cardiac troponins are the “preferred standard” for establishing a biomarker diagnosis of acute myocardial infarction, allowing for more accurate detection and exclusion of myocardial injury, they added.
“While there is no one ‘best test’ for every patient, the guideline emphasizes the tests that may be most appropriate, depending on the individual situation, and which ones won’t provide additional information; therefore, these tests should not be done just for the sake of doing them,” Dr. Gulati said in a news release.
“Appropriate testing is also dependent upon the technology and screening devices that are available at the hospital or healthcare center where the patient is receiving care. All imaging modalities highlighted in the guideline have an important role in the assessment of chest pain to help determine the underlying cause, with the goal of preventing a serious cardiac event,” Dr. Gulati added.
The guideline was prepared on behalf of and approved by the AHA and ACC Joint Committee on Clinical Practice Guidelines.
Five other partnering organizations participated in and approved the guideline: the American Society of Echocardiography, the American College of Chest Physicians, the Society for Academic Emergency Medicine, the Society of Cardiovascular Computed Tomography, and the Society for Cardiovascular Magnetic Resonance.
The writing group included representatives from each of the partnering organizations and experts in the field (cardiac intensivists, cardiac interventionalists, cardiac surgeons, cardiologists, emergency physicians, and epidemiologists), as well as a lay/patient representative.
The research had no commercial funding.
A version of this article first appeared on Medscape.com.
FDA panel votes to approve Pfizer’s vaccine for children
Seventeen of the 18 members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Oct. 26 voted to recommend the 10-microgram shot for kids, which is one-third the dose given to adults.
One member, Michael Kurilla, MD, director of the division of clinical innovation at the National Institutes of Health, Bethesda, Md., abstained from voting.
If the FDA follows the recommendation, as it typically does, and issues an Emergency Use Authorization for the vaccine, the shots could be available within days.
After the FDA’s final decision, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make specific recommendations for its use. The CDC committee must stick closely to the conditions for use spelled out in the EUA, so their recommendations are likely to be similar to those made by the FDA. Their next meeting is scheduled for Nov. 2 and 3.
In the end, some on the panel felt uneasy with their decision.
“I voted yes primarily because I wanted to make sure that children who really need this vaccine, the Black and brown children of our country, get the vaccine,” said James Hildreth, MD, PhD, president and CEO of Meharry Medical College in Nashville.
“But to be honest, the best way to protect the health of some children will be to do nothing because they will be just fine,” he said.
Others said they were surprised by how difficult the decision had been.
“This is a much tougher one than we had expected going into it,” said committee member Eric Rubin, MD, editor and chief of the New England Journal of Medicine, during the FDA advisory committee’s meeting.
Ahead of the vote, the committee heard presentations outlining the expected benefits of vaccinating children along with potential risks.
“Children have been greatly impacted by the pandemic,” said Fiona Havers, MD, a medical officer with the CDC in Atlanta who reviewed the epidemiology of COVID-19 in kids.
In the second year of the pandemic, as more seniors have been vaccinated against the virus, COVID cases have largely shifted from older to younger age groups.
So far, there have been more than 1.9 million COVID-19 cases in children ages 5 through 11 in the United States.. Cases in kids saw a big jump in July and August with summer travel, schools reopening, and the dominance of the Delta variant.
And those are just the cases reported to the CDC. Regular testing of anonymous blood samples collected at sites across the United States indicates that 6 times as many kids have had COVID than what is reflected in official counts.
Last winter, blood sample testing showed about 13% of children had antibodies against the virus, suggesting they’d been infected. By this summer, that number had risen to 42%.
That figure clearly made an impression on many members of the committee who asked the FDA’s vaccine reviewers if they had tried to account for immunity from past infections in their modeling. They had not.
Some felt that even with a highly effective vaccine — new data presented by Pfizer showed the children’s dose was 90% effective at preventing symptomatic infections in kids — caution was warranted as much is still unknown about myocarditis, a rare side effect of the mRNA vaccines.
Myocarditis has been more common in younger age groups. It usually goes away over time but requires hospital care. It’s not known if myocarditis could have lingering effects for those who experience it.
There were no cases of myocarditis seen in Pfizer’s studies of the vaccine in children, and no other serious events were seen. Vaccine side effects reported in the Pfizer studies were mostly mild and included fatigue, headache, and pain at the injection site.
“We think we have optimized the immune response and minimized our reactions,” said William Gruber, MD, senior vice president vaccine research and clinical development at Pfizer.
But the studies didn’t include enough participants to pick up rare, but serious adverse events like myocarditis.
“We’re worried about a side effect that we can’t measure yet, but it’s probably real, and we see a benefit that isn’t the same as it is in older age groups,” said Dr. Rubin.
Benefits vs. risks
FDA modeled the benefits and risks for children under a variety of scenarios. The benefits of the vaccines to children very much depend on the amount of transmission in the community.
When transmission is high, the benefits to children — in terms of infections, hospitalizations, ICU admissions — clearly outweigh its risks.
But when COVID-19 rates are low in the community, as they were in June, FDA analysts predicted the vaccines might send more children to the hospital for myocarditis than the virus would.
The FDA noted that kids who are hospitalized for myocarditis tend not to be as ill as children with COVID-19, however.
“If the trends continue the way they are going, the emergency for children is not what we might think it would be. That was my concern,” Dr. Hildreth said.
But others warned against complacency.
“Thinking that this is going to be the end of the wave permanently may be a little overly optimistic,” said committee chairman Arnold Monto, MD, a professor of public health and epidemiology at the University of Michigan, Ann Arbor.
The majority of COVID-19 cases in children are mild. Only about 1% of kids are hospitalized for their infections, according to CDC data. But the rates of hospitalizations in kids are about 3 times higher for people of color — including Blacks, Hispanics, and Native Americans, as compared to Whites and Asian Americans.
Since the start of the pandemic, 94 children ages 5 to 11 have died, making it the eighth leading cause of death for kids this age last year.
More than 5,200 children have developed a delayed complication from their infections called Multi-System Inflammatory Syndrome (MIS-C).
MIS-C can be severe and require hospital care and can lead to myocarditis. Children ages 5 to 11 are the age group at greatest risk for this complication.
Kids can also get long COVID. There’s not a lot of data on how often this happens, though it appears to be less frequent in children than in adults.
But a survey in the United Kingdom found that 7%-8% of kids have symptoms from their infections that last longer than 12 weeks, Dr. Havers said. Symptoms that can linger for kids include fatigue, cough, muscle and joint pain, headaches, and insomnia.
More than 1 million children have been impacted by school closures so far this year, and quarantines have had lasting impacts on learning, social development, and mental health.
Even though kids aren’t usually COVID superspreaders, they can still pass the infection on to others.
“What is clear is that secondary transmission from children, both to other children and to adults, does occur,” Dr. Havers said.
For that reason, they can continue the spread of the virus and give it opportunities to mutate and become more dangerous.
Safety monitoring to continue
Some committee members referenced thousands of letters they had received within the past few days urging them to vote against the vaccine.
Jay Portnoy, MD, a professor of pediatrics at Children’s Mercy Hospital in Kansas City, Mo., said he had personally received about 4,000 emails.
“But I feel like I need to also represent the consumers, the parents that I see every day in the clinic who are terrified of sending their children to school because they’re not protected against COVID,” he said, explaining his vote to recommend authorization.
“Our kids are going to be dealing with this virus for many years to come. It’s going to come repeatedly. Getting this vaccine is just the first step that they can take to protect themselves from having bad outcomes,” Dr. Portnoy said.
Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, reminded members of the committee that there were several government surveillance systems in place to catch any potential safety issues in near real time.
“I really appreciate very much the concern here. The safety monitoring of this vaccine will continue,” Dr. Marks said. “I do view this as one of our greatest responsibilities.”
“I really am so grateful that we had this discussion and voted to approve,” said Capt. Amanda Cohn, MD, chief medical officer at the National Center for Immunization and Respiratory Diseases.
“I think the benefits in this age group really are super important even if they are lower than for other age groups.”
This article was updated 10/27/21.
A version of this article first appeared on WebMD.com.
Seventeen of the 18 members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Oct. 26 voted to recommend the 10-microgram shot for kids, which is one-third the dose given to adults.
One member, Michael Kurilla, MD, director of the division of clinical innovation at the National Institutes of Health, Bethesda, Md., abstained from voting.
If the FDA follows the recommendation, as it typically does, and issues an Emergency Use Authorization for the vaccine, the shots could be available within days.
After the FDA’s final decision, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make specific recommendations for its use. The CDC committee must stick closely to the conditions for use spelled out in the EUA, so their recommendations are likely to be similar to those made by the FDA. Their next meeting is scheduled for Nov. 2 and 3.
In the end, some on the panel felt uneasy with their decision.
“I voted yes primarily because I wanted to make sure that children who really need this vaccine, the Black and brown children of our country, get the vaccine,” said James Hildreth, MD, PhD, president and CEO of Meharry Medical College in Nashville.
“But to be honest, the best way to protect the health of some children will be to do nothing because they will be just fine,” he said.
Others said they were surprised by how difficult the decision had been.
“This is a much tougher one than we had expected going into it,” said committee member Eric Rubin, MD, editor and chief of the New England Journal of Medicine, during the FDA advisory committee’s meeting.
Ahead of the vote, the committee heard presentations outlining the expected benefits of vaccinating children along with potential risks.
“Children have been greatly impacted by the pandemic,” said Fiona Havers, MD, a medical officer with the CDC in Atlanta who reviewed the epidemiology of COVID-19 in kids.
In the second year of the pandemic, as more seniors have been vaccinated against the virus, COVID cases have largely shifted from older to younger age groups.
So far, there have been more than 1.9 million COVID-19 cases in children ages 5 through 11 in the United States.. Cases in kids saw a big jump in July and August with summer travel, schools reopening, and the dominance of the Delta variant.
And those are just the cases reported to the CDC. Regular testing of anonymous blood samples collected at sites across the United States indicates that 6 times as many kids have had COVID than what is reflected in official counts.
Last winter, blood sample testing showed about 13% of children had antibodies against the virus, suggesting they’d been infected. By this summer, that number had risen to 42%.
That figure clearly made an impression on many members of the committee who asked the FDA’s vaccine reviewers if they had tried to account for immunity from past infections in their modeling. They had not.
Some felt that even with a highly effective vaccine — new data presented by Pfizer showed the children’s dose was 90% effective at preventing symptomatic infections in kids — caution was warranted as much is still unknown about myocarditis, a rare side effect of the mRNA vaccines.
Myocarditis has been more common in younger age groups. It usually goes away over time but requires hospital care. It’s not known if myocarditis could have lingering effects for those who experience it.
There were no cases of myocarditis seen in Pfizer’s studies of the vaccine in children, and no other serious events were seen. Vaccine side effects reported in the Pfizer studies were mostly mild and included fatigue, headache, and pain at the injection site.
“We think we have optimized the immune response and minimized our reactions,” said William Gruber, MD, senior vice president vaccine research and clinical development at Pfizer.
But the studies didn’t include enough participants to pick up rare, but serious adverse events like myocarditis.
“We’re worried about a side effect that we can’t measure yet, but it’s probably real, and we see a benefit that isn’t the same as it is in older age groups,” said Dr. Rubin.
Benefits vs. risks
FDA modeled the benefits and risks for children under a variety of scenarios. The benefits of the vaccines to children very much depend on the amount of transmission in the community.
When transmission is high, the benefits to children — in terms of infections, hospitalizations, ICU admissions — clearly outweigh its risks.
But when COVID-19 rates are low in the community, as they were in June, FDA analysts predicted the vaccines might send more children to the hospital for myocarditis than the virus would.
The FDA noted that kids who are hospitalized for myocarditis tend not to be as ill as children with COVID-19, however.
“If the trends continue the way they are going, the emergency for children is not what we might think it would be. That was my concern,” Dr. Hildreth said.
But others warned against complacency.
“Thinking that this is going to be the end of the wave permanently may be a little overly optimistic,” said committee chairman Arnold Monto, MD, a professor of public health and epidemiology at the University of Michigan, Ann Arbor.
The majority of COVID-19 cases in children are mild. Only about 1% of kids are hospitalized for their infections, according to CDC data. But the rates of hospitalizations in kids are about 3 times higher for people of color — including Blacks, Hispanics, and Native Americans, as compared to Whites and Asian Americans.
Since the start of the pandemic, 94 children ages 5 to 11 have died, making it the eighth leading cause of death for kids this age last year.
More than 5,200 children have developed a delayed complication from their infections called Multi-System Inflammatory Syndrome (MIS-C).
MIS-C can be severe and require hospital care and can lead to myocarditis. Children ages 5 to 11 are the age group at greatest risk for this complication.
Kids can also get long COVID. There’s not a lot of data on how often this happens, though it appears to be less frequent in children than in adults.
But a survey in the United Kingdom found that 7%-8% of kids have symptoms from their infections that last longer than 12 weeks, Dr. Havers said. Symptoms that can linger for kids include fatigue, cough, muscle and joint pain, headaches, and insomnia.
More than 1 million children have been impacted by school closures so far this year, and quarantines have had lasting impacts on learning, social development, and mental health.
Even though kids aren’t usually COVID superspreaders, they can still pass the infection on to others.
“What is clear is that secondary transmission from children, both to other children and to adults, does occur,” Dr. Havers said.
For that reason, they can continue the spread of the virus and give it opportunities to mutate and become more dangerous.
Safety monitoring to continue
Some committee members referenced thousands of letters they had received within the past few days urging them to vote against the vaccine.
Jay Portnoy, MD, a professor of pediatrics at Children’s Mercy Hospital in Kansas City, Mo., said he had personally received about 4,000 emails.
“But I feel like I need to also represent the consumers, the parents that I see every day in the clinic who are terrified of sending their children to school because they’re not protected against COVID,” he said, explaining his vote to recommend authorization.
“Our kids are going to be dealing with this virus for many years to come. It’s going to come repeatedly. Getting this vaccine is just the first step that they can take to protect themselves from having bad outcomes,” Dr. Portnoy said.
Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, reminded members of the committee that there were several government surveillance systems in place to catch any potential safety issues in near real time.
“I really appreciate very much the concern here. The safety monitoring of this vaccine will continue,” Dr. Marks said. “I do view this as one of our greatest responsibilities.”
“I really am so grateful that we had this discussion and voted to approve,” said Capt. Amanda Cohn, MD, chief medical officer at the National Center for Immunization and Respiratory Diseases.
“I think the benefits in this age group really are super important even if they are lower than for other age groups.”
This article was updated 10/27/21.
A version of this article first appeared on WebMD.com.
Seventeen of the 18 members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Oct. 26 voted to recommend the 10-microgram shot for kids, which is one-third the dose given to adults.
One member, Michael Kurilla, MD, director of the division of clinical innovation at the National Institutes of Health, Bethesda, Md., abstained from voting.
If the FDA follows the recommendation, as it typically does, and issues an Emergency Use Authorization for the vaccine, the shots could be available within days.
After the FDA’s final decision, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make specific recommendations for its use. The CDC committee must stick closely to the conditions for use spelled out in the EUA, so their recommendations are likely to be similar to those made by the FDA. Their next meeting is scheduled for Nov. 2 and 3.
In the end, some on the panel felt uneasy with their decision.
“I voted yes primarily because I wanted to make sure that children who really need this vaccine, the Black and brown children of our country, get the vaccine,” said James Hildreth, MD, PhD, president and CEO of Meharry Medical College in Nashville.
“But to be honest, the best way to protect the health of some children will be to do nothing because they will be just fine,” he said.
Others said they were surprised by how difficult the decision had been.
“This is a much tougher one than we had expected going into it,” said committee member Eric Rubin, MD, editor and chief of the New England Journal of Medicine, during the FDA advisory committee’s meeting.
Ahead of the vote, the committee heard presentations outlining the expected benefits of vaccinating children along with potential risks.
“Children have been greatly impacted by the pandemic,” said Fiona Havers, MD, a medical officer with the CDC in Atlanta who reviewed the epidemiology of COVID-19 in kids.
In the second year of the pandemic, as more seniors have been vaccinated against the virus, COVID cases have largely shifted from older to younger age groups.
So far, there have been more than 1.9 million COVID-19 cases in children ages 5 through 11 in the United States.. Cases in kids saw a big jump in July and August with summer travel, schools reopening, and the dominance of the Delta variant.
And those are just the cases reported to the CDC. Regular testing of anonymous blood samples collected at sites across the United States indicates that 6 times as many kids have had COVID than what is reflected in official counts.
Last winter, blood sample testing showed about 13% of children had antibodies against the virus, suggesting they’d been infected. By this summer, that number had risen to 42%.
That figure clearly made an impression on many members of the committee who asked the FDA’s vaccine reviewers if they had tried to account for immunity from past infections in their modeling. They had not.
Some felt that even with a highly effective vaccine — new data presented by Pfizer showed the children’s dose was 90% effective at preventing symptomatic infections in kids — caution was warranted as much is still unknown about myocarditis, a rare side effect of the mRNA vaccines.
Myocarditis has been more common in younger age groups. It usually goes away over time but requires hospital care. It’s not known if myocarditis could have lingering effects for those who experience it.
There were no cases of myocarditis seen in Pfizer’s studies of the vaccine in children, and no other serious events were seen. Vaccine side effects reported in the Pfizer studies were mostly mild and included fatigue, headache, and pain at the injection site.
“We think we have optimized the immune response and minimized our reactions,” said William Gruber, MD, senior vice president vaccine research and clinical development at Pfizer.
But the studies didn’t include enough participants to pick up rare, but serious adverse events like myocarditis.
“We’re worried about a side effect that we can’t measure yet, but it’s probably real, and we see a benefit that isn’t the same as it is in older age groups,” said Dr. Rubin.
Benefits vs. risks
FDA modeled the benefits and risks for children under a variety of scenarios. The benefits of the vaccines to children very much depend on the amount of transmission in the community.
When transmission is high, the benefits to children — in terms of infections, hospitalizations, ICU admissions — clearly outweigh its risks.
But when COVID-19 rates are low in the community, as they were in June, FDA analysts predicted the vaccines might send more children to the hospital for myocarditis than the virus would.
The FDA noted that kids who are hospitalized for myocarditis tend not to be as ill as children with COVID-19, however.
“If the trends continue the way they are going, the emergency for children is not what we might think it would be. That was my concern,” Dr. Hildreth said.
But others warned against complacency.
“Thinking that this is going to be the end of the wave permanently may be a little overly optimistic,” said committee chairman Arnold Monto, MD, a professor of public health and epidemiology at the University of Michigan, Ann Arbor.
The majority of COVID-19 cases in children are mild. Only about 1% of kids are hospitalized for their infections, according to CDC data. But the rates of hospitalizations in kids are about 3 times higher for people of color — including Blacks, Hispanics, and Native Americans, as compared to Whites and Asian Americans.
Since the start of the pandemic, 94 children ages 5 to 11 have died, making it the eighth leading cause of death for kids this age last year.
More than 5,200 children have developed a delayed complication from their infections called Multi-System Inflammatory Syndrome (MIS-C).
MIS-C can be severe and require hospital care and can lead to myocarditis. Children ages 5 to 11 are the age group at greatest risk for this complication.
Kids can also get long COVID. There’s not a lot of data on how often this happens, though it appears to be less frequent in children than in adults.
But a survey in the United Kingdom found that 7%-8% of kids have symptoms from their infections that last longer than 12 weeks, Dr. Havers said. Symptoms that can linger for kids include fatigue, cough, muscle and joint pain, headaches, and insomnia.
More than 1 million children have been impacted by school closures so far this year, and quarantines have had lasting impacts on learning, social development, and mental health.
Even though kids aren’t usually COVID superspreaders, they can still pass the infection on to others.
“What is clear is that secondary transmission from children, both to other children and to adults, does occur,” Dr. Havers said.
For that reason, they can continue the spread of the virus and give it opportunities to mutate and become more dangerous.
Safety monitoring to continue
Some committee members referenced thousands of letters they had received within the past few days urging them to vote against the vaccine.
Jay Portnoy, MD, a professor of pediatrics at Children’s Mercy Hospital in Kansas City, Mo., said he had personally received about 4,000 emails.
“But I feel like I need to also represent the consumers, the parents that I see every day in the clinic who are terrified of sending their children to school because they’re not protected against COVID,” he said, explaining his vote to recommend authorization.
“Our kids are going to be dealing with this virus for many years to come. It’s going to come repeatedly. Getting this vaccine is just the first step that they can take to protect themselves from having bad outcomes,” Dr. Portnoy said.
Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, reminded members of the committee that there were several government surveillance systems in place to catch any potential safety issues in near real time.
“I really appreciate very much the concern here. The safety monitoring of this vaccine will continue,” Dr. Marks said. “I do view this as one of our greatest responsibilities.”
“I really am so grateful that we had this discussion and voted to approve,” said Capt. Amanda Cohn, MD, chief medical officer at the National Center for Immunization and Respiratory Diseases.
“I think the benefits in this age group really are super important even if they are lower than for other age groups.”
This article was updated 10/27/21.
A version of this article first appeared on WebMD.com.