Rural hospitalists confront COVID-19

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Tue, 11/02/2021 - 15:55

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. Atashi Mandal

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.

Dr. Ken Simone

“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.

Alan Morgan

“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.

Brock Slabach

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.

Dr. Lisa Kaufmann is a hospitalist at Appalachian Regional Healthcare System, Boone, N.C.

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.”

Dr. Sukhbir Pannu

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.

Dr. David Aymond

“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 [email protected].
 

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.

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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. Atashi Mandal

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.

Dr. Ken Simone

“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.

Alan Morgan

“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.

Brock Slabach

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.

Dr. Lisa Kaufmann is a hospitalist at Appalachian Regional Healthcare System, Boone, N.C.

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.”

Dr. Sukhbir Pannu

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.

Dr. David Aymond

“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 [email protected].
 

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. Atashi Mandal

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.

Dr. Ken Simone

“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.

Alan Morgan

“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.

Brock Slabach

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.

Dr. Lisa Kaufmann is a hospitalist at Appalachian Regional Healthcare System, Boone, N.C.

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.”

Dr. Sukhbir Pannu

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.

Dr. David Aymond

“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 [email protected].
 

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.

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Children and COVID: A look at the pace of vaccination

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Tue, 11/02/2021 - 12:38

With children aged 5-11 years about to enter the battle-of-the-COVID-vaccine phase of the war on COVID, there are many questions. MDedge takes a look at one: How long will it take to get 5- to 11-year-olds vaccinated?

Previous experience may provide some guidance. The vaccine was approved by the Centers for Disease Control and Prevention for the closest group in age, 12- to 15-year-olds, on May 12, 2021, and by May 17, over 750,000 children, or 5% of the demographic category, had received at least one dose. By Sept. 9 – 109 days later – 50% of all 15.2 million children aged 12-15 had received at least one dose of the COVID-19 vaccine, according to data from the CDC.

(Use of the 5% figure acknowledges the uneven start after approval – the vaccine became available to different age groups at different times, even though it had been approved for all adults aged 18 years and older.)

The 16- to 17-year-olds, despite being a smaller group of less than 7.6 million individuals, took 120 days to go from 5% to 50% coverage. For those aged 18-24 years, the corresponding time was 132 days, while the 24- to 36-year-olds took longer than any other age group, 135 days, to reach the 50%-with-at-least-one-dose milestone. The time, in turn, decreased for each group as age increased, with those aged 75 and older taking just 41 days to get at least one dose in 50% of individuals, the CDC data show.

That trend also applies to full vaccination, for the most part. The oldest group, 75 and older, had the shortest time to 50% being fully vaccinated at 69 days, and the 25- to 39-year-olds had the longest time at 206 days, with the length rising as age decreased and dropping for groups younger than 25-39. Except for the 12- to 15-year-olds. It has been 160 days (as of Nov. 2) since the 5% mark was reached on May 17, but only 47.4% of the group is fully vaccinated, making it unlikely that the 50% mark will be reached earlier than the 169 days it took the 16- to 17-year-olds.

So where does that put the 5- to 11-year-olds?

The White House said on Nov. 1 that vaccinations could start the first week of November, pending approval from the CDC’s Advisory Committee on Immunization Practices, which meets on Nov. 2. “This is an important step forward in our nation’s fight against the virus,” Jeff Zients, the White House COVID-19 Response Coordinator, said in a briefing. “As we await the CDC decision, we are not waiting on the operations and logistics. In fact, we’ve been preparing for weeks.”

Availability, of course, is not the only factor involved. In a survey conducted Oct. 14-24, the Kaiser Family Foundation found that only 27% of parents of children aged 5-11 years are planning to have them vaccinated against COVID-19 “right away” once the vaccine is available, and that 33% would “wait and see” how the vaccine works.

“Parents of 5-11 year-olds cite a range of concerns when it comes to vaccinating their children for COVID-19, with safety issues topping off the list,” and “two-thirds say they are concerned the vaccine may negatively impact their child’s fertility in the future,” Kaiser said.

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With children aged 5-11 years about to enter the battle-of-the-COVID-vaccine phase of the war on COVID, there are many questions. MDedge takes a look at one: How long will it take to get 5- to 11-year-olds vaccinated?

Previous experience may provide some guidance. The vaccine was approved by the Centers for Disease Control and Prevention for the closest group in age, 12- to 15-year-olds, on May 12, 2021, and by May 17, over 750,000 children, or 5% of the demographic category, had received at least one dose. By Sept. 9 – 109 days later – 50% of all 15.2 million children aged 12-15 had received at least one dose of the COVID-19 vaccine, according to data from the CDC.

(Use of the 5% figure acknowledges the uneven start after approval – the vaccine became available to different age groups at different times, even though it had been approved for all adults aged 18 years and older.)

The 16- to 17-year-olds, despite being a smaller group of less than 7.6 million individuals, took 120 days to go from 5% to 50% coverage. For those aged 18-24 years, the corresponding time was 132 days, while the 24- to 36-year-olds took longer than any other age group, 135 days, to reach the 50%-with-at-least-one-dose milestone. The time, in turn, decreased for each group as age increased, with those aged 75 and older taking just 41 days to get at least one dose in 50% of individuals, the CDC data show.

That trend also applies to full vaccination, for the most part. The oldest group, 75 and older, had the shortest time to 50% being fully vaccinated at 69 days, and the 25- to 39-year-olds had the longest time at 206 days, with the length rising as age decreased and dropping for groups younger than 25-39. Except for the 12- to 15-year-olds. It has been 160 days (as of Nov. 2) since the 5% mark was reached on May 17, but only 47.4% of the group is fully vaccinated, making it unlikely that the 50% mark will be reached earlier than the 169 days it took the 16- to 17-year-olds.

So where does that put the 5- to 11-year-olds?

The White House said on Nov. 1 that vaccinations could start the first week of November, pending approval from the CDC’s Advisory Committee on Immunization Practices, which meets on Nov. 2. “This is an important step forward in our nation’s fight against the virus,” Jeff Zients, the White House COVID-19 Response Coordinator, said in a briefing. “As we await the CDC decision, we are not waiting on the operations and logistics. In fact, we’ve been preparing for weeks.”

Availability, of course, is not the only factor involved. In a survey conducted Oct. 14-24, the Kaiser Family Foundation found that only 27% of parents of children aged 5-11 years are planning to have them vaccinated against COVID-19 “right away” once the vaccine is available, and that 33% would “wait and see” how the vaccine works.

“Parents of 5-11 year-olds cite a range of concerns when it comes to vaccinating their children for COVID-19, with safety issues topping off the list,” and “two-thirds say they are concerned the vaccine may negatively impact their child’s fertility in the future,” Kaiser said.

With children aged 5-11 years about to enter the battle-of-the-COVID-vaccine phase of the war on COVID, there are many questions. MDedge takes a look at one: How long will it take to get 5- to 11-year-olds vaccinated?

Previous experience may provide some guidance. The vaccine was approved by the Centers for Disease Control and Prevention for the closest group in age, 12- to 15-year-olds, on May 12, 2021, and by May 17, over 750,000 children, or 5% of the demographic category, had received at least one dose. By Sept. 9 – 109 days later – 50% of all 15.2 million children aged 12-15 had received at least one dose of the COVID-19 vaccine, according to data from the CDC.

(Use of the 5% figure acknowledges the uneven start after approval – the vaccine became available to different age groups at different times, even though it had been approved for all adults aged 18 years and older.)

The 16- to 17-year-olds, despite being a smaller group of less than 7.6 million individuals, took 120 days to go from 5% to 50% coverage. For those aged 18-24 years, the corresponding time was 132 days, while the 24- to 36-year-olds took longer than any other age group, 135 days, to reach the 50%-with-at-least-one-dose milestone. The time, in turn, decreased for each group as age increased, with those aged 75 and older taking just 41 days to get at least one dose in 50% of individuals, the CDC data show.

That trend also applies to full vaccination, for the most part. The oldest group, 75 and older, had the shortest time to 50% being fully vaccinated at 69 days, and the 25- to 39-year-olds had the longest time at 206 days, with the length rising as age decreased and dropping for groups younger than 25-39. Except for the 12- to 15-year-olds. It has been 160 days (as of Nov. 2) since the 5% mark was reached on May 17, but only 47.4% of the group is fully vaccinated, making it unlikely that the 50% mark will be reached earlier than the 169 days it took the 16- to 17-year-olds.

So where does that put the 5- to 11-year-olds?

The White House said on Nov. 1 that vaccinations could start the first week of November, pending approval from the CDC’s Advisory Committee on Immunization Practices, which meets on Nov. 2. “This is an important step forward in our nation’s fight against the virus,” Jeff Zients, the White House COVID-19 Response Coordinator, said in a briefing. “As we await the CDC decision, we are not waiting on the operations and logistics. In fact, we’ve been preparing for weeks.”

Availability, of course, is not the only factor involved. In a survey conducted Oct. 14-24, the Kaiser Family Foundation found that only 27% of parents of children aged 5-11 years are planning to have them vaccinated against COVID-19 “right away” once the vaccine is available, and that 33% would “wait and see” how the vaccine works.

“Parents of 5-11 year-olds cite a range of concerns when it comes to vaccinating their children for COVID-19, with safety issues topping off the list,” and “two-thirds say they are concerned the vaccine may negatively impact their child’s fertility in the future,” Kaiser said.

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COVID-19 vaccines provide 5 times the protection of natural immunity, CDC study says

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Thu, 11/04/2021 - 12:14

Unvaccinated people who had a recent infection were five times more likely to be reinfected with the coronavirus compared to those who were fully vaccinated and didn’t have a prior infection, according to a new study published recently in the CDC’s Morbidity and Mortality Weekly Report.

The 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.

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Unvaccinated people who had a recent infection were five times more likely to be reinfected with the coronavirus compared to those who were fully vaccinated and didn’t have a prior infection, according to a new study published recently in the CDC’s Morbidity and Mortality Weekly Report.

The 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.

Unvaccinated people who had a recent infection were five times more likely to be reinfected with the coronavirus compared to those who were fully vaccinated and didn’t have a prior infection, according to a new study published recently in the CDC’s Morbidity and Mortality Weekly Report.

The 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.

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Video of nurse escorted from hospital for refusing vaccine goes viral

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Tue, 11/02/2021 - 09:38

A Twitter post of an unmasked nurse being escorted from a Kaiser Permanente hospital for what she called “sincerely held religious beliefs” has gone viral. It had been viewed more than 6 million times at press time.

The 5-minute video of the nurse leaving the hospital, both of which are unidentified in the clip, was a peaceful protest by the frontline worker against COVID-19 vaccine mandates, which many employers globally are enforcing.

In her video, which was originally posted October 30 on Rumble, the nurse explained, “I am being escorted out of Kaiser Permanente hospital for my religious beliefs because I don’t want to get the jab. And I asked all day for someone to explain to me why my sincerely held religious beliefs are not good enough for Kaiser. And no one was able to do that for me,” she continued.

“So now they’re escorting me out because I wanted an answer. And I’m not leaving without an answer. I have some nurses here who are standing with me in solidarity, and I appreciate that.”

The nurse, seen walking through the halls of the hospital surrounded by masked personnel, including a security guard, further stated that she had been put on unpaid administrative leave. Kaiser Permanente had not responded at press time to media requests for comment.

“I just want all of you to count the costs,” she said. “I want you to watch this and think, what really matters to me? Because I am willing to lose my safety and security, my house, everything, for my freedom. And I want you to think about that.”

While waiting for an elevator, she also posed questions to a few random people about their views on the subject. “Let me ask you, do you believe in religious freedom?” Offscreen, those responding indicated affirmatively. “Well, Kaiser doesn’t. Because they are not accepting my religious exemption based on my sincerely held religious beliefs. So that’s a problem.”

Also on the video she stated that she has worked since the beginning of the pandemic, “when we didn’t know what was going on,” and that she had shown up the day of her expulsion “happy to work.” She also touted Kaiser for paying well. She even quoted the company’s signs in a parking garage that encourages employees to climb the stairs for exercise as she went with the security guard who was escorting her up seven flights to the top of the parking garage.

“It’s a sad day. I don’t know what kind of a pandemic it is if they’re firing nurses who are willing to work. I don’t know,” she concluded. “It doesn’t make sense to me. So you have got to ask yourself that question: what kind of world are we living in when we have a pandemic where my kids have to wear masks at school and they have to get a vaccine for something that they are not at risk of dying from at all.”

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

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A Twitter post of an unmasked nurse being escorted from a Kaiser Permanente hospital for what she called “sincerely held religious beliefs” has gone viral. It had been viewed more than 6 million times at press time.

The 5-minute video of the nurse leaving the hospital, both of which are unidentified in the clip, was a peaceful protest by the frontline worker against COVID-19 vaccine mandates, which many employers globally are enforcing.

In her video, which was originally posted October 30 on Rumble, the nurse explained, “I am being escorted out of Kaiser Permanente hospital for my religious beliefs because I don’t want to get the jab. And I asked all day for someone to explain to me why my sincerely held religious beliefs are not good enough for Kaiser. And no one was able to do that for me,” she continued.

“So now they’re escorting me out because I wanted an answer. And I’m not leaving without an answer. I have some nurses here who are standing with me in solidarity, and I appreciate that.”

The nurse, seen walking through the halls of the hospital surrounded by masked personnel, including a security guard, further stated that she had been put on unpaid administrative leave. Kaiser Permanente had not responded at press time to media requests for comment.

“I just want all of you to count the costs,” she said. “I want you to watch this and think, what really matters to me? Because I am willing to lose my safety and security, my house, everything, for my freedom. And I want you to think about that.”

While waiting for an elevator, she also posed questions to a few random people about their views on the subject. “Let me ask you, do you believe in religious freedom?” Offscreen, those responding indicated affirmatively. “Well, Kaiser doesn’t. Because they are not accepting my religious exemption based on my sincerely held religious beliefs. So that’s a problem.”

Also on the video she stated that she has worked since the beginning of the pandemic, “when we didn’t know what was going on,” and that she had shown up the day of her expulsion “happy to work.” She also touted Kaiser for paying well. She even quoted the company’s signs in a parking garage that encourages employees to climb the stairs for exercise as she went with the security guard who was escorting her up seven flights to the top of the parking garage.

“It’s a sad day. I don’t know what kind of a pandemic it is if they’re firing nurses who are willing to work. I don’t know,” she concluded. “It doesn’t make sense to me. So you have got to ask yourself that question: what kind of world are we living in when we have a pandemic where my kids have to wear masks at school and they have to get a vaccine for something that they are not at risk of dying from at all.”

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

A Twitter post of an unmasked nurse being escorted from a Kaiser Permanente hospital for what she called “sincerely held religious beliefs” has gone viral. It had been viewed more than 6 million times at press time.

The 5-minute video of the nurse leaving the hospital, both of which are unidentified in the clip, was a peaceful protest by the frontline worker against COVID-19 vaccine mandates, which many employers globally are enforcing.

In her video, which was originally posted October 30 on Rumble, the nurse explained, “I am being escorted out of Kaiser Permanente hospital for my religious beliefs because I don’t want to get the jab. And I asked all day for someone to explain to me why my sincerely held religious beliefs are not good enough for Kaiser. And no one was able to do that for me,” she continued.

“So now they’re escorting me out because I wanted an answer. And I’m not leaving without an answer. I have some nurses here who are standing with me in solidarity, and I appreciate that.”

The nurse, seen walking through the halls of the hospital surrounded by masked personnel, including a security guard, further stated that she had been put on unpaid administrative leave. Kaiser Permanente had not responded at press time to media requests for comment.

“I just want all of you to count the costs,” she said. “I want you to watch this and think, what really matters to me? Because I am willing to lose my safety and security, my house, everything, for my freedom. And I want you to think about that.”

While waiting for an elevator, she also posed questions to a few random people about their views on the subject. “Let me ask you, do you believe in religious freedom?” Offscreen, those responding indicated affirmatively. “Well, Kaiser doesn’t. Because they are not accepting my religious exemption based on my sincerely held religious beliefs. So that’s a problem.”

Also on the video she stated that she has worked since the beginning of the pandemic, “when we didn’t know what was going on,” and that she had shown up the day of her expulsion “happy to work.” She also touted Kaiser for paying well. She even quoted the company’s signs in a parking garage that encourages employees to climb the stairs for exercise as she went with the security guard who was escorting her up seven flights to the top of the parking garage.

“It’s a sad day. I don’t know what kind of a pandemic it is if they’re firing nurses who are willing to work. I don’t know,” she concluded. “It doesn’t make sense to me. So you have got to ask yourself that question: what kind of world are we living in when we have a pandemic where my kids have to wear masks at school and they have to get a vaccine for something that they are not at risk of dying from at all.”

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

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With a Captive Audience, a Hospitalist Tries to Reach the Unvaccinated

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Mon, 03/07/2022 - 10:29
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With a Captive Audience, a Hospitalist Tries to Reach the Unvaccinated

Cheryl K. Lee, MD, an Assistant Professor Of Medicine at Northwestern Feinberg School of Medicine, practices internal medicine and pediatrics at Northwestern Memorial and the Ann & Robert H. Lurie Children's Hospital, both in Chicago, IL. She also serves on the Northwestern Medicine Covid Quality Committee and as core clinical faculty in the Internal Medicine Residency.  

 

Dr. Lee reported no disclosures.

 

You have been treating COVID-19 patients since before the US Food and Drug Administration (FDA) granted emergency authorization to 3 pharma vaccine producers. But now you have patients, on oxygen or under observation, who have foregone vaccination. What do you think about that?

 

This question raises a good point that is often missed: how the unvaccinated are often portrayed. The reasons these patients remain unvaccinated are not necessarily uniform.

 

What we know based on attitude surveys done by the Kaiser Family Foundation1 is that people are vaccine hesitant for varied reasons. And this finding isn’t unique. The pediatric literature shows that those who are opposed to childhood vaccination do not share the same motivations.2 Yes, some are strident about their beliefs against vaccination, usually in concert with popularized myths. Many unvaccinated people are hesitant based on misconceptions, do not have access to a clinician who can answer their questions, can’t afford to lose a day of work due to the vaccine’s expected side effects, or understandably mistrust the healthcare community based on personal or historical context.

 

What do the unvaccinated have in common? Education levels, income levels?

 

We know from surveys3 that generally, more men than women are hesitant. Those who are uninsured or underinsured4 and those of lower socioeconomic status are more hesitant than their counterparts. It's changing a bit, but those who are in minority communities, Black and Latinx communities, are more likely to be unvaccinated compared to other groups. Even in Chicago, where we have a relatively good vaccination rate (59%),5 Black and Latinx communities are under vaccinated as compared to those who are White or Asian. The reasons for this are complex and include historical disinvestment in communities and decreased access to medical care. Some wonderful agencies are pairing up with community leaders in target neighborhoods to address this equity gap.

 

What do you say to these patients, if anything, about their status?

 

It’s not what you might expect. At first, I listen. I find that most are well-intentioned people trying to make the right decision for themselves and their family. It is, therefore, helpful to hear what their motivations and fears are first, before delving into facts. Furthermore, although facts are wonderful and necessary, what is more persuasive is a personal anecdote. I will tell folks my personal story about deciding to be vaccinated. I talk about how I found accurate information about the vaccine and what a relief it was afterwards to know that I would be safe, especially as a mom. I even talk about feeling tired and achy after the second shot, which means that the vaccine is working. I joke that it is the only time I’ve felt so relieved to feel sick. Last, I often say that it’s okay to feel scared or apprehensive, and that they deserve to get the best information. What’s important is that these conversations feel genuine.

 

Can you share an anecdote or two?

 

A few months ago, I took care of an unvaccinated gentleman who was in the hospital for a chronic medical condition. Before this hospitalization, his personal physicians had tried to convince him to get the vaccine over a period of several months.

 

It would have been easy to assume that he would remain unvaccinated and that I should put my energy into convincing someone else. However, I found him surprisingly open to discussion, and we were able to have many conversations about what he'd heard from nonmedical sources. We bonded over the sheer volume of available information and how difficult it is to know what is true. We then walked through what was truth vs fiction, and I tailored the discussion to how the vaccine could specifically improve his quality of life and his family's. He confided that what made his decision more difficult was the fact that he hadn’t met anyone who had gotten the vaccine among his friends and family. He ultimately did decide to get vaccinated, along with a family member. We made the appointment for the week after he was discharged. What a feeling it was to get a text message from his clinic physician saying that he got his first shot and that it went great!

 

I wasn’t the only physician who had spoken to this patient about getting vaccinated; others had done the same before he came to the hospital. It is a good reminder that each conversation can act like a gentle nudge in the right direction.

 

In terms of the data on the unvaccinated–reasons they stay away, what their backgrounds are and so forth–how close do those data play out in real life?

 

It is not advisable to assume why someone would be unvaccinated based on first impressions. I find the reasons are highly specific to that individual, ranging from false impressions about fertility to concerns about missing work. In my experience, several patients simply wanted to get more facts from a healthcare worker directly before signing up. Pregnancy is particularly important to talk about, considering how devastating the Delta variant has been to this group of women. One gentleman that I spoke to was worried about affecting his wife’s pregnancy with the vaccine. We know now that vaccines are safe and prevent pregnant patients from getting seriously ill and dying, but that knowledge isn’t widely known to the public. So many kind and well-meaning people have foregone vaccination because they're concerned about doing anything to upset the pregnancy.

 

How long, generally, does it take for unvaccinated patients to discuss the reasons for their choice?

 

It takes time, and that's a real barrier for many healthcare professionals, especially in a clinic setting where the luxury of extra time is nonexistent. How much time differs for everyone, and usually a change of heart takes more than one conversation.

 

Truly, the first conversation is just to listen, to understand their hesitation, and to develop trust. For anyone to really hear what I have to say, they must trust that what I'm saying is solely motivated by caring about what happens to them and their family.

 

One gentleman said something pointed during our first conversation: Thank you for listening. When I tell people I am not vaccinated I can feel them judging me, that they've already decided what to think of me.

 

I always tell people that they have good questions because they do. I respect the fact that they're feeling open enough to share what they're hearing or what they're afraid of. It's a privilege for me to be involved in that conversation.

 

What advice would you give other hospitalists in terms of treating and counseling patients who are unvaccinated?

 

Every hospitalization, whether it’s COVID-related or not, is an opportunity to speak with those who are still unvaccinated. Every encounter can be used to further the conversation about vaccines, by increasing their trust in the healthcare community, answering their questions, and providing facts in place of confusion. Using those opportunities is the best way to get us out of this pandemic.

 

That said, it's been a long two years, so it's okay if physicians don't have the emotional bandwidth or the time to have these discussions. Maybe save that conversation for another day. But for some providers, perhaps knowing that those who are unvaccinated can change and that anxiety could be preventing some from getting their shot will motivate them to start these conversations with their patients.

References

References

1. Does the public want to get a Covid-19 vaccine? When? Kaiser Family Foundation. Sept. 13-22, 2021. Accessed October 26, 2021. https://www.kff.org/coronavirus-covid-19/dashboard/kff-covid-19-vaccine-monitor-dashboard/#concernsorbarriers

 

2. Report of the SAGE Working Group on Vaccine Hesitancy. World Health Organization. November 12, 2014. Accessed October 25, 2021. https://www.who.int/immunization/sage/meetings/2014/october/SAGE_working_group_revised_report_vaccine_hesitancy.pdf?ua=1

 

3. Lazarus JV, Ratzan SC, Palayew A, et al. A global survey of potential acceptance of a COVID-19 vaccine. Nat Med. 2021;27:225-228. Erratum in: Nat Med. 2021;27:354.

Author and Disclosure Information

Cheryl K. Lee, MD,  Assistant Professor Of Medicine - Northwestern Feinberg School of Medicine.


Cheryl K. Lee, MD, an Assistant Professor Of Medicine at Northwestern Feinberg School of Medicine, practices internal medicine and pediatrics at Northwestern Memorial and the Ann & Robert H. Lurie Children's Hospital, both in Chicago, IL. She also serves on the Northwestern Medicine Covid Quality Committee and as core clinical faculty in the Internal Medicine Residency.  

 

Dr. Lee reported no disclosures.

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Cheryl K. Lee, MD,  Assistant Professor Of Medicine - Northwestern Feinberg School of Medicine.


Cheryl K. Lee, MD, an Assistant Professor Of Medicine at Northwestern Feinberg School of Medicine, practices internal medicine and pediatrics at Northwestern Memorial and the Ann & Robert H. Lurie Children's Hospital, both in Chicago, IL. She also serves on the Northwestern Medicine Covid Quality Committee and as core clinical faculty in the Internal Medicine Residency.  

 

Dr. Lee reported no disclosures.

Author and Disclosure Information

Cheryl K. Lee, MD,  Assistant Professor Of Medicine - Northwestern Feinberg School of Medicine.


Cheryl K. Lee, MD, an Assistant Professor Of Medicine at Northwestern Feinberg School of Medicine, practices internal medicine and pediatrics at Northwestern Memorial and the Ann & Robert H. Lurie Children's Hospital, both in Chicago, IL. She also serves on the Northwestern Medicine Covid Quality Committee and as core clinical faculty in the Internal Medicine Residency.  

 

Dr. Lee reported no disclosures.

Cheryl K. Lee, MD, an Assistant Professor Of Medicine at Northwestern Feinberg School of Medicine, practices internal medicine and pediatrics at Northwestern Memorial and the Ann & Robert H. Lurie Children's Hospital, both in Chicago, IL. She also serves on the Northwestern Medicine Covid Quality Committee and as core clinical faculty in the Internal Medicine Residency.  

 

Dr. Lee reported no disclosures.

 

You have been treating COVID-19 patients since before the US Food and Drug Administration (FDA) granted emergency authorization to 3 pharma vaccine producers. But now you have patients, on oxygen or under observation, who have foregone vaccination. What do you think about that?

 

This question raises a good point that is often missed: how the unvaccinated are often portrayed. The reasons these patients remain unvaccinated are not necessarily uniform.

 

What we know based on attitude surveys done by the Kaiser Family Foundation1 is that people are vaccine hesitant for varied reasons. And this finding isn’t unique. The pediatric literature shows that those who are opposed to childhood vaccination do not share the same motivations.2 Yes, some are strident about their beliefs against vaccination, usually in concert with popularized myths. Many unvaccinated people are hesitant based on misconceptions, do not have access to a clinician who can answer their questions, can’t afford to lose a day of work due to the vaccine’s expected side effects, or understandably mistrust the healthcare community based on personal or historical context.

 

What do the unvaccinated have in common? Education levels, income levels?

 

We know from surveys3 that generally, more men than women are hesitant. Those who are uninsured or underinsured4 and those of lower socioeconomic status are more hesitant than their counterparts. It's changing a bit, but those who are in minority communities, Black and Latinx communities, are more likely to be unvaccinated compared to other groups. Even in Chicago, where we have a relatively good vaccination rate (59%),5 Black and Latinx communities are under vaccinated as compared to those who are White or Asian. The reasons for this are complex and include historical disinvestment in communities and decreased access to medical care. Some wonderful agencies are pairing up with community leaders in target neighborhoods to address this equity gap.

 

What do you say to these patients, if anything, about their status?

 

It’s not what you might expect. At first, I listen. I find that most are well-intentioned people trying to make the right decision for themselves and their family. It is, therefore, helpful to hear what their motivations and fears are first, before delving into facts. Furthermore, although facts are wonderful and necessary, what is more persuasive is a personal anecdote. I will tell folks my personal story about deciding to be vaccinated. I talk about how I found accurate information about the vaccine and what a relief it was afterwards to know that I would be safe, especially as a mom. I even talk about feeling tired and achy after the second shot, which means that the vaccine is working. I joke that it is the only time I’ve felt so relieved to feel sick. Last, I often say that it’s okay to feel scared or apprehensive, and that they deserve to get the best information. What’s important is that these conversations feel genuine.

 

Can you share an anecdote or two?

 

A few months ago, I took care of an unvaccinated gentleman who was in the hospital for a chronic medical condition. Before this hospitalization, his personal physicians had tried to convince him to get the vaccine over a period of several months.

 

It would have been easy to assume that he would remain unvaccinated and that I should put my energy into convincing someone else. However, I found him surprisingly open to discussion, and we were able to have many conversations about what he'd heard from nonmedical sources. We bonded over the sheer volume of available information and how difficult it is to know what is true. We then walked through what was truth vs fiction, and I tailored the discussion to how the vaccine could specifically improve his quality of life and his family's. He confided that what made his decision more difficult was the fact that he hadn’t met anyone who had gotten the vaccine among his friends and family. He ultimately did decide to get vaccinated, along with a family member. We made the appointment for the week after he was discharged. What a feeling it was to get a text message from his clinic physician saying that he got his first shot and that it went great!

 

I wasn’t the only physician who had spoken to this patient about getting vaccinated; others had done the same before he came to the hospital. It is a good reminder that each conversation can act like a gentle nudge in the right direction.

 

In terms of the data on the unvaccinated–reasons they stay away, what their backgrounds are and so forth–how close do those data play out in real life?

 

It is not advisable to assume why someone would be unvaccinated based on first impressions. I find the reasons are highly specific to that individual, ranging from false impressions about fertility to concerns about missing work. In my experience, several patients simply wanted to get more facts from a healthcare worker directly before signing up. Pregnancy is particularly important to talk about, considering how devastating the Delta variant has been to this group of women. One gentleman that I spoke to was worried about affecting his wife’s pregnancy with the vaccine. We know now that vaccines are safe and prevent pregnant patients from getting seriously ill and dying, but that knowledge isn’t widely known to the public. So many kind and well-meaning people have foregone vaccination because they're concerned about doing anything to upset the pregnancy.

 

How long, generally, does it take for unvaccinated patients to discuss the reasons for their choice?

 

It takes time, and that's a real barrier for many healthcare professionals, especially in a clinic setting where the luxury of extra time is nonexistent. How much time differs for everyone, and usually a change of heart takes more than one conversation.

 

Truly, the first conversation is just to listen, to understand their hesitation, and to develop trust. For anyone to really hear what I have to say, they must trust that what I'm saying is solely motivated by caring about what happens to them and their family.

 

One gentleman said something pointed during our first conversation: Thank you for listening. When I tell people I am not vaccinated I can feel them judging me, that they've already decided what to think of me.

 

I always tell people that they have good questions because they do. I respect the fact that they're feeling open enough to share what they're hearing or what they're afraid of. It's a privilege for me to be involved in that conversation.

 

What advice would you give other hospitalists in terms of treating and counseling patients who are unvaccinated?

 

Every hospitalization, whether it’s COVID-related or not, is an opportunity to speak with those who are still unvaccinated. Every encounter can be used to further the conversation about vaccines, by increasing their trust in the healthcare community, answering their questions, and providing facts in place of confusion. Using those opportunities is the best way to get us out of this pandemic.

 

That said, it's been a long two years, so it's okay if physicians don't have the emotional bandwidth or the time to have these discussions. Maybe save that conversation for another day. But for some providers, perhaps knowing that those who are unvaccinated can change and that anxiety could be preventing some from getting their shot will motivate them to start these conversations with their patients.

Cheryl K. Lee, MD, an Assistant Professor Of Medicine at Northwestern Feinberg School of Medicine, practices internal medicine and pediatrics at Northwestern Memorial and the Ann & Robert H. Lurie Children's Hospital, both in Chicago, IL. She also serves on the Northwestern Medicine Covid Quality Committee and as core clinical faculty in the Internal Medicine Residency.  

 

Dr. Lee reported no disclosures.

 

You have been treating COVID-19 patients since before the US Food and Drug Administration (FDA) granted emergency authorization to 3 pharma vaccine producers. But now you have patients, on oxygen or under observation, who have foregone vaccination. What do you think about that?

 

This question raises a good point that is often missed: how the unvaccinated are often portrayed. The reasons these patients remain unvaccinated are not necessarily uniform.

 

What we know based on attitude surveys done by the Kaiser Family Foundation1 is that people are vaccine hesitant for varied reasons. And this finding isn’t unique. The pediatric literature shows that those who are opposed to childhood vaccination do not share the same motivations.2 Yes, some are strident about their beliefs against vaccination, usually in concert with popularized myths. Many unvaccinated people are hesitant based on misconceptions, do not have access to a clinician who can answer their questions, can’t afford to lose a day of work due to the vaccine’s expected side effects, or understandably mistrust the healthcare community based on personal or historical context.

 

What do the unvaccinated have in common? Education levels, income levels?

 

We know from surveys3 that generally, more men than women are hesitant. Those who are uninsured or underinsured4 and those of lower socioeconomic status are more hesitant than their counterparts. It's changing a bit, but those who are in minority communities, Black and Latinx communities, are more likely to be unvaccinated compared to other groups. Even in Chicago, where we have a relatively good vaccination rate (59%),5 Black and Latinx communities are under vaccinated as compared to those who are White or Asian. The reasons for this are complex and include historical disinvestment in communities and decreased access to medical care. Some wonderful agencies are pairing up with community leaders in target neighborhoods to address this equity gap.

 

What do you say to these patients, if anything, about their status?

 

It’s not what you might expect. At first, I listen. I find that most are well-intentioned people trying to make the right decision for themselves and their family. It is, therefore, helpful to hear what their motivations and fears are first, before delving into facts. Furthermore, although facts are wonderful and necessary, what is more persuasive is a personal anecdote. I will tell folks my personal story about deciding to be vaccinated. I talk about how I found accurate information about the vaccine and what a relief it was afterwards to know that I would be safe, especially as a mom. I even talk about feeling tired and achy after the second shot, which means that the vaccine is working. I joke that it is the only time I’ve felt so relieved to feel sick. Last, I often say that it’s okay to feel scared or apprehensive, and that they deserve to get the best information. What’s important is that these conversations feel genuine.

 

Can you share an anecdote or two?

 

A few months ago, I took care of an unvaccinated gentleman who was in the hospital for a chronic medical condition. Before this hospitalization, his personal physicians had tried to convince him to get the vaccine over a period of several months.

 

It would have been easy to assume that he would remain unvaccinated and that I should put my energy into convincing someone else. However, I found him surprisingly open to discussion, and we were able to have many conversations about what he'd heard from nonmedical sources. We bonded over the sheer volume of available information and how difficult it is to know what is true. We then walked through what was truth vs fiction, and I tailored the discussion to how the vaccine could specifically improve his quality of life and his family's. He confided that what made his decision more difficult was the fact that he hadn’t met anyone who had gotten the vaccine among his friends and family. He ultimately did decide to get vaccinated, along with a family member. We made the appointment for the week after he was discharged. What a feeling it was to get a text message from his clinic physician saying that he got his first shot and that it went great!

 

I wasn’t the only physician who had spoken to this patient about getting vaccinated; others had done the same before he came to the hospital. It is a good reminder that each conversation can act like a gentle nudge in the right direction.

 

In terms of the data on the unvaccinated–reasons they stay away, what their backgrounds are and so forth–how close do those data play out in real life?

 

It is not advisable to assume why someone would be unvaccinated based on first impressions. I find the reasons are highly specific to that individual, ranging from false impressions about fertility to concerns about missing work. In my experience, several patients simply wanted to get more facts from a healthcare worker directly before signing up. Pregnancy is particularly important to talk about, considering how devastating the Delta variant has been to this group of women. One gentleman that I spoke to was worried about affecting his wife’s pregnancy with the vaccine. We know now that vaccines are safe and prevent pregnant patients from getting seriously ill and dying, but that knowledge isn’t widely known to the public. So many kind and well-meaning people have foregone vaccination because they're concerned about doing anything to upset the pregnancy.

 

How long, generally, does it take for unvaccinated patients to discuss the reasons for their choice?

 

It takes time, and that's a real barrier for many healthcare professionals, especially in a clinic setting where the luxury of extra time is nonexistent. How much time differs for everyone, and usually a change of heart takes more than one conversation.

 

Truly, the first conversation is just to listen, to understand their hesitation, and to develop trust. For anyone to really hear what I have to say, they must trust that what I'm saying is solely motivated by caring about what happens to them and their family.

 

One gentleman said something pointed during our first conversation: Thank you for listening. When I tell people I am not vaccinated I can feel them judging me, that they've already decided what to think of me.

 

I always tell people that they have good questions because they do. I respect the fact that they're feeling open enough to share what they're hearing or what they're afraid of. It's a privilege for me to be involved in that conversation.

 

What advice would you give other hospitalists in terms of treating and counseling patients who are unvaccinated?

 

Every hospitalization, whether it’s COVID-related or not, is an opportunity to speak with those who are still unvaccinated. Every encounter can be used to further the conversation about vaccines, by increasing their trust in the healthcare community, answering their questions, and providing facts in place of confusion. Using those opportunities is the best way to get us out of this pandemic.

 

That said, it's been a long two years, so it's okay if physicians don't have the emotional bandwidth or the time to have these discussions. Maybe save that conversation for another day. But for some providers, perhaps knowing that those who are unvaccinated can change and that anxiety could be preventing some from getting their shot will motivate them to start these conversations with their patients.

References

References

1. Does the public want to get a Covid-19 vaccine? When? Kaiser Family Foundation. Sept. 13-22, 2021. Accessed October 26, 2021. https://www.kff.org/coronavirus-covid-19/dashboard/kff-covid-19-vaccine-monitor-dashboard/#concernsorbarriers

 

2. Report of the SAGE Working Group on Vaccine Hesitancy. World Health Organization. November 12, 2014. Accessed October 25, 2021. https://www.who.int/immunization/sage/meetings/2014/october/SAGE_working_group_revised_report_vaccine_hesitancy.pdf?ua=1

 

3. Lazarus JV, Ratzan SC, Palayew A, et al. A global survey of potential acceptance of a COVID-19 vaccine. Nat Med. 2021;27:225-228. Erratum in: Nat Med. 2021;27:354.

References

References

1. Does the public want to get a Covid-19 vaccine? When? Kaiser Family Foundation. Sept. 13-22, 2021. Accessed October 26, 2021. https://www.kff.org/coronavirus-covid-19/dashboard/kff-covid-19-vaccine-monitor-dashboard/#concernsorbarriers

 

2. Report of the SAGE Working Group on Vaccine Hesitancy. World Health Organization. November 12, 2014. Accessed October 25, 2021. https://www.who.int/immunization/sage/meetings/2014/october/SAGE_working_group_revised_report_vaccine_hesitancy.pdf?ua=1

 

3. Lazarus JV, Ratzan SC, Palayew A, et al. A global survey of potential acceptance of a COVID-19 vaccine. Nat Med. 2021;27:225-228. Erratum in: Nat Med. 2021;27:354.

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FDA authorizes Pfizer’s COVID-19 vaccine for kids

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The Food and Drug Administration has authorized Pfizer’s COVID-19 vaccine for children ages 5 to 11, which means vaccines could be available to school-aged children starting next week.

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.

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The Food and Drug Administration has authorized Pfizer’s COVID-19 vaccine for children ages 5 to 11, which means vaccines could be available to school-aged children starting next week.

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 Food and Drug Administration has authorized Pfizer’s COVID-19 vaccine for children ages 5 to 11, which means vaccines could be available to school-aged children starting next week.

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.

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Antidepressant may cut COVID-19–related hospitalization, mortality: TOGETHER

Article Type
Changed
Mon, 11/01/2021 - 15:33

The antidepressant fluvoxamine (Luvox) may prevent hospitalization and death in outpatients with COVID-19, new research suggests.

HconQ/ThinkStock

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.

Based on accumulating data, Dr. Reiersen said, some experts are recommending fluvoxamine for COVID-19 patients at high risk for morbidity and mortality 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.

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The antidepressant fluvoxamine (Luvox) may prevent hospitalization and death in outpatients with COVID-19, new research suggests.

HconQ/ThinkStock

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.

Based on accumulating data, Dr. Reiersen said, some experts are recommending fluvoxamine for COVID-19 patients at high risk for morbidity and mortality 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.

HconQ/ThinkStock

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.

Based on accumulating data, Dr. Reiersen said, some experts are recommending fluvoxamine for COVID-19 patients at high risk for morbidity and mortality 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.

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MS and COVID: Docs switched DMTs but maybe didn’t need to

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Mon, 01/03/2022 - 13:26

Most U.S. medical professionals who treat patients with multiple sclerosis (MS) appear to have adjusted drug regimens during the pandemic’s early months to lower the risk of COVID-19 infection. But they actually didn’t need to make changes then – or now. These are the messages of a pair of new studies that examine the impact of the pandemic on the treatment of MS.

One report finds that 80% of specialists surveyed in the summer of 2020 said the pandemic may have changed how they prescribe disease-modifying therapies (DMTs). However, the other report finds no evidence that choice of DMT affects risk of COVID-19 infection. Both studies were presented at the 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC).

For the survey, researchers led by neurologist Elizabeth H. Morrison-Banks, MD, of the University of California, Riverside, sent questions to 188 clinicians who serve on regional National Multiple Sclerosis Society Healthcare Provider Councils. A total of 86 people responded: 45 physicians, 18 rehabilitation therapists, 7 psychologists, 8 advanced practice clinicians, 4 social workers, 2 nurses, a pharmacist, and a researcher.

The results, which were published earlier in 2021 in Multiple Sclerosis and Related Disorders, revealed that the survey participants were prescribing certain DMTs more often: beta-interferons (prescribed more by 28.6% of prescribers), natalizumab (23.8%), and glatiramer acetate (21.4%). Those prescribed less included alemtuzumab (64.2% prescribed it less), cladribine (52.4%), and B cell–depleting agents including ocrelizumab and rituximab (50%). Some specialists suspended drugs entirely (21.4% for alemtuzumab, 16.7% for B cell–depleting agents) or extending dosing intervals (38.1% for natalizumab, 11.9% for fingolimod and siponimod).

“We suspect that some of the lower-efficacy therapies were prescribed more often because these therapies were much less immunosuppressive, and because they did not require in-person visits that would increase risk of viral exposure from infusion center staff, or from other infusion patients,” Dr. Morrison-Banks said in an interview. “We also suspect that some of our survey respondents may have increased the dosing intervals for higher-efficacy therapies such as B cell–modulating agents – or even avoided these therapies altogether – because they were concerned that immunosuppressive agents might trigger severe complications from COVID-19.”

As she noted, “in retrospect, at least some of the concerns expressed in our survey may not have been entirely warranted, but then again, we all knew even less then about COVID-19.”

Indeed, researchers led by neurologist Tyler E. Smith, MD, of New York University Langone Multiple Sclerosis Care Center are reporting that they couldn’t find any link between the following DMTs and higher rates of COVID-19 at the New York City center: rituximab, ocrelizumab, fumerate (dimethyl fumarate, monomethyl fumarate, diroximel fumarate), sphingosine-1-phosphate modulators (fingolimod, siponimod), and natalizumab.

The researchers tracked 1,439 patients with MS who were taking the DMTs from March 2020 to March 2021. Of those, 16.0% were infected with COVID-19 (75% lab confirmed), 6.5% were hospitalized, and 0.9% died.

“We did not find an association between the choice of disease-modifying therapy and developing COVID-19 infection, nor having increased disease severity,” Dr. Smith said in an interview. “We are still analyzing data and hope to publish an updated analysis, but at this point, we don’t have conclusive evidence that DMTs, including anti-CD20 agents, need to be changed to lower the risk of COVID-19.”

Instead, he said, “at this point, we feel our energies should be spent on educating our patients on importance of vaccines and boosters. I don’t think it is necessary to switch DMTs because of COVID-19 concerns. However, this should be reviewed on a case-by-case basis.”

No funding is reported for the survey study, and the authors reported various disclosures. The DMT study was funded by an investigator-initiated grant from the Consortium of Multiple Sclerosis Centers, and the authors reported various disclosures.
 

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Most U.S. medical professionals who treat patients with multiple sclerosis (MS) appear to have adjusted drug regimens during the pandemic’s early months to lower the risk of COVID-19 infection. But they actually didn’t need to make changes then – or now. These are the messages of a pair of new studies that examine the impact of the pandemic on the treatment of MS.

One report finds that 80% of specialists surveyed in the summer of 2020 said the pandemic may have changed how they prescribe disease-modifying therapies (DMTs). However, the other report finds no evidence that choice of DMT affects risk of COVID-19 infection. Both studies were presented at the 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC).

For the survey, researchers led by neurologist Elizabeth H. Morrison-Banks, MD, of the University of California, Riverside, sent questions to 188 clinicians who serve on regional National Multiple Sclerosis Society Healthcare Provider Councils. A total of 86 people responded: 45 physicians, 18 rehabilitation therapists, 7 psychologists, 8 advanced practice clinicians, 4 social workers, 2 nurses, a pharmacist, and a researcher.

The results, which were published earlier in 2021 in Multiple Sclerosis and Related Disorders, revealed that the survey participants were prescribing certain DMTs more often: beta-interferons (prescribed more by 28.6% of prescribers), natalizumab (23.8%), and glatiramer acetate (21.4%). Those prescribed less included alemtuzumab (64.2% prescribed it less), cladribine (52.4%), and B cell–depleting agents including ocrelizumab and rituximab (50%). Some specialists suspended drugs entirely (21.4% for alemtuzumab, 16.7% for B cell–depleting agents) or extending dosing intervals (38.1% for natalizumab, 11.9% for fingolimod and siponimod).

“We suspect that some of the lower-efficacy therapies were prescribed more often because these therapies were much less immunosuppressive, and because they did not require in-person visits that would increase risk of viral exposure from infusion center staff, or from other infusion patients,” Dr. Morrison-Banks said in an interview. “We also suspect that some of our survey respondents may have increased the dosing intervals for higher-efficacy therapies such as B cell–modulating agents – or even avoided these therapies altogether – because they were concerned that immunosuppressive agents might trigger severe complications from COVID-19.”

As she noted, “in retrospect, at least some of the concerns expressed in our survey may not have been entirely warranted, but then again, we all knew even less then about COVID-19.”

Indeed, researchers led by neurologist Tyler E. Smith, MD, of New York University Langone Multiple Sclerosis Care Center are reporting that they couldn’t find any link between the following DMTs and higher rates of COVID-19 at the New York City center: rituximab, ocrelizumab, fumerate (dimethyl fumarate, monomethyl fumarate, diroximel fumarate), sphingosine-1-phosphate modulators (fingolimod, siponimod), and natalizumab.

The researchers tracked 1,439 patients with MS who were taking the DMTs from March 2020 to March 2021. Of those, 16.0% were infected with COVID-19 (75% lab confirmed), 6.5% were hospitalized, and 0.9% died.

“We did not find an association between the choice of disease-modifying therapy and developing COVID-19 infection, nor having increased disease severity,” Dr. Smith said in an interview. “We are still analyzing data and hope to publish an updated analysis, but at this point, we don’t have conclusive evidence that DMTs, including anti-CD20 agents, need to be changed to lower the risk of COVID-19.”

Instead, he said, “at this point, we feel our energies should be spent on educating our patients on importance of vaccines and boosters. I don’t think it is necessary to switch DMTs because of COVID-19 concerns. However, this should be reviewed on a case-by-case basis.”

No funding is reported for the survey study, and the authors reported various disclosures. The DMT study was funded by an investigator-initiated grant from the Consortium of Multiple Sclerosis Centers, and the authors reported various disclosures.
 

Most U.S. medical professionals who treat patients with multiple sclerosis (MS) appear to have adjusted drug regimens during the pandemic’s early months to lower the risk of COVID-19 infection. But they actually didn’t need to make changes then – or now. These are the messages of a pair of new studies that examine the impact of the pandemic on the treatment of MS.

One report finds that 80% of specialists surveyed in the summer of 2020 said the pandemic may have changed how they prescribe disease-modifying therapies (DMTs). However, the other report finds no evidence that choice of DMT affects risk of COVID-19 infection. Both studies were presented at the 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC).

For the survey, researchers led by neurologist Elizabeth H. Morrison-Banks, MD, of the University of California, Riverside, sent questions to 188 clinicians who serve on regional National Multiple Sclerosis Society Healthcare Provider Councils. A total of 86 people responded: 45 physicians, 18 rehabilitation therapists, 7 psychologists, 8 advanced practice clinicians, 4 social workers, 2 nurses, a pharmacist, and a researcher.

The results, which were published earlier in 2021 in Multiple Sclerosis and Related Disorders, revealed that the survey participants were prescribing certain DMTs more often: beta-interferons (prescribed more by 28.6% of prescribers), natalizumab (23.8%), and glatiramer acetate (21.4%). Those prescribed less included alemtuzumab (64.2% prescribed it less), cladribine (52.4%), and B cell–depleting agents including ocrelizumab and rituximab (50%). Some specialists suspended drugs entirely (21.4% for alemtuzumab, 16.7% for B cell–depleting agents) or extending dosing intervals (38.1% for natalizumab, 11.9% for fingolimod and siponimod).

“We suspect that some of the lower-efficacy therapies were prescribed more often because these therapies were much less immunosuppressive, and because they did not require in-person visits that would increase risk of viral exposure from infusion center staff, or from other infusion patients,” Dr. Morrison-Banks said in an interview. “We also suspect that some of our survey respondents may have increased the dosing intervals for higher-efficacy therapies such as B cell–modulating agents – or even avoided these therapies altogether – because they were concerned that immunosuppressive agents might trigger severe complications from COVID-19.”

As she noted, “in retrospect, at least some of the concerns expressed in our survey may not have been entirely warranted, but then again, we all knew even less then about COVID-19.”

Indeed, researchers led by neurologist Tyler E. Smith, MD, of New York University Langone Multiple Sclerosis Care Center are reporting that they couldn’t find any link between the following DMTs and higher rates of COVID-19 at the New York City center: rituximab, ocrelizumab, fumerate (dimethyl fumarate, monomethyl fumarate, diroximel fumarate), sphingosine-1-phosphate modulators (fingolimod, siponimod), and natalizumab.

The researchers tracked 1,439 patients with MS who were taking the DMTs from March 2020 to March 2021. Of those, 16.0% were infected with COVID-19 (75% lab confirmed), 6.5% were hospitalized, and 0.9% died.

“We did not find an association between the choice of disease-modifying therapy and developing COVID-19 infection, nor having increased disease severity,” Dr. Smith said in an interview. “We are still analyzing data and hope to publish an updated analysis, but at this point, we don’t have conclusive evidence that DMTs, including anti-CD20 agents, need to be changed to lower the risk of COVID-19.”

Instead, he said, “at this point, we feel our energies should be spent on educating our patients on importance of vaccines and boosters. I don’t think it is necessary to switch DMTs because of COVID-19 concerns. However, this should be reviewed on a case-by-case basis.”

No funding is reported for the survey study, and the authors reported various disclosures. The DMT study was funded by an investigator-initiated grant from the Consortium of Multiple Sclerosis Centers, and the authors reported various disclosures.
 

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CDC: Urgency remains to vaccinate children

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The CDC is urging parents and guardians to vaccinate children ages 5-11 against COVID-19 once the shot is fully approved, despite questions from FDA advisers about the urgency given falling national case rates.

On Oct. 26, the FDA’s Vaccines and Related Biological Products Advisory Committee voted to recommend a 10-microgram shot for children. Though 17 of the 18 panelists voted in favor of it, some members said it was a hard decision and questioned the need for it now that cases and hospitalizations are down.

“There’s urgency because we’re seeing disease in children, we’ve seen deaths in children, we’ve seen long COVID,” CDC Director Rochelle Walensky, MD, said at a White House briefing on Oct. 27. “Certainly we’ve seen cases come down before, and the way to prevent surges again is to get more and more people vaccinated.”

CDC data presented at an Oct. 26 advisory committee meeting show that among children 5-11, COVID-19 was one of top 10 causes of death over last year, Dr. Walensky said. There have been more than 8,300 hospitalizations and 745 deaths in children under 18.

As of yesterday, the 7-day average of daily COVID-19 cases was 65,900, a 16% decrease from the prior week. Hospitalizations are down 54% from the week of Aug. 28, Dr. Walensky said.

“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,” James Hildreth, MD, president and CEO at Meharry Medical College in Nashville, said at the advisory committee meeting on Oct. 26.

But according to one CDC study, hospitalization rates for adolescents were 10 times higher in those who were unvaccinated. Another study found that COVID-related emergency room visits and hospital admissions among children were more than 3 times as high in states with the lowest vaccination rates.

“We are down from our peak in early September, and we are now heading in the right direction, but with cases still high, we must remain vigilant heading into the colder, drier winter months,” Dr. Walensky said, noting that the 7-day average of daily deaths still exceeds 1,000.

Meanwhile, the booster program is off to a “very strong start,” said White House COVID-19 Response Coordinator Jeff Zients.

In the 5 days since authorizations, about 15 million people have received an additional dose of the Pfizer, Moderna, and Johnson & Johnson vaccines.

A version of this article first appeared on WebMD.com.

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The CDC is urging parents and guardians to vaccinate children ages 5-11 against COVID-19 once the shot is fully approved, despite questions from FDA advisers about the urgency given falling national case rates.

On Oct. 26, the FDA’s Vaccines and Related Biological Products Advisory Committee voted to recommend a 10-microgram shot for children. Though 17 of the 18 panelists voted in favor of it, some members said it was a hard decision and questioned the need for it now that cases and hospitalizations are down.

“There’s urgency because we’re seeing disease in children, we’ve seen deaths in children, we’ve seen long COVID,” CDC Director Rochelle Walensky, MD, said at a White House briefing on Oct. 27. “Certainly we’ve seen cases come down before, and the way to prevent surges again is to get more and more people vaccinated.”

CDC data presented at an Oct. 26 advisory committee meeting show that among children 5-11, COVID-19 was one of top 10 causes of death over last year, Dr. Walensky said. There have been more than 8,300 hospitalizations and 745 deaths in children under 18.

As of yesterday, the 7-day average of daily COVID-19 cases was 65,900, a 16% decrease from the prior week. Hospitalizations are down 54% from the week of Aug. 28, Dr. Walensky said.

“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,” James Hildreth, MD, president and CEO at Meharry Medical College in Nashville, said at the advisory committee meeting on Oct. 26.

But according to one CDC study, hospitalization rates for adolescents were 10 times higher in those who were unvaccinated. Another study found that COVID-related emergency room visits and hospital admissions among children were more than 3 times as high in states with the lowest vaccination rates.

“We are down from our peak in early September, and we are now heading in the right direction, but with cases still high, we must remain vigilant heading into the colder, drier winter months,” Dr. Walensky said, noting that the 7-day average of daily deaths still exceeds 1,000.

Meanwhile, the booster program is off to a “very strong start,” said White House COVID-19 Response Coordinator Jeff Zients.

In the 5 days since authorizations, about 15 million people have received an additional dose of the Pfizer, Moderna, and Johnson & Johnson vaccines.

A version of this article first appeared on WebMD.com.

The CDC is urging parents and guardians to vaccinate children ages 5-11 against COVID-19 once the shot is fully approved, despite questions from FDA advisers about the urgency given falling national case rates.

On Oct. 26, the FDA’s Vaccines and Related Biological Products Advisory Committee voted to recommend a 10-microgram shot for children. Though 17 of the 18 panelists voted in favor of it, some members said it was a hard decision and questioned the need for it now that cases and hospitalizations are down.

“There’s urgency because we’re seeing disease in children, we’ve seen deaths in children, we’ve seen long COVID,” CDC Director Rochelle Walensky, MD, said at a White House briefing on Oct. 27. “Certainly we’ve seen cases come down before, and the way to prevent surges again is to get more and more people vaccinated.”

CDC data presented at an Oct. 26 advisory committee meeting show that among children 5-11, COVID-19 was one of top 10 causes of death over last year, Dr. Walensky said. There have been more than 8,300 hospitalizations and 745 deaths in children under 18.

As of yesterday, the 7-day average of daily COVID-19 cases was 65,900, a 16% decrease from the prior week. Hospitalizations are down 54% from the week of Aug. 28, Dr. Walensky said.

“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,” James Hildreth, MD, president and CEO at Meharry Medical College in Nashville, said at the advisory committee meeting on Oct. 26.

But according to one CDC study, hospitalization rates for adolescents were 10 times higher in those who were unvaccinated. Another study found that COVID-related emergency room visits and hospital admissions among children were more than 3 times as high in states with the lowest vaccination rates.

“We are down from our peak in early September, and we are now heading in the right direction, but with cases still high, we must remain vigilant heading into the colder, drier winter months,” Dr. Walensky said, noting that the 7-day average of daily deaths still exceeds 1,000.

Meanwhile, the booster program is off to a “very strong start,” said White House COVID-19 Response Coordinator Jeff Zients.

In the 5 days since authorizations, about 15 million people have received an additional dose of the Pfizer, Moderna, and Johnson & Johnson vaccines.

A version of this article first appeared on WebMD.com.

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Chatbots can improve mental health in vulnerable populations

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Mon, 11/15/2021 - 08:55

In this modern age of health care where telemedicine rules, conversational agents (CAs) that use text messaging systems are becoming a major mode of communication.

Sammi Wong

Many people are familiar with voice-enabled agents, such as Apple’s Siri, Google Now, and Microsoft’s Cortana. However, CAs come in different forms of complexity, ranging from a short message service–based texting platform to an embodied conversational agent (ECA).

ECAs allow participants to interact with a physical or graphical figure that simulates a person in appearance, behavior, and dialect. These are essentially virtual humans, or avatars, who talk with participants. By taking greater advantage of these automated agents, some have projected there may be $11 billion in combined cost savings across a variety of business sectors by 2023.1 The health care field is one sector in which CAs can play an important role. Because of their accessibility, CAs have the potential to improve mental health by combating health care inequities and stigma, encouraging disclosure from participants, and serving as companions during the COVID-19 pandemic.

CAs provide accessible health care for rural, low socioeconomic status (SES), and minority communities in a variety of advantageous ways. For example, one study found that long-term use of a text-based agent that combines motivational interviewing and cognitive-behavioral therapy (CBT) can support smoking cessation in adolescents of low SES.2

CAs can help vulnerable participants advocate for themselves and proactively maintain their mental health through access to health care resources. In specific cases, these agents equalize health care treatment for different populations. Even though some participants live in secluded areas or are blocked by barriers, these text-based agents can still provide self-help intervention for them at any time on an individual basis, regardless of their location or socioeconomic status. Furthermore, they serve as highly cost-effective mental health promotion tools for large populations, some of which might not otherwise be reached by mental health care.

In combating mental illnesses such as depression and anxiety, studies have found that CAs are great treatment tools. For example, participants in an experimental group who received a self-help program based on CBT from a text-based CA named Woebot experienced significantly reduced depression symptoms when compared to the control group of participants, who received only information from a self-help electronic book.3 As a result, CAs might prove successful in treating younger populations who find online tools more feasible and accessible. Often, this population self-identifies depressive and anxiety symptoms without consulting a health care professional. Thus, this tool would prove useful to those who are bothered by the stigma of seeing a mental health professional.

Virtual human–based CAs also encourage participants to disclose more information in a nonjudgmental manner, especially among people with diseases with stigma. CAs use neutral languages, which may be helpful when dealing with stigmatized issues such as HIV, family planning, and abortion care because this heightens confidentiality and privacy. When participants believe that the agent does not “judge” or evaluate their capabilities, this elicits more sensitive information from them. For example, one study found that military service members who believed that they were interacting with a computer rather than a human operator reported lower fear of self-disclosure, displayed more sadness, and were rated by observers as more willing to disclose posttraumatic stress disorder symptoms.4 Additional findings show that participants prefer CAs when topics are highly sensitive and more likely to evoke negative self-admissions.

In what we hope will soon be a post–COVID-19 landscape of medicine, CAs are fast being used on the front lines of health care technology. Empathetic CAs can combat adverse effects of social exclusion during these pressing times. Etsuko Ishii, a researcher affiliated with the Hong Kong University of Science and Technology, and associates demonstrated that a virtual CA was as effective as a COVID-19 companion because it uses natural language processing (NLP) and nonverbal facial expressions to give users the feeling that they are being treated with empathy.5 While minimizing the number of in-person interactions that could potentially spread COVID-19, these agents promote virtual companionship that mirrors natural conversations and provide emotional support with psychological safety as participants express their pent-up thoughts. Not only do these agents help recover mood quickly, but they also have the power to overcome geographic barriers, be constantly available, and alleviate the high demand for mental health care. As a result, CAs have the potential to facilitate better communication and sustain social interactions within the isolated environment the pandemic has created.

CAs can predict, detect, and determine treatment solutions for mental health conditions based on behavioral insights. These agents’ natural language processing also allows them to be powerful therapeutic agents that can serve different communities, particularly for populations with limited access to medical resources. As the use of CAs becomes more integrated into telemedicine, their utility will continue to grow as their proven versatility in many situations expands the boundaries of health care technology.
 

Ms. Wong, a medical student at New York Institute of Technology College of Osteopathic Medicine in Old Westbury, conducts research related to mental health care services. She disclosed writing a telemental health software platform called Orchid. Dr. Vo, a board-certified psychiatrist, is the medical director of telehealth for the department of child and adolescent psychiatry and behavioral sciences at Children’s Hospital of Philadelphia. She is a faculty member of the University of Pennsylvania, also in Philadelphia. Dr. Vo conducts digital health research focused on using automation and artificial intelligence for suicide risk screening and connecting patients to mental health care services. She disclosed serving as cofounder of Orchid.

References

1. Chatbots: Vendor opportunities & market forecasts 2020-2024. Juniper Research, 2020.

2. Simon P et al. On using chatbots to promote smoking cessation among adolescents of low socioeconomic status, Artificial Intelligence and Work: Association for the Advancement of Artificial Intelligence (AAAI) 2019 Fall Symposium, 2019.

3. Fitzpatrick KK et al. JMIR Mental Health. 2017;4(2):e19.

4. Lucas GM et al. Front Robot AI. 2017 Oct 12. doi: 10.3389/frobt.2017.00051.

5. Ishii E et al. ERICA: An empathetic android companion for COVID-19 quarantine. arXiv preprint arXiv:2106.02325.

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In this modern age of health care where telemedicine rules, conversational agents (CAs) that use text messaging systems are becoming a major mode of communication.

Sammi Wong

Many people are familiar with voice-enabled agents, such as Apple’s Siri, Google Now, and Microsoft’s Cortana. However, CAs come in different forms of complexity, ranging from a short message service–based texting platform to an embodied conversational agent (ECA).

ECAs allow participants to interact with a physical or graphical figure that simulates a person in appearance, behavior, and dialect. These are essentially virtual humans, or avatars, who talk with participants. By taking greater advantage of these automated agents, some have projected there may be $11 billion in combined cost savings across a variety of business sectors by 2023.1 The health care field is one sector in which CAs can play an important role. Because of their accessibility, CAs have the potential to improve mental health by combating health care inequities and stigma, encouraging disclosure from participants, and serving as companions during the COVID-19 pandemic.

CAs provide accessible health care for rural, low socioeconomic status (SES), and minority communities in a variety of advantageous ways. For example, one study found that long-term use of a text-based agent that combines motivational interviewing and cognitive-behavioral therapy (CBT) can support smoking cessation in adolescents of low SES.2

CAs can help vulnerable participants advocate for themselves and proactively maintain their mental health through access to health care resources. In specific cases, these agents equalize health care treatment for different populations. Even though some participants live in secluded areas or are blocked by barriers, these text-based agents can still provide self-help intervention for them at any time on an individual basis, regardless of their location or socioeconomic status. Furthermore, they serve as highly cost-effective mental health promotion tools for large populations, some of which might not otherwise be reached by mental health care.

In combating mental illnesses such as depression and anxiety, studies have found that CAs are great treatment tools. For example, participants in an experimental group who received a self-help program based on CBT from a text-based CA named Woebot experienced significantly reduced depression symptoms when compared to the control group of participants, who received only information from a self-help electronic book.3 As a result, CAs might prove successful in treating younger populations who find online tools more feasible and accessible. Often, this population self-identifies depressive and anxiety symptoms without consulting a health care professional. Thus, this tool would prove useful to those who are bothered by the stigma of seeing a mental health professional.

Virtual human–based CAs also encourage participants to disclose more information in a nonjudgmental manner, especially among people with diseases with stigma. CAs use neutral languages, which may be helpful when dealing with stigmatized issues such as HIV, family planning, and abortion care because this heightens confidentiality and privacy. When participants believe that the agent does not “judge” or evaluate their capabilities, this elicits more sensitive information from them. For example, one study found that military service members who believed that they were interacting with a computer rather than a human operator reported lower fear of self-disclosure, displayed more sadness, and were rated by observers as more willing to disclose posttraumatic stress disorder symptoms.4 Additional findings show that participants prefer CAs when topics are highly sensitive and more likely to evoke negative self-admissions.

In what we hope will soon be a post–COVID-19 landscape of medicine, CAs are fast being used on the front lines of health care technology. Empathetic CAs can combat adverse effects of social exclusion during these pressing times. Etsuko Ishii, a researcher affiliated with the Hong Kong University of Science and Technology, and associates demonstrated that a virtual CA was as effective as a COVID-19 companion because it uses natural language processing (NLP) and nonverbal facial expressions to give users the feeling that they are being treated with empathy.5 While minimizing the number of in-person interactions that could potentially spread COVID-19, these agents promote virtual companionship that mirrors natural conversations and provide emotional support with psychological safety as participants express their pent-up thoughts. Not only do these agents help recover mood quickly, but they also have the power to overcome geographic barriers, be constantly available, and alleviate the high demand for mental health care. As a result, CAs have the potential to facilitate better communication and sustain social interactions within the isolated environment the pandemic has created.

CAs can predict, detect, and determine treatment solutions for mental health conditions based on behavioral insights. These agents’ natural language processing also allows them to be powerful therapeutic agents that can serve different communities, particularly for populations with limited access to medical resources. As the use of CAs becomes more integrated into telemedicine, their utility will continue to grow as their proven versatility in many situations expands the boundaries of health care technology.
 

Ms. Wong, a medical student at New York Institute of Technology College of Osteopathic Medicine in Old Westbury, conducts research related to mental health care services. She disclosed writing a telemental health software platform called Orchid. Dr. Vo, a board-certified psychiatrist, is the medical director of telehealth for the department of child and adolescent psychiatry and behavioral sciences at Children’s Hospital of Philadelphia. She is a faculty member of the University of Pennsylvania, also in Philadelphia. Dr. Vo conducts digital health research focused on using automation and artificial intelligence for suicide risk screening and connecting patients to mental health care services. She disclosed serving as cofounder of Orchid.

References

1. Chatbots: Vendor opportunities & market forecasts 2020-2024. Juniper Research, 2020.

2. Simon P et al. On using chatbots to promote smoking cessation among adolescents of low socioeconomic status, Artificial Intelligence and Work: Association for the Advancement of Artificial Intelligence (AAAI) 2019 Fall Symposium, 2019.

3. Fitzpatrick KK et al. JMIR Mental Health. 2017;4(2):e19.

4. Lucas GM et al. Front Robot AI. 2017 Oct 12. doi: 10.3389/frobt.2017.00051.

5. Ishii E et al. ERICA: An empathetic android companion for COVID-19 quarantine. arXiv preprint arXiv:2106.02325.

In this modern age of health care where telemedicine rules, conversational agents (CAs) that use text messaging systems are becoming a major mode of communication.

Sammi Wong

Many people are familiar with voice-enabled agents, such as Apple’s Siri, Google Now, and Microsoft’s Cortana. However, CAs come in different forms of complexity, ranging from a short message service–based texting platform to an embodied conversational agent (ECA).

ECAs allow participants to interact with a physical or graphical figure that simulates a person in appearance, behavior, and dialect. These are essentially virtual humans, or avatars, who talk with participants. By taking greater advantage of these automated agents, some have projected there may be $11 billion in combined cost savings across a variety of business sectors by 2023.1 The health care field is one sector in which CAs can play an important role. Because of their accessibility, CAs have the potential to improve mental health by combating health care inequities and stigma, encouraging disclosure from participants, and serving as companions during the COVID-19 pandemic.

CAs provide accessible health care for rural, low socioeconomic status (SES), and minority communities in a variety of advantageous ways. For example, one study found that long-term use of a text-based agent that combines motivational interviewing and cognitive-behavioral therapy (CBT) can support smoking cessation in adolescents of low SES.2

CAs can help vulnerable participants advocate for themselves and proactively maintain their mental health through access to health care resources. In specific cases, these agents equalize health care treatment for different populations. Even though some participants live in secluded areas or are blocked by barriers, these text-based agents can still provide self-help intervention for them at any time on an individual basis, regardless of their location or socioeconomic status. Furthermore, they serve as highly cost-effective mental health promotion tools for large populations, some of which might not otherwise be reached by mental health care.

In combating mental illnesses such as depression and anxiety, studies have found that CAs are great treatment tools. For example, participants in an experimental group who received a self-help program based on CBT from a text-based CA named Woebot experienced significantly reduced depression symptoms when compared to the control group of participants, who received only information from a self-help electronic book.3 As a result, CAs might prove successful in treating younger populations who find online tools more feasible and accessible. Often, this population self-identifies depressive and anxiety symptoms without consulting a health care professional. Thus, this tool would prove useful to those who are bothered by the stigma of seeing a mental health professional.

Virtual human–based CAs also encourage participants to disclose more information in a nonjudgmental manner, especially among people with diseases with stigma. CAs use neutral languages, which may be helpful when dealing with stigmatized issues such as HIV, family planning, and abortion care because this heightens confidentiality and privacy. When participants believe that the agent does not “judge” or evaluate their capabilities, this elicits more sensitive information from them. For example, one study found that military service members who believed that they were interacting with a computer rather than a human operator reported lower fear of self-disclosure, displayed more sadness, and were rated by observers as more willing to disclose posttraumatic stress disorder symptoms.4 Additional findings show that participants prefer CAs when topics are highly sensitive and more likely to evoke negative self-admissions.

In what we hope will soon be a post–COVID-19 landscape of medicine, CAs are fast being used on the front lines of health care technology. Empathetic CAs can combat adverse effects of social exclusion during these pressing times. Etsuko Ishii, a researcher affiliated with the Hong Kong University of Science and Technology, and associates demonstrated that a virtual CA was as effective as a COVID-19 companion because it uses natural language processing (NLP) and nonverbal facial expressions to give users the feeling that they are being treated with empathy.5 While minimizing the number of in-person interactions that could potentially spread COVID-19, these agents promote virtual companionship that mirrors natural conversations and provide emotional support with psychological safety as participants express their pent-up thoughts. Not only do these agents help recover mood quickly, but they also have the power to overcome geographic barriers, be constantly available, and alleviate the high demand for mental health care. As a result, CAs have the potential to facilitate better communication and sustain social interactions within the isolated environment the pandemic has created.

CAs can predict, detect, and determine treatment solutions for mental health conditions based on behavioral insights. These agents’ natural language processing also allows them to be powerful therapeutic agents that can serve different communities, particularly for populations with limited access to medical resources. As the use of CAs becomes more integrated into telemedicine, their utility will continue to grow as their proven versatility in many situations expands the boundaries of health care technology.
 

Ms. Wong, a medical student at New York Institute of Technology College of Osteopathic Medicine in Old Westbury, conducts research related to mental health care services. She disclosed writing a telemental health software platform called Orchid. Dr. Vo, a board-certified psychiatrist, is the medical director of telehealth for the department of child and adolescent psychiatry and behavioral sciences at Children’s Hospital of Philadelphia. She is a faculty member of the University of Pennsylvania, also in Philadelphia. Dr. Vo conducts digital health research focused on using automation and artificial intelligence for suicide risk screening and connecting patients to mental health care services. She disclosed serving as cofounder of Orchid.

References

1. Chatbots: Vendor opportunities & market forecasts 2020-2024. Juniper Research, 2020.

2. Simon P et al. On using chatbots to promote smoking cessation among adolescents of low socioeconomic status, Artificial Intelligence and Work: Association for the Advancement of Artificial Intelligence (AAAI) 2019 Fall Symposium, 2019.

3. Fitzpatrick KK et al. JMIR Mental Health. 2017;4(2):e19.

4. Lucas GM et al. Front Robot AI. 2017 Oct 12. doi: 10.3389/frobt.2017.00051.

5. Ishii E et al. ERICA: An empathetic android companion for COVID-19 quarantine. arXiv preprint arXiv:2106.02325.

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