Rheumatology News

The US Food and Drug Administration on Aug. 28 expanded its emergency use authorization (EUA) of remdesivir (Veklury) to include treatment of all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease.

An EUA of remdesivir issued in May allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who need oxygen therapy or mechanical ventilation.

“Today, based on the Agency’s ongoing review of the EUA, including its review of the totality of scientific information now available, the FDA has determined that it is reasonable to believe Veklury may be effective for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients,” the FDA news release about the expanded EUA said. “The Agency’s review has also concluded that the known and potential benefits of Veklury outweigh the known and potential risks for these uses.”
 

‘Further evaluation’ needed

The EUA expansion is partially based on the results of a randomized, open-label trial that Gilead Sciences, remdesivir’s manufacturer, conducted at multiple sites.

The trial showed that a 5-day course of remdesivir was associated with statistically significant improvement among patients hospitalized with moderate COVID-19 in comparison with those receiving standard care. However, patients who were randomly assigned to a receive longer, 10-day remdesivir course had not improved significantly 11 days after treatment started, compared with those who received standard care.

Results with remdesivir in this trial and in two previously reported randomized trials varied, “raising the question of whether the discrepancies are artifacts of study design choices, including patient populations, or whether the drug is less efficacious than hoped,” wrote Erin K. McCreary, PharmD, and Derek C. Angus, MD, MPH, with the University of Pittsburgh School of Medicine, in an editorial that accompanied publication of the trials in JAMA.

Angus previously expressed concern that expanding remdesivir’s EUA could “interrupt or thwart efforts to execute the needed RCTs [randomized controlled trials].

“We think there really needs to be further evaluation of remdesivir in large-scale RCTs adequately powered to understand in which patients, at which dose, given at which point in the course of illness leads to what concrete and tangible improvement in clinical outcomes,” he told Medscape Medical News.

“At this point, remdesivir definitely holds promise, but given the cost to produce and distribute the drug, it seems crucial to know with more certainty how best to use it,” Angus said.

The EUA expansion is also partially based on results from a randomized, double-blind, placebo-controlled clinical trial that the National Institutes of Allergy and Infectious Diseases conducted. In that trial, there was a statistically significant reduction in median recovery time and higher odds of clinical improvement after 2 weeks for hospitalized patients who received remdesivir.

For hospitalized patients with mild to moderate disease, the results were consistent with the overall study results but were not statistically significant.
 

This article first appeared on Medscape.com.

The US Food and Drug Administration on Aug. 28 expanded its emergency use authorization (EUA) of remdesivir (Veklury) to include treatment of all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease.

An EUA of remdesivir issued in May allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who need oxygen therapy or mechanical ventilation.

“Today, based on the Agency’s ongoing review of the EUA, including its review of the totality of scientific information now available, the FDA has determined that it is reasonable to believe Veklury may be effective for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients,” the FDA news release about the expanded EUA said. “The Agency’s review has also concluded that the known and potential benefits of Veklury outweigh the known and potential risks for these uses.”
 

‘Further evaluation’ needed

The EUA expansion is partially based on the results of a randomized, open-label trial that Gilead Sciences, remdesivir’s manufacturer, conducted at multiple sites.

The trial showed that a 5-day course of remdesivir was associated with statistically significant improvement among patients hospitalized with moderate COVID-19 in comparison with those receiving standard care. However, patients who were randomly assigned to a receive longer, 10-day remdesivir course had not improved significantly 11 days after treatment started, compared with those who received standard care.

Results with remdesivir in this trial and in two previously reported randomized trials varied, “raising the question of whether the discrepancies are artifacts of study design choices, including patient populations, or whether the drug is less efficacious than hoped,” wrote Erin K. McCreary, PharmD, and Derek C. Angus, MD, MPH, with the University of Pittsburgh School of Medicine, in an editorial that accompanied publication of the trials in JAMA.

Angus previously expressed concern that expanding remdesivir’s EUA could “interrupt or thwart efforts to execute the needed RCTs [randomized controlled trials].

“We think there really needs to be further evaluation of remdesivir in large-scale RCTs adequately powered to understand in which patients, at which dose, given at which point in the course of illness leads to what concrete and tangible improvement in clinical outcomes,” he told Medscape Medical News.

“At this point, remdesivir definitely holds promise, but given the cost to produce and distribute the drug, it seems crucial to know with more certainty how best to use it,” Angus said.

The EUA expansion is also partially based on results from a randomized, double-blind, placebo-controlled clinical trial that the National Institutes of Allergy and Infectious Diseases conducted. In that trial, there was a statistically significant reduction in median recovery time and higher odds of clinical improvement after 2 weeks for hospitalized patients who received remdesivir.

For hospitalized patients with mild to moderate disease, the results were consistent with the overall study results but were not statistically significant.
 

This article first appeared on Medscape.com.

The US Food and Drug Administration on Aug. 28 expanded its emergency use authorization (EUA) of remdesivir (Veklury) to include treatment of all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease.

An EUA of remdesivir issued in May allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who need oxygen therapy or mechanical ventilation.

“Today, based on the Agency’s ongoing review of the EUA, including its review of the totality of scientific information now available, the FDA has determined that it is reasonable to believe Veklury may be effective for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients,” the FDA news release about the expanded EUA said. “The Agency’s review has also concluded that the known and potential benefits of Veklury outweigh the known and potential risks for these uses.”
 

‘Further evaluation’ needed

The EUA expansion is partially based on the results of a randomized, open-label trial that Gilead Sciences, remdesivir’s manufacturer, conducted at multiple sites.

The trial showed that a 5-day course of remdesivir was associated with statistically significant improvement among patients hospitalized with moderate COVID-19 in comparison with those receiving standard care. However, patients who were randomly assigned to a receive longer, 10-day remdesivir course had not improved significantly 11 days after treatment started, compared with those who received standard care.

Results with remdesivir in this trial and in two previously reported randomized trials varied, “raising the question of whether the discrepancies are artifacts of study design choices, including patient populations, or whether the drug is less efficacious than hoped,” wrote Erin K. McCreary, PharmD, and Derek C. Angus, MD, MPH, with the University of Pittsburgh School of Medicine, in an editorial that accompanied publication of the trials in JAMA.

Angus previously expressed concern that expanding remdesivir’s EUA could “interrupt or thwart efforts to execute the needed RCTs [randomized controlled trials].

“We think there really needs to be further evaluation of remdesivir in large-scale RCTs adequately powered to understand in which patients, at which dose, given at which point in the course of illness leads to what concrete and tangible improvement in clinical outcomes,” he told Medscape Medical News.

“At this point, remdesivir definitely holds promise, but given the cost to produce and distribute the drug, it seems crucial to know with more certainty how best to use it,” Angus said.

The EUA expansion is also partially based on results from a randomized, double-blind, placebo-controlled clinical trial that the National Institutes of Allergy and Infectious Diseases conducted. In that trial, there was a statistically significant reduction in median recovery time and higher odds of clinical improvement after 2 weeks for hospitalized patients who received remdesivir.

For hospitalized patients with mild to moderate disease, the results were consistent with the overall study results but were not statistically significant.
 

This article first appeared on Medscape.com.

New York City Health + Hospitals (NYCH+H), the country’s largest public health care system, encompasses 11 hospitals with 4,354 staffed acute beds during normal times. It serves as the safety net for 1.1 million of the 8.4 million residents of the most populous city in the United States, many of them uninsured, undocumented, covered by Medicaid, or otherwise disadvantaged.

At the very epicenter in the early days of the historic COVID-19 pandemic, NYCH+H transferred patients between its facilities, added medical and ICU beds by the hundreds, mobilized palliative care volunteers, harnessed telemedicine and a clinician hotline, and made other sweeping changes to ensure that the city’s public health system would be able to respond to demand at the peak of the surge. That peak hit in April, when an average of 9,000 new COVID-19 cases were being reported in the city every day.

Through it all, hospitalists have played critical roles in both planning for the system’s response and caring for severely ill COVID-19 patients. Their stories reflect both the unprecedented demands on the system and the dedication of frontline clinicians.

One of those, Carla Saladini-Aponte, MD, who just finished her residency in June 2019, found herself on the firing line in March 2020 as an attending physician at 457-bed NYCH+H/Jacobi Hospital in the Bronx. “I have experienced so much in my first year on the job, dealing with a disease that we’ve never seen before,” she said. “We didn’t grasp the extent of the COVID crisis in the beginning, so we were emotionally unprepared when it first hit.”

Starting on March 30, NYCH+H administration mobilized a centralized incident command structure to coordinate response systemwide to a rapidly changing situation.

Two weeks later Jacobi was a COVID-19 hospital, top to bottom, with its medical ICU beds increased from 12 to more than 100. By mid-April, Dr. Saladini-Aponte’s team, one of 11 medical teams in the hospital, had 26 patients, all of them with COVID-19. There was not a consensus in the early days on how to manage patients with severe respiratory distress. “But by the time the surge came, we had a better understanding of the scope of the situation,” she said.

Learning to be an attending

“They don’t teach you how to be an attending during residency,” Dr. Saladini-Aponte said. “At the beginning I wasn’t such a good teacher. I just wanted to prove myself and stay one step ahead of the residents. But as an academic hospitalist you have to listen to others. I learned to ask questions of the residents every morning, including how they were doing personally.”

Sometimes a visiting consultant would ask on the floor: “‘Where’s your attending?’” not recognizing Dr. Saladini-Aponte, fresh out of residency, filling that role. At times, she felt like a PGY-4 (postgraduate year 4). But she quickly grew into the attending role and was asked to be site coordinator for the mobilization of palliative medicine volunteers at Jacobi.

“We found ourselves having to make tough ethical decisions. Some patients, even if we provided a ventilator and maximum oxygen therapy, would still die. There were difficult discussions when we didn’t know if we had enough dialysis machines, or how to manage other limited resources. The hospital was saying: You decide, if there’s a high degree of certainty about the outcome. But we had never practiced medicine this way before,” she said.

“That’s why our hospital provided daily ethics meetings with our ethics council. There would be eight people sitting 6 feet apart in a conference room, all wearing masks. We’d talk about situations that were giving us trouble. Their role wasn’t to provide answers but to help us see the scope of the situation and the complexities,” she explained.

Dr. Saladini-Aponte said she has had many sleepless nights since the pandemic began. “Sometimes, I would come home from work and lie down on the floor and cry,” she said. “But we had so much support from volunteers helping our little hospitalist service of seven.” It was also important to keep up with the clinical information, and one of her coworkers created “cheat sheets” for the clinicians, regularly updated with the latest essential information on antibiotics, testing, and the like.

“At the peak, I was trying to read everything I could about the virus. I was just pulling myself in too many directions. I asked for help from my boyfriend to remind me not to log onto my computer when I came home from work,” she said. “One of my techniques for preventing burnout was just to avoid social media. I couldn’t deal with what was going on in the news. It just angered me. Even now, seeing people without masks makes me very uncomfortable.”
 

Organizing the crisis response

As chief value officer for NYCH+H, Hyung (Harry) Cho, MD, FACP, SFHM, typically focuses on issues of patient safety and overuse of medical treatments in the health system. But in the COVID-19 crisis, he found himself at the forefront of organizing its response. “We tried to provide support centrally and to standardize practice in how we test and treat,” he said.

“We were truly at the epicenter of the pandemic,” Dr. Cho said. “All of our hospitals had different experiences, and unique responses. But the system worked well.” Patients were transferred from the more overtaxed hospitals to Bellevue and other NYCH+H hospitals with spare beds. An emergency medical response structure was put in place, and every morning the system’s Tiger Team, with multidisciplinary personnel from administration, operations, logistics, and medical/technical specialists, would gather virtually to discuss needs across the system.

“It was a very open atmosphere and we asked people to report what was happening on the ground,” Dr. Cho said. “We started rapidly reviewing batches of 20 patients at a time for transfer in order to alleviate pressure in the most overtaxed ERs.”

NYCH+H also had to work through concerns about PPE, just like other U.S. hospitals. Treatment guidelines were changing by the day. Medical concerns were relayed at a rapid pace. Another priority was trying to limit unnecessary exposure for staff through a recommendation that only one clinician from a team would go into the room of an infected patient, unless another was absolutely needed.

The reality of public health

NYCH+H was created by the New York State Legislature in 1969 and rebranded in 2015. It includes a low- to no-cost health insurance plan called MetroPlus, along with outpatient centers, comprehensive case management, and social supports in the home.

“What people know about public health systems is that we typically are underresourced. That’s just the reality of public health,” Dr. Cho said. “We help the community, the underserved. The people who truly needed our help are also the ones who have been disproportionately affected by COVID-19. And that is where we really shine as a system.”

Dr. Cho lauded the performance of the health system’s frontline staff. “Watching them come together during the entire pandemic, and do their best every day, was truly inspiring,” he said. “But when they got to the peak, it really took an emotional toll on them.”

NYCH+H’s in-house staff support program, called Helping Healers Heal, was mobilized with specially trained teams at each of its 11 hospitals to provide peer-to-peer support, mental health expertise, and team-debriefing sessions to staff members following traumatic events. Support is provided both over the phone and in person on the floors, Dr. Cho said. “During the surge, everything was happening so quickly, there was no time to take a pause. Now, as we are able to catch our breath, that’s when they most need support.”

The hospitalists at NYCH+H hospitals intended to have goals-of-care conversations with all patients, but everyone was very busy – so having these conversations became harder and harder, Dr. Cho said. Recognizing limited staffing for the quadrupling of patients who needed palliative care at NYCH+H hospitals, he asked the medicine chairs about their palliative care needs and then used social media outreach to ask for help. The message went viral, attracting 413 volunteers from across the country. Sixty-seven telepalliative volunteers were put to work doing goals-of-care conversations remotely with inpatients and their families.¹

Expediting transfers

For Ian Fagan, MD, a hospitalist and associate medical director for general internal medicine Inpatient Services at Bellevue Hospital in Manhattan, hospitalist shifts are a normal part of his job. But he had to give them up during the surge to focus on planning, management, and especially scheduling other doctors, with sufficient backups needed to cover last minute changes. Dr. Fagan did that by using the existing pool of hospitalist staff, physicians who were reassigned from other specialties, agency staff, military medical personnel, and volunteer doctors who flew in from around the country to help. He also worked 10- to 12-hour days for 36 consecutive days.

The impact of disparities in access to care in New York City was reflected in the greater demand for care in the hospitals in Brooklyn, Queens, and the Bronx. “With fewer patients and more hospital beds in Manhattan, we had the capacity to share our beds,” Dr. Fagan said. “It was so amazing to me how quickly we could move patients from one hospital to another. We started accepting up to 40 transfers a day. But hey, we were still really busy.”

Bellevue is the nation’s oldest public hospital. “We care for the homeless, for immigrants, and we don’t ask questions. That’s our mission. I’m so proud to work here, and so grateful,” Dr. Fagan said. “If someone is undocumented or without insurance, I will give them exactly the same care. We stepped up in a big way to care for people of New York, but we’ve always been there for them – and we were there for them during the COVID surge.”

The hospitals in the system also worked together in ways Dr. Fagan had never seen. “It helped to have a central command structure with a bird’s eye view from above the level of individual hospitals, to organize and see which hospitals could step up. It’s good to have the data to put it in perspective,” he said. The system also utilized a temporary low-acuity medical center set up by NYCH+H on Roosevelt Island, as well as field hospitals organized at the Jacob K. Javits Convention Center and the USTA Billie Jean King National Tennis Center.

“At Bellevue we tried to stay ready, with the ability to turn former hospital units that were being used as offices back to beds. We always had three units lined up that were fully ready to convert. For example, I was medical director of the preop clinic and one day they gave us 24 hours to pack everything and move out. Three days later, it was a 24-bed unit. We also built a more robust rapid response and code team,” he said.

“It was hard for me not to take hospitalist shifts, because my identity is being a doctor. I eventually came to terms with the importance of the role that I was doing every day. I felt I could protect my colleagues, and if they were having an emotional day, to give them the opportunity to talk to someone. I also did the onboarding, one-on-one, of the new doctors.”

As the crisis in New York City has ebbed, Dr. Fagan was recently able to again take a week of clinical service. “The first day back on the floor I felt that I had forgotten everything. But by the end of the day, I thought, ‘Okay, I do know how to do this, after all.’ Census is down here. It’s quiet. That’s good. We need it now,” he said.

“I think the hardest moment for me was when the head nurse on our trauma unit, Ernesto DeLeon, known to everybody here, died of COVID in our ICU in April,” Dr. Fagan said. When Mr. DeLeon died, 100 hospital personnel gathered in the halls outside the room to pay their respects. “There had been a palpable fear in our lives – and this showed us that the fear was real. Ernesto was the first person I knew well who died, who acquired COVID at work doing what we’re all doing. We haven’t lost any doctors yet, but when this nurse died, we allowed ourselves to realize that this is personal. In that moment, we needed to allow ourselves to be human.”

Joan Curcio, MD, associate director of medicine at Elmhurst Hospital, said Elmhurst was where the story started for New York City and for NYCH+H. “I trained here and have spent my entire career at this hospital. It came to feel like what a battleground must be like, with things coming at you from every direction,” she said. “It was overwhelming in ways I could not have foreseen. I had seen videos from Italy [an early COVID-19 epicenter], but until it happened here, it was just hard to process.”

Things started slowly, with a few patients with severe acute respiratory distress syndrome and a 5- to 7-day turnaround to get results of their viral infection tests. “By week 2, a greater number of patients from our clinics and testing sites were filtering through the emergency department. Then hundreds.”

The normal occupancy rate for the department of medicine at Elmhurst is 110-115%, which typically means full beds plus patients in the emergency department. “We started to grow to 160, then 180, and then a peak of 250% of occupancy. We took over a rehab surgery floor, then a 35-bed surgery and hospice floor, which went to full capacity just like that,” she said. The number of non–critical care service teams increased to 20, working with redeployed staff, volunteers, military, and agency personnel, while ICU beds increased from 20 to 105.

“We were dealing with a much higher acuity level and enduring emotional turmoil with families, trying to carve out time to call them after our shift was over,” Dr. Curcio explained. Elmhurst developed a call-in hotline and a daily call-out service for families. Technology was mobilized to provide video visits and new systems were designed for isolation and for PPE distribution and use.

“I just felt that I couldn’t get everything done. I felt continually overwhelmed, and it didn’t matter how much time I took. I never felt I was able to give enough to anybody in any area, which was hard to take,” Dr. Curcio said. “But I still felt a sense of purpose and that I was making a difference – thanks to lots of support from the central office.”

Patient volume at Elmhurst is now down, lower than Dr. Curcio has ever seen it. “One of the main issues right now, moving forward, is ‘how do we function in a post-crisis mode?’” she said. The process of transitioning back to non-COVID-19 care will be complex. “When we clear a floor and clean it to go back to being a cold [COVID-19-negative] unit, it’s a whole different level of cleaning that takes 7 days.”

One moment that was particularly jarring for Dr. Curcio occurred while she was giving a tour of the hospital to visiting military medical personnel. “We went into the emergency department and I turned around and looked into a shower room, which was full of body bags. They were all full.”

But the experience has also been inspiring. “People gave their all without complaint. We hospitalists, and all those recruited to act as hospitalists, essentially took responsibility for the COVID response,” she said. “This was, hopefully, the experience of a lifetime as a medical professional. I wouldn’t want to ever experience something as daunting as this again.”
 

Reference

1. Israilov S et al. National outreach of telepalliative medicine volunteers for a New York City safety net system COVID-19 pandemic response. J Pain Symptom Manag. 2020 May 29. doi: 10.1016/j.jpainsymman.2020.05.026.

New York City Health + Hospitals (NYCH+H), the country’s largest public health care system, encompasses 11 hospitals with 4,354 staffed acute beds during normal times. It serves as the safety net for 1.1 million of the 8.4 million residents of the most populous city in the United States, many of them uninsured, undocumented, covered by Medicaid, or otherwise disadvantaged.

At the very epicenter in the early days of the historic COVID-19 pandemic, NYCH+H transferred patients between its facilities, added medical and ICU beds by the hundreds, mobilized palliative care volunteers, harnessed telemedicine and a clinician hotline, and made other sweeping changes to ensure that the city’s public health system would be able to respond to demand at the peak of the surge. That peak hit in April, when an average of 9,000 new COVID-19 cases were being reported in the city every day.

Through it all, hospitalists have played critical roles in both planning for the system’s response and caring for severely ill COVID-19 patients. Their stories reflect both the unprecedented demands on the system and the dedication of frontline clinicians.

One of those, Carla Saladini-Aponte, MD, who just finished her residency in June 2019, found herself on the firing line in March 2020 as an attending physician at 457-bed NYCH+H/Jacobi Hospital in the Bronx. “I have experienced so much in my first year on the job, dealing with a disease that we’ve never seen before,” she said. “We didn’t grasp the extent of the COVID crisis in the beginning, so we were emotionally unprepared when it first hit.”

Starting on March 30, NYCH+H administration mobilized a centralized incident command structure to coordinate response systemwide to a rapidly changing situation.

Two weeks later Jacobi was a COVID-19 hospital, top to bottom, with its medical ICU beds increased from 12 to more than 100. By mid-April, Dr. Saladini-Aponte’s team, one of 11 medical teams in the hospital, had 26 patients, all of them with COVID-19. There was not a consensus in the early days on how to manage patients with severe respiratory distress. “But by the time the surge came, we had a better understanding of the scope of the situation,” she said.

Learning to be an attending

“They don’t teach you how to be an attending during residency,” Dr. Saladini-Aponte said. “At the beginning I wasn’t such a good teacher. I just wanted to prove myself and stay one step ahead of the residents. But as an academic hospitalist you have to listen to others. I learned to ask questions of the residents every morning, including how they were doing personally.”

Sometimes a visiting consultant would ask on the floor: “‘Where’s your attending?’” not recognizing Dr. Saladini-Aponte, fresh out of residency, filling that role. At times, she felt like a PGY-4 (postgraduate year 4). But she quickly grew into the attending role and was asked to be site coordinator for the mobilization of palliative medicine volunteers at Jacobi.

“We found ourselves having to make tough ethical decisions. Some patients, even if we provided a ventilator and maximum oxygen therapy, would still die. There were difficult discussions when we didn’t know if we had enough dialysis machines, or how to manage other limited resources. The hospital was saying: You decide, if there’s a high degree of certainty about the outcome. But we had never practiced medicine this way before,” she said.

“That’s why our hospital provided daily ethics meetings with our ethics council. There would be eight people sitting 6 feet apart in a conference room, all wearing masks. We’d talk about situations that were giving us trouble. Their role wasn’t to provide answers but to help us see the scope of the situation and the complexities,” she explained.

Dr. Saladini-Aponte said she has had many sleepless nights since the pandemic began. “Sometimes, I would come home from work and lie down on the floor and cry,” she said. “But we had so much support from volunteers helping our little hospitalist service of seven.” It was also important to keep up with the clinical information, and one of her coworkers created “cheat sheets” for the clinicians, regularly updated with the latest essential information on antibiotics, testing, and the like.

“At the peak, I was trying to read everything I could about the virus. I was just pulling myself in too many directions. I asked for help from my boyfriend to remind me not to log onto my computer when I came home from work,” she said. “One of my techniques for preventing burnout was just to avoid social media. I couldn’t deal with what was going on in the news. It just angered me. Even now, seeing people without masks makes me very uncomfortable.”
 

Organizing the crisis response

As chief value officer for NYCH+H, Hyung (Harry) Cho, MD, FACP, SFHM, typically focuses on issues of patient safety and overuse of medical treatments in the health system. But in the COVID-19 crisis, he found himself at the forefront of organizing its response. “We tried to provide support centrally and to standardize practice in how we test and treat,” he said.

“We were truly at the epicenter of the pandemic,” Dr. Cho said. “All of our hospitals had different experiences, and unique responses. But the system worked well.” Patients were transferred from the more overtaxed hospitals to Bellevue and other NYCH+H hospitals with spare beds. An emergency medical response structure was put in place, and every morning the system’s Tiger Team, with multidisciplinary personnel from administration, operations, logistics, and medical/technical specialists, would gather virtually to discuss needs across the system.

“It was a very open atmosphere and we asked people to report what was happening on the ground,” Dr. Cho said. “We started rapidly reviewing batches of 20 patients at a time for transfer in order to alleviate pressure in the most overtaxed ERs.”

NYCH+H also had to work through concerns about PPE, just like other U.S. hospitals. Treatment guidelines were changing by the day. Medical concerns were relayed at a rapid pace. Another priority was trying to limit unnecessary exposure for staff through a recommendation that only one clinician from a team would go into the room of an infected patient, unless another was absolutely needed.

The reality of public health

NYCH+H was created by the New York State Legislature in 1969 and rebranded in 2015. It includes a low- to no-cost health insurance plan called MetroPlus, along with outpatient centers, comprehensive case management, and social supports in the home.

“What people know about public health systems is that we typically are underresourced. That’s just the reality of public health,” Dr. Cho said. “We help the community, the underserved. The people who truly needed our help are also the ones who have been disproportionately affected by COVID-19. And that is where we really shine as a system.”

Dr. Cho lauded the performance of the health system’s frontline staff. “Watching them come together during the entire pandemic, and do their best every day, was truly inspiring,” he said. “But when they got to the peak, it really took an emotional toll on them.”

NYCH+H’s in-house staff support program, called Helping Healers Heal, was mobilized with specially trained teams at each of its 11 hospitals to provide peer-to-peer support, mental health expertise, and team-debriefing sessions to staff members following traumatic events. Support is provided both over the phone and in person on the floors, Dr. Cho said. “During the surge, everything was happening so quickly, there was no time to take a pause. Now, as we are able to catch our breath, that’s when they most need support.”

The hospitalists at NYCH+H hospitals intended to have goals-of-care conversations with all patients, but everyone was very busy – so having these conversations became harder and harder, Dr. Cho said. Recognizing limited staffing for the quadrupling of patients who needed palliative care at NYCH+H hospitals, he asked the medicine chairs about their palliative care needs and then used social media outreach to ask for help. The message went viral, attracting 413 volunteers from across the country. Sixty-seven telepalliative volunteers were put to work doing goals-of-care conversations remotely with inpatients and their families.¹

Expediting transfers

For Ian Fagan, MD, a hospitalist and associate medical director for general internal medicine Inpatient Services at Bellevue Hospital in Manhattan, hospitalist shifts are a normal part of his job. But he had to give them up during the surge to focus on planning, management, and especially scheduling other doctors, with sufficient backups needed to cover last minute changes. Dr. Fagan did that by using the existing pool of hospitalist staff, physicians who were reassigned from other specialties, agency staff, military medical personnel, and volunteer doctors who flew in from around the country to help. He also worked 10- to 12-hour days for 36 consecutive days.

The impact of disparities in access to care in New York City was reflected in the greater demand for care in the hospitals in Brooklyn, Queens, and the Bronx. “With fewer patients and more hospital beds in Manhattan, we had the capacity to share our beds,” Dr. Fagan said. “It was so amazing to me how quickly we could move patients from one hospital to another. We started accepting up to 40 transfers a day. But hey, we were still really busy.”

Bellevue is the nation’s oldest public hospital. “We care for the homeless, for immigrants, and we don’t ask questions. That’s our mission. I’m so proud to work here, and so grateful,” Dr. Fagan said. “If someone is undocumented or without insurance, I will give them exactly the same care. We stepped up in a big way to care for people of New York, but we’ve always been there for them – and we were there for them during the COVID surge.”

The hospitals in the system also worked together in ways Dr. Fagan had never seen. “It helped to have a central command structure with a bird’s eye view from above the level of individual hospitals, to organize and see which hospitals could step up. It’s good to have the data to put it in perspective,” he said. The system also utilized a temporary low-acuity medical center set up by NYCH+H on Roosevelt Island, as well as field hospitals organized at the Jacob K. Javits Convention Center and the USTA Billie Jean King National Tennis Center.

“At Bellevue we tried to stay ready, with the ability to turn former hospital units that were being used as offices back to beds. We always had three units lined up that were fully ready to convert. For example, I was medical director of the preop clinic and one day they gave us 24 hours to pack everything and move out. Three days later, it was a 24-bed unit. We also built a more robust rapid response and code team,” he said.

“It was hard for me not to take hospitalist shifts, because my identity is being a doctor. I eventually came to terms with the importance of the role that I was doing every day. I felt I could protect my colleagues, and if they were having an emotional day, to give them the opportunity to talk to someone. I also did the onboarding, one-on-one, of the new doctors.”

As the crisis in New York City has ebbed, Dr. Fagan was recently able to again take a week of clinical service. “The first day back on the floor I felt that I had forgotten everything. But by the end of the day, I thought, ‘Okay, I do know how to do this, after all.’ Census is down here. It’s quiet. That’s good. We need it now,” he said.

“I think the hardest moment for me was when the head nurse on our trauma unit, Ernesto DeLeon, known to everybody here, died of COVID in our ICU in April,” Dr. Fagan said. When Mr. DeLeon died, 100 hospital personnel gathered in the halls outside the room to pay their respects. “There had been a palpable fear in our lives – and this showed us that the fear was real. Ernesto was the first person I knew well who died, who acquired COVID at work doing what we’re all doing. We haven’t lost any doctors yet, but when this nurse died, we allowed ourselves to realize that this is personal. In that moment, we needed to allow ourselves to be human.”

Joan Curcio, MD, associate director of medicine at Elmhurst Hospital, said Elmhurst was where the story started for New York City and for NYCH+H. “I trained here and have spent my entire career at this hospital. It came to feel like what a battleground must be like, with things coming at you from every direction,” she said. “It was overwhelming in ways I could not have foreseen. I had seen videos from Italy [an early COVID-19 epicenter], but until it happened here, it was just hard to process.”

Things started slowly, with a few patients with severe acute respiratory distress syndrome and a 5- to 7-day turnaround to get results of their viral infection tests. “By week 2, a greater number of patients from our clinics and testing sites were filtering through the emergency department. Then hundreds.”

The normal occupancy rate for the department of medicine at Elmhurst is 110-115%, which typically means full beds plus patients in the emergency department. “We started to grow to 160, then 180, and then a peak of 250% of occupancy. We took over a rehab surgery floor, then a 35-bed surgery and hospice floor, which went to full capacity just like that,” she said. The number of non–critical care service teams increased to 20, working with redeployed staff, volunteers, military, and agency personnel, while ICU beds increased from 20 to 105.

“We were dealing with a much higher acuity level and enduring emotional turmoil with families, trying to carve out time to call them after our shift was over,” Dr. Curcio explained. Elmhurst developed a call-in hotline and a daily call-out service for families. Technology was mobilized to provide video visits and new systems were designed for isolation and for PPE distribution and use.

“I just felt that I couldn’t get everything done. I felt continually overwhelmed, and it didn’t matter how much time I took. I never felt I was able to give enough to anybody in any area, which was hard to take,” Dr. Curcio said. “But I still felt a sense of purpose and that I was making a difference – thanks to lots of support from the central office.”

Patient volume at Elmhurst is now down, lower than Dr. Curcio has ever seen it. “One of the main issues right now, moving forward, is ‘how do we function in a post-crisis mode?’” she said. The process of transitioning back to non-COVID-19 care will be complex. “When we clear a floor and clean it to go back to being a cold [COVID-19-negative] unit, it’s a whole different level of cleaning that takes 7 days.”

One moment that was particularly jarring for Dr. Curcio occurred while she was giving a tour of the hospital to visiting military medical personnel. “We went into the emergency department and I turned around and looked into a shower room, which was full of body bags. They were all full.”

But the experience has also been inspiring. “People gave their all without complaint. We hospitalists, and all those recruited to act as hospitalists, essentially took responsibility for the COVID response,” she said. “This was, hopefully, the experience of a lifetime as a medical professional. I wouldn’t want to ever experience something as daunting as this again.”
 

Reference

1. Israilov S et al. National outreach of telepalliative medicine volunteers for a New York City safety net system COVID-19 pandemic response. J Pain Symptom Manag. 2020 May 29. doi: 10.1016/j.jpainsymman.2020.05.026.

New York City Health + Hospitals (NYCH+H), the country’s largest public health care system, encompasses 11 hospitals with 4,354 staffed acute beds during normal times. It serves as the safety net for 1.1 million of the 8.4 million residents of the most populous city in the United States, many of them uninsured, undocumented, covered by Medicaid, or otherwise disadvantaged.

At the very epicenter in the early days of the historic COVID-19 pandemic, NYCH+H transferred patients between its facilities, added medical and ICU beds by the hundreds, mobilized palliative care volunteers, harnessed telemedicine and a clinician hotline, and made other sweeping changes to ensure that the city’s public health system would be able to respond to demand at the peak of the surge. That peak hit in April, when an average of 9,000 new COVID-19 cases were being reported in the city every day.

Through it all, hospitalists have played critical roles in both planning for the system’s response and caring for severely ill COVID-19 patients. Their stories reflect both the unprecedented demands on the system and the dedication of frontline clinicians.

One of those, Carla Saladini-Aponte, MD, who just finished her residency in June 2019, found herself on the firing line in March 2020 as an attending physician at 457-bed NYCH+H/Jacobi Hospital in the Bronx. “I have experienced so much in my first year on the job, dealing with a disease that we’ve never seen before,” she said. “We didn’t grasp the extent of the COVID crisis in the beginning, so we were emotionally unprepared when it first hit.”

Starting on March 30, NYCH+H administration mobilized a centralized incident command structure to coordinate response systemwide to a rapidly changing situation.

Two weeks later Jacobi was a COVID-19 hospital, top to bottom, with its medical ICU beds increased from 12 to more than 100. By mid-April, Dr. Saladini-Aponte’s team, one of 11 medical teams in the hospital, had 26 patients, all of them with COVID-19. There was not a consensus in the early days on how to manage patients with severe respiratory distress. “But by the time the surge came, we had a better understanding of the scope of the situation,” she said.

Learning to be an attending

“They don’t teach you how to be an attending during residency,” Dr. Saladini-Aponte said. “At the beginning I wasn’t such a good teacher. I just wanted to prove myself and stay one step ahead of the residents. But as an academic hospitalist you have to listen to others. I learned to ask questions of the residents every morning, including how they were doing personally.”

Sometimes a visiting consultant would ask on the floor: “‘Where’s your attending?’” not recognizing Dr. Saladini-Aponte, fresh out of residency, filling that role. At times, she felt like a PGY-4 (postgraduate year 4). But she quickly grew into the attending role and was asked to be site coordinator for the mobilization of palliative medicine volunteers at Jacobi.

“We found ourselves having to make tough ethical decisions. Some patients, even if we provided a ventilator and maximum oxygen therapy, would still die. There were difficult discussions when we didn’t know if we had enough dialysis machines, or how to manage other limited resources. The hospital was saying: You decide, if there’s a high degree of certainty about the outcome. But we had never practiced medicine this way before,” she said.

“That’s why our hospital provided daily ethics meetings with our ethics council. There would be eight people sitting 6 feet apart in a conference room, all wearing masks. We’d talk about situations that were giving us trouble. Their role wasn’t to provide answers but to help us see the scope of the situation and the complexities,” she explained.

Dr. Saladini-Aponte said she has had many sleepless nights since the pandemic began. “Sometimes, I would come home from work and lie down on the floor and cry,” she said. “But we had so much support from volunteers helping our little hospitalist service of seven.” It was also important to keep up with the clinical information, and one of her coworkers created “cheat sheets” for the clinicians, regularly updated with the latest essential information on antibiotics, testing, and the like.

“At the peak, I was trying to read everything I could about the virus. I was just pulling myself in too many directions. I asked for help from my boyfriend to remind me not to log onto my computer when I came home from work,” she said. “One of my techniques for preventing burnout was just to avoid social media. I couldn’t deal with what was going on in the news. It just angered me. Even now, seeing people without masks makes me very uncomfortable.”
 

Organizing the crisis response

As chief value officer for NYCH+H, Hyung (Harry) Cho, MD, FACP, SFHM, typically focuses on issues of patient safety and overuse of medical treatments in the health system. But in the COVID-19 crisis, he found himself at the forefront of organizing its response. “We tried to provide support centrally and to standardize practice in how we test and treat,” he said.

“We were truly at the epicenter of the pandemic,” Dr. Cho said. “All of our hospitals had different experiences, and unique responses. But the system worked well.” Patients were transferred from the more overtaxed hospitals to Bellevue and other NYCH+H hospitals with spare beds. An emergency medical response structure was put in place, and every morning the system’s Tiger Team, with multidisciplinary personnel from administration, operations, logistics, and medical/technical specialists, would gather virtually to discuss needs across the system.

“It was a very open atmosphere and we asked people to report what was happening on the ground,” Dr. Cho said. “We started rapidly reviewing batches of 20 patients at a time for transfer in order to alleviate pressure in the most overtaxed ERs.”

NYCH+H also had to work through concerns about PPE, just like other U.S. hospitals. Treatment guidelines were changing by the day. Medical concerns were relayed at a rapid pace. Another priority was trying to limit unnecessary exposure for staff through a recommendation that only one clinician from a team would go into the room of an infected patient, unless another was absolutely needed.

The reality of public health

NYCH+H was created by the New York State Legislature in 1969 and rebranded in 2015. It includes a low- to no-cost health insurance plan called MetroPlus, along with outpatient centers, comprehensive case management, and social supports in the home.

“What people know about public health systems is that we typically are underresourced. That’s just the reality of public health,” Dr. Cho said. “We help the community, the underserved. The people who truly needed our help are also the ones who have been disproportionately affected by COVID-19. And that is where we really shine as a system.”

Dr. Cho lauded the performance of the health system’s frontline staff. “Watching them come together during the entire pandemic, and do their best every day, was truly inspiring,” he said. “But when they got to the peak, it really took an emotional toll on them.”

NYCH+H’s in-house staff support program, called Helping Healers Heal, was mobilized with specially trained teams at each of its 11 hospitals to provide peer-to-peer support, mental health expertise, and team-debriefing sessions to staff members following traumatic events. Support is provided both over the phone and in person on the floors, Dr. Cho said. “During the surge, everything was happening so quickly, there was no time to take a pause. Now, as we are able to catch our breath, that’s when they most need support.”

The hospitalists at NYCH+H hospitals intended to have goals-of-care conversations with all patients, but everyone was very busy – so having these conversations became harder and harder, Dr. Cho said. Recognizing limited staffing for the quadrupling of patients who needed palliative care at NYCH+H hospitals, he asked the medicine chairs about their palliative care needs and then used social media outreach to ask for help. The message went viral, attracting 413 volunteers from across the country. Sixty-seven telepalliative volunteers were put to work doing goals-of-care conversations remotely with inpatients and their families.¹

Expediting transfers

For Ian Fagan, MD, a hospitalist and associate medical director for general internal medicine Inpatient Services at Bellevue Hospital in Manhattan, hospitalist shifts are a normal part of his job. But he had to give them up during the surge to focus on planning, management, and especially scheduling other doctors, with sufficient backups needed to cover last minute changes. Dr. Fagan did that by using the existing pool of hospitalist staff, physicians who were reassigned from other specialties, agency staff, military medical personnel, and volunteer doctors who flew in from around the country to help. He also worked 10- to 12-hour days for 36 consecutive days.

The impact of disparities in access to care in New York City was reflected in the greater demand for care in the hospitals in Brooklyn, Queens, and the Bronx. “With fewer patients and more hospital beds in Manhattan, we had the capacity to share our beds,” Dr. Fagan said. “It was so amazing to me how quickly we could move patients from one hospital to another. We started accepting up to 40 transfers a day. But hey, we were still really busy.”

Bellevue is the nation’s oldest public hospital. “We care for the homeless, for immigrants, and we don’t ask questions. That’s our mission. I’m so proud to work here, and so grateful,” Dr. Fagan said. “If someone is undocumented or without insurance, I will give them exactly the same care. We stepped up in a big way to care for people of New York, but we’ve always been there for them – and we were there for them during the COVID surge.”

The hospitals in the system also worked together in ways Dr. Fagan had never seen. “It helped to have a central command structure with a bird’s eye view from above the level of individual hospitals, to organize and see which hospitals could step up. It’s good to have the data to put it in perspective,” he said. The system also utilized a temporary low-acuity medical center set up by NYCH+H on Roosevelt Island, as well as field hospitals organized at the Jacob K. Javits Convention Center and the USTA Billie Jean King National Tennis Center.

“At Bellevue we tried to stay ready, with the ability to turn former hospital units that were being used as offices back to beds. We always had three units lined up that were fully ready to convert. For example, I was medical director of the preop clinic and one day they gave us 24 hours to pack everything and move out. Three days later, it was a 24-bed unit. We also built a more robust rapid response and code team,” he said.

“It was hard for me not to take hospitalist shifts, because my identity is being a doctor. I eventually came to terms with the importance of the role that I was doing every day. I felt I could protect my colleagues, and if they were having an emotional day, to give them the opportunity to talk to someone. I also did the onboarding, one-on-one, of the new doctors.”

As the crisis in New York City has ebbed, Dr. Fagan was recently able to again take a week of clinical service. “The first day back on the floor I felt that I had forgotten everything. But by the end of the day, I thought, ‘Okay, I do know how to do this, after all.’ Census is down here. It’s quiet. That’s good. We need it now,” he said.

“I think the hardest moment for me was when the head nurse on our trauma unit, Ernesto DeLeon, known to everybody here, died of COVID in our ICU in April,” Dr. Fagan said. When Mr. DeLeon died, 100 hospital personnel gathered in the halls outside the room to pay their respects. “There had been a palpable fear in our lives – and this showed us that the fear was real. Ernesto was the first person I knew well who died, who acquired COVID at work doing what we’re all doing. We haven’t lost any doctors yet, but when this nurse died, we allowed ourselves to realize that this is personal. In that moment, we needed to allow ourselves to be human.”

Joan Curcio, MD, associate director of medicine at Elmhurst Hospital, said Elmhurst was where the story started for New York City and for NYCH+H. “I trained here and have spent my entire career at this hospital. It came to feel like what a battleground must be like, with things coming at you from every direction,” she said. “It was overwhelming in ways I could not have foreseen. I had seen videos from Italy [an early COVID-19 epicenter], but until it happened here, it was just hard to process.”

Things started slowly, with a few patients with severe acute respiratory distress syndrome and a 5- to 7-day turnaround to get results of their viral infection tests. “By week 2, a greater number of patients from our clinics and testing sites were filtering through the emergency department. Then hundreds.”

The normal occupancy rate for the department of medicine at Elmhurst is 110-115%, which typically means full beds plus patients in the emergency department. “We started to grow to 160, then 180, and then a peak of 250% of occupancy. We took over a rehab surgery floor, then a 35-bed surgery and hospice floor, which went to full capacity just like that,” she said. The number of non–critical care service teams increased to 20, working with redeployed staff, volunteers, military, and agency personnel, while ICU beds increased from 20 to 105.

“We were dealing with a much higher acuity level and enduring emotional turmoil with families, trying to carve out time to call them after our shift was over,” Dr. Curcio explained. Elmhurst developed a call-in hotline and a daily call-out service for families. Technology was mobilized to provide video visits and new systems were designed for isolation and for PPE distribution and use.

“I just felt that I couldn’t get everything done. I felt continually overwhelmed, and it didn’t matter how much time I took. I never felt I was able to give enough to anybody in any area, which was hard to take,” Dr. Curcio said. “But I still felt a sense of purpose and that I was making a difference – thanks to lots of support from the central office.”

Patient volume at Elmhurst is now down, lower than Dr. Curcio has ever seen it. “One of the main issues right now, moving forward, is ‘how do we function in a post-crisis mode?’” she said. The process of transitioning back to non-COVID-19 care will be complex. “When we clear a floor and clean it to go back to being a cold [COVID-19-negative] unit, it’s a whole different level of cleaning that takes 7 days.”

One moment that was particularly jarring for Dr. Curcio occurred while she was giving a tour of the hospital to visiting military medical personnel. “We went into the emergency department and I turned around and looked into a shower room, which was full of body bags. They were all full.”

But the experience has also been inspiring. “People gave their all without complaint. We hospitalists, and all those recruited to act as hospitalists, essentially took responsibility for the COVID response,” she said. “This was, hopefully, the experience of a lifetime as a medical professional. I wouldn’t want to ever experience something as daunting as this again.”
 

Reference

1. Israilov S et al. National outreach of telepalliative medicine volunteers for a New York City safety net system COVID-19 pandemic response. J Pain Symptom Manag. 2020 May 29. doi: 10.1016/j.jpainsymman.2020.05.026.

Breast milk is an unlikely source of transmission of SARS-CoV-2 from mothers to infants, according to data from case reports and breast milk samples from 18 women.

South_agency/Getty Images

“To date, SARS-CoV-2 has not been isolated from breast milk, and there are no documented cases of transmission of infectious virus to the infant through breast milk,” but the potential for transmission remains a concern among women who want to breastfeed, wrote Christina Chambers, PhD, of the University of California, San Diego, and colleagues.

In a research letter published in JAMA, the investigators identified 18 women with confirmed SARS-CoV-2 infections (all but 1 of the women had symptomatic COVID-19 disease) and infants aged 0-19 months between March 27 and May 6, 2020. The average age of the mothers was 34 years, and 78% were non-Hispanic White. The women provided 1-12 samples of breast milk for a total of 64 samples collected before and after positive COVID-19 tests.

One sample yielded detectable RNA from SARS-CoV-2 and was collected on the day of the woman’s symptom onset. However, one sample taken 2 days prior to symptom onset and two samples collected 12 and 41 days later tested negative for viral RNA, the researchers said. In addition, no replication-competent virus was identified in the positive sample or any of the other samples.

The researchers spiked two stored milk samples collected prior to the pandemic with replication-competent SARS-CoV-2. Virus was not detected by culture in the samples after Holder pasteurization, but was detected by culture in nonpasteurized aliquots of the same samples.

“These data suggest that SARS-CoV-2 RNA does not represent replication-competent virus and that breast milk may not be a source of infection for the infant,” Dr. Chambers and associates said.

The results were limited by several factors including the small sample size and potential for selection bias, as well as the use of self-reports of positive tests and self-collection of breast milk, the researchers noted. However, the findings are reassuring in light of the known benefits of breastfeeding and the use of milk banks.

“This research is important because the pandemic is ongoing and has far-reaching consequences: as the authors indicate, the potential for viral transmission through breast milk remains a critical question for women infected with SARS-CoV-2 who wish to breastfeed,” Janet R. Hardy, PhD, MPH, MSc, a consultant on global maternal-child health and pharmacoepidemiology, said in an interview.

“This virus has everyone on a rapid learning track, and all information that helps build evidence to support women’s decision-making in the care of their children is valuable,” she said. “These findings suggest that breast milk may not be a source of SARS-CoV-2 infection for the infant. They provide some reassurance given the recognized benefits of breastfeeding and human milk.”

However, “This study is very specific to breast milk,” she emphasized. “In advising women infected with SARS-CoV-2, clinicians may want to include a discussion of protection methods to prevent maternal transmission of the virus through respiratory droplets.”

Although the data are preliminary, “the investigators established and validated an RT-PCR [reverse transcription polymerase chain reaction] assay and developed tissue culture methods for replication-competent SARS-CoV-2 in breast milk, both valuable tools for further studies. Next steps will include controlled studies of greater sample size with independent verification of RT-PCR positivity,” said Dr. Hardy, a consultant to Biohaven Pharmaceuticals, New Haven, Conn.

The study was supported by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health. Medela Corporation provided milk sample collection materials. The Family Larsson-Rosenquist Foundation provided an unrestricted COVID19 emergency gift fund. The Mothers’ Milk Bank at Austin paid for shipping costs.

SOURCE: Chambers C et al. JAMA. 2020 Aug 19. doi: 10.1001/jama.2020.15580.

Breast milk is an unlikely source of transmission of SARS-CoV-2 from mothers to infants, according to data from case reports and breast milk samples from 18 women.

South_agency/Getty Images

“To date, SARS-CoV-2 has not been isolated from breast milk, and there are no documented cases of transmission of infectious virus to the infant through breast milk,” but the potential for transmission remains a concern among women who want to breastfeed, wrote Christina Chambers, PhD, of the University of California, San Diego, and colleagues.

In a research letter published in JAMA, the investigators identified 18 women with confirmed SARS-CoV-2 infections (all but 1 of the women had symptomatic COVID-19 disease) and infants aged 0-19 months between March 27 and May 6, 2020. The average age of the mothers was 34 years, and 78% were non-Hispanic White. The women provided 1-12 samples of breast milk for a total of 64 samples collected before and after positive COVID-19 tests.

One sample yielded detectable RNA from SARS-CoV-2 and was collected on the day of the woman’s symptom onset. However, one sample taken 2 days prior to symptom onset and two samples collected 12 and 41 days later tested negative for viral RNA, the researchers said. In addition, no replication-competent virus was identified in the positive sample or any of the other samples.

The researchers spiked two stored milk samples collected prior to the pandemic with replication-competent SARS-CoV-2. Virus was not detected by culture in the samples after Holder pasteurization, but was detected by culture in nonpasteurized aliquots of the same samples.

“These data suggest that SARS-CoV-2 RNA does not represent replication-competent virus and that breast milk may not be a source of infection for the infant,” Dr. Chambers and associates said.

The results were limited by several factors including the small sample size and potential for selection bias, as well as the use of self-reports of positive tests and self-collection of breast milk, the researchers noted. However, the findings are reassuring in light of the known benefits of breastfeeding and the use of milk banks.

“This research is important because the pandemic is ongoing and has far-reaching consequences: as the authors indicate, the potential for viral transmission through breast milk remains a critical question for women infected with SARS-CoV-2 who wish to breastfeed,” Janet R. Hardy, PhD, MPH, MSc, a consultant on global maternal-child health and pharmacoepidemiology, said in an interview.

“This virus has everyone on a rapid learning track, and all information that helps build evidence to support women’s decision-making in the care of their children is valuable,” she said. “These findings suggest that breast milk may not be a source of SARS-CoV-2 infection for the infant. They provide some reassurance given the recognized benefits of breastfeeding and human milk.”

However, “This study is very specific to breast milk,” she emphasized. “In advising women infected with SARS-CoV-2, clinicians may want to include a discussion of protection methods to prevent maternal transmission of the virus through respiratory droplets.”

Although the data are preliminary, “the investigators established and validated an RT-PCR [reverse transcription polymerase chain reaction] assay and developed tissue culture methods for replication-competent SARS-CoV-2 in breast milk, both valuable tools for further studies. Next steps will include controlled studies of greater sample size with independent verification of RT-PCR positivity,” said Dr. Hardy, a consultant to Biohaven Pharmaceuticals, New Haven, Conn.

The study was supported by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health. Medela Corporation provided milk sample collection materials. The Family Larsson-Rosenquist Foundation provided an unrestricted COVID19 emergency gift fund. The Mothers’ Milk Bank at Austin paid for shipping costs.

SOURCE: Chambers C et al. JAMA. 2020 Aug 19. doi: 10.1001/jama.2020.15580.

Breast milk is an unlikely source of transmission of SARS-CoV-2 from mothers to infants, according to data from case reports and breast milk samples from 18 women.

South_agency/Getty Images

“To date, SARS-CoV-2 has not been isolated from breast milk, and there are no documented cases of transmission of infectious virus to the infant through breast milk,” but the potential for transmission remains a concern among women who want to breastfeed, wrote Christina Chambers, PhD, of the University of California, San Diego, and colleagues.

In a research letter published in JAMA, the investigators identified 18 women with confirmed SARS-CoV-2 infections (all but 1 of the women had symptomatic COVID-19 disease) and infants aged 0-19 months between March 27 and May 6, 2020. The average age of the mothers was 34 years, and 78% were non-Hispanic White. The women provided 1-12 samples of breast milk for a total of 64 samples collected before and after positive COVID-19 tests.

One sample yielded detectable RNA from SARS-CoV-2 and was collected on the day of the woman’s symptom onset. However, one sample taken 2 days prior to symptom onset and two samples collected 12 and 41 days later tested negative for viral RNA, the researchers said. In addition, no replication-competent virus was identified in the positive sample or any of the other samples.

The researchers spiked two stored milk samples collected prior to the pandemic with replication-competent SARS-CoV-2. Virus was not detected by culture in the samples after Holder pasteurization, but was detected by culture in nonpasteurized aliquots of the same samples.

“These data suggest that SARS-CoV-2 RNA does not represent replication-competent virus and that breast milk may not be a source of infection for the infant,” Dr. Chambers and associates said.

The results were limited by several factors including the small sample size and potential for selection bias, as well as the use of self-reports of positive tests and self-collection of breast milk, the researchers noted. However, the findings are reassuring in light of the known benefits of breastfeeding and the use of milk banks.

“This research is important because the pandemic is ongoing and has far-reaching consequences: as the authors indicate, the potential for viral transmission through breast milk remains a critical question for women infected with SARS-CoV-2 who wish to breastfeed,” Janet R. Hardy, PhD, MPH, MSc, a consultant on global maternal-child health and pharmacoepidemiology, said in an interview.

“This virus has everyone on a rapid learning track, and all information that helps build evidence to support women’s decision-making in the care of their children is valuable,” she said. “These findings suggest that breast milk may not be a source of SARS-CoV-2 infection for the infant. They provide some reassurance given the recognized benefits of breastfeeding and human milk.”

However, “This study is very specific to breast milk,” she emphasized. “In advising women infected with SARS-CoV-2, clinicians may want to include a discussion of protection methods to prevent maternal transmission of the virus through respiratory droplets.”

Although the data are preliminary, “the investigators established and validated an RT-PCR [reverse transcription polymerase chain reaction] assay and developed tissue culture methods for replication-competent SARS-CoV-2 in breast milk, both valuable tools for further studies. Next steps will include controlled studies of greater sample size with independent verification of RT-PCR positivity,” said Dr. Hardy, a consultant to Biohaven Pharmaceuticals, New Haven, Conn.

The study was supported by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health. Medela Corporation provided milk sample collection materials. The Family Larsson-Rosenquist Foundation provided an unrestricted COVID19 emergency gift fund. The Mothers’ Milk Bank at Austin paid for shipping costs.

SOURCE: Chambers C et al. JAMA. 2020 Aug 19. doi: 10.1001/jama.2020.15580.

Case: A 56-year-old man with a history of type 2 diabetes, hypertension, hyperlipidemia, and obesity calls clinic to discuss concerns about COVID-19, stating: “I want to do everything I can to reduce my risk of infection.” In addition to physical distancing, mask wearing, hand hygiene, and control of chronic conditions, which of the following supplements would you recommend for this patient?

1. Coenzyme Q10 160 mg twice a day

2. Vitamin D 2,000 IU daily

3. Vitamin E 400 IU daily

4. Vitamin B₁₂ 1,000 mcg daily

Of these choices, vitamin D supplementation is likely the best option, based on the limited data that is available.

Vitamin D has been implicated in the prevention of many disease processes, including acute respiratory infections. Risk factors for worse COVID-19 outcome, such as older age, obesity, and more pigmented skin are also risk factors for vitamin D deficiency. This makes the study of vitamin D and COVID-19 both challenging and relevant.

In a recent study of 7,807 people living in Israel, Merzon and colleagues found that low plasma vitamin D level was an independent risk factor for COVID-19 infection. Mean plasma vitamin D level was significantly lower among those who tested positive for COVID-19 (19.00 ng/mL) than negative (20.55 ng/ mL). After controlling for demographic variables and several medical conditions, the adjusted odds ratio of COVID-19 infection in those with lower vitamin D was 1.45 (95% confidence interval, 1.08-1.95; P < .001). However, the odds of hospitalization for COVID-19 was not significantly associated with vitamin D level.¹

yulka3ice/Getty Images

Prior studies have also looked at vitamin D and respiratory infection. Martineau and colleagues analyzed 25 randomized, controlled trials with a pooled number of 11,321 individuals, including healthy ones and those with comorbidities, and found that oral vitamin D supplementation in daily or weekly doses had a protective effect against acute respiratory infection (adjusted odds ratio, 0.88; 95% CI, 0.81-0.96; P < .001). Patients with vitamin D deficiency (less than 25 nmol/L) experienced the most protective benefit. Vitamin D did not influence respiratory infection outcome.²

These studies suggest an adequate vitamin D level may be protective against infection with COVID-19, but who will benefit from vitamin D supplementation, and in what dose? Per U.S. Preventive Services Task Force guidelines, there is insufficient evidence to recommend screening for vitamin D deficiency in asymptomatic adults. Regarding daily dietary intake, the Institute of Medicine recommends 600 IU for persons aged 1-70, and 800 IU for those aged over 70 years. Salmon (447 IU per 3 oz serving), tuna (154 IU), and fortified milk (116 IU) are among the most vitamin D–rich foods.³ The recommended upper level of intake is 4,000 IU/day.
 

Too much of a good thing?

Extra vitamin D is stored in adipose tissue. If it builds up over time, storage sites may be overwhelmed, causing a rise in serum D level. While one might expect a subsequent rise in calcium levels, studies have shown this happens inconsistently, and at very high vitamin D levels, over 120 ng/mL.⁴ Most people would have to take at least 50,000 IU daily for several months to see an effect. The main adverse outcome of vitamin D toxicity is kidney stones, mediated by increased calcium in the blood and urine.

Several animal models have demonstrated hypervitaminosis D–induced aortic and coronary artery calcification. Like with kidney stones, the mechanism appears to be through increased calcium and phosphate levels. Shroff and colleagues studied serum vitamin D levels and vascular disease in children with renal disease on dialysis and found a U-shaped distribution: Children with both low and high vitamin D levels had significantly increased carotid artery intima-media thickness and calcification.⁵ Given the specialized nature of this population, it’s unclear whether these results can be generalized to most people. More studies are warranted on this topic.
 

Other benefits

Vitamin D is perhaps most famous for helping to build strong bones. Avenell and colleagues performed a Cochrane meta-analysis of vitamin D supplementation in older adults and found that vitamin D alone did not significantly reduce the risk of hip or other new fracture. Vitamin D plus calcium supplementation did reduce the risk of hip fracture (nine trials, pooled number of individuals was 49,853; relative risk, 0.84; P = .01).⁶

A lesser-known benefit of vitamin D is muscle protection. A prospective study out of the Jewish Hospital of Cincinnati followed 146 adults who were intolerant to two or more statins because of muscle side effects and found to have a vitamin D level below 32 ng per mL. Subjects were given vitamin D replacement (50,000 units weekly) and followed for 2 years. On statin rechallenge, 88-95% tolerated a statin with vitamin D levels 53-55 ng/mL.⁷

Pearl

Vitamin D supplementation may protect against COVID-19 infection and has very low chance of harm at daily doses at or below 4,000 IU. Other benefits of taking vitamin D include bone protection and reduction in statin-induced myopathy. The main adverse effect is kidney stones.

Ms. Sharninghausen is a medical student at the University of Washington, Seattle. Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Merzon E et al. Low plasma 25(OH) vitamin D level is associated with increased risk of COVID‐19 infection: An Israeli population‐based study. FEBS J. 2020. doi: 10.1111/febs.15495.

2. Martineau AR et al. Vitamin D supplementation to prevent acute respiratory tract infections: Systematic review and meta-analysis of individual participant data. BMJ. 2017;356:i6583. doi:10.1136/bmj.i6583

3. “How to Get More Vitamin D From Your Food,” Cleveland Clinic. 2019 Oct 23. https://health.clevelandclinic.org/how-to-get-more-vitamin-d-from-your-food/.

4. Galior K et al. Development of vitamin d toxicity from overcorrection of vitamin D Deficiency: A review of case reports. Nutrients. 2018;10(8):953. doi: 10.3390/nu10080953

5. Shroff R et al. A bimodal association of vitamin D levels and vascular disease in children on dialysis. J Am Soc Nephrol. 2008;19(6):1239-46. doi: 10.1681/ASN.2007090993.

6. Avenell A et al. Vitamin D and vitamin D analogues for preventing fractures in post‐menopausal women and older men. Cochrane Database Syst Rev. 2014 Apr 14;2014(4):CD000227. doi: 10.1002/14651858.CD000227.pub4.

7. Khayznikov M et al. Statin intolerance because of myalgia, myositis, myopathy, or myonecrosis can in most cases be safely resolved by vitamin D supplementation. N Am J Med Sci. 2015;7(3):86-93. doi:10.4103/1947-2714.153919
 

Case: A 56-year-old man with a history of type 2 diabetes, hypertension, hyperlipidemia, and obesity calls clinic to discuss concerns about COVID-19, stating: “I want to do everything I can to reduce my risk of infection.” In addition to physical distancing, mask wearing, hand hygiene, and control of chronic conditions, which of the following supplements would you recommend for this patient?

1. Coenzyme Q10 160 mg twice a day

2. Vitamin D 2,000 IU daily

3. Vitamin E 400 IU daily

4. Vitamin B₁₂ 1,000 mcg daily

Of these choices, vitamin D supplementation is likely the best option, based on the limited data that is available.

Vitamin D has been implicated in the prevention of many disease processes, including acute respiratory infections. Risk factors for worse COVID-19 outcome, such as older age, obesity, and more pigmented skin are also risk factors for vitamin D deficiency. This makes the study of vitamin D and COVID-19 both challenging and relevant.

In a recent study of 7,807 people living in Israel, Merzon and colleagues found that low plasma vitamin D level was an independent risk factor for COVID-19 infection. Mean plasma vitamin D level was significantly lower among those who tested positive for COVID-19 (19.00 ng/mL) than negative (20.55 ng/ mL). After controlling for demographic variables and several medical conditions, the adjusted odds ratio of COVID-19 infection in those with lower vitamin D was 1.45 (95% confidence interval, 1.08-1.95; P < .001). However, the odds of hospitalization for COVID-19 was not significantly associated with vitamin D level.¹

yulka3ice/Getty Images

Prior studies have also looked at vitamin D and respiratory infection. Martineau and colleagues analyzed 25 randomized, controlled trials with a pooled number of 11,321 individuals, including healthy ones and those with comorbidities, and found that oral vitamin D supplementation in daily or weekly doses had a protective effect against acute respiratory infection (adjusted odds ratio, 0.88; 95% CI, 0.81-0.96; P < .001). Patients with vitamin D deficiency (less than 25 nmol/L) experienced the most protective benefit. Vitamin D did not influence respiratory infection outcome.²

These studies suggest an adequate vitamin D level may be protective against infection with COVID-19, but who will benefit from vitamin D supplementation, and in what dose? Per U.S. Preventive Services Task Force guidelines, there is insufficient evidence to recommend screening for vitamin D deficiency in asymptomatic adults. Regarding daily dietary intake, the Institute of Medicine recommends 600 IU for persons aged 1-70, and 800 IU for those aged over 70 years. Salmon (447 IU per 3 oz serving), tuna (154 IU), and fortified milk (116 IU) are among the most vitamin D–rich foods.³ The recommended upper level of intake is 4,000 IU/day.
 

Too much of a good thing?

Extra vitamin D is stored in adipose tissue. If it builds up over time, storage sites may be overwhelmed, causing a rise in serum D level. While one might expect a subsequent rise in calcium levels, studies have shown this happens inconsistently, and at very high vitamin D levels, over 120 ng/mL.⁴ Most people would have to take at least 50,000 IU daily for several months to see an effect. The main adverse outcome of vitamin D toxicity is kidney stones, mediated by increased calcium in the blood and urine.

Several animal models have demonstrated hypervitaminosis D–induced aortic and coronary artery calcification. Like with kidney stones, the mechanism appears to be through increased calcium and phosphate levels. Shroff and colleagues studied serum vitamin D levels and vascular disease in children with renal disease on dialysis and found a U-shaped distribution: Children with both low and high vitamin D levels had significantly increased carotid artery intima-media thickness and calcification.⁵ Given the specialized nature of this population, it’s unclear whether these results can be generalized to most people. More studies are warranted on this topic.
 

Other benefits

Vitamin D is perhaps most famous for helping to build strong bones. Avenell and colleagues performed a Cochrane meta-analysis of vitamin D supplementation in older adults and found that vitamin D alone did not significantly reduce the risk of hip or other new fracture. Vitamin D plus calcium supplementation did reduce the risk of hip fracture (nine trials, pooled number of individuals was 49,853; relative risk, 0.84; P = .01).⁶

A lesser-known benefit of vitamin D is muscle protection. A prospective study out of the Jewish Hospital of Cincinnati followed 146 adults who were intolerant to two or more statins because of muscle side effects and found to have a vitamin D level below 32 ng per mL. Subjects were given vitamin D replacement (50,000 units weekly) and followed for 2 years. On statin rechallenge, 88-95% tolerated a statin with vitamin D levels 53-55 ng/mL.⁷

Pearl

Vitamin D supplementation may protect against COVID-19 infection and has very low chance of harm at daily doses at or below 4,000 IU. Other benefits of taking vitamin D include bone protection and reduction in statin-induced myopathy. The main adverse effect is kidney stones.

Ms. Sharninghausen is a medical student at the University of Washington, Seattle. Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Merzon E et al. Low plasma 25(OH) vitamin D level is associated with increased risk of COVID‐19 infection: An Israeli population‐based study. FEBS J. 2020. doi: 10.1111/febs.15495.

2. Martineau AR et al. Vitamin D supplementation to prevent acute respiratory tract infections: Systematic review and meta-analysis of individual participant data. BMJ. 2017;356:i6583. doi:10.1136/bmj.i6583

3. “How to Get More Vitamin D From Your Food,” Cleveland Clinic. 2019 Oct 23. https://health.clevelandclinic.org/how-to-get-more-vitamin-d-from-your-food/.

4. Galior K et al. Development of vitamin d toxicity from overcorrection of vitamin D Deficiency: A review of case reports. Nutrients. 2018;10(8):953. doi: 10.3390/nu10080953

5. Shroff R et al. A bimodal association of vitamin D levels and vascular disease in children on dialysis. J Am Soc Nephrol. 2008;19(6):1239-46. doi: 10.1681/ASN.2007090993.

6. Avenell A et al. Vitamin D and vitamin D analogues for preventing fractures in post‐menopausal women and older men. Cochrane Database Syst Rev. 2014 Apr 14;2014(4):CD000227. doi: 10.1002/14651858.CD000227.pub4.

7. Khayznikov M et al. Statin intolerance because of myalgia, myositis, myopathy, or myonecrosis can in most cases be safely resolved by vitamin D supplementation. N Am J Med Sci. 2015;7(3):86-93. doi:10.4103/1947-2714.153919
 

Case: A 56-year-old man with a history of type 2 diabetes, hypertension, hyperlipidemia, and obesity calls clinic to discuss concerns about COVID-19, stating: “I want to do everything I can to reduce my risk of infection.” In addition to physical distancing, mask wearing, hand hygiene, and control of chronic conditions, which of the following supplements would you recommend for this patient?

1. Coenzyme Q10 160 mg twice a day

2. Vitamin D 2,000 IU daily

3. Vitamin E 400 IU daily

4. Vitamin B₁₂ 1,000 mcg daily

Of these choices, vitamin D supplementation is likely the best option, based on the limited data that is available.

Vitamin D has been implicated in the prevention of many disease processes, including acute respiratory infections. Risk factors for worse COVID-19 outcome, such as older age, obesity, and more pigmented skin are also risk factors for vitamin D deficiency. This makes the study of vitamin D and COVID-19 both challenging and relevant.

In a recent study of 7,807 people living in Israel, Merzon and colleagues found that low plasma vitamin D level was an independent risk factor for COVID-19 infection. Mean plasma vitamin D level was significantly lower among those who tested positive for COVID-19 (19.00 ng/mL) than negative (20.55 ng/ mL). After controlling for demographic variables and several medical conditions, the adjusted odds ratio of COVID-19 infection in those with lower vitamin D was 1.45 (95% confidence interval, 1.08-1.95; P < .001). However, the odds of hospitalization for COVID-19 was not significantly associated with vitamin D level.¹

yulka3ice/Getty Images

Prior studies have also looked at vitamin D and respiratory infection. Martineau and colleagues analyzed 25 randomized, controlled trials with a pooled number of 11,321 individuals, including healthy ones and those with comorbidities, and found that oral vitamin D supplementation in daily or weekly doses had a protective effect against acute respiratory infection (adjusted odds ratio, 0.88; 95% CI, 0.81-0.96; P < .001). Patients with vitamin D deficiency (less than 25 nmol/L) experienced the most protective benefit. Vitamin D did not influence respiratory infection outcome.²

These studies suggest an adequate vitamin D level may be protective against infection with COVID-19, but who will benefit from vitamin D supplementation, and in what dose? Per U.S. Preventive Services Task Force guidelines, there is insufficient evidence to recommend screening for vitamin D deficiency in asymptomatic adults. Regarding daily dietary intake, the Institute of Medicine recommends 600 IU for persons aged 1-70, and 800 IU for those aged over 70 years. Salmon (447 IU per 3 oz serving), tuna (154 IU), and fortified milk (116 IU) are among the most vitamin D–rich foods.³ The recommended upper level of intake is 4,000 IU/day.
 

Too much of a good thing?

Extra vitamin D is stored in adipose tissue. If it builds up over time, storage sites may be overwhelmed, causing a rise in serum D level. While one might expect a subsequent rise in calcium levels, studies have shown this happens inconsistently, and at very high vitamin D levels, over 120 ng/mL.⁴ Most people would have to take at least 50,000 IU daily for several months to see an effect. The main adverse outcome of vitamin D toxicity is kidney stones, mediated by increased calcium in the blood and urine.

Several animal models have demonstrated hypervitaminosis D–induced aortic and coronary artery calcification. Like with kidney stones, the mechanism appears to be through increased calcium and phosphate levels. Shroff and colleagues studied serum vitamin D levels and vascular disease in children with renal disease on dialysis and found a U-shaped distribution: Children with both low and high vitamin D levels had significantly increased carotid artery intima-media thickness and calcification.⁵ Given the specialized nature of this population, it’s unclear whether these results can be generalized to most people. More studies are warranted on this topic.
 

Other benefits

Vitamin D is perhaps most famous for helping to build strong bones. Avenell and colleagues performed a Cochrane meta-analysis of vitamin D supplementation in older adults and found that vitamin D alone did not significantly reduce the risk of hip or other new fracture. Vitamin D plus calcium supplementation did reduce the risk of hip fracture (nine trials, pooled number of individuals was 49,853; relative risk, 0.84; P = .01).⁶

A lesser-known benefit of vitamin D is muscle protection. A prospective study out of the Jewish Hospital of Cincinnati followed 146 adults who were intolerant to two or more statins because of muscle side effects and found to have a vitamin D level below 32 ng per mL. Subjects were given vitamin D replacement (50,000 units weekly) and followed for 2 years. On statin rechallenge, 88-95% tolerated a statin with vitamin D levels 53-55 ng/mL.⁷

Pearl

Vitamin D supplementation may protect against COVID-19 infection and has very low chance of harm at daily doses at or below 4,000 IU. Other benefits of taking vitamin D include bone protection and reduction in statin-induced myopathy. The main adverse effect is kidney stones.

Ms. Sharninghausen is a medical student at the University of Washington, Seattle. Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Merzon E et al. Low plasma 25(OH) vitamin D level is associated with increased risk of COVID‐19 infection: An Israeli population‐based study. FEBS J. 2020. doi: 10.1111/febs.15495.

2. Martineau AR et al. Vitamin D supplementation to prevent acute respiratory tract infections: Systematic review and meta-analysis of individual participant data. BMJ. 2017;356:i6583. doi:10.1136/bmj.i6583

3. “How to Get More Vitamin D From Your Food,” Cleveland Clinic. 2019 Oct 23. https://health.clevelandclinic.org/how-to-get-more-vitamin-d-from-your-food/.

4. Galior K et al. Development of vitamin d toxicity from overcorrection of vitamin D Deficiency: A review of case reports. Nutrients. 2018;10(8):953. doi: 10.3390/nu10080953

5. Shroff R et al. A bimodal association of vitamin D levels and vascular disease in children on dialysis. J Am Soc Nephrol. 2008;19(6):1239-46. doi: 10.1681/ASN.2007090993.

6. Avenell A et al. Vitamin D and vitamin D analogues for preventing fractures in post‐menopausal women and older men. Cochrane Database Syst Rev. 2014 Apr 14;2014(4):CD000227. doi: 10.1002/14651858.CD000227.pub4.

7. Khayznikov M et al. Statin intolerance because of myalgia, myositis, myopathy, or myonecrosis can in most cases be safely resolved by vitamin D supplementation. N Am J Med Sci. 2015;7(3):86-93. doi:10.4103/1947-2714.153919
 

In a previous column, I addressed some of the issues that quickly arose in the context of the COVID-19 pandemic and their implications for reproductive psychiatry. These issues ranged from the importance of sustaining well-being in pregnant and postpartum women during the pandemic, to temporary restrictions that were in place during the early part of the pandemic with respect to performing infertility procedures, to the practical issues of limiting the number of people who could attend to women during labor and delivery in the hospital.

lechatnoir/E+

Five months later, we’ve learned a great deal about trying to sustain emotional well-being among pregnant women during COVID-19. There is a high rate of anxiety among women who are pregnant and women who have particularly young children around the various issues of juggling activities of daily living during the pandemic, including switching to remote work and homeschooling children. There is fear of contracting COVID-19 during pregnancy, the exact effects of which are still somewhat unknown. We have seen a shift to telemedicine for prenatal and postpartum obstetrics visits, and a change with respect to visitors and even in-home nurses that would help during the first weeks of life for some couples.

We wondered whether we would see a falloff in the numbers of women presenting to our clinic with questions about the reproductive safety of taking psychiatric medications during pregnancy. We were unclear as to whether women would defer plans to get pregnant given some of the uncertainties that have come with COVID-19. What we’ve seen, at least early on in the pandemic in Massachusetts, has been the opposite. More women during the first 4 months of the pandemic have been seen in our center compared with the same corresponding period over the last 5 years. The precise reasons for this are unclear, but one reason may be that shifting the practice of reproductive psychiatry and pregnancy planning for reproductive-age women to full virtual care has dropped the number of missed appointments to essentially zero. Women perhaps feel an urgency to have a plan for using psychiatric medication during pregnancy. They may also see the benefit of being able to have extended telemedicine consultations that frequently involve their partners, a practice we have always supported, but posed logistical challenges for some.

As our colleagues learned that we had shifted our clinical rounds at the Center for Women’s Mental Health, which we’ve been doing for 25 years, to a virtual format, we began offering a free 1-hour forum to discuss relevant issues around caring for psychiatrically ill women, with a focus on some of the issues that were particularly relevant during the pandemic. The most common reasons for consultation on our service are the appropriate, safest use of antidepressants and mood stabilizers during pregnancy, and that continues to be the case.

If there has been one guiding principle in treating perinatal depression during pregnancy, it has been our long-standing, laser-like focus on keeping women emotionally well during pregnancy, and to highlight the importance of this with women during consultations prior to and during pregnancy. Relapse of psychiatric disorder during pregnancy is one the strongest predictors of postpartum depression, and the impact of untreated depression during pregnancy has been described in the literature and over the years in this column. However, the implications of having severe relapse of a mood disorder, for example, such as depression or bipolar disorder during the pandemic, takes on a new context where we want to minimize, if possible, severe onset of illness requiring hospitalization or emergent attention considering it may make social distancing and some of the other mitigating factors vis-à-vis COVID-19 more challenging.

Despite the accumulated data over the last 2 decades on the reproductive safety of antidepressants, women continue to have questions about the safety of these medications during pregnancy. Studies show now that many women would prefer, if at all possible, to defer treatment with antidepressants, and so they come to us with questions about their reproductive safety, the potential of switching to nonpharmacologic interventions, and the use of alternative interventions that might be used to treat their underlying mood disorder.

Investigators at the University of British Columbia recently have tried to inform the field with still another look, not at reproductive safety per se, but at risk of relapse of depression if women discontinue those medicines during pregnancy.¹ There is a timeliness to this investigation, which was a systematic review and meta-analysis of studies that met a priori criteria for inclusion. Since some of our own group’s early work over 15 years ago on relapse of psychiatric disorder during pregnancy,² which indicated a substantial difference in risk of relapse between women who continued versus who discontinued antidepressants, other investigators have showed the difference in risk for relapse is not as substantial, and that continuation of medication did not appear to mitigate risk for relapse. In fact, in the systematic review, the investigators demonstrated that as a group, maintaining medicine did not appear to confer particular benefit to patients relative to risk for relapse compared to discontinuation of antidepressants.

However, looking more closely, Bayrampour and colleagues note for women with histories of more severe recurrent, major depression, relapse did in fact appear to be greater in women who discontinued compared with those with cases of mild to moderate depression. It is noteworthy that in both our early and later work, and certainly dovetailing with our clinical practice, we have noted severity of illness does not appear to correlate with the actual decisions women ultimately make regarding what they will do with antidepressants. Specifically, some women with very severe illness histories will discontinue antidepressants regardless of their risk for relapse. Alternatively, women with mild to moderate illness will sometimes elect to stay on antidepressant therapy. With all the information that we have about fetal exposure to antidepressants on one hand, the “unknown unknowns” are an understandable concern to both patients and clinicians. Clinicians are faced with the dilemma of how to best counsel women on continuing or discontinuing antidepressants as they plan to conceive or during pregnancy and in the postpartum period.

The literature cited and clinical experience over the last 3 decades suggests rather strongly that there is a relatively low likelihood women with histories of severe recurrent disease will be able to successfully discontinue antidepressants in the absence of relapse. A greater question is, what is the best way to proceed for women who have been on maintenance therapy and had more moderate symptoms?

I am inspired by some of the more recent literature that has tried to elucidate the role of nonpharmacologic interventions such as mindfulness-based cognitive therapy (MBCT) in an effort to mitigate risk for depressive relapse in pregnant women who are well with histories of depression. To date, data do not inform the question as to whether MBCT can be used to mitigate risk of depressive relapse in pregnant women who continue or discontinue antidepressants. That research question is actively being studied by several investigators, including ourselves.

Of particular interest is whether the addition of mindfulness practices such as MBCT in treatment could mitigate risk for depressive relapse in pregnant women who continue or discontinue antidepressant treatment, as that would certainly be a no-harm intervention that could mitigate risk even in a lower risk sample of patients. The question of how to “thread the needle” during the pandemic and best approach woman with a history of recurrent major depression on antidepressants is particularly timely and critical.

Regardless, we make clinical decisions collaboratively with patients based on their histories and individual wishes, and perhaps what we have learned over the last 5 months is the use of telemedicine does afford us the opportunity, regardless of the decisions that patients make, to more closely follow the clinical trajectory of women during pregnancy and the postpartum period so that regardless of treatment, we have an opportunity to intervene early when needed and to ascertain changes in clinical status early to mitigate the risk of frank relapse. From a reproductive psychiatric point of view, that is a silver lining with respect to the associated challenges that have come along with the pandemic.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

References

1. J Clin Psychiatry 2020;81(4):19r13134.

2. JAMA. 2006 Feb 1;295(5):499-507.

In a previous column, I addressed some of the issues that quickly arose in the context of the COVID-19 pandemic and their implications for reproductive psychiatry. These issues ranged from the importance of sustaining well-being in pregnant and postpartum women during the pandemic, to temporary restrictions that were in place during the early part of the pandemic with respect to performing infertility procedures, to the practical issues of limiting the number of people who could attend to women during labor and delivery in the hospital.

lechatnoir/E+

Five months later, we’ve learned a great deal about trying to sustain emotional well-being among pregnant women during COVID-19. There is a high rate of anxiety among women who are pregnant and women who have particularly young children around the various issues of juggling activities of daily living during the pandemic, including switching to remote work and homeschooling children. There is fear of contracting COVID-19 during pregnancy, the exact effects of which are still somewhat unknown. We have seen a shift to telemedicine for prenatal and postpartum obstetrics visits, and a change with respect to visitors and even in-home nurses that would help during the first weeks of life for some couples.

We wondered whether we would see a falloff in the numbers of women presenting to our clinic with questions about the reproductive safety of taking psychiatric medications during pregnancy. We were unclear as to whether women would defer plans to get pregnant given some of the uncertainties that have come with COVID-19. What we’ve seen, at least early on in the pandemic in Massachusetts, has been the opposite. More women during the first 4 months of the pandemic have been seen in our center compared with the same corresponding period over the last 5 years. The precise reasons for this are unclear, but one reason may be that shifting the practice of reproductive psychiatry and pregnancy planning for reproductive-age women to full virtual care has dropped the number of missed appointments to essentially zero. Women perhaps feel an urgency to have a plan for using psychiatric medication during pregnancy. They may also see the benefit of being able to have extended telemedicine consultations that frequently involve their partners, a practice we have always supported, but posed logistical challenges for some.

As our colleagues learned that we had shifted our clinical rounds at the Center for Women’s Mental Health, which we’ve been doing for 25 years, to a virtual format, we began offering a free 1-hour forum to discuss relevant issues around caring for psychiatrically ill women, with a focus on some of the issues that were particularly relevant during the pandemic. The most common reasons for consultation on our service are the appropriate, safest use of antidepressants and mood stabilizers during pregnancy, and that continues to be the case.

If there has been one guiding principle in treating perinatal depression during pregnancy, it has been our long-standing, laser-like focus on keeping women emotionally well during pregnancy, and to highlight the importance of this with women during consultations prior to and during pregnancy. Relapse of psychiatric disorder during pregnancy is one the strongest predictors of postpartum depression, and the impact of untreated depression during pregnancy has been described in the literature and over the years in this column. However, the implications of having severe relapse of a mood disorder, for example, such as depression or bipolar disorder during the pandemic, takes on a new context where we want to minimize, if possible, severe onset of illness requiring hospitalization or emergent attention considering it may make social distancing and some of the other mitigating factors vis-à-vis COVID-19 more challenging.

Despite the accumulated data over the last 2 decades on the reproductive safety of antidepressants, women continue to have questions about the safety of these medications during pregnancy. Studies show now that many women would prefer, if at all possible, to defer treatment with antidepressants, and so they come to us with questions about their reproductive safety, the potential of switching to nonpharmacologic interventions, and the use of alternative interventions that might be used to treat their underlying mood disorder.

Investigators at the University of British Columbia recently have tried to inform the field with still another look, not at reproductive safety per se, but at risk of relapse of depression if women discontinue those medicines during pregnancy.¹ There is a timeliness to this investigation, which was a systematic review and meta-analysis of studies that met a priori criteria for inclusion. Since some of our own group’s early work over 15 years ago on relapse of psychiatric disorder during pregnancy,² which indicated a substantial difference in risk of relapse between women who continued versus who discontinued antidepressants, other investigators have showed the difference in risk for relapse is not as substantial, and that continuation of medication did not appear to mitigate risk for relapse. In fact, in the systematic review, the investigators demonstrated that as a group, maintaining medicine did not appear to confer particular benefit to patients relative to risk for relapse compared to discontinuation of antidepressants.

However, looking more closely, Bayrampour and colleagues note for women with histories of more severe recurrent, major depression, relapse did in fact appear to be greater in women who discontinued compared with those with cases of mild to moderate depression. It is noteworthy that in both our early and later work, and certainly dovetailing with our clinical practice, we have noted severity of illness does not appear to correlate with the actual decisions women ultimately make regarding what they will do with antidepressants. Specifically, some women with very severe illness histories will discontinue antidepressants regardless of their risk for relapse. Alternatively, women with mild to moderate illness will sometimes elect to stay on antidepressant therapy. With all the information that we have about fetal exposure to antidepressants on one hand, the “unknown unknowns” are an understandable concern to both patients and clinicians. Clinicians are faced with the dilemma of how to best counsel women on continuing or discontinuing antidepressants as they plan to conceive or during pregnancy and in the postpartum period.

The literature cited and clinical experience over the last 3 decades suggests rather strongly that there is a relatively low likelihood women with histories of severe recurrent disease will be able to successfully discontinue antidepressants in the absence of relapse. A greater question is, what is the best way to proceed for women who have been on maintenance therapy and had more moderate symptoms?

I am inspired by some of the more recent literature that has tried to elucidate the role of nonpharmacologic interventions such as mindfulness-based cognitive therapy (MBCT) in an effort to mitigate risk for depressive relapse in pregnant women who are well with histories of depression. To date, data do not inform the question as to whether MBCT can be used to mitigate risk of depressive relapse in pregnant women who continue or discontinue antidepressants. That research question is actively being studied by several investigators, including ourselves.

Of particular interest is whether the addition of mindfulness practices such as MBCT in treatment could mitigate risk for depressive relapse in pregnant women who continue or discontinue antidepressant treatment, as that would certainly be a no-harm intervention that could mitigate risk even in a lower risk sample of patients. The question of how to “thread the needle” during the pandemic and best approach woman with a history of recurrent major depression on antidepressants is particularly timely and critical.

Regardless, we make clinical decisions collaboratively with patients based on their histories and individual wishes, and perhaps what we have learned over the last 5 months is the use of telemedicine does afford us the opportunity, regardless of the decisions that patients make, to more closely follow the clinical trajectory of women during pregnancy and the postpartum period so that regardless of treatment, we have an opportunity to intervene early when needed and to ascertain changes in clinical status early to mitigate the risk of frank relapse. From a reproductive psychiatric point of view, that is a silver lining with respect to the associated challenges that have come along with the pandemic.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

References

1. J Clin Psychiatry 2020;81(4):19r13134.

2. JAMA. 2006 Feb 1;295(5):499-507.

In a previous column, I addressed some of the issues that quickly arose in the context of the COVID-19 pandemic and their implications for reproductive psychiatry. These issues ranged from the importance of sustaining well-being in pregnant and postpartum women during the pandemic, to temporary restrictions that were in place during the early part of the pandemic with respect to performing infertility procedures, to the practical issues of limiting the number of people who could attend to women during labor and delivery in the hospital.

lechatnoir/E+

Five months later, we’ve learned a great deal about trying to sustain emotional well-being among pregnant women during COVID-19. There is a high rate of anxiety among women who are pregnant and women who have particularly young children around the various issues of juggling activities of daily living during the pandemic, including switching to remote work and homeschooling children. There is fear of contracting COVID-19 during pregnancy, the exact effects of which are still somewhat unknown. We have seen a shift to telemedicine for prenatal and postpartum obstetrics visits, and a change with respect to visitors and even in-home nurses that would help during the first weeks of life for some couples.

We wondered whether we would see a falloff in the numbers of women presenting to our clinic with questions about the reproductive safety of taking psychiatric medications during pregnancy. We were unclear as to whether women would defer plans to get pregnant given some of the uncertainties that have come with COVID-19. What we’ve seen, at least early on in the pandemic in Massachusetts, has been the opposite. More women during the first 4 months of the pandemic have been seen in our center compared with the same corresponding period over the last 5 years. The precise reasons for this are unclear, but one reason may be that shifting the practice of reproductive psychiatry and pregnancy planning for reproductive-age women to full virtual care has dropped the number of missed appointments to essentially zero. Women perhaps feel an urgency to have a plan for using psychiatric medication during pregnancy. They may also see the benefit of being able to have extended telemedicine consultations that frequently involve their partners, a practice we have always supported, but posed logistical challenges for some.

As our colleagues learned that we had shifted our clinical rounds at the Center for Women’s Mental Health, which we’ve been doing for 25 years, to a virtual format, we began offering a free 1-hour forum to discuss relevant issues around caring for psychiatrically ill women, with a focus on some of the issues that were particularly relevant during the pandemic. The most common reasons for consultation on our service are the appropriate, safest use of antidepressants and mood stabilizers during pregnancy, and that continues to be the case.

If there has been one guiding principle in treating perinatal depression during pregnancy, it has been our long-standing, laser-like focus on keeping women emotionally well during pregnancy, and to highlight the importance of this with women during consultations prior to and during pregnancy. Relapse of psychiatric disorder during pregnancy is one the strongest predictors of postpartum depression, and the impact of untreated depression during pregnancy has been described in the literature and over the years in this column. However, the implications of having severe relapse of a mood disorder, for example, such as depression or bipolar disorder during the pandemic, takes on a new context where we want to minimize, if possible, severe onset of illness requiring hospitalization or emergent attention considering it may make social distancing and some of the other mitigating factors vis-à-vis COVID-19 more challenging.

Despite the accumulated data over the last 2 decades on the reproductive safety of antidepressants, women continue to have questions about the safety of these medications during pregnancy. Studies show now that many women would prefer, if at all possible, to defer treatment with antidepressants, and so they come to us with questions about their reproductive safety, the potential of switching to nonpharmacologic interventions, and the use of alternative interventions that might be used to treat their underlying mood disorder.

Investigators at the University of British Columbia recently have tried to inform the field with still another look, not at reproductive safety per se, but at risk of relapse of depression if women discontinue those medicines during pregnancy.¹ There is a timeliness to this investigation, which was a systematic review and meta-analysis of studies that met a priori criteria for inclusion. Since some of our own group’s early work over 15 years ago on relapse of psychiatric disorder during pregnancy,² which indicated a substantial difference in risk of relapse between women who continued versus who discontinued antidepressants, other investigators have showed the difference in risk for relapse is not as substantial, and that continuation of medication did not appear to mitigate risk for relapse. In fact, in the systematic review, the investigators demonstrated that as a group, maintaining medicine did not appear to confer particular benefit to patients relative to risk for relapse compared to discontinuation of antidepressants.

However, looking more closely, Bayrampour and colleagues note for women with histories of more severe recurrent, major depression, relapse did in fact appear to be greater in women who discontinued compared with those with cases of mild to moderate depression. It is noteworthy that in both our early and later work, and certainly dovetailing with our clinical practice, we have noted severity of illness does not appear to correlate with the actual decisions women ultimately make regarding what they will do with antidepressants. Specifically, some women with very severe illness histories will discontinue antidepressants regardless of their risk for relapse. Alternatively, women with mild to moderate illness will sometimes elect to stay on antidepressant therapy. With all the information that we have about fetal exposure to antidepressants on one hand, the “unknown unknowns” are an understandable concern to both patients and clinicians. Clinicians are faced with the dilemma of how to best counsel women on continuing or discontinuing antidepressants as they plan to conceive or during pregnancy and in the postpartum period.

The literature cited and clinical experience over the last 3 decades suggests rather strongly that there is a relatively low likelihood women with histories of severe recurrent disease will be able to successfully discontinue antidepressants in the absence of relapse. A greater question is, what is the best way to proceed for women who have been on maintenance therapy and had more moderate symptoms?

I am inspired by some of the more recent literature that has tried to elucidate the role of nonpharmacologic interventions such as mindfulness-based cognitive therapy (MBCT) in an effort to mitigate risk for depressive relapse in pregnant women who are well with histories of depression. To date, data do not inform the question as to whether MBCT can be used to mitigate risk of depressive relapse in pregnant women who continue or discontinue antidepressants. That research question is actively being studied by several investigators, including ourselves.

Of particular interest is whether the addition of mindfulness practices such as MBCT in treatment could mitigate risk for depressive relapse in pregnant women who continue or discontinue antidepressant treatment, as that would certainly be a no-harm intervention that could mitigate risk even in a lower risk sample of patients. The question of how to “thread the needle” during the pandemic and best approach woman with a history of recurrent major depression on antidepressants is particularly timely and critical.

Regardless, we make clinical decisions collaboratively with patients based on their histories and individual wishes, and perhaps what we have learned over the last 5 months is the use of telemedicine does afford us the opportunity, regardless of the decisions that patients make, to more closely follow the clinical trajectory of women during pregnancy and the postpartum period so that regardless of treatment, we have an opportunity to intervene early when needed and to ascertain changes in clinical status early to mitigate the risk of frank relapse. From a reproductive psychiatric point of view, that is a silver lining with respect to the associated challenges that have come along with the pandemic.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

References

1. J Clin Psychiatry 2020;81(4):19r13134.

2. JAMA. 2006 Feb 1;295(5):499-507.

The US Food and Drug Administration (FDA) has approved marketing of the first authorized diagnostic antigen test for SARS-CoV-2 that can be used without an analyzer.

Abbott

The BinaxNOW COVID-19 Ag Card (Abbott) is similar in some ways to a home pregnancy test. Clinicians read results on a card – one line for a negative result, two lines for positive.

A health care provider swabs a symptomatic patient’s nose, twirls the sample on a test card with a reagent, and waits approximately 15 minutes for results. No additional equipment is required.

Abbott expects the test to cost about $5.00, the company announced.

Office-based physicians, ED physicians, and school nurses could potentially use the product as a point-of-care test. The FDA granted the test emergency use authorization. It is approved for people suspected of having COVID-19 who are within 7 days of symptom onset.

“This new COVID-19 antigen test is an important addition to available tests because the results can be read in minutes, right off the testing card,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, wrote in a news release. “This means people will know if they have the virus in almost real time.”

“This fits into the testing landscape as a simple, inexpensive test that does not require additional equipment,” Marcus Lynch, PhD, assistant manager of the Health Care Horizon Scanning program at ECRI, told Medscape Medical News when asked to comment. ECRI is an independent, nonprofit organization that reviews and analyses COVID-19 therapeutics and diagnostics.

The test could help with early triage of patients who test positive, perhaps alerting physicians to the need to start COVID-19 therapy, added Lynch, who specializes in immunology and vaccine development. The test also could be useful in low-resource settings.

The FDA included a caveat: antigen tests are generally less sensitive than molecular assays. “Due to the potential for decreased sensitivity compared to molecular assays, negative results from an antigen test may need to be confirmed with a molecular test prior to making treatment decisions,” the agency noted.

Lynch agreed and said that when a patient tests negative, physicians still need to use their clinical judgment on the basis of symptoms and other factors. The test is not designed for population-based screening of asymptomatic people, he added.

Abbott announced plans to make up to 50 million tests available per month in the United States starting in October. The product comes with a free smartphone app that people can use to share results with an employer or with others as needed.
 

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved marketing of the first authorized diagnostic antigen test for SARS-CoV-2 that can be used without an analyzer.

Abbott

The BinaxNOW COVID-19 Ag Card (Abbott) is similar in some ways to a home pregnancy test. Clinicians read results on a card – one line for a negative result, two lines for positive.

A health care provider swabs a symptomatic patient’s nose, twirls the sample on a test card with a reagent, and waits approximately 15 minutes for results. No additional equipment is required.

Abbott expects the test to cost about $5.00, the company announced.

Office-based physicians, ED physicians, and school nurses could potentially use the product as a point-of-care test. The FDA granted the test emergency use authorization. It is approved for people suspected of having COVID-19 who are within 7 days of symptom onset.

“This new COVID-19 antigen test is an important addition to available tests because the results can be read in minutes, right off the testing card,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, wrote in a news release. “This means people will know if they have the virus in almost real time.”

“This fits into the testing landscape as a simple, inexpensive test that does not require additional equipment,” Marcus Lynch, PhD, assistant manager of the Health Care Horizon Scanning program at ECRI, told Medscape Medical News when asked to comment. ECRI is an independent, nonprofit organization that reviews and analyses COVID-19 therapeutics and diagnostics.

The test could help with early triage of patients who test positive, perhaps alerting physicians to the need to start COVID-19 therapy, added Lynch, who specializes in immunology and vaccine development. The test also could be useful in low-resource settings.

The FDA included a caveat: antigen tests are generally less sensitive than molecular assays. “Due to the potential for decreased sensitivity compared to molecular assays, negative results from an antigen test may need to be confirmed with a molecular test prior to making treatment decisions,” the agency noted.

Lynch agreed and said that when a patient tests negative, physicians still need to use their clinical judgment on the basis of symptoms and other factors. The test is not designed for population-based screening of asymptomatic people, he added.

Abbott announced plans to make up to 50 million tests available per month in the United States starting in October. The product comes with a free smartphone app that people can use to share results with an employer or with others as needed.
 

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved marketing of the first authorized diagnostic antigen test for SARS-CoV-2 that can be used without an analyzer.

Abbott

The BinaxNOW COVID-19 Ag Card (Abbott) is similar in some ways to a home pregnancy test. Clinicians read results on a card – one line for a negative result, two lines for positive.

A health care provider swabs a symptomatic patient’s nose, twirls the sample on a test card with a reagent, and waits approximately 15 minutes for results. No additional equipment is required.

Abbott expects the test to cost about $5.00, the company announced.

Office-based physicians, ED physicians, and school nurses could potentially use the product as a point-of-care test. The FDA granted the test emergency use authorization. It is approved for people suspected of having COVID-19 who are within 7 days of symptom onset.

“This new COVID-19 antigen test is an important addition to available tests because the results can be read in minutes, right off the testing card,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, wrote in a news release. “This means people will know if they have the virus in almost real time.”

“This fits into the testing landscape as a simple, inexpensive test that does not require additional equipment,” Marcus Lynch, PhD, assistant manager of the Health Care Horizon Scanning program at ECRI, told Medscape Medical News when asked to comment. ECRI is an independent, nonprofit organization that reviews and analyses COVID-19 therapeutics and diagnostics.

The test could help with early triage of patients who test positive, perhaps alerting physicians to the need to start COVID-19 therapy, added Lynch, who specializes in immunology and vaccine development. The test also could be useful in low-resource settings.

The FDA included a caveat: antigen tests are generally less sensitive than molecular assays. “Due to the potential for decreased sensitivity compared to molecular assays, negative results from an antigen test may need to be confirmed with a molecular test prior to making treatment decisions,” the agency noted.

Lynch agreed and said that when a patient tests negative, physicians still need to use their clinical judgment on the basis of symptoms and other factors. The test is not designed for population-based screening of asymptomatic people, he added.

Abbott announced plans to make up to 50 million tests available per month in the United States starting in October. The product comes with a free smartphone app that people can use to share results with an employer or with others as needed.
 

This article first appeared on Medscape.com.

Women rheumatologists have made inroads in closing the gender gap as their numbers have risen in the profession, but disparities remain. They’re less likely to hold a higher-level professorship position, feature as a senior author on a paper, or receive a federal grant. Two recent studies underscore progress for and barriers to career advancement.

One cross-sectional analysis of practicing U.S. rheumatologists found that fewer women are professors compared with men (12.6% vs. 36.8%) or associate professors (17.5% vs. 28%). A larger proportion of women serve as assistant professors (55.5% vs. 31.5%). From a leadership perspective, women are making progress. Their odds are similar to men as far as holding a fellowship or division director position in a rheumatology division.

For this study, published in Arthritis & Rheumatology on Aug. 16, April Jorge, MD, and her colleagues at Massachusetts General Hospital and Harvard Medical School, both in Boston, identified 6,125 rheumatologists from a database of all licensed physicians and used multivariate logistic regression to assess gender differences in academic advancement. They arrived at their results after accounting for variables such as age, research and academic appointments, publications, achievements, and years since residency graduation.

Women rheumatologists are younger, completing their residency more recently than their male colleagues. Their numbers in academic rheumatology have gradually increased over the last few decades, recently outpacing men. In 2015, the American College of Rheumatology reported that women made up 41% of the workforce and 66% of rheumatology fellows. Dr. Jorge and associates stressed the importance of fostering women in leadership positions and ensuring gender equity in academic career advancement.

Women also had fewer publications and grants from the National Institutes of Health. Several factors could account for this, such as time spent in the workforce or on parental leave, work-life balance, and mentorship. “However, gender differences in academic promotion remained after adjusting for each of these typical promotion criteria, indicating that other unidentified factors also contribute to the gap in promotion for women academic rheumatologists,” the investigators noted.

The authors weren’t able to assess how parental leave and work effort affected results or why pay differences existed between men and women. They also weren’t able to determine how many physicians left academic practice. “If greater numbers of women than men left the academic rheumatology workforce – for one of many reasons, including that they were not promoted – our findings could underestimate sex differences in academic rank,” they acknowledged.

Lower authorship rate examined

Fewer women in full or associate professor positions might explain why female authorship on research papers is underrepresented, according to another study published Aug. 18 in Arthritis & Rheumatology. Ekta Bagga and colleagues at the University of Auckland (New Zealand) examined 7,651 original research articles from high-impact rheumatology and general medical journals published during 2015-2019 and reported that women were much less likely to achieve first or senior author positions in reports of randomized, controlled trials. This was especially true for studies initiated and funded by industry, compared with other research designs.

More gender parity existed for first authorship than senior authorship – women first authors and senior authors appeared in 51.5% and 35.3% of the papers, respectively. For all geographical regions, the proportion of women senior authors fell below 40%. Representation was especially low in regions other than Europe and North America. These observations likely reflect gender disparities in the medical workforce, Nicola Dalbeth, MD, the study’s senior author, said in an interview.

“We know that, although women make up almost half the rheumatology workforce in many countries around the world, we are less likely to be in positions of senior academic leadership,” added Dr. Dalbeth, a rheumatologist and professor at the University of Auckland’s Bone and Joint Research Group. Institutions and industry should take steps to ensure that women rheumatologists get equal representation, particularly in clinical trial development, she added.

The study had its limitations, one of which was that the researchers didn’t analyze individual author names. This means that one person may have authored multiple articles. “Given the relatively low number of women in academic rheumatology leadership positions, our method of analysis may have overrepresented the number of women authors of rheumatology publications, particularly in senior positions,” stated Dr. Dalbeth and colleagues.
 

Implicit bias in academia

The articles by Jorge et al. and Bagga et al. suggest that implicit bias is as prevalent in medicine as it is in general society, Jason Kolfenbach, MD, said in an interview. Dr. Kolfenbach is an associate professor of medicine and rheumatology and director of the rheumatology fellowship program at University of Colorado at Denver, Aurora.

“The study by Jorge et al. is eye opening because it demonstrates that academic promotion is lower among women even after adjustment for some of these measures of academic productivity,” Dr. Kolfenbach said. It’s likely that bias plays some role “since there is a human element behind promotions committees, as well as committees selecting faculty for the creation of guidelines and speaker panels at national conferences.”

The study by Bagga et al. “matches my personal perception of industry-sponsored studies and pharmaceutical-sponsored speakers bureaus, namely that they are overrepresented by male faculty,” Dr. Kolfenbach continued.

Prior to COVID-19, the department of medicine at the University of Colorado had begun participating in a formal program called the Bias Reduction in Internal Medicine Initiative, a National Institutes of Health–sponsored study. “I’m hopeful programs such as this can lead to a more equitable situation than described by the findings in these two studies,” he added.
 

Article type, country of origin play a role

Other research corroborates the findings in these two papers. Giovanni Adami, MD, and coauthors examined 366 rheumatology guidelines and recommendations and determined that only 32% featured a female first author. However, authorship did increase for women over time, achieving parity in 2017.

There are several points to consider when exploring gender disparity, Dr. Adami said in an interview. “Original articles, industry-sponsored articles, and recommendation articles explore different disparities,” he offered. Recommendations and industry-sponsored articles are usually authored by international experts such as division directors or full professors. Original articles, in comparison, aren’t as affected by the “opinion leader” effect, he added.

Country of origin is also a crucial aspect, Dr. Adami said. In his own search of guidelines and articles published by Japanese or Chinese researchers, he noticed that males made up the vast majority of authors. “The cultural aspects of the country where research develops is a vital thing to consider when analyzing gender disparity.”

Dr. Adami’s homeland of Italy is a case in point: most of the division chiefs and professors are male. “Here in Italy, there’s a common belief that a woman cannot pursue an academic career or aim for a leadership position,” he noted.

Italy’s public university system has seen some improvements in gender parity, he continued. “For example, in 2009 there were 61,000 new medical students in Italy, and the majority [57%] were female. Nonetheless, we still have more male professors of medicine and more male PhD candidates.”
 

Gender gap narrows for conference speakers

In another study, rheumatologists Jean Liew, MD, of the University of Washington, Seattle, and Kanika Monga, MD, of the University of Texas Health Science Center at Houston, found notable gender gaps in speakers at ACR conferences. Women represented under 50% of speakers at these meetings over a 2-year period. “Although the gender gap at recent ACR meetings was narrower as compared with other conferences, we must remain cognizant of its presence and continue to work towards equal representation,” the authors wrote in a correspondence letter in Annals of the Rheumatic Diseases.

Dr. Monga said she was excited to see so many studies on the topic of gender disparities in rheumatology. The Jorge et al. and Bagga et al. papers “delve deeper into quantifying the gender gap in rheumatology. These studies allow us to better identify where the discrepancies may be,” she said in an interview.

“I found it very interesting that women were less likely to be promoted in academic rank but as likely as men to hold leadership positions,” Dr. Monga said. She agreed with the authors that criteria for academic promotion should be reassessed to ensure that it values the diversity of scholarly work that rheumatologists pursue.

Men may still outnumber women speakers at ACR meetings, but the Liew and Monga study did report a 4.2% increase in female speaker representation from 2017 to 2018. “We were happy to note that that continued to be the case at The American College of Rheumatology’s Annual Meeting in 2019. I hope that this reflects a positive change in our specialty,” she said.

Dr. Dalbeth’s study received support from a University of Auckland Summer Studentship Award. She has received consulting fees, speaker fees, or grants from AstraZeneca, Horizon, Amgen, Janssen, and other companies outside of the submitted work. The other authors declared no competing interests.

Dr. Jorge receives funds from the Rheumatology Research Foundation. The senior author on her study receives funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

Women rheumatologists have made inroads in closing the gender gap as their numbers have risen in the profession, but disparities remain. They’re less likely to hold a higher-level professorship position, feature as a senior author on a paper, or receive a federal grant. Two recent studies underscore progress for and barriers to career advancement.

One cross-sectional analysis of practicing U.S. rheumatologists found that fewer women are professors compared with men (12.6% vs. 36.8%) or associate professors (17.5% vs. 28%). A larger proportion of women serve as assistant professors (55.5% vs. 31.5%). From a leadership perspective, women are making progress. Their odds are similar to men as far as holding a fellowship or division director position in a rheumatology division.

For this study, published in Arthritis & Rheumatology on Aug. 16, April Jorge, MD, and her colleagues at Massachusetts General Hospital and Harvard Medical School, both in Boston, identified 6,125 rheumatologists from a database of all licensed physicians and used multivariate logistic regression to assess gender differences in academic advancement. They arrived at their results after accounting for variables such as age, research and academic appointments, publications, achievements, and years since residency graduation.

Women rheumatologists are younger, completing their residency more recently than their male colleagues. Their numbers in academic rheumatology have gradually increased over the last few decades, recently outpacing men. In 2015, the American College of Rheumatology reported that women made up 41% of the workforce and 66% of rheumatology fellows. Dr. Jorge and associates stressed the importance of fostering women in leadership positions and ensuring gender equity in academic career advancement.

Women also had fewer publications and grants from the National Institutes of Health. Several factors could account for this, such as time spent in the workforce or on parental leave, work-life balance, and mentorship. “However, gender differences in academic promotion remained after adjusting for each of these typical promotion criteria, indicating that other unidentified factors also contribute to the gap in promotion for women academic rheumatologists,” the investigators noted.

The authors weren’t able to assess how parental leave and work effort affected results or why pay differences existed between men and women. They also weren’t able to determine how many physicians left academic practice. “If greater numbers of women than men left the academic rheumatology workforce – for one of many reasons, including that they were not promoted – our findings could underestimate sex differences in academic rank,” they acknowledged.

Lower authorship rate examined

Fewer women in full or associate professor positions might explain why female authorship on research papers is underrepresented, according to another study published Aug. 18 in Arthritis & Rheumatology. Ekta Bagga and colleagues at the University of Auckland (New Zealand) examined 7,651 original research articles from high-impact rheumatology and general medical journals published during 2015-2019 and reported that women were much less likely to achieve first or senior author positions in reports of randomized, controlled trials. This was especially true for studies initiated and funded by industry, compared with other research designs.

More gender parity existed for first authorship than senior authorship – women first authors and senior authors appeared in 51.5% and 35.3% of the papers, respectively. For all geographical regions, the proportion of women senior authors fell below 40%. Representation was especially low in regions other than Europe and North America. These observations likely reflect gender disparities in the medical workforce, Nicola Dalbeth, MD, the study’s senior author, said in an interview.

“We know that, although women make up almost half the rheumatology workforce in many countries around the world, we are less likely to be in positions of senior academic leadership,” added Dr. Dalbeth, a rheumatologist and professor at the University of Auckland’s Bone and Joint Research Group. Institutions and industry should take steps to ensure that women rheumatologists get equal representation, particularly in clinical trial development, she added.

The study had its limitations, one of which was that the researchers didn’t analyze individual author names. This means that one person may have authored multiple articles. “Given the relatively low number of women in academic rheumatology leadership positions, our method of analysis may have overrepresented the number of women authors of rheumatology publications, particularly in senior positions,” stated Dr. Dalbeth and colleagues.
 

Implicit bias in academia

The articles by Jorge et al. and Bagga et al. suggest that implicit bias is as prevalent in medicine as it is in general society, Jason Kolfenbach, MD, said in an interview. Dr. Kolfenbach is an associate professor of medicine and rheumatology and director of the rheumatology fellowship program at University of Colorado at Denver, Aurora.

“The study by Jorge et al. is eye opening because it demonstrates that academic promotion is lower among women even after adjustment for some of these measures of academic productivity,” Dr. Kolfenbach said. It’s likely that bias plays some role “since there is a human element behind promotions committees, as well as committees selecting faculty for the creation of guidelines and speaker panels at national conferences.”

The study by Bagga et al. “matches my personal perception of industry-sponsored studies and pharmaceutical-sponsored speakers bureaus, namely that they are overrepresented by male faculty,” Dr. Kolfenbach continued.

Prior to COVID-19, the department of medicine at the University of Colorado had begun participating in a formal program called the Bias Reduction in Internal Medicine Initiative, a National Institutes of Health–sponsored study. “I’m hopeful programs such as this can lead to a more equitable situation than described by the findings in these two studies,” he added.
 

Article type, country of origin play a role

Other research corroborates the findings in these two papers. Giovanni Adami, MD, and coauthors examined 366 rheumatology guidelines and recommendations and determined that only 32% featured a female first author. However, authorship did increase for women over time, achieving parity in 2017.

There are several points to consider when exploring gender disparity, Dr. Adami said in an interview. “Original articles, industry-sponsored articles, and recommendation articles explore different disparities,” he offered. Recommendations and industry-sponsored articles are usually authored by international experts such as division directors or full professors. Original articles, in comparison, aren’t as affected by the “opinion leader” effect, he added.

Country of origin is also a crucial aspect, Dr. Adami said. In his own search of guidelines and articles published by Japanese or Chinese researchers, he noticed that males made up the vast majority of authors. “The cultural aspects of the country where research develops is a vital thing to consider when analyzing gender disparity.”

Dr. Adami’s homeland of Italy is a case in point: most of the division chiefs and professors are male. “Here in Italy, there’s a common belief that a woman cannot pursue an academic career or aim for a leadership position,” he noted.

Italy’s public university system has seen some improvements in gender parity, he continued. “For example, in 2009 there were 61,000 new medical students in Italy, and the majority [57%] were female. Nonetheless, we still have more male professors of medicine and more male PhD candidates.”
 

Gender gap narrows for conference speakers

In another study, rheumatologists Jean Liew, MD, of the University of Washington, Seattle, and Kanika Monga, MD, of the University of Texas Health Science Center at Houston, found notable gender gaps in speakers at ACR conferences. Women represented under 50% of speakers at these meetings over a 2-year period. “Although the gender gap at recent ACR meetings was narrower as compared with other conferences, we must remain cognizant of its presence and continue to work towards equal representation,” the authors wrote in a correspondence letter in Annals of the Rheumatic Diseases.