Ob.Gyn. News

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.

As in its typical fashion, the question sprang out from a young Black patient after some meandering conversation during preconception counseling: “How do y’all prevent Black maternal mortality?” At the beginning of my career, I used to think preparing a patient for pregnancy involved recommending prenatal vitamins and rubella immunity screening. Now, having worked in a society with substantial racial health disparities for 14 years, there is greater awareness that pregnancy can be a matter of life or death that disproportionately affects people of color.

SDI Productions/E+

For Black patients in the United States, the maternal mortality ratio is almost four times higher than the ratio for White patients, 42 deaths versus 13 deaths per 100,000 live births, respectively.¹ Georgia has the highest maternal mortality ratio in the United States at 67 maternal deaths per 100,000 live births. However, if you are a Black woman in Georgia, your chance of dying of pregnancy-related causes is 2.7 times that of a non-Hispanic White woman living in Georgia.²

How do we answer this patient’s question in a way that addresses the systemic racism that underlies these disparities? We start by actively listening. Black patients often are not taken seriously, even when they are wealthy, have attained high levels of education, or are famous. Serena Williams, a Black woman and one of the most talented tennis players of all time, was ignored when complaining that she felt a blood clot had returned in her lungs post partum. As a recognition of this crisis, the Centers for Disease Control and Prevention has a new campaign to improve recognition of the warning signs of problems in pregnancy called the HEAR HER campaign. This issue is a pervasive problem in our lives that runs across the spectrum of Black experience. I have had Black friends, patients, and colleagues who have been ignored when complaining about labor pain, workplace discrimination, and even when trying to advocate for their patients. We need to uplift Black voices so they can be heard and support the initiatives and interventions they are asking for.

We practice standardized responses to emergencies and to health conditions. We use drills to practice our responses to life-threatening emergencies such as STAT cesarean delivery, shoulder dystocia, obstetrical hemorrhage, or treatment of preeclampsia and eclampsia. The Alliance for Innovation on Maternal Health has organized evidence-driven protocols called AIM bundles to reduce preventable maternal morbidity and mortality when implemented. Standardization is an important component of equitable treatment and reduction of disparities. The concept has been used across industries to reduce error and bias. The Alliance for Innovation on Maternal Health bundles even include a section on Reduction of Peripartum and Ethnic Disparities.

We admit that bias exists and that we need training to recognize and eliminate it. According to a study in the Proceedings of the National Academy of Sciences of the United States of America about racial bias in pain assessment more than 20% of White residents and medical students surveyed believed that Black people had less sensitive nerve endings than Whites.³ Studies show that this stereotype leads to inappropriate pain management in Black patients, a chief concern when considering how patients are treated on labor and delivery or after surgery.⁴ Additionally, unconscious bias can be addressed by hiring a diverse workforce at all levels. Familiarity with a diverse group can help us learn from one another in our day-to-day lives.

We need to offer the same high-quality preconception counseling to all of our patients. A patient’s perceived race or ethnicity is a poor indicator of their actual health needs. The amount of melanin in our skin is highly variable but our genetics are remarkably similar, therefore our health concerns are similar. All patients deserve a focus on prevention. Folic acid supplements in the form of prenatal vitamins should be recommended. Routine vaccinations and rubella immunity checks should be offered. Basic carrier screening for diseases of hemoglobin (which includes sickle cell trait), fragile X, spinomuscular atrophy, and cystic fibrosis should be offered. Finally, an emphasis on safety, mental health, and daily low-level exercise (i.e., walking) should be promoted to help prevent illness and injury in this age group. The leading causes of death for people of reproductive age are accidents, suicide, homicide, and heart disease – all preventable.

We treat the social determinants of health, not just the patient in front of us. When “race” is a risk factor for disease, it’s usually racism that’s the problem. As stated earlier, how much melanin is in our skin has little to do with our genetics – if we removed our skin, we’d have similar life expectancies and die of similar things. However, it has everything to do with how we navigate our society and access health care. The stress associated with being Black in America is the likely cause of preterm birth rates – leading to infant illness and death – and maternal mortality being higher in Black patients. This is referred to as “weathering” – the cumulative effects of stress as we age. It explains why Black women are more likely to die in pregnancy despite higher levels of education and increasing age – factors that are protective for other groups. Improving access to quality education, reforming the criminal justice system, affordable housing and child care, living wages, family planning, and universal basic health care exemplify the intersectionality of some of our greatest societal challenges. Addressing these root causes will reduce weathering and ultimately, save Black lives.

We strive to train more “underrepresented minorities” in medicine. According to the American Association of Medical Colleges, only 7.3% of medical students in 2019-2020 identified as Black or African American. This is way below their representation of 13% of the U.S. population. I’m proud that my division and department as a whole have hired and promoted diverse faculty with 30% of my generalist ob.gyn. colleagues being people of color. This shows that we have the input of diverse experiences as well as recognize the special concerns of patients of color. Underrepresented students interested in the health professions need us to do more to get their “foot in the door.” They are less likely to have connections to the field of medicine (family members, mentors), have access to prep courses or advisors, or have the finances to support the expensive application process. Reach out to your alma maters and ask how you can help mentor students at a young age and continue through adulthood, support scholarships, support unpaid internship recipients, and promote interconnectedness throughout this community.

I hope I answered my patient’s question in that moment, but I know what needs to be done is bigger that taking care of one patient. It will require small progress, by us, every single day. Until these interventions and others reshape our society, I’ll still have Black patients who say: “Don’t let me die, okay?” with a look right into my soul and a tight grip on my hand. And I’ll feel the immense weight of that trust, and squeeze the hand back.
 

Dr. Collins (she/her/hers) is assistant professor of obstetrics and gynecology, generalist division, at Emory University, Atlanta. She has no relevant financial disclosures. Email Dr. Collins at obnews@mdedge.com.
 

References

1. CDC Pregnancy Mortality Surveillance System, 2016. https://www.cdc.gov/reproductivehealth/maternal-mortality/pregnancy-mortality-surveillance-system.htm.

2. Maternal Mortality Fact Sheet, 2012-2015. https://dph.georgia.gov/maternal-mortality.

3. Proc Natl Acad Sci U S A. 2016 Apr 19;113(16):4296-301.

4. Pain Med. 2012 Feb;13(2):150-74.

As in its typical fashion, the question sprang out from a young Black patient after some meandering conversation during preconception counseling: “How do y’all prevent Black maternal mortality?” At the beginning of my career, I used to think preparing a patient for pregnancy involved recommending prenatal vitamins and rubella immunity screening. Now, having worked in a society with substantial racial health disparities for 14 years, there is greater awareness that pregnancy can be a matter of life or death that disproportionately affects people of color.

SDI Productions/E+

For Black patients in the United States, the maternal mortality ratio is almost four times higher than the ratio for White patients, 42 deaths versus 13 deaths per 100,000 live births, respectively.¹ Georgia has the highest maternal mortality ratio in the United States at 67 maternal deaths per 100,000 live births. However, if you are a Black woman in Georgia, your chance of dying of pregnancy-related causes is 2.7 times that of a non-Hispanic White woman living in Georgia.²

How do we answer this patient’s question in a way that addresses the systemic racism that underlies these disparities? We start by actively listening. Black patients often are not taken seriously, even when they are wealthy, have attained high levels of education, or are famous. Serena Williams, a Black woman and one of the most talented tennis players of all time, was ignored when complaining that she felt a blood clot had returned in her lungs post partum. As a recognition of this crisis, the Centers for Disease Control and Prevention has a new campaign to improve recognition of the warning signs of problems in pregnancy called the HEAR HER campaign. This issue is a pervasive problem in our lives that runs across the spectrum of Black experience. I have had Black friends, patients, and colleagues who have been ignored when complaining about labor pain, workplace discrimination, and even when trying to advocate for their patients. We need to uplift Black voices so they can be heard and support the initiatives and interventions they are asking for.

We practice standardized responses to emergencies and to health conditions. We use drills to practice our responses to life-threatening emergencies such as STAT cesarean delivery, shoulder dystocia, obstetrical hemorrhage, or treatment of preeclampsia and eclampsia. The Alliance for Innovation on Maternal Health has organized evidence-driven protocols called AIM bundles to reduce preventable maternal morbidity and mortality when implemented. Standardization is an important component of equitable treatment and reduction of disparities. The concept has been used across industries to reduce error and bias. The Alliance for Innovation on Maternal Health bundles even include a section on Reduction of Peripartum and Ethnic Disparities.

We admit that bias exists and that we need training to recognize and eliminate it. According to a study in the Proceedings of the National Academy of Sciences of the United States of America about racial bias in pain assessment more than 20% of White residents and medical students surveyed believed that Black people had less sensitive nerve endings than Whites.³ Studies show that this stereotype leads to inappropriate pain management in Black patients, a chief concern when considering how patients are treated on labor and delivery or after surgery.⁴ Additionally, unconscious bias can be addressed by hiring a diverse workforce at all levels. Familiarity with a diverse group can help us learn from one another in our day-to-day lives.

We need to offer the same high-quality preconception counseling to all of our patients. A patient’s perceived race or ethnicity is a poor indicator of their actual health needs. The amount of melanin in our skin is highly variable but our genetics are remarkably similar, therefore our health concerns are similar. All patients deserve a focus on prevention. Folic acid supplements in the form of prenatal vitamins should be recommended. Routine vaccinations and rubella immunity checks should be offered. Basic carrier screening for diseases of hemoglobin (which includes sickle cell trait), fragile X, spinomuscular atrophy, and cystic fibrosis should be offered. Finally, an emphasis on safety, mental health, and daily low-level exercise (i.e., walking) should be promoted to help prevent illness and injury in this age group. The leading causes of death for people of reproductive age are accidents, suicide, homicide, and heart disease – all preventable.

We treat the social determinants of health, not just the patient in front of us. When “race” is a risk factor for disease, it’s usually racism that’s the problem. As stated earlier, how much melanin is in our skin has little to do with our genetics – if we removed our skin, we’d have similar life expectancies and die of similar things. However, it has everything to do with how we navigate our society and access health care. The stress associated with being Black in America is the likely cause of preterm birth rates – leading to infant illness and death – and maternal mortality being higher in Black patients. This is referred to as “weathering” – the cumulative effects of stress as we age. It explains why Black women are more likely to die in pregnancy despite higher levels of education and increasing age – factors that are protective for other groups. Improving access to quality education, reforming the criminal justice system, affordable housing and child care, living wages, family planning, and universal basic health care exemplify the intersectionality of some of our greatest societal challenges. Addressing these root causes will reduce weathering and ultimately, save Black lives.

We strive to train more “underrepresented minorities” in medicine. According to the American Association of Medical Colleges, only 7.3% of medical students in 2019-2020 identified as Black or African American. This is way below their representation of 13% of the U.S. population. I’m proud that my division and department as a whole have hired and promoted diverse faculty with 30% of my generalist ob.gyn. colleagues being people of color. This shows that we have the input of diverse experiences as well as recognize the special concerns of patients of color. Underrepresented students interested in the health professions need us to do more to get their “foot in the door.” They are less likely to have connections to the field of medicine (family members, mentors), have access to prep courses or advisors, or have the finances to support the expensive application process. Reach out to your alma maters and ask how you can help mentor students at a young age and continue through adulthood, support scholarships, support unpaid internship recipients, and promote interconnectedness throughout this community.

I hope I answered my patient’s question in that moment, but I know what needs to be done is bigger that taking care of one patient. It will require small progress, by us, every single day. Until these interventions and others reshape our society, I’ll still have Black patients who say: “Don’t let me die, okay?” with a look right into my soul and a tight grip on my hand. And I’ll feel the immense weight of that trust, and squeeze the hand back.
 

Dr. Collins (she/her/hers) is assistant professor of obstetrics and gynecology, generalist division, at Emory University, Atlanta. She has no relevant financial disclosures. Email Dr. Collins at obnews@mdedge.com.
 

References

1. CDC Pregnancy Mortality Surveillance System, 2016. https://www.cdc.gov/reproductivehealth/maternal-mortality/pregnancy-mortality-surveillance-system.htm.

2. Maternal Mortality Fact Sheet, 2012-2015. https://dph.georgia.gov/maternal-mortality.

3. Proc Natl Acad Sci U S A. 2016 Apr 19;113(16):4296-301.

4. Pain Med. 2012 Feb;13(2):150-74.

As in its typical fashion, the question sprang out from a young Black patient after some meandering conversation during preconception counseling: “How do y’all prevent Black maternal mortality?” At the beginning of my career, I used to think preparing a patient for pregnancy involved recommending prenatal vitamins and rubella immunity screening. Now, having worked in a society with substantial racial health disparities for 14 years, there is greater awareness that pregnancy can be a matter of life or death that disproportionately affects people of color.

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For Black patients in the United States, the maternal mortality ratio is almost four times higher than the ratio for White patients, 42 deaths versus 13 deaths per 100,000 live births, respectively.¹ Georgia has the highest maternal mortality ratio in the United States at 67 maternal deaths per 100,000 live births. However, if you are a Black woman in Georgia, your chance of dying of pregnancy-related causes is 2.7 times that of a non-Hispanic White woman living in Georgia.²

How do we answer this patient’s question in a way that addresses the systemic racism that underlies these disparities? We start by actively listening. Black patients often are not taken seriously, even when they are wealthy, have attained high levels of education, or are famous. Serena Williams, a Black woman and one of the most talented tennis players of all time, was ignored when complaining that she felt a blood clot had returned in her lungs post partum. As a recognition of this crisis, the Centers for Disease Control and Prevention has a new campaign to improve recognition of the warning signs of problems in pregnancy called the HEAR HER campaign. This issue is a pervasive problem in our lives that runs across the spectrum of Black experience. I have had Black friends, patients, and colleagues who have been ignored when complaining about labor pain, workplace discrimination, and even when trying to advocate for their patients. We need to uplift Black voices so they can be heard and support the initiatives and interventions they are asking for.

We practice standardized responses to emergencies and to health conditions. We use drills to practice our responses to life-threatening emergencies such as STAT cesarean delivery, shoulder dystocia, obstetrical hemorrhage, or treatment of preeclampsia and eclampsia. The Alliance for Innovation on Maternal Health has organized evidence-driven protocols called AIM bundles to reduce preventable maternal morbidity and mortality when implemented. Standardization is an important component of equitable treatment and reduction of disparities. The concept has been used across industries to reduce error and bias. The Alliance for Innovation on Maternal Health bundles even include a section on Reduction of Peripartum and Ethnic Disparities.

We admit that bias exists and that we need training to recognize and eliminate it. According to a study in the Proceedings of the National Academy of Sciences of the United States of America about racial bias in pain assessment more than 20% of White residents and medical students surveyed believed that Black people had less sensitive nerve endings than Whites.³ Studies show that this stereotype leads to inappropriate pain management in Black patients, a chief concern when considering how patients are treated on labor and delivery or after surgery.⁴ Additionally, unconscious bias can be addressed by hiring a diverse workforce at all levels. Familiarity with a diverse group can help us learn from one another in our day-to-day lives.

We need to offer the same high-quality preconception counseling to all of our patients. A patient’s perceived race or ethnicity is a poor indicator of their actual health needs. The amount of melanin in our skin is highly variable but our genetics are remarkably similar, therefore our health concerns are similar. All patients deserve a focus on prevention. Folic acid supplements in the form of prenatal vitamins should be recommended. Routine vaccinations and rubella immunity checks should be offered. Basic carrier screening for diseases of hemoglobin (which includes sickle cell trait), fragile X, spinomuscular atrophy, and cystic fibrosis should be offered. Finally, an emphasis on safety, mental health, and daily low-level exercise (i.e., walking) should be promoted to help prevent illness and injury in this age group. The leading causes of death for people of reproductive age are accidents, suicide, homicide, and heart disease – all preventable.

We treat the social determinants of health, not just the patient in front of us. When “race” is a risk factor for disease, it’s usually racism that’s the problem. As stated earlier, how much melanin is in our skin has little to do with our genetics – if we removed our skin, we’d have similar life expectancies and die of similar things. However, it has everything to do with how we navigate our society and access health care. The stress associated with being Black in America is the likely cause of preterm birth rates – leading to infant illness and death – and maternal mortality being higher in Black patients. This is referred to as “weathering” – the cumulative effects of stress as we age. It explains why Black women are more likely to die in pregnancy despite higher levels of education and increasing age – factors that are protective for other groups. Improving access to quality education, reforming the criminal justice system, affordable housing and child care, living wages, family planning, and universal basic health care exemplify the intersectionality of some of our greatest societal challenges. Addressing these root causes will reduce weathering and ultimately, save Black lives.

We strive to train more “underrepresented minorities” in medicine. According to the American Association of Medical Colleges, only 7.3% of medical students in 2019-2020 identified as Black or African American. This is way below their representation of 13% of the U.S. population. I’m proud that my division and department as a whole have hired and promoted diverse faculty with 30% of my generalist ob.gyn. colleagues being people of color. This shows that we have the input of diverse experiences as well as recognize the special concerns of patients of color. Underrepresented students interested in the health professions need us to do more to get their “foot in the door.” They are less likely to have connections to the field of medicine (family members, mentors), have access to prep courses or advisors, or have the finances to support the expensive application process. Reach out to your alma maters and ask how you can help mentor students at a young age and continue through adulthood, support scholarships, support unpaid internship recipients, and promote interconnectedness throughout this community.

I hope I answered my patient’s question in that moment, but I know what needs to be done is bigger that taking care of one patient. It will require small progress, by us, every single day. Until these interventions and others reshape our society, I’ll still have Black patients who say: “Don’t let me die, okay?” with a look right into my soul and a tight grip on my hand. And I’ll feel the immense weight of that trust, and squeeze the hand back.
 

Dr. Collins (she/her/hers) is assistant professor of obstetrics and gynecology, generalist division, at Emory University, Atlanta. She has no relevant financial disclosures. Email Dr. Collins at obnews@mdedge.com.
 

References

1. CDC Pregnancy Mortality Surveillance System, 2016. https://www.cdc.gov/reproductivehealth/maternal-mortality/pregnancy-mortality-surveillance-system.htm.

2. Maternal Mortality Fact Sheet, 2012-2015. https://dph.georgia.gov/maternal-mortality.

3. Proc Natl Acad Sci U S A. 2016 Apr 19;113(16):4296-301.

4. Pain Med. 2012 Feb;13(2):150-74.

Against the backdrop of the COVID-19 pandemic and ongoing national conversations around racial injustice, it is more important than ever that we identify and root out systemic discrimination – including in our health care system. As an ob.gyn., I’ve spent my entire career making sure that women receive the best care, and have witnessed firsthand the results of a system that provides differing levels of care based on one’s socioeconomic level, race, or ethnicity. The simple and sad reality is black and Hispanic women in this country continue to have less access to critical maternal and prenatal care.

This disparity is borne out in this country’s maternal health outcomes. For example, the latest figures from the Centers for Disease Control and Prevention indicate that the maternal mortality rate for black women, 37.1 deaths per 100,000 live births, is more than double the rate for white women at 14.7. In addition, the black infant mortality rate, at 11.4 per 1,000 live births, is also more than double the white infant mortality rate, 4.9. While many of these differences stem from discriminatory levels of coverage and care after delivery, just as important is the coverage and care before delivery: prenatal care.

Prenatal care includes a variety of screening tests, including those that can help expecting mothers identify whether the baby is more or less likely to have certain genetic disorders. These tests include traditional and less accurate options like serum or combined screening, and newer noninvasive prenatal testing (NIPT) options that use blood samples from the mother to analyze the baby’s DNA.

Research already has demonstrated that NIPT is the most accurate and effective screening option for common chromosomal abnormalities (Ont Health Technol Assess Ser. 2019;19[4]:1-166). A 2015 New England Journal of Medicine study showed that, without access to NIPT, 22% of pregnancies with Down syndrome were missed. With older screening methods, 5.4% of positive results for Down syndrome were false, compared with 0.06% of the NIPT tests (N Engl J Med 2015;372:1589-97). Older, less accurate screening tests cause unnecessary referrals to specialists for possible invasive testing, resulting in additional costs and undue stress on women and their families.

And yet, troubling new data have shown that black and Hispanic women have less access to NIPT than white women. Currently, NIPT is available to all California women through the state-funded prenatal screening program as a second-tier test. Many women, however, decide to opt out or go outside of the state program to have NIPT as a first-tier test, choosing private payer or other plans instead. New data shared by the California Department of Public Health with ob.gyns. and maternal-fetal medicine physicians in California showed that white women who opted out of California’s state-funded prenatal screening program were more than twice as likely to gain access to NIPT as black and Hispanic women (39%-17%). We can assume this to be true of women outside California as well – women who have no access to a state-funded program like California’s and depend solely on private payer or other health care plans. In fact, although some commercial insurance companies do cover NIPT, noninvasive prenatal screening is not covered by large insurance companies like Aetna and UnitedHealthcare.

As ob.gyns., physicians, and health professionals, we need to ask ourselves: Why is there such a great disparity in the access of superior and more effective NIPT options for black and Hispanic women?

Many reasons are apparent. There are significant differences by ethnic and racial groups in their knowledge of the availability of prenatal testing. Furthermore, there are higher levels of mistrust along certain racial and ethnic lines of the medical system in this country; specific religious or ethnic beliefs also may obviate the use of prenatal testing or diagnosis. Significant differences also exist in the types of health coverage by race and ethnicity, ultimately impacting the ability to have prenatal testing. Finally, there are different physician group recommendations. While medical societies such as the American College of Medical Genetics, International Society for Prenatal Diagnosis, and the American Society of Human Genetics all have long endorsed newer NIPT option for all pregnant women, two of the national physician groups that make recommendations about what care pregnant women should be able to access – the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine – only recently have recommended broad access to NIPT. As a result, some state Medicaid programs have not made NIPT available to patients.

We know that racial disparities are a public health crisis in America. The recent data from the California Department of Public Health, paired with COVID-19’s disproportionate impact on blacks and Hispanics, only further illustrate the existing health disparities experienced by this country’s communities of color.

We need to root out systemic discrimination in health care and we can begin with our maternal health care. Providing equitable access to the most accurate and consistent prenatal screenings, including NIPT options, regardless of insurance plan, socioeconomic level, race, or ethnicity is paramount in starting this work.
 

Dr. Gaither is a double board–certified physician in ob.gyn. and maternal-fetal medicine. She is director of perinatal services for NYC Health+Hospitals/Lincoln. She reports no conflicts of interest. Email her at obnews@mdedge.com.

Against the backdrop of the COVID-19 pandemic and ongoing national conversations around racial injustice, it is more important than ever that we identify and root out systemic discrimination – including in our health care system. As an ob.gyn., I’ve spent my entire career making sure that women receive the best care, and have witnessed firsthand the results of a system that provides differing levels of care based on one’s socioeconomic level, race, or ethnicity. The simple and sad reality is black and Hispanic women in this country continue to have less access to critical maternal and prenatal care.

This disparity is borne out in this country’s maternal health outcomes. For example, the latest figures from the Centers for Disease Control and Prevention indicate that the maternal mortality rate for black women, 37.1 deaths per 100,000 live births, is more than double the rate for white women at 14.7. In addition, the black infant mortality rate, at 11.4 per 1,000 live births, is also more than double the white infant mortality rate, 4.9. While many of these differences stem from discriminatory levels of coverage and care after delivery, just as important is the coverage and care before delivery: prenatal care.

Prenatal care includes a variety of screening tests, including those that can help expecting mothers identify whether the baby is more or less likely to have certain genetic disorders. These tests include traditional and less accurate options like serum or combined screening, and newer noninvasive prenatal testing (NIPT) options that use blood samples from the mother to analyze the baby’s DNA.

Research already has demonstrated that NIPT is the most accurate and effective screening option for common chromosomal abnormalities (Ont Health Technol Assess Ser. 2019;19[4]:1-166). A 2015 New England Journal of Medicine study showed that, without access to NIPT, 22% of pregnancies with Down syndrome were missed. With older screening methods, 5.4% of positive results for Down syndrome were false, compared with 0.06% of the NIPT tests (N Engl J Med 2015;372:1589-97). Older, less accurate screening tests cause unnecessary referrals to specialists for possible invasive testing, resulting in additional costs and undue stress on women and their families.

And yet, troubling new data have shown that black and Hispanic women have less access to NIPT than white women. Currently, NIPT is available to all California women through the state-funded prenatal screening program as a second-tier test. Many women, however, decide to opt out or go outside of the state program to have NIPT as a first-tier test, choosing private payer or other plans instead. New data shared by the California Department of Public Health with ob.gyns. and maternal-fetal medicine physicians in California showed that white women who opted out of California’s state-funded prenatal screening program were more than twice as likely to gain access to NIPT as black and Hispanic women (39%-17%). We can assume this to be true of women outside California as well – women who have no access to a state-funded program like California’s and depend solely on private payer or other health care plans. In fact, although some commercial insurance companies do cover NIPT, noninvasive prenatal screening is not covered by large insurance companies like Aetna and UnitedHealthcare.

As ob.gyns., physicians, and health professionals, we need to ask ourselves: Why is there such a great disparity in the access of superior and more effective NIPT options for black and Hispanic women?

Many reasons are apparent. There are significant differences by ethnic and racial groups in their knowledge of the availability of prenatal testing. Furthermore, there are higher levels of mistrust along certain racial and ethnic lines of the medical system in this country; specific religious or ethnic beliefs also may obviate the use of prenatal testing or diagnosis. Significant differences also exist in the types of health coverage by race and ethnicity, ultimately impacting the ability to have prenatal testing. Finally, there are different physician group recommendations. While medical societies such as the American College of Medical Genetics, International Society for Prenatal Diagnosis, and the American Society of Human Genetics all have long endorsed newer NIPT option for all pregnant women, two of the national physician groups that make recommendations about what care pregnant women should be able to access – the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine – only recently have recommended broad access to NIPT. As a result, some state Medicaid programs have not made NIPT available to patients.

We know that racial disparities are a public health crisis in America. The recent data from the California Department of Public Health, paired with COVID-19’s disproportionate impact on blacks and Hispanics, only further illustrate the existing health disparities experienced by this country’s communities of color.

We need to root out systemic discrimination in health care and we can begin with our maternal health care. Providing equitable access to the most accurate and consistent prenatal screenings, including NIPT options, regardless of insurance plan, socioeconomic level, race, or ethnicity is paramount in starting this work.
 

Dr. Gaither is a double board–certified physician in ob.gyn. and maternal-fetal medicine. She is director of perinatal services for NYC Health+Hospitals/Lincoln. She reports no conflicts of interest. Email her at obnews@mdedge.com.

Against the backdrop of the COVID-19 pandemic and ongoing national conversations around racial injustice, it is more important than ever that we identify and root out systemic discrimination – including in our health care system. As an ob.gyn., I’ve spent my entire career making sure that women receive the best care, and have witnessed firsthand the results of a system that provides differing levels of care based on one’s socioeconomic level, race, or ethnicity. The simple and sad reality is black and Hispanic women in this country continue to have less access to critical maternal and prenatal care.

This disparity is borne out in this country’s maternal health outcomes. For example, the latest figures from the Centers for Disease Control and Prevention indicate that the maternal mortality rate for black women, 37.1 deaths per 100,000 live births, is more than double the rate for white women at 14.7. In addition, the black infant mortality rate, at 11.4 per 1,000 live births, is also more than double the white infant mortality rate, 4.9. While many of these differences stem from discriminatory levels of coverage and care after delivery, just as important is the coverage and care before delivery: prenatal care.

Prenatal care includes a variety of screening tests, including those that can help expecting mothers identify whether the baby is more or less likely to have certain genetic disorders. These tests include traditional and less accurate options like serum or combined screening, and newer noninvasive prenatal testing (NIPT) options that use blood samples from the mother to analyze the baby’s DNA.

Research already has demonstrated that NIPT is the most accurate and effective screening option for common chromosomal abnormalities (Ont Health Technol Assess Ser. 2019;19[4]:1-166). A 2015 New England Journal of Medicine study showed that, without access to NIPT, 22% of pregnancies with Down syndrome were missed. With older screening methods, 5.4% of positive results for Down syndrome were false, compared with 0.06% of the NIPT tests (N Engl J Med 2015;372:1589-97). Older, less accurate screening tests cause unnecessary referrals to specialists for possible invasive testing, resulting in additional costs and undue stress on women and their families.

And yet, troubling new data have shown that black and Hispanic women have less access to NIPT than white women. Currently, NIPT is available to all California women through the state-funded prenatal screening program as a second-tier test. Many women, however, decide to opt out or go outside of the state program to have NIPT as a first-tier test, choosing private payer or other plans instead. New data shared by the California Department of Public Health with ob.gyns. and maternal-fetal medicine physicians in California showed that white women who opted out of California’s state-funded prenatal screening program were more than twice as likely to gain access to NIPT as black and Hispanic women (39%-17%). We can assume this to be true of women outside California as well – women who have no access to a state-funded program like California’s and depend solely on private payer or other health care plans. In fact, although some commercial insurance companies do cover NIPT, noninvasive prenatal screening is not covered by large insurance companies like Aetna and UnitedHealthcare.

As ob.gyns., physicians, and health professionals, we need to ask ourselves: Why is there such a great disparity in the access of superior and more effective NIPT options for black and Hispanic women?

Many reasons are apparent. There are significant differences by ethnic and racial groups in their knowledge of the availability of prenatal testing. Furthermore, there are higher levels of mistrust along certain racial and ethnic lines of the medical system in this country; specific religious or ethnic beliefs also may obviate the use of prenatal testing or diagnosis. Significant differences also exist in the types of health coverage by race and ethnicity, ultimately impacting the ability to have prenatal testing. Finally, there are different physician group recommendations. While medical societies such as the American College of Medical Genetics, International Society for Prenatal Diagnosis, and the American Society of Human Genetics all have long endorsed newer NIPT option for all pregnant women, two of the national physician groups that make recommendations about what care pregnant women should be able to access – the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine – only recently have recommended broad access to NIPT. As a result, some state Medicaid programs have not made NIPT available to patients.

We know that racial disparities are a public health crisis in America. The recent data from the California Department of Public Health, paired with COVID-19’s disproportionate impact on blacks and Hispanics, only further illustrate the existing health disparities experienced by this country’s communities of color.

We need to root out systemic discrimination in health care and we can begin with our maternal health care. Providing equitable access to the most accurate and consistent prenatal screenings, including NIPT options, regardless of insurance plan, socioeconomic level, race, or ethnicity is paramount in starting this work.
 

Dr. Gaither is a double board–certified physician in ob.gyn. and maternal-fetal medicine. She is director of perinatal services for NYC Health+Hospitals/Lincoln. She reports no conflicts of interest. Email her at obnews@mdedge.com.

Recommendations on the use of next-generation sequencing (NGS) tests for patients with metastatic cancer have been issued by the European Society for Medical Oncology, the first recommendations of their kind to be published by any medical society.

“Until now, there were no recommendations from scientific societies on how to use this technique in daily clinical practice to profile metastatic cancers,” Fernanda Mosele, MD, medical oncologist, Gustave Roussy, Villejuif, France, said in a statement.

NGS testing is already used extensively in oncology, particularly in metastatic cancer, she noted. The technology is used to assess the sequence of DNA in genes from a tumor tissue sample. Numerous genes can be quickly sequenced at the same time at relatively low cost. The results provide information on mutations that are present, which, in turn, helps with deciding which treatments to use, including drugs targeting the identified mutations.

“Our intent is that they [the guidelines] will unify decision-making about how NGS should be used for patients with metastatic cancer,” Dr. Mosele said.

The recommendations were published online August 25 in Annals of Oncology.

Overall, ESMO recommends the use of tumor multigene NGS for non–small cell lung cancer (NSCLC), prostate cancer, ovarian cancer, and cholangiocarcinoma.

For other cancers, the authors said that NGS is not recommended in clinical practice but could be used for research purposes.

However, patients should be informed that it is unlikely that test results would benefit them much personally.

Physicians and patients may decide together to subject the tumor to mutational testing using a large panel of genes, provided testing doesn’t burden the health care system with additional costs.

“This recommendation acknowledges that a small number of patients could benefit from a drug because they have a rare mutation,” Joaquin Mateo, MD, chair of the ESMO working group, said in a statement.

“So beyond the cancers in which everyone should receive NGS, there is room for physicians and patients to discuss the pros and cons of ordering these tests,” he added.

ESMO also does not recommend the use of off-label drugs matched to any genomic alteration detected by NGS unless an access program and a decisional procedure have been developed, either regionally or nationally.
 

No need for NGS testing of other cancers

In contrast to NSCLC, “there is currently no need to perform tumor multigene NGS for patients with mBC [metastatic breast cancer] in the context of daily practice,” ESMO stated.

This is largely because somatic sequencing cannot fully substitute for germline testing for BRCA status, and other mutations, such as HER2, can be detected using immunohistochemistry (IHC).

The same can be said for patients with metastatic gastric cancer, inasmuch as detection of alterations can and should be done using cheaper testing methods, ESMO pointed out.

However, ESMO members still emphasized that it’s important to include patients with metastatic breast cancer in molecular screening programs as well as in clinical trials testing targeted agents.

Similarly, there is no need to test metastatic colorectal cancer (mCRC) using multigene NGS in daily practice, inasmuch as most level 1 alterations in mCRC can be determined by IHC or PCR.

However, NGS can be considered as an alternative to PCR-based tests in mCRC, provided NGS is not associated with additional cost.

ESMO again recommended that research centers include mCRC patients in molecular screening programs in order for them to have access to innovative clinical trial agents.

As for advanced prostate cancer, ESMO does recommend that clinicians perform NGS on tissue samples to assess the tumor’s mutational status, at least for the presence of BRCA1 and BRCA2 mutations, when patients have access to the poly (ADP-ribose) polymerase inhibitors for treatment.

The authors cautioned, however, that this strategy is unlikely to be cost-effective, so larger panels should be used only when there are specific agreements with payers.

Multigene NGS is also not recommended for patients with advanced pancreatic ductal adenocarcinoma (PDAC), although ESMO points out that it is the role of research centers to propose multigene sequencing for these patients in the context of molecular screening programs.

This is again to facilitate access to innovative drugs for these patients.

Similar to recommendations for patients with advanced PDAC, patients with advanced hepatocellular carcinoma (HCC) do not need to have tumor multigene NGS either.

Considering the high unmet needs of HCC patients, ESMO feels that research centers should propose multigene sequencing to patients with advanced HCC in the context of molecular screening programs.

In contrast, ESMO recommended that tumor multigene NGS be used to detect actionable alterations in patients with advanced cholangiocarcinoma.

Again, they predict that this strategy is unlikely to be cost-effective, so larger panels should only be used if a specific agreement is in place with payers.

ESMO also assessed the frequency of level 1 alterations in less frequent tumor types, including ovarian cancers. Because BRCA1 and BRCA2 somatic mutations in ovarian tumors have been associated with increased response to the PARP inhibitors, the use of multigene NGS is justified with this malignancy, ESMO states.

The authors also recommend that tumor mutational burden be determined in cervical cancer, moderately differentiated neuroendocrine tumors, salivary cancers, vulvar cancer, and thyroid cancers.

Dr. Mosele has disclosed no relevant financial relationships. Many coauthors have relationships with the pharmaceutical industry, as listed in the article.

This article first appeared on Medscape.com.

Recommendations on the use of next-generation sequencing (NGS) tests for patients with metastatic cancer have been issued by the European Society for Medical Oncology, the first recommendations of their kind to be published by any medical society.

“Until now, there were no recommendations from scientific societies on how to use this technique in daily clinical practice to profile metastatic cancers,” Fernanda Mosele, MD, medical oncologist, Gustave Roussy, Villejuif, France, said in a statement.

NGS testing is already used extensively in oncology, particularly in metastatic cancer, she noted. The technology is used to assess the sequence of DNA in genes from a tumor tissue sample. Numerous genes can be quickly sequenced at the same time at relatively low cost. The results provide information on mutations that are present, which, in turn, helps with deciding which treatments to use, including drugs targeting the identified mutations.

“Our intent is that they [the guidelines] will unify decision-making about how NGS should be used for patients with metastatic cancer,” Dr. Mosele said.

The recommendations were published online August 25 in Annals of Oncology.

Overall, ESMO recommends the use of tumor multigene NGS for non–small cell lung cancer (NSCLC), prostate cancer, ovarian cancer, and cholangiocarcinoma.

For other cancers, the authors said that NGS is not recommended in clinical practice but could be used for research purposes.

However, patients should be informed that it is unlikely that test results would benefit them much personally.

Physicians and patients may decide together to subject the tumor to mutational testing using a large panel of genes, provided testing doesn’t burden the health care system with additional costs.

“This recommendation acknowledges that a small number of patients could benefit from a drug because they have a rare mutation,” Joaquin Mateo, MD, chair of the ESMO working group, said in a statement.

“So beyond the cancers in which everyone should receive NGS, there is room for physicians and patients to discuss the pros and cons of ordering these tests,” he added.

ESMO also does not recommend the use of off-label drugs matched to any genomic alteration detected by NGS unless an access program and a decisional procedure have been developed, either regionally or nationally.
 

No need for NGS testing of other cancers

In contrast to NSCLC, “there is currently no need to perform tumor multigene NGS for patients with mBC [metastatic breast cancer] in the context of daily practice,” ESMO stated.

This is largely because somatic sequencing cannot fully substitute for germline testing for BRCA status, and other mutations, such as HER2, can be detected using immunohistochemistry (IHC).

The same can be said for patients with metastatic gastric cancer, inasmuch as detection of alterations can and should be done using cheaper testing methods, ESMO pointed out.

However, ESMO members still emphasized that it’s important to include patients with metastatic breast cancer in molecular screening programs as well as in clinical trials testing targeted agents.

Similarly, there is no need to test metastatic colorectal cancer (mCRC) using multigene NGS in daily practice, inasmuch as most level 1 alterations in mCRC can be determined by IHC or PCR.

However, NGS can be considered as an alternative to PCR-based tests in mCRC, provided NGS is not associated with additional cost.

ESMO again recommended that research centers include mCRC patients in molecular screening programs in order for them to have access to innovative clinical trial agents.

As for advanced prostate cancer, ESMO does recommend that clinicians perform NGS on tissue samples to assess the tumor’s mutational status, at least for the presence of BRCA1 and BRCA2 mutations, when patients have access to the poly (ADP-ribose) polymerase inhibitors for treatment.

The authors cautioned, however, that this strategy is unlikely to be cost-effective, so larger panels should be used only when there are specific agreements with payers.

Multigene NGS is also not recommended for patients with advanced pancreatic ductal adenocarcinoma (PDAC), although ESMO points out that it is the role of research centers to propose multigene sequencing for these patients in the context of molecular screening programs.

This is again to facilitate access to innovative drugs for these patients.

Similar to recommendations for patients with advanced PDAC, patients with advanced hepatocellular carcinoma (HCC) do not need to have tumor multigene NGS either.

Considering the high unmet needs of HCC patients, ESMO feels that research centers should propose multigene sequencing to patients with advanced HCC in the context of molecular screening programs.

In contrast, ESMO recommended that tumor multigene NGS be used to detect actionable alterations in patients with advanced cholangiocarcinoma.

Again, they predict that this strategy is unlikely to be cost-effective, so larger panels should only be used if a specific agreement is in place with payers.

ESMO also assessed the frequency of level 1 alterations in less frequent tumor types, including ovarian cancers. Because BRCA1 and BRCA2 somatic mutations in ovarian tumors have been associated with increased response to the PARP inhibitors, the use of multigene NGS is justified with this malignancy, ESMO states.

The authors also recommend that tumor mutational burden be determined in cervical cancer, moderately differentiated neuroendocrine tumors, salivary cancers, vulvar cancer, and thyroid cancers.

Dr. Mosele has disclosed no relevant financial relationships. Many coauthors have relationships with the pharmaceutical industry, as listed in the article.

This article first appeared on Medscape.com.

Recommendations on the use of next-generation sequencing (NGS) tests for patients with metastatic cancer have been issued by the European Society for Medical Oncology, the first recommendations of their kind to be published by any medical society.

“Until now, there were no recommendations from scientific societies on how to use this technique in daily clinical practice to profile metastatic cancers,” Fernanda Mosele, MD, medical oncologist, Gustave Roussy, Villejuif, France, said in a statement.

NGS testing is already used extensively in oncology, particularly in metastatic cancer, she noted. The technology is used to assess the sequence of DNA in genes from a tumor tissue sample. Numerous genes can be quickly sequenced at the same time at relatively low cost. The results provide information on mutations that are present, which, in turn, helps with deciding which treatments to use, including drugs targeting the identified mutations.

“Our intent is that they [the guidelines] will unify decision-making about how NGS should be used for patients with metastatic cancer,” Dr. Mosele said.

The recommendations were published online August 25 in Annals of Oncology.

Overall, ESMO recommends the use of tumor multigene NGS for non–small cell lung cancer (NSCLC), prostate cancer, ovarian cancer, and cholangiocarcinoma.

For other cancers, the authors said that NGS is not recommended in clinical practice but could be used for research purposes.

However, patients should be informed that it is unlikely that test results would benefit them much personally.

Physicians and patients may decide together to subject the tumor to mutational testing using a large panel of genes, provided testing doesn’t burden the health care system with additional costs.

“This recommendation acknowledges that a small number of patients could benefit from a drug because they have a rare mutation,” Joaquin Mateo, MD, chair of the ESMO working group, said in a statement.

“So beyond the cancers in which everyone should receive NGS, there is room for physicians and patients to discuss the pros and cons of ordering these tests,” he added.

ESMO also does not recommend the use of off-label drugs matched to any genomic alteration detected by NGS unless an access program and a decisional procedure have been developed, either regionally or nationally.
 

No need for NGS testing of other cancers

In contrast to NSCLC, “there is currently no need to perform tumor multigene NGS for patients with mBC [metastatic breast cancer] in the context of daily practice,” ESMO stated.

This is largely because somatic sequencing cannot fully substitute for germline testing for BRCA status, and other mutations, such as HER2, can be detected using immunohistochemistry (IHC).

The same can be said for patients with metastatic gastric cancer, inasmuch as detection of alterations can and should be done using cheaper testing methods, ESMO pointed out.

However, ESMO members still emphasized that it’s important to include patients with metastatic breast cancer in molecular screening programs as well as in clinical trials testing targeted agents.

Similarly, there is no need to test metastatic colorectal cancer (mCRC) using multigene NGS in daily practice, inasmuch as most level 1 alterations in mCRC can be determined by IHC or PCR.

However, NGS can be considered as an alternative to PCR-based tests in mCRC, provided NGS is not associated with additional cost.

ESMO again recommended that research centers include mCRC patients in molecular screening programs in order for them to have access to innovative clinical trial agents.

As for advanced prostate cancer, ESMO does recommend that clinicians perform NGS on tissue samples to assess the tumor’s mutational status, at least for the presence of BRCA1 and BRCA2 mutations, when patients have access to the poly (ADP-ribose) polymerase inhibitors for treatment.

The authors cautioned, however, that this strategy is unlikely to be cost-effective, so larger panels should be used only when there are specific agreements with payers.

Multigene NGS is also not recommended for patients with advanced pancreatic ductal adenocarcinoma (PDAC), although ESMO points out that it is the role of research centers to propose multigene sequencing for these patients in the context of molecular screening programs.

This is again to facilitate access to innovative drugs for these patients.

Similar to recommendations for patients with advanced PDAC, patients with advanced hepatocellular carcinoma (HCC) do not need to have tumor multigene NGS either.

Considering the high unmet needs of HCC patients, ESMO feels that research centers should propose multigene sequencing to patients with advanced HCC in the context of molecular screening programs.

In contrast, ESMO recommended that tumor multigene NGS be used to detect actionable alterations in patients with advanced cholangiocarcinoma.

Again, they predict that this strategy is unlikely to be cost-effective, so larger panels should only be used if a specific agreement is in place with payers.

ESMO also assessed the frequency of level 1 alterations in less frequent tumor types, including ovarian cancers. Because BRCA1 and BRCA2 somatic mutations in ovarian tumors have been associated with increased response to the PARP inhibitors, the use of multigene NGS is justified with this malignancy, ESMO states.

The authors also recommend that tumor mutational burden be determined in cervical cancer, moderately differentiated neuroendocrine tumors, salivary cancers, vulvar cancer, and thyroid cancers.

Dr. Mosele has disclosed no relevant financial relationships. Many coauthors have relationships with the pharmaceutical industry, as listed in the article.

This article first appeared on Medscape.com.

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 obnews@mdedge.com.

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 obnews@mdedge.com.

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 obnews@mdedge.com.

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.

Two COVID-19 vaccines are entering phase 3 clinical trials, according to data presented at a virtual meeting of vaccine and infectious disease experts.

The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) yesterday held its third meeting this summer to discuss the vaccines and plan how initial vaccines will be allocated, inasmuch as supplies will likely be limited at first. Vaccines are expected to be more available as production ramps up and as more than one vaccine become available, but vaccine allocation initially will need to take place in phases.

Considerations include first getting the vaccine to individuals who need it the most, such as healthcare personnel and essential workers, as well as those at higher risk for severe illness or death, including the elderly, those with underlying conditions, and certain racial and ethnic minorities. Other factors include storage requirements that might be difficult to meet in certain settings and the fact that both vaccines must be given in two doses.

Vaccine allocation models

The group presented two possible models for allocating initial vaccine supplies.

The first population model considers risk status within each age group on the basis of underlying health conditions and occupational group, with priority given to healthcare personnel (paid or unpaid) and essential workers. The model considers partial reopening and social distancing, expected vaccine efficacy, prevaccination immunity, mortality, and the direct and indirect benefits of vaccination.

In this model, COVID-19 infections and deaths were reduced when healthcare personnel, essential workers, or adults with underlying conditions were vaccinated. There were smaller differences between the groups with respect to the impact of vaccination. Declines in infections were “more modest” and declines in deaths were greater when adults aged 65 years and older were vaccinated in comparison with other age groups.

The second model focused on vaccination of nursing home healthcare personnel and residents. Vaccinating nursing home healthcare personnel reduced infections and deaths more than vaccinating nursing home residents.

In settings such as long-term care facilities and correction facilities, where people gather in groups, cases increase first among staff. The vaccine working group suggests that vaccinating staff may also benefit individuals living in those facilities.

The working group expects that from 15 to 45 million doses of vaccine will be available by the end of December, depending on which vaccine is approved by then or whether both are approved.

Supplies won’t be nearly enough to vaccinate everyone: There are approximately 17 to 20 million healthcare workers in the United States and 60 to 80 million essential workers who do not work in healthcare. More than 100 million adults have underlying medical conditions that put them at higher risk for hospitalization and death, such as obesity, cardiovascular disease, diabetes, and chronic obstructive pulmonary disease. And approximately 53 million adults are aged 65 years or older.

The group reviewed promising early data for two vaccines under development.

The mRNA-1273 vaccine, made by Moderna with support from two federal agencies, is moving into phase 3 clinical trials – enrollment into the COVID-19 Efficacy and Safety (COVE) study is ongoing, according to Jacqueline M. Miller, MD, senior vice president and therapeutic area head of infectious diseases. The study’s primary objective will be to determine whether two doses can prevent symptomatic COVID-19, according to an NIH news release.

A second mRNA vaccine, BNT 162b2, made by Pfizer and BioNTech, is entering phase 2/3 trials. Nearly 20% of people enrolled are Black or Hispanic persons, and 4% are Asian persons. The team is also trying to recruit Native American participants, Nicholas Kitchin, MD, senior director in Pfizer’s vaccine clinical research and development group, said in a presentation to the advisory committee.

‘Ultra-cold’ temperatures required for storage

Both vaccines require storage at lower temperatures than is usually needed for vaccines. One vaccine must be distributed and stored at -20° C, and the other must be stored, distributed, and handled at -70° C.

This issue stands out most to ACIP Chair Jose Romero, MD. He says the “ultra-cold” temperatures required for storage and transportation of the vaccines will be a “significant problem” for those in rural areas.

High-risk populations such as meat processors and agricultural workers “may have to wait until we have a more stable vaccine that can be transported and delivered more or less at room temperature,” Romero explained. He is the chief medical officer at the Arkansas Department of Health and is a professor of pediatrics and pediatric infectious diseases at the University of Arkansas for Medical Sciences, both in Little Rock.

The advisory committee will meet again on September 22. At that time, they’ll vote on an interim plan for prioritization of the first COVID-19 vaccine.

This article first appeared on Medscape.com.

Two COVID-19 vaccines are entering phase 3 clinical trials, according to data presented at a virtual meeting of vaccine and infectious disease experts.

The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) yesterday held its third meeting this summer to discuss the vaccines and plan how initial vaccines will be allocated, inasmuch as supplies will likely be limited at first. Vaccines are expected to be more available as production ramps up and as more than one vaccine become available, but vaccine allocation initially will need to take place in phases.

Considerations include first getting the vaccine to individuals who need it the most, such as healthcare personnel and essential workers, as well as those at higher risk for severe illness or death, including the elderly, those with underlying conditions, and certain racial and ethnic minorities. Other factors include storage requirements that might be difficult to meet in certain settings and the fact that both vaccines must be given in two doses.

Vaccine allocation models

The group presented two possible models for allocating initial vaccine supplies.

The first population model considers risk status within each age group on the basis of underlying health conditions and occupational group, with priority given to healthcare personnel (paid or unpaid) and essential workers. The model considers partial reopening and social distancing, expected vaccine efficacy, prevaccination immunity, mortality, and the direct and indirect benefits of vaccination.

In this model, COVID-19 infections and deaths were reduced when healthcare personnel, essential workers, or adults with underlying conditions were vaccinated. There were smaller differences between the groups with respect to the impact of vaccination. Declines in infections were “more modest” and declines in deaths were greater when adults aged 65 years and older were vaccinated in comparison with other age groups.

The second model focused on vaccination of nursing home healthcare personnel and residents. Vaccinating nursing home healthcare personnel reduced infections and deaths more than vaccinating nursing home residents.

In settings such as long-term care facilities and correction facilities, where people gather in groups, cases increase first among staff. The vaccine working group suggests that vaccinating staff may also benefit individuals living in those facilities.

The working group expects that from 15 to 45 million doses of vaccine will be available by the end of December, depending on which vaccine is approved by then or whether both are approved.

Supplies won’t be nearly enough to vaccinate everyone: There are approximately 17 to 20 million healthcare workers in the United States and 60 to 80 million essential workers who do not work in healthcare. More than 100 million adults have underlying medical conditions that put them at higher risk for hospitalization and death, such as obesity, cardiovascular disease, diabetes, and chronic obstructive pulmonary disease. And approximately 53 million adults are aged 65 years or older.

The group reviewed promising early data for two vaccines under development.

The mRNA-1273 vaccine, made by Moderna with support from two federal agencies, is moving into phase 3 clinical trials – enrollment into the COVID-19 Efficacy and Safety (COVE) study is ongoing, according to Jacqueline M. Miller, MD, senior vice president and therapeutic area head of infectious diseases. The study’s primary objective will be to determine whether two doses can prevent symptomatic COVID-19, according to an NIH news release.

A second mRNA vaccine, BNT 162b2, made by Pfizer and BioNTech, is entering phase 2/3 trials. Nearly 20% of people enrolled are Black or Hispanic persons, and 4% are Asian persons. The team is also trying to recruit Native American participants, Nicholas Kitchin, MD, senior director in Pfizer’s vaccine clinical research and development group, said in a presentation to the advisory committee.

‘Ultra-cold’ temperatures required for storage

Both vaccines require storage at lower temperatures than is usually needed for vaccines. One vaccine must be distributed and stored at -20° C, and the other must be stored, distributed, and handled at -70° C.

This issue stands out most to ACIP Chair Jose Romero, MD. He says the “ultra-cold” temperatures required for storage and transportation of the vaccines will be a “significant problem” for those in rural areas.

High-risk populations such as meat processors and agricultural workers “may have to wait until we have a more stable vaccine that can be transported and delivered more or less at room temperature,” Romero explained. He is the chief medical officer at the Arkansas Department of Health and is a professor of pediatrics and pediatric infectious diseases at the University of Arkansas for Medical Sciences, both in Little Rock.

The advisory committee will meet again on September 22. At that time, they’ll vote on an interim plan for prioritization of the first COVID-19 vaccine.

This article first appeared on Medscape.com.