User login
NCCN recommends third COVID-19 dose for patients with cancer
Experts at the National Comprehensive Cancer Network have now issued an updated recommendation for COVID-19 vaccination in people with cancer. The panel calls for these patients to be among the highest-priority group to be vaccinated against COVID-19 and to receive the newly approved third dose of vaccine.
The NCCN has recommended in February that all patients receiving active cancer treatment should receive a COVID-19 vaccine and should be prioritized for vaccination. In August, the FDA authorized a third dose of either the Pfizer or Moderna COVID-19 vaccines for people with compromised immune systems. Those eligible for a third dose include solid organ transplant recipients, those undergoing cancer treatments, and people with autoimmune diseases that suppress their immune systems
The new NCCN recommendations state that the following groups should be considered eligible for a third dose of the mRNA COVID-19 vaccine immediately, based on the latest decisions from the Food and Drug Administration and the Centers for Disease Control and Prevention:
- Patients with solid tumors (either new or recurring) receiving treatment within 1 year of their initial vaccine dose, regardless of their type of cancer therapy.
- Patients with active hematologic malignancies regardless of whether they are currently receiving cancer therapy.
- Anyone who received a stem cell transplant (SCT) or engineered cellular therapy (for example, chimeric antigen receptor T cells), especially within the past 2 years.
- Any recipients of allogeneic SCT on immunosuppressive therapy or with a history of graft-versus-host disease regardless of the time of transplant.
- Anyone with an additional immunosuppressive condition (for example, HIV) or being treated with immunosuppressive agents unrelated to their cancer therapy.
Cancer patients at high risk of complications
As previously reported by this news organization, infection with COVID-19 in people with cancer can severely impact survival. One study published in 2020 found that patients with both COVID-19 infection and progressing cancer had a fivefold increase in the risk of 30-day mortality, compared with COVID-19–positive cancer patients who were in remission or had no evidence of cancer.
Another study found that cancer type, stage, and recent treatment could affect outcomes of COVID-19 in patients with cancer. Patients with hematologic malignancies and metastatic cancers had higher risks of developing severe or critical COVID-19 symptoms, being admitted to the ICU, requiring ventilation, and dying. Conversely, those with nonmetastatic disease had outcomes that were comparable with persons without cancer and a COVID-19 infection. This study also found that having undergone recent surgery or receiving immunotherapy also put patients at a higher risk of poor outcomes, although patients with cancer who were treated with radiotherapy had outcomes similar to those of noncancer COVID-19 patients.
“COVID-19 can be very dangerous, especially for people living with cancer, which is why we’re so grateful for safe and effective vaccines that are saving lives,” Robert W. Carlson, MD, CEO of NCCN, said in a statement.
Right timing and location
The current NCCN update also recommends that individuals wait at least 4 weeks between the second and third doses, and those who are infected with COVID-19 after being vaccinated should wait until they have documented clearance of the virus before receiving a third dose.
It also recommends that people who live in the same household with immunocompromised individuals should also get a third dose once it becomes available, and that it is best to have a third dose of the same type of vaccine as the first two doses. However, a different mRNA vaccine is also acceptable.
Immunocompromised individuals should try to receive their third dose in a health care delivery setting, as opposed to a pharmacy or public vaccination clinic if possible, as it would limit their risk of exposure to the general population.
Steve Pergam, MD, MPH, associate professor, vaccine and infectious disease division, Fred Hutchinson Cancer Research Center, Seattle, commented that it is still necessary to take precautions, even after getting the booster dose.
“That means, even after a third dose of vaccine, we still recommend immunocompromised people, such as those undergoing cancer treatment, continue to be cautious, wear masks, and avoid large group gatherings, particularly around those who are unvaccinated,” said Dr. Pergam, who is also coleader of the NCCN COVID-19 Vaccination Advisory Committee. “All of us should do our part to reduce the spread of COVID-19 and get vaccinated to protect those around us from preventable suffering.”
A version of this article first appeared on Medscape.com.
Experts at the National Comprehensive Cancer Network have now issued an updated recommendation for COVID-19 vaccination in people with cancer. The panel calls for these patients to be among the highest-priority group to be vaccinated against COVID-19 and to receive the newly approved third dose of vaccine.
The NCCN has recommended in February that all patients receiving active cancer treatment should receive a COVID-19 vaccine and should be prioritized for vaccination. In August, the FDA authorized a third dose of either the Pfizer or Moderna COVID-19 vaccines for people with compromised immune systems. Those eligible for a third dose include solid organ transplant recipients, those undergoing cancer treatments, and people with autoimmune diseases that suppress their immune systems
The new NCCN recommendations state that the following groups should be considered eligible for a third dose of the mRNA COVID-19 vaccine immediately, based on the latest decisions from the Food and Drug Administration and the Centers for Disease Control and Prevention:
- Patients with solid tumors (either new or recurring) receiving treatment within 1 year of their initial vaccine dose, regardless of their type of cancer therapy.
- Patients with active hematologic malignancies regardless of whether they are currently receiving cancer therapy.
- Anyone who received a stem cell transplant (SCT) or engineered cellular therapy (for example, chimeric antigen receptor T cells), especially within the past 2 years.
- Any recipients of allogeneic SCT on immunosuppressive therapy or with a history of graft-versus-host disease regardless of the time of transplant.
- Anyone with an additional immunosuppressive condition (for example, HIV) or being treated with immunosuppressive agents unrelated to their cancer therapy.
Cancer patients at high risk of complications
As previously reported by this news organization, infection with COVID-19 in people with cancer can severely impact survival. One study published in 2020 found that patients with both COVID-19 infection and progressing cancer had a fivefold increase in the risk of 30-day mortality, compared with COVID-19–positive cancer patients who were in remission or had no evidence of cancer.
Another study found that cancer type, stage, and recent treatment could affect outcomes of COVID-19 in patients with cancer. Patients with hematologic malignancies and metastatic cancers had higher risks of developing severe or critical COVID-19 symptoms, being admitted to the ICU, requiring ventilation, and dying. Conversely, those with nonmetastatic disease had outcomes that were comparable with persons without cancer and a COVID-19 infection. This study also found that having undergone recent surgery or receiving immunotherapy also put patients at a higher risk of poor outcomes, although patients with cancer who were treated with radiotherapy had outcomes similar to those of noncancer COVID-19 patients.
“COVID-19 can be very dangerous, especially for people living with cancer, which is why we’re so grateful for safe and effective vaccines that are saving lives,” Robert W. Carlson, MD, CEO of NCCN, said in a statement.
Right timing and location
The current NCCN update also recommends that individuals wait at least 4 weeks between the second and third doses, and those who are infected with COVID-19 after being vaccinated should wait until they have documented clearance of the virus before receiving a third dose.
It also recommends that people who live in the same household with immunocompromised individuals should also get a third dose once it becomes available, and that it is best to have a third dose of the same type of vaccine as the first two doses. However, a different mRNA vaccine is also acceptable.
Immunocompromised individuals should try to receive their third dose in a health care delivery setting, as opposed to a pharmacy or public vaccination clinic if possible, as it would limit their risk of exposure to the general population.
Steve Pergam, MD, MPH, associate professor, vaccine and infectious disease division, Fred Hutchinson Cancer Research Center, Seattle, commented that it is still necessary to take precautions, even after getting the booster dose.
“That means, even after a third dose of vaccine, we still recommend immunocompromised people, such as those undergoing cancer treatment, continue to be cautious, wear masks, and avoid large group gatherings, particularly around those who are unvaccinated,” said Dr. Pergam, who is also coleader of the NCCN COVID-19 Vaccination Advisory Committee. “All of us should do our part to reduce the spread of COVID-19 and get vaccinated to protect those around us from preventable suffering.”
A version of this article first appeared on Medscape.com.
Experts at the National Comprehensive Cancer Network have now issued an updated recommendation for COVID-19 vaccination in people with cancer. The panel calls for these patients to be among the highest-priority group to be vaccinated against COVID-19 and to receive the newly approved third dose of vaccine.
The NCCN has recommended in February that all patients receiving active cancer treatment should receive a COVID-19 vaccine and should be prioritized for vaccination. In August, the FDA authorized a third dose of either the Pfizer or Moderna COVID-19 vaccines for people with compromised immune systems. Those eligible for a third dose include solid organ transplant recipients, those undergoing cancer treatments, and people with autoimmune diseases that suppress their immune systems
The new NCCN recommendations state that the following groups should be considered eligible for a third dose of the mRNA COVID-19 vaccine immediately, based on the latest decisions from the Food and Drug Administration and the Centers for Disease Control and Prevention:
- Patients with solid tumors (either new or recurring) receiving treatment within 1 year of their initial vaccine dose, regardless of their type of cancer therapy.
- Patients with active hematologic malignancies regardless of whether they are currently receiving cancer therapy.
- Anyone who received a stem cell transplant (SCT) or engineered cellular therapy (for example, chimeric antigen receptor T cells), especially within the past 2 years.
- Any recipients of allogeneic SCT on immunosuppressive therapy or with a history of graft-versus-host disease regardless of the time of transplant.
- Anyone with an additional immunosuppressive condition (for example, HIV) or being treated with immunosuppressive agents unrelated to their cancer therapy.
Cancer patients at high risk of complications
As previously reported by this news organization, infection with COVID-19 in people with cancer can severely impact survival. One study published in 2020 found that patients with both COVID-19 infection and progressing cancer had a fivefold increase in the risk of 30-day mortality, compared with COVID-19–positive cancer patients who were in remission or had no evidence of cancer.
Another study found that cancer type, stage, and recent treatment could affect outcomes of COVID-19 in patients with cancer. Patients with hematologic malignancies and metastatic cancers had higher risks of developing severe or critical COVID-19 symptoms, being admitted to the ICU, requiring ventilation, and dying. Conversely, those with nonmetastatic disease had outcomes that were comparable with persons without cancer and a COVID-19 infection. This study also found that having undergone recent surgery or receiving immunotherapy also put patients at a higher risk of poor outcomes, although patients with cancer who were treated with radiotherapy had outcomes similar to those of noncancer COVID-19 patients.
“COVID-19 can be very dangerous, especially for people living with cancer, which is why we’re so grateful for safe and effective vaccines that are saving lives,” Robert W. Carlson, MD, CEO of NCCN, said in a statement.
Right timing and location
The current NCCN update also recommends that individuals wait at least 4 weeks between the second and third doses, and those who are infected with COVID-19 after being vaccinated should wait until they have documented clearance of the virus before receiving a third dose.
It also recommends that people who live in the same household with immunocompromised individuals should also get a third dose once it becomes available, and that it is best to have a third dose of the same type of vaccine as the first two doses. However, a different mRNA vaccine is also acceptable.
Immunocompromised individuals should try to receive their third dose in a health care delivery setting, as opposed to a pharmacy or public vaccination clinic if possible, as it would limit their risk of exposure to the general population.
Steve Pergam, MD, MPH, associate professor, vaccine and infectious disease division, Fred Hutchinson Cancer Research Center, Seattle, commented that it is still necessary to take precautions, even after getting the booster dose.
“That means, even after a third dose of vaccine, we still recommend immunocompromised people, such as those undergoing cancer treatment, continue to be cautious, wear masks, and avoid large group gatherings, particularly around those who are unvaccinated,” said Dr. Pergam, who is also coleader of the NCCN COVID-19 Vaccination Advisory Committee. “All of us should do our part to reduce the spread of COVID-19 and get vaccinated to protect those around us from preventable suffering.”
A version of this article first appeared on Medscape.com.
The trauma and healing of 9/11 echo in COVID-19
The scope and magnitude of the Sept. 11, 2001, attacks on the World Trade Center and the Pentagon were unprecedented in U.S. history. It was arguably the most serious trauma to beset Americans on U.S. soil. The 20th anniversary of 9/11 will take place during another crisis, not only in American history but also in world history – the COVID-19 pandemic.
“As different as these two events are, there are obvious points of comparison,” Jonathan DePierro, PhD, assistant professor of psychiatry, Icahn School of Medicine at Mount Sinai, New York, said in an interview. “Both were unprecedented life-threatening situations, presenting threats to individuals’ lives and profoundly traumatizing not only society as a whole but also first responders.”
Dr. DePierro, who is also the clinical director of the Center for Stress, Resilience, and Personal Growth at Mount Sinai, thinks there are many lessons to be learned from the mental health response to 9/11 that can inform our understanding of and response to the mental health needs of today’s first responders in the COVID-19 crisis, particularly health care professionals.
“Every one of our hospitals became a ‘ground zero’ early during the pandemic, and we see the numbers rising again and hospitals again overwhelmed, so he said.
Placing trauma within a new framework
According to Priscilla Dass-Brailsford, EdD, MPH, professor of psychology, department of psychiatry, Georgetown University, Washington, Sept. 11, 2001, “placed trauma within a new framework.”
“Prior to 9/11, crisis protocols and how to manage stress in the aftermath of violent events were uncommon,” Dr. Dass-Brailsford, a clinical psychologist with expertise in trauma who also chairs a clinical psychology program for the Chicago School of Professional Psychology, said in an interview.
As a first responder, she was involved in early interventions for survivors of 9/11. On Sept. 11, 2001, she had just resigned her position as coordinator of the community crisis response team – the first of its kind in the United States – through the Victims of Violence Program in Cambridge, in Cambridge, Mass.
The program responded to communities in which there were high rates of drive-by shootings and similar acts of violence. Because of her crisis experience, Dr. Dass-Brailsford was asked to conduct debriefings in Boston in the area where the 9/11 terrorists had stayed prior to boarding the planes that were used in the terrorist attacks. She subsequently went to New York City to conduct similar psychological debriefings with affected communities.
“What we’ve learned is that we had no crisis protocol on how to manage the stress in the aftermath of such a violent event, no standard operating procedures. There were very few people trained in crisis and trauma response at that time. Partially spurred by 9/11, trauma training programs became more prolific,” she said. Dr. Dass-Brailsford developed a trauma certification program at Lesley University in Cambridge, Mass., where she began to teach after 9/11. “I saw the importance of having clinicians trained to respond in a crisis, because responding to a crisis is very different from conducting regular mental health interventions.”
Short- and long-term interventions
Dr. DePierro said that Mount Sinai has a 20-year history of responding to the physical and mental health needs of 9/11 responders.
“We saw a number of first responders experiencing clinical depression, anxiety, a lot of worry, symptoms of posttraumatic stress disorder, and an increase in alcohol and/or substance use,” he recounted. In some, these responses were immediate; in others, the onset of symptoms was more gradual. Some responders had acute reactions that lasted for several months to a year, whereas for others, the reactions were prolonged, and they remained “chronically distressed long after the immediate exposure to the event,” he said.
Recent studies have shown that, during the COVID-19 pandemic, health care professionals and many essential workers have experienced similar symptoms, Dr. DePierro noted.
Mental health care professionals who provided interventions for workers involved in recovery and cleanup at the World Trade Center have highlighted the need for long-term monitoring of people on the front lines during the COVID-19 pandemic – especially health care workers, other essential personnel (for example, delivery, postal, and grocery store workers) and surviving family members. “Health monitoring and treatment efforts for 9/11 survivors and responders were put into place soon after the attacks and continue to this day,” using funding provided through the James Zadroga Act, Dr. DePierro said.
“Without similarly unified health registry and treatment services, many individuals – especially from underserved groups – will likely experience chronic mental health consequences and will be unable to access high-quality health care services,” he stated.
‘Psychological first aid’
“Although many people who go through a crisis – whether as a result of terrorism, such as 9/11, or a medical crisis, such as the current pandemic, or a natural disaster, such as Hurricane Katrina – experience PTSD, it’s important to note that not everyone who goes through a crisis and is traumatized will go on to develop PTSD,” Dr. Dass-Brailsford emphasized.
“To me, 9/11 placed psychological first aid on the map. Even if you are not a clinician, you can be trained to provide psychological first aid by becoming familiar with people’s reactions to trauma and how you can support them through it,” she continued.
For example, if a coworker is agitated or “seems to be having a meltdown, you can be there by offering support and getting them the appropriate help.” Research has suggested that having social support before and after a traumatic event can be helpful in determining vulnerability to the development of PTSD and in modulating the impact of the trauma.
Psychological first aid is helpful as an interim measure. “If you see a coworker holding their head in their hands all day and staring at the screen, identifying whether the person might be having a dissociative episode is critical. Providing some support is important, but if more intensive professional support is needed, determining that and making a referral becomes key,” Dr. Dass-Brailsford stated.
Dr. DePierro added: “One of the most important messages that I want health care workers to know from my years of working with 9/11 survivors is that feeling distressed after a traumatic event is very common, but with effective care, one doesn’t necessarily need to be in treatment for years.”
Danielle Ofri, MD, PhD, clinical professor, department of medicine, New York University, agreed. “It is important to continue keeping tabs on each other and remaining sensitive to the collateral struggles of our colleagues. Some have children who are struggling in school, others have parents who have lost a job. Continuing to check in on others and offer support is critical going forward,” she said in an interview.
Cohesiveness and volunteerism
One of the most powerful antidotes to long-term traumatization is a sense of community cohesiveness. This was the case following 9/11, and it is the case during the COVID-19 pandemic, according to Dr. Ofri, an internist at Bellevue Hospital in New York.
“There was an enormous mobilization. Bellevue is a city hospital with a level 1 trauma center, and we expected to be swamped, so the whole hospital shifted into gear,” said Dr. Ofri. “What would have been terrifying seemed tolerable because we felt that we were in it together. We discharged the inpatients to make beds available. Within hours, we had converted clinics into emergency departments and ICUs. We worked seamlessly, and the crisis brought us together ... but then, of course, no patients showed up.”
She described her relationship with her colleagues as “feeling almost like a family, especially during the pandemic, when so many others were in lockdown and feeling isolated and useless.”
She and her colleagues saw each other daily. Although the content of their tasks and responsibilities changed and people were redeployed to other areas, “our workday didn’t really change. It would have been overwhelming if we hadn’t had our daily meetings to regroup and assess where we were. Each day, everything we had learned or implemented the day before – treatment protocols, testing protocols, our understanding of how the virus was communicated – would change and need to be reevaluated. Those morning meetings were critical to staying centered. It felt as though we were building a plane and flying it at the same time, which felt both scary and heady. Luckily, it took place within the fraternity of a committed and caring group.”
Dr. Ofri recounted that, after 9/11, as well as during the pandemic, “professionals kept jumping in from the sidelines to volunteer. Within hours of the collapse of the towers, the ED had filled with staff. People came out of retirement and out from vacation and out of the woodwork. It was very heartening.”
Even more inspiring, “all the departmental barriers seemed to break down. People were willing to step out of their ordinary roles and check their egos at the door. Seasoned physicians were willing to function as medical interns.”
This generosity of time and spirit “helped keep us going,” she said.
Dr. DePierro agreed. “One of the things I’ve seen on medical floors is that COVID actually brought some units together, increasing their cohesion and mutual support and increasing the bonds between people.” These intensified bonds “increased the resilience of everyone involved.”
Commitment to the community
Dr. Ofri recalls families gathering at the hospital after 9/11, watching posters of missing people going up all over the hospital as well as on mailboxes and lampposts. Because the center for missing people was located right next door to Bellevue, there were long lines of families coming in to register. The chief medical office was there, and a huge tent was built to accommodate the families. The tent took up the entire block. “We felt a lot of ownership, because families were coming here,” she said.
The street remained closed even as the days, weeks, and years stretched on, and the tent remained. It was used as a reflection area for families. During the pandemic, that area was used for refrigerated trucks that served as temporary morgues.
“Both logistically and emotionally, we had a feeling during the pandemic of, ‘We’ve been here before, we’ll do it again and be there for the community,’ ” Dr. Ofri said.
She noted that the sense of commitment to the community carried her and fellow clinicians through the toughest parts of 9/11 and of the COVID-19 pandemic.
“People look to the medical system as a lodestar. ‘Where’s my family member? What should I do? Should I be tested? Vaccinated?’ We were there to be a steady presence for the community physically, psychologically, emotionally, and medically, which helped center us as well,” Dr. Ofri said. “If we didn’t have that, we might have all given in to existential panic.”
She added: “Although we had to work twice as hard, often amid great personal risk, we had the good fortune of having a sense of purpose, something to contribute, plus the community of colleagues we cared about and trusted with our lives.”
Crisis and personal growth
Dr. DePierro said that participants who went through 9/11 have been coming to Mount Sinai’s World Trade Center Health Program for care for nearly two decades. “Many are doing quite well, despite the emotional trauma and the dust and toxin exposure, which has given us a window into what makes people resilient.”
Social and community support are key factors in resilience. Another is recognizing opportunities for personal or professional growth during the crisis, according to Dr. DePierro.
During the pandemic, hospital staff were redeployed to departments where they didn’t typically work. They worked with new colleagues and used skills in patient care that they hadn’t needed for years or even decades. “Although this was stressful and distressing, quite a number said they came through with more medical knowledge than before and that they had forged relationships in the trenches that have been lasting and have become important to them,” he reported.
He noted that, during both crises, for first responders and health care practitioners, religious or spiritual faith was a source of resilience. “During the peak of the pandemic, chaplains provided an exorbitant amount of staff support as clinicians turned to the chaplain to help make sense of what they were going through and connect to something greater than themselves.” Similarly, during 9/11, police and fire department chaplains “played a huge role in supporting the first responders,” Dr. DePierro said.
He said that Mount Sinai holds resilience workshops “where we focus on these topics and teach health care workers how to build resilience in their lives, heal day-to-day stressors, and even grow from the experience.”
Dr. Ofri, who is the founder and editor-in-chief of the Bellevue Literary Review, added that the arts played an important role in bolstering resilience and providing a creative outlet for clinicians after 9/11 and again during the pandemic.
The publication is celebrating its twentieth anniversary – its first issue went to press in September 2001. The cover contained an acknowledgment of 9/11.
Dr. Ofri said that a gala event had been planned for Oct. 7, 2001, to celebrate the inaugural issue of the publication. She assumed no one would show up, given that the United States had invaded Afghanistan only hours earlier. To her surprise, over a hundred people attended, “which made me realize the role of the arts during trauma. People were seeking to come together and hear poetry, fiction, and creative nonfiction.”
Dr. Ofri has been “impressed by the amount of incredible creative writing of all sorts that has been submitted [to the publication] during the pandemic, an unexpected flowering of the arts.”
Unique challenges, unique opportunities
All three experts pointed to several noteworthy differences between the experiences of first responders following 9/11 and those of today’s health care professionals during the pandemic.
“What happened on Sept. 11 was one discrete event, and although it obviously led to years of recovering body parts and cleaning up Ground Zero, and on a national level it led to a war, it nevertheless was a single event,” Dr. DePierro observed. By contrast, the COVID-19 pandemic is ongoing, and for health care practitioners, “it’s by no means over. Again and again, they are being thrown back into battle, dealing with fatigue, weariness, and loss of life.”
Moreover, “it is my understanding that immediately following 9/11, there was a general coming together in our country, but it’s obvious that today, there’s a great deal of fractiousness, contention, disagreement, and disunity in our country when it comes to COVID-19,” Dr. DePierro continued.
“This takes a great toll, particularly on health care workers who are dealing with COVID-19 on a daily basis and experience a disconnect between what they see on their floors and ICUs of the hospital, experiencing loss of life they’ve likely never encountered in their careers, and what people are saying when they downplay the seriousness of COVID-19,” he said.
Dr. Ofri agreed. “The fragmentation of our country and the failure of leadership at the highest level to provide even the basics, such as PPE [personal protective equipment] for health care professionals, left us baffled, profoundly hurt, and angry.”
A positive difference between the COVID-19 pandemic and the aftermath of 9/11 is the development of sophisticated technology that allows interventions for traumatized individuals – both health care professionals and the general public – through telehealth, Dr. DePierro pointed out.
“I would say that these resources and technologies are a silver lining and should continue to be expanded on,” he said. “Now, busy health care workers can access all manner of supportive services, including teletherapy, right from home or between shifts.”
Another “silver lining” is that the pandemic has shone a spotlight on an issue that predated the pandemic – the mental health of health care professionals. Opening a discussion about this has reduced stigma and hopefully has paved the way for improved treatments and for providing resources.
Dr. Dass-Brailsford added that “it is important, going forward, for all of us to be trauma informed, to know how trauma and trauma-related stress unfolds in both other people and yourself, and to know what coping skills can be used to avoid crises from developing – a task that extends across all types of disasters.”
A version of this article first appeared on Medscape.com.
The scope and magnitude of the Sept. 11, 2001, attacks on the World Trade Center and the Pentagon were unprecedented in U.S. history. It was arguably the most serious trauma to beset Americans on U.S. soil. The 20th anniversary of 9/11 will take place during another crisis, not only in American history but also in world history – the COVID-19 pandemic.
“As different as these two events are, there are obvious points of comparison,” Jonathan DePierro, PhD, assistant professor of psychiatry, Icahn School of Medicine at Mount Sinai, New York, said in an interview. “Both were unprecedented life-threatening situations, presenting threats to individuals’ lives and profoundly traumatizing not only society as a whole but also first responders.”
Dr. DePierro, who is also the clinical director of the Center for Stress, Resilience, and Personal Growth at Mount Sinai, thinks there are many lessons to be learned from the mental health response to 9/11 that can inform our understanding of and response to the mental health needs of today’s first responders in the COVID-19 crisis, particularly health care professionals.
“Every one of our hospitals became a ‘ground zero’ early during the pandemic, and we see the numbers rising again and hospitals again overwhelmed, so he said.
Placing trauma within a new framework
According to Priscilla Dass-Brailsford, EdD, MPH, professor of psychology, department of psychiatry, Georgetown University, Washington, Sept. 11, 2001, “placed trauma within a new framework.”
“Prior to 9/11, crisis protocols and how to manage stress in the aftermath of violent events were uncommon,” Dr. Dass-Brailsford, a clinical psychologist with expertise in trauma who also chairs a clinical psychology program for the Chicago School of Professional Psychology, said in an interview.
As a first responder, she was involved in early interventions for survivors of 9/11. On Sept. 11, 2001, she had just resigned her position as coordinator of the community crisis response team – the first of its kind in the United States – through the Victims of Violence Program in Cambridge, in Cambridge, Mass.
The program responded to communities in which there were high rates of drive-by shootings and similar acts of violence. Because of her crisis experience, Dr. Dass-Brailsford was asked to conduct debriefings in Boston in the area where the 9/11 terrorists had stayed prior to boarding the planes that were used in the terrorist attacks. She subsequently went to New York City to conduct similar psychological debriefings with affected communities.
“What we’ve learned is that we had no crisis protocol on how to manage the stress in the aftermath of such a violent event, no standard operating procedures. There were very few people trained in crisis and trauma response at that time. Partially spurred by 9/11, trauma training programs became more prolific,” she said. Dr. Dass-Brailsford developed a trauma certification program at Lesley University in Cambridge, Mass., where she began to teach after 9/11. “I saw the importance of having clinicians trained to respond in a crisis, because responding to a crisis is very different from conducting regular mental health interventions.”
Short- and long-term interventions
Dr. DePierro said that Mount Sinai has a 20-year history of responding to the physical and mental health needs of 9/11 responders.
“We saw a number of first responders experiencing clinical depression, anxiety, a lot of worry, symptoms of posttraumatic stress disorder, and an increase in alcohol and/or substance use,” he recounted. In some, these responses were immediate; in others, the onset of symptoms was more gradual. Some responders had acute reactions that lasted for several months to a year, whereas for others, the reactions were prolonged, and they remained “chronically distressed long after the immediate exposure to the event,” he said.
Recent studies have shown that, during the COVID-19 pandemic, health care professionals and many essential workers have experienced similar symptoms, Dr. DePierro noted.
Mental health care professionals who provided interventions for workers involved in recovery and cleanup at the World Trade Center have highlighted the need for long-term monitoring of people on the front lines during the COVID-19 pandemic – especially health care workers, other essential personnel (for example, delivery, postal, and grocery store workers) and surviving family members. “Health monitoring and treatment efforts for 9/11 survivors and responders were put into place soon after the attacks and continue to this day,” using funding provided through the James Zadroga Act, Dr. DePierro said.
“Without similarly unified health registry and treatment services, many individuals – especially from underserved groups – will likely experience chronic mental health consequences and will be unable to access high-quality health care services,” he stated.
‘Psychological first aid’
“Although many people who go through a crisis – whether as a result of terrorism, such as 9/11, or a medical crisis, such as the current pandemic, or a natural disaster, such as Hurricane Katrina – experience PTSD, it’s important to note that not everyone who goes through a crisis and is traumatized will go on to develop PTSD,” Dr. Dass-Brailsford emphasized.
“To me, 9/11 placed psychological first aid on the map. Even if you are not a clinician, you can be trained to provide psychological first aid by becoming familiar with people’s reactions to trauma and how you can support them through it,” she continued.
For example, if a coworker is agitated or “seems to be having a meltdown, you can be there by offering support and getting them the appropriate help.” Research has suggested that having social support before and after a traumatic event can be helpful in determining vulnerability to the development of PTSD and in modulating the impact of the trauma.
Psychological first aid is helpful as an interim measure. “If you see a coworker holding their head in their hands all day and staring at the screen, identifying whether the person might be having a dissociative episode is critical. Providing some support is important, but if more intensive professional support is needed, determining that and making a referral becomes key,” Dr. Dass-Brailsford stated.
Dr. DePierro added: “One of the most important messages that I want health care workers to know from my years of working with 9/11 survivors is that feeling distressed after a traumatic event is very common, but with effective care, one doesn’t necessarily need to be in treatment for years.”
Danielle Ofri, MD, PhD, clinical professor, department of medicine, New York University, agreed. “It is important to continue keeping tabs on each other and remaining sensitive to the collateral struggles of our colleagues. Some have children who are struggling in school, others have parents who have lost a job. Continuing to check in on others and offer support is critical going forward,” she said in an interview.
Cohesiveness and volunteerism
One of the most powerful antidotes to long-term traumatization is a sense of community cohesiveness. This was the case following 9/11, and it is the case during the COVID-19 pandemic, according to Dr. Ofri, an internist at Bellevue Hospital in New York.
“There was an enormous mobilization. Bellevue is a city hospital with a level 1 trauma center, and we expected to be swamped, so the whole hospital shifted into gear,” said Dr. Ofri. “What would have been terrifying seemed tolerable because we felt that we were in it together. We discharged the inpatients to make beds available. Within hours, we had converted clinics into emergency departments and ICUs. We worked seamlessly, and the crisis brought us together ... but then, of course, no patients showed up.”
She described her relationship with her colleagues as “feeling almost like a family, especially during the pandemic, when so many others were in lockdown and feeling isolated and useless.”
She and her colleagues saw each other daily. Although the content of their tasks and responsibilities changed and people were redeployed to other areas, “our workday didn’t really change. It would have been overwhelming if we hadn’t had our daily meetings to regroup and assess where we were. Each day, everything we had learned or implemented the day before – treatment protocols, testing protocols, our understanding of how the virus was communicated – would change and need to be reevaluated. Those morning meetings were critical to staying centered. It felt as though we were building a plane and flying it at the same time, which felt both scary and heady. Luckily, it took place within the fraternity of a committed and caring group.”
Dr. Ofri recounted that, after 9/11, as well as during the pandemic, “professionals kept jumping in from the sidelines to volunteer. Within hours of the collapse of the towers, the ED had filled with staff. People came out of retirement and out from vacation and out of the woodwork. It was very heartening.”
Even more inspiring, “all the departmental barriers seemed to break down. People were willing to step out of their ordinary roles and check their egos at the door. Seasoned physicians were willing to function as medical interns.”
This generosity of time and spirit “helped keep us going,” she said.
Dr. DePierro agreed. “One of the things I’ve seen on medical floors is that COVID actually brought some units together, increasing their cohesion and mutual support and increasing the bonds between people.” These intensified bonds “increased the resilience of everyone involved.”
Commitment to the community
Dr. Ofri recalls families gathering at the hospital after 9/11, watching posters of missing people going up all over the hospital as well as on mailboxes and lampposts. Because the center for missing people was located right next door to Bellevue, there were long lines of families coming in to register. The chief medical office was there, and a huge tent was built to accommodate the families. The tent took up the entire block. “We felt a lot of ownership, because families were coming here,” she said.
The street remained closed even as the days, weeks, and years stretched on, and the tent remained. It was used as a reflection area for families. During the pandemic, that area was used for refrigerated trucks that served as temporary morgues.
“Both logistically and emotionally, we had a feeling during the pandemic of, ‘We’ve been here before, we’ll do it again and be there for the community,’ ” Dr. Ofri said.
She noted that the sense of commitment to the community carried her and fellow clinicians through the toughest parts of 9/11 and of the COVID-19 pandemic.
“People look to the medical system as a lodestar. ‘Where’s my family member? What should I do? Should I be tested? Vaccinated?’ We were there to be a steady presence for the community physically, psychologically, emotionally, and medically, which helped center us as well,” Dr. Ofri said. “If we didn’t have that, we might have all given in to existential panic.”
She added: “Although we had to work twice as hard, often amid great personal risk, we had the good fortune of having a sense of purpose, something to contribute, plus the community of colleagues we cared about and trusted with our lives.”
Crisis and personal growth
Dr. DePierro said that participants who went through 9/11 have been coming to Mount Sinai’s World Trade Center Health Program for care for nearly two decades. “Many are doing quite well, despite the emotional trauma and the dust and toxin exposure, which has given us a window into what makes people resilient.”
Social and community support are key factors in resilience. Another is recognizing opportunities for personal or professional growth during the crisis, according to Dr. DePierro.
During the pandemic, hospital staff were redeployed to departments where they didn’t typically work. They worked with new colleagues and used skills in patient care that they hadn’t needed for years or even decades. “Although this was stressful and distressing, quite a number said they came through with more medical knowledge than before and that they had forged relationships in the trenches that have been lasting and have become important to them,” he reported.
He noted that, during both crises, for first responders and health care practitioners, religious or spiritual faith was a source of resilience. “During the peak of the pandemic, chaplains provided an exorbitant amount of staff support as clinicians turned to the chaplain to help make sense of what they were going through and connect to something greater than themselves.” Similarly, during 9/11, police and fire department chaplains “played a huge role in supporting the first responders,” Dr. DePierro said.
He said that Mount Sinai holds resilience workshops “where we focus on these topics and teach health care workers how to build resilience in their lives, heal day-to-day stressors, and even grow from the experience.”
Dr. Ofri, who is the founder and editor-in-chief of the Bellevue Literary Review, added that the arts played an important role in bolstering resilience and providing a creative outlet for clinicians after 9/11 and again during the pandemic.
The publication is celebrating its twentieth anniversary – its first issue went to press in September 2001. The cover contained an acknowledgment of 9/11.
Dr. Ofri said that a gala event had been planned for Oct. 7, 2001, to celebrate the inaugural issue of the publication. She assumed no one would show up, given that the United States had invaded Afghanistan only hours earlier. To her surprise, over a hundred people attended, “which made me realize the role of the arts during trauma. People were seeking to come together and hear poetry, fiction, and creative nonfiction.”
Dr. Ofri has been “impressed by the amount of incredible creative writing of all sorts that has been submitted [to the publication] during the pandemic, an unexpected flowering of the arts.”
Unique challenges, unique opportunities
All three experts pointed to several noteworthy differences between the experiences of first responders following 9/11 and those of today’s health care professionals during the pandemic.
“What happened on Sept. 11 was one discrete event, and although it obviously led to years of recovering body parts and cleaning up Ground Zero, and on a national level it led to a war, it nevertheless was a single event,” Dr. DePierro observed. By contrast, the COVID-19 pandemic is ongoing, and for health care practitioners, “it’s by no means over. Again and again, they are being thrown back into battle, dealing with fatigue, weariness, and loss of life.”
Moreover, “it is my understanding that immediately following 9/11, there was a general coming together in our country, but it’s obvious that today, there’s a great deal of fractiousness, contention, disagreement, and disunity in our country when it comes to COVID-19,” Dr. DePierro continued.
“This takes a great toll, particularly on health care workers who are dealing with COVID-19 on a daily basis and experience a disconnect between what they see on their floors and ICUs of the hospital, experiencing loss of life they’ve likely never encountered in their careers, and what people are saying when they downplay the seriousness of COVID-19,” he said.
Dr. Ofri agreed. “The fragmentation of our country and the failure of leadership at the highest level to provide even the basics, such as PPE [personal protective equipment] for health care professionals, left us baffled, profoundly hurt, and angry.”
A positive difference between the COVID-19 pandemic and the aftermath of 9/11 is the development of sophisticated technology that allows interventions for traumatized individuals – both health care professionals and the general public – through telehealth, Dr. DePierro pointed out.
“I would say that these resources and technologies are a silver lining and should continue to be expanded on,” he said. “Now, busy health care workers can access all manner of supportive services, including teletherapy, right from home or between shifts.”
Another “silver lining” is that the pandemic has shone a spotlight on an issue that predated the pandemic – the mental health of health care professionals. Opening a discussion about this has reduced stigma and hopefully has paved the way for improved treatments and for providing resources.
Dr. Dass-Brailsford added that “it is important, going forward, for all of us to be trauma informed, to know how trauma and trauma-related stress unfolds in both other people and yourself, and to know what coping skills can be used to avoid crises from developing – a task that extends across all types of disasters.”
A version of this article first appeared on Medscape.com.
The scope and magnitude of the Sept. 11, 2001, attacks on the World Trade Center and the Pentagon were unprecedented in U.S. history. It was arguably the most serious trauma to beset Americans on U.S. soil. The 20th anniversary of 9/11 will take place during another crisis, not only in American history but also in world history – the COVID-19 pandemic.
“As different as these two events are, there are obvious points of comparison,” Jonathan DePierro, PhD, assistant professor of psychiatry, Icahn School of Medicine at Mount Sinai, New York, said in an interview. “Both were unprecedented life-threatening situations, presenting threats to individuals’ lives and profoundly traumatizing not only society as a whole but also first responders.”
Dr. DePierro, who is also the clinical director of the Center for Stress, Resilience, and Personal Growth at Mount Sinai, thinks there are many lessons to be learned from the mental health response to 9/11 that can inform our understanding of and response to the mental health needs of today’s first responders in the COVID-19 crisis, particularly health care professionals.
“Every one of our hospitals became a ‘ground zero’ early during the pandemic, and we see the numbers rising again and hospitals again overwhelmed, so he said.
Placing trauma within a new framework
According to Priscilla Dass-Brailsford, EdD, MPH, professor of psychology, department of psychiatry, Georgetown University, Washington, Sept. 11, 2001, “placed trauma within a new framework.”
“Prior to 9/11, crisis protocols and how to manage stress in the aftermath of violent events were uncommon,” Dr. Dass-Brailsford, a clinical psychologist with expertise in trauma who also chairs a clinical psychology program for the Chicago School of Professional Psychology, said in an interview.
As a first responder, she was involved in early interventions for survivors of 9/11. On Sept. 11, 2001, she had just resigned her position as coordinator of the community crisis response team – the first of its kind in the United States – through the Victims of Violence Program in Cambridge, in Cambridge, Mass.
The program responded to communities in which there were high rates of drive-by shootings and similar acts of violence. Because of her crisis experience, Dr. Dass-Brailsford was asked to conduct debriefings in Boston in the area where the 9/11 terrorists had stayed prior to boarding the planes that were used in the terrorist attacks. She subsequently went to New York City to conduct similar psychological debriefings with affected communities.
“What we’ve learned is that we had no crisis protocol on how to manage the stress in the aftermath of such a violent event, no standard operating procedures. There were very few people trained in crisis and trauma response at that time. Partially spurred by 9/11, trauma training programs became more prolific,” she said. Dr. Dass-Brailsford developed a trauma certification program at Lesley University in Cambridge, Mass., where she began to teach after 9/11. “I saw the importance of having clinicians trained to respond in a crisis, because responding to a crisis is very different from conducting regular mental health interventions.”
Short- and long-term interventions
Dr. DePierro said that Mount Sinai has a 20-year history of responding to the physical and mental health needs of 9/11 responders.
“We saw a number of first responders experiencing clinical depression, anxiety, a lot of worry, symptoms of posttraumatic stress disorder, and an increase in alcohol and/or substance use,” he recounted. In some, these responses were immediate; in others, the onset of symptoms was more gradual. Some responders had acute reactions that lasted for several months to a year, whereas for others, the reactions were prolonged, and they remained “chronically distressed long after the immediate exposure to the event,” he said.
Recent studies have shown that, during the COVID-19 pandemic, health care professionals and many essential workers have experienced similar symptoms, Dr. DePierro noted.
Mental health care professionals who provided interventions for workers involved in recovery and cleanup at the World Trade Center have highlighted the need for long-term monitoring of people on the front lines during the COVID-19 pandemic – especially health care workers, other essential personnel (for example, delivery, postal, and grocery store workers) and surviving family members. “Health monitoring and treatment efforts for 9/11 survivors and responders were put into place soon after the attacks and continue to this day,” using funding provided through the James Zadroga Act, Dr. DePierro said.
“Without similarly unified health registry and treatment services, many individuals – especially from underserved groups – will likely experience chronic mental health consequences and will be unable to access high-quality health care services,” he stated.
‘Psychological first aid’
“Although many people who go through a crisis – whether as a result of terrorism, such as 9/11, or a medical crisis, such as the current pandemic, or a natural disaster, such as Hurricane Katrina – experience PTSD, it’s important to note that not everyone who goes through a crisis and is traumatized will go on to develop PTSD,” Dr. Dass-Brailsford emphasized.
“To me, 9/11 placed psychological first aid on the map. Even if you are not a clinician, you can be trained to provide psychological first aid by becoming familiar with people’s reactions to trauma and how you can support them through it,” she continued.
For example, if a coworker is agitated or “seems to be having a meltdown, you can be there by offering support and getting them the appropriate help.” Research has suggested that having social support before and after a traumatic event can be helpful in determining vulnerability to the development of PTSD and in modulating the impact of the trauma.
Psychological first aid is helpful as an interim measure. “If you see a coworker holding their head in their hands all day and staring at the screen, identifying whether the person might be having a dissociative episode is critical. Providing some support is important, but if more intensive professional support is needed, determining that and making a referral becomes key,” Dr. Dass-Brailsford stated.
Dr. DePierro added: “One of the most important messages that I want health care workers to know from my years of working with 9/11 survivors is that feeling distressed after a traumatic event is very common, but with effective care, one doesn’t necessarily need to be in treatment for years.”
Danielle Ofri, MD, PhD, clinical professor, department of medicine, New York University, agreed. “It is important to continue keeping tabs on each other and remaining sensitive to the collateral struggles of our colleagues. Some have children who are struggling in school, others have parents who have lost a job. Continuing to check in on others and offer support is critical going forward,” she said in an interview.
Cohesiveness and volunteerism
One of the most powerful antidotes to long-term traumatization is a sense of community cohesiveness. This was the case following 9/11, and it is the case during the COVID-19 pandemic, according to Dr. Ofri, an internist at Bellevue Hospital in New York.
“There was an enormous mobilization. Bellevue is a city hospital with a level 1 trauma center, and we expected to be swamped, so the whole hospital shifted into gear,” said Dr. Ofri. “What would have been terrifying seemed tolerable because we felt that we were in it together. We discharged the inpatients to make beds available. Within hours, we had converted clinics into emergency departments and ICUs. We worked seamlessly, and the crisis brought us together ... but then, of course, no patients showed up.”
She described her relationship with her colleagues as “feeling almost like a family, especially during the pandemic, when so many others were in lockdown and feeling isolated and useless.”
She and her colleagues saw each other daily. Although the content of their tasks and responsibilities changed and people were redeployed to other areas, “our workday didn’t really change. It would have been overwhelming if we hadn’t had our daily meetings to regroup and assess where we were. Each day, everything we had learned or implemented the day before – treatment protocols, testing protocols, our understanding of how the virus was communicated – would change and need to be reevaluated. Those morning meetings were critical to staying centered. It felt as though we were building a plane and flying it at the same time, which felt both scary and heady. Luckily, it took place within the fraternity of a committed and caring group.”
Dr. Ofri recounted that, after 9/11, as well as during the pandemic, “professionals kept jumping in from the sidelines to volunteer. Within hours of the collapse of the towers, the ED had filled with staff. People came out of retirement and out from vacation and out of the woodwork. It was very heartening.”
Even more inspiring, “all the departmental barriers seemed to break down. People were willing to step out of their ordinary roles and check their egos at the door. Seasoned physicians were willing to function as medical interns.”
This generosity of time and spirit “helped keep us going,” she said.
Dr. DePierro agreed. “One of the things I’ve seen on medical floors is that COVID actually brought some units together, increasing their cohesion and mutual support and increasing the bonds between people.” These intensified bonds “increased the resilience of everyone involved.”
Commitment to the community
Dr. Ofri recalls families gathering at the hospital after 9/11, watching posters of missing people going up all over the hospital as well as on mailboxes and lampposts. Because the center for missing people was located right next door to Bellevue, there were long lines of families coming in to register. The chief medical office was there, and a huge tent was built to accommodate the families. The tent took up the entire block. “We felt a lot of ownership, because families were coming here,” she said.
The street remained closed even as the days, weeks, and years stretched on, and the tent remained. It was used as a reflection area for families. During the pandemic, that area was used for refrigerated trucks that served as temporary morgues.
“Both logistically and emotionally, we had a feeling during the pandemic of, ‘We’ve been here before, we’ll do it again and be there for the community,’ ” Dr. Ofri said.
She noted that the sense of commitment to the community carried her and fellow clinicians through the toughest parts of 9/11 and of the COVID-19 pandemic.
“People look to the medical system as a lodestar. ‘Where’s my family member? What should I do? Should I be tested? Vaccinated?’ We were there to be a steady presence for the community physically, psychologically, emotionally, and medically, which helped center us as well,” Dr. Ofri said. “If we didn’t have that, we might have all given in to existential panic.”
She added: “Although we had to work twice as hard, often amid great personal risk, we had the good fortune of having a sense of purpose, something to contribute, plus the community of colleagues we cared about and trusted with our lives.”
Crisis and personal growth
Dr. DePierro said that participants who went through 9/11 have been coming to Mount Sinai’s World Trade Center Health Program for care for nearly two decades. “Many are doing quite well, despite the emotional trauma and the dust and toxin exposure, which has given us a window into what makes people resilient.”
Social and community support are key factors in resilience. Another is recognizing opportunities for personal or professional growth during the crisis, according to Dr. DePierro.
During the pandemic, hospital staff were redeployed to departments where they didn’t typically work. They worked with new colleagues and used skills in patient care that they hadn’t needed for years or even decades. “Although this was stressful and distressing, quite a number said they came through with more medical knowledge than before and that they had forged relationships in the trenches that have been lasting and have become important to them,” he reported.
He noted that, during both crises, for first responders and health care practitioners, religious or spiritual faith was a source of resilience. “During the peak of the pandemic, chaplains provided an exorbitant amount of staff support as clinicians turned to the chaplain to help make sense of what they were going through and connect to something greater than themselves.” Similarly, during 9/11, police and fire department chaplains “played a huge role in supporting the first responders,” Dr. DePierro said.
He said that Mount Sinai holds resilience workshops “where we focus on these topics and teach health care workers how to build resilience in their lives, heal day-to-day stressors, and even grow from the experience.”
Dr. Ofri, who is the founder and editor-in-chief of the Bellevue Literary Review, added that the arts played an important role in bolstering resilience and providing a creative outlet for clinicians after 9/11 and again during the pandemic.
The publication is celebrating its twentieth anniversary – its first issue went to press in September 2001. The cover contained an acknowledgment of 9/11.
Dr. Ofri said that a gala event had been planned for Oct. 7, 2001, to celebrate the inaugural issue of the publication. She assumed no one would show up, given that the United States had invaded Afghanistan only hours earlier. To her surprise, over a hundred people attended, “which made me realize the role of the arts during trauma. People were seeking to come together and hear poetry, fiction, and creative nonfiction.”
Dr. Ofri has been “impressed by the amount of incredible creative writing of all sorts that has been submitted [to the publication] during the pandemic, an unexpected flowering of the arts.”
Unique challenges, unique opportunities
All three experts pointed to several noteworthy differences between the experiences of first responders following 9/11 and those of today’s health care professionals during the pandemic.
“What happened on Sept. 11 was one discrete event, and although it obviously led to years of recovering body parts and cleaning up Ground Zero, and on a national level it led to a war, it nevertheless was a single event,” Dr. DePierro observed. By contrast, the COVID-19 pandemic is ongoing, and for health care practitioners, “it’s by no means over. Again and again, they are being thrown back into battle, dealing with fatigue, weariness, and loss of life.”
Moreover, “it is my understanding that immediately following 9/11, there was a general coming together in our country, but it’s obvious that today, there’s a great deal of fractiousness, contention, disagreement, and disunity in our country when it comes to COVID-19,” Dr. DePierro continued.
“This takes a great toll, particularly on health care workers who are dealing with COVID-19 on a daily basis and experience a disconnect between what they see on their floors and ICUs of the hospital, experiencing loss of life they’ve likely never encountered in their careers, and what people are saying when they downplay the seriousness of COVID-19,” he said.
Dr. Ofri agreed. “The fragmentation of our country and the failure of leadership at the highest level to provide even the basics, such as PPE [personal protective equipment] for health care professionals, left us baffled, profoundly hurt, and angry.”
A positive difference between the COVID-19 pandemic and the aftermath of 9/11 is the development of sophisticated technology that allows interventions for traumatized individuals – both health care professionals and the general public – through telehealth, Dr. DePierro pointed out.
“I would say that these resources and technologies are a silver lining and should continue to be expanded on,” he said. “Now, busy health care workers can access all manner of supportive services, including teletherapy, right from home or between shifts.”
Another “silver lining” is that the pandemic has shone a spotlight on an issue that predated the pandemic – the mental health of health care professionals. Opening a discussion about this has reduced stigma and hopefully has paved the way for improved treatments and for providing resources.
Dr. Dass-Brailsford added that “it is important, going forward, for all of us to be trauma informed, to know how trauma and trauma-related stress unfolds in both other people and yourself, and to know what coping skills can be used to avoid crises from developing – a task that extends across all types of disasters.”
A version of this article first appeared on Medscape.com.
I did peer review: I saw turf wars, ego, and unfairness
After making an insulting comment to a surgery scheduler, a surgeon become the subject of a peer review investigation.
The surgeon had been called in on a Saturday morning for surgery, but when he arrived at the hospital, staff informed him that the operating room had been incorrectly booked and asked him to come back that afternoon. When the surgeon returned, the room still wasn’t ready, recounted David Beran, DO, a peer reviewer and medical director for the emergency department at University Medical Center New Orleans, in Louisiana. After more waiting and staff uncertainty about which operating room was going to open, the surgeon became frustrated and said to the scheduler: “Any idiot could figure this out!”
During his peer review, the surgeon acknowledged that he shouldn’t have made the rude remark to the scheduler, Dr. Beran said. His exasperation stemmed from an ongoing problem – operating rooms at the hospital were being inefficiently managed.
“The surgeon acknowledged that even though there was a systems issue at the root, that’s not justification to speak to people unprofessionally,” Dr. Beran said. “So, there was education for the surgeon, but the surgeon was also able to explain the frustration that led to that point.”
System problems are commonly encountered by peer reviewers, said Dr. Beran.
“There’s a huge gap between administration and clinical professionals when it comes to peer review,” he said. “So many times, bad situations, whether they’re clinical or behavioral, often boil down to systems issues or some inadequacy, whether it’s an EMR [electronic medical record] problem, an inefficacy, or how complicated a process is for an end user. But having a peer review situation that then leads to a system-level change that prevents that problem from happening again is really unlikely. There’s a huge disconnect between those two.”
Peer review is generally a process that goes on behind closed doors. Although structures may differ, peer review is generally described as the process by which physicians assess the quality of their peers’ work to ensure that standards of care are being met. The process is often used to evaluate issues regarding clinical care as well as behavioral complaints against physicians.
Doctors who undergo peer review frequently share their experiences, but reviewers themselves rarely speak out. For this story,
“Peer review processes are in place to build stronger institutions and stronger practices, and they’re supposed to be helpful,” Dr. Beran said. “But because of how opaque they are, it immediately puts physicians on the defensive, and it doesn’t always succeed in what it’s trying to do. I think that’s one of the biggest challenges.”
Biased reviewers taint evaluations
A peer reviewer on and off throughout her career, Indiana family physician Lana Patch, MD, said she always strived to be fair when evaluating fellow physicians. But not every reviewer she encountered operated the same way, she said. Some were biased.
In one case, Dr. Patch peer reviewed a general surgeon who had performed a hysterectomy on a 16-year-old girl. The surgeon believed the teenager likely had an acute appendicitis, but it turned out she had a uterine pathology, Dr. Patch said. The surgeon saved the girl’s life, but the case came under review because of the patient’s age and the fact that her uterus was removed. A local obstetrician-gynecologist weighed in on the case.
“The local ob.gyn. saw it as a turf battle,” recalled Dr. Patch, who is now retired after 30 years of practice in eastern Indiana. “The doctor had nothing but bad to say about the surgeon. He was a competitor.”
Because it was a small hospital, the committee sometimes had trouble finding a specialist who was qualified to give an opinion and who wasn’t in competition with the physician in question, said Dr. Patch. Eventually they found an outside pediatric gynecologist who reviewed the case and concluded that the surgeon had followed the standard of care.
Personal agendas in can come from different directions, said Robert Marder, MD, the author of several books on peer review. Dr. Marder is a consultant who assists with peer review redesign. He has worked with hundreds of medical staff leaders and is a former vice president at the Greeley Company, a consulting firm in Danvers, Mass., that performs peer review redesign. Dr. Marder is president of Robert J. Marder Consulting.
“It goes both ways,” Dr. Marder said. “I’ve seen where somebody with a personal view decides to bring things to the peer review committee specifically because they want the peer review committee to have an adverse view of this person and get them off the medical staff. And I’ve seen hospitals that are uncomfortable with a certain person for whatever reason and want the peer review committee to address it, as opposed to addressing it from a human resource standpoint.”
Dr. Patch recalled a case in which reviewers and hospital leaders were at odds over the credentialing of a physician. Fifteen years earlier, while driving in California, the psychiatrist had been pulled over and was found with an ounce of marijuana, she said.
“We wanted to privilege him,” Dr. Patch said. “As staff physicians, we felt that was 15 years ago, people change over time. Doctors are human beings, too. He seemed to have good credentials and good training. The hospital said, ‘Oh no, we can’t have somebody like this.’ “
The psychiatrist was placed on probation and had to undergo a review every 90 days for about 3 years. Eventually, he was privileged, Dr. Patch said.
Bias among reviewers, including unintentional bias, is also a challenge, Dr. Marder noted. Some initial reviewers score a physician too harshly, he said, whereas others underscore.
“Underscoring is more insidious and more difficult to deal with,” Dr. Marder said. “Underscoring is where the reviewer is too nice. They tend to dismiss things from their colleagues rather than recognize them as an opportunity to help them improve. With underscoring, a lot of committees, if the initial reviewer says the care was appropriate, they don’t even look at the case. They just take that one person’s word for it.”
Reviewers: Looks can be deceiving
When first examining the documented details of a case, it can be easy for peer reviewers to make a quick judgment about what happened, Dr. Beran said.
“You get these complaints, and you read through it, and you think, ‘Oh man, this person really messed up,’ “ he said. “Then you hear the doctor’s side of it, and you realize, ‘No, there’s a much bigger picture at play.’ You realize both sides have valid perspectives on it.”
In one case, for example, Dr. Beran recalled a complaint against a physician who made a snarky remark to a nurse. The doctor had asked the nurse for a piece of equipment, and the nurse said she was busy preparing the room for a patient. The doctor made a comment along the lines of, “Well, would you like me to do that for you and also intubate the patient while you do some charting?!”
At first glance, it appeared that the physician lashed out inappropriately at the nurse. But when reviewers heard from the doctor, they learned that the nurses knew that a trauma patient was coming by ambulance and that he would likely require a ventilator, Dr. Beran said. As the minutes ticked by, however, the nurses were seen in the break room chatting. Nothing had been prepared in the room, including any airway supply.
“The patient had a prolonged course and a very difficult intubation and could have very easily wound up with a much worse outcome for something the nurses had been warned about prior to the patient’s arrival,” he said. “I can see anybody getting upset in that situation if I warned them 5 or 10 minutes beforehand, ‘Get this stuff ready,’ and then nothing was done.”
There was no direct penalty for the physician.
Just as some complaints can be misleading, the clinical record in some peer review cases can also lead reviewers astray.
Physicians frequently include too much irrelevant information in the record, which can cloud a peer review, said Hans Duvefelt, MD, a family physician at Pines Health Services, in Van Buren, Maine. Dr. Duvefelt is a former medical director at Bucksport Regional Health Center, in Ellsworth, Maine. Both facilities are federally qualified health centers where continuous, random peer reviews are required.
In one case, Dr. Duvefelt was peer reviewing a physician’s office note regarding an elderly patient with a low-grade fever. The final diagnosis was urinary tract infection. Dr. Duvefelt said he had trouble following the doctor’s line of thinking because of a plethora of unnecessary data in the 10-page document. The office note included past medical history, prior lab and imaging test results, and an extensive narrative section that included a mixture of active medical problems and ongoing relationships with specialists, he said.
After reading through the printout three times, Dr. Duvefelt said he finally found mention of increased urinary dribbling and details about an enlarged prostate. He also spotted a same-day urinalysis among nearly a dozen other previous lab tests that had no connection to body temperature. Dr. Duvefelt gave the physician a passing grade but also left a scathing note about all the irrelevant information.
“It’s very common,” Dr. Duvefelt said. “It’s a disaster. Other doctors can’t follow your thinking. A reviewer has a hard time determining whether the doctor acted reasonably.”
Slackers make bad reviewers
Although dedicated reviewers work hard to get to the bottom of cases, it’s not uncommon for some committee members to hardly work at all, according to experts.
Dr. Marder said he’s seen many instances in which reviewers were assigned a review but did not complete it for months. Most committees have set time frames in which reviewers must complete their review.
“That delays that review, and by that time, the review is older and it’s harder to remember things,” he said. “It’s not fair to the physician. If there was a problem the physician could fix and you don’t tell him for 3 or 4 months what it is, he may do the same thing again. The case might come before the committee again and it looks like he’s repeated something, but you never gave him the opportunity to improve.”
Other reviewers fail to attend meetings regularly. Peer review committee members are generally volunteers, and meetings are usually held in the early mornings or late evenings.
“There are reasons for not attending occasionally, but some people put on a committee just don’t take it seriously,” Dr. Marder said. “They don’t fulfill their responsibilities as well as they should. If you accept the job, do the job.”
For physicians considering becoming a peer reviewer, Dr. Beran offers these tips: Be transparent, help physicians understand next steps, and make yourself as available as allowed to answer questions.
Know your committee’s policies and procedures, and follow them, added Dr. Marder. It’s also a good idea to work with your hospital’s quality staff, he said.
Reviewers should keep in mind that they may not always be the one assessing someone else, Dr. Beran said.
“Realize very easily you could be on the other side of that table for things that are outside your control,” he said. “How would you want to be treated?”
A version of this article first appeared on Medscape.com.
After making an insulting comment to a surgery scheduler, a surgeon become the subject of a peer review investigation.
The surgeon had been called in on a Saturday morning for surgery, but when he arrived at the hospital, staff informed him that the operating room had been incorrectly booked and asked him to come back that afternoon. When the surgeon returned, the room still wasn’t ready, recounted David Beran, DO, a peer reviewer and medical director for the emergency department at University Medical Center New Orleans, in Louisiana. After more waiting and staff uncertainty about which operating room was going to open, the surgeon became frustrated and said to the scheduler: “Any idiot could figure this out!”
During his peer review, the surgeon acknowledged that he shouldn’t have made the rude remark to the scheduler, Dr. Beran said. His exasperation stemmed from an ongoing problem – operating rooms at the hospital were being inefficiently managed.
“The surgeon acknowledged that even though there was a systems issue at the root, that’s not justification to speak to people unprofessionally,” Dr. Beran said. “So, there was education for the surgeon, but the surgeon was also able to explain the frustration that led to that point.”
System problems are commonly encountered by peer reviewers, said Dr. Beran.
“There’s a huge gap between administration and clinical professionals when it comes to peer review,” he said. “So many times, bad situations, whether they’re clinical or behavioral, often boil down to systems issues or some inadequacy, whether it’s an EMR [electronic medical record] problem, an inefficacy, or how complicated a process is for an end user. But having a peer review situation that then leads to a system-level change that prevents that problem from happening again is really unlikely. There’s a huge disconnect between those two.”
Peer review is generally a process that goes on behind closed doors. Although structures may differ, peer review is generally described as the process by which physicians assess the quality of their peers’ work to ensure that standards of care are being met. The process is often used to evaluate issues regarding clinical care as well as behavioral complaints against physicians.
Doctors who undergo peer review frequently share their experiences, but reviewers themselves rarely speak out. For this story,
“Peer review processes are in place to build stronger institutions and stronger practices, and they’re supposed to be helpful,” Dr. Beran said. “But because of how opaque they are, it immediately puts physicians on the defensive, and it doesn’t always succeed in what it’s trying to do. I think that’s one of the biggest challenges.”
Biased reviewers taint evaluations
A peer reviewer on and off throughout her career, Indiana family physician Lana Patch, MD, said she always strived to be fair when evaluating fellow physicians. But not every reviewer she encountered operated the same way, she said. Some were biased.
In one case, Dr. Patch peer reviewed a general surgeon who had performed a hysterectomy on a 16-year-old girl. The surgeon believed the teenager likely had an acute appendicitis, but it turned out she had a uterine pathology, Dr. Patch said. The surgeon saved the girl’s life, but the case came under review because of the patient’s age and the fact that her uterus was removed. A local obstetrician-gynecologist weighed in on the case.
“The local ob.gyn. saw it as a turf battle,” recalled Dr. Patch, who is now retired after 30 years of practice in eastern Indiana. “The doctor had nothing but bad to say about the surgeon. He was a competitor.”
Because it was a small hospital, the committee sometimes had trouble finding a specialist who was qualified to give an opinion and who wasn’t in competition with the physician in question, said Dr. Patch. Eventually they found an outside pediatric gynecologist who reviewed the case and concluded that the surgeon had followed the standard of care.
Personal agendas in can come from different directions, said Robert Marder, MD, the author of several books on peer review. Dr. Marder is a consultant who assists with peer review redesign. He has worked with hundreds of medical staff leaders and is a former vice president at the Greeley Company, a consulting firm in Danvers, Mass., that performs peer review redesign. Dr. Marder is president of Robert J. Marder Consulting.
“It goes both ways,” Dr. Marder said. “I’ve seen where somebody with a personal view decides to bring things to the peer review committee specifically because they want the peer review committee to have an adverse view of this person and get them off the medical staff. And I’ve seen hospitals that are uncomfortable with a certain person for whatever reason and want the peer review committee to address it, as opposed to addressing it from a human resource standpoint.”
Dr. Patch recalled a case in which reviewers and hospital leaders were at odds over the credentialing of a physician. Fifteen years earlier, while driving in California, the psychiatrist had been pulled over and was found with an ounce of marijuana, she said.
“We wanted to privilege him,” Dr. Patch said. “As staff physicians, we felt that was 15 years ago, people change over time. Doctors are human beings, too. He seemed to have good credentials and good training. The hospital said, ‘Oh no, we can’t have somebody like this.’ “
The psychiatrist was placed on probation and had to undergo a review every 90 days for about 3 years. Eventually, he was privileged, Dr. Patch said.
Bias among reviewers, including unintentional bias, is also a challenge, Dr. Marder noted. Some initial reviewers score a physician too harshly, he said, whereas others underscore.
“Underscoring is more insidious and more difficult to deal with,” Dr. Marder said. “Underscoring is where the reviewer is too nice. They tend to dismiss things from their colleagues rather than recognize them as an opportunity to help them improve. With underscoring, a lot of committees, if the initial reviewer says the care was appropriate, they don’t even look at the case. They just take that one person’s word for it.”
Reviewers: Looks can be deceiving
When first examining the documented details of a case, it can be easy for peer reviewers to make a quick judgment about what happened, Dr. Beran said.
“You get these complaints, and you read through it, and you think, ‘Oh man, this person really messed up,’ “ he said. “Then you hear the doctor’s side of it, and you realize, ‘No, there’s a much bigger picture at play.’ You realize both sides have valid perspectives on it.”
In one case, for example, Dr. Beran recalled a complaint against a physician who made a snarky remark to a nurse. The doctor had asked the nurse for a piece of equipment, and the nurse said she was busy preparing the room for a patient. The doctor made a comment along the lines of, “Well, would you like me to do that for you and also intubate the patient while you do some charting?!”
At first glance, it appeared that the physician lashed out inappropriately at the nurse. But when reviewers heard from the doctor, they learned that the nurses knew that a trauma patient was coming by ambulance and that he would likely require a ventilator, Dr. Beran said. As the minutes ticked by, however, the nurses were seen in the break room chatting. Nothing had been prepared in the room, including any airway supply.
“The patient had a prolonged course and a very difficult intubation and could have very easily wound up with a much worse outcome for something the nurses had been warned about prior to the patient’s arrival,” he said. “I can see anybody getting upset in that situation if I warned them 5 or 10 minutes beforehand, ‘Get this stuff ready,’ and then nothing was done.”
There was no direct penalty for the physician.
Just as some complaints can be misleading, the clinical record in some peer review cases can also lead reviewers astray.
Physicians frequently include too much irrelevant information in the record, which can cloud a peer review, said Hans Duvefelt, MD, a family physician at Pines Health Services, in Van Buren, Maine. Dr. Duvefelt is a former medical director at Bucksport Regional Health Center, in Ellsworth, Maine. Both facilities are federally qualified health centers where continuous, random peer reviews are required.
In one case, Dr. Duvefelt was peer reviewing a physician’s office note regarding an elderly patient with a low-grade fever. The final diagnosis was urinary tract infection. Dr. Duvefelt said he had trouble following the doctor’s line of thinking because of a plethora of unnecessary data in the 10-page document. The office note included past medical history, prior lab and imaging test results, and an extensive narrative section that included a mixture of active medical problems and ongoing relationships with specialists, he said.
After reading through the printout three times, Dr. Duvefelt said he finally found mention of increased urinary dribbling and details about an enlarged prostate. He also spotted a same-day urinalysis among nearly a dozen other previous lab tests that had no connection to body temperature. Dr. Duvefelt gave the physician a passing grade but also left a scathing note about all the irrelevant information.
“It’s very common,” Dr. Duvefelt said. “It’s a disaster. Other doctors can’t follow your thinking. A reviewer has a hard time determining whether the doctor acted reasonably.”
Slackers make bad reviewers
Although dedicated reviewers work hard to get to the bottom of cases, it’s not uncommon for some committee members to hardly work at all, according to experts.
Dr. Marder said he’s seen many instances in which reviewers were assigned a review but did not complete it for months. Most committees have set time frames in which reviewers must complete their review.
“That delays that review, and by that time, the review is older and it’s harder to remember things,” he said. “It’s not fair to the physician. If there was a problem the physician could fix and you don’t tell him for 3 or 4 months what it is, he may do the same thing again. The case might come before the committee again and it looks like he’s repeated something, but you never gave him the opportunity to improve.”
Other reviewers fail to attend meetings regularly. Peer review committee members are generally volunteers, and meetings are usually held in the early mornings or late evenings.
“There are reasons for not attending occasionally, but some people put on a committee just don’t take it seriously,” Dr. Marder said. “They don’t fulfill their responsibilities as well as they should. If you accept the job, do the job.”
For physicians considering becoming a peer reviewer, Dr. Beran offers these tips: Be transparent, help physicians understand next steps, and make yourself as available as allowed to answer questions.
Know your committee’s policies and procedures, and follow them, added Dr. Marder. It’s also a good idea to work with your hospital’s quality staff, he said.
Reviewers should keep in mind that they may not always be the one assessing someone else, Dr. Beran said.
“Realize very easily you could be on the other side of that table for things that are outside your control,” he said. “How would you want to be treated?”
A version of this article first appeared on Medscape.com.
After making an insulting comment to a surgery scheduler, a surgeon become the subject of a peer review investigation.
The surgeon had been called in on a Saturday morning for surgery, but when he arrived at the hospital, staff informed him that the operating room had been incorrectly booked and asked him to come back that afternoon. When the surgeon returned, the room still wasn’t ready, recounted David Beran, DO, a peer reviewer and medical director for the emergency department at University Medical Center New Orleans, in Louisiana. After more waiting and staff uncertainty about which operating room was going to open, the surgeon became frustrated and said to the scheduler: “Any idiot could figure this out!”
During his peer review, the surgeon acknowledged that he shouldn’t have made the rude remark to the scheduler, Dr. Beran said. His exasperation stemmed from an ongoing problem – operating rooms at the hospital were being inefficiently managed.
“The surgeon acknowledged that even though there was a systems issue at the root, that’s not justification to speak to people unprofessionally,” Dr. Beran said. “So, there was education for the surgeon, but the surgeon was also able to explain the frustration that led to that point.”
System problems are commonly encountered by peer reviewers, said Dr. Beran.
“There’s a huge gap between administration and clinical professionals when it comes to peer review,” he said. “So many times, bad situations, whether they’re clinical or behavioral, often boil down to systems issues or some inadequacy, whether it’s an EMR [electronic medical record] problem, an inefficacy, or how complicated a process is for an end user. But having a peer review situation that then leads to a system-level change that prevents that problem from happening again is really unlikely. There’s a huge disconnect between those two.”
Peer review is generally a process that goes on behind closed doors. Although structures may differ, peer review is generally described as the process by which physicians assess the quality of their peers’ work to ensure that standards of care are being met. The process is often used to evaluate issues regarding clinical care as well as behavioral complaints against physicians.
Doctors who undergo peer review frequently share their experiences, but reviewers themselves rarely speak out. For this story,
“Peer review processes are in place to build stronger institutions and stronger practices, and they’re supposed to be helpful,” Dr. Beran said. “But because of how opaque they are, it immediately puts physicians on the defensive, and it doesn’t always succeed in what it’s trying to do. I think that’s one of the biggest challenges.”
Biased reviewers taint evaluations
A peer reviewer on and off throughout her career, Indiana family physician Lana Patch, MD, said she always strived to be fair when evaluating fellow physicians. But not every reviewer she encountered operated the same way, she said. Some were biased.
In one case, Dr. Patch peer reviewed a general surgeon who had performed a hysterectomy on a 16-year-old girl. The surgeon believed the teenager likely had an acute appendicitis, but it turned out she had a uterine pathology, Dr. Patch said. The surgeon saved the girl’s life, but the case came under review because of the patient’s age and the fact that her uterus was removed. A local obstetrician-gynecologist weighed in on the case.
“The local ob.gyn. saw it as a turf battle,” recalled Dr. Patch, who is now retired after 30 years of practice in eastern Indiana. “The doctor had nothing but bad to say about the surgeon. He was a competitor.”
Because it was a small hospital, the committee sometimes had trouble finding a specialist who was qualified to give an opinion and who wasn’t in competition with the physician in question, said Dr. Patch. Eventually they found an outside pediatric gynecologist who reviewed the case and concluded that the surgeon had followed the standard of care.
Personal agendas in can come from different directions, said Robert Marder, MD, the author of several books on peer review. Dr. Marder is a consultant who assists with peer review redesign. He has worked with hundreds of medical staff leaders and is a former vice president at the Greeley Company, a consulting firm in Danvers, Mass., that performs peer review redesign. Dr. Marder is president of Robert J. Marder Consulting.
“It goes both ways,” Dr. Marder said. “I’ve seen where somebody with a personal view decides to bring things to the peer review committee specifically because they want the peer review committee to have an adverse view of this person and get them off the medical staff. And I’ve seen hospitals that are uncomfortable with a certain person for whatever reason and want the peer review committee to address it, as opposed to addressing it from a human resource standpoint.”
Dr. Patch recalled a case in which reviewers and hospital leaders were at odds over the credentialing of a physician. Fifteen years earlier, while driving in California, the psychiatrist had been pulled over and was found with an ounce of marijuana, she said.
“We wanted to privilege him,” Dr. Patch said. “As staff physicians, we felt that was 15 years ago, people change over time. Doctors are human beings, too. He seemed to have good credentials and good training. The hospital said, ‘Oh no, we can’t have somebody like this.’ “
The psychiatrist was placed on probation and had to undergo a review every 90 days for about 3 years. Eventually, he was privileged, Dr. Patch said.
Bias among reviewers, including unintentional bias, is also a challenge, Dr. Marder noted. Some initial reviewers score a physician too harshly, he said, whereas others underscore.
“Underscoring is more insidious and more difficult to deal with,” Dr. Marder said. “Underscoring is where the reviewer is too nice. They tend to dismiss things from their colleagues rather than recognize them as an opportunity to help them improve. With underscoring, a lot of committees, if the initial reviewer says the care was appropriate, they don’t even look at the case. They just take that one person’s word for it.”
Reviewers: Looks can be deceiving
When first examining the documented details of a case, it can be easy for peer reviewers to make a quick judgment about what happened, Dr. Beran said.
“You get these complaints, and you read through it, and you think, ‘Oh man, this person really messed up,’ “ he said. “Then you hear the doctor’s side of it, and you realize, ‘No, there’s a much bigger picture at play.’ You realize both sides have valid perspectives on it.”
In one case, for example, Dr. Beran recalled a complaint against a physician who made a snarky remark to a nurse. The doctor had asked the nurse for a piece of equipment, and the nurse said she was busy preparing the room for a patient. The doctor made a comment along the lines of, “Well, would you like me to do that for you and also intubate the patient while you do some charting?!”
At first glance, it appeared that the physician lashed out inappropriately at the nurse. But when reviewers heard from the doctor, they learned that the nurses knew that a trauma patient was coming by ambulance and that he would likely require a ventilator, Dr. Beran said. As the minutes ticked by, however, the nurses were seen in the break room chatting. Nothing had been prepared in the room, including any airway supply.
“The patient had a prolonged course and a very difficult intubation and could have very easily wound up with a much worse outcome for something the nurses had been warned about prior to the patient’s arrival,” he said. “I can see anybody getting upset in that situation if I warned them 5 or 10 minutes beforehand, ‘Get this stuff ready,’ and then nothing was done.”
There was no direct penalty for the physician.
Just as some complaints can be misleading, the clinical record in some peer review cases can also lead reviewers astray.
Physicians frequently include too much irrelevant information in the record, which can cloud a peer review, said Hans Duvefelt, MD, a family physician at Pines Health Services, in Van Buren, Maine. Dr. Duvefelt is a former medical director at Bucksport Regional Health Center, in Ellsworth, Maine. Both facilities are federally qualified health centers where continuous, random peer reviews are required.
In one case, Dr. Duvefelt was peer reviewing a physician’s office note regarding an elderly patient with a low-grade fever. The final diagnosis was urinary tract infection. Dr. Duvefelt said he had trouble following the doctor’s line of thinking because of a plethora of unnecessary data in the 10-page document. The office note included past medical history, prior lab and imaging test results, and an extensive narrative section that included a mixture of active medical problems and ongoing relationships with specialists, he said.
After reading through the printout three times, Dr. Duvefelt said he finally found mention of increased urinary dribbling and details about an enlarged prostate. He also spotted a same-day urinalysis among nearly a dozen other previous lab tests that had no connection to body temperature. Dr. Duvefelt gave the physician a passing grade but also left a scathing note about all the irrelevant information.
“It’s very common,” Dr. Duvefelt said. “It’s a disaster. Other doctors can’t follow your thinking. A reviewer has a hard time determining whether the doctor acted reasonably.”
Slackers make bad reviewers
Although dedicated reviewers work hard to get to the bottom of cases, it’s not uncommon for some committee members to hardly work at all, according to experts.
Dr. Marder said he’s seen many instances in which reviewers were assigned a review but did not complete it for months. Most committees have set time frames in which reviewers must complete their review.
“That delays that review, and by that time, the review is older and it’s harder to remember things,” he said. “It’s not fair to the physician. If there was a problem the physician could fix and you don’t tell him for 3 or 4 months what it is, he may do the same thing again. The case might come before the committee again and it looks like he’s repeated something, but you never gave him the opportunity to improve.”
Other reviewers fail to attend meetings regularly. Peer review committee members are generally volunteers, and meetings are usually held in the early mornings or late evenings.
“There are reasons for not attending occasionally, but some people put on a committee just don’t take it seriously,” Dr. Marder said. “They don’t fulfill their responsibilities as well as they should. If you accept the job, do the job.”
For physicians considering becoming a peer reviewer, Dr. Beran offers these tips: Be transparent, help physicians understand next steps, and make yourself as available as allowed to answer questions.
Know your committee’s policies and procedures, and follow them, added Dr. Marder. It’s also a good idea to work with your hospital’s quality staff, he said.
Reviewers should keep in mind that they may not always be the one assessing someone else, Dr. Beran said.
“Realize very easily you could be on the other side of that table for things that are outside your control,” he said. “How would you want to be treated?”
A version of this article first appeared on Medscape.com.
COVID-19 and liver disease: Answering the key questions
For those of us treating patients with liver disease throughout the pandemic, we have anticipated evidence-based guidance regarding the contribution of specific liver disease phenotypes and immune suppression/transplantation on COVID-19 susceptibility and outcome. Now, data are emerging to help answer some of the major questions surrounding COVID-19 and the liver.
Does the virus itself cause liver disease?
The answer to this question is still a bit unclear. Multiple early reports1-11 stated that hospitalized patients with SARS-CoV-2 infection frequently had elevated values on liver biochemistry tests. For example, the reported incidence of elevated serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ranged from 14% to 83%, yet the magnitude of enzyme elevation was generally reported to be mild and normalized as COVID-19 symptoms improved.
Unsurprisingly, patients with severe liver injury (defined as AST and ALT levels more than five times the upper limit of normal) were more likely to have a complicated clinical course, including having elevated inflammatory markers and requiring intensive care unit admission, renal replacement therapy, and/or intubation. Currier and colleagues reported that patients with COVID-19 who had elevated AST and ALT levels had significantly higher odds of these same adverse outcomes and death.
This reflects the multifactorial pathogenesis of enzyme elevation, including a direct injurious effect of the virus on hepatocytes, cytokine or immune-mediated liver damage, drug hepatoxicity, or hypoxia and systemic inflammation.
Pellegrini and colleagues reported that 7% of patients infected with SARS-CoV-2 developed acute liver failure during their hospitalization, with a resulting mortality rate of 74%. Wagner and colleagues suggested that the pattern of peak elevated enzyme elevation was prognostic of severe clinical outcomes in hospitalized patients with COVID-19. Patients with a predominantly mixed pattern (AST/ALT and alkaline phosphatase elevations) had worse outcomes than those with a hepatocellular phenotype (isolated AST and/or ALT elevation).
Severe liver injury associated with SARS-CoV-2 infection is uncommon in children. However, elevated AST and ALT levels may be seen in association with multisystem inflammatory syndrome.12-15
Are patients with preexisting chronic liver disease more susceptible to adverse outcomes?
Early observations suggested that patients with chronic liver disease, such as cirrhosis, who acquire SARS-CoV-2 have high rates of hospitalization and mortality. However, it is unclear whether all such patients are affected or whether certain subgroups are at higher risk.
In results that they hoped would allow for better risk stratification and personalization of care, Kim and colleagues reported that patients with alcohol-related liver disease, decompensated cirrhosis, and hepatocellular carcinoma have the highest risk for all-cause mortality from COVID-19. Separate presentations at Digestive Disease Week 2021 confirmed that patients with preexisting liver disease had a threefold higher rate of mortality, thromboembolism, acute respiratory distress syndrome, and a severe COVID-19 disease course, and that patients with both COVID-19 and cirrhosis had significantly higher rates of mortality (18% vs. 13%), ICU admission (46% vs. 34%), and longer lengths of stay than those without cirrhosis.
Nonalcoholic fatty liver disease (NAFLD) is currently the most common chronic liver disease, and its impact on the course of SARS-CoV-2 infection (and vice versa) is controversial. However, metabolic risk factors, such as obesity, diabetes mellitus, and hypertension, are known to be associated with severe illness from COVID-19. It was also reported that hepatic steatosis was associated with worse outcomes in patients with liver injury and SARS-CoV-2 infection, and that a higher proportion of patients with NAFLD required mechanical ventilation during their hospital course (47% vs. 17%) and had increased mortality (41% vs. 17%).
Do immunosuppressed patients face unique risks from infection?
Data from a limited case series, patient registries, and multicenter international studies have indicated that the clinical outcome of SARS-CoV-2 infection in adults with autoimmune hepatitis (AIH) was comparable to that noted in nonimmunosuppressed persons. However, it has also been suggested that a more complicated relationship exists between this virus and autoimmunity because immunosuppression may actually protect against the inappropriate immune response, or cytokine storm, engendered during severe SARS-CoV-2 infection.
The complexity of this relationship is further illustrated by a report from Bril and colleagues that described a case of AIH that developed after a patient had received a COVID-19 vaccine. The authors were careful to state that a causal relationship between receipt of the vaccine and the onset of AIH cannot be proven.
What’s the impact on liver transplant recipients?
Findings are limited regarding clinical outcomes and disease severity of SARS-CoV-2 infection in liver transplant recipients, but initial reports raised concern for high rates of adverse outcomes.16-25
Tien and colleagues reported an increased risk for COVID-related death among liver transplant recipients. Separate international multicenter studies published in 2020 and 2021 found that liver transplant patients with COVID-19 had a significantly higher risk for hospitalization but no higher risk for mortality, thrombosis, or ICU requirement, compared with patients with COVID-19 who had not undergone liver transplantation. Increased age and the presence of comorbidities were determinants of the severity of SARS-CoV-2 infection and of mortality among liver transplant recipients.
Clearly, more data are needed to address the influence of liver transplantation in patients with COVID-19; however, some risk/protective factors have been cited. For example, Belli and colleagues reported that the use of tacrolimus was associated with a better outcome. Conversely, baseline immunosuppression containing mycophenolate mofetil was an independent predictor of severe COVID-19 in liver transplant recipients.
Do COVID-19 vaccines work differently in patients with liver disease?
Unfortunately, we haven’t been able to address many of our patients’ questions related to vaccine efficacy, safety, and durability. Data are limited because immunocompromised patients were excluded from the phase 3 trials of the COVID-19 vaccines.
We also need greater clarity on the robustness of the response to these vaccines in liver transplant recipients. Rabinowich and colleagues evaluated humoral antibody responses after vaccination with the mRNA-based vaccine BNT162b2 (BioNTech/Pfizer) and confirmed lower immunogenicity in liver transplant recipients. Antibodies were detectable in only 48% of patients, compared with 100% of healthy controls; in addition, antibody titers were significantly lower. Unfortunately, there are no data on the correlation of protection from SARS-CoV-2 with antibody titers.
Additional data will be required to assess vaccine effectiveness in protecting against severe COVID-19 as well as to determine the magnitude of humoral vaccine responses in recipients treated with high-dose steroids and mycophenolate mofetil. In addition, we eagerly await studies that determine whether booster doses are required.
What’s the bottom line?
In the face of the COVID-19 pandemic, our understanding of the impact on our patients remains a work in progress.
As we await more clarity, there are a few practical points of clinical relevance we take away from the literature, the recently released joint Statement on COVID-19 Vaccination in Solid Organ Transplant Recipients, and the American Association for the Study of Liver Diseases (AASLD) consensus statement. These suggest clinicians take the following steps:
- When assessing patients with SARS-CoV-2 infection and elevated AST and ALT levels, the first objective is to rule out etiologies unrelated to COVID-19, specifically other viruses and drug-induced injury, as well as nonhepatic causes (e.g., myositis, cardiac injury, ischemia).
- Reduction in immunosuppression in SARS-CoV-2–infected patients with AIH should be considered carefully and generally undertaken only in those with severe illness.
- Pretransplant SARS-CoV-2 vaccination is recommended for all liver transplant candidates and liver transplant recipients as well as their household members and caregivers, to reduce exposure for these patients, along with continued adherence to protective measures (masking and social distancing).
- Continuation of a stable posttransplant immunosuppression regimen at the time of vaccination is recommended to avoid the risk for organ rejection until more comprehensive data are available.
For updated responses to the evolving guidelines, visit the AASLD’s resource center.
William F. Balistreri, MD, is the Dorothy M.M. Kersten Professor of Pediatrics; director emeritus, pediatric liver care center; medical director emeritus, liver transplantation; and professor, University of Cincinnati College of Medicine, department of pediatrics, Cincinnati Children’s Hospital Medical Center. He has served as director of the division of gastroenterology, hepatology and nutrition at Cincinnati Children’s for 25 years and frequently covers gastroenterology, liver, and nutrition-related topics for this news organization. Dr Balistreri is currently editor-in-chief of the Journal of Pediatrics, having previously served as editor-in-chief of several journals and textbooks. He also became the first pediatrician to act as president of the American Association for the Study of Liver Diseases. He has disclosed no relevant financial relationships.
References
1. Bloom PB et al. Hepatology. 2021 Mar;73:890-900.
2. Guan WJ et al. N Engl J Med. 2020 Apr;382:1708-20.
3. Chen N et al. Lancet. 2020 Feb;395:507-13.
4. Fan Z et al. Clin Gastroenterol Hepatol. 2020 Jun;18:1561-6.
5. Huang C et al. Lancet. 2020 Feb;395:497-506.
6. Xu L et al. Liver Int. 2020 May;40:998-1004.
7. Zhang C et al. Lancet Gastroenterol Hepatol. 2020 May;5:428-30.
8. Richardson S et al. JAMA. 2020 May;323:2052-9.
9. Phipps MM et al. Hepatology. 2020 Sep;72:807-17.
10. Ferm S et al. Clin Gastroenterol Hepatol. 2020 Sep;18:2378-9.
11. Hundt MA et al. Hepatology. 2020 Oct;72:1169-76.
12. Zhou YH et al. Pediatr Obes. 2020 Dec;15:e12723.
13. Kehar M et al. J Pediatr Gastroenterol Nutr. 2021 Jun;72:807-814.
14. Lu X et al. N Engl J Med. 2020 Apr;382:1663-5.
15. Cantor A et al. Hepatology. 2020 Nov;72:1522-7.
16. Kim D et al. Clin Gastroenterol Hepatol. 2021 Jul;19:1469-79.
17. Colmenero J et al. J Hepatol. 2021 Jan;74:148-155.
18. Lee BT et al. Gastroenterology. 2020 Sep;159:1176-8.e2.
19. Becchetti C et al. Gut. 2020 Oct;69:1832-40.
20. Belli LS et al. Lancet Gastroenterol Hepatol. 2020 Aug;5:724-5.
21. Bhoori S et al. Lancet Gastroenterol Hepatol. 2020 Jun;5:532-3.
22. Rabiee A et al; COLD Consortium. Hepatology. 2020 Dec;72:1900-11.
23. Belli LS et al. Gastroenterology. 2021 Mar;160:1151-63.e3.
24. Webb GJ et al. Lancet Gastroenterol Hepatol. 2020 Nov;5:1008-16.
25. Marjot T et al. J Hepatol. 2021 Mar;74:567-77.
A version of this article first appeared on Medscape.com.
For those of us treating patients with liver disease throughout the pandemic, we have anticipated evidence-based guidance regarding the contribution of specific liver disease phenotypes and immune suppression/transplantation on COVID-19 susceptibility and outcome. Now, data are emerging to help answer some of the major questions surrounding COVID-19 and the liver.
Does the virus itself cause liver disease?
The answer to this question is still a bit unclear. Multiple early reports1-11 stated that hospitalized patients with SARS-CoV-2 infection frequently had elevated values on liver biochemistry tests. For example, the reported incidence of elevated serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ranged from 14% to 83%, yet the magnitude of enzyme elevation was generally reported to be mild and normalized as COVID-19 symptoms improved.
Unsurprisingly, patients with severe liver injury (defined as AST and ALT levels more than five times the upper limit of normal) were more likely to have a complicated clinical course, including having elevated inflammatory markers and requiring intensive care unit admission, renal replacement therapy, and/or intubation. Currier and colleagues reported that patients with COVID-19 who had elevated AST and ALT levels had significantly higher odds of these same adverse outcomes and death.
This reflects the multifactorial pathogenesis of enzyme elevation, including a direct injurious effect of the virus on hepatocytes, cytokine or immune-mediated liver damage, drug hepatoxicity, or hypoxia and systemic inflammation.
Pellegrini and colleagues reported that 7% of patients infected with SARS-CoV-2 developed acute liver failure during their hospitalization, with a resulting mortality rate of 74%. Wagner and colleagues suggested that the pattern of peak elevated enzyme elevation was prognostic of severe clinical outcomes in hospitalized patients with COVID-19. Patients with a predominantly mixed pattern (AST/ALT and alkaline phosphatase elevations) had worse outcomes than those with a hepatocellular phenotype (isolated AST and/or ALT elevation).
Severe liver injury associated with SARS-CoV-2 infection is uncommon in children. However, elevated AST and ALT levels may be seen in association with multisystem inflammatory syndrome.12-15
Are patients with preexisting chronic liver disease more susceptible to adverse outcomes?
Early observations suggested that patients with chronic liver disease, such as cirrhosis, who acquire SARS-CoV-2 have high rates of hospitalization and mortality. However, it is unclear whether all such patients are affected or whether certain subgroups are at higher risk.
In results that they hoped would allow for better risk stratification and personalization of care, Kim and colleagues reported that patients with alcohol-related liver disease, decompensated cirrhosis, and hepatocellular carcinoma have the highest risk for all-cause mortality from COVID-19. Separate presentations at Digestive Disease Week 2021 confirmed that patients with preexisting liver disease had a threefold higher rate of mortality, thromboembolism, acute respiratory distress syndrome, and a severe COVID-19 disease course, and that patients with both COVID-19 and cirrhosis had significantly higher rates of mortality (18% vs. 13%), ICU admission (46% vs. 34%), and longer lengths of stay than those without cirrhosis.
Nonalcoholic fatty liver disease (NAFLD) is currently the most common chronic liver disease, and its impact on the course of SARS-CoV-2 infection (and vice versa) is controversial. However, metabolic risk factors, such as obesity, diabetes mellitus, and hypertension, are known to be associated with severe illness from COVID-19. It was also reported that hepatic steatosis was associated with worse outcomes in patients with liver injury and SARS-CoV-2 infection, and that a higher proportion of patients with NAFLD required mechanical ventilation during their hospital course (47% vs. 17%) and had increased mortality (41% vs. 17%).
Do immunosuppressed patients face unique risks from infection?
Data from a limited case series, patient registries, and multicenter international studies have indicated that the clinical outcome of SARS-CoV-2 infection in adults with autoimmune hepatitis (AIH) was comparable to that noted in nonimmunosuppressed persons. However, it has also been suggested that a more complicated relationship exists between this virus and autoimmunity because immunosuppression may actually protect against the inappropriate immune response, or cytokine storm, engendered during severe SARS-CoV-2 infection.
The complexity of this relationship is further illustrated by a report from Bril and colleagues that described a case of AIH that developed after a patient had received a COVID-19 vaccine. The authors were careful to state that a causal relationship between receipt of the vaccine and the onset of AIH cannot be proven.
What’s the impact on liver transplant recipients?
Findings are limited regarding clinical outcomes and disease severity of SARS-CoV-2 infection in liver transplant recipients, but initial reports raised concern for high rates of adverse outcomes.16-25
Tien and colleagues reported an increased risk for COVID-related death among liver transplant recipients. Separate international multicenter studies published in 2020 and 2021 found that liver transplant patients with COVID-19 had a significantly higher risk for hospitalization but no higher risk for mortality, thrombosis, or ICU requirement, compared with patients with COVID-19 who had not undergone liver transplantation. Increased age and the presence of comorbidities were determinants of the severity of SARS-CoV-2 infection and of mortality among liver transplant recipients.
Clearly, more data are needed to address the influence of liver transplantation in patients with COVID-19; however, some risk/protective factors have been cited. For example, Belli and colleagues reported that the use of tacrolimus was associated with a better outcome. Conversely, baseline immunosuppression containing mycophenolate mofetil was an independent predictor of severe COVID-19 in liver transplant recipients.
Do COVID-19 vaccines work differently in patients with liver disease?
Unfortunately, we haven’t been able to address many of our patients’ questions related to vaccine efficacy, safety, and durability. Data are limited because immunocompromised patients were excluded from the phase 3 trials of the COVID-19 vaccines.
We also need greater clarity on the robustness of the response to these vaccines in liver transplant recipients. Rabinowich and colleagues evaluated humoral antibody responses after vaccination with the mRNA-based vaccine BNT162b2 (BioNTech/Pfizer) and confirmed lower immunogenicity in liver transplant recipients. Antibodies were detectable in only 48% of patients, compared with 100% of healthy controls; in addition, antibody titers were significantly lower. Unfortunately, there are no data on the correlation of protection from SARS-CoV-2 with antibody titers.
Additional data will be required to assess vaccine effectiveness in protecting against severe COVID-19 as well as to determine the magnitude of humoral vaccine responses in recipients treated with high-dose steroids and mycophenolate mofetil. In addition, we eagerly await studies that determine whether booster doses are required.
What’s the bottom line?
In the face of the COVID-19 pandemic, our understanding of the impact on our patients remains a work in progress.
As we await more clarity, there are a few practical points of clinical relevance we take away from the literature, the recently released joint Statement on COVID-19 Vaccination in Solid Organ Transplant Recipients, and the American Association for the Study of Liver Diseases (AASLD) consensus statement. These suggest clinicians take the following steps:
- When assessing patients with SARS-CoV-2 infection and elevated AST and ALT levels, the first objective is to rule out etiologies unrelated to COVID-19, specifically other viruses and drug-induced injury, as well as nonhepatic causes (e.g., myositis, cardiac injury, ischemia).
- Reduction in immunosuppression in SARS-CoV-2–infected patients with AIH should be considered carefully and generally undertaken only in those with severe illness.
- Pretransplant SARS-CoV-2 vaccination is recommended for all liver transplant candidates and liver transplant recipients as well as their household members and caregivers, to reduce exposure for these patients, along with continued adherence to protective measures (masking and social distancing).
- Continuation of a stable posttransplant immunosuppression regimen at the time of vaccination is recommended to avoid the risk for organ rejection until more comprehensive data are available.
For updated responses to the evolving guidelines, visit the AASLD’s resource center.
William F. Balistreri, MD, is the Dorothy M.M. Kersten Professor of Pediatrics; director emeritus, pediatric liver care center; medical director emeritus, liver transplantation; and professor, University of Cincinnati College of Medicine, department of pediatrics, Cincinnati Children’s Hospital Medical Center. He has served as director of the division of gastroenterology, hepatology and nutrition at Cincinnati Children’s for 25 years and frequently covers gastroenterology, liver, and nutrition-related topics for this news organization. Dr Balistreri is currently editor-in-chief of the Journal of Pediatrics, having previously served as editor-in-chief of several journals and textbooks. He also became the first pediatrician to act as president of the American Association for the Study of Liver Diseases. He has disclosed no relevant financial relationships.
References
1. Bloom PB et al. Hepatology. 2021 Mar;73:890-900.
2. Guan WJ et al. N Engl J Med. 2020 Apr;382:1708-20.
3. Chen N et al. Lancet. 2020 Feb;395:507-13.
4. Fan Z et al. Clin Gastroenterol Hepatol. 2020 Jun;18:1561-6.
5. Huang C et al. Lancet. 2020 Feb;395:497-506.
6. Xu L et al. Liver Int. 2020 May;40:998-1004.
7. Zhang C et al. Lancet Gastroenterol Hepatol. 2020 May;5:428-30.
8. Richardson S et al. JAMA. 2020 May;323:2052-9.
9. Phipps MM et al. Hepatology. 2020 Sep;72:807-17.
10. Ferm S et al. Clin Gastroenterol Hepatol. 2020 Sep;18:2378-9.
11. Hundt MA et al. Hepatology. 2020 Oct;72:1169-76.
12. Zhou YH et al. Pediatr Obes. 2020 Dec;15:e12723.
13. Kehar M et al. J Pediatr Gastroenterol Nutr. 2021 Jun;72:807-814.
14. Lu X et al. N Engl J Med. 2020 Apr;382:1663-5.
15. Cantor A et al. Hepatology. 2020 Nov;72:1522-7.
16. Kim D et al. Clin Gastroenterol Hepatol. 2021 Jul;19:1469-79.
17. Colmenero J et al. J Hepatol. 2021 Jan;74:148-155.
18. Lee BT et al. Gastroenterology. 2020 Sep;159:1176-8.e2.
19. Becchetti C et al. Gut. 2020 Oct;69:1832-40.
20. Belli LS et al. Lancet Gastroenterol Hepatol. 2020 Aug;5:724-5.
21. Bhoori S et al. Lancet Gastroenterol Hepatol. 2020 Jun;5:532-3.
22. Rabiee A et al; COLD Consortium. Hepatology. 2020 Dec;72:1900-11.
23. Belli LS et al. Gastroenterology. 2021 Mar;160:1151-63.e3.
24. Webb GJ et al. Lancet Gastroenterol Hepatol. 2020 Nov;5:1008-16.
25. Marjot T et al. J Hepatol. 2021 Mar;74:567-77.
A version of this article first appeared on Medscape.com.
For those of us treating patients with liver disease throughout the pandemic, we have anticipated evidence-based guidance regarding the contribution of specific liver disease phenotypes and immune suppression/transplantation on COVID-19 susceptibility and outcome. Now, data are emerging to help answer some of the major questions surrounding COVID-19 and the liver.
Does the virus itself cause liver disease?
The answer to this question is still a bit unclear. Multiple early reports1-11 stated that hospitalized patients with SARS-CoV-2 infection frequently had elevated values on liver biochemistry tests. For example, the reported incidence of elevated serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ranged from 14% to 83%, yet the magnitude of enzyme elevation was generally reported to be mild and normalized as COVID-19 symptoms improved.
Unsurprisingly, patients with severe liver injury (defined as AST and ALT levels more than five times the upper limit of normal) were more likely to have a complicated clinical course, including having elevated inflammatory markers and requiring intensive care unit admission, renal replacement therapy, and/or intubation. Currier and colleagues reported that patients with COVID-19 who had elevated AST and ALT levels had significantly higher odds of these same adverse outcomes and death.
This reflects the multifactorial pathogenesis of enzyme elevation, including a direct injurious effect of the virus on hepatocytes, cytokine or immune-mediated liver damage, drug hepatoxicity, or hypoxia and systemic inflammation.
Pellegrini and colleagues reported that 7% of patients infected with SARS-CoV-2 developed acute liver failure during their hospitalization, with a resulting mortality rate of 74%. Wagner and colleagues suggested that the pattern of peak elevated enzyme elevation was prognostic of severe clinical outcomes in hospitalized patients with COVID-19. Patients with a predominantly mixed pattern (AST/ALT and alkaline phosphatase elevations) had worse outcomes than those with a hepatocellular phenotype (isolated AST and/or ALT elevation).
Severe liver injury associated with SARS-CoV-2 infection is uncommon in children. However, elevated AST and ALT levels may be seen in association with multisystem inflammatory syndrome.12-15
Are patients with preexisting chronic liver disease more susceptible to adverse outcomes?
Early observations suggested that patients with chronic liver disease, such as cirrhosis, who acquire SARS-CoV-2 have high rates of hospitalization and mortality. However, it is unclear whether all such patients are affected or whether certain subgroups are at higher risk.
In results that they hoped would allow for better risk stratification and personalization of care, Kim and colleagues reported that patients with alcohol-related liver disease, decompensated cirrhosis, and hepatocellular carcinoma have the highest risk for all-cause mortality from COVID-19. Separate presentations at Digestive Disease Week 2021 confirmed that patients with preexisting liver disease had a threefold higher rate of mortality, thromboembolism, acute respiratory distress syndrome, and a severe COVID-19 disease course, and that patients with both COVID-19 and cirrhosis had significantly higher rates of mortality (18% vs. 13%), ICU admission (46% vs. 34%), and longer lengths of stay than those without cirrhosis.
Nonalcoholic fatty liver disease (NAFLD) is currently the most common chronic liver disease, and its impact on the course of SARS-CoV-2 infection (and vice versa) is controversial. However, metabolic risk factors, such as obesity, diabetes mellitus, and hypertension, are known to be associated with severe illness from COVID-19. It was also reported that hepatic steatosis was associated with worse outcomes in patients with liver injury and SARS-CoV-2 infection, and that a higher proportion of patients with NAFLD required mechanical ventilation during their hospital course (47% vs. 17%) and had increased mortality (41% vs. 17%).
Do immunosuppressed patients face unique risks from infection?
Data from a limited case series, patient registries, and multicenter international studies have indicated that the clinical outcome of SARS-CoV-2 infection in adults with autoimmune hepatitis (AIH) was comparable to that noted in nonimmunosuppressed persons. However, it has also been suggested that a more complicated relationship exists between this virus and autoimmunity because immunosuppression may actually protect against the inappropriate immune response, or cytokine storm, engendered during severe SARS-CoV-2 infection.
The complexity of this relationship is further illustrated by a report from Bril and colleagues that described a case of AIH that developed after a patient had received a COVID-19 vaccine. The authors were careful to state that a causal relationship between receipt of the vaccine and the onset of AIH cannot be proven.
What’s the impact on liver transplant recipients?
Findings are limited regarding clinical outcomes and disease severity of SARS-CoV-2 infection in liver transplant recipients, but initial reports raised concern for high rates of adverse outcomes.16-25
Tien and colleagues reported an increased risk for COVID-related death among liver transplant recipients. Separate international multicenter studies published in 2020 and 2021 found that liver transplant patients with COVID-19 had a significantly higher risk for hospitalization but no higher risk for mortality, thrombosis, or ICU requirement, compared with patients with COVID-19 who had not undergone liver transplantation. Increased age and the presence of comorbidities were determinants of the severity of SARS-CoV-2 infection and of mortality among liver transplant recipients.
Clearly, more data are needed to address the influence of liver transplantation in patients with COVID-19; however, some risk/protective factors have been cited. For example, Belli and colleagues reported that the use of tacrolimus was associated with a better outcome. Conversely, baseline immunosuppression containing mycophenolate mofetil was an independent predictor of severe COVID-19 in liver transplant recipients.
Do COVID-19 vaccines work differently in patients with liver disease?
Unfortunately, we haven’t been able to address many of our patients’ questions related to vaccine efficacy, safety, and durability. Data are limited because immunocompromised patients were excluded from the phase 3 trials of the COVID-19 vaccines.
We also need greater clarity on the robustness of the response to these vaccines in liver transplant recipients. Rabinowich and colleagues evaluated humoral antibody responses after vaccination with the mRNA-based vaccine BNT162b2 (BioNTech/Pfizer) and confirmed lower immunogenicity in liver transplant recipients. Antibodies were detectable in only 48% of patients, compared with 100% of healthy controls; in addition, antibody titers were significantly lower. Unfortunately, there are no data on the correlation of protection from SARS-CoV-2 with antibody titers.
Additional data will be required to assess vaccine effectiveness in protecting against severe COVID-19 as well as to determine the magnitude of humoral vaccine responses in recipients treated with high-dose steroids and mycophenolate mofetil. In addition, we eagerly await studies that determine whether booster doses are required.
What’s the bottom line?
In the face of the COVID-19 pandemic, our understanding of the impact on our patients remains a work in progress.
As we await more clarity, there are a few practical points of clinical relevance we take away from the literature, the recently released joint Statement on COVID-19 Vaccination in Solid Organ Transplant Recipients, and the American Association for the Study of Liver Diseases (AASLD) consensus statement. These suggest clinicians take the following steps:
- When assessing patients with SARS-CoV-2 infection and elevated AST and ALT levels, the first objective is to rule out etiologies unrelated to COVID-19, specifically other viruses and drug-induced injury, as well as nonhepatic causes (e.g., myositis, cardiac injury, ischemia).
- Reduction in immunosuppression in SARS-CoV-2–infected patients with AIH should be considered carefully and generally undertaken only in those with severe illness.
- Pretransplant SARS-CoV-2 vaccination is recommended for all liver transplant candidates and liver transplant recipients as well as their household members and caregivers, to reduce exposure for these patients, along with continued adherence to protective measures (masking and social distancing).
- Continuation of a stable posttransplant immunosuppression regimen at the time of vaccination is recommended to avoid the risk for organ rejection until more comprehensive data are available.
For updated responses to the evolving guidelines, visit the AASLD’s resource center.
William F. Balistreri, MD, is the Dorothy M.M. Kersten Professor of Pediatrics; director emeritus, pediatric liver care center; medical director emeritus, liver transplantation; and professor, University of Cincinnati College of Medicine, department of pediatrics, Cincinnati Children’s Hospital Medical Center. He has served as director of the division of gastroenterology, hepatology and nutrition at Cincinnati Children’s for 25 years and frequently covers gastroenterology, liver, and nutrition-related topics for this news organization. Dr Balistreri is currently editor-in-chief of the Journal of Pediatrics, having previously served as editor-in-chief of several journals and textbooks. He also became the first pediatrician to act as president of the American Association for the Study of Liver Diseases. He has disclosed no relevant financial relationships.
References
1. Bloom PB et al. Hepatology. 2021 Mar;73:890-900.
2. Guan WJ et al. N Engl J Med. 2020 Apr;382:1708-20.
3. Chen N et al. Lancet. 2020 Feb;395:507-13.
4. Fan Z et al. Clin Gastroenterol Hepatol. 2020 Jun;18:1561-6.
5. Huang C et al. Lancet. 2020 Feb;395:497-506.
6. Xu L et al. Liver Int. 2020 May;40:998-1004.
7. Zhang C et al. Lancet Gastroenterol Hepatol. 2020 May;5:428-30.
8. Richardson S et al. JAMA. 2020 May;323:2052-9.
9. Phipps MM et al. Hepatology. 2020 Sep;72:807-17.
10. Ferm S et al. Clin Gastroenterol Hepatol. 2020 Sep;18:2378-9.
11. Hundt MA et al. Hepatology. 2020 Oct;72:1169-76.
12. Zhou YH et al. Pediatr Obes. 2020 Dec;15:e12723.
13. Kehar M et al. J Pediatr Gastroenterol Nutr. 2021 Jun;72:807-814.
14. Lu X et al. N Engl J Med. 2020 Apr;382:1663-5.
15. Cantor A et al. Hepatology. 2020 Nov;72:1522-7.
16. Kim D et al. Clin Gastroenterol Hepatol. 2021 Jul;19:1469-79.
17. Colmenero J et al. J Hepatol. 2021 Jan;74:148-155.
18. Lee BT et al. Gastroenterology. 2020 Sep;159:1176-8.e2.
19. Becchetti C et al. Gut. 2020 Oct;69:1832-40.
20. Belli LS et al. Lancet Gastroenterol Hepatol. 2020 Aug;5:724-5.
21. Bhoori S et al. Lancet Gastroenterol Hepatol. 2020 Jun;5:532-3.
22. Rabiee A et al; COLD Consortium. Hepatology. 2020 Dec;72:1900-11.
23. Belli LS et al. Gastroenterology. 2021 Mar;160:1151-63.e3.
24. Webb GJ et al. Lancet Gastroenterol Hepatol. 2020 Nov;5:1008-16.
25. Marjot T et al. J Hepatol. 2021 Mar;74:567-77.
A version of this article first appeared on Medscape.com.
Changing minds: What moves the needle for the unvaccinated?
Not so long ago, Heather Simpson of Dallas was known as the anti-vaccine mom who dressed as “the measles” for Halloween. She painted red spots on her face and posted her photo on Facebook, joking: “Was trying to think of the least scary thing I could be for Halloween … so I became the measles.” It went viral with the anti-vaccine crowd.
But between that Halloween and today, a series of “aha” moments transformed Ms. Simpson’s attitudes toward vaccines.
In January 2021, one of those moments involved her daughter, now 4, who was scratched by a feral cat, raising concerns about tetanus. Her daughter had been bitten by a dog when she was just 1, and Ms. Simpson turned down advice then to get a tetanus shot. “I was convinced the tetanus shot would kill her faster than the tetanus.”
After the cat incident, the anxiety was so exhausting, she listened to the nurse practitioner at the clinic, whom she trusted. The nurse gently reassured Ms. Simpson that the shot was less risky than the possibility of tetanus – but did not bombard her with statistics – and that won over Ms. Simpson and triggered an overall rethinking of her vaccine stance.
Fast-forward to February, and that “aha” turned into action when Ms. Simpson launched a “Back to the Vax” effort with a fellow former vaccine opponent. Through their website, Facebook page, and podcasts, they now encourage people to get the COVID-19 vaccine, as well as other immunizations.
Challenge: Reaching the rest
With just over 52% of those eligible in the United States fully vaccinated as of Sept. 1,
Recent data and a poll show some movement in the right direction, as immunizations are increasing and hesitancy is declining among certain groups. According to federal officials, about 14 million people in the United States got their first dose in August, an increase of 4 million, compared to the numbers who got it in July.
And a new poll from the Axios-IPSOS Coronavirus Index found only one in five Americans, or 20%, say they are not likely to get the vaccine, while “hard opposition,” those not at all likely, has dropped to 14% of those adults.
But there is still a lot of work to do. So, how do medical professionals or concerned citizens reach those who haven’t gotten vaccinated yet, whatever their reason?
Many experts in communication and persuasion that this news organization talked to agree that throwing statistics at people hesitant to get the COVID-19 vaccine is generally useless and often backfires.
So what does work, according to these experts?
- Emphasizing the trends of more people getting vaccinated.
- Focusing on everyone’s freedom of choice.
- Listening to concerns without judgment.
- Offering credible information.
- Correcting myths when necessary.
- Helping them fit vaccination into their “world view.”
Stories over statistics
Talking about the trends of vaccinations can definitely change minds about getting vaccinated, said Robert Cialdini, PhD, regents professor emeritus of psychology and marketing at Arizona State University, Tempe, and author of the recently updated book, “Influence: The Psychology of Persuasion,” which has sold over 5 million copies since it was first published in 1984.
Face-to-face with a hesitant patient, a doctor can say: “More and more people are being vaccinated every day,” Dr. Cialdini says. “The reason you say more and more is [that] it conveys a trend. When people see a trend, they project it into the future that it is going to get even larger.”
A focus on choice can also help people change their minds and accept the vaccine, he says. “A lot of conspiracy theorists claim they don’t want to do it because they are being pushed or forced by the government, and they are resisting that.”
If that’s the case, presenting people with new information, such as the increased infectiousness of the Delta variant, and suggesting that a decision be made based on the new information, can work, Dr. Cialdini says, but be sure to end with: “It’s completely up to you.”
“This removes all their sense of being pushed. It says, ‘Here is all the evidence.’ ” At this point, a doctor’s personal recommendation with a patient who trusts him or her may sway them, Dr. Cialdini said. “I think you have to personalize the communication in both directions. That is, to say, ‘For someone in your situation, I would personally recommend that you get the vaccine.’ ” A health care professional’s authority and expertise can carry the day, he says, although “not always.”
This approach worked, Dr. Cialdini says, with a friend of the family hesitant about the COVID-19 vaccine. “I told him: ‘We have gotten it. You trust us, right?’ ” He waited for the person to say yes.
Then: “For someone in your position, my personal recommendation is to get vaccinated. There is new information about the vaccine, and more and more people are getting vaccinated. And of course, it is completely up to you.”
The person decided to get the vaccine.
‘Live in that space’
“People develop negative attitudes [about vaccines] by accessing alternative sources of information, anecdotes, and personal stories,” said Matthew Seeger, PhD, dean of the College of Fine, Performing, and Communication Arts and codirector of the Center for Emerging Infectious Diseases at Wayne State University in Detroit.
“If we are going to change their opinion, we need to live in that space.” That means listening first, he says. Ask: “Where did you get that information? How credible do you think the sources are? What do you mean about the vaccine changing DNA?”
Then, you might respond, he said, by addressing that specific information, such as, “We have no cases of DNA being changed.”
Dr. Seeger recalls that his mother would simply talk louder when she couldn’t understand someone who wasn’t a native English speaker. “That’s what we are trying to do with the vaccine-hesitant,” he says. “In some cases, we are yelling at them.” Instead, he says, probe their sources of information.
For some who are vaccine-hesitant, Dr. Seeger said, it is not just about the vaccine. The attitude about vaccines is tied in, often, with a distrust of government and feelings about personal freedom. “That’s one reason it’s so hard to change the attitude.” For some, getting the vaccine in a family against the vaccine might also disrupt their social structure or even get them ostracized.
For these people, a health care provider might give opportunities to get the vaccine without affecting either what they see as their political stance or upsetting family harmony. “There are places you can go, make an appointment, get a vaccine, and nobody knows,” Dr. Seeger said.
One Missouri doctor told CNN that some people calling for a vaccine appointment do request privacy, such as going through a drive-thru or having the shot as they sit in their cars. She said the hospital tries to accommodate them, reasoning that every additional vaccine shot is a win.
Dr. Seeger agrees. “Of course there are still public records,” he says, “but you can still claim you are a vaccine denier. It’s very difficult to persuade people to give up their whole world. Vaccine denial is part of that world. At this point, we need to do whatever we can to get people vaccinated.”
From peer to peer
A theme that runs through many of these persuasion techniques is peer pressure.
One example, while a bit more profane and confrontational than some groups, is COVIDAteMyFace, a subgroup, or “subreddit,” of the popular online site Reddit, which hosts numerous forums inviting users to share news and comments on a variety of topics. The subreddit has over 20,000 members. Its purpose, says the sub’s creator, “was to document the folks who denied COVID, then got bitten in the ass by it.” Reports are of actual cases.
“It’s interesting and powerful that Reddit users are taking this on,” Dr. Seeger said. And this kind of peer pressure, or peer-to-peer information, can be persuasive, he says. “We often seek consensual validation from peers about risk messages and risk behaviors.”
For instance, hurricane evacuation notices are more effective, he said, when people learn their neighbors are leaving.
Peer information – “the number of others who are doing or believing or responding to something – definitely persuades people,” agreed Dr. Cialdini. “When a lot of others are responding in a particular way – for example, getting vaccinated – people follow for three reasons: The action seems more appropriate or correct, it appears more feasible to perform, and it avoids social disapproval from those others.”
Let them talk, give them time
Gladys Jimenez is a contact tracer and “vaccine ambassador” for Tracing Health, a partnership between the Oregon Public Health Institute and the Public Health Institute that has nearly 300 bilingual contract tracers who serve the ethnic communities they’re from. During a typical week, she talks to 50 people or more, and promoting the vaccine is top of mind.
The conversations, Ms. Jimenez said, are like a dance. She presents information, then steps back and lets them talk. “I want to hear the person talk, where they are coming from, where they are at.” Depending on what they say, she gives them more information or corrects their misinformation. “They often will say, ‘Oh, I didn’t know that.’ ”
It’s rarely one conversation that convinces hesitant people, she said. “I’m planting this seed in their brain. ... people want someone to listen to them ... they want to vent.”
Once you let them do that, Ms. Jimenez said, “I can tell the person is in a different state of mind.” She also knows that people “will make the decision in their own time.”
With time, people can change their minds, as a Southern California woman who resisted at first (and asked to remain anonymous) can attest. “When the vaccine first came out, I remember thinking [that] it was a quick fix to a very big problem,” she said. The lack of full FDA approval, which has since been granted, was also an issue. She doesn’t oppose vaccines, she said, but was leery just of the COVID-19 vaccine.
When her longtime partner got his vaccine, he urged her to go right away for hers. She stalled. He got his second dose and grew impatient with her hesitancy. It began to wear on the relationship. Finally, the woman talked to two health care professionals she knew socially. They both follow the science, and “they both could explain vaccination to me in a way that resonated. The information was coming from sources I already trusted.”
Those conversations are what convinced her to get vaccinated this summer.
Simpson’s transformation
Ms. Simpson of Back to the Vax got her first COVID-19 immunization April 16. She had an allergic reaction, including severe itchiness and a bad headache, and needed emergency care, she said. Even so, she scheduled her second shot appointment.
Like many who turned against vaccines as adults, Ms. Simpson had all her childhood vaccines, but she developed a distrust after watching a lengthy documentary series that warned of vaccine dangers as an adult.
Looking back at that documentary, she thought about how it seems to blame everything – childhood cancer, ADHD, autism, allergies – on vaccinations. That suddenly seemed like sketchy science to her.
So did the claim from a family friend who said she knew someone who got the flu shot and began walking backward. She researched on her own, and with time, she decided to be pro-vaccines.
These days, she continues to find that stories, not statistics, are changing the minds of many who decide to get vaccinated. If the nurse practitioner urging the tetanus shot for her daughter had told her that the tetanus shot is linked with problems in one of a specific number of people who get it, no matter how large that second number was, Ms. Simpson said she would have thought: “What if she is that one?”
So she relies on stories that point out how universally vulnerable people are to COVID-19 first, facts next.
“Facts help once you are already moved,” Ms. Simpson said.
A version of this article first appeared on WebMD.com.
Not so long ago, Heather Simpson of Dallas was known as the anti-vaccine mom who dressed as “the measles” for Halloween. She painted red spots on her face and posted her photo on Facebook, joking: “Was trying to think of the least scary thing I could be for Halloween … so I became the measles.” It went viral with the anti-vaccine crowd.
But between that Halloween and today, a series of “aha” moments transformed Ms. Simpson’s attitudes toward vaccines.
In January 2021, one of those moments involved her daughter, now 4, who was scratched by a feral cat, raising concerns about tetanus. Her daughter had been bitten by a dog when she was just 1, and Ms. Simpson turned down advice then to get a tetanus shot. “I was convinced the tetanus shot would kill her faster than the tetanus.”
After the cat incident, the anxiety was so exhausting, she listened to the nurse practitioner at the clinic, whom she trusted. The nurse gently reassured Ms. Simpson that the shot was less risky than the possibility of tetanus – but did not bombard her with statistics – and that won over Ms. Simpson and triggered an overall rethinking of her vaccine stance.
Fast-forward to February, and that “aha” turned into action when Ms. Simpson launched a “Back to the Vax” effort with a fellow former vaccine opponent. Through their website, Facebook page, and podcasts, they now encourage people to get the COVID-19 vaccine, as well as other immunizations.
Challenge: Reaching the rest
With just over 52% of those eligible in the United States fully vaccinated as of Sept. 1,
Recent data and a poll show some movement in the right direction, as immunizations are increasing and hesitancy is declining among certain groups. According to federal officials, about 14 million people in the United States got their first dose in August, an increase of 4 million, compared to the numbers who got it in July.
And a new poll from the Axios-IPSOS Coronavirus Index found only one in five Americans, or 20%, say they are not likely to get the vaccine, while “hard opposition,” those not at all likely, has dropped to 14% of those adults.
But there is still a lot of work to do. So, how do medical professionals or concerned citizens reach those who haven’t gotten vaccinated yet, whatever their reason?
Many experts in communication and persuasion that this news organization talked to agree that throwing statistics at people hesitant to get the COVID-19 vaccine is generally useless and often backfires.
So what does work, according to these experts?
- Emphasizing the trends of more people getting vaccinated.
- Focusing on everyone’s freedom of choice.
- Listening to concerns without judgment.
- Offering credible information.
- Correcting myths when necessary.
- Helping them fit vaccination into their “world view.”
Stories over statistics
Talking about the trends of vaccinations can definitely change minds about getting vaccinated, said Robert Cialdini, PhD, regents professor emeritus of psychology and marketing at Arizona State University, Tempe, and author of the recently updated book, “Influence: The Psychology of Persuasion,” which has sold over 5 million copies since it was first published in 1984.
Face-to-face with a hesitant patient, a doctor can say: “More and more people are being vaccinated every day,” Dr. Cialdini says. “The reason you say more and more is [that] it conveys a trend. When people see a trend, they project it into the future that it is going to get even larger.”
A focus on choice can also help people change their minds and accept the vaccine, he says. “A lot of conspiracy theorists claim they don’t want to do it because they are being pushed or forced by the government, and they are resisting that.”
If that’s the case, presenting people with new information, such as the increased infectiousness of the Delta variant, and suggesting that a decision be made based on the new information, can work, Dr. Cialdini says, but be sure to end with: “It’s completely up to you.”
“This removes all their sense of being pushed. It says, ‘Here is all the evidence.’ ” At this point, a doctor’s personal recommendation with a patient who trusts him or her may sway them, Dr. Cialdini said. “I think you have to personalize the communication in both directions. That is, to say, ‘For someone in your situation, I would personally recommend that you get the vaccine.’ ” A health care professional’s authority and expertise can carry the day, he says, although “not always.”
This approach worked, Dr. Cialdini says, with a friend of the family hesitant about the COVID-19 vaccine. “I told him: ‘We have gotten it. You trust us, right?’ ” He waited for the person to say yes.
Then: “For someone in your position, my personal recommendation is to get vaccinated. There is new information about the vaccine, and more and more people are getting vaccinated. And of course, it is completely up to you.”
The person decided to get the vaccine.
‘Live in that space’
“People develop negative attitudes [about vaccines] by accessing alternative sources of information, anecdotes, and personal stories,” said Matthew Seeger, PhD, dean of the College of Fine, Performing, and Communication Arts and codirector of the Center for Emerging Infectious Diseases at Wayne State University in Detroit.
“If we are going to change their opinion, we need to live in that space.” That means listening first, he says. Ask: “Where did you get that information? How credible do you think the sources are? What do you mean about the vaccine changing DNA?”
Then, you might respond, he said, by addressing that specific information, such as, “We have no cases of DNA being changed.”
Dr. Seeger recalls that his mother would simply talk louder when she couldn’t understand someone who wasn’t a native English speaker. “That’s what we are trying to do with the vaccine-hesitant,” he says. “In some cases, we are yelling at them.” Instead, he says, probe their sources of information.
For some who are vaccine-hesitant, Dr. Seeger said, it is not just about the vaccine. The attitude about vaccines is tied in, often, with a distrust of government and feelings about personal freedom. “That’s one reason it’s so hard to change the attitude.” For some, getting the vaccine in a family against the vaccine might also disrupt their social structure or even get them ostracized.
For these people, a health care provider might give opportunities to get the vaccine without affecting either what they see as their political stance or upsetting family harmony. “There are places you can go, make an appointment, get a vaccine, and nobody knows,” Dr. Seeger said.
One Missouri doctor told CNN that some people calling for a vaccine appointment do request privacy, such as going through a drive-thru or having the shot as they sit in their cars. She said the hospital tries to accommodate them, reasoning that every additional vaccine shot is a win.
Dr. Seeger agrees. “Of course there are still public records,” he says, “but you can still claim you are a vaccine denier. It’s very difficult to persuade people to give up their whole world. Vaccine denial is part of that world. At this point, we need to do whatever we can to get people vaccinated.”
From peer to peer
A theme that runs through many of these persuasion techniques is peer pressure.
One example, while a bit more profane and confrontational than some groups, is COVIDAteMyFace, a subgroup, or “subreddit,” of the popular online site Reddit, which hosts numerous forums inviting users to share news and comments on a variety of topics. The subreddit has over 20,000 members. Its purpose, says the sub’s creator, “was to document the folks who denied COVID, then got bitten in the ass by it.” Reports are of actual cases.
“It’s interesting and powerful that Reddit users are taking this on,” Dr. Seeger said. And this kind of peer pressure, or peer-to-peer information, can be persuasive, he says. “We often seek consensual validation from peers about risk messages and risk behaviors.”
For instance, hurricane evacuation notices are more effective, he said, when people learn their neighbors are leaving.
Peer information – “the number of others who are doing or believing or responding to something – definitely persuades people,” agreed Dr. Cialdini. “When a lot of others are responding in a particular way – for example, getting vaccinated – people follow for three reasons: The action seems more appropriate or correct, it appears more feasible to perform, and it avoids social disapproval from those others.”
Let them talk, give them time
Gladys Jimenez is a contact tracer and “vaccine ambassador” for Tracing Health, a partnership between the Oregon Public Health Institute and the Public Health Institute that has nearly 300 bilingual contract tracers who serve the ethnic communities they’re from. During a typical week, she talks to 50 people or more, and promoting the vaccine is top of mind.
The conversations, Ms. Jimenez said, are like a dance. She presents information, then steps back and lets them talk. “I want to hear the person talk, where they are coming from, where they are at.” Depending on what they say, she gives them more information or corrects their misinformation. “They often will say, ‘Oh, I didn’t know that.’ ”
It’s rarely one conversation that convinces hesitant people, she said. “I’m planting this seed in their brain. ... people want someone to listen to them ... they want to vent.”
Once you let them do that, Ms. Jimenez said, “I can tell the person is in a different state of mind.” She also knows that people “will make the decision in their own time.”
With time, people can change their minds, as a Southern California woman who resisted at first (and asked to remain anonymous) can attest. “When the vaccine first came out, I remember thinking [that] it was a quick fix to a very big problem,” she said. The lack of full FDA approval, which has since been granted, was also an issue. She doesn’t oppose vaccines, she said, but was leery just of the COVID-19 vaccine.
When her longtime partner got his vaccine, he urged her to go right away for hers. She stalled. He got his second dose and grew impatient with her hesitancy. It began to wear on the relationship. Finally, the woman talked to two health care professionals she knew socially. They both follow the science, and “they both could explain vaccination to me in a way that resonated. The information was coming from sources I already trusted.”
Those conversations are what convinced her to get vaccinated this summer.
Simpson’s transformation
Ms. Simpson of Back to the Vax got her first COVID-19 immunization April 16. She had an allergic reaction, including severe itchiness and a bad headache, and needed emergency care, she said. Even so, she scheduled her second shot appointment.
Like many who turned against vaccines as adults, Ms. Simpson had all her childhood vaccines, but she developed a distrust after watching a lengthy documentary series that warned of vaccine dangers as an adult.
Looking back at that documentary, she thought about how it seems to blame everything – childhood cancer, ADHD, autism, allergies – on vaccinations. That suddenly seemed like sketchy science to her.
So did the claim from a family friend who said she knew someone who got the flu shot and began walking backward. She researched on her own, and with time, she decided to be pro-vaccines.
These days, she continues to find that stories, not statistics, are changing the minds of many who decide to get vaccinated. If the nurse practitioner urging the tetanus shot for her daughter had told her that the tetanus shot is linked with problems in one of a specific number of people who get it, no matter how large that second number was, Ms. Simpson said she would have thought: “What if she is that one?”
So she relies on stories that point out how universally vulnerable people are to COVID-19 first, facts next.
“Facts help once you are already moved,” Ms. Simpson said.
A version of this article first appeared on WebMD.com.
Not so long ago, Heather Simpson of Dallas was known as the anti-vaccine mom who dressed as “the measles” for Halloween. She painted red spots on her face and posted her photo on Facebook, joking: “Was trying to think of the least scary thing I could be for Halloween … so I became the measles.” It went viral with the anti-vaccine crowd.
But between that Halloween and today, a series of “aha” moments transformed Ms. Simpson’s attitudes toward vaccines.
In January 2021, one of those moments involved her daughter, now 4, who was scratched by a feral cat, raising concerns about tetanus. Her daughter had been bitten by a dog when she was just 1, and Ms. Simpson turned down advice then to get a tetanus shot. “I was convinced the tetanus shot would kill her faster than the tetanus.”
After the cat incident, the anxiety was so exhausting, she listened to the nurse practitioner at the clinic, whom she trusted. The nurse gently reassured Ms. Simpson that the shot was less risky than the possibility of tetanus – but did not bombard her with statistics – and that won over Ms. Simpson and triggered an overall rethinking of her vaccine stance.
Fast-forward to February, and that “aha” turned into action when Ms. Simpson launched a “Back to the Vax” effort with a fellow former vaccine opponent. Through their website, Facebook page, and podcasts, they now encourage people to get the COVID-19 vaccine, as well as other immunizations.
Challenge: Reaching the rest
With just over 52% of those eligible in the United States fully vaccinated as of Sept. 1,
Recent data and a poll show some movement in the right direction, as immunizations are increasing and hesitancy is declining among certain groups. According to federal officials, about 14 million people in the United States got their first dose in August, an increase of 4 million, compared to the numbers who got it in July.
And a new poll from the Axios-IPSOS Coronavirus Index found only one in five Americans, or 20%, say they are not likely to get the vaccine, while “hard opposition,” those not at all likely, has dropped to 14% of those adults.
But there is still a lot of work to do. So, how do medical professionals or concerned citizens reach those who haven’t gotten vaccinated yet, whatever their reason?
Many experts in communication and persuasion that this news organization talked to agree that throwing statistics at people hesitant to get the COVID-19 vaccine is generally useless and often backfires.
So what does work, according to these experts?
- Emphasizing the trends of more people getting vaccinated.
- Focusing on everyone’s freedom of choice.
- Listening to concerns without judgment.
- Offering credible information.
- Correcting myths when necessary.
- Helping them fit vaccination into their “world view.”
Stories over statistics
Talking about the trends of vaccinations can definitely change minds about getting vaccinated, said Robert Cialdini, PhD, regents professor emeritus of psychology and marketing at Arizona State University, Tempe, and author of the recently updated book, “Influence: The Psychology of Persuasion,” which has sold over 5 million copies since it was first published in 1984.
Face-to-face with a hesitant patient, a doctor can say: “More and more people are being vaccinated every day,” Dr. Cialdini says. “The reason you say more and more is [that] it conveys a trend. When people see a trend, they project it into the future that it is going to get even larger.”
A focus on choice can also help people change their minds and accept the vaccine, he says. “A lot of conspiracy theorists claim they don’t want to do it because they are being pushed or forced by the government, and they are resisting that.”
If that’s the case, presenting people with new information, such as the increased infectiousness of the Delta variant, and suggesting that a decision be made based on the new information, can work, Dr. Cialdini says, but be sure to end with: “It’s completely up to you.”
“This removes all their sense of being pushed. It says, ‘Here is all the evidence.’ ” At this point, a doctor’s personal recommendation with a patient who trusts him or her may sway them, Dr. Cialdini said. “I think you have to personalize the communication in both directions. That is, to say, ‘For someone in your situation, I would personally recommend that you get the vaccine.’ ” A health care professional’s authority and expertise can carry the day, he says, although “not always.”
This approach worked, Dr. Cialdini says, with a friend of the family hesitant about the COVID-19 vaccine. “I told him: ‘We have gotten it. You trust us, right?’ ” He waited for the person to say yes.
Then: “For someone in your position, my personal recommendation is to get vaccinated. There is new information about the vaccine, and more and more people are getting vaccinated. And of course, it is completely up to you.”
The person decided to get the vaccine.
‘Live in that space’
“People develop negative attitudes [about vaccines] by accessing alternative sources of information, anecdotes, and personal stories,” said Matthew Seeger, PhD, dean of the College of Fine, Performing, and Communication Arts and codirector of the Center for Emerging Infectious Diseases at Wayne State University in Detroit.
“If we are going to change their opinion, we need to live in that space.” That means listening first, he says. Ask: “Where did you get that information? How credible do you think the sources are? What do you mean about the vaccine changing DNA?”
Then, you might respond, he said, by addressing that specific information, such as, “We have no cases of DNA being changed.”
Dr. Seeger recalls that his mother would simply talk louder when she couldn’t understand someone who wasn’t a native English speaker. “That’s what we are trying to do with the vaccine-hesitant,” he says. “In some cases, we are yelling at them.” Instead, he says, probe their sources of information.
For some who are vaccine-hesitant, Dr. Seeger said, it is not just about the vaccine. The attitude about vaccines is tied in, often, with a distrust of government and feelings about personal freedom. “That’s one reason it’s so hard to change the attitude.” For some, getting the vaccine in a family against the vaccine might also disrupt their social structure or even get them ostracized.
For these people, a health care provider might give opportunities to get the vaccine without affecting either what they see as their political stance or upsetting family harmony. “There are places you can go, make an appointment, get a vaccine, and nobody knows,” Dr. Seeger said.
One Missouri doctor told CNN that some people calling for a vaccine appointment do request privacy, such as going through a drive-thru or having the shot as they sit in their cars. She said the hospital tries to accommodate them, reasoning that every additional vaccine shot is a win.
Dr. Seeger agrees. “Of course there are still public records,” he says, “but you can still claim you are a vaccine denier. It’s very difficult to persuade people to give up their whole world. Vaccine denial is part of that world. At this point, we need to do whatever we can to get people vaccinated.”
From peer to peer
A theme that runs through many of these persuasion techniques is peer pressure.
One example, while a bit more profane and confrontational than some groups, is COVIDAteMyFace, a subgroup, or “subreddit,” of the popular online site Reddit, which hosts numerous forums inviting users to share news and comments on a variety of topics. The subreddit has over 20,000 members. Its purpose, says the sub’s creator, “was to document the folks who denied COVID, then got bitten in the ass by it.” Reports are of actual cases.
“It’s interesting and powerful that Reddit users are taking this on,” Dr. Seeger said. And this kind of peer pressure, or peer-to-peer information, can be persuasive, he says. “We often seek consensual validation from peers about risk messages and risk behaviors.”
For instance, hurricane evacuation notices are more effective, he said, when people learn their neighbors are leaving.
Peer information – “the number of others who are doing or believing or responding to something – definitely persuades people,” agreed Dr. Cialdini. “When a lot of others are responding in a particular way – for example, getting vaccinated – people follow for three reasons: The action seems more appropriate or correct, it appears more feasible to perform, and it avoids social disapproval from those others.”
Let them talk, give them time
Gladys Jimenez is a contact tracer and “vaccine ambassador” for Tracing Health, a partnership between the Oregon Public Health Institute and the Public Health Institute that has nearly 300 bilingual contract tracers who serve the ethnic communities they’re from. During a typical week, she talks to 50 people or more, and promoting the vaccine is top of mind.
The conversations, Ms. Jimenez said, are like a dance. She presents information, then steps back and lets them talk. “I want to hear the person talk, where they are coming from, where they are at.” Depending on what they say, she gives them more information or corrects their misinformation. “They often will say, ‘Oh, I didn’t know that.’ ”
It’s rarely one conversation that convinces hesitant people, she said. “I’m planting this seed in their brain. ... people want someone to listen to them ... they want to vent.”
Once you let them do that, Ms. Jimenez said, “I can tell the person is in a different state of mind.” She also knows that people “will make the decision in their own time.”
With time, people can change their minds, as a Southern California woman who resisted at first (and asked to remain anonymous) can attest. “When the vaccine first came out, I remember thinking [that] it was a quick fix to a very big problem,” she said. The lack of full FDA approval, which has since been granted, was also an issue. She doesn’t oppose vaccines, she said, but was leery just of the COVID-19 vaccine.
When her longtime partner got his vaccine, he urged her to go right away for hers. She stalled. He got his second dose and grew impatient with her hesitancy. It began to wear on the relationship. Finally, the woman talked to two health care professionals she knew socially. They both follow the science, and “they both could explain vaccination to me in a way that resonated. The information was coming from sources I already trusted.”
Those conversations are what convinced her to get vaccinated this summer.
Simpson’s transformation
Ms. Simpson of Back to the Vax got her first COVID-19 immunization April 16. She had an allergic reaction, including severe itchiness and a bad headache, and needed emergency care, she said. Even so, she scheduled her second shot appointment.
Like many who turned against vaccines as adults, Ms. Simpson had all her childhood vaccines, but she developed a distrust after watching a lengthy documentary series that warned of vaccine dangers as an adult.
Looking back at that documentary, she thought about how it seems to blame everything – childhood cancer, ADHD, autism, allergies – on vaccinations. That suddenly seemed like sketchy science to her.
So did the claim from a family friend who said she knew someone who got the flu shot and began walking backward. She researched on her own, and with time, she decided to be pro-vaccines.
These days, she continues to find that stories, not statistics, are changing the minds of many who decide to get vaccinated. If the nurse practitioner urging the tetanus shot for her daughter had told her that the tetanus shot is linked with problems in one of a specific number of people who get it, no matter how large that second number was, Ms. Simpson said she would have thought: “What if she is that one?”
So she relies on stories that point out how universally vulnerable people are to COVID-19 first, facts next.
“Facts help once you are already moved,” Ms. Simpson said.
A version of this article first appeared on WebMD.com.
Toward ‘superhuman cognition’: The future of brain-computer interfaces
The brain is inarguably the most complex and mysterious organ in the human body.
As the epicenter of intelligence, mastermind of movement, and song for our senses, the brain is more than a 3-lb organ encased in shell and fluid. Rather, it is the crown jewel that defines the self and, broadly, humanity.
For decades now, researchers have been exploring the potential for connecting our own astounding biological “computer” with actual physical mainframes. These so-called “brain-computer interfaces” (BCIs) are showing promise in treating an array of conditions, including paralysis, deafness, stroke, and even psychiatric disorders.
Among the big players in this area of research is billionaire entrepreneur Elon Musk, who in 2016 founded Neuralink. The company’s short-term mission is to develop a brain-to-machine interface to help people with neurologic conditions (for example, Parkinson’s disease). The long-term mission is to steer humanity into the era of “superhuman cognition.”
But first, some neuroscience 101.
Neurons are specialized cells that transmit and receive information. The basic structure of a neuron includes the dendrite, soma, and axon. The dendrite is the signal receiver. The soma is the cell body that is connected to the dendrites and serves as a structure to pass signals. The axon, also known as the nerve fiber, transmits the signal away from the soma.
Neurons communicate with each other at the synapse (for example, axon-dendrite connection). Neurons send information to each other through action potentials. An action potential may be defined as an electric impulse that transmits down the axon, causing the release of neurotransmitters, which may consequently either inhibit or excite the next neuron (leading to the initiation of another action potential).
So how will the company and other BCI companies tap into this evolutionarily ancient system to develop an implant that will obtain and decode information output from the brain?
The Neuralink implant is composed of three parts: The Link, neural threads, and the charger.
A robotic system, controlled by a neurosurgeon, will place an implant into the brain. The Link is the central component. It processes and transmits neural signals. The micron-scale neural threads are connected to the Link and other areas of the brain. The threads also contain electrodes, which are responsible for detecting neural signals. The charger ensures the battery is charged via wireless connection.
The invasive nature of this implant allows for precise readouts of electric outputs from the brain – unlike noninvasive devices, which are less sensitive and specific. Additionally, owing to its small size, engineers and neurosurgeons can implant the device in very specific brain regions as well as customize electrode distribution.
The Neuralink implant would be paired with an application via Bluetooth connection. The goal is to enable someone with the implant to control their device or computer by simply thinking. The application offers several exercises to help guide and train individuals on how to use the implant for its intended purpose. , as well as partake in creative activities such as photography.
Existing text and speech synthesis technology are already underway. For example, Synchron, a BCI platform company, is investigating the use of Stentrode for people with severe paralysis. This neuroprosthesis was designed to help people associate thought with movement through Bluetooth technology (for example, texting, emailing, shopping, online banking). Preliminary results from a study in which the device was used for patients with amyotrophic lateral sclerosis showed improvements in functional independence via direct thinking.
Software intended to enable high-performance handwriting utilizing BCI technology is being developed by Francis R. Willett, PhD, at Stanford (Calif.) University. The technology has also shown promise.
“We’ve learned that the brain retains its ability to prescribe fine movements a full decade after the body has lost its ability to execute those movements,” says Dr. Willett, who recently reported on results from a BCI study of handwriting conversion in an individual with full-body paralysis. Through a recurrent neural networking decoding approach, the BrainGate study participant was able to type 90 characters per minute – with an impressive 94.1% raw accuracy – using thoughts alone.
Although not a fully implantable brain device, this percutaneous implant has also been studied of its capacity to restore arm function among individuals who suffered from chronic stroke. Preliminary results from the Cortimo trials, led by Mijail D. Serruya, MD, an assistant professor at Thomas Jefferson University, Philadelphia, have been positive. Researchers implanted microelectrode arrays to decode brain signals and power motor function in a participant who had experienced a stroke 2 years earlier. The participant was able to use a powered arm brace on their paralyzed arm.
Neuralink recently released a video demonstrating the use of the interface in a monkey named Pager as it played a game with a joystick. Company researchers inserted a 1024-Electrode neural recording and data transmission device called the N1 Link into the left and right motor cortices. Using the implant, neural activity was sent to a decoder algorithm. Throughout the process, the decoder algorithm was refined and calibrated. After a few minutes, Pager was able to control the cursor on the screen using his mind instead of the joystick.
Mr. Musk hopes to develop Neuralink further to change not only the way we treat neurological disorders but also the way we interact with ourselves and our environment. It’s a lofty goal to be sure, but one that doesn’t seem outside the realm of possibility in the near future.
Known unknowns: The ethical dilemmas
One major conundrum facing the future of BCI technology is that researchers don’t fully understand the science regarding how brain signaling, artificial intelligence (AI) software, and prostheses interact. Although offloading computations improves the predictive nature of AI algorithms, there are concerns of identity and personal agency.
How do we know that an action is truly the result of one’s own thinking or, rather, the outcome of AI software? In this context, the autocorrect function while typing can be incredibly useful when we’re in a pinch for time, when we’re using one hand to type, or because of ease. However, it’s also easy to create and send out unintended or inappropriate messages.
These algorithms are designed to learn from our behavior and anticipate our next move. However, a question arises as to whether we are the authors of our own thoughts or whether we are simply the device that delivers messages under the control of external forces.
“People may question whether new personality changes they experience are truly representative of themselves or whether they are now a product of the implant (e.g., ‘Is that really me?’; ‘Have I grown as a person, or is it the technology?’). This then raises questions about agency and who we are as people,” says Kerry Bowman, PhD, a clinical bioethicist and assistant professor at the Temerty Faculty of Medicine of the University of Toronto.
It’s important to have safeguards in place to ensure the privacy of our thoughts. In an age where data is currency, it’s crucial to establish boundaries to preserve our autonomy and prevent exploitation (for example, by private companies or hackers). Although Neuralink and BCIs generally are certainly pushing the boundaries of neural engineering in profound ways, it’s important to note the biological and ethical implications of this technology.
As Dr. Bowman points out, “throughout the entire human story, under the worst of human circumstances, such as captivity and torture, the one safe ground and place for all people has been the privacy of one’s own mind. No one could ever interfere, take away, or be aware of those thoughts. However, this technology challenges one’s own privacy – that this technology (and, by extension, a company) could be aware of those thoughts.”
A version of this article first appeared on Medscape.com.
The brain is inarguably the most complex and mysterious organ in the human body.
As the epicenter of intelligence, mastermind of movement, and song for our senses, the brain is more than a 3-lb organ encased in shell and fluid. Rather, it is the crown jewel that defines the self and, broadly, humanity.
For decades now, researchers have been exploring the potential for connecting our own astounding biological “computer” with actual physical mainframes. These so-called “brain-computer interfaces” (BCIs) are showing promise in treating an array of conditions, including paralysis, deafness, stroke, and even psychiatric disorders.
Among the big players in this area of research is billionaire entrepreneur Elon Musk, who in 2016 founded Neuralink. The company’s short-term mission is to develop a brain-to-machine interface to help people with neurologic conditions (for example, Parkinson’s disease). The long-term mission is to steer humanity into the era of “superhuman cognition.”
But first, some neuroscience 101.
Neurons are specialized cells that transmit and receive information. The basic structure of a neuron includes the dendrite, soma, and axon. The dendrite is the signal receiver. The soma is the cell body that is connected to the dendrites and serves as a structure to pass signals. The axon, also known as the nerve fiber, transmits the signal away from the soma.
Neurons communicate with each other at the synapse (for example, axon-dendrite connection). Neurons send information to each other through action potentials. An action potential may be defined as an electric impulse that transmits down the axon, causing the release of neurotransmitters, which may consequently either inhibit or excite the next neuron (leading to the initiation of another action potential).
So how will the company and other BCI companies tap into this evolutionarily ancient system to develop an implant that will obtain and decode information output from the brain?
The Neuralink implant is composed of three parts: The Link, neural threads, and the charger.
A robotic system, controlled by a neurosurgeon, will place an implant into the brain. The Link is the central component. It processes and transmits neural signals. The micron-scale neural threads are connected to the Link and other areas of the brain. The threads also contain electrodes, which are responsible for detecting neural signals. The charger ensures the battery is charged via wireless connection.
The invasive nature of this implant allows for precise readouts of electric outputs from the brain – unlike noninvasive devices, which are less sensitive and specific. Additionally, owing to its small size, engineers and neurosurgeons can implant the device in very specific brain regions as well as customize electrode distribution.
The Neuralink implant would be paired with an application via Bluetooth connection. The goal is to enable someone with the implant to control their device or computer by simply thinking. The application offers several exercises to help guide and train individuals on how to use the implant for its intended purpose. , as well as partake in creative activities such as photography.
Existing text and speech synthesis technology are already underway. For example, Synchron, a BCI platform company, is investigating the use of Stentrode for people with severe paralysis. This neuroprosthesis was designed to help people associate thought with movement through Bluetooth technology (for example, texting, emailing, shopping, online banking). Preliminary results from a study in which the device was used for patients with amyotrophic lateral sclerosis showed improvements in functional independence via direct thinking.
Software intended to enable high-performance handwriting utilizing BCI technology is being developed by Francis R. Willett, PhD, at Stanford (Calif.) University. The technology has also shown promise.
“We’ve learned that the brain retains its ability to prescribe fine movements a full decade after the body has lost its ability to execute those movements,” says Dr. Willett, who recently reported on results from a BCI study of handwriting conversion in an individual with full-body paralysis. Through a recurrent neural networking decoding approach, the BrainGate study participant was able to type 90 characters per minute – with an impressive 94.1% raw accuracy – using thoughts alone.
Although not a fully implantable brain device, this percutaneous implant has also been studied of its capacity to restore arm function among individuals who suffered from chronic stroke. Preliminary results from the Cortimo trials, led by Mijail D. Serruya, MD, an assistant professor at Thomas Jefferson University, Philadelphia, have been positive. Researchers implanted microelectrode arrays to decode brain signals and power motor function in a participant who had experienced a stroke 2 years earlier. The participant was able to use a powered arm brace on their paralyzed arm.
Neuralink recently released a video demonstrating the use of the interface in a monkey named Pager as it played a game with a joystick. Company researchers inserted a 1024-Electrode neural recording and data transmission device called the N1 Link into the left and right motor cortices. Using the implant, neural activity was sent to a decoder algorithm. Throughout the process, the decoder algorithm was refined and calibrated. After a few minutes, Pager was able to control the cursor on the screen using his mind instead of the joystick.
Mr. Musk hopes to develop Neuralink further to change not only the way we treat neurological disorders but also the way we interact with ourselves and our environment. It’s a lofty goal to be sure, but one that doesn’t seem outside the realm of possibility in the near future.
Known unknowns: The ethical dilemmas
One major conundrum facing the future of BCI technology is that researchers don’t fully understand the science regarding how brain signaling, artificial intelligence (AI) software, and prostheses interact. Although offloading computations improves the predictive nature of AI algorithms, there are concerns of identity and personal agency.
How do we know that an action is truly the result of one’s own thinking or, rather, the outcome of AI software? In this context, the autocorrect function while typing can be incredibly useful when we’re in a pinch for time, when we’re using one hand to type, or because of ease. However, it’s also easy to create and send out unintended or inappropriate messages.
These algorithms are designed to learn from our behavior and anticipate our next move. However, a question arises as to whether we are the authors of our own thoughts or whether we are simply the device that delivers messages under the control of external forces.
“People may question whether new personality changes they experience are truly representative of themselves or whether they are now a product of the implant (e.g., ‘Is that really me?’; ‘Have I grown as a person, or is it the technology?’). This then raises questions about agency and who we are as people,” says Kerry Bowman, PhD, a clinical bioethicist and assistant professor at the Temerty Faculty of Medicine of the University of Toronto.
It’s important to have safeguards in place to ensure the privacy of our thoughts. In an age where data is currency, it’s crucial to establish boundaries to preserve our autonomy and prevent exploitation (for example, by private companies or hackers). Although Neuralink and BCIs generally are certainly pushing the boundaries of neural engineering in profound ways, it’s important to note the biological and ethical implications of this technology.
As Dr. Bowman points out, “throughout the entire human story, under the worst of human circumstances, such as captivity and torture, the one safe ground and place for all people has been the privacy of one’s own mind. No one could ever interfere, take away, or be aware of those thoughts. However, this technology challenges one’s own privacy – that this technology (and, by extension, a company) could be aware of those thoughts.”
A version of this article first appeared on Medscape.com.
The brain is inarguably the most complex and mysterious organ in the human body.
As the epicenter of intelligence, mastermind of movement, and song for our senses, the brain is more than a 3-lb organ encased in shell and fluid. Rather, it is the crown jewel that defines the self and, broadly, humanity.
For decades now, researchers have been exploring the potential for connecting our own astounding biological “computer” with actual physical mainframes. These so-called “brain-computer interfaces” (BCIs) are showing promise in treating an array of conditions, including paralysis, deafness, stroke, and even psychiatric disorders.
Among the big players in this area of research is billionaire entrepreneur Elon Musk, who in 2016 founded Neuralink. The company’s short-term mission is to develop a brain-to-machine interface to help people with neurologic conditions (for example, Parkinson’s disease). The long-term mission is to steer humanity into the era of “superhuman cognition.”
But first, some neuroscience 101.
Neurons are specialized cells that transmit and receive information. The basic structure of a neuron includes the dendrite, soma, and axon. The dendrite is the signal receiver. The soma is the cell body that is connected to the dendrites and serves as a structure to pass signals. The axon, also known as the nerve fiber, transmits the signal away from the soma.
Neurons communicate with each other at the synapse (for example, axon-dendrite connection). Neurons send information to each other through action potentials. An action potential may be defined as an electric impulse that transmits down the axon, causing the release of neurotransmitters, which may consequently either inhibit or excite the next neuron (leading to the initiation of another action potential).
So how will the company and other BCI companies tap into this evolutionarily ancient system to develop an implant that will obtain and decode information output from the brain?
The Neuralink implant is composed of three parts: The Link, neural threads, and the charger.
A robotic system, controlled by a neurosurgeon, will place an implant into the brain. The Link is the central component. It processes and transmits neural signals. The micron-scale neural threads are connected to the Link and other areas of the brain. The threads also contain electrodes, which are responsible for detecting neural signals. The charger ensures the battery is charged via wireless connection.
The invasive nature of this implant allows for precise readouts of electric outputs from the brain – unlike noninvasive devices, which are less sensitive and specific. Additionally, owing to its small size, engineers and neurosurgeons can implant the device in very specific brain regions as well as customize electrode distribution.
The Neuralink implant would be paired with an application via Bluetooth connection. The goal is to enable someone with the implant to control their device or computer by simply thinking. The application offers several exercises to help guide and train individuals on how to use the implant for its intended purpose. , as well as partake in creative activities such as photography.
Existing text and speech synthesis technology are already underway. For example, Synchron, a BCI platform company, is investigating the use of Stentrode for people with severe paralysis. This neuroprosthesis was designed to help people associate thought with movement through Bluetooth technology (for example, texting, emailing, shopping, online banking). Preliminary results from a study in which the device was used for patients with amyotrophic lateral sclerosis showed improvements in functional independence via direct thinking.
Software intended to enable high-performance handwriting utilizing BCI technology is being developed by Francis R. Willett, PhD, at Stanford (Calif.) University. The technology has also shown promise.
“We’ve learned that the brain retains its ability to prescribe fine movements a full decade after the body has lost its ability to execute those movements,” says Dr. Willett, who recently reported on results from a BCI study of handwriting conversion in an individual with full-body paralysis. Through a recurrent neural networking decoding approach, the BrainGate study participant was able to type 90 characters per minute – with an impressive 94.1% raw accuracy – using thoughts alone.
Although not a fully implantable brain device, this percutaneous implant has also been studied of its capacity to restore arm function among individuals who suffered from chronic stroke. Preliminary results from the Cortimo trials, led by Mijail D. Serruya, MD, an assistant professor at Thomas Jefferson University, Philadelphia, have been positive. Researchers implanted microelectrode arrays to decode brain signals and power motor function in a participant who had experienced a stroke 2 years earlier. The participant was able to use a powered arm brace on their paralyzed arm.
Neuralink recently released a video demonstrating the use of the interface in a monkey named Pager as it played a game with a joystick. Company researchers inserted a 1024-Electrode neural recording and data transmission device called the N1 Link into the left and right motor cortices. Using the implant, neural activity was sent to a decoder algorithm. Throughout the process, the decoder algorithm was refined and calibrated. After a few minutes, Pager was able to control the cursor on the screen using his mind instead of the joystick.
Mr. Musk hopes to develop Neuralink further to change not only the way we treat neurological disorders but also the way we interact with ourselves and our environment. It’s a lofty goal to be sure, but one that doesn’t seem outside the realm of possibility in the near future.
Known unknowns: The ethical dilemmas
One major conundrum facing the future of BCI technology is that researchers don’t fully understand the science regarding how brain signaling, artificial intelligence (AI) software, and prostheses interact. Although offloading computations improves the predictive nature of AI algorithms, there are concerns of identity and personal agency.
How do we know that an action is truly the result of one’s own thinking or, rather, the outcome of AI software? In this context, the autocorrect function while typing can be incredibly useful when we’re in a pinch for time, when we’re using one hand to type, or because of ease. However, it’s also easy to create and send out unintended or inappropriate messages.
These algorithms are designed to learn from our behavior and anticipate our next move. However, a question arises as to whether we are the authors of our own thoughts or whether we are simply the device that delivers messages under the control of external forces.
“People may question whether new personality changes they experience are truly representative of themselves or whether they are now a product of the implant (e.g., ‘Is that really me?’; ‘Have I grown as a person, or is it the technology?’). This then raises questions about agency and who we are as people,” says Kerry Bowman, PhD, a clinical bioethicist and assistant professor at the Temerty Faculty of Medicine of the University of Toronto.
It’s important to have safeguards in place to ensure the privacy of our thoughts. In an age where data is currency, it’s crucial to establish boundaries to preserve our autonomy and prevent exploitation (for example, by private companies or hackers). Although Neuralink and BCIs generally are certainly pushing the boundaries of neural engineering in profound ways, it’s important to note the biological and ethical implications of this technology.
As Dr. Bowman points out, “throughout the entire human story, under the worst of human circumstances, such as captivity and torture, the one safe ground and place for all people has been the privacy of one’s own mind. No one could ever interfere, take away, or be aware of those thoughts. However, this technology challenges one’s own privacy – that this technology (and, by extension, a company) could be aware of those thoughts.”
A version of this article first appeared on Medscape.com.
United Healthcare settles claims it violated mental health parity
The nation’s largest health care insurer has agreed to pay $16 million in restitution and penalties to consumers, the federal government, and the state of New York to settle complaints that it illegally limited outpatient psychotherapy.
The settlement resolves a joint U.S. Department of Labor and New York Attorney General investigation and lawsuit that found that United Healthcare and United Behavioral Health (UBH) had, since at least 2013, violated the federal Mental Health Parity and Addiction Equity Act of 2008.
United Healthcare and UBH are fighting similar claims in Wit v United Behavioral Health, which is currently on appeal at the U.S. Court of Appeals for the Ninth Circuit. If that complaint is decided against UBH, the insurer might have to reprocess more than 67,000 claims.
The joint New York–federal investigation determined that United Healthcare reduced reimbursement rates for out-of-network mental health services and denied payment for many services using its Algorithms for Effective Reporting and Treatment (ALERT) utilization review program.
All outpatient psychotherapy was subjected to review; by comparison, only a handful of medical and surgical services were. That violated parity laws, the New York Attorney General’s office said in a statement.
“United’s denial of these vital services was both unlawful and dangerous,” New York Attorney General Letitia James said in the statement.
“Protecting access to mental health and substance disorder treatment is a priority for the Department of Labor and something I believe in strongly as a person in long-term recovery,” U.S. Secretary of Labor Marty Walsh said in another statement.
Mr. Walsh added that the settlement “provides compensation for many people who were denied full benefits and equitable treatment.”
‘Investigations change behavior’
Commenting for this news organization, Joe Parks, MD, medical director of the National Council for Mental Wellbeing, applauded the settlement.
“These kinds of investigations change behavior, and people get better coverage,” Dr. Parks said.
He also applauded New York, saying that it “has been one of the more assertive states in expecting companies to comply with parity requirements. They should be emulated by other states.”
Dr. Parks noted that a 2019 U.S. Government Accountability Office report showed that only 20 states routinely conducted parity compliance reviews.
A spokesperson for the American Psychiatric Association said it was notable that the Department of Labor focused on three issues that it had not publicly investigated before.
These were payment parity, the use of algorithms in mental health to identify practitioners and patients who use more health care than expected of the “average” person, and requiring disclosure of how the insurer set rates, guidelines, and medical necessity standards.
The American Psychological Association’s chief of psychological practice, Jared L. Skillings, PhD, said the group was gratified that the Department of Labor and New York took complaints seriously and that it “is encouraged that United Behavioral Health and United Healthcare have agreed to change their unfair procedures regarding reimbursement and denial of psychological care.”
The association “will monitor implementation of the settlement with high hopes for fair treatment for patients with mental health needs,” Dr. Skillings said in an interview.
Across-the-board cuts for therapy
The investigation found that United Healthcare reduced the allowable reimbursement amount for all nonphysicians across the board for psychotherapy – by 25% for PhD-level psychologists and by 35% for all MA-level therapists.
The company’s ALERT system used arbitrary thresholds to trigger utilization review, which “often led to denials of coverage when providers could not justify continued treatment after 20 sessions,” said the New York attorney general.
Beneficiaries had to figure out how to pay for continuing services or abruptly end necessary treatment.
United Healthcare agreed to stop reducing reimbursement and to not employ a similar policy in New York for at least 2 years. It will stop using ALERT and stop issuing denials for psychotherapy through at least 2023.
In addition, “We are committed to ensuring all our members have access to care and to reimbursing providers consistent with the terms of the member’s health plan and state and federal rules,” United Healthcare said.
Dr. Parks noted that United Healthcare had stopped using ALERT long before the settlement and was instead employing Level of Care Utilization System for Psychiatric and Addiction Services (LOCUS) and American Society of Addiction Medicine criteria, which he called “a good step forward.”
‘Meaningful’ payout
United Healthcare will pay $14.3 million in restitution to consumers, including $9 million to 20,000 New Yorkers who received denials of or reductions in reimbursement. The company will also pay more than $2 million in penalties, with $1.3 million going to New York.
The insurer has annual revenues of some $250 billion.
“It’s not a large amount of money in United’s overall business operation,” said Dr. Parks.
However, “It certainly could be a meaningful amount of money for the individuals that didn’t get coverage that paid out of pocket,” he added.
A version of this article first appeared on Medscape.com.
The nation’s largest health care insurer has agreed to pay $16 million in restitution and penalties to consumers, the federal government, and the state of New York to settle complaints that it illegally limited outpatient psychotherapy.
The settlement resolves a joint U.S. Department of Labor and New York Attorney General investigation and lawsuit that found that United Healthcare and United Behavioral Health (UBH) had, since at least 2013, violated the federal Mental Health Parity and Addiction Equity Act of 2008.
United Healthcare and UBH are fighting similar claims in Wit v United Behavioral Health, which is currently on appeal at the U.S. Court of Appeals for the Ninth Circuit. If that complaint is decided against UBH, the insurer might have to reprocess more than 67,000 claims.
The joint New York–federal investigation determined that United Healthcare reduced reimbursement rates for out-of-network mental health services and denied payment for many services using its Algorithms for Effective Reporting and Treatment (ALERT) utilization review program.
All outpatient psychotherapy was subjected to review; by comparison, only a handful of medical and surgical services were. That violated parity laws, the New York Attorney General’s office said in a statement.
“United’s denial of these vital services was both unlawful and dangerous,” New York Attorney General Letitia James said in the statement.
“Protecting access to mental health and substance disorder treatment is a priority for the Department of Labor and something I believe in strongly as a person in long-term recovery,” U.S. Secretary of Labor Marty Walsh said in another statement.
Mr. Walsh added that the settlement “provides compensation for many people who were denied full benefits and equitable treatment.”
‘Investigations change behavior’
Commenting for this news organization, Joe Parks, MD, medical director of the National Council for Mental Wellbeing, applauded the settlement.
“These kinds of investigations change behavior, and people get better coverage,” Dr. Parks said.
He also applauded New York, saying that it “has been one of the more assertive states in expecting companies to comply with parity requirements. They should be emulated by other states.”
Dr. Parks noted that a 2019 U.S. Government Accountability Office report showed that only 20 states routinely conducted parity compliance reviews.
A spokesperson for the American Psychiatric Association said it was notable that the Department of Labor focused on three issues that it had not publicly investigated before.
These were payment parity, the use of algorithms in mental health to identify practitioners and patients who use more health care than expected of the “average” person, and requiring disclosure of how the insurer set rates, guidelines, and medical necessity standards.
The American Psychological Association’s chief of psychological practice, Jared L. Skillings, PhD, said the group was gratified that the Department of Labor and New York took complaints seriously and that it “is encouraged that United Behavioral Health and United Healthcare have agreed to change their unfair procedures regarding reimbursement and denial of psychological care.”
The association “will monitor implementation of the settlement with high hopes for fair treatment for patients with mental health needs,” Dr. Skillings said in an interview.
Across-the-board cuts for therapy
The investigation found that United Healthcare reduced the allowable reimbursement amount for all nonphysicians across the board for psychotherapy – by 25% for PhD-level psychologists and by 35% for all MA-level therapists.
The company’s ALERT system used arbitrary thresholds to trigger utilization review, which “often led to denials of coverage when providers could not justify continued treatment after 20 sessions,” said the New York attorney general.
Beneficiaries had to figure out how to pay for continuing services or abruptly end necessary treatment.
United Healthcare agreed to stop reducing reimbursement and to not employ a similar policy in New York for at least 2 years. It will stop using ALERT and stop issuing denials for psychotherapy through at least 2023.
In addition, “We are committed to ensuring all our members have access to care and to reimbursing providers consistent with the terms of the member’s health plan and state and federal rules,” United Healthcare said.
Dr. Parks noted that United Healthcare had stopped using ALERT long before the settlement and was instead employing Level of Care Utilization System for Psychiatric and Addiction Services (LOCUS) and American Society of Addiction Medicine criteria, which he called “a good step forward.”
‘Meaningful’ payout
United Healthcare will pay $14.3 million in restitution to consumers, including $9 million to 20,000 New Yorkers who received denials of or reductions in reimbursement. The company will also pay more than $2 million in penalties, with $1.3 million going to New York.
The insurer has annual revenues of some $250 billion.
“It’s not a large amount of money in United’s overall business operation,” said Dr. Parks.
However, “It certainly could be a meaningful amount of money for the individuals that didn’t get coverage that paid out of pocket,” he added.
A version of this article first appeared on Medscape.com.
The nation’s largest health care insurer has agreed to pay $16 million in restitution and penalties to consumers, the federal government, and the state of New York to settle complaints that it illegally limited outpatient psychotherapy.
The settlement resolves a joint U.S. Department of Labor and New York Attorney General investigation and lawsuit that found that United Healthcare and United Behavioral Health (UBH) had, since at least 2013, violated the federal Mental Health Parity and Addiction Equity Act of 2008.
United Healthcare and UBH are fighting similar claims in Wit v United Behavioral Health, which is currently on appeal at the U.S. Court of Appeals for the Ninth Circuit. If that complaint is decided against UBH, the insurer might have to reprocess more than 67,000 claims.
The joint New York–federal investigation determined that United Healthcare reduced reimbursement rates for out-of-network mental health services and denied payment for many services using its Algorithms for Effective Reporting and Treatment (ALERT) utilization review program.
All outpatient psychotherapy was subjected to review; by comparison, only a handful of medical and surgical services were. That violated parity laws, the New York Attorney General’s office said in a statement.
“United’s denial of these vital services was both unlawful and dangerous,” New York Attorney General Letitia James said in the statement.
“Protecting access to mental health and substance disorder treatment is a priority for the Department of Labor and something I believe in strongly as a person in long-term recovery,” U.S. Secretary of Labor Marty Walsh said in another statement.
Mr. Walsh added that the settlement “provides compensation for many people who were denied full benefits and equitable treatment.”
‘Investigations change behavior’
Commenting for this news organization, Joe Parks, MD, medical director of the National Council for Mental Wellbeing, applauded the settlement.
“These kinds of investigations change behavior, and people get better coverage,” Dr. Parks said.
He also applauded New York, saying that it “has been one of the more assertive states in expecting companies to comply with parity requirements. They should be emulated by other states.”
Dr. Parks noted that a 2019 U.S. Government Accountability Office report showed that only 20 states routinely conducted parity compliance reviews.
A spokesperson for the American Psychiatric Association said it was notable that the Department of Labor focused on three issues that it had not publicly investigated before.
These were payment parity, the use of algorithms in mental health to identify practitioners and patients who use more health care than expected of the “average” person, and requiring disclosure of how the insurer set rates, guidelines, and medical necessity standards.
The American Psychological Association’s chief of psychological practice, Jared L. Skillings, PhD, said the group was gratified that the Department of Labor and New York took complaints seriously and that it “is encouraged that United Behavioral Health and United Healthcare have agreed to change their unfair procedures regarding reimbursement and denial of psychological care.”
The association “will monitor implementation of the settlement with high hopes for fair treatment for patients with mental health needs,” Dr. Skillings said in an interview.
Across-the-board cuts for therapy
The investigation found that United Healthcare reduced the allowable reimbursement amount for all nonphysicians across the board for psychotherapy – by 25% for PhD-level psychologists and by 35% for all MA-level therapists.
The company’s ALERT system used arbitrary thresholds to trigger utilization review, which “often led to denials of coverage when providers could not justify continued treatment after 20 sessions,” said the New York attorney general.
Beneficiaries had to figure out how to pay for continuing services or abruptly end necessary treatment.
United Healthcare agreed to stop reducing reimbursement and to not employ a similar policy in New York for at least 2 years. It will stop using ALERT and stop issuing denials for psychotherapy through at least 2023.
In addition, “We are committed to ensuring all our members have access to care and to reimbursing providers consistent with the terms of the member’s health plan and state and federal rules,” United Healthcare said.
Dr. Parks noted that United Healthcare had stopped using ALERT long before the settlement and was instead employing Level of Care Utilization System for Psychiatric and Addiction Services (LOCUS) and American Society of Addiction Medicine criteria, which he called “a good step forward.”
‘Meaningful’ payout
United Healthcare will pay $14.3 million in restitution to consumers, including $9 million to 20,000 New Yorkers who received denials of or reductions in reimbursement. The company will also pay more than $2 million in penalties, with $1.3 million going to New York.
The insurer has annual revenues of some $250 billion.
“It’s not a large amount of money in United’s overall business operation,” said Dr. Parks.
However, “It certainly could be a meaningful amount of money for the individuals that didn’t get coverage that paid out of pocket,” he added.
A version of this article first appeared on Medscape.com.
Politics or protection? What’s behind the push for boosters?
That plan, which was first announced on Aug. 18, has raised eyebrows because it comes in advance of regulatory reviews by the Food and Drug Administration and recommendations from the Centers for Disease Control and Prevention. Those reviews are needed to determine whether third doses of these vaccines are effective or even safe. The move could have important legal ramifications for doctors and patients, too.
On Aug. 31, two high-level officials in the FDA’s Office of Vaccines Research and Review abruptly resigned amid reports that they were angry that the Biden administration was making decisions that should be left up to that agency.
So far, data show that the vaccines are highly effective at preventing the most severe consequences of COVID-19 – hospitalization and death – even regarding the Delta variant. The World Health Organization has urged wealthy nations such as the United States not to offer boosters so that the limited supply of vaccines can be directed to countries with fewer resources.
White House supports boosters
In a recent press briefing, Jeff Zients, the White House COVID-19 response coordinator, defended the move.
“You know, the booster decision, which you referenced ... was made by and announced by the nation’s leading public health officials, including Dr. Walensky; Dr. Fauci; Surgeon General Vivek Murthy; Dr. Janet Woodcock; the FDA acting commissioner, Dr. Francis Collins; Dr. Kessler; and others,” Mr. Zients said.
“And as our medical experts laid out, having reviewed all of the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot.”
He said a target date of Sept. 20 was announced so as to give states and practitioners time to prepare. He also said the move to give boosters was meant to help the United States stay ahead of a rapidly changing virus. Mr. Zients added that whether boosters will be administered starting on Sept. 20 depends on the FDA’s and CDC’s giving the go-ahead.
“Booster doses are going to be handled the same way all vaccines are handled,” said Kristen Nordlund, a CDC spokesperson. “Companies will have to provide data to FDA. FDA will have to make a decision and authorize the use of those, and ACIP [the Advisory Committee on Immunization Practices] will have to look at the evidence as well and make recommendations on top of FDA’s regulatory action,” she said.
Ms. Nordlund agreed that the planned Sept. 20 start date for boosters was something to which they aspired and was not necessarily set.
Historically, the FDA has needed at least 4 months to review a change to a vaccine’s approval, even on an accelerated schedule. Reviewers use that time to assess data regarding individual patients in a study, to review raw data, and essentially to check a drug company’s math and conclusions. The Biden administration’s timeline would shorten that review period from months to just a few weeks.
‘FDA in a very difficult position’
After the FDA approves, the ACIP of the CDC must meet to review the evidence and make recommendations on the use of the boosters in the United States.
Pfizer says it completed its submission for a supplemental biologics license application to the FDA on Aug. 27. To meet a Sept. 20 timeline, the entire process would have to be completed within 3 weeks.
“I don’t think that was handled, you know, ideally,” said Peter Lurie, MD, president of the Center for Science in the Public Interest and former associate commissioner of public health strategy and analysis at the FDA.
“It puts FDA in a very difficult position,” Dr. Lurie said. “It’s almost as if the decision has been made and they’re just checking a box, and that is, you know, contrary to the what FDA – at least the internal people at FDA – have been trying to do for ages.”
He said the agency took great pains with the emergency use authorizations and the full approvals of the vaccines to work as rapidly but thoroughly as possible. They did not skip steps.
“I think all of that reflected very well on the agency,” Dr. Lurie said. “And I think it worked out well in terms of trust in the vaccines.”
Although additional doses of vaccine are expected to be safe, little is known about side effects or adverse events after a third dose.
“It’s critical to wait for additional data and regulatory allowance for booster doses,” Sara Oliver, MD, a member of the CDC’s epidemic intelligence service, said in an Aug. 30 presentation to the ACIP, which is charged with making recommendations for use of all vaccines in the United States.
Boosters already being given
But after the White House announced that boosters were on the way, many people are not waiting.
Many health care practitioners and pharmacies have already been giving people third doses of vaccines, even if they are not among the immunocompromised – the group for which the shots are currently approved.
“You can walk into a pharmacy and ask for a third dose. Depending on which pharmacy you go to, you may get it,” said Helen Talbot, MD, associate professor of medicine at Vanderbilt University, Nashville, Tenn., and a member of the ACIP.
She says she has a friend who recently went for a checkup and was offered a third dose. His physician is already giving extra doses to everyone who is older than 65.
Dr. Talbot said that in fairness, pharmacies in the United States are throwing away doses of vaccine because they are expiring before they get used.
“Many of us may or may not be ready to give a third dose but would rather give someone a third dose than throw a vaccine away,” she said.
Consequences of a third shot
But giving or getting a third dose before approval by the FDA may have legal consequences.
In the ACIP meeting on Aug. 30, Demetre Daskalakis, MD, who leads vaccine equity efforts at the CDC, cautioned that physicians who give extra doses of the vaccine before the FDA and CDC have signed off may be in violation of practitioner agreements with the federal government and might not be covered by the federal PREP Act. The PREP Act provides immunity from lawsuits for people who administer COVID-19 vaccines and compensates patients in the event of injury. Patients who get a vaccine and suffer a rare but serious side effect may lose the ability to claim compensation offered by the act.
“Many of us gasped when he said that,” Dr. Talbot said, “because that’s a big deal.”
The ACIP signaled that it is considering recommending boosters for a much narrower slice of the American population than the Biden administration has suggested.
They said that so far, the data point only to the need for boosters for seniors, who are the patients most likely to experience breakthrough infections that require hospitalization, and health care workers, who are needed now more than ever and cannot work if they’re sick.
In a White House news briefing Aug. 31, CDC Director Rochelle Walensky, MD, was asked about the ACIP’s conclusions and whether she believed there were enough data to recommend booster shots for most Americans 8 months after their last dose.
“The ACIP did not review international data that actually has led us to be even more concerned about increased risk of vaccine effectiveness waning against hospitalization, severe disease, and death. They will be reviewing that as well,” she said.
A version of this article first appeared on Medscape.com.
That plan, which was first announced on Aug. 18, has raised eyebrows because it comes in advance of regulatory reviews by the Food and Drug Administration and recommendations from the Centers for Disease Control and Prevention. Those reviews are needed to determine whether third doses of these vaccines are effective or even safe. The move could have important legal ramifications for doctors and patients, too.
On Aug. 31, two high-level officials in the FDA’s Office of Vaccines Research and Review abruptly resigned amid reports that they were angry that the Biden administration was making decisions that should be left up to that agency.
So far, data show that the vaccines are highly effective at preventing the most severe consequences of COVID-19 – hospitalization and death – even regarding the Delta variant. The World Health Organization has urged wealthy nations such as the United States not to offer boosters so that the limited supply of vaccines can be directed to countries with fewer resources.
White House supports boosters
In a recent press briefing, Jeff Zients, the White House COVID-19 response coordinator, defended the move.
“You know, the booster decision, which you referenced ... was made by and announced by the nation’s leading public health officials, including Dr. Walensky; Dr. Fauci; Surgeon General Vivek Murthy; Dr. Janet Woodcock; the FDA acting commissioner, Dr. Francis Collins; Dr. Kessler; and others,” Mr. Zients said.
“And as our medical experts laid out, having reviewed all of the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot.”
He said a target date of Sept. 20 was announced so as to give states and practitioners time to prepare. He also said the move to give boosters was meant to help the United States stay ahead of a rapidly changing virus. Mr. Zients added that whether boosters will be administered starting on Sept. 20 depends on the FDA’s and CDC’s giving the go-ahead.
“Booster doses are going to be handled the same way all vaccines are handled,” said Kristen Nordlund, a CDC spokesperson. “Companies will have to provide data to FDA. FDA will have to make a decision and authorize the use of those, and ACIP [the Advisory Committee on Immunization Practices] will have to look at the evidence as well and make recommendations on top of FDA’s regulatory action,” she said.
Ms. Nordlund agreed that the planned Sept. 20 start date for boosters was something to which they aspired and was not necessarily set.
Historically, the FDA has needed at least 4 months to review a change to a vaccine’s approval, even on an accelerated schedule. Reviewers use that time to assess data regarding individual patients in a study, to review raw data, and essentially to check a drug company’s math and conclusions. The Biden administration’s timeline would shorten that review period from months to just a few weeks.
‘FDA in a very difficult position’
After the FDA approves, the ACIP of the CDC must meet to review the evidence and make recommendations on the use of the boosters in the United States.
Pfizer says it completed its submission for a supplemental biologics license application to the FDA on Aug. 27. To meet a Sept. 20 timeline, the entire process would have to be completed within 3 weeks.
“I don’t think that was handled, you know, ideally,” said Peter Lurie, MD, president of the Center for Science in the Public Interest and former associate commissioner of public health strategy and analysis at the FDA.
“It puts FDA in a very difficult position,” Dr. Lurie said. “It’s almost as if the decision has been made and they’re just checking a box, and that is, you know, contrary to the what FDA – at least the internal people at FDA – have been trying to do for ages.”
He said the agency took great pains with the emergency use authorizations and the full approvals of the vaccines to work as rapidly but thoroughly as possible. They did not skip steps.
“I think all of that reflected very well on the agency,” Dr. Lurie said. “And I think it worked out well in terms of trust in the vaccines.”
Although additional doses of vaccine are expected to be safe, little is known about side effects or adverse events after a third dose.
“It’s critical to wait for additional data and regulatory allowance for booster doses,” Sara Oliver, MD, a member of the CDC’s epidemic intelligence service, said in an Aug. 30 presentation to the ACIP, which is charged with making recommendations for use of all vaccines in the United States.
Boosters already being given
But after the White House announced that boosters were on the way, many people are not waiting.
Many health care practitioners and pharmacies have already been giving people third doses of vaccines, even if they are not among the immunocompromised – the group for which the shots are currently approved.
“You can walk into a pharmacy and ask for a third dose. Depending on which pharmacy you go to, you may get it,” said Helen Talbot, MD, associate professor of medicine at Vanderbilt University, Nashville, Tenn., and a member of the ACIP.
She says she has a friend who recently went for a checkup and was offered a third dose. His physician is already giving extra doses to everyone who is older than 65.
Dr. Talbot said that in fairness, pharmacies in the United States are throwing away doses of vaccine because they are expiring before they get used.
“Many of us may or may not be ready to give a third dose but would rather give someone a third dose than throw a vaccine away,” she said.
Consequences of a third shot
But giving or getting a third dose before approval by the FDA may have legal consequences.
In the ACIP meeting on Aug. 30, Demetre Daskalakis, MD, who leads vaccine equity efforts at the CDC, cautioned that physicians who give extra doses of the vaccine before the FDA and CDC have signed off may be in violation of practitioner agreements with the federal government and might not be covered by the federal PREP Act. The PREP Act provides immunity from lawsuits for people who administer COVID-19 vaccines and compensates patients in the event of injury. Patients who get a vaccine and suffer a rare but serious side effect may lose the ability to claim compensation offered by the act.
“Many of us gasped when he said that,” Dr. Talbot said, “because that’s a big deal.”
The ACIP signaled that it is considering recommending boosters for a much narrower slice of the American population than the Biden administration has suggested.
They said that so far, the data point only to the need for boosters for seniors, who are the patients most likely to experience breakthrough infections that require hospitalization, and health care workers, who are needed now more than ever and cannot work if they’re sick.
In a White House news briefing Aug. 31, CDC Director Rochelle Walensky, MD, was asked about the ACIP’s conclusions and whether she believed there were enough data to recommend booster shots for most Americans 8 months after their last dose.
“The ACIP did not review international data that actually has led us to be even more concerned about increased risk of vaccine effectiveness waning against hospitalization, severe disease, and death. They will be reviewing that as well,” she said.
A version of this article first appeared on Medscape.com.
That plan, which was first announced on Aug. 18, has raised eyebrows because it comes in advance of regulatory reviews by the Food and Drug Administration and recommendations from the Centers for Disease Control and Prevention. Those reviews are needed to determine whether third doses of these vaccines are effective or even safe. The move could have important legal ramifications for doctors and patients, too.
On Aug. 31, two high-level officials in the FDA’s Office of Vaccines Research and Review abruptly resigned amid reports that they were angry that the Biden administration was making decisions that should be left up to that agency.
So far, data show that the vaccines are highly effective at preventing the most severe consequences of COVID-19 – hospitalization and death – even regarding the Delta variant. The World Health Organization has urged wealthy nations such as the United States not to offer boosters so that the limited supply of vaccines can be directed to countries with fewer resources.
White House supports boosters
In a recent press briefing, Jeff Zients, the White House COVID-19 response coordinator, defended the move.
“You know, the booster decision, which you referenced ... was made by and announced by the nation’s leading public health officials, including Dr. Walensky; Dr. Fauci; Surgeon General Vivek Murthy; Dr. Janet Woodcock; the FDA acting commissioner, Dr. Francis Collins; Dr. Kessler; and others,” Mr. Zients said.
“And as our medical experts laid out, having reviewed all of the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot.”
He said a target date of Sept. 20 was announced so as to give states and practitioners time to prepare. He also said the move to give boosters was meant to help the United States stay ahead of a rapidly changing virus. Mr. Zients added that whether boosters will be administered starting on Sept. 20 depends on the FDA’s and CDC’s giving the go-ahead.
“Booster doses are going to be handled the same way all vaccines are handled,” said Kristen Nordlund, a CDC spokesperson. “Companies will have to provide data to FDA. FDA will have to make a decision and authorize the use of those, and ACIP [the Advisory Committee on Immunization Practices] will have to look at the evidence as well and make recommendations on top of FDA’s regulatory action,” she said.
Ms. Nordlund agreed that the planned Sept. 20 start date for boosters was something to which they aspired and was not necessarily set.
Historically, the FDA has needed at least 4 months to review a change to a vaccine’s approval, even on an accelerated schedule. Reviewers use that time to assess data regarding individual patients in a study, to review raw data, and essentially to check a drug company’s math and conclusions. The Biden administration’s timeline would shorten that review period from months to just a few weeks.
‘FDA in a very difficult position’
After the FDA approves, the ACIP of the CDC must meet to review the evidence and make recommendations on the use of the boosters in the United States.
Pfizer says it completed its submission for a supplemental biologics license application to the FDA on Aug. 27. To meet a Sept. 20 timeline, the entire process would have to be completed within 3 weeks.
“I don’t think that was handled, you know, ideally,” said Peter Lurie, MD, president of the Center for Science in the Public Interest and former associate commissioner of public health strategy and analysis at the FDA.
“It puts FDA in a very difficult position,” Dr. Lurie said. “It’s almost as if the decision has been made and they’re just checking a box, and that is, you know, contrary to the what FDA – at least the internal people at FDA – have been trying to do for ages.”
He said the agency took great pains with the emergency use authorizations and the full approvals of the vaccines to work as rapidly but thoroughly as possible. They did not skip steps.
“I think all of that reflected very well on the agency,” Dr. Lurie said. “And I think it worked out well in terms of trust in the vaccines.”
Although additional doses of vaccine are expected to be safe, little is known about side effects or adverse events after a third dose.
“It’s critical to wait for additional data and regulatory allowance for booster doses,” Sara Oliver, MD, a member of the CDC’s epidemic intelligence service, said in an Aug. 30 presentation to the ACIP, which is charged with making recommendations for use of all vaccines in the United States.
Boosters already being given
But after the White House announced that boosters were on the way, many people are not waiting.
Many health care practitioners and pharmacies have already been giving people third doses of vaccines, even if they are not among the immunocompromised – the group for which the shots are currently approved.
“You can walk into a pharmacy and ask for a third dose. Depending on which pharmacy you go to, you may get it,” said Helen Talbot, MD, associate professor of medicine at Vanderbilt University, Nashville, Tenn., and a member of the ACIP.
She says she has a friend who recently went for a checkup and was offered a third dose. His physician is already giving extra doses to everyone who is older than 65.
Dr. Talbot said that in fairness, pharmacies in the United States are throwing away doses of vaccine because they are expiring before they get used.
“Many of us may or may not be ready to give a third dose but would rather give someone a third dose than throw a vaccine away,” she said.
Consequences of a third shot
But giving or getting a third dose before approval by the FDA may have legal consequences.
In the ACIP meeting on Aug. 30, Demetre Daskalakis, MD, who leads vaccine equity efforts at the CDC, cautioned that physicians who give extra doses of the vaccine before the FDA and CDC have signed off may be in violation of practitioner agreements with the federal government and might not be covered by the federal PREP Act. The PREP Act provides immunity from lawsuits for people who administer COVID-19 vaccines and compensates patients in the event of injury. Patients who get a vaccine and suffer a rare but serious side effect may lose the ability to claim compensation offered by the act.
“Many of us gasped when he said that,” Dr. Talbot said, “because that’s a big deal.”
The ACIP signaled that it is considering recommending boosters for a much narrower slice of the American population than the Biden administration has suggested.
They said that so far, the data point only to the need for boosters for seniors, who are the patients most likely to experience breakthrough infections that require hospitalization, and health care workers, who are needed now more than ever and cannot work if they’re sick.
In a White House news briefing Aug. 31, CDC Director Rochelle Walensky, MD, was asked about the ACIP’s conclusions and whether she believed there were enough data to recommend booster shots for most Americans 8 months after their last dose.
“The ACIP did not review international data that actually has led us to be even more concerned about increased risk of vaccine effectiveness waning against hospitalization, severe disease, and death. They will be reviewing that as well,” she said.
A version of this article first appeared on Medscape.com.
COVID-19 linked to baby bust in high-income countries
In an assessment of the pandemic’s early effects, Arnstein Aassve, PhD, and colleagues found a significant COVID-19–related decline in crude birth rates (CBRs) in 7 of 22 high-income countries, particularly in Southwestern Europe.
Dr. Aassve, an economist at the Carlo F. Dondena Center for Research on Social Dynamics and Public Policy at the Università Commerciale Luigi Bocconi, Milan, and colleagues report the results in an article published online August 30 in the Proceedings of the National Academy of Sciences.
Defining the start of the COVID-19 pandemic as February 2020, the study identifies strong declines in Italy (-9.1%), Hungary (-8.5%), Spain (-8.4%), and Portugal (-6.6%) beyond those predicted by past trends. In the United States, CBRs fell by 7.1% relative to 2019 for births occurring in Nov. and Dec. 2020 following conceptions in February and March of that year.
Significant declines in CBR also occurred in Belgium, Austria, and Singapore.
A year-to-year comparison of the mean for monthly CBRs per 1,000 population before and during the pandemic suggests a negative difference for all countries studied except for Denmark, Finland, Germany, and the Netherlands, Dr. Aassve and colleagues write. These findings may have policy implications for childcare, housing, and the labor market.
The Milan researchers compared monthly vital statistics data on live births from the international Human Fertility Database for the period of Jan. 2016 to March 2021. These figures reflect conceptions carried to term between April 2015 and June 2020. The 22 countries in the analysis represent 37% of the total reported COVID-19 cases and 34% of deaths worldwide.
The study findings align with surveys on “fertility intentions” collected early in the first COVID-19 wave in Germany, France, Spain, and the United Kingdom. These surveys indicated that 73% of people who were planning pregnancies in 2020 either decided to delay the pregnancy or they abandoned their plans.
“The popular media speculated that the lockdown would lead to a baby boom, as couples spent more time together,” Dr. Aassve told this news organization. “There’s very little evidence of this when you look to previous disasters and shocks, and the first data suggest more of an immediate collapse than a boom. But as you also see from the paper, the collapse is not seen everywhere.” Other current studies suggest the fertility drop is immediate but temporary, says Dr. Aassve, who is also a professor of demography.
Interestingly, Dr. Aassve and colleagues found that CBRs were relatively stable in Northern Europe. The authors point to supportive social and family policies in that region that might have reduced the effect of the pandemic on births. “These factors are likely to affect CBRs in the subsequent pandemic waves,” they write. They call for future studies to assess the full population implications of the pandemic, the moderating impact of policy interventions, and the nexus between short- and long-run effects in relation to the various waves of the COVID-19 pandemic.
Rebounds
Some regions have already reported a rebound from the COVID-19 fertility trough. Molly J. Stout, MD, director of maternal fetal medicine at the University of Michigan, Ann Arbor, and colleagues used electronic medical records to predict a surge in births after the initial decline.
“The surge we’ve seen at the end of this summer is exceeding the usual annual birth rate, as predicted,” she said in an interview. “But I think there’ll be a return to normal after this transient escalation. I don’t think birth rates will stay elevated above the normal because the birth surge is a temporary response to an event, although there will likely be regional differences.”
Looking ahead, Dr. Stout, who was not involved in Dr. Aassve’s analysis, is not certain how a fourth pandemic wave might ultimately modify a couple’s overall family size. But the toll the health crisis has taken on working women who have been forced to withdraw from the economy because of a lack of childcare points to a societal need that should be addressed.
According to Philip N. Cohen, PhD, a professor of sociology at the University of Maryland, College Park, who’s been tracking fertility trends since the onset of the COVID-19 emergency, the pandemic has combined a health crisis with an economic crisis, along with “the additional factor of social distancing and isolation, which all contributed to the decline in birth rates. Some people changed their plans to hold off on having children, while others didn’t get pregnant because they weren’t socializing and meeting people as much.”
Dr. Cohen, who was not involved in the study by Dr. Aassve and associates, said his provisional data show that although in many places, birth rates have rebounded more or less to prepandemic levels after a nadir around Jan. 2021, some areas of the United States still show substantially lower rates, including California, Hawaii, and Oregon.
As to the duration of the pandemic effect, Dr. Aassve cautions that his group’s estimates refer to the first wave only. “We then have the second, third, and currently the fourth wave. We can’t be sure about the impact of these waves on fertility since the data are not there yet, but I’d be surprised if they didn’t continue to have an impact on fertility rates,” he said.
Dr. Cohen agreed: “Some people who delayed childbearing will make up the delay. However, whenever there’s a delay, there’s inevitably some portion of the decline that’s not recouped.”
As for the wider effect across the world, Dr. Aassve said his team’s figures derive from high-income countries where data are readily available. For middle- and low-income countries, fewer data exist, and the quality of those data is not as good.
The lessons from this and other upheavals teach us that unforeseen shocks almost always have a negative impact on fertility, says Dr. Aassve. “[B]ut these effects may be separate from existing declining trends. The issue here is that those overall declining trends may be driven by other factors. In contrast, the shock of the pandemic is short-lived, and we may return to normal rather quickly. But if the pandemic also impacts other societal structures, such as the occupational and industrial sectors, then the pandemic might exacerbate the negative trend.”
The study was supported by funding from the European Research Council for funding under the European Union’s Horizon 2020 Research and Innovation Programme. The study authors, Dr. Stout, and Dr. Cohen have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In an assessment of the pandemic’s early effects, Arnstein Aassve, PhD, and colleagues found a significant COVID-19–related decline in crude birth rates (CBRs) in 7 of 22 high-income countries, particularly in Southwestern Europe.
Dr. Aassve, an economist at the Carlo F. Dondena Center for Research on Social Dynamics and Public Policy at the Università Commerciale Luigi Bocconi, Milan, and colleagues report the results in an article published online August 30 in the Proceedings of the National Academy of Sciences.
Defining the start of the COVID-19 pandemic as February 2020, the study identifies strong declines in Italy (-9.1%), Hungary (-8.5%), Spain (-8.4%), and Portugal (-6.6%) beyond those predicted by past trends. In the United States, CBRs fell by 7.1% relative to 2019 for births occurring in Nov. and Dec. 2020 following conceptions in February and March of that year.
Significant declines in CBR also occurred in Belgium, Austria, and Singapore.
A year-to-year comparison of the mean for monthly CBRs per 1,000 population before and during the pandemic suggests a negative difference for all countries studied except for Denmark, Finland, Germany, and the Netherlands, Dr. Aassve and colleagues write. These findings may have policy implications for childcare, housing, and the labor market.
The Milan researchers compared monthly vital statistics data on live births from the international Human Fertility Database for the period of Jan. 2016 to March 2021. These figures reflect conceptions carried to term between April 2015 and June 2020. The 22 countries in the analysis represent 37% of the total reported COVID-19 cases and 34% of deaths worldwide.
The study findings align with surveys on “fertility intentions” collected early in the first COVID-19 wave in Germany, France, Spain, and the United Kingdom. These surveys indicated that 73% of people who were planning pregnancies in 2020 either decided to delay the pregnancy or they abandoned their plans.
“The popular media speculated that the lockdown would lead to a baby boom, as couples spent more time together,” Dr. Aassve told this news organization. “There’s very little evidence of this when you look to previous disasters and shocks, and the first data suggest more of an immediate collapse than a boom. But as you also see from the paper, the collapse is not seen everywhere.” Other current studies suggest the fertility drop is immediate but temporary, says Dr. Aassve, who is also a professor of demography.
Interestingly, Dr. Aassve and colleagues found that CBRs were relatively stable in Northern Europe. The authors point to supportive social and family policies in that region that might have reduced the effect of the pandemic on births. “These factors are likely to affect CBRs in the subsequent pandemic waves,” they write. They call for future studies to assess the full population implications of the pandemic, the moderating impact of policy interventions, and the nexus between short- and long-run effects in relation to the various waves of the COVID-19 pandemic.
Rebounds
Some regions have already reported a rebound from the COVID-19 fertility trough. Molly J. Stout, MD, director of maternal fetal medicine at the University of Michigan, Ann Arbor, and colleagues used electronic medical records to predict a surge in births after the initial decline.
“The surge we’ve seen at the end of this summer is exceeding the usual annual birth rate, as predicted,” she said in an interview. “But I think there’ll be a return to normal after this transient escalation. I don’t think birth rates will stay elevated above the normal because the birth surge is a temporary response to an event, although there will likely be regional differences.”
Looking ahead, Dr. Stout, who was not involved in Dr. Aassve’s analysis, is not certain how a fourth pandemic wave might ultimately modify a couple’s overall family size. But the toll the health crisis has taken on working women who have been forced to withdraw from the economy because of a lack of childcare points to a societal need that should be addressed.
According to Philip N. Cohen, PhD, a professor of sociology at the University of Maryland, College Park, who’s been tracking fertility trends since the onset of the COVID-19 emergency, the pandemic has combined a health crisis with an economic crisis, along with “the additional factor of social distancing and isolation, which all contributed to the decline in birth rates. Some people changed their plans to hold off on having children, while others didn’t get pregnant because they weren’t socializing and meeting people as much.”
Dr. Cohen, who was not involved in the study by Dr. Aassve and associates, said his provisional data show that although in many places, birth rates have rebounded more or less to prepandemic levels after a nadir around Jan. 2021, some areas of the United States still show substantially lower rates, including California, Hawaii, and Oregon.
As to the duration of the pandemic effect, Dr. Aassve cautions that his group’s estimates refer to the first wave only. “We then have the second, third, and currently the fourth wave. We can’t be sure about the impact of these waves on fertility since the data are not there yet, but I’d be surprised if they didn’t continue to have an impact on fertility rates,” he said.
Dr. Cohen agreed: “Some people who delayed childbearing will make up the delay. However, whenever there’s a delay, there’s inevitably some portion of the decline that’s not recouped.”
As for the wider effect across the world, Dr. Aassve said his team’s figures derive from high-income countries where data are readily available. For middle- and low-income countries, fewer data exist, and the quality of those data is not as good.
The lessons from this and other upheavals teach us that unforeseen shocks almost always have a negative impact on fertility, says Dr. Aassve. “[B]ut these effects may be separate from existing declining trends. The issue here is that those overall declining trends may be driven by other factors. In contrast, the shock of the pandemic is short-lived, and we may return to normal rather quickly. But if the pandemic also impacts other societal structures, such as the occupational and industrial sectors, then the pandemic might exacerbate the negative trend.”
The study was supported by funding from the European Research Council for funding under the European Union’s Horizon 2020 Research and Innovation Programme. The study authors, Dr. Stout, and Dr. Cohen have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In an assessment of the pandemic’s early effects, Arnstein Aassve, PhD, and colleagues found a significant COVID-19–related decline in crude birth rates (CBRs) in 7 of 22 high-income countries, particularly in Southwestern Europe.
Dr. Aassve, an economist at the Carlo F. Dondena Center for Research on Social Dynamics and Public Policy at the Università Commerciale Luigi Bocconi, Milan, and colleagues report the results in an article published online August 30 in the Proceedings of the National Academy of Sciences.
Defining the start of the COVID-19 pandemic as February 2020, the study identifies strong declines in Italy (-9.1%), Hungary (-8.5%), Spain (-8.4%), and Portugal (-6.6%) beyond those predicted by past trends. In the United States, CBRs fell by 7.1% relative to 2019 for births occurring in Nov. and Dec. 2020 following conceptions in February and March of that year.
Significant declines in CBR also occurred in Belgium, Austria, and Singapore.
A year-to-year comparison of the mean for monthly CBRs per 1,000 population before and during the pandemic suggests a negative difference for all countries studied except for Denmark, Finland, Germany, and the Netherlands, Dr. Aassve and colleagues write. These findings may have policy implications for childcare, housing, and the labor market.
The Milan researchers compared monthly vital statistics data on live births from the international Human Fertility Database for the period of Jan. 2016 to March 2021. These figures reflect conceptions carried to term between April 2015 and June 2020. The 22 countries in the analysis represent 37% of the total reported COVID-19 cases and 34% of deaths worldwide.
The study findings align with surveys on “fertility intentions” collected early in the first COVID-19 wave in Germany, France, Spain, and the United Kingdom. These surveys indicated that 73% of people who were planning pregnancies in 2020 either decided to delay the pregnancy or they abandoned their plans.
“The popular media speculated that the lockdown would lead to a baby boom, as couples spent more time together,” Dr. Aassve told this news organization. “There’s very little evidence of this when you look to previous disasters and shocks, and the first data suggest more of an immediate collapse than a boom. But as you also see from the paper, the collapse is not seen everywhere.” Other current studies suggest the fertility drop is immediate but temporary, says Dr. Aassve, who is also a professor of demography.
Interestingly, Dr. Aassve and colleagues found that CBRs were relatively stable in Northern Europe. The authors point to supportive social and family policies in that region that might have reduced the effect of the pandemic on births. “These factors are likely to affect CBRs in the subsequent pandemic waves,” they write. They call for future studies to assess the full population implications of the pandemic, the moderating impact of policy interventions, and the nexus between short- and long-run effects in relation to the various waves of the COVID-19 pandemic.
Rebounds
Some regions have already reported a rebound from the COVID-19 fertility trough. Molly J. Stout, MD, director of maternal fetal medicine at the University of Michigan, Ann Arbor, and colleagues used electronic medical records to predict a surge in births after the initial decline.
“The surge we’ve seen at the end of this summer is exceeding the usual annual birth rate, as predicted,” she said in an interview. “But I think there’ll be a return to normal after this transient escalation. I don’t think birth rates will stay elevated above the normal because the birth surge is a temporary response to an event, although there will likely be regional differences.”
Looking ahead, Dr. Stout, who was not involved in Dr. Aassve’s analysis, is not certain how a fourth pandemic wave might ultimately modify a couple’s overall family size. But the toll the health crisis has taken on working women who have been forced to withdraw from the economy because of a lack of childcare points to a societal need that should be addressed.
According to Philip N. Cohen, PhD, a professor of sociology at the University of Maryland, College Park, who’s been tracking fertility trends since the onset of the COVID-19 emergency, the pandemic has combined a health crisis with an economic crisis, along with “the additional factor of social distancing and isolation, which all contributed to the decline in birth rates. Some people changed their plans to hold off on having children, while others didn’t get pregnant because they weren’t socializing and meeting people as much.”
Dr. Cohen, who was not involved in the study by Dr. Aassve and associates, said his provisional data show that although in many places, birth rates have rebounded more or less to prepandemic levels after a nadir around Jan. 2021, some areas of the United States still show substantially lower rates, including California, Hawaii, and Oregon.
As to the duration of the pandemic effect, Dr. Aassve cautions that his group’s estimates refer to the first wave only. “We then have the second, third, and currently the fourth wave. We can’t be sure about the impact of these waves on fertility since the data are not there yet, but I’d be surprised if they didn’t continue to have an impact on fertility rates,” he said.
Dr. Cohen agreed: “Some people who delayed childbearing will make up the delay. However, whenever there’s a delay, there’s inevitably some portion of the decline that’s not recouped.”
As for the wider effect across the world, Dr. Aassve said his team’s figures derive from high-income countries where data are readily available. For middle- and low-income countries, fewer data exist, and the quality of those data is not as good.
The lessons from this and other upheavals teach us that unforeseen shocks almost always have a negative impact on fertility, says Dr. Aassve. “[B]ut these effects may be separate from existing declining trends. The issue here is that those overall declining trends may be driven by other factors. In contrast, the shock of the pandemic is short-lived, and we may return to normal rather quickly. But if the pandemic also impacts other societal structures, such as the occupational and industrial sectors, then the pandemic might exacerbate the negative trend.”
The study was supported by funding from the European Research Council for funding under the European Union’s Horizon 2020 Research and Innovation Programme. The study authors, Dr. Stout, and Dr. Cohen have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Exercising to lose weight is not for every ‘body’
Exercising to lose weight is not for every ‘body’
This first item comes from the “You’ve got to be kidding” section of LOTME’s supersecret topics-of-interest file.
Investigators at the Shenzhen Institute of Advanced Technology of the Chinese Academy of Sciences and the University of Roehampton noticed that some people who enrolled in exercise programs to lose weight did just the opposite: they gained weight.
Being scientists, they decided to look at the effects of energy expenditure and how those effects varied among individuals. The likely culprit in this case, they determined, is something called compensatory mechanisms. One such mechanism involves eating more food because exercise stimulates appetite, and another might reduce energy expenditure on other components like resting metabolism so that the exercise is, in effect, less costly.
A look at the numbers shows how compensatory mechanisms worked in the study population of 1,750 adults. Among individuals with the highest BMI, 51% of the calories burned during activity translated into calories burned at the end of the day. For those with normal BMI, however, 72% of calories burned during activity were reflected in total expenditure.
“People living with obesity cut back their resting metabolism when they are more active. The result is that for every calorie they spend on exercise they save about half a calorie on resting,” the investigators explained.
In other words, some bodies will, unconsciously, work against the conscious effort of exercising to lose weight. Thank you very much, compensatory mechanisms, for the boundarylessness exhibited in exceeding your job description.
When it comes to the mix, walnuts go nuts
When it comes to mixed nuts, walnuts get no love. But we may be able to give you a reason to not pick them out: Your arteries.
Participants in a recent study who ate about a half-cup of walnuts every day for 2 years saw a drop in their low-density lipoprotein (LDL) cholesterol. The number and quality of LDL particles in healthy older adults also improved. How? Good ol’ omega-3 fatty acids.
Omega-3 is found in many foods linked to lower risks of heart disease, lower cholesterol levels, and lower blood sugar levels, but the one thing that makes the walnut a front runner for Miss Super Food 2021 is their ability to improve the quality of LDL particles.
“LDL particles come in various sizes [and] research has shown that small, dense LDL particles are more often associated with atherosclerosis, the plaque or fatty deposits that build up in the arteries,” Emilio Ros, MD, PhD, of the Hospital Clínic of Barcelona and the study’s senior investigator, said in a written statement.
The 708 participants, aged 63-79 years and mostly women, were divided into two groups: One received the walnut diet and the other did not. After 2 years, the walnut group had lower LDL levels by an average of 4.3 mg/dL. Total cholesterol was reduced by an average of 8.5 mg/dL. Also, their total LDL particle count was 4.3% lower and small LDL particles were down by 6.1%.
So instead of picking the walnuts out of the mix, try to find it in your heart to appreciate them. Your body already does.
Begun, the clone war has
Well, not quite yet, Master Yoda, but perhaps one day soon, if a study from Japan into the uncanny valley of the usage of cloned humanlike faces in robotics and artificial intelligence, published in PLOS One, is to be believed.
The study consisted of a number of six smaller experiments in which participants judged a series of images based on subjective eeriness, emotional valence, and realism. The images included people with the same cloned face; people with different faces; dogs; identical twins, triplets, quadruplets, etc.; and cloned animated characters. In the sixth experiment, the photos were the same as in the second (six cloned faces, six different faces, and a single face) but participants also answered the Disgust Scale–Revised to accurately analyze disgust sensitivity.
The results of all these experiments were quite clear: People found the cloned faces far creepier than the varied or single face, an effect the researchers called clone devaluation. Notably, this effect only applied to realistic human faces; most people didn’t find the cloned dogs or cloned animated characters creepy. However, those who did were more likely to find the human clones eerie on the Disgust Scale.
The authors noted that future robotics technology needs to be carefully considered to avoid the uncanny valley and this clone devaluation effect, which is a very good point. The last thing we need is a few million robots with identical faces getting angry at us and pulling a Terminator/Order 66 combo. We’re already in a viral apocalypse; we don’t need a robot one on top of that.
Congratulations to our new favorite reader
The winner of last week’s inaugural Pandemic Pandemonium comes to us from Tiffanie Roe. By getting her entry in first, just ahead of the flood of responses we received – and by flood we mean a very slow and very quickly repaired drip – Ms. Roe puts the gold medal for COVID-related insanity around the necks of Australian magpies, who may start attacking people wearing face masks during “swooping season” because the birds don’t recognize them.
Exercising to lose weight is not for every ‘body’
This first item comes from the “You’ve got to be kidding” section of LOTME’s supersecret topics-of-interest file.
Investigators at the Shenzhen Institute of Advanced Technology of the Chinese Academy of Sciences and the University of Roehampton noticed that some people who enrolled in exercise programs to lose weight did just the opposite: they gained weight.
Being scientists, they decided to look at the effects of energy expenditure and how those effects varied among individuals. The likely culprit in this case, they determined, is something called compensatory mechanisms. One such mechanism involves eating more food because exercise stimulates appetite, and another might reduce energy expenditure on other components like resting metabolism so that the exercise is, in effect, less costly.
A look at the numbers shows how compensatory mechanisms worked in the study population of 1,750 adults. Among individuals with the highest BMI, 51% of the calories burned during activity translated into calories burned at the end of the day. For those with normal BMI, however, 72% of calories burned during activity were reflected in total expenditure.
“People living with obesity cut back their resting metabolism when they are more active. The result is that for every calorie they spend on exercise they save about half a calorie on resting,” the investigators explained.
In other words, some bodies will, unconsciously, work against the conscious effort of exercising to lose weight. Thank you very much, compensatory mechanisms, for the boundarylessness exhibited in exceeding your job description.
When it comes to the mix, walnuts go nuts
When it comes to mixed nuts, walnuts get no love. But we may be able to give you a reason to not pick them out: Your arteries.
Participants in a recent study who ate about a half-cup of walnuts every day for 2 years saw a drop in their low-density lipoprotein (LDL) cholesterol. The number and quality of LDL particles in healthy older adults also improved. How? Good ol’ omega-3 fatty acids.
Omega-3 is found in many foods linked to lower risks of heart disease, lower cholesterol levels, and lower blood sugar levels, but the one thing that makes the walnut a front runner for Miss Super Food 2021 is their ability to improve the quality of LDL particles.
“LDL particles come in various sizes [and] research has shown that small, dense LDL particles are more often associated with atherosclerosis, the plaque or fatty deposits that build up in the arteries,” Emilio Ros, MD, PhD, of the Hospital Clínic of Barcelona and the study’s senior investigator, said in a written statement.
The 708 participants, aged 63-79 years and mostly women, were divided into two groups: One received the walnut diet and the other did not. After 2 years, the walnut group had lower LDL levels by an average of 4.3 mg/dL. Total cholesterol was reduced by an average of 8.5 mg/dL. Also, their total LDL particle count was 4.3% lower and small LDL particles were down by 6.1%.
So instead of picking the walnuts out of the mix, try to find it in your heart to appreciate them. Your body already does.
Begun, the clone war has
Well, not quite yet, Master Yoda, but perhaps one day soon, if a study from Japan into the uncanny valley of the usage of cloned humanlike faces in robotics and artificial intelligence, published in PLOS One, is to be believed.
The study consisted of a number of six smaller experiments in which participants judged a series of images based on subjective eeriness, emotional valence, and realism. The images included people with the same cloned face; people with different faces; dogs; identical twins, triplets, quadruplets, etc.; and cloned animated characters. In the sixth experiment, the photos were the same as in the second (six cloned faces, six different faces, and a single face) but participants also answered the Disgust Scale–Revised to accurately analyze disgust sensitivity.
The results of all these experiments were quite clear: People found the cloned faces far creepier than the varied or single face, an effect the researchers called clone devaluation. Notably, this effect only applied to realistic human faces; most people didn’t find the cloned dogs or cloned animated characters creepy. However, those who did were more likely to find the human clones eerie on the Disgust Scale.
The authors noted that future robotics technology needs to be carefully considered to avoid the uncanny valley and this clone devaluation effect, which is a very good point. The last thing we need is a few million robots with identical faces getting angry at us and pulling a Terminator/Order 66 combo. We’re already in a viral apocalypse; we don’t need a robot one on top of that.
Congratulations to our new favorite reader
The winner of last week’s inaugural Pandemic Pandemonium comes to us from Tiffanie Roe. By getting her entry in first, just ahead of the flood of responses we received – and by flood we mean a very slow and very quickly repaired drip – Ms. Roe puts the gold medal for COVID-related insanity around the necks of Australian magpies, who may start attacking people wearing face masks during “swooping season” because the birds don’t recognize them.
Exercising to lose weight is not for every ‘body’
This first item comes from the “You’ve got to be kidding” section of LOTME’s supersecret topics-of-interest file.
Investigators at the Shenzhen Institute of Advanced Technology of the Chinese Academy of Sciences and the University of Roehampton noticed that some people who enrolled in exercise programs to lose weight did just the opposite: they gained weight.
Being scientists, they decided to look at the effects of energy expenditure and how those effects varied among individuals. The likely culprit in this case, they determined, is something called compensatory mechanisms. One such mechanism involves eating more food because exercise stimulates appetite, and another might reduce energy expenditure on other components like resting metabolism so that the exercise is, in effect, less costly.
A look at the numbers shows how compensatory mechanisms worked in the study population of 1,750 adults. Among individuals with the highest BMI, 51% of the calories burned during activity translated into calories burned at the end of the day. For those with normal BMI, however, 72% of calories burned during activity were reflected in total expenditure.
“People living with obesity cut back their resting metabolism when they are more active. The result is that for every calorie they spend on exercise they save about half a calorie on resting,” the investigators explained.
In other words, some bodies will, unconsciously, work against the conscious effort of exercising to lose weight. Thank you very much, compensatory mechanisms, for the boundarylessness exhibited in exceeding your job description.
When it comes to the mix, walnuts go nuts
When it comes to mixed nuts, walnuts get no love. But we may be able to give you a reason to not pick them out: Your arteries.
Participants in a recent study who ate about a half-cup of walnuts every day for 2 years saw a drop in their low-density lipoprotein (LDL) cholesterol. The number and quality of LDL particles in healthy older adults also improved. How? Good ol’ omega-3 fatty acids.
Omega-3 is found in many foods linked to lower risks of heart disease, lower cholesterol levels, and lower blood sugar levels, but the one thing that makes the walnut a front runner for Miss Super Food 2021 is their ability to improve the quality of LDL particles.
“LDL particles come in various sizes [and] research has shown that small, dense LDL particles are more often associated with atherosclerosis, the plaque or fatty deposits that build up in the arteries,” Emilio Ros, MD, PhD, of the Hospital Clínic of Barcelona and the study’s senior investigator, said in a written statement.
The 708 participants, aged 63-79 years and mostly women, were divided into two groups: One received the walnut diet and the other did not. After 2 years, the walnut group had lower LDL levels by an average of 4.3 mg/dL. Total cholesterol was reduced by an average of 8.5 mg/dL. Also, their total LDL particle count was 4.3% lower and small LDL particles were down by 6.1%.
So instead of picking the walnuts out of the mix, try to find it in your heart to appreciate them. Your body already does.
Begun, the clone war has
Well, not quite yet, Master Yoda, but perhaps one day soon, if a study from Japan into the uncanny valley of the usage of cloned humanlike faces in robotics and artificial intelligence, published in PLOS One, is to be believed.
The study consisted of a number of six smaller experiments in which participants judged a series of images based on subjective eeriness, emotional valence, and realism. The images included people with the same cloned face; people with different faces; dogs; identical twins, triplets, quadruplets, etc.; and cloned animated characters. In the sixth experiment, the photos were the same as in the second (six cloned faces, six different faces, and a single face) but participants also answered the Disgust Scale–Revised to accurately analyze disgust sensitivity.
The results of all these experiments were quite clear: People found the cloned faces far creepier than the varied or single face, an effect the researchers called clone devaluation. Notably, this effect only applied to realistic human faces; most people didn’t find the cloned dogs or cloned animated characters creepy. However, those who did were more likely to find the human clones eerie on the Disgust Scale.
The authors noted that future robotics technology needs to be carefully considered to avoid the uncanny valley and this clone devaluation effect, which is a very good point. The last thing we need is a few million robots with identical faces getting angry at us and pulling a Terminator/Order 66 combo. We’re already in a viral apocalypse; we don’t need a robot one on top of that.
Congratulations to our new favorite reader
The winner of last week’s inaugural Pandemic Pandemonium comes to us from Tiffanie Roe. By getting her entry in first, just ahead of the flood of responses we received – and by flood we mean a very slow and very quickly repaired drip – Ms. Roe puts the gold medal for COVID-related insanity around the necks of Australian magpies, who may start attacking people wearing face masks during “swooping season” because the birds don’t recognize them.