COVID-19 Updates

The COVID-19 pandemic continues to impact child and adolescent mental health, and clinicians are learning as they go to develop strategies that address the challenges of providing both medical and mental health care to young patients, including those who test positive for COVID-19, according to Hani Talebi, PhD, director of pediatric psychology, and Jorge Ganem, MD, FAAP, director of pediatric hospital medicine, both of the University of Texas at Austin and Dell Children’s Medical Center.

In a presentation at the 2021 virtual Pediatric Hospital Medicine conference, Dr. Talebi and Dr. Ganem shared their experiences in identifying the impact of the pandemic on mental health services in a freestanding hospital, and synthesizing inpatient mental health care and medical care outside of a dedicated mental health unit.

Mental health is a significant pediatric issue; approximately one in five children have a diagnosable mental or behavioral health problem, but nearly two-thirds get little or no help, Dr. Talebi said. “COVID-19 has only exacerbated these mental health challenges,” he said.

He noted that beginning in April 2020, the proportion of children’s mental health-related emergency department visits increased and remained elevated through the spring, summer, and fall of 2020, as families fearful of COVID-19 avoided regular hospital visits.

Data suggest that up to 50% of all adolescent psychiatric crises that led to inpatient admissions were related in some way to COVID-19, Dr. Talebi said. In addition, “individuals with a recent diagnosis of a mental health disorder are at increased risk for COVID-19 infection,” and the risk is even higher among women and African Americans, he said.

The past year significantly impacted the mental wellbeing of parents and children, Dr. Talebi said. He cited a June 2020 study in Pediatrics in which 27% of parents reported worsening mental health for themselves, and 14% reported worsening behavioral health for their children. Ongoing issues including food insecurity, loss of regular child care, and an overall “very disorienting experience in the day-to-day” compromised the mental health of families, Dr. Talebi emphasized. Children isolated at home were not meeting developmental milestones that organically occur when socializing with peers, parents didn’t know how to handle some of their children’s issues without support from schools, and many people were struggling with other preexisting health conditions, he said.

This confluence of factors helped drive a surge in emergency department visits, meaning longer wait times and concerns about meeting urgent medical and mental health needs while maintaining safety, he added.

Parents and children waited longer to seek care, and community hospitals such as Dell Children’s Medical Center were faced with children in the emergency department with crisis-level mental health issues, along with children already waiting in the ED to address medical emergencies. All these patients had to be tested for COVID-19 and managed accordingly, Dr. Talebi noted.

Dr. Talebi emphasized the need for clinically robust care of the children who were in isolation for 10 days on the medical unit, waiting to test negative. New protocols were created for social workers to conduct daily safety checks, and to develop regular schedules for screening, “so they are having an experience on the medical floors similar to what they would have in a mental health unit,” he said.

Dr. Ganem reflected on the logistical challenges of managing mental health care while observing COVID-19 safety protocols. “COVID-19 added a new wrinkle of isolation,” he said. As institutional guidelines on testing and isolation evolved, negative COVID-19 tests were required for admission to the mental health units both in the hospital and throughout the region. Patients who tested positive had to be quarantined for 10 days, at which time they could be admitted to a mental health unit if necessary, he said.

Dr. Ganem shared details of some strategies adopted by Dell Children’s. He explained that the COVID-19 psychiatry patient workflow started with an ED evaluation, followed by medical clearance and consideration for admission.

“There was significant coordination between the social worker in the emergency department and the psychiatry social worker,” he said.

Key elements of the treatment plan for children with positive COVID-19 tests included an “interprofessional huddle” to coordinate the plan of care, goals for admission, and goals for safety, Dr. Ganem said.

Patients who required admission were expected to have an initial length of stay of 72 hours, and those who tested positive for COVID-19 were admitted to a medical unit with COVID-19 isolation, he said.

Once a patient is admitted, an RN activates a suicide prevention pathway, and an interprofessional team meets to determine what patients need for safe and effective discharge, said Dr. Ganem. He cited the SAFE-T protocol (Suicide Assessment Five-step Evaluation and Triage) as one of the tools used to determine safe discharge criteria. Considerations on the SAFE-T list include family support, an established outpatient therapist and psychiatrist, no suicide attempts prior to the current admission, or a low lethality attempt, and access to partial hospitalization or intensive outpatient programs.

Patients who could not be discharged because of suicidality or inadequate support or concerns about safety at home were considered for inpatient admission. Patients with COVID-19–positive tests who had continued need for inpatient mental health services could be transferred to an inpatient mental health unit after a 10-day quarantine.

Overall, “this has been a continuum of lessons learned, with some things we know now that we didn’t know in April or May of 2020,” Dr. Ganem said. Early in the pandemic, the focus was on minimizing risk, securing personal protective equipment, and determining who provided services in a patient’s room. “We developed new paradigms on the fly,” he said, including the use of virtual visits, which included securing and cleaning devices, as well as learning how to use them in this setting,” he said.

More recently, the emphasis has been on providing services to patients before they need to visit the hospital, rather than automatically admitting any patients with suicidal ideation and a positive COVID-19 test, Dr. Ganem said.

Dr. Talebi and Dr. Ganem had no financial conflicts to disclose. The conference was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

The COVID-19 pandemic continues to impact child and adolescent mental health, and clinicians are learning as they go to develop strategies that address the challenges of providing both medical and mental health care to young patients, including those who test positive for COVID-19, according to Hani Talebi, PhD, director of pediatric psychology, and Jorge Ganem, MD, FAAP, director of pediatric hospital medicine, both of the University of Texas at Austin and Dell Children’s Medical Center.

In a presentation at the 2021 virtual Pediatric Hospital Medicine conference, Dr. Talebi and Dr. Ganem shared their experiences in identifying the impact of the pandemic on mental health services in a freestanding hospital, and synthesizing inpatient mental health care and medical care outside of a dedicated mental health unit.

Mental health is a significant pediatric issue; approximately one in five children have a diagnosable mental or behavioral health problem, but nearly two-thirds get little or no help, Dr. Talebi said. “COVID-19 has only exacerbated these mental health challenges,” he said.

He noted that beginning in April 2020, the proportion of children’s mental health-related emergency department visits increased and remained elevated through the spring, summer, and fall of 2020, as families fearful of COVID-19 avoided regular hospital visits.

Data suggest that up to 50% of all adolescent psychiatric crises that led to inpatient admissions were related in some way to COVID-19, Dr. Talebi said. In addition, “individuals with a recent diagnosis of a mental health disorder are at increased risk for COVID-19 infection,” and the risk is even higher among women and African Americans, he said.

The past year significantly impacted the mental wellbeing of parents and children, Dr. Talebi said. He cited a June 2020 study in Pediatrics in which 27% of parents reported worsening mental health for themselves, and 14% reported worsening behavioral health for their children. Ongoing issues including food insecurity, loss of regular child care, and an overall “very disorienting experience in the day-to-day” compromised the mental health of families, Dr. Talebi emphasized. Children isolated at home were not meeting developmental milestones that organically occur when socializing with peers, parents didn’t know how to handle some of their children’s issues without support from schools, and many people were struggling with other preexisting health conditions, he said.

This confluence of factors helped drive a surge in emergency department visits, meaning longer wait times and concerns about meeting urgent medical and mental health needs while maintaining safety, he added.

Parents and children waited longer to seek care, and community hospitals such as Dell Children’s Medical Center were faced with children in the emergency department with crisis-level mental health issues, along with children already waiting in the ED to address medical emergencies. All these patients had to be tested for COVID-19 and managed accordingly, Dr. Talebi noted.

Dr. Talebi emphasized the need for clinically robust care of the children who were in isolation for 10 days on the medical unit, waiting to test negative. New protocols were created for social workers to conduct daily safety checks, and to develop regular schedules for screening, “so they are having an experience on the medical floors similar to what they would have in a mental health unit,” he said.

Dr. Ganem reflected on the logistical challenges of managing mental health care while observing COVID-19 safety protocols. “COVID-19 added a new wrinkle of isolation,” he said. As institutional guidelines on testing and isolation evolved, negative COVID-19 tests were required for admission to the mental health units both in the hospital and throughout the region. Patients who tested positive had to be quarantined for 10 days, at which time they could be admitted to a mental health unit if necessary, he said.

Dr. Ganem shared details of some strategies adopted by Dell Children’s. He explained that the COVID-19 psychiatry patient workflow started with an ED evaluation, followed by medical clearance and consideration for admission.

“There was significant coordination between the social worker in the emergency department and the psychiatry social worker,” he said.

Key elements of the treatment plan for children with positive COVID-19 tests included an “interprofessional huddle” to coordinate the plan of care, goals for admission, and goals for safety, Dr. Ganem said.

Patients who required admission were expected to have an initial length of stay of 72 hours, and those who tested positive for COVID-19 were admitted to a medical unit with COVID-19 isolation, he said.

Once a patient is admitted, an RN activates a suicide prevention pathway, and an interprofessional team meets to determine what patients need for safe and effective discharge, said Dr. Ganem. He cited the SAFE-T protocol (Suicide Assessment Five-step Evaluation and Triage) as one of the tools used to determine safe discharge criteria. Considerations on the SAFE-T list include family support, an established outpatient therapist and psychiatrist, no suicide attempts prior to the current admission, or a low lethality attempt, and access to partial hospitalization or intensive outpatient programs.

Patients who could not be discharged because of suicidality or inadequate support or concerns about safety at home were considered for inpatient admission. Patients with COVID-19–positive tests who had continued need for inpatient mental health services could be transferred to an inpatient mental health unit after a 10-day quarantine.

Overall, “this has been a continuum of lessons learned, with some things we know now that we didn’t know in April or May of 2020,” Dr. Ganem said. Early in the pandemic, the focus was on minimizing risk, securing personal protective equipment, and determining who provided services in a patient’s room. “We developed new paradigms on the fly,” he said, including the use of virtual visits, which included securing and cleaning devices, as well as learning how to use them in this setting,” he said.

More recently, the emphasis has been on providing services to patients before they need to visit the hospital, rather than automatically admitting any patients with suicidal ideation and a positive COVID-19 test, Dr. Ganem said.

Dr. Talebi and Dr. Ganem had no financial conflicts to disclose. The conference was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

The COVID-19 pandemic continues to impact child and adolescent mental health, and clinicians are learning as they go to develop strategies that address the challenges of providing both medical and mental health care to young patients, including those who test positive for COVID-19, according to Hani Talebi, PhD, director of pediatric psychology, and Jorge Ganem, MD, FAAP, director of pediatric hospital medicine, both of the University of Texas at Austin and Dell Children’s Medical Center.

In a presentation at the 2021 virtual Pediatric Hospital Medicine conference, Dr. Talebi and Dr. Ganem shared their experiences in identifying the impact of the pandemic on mental health services in a freestanding hospital, and synthesizing inpatient mental health care and medical care outside of a dedicated mental health unit.

Mental health is a significant pediatric issue; approximately one in five children have a diagnosable mental or behavioral health problem, but nearly two-thirds get little or no help, Dr. Talebi said. “COVID-19 has only exacerbated these mental health challenges,” he said.

He noted that beginning in April 2020, the proportion of children’s mental health-related emergency department visits increased and remained elevated through the spring, summer, and fall of 2020, as families fearful of COVID-19 avoided regular hospital visits.

Data suggest that up to 50% of all adolescent psychiatric crises that led to inpatient admissions were related in some way to COVID-19, Dr. Talebi said. In addition, “individuals with a recent diagnosis of a mental health disorder are at increased risk for COVID-19 infection,” and the risk is even higher among women and African Americans, he said.

The past year significantly impacted the mental wellbeing of parents and children, Dr. Talebi said. He cited a June 2020 study in Pediatrics in which 27% of parents reported worsening mental health for themselves, and 14% reported worsening behavioral health for their children. Ongoing issues including food insecurity, loss of regular child care, and an overall “very disorienting experience in the day-to-day” compromised the mental health of families, Dr. Talebi emphasized. Children isolated at home were not meeting developmental milestones that organically occur when socializing with peers, parents didn’t know how to handle some of their children’s issues without support from schools, and many people were struggling with other preexisting health conditions, he said.

This confluence of factors helped drive a surge in emergency department visits, meaning longer wait times and concerns about meeting urgent medical and mental health needs while maintaining safety, he added.

Parents and children waited longer to seek care, and community hospitals such as Dell Children’s Medical Center were faced with children in the emergency department with crisis-level mental health issues, along with children already waiting in the ED to address medical emergencies. All these patients had to be tested for COVID-19 and managed accordingly, Dr. Talebi noted.

Dr. Talebi emphasized the need for clinically robust care of the children who were in isolation for 10 days on the medical unit, waiting to test negative. New protocols were created for social workers to conduct daily safety checks, and to develop regular schedules for screening, “so they are having an experience on the medical floors similar to what they would have in a mental health unit,” he said.

Dr. Ganem reflected on the logistical challenges of managing mental health care while observing COVID-19 safety protocols. “COVID-19 added a new wrinkle of isolation,” he said. As institutional guidelines on testing and isolation evolved, negative COVID-19 tests were required for admission to the mental health units both in the hospital and throughout the region. Patients who tested positive had to be quarantined for 10 days, at which time they could be admitted to a mental health unit if necessary, he said.

Dr. Ganem shared details of some strategies adopted by Dell Children’s. He explained that the COVID-19 psychiatry patient workflow started with an ED evaluation, followed by medical clearance and consideration for admission.

“There was significant coordination between the social worker in the emergency department and the psychiatry social worker,” he said.

Key elements of the treatment plan for children with positive COVID-19 tests included an “interprofessional huddle” to coordinate the plan of care, goals for admission, and goals for safety, Dr. Ganem said.

Patients who required admission were expected to have an initial length of stay of 72 hours, and those who tested positive for COVID-19 were admitted to a medical unit with COVID-19 isolation, he said.

Once a patient is admitted, an RN activates a suicide prevention pathway, and an interprofessional team meets to determine what patients need for safe and effective discharge, said Dr. Ganem. He cited the SAFE-T protocol (Suicide Assessment Five-step Evaluation and Triage) as one of the tools used to determine safe discharge criteria. Considerations on the SAFE-T list include family support, an established outpatient therapist and psychiatrist, no suicide attempts prior to the current admission, or a low lethality attempt, and access to partial hospitalization or intensive outpatient programs.

Patients who could not be discharged because of suicidality or inadequate support or concerns about safety at home were considered for inpatient admission. Patients with COVID-19–positive tests who had continued need for inpatient mental health services could be transferred to an inpatient mental health unit after a 10-day quarantine.

Overall, “this has been a continuum of lessons learned, with some things we know now that we didn’t know in April or May of 2020,” Dr. Ganem said. Early in the pandemic, the focus was on minimizing risk, securing personal protective equipment, and determining who provided services in a patient’s room. “We developed new paradigms on the fly,” he said, including the use of virtual visits, which included securing and cleaning devices, as well as learning how to use them in this setting,” he said.

More recently, the emphasis has been on providing services to patients before they need to visit the hospital, rather than automatically admitting any patients with suicidal ideation and a positive COVID-19 test, Dr. Ganem said.

Dr. Talebi and Dr. Ganem had no financial conflicts to disclose. The conference was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Hospitalized COVID-19 patients at increased risk for respiratory failure showed significant improvement after treatment with anakinra, compared with placebo, based on data from a phase 3, randomized trial of nearly 600 patients who also received standard of care treatment.

Anakinra, a recombinant interleukin (IL)-1 receptor antagonist that blocks activity for both IL-1 alpha and beta, showed a 70% decrease in the risk of progression to severe respiratory failure in a prior open-label, phase 2, proof-of-concept study, wrote Evdoxia Kyriazopoulou, MD, PhD, of National and Kapodistrian University of Athens, and colleagues.

Previous research has shown that soluble urokinase plasminogen activator receptor (suPAR) serum levels can signal increased risk of progression to severe disease and respiratory failure in COVID-19 patients, they noted.

Supported by these early findings, “the SAVE-MORE study (suPAR-guided anakinra treatment for validation of the risk and early management of severe respiratory failure by COVID-19) is a pivotal, confirmatory, phase 3, double-blind, randomized controlled trial that evaluated the efficacy and safety of early initiation of anakinra treatment in hospitalized patients with moderate or severe COVID-19,” the researchers said.

In the SAVE-MORE study published Sept. 3 in Nature Medicine, the researchers identified 594 adults with COVID-19 who were hospitalized at 37 centers in Greece and Italy and at risk of progressing to respiratory failure based on plasma suPAR levels of at least 6 ng/mL.

The primary objective was to assess the impact of early anakinra treatment on the clinical status of COVID-19 patients at risk for severe disease according to the 11-point, ordinal World Health Organization Clinical Progression Scale (WHO-CPS) at 28 days after starting treatment. All patients received standard of care, which consisted of regular monitoring of physical signs, oximetry, and anticoagulation. Patients with severe disease by the WHO definition were also received 6 mg of dexamethasone intravenously daily for 10 days. A total of 405 were randomized to anakinra and 189 to placebo. Approximately 92% of the study participants had severe pneumonia according to the WHO classification for COVID-19. The average age of the patients was 62 years, 58% were male, and the average body mass index was 29.5 kg/m².

At 28 days, 204 (50.4%) of the anakinra-treated patients had fully recovered, with no detectable viral RNA, compared with 50 (26.5%) of the placebo-treated patients (P < .0001). In addition, significantly fewer patients in the anakinra group had died by 28 days (13 patients, 3.2%), compared with patients in the placebo group (13 patients, 6.9%).

The median decrease in WHO-CPS scores from baseline to 28 days was 4 points in the anakinra group and 3 points in the placebo group, a statistically significant difference (P < .0001).

“Overall, the unadjusted proportional odds of having a worse score on the 11-point WHO-CPS at day 28 with anakinra was 0.36 versus placebo,” and this number remained the same in adjusted analysis, the researchers wrote.

All five secondary endpoints on the WHO-CPS showed significant benefits of anakinra, compared with placebo. These included an absolute decrease of WHO-CPS at day 28 and day 14 from baseline; an absolute decrease of Sequential Organ Failure Assessment scores at day 7 from baseline; and a significantly shorter mean time to both hospital and ICU discharge (1 day and 4 days, respectively) with anakinra versus placebo.

Follow-up laboratory data showed a significant increase in absolute lymphocyte count at 7 days, a significant decrease in circulating IL-6 levels at 4 and 7 days, and significantly decreased plasma C-reactive protein (CRP) levels at 7 days.

Serious treatment-emergent adverse events were reported in 16% with anakinra and in 21.7% with placebo; the most common of these events were infections (8.4% with anakinra and 15.9% with placebo). The next most common serious treatment-emergent adverse events were ventilator-associated pneumonia, septic shock and multiple organ dysfunction, bloodstream infections, and pulmonary embolism. The most common nonserious treatment-emergent adverse events were an increase of liver function tests and hyperglycemia (similar in anakinra and placebo groups) and nonserious anemia (lower in the anakinra group).

The study findings were limited by several factors, including the lack of patients with critical COVID-19 disease and the challenge of application of suPAR in all hospital settings, the researchers noted. However, “the results validate the findings of the previous SAVE open-label phase 2 trial,” they said. The results suggest “that suPAR should be measured upon admission of all patients with COVID-19 who do not need oxygen or who need nasal or mask oxygen, and that, if suPAR levels are 6 ng/mL or higher, anakinra treatment might be a suitable therapy,” they concluded.
 

Cytokine storm syndrome remains a treatment challenge

“Many who die from COVID-19 suffer hyperinflammation with features of cytokine storm syndrome (CSS) and associated acute respiratory distress syndrome,” wrote Randy Q. Cron, MD, and W. Winn Chatham, MD, of the University of Alabama at Birmingham, and Roberto Caricchio, MD, of Temple University, Philadelphia, in an accompanying editorial. They noted that the SAVE-MORE trial results contrast with another recent randomized trial of canakinumab, which failed to show notable benefits, compared with placebo, in treating hospitalized patients with COVID-19 pneumonia.

“There are some key differences between these trials, one being that anakinra blocks signaling of both IL-1 alpha and IL-1 beta, whereas canakinumab binds only IL-1 beta,” the editorialists explained. “SARS-CoV-2–infected endothelium may be a particularly important source of IL-1 alpha that is not targeted by canakinumab,” they noted.

Additional studies have examined IL-6 inhibition to treat COVID-19 patients, but data have been inconsistent, the editorialists said.

“One thing that is clearly emerging from this pandemic is that the CSS associated with COVID-19 is relatively unique, with only modestly elevated levels of IL-6, CRP, and ferritin, for example,” they noted. However, the SAVE-MORE study suggests that more targeted approaches, such as anakinra, “may allow earlier introduction of anticytokine treatment” and support the use of IL-1 blockade with anakinra for cases of severe COVID-19 pneumonia.
 

Predicting risk for severe disease

“One of the major challenges in the management of patients with COVID-19 is identifying patients at risk of severe disease who would warrant early intervention with anti-inflammatory therapy,” said Salim Hayek, MD, medical director of the University of Michigan’s Frankel Cardiovascular Center Clinics, in an interview. “We and others had found that soluble urokinase plasminogen activator receptor (suPAR) levels are the strongest predictor of severe disease amongst biomarkers of inflammation,” he said. “In this study, patients with high suPAR levels derived benefit from anakinra, compared to those with placebo. This study is a great example of how suPAR levels could be used to identify high-risk patients that would benefit from therapies targeting inflammation,” Dr. Hayek emphasized.

“The findings are in line with the hypothesis that patients with the highest degrees of inflammation would benefit the best from targeting the hyperinflammatory cascade using anakinra or other interleukin antagonists,” Dr. Hayek said. “Given suPAR levels are the best predictors of high-risk disease, it is not surprising to see that patients with high levels benefit from targeting inflammation,” he noted.

The take-home message for clinicians at this time is that anakinra effectively improves outcomes in COVID-19 patients with high suPAR levels, Dr. Hayek said. “SuPAR can be measured easily at the point of care. Thus, a targeted strategy using suPAR to identify patients who would benefit from anakinra appears to be viable,” he explained.

However, “Whether anakinra is effective in patients with lower suPAR levels (<6 ng/mL) is unclear and was not answered by this study,” he said. “We eagerly await results of other trials to make that determination. Whether suPAR levels can also help guide the use of other therapies for COVID-19 should be explored and would enhance the personalization of treatment for COVID-19 according to the underlying inflammatory state,” he added.

The SAVE-MORE study was funded by the Hellenic Institute for the Study of Sepsis and Sobi, which manufactures anakinra. Some of the study authors reported financial relationships with Sobi and other pharmaceutical companies.

Dr. Cron disclosed serving as a consultant to Sobi, Novartis, Pfizer, and Sironax. Dr. Cron and Dr. Chatham disclosed having received grant support from Sobi for investigator-initiated clinical trials, and Dr. Caricchio disclosed serving as a consultant to GlaxoSmithKline, Johnson & Johnson, Aurinia, and Bristol-Myers Squibb. Dr. Hayek had no relevant financial conflicts to disclose.

Hospitalized COVID-19 patients at increased risk for respiratory failure showed significant improvement after treatment with anakinra, compared with placebo, based on data from a phase 3, randomized trial of nearly 600 patients who also received standard of care treatment.

Anakinra, a recombinant interleukin (IL)-1 receptor antagonist that blocks activity for both IL-1 alpha and beta, showed a 70% decrease in the risk of progression to severe respiratory failure in a prior open-label, phase 2, proof-of-concept study, wrote Evdoxia Kyriazopoulou, MD, PhD, of National and Kapodistrian University of Athens, and colleagues.

Previous research has shown that soluble urokinase plasminogen activator receptor (suPAR) serum levels can signal increased risk of progression to severe disease and respiratory failure in COVID-19 patients, they noted.

Supported by these early findings, “the SAVE-MORE study (suPAR-guided anakinra treatment for validation of the risk and early management of severe respiratory failure by COVID-19) is a pivotal, confirmatory, phase 3, double-blind, randomized controlled trial that evaluated the efficacy and safety of early initiation of anakinra treatment in hospitalized patients with moderate or severe COVID-19,” the researchers said.

In the SAVE-MORE study published Sept. 3 in Nature Medicine, the researchers identified 594 adults with COVID-19 who were hospitalized at 37 centers in Greece and Italy and at risk of progressing to respiratory failure based on plasma suPAR levels of at least 6 ng/mL.

The primary objective was to assess the impact of early anakinra treatment on the clinical status of COVID-19 patients at risk for severe disease according to the 11-point, ordinal World Health Organization Clinical Progression Scale (WHO-CPS) at 28 days after starting treatment. All patients received standard of care, which consisted of regular monitoring of physical signs, oximetry, and anticoagulation. Patients with severe disease by the WHO definition were also received 6 mg of dexamethasone intravenously daily for 10 days. A total of 405 were randomized to anakinra and 189 to placebo. Approximately 92% of the study participants had severe pneumonia according to the WHO classification for COVID-19. The average age of the patients was 62 years, 58% were male, and the average body mass index was 29.5 kg/m².

At 28 days, 204 (50.4%) of the anakinra-treated patients had fully recovered, with no detectable viral RNA, compared with 50 (26.5%) of the placebo-treated patients (P < .0001). In addition, significantly fewer patients in the anakinra group had died by 28 days (13 patients, 3.2%), compared with patients in the placebo group (13 patients, 6.9%).

The median decrease in WHO-CPS scores from baseline to 28 days was 4 points in the anakinra group and 3 points in the placebo group, a statistically significant difference (P < .0001).

“Overall, the unadjusted proportional odds of having a worse score on the 11-point WHO-CPS at day 28 with anakinra was 0.36 versus placebo,” and this number remained the same in adjusted analysis, the researchers wrote.

All five secondary endpoints on the WHO-CPS showed significant benefits of anakinra, compared with placebo. These included an absolute decrease of WHO-CPS at day 28 and day 14 from baseline; an absolute decrease of Sequential Organ Failure Assessment scores at day 7 from baseline; and a significantly shorter mean time to both hospital and ICU discharge (1 day and 4 days, respectively) with anakinra versus placebo.

Follow-up laboratory data showed a significant increase in absolute lymphocyte count at 7 days, a significant decrease in circulating IL-6 levels at 4 and 7 days, and significantly decreased plasma C-reactive protein (CRP) levels at 7 days.

Serious treatment-emergent adverse events were reported in 16% with anakinra and in 21.7% with placebo; the most common of these events were infections (8.4% with anakinra and 15.9% with placebo). The next most common serious treatment-emergent adverse events were ventilator-associated pneumonia, septic shock and multiple organ dysfunction, bloodstream infections, and pulmonary embolism. The most common nonserious treatment-emergent adverse events were an increase of liver function tests and hyperglycemia (similar in anakinra and placebo groups) and nonserious anemia (lower in the anakinra group).

The study findings were limited by several factors, including the lack of patients with critical COVID-19 disease and the challenge of application of suPAR in all hospital settings, the researchers noted. However, “the results validate the findings of the previous SAVE open-label phase 2 trial,” they said. The results suggest “that suPAR should be measured upon admission of all patients with COVID-19 who do not need oxygen or who need nasal or mask oxygen, and that, if suPAR levels are 6 ng/mL or higher, anakinra treatment might be a suitable therapy,” they concluded.
 

Cytokine storm syndrome remains a treatment challenge

“Many who die from COVID-19 suffer hyperinflammation with features of cytokine storm syndrome (CSS) and associated acute respiratory distress syndrome,” wrote Randy Q. Cron, MD, and W. Winn Chatham, MD, of the University of Alabama at Birmingham, and Roberto Caricchio, MD, of Temple University, Philadelphia, in an accompanying editorial. They noted that the SAVE-MORE trial results contrast with another recent randomized trial of canakinumab, which failed to show notable benefits, compared with placebo, in treating hospitalized patients with COVID-19 pneumonia.

“There are some key differences between these trials, one being that anakinra blocks signaling of both IL-1 alpha and IL-1 beta, whereas canakinumab binds only IL-1 beta,” the editorialists explained. “SARS-CoV-2–infected endothelium may be a particularly important source of IL-1 alpha that is not targeted by canakinumab,” they noted.

Additional studies have examined IL-6 inhibition to treat COVID-19 patients, but data have been inconsistent, the editorialists said.

“One thing that is clearly emerging from this pandemic is that the CSS associated with COVID-19 is relatively unique, with only modestly elevated levels of IL-6, CRP, and ferritin, for example,” they noted. However, the SAVE-MORE study suggests that more targeted approaches, such as anakinra, “may allow earlier introduction of anticytokine treatment” and support the use of IL-1 blockade with anakinra for cases of severe COVID-19 pneumonia.
 

Predicting risk for severe disease

“One of the major challenges in the management of patients with COVID-19 is identifying patients at risk of severe disease who would warrant early intervention with anti-inflammatory therapy,” said Salim Hayek, MD, medical director of the University of Michigan’s Frankel Cardiovascular Center Clinics, in an interview. “We and others had found that soluble urokinase plasminogen activator receptor (suPAR) levels are the strongest predictor of severe disease amongst biomarkers of inflammation,” he said. “In this study, patients with high suPAR levels derived benefit from anakinra, compared to those with placebo. This study is a great example of how suPAR levels could be used to identify high-risk patients that would benefit from therapies targeting inflammation,” Dr. Hayek emphasized.

“The findings are in line with the hypothesis that patients with the highest degrees of inflammation would benefit the best from targeting the hyperinflammatory cascade using anakinra or other interleukin antagonists,” Dr. Hayek said. “Given suPAR levels are the best predictors of high-risk disease, it is not surprising to see that patients with high levels benefit from targeting inflammation,” he noted.

The take-home message for clinicians at this time is that anakinra effectively improves outcomes in COVID-19 patients with high suPAR levels, Dr. Hayek said. “SuPAR can be measured easily at the point of care. Thus, a targeted strategy using suPAR to identify patients who would benefit from anakinra appears to be viable,” he explained.

However, “Whether anakinra is effective in patients with lower suPAR levels (<6 ng/mL) is unclear and was not answered by this study,” he said. “We eagerly await results of other trials to make that determination. Whether suPAR levels can also help guide the use of other therapies for COVID-19 should be explored and would enhance the personalization of treatment for COVID-19 according to the underlying inflammatory state,” he added.

The SAVE-MORE study was funded by the Hellenic Institute for the Study of Sepsis and Sobi, which manufactures anakinra. Some of the study authors reported financial relationships with Sobi and other pharmaceutical companies.

Dr. Cron disclosed serving as a consultant to Sobi, Novartis, Pfizer, and Sironax. Dr. Cron and Dr. Chatham disclosed having received grant support from Sobi for investigator-initiated clinical trials, and Dr. Caricchio disclosed serving as a consultant to GlaxoSmithKline, Johnson & Johnson, Aurinia, and Bristol-Myers Squibb. Dr. Hayek had no relevant financial conflicts to disclose.

Hospitalized COVID-19 patients at increased risk for respiratory failure showed significant improvement after treatment with anakinra, compared with placebo, based on data from a phase 3, randomized trial of nearly 600 patients who also received standard of care treatment.

Anakinra, a recombinant interleukin (IL)-1 receptor antagonist that blocks activity for both IL-1 alpha and beta, showed a 70% decrease in the risk of progression to severe respiratory failure in a prior open-label, phase 2, proof-of-concept study, wrote Evdoxia Kyriazopoulou, MD, PhD, of National and Kapodistrian University of Athens, and colleagues.

Previous research has shown that soluble urokinase plasminogen activator receptor (suPAR) serum levels can signal increased risk of progression to severe disease and respiratory failure in COVID-19 patients, they noted.

Supported by these early findings, “the SAVE-MORE study (suPAR-guided anakinra treatment for validation of the risk and early management of severe respiratory failure by COVID-19) is a pivotal, confirmatory, phase 3, double-blind, randomized controlled trial that evaluated the efficacy and safety of early initiation of anakinra treatment in hospitalized patients with moderate or severe COVID-19,” the researchers said.

In the SAVE-MORE study published Sept. 3 in Nature Medicine, the researchers identified 594 adults with COVID-19 who were hospitalized at 37 centers in Greece and Italy and at risk of progressing to respiratory failure based on plasma suPAR levels of at least 6 ng/mL.

The primary objective was to assess the impact of early anakinra treatment on the clinical status of COVID-19 patients at risk for severe disease according to the 11-point, ordinal World Health Organization Clinical Progression Scale (WHO-CPS) at 28 days after starting treatment. All patients received standard of care, which consisted of regular monitoring of physical signs, oximetry, and anticoagulation. Patients with severe disease by the WHO definition were also received 6 mg of dexamethasone intravenously daily for 10 days. A total of 405 were randomized to anakinra and 189 to placebo. Approximately 92% of the study participants had severe pneumonia according to the WHO classification for COVID-19. The average age of the patients was 62 years, 58% were male, and the average body mass index was 29.5 kg/m².

At 28 days, 204 (50.4%) of the anakinra-treated patients had fully recovered, with no detectable viral RNA, compared with 50 (26.5%) of the placebo-treated patients (P < .0001). In addition, significantly fewer patients in the anakinra group had died by 28 days (13 patients, 3.2%), compared with patients in the placebo group (13 patients, 6.9%).

The median decrease in WHO-CPS scores from baseline to 28 days was 4 points in the anakinra group and 3 points in the placebo group, a statistically significant difference (P < .0001).

“Overall, the unadjusted proportional odds of having a worse score on the 11-point WHO-CPS at day 28 with anakinra was 0.36 versus placebo,” and this number remained the same in adjusted analysis, the researchers wrote.

All five secondary endpoints on the WHO-CPS showed significant benefits of anakinra, compared with placebo. These included an absolute decrease of WHO-CPS at day 28 and day 14 from baseline; an absolute decrease of Sequential Organ Failure Assessment scores at day 7 from baseline; and a significantly shorter mean time to both hospital and ICU discharge (1 day and 4 days, respectively) with anakinra versus placebo.

Follow-up laboratory data showed a significant increase in absolute lymphocyte count at 7 days, a significant decrease in circulating IL-6 levels at 4 and 7 days, and significantly decreased plasma C-reactive protein (CRP) levels at 7 days.

Serious treatment-emergent adverse events were reported in 16% with anakinra and in 21.7% with placebo; the most common of these events were infections (8.4% with anakinra and 15.9% with placebo). The next most common serious treatment-emergent adverse events were ventilator-associated pneumonia, septic shock and multiple organ dysfunction, bloodstream infections, and pulmonary embolism. The most common nonserious treatment-emergent adverse events were an increase of liver function tests and hyperglycemia (similar in anakinra and placebo groups) and nonserious anemia (lower in the anakinra group).

The study findings were limited by several factors, including the lack of patients with critical COVID-19 disease and the challenge of application of suPAR in all hospital settings, the researchers noted. However, “the results validate the findings of the previous SAVE open-label phase 2 trial,” they said. The results suggest “that suPAR should be measured upon admission of all patients with COVID-19 who do not need oxygen or who need nasal or mask oxygen, and that, if suPAR levels are 6 ng/mL or higher, anakinra treatment might be a suitable therapy,” they concluded.
 

Cytokine storm syndrome remains a treatment challenge

“Many who die from COVID-19 suffer hyperinflammation with features of cytokine storm syndrome (CSS) and associated acute respiratory distress syndrome,” wrote Randy Q. Cron, MD, and W. Winn Chatham, MD, of the University of Alabama at Birmingham, and Roberto Caricchio, MD, of Temple University, Philadelphia, in an accompanying editorial. They noted that the SAVE-MORE trial results contrast with another recent randomized trial of canakinumab, which failed to show notable benefits, compared with placebo, in treating hospitalized patients with COVID-19 pneumonia.

“There are some key differences between these trials, one being that anakinra blocks signaling of both IL-1 alpha and IL-1 beta, whereas canakinumab binds only IL-1 beta,” the editorialists explained. “SARS-CoV-2–infected endothelium may be a particularly important source of IL-1 alpha that is not targeted by canakinumab,” they noted.

Additional studies have examined IL-6 inhibition to treat COVID-19 patients, but data have been inconsistent, the editorialists said.

“One thing that is clearly emerging from this pandemic is that the CSS associated with COVID-19 is relatively unique, with only modestly elevated levels of IL-6, CRP, and ferritin, for example,” they noted. However, the SAVE-MORE study suggests that more targeted approaches, such as anakinra, “may allow earlier introduction of anticytokine treatment” and support the use of IL-1 blockade with anakinra for cases of severe COVID-19 pneumonia.
 

Predicting risk for severe disease

“One of the major challenges in the management of patients with COVID-19 is identifying patients at risk of severe disease who would warrant early intervention with anti-inflammatory therapy,” said Salim Hayek, MD, medical director of the University of Michigan’s Frankel Cardiovascular Center Clinics, in an interview. “We and others had found that soluble urokinase plasminogen activator receptor (suPAR) levels are the strongest predictor of severe disease amongst biomarkers of inflammation,” he said. “In this study, patients with high suPAR levels derived benefit from anakinra, compared to those with placebo. This study is a great example of how suPAR levels could be used to identify high-risk patients that would benefit from therapies targeting inflammation,” Dr. Hayek emphasized.

“The findings are in line with the hypothesis that patients with the highest degrees of inflammation would benefit the best from targeting the hyperinflammatory cascade using anakinra or other interleukin antagonists,” Dr. Hayek said. “Given suPAR levels are the best predictors of high-risk disease, it is not surprising to see that patients with high levels benefit from targeting inflammation,” he noted.

The take-home message for clinicians at this time is that anakinra effectively improves outcomes in COVID-19 patients with high suPAR levels, Dr. Hayek said. “SuPAR can be measured easily at the point of care. Thus, a targeted strategy using suPAR to identify patients who would benefit from anakinra appears to be viable,” he explained.

However, “Whether anakinra is effective in patients with lower suPAR levels (<6 ng/mL) is unclear and was not answered by this study,” he said. “We eagerly await results of other trials to make that determination. Whether suPAR levels can also help guide the use of other therapies for COVID-19 should be explored and would enhance the personalization of treatment for COVID-19 according to the underlying inflammatory state,” he added.

The SAVE-MORE study was funded by the Hellenic Institute for the Study of Sepsis and Sobi, which manufactures anakinra. Some of the study authors reported financial relationships with Sobi and other pharmaceutical companies.

Dr. Cron disclosed serving as a consultant to Sobi, Novartis, Pfizer, and Sironax. Dr. Cron and Dr. Chatham disclosed having received grant support from Sobi for investigator-initiated clinical trials, and Dr. Caricchio disclosed serving as a consultant to GlaxoSmithKline, Johnson & Johnson, Aurinia, and Bristol-Myers Squibb. Dr. Hayek had no relevant financial conflicts to disclose.

The COVID-19 pandemic is a worldwide tragedy. In the beginning there was a lack of testing, personal protective equipment, COVID tests, and support for health care workers and patients. As 2020 came to a close, the world was given a glimpse of hope with the development of a vaccine against the deadly virus. Many world citizens celebrated the scientific accomplishment and began to breathe a sigh of relief that there was an end in sight. However, the development and distribution of the COVID-19 vaccine revealed a new challenge, vaccine hesitancy.

Community members, young healthy people, and even critically ill hospitalized patients who have the fortune of surviving acute illness are hesitant to the COVID-19 vaccine. I recently cared for a critically ill young patient who was intubated for days with status asthmaticus, one of the worst cases I’d ever seen. She was extubated and made a full recovery. Prior to discharge I asked if she wanted the first dose of the COVID-19 vaccine and she said, “No.” I was shocked. This was an otherwise healthy 30-something-year-old who was lucky enough to survive without any underlying infection in the setting of severe obstructive lung disease. A co-infection with COVID-19 would be disastrous and increase her mortality. I had a long talk at the bedside and asked the reason for her hesitancy. Her answer left me speechless, “I don’t know, I just don’t want to.” I ultimately convinced her that contracting COVID-19 would be a fate worse than she could imagine, and she agreed to the vaccine prior to discharge. This interaction made me ponder – “why are our patients, friends, and family members hesitant about receiving a lifesaving vaccine, especially when they are aware of how sick they or others can become without it?”

According to the World Health Organization, vaccine hesitancy refers to a delay in acceptance or refusal of vaccines despite availability of vaccine services. Vaccine hesitancy is complex and context specific, varying across time, place, and vaccines. It is influenced by factors such as complacency, convenience, and confidence.¹ No vaccine is 100% effective. However, throughout history, the work of scientists and doctors to create vaccines saved millions of lives and revolutionized global health. Arguably, the single most life-saving innovation in the history of medicine, vaccines have eradicated smallpox, protected against whooping cough (1914), diphtheria (1926), tetanus (1938), influenza (1945) and mumps (1948), polio (1955), measles (1963), and rubella (1969), and worldwide vaccination rates increased dramatically thanks to successful global health campaigns.² However, there was a paradox of vaccine success. As terrifying diseases decreased in prevalence, so did the fear of these diseases and their effects – paralysis, brain damage, blindness, and death. This gave birth to a new challenge in modern medicine, vaccine hesitancy – a privilege of first world nations.

Vaccines saved countless lives and improved health and wellbeing around the world for decades. However, to prevent the morbidity and mortality associated with vaccine-preventable diseases and their complications, and optimize control of vaccine-preventable diseases in communities, high vaccination rates must be achieved. Enter the COVID-19 pandemic, the creation of the COVID-19 vaccine, and vaccine hesitancy.

The question we ask ourselves as health care providers is ‘how do we convince the skeptics and those opposed to vaccination to take the vaccine?’ The answer is complicated. If you are like me, you’ve had many conversations with people – friends, patients, family members, who are resistant to the vaccine. Very often the facts are not well received, and those discussions end in argument, high emotions, and broken relationships. With the delta variant of COVID-19 on the rise, spreading aggressively among the unvaccinated, and increased hospitalizations, we foresee the reoccurrence of overwhelmed health systems and a continued death toll.

The new paradox we are faced with is that people choose to believe fiction versus fact, despite the real life evidence of the severe health effects and increased deaths related to COVID-19. Do these skeptics simply have a cavalier attitude towards not only their own life, but the lives of others? Or, is there something deeper? It is not enough to tell people that the vaccines are proven safe³ and are more widely available than ever. It is not enough to tell people that they can die of COVID-19 – they already know that. Emotional pleas to family members are falling on deaf ears. This past month, when asking patients why they don’t want the vaccine, many have no real legitimate health-related reason and respond with a simple, “I don’t want to.” So, how do we get through to the unvaccinated?
 

A compassionate approach

We navigate these difficult conversations over time with the approach of compassion and empathy, not hostility or bullying. As health care providers, we start by being good empathic listeners. Similar to when we have advance care planning and code status conversations, we cannot enter the dialogue with our intention, beliefs, or formulated goals for that person. We have to listen without judgement to the wide range of reasons why others are reluctant or unwilling to get the vaccine – historical mistrust, political identity, religious reasons, short-term side effects that may cause them to lose a day or two of work – and understand that for each person their reasons are different. The point is to not assume that you know or understand what barriers and beliefs they have towards vaccination, but to meet them at their point of view and listen while keeping your own emotions level and steady.

Identifying the reason for vaccine hesitancy is the first step to getting the unvaccinated closer to vaccination. Ask open ended questions: “Can you help me understand, what is your hesitancy to the vaccine?”; “What about the vaccine worries you?”; “What have you heard about/know about the COVID-19 vaccine?”; or “Can you tell me more about why you feel that way?” As meticulous as it sounds, we have to go back to the basics of patient interviewing.

It is important to remember that this is not a debate and escalation to arguments will certainly backfire. Think about any time you disagreed with someone on a topic. Did criticizing, blaming, and shaming ever convince you to change your beliefs or behaviors? The likely answer is, “No.” Avoid the “backfire effect”– which is when giving people facts disproving their “incorrect” beliefs can actually reinforce those beliefs. The more people are confronted with facts at odds with their opinions, the stronger they cling to those opinions. If you want them to change their mind, you cannot approach the conversation as a debate. You are having this vaccine discussion to try to meet the other person where they are, understand their position, and talk with them, and not at them, about their concerns.

As leaders in health care, we have to be willing to give up control and lead with empathy. We have to show others that we hear them, believe their concerns, and acknowledge that their beliefs are valid to them as individuals. Even if you disagree, this is not the place to let anger, disappointment, or resentment take a front seat. This is about balance, and highlighting the autonomy in decision making that the other person has to make a choice. Be humble in these conversations and avoid condescending tones or statements.

We already know that you are a caring health care provider. As hospitalists, we are frontline providers who have seen unnecessary deaths and illness due to COVID-19. You are passionate and motivated because you are committed to your oath to save lives. However, you have to check your own feelings and remember that you are not speaking with an unvaccinated person to make them get vaccinated, but rather to understand their cognitive process and hopefully walk with them down a path that provides them with a clarity of options they truly have. Extend empathy and they will see your motivation is rooted in good-heartedness and a concern for their wellbeing.

If someone admits to reasons for avoiding vaccination that are not rooted in any fact, then guide them to the best resources. Our health care system recently released a COVID-19 fact versus myth handout called Trust the Facts. This could be the kind of vetted resource you offer. Guide them to accredited websites, such as the World Health Organization, the Center for Disease Control, or their local and state departments of health to help debunk fiction by reviewing it with them. Discuss myths such as, ‘the vaccine will cause infertility,’ ‘the vaccine will give me COVID,’ ‘the vaccine was rushed and is not safe,’ ‘the vaccine is not needed if I am young and healthy,’ ‘the vaccine has a microchip,’ etc. Knowledge is power and disinformation is deadly, but how facts are presented will make the biggest difference in how others receive them, so remember your role is not to argue with these statements, but rather to provide perspective without agreeing or disagreeing.

Respond to their concerns with statements such as, “I hear you…it sounds like you are worried/fearful/mistrusting about the side effects/safety/efficacy of the vaccine…can we talk more about that?” Ask them where these concerns come from – the news, social media, an article, word of mouth, friends, or family. Ask them about the information they have and show genuine interest that you want to see it from their perspective. This is the key to compassionate and empathic dialogue – you relinquish your intentions.

Once you know or unveil their reasons for hesitancy, ask them what they would like to see with regards to COVID-19 and ending the pandemic. Would they like to get back to a new normal, to visit family members, to travel once again, to not have to wear masks and quarantine? What do they want for themselves, their families, communities, the country, or even the world? The goal is to find something in our shared humanity, to connect on a deeper level so they start to open up and let down walls, and find something you both see eye-to-eye on. Know your audience and speak to what serves them. To effectively persuade someone to come around to your point of view starts with recognizing the root of the disagreement and trying to overcome it before trying to change the person’s mind, understanding both the logic and the emotion that’s driving their decision making.⁴
 

Building trust

Reminding patients, friends or family members that their health and well-being means a lot to you can also be a strategy to keeping the conversation open and friendly. Sharing stories as hospitalists caring for many critically ill COVID patients or patients who died alone due to COVID-19, and the trauma you experienced as a health care provider feeling paralyzed by the limitations of modern medicine against the deadly virus, will only serve to humanize you in such an interaction.

Building trust will also increase vaccine willingness. This will require a concerted effort by scientists, doctors, and health care systems to engage with community leaders and members. To address hesitancy, the people we serve have to hear those local, personal, and relatable stories about vaccinations, and how it benefits not just themselves, but others around them in their community. As part of the #VaxUp campaign in Virginia, community and physician leaders shared their stories of hesitancy and motivation surrounding the vaccine. These are real people in the community discussing why getting vaccinated is so important and what helped them make an informed decision. I discussed my own hesitancy and concerns and also tackled a few vaccine myths.

As vaccinated health care workers or community leaders, you are living proof of the benefits of getting the COVID vaccine. Focus on the positives but also be honest. If your second shot gave you fevers, chills, or myalgias, then admit it and share how you overcame these expected reactions. Refocus on the safety of the vaccine and the fact that it is freely available to all people. Maybe the person you are speaking with doesn’t know where or how to get an appointment to get vaccinated. Help them find the nearest place to get an appointment and identify barriers they may have in transportation, child, or senior care to leave home safely to get vaccinated, or physical conditions that are preventing them from receiving the vaccine. Share that being vaccinated protects you from contracting the virus and spreading it to loved ones. Focus on how a fully vaccinated community and country can open up opportunities to heal and connect as a society, spend time with family/friends in another county or state, hold a newborn grandchild, or even travel outside the U.S.

There is no guarantee that you will be able to persuade someone to get vaccinated. It’s possible the outcome of your conversation will not result in the other person changing their mind in that moment. That doesn’t mean that you failed, because you started the dialogue and planted the seed. If you are a vaccinated health care provider, your words have influence and power, and we are obliged by our positions to have responsibility for the health of our communities. Don’t be discouraged, as it is through caring, compassionate, respectful, and empathic conversations that your influence will make the most difference in these relationships as you continue to advocate for all human life.
 

Dr. Williams is vice president of the Hampton Roads chapter of the Society of Hospital Medicine. She is a hospitalist at Sentara Careplex Hospital in Hampton, Va., where she also serves as vice president of the Medical Executive Committee.

References

1. World Health Organization. Report of the SAGE working group on vaccine hesitancy. Oct 2014. https://www.who.int/immunization/sage/meetings/2014/october/1_Report_WORKING_GROUP_vaccine_hesitancy_final.pdf

2. Hsu JL. A brief history of vaccines: Smallpox to the present. S D Med. 2013;Spec no:33-7. PMID: 23444589.

3. Chiu A, Bever L. Are they experimental? Can they alter DNA? Experts tackle lingering coronavirus vaccine fears. The Washington Post. 2021 May 14. https://www.washingtonpost.com/lifestyle/2021/05/14/safe-fast-vaccine-fear-infertility-dna/

4. Huang L. Edge: Turning Adversity into Advantage. New York: Portfolio/Penguin, 2020.

The COVID-19 pandemic is a worldwide tragedy. In the beginning there was a lack of testing, personal protective equipment, COVID tests, and support for health care workers and patients. As 2020 came to a close, the world was given a glimpse of hope with the development of a vaccine against the deadly virus. Many world citizens celebrated the scientific accomplishment and began to breathe a sigh of relief that there was an end in sight. However, the development and distribution of the COVID-19 vaccine revealed a new challenge, vaccine hesitancy.

Community members, young healthy people, and even critically ill hospitalized patients who have the fortune of surviving acute illness are hesitant to the COVID-19 vaccine. I recently cared for a critically ill young patient who was intubated for days with status asthmaticus, one of the worst cases I’d ever seen. She was extubated and made a full recovery. Prior to discharge I asked if she wanted the first dose of the COVID-19 vaccine and she said, “No.” I was shocked. This was an otherwise healthy 30-something-year-old who was lucky enough to survive without any underlying infection in the setting of severe obstructive lung disease. A co-infection with COVID-19 would be disastrous and increase her mortality. I had a long talk at the bedside and asked the reason for her hesitancy. Her answer left me speechless, “I don’t know, I just don’t want to.” I ultimately convinced her that contracting COVID-19 would be a fate worse than she could imagine, and she agreed to the vaccine prior to discharge. This interaction made me ponder – “why are our patients, friends, and family members hesitant about receiving a lifesaving vaccine, especially when they are aware of how sick they or others can become without it?”

According to the World Health Organization, vaccine hesitancy refers to a delay in acceptance or refusal of vaccines despite availability of vaccine services. Vaccine hesitancy is complex and context specific, varying across time, place, and vaccines. It is influenced by factors such as complacency, convenience, and confidence.¹ No vaccine is 100% effective. However, throughout history, the work of scientists and doctors to create vaccines saved millions of lives and revolutionized global health. Arguably, the single most life-saving innovation in the history of medicine, vaccines have eradicated smallpox, protected against whooping cough (1914), diphtheria (1926), tetanus (1938), influenza (1945) and mumps (1948), polio (1955), measles (1963), and rubella (1969), and worldwide vaccination rates increased dramatically thanks to successful global health campaigns.² However, there was a paradox of vaccine success. As terrifying diseases decreased in prevalence, so did the fear of these diseases and their effects – paralysis, brain damage, blindness, and death. This gave birth to a new challenge in modern medicine, vaccine hesitancy – a privilege of first world nations.

Vaccines saved countless lives and improved health and wellbeing around the world for decades. However, to prevent the morbidity and mortality associated with vaccine-preventable diseases and their complications, and optimize control of vaccine-preventable diseases in communities, high vaccination rates must be achieved. Enter the COVID-19 pandemic, the creation of the COVID-19 vaccine, and vaccine hesitancy.

The question we ask ourselves as health care providers is ‘how do we convince the skeptics and those opposed to vaccination to take the vaccine?’ The answer is complicated. If you are like me, you’ve had many conversations with people – friends, patients, family members, who are resistant to the vaccine. Very often the facts are not well received, and those discussions end in argument, high emotions, and broken relationships. With the delta variant of COVID-19 on the rise, spreading aggressively among the unvaccinated, and increased hospitalizations, we foresee the reoccurrence of overwhelmed health systems and a continued death toll.

The new paradox we are faced with is that people choose to believe fiction versus fact, despite the real life evidence of the severe health effects and increased deaths related to COVID-19. Do these skeptics simply have a cavalier attitude towards not only their own life, but the lives of others? Or, is there something deeper? It is not enough to tell people that the vaccines are proven safe³ and are more widely available than ever. It is not enough to tell people that they can die of COVID-19 – they already know that. Emotional pleas to family members are falling on deaf ears. This past month, when asking patients why they don’t want the vaccine, many have no real legitimate health-related reason and respond with a simple, “I don’t want to.” So, how do we get through to the unvaccinated?
 

A compassionate approach

We navigate these difficult conversations over time with the approach of compassion and empathy, not hostility or bullying. As health care providers, we start by being good empathic listeners. Similar to when we have advance care planning and code status conversations, we cannot enter the dialogue with our intention, beliefs, or formulated goals for that person. We have to listen without judgement to the wide range of reasons why others are reluctant or unwilling to get the vaccine – historical mistrust, political identity, religious reasons, short-term side effects that may cause them to lose a day or two of work – and understand that for each person their reasons are different. The point is to not assume that you know or understand what barriers and beliefs they have towards vaccination, but to meet them at their point of view and listen while keeping your own emotions level and steady.

Identifying the reason for vaccine hesitancy is the first step to getting the unvaccinated closer to vaccination. Ask open ended questions: “Can you help me understand, what is your hesitancy to the vaccine?”; “What about the vaccine worries you?”; “What have you heard about/know about the COVID-19 vaccine?”; or “Can you tell me more about why you feel that way?” As meticulous as it sounds, we have to go back to the basics of patient interviewing.

It is important to remember that this is not a debate and escalation to arguments will certainly backfire. Think about any time you disagreed with someone on a topic. Did criticizing, blaming, and shaming ever convince you to change your beliefs or behaviors? The likely answer is, “No.” Avoid the “backfire effect”– which is when giving people facts disproving their “incorrect” beliefs can actually reinforce those beliefs. The more people are confronted with facts at odds with their opinions, the stronger they cling to those opinions. If you want them to change their mind, you cannot approach the conversation as a debate. You are having this vaccine discussion to try to meet the other person where they are, understand their position, and talk with them, and not at them, about their concerns.

As leaders in health care, we have to be willing to give up control and lead with empathy. We have to show others that we hear them, believe their concerns, and acknowledge that their beliefs are valid to them as individuals. Even if you disagree, this is not the place to let anger, disappointment, or resentment take a front seat. This is about balance, and highlighting the autonomy in decision making that the other person has to make a choice. Be humble in these conversations and avoid condescending tones or statements.

We already know that you are a caring health care provider. As hospitalists, we are frontline providers who have seen unnecessary deaths and illness due to COVID-19. You are passionate and motivated because you are committed to your oath to save lives. However, you have to check your own feelings and remember that you are not speaking with an unvaccinated person to make them get vaccinated, but rather to understand their cognitive process and hopefully walk with them down a path that provides them with a clarity of options they truly have. Extend empathy and they will see your motivation is rooted in good-heartedness and a concern for their wellbeing.

If someone admits to reasons for avoiding vaccination that are not rooted in any fact, then guide them to the best resources. Our health care system recently released a COVID-19 fact versus myth handout called Trust the Facts. This could be the kind of vetted resource you offer. Guide them to accredited websites, such as the World Health Organization, the Center for Disease Control, or their local and state departments of health to help debunk fiction by reviewing it with them. Discuss myths such as, ‘the vaccine will cause infertility,’ ‘the vaccine will give me COVID,’ ‘the vaccine was rushed and is not safe,’ ‘the vaccine is not needed if I am young and healthy,’ ‘the vaccine has a microchip,’ etc. Knowledge is power and disinformation is deadly, but how facts are presented will make the biggest difference in how others receive them, so remember your role is not to argue with these statements, but rather to provide perspective without agreeing or disagreeing.

Respond to their concerns with statements such as, “I hear you…it sounds like you are worried/fearful/mistrusting about the side effects/safety/efficacy of the vaccine…can we talk more about that?” Ask them where these concerns come from – the news, social media, an article, word of mouth, friends, or family. Ask them about the information they have and show genuine interest that you want to see it from their perspective. This is the key to compassionate and empathic dialogue – you relinquish your intentions.

Once you know or unveil their reasons for hesitancy, ask them what they would like to see with regards to COVID-19 and ending the pandemic. Would they like to get back to a new normal, to visit family members, to travel once again, to not have to wear masks and quarantine? What do they want for themselves, their families, communities, the country, or even the world? The goal is to find something in our shared humanity, to connect on a deeper level so they start to open up and let down walls, and find something you both see eye-to-eye on. Know your audience and speak to what serves them. To effectively persuade someone to come around to your point of view starts with recognizing the root of the disagreement and trying to overcome it before trying to change the person’s mind, understanding both the logic and the emotion that’s driving their decision making.⁴
 

Building trust

Reminding patients, friends or family members that their health and well-being means a lot to you can also be a strategy to keeping the conversation open and friendly. Sharing stories as hospitalists caring for many critically ill COVID patients or patients who died alone due to COVID-19, and the trauma you experienced as a health care provider feeling paralyzed by the limitations of modern medicine against the deadly virus, will only serve to humanize you in such an interaction.

Building trust will also increase vaccine willingness. This will require a concerted effort by scientists, doctors, and health care systems to engage with community leaders and members. To address hesitancy, the people we serve have to hear those local, personal, and relatable stories about vaccinations, and how it benefits not just themselves, but others around them in their community. As part of the #VaxUp campaign in Virginia, community and physician leaders shared their stories of hesitancy and motivation surrounding the vaccine. These are real people in the community discussing why getting vaccinated is so important and what helped them make an informed decision. I discussed my own hesitancy and concerns and also tackled a few vaccine myths.

As vaccinated health care workers or community leaders, you are living proof of the benefits of getting the COVID vaccine. Focus on the positives but also be honest. If your second shot gave you fevers, chills, or myalgias, then admit it and share how you overcame these expected reactions. Refocus on the safety of the vaccine and the fact that it is freely available to all people. Maybe the person you are speaking with doesn’t know where or how to get an appointment to get vaccinated. Help them find the nearest place to get an appointment and identify barriers they may have in transportation, child, or senior care to leave home safely to get vaccinated, or physical conditions that are preventing them from receiving the vaccine. Share that being vaccinated protects you from contracting the virus and spreading it to loved ones. Focus on how a fully vaccinated community and country can open up opportunities to heal and connect as a society, spend time with family/friends in another county or state, hold a newborn grandchild, or even travel outside the U.S.

There is no guarantee that you will be able to persuade someone to get vaccinated. It’s possible the outcome of your conversation will not result in the other person changing their mind in that moment. That doesn’t mean that you failed, because you started the dialogue and planted the seed. If you are a vaccinated health care provider, your words have influence and power, and we are obliged by our positions to have responsibility for the health of our communities. Don’t be discouraged, as it is through caring, compassionate, respectful, and empathic conversations that your influence will make the most difference in these relationships as you continue to advocate for all human life.
 

Dr. Williams is vice president of the Hampton Roads chapter of the Society of Hospital Medicine. She is a hospitalist at Sentara Careplex Hospital in Hampton, Va., where she also serves as vice president of the Medical Executive Committee.

References

1. World Health Organization. Report of the SAGE working group on vaccine hesitancy. Oct 2014. https://www.who.int/immunization/sage/meetings/2014/october/1_Report_WORKING_GROUP_vaccine_hesitancy_final.pdf

2. Hsu JL. A brief history of vaccines: Smallpox to the present. S D Med. 2013;Spec no:33-7. PMID: 23444589.

3. Chiu A, Bever L. Are they experimental? Can they alter DNA? Experts tackle lingering coronavirus vaccine fears. The Washington Post. 2021 May 14. https://www.washingtonpost.com/lifestyle/2021/05/14/safe-fast-vaccine-fear-infertility-dna/

4. Huang L. Edge: Turning Adversity into Advantage. New York: Portfolio/Penguin, 2020.

The COVID-19 pandemic is a worldwide tragedy. In the beginning there was a lack of testing, personal protective equipment, COVID tests, and support for health care workers and patients. As 2020 came to a close, the world was given a glimpse of hope with the development of a vaccine against the deadly virus. Many world citizens celebrated the scientific accomplishment and began to breathe a sigh of relief that there was an end in sight. However, the development and distribution of the COVID-19 vaccine revealed a new challenge, vaccine hesitancy.

Community members, young healthy people, and even critically ill hospitalized patients who have the fortune of surviving acute illness are hesitant to the COVID-19 vaccine. I recently cared for a critically ill young patient who was intubated for days with status asthmaticus, one of the worst cases I’d ever seen. She was extubated and made a full recovery. Prior to discharge I asked if she wanted the first dose of the COVID-19 vaccine and she said, “No.” I was shocked. This was an otherwise healthy 30-something-year-old who was lucky enough to survive without any underlying infection in the setting of severe obstructive lung disease. A co-infection with COVID-19 would be disastrous and increase her mortality. I had a long talk at the bedside and asked the reason for her hesitancy. Her answer left me speechless, “I don’t know, I just don’t want to.” I ultimately convinced her that contracting COVID-19 would be a fate worse than she could imagine, and she agreed to the vaccine prior to discharge. This interaction made me ponder – “why are our patients, friends, and family members hesitant about receiving a lifesaving vaccine, especially when they are aware of how sick they or others can become without it?”

According to the World Health Organization, vaccine hesitancy refers to a delay in acceptance or refusal of vaccines despite availability of vaccine services. Vaccine hesitancy is complex and context specific, varying across time, place, and vaccines. It is influenced by factors such as complacency, convenience, and confidence.¹ No vaccine is 100% effective. However, throughout history, the work of scientists and doctors to create vaccines saved millions of lives and revolutionized global health. Arguably, the single most life-saving innovation in the history of medicine, vaccines have eradicated smallpox, protected against whooping cough (1914), diphtheria (1926), tetanus (1938), influenza (1945) and mumps (1948), polio (1955), measles (1963), and rubella (1969), and worldwide vaccination rates increased dramatically thanks to successful global health campaigns.² However, there was a paradox of vaccine success. As terrifying diseases decreased in prevalence, so did the fear of these diseases and their effects – paralysis, brain damage, blindness, and death. This gave birth to a new challenge in modern medicine, vaccine hesitancy – a privilege of first world nations.

Vaccines saved countless lives and improved health and wellbeing around the world for decades. However, to prevent the morbidity and mortality associated with vaccine-preventable diseases and their complications, and optimize control of vaccine-preventable diseases in communities, high vaccination rates must be achieved. Enter the COVID-19 pandemic, the creation of the COVID-19 vaccine, and vaccine hesitancy.

The question we ask ourselves as health care providers is ‘how do we convince the skeptics and those opposed to vaccination to take the vaccine?’ The answer is complicated. If you are like me, you’ve had many conversations with people – friends, patients, family members, who are resistant to the vaccine. Very often the facts are not well received, and those discussions end in argument, high emotions, and broken relationships. With the delta variant of COVID-19 on the rise, spreading aggressively among the unvaccinated, and increased hospitalizations, we foresee the reoccurrence of overwhelmed health systems and a continued death toll.

The new paradox we are faced with is that people choose to believe fiction versus fact, despite the real life evidence of the severe health effects and increased deaths related to COVID-19. Do these skeptics simply have a cavalier attitude towards not only their own life, but the lives of others? Or, is there something deeper? It is not enough to tell people that the vaccines are proven safe³ and are more widely available than ever. It is not enough to tell people that they can die of COVID-19 – they already know that. Emotional pleas to family members are falling on deaf ears. This past month, when asking patients why they don’t want the vaccine, many have no real legitimate health-related reason and respond with a simple, “I don’t want to.” So, how do we get through to the unvaccinated?
 

A compassionate approach

We navigate these difficult conversations over time with the approach of compassion and empathy, not hostility or bullying. As health care providers, we start by being good empathic listeners. Similar to when we have advance care planning and code status conversations, we cannot enter the dialogue with our intention, beliefs, or formulated goals for that person. We have to listen without judgement to the wide range of reasons why others are reluctant or unwilling to get the vaccine – historical mistrust, political identity, religious reasons, short-term side effects that may cause them to lose a day or two of work – and understand that for each person their reasons are different. The point is to not assume that you know or understand what barriers and beliefs they have towards vaccination, but to meet them at their point of view and listen while keeping your own emotions level and steady.

Identifying the reason for vaccine hesitancy is the first step to getting the unvaccinated closer to vaccination. Ask open ended questions: “Can you help me understand, what is your hesitancy to the vaccine?”; “What about the vaccine worries you?”; “What have you heard about/know about the COVID-19 vaccine?”; or “Can you tell me more about why you feel that way?” As meticulous as it sounds, we have to go back to the basics of patient interviewing.

It is important to remember that this is not a debate and escalation to arguments will certainly backfire. Think about any time you disagreed with someone on a topic. Did criticizing, blaming, and shaming ever convince you to change your beliefs or behaviors? The likely answer is, “No.” Avoid the “backfire effect”– which is when giving people facts disproving their “incorrect” beliefs can actually reinforce those beliefs. The more people are confronted with facts at odds with their opinions, the stronger they cling to those opinions. If you want them to change their mind, you cannot approach the conversation as a debate. You are having this vaccine discussion to try to meet the other person where they are, understand their position, and talk with them, and not at them, about their concerns.

As leaders in health care, we have to be willing to give up control and lead with empathy. We have to show others that we hear them, believe their concerns, and acknowledge that their beliefs are valid to them as individuals. Even if you disagree, this is not the place to let anger, disappointment, or resentment take a front seat. This is about balance, and highlighting the autonomy in decision making that the other person has to make a choice. Be humble in these conversations and avoid condescending tones or statements.

We already know that you are a caring health care provider. As hospitalists, we are frontline providers who have seen unnecessary deaths and illness due to COVID-19. You are passionate and motivated because you are committed to your oath to save lives. However, you have to check your own feelings and remember that you are not speaking with an unvaccinated person to make them get vaccinated, but rather to understand their cognitive process and hopefully walk with them down a path that provides them with a clarity of options they truly have. Extend empathy and they will see your motivation is rooted in good-heartedness and a concern for their wellbeing.

If someone admits to reasons for avoiding vaccination that are not rooted in any fact, then guide them to the best resources. Our health care system recently released a COVID-19 fact versus myth handout called Trust the Facts. This could be the kind of vetted resource you offer. Guide them to accredited websites, such as the World Health Organization, the Center for Disease Control, or their local and state departments of health to help debunk fiction by reviewing it with them. Discuss myths such as, ‘the vaccine will cause infertility,’ ‘the vaccine will give me COVID,’ ‘the vaccine was rushed and is not safe,’ ‘the vaccine is not needed if I am young and healthy,’ ‘the vaccine has a microchip,’ etc. Knowledge is power and disinformation is deadly, but how facts are presented will make the biggest difference in how others receive them, so remember your role is not to argue with these statements, but rather to provide perspective without agreeing or disagreeing.

Respond to their concerns with statements such as, “I hear you…it sounds like you are worried/fearful/mistrusting about the side effects/safety/efficacy of the vaccine…can we talk more about that?” Ask them where these concerns come from – the news, social media, an article, word of mouth, friends, or family. Ask them about the information they have and show genuine interest that you want to see it from their perspective. This is the key to compassionate and empathic dialogue – you relinquish your intentions.

Once you know or unveil their reasons for hesitancy, ask them what they would like to see with regards to COVID-19 and ending the pandemic. Would they like to get back to a new normal, to visit family members, to travel once again, to not have to wear masks and quarantine? What do they want for themselves, their families, communities, the country, or even the world? The goal is to find something in our shared humanity, to connect on a deeper level so they start to open up and let down walls, and find something you both see eye-to-eye on. Know your audience and speak to what serves them. To effectively persuade someone to come around to your point of view starts with recognizing the root of the disagreement and trying to overcome it before trying to change the person’s mind, understanding both the logic and the emotion that’s driving their decision making.⁴
 

Building trust

Reminding patients, friends or family members that their health and well-being means a lot to you can also be a strategy to keeping the conversation open and friendly. Sharing stories as hospitalists caring for many critically ill COVID patients or patients who died alone due to COVID-19, and the trauma you experienced as a health care provider feeling paralyzed by the limitations of modern medicine against the deadly virus, will only serve to humanize you in such an interaction.

Building trust will also increase vaccine willingness. This will require a concerted effort by scientists, doctors, and health care systems to engage with community leaders and members. To address hesitancy, the people we serve have to hear those local, personal, and relatable stories about vaccinations, and how it benefits not just themselves, but others around them in their community. As part of the #VaxUp campaign in Virginia, community and physician leaders shared their stories of hesitancy and motivation surrounding the vaccine. These are real people in the community discussing why getting vaccinated is so important and what helped them make an informed decision. I discussed my own hesitancy and concerns and also tackled a few vaccine myths.

As vaccinated health care workers or community leaders, you are living proof of the benefits of getting the COVID vaccine. Focus on the positives but also be honest. If your second shot gave you fevers, chills, or myalgias, then admit it and share how you overcame these expected reactions. Refocus on the safety of the vaccine and the fact that it is freely available to all people. Maybe the person you are speaking with doesn’t know where or how to get an appointment to get vaccinated. Help them find the nearest place to get an appointment and identify barriers they may have in transportation, child, or senior care to leave home safely to get vaccinated, or physical conditions that are preventing them from receiving the vaccine. Share that being vaccinated protects you from contracting the virus and spreading it to loved ones. Focus on how a fully vaccinated community and country can open up opportunities to heal and connect as a society, spend time with family/friends in another county or state, hold a newborn grandchild, or even travel outside the U.S.

There is no guarantee that you will be able to persuade someone to get vaccinated. It’s possible the outcome of your conversation will not result in the other person changing their mind in that moment. That doesn’t mean that you failed, because you started the dialogue and planted the seed. If you are a vaccinated health care provider, your words have influence and power, and we are obliged by our positions to have responsibility for the health of our communities. Don’t be discouraged, as it is through caring, compassionate, respectful, and empathic conversations that your influence will make the most difference in these relationships as you continue to advocate for all human life.
 

Dr. Williams is vice president of the Hampton Roads chapter of the Society of Hospital Medicine. She is a hospitalist at Sentara Careplex Hospital in Hampton, Va., where she also serves as vice president of the Medical Executive Committee.

References

1. World Health Organization. Report of the SAGE working group on vaccine hesitancy. Oct 2014. https://www.who.int/immunization/sage/meetings/2014/october/1_Report_WORKING_GROUP_vaccine_hesitancy_final.pdf

2. Hsu JL. A brief history of vaccines: Smallpox to the present. S D Med. 2013;Spec no:33-7. PMID: 23444589.

3. Chiu A, Bever L. Are they experimental? Can they alter DNA? Experts tackle lingering coronavirus vaccine fears. The Washington Post. 2021 May 14. https://www.washingtonpost.com/lifestyle/2021/05/14/safe-fast-vaccine-fear-infertility-dna/

4. Huang L. Edge: Turning Adversity into Advantage. New York: Portfolio/Penguin, 2020.

A large, real-world test of face masks in Bangladesh shows that masks work to reduce community spread of COVID-19. It also shows that surgical masks are more effective than cloth face coverings.

OsakaWayne Studios/Moment

The study, which was published ahead of peer review, demonstrates the power of careful investigation and offers a host of lessons about mask wearing that will be important worldwide. One key finding of the study, for example, is that wearing a mask doesn’t lead people to abandon social distancing, something public health officials had feared might happen if masks gave people a false sense of security.

“What we really were able to achieve is to demonstrate that masks are effective against COVID-19, even under a rigorous and systematic evaluation that was done in the throes of the pandemic,” said Ashley Styczynski, MD, who was an infectious disease fellow at Stanford (Calif.) University when she collaborated on the study with other colleagues at Stanford, Yale, and Innovations for Poverty Action, a large research and policy nonprofit organization that currently works in 22 countries.

“And so, I think people who have been holding out on wearing masks because [they] felt like there wasn’t enough evidence for it, we’re hoping this will really help bridge that gap for them,” she said.

It included more than 600 unions – or local governmental districts in Bangladesh – and roughly 340,000 people.

Half of the districts were given cloth or surgical face masks along with continual reminders to wear them properly; the other half were tracked with no intervention. Blood tests of people who developed symptoms during the study verified their infections.

Compared to villages that didn’t mask, those in which masks of any type were worn had about 9% fewer symptomatic cases of COVID-19. The finding was statistically significant and was unlikely to have occurred by chance alone.

“Somebody could read this study and say, ‘OK, you reduced COVID-19 by 9%. Big deal.’ And what I would respond to that would be that, if anything, we think that that is a substantial underestimate,” Dr. Styczynski said.

One reason they think they underestimated the effectiveness of masks is that they tested only people who were having symptoms, so people who had only very mild or asymptomatic infections were missed.

Another reason is that, among people who had symptoms, only one-third agreed to undergo a blood test. The effect may have been bigger had participation been universal.

Local transmission may have played a role, too. Rates of COVID-19 in Bangladesh were relatively low during the study. Most infections were caused by the B.1.1.7, or Alpha, variant.

Since then, Delta has taken over. Delta is thought to be more transmissible, and some studies have suggested that people infected with Delta shed more viral particles. Masks may be more effective when more virus is circulating.

The investigators also found important differences by age and by the type of mask. Villages in which surgical masks were worn had 11% fewer COVID-19 cases than villages in which masks were not worn. In villages in which cloth masks were worn, on the other hand, infections were reduced by only 5%.

The cloth masks were substantial. Each had three layers – two layers of fabric with an outer layer of polypropylene. On testing, the filtration efficiency of the cloth masks was only about 37%, compared with 95% for the three-layer surgical masks, which were also made of polypropylene.

Masks were most effective for older individuals. People aged 50-60 years who wore surgical masks were 23% less likely to test positive for COVID, compared with their peers who didn’t wear masks. For people older than 60, the reduction in risk was greater – 35%.
 

Rigorous research

The study took place over a period of 8 weeks in each district. The interventions were rolled out in waves, with the first starting in November 2020 and the last in January 2021.

Investigators gave each household free cloth or surgical face masks and showed families a video about proper mask wearing with promotional messages from the prime minister, a head imam, and a national cricket star. They also handed out free masks.

Previous studies have shown that people aren’t always truthful about wearing masks in public. In Kenya, for example, 88% of people answering a phone survey said that they wore masks regularly, but researchers determined that only 10% of them actually did so.

Investigators in the Bangladesh study didn’t just ask people if they’d worn masks, they stationed themselves in public markets, mosques, tea stalls, and on roads that were the main entrances to the villages and took notes.

They also tested various ways to educate people and to remind them to wear masks. They found that four factors were effective at promoting the wearing of masks, and they gave them an acronym – NORM.

• N for no-cost masks.
• O for offering information through the video and local leaders.
• R for regular reminders to people by investigators who stand in public markets and offer masks or encourage anyone who wasn’t wearing one or wasn’t wearing it correctly.
• M for modeling, in which local leaders, such as imams, wear masks and remind their followers to wear them.

These four measures tripled the wearing of masks in the intervention communities, from a baseline level of 13% to 42%. People continued to wear their masks properly for about 2 weeks after the study ended, indicating that they’d gotten used to wearing them.

Dr. Styczynski said that nothing else – not text message reminders, or signs posted in public places, or local incentives – moved the needle on mask wearing.
 

Saved lives and money

The study found that the strategy was cost effective, too. Giving masks to a large population and getting people to use them costs about $10,000 per life saved from COVID, on par with the cost of deploying mosquito nets to save people from malaria, Dr. Styczynski said.

“I think that what we’ve been able to show is that this is a really important tool to be used globally, especially as countries have delays in getting access to vaccines and rolling them out,” she said.

Dr. Styczynski said masks will continue to be important even in countries such as the United States, where vaccines aren’t stopping transmission 100% and there are still large portions of the population who are unvaccinated, such as children.

“If we want to reduce COVID-19 here, it’s really important that we consider the ongoing utility of masks, in addition to vaccines, and not really thinking of them as one or the other,” she said.

The study was funded by a grant from GiveWell.org. The funder had no role in the study design, interpretation, or the decision to publish.

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

A large, real-world test of face masks in Bangladesh shows that masks work to reduce community spread of COVID-19. It also shows that surgical masks are more effective than cloth face coverings.

OsakaWayne Studios/Moment

The study, which was published ahead of peer review, demonstrates the power of careful investigation and offers a host of lessons about mask wearing that will be important worldwide. One key finding of the study, for example, is that wearing a mask doesn’t lead people to abandon social distancing, something public health officials had feared might happen if masks gave people a false sense of security.

“What we really were able to achieve is to demonstrate that masks are effective against COVID-19, even under a rigorous and systematic evaluation that was done in the throes of the pandemic,” said Ashley Styczynski, MD, who was an infectious disease fellow at Stanford (Calif.) University when she collaborated on the study with other colleagues at Stanford, Yale, and Innovations for Poverty Action, a large research and policy nonprofit organization that currently works in 22 countries.

“And so, I think people who have been holding out on wearing masks because [they] felt like there wasn’t enough evidence for it, we’re hoping this will really help bridge that gap for them,” she said.

It included more than 600 unions – or local governmental districts in Bangladesh – and roughly 340,000 people.

Half of the districts were given cloth or surgical face masks along with continual reminders to wear them properly; the other half were tracked with no intervention. Blood tests of people who developed symptoms during the study verified their infections.

Compared to villages that didn’t mask, those in which masks of any type were worn had about 9% fewer symptomatic cases of COVID-19. The finding was statistically significant and was unlikely to have occurred by chance alone.

“Somebody could read this study and say, ‘OK, you reduced COVID-19 by 9%. Big deal.’ And what I would respond to that would be that, if anything, we think that that is a substantial underestimate,” Dr. Styczynski said.

One reason they think they underestimated the effectiveness of masks is that they tested only people who were having symptoms, so people who had only very mild or asymptomatic infections were missed.

Another reason is that, among people who had symptoms, only one-third agreed to undergo a blood test. The effect may have been bigger had participation been universal.

Local transmission may have played a role, too. Rates of COVID-19 in Bangladesh were relatively low during the study. Most infections were caused by the B.1.1.7, or Alpha, variant.

Since then, Delta has taken over. Delta is thought to be more transmissible, and some studies have suggested that people infected with Delta shed more viral particles. Masks may be more effective when more virus is circulating.

The investigators also found important differences by age and by the type of mask. Villages in which surgical masks were worn had 11% fewer COVID-19 cases than villages in which masks were not worn. In villages in which cloth masks were worn, on the other hand, infections were reduced by only 5%.

The cloth masks were substantial. Each had three layers – two layers of fabric with an outer layer of polypropylene. On testing, the filtration efficiency of the cloth masks was only about 37%, compared with 95% for the three-layer surgical masks, which were also made of polypropylene.

Masks were most effective for older individuals. People aged 50-60 years who wore surgical masks were 23% less likely to test positive for COVID, compared with their peers who didn’t wear masks. For people older than 60, the reduction in risk was greater – 35%.
 

Rigorous research

The study took place over a period of 8 weeks in each district. The interventions were rolled out in waves, with the first starting in November 2020 and the last in January 2021.

Investigators gave each household free cloth or surgical face masks and showed families a video about proper mask wearing with promotional messages from the prime minister, a head imam, and a national cricket star. They also handed out free masks.

Previous studies have shown that people aren’t always truthful about wearing masks in public. In Kenya, for example, 88% of people answering a phone survey said that they wore masks regularly, but researchers determined that only 10% of them actually did so.

Investigators in the Bangladesh study didn’t just ask people if they’d worn masks, they stationed themselves in public markets, mosques, tea stalls, and on roads that were the main entrances to the villages and took notes.

They also tested various ways to educate people and to remind them to wear masks. They found that four factors were effective at promoting the wearing of masks, and they gave them an acronym – NORM.

• N for no-cost masks.
• O for offering information through the video and local leaders.
• R for regular reminders to people by investigators who stand in public markets and offer masks or encourage anyone who wasn’t wearing one or wasn’t wearing it correctly.
• M for modeling, in which local leaders, such as imams, wear masks and remind their followers to wear them.

These four measures tripled the wearing of masks in the intervention communities, from a baseline level of 13% to 42%. People continued to wear their masks properly for about 2 weeks after the study ended, indicating that they’d gotten used to wearing them.

Dr. Styczynski said that nothing else – not text message reminders, or signs posted in public places, or local incentives – moved the needle on mask wearing.
 

Saved lives and money

The study found that the strategy was cost effective, too. Giving masks to a large population and getting people to use them costs about $10,000 per life saved from COVID, on par with the cost of deploying mosquito nets to save people from malaria, Dr. Styczynski said.

“I think that what we’ve been able to show is that this is a really important tool to be used globally, especially as countries have delays in getting access to vaccines and rolling them out,” she said.

Dr. Styczynski said masks will continue to be important even in countries such as the United States, where vaccines aren’t stopping transmission 100% and there are still large portions of the population who are unvaccinated, such as children.

“If we want to reduce COVID-19 here, it’s really important that we consider the ongoing utility of masks, in addition to vaccines, and not really thinking of them as one or the other,” she said.

The study was funded by a grant from GiveWell.org. The funder had no role in the study design, interpretation, or the decision to publish.

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

A large, real-world test of face masks in Bangladesh shows that masks work to reduce community spread of COVID-19. It also shows that surgical masks are more effective than cloth face coverings.

OsakaWayne Studios/Moment

The study, which was published ahead of peer review, demonstrates the power of careful investigation and offers a host of lessons about mask wearing that will be important worldwide. One key finding of the study, for example, is that wearing a mask doesn’t lead people to abandon social distancing, something public health officials had feared might happen if masks gave people a false sense of security.

“What we really were able to achieve is to demonstrate that masks are effective against COVID-19, even under a rigorous and systematic evaluation that was done in the throes of the pandemic,” said Ashley Styczynski, MD, who was an infectious disease fellow at Stanford (Calif.) University when she collaborated on the study with other colleagues at Stanford, Yale, and Innovations for Poverty Action, a large research and policy nonprofit organization that currently works in 22 countries.

“And so, I think people who have been holding out on wearing masks because [they] felt like there wasn’t enough evidence for it, we’re hoping this will really help bridge that gap for them,” she said.

It included more than 600 unions – or local governmental districts in Bangladesh – and roughly 340,000 people.

Half of the districts were given cloth or surgical face masks along with continual reminders to wear them properly; the other half were tracked with no intervention. Blood tests of people who developed symptoms during the study verified their infections.

Compared to villages that didn’t mask, those in which masks of any type were worn had about 9% fewer symptomatic cases of COVID-19. The finding was statistically significant and was unlikely to have occurred by chance alone.

“Somebody could read this study and say, ‘OK, you reduced COVID-19 by 9%. Big deal.’ And what I would respond to that would be that, if anything, we think that that is a substantial underestimate,” Dr. Styczynski said.

One reason they think they underestimated the effectiveness of masks is that they tested only people who were having symptoms, so people who had only very mild or asymptomatic infections were missed.

Another reason is that, among people who had symptoms, only one-third agreed to undergo a blood test. The effect may have been bigger had participation been universal.

Local transmission may have played a role, too. Rates of COVID-19 in Bangladesh were relatively low during the study. Most infections were caused by the B.1.1.7, or Alpha, variant.

Since then, Delta has taken over. Delta is thought to be more transmissible, and some studies have suggested that people infected with Delta shed more viral particles. Masks may be more effective when more virus is circulating.

The investigators also found important differences by age and by the type of mask. Villages in which surgical masks were worn had 11% fewer COVID-19 cases than villages in which masks were not worn. In villages in which cloth masks were worn, on the other hand, infections were reduced by only 5%.

The cloth masks were substantial. Each had three layers – two layers of fabric with an outer layer of polypropylene. On testing, the filtration efficiency of the cloth masks was only about 37%, compared with 95% for the three-layer surgical masks, which were also made of polypropylene.

Masks were most effective for older individuals. People aged 50-60 years who wore surgical masks were 23% less likely to test positive for COVID, compared with their peers who didn’t wear masks. For people older than 60, the reduction in risk was greater – 35%.
 

Rigorous research

The study took place over a period of 8 weeks in each district. The interventions were rolled out in waves, with the first starting in November 2020 and the last in January 2021.

Investigators gave each household free cloth or surgical face masks and showed families a video about proper mask wearing with promotional messages from the prime minister, a head imam, and a national cricket star. They also handed out free masks.

Previous studies have shown that people aren’t always truthful about wearing masks in public. In Kenya, for example, 88% of people answering a phone survey said that they wore masks regularly, but researchers determined that only 10% of them actually did so.

Investigators in the Bangladesh study didn’t just ask people if they’d worn masks, they stationed themselves in public markets, mosques, tea stalls, and on roads that were the main entrances to the villages and took notes.

They also tested various ways to educate people and to remind them to wear masks. They found that four factors were effective at promoting the wearing of masks, and they gave them an acronym – NORM.

• N for no-cost masks.
• O for offering information through the video and local leaders.
• R for regular reminders to people by investigators who stand in public markets and offer masks or encourage anyone who wasn’t wearing one or wasn’t wearing it correctly.
• M for modeling, in which local leaders, such as imams, wear masks and remind their followers to wear them.

These four measures tripled the wearing of masks in the intervention communities, from a baseline level of 13% to 42%. People continued to wear their masks properly for about 2 weeks after the study ended, indicating that they’d gotten used to wearing them.

Dr. Styczynski said that nothing else – not text message reminders, or signs posted in public places, or local incentives – moved the needle on mask wearing.
 

Saved lives and money

The study found that the strategy was cost effective, too. Giving masks to a large population and getting people to use them costs about $10,000 per life saved from COVID, on par with the cost of deploying mosquito nets to save people from malaria, Dr. Styczynski said.

“I think that what we’ve been able to show is that this is a really important tool to be used globally, especially as countries have delays in getting access to vaccines and rolling them out,” she said.

Dr. Styczynski said masks will continue to be important even in countries such as the United States, where vaccines aren’t stopping transmission 100% and there are still large portions of the population who are unvaccinated, such as children.

“If we want to reduce COVID-19 here, it’s really important that we consider the ongoing utility of masks, in addition to vaccines, and not really thinking of them as one or the other,” she said.

The study was funded by a grant from GiveWell.org. The funder had no role in the study design, interpretation, or the decision to publish.

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

In a small study, intravenous administration of the beta-blocker metoprolol to critically ill COVID-19 patients with acute respiratory distress syndrome (ARDS) safely blunted lung inflammation associated with the disease.

Metoprolol administration also resulted in better oxygenation and fewer days on intensive mechanical ventilation and in the ICU, compared with no treatment.

These data suggest that metoprolol repurposing for the treatment of ARDS in COVID-19 patients is a safe and inexpensive strategy with the potential to improve outcomes, the researchers said.

“Metoprolol repurposing for the treatment of ARDS associated with COVID-19 is a safe and cheap intervention that can help to alleviate the massive personal and health care burden associated with the pandemic,” they concluded.

The results, from the MADRID-COVID pilot trial from Agustin Clemente-Moragon, BSc, Centro National de Investigaciones Cardiovasculares, Madrid, and colleagues, were published online Aug. 30, 2021, in the Journal of the American College of Cardiology.

In previous work, the researchers showed that metoprolol, but not other clinically available intravenous beta-blockers, abrogates neutrophil-driven exacerbated inflammation, neutrophil-platelet interaction, and formation of neutrophil extracellular traps in a mouse model of acute lung injury.

These results prompted the current pilot trial in 20 patients, ages 18-80 years, with COVID-19–associated ARDS.

Randomization was stratified by age (59 and younger vs. 60 and older), history of hypertension (yes or no), and circulating neutrophil counts (<6,000 vs. ≥6,000). Bronchoalveolar lavage (BAL) fluid and blood samples were obtained from patients at randomization and 24 hours after the third metoprolol dose in the treatment group, and on day 4 in controls.

Because of the cardiovascular effects of metoprolol, patients were monitored invasively and by echocardiography, the authors noted.

As expected, metoprolol significantly reduced heart rate (P < .01) and systolic blood pressure (P < .05), although both remained within the physiological range. Echocardiography showed no deterioration of cardiac function after metoprolol treatment.

To assess the ability of metoprolol to address neutrophil-mediated exacerbated lung inflammation, the researchers analyzed leukocyte populations in BAL samples by flow cytometry at baseline and on day 4.

At baseline, the metoprolol and control groups showed no differences in BAL neutrophil content. But on day 4, after 3 days of treatment with metoprolol, neutrophil content was significantly lower in the metoprolol group (median, 14.3 neutrophils/mcL) than in the control group (median, 397 neutrophils/mcL).

Metoprolol-treated patients also had lower total inflammatory-cell content and lower monocyte/macrophage content. Lymphocytes did not differ between the groups.

The investigators also explored the impact of metoprolol on the chemokine, monocyte chemoattractant protein–1 (MCP-1), as it has been shown to promote pulmonary fibrosis in late-stage ARDS.

They found that MCP-1 was significantly attenuated after 3 days of metoprolol treatment. At baseline, the median MCP-1 level was 298 pg/mL; on day 4 after metoprolol, it was 203 pg/mL (P = .009).

MCP-1 levels remained unchanged in control patients.
 

An elegant study

In an accompanying editorial, Mourad H. Senussi, MD, assistant professor at Baylor College of Medicine, Houston, wrote: “Although the study has a small sample size, we commend the authors, who attempt to shed light on the important pathophysiological underpinnings that help establish biological plausibility for this inexpensive, safe, and widely available medication.”

In an interview with this news organization, Dr. Senussi added that metoprolol is not itself something primarily used to treat COVID-19 per se. “Rather, the drug blunts the sympathetic-host response. There is a fine balance between that sympathetic surge that is helpful to the body, and then a sympathetic surge that if left unchecked, can lead to significant damage. And so, I think this study really shows that medications like metoprolol can help blunt that initial sympathetic effect.”

A larger study is “absolutely” warranted, he added, “this is a drug that is readily available, safe, and inexpensive. The study design here was simple and most importantly, showed biological plausibility.”

Dr. Senussi also noted that, although the benefit was noted in COVID-19 patients, the study sets the groundwork for further research in the use of beta-blockade in the critically ill. “Further studies are needed to elucidate and identify where along the inflammatory spectrum these critically ill patients lie, which patients would benefit from beta-blockers, and at what time point during their hospital stay.”

The MADRID-COVID authors and Dr. Senussi disclosed no relevant financial relationships.

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

In a small study, intravenous administration of the beta-blocker metoprolol to critically ill COVID-19 patients with acute respiratory distress syndrome (ARDS) safely blunted lung inflammation associated with the disease.

Metoprolol administration also resulted in better oxygenation and fewer days on intensive mechanical ventilation and in the ICU, compared with no treatment.

These data suggest that metoprolol repurposing for the treatment of ARDS in COVID-19 patients is a safe and inexpensive strategy with the potential to improve outcomes, the researchers said.

“Metoprolol repurposing for the treatment of ARDS associated with COVID-19 is a safe and cheap intervention that can help to alleviate the massive personal and health care burden associated with the pandemic,” they concluded.

The results, from the MADRID-COVID pilot trial from Agustin Clemente-Moragon, BSc, Centro National de Investigaciones Cardiovasculares, Madrid, and colleagues, were published online Aug. 30, 2021, in the Journal of the American College of Cardiology.

In previous work, the researchers showed that metoprolol, but not other clinically available intravenous beta-blockers, abrogates neutrophil-driven exacerbated inflammation, neutrophil-platelet interaction, and formation of neutrophil extracellular traps in a mouse model of acute lung injury.

These results prompted the current pilot trial in 20 patients, ages 18-80 years, with COVID-19–associated ARDS.

Randomization was stratified by age (59 and younger vs. 60 and older), history of hypertension (yes or no), and circulating neutrophil counts (<6,000 vs. ≥6,000). Bronchoalveolar lavage (BAL) fluid and blood samples were obtained from patients at randomization and 24 hours after the third metoprolol dose in the treatment group, and on day 4 in controls.

Because of the cardiovascular effects of metoprolol, patients were monitored invasively and by echocardiography, the authors noted.

As expected, metoprolol significantly reduced heart rate (P < .01) and systolic blood pressure (P < .05), although both remained within the physiological range. Echocardiography showed no deterioration of cardiac function after metoprolol treatment.

To assess the ability of metoprolol to address neutrophil-mediated exacerbated lung inflammation, the researchers analyzed leukocyte populations in BAL samples by flow cytometry at baseline and on day 4.

At baseline, the metoprolol and control groups showed no differences in BAL neutrophil content. But on day 4, after 3 days of treatment with metoprolol, neutrophil content was significantly lower in the metoprolol group (median, 14.3 neutrophils/mcL) than in the control group (median, 397 neutrophils/mcL).

Metoprolol-treated patients also had lower total inflammatory-cell content and lower monocyte/macrophage content. Lymphocytes did not differ between the groups.

The investigators also explored the impact of metoprolol on the chemokine, monocyte chemoattractant protein–1 (MCP-1), as it has been shown to promote pulmonary fibrosis in late-stage ARDS.

They found that MCP-1 was significantly attenuated after 3 days of metoprolol treatment. At baseline, the median MCP-1 level was 298 pg/mL; on day 4 after metoprolol, it was 203 pg/mL (P = .009).

MCP-1 levels remained unchanged in control patients.
 

An elegant study

In an accompanying editorial, Mourad H. Senussi, MD, assistant professor at Baylor College of Medicine, Houston, wrote: “Although the study has a small sample size, we commend the authors, who attempt to shed light on the important pathophysiological underpinnings that help establish biological plausibility for this inexpensive, safe, and widely available medication.”

In an interview with this news organization, Dr. Senussi added that metoprolol is not itself something primarily used to treat COVID-19 per se. “Rather, the drug blunts the sympathetic-host response. There is a fine balance between that sympathetic surge that is helpful to the body, and then a sympathetic surge that if left unchecked, can lead to significant damage. And so, I think this study really shows that medications like metoprolol can help blunt that initial sympathetic effect.”

A larger study is “absolutely” warranted, he added, “this is a drug that is readily available, safe, and inexpensive. The study design here was simple and most importantly, showed biological plausibility.”

Dr. Senussi also noted that, although the benefit was noted in COVID-19 patients, the study sets the groundwork for further research in the use of beta-blockade in the critically ill. “Further studies are needed to elucidate and identify where along the inflammatory spectrum these critically ill patients lie, which patients would benefit from beta-blockers, and at what time point during their hospital stay.”

The MADRID-COVID authors and Dr. Senussi disclosed no relevant financial relationships.

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

In a small study, intravenous administration of the beta-blocker metoprolol to critically ill COVID-19 patients with acute respiratory distress syndrome (ARDS) safely blunted lung inflammation associated with the disease.

Metoprolol administration also resulted in better oxygenation and fewer days on intensive mechanical ventilation and in the ICU, compared with no treatment.

These data suggest that metoprolol repurposing for the treatment of ARDS in COVID-19 patients is a safe and inexpensive strategy with the potential to improve outcomes, the researchers said.

“Metoprolol repurposing for the treatment of ARDS associated with COVID-19 is a safe and cheap intervention that can help to alleviate the massive personal and health care burden associated with the pandemic,” they concluded.

The results, from the MADRID-COVID pilot trial from Agustin Clemente-Moragon, BSc, Centro National de Investigaciones Cardiovasculares, Madrid, and colleagues, were published online Aug. 30, 2021, in the Journal of the American College of Cardiology.

In previous work, the researchers showed that metoprolol, but not other clinically available intravenous beta-blockers, abrogates neutrophil-driven exacerbated inflammation, neutrophil-platelet interaction, and formation of neutrophil extracellular traps in a mouse model of acute lung injury.

These results prompted the current pilot trial in 20 patients, ages 18-80 years, with COVID-19–associated ARDS.

Randomization was stratified by age (59 and younger vs. 60 and older), history of hypertension (yes or no), and circulating neutrophil counts (<6,000 vs. ≥6,000). Bronchoalveolar lavage (BAL) fluid and blood samples were obtained from patients at randomization and 24 hours after the third metoprolol dose in the treatment group, and on day 4 in controls.

Because of the cardiovascular effects of metoprolol, patients were monitored invasively and by echocardiography, the authors noted.

As expected, metoprolol significantly reduced heart rate (P < .01) and systolic blood pressure (P < .05), although both remained within the physiological range. Echocardiography showed no deterioration of cardiac function after metoprolol treatment.

To assess the ability of metoprolol to address neutrophil-mediated exacerbated lung inflammation, the researchers analyzed leukocyte populations in BAL samples by flow cytometry at baseline and on day 4.

At baseline, the metoprolol and control groups showed no differences in BAL neutrophil content. But on day 4, after 3 days of treatment with metoprolol, neutrophil content was significantly lower in the metoprolol group (median, 14.3 neutrophils/mcL) than in the control group (median, 397 neutrophils/mcL).

Metoprolol-treated patients also had lower total inflammatory-cell content and lower monocyte/macrophage content. Lymphocytes did not differ between the groups.

The investigators also explored the impact of metoprolol on the chemokine, monocyte chemoattractant protein–1 (MCP-1), as it has been shown to promote pulmonary fibrosis in late-stage ARDS.

They found that MCP-1 was significantly attenuated after 3 days of metoprolol treatment. At baseline, the median MCP-1 level was 298 pg/mL; on day 4 after metoprolol, it was 203 pg/mL (P = .009).

MCP-1 levels remained unchanged in control patients.
 

An elegant study

In an accompanying editorial, Mourad H. Senussi, MD, assistant professor at Baylor College of Medicine, Houston, wrote: “Although the study has a small sample size, we commend the authors, who attempt to shed light on the important pathophysiological underpinnings that help establish biological plausibility for this inexpensive, safe, and widely available medication.”

In an interview with this news organization, Dr. Senussi added that metoprolol is not itself something primarily used to treat COVID-19 per se. “Rather, the drug blunts the sympathetic-host response. There is a fine balance between that sympathetic surge that is helpful to the body, and then a sympathetic surge that if left unchecked, can lead to significant damage. And so, I think this study really shows that medications like metoprolol can help blunt that initial sympathetic effect.”

A larger study is “absolutely” warranted, he added, “this is a drug that is readily available, safe, and inexpensive. The study design here was simple and most importantly, showed biological plausibility.”

Dr. Senussi also noted that, although the benefit was noted in COVID-19 patients, the study sets the groundwork for further research in the use of beta-blockade in the critically ill. “Further studies are needed to elucidate and identify where along the inflammatory spectrum these critically ill patients lie, which patients would benefit from beta-blockers, and at what time point during their hospital stay.”

The MADRID-COVID authors and Dr. Senussi disclosed no relevant financial relationships.

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.

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 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.

Photo by Mario Tama/Getty Images

“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 our institutions need to design interventions to meet the needs of our health care professionals,” 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.

Photo by Mario Tama/Getty Images

“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 our institutions need to design interventions to meet the needs of our health care professionals,” 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.

Photo by Mario Tama/Getty Images

“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 our institutions need to design interventions to meet the needs of our health care professionals,” 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.

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, health care providers and others have a continuing challenge ahead: Trying to convince those who are eligible but still holding out to get vaccinated.

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, health care providers and others have a continuing challenge ahead: Trying to convince those who are eligible but still holding out to get vaccinated.

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, health care providers and others have a continuing challenge ahead: Trying to convince those who are eligible but still holding out to get vaccinated.

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.

A patient’s lived experience of being in the hospital is shaped by a variety of factors, according to Minesh Patel, MD, Mid-Atlantic regional medical director for the Tacoma, Wash.–based hospitalist performance company Sound Physicians. Some – but not all – of these factors are captured in the “patient experience” questions on the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey that is sent to randomly selected patients shortly after their discharge from the hospital.

In March 2020, the COVID-19 pandemic caused hospitals to institute quarantining measures and “no visitor” policies as doctors and other hospital staff donned masks, visors, and other emotionally distancing personal protective equipment (PPE). All of these factors impacted patients’ experience as well as their hospitals’ HCAHPS scores, Dr. Patel said. And since these policies applied to all hospitalized patients, a patient did not need to have COVID-19 to experience many of the same restrictions imposed by the pandemic.

“A lot of the care hospitalists provide involves touch, sitting down and looking at the patient eye to eye, on the same level,” said Dr. Patel, a practicing hospitalist at Frederick (Md.) Health Hospital. “That had to take a back seat to infection control.”

Meanwhile, lengths of stay were longer for COVID-19 patients, who were often very sick and alone in their hospital rooms for prolonged periods, sometimes on mechanical ventilation, isolated without the support of their families. Health care providers tried to minimize time spent at the bedside because of viral exposure risks. Nobody really knew how to treat patients’ severe respiratory distress, especially at first. “So we basically threw the kitchen sink at it, following the evolving CDC guidelines, and hoped it would work,” he explained.

“When we saw our patient experience scores plummeting across the division, we said, ‘This is not good.’ We could see that we weren’t spending as much time at the bedside, and our patients were lonely and scared.” There was also greater fragmentation of care, all of which impacted patients’ experience in partnering hospitals.

Dr. Patel and his team spearheaded a number of processes across their partner hospitals to help patients and their families get the information they needed and understand what was happening during their treatment. “At that moment, real-time feedback was essential,” he explained. “We implemented the TED protocol – Teach back, Empathy and ‘Double-backing,’ which means spending a shorter visit on morning rounds but going back to the patient’s bedside for a second daily visit at the end of the shift, thereby establishing a second touch point.” Teach back is a strategy of asking patients to repeat back in their own words what they understood the doctor to be saying about their care.

The group developed ID buttons – called “Suttons” or Sound Buttons – with a larger picture of the doctor’s smiling face pinned to their medical gowns. The hospitalists started scheduling Zoom calls with families from the ICU rooms of COVID-19 patients. “We employ clinical performance nurses as collaborative influencers. They visit patients’ bedsides and work with staff on improving patient experience,” Dr. Patel said. “And we printed thank-you cards with the doctor’s name, photo, and an individualized message for their patients.” Together these measures measurably improved patient experience scores across partnering hospitals.

Sound Physicians

What is patient experience?

Evaluated by the Agency for Healthcare Research and Quality and endorsed by the National Quality Forum, HCAHPS hospital quality surveys ask patients (or their family members, who may be the ones completing the survey) 29 well-tested questions about the recent hospital stay and how they experienced it. Nineteen of those questions explore critical aspects of the patient’s experience in areas such as communication, responsiveness of staff, information about their diagnosis, medications, and discharge – and if they would recommend the hospital to others.

Surveys can be done by mail, phone, or interactive voice recognition and are offered in seven different languages. They can be administered by the hospital itself or by an approved survey vendor. They are sent between 48 hours and 6 weeks after the patient’s hospital discharge.

Nationwide results from HCAHPS survey have been published since 2008 in a searchable, comparable format on the consumer-focused government website Hospital Compare. The data have been used in a value-based incentive purchasing program since 2012. Hospital Compare also incorporates measures of quality such as mortality, readmission, and hospital-acquired infection rates as well as process measures such as how well facilities provide recommended care.

Starting in 2016, overall hospital quality has been encapsulated in a Star rating, which summarizes a variety of measures across seven areas of quality into a single number from one to five for each hospital. One of those seven areas is patient experience.

Hospitals may choose to ask additional questions of their own along with the HCAHPS survey, to gather additional, actionable quality data for internal purposes. Internal surveys with results closer to real time, instead of the months-to-years lag in posting HCAHPS scores, enable the hospital to respond to issues that emerge.
 

It’s not just the scores

“A lot of leaders in the hospital business will tell you ‘It’s not about the scores,’ ” Dr. Patel related. “But you need scores to tell how your practice is doing. It’s a testament to the kind of care you are providing as a hospital medicine program. These are important questions: Did your doctor listen to you, communicate in ways you understood, and treat you with courtesy?” Scores are scores, he said, but more importantly, are patients getting the information they need? Do they understand what’s going on in their care?

“You have to look at the scores and ask, what can we do differently to impact patient experience? What are we doing wrong? What can we do better? If the scores as a collective experience of hospitalized patients are plummeting, it must mean they’re not feeling good about the care they are receiving, and not recognizing what we’re trying to do for them.”

Declining HCAHPS scores last year could easily be explained by what was going on with COVID-19, Dr. Patel said. “But we want our patient experience to be seamless. We have to put ourselves in the patient’s shoes. For them, it’s about whether they felt they were treated well or not. We had to reinvent ourselves and find new ways to compensate for the limitations imposed by the pandemic,” he said.

“We also recognized that our No. 1 job as a group is to take care of our doctors, so that they can take care of their patients. We provided quarantine pay, implemented a buddy system for doctors, used CME dollars to pay for COVID education and, if they felt ill, we said they needed to stay home, while we paid their shift anyway,” he said. “When you do that kind of thing and engage them in your mission, frontline hospitalists can help to improve quality of care, decrease costs, and increase patient safety.”
 

A sacred encounter

For Sarah Richards, MD, a hospitalist with Nebraska Medicine in Omaha, what happens in the hospital room between the hospitalist and the patient is a sacred encounter. “It’s about relationship and trust,” she said, noting that it’s hard to capture all of that in survey data. It might be better expressed in words: “ ‘How are things going for you?’ To me, that’s the real patient experience. When I talk with physicians about patient experience, I start with why this matters. We know, for example, that when patients trust us, they are more likely to engage with their care and adhere to the treatment plan.”

Dr. Richards said standard hospital quality surveys can be a blunt tool. The HCAHPS survey, conducted around a week after the hospitalization, has a low response rate, and returns are not representative of the demographic served in the hospital. “The inpatient data are not always helpful, but this is what we have to work with. One choice hospitals have is for the leadership to choose not to use the data for individual bonuses, recognition, or discipline, since the questions ask patients about the care they received collectively from all of their doctors,” she said.

But as hospitalists have worked longer shifts under more stress while wearing PPE – which makes it harder to communicate with their patients – there is a dynamic that has emerged, which deserves more study. “I think doctors gave it their all in the pandemic. I’m a hospitalist, and people told me I’m a hero. But did that change my impact at work (on patient experience)?” she said.

Dr. Richards sits on SHM’s Patient Experience Special Interest Group (SIG), which was tasked with providing tools to help mitigate the effects of the pandemic. These include a fact sheet, “Communication Tips for 5 Common Conundrums in the COVID-19 Pandemic”, and a downloadable pocket card called “The 5 Rs of Cultural Humility.”

Also on the SIG is Mark Rudolph, MD, SFHM, Sound Physicians’ chief experience officer, whose job title reflects a growing, systematic attention to patient experience in U.S. hospitals. “Most clinicians are familiar with the surveys and the results of those surveys,” he told The Hospitalist. “People in our field can get frustrated with the surveys, and have a lot to say about the quality of the scores themselves – what is actually being measured. Is the patient upset because the coffee was cold, or due to a bad clinical experience? Is it about the care they received from the hospitalist, or the physical setting of the hospital?”

Doing the right thing

To be a patient hospitalized with an acute illness is a form of suffering, Dr. Rudolph said. “We know patient experience in the hospital since March of 2020 has been frightening and horrible. These people are as sick as can be. Everything about the experience is horrible. Every effort you can make to reduce that suffering is important. If you are a patient in the hospital and don’t know what’s happening to you, that’s terrifying.”

He encourages hospitalists to look beyond the scores or the idea that they are just trying to improve their scores. “Look instead at the actual content of the questions around communication with doctors. The competencies addressed in the survey questions – listening and explaining things clearly, for example – are effective guides for patient experience improvement efforts. You can be confident you’re doing the right thing for the patient by focusing on these skills, even if you don’t see immediate changes in survey scores.”

Hospitals that did not allow visitors had worse clinical outcomes and worse patient experience ratings, and recent research confirms that when family visitors are not allowed, outcomes are worse in areas such as patient ratings of medical staff responsiveness, fall rates, and sepsis rates.¹ “None of that should be surprising. Not having family present just ups the ante. Any hospital patients could benefit from an advocate sitting next to them, helping them to the bathroom, and keeping them from falling out of bed,” Dr. Rudolph said.

“In the past year, we have placed a premium on communicating with these patients with kindness and compassion, to help them understand what’s happening to them,” he said. Out of necessity, hospitals have had to rejigger their processes, which has led to more efficient and better care, although the jury is still out on whether that will persist post pandemic.
 

Communicating with compassion

Swati Mehta, MD, a hospitalist at Sequoia Hospital in Redwood City, Calif., and director of quality performance and patient experience at Vituity, a physician-owned and -led multispecialty partnership, said COVID-19 was a wake-up call for hospitalists. There have been successful models for enhancing hospitalized patients’ experience, but it took the challenges of COVID-19 for many hospitalists to adopt them.

“Early in 2020, our data analysis showed emerging positive trends, reflecting our patients’ appreciation for what doctors were doing in the crisis and awareness of the challenges they faced. But after that uptick, global measures and national data showed drops for health care organizations and providers. Patients’ expectations were not being met. We needed to respond and meet patients where they were at. We needed to do things differently,” she said.

Keeping patients well informed and treating them with respect are paramount – and more important than ever – as reflected in Dr. Mehta’s “6H” model to promote a human connection between doctors and patients.² As chair of SHM’s Patient Experience SIG, she led the creation of COVID-19–specific communication tips for hospitalists based on the 6H model. “I’m very committed to treating patients with compassion,” she said.

For Vituity, those approaches included making greater use of the hospital at home model for patients who reported to the emergency department but met certain criteria for discharge. They would be sent home with daily nursing visits and 24-hour virtual access to hospitalists. Vituity hospitalists also worked more closely with emergency departments to provide emergency psychiatric interventions for anxious patients, and with primary care physicians. Patient care navigators helped to enhance transitions of care. In addition, their hospitalist team added personalized pictures over their gowns so patients could see the hospitalists’ faces despite PPE.

Another Vituity innovation was virtual rounding, with iPads in the patient’s room and the physician in another room. “I did telerounds at our Redwood City hospital with patients with COVID who were very lonely, anxious, and afraid because they couldn’t have family visitors,” Dr. Mehta said. Telerounds offered greater protection and safety for both providers and patients, reduced the need for PPE, and improved collaboration with the nursing team, primary care providers, and families.

A recent perspective published in the New England Journal of Medicine suggests that the Zoom family conference may offer distinct advantages over in-person family conferences.³ It allows for greater participation by primary care clinicians who knew the patient before the current hospitalization and thus might have important contributions to discharge plans.

The pandemic stimulated many hospitals to take a closer look at all areas of their service delivery, Dr. Rudolph concluded. “We’ve made big changes with a lot of fearlessness in a short amount of time, which is not typical for hospitals. We showed that the pace of innovation can be faster if we lower the threshold of risk.”
 

References

1. Silvera GA et al. The influence of COVID-19 visitation restrictions on patient experience and safety outcomes: A critical role for subjective advocates. Patient Experience Journal. 8(1) doi: 10.35680/2372-0247.1596.

2. Mehta S. How to truly connect with your patients: Introducing the ‘6H model.’ The Hospitalist. 2020 Aug 14.

3. Lee TH. Zoom family meeting. N Engl J Med. 2021 Apr 29;384(17):1586-7.

A patient’s lived experience of being in the hospital is shaped by a variety of factors, according to Minesh Patel, MD, Mid-Atlantic regional medical director for the Tacoma, Wash.–based hospitalist performance company Sound Physicians. Some – but not all – of these factors are captured in the “patient experience” questions on the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey that is sent to randomly selected patients shortly after their discharge from the hospital.

In March 2020, the COVID-19 pandemic caused hospitals to institute quarantining measures and “no visitor” policies as doctors and other hospital staff donned masks, visors, and other emotionally distancing personal protective equipment (PPE). All of these factors impacted patients’ experience as well as their hospitals’ HCAHPS scores, Dr. Patel said. And since these policies applied to all hospitalized patients, a patient did not need to have COVID-19 to experience many of the same restrictions imposed by the pandemic.

“A lot of the care hospitalists provide involves touch, sitting down and looking at the patient eye to eye, on the same level,” said Dr. Patel, a practicing hospitalist at Frederick (Md.) Health Hospital. “That had to take a back seat to infection control.”

Meanwhile, lengths of stay were longer for COVID-19 patients, who were often very sick and alone in their hospital rooms for prolonged periods, sometimes on mechanical ventilation, isolated without the support of their families. Health care providers tried to minimize time spent at the bedside because of viral exposure risks. Nobody really knew how to treat patients’ severe respiratory distress, especially at first. “So we basically threw the kitchen sink at it, following the evolving CDC guidelines, and hoped it would work,” he explained.

“When we saw our patient experience scores plummeting across the division, we said, ‘This is not good.’ We could see that we weren’t spending as much time at the bedside, and our patients were lonely and scared.” There was also greater fragmentation of care, all of which impacted patients’ experience in partnering hospitals.

Dr. Patel and his team spearheaded a number of processes across their partner hospitals to help patients and their families get the information they needed and understand what was happening during their treatment. “At that moment, real-time feedback was essential,” he explained. “We implemented the TED protocol – Teach back, Empathy and ‘Double-backing,’ which means spending a shorter visit on morning rounds but going back to the patient’s bedside for a second daily visit at the end of the shift, thereby establishing a second touch point.” Teach back is a strategy of asking patients to repeat back in their own words what they understood the doctor to be saying about their care.

The group developed ID buttons – called “Suttons” or Sound Buttons – with a larger picture of the doctor’s smiling face pinned to their medical gowns. The hospitalists started scheduling Zoom calls with families from the ICU rooms of COVID-19 patients. “We employ clinical performance nurses as collaborative influencers. They visit patients’ bedsides and work with staff on improving patient experience,” Dr. Patel said. “And we printed thank-you cards with the doctor’s name, photo, and an individualized message for their patients.” Together these measures measurably improved patient experience scores across partnering hospitals.

Sound Physicians

What is patient experience?

Evaluated by the Agency for Healthcare Research and Quality and endorsed by the National Quality Forum, HCAHPS hospital quality surveys ask patients (or their family members, who may be the ones completing the survey) 29 well-tested questions about the recent hospital stay and how they experienced it. Nineteen of those questions explore critical aspects of the patient’s experience in areas such as communication, responsiveness of staff, information about their diagnosis, medications, and discharge – and if they would recommend the hospital to others.

Surveys can be done by mail, phone, or interactive voice recognition and are offered in seven different languages. They can be administered by the hospital itself or by an approved survey vendor. They are sent between 48 hours and 6 weeks after the patient’s hospital discharge.

Nationwide results from HCAHPS survey have been published since 2008 in a searchable, comparable format on the consumer-focused government website Hospital Compare. The data have been used in a value-based incentive purchasing program since 2012. Hospital Compare also incorporates measures of quality such as mortality, readmission, and hospital-acquired infection rates as well as process measures such as how well facilities provide recommended care.

Starting in 2016, overall hospital quality has been encapsulated in a Star rating, which summarizes a variety of measures across seven areas of quality into a single number from one to five for each hospital. One of those seven areas is patient experience.

Hospitals may choose to ask additional questions of their own along with the HCAHPS survey, to gather additional, actionable quality data for internal purposes. Internal surveys with results closer to real time, instead of the months-to-years lag in posting HCAHPS scores, enable the hospital to respond to issues that emerge.
 

It’s not just the scores

“A lot of leaders in the hospital business will tell you ‘It’s not about the scores,’ ” Dr. Patel related. “But you need scores to tell how your practice is doing. It’s a testament to the kind of care you are providing as a hospital medicine program. These are important questions: Did your doctor listen to you, communicate in ways you understood, and treat you with courtesy?” Scores are scores, he said, but more importantly, are patients getting the information they need? Do they understand what’s going on in their care?

“You have to look at the scores and ask, what can we do differently to impact patient experience? What are we doing wrong? What can we do better? If the scores as a collective experience of hospitalized patients are plummeting, it must mean they’re not feeling good about the care they are receiving, and not recognizing what we’re trying to do for them.”

Declining HCAHPS scores last year could easily be explained by what was going on with COVID-19, Dr. Patel said. “But we want our patient experience to be seamless. We have to put ourselves in the patient’s shoes. For them, it’s about whether they felt they were treated well or not. We had to reinvent ourselves and find new ways to compensate for the limitations imposed by the pandemic,” he said.

“We also recognized that our No. 1 job as a group is to take care of our doctors, so that they can take care of their patients. We provided quarantine pay, implemented a buddy system for doctors, used CME dollars to pay for COVID education and, if they felt ill, we said they needed to stay home, while we paid their shift anyway,” he said. “When you do that kind of thing and engage them in your mission, frontline hospitalists can help to improve quality of care, decrease costs, and increase patient safety.”
 

A sacred encounter

For Sarah Richards, MD, a hospitalist with Nebraska Medicine in Omaha, what happens in the hospital room between the hospitalist and the patient is a sacred encounter. “It’s about relationship and trust,” she said, noting that it’s hard to capture all of that in survey data. It might be better expressed in words: “ ‘How are things going for you?’ To me, that’s the real patient experience. When I talk with physicians about patient experience, I start with why this matters. We know, for example, that when patients trust us, they are more likely to engage with their care and adhere to the treatment plan.”

Dr. Richards said standard hospital quality surveys can be a blunt tool. The HCAHPS survey, conducted around a week after the hospitalization, has a low response rate, and returns are not representative of the demographic served in the hospital. “The inpatient data are not always helpful, but this is what we have to work with. One choice hospitals have is for the leadership to choose not to use the data for individual bonuses, recognition, or discipline, since the questions ask patients about the care they received collectively from all of their doctors,” she said.

But as hospitalists have worked longer shifts under more stress while wearing PPE – which makes it harder to communicate with their patients – there is a dynamic that has emerged, which deserves more study. “I think doctors gave it their all in the pandemic. I’m a hospitalist, and people told me I’m a hero. But did that change my impact at work (on patient experience)?” she said.

Dr. Richards sits on SHM’s Patient Experience Special Interest Group (SIG), which was tasked with providing tools to help mitigate the effects of the pandemic. These include a fact sheet, “Communication Tips for 5 Common Conundrums in the COVID-19 Pandemic”, and a downloadable pocket card called “The 5 Rs of Cultural Humility.”

Also on the SIG is Mark Rudolph, MD, SFHM, Sound Physicians’ chief experience officer, whose job title reflects a growing, systematic attention to patient experience in U.S. hospitals. “Most clinicians are familiar with the surveys and the results of those surveys,” he told The Hospitalist. “People in our field can get frustrated with the surveys, and have a lot to say about the quality of the scores themselves – what is actually being measured. Is the patient upset because the coffee was cold, or due to a bad clinical experience? Is it about the care they received from the hospitalist, or the physical setting of the hospital?”

Doing the right thing

To be a patient hospitalized with an acute illness is a form of suffering, Dr. Rudolph said. “We know patient experience in the hospital since March of 2020 has been frightening and horrible. These people are as sick as can be. Everything about the experience is horrible. Every effort you can make to reduce that suffering is important. If you are a patient in the hospital and don’t know what’s happening to you, that’s terrifying.”

He encourages hospitalists to look beyond the scores or the idea that they are just trying to improve their scores. “Look instead at the actual content of the questions around communication with doctors. The competencies addressed in the survey questions – listening and explaining things clearly, for example – are effective guides for patient experience improvement efforts. You can be confident you’re doing the right thing for the patient by focusing on these skills, even if you don’t see immediate changes in survey scores.”

Hospitals that did not allow visitors had worse clinical outcomes and worse patient experience ratings, and recent research confirms that when family visitors are not allowed, outcomes are worse in areas such as patient ratings of medical staff responsiveness, fall rates, and sepsis rates.¹ “None of that should be surprising. Not having family present just ups the ante. Any hospital patients could benefit from an advocate sitting next to them, helping them to the bathroom, and keeping them from falling out of bed,” Dr. Rudolph said.

“In the past year, we have placed a premium on communicating with these patients with kindness and compassion, to help them understand what’s happening to them,” he said. Out of necessity, hospitals have had to rejigger their processes, which has led to more efficient and better care, although the jury is still out on whether that will persist post pandemic.
 

Communicating with compassion

Swati Mehta, MD, a hospitalist at Sequoia Hospital in Redwood City, Calif., and director of quality performance and patient experience at Vituity, a physician-owned and -led multispecialty partnership, said COVID-19 was a wake-up call for hospitalists. There have been successful models for enhancing hospitalized patients’ experience, but it took the challenges of COVID-19 for many hospitalists to adopt them.

“Early in 2020, our data analysis showed emerging positive trends, reflecting our patients’ appreciation for what doctors were doing in the crisis and awareness of the challenges they faced. But after that uptick, global measures and national data showed drops for health care organizations and providers. Patients’ expectations were not being met. We needed to respond and meet patients where they were at. We needed to do things differently,” she said.

Keeping patients well informed and treating them with respect are paramount – and more important than ever – as reflected in Dr. Mehta’s “6H” model to promote a human connection between doctors and patients.² As chair of SHM’s Patient Experience SIG, she led the creation of COVID-19–specific communication tips for hospitalists based on the 6H model. “I’m very committed to treating patients with compassion,” she said.

For Vituity, those approaches included making greater use of the hospital at home model for patients who reported to the emergency department but met certain criteria for discharge. They would be sent home with daily nursing visits and 24-hour virtual access to hospitalists. Vituity hospitalists also worked more closely with emergency departments to provide emergency psychiatric interventions for anxious patients, and with primary care physicians. Patient care navigators helped to enhance transitions of care. In addition, their hospitalist team added personalized pictures over their gowns so patients could see the hospitalists’ faces despite PPE.

Another Vituity innovation was virtual rounding, with iPads in the patient’s room and the physician in another room. “I did telerounds at our Redwood City hospital with patients with COVID who were very lonely, anxious, and afraid because they couldn’t have family visitors,” Dr. Mehta said. Telerounds offered greater protection and safety for both providers and patients, reduced the need for PPE, and improved collaboration with the nursing team, primary care providers, and families.

A recent perspective published in the New England Journal of Medicine suggests that the Zoom family conference may offer distinct advantages over in-person family conferences.³ It allows for greater participation by primary care clinicians who knew the patient before the current hospitalization and thus might have important contributions to discharge plans.

The pandemic stimulated many hospitals to take a closer look at all areas of their service delivery, Dr. Rudolph concluded. “We’ve made big changes with a lot of fearlessness in a short amount of time, which is not typical for hospitals. We showed that the pace of innovation can be faster if we lower the threshold of risk.”
 

References

1. Silvera GA et al. The influence of COVID-19 visitation restrictions on patient experience and safety outcomes: A critical role for subjective advocates. Patient Experience Journal. 8(1) doi: 10.35680/2372-0247.1596.

2. Mehta S. How to truly connect with your patients: Introducing the ‘6H model.’ The Hospitalist. 2020 Aug 14.

3. Lee TH. Zoom family meeting. N Engl J Med. 2021 Apr 29;384(17):1586-7.

A patient’s lived experience of being in the hospital is shaped by a variety of factors, according to Minesh Patel, MD, Mid-Atlantic regional medical director for the Tacoma, Wash.–based hospitalist performance company Sound Physicians. Some – but not all – of these factors are captured in the “patient experience” questions on the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey that is sent to randomly selected patients shortly after their discharge from the hospital.

In March 2020, the COVID-19 pandemic caused hospitals to institute quarantining measures and “no visitor” policies as doctors and other hospital staff donned masks, visors, and other emotionally distancing personal protective equipment (PPE). All of these factors impacted patients’ experience as well as their hospitals’ HCAHPS scores, Dr. Patel said. And since these policies applied to all hospitalized patients, a patient did not need to have COVID-19 to experience many of the same restrictions imposed by the pandemic.

“A lot of the care hospitalists provide involves touch, sitting down and looking at the patient eye to eye, on the same level,” said Dr. Patel, a practicing hospitalist at Frederick (Md.) Health Hospital. “That had to take a back seat to infection control.”

Meanwhile, lengths of stay were longer for COVID-19 patients, who were often very sick and alone in their hospital rooms for prolonged periods, sometimes on mechanical ventilation, isolated without the support of their families. Health care providers tried to minimize time spent at the bedside because of viral exposure risks. Nobody really knew how to treat patients’ severe respiratory distress, especially at first. “So we basically threw the kitchen sink at it, following the evolving CDC guidelines, and hoped it would work,” he explained.

“When we saw our patient experience scores plummeting across the division, we said, ‘This is not good.’ We could see that we weren’t spending as much time at the bedside, and our patients were lonely and scared.” There was also greater fragmentation of care, all of which impacted patients’ experience in partnering hospitals.

Dr. Patel and his team spearheaded a number of processes across their partner hospitals to help patients and their families get the information they needed and understand what was happening during their treatment. “At that moment, real-time feedback was essential,” he explained. “We implemented the TED protocol – Teach back, Empathy and ‘Double-backing,’ which means spending a shorter visit on morning rounds but going back to the patient’s bedside for a second daily visit at the end of the shift, thereby establishing a second touch point.” Teach back is a strategy of asking patients to repeat back in their own words what they understood the doctor to be saying about their care.

The group developed ID buttons – called “Suttons” or Sound Buttons – with a larger picture of the doctor’s smiling face pinned to their medical gowns. The hospitalists started scheduling Zoom calls with families from the ICU rooms of COVID-19 patients. “We employ clinical performance nurses as collaborative influencers. They visit patients’ bedsides and work with staff on improving patient experience,” Dr. Patel said. “And we printed thank-you cards with the doctor’s name, photo, and an individualized message for their patients.” Together these measures measurably improved patient experience scores across partnering hospitals.

Sound Physicians

What is patient experience?

Evaluated by the Agency for Healthcare Research and Quality and endorsed by the National Quality Forum, HCAHPS hospital quality surveys ask patients (or their family members, who may be the ones completing the survey) 29 well-tested questions about the recent hospital stay and how they experienced it. Nineteen of those questions explore critical aspects of the patient’s experience in areas such as communication, responsiveness of staff, information about their diagnosis, medications, and discharge – and if they would recommend the hospital to others.

Surveys can be done by mail, phone, or interactive voice recognition and are offered in seven different languages. They can be administered by the hospital itself or by an approved survey vendor. They are sent between 48 hours and 6 weeks after the patient’s hospital discharge.

Nationwide results from HCAHPS survey have been published since 2008 in a searchable, comparable format on the consumer-focused government website Hospital Compare. The data have been used in a value-based incentive purchasing program since 2012. Hospital Compare also incorporates measures of quality such as mortality, readmission, and hospital-acquired infection rates as well as process measures such as how well facilities provide recommended care.

Starting in 2016, overall hospital quality has been encapsulated in a Star rating, which summarizes a variety of measures across seven areas of quality into a single number from one to five for each hospital. One of those seven areas is patient experience.

Hospitals may choose to ask additional questions of their own along with the HCAHPS survey, to gather additional, actionable quality data for internal purposes. Internal surveys with results closer to real time, instead of the months-to-years lag in posting HCAHPS scores, enable the hospital to respond to issues that emerge.
 

It’s not just the scores

“A lot of leaders in the hospital business will tell you ‘It’s not about the scores,’ ” Dr. Patel related. “But you need scores to tell how your practice is doing. It’s a testament to the kind of care you are providing as a hospital medicine program. These are important questions: Did your doctor listen to you, communicate in ways you understood, and treat you with courtesy?” Scores are scores, he said, but more importantly, are patients getting the information they need? Do they understand what’s going on in their care?

“You have to look at the scores and ask, what can we do differently to impact patient experience? What are we doing wrong? What can we do better? If the scores as a collective experience of hospitalized patients are plummeting, it must mean they’re not feeling good about the care they are receiving, and not recognizing what we’re trying to do for them.”

Declining HCAHPS scores last year could easily be explained by what was going on with COVID-19, Dr. Patel said. “But we want our patient experience to be seamless. We have to put ourselves in the patient’s shoes. For them, it’s about whether they felt they were treated well or not. We had to reinvent ourselves and find new ways to compensate for the limitations imposed by the pandemic,” he said.

“We also recognized that our No. 1 job as a group is to take care of our doctors, so that they can take care of their patients. We provided quarantine pay, implemented a buddy system for doctors, used CME dollars to pay for COVID education and, if they felt ill, we said they needed to stay home, while we paid their shift anyway,” he said. “When you do that kind of thing and engage them in your mission, frontline hospitalists can help to improve quality of care, decrease costs, and increase patient safety.”
 

A sacred encounter

For Sarah Richards, MD, a hospitalist with Nebraska Medicine in Omaha, what happens in the hospital room between the hospitalist and the patient is a sacred encounter. “It’s about relationship and trust,” she said, noting that it’s hard to capture all of that in survey data. It might be better expressed in words: “ ‘How are things going for you?’ To me, that’s the real patient experience. When I talk with physicians about patient experience, I start with why this matters. We know, for example, that when patients trust us, they are more likely to engage with their care and adhere to the treatment plan.”

Dr. Richards said standard hospital quality surveys can be a blunt tool. The HCAHPS survey, conducted around a week after the hospitalization, has a low response rate, and returns are not representative of the demographic served in the hospital. “The inpatient data are not always helpful, but this is what we have to work with. One choice hospitals have is for the leadership to choose not to use the data for individual bonuses, recognition, or discipline, since the questions ask patients about the care they received collectively from all of their doctors,” she said.

But as hospitalists have worked longer shifts under more stress while wearing PPE – which makes it harder to communicate with their patients – there is a dynamic that has emerged, which deserves more study. “I think doctors gave it their all in the pandemic. I’m a hospitalist, and people told me I’m a hero. But did that change my impact at work (on patient experience)?” she said.

Dr. Richards sits on SHM’s Patient Experience Special Interest Group (SIG), which was tasked with providing tools to help mitigate the effects of the pandemic. These include a fact sheet, “Communication Tips for 5 Common Conundrums in the COVID-19 Pandemic”, and a downloadable pocket card called “The 5 Rs of Cultural Humility.”

Also on the SIG is Mark Rudolph, MD, SFHM, Sound Physicians’ chief experience officer, whose job title reflects a growing, systematic attention to patient experience in U.S. hospitals. “Most clinicians are familiar with the surveys and the results of those surveys,” he told The Hospitalist. “People in our field can get frustrated with the surveys, and have a lot to say about the quality of the scores themselves – what is actually being measured. Is the patient upset because the coffee was cold, or due to a bad clinical experience? Is it about the care they received from the hospitalist, or the physical setting of the hospital?”

Doing the right thing

To be a patient hospitalized with an acute illness is a form of suffering, Dr. Rudolph said. “We know patient experience in the hospital since March of 2020 has been frightening and horrible. These people are as sick as can be. Everything about the experience is horrible. Every effort you can make to reduce that suffering is important. If you are a patient in the hospital and don’t know what’s happening to you, that’s terrifying.”

He encourages hospitalists to look beyond the scores or the idea that they are just trying to improve their scores. “Look instead at the actual content of the questions around communication with doctors. The competencies addressed in the survey questions – listening and explaining things clearly, for example – are effective guides for patient experience improvement efforts. You can be confident you’re doing the right thing for the patient by focusing on these skills, even if you don’t see immediate changes in survey scores.”

Hospitals that did not allow visitors had worse clinical outcomes and worse patient experience ratings, and recent research confirms that when family visitors are not allowed, outcomes are worse in areas such as patient ratings of medical staff responsiveness, fall rates, and sepsis rates.¹ “None of that should be surprising. Not having family present just ups the ante. Any hospital patients could benefit from an advocate sitting next to them, helping them to the bathroom, and keeping them from falling out of bed,” Dr. Rudolph said.

“In the past year, we have placed a premium on communicating with these patients with kindness and compassion, to help them understand what’s happening to them,” he said. Out of necessity, hospitals have had to rejigger their processes, which has led to more efficient and better care, although the jury is still out on whether that will persist post pandemic.
 

Communicating with compassion

Swati Mehta, MD, a hospitalist at Sequoia Hospital in Redwood City, Calif., and director of quality performance and patient experience at Vituity, a physician-owned and -led multispecialty partnership, said COVID-19 was a wake-up call for hospitalists. There have been successful models for enhancing hospitalized patients’ experience, but it took the challenges of COVID-19 for many hospitalists to adopt them.

“Early in 2020, our data analysis showed emerging positive trends, reflecting our patients’ appreciation for what doctors were doing in the crisis and awareness of the challenges they faced. But after that uptick, global measures and national data showed drops for health care organizations and providers. Patients’ expectations were not being met. We needed to respond and meet patients where they were at. We needed to do things differently,” she said.

Keeping patients well informed and treating them with respect are paramount – and more important than ever – as reflected in Dr. Mehta’s “6H” model to promote a human connection between doctors and patients.² As chair of SHM’s Patient Experience SIG, she led the creation of COVID-19–specific communication tips for hospitalists based on the 6H model. “I’m very committed to treating patients with compassion,” she said.

For Vituity, those approaches included making greater use of the hospital at home model for patients who reported to the emergency department but met certain criteria for discharge. They would be sent home with daily nursing visits and 24-hour virtual access to hospitalists. Vituity hospitalists also worked more closely with emergency departments to provide emergency psychiatric interventions for anxious patients, and with primary care physicians. Patient care navigators helped to enhance transitions of care. In addition, their hospitalist team added personalized pictures over their gowns so patients could see the hospitalists’ faces despite PPE.

Another Vituity innovation was virtual rounding, with iPads in the patient’s room and the physician in another room. “I did telerounds at our Redwood City hospital with patients with COVID who were very lonely, anxious, and afraid because they couldn’t have family visitors,” Dr. Mehta said. Telerounds offered greater protection and safety for both providers and patients, reduced the need for PPE, and improved collaboration with the nursing team, primary care providers, and families.

A recent perspective published in the New England Journal of Medicine suggests that the Zoom family conference may offer distinct advantages over in-person family conferences.³ It allows for greater participation by primary care clinicians who knew the patient before the current hospitalization and thus might have important contributions to discharge plans.

The pandemic stimulated many hospitals to take a closer look at all areas of their service delivery, Dr. Rudolph concluded. “We’ve made big changes with a lot of fearlessness in a short amount of time, which is not typical for hospitals. We showed that the pace of innovation can be faster if we lower the threshold of risk.”
 

References

1. Silvera GA et al. The influence of COVID-19 visitation restrictions on patient experience and safety outcomes: A critical role for subjective advocates. Patient Experience Journal. 8(1) doi: 10.35680/2372-0247.1596.

2. Mehta S. How to truly connect with your patients: Introducing the ‘6H model.’ The Hospitalist. 2020 Aug 14.

3. Lee TH. Zoom family meeting. N Engl J Med. 2021 Apr 29;384(17):1586-7.

Many Americans are clamoring for a booster dose of a COVID-19 vaccine after reports of rising numbers of breakthrough infections, and demand increased after the Biden administration said those shots would be offered starting on Sept. 20.

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.

Many Americans are clamoring for a booster dose of a COVID-19 vaccine after reports of rising numbers of breakthrough infections, and demand increased after the Biden administration said those shots would be offered starting on Sept. 20.

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.

Many Americans are clamoring for a booster dose of a COVID-19 vaccine after reports of rising numbers of breakthrough infections, and demand increased after the Biden administration said those shots would be offered starting on Sept. 20.

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.