MDedge Rheumatology

By the time she was discharged from a suburban New Jersey hospital on April 10, Kathleen Ronan thought the worst was behind her. For a week before her husband rushed her to the emergency department (ED), incoherent and struggling to breathe, the novel coronavirus had ravaged her body. She tried to treat her fevers with acetaminophen and ice packs. Despite taking enough Tylenol to risk liver damage and packing herself on ice like the catch of the day, Ronan’s fever continued to rise. By the time her temperature reached 104.5° F, Ronan knew the time had come for more drastic measures.

A team of masked and gowned nurses greeted her at a triage tent outside the ED, and from there, everything becomes hazy for Ronan. She was immediately rushed to the hospital’s special COVID-19 intensive care unit (ICU), where she spent 5 days. But she has few distinct memories from this time. What she does remember is the exhaustion, the pain, the loneliness, and the fear. Her family couldn’t visit, and though Ronan works as a home health nurse, her brain was so addled with fever that she couldn’t make sense of what was happening. After a week in the hospital, 5 days of which were spent in the ICU, 51-year-old Ronan was discharged.

Her years of working as a home health nurse told her that the return home wouldn’t be easy, but nothing prepared her for just how much she would struggle. The once-active Ronan, who had supplemented long days on her feet caring for others as a nurse with regular trips to the gym, now needed a walker to traverse the few steps from her bed to the toilet, an effort that left her gasping for air. Her brain couldn’t even focus on an audiobook, let alone a short magazine article.

“It just completely knocked the stuffing out of me,” Ronan said.

Ronan’s lingering symptoms aren’t unique to COVID-19 patients. In as many as 80% of patients leaving the ICU, researchers have documented what they call post–intensive care syndrome (PICS) — a constellation of physical, cognitive, and psychiatric symptoms that result from an ICU stay. Although underlying illness plays a role in these symptoms, the amount of time spent in critical care is a major factor.

Nor is PICS simply a set of side effects that will go away on their own. It includes ongoing cognitive difficulties and physical weakness, both of which can lead to employment problems. Beyond that, depression and anxiety can exacerbate – and be exacerbated by – these challenges. Psychologist Jim Jackson, PsyD, assistant director of the ICU Recovery Center at Vanderbilt University Medical Center, Nashville, Tennessee, recently spoke with a former ICU patient who has struggled since her discharge 30 years ago.

“Her life essentially stopped with her critical care stay. She hasn’t been able to move forward,” he said. “She’s part of a whole fraternity of people who are struggling.”

The good news is that over the past decade, researchers have made important strides in understanding what makes PICS symptoms worse and how critical care physicians can tweak ICU protocols to reduce PICS severity. Practitioners will need to draw on this knowledge to help Ronan and the thousands of COVID-19 ICU patients like her.
 

Surviving the ICU

Although the new coronavirus has pushed the world’s critical care system to its limits, it was an outbreak in 1952 that inspired the creation of intensive care units. That summer, a wave of paralytic polio swept over Copenhagen, Denmark, and anesthesiologist Bjørn Ibsen, MD, PhD, used mechanical ventilation — physically operated by medical and dental students – to help 316 children breathe for weeks at a time while their small bodies worked to fight off the virus. The effort halved the mortality rate from polio that affected breathing, from 80% to 40%.

In these wards, dedicated to the very sickest, each patient was assigned his or her own nurse. Over the next decade, hospitals in the United Kingdom and the United States established their own ICUs to treat patients with a variety of conditions. Although it helped improve survival, mortality rates in critical care units remained stubbornly high, owing to the patients’ severe underlying illnesses.

“We thought we were doing a good job if the patient survived, but we had no idea what happened after discharge,” said Carla Sevin, MD, medical director of Vanderbilt’s ICU Recovery Center. Nor did their efforts to find out always bring answers. “We struggled to get people to come in for support — they were debilitated, physically burdened, and weak.”

Through further advances in life support, by the early 2000s, the average mortality rates in American ICUs had dropped to 8% to 19%. As the number of critical care survivors began to climb, clinical researchers noticed that the lives of these patients and their families were profoundly altered by their severe illness.

As Dale Needham, MD, PhD, began his pulmonology and critical care residency in Toronto, Canada, in 2005, a group of physicians there began a 5-year longitudinal study to assess long-term outcomes of patients who developed acute respiratory distress syndrome (ARDS). Although ARDS is an acute condition, the investigators found that patients felt effects for years. Younger patients recovered better than older ones, but none of the patients› physical functioning was equivalent to that of age-matched control persons. Even 5 years later, former ICU patients only reached 76% of expected physical functioning, according to results published in the New England Journal of Medicine. The study was a wake-up call.

At a meeting in Chicago in 2010, Needham, now an intensivist at Johns Hopkins Hospital in Baltimore, Maryland, gathered an interdisciplinary group of colleagues, including patients and caregivers, to clarify the phenomena they were seeing. What emerged from that meeting, published in 2012 in Critical Care Medicine, were the diagnostic criteria for PICS: According to the new definition, PICS is characterized by new or worsening physical and neuropsychiatric deficits that range from forgetfulness and loss of motivation to physical weakness and insomnia.

The issue, Needham says, is that although the trouble starts in the ICU, it only becomes clear once patients leave. “ICU doctors aren’t the ones dealing with this,” Needham said. “We need to build stronger bridges between critical care and other professions.” That’s where PICS comes in, a definition that exists explicitly to alert healthcare providers about the constellation of challenges many of these individuals face as they try to reenter “normal” life.
 

Defining the problem

As an ICU nurse at the Mayo Clinic in Rochester, Minnesota, Annie Johnson, ACNP-BC, knew lots about helping hospitalized patients, but she says she didn’t know anything about what to do after discharge – at least not until her own mother became a patient.

On the first day of retirement in October 2014, Johnson’s mother flatlined. Quick-thinking paramedics resuscitated her, and after several days in critical care, she was discharged. Since then, her heart has remained healthy. Johnson’s sister, who spent time worrying over her mother at the hospital, also had lingering effects. Both have since struggled, plagued by nightmares, flashbacks, and insomnia.

Johnson initially believed her mom’s and sister’s neuropsychiatric, post-ICU struggles were unique to her family. It was only a year later, at a seminar she was attending, that she first heard the words “post–intensive care syndrome.” Suddenly, Johnson had a name for her family’s experiences, and she began to create support groups and resources to help other families like hers.

“I thought of all the patients I had treated over the years who had been on ventilators for days and days and days. And if this happened to my mom after 48 hours, what must they be going through?” she asked.

Once physicians formally defined PICS, the Society for Critical Care Medicine helped create programs to educate ICU staff, patients, and families about potential post-discharge challenges. Researchers also began to investigate factors affecting post-ICU functioning. Follow-up studies of patients with delirium (ranging from general confusion about time and place to extreme agitation and violence) showed they had striking cognitive deficits. Problems with short-term memory, flexible thinking, and motivation plagued patients for years after their critical illness, similar to the physical deficiencies seen after ARDS. Delirium was one of the strongest risk factors for neuropsychiatric problems.

“Delirium is basically a stress test for the brain,” said Babar Khan, MD, a critical care specialist at Indiana University’s Regenstrief Institute, in Bloomington. But whether delirium accentuates preexisting cognitive difficulties or creates them afresh isn’t yet clear.

Sophia Wang, MD, a geriatric psychiatrist at Indiana University who works with many critical care patients, says patients who had experienced delirium in the ICU showed significant defects in memory and executive functioning long after their hospital stay. She points to a 2015 study that followed 47 ICU patients for a year post discharge. Among those who experienced delirium, brain volumes, as measured by MRI, were smaller at 3 months, something associated with cognitive problems at 1 year. Many struggled at work, and unemployment was common. Depression and posttraumatic stress compounded these difficulties. Among those with acute respiratory distress, ICU patients who are young, female, and unemployed are most likely to suffer from posttraumatic stress disorder after they are discharge.

Critical care medicine may have given these patients a second chance at life, Wang says, but the life they return to often looks nothing like the one they had before their illness.

Prolonged mechanical ventilation and the heavy sedation that often accompanies it are predictors of PICS severity. Some of these links could be explained by the gravity of the illness that landed someone in critical care, but others are more likely to be iatrogenic, says Gerald Weinhouse, MD, a pulmonology and critical care physician and co-director of the Critical Illness Recovery Program at the Brigham and Women’s Hospital in Boston. The involvement of loved ones at the patient’s bedside, however, improved the entire family’s outcome.

When Weinhouse saw those data, he and his colleagues founded a peer support program for ICU survivors. In a study published in 2019 in Critical Care Medicine, they identified six different models for peer support for those with PICS and their families, including both online and in-person approaches. An ongoing challenge for physicians, Weinhouse says, is getting patients to engage with these programs, given that their calendars are crowded with medical appointments and that they suffer from increased physical and mental disability.

Studies such as these led critical care physicians to form the ICU Liberation Collaborative to rethink critical care medicine. At Vanderbilt, Sevin and Jackson headed up one of the world’s first post-ICU clinics, which uses an interdisciplinary team to help patients maximize their functioning. They redesigned their critical care unit in a way that allows families to spend the night and that encourages patient mobility. Both Needham and Weinhouse continue tracking patient outcomes.

Even before the novel coronavirus struck, the United States — and the world — had begun to realize that graduating from the ICU was only the start of what was often an extensive recovery.
 

The long road back

When COVID-19 patients began flooding intensive care wards around the world, physicians scrambled to meet their complex and desperate acute medical needs. Over the past few months, physicians have focused on keeping these patients alive. “We’ve never seen anything like it ― not even during polio — with the sheer number of patients, all with respiratory distress,” Needham said.

But he and his colleagues know this is only the beginning.

“We’re aware that survivorship issues are coming. There’s going to be a wave of sick people who survived the coronavirus but are going to need more help,” Weinhouse said.

Intensivists have been drawing on PICS research in their fight to help COVID-19 patients. Work from the past few years has shown that although sedation is required during intubation itself, not everyone needs it while on a ventilator. Titrating down sedating medication helps reduce delirium, Wang says. Such medication has been shown to contribute to later cognitive problems. Needham’s studies showing that prolonged bedrest by ICU patients causes muscular atrophy has led him to encourage patients to move as much as possible. With the help of physical therapists, many patients on ventilators can be awake, alert, and moving around the ward.

One of the biggest challenges critical-care coronavirus patients face is prolonged isolation. The constant presence of a familiar face helps orient confused and delirious patients and provides emotional support during a frightening time. But because the immediate need for infection control outweighs these benefits, few hospitals allow visitors, especially for COVID-19 patients.

To address this, some units have been using video technology to allow loved ones to call in. At Johns Hopkins, physicians have also been relying on the expertise of occupational therapists (OTs). Needham says that one OT found that rubbing the hand and back of an agitated, delirious patient helped soothe and calm him better than many medications.

Ronan, who spent 5 days in intensive care, echoes that problem. She says she found the relative lack of human contact to be one of the most challenging parts of being in a bed on a COVID-19 ward. Separated from her husband and daughter, suffering from high fever and severe illness, she lost all track of time.

Her return home was difficult, too. Although her job as a home health nurse had prepared her on some level for the challenges she would face after discharge, Ronan says the hospital provided little practical help.

“Everything is so much harder at home, even little things like going to the bathroom,” she said. “I feel like I’m trying to bail out a sinking ship with a teacup.”

Khan and other physicians, aware of the challenges Ronan and others face once home, aim to create post-ICU clinics specifically for COVID-19 patients. They want to build what Khan calls a “one-stop shop” for all the support patients need to recover. Some of that can be provided via telehealth, which may also help ease the physical burden.

Because there’s so much physicians don’t know about the coronavirus, Johnson says, such clinics are not only a chance to help the sickest COVID-19 patients, they will also help researchers learn more about the virus and improve critical care for other illnesses.

Today, nearly 2 months after discharge, Ronan is back on the job but struggles with a persistent cough — likely due to the lung damage she sustained while ill. She has constant fatigue, as well as ongoing upset stomach from all the medications she took to reduce fever and body aches. When she dons a mask for work, the tangible reminder of her hospital stay sends her into a panic attack. Physically, she’s weaker than before.

Researchers are still trying to understand everything that Ronan and other COVID-19 patients need to move on with their lives after being in the ICU. Mysteries abound, but the ground laid by Sevin, Needham, Weinhouse, and others has provided a solid foundation on which to build.
 

This article first appeared on Medscape.com.

By the time she was discharged from a suburban New Jersey hospital on April 10, Kathleen Ronan thought the worst was behind her. For a week before her husband rushed her to the emergency department (ED), incoherent and struggling to breathe, the novel coronavirus had ravaged her body. She tried to treat her fevers with acetaminophen and ice packs. Despite taking enough Tylenol to risk liver damage and packing herself on ice like the catch of the day, Ronan’s fever continued to rise. By the time her temperature reached 104.5° F, Ronan knew the time had come for more drastic measures.

A team of masked and gowned nurses greeted her at a triage tent outside the ED, and from there, everything becomes hazy for Ronan. She was immediately rushed to the hospital’s special COVID-19 intensive care unit (ICU), where she spent 5 days. But she has few distinct memories from this time. What she does remember is the exhaustion, the pain, the loneliness, and the fear. Her family couldn’t visit, and though Ronan works as a home health nurse, her brain was so addled with fever that she couldn’t make sense of what was happening. After a week in the hospital, 5 days of which were spent in the ICU, 51-year-old Ronan was discharged.

Her years of working as a home health nurse told her that the return home wouldn’t be easy, but nothing prepared her for just how much she would struggle. The once-active Ronan, who had supplemented long days on her feet caring for others as a nurse with regular trips to the gym, now needed a walker to traverse the few steps from her bed to the toilet, an effort that left her gasping for air. Her brain couldn’t even focus on an audiobook, let alone a short magazine article.

“It just completely knocked the stuffing out of me,” Ronan said.

Ronan’s lingering symptoms aren’t unique to COVID-19 patients. In as many as 80% of patients leaving the ICU, researchers have documented what they call post–intensive care syndrome (PICS) — a constellation of physical, cognitive, and psychiatric symptoms that result from an ICU stay. Although underlying illness plays a role in these symptoms, the amount of time spent in critical care is a major factor.

Nor is PICS simply a set of side effects that will go away on their own. It includes ongoing cognitive difficulties and physical weakness, both of which can lead to employment problems. Beyond that, depression and anxiety can exacerbate – and be exacerbated by – these challenges. Psychologist Jim Jackson, PsyD, assistant director of the ICU Recovery Center at Vanderbilt University Medical Center, Nashville, Tennessee, recently spoke with a former ICU patient who has struggled since her discharge 30 years ago.

“Her life essentially stopped with her critical care stay. She hasn’t been able to move forward,” he said. “She’s part of a whole fraternity of people who are struggling.”

The good news is that over the past decade, researchers have made important strides in understanding what makes PICS symptoms worse and how critical care physicians can tweak ICU protocols to reduce PICS severity. Practitioners will need to draw on this knowledge to help Ronan and the thousands of COVID-19 ICU patients like her.
 

Surviving the ICU

Although the new coronavirus has pushed the world’s critical care system to its limits, it was an outbreak in 1952 that inspired the creation of intensive care units. That summer, a wave of paralytic polio swept over Copenhagen, Denmark, and anesthesiologist Bjørn Ibsen, MD, PhD, used mechanical ventilation — physically operated by medical and dental students – to help 316 children breathe for weeks at a time while their small bodies worked to fight off the virus. The effort halved the mortality rate from polio that affected breathing, from 80% to 40%.

In these wards, dedicated to the very sickest, each patient was assigned his or her own nurse. Over the next decade, hospitals in the United Kingdom and the United States established their own ICUs to treat patients with a variety of conditions. Although it helped improve survival, mortality rates in critical care units remained stubbornly high, owing to the patients’ severe underlying illnesses.

“We thought we were doing a good job if the patient survived, but we had no idea what happened after discharge,” said Carla Sevin, MD, medical director of Vanderbilt’s ICU Recovery Center. Nor did their efforts to find out always bring answers. “We struggled to get people to come in for support — they were debilitated, physically burdened, and weak.”

Through further advances in life support, by the early 2000s, the average mortality rates in American ICUs had dropped to 8% to 19%. As the number of critical care survivors began to climb, clinical researchers noticed that the lives of these patients and their families were profoundly altered by their severe illness.

As Dale Needham, MD, PhD, began his pulmonology and critical care residency in Toronto, Canada, in 2005, a group of physicians there began a 5-year longitudinal study to assess long-term outcomes of patients who developed acute respiratory distress syndrome (ARDS). Although ARDS is an acute condition, the investigators found that patients felt effects for years. Younger patients recovered better than older ones, but none of the patients› physical functioning was equivalent to that of age-matched control persons. Even 5 years later, former ICU patients only reached 76% of expected physical functioning, according to results published in the New England Journal of Medicine. The study was a wake-up call.

At a meeting in Chicago in 2010, Needham, now an intensivist at Johns Hopkins Hospital in Baltimore, Maryland, gathered an interdisciplinary group of colleagues, including patients and caregivers, to clarify the phenomena they were seeing. What emerged from that meeting, published in 2012 in Critical Care Medicine, were the diagnostic criteria for PICS: According to the new definition, PICS is characterized by new or worsening physical and neuropsychiatric deficits that range from forgetfulness and loss of motivation to physical weakness and insomnia.

The issue, Needham says, is that although the trouble starts in the ICU, it only becomes clear once patients leave. “ICU doctors aren’t the ones dealing with this,” Needham said. “We need to build stronger bridges between critical care and other professions.” That’s where PICS comes in, a definition that exists explicitly to alert healthcare providers about the constellation of challenges many of these individuals face as they try to reenter “normal” life.
 

Defining the problem

As an ICU nurse at the Mayo Clinic in Rochester, Minnesota, Annie Johnson, ACNP-BC, knew lots about helping hospitalized patients, but she says she didn’t know anything about what to do after discharge – at least not until her own mother became a patient.

On the first day of retirement in October 2014, Johnson’s mother flatlined. Quick-thinking paramedics resuscitated her, and after several days in critical care, she was discharged. Since then, her heart has remained healthy. Johnson’s sister, who spent time worrying over her mother at the hospital, also had lingering effects. Both have since struggled, plagued by nightmares, flashbacks, and insomnia.

Johnson initially believed her mom’s and sister’s neuropsychiatric, post-ICU struggles were unique to her family. It was only a year later, at a seminar she was attending, that she first heard the words “post–intensive care syndrome.” Suddenly, Johnson had a name for her family’s experiences, and she began to create support groups and resources to help other families like hers.

“I thought of all the patients I had treated over the years who had been on ventilators for days and days and days. And if this happened to my mom after 48 hours, what must they be going through?” she asked.

Once physicians formally defined PICS, the Society for Critical Care Medicine helped create programs to educate ICU staff, patients, and families about potential post-discharge challenges. Researchers also began to investigate factors affecting post-ICU functioning. Follow-up studies of patients with delirium (ranging from general confusion about time and place to extreme agitation and violence) showed they had striking cognitive deficits. Problems with short-term memory, flexible thinking, and motivation plagued patients for years after their critical illness, similar to the physical deficiencies seen after ARDS. Delirium was one of the strongest risk factors for neuropsychiatric problems.

“Delirium is basically a stress test for the brain,” said Babar Khan, MD, a critical care specialist at Indiana University’s Regenstrief Institute, in Bloomington. But whether delirium accentuates preexisting cognitive difficulties or creates them afresh isn’t yet clear.

Sophia Wang, MD, a geriatric psychiatrist at Indiana University who works with many critical care patients, says patients who had experienced delirium in the ICU showed significant defects in memory and executive functioning long after their hospital stay. She points to a 2015 study that followed 47 ICU patients for a year post discharge. Among those who experienced delirium, brain volumes, as measured by MRI, were smaller at 3 months, something associated with cognitive problems at 1 year. Many struggled at work, and unemployment was common. Depression and posttraumatic stress compounded these difficulties. Among those with acute respiratory distress, ICU patients who are young, female, and unemployed are most likely to suffer from posttraumatic stress disorder after they are discharge.

Critical care medicine may have given these patients a second chance at life, Wang says, but the life they return to often looks nothing like the one they had before their illness.

Prolonged mechanical ventilation and the heavy sedation that often accompanies it are predictors of PICS severity. Some of these links could be explained by the gravity of the illness that landed someone in critical care, but others are more likely to be iatrogenic, says Gerald Weinhouse, MD, a pulmonology and critical care physician and co-director of the Critical Illness Recovery Program at the Brigham and Women’s Hospital in Boston. The involvement of loved ones at the patient’s bedside, however, improved the entire family’s outcome.

When Weinhouse saw those data, he and his colleagues founded a peer support program for ICU survivors. In a study published in 2019 in Critical Care Medicine, they identified six different models for peer support for those with PICS and their families, including both online and in-person approaches. An ongoing challenge for physicians, Weinhouse says, is getting patients to engage with these programs, given that their calendars are crowded with medical appointments and that they suffer from increased physical and mental disability.

Studies such as these led critical care physicians to form the ICU Liberation Collaborative to rethink critical care medicine. At Vanderbilt, Sevin and Jackson headed up one of the world’s first post-ICU clinics, which uses an interdisciplinary team to help patients maximize their functioning. They redesigned their critical care unit in a way that allows families to spend the night and that encourages patient mobility. Both Needham and Weinhouse continue tracking patient outcomes.

Even before the novel coronavirus struck, the United States — and the world — had begun to realize that graduating from the ICU was only the start of what was often an extensive recovery.
 

The long road back

When COVID-19 patients began flooding intensive care wards around the world, physicians scrambled to meet their complex and desperate acute medical needs. Over the past few months, physicians have focused on keeping these patients alive. “We’ve never seen anything like it ― not even during polio — with the sheer number of patients, all with respiratory distress,” Needham said.

But he and his colleagues know this is only the beginning.

“We’re aware that survivorship issues are coming. There’s going to be a wave of sick people who survived the coronavirus but are going to need more help,” Weinhouse said.

Intensivists have been drawing on PICS research in their fight to help COVID-19 patients. Work from the past few years has shown that although sedation is required during intubation itself, not everyone needs it while on a ventilator. Titrating down sedating medication helps reduce delirium, Wang says. Such medication has been shown to contribute to later cognitive problems. Needham’s studies showing that prolonged bedrest by ICU patients causes muscular atrophy has led him to encourage patients to move as much as possible. With the help of physical therapists, many patients on ventilators can be awake, alert, and moving around the ward.

One of the biggest challenges critical-care coronavirus patients face is prolonged isolation. The constant presence of a familiar face helps orient confused and delirious patients and provides emotional support during a frightening time. But because the immediate need for infection control outweighs these benefits, few hospitals allow visitors, especially for COVID-19 patients.

To address this, some units have been using video technology to allow loved ones to call in. At Johns Hopkins, physicians have also been relying on the expertise of occupational therapists (OTs). Needham says that one OT found that rubbing the hand and back of an agitated, delirious patient helped soothe and calm him better than many medications.

Ronan, who spent 5 days in intensive care, echoes that problem. She says she found the relative lack of human contact to be one of the most challenging parts of being in a bed on a COVID-19 ward. Separated from her husband and daughter, suffering from high fever and severe illness, she lost all track of time.

Her return home was difficult, too. Although her job as a home health nurse had prepared her on some level for the challenges she would face after discharge, Ronan says the hospital provided little practical help.

“Everything is so much harder at home, even little things like going to the bathroom,” she said. “I feel like I’m trying to bail out a sinking ship with a teacup.”

Khan and other physicians, aware of the challenges Ronan and others face once home, aim to create post-ICU clinics specifically for COVID-19 patients. They want to build what Khan calls a “one-stop shop” for all the support patients need to recover. Some of that can be provided via telehealth, which may also help ease the physical burden.

Because there’s so much physicians don’t know about the coronavirus, Johnson says, such clinics are not only a chance to help the sickest COVID-19 patients, they will also help researchers learn more about the virus and improve critical care for other illnesses.

Today, nearly 2 months after discharge, Ronan is back on the job but struggles with a persistent cough — likely due to the lung damage she sustained while ill. She has constant fatigue, as well as ongoing upset stomach from all the medications she took to reduce fever and body aches. When she dons a mask for work, the tangible reminder of her hospital stay sends her into a panic attack. Physically, she’s weaker than before.

Researchers are still trying to understand everything that Ronan and other COVID-19 patients need to move on with their lives after being in the ICU. Mysteries abound, but the ground laid by Sevin, Needham, Weinhouse, and others has provided a solid foundation on which to build.
 

This article first appeared on Medscape.com.

By the time she was discharged from a suburban New Jersey hospital on April 10, Kathleen Ronan thought the worst was behind her. For a week before her husband rushed her to the emergency department (ED), incoherent and struggling to breathe, the novel coronavirus had ravaged her body. She tried to treat her fevers with acetaminophen and ice packs. Despite taking enough Tylenol to risk liver damage and packing herself on ice like the catch of the day, Ronan’s fever continued to rise. By the time her temperature reached 104.5° F, Ronan knew the time had come for more drastic measures.

A team of masked and gowned nurses greeted her at a triage tent outside the ED, and from there, everything becomes hazy for Ronan. She was immediately rushed to the hospital’s special COVID-19 intensive care unit (ICU), where she spent 5 days. But she has few distinct memories from this time. What she does remember is the exhaustion, the pain, the loneliness, and the fear. Her family couldn’t visit, and though Ronan works as a home health nurse, her brain was so addled with fever that she couldn’t make sense of what was happening. After a week in the hospital, 5 days of which were spent in the ICU, 51-year-old Ronan was discharged.

Her years of working as a home health nurse told her that the return home wouldn’t be easy, but nothing prepared her for just how much she would struggle. The once-active Ronan, who had supplemented long days on her feet caring for others as a nurse with regular trips to the gym, now needed a walker to traverse the few steps from her bed to the toilet, an effort that left her gasping for air. Her brain couldn’t even focus on an audiobook, let alone a short magazine article.

“It just completely knocked the stuffing out of me,” Ronan said.

Ronan’s lingering symptoms aren’t unique to COVID-19 patients. In as many as 80% of patients leaving the ICU, researchers have documented what they call post–intensive care syndrome (PICS) — a constellation of physical, cognitive, and psychiatric symptoms that result from an ICU stay. Although underlying illness plays a role in these symptoms, the amount of time spent in critical care is a major factor.

Nor is PICS simply a set of side effects that will go away on their own. It includes ongoing cognitive difficulties and physical weakness, both of which can lead to employment problems. Beyond that, depression and anxiety can exacerbate – and be exacerbated by – these challenges. Psychologist Jim Jackson, PsyD, assistant director of the ICU Recovery Center at Vanderbilt University Medical Center, Nashville, Tennessee, recently spoke with a former ICU patient who has struggled since her discharge 30 years ago.

“Her life essentially stopped with her critical care stay. She hasn’t been able to move forward,” he said. “She’s part of a whole fraternity of people who are struggling.”

The good news is that over the past decade, researchers have made important strides in understanding what makes PICS symptoms worse and how critical care physicians can tweak ICU protocols to reduce PICS severity. Practitioners will need to draw on this knowledge to help Ronan and the thousands of COVID-19 ICU patients like her.
 

Surviving the ICU

Although the new coronavirus has pushed the world’s critical care system to its limits, it was an outbreak in 1952 that inspired the creation of intensive care units. That summer, a wave of paralytic polio swept over Copenhagen, Denmark, and anesthesiologist Bjørn Ibsen, MD, PhD, used mechanical ventilation — physically operated by medical and dental students – to help 316 children breathe for weeks at a time while their small bodies worked to fight off the virus. The effort halved the mortality rate from polio that affected breathing, from 80% to 40%.

In these wards, dedicated to the very sickest, each patient was assigned his or her own nurse. Over the next decade, hospitals in the United Kingdom and the United States established their own ICUs to treat patients with a variety of conditions. Although it helped improve survival, mortality rates in critical care units remained stubbornly high, owing to the patients’ severe underlying illnesses.

“We thought we were doing a good job if the patient survived, but we had no idea what happened after discharge,” said Carla Sevin, MD, medical director of Vanderbilt’s ICU Recovery Center. Nor did their efforts to find out always bring answers. “We struggled to get people to come in for support — they were debilitated, physically burdened, and weak.”

Through further advances in life support, by the early 2000s, the average mortality rates in American ICUs had dropped to 8% to 19%. As the number of critical care survivors began to climb, clinical researchers noticed that the lives of these patients and their families were profoundly altered by their severe illness.

As Dale Needham, MD, PhD, began his pulmonology and critical care residency in Toronto, Canada, in 2005, a group of physicians there began a 5-year longitudinal study to assess long-term outcomes of patients who developed acute respiratory distress syndrome (ARDS). Although ARDS is an acute condition, the investigators found that patients felt effects for years. Younger patients recovered better than older ones, but none of the patients› physical functioning was equivalent to that of age-matched control persons. Even 5 years later, former ICU patients only reached 76% of expected physical functioning, according to results published in the New England Journal of Medicine. The study was a wake-up call.

At a meeting in Chicago in 2010, Needham, now an intensivist at Johns Hopkins Hospital in Baltimore, Maryland, gathered an interdisciplinary group of colleagues, including patients and caregivers, to clarify the phenomena they were seeing. What emerged from that meeting, published in 2012 in Critical Care Medicine, were the diagnostic criteria for PICS: According to the new definition, PICS is characterized by new or worsening physical and neuropsychiatric deficits that range from forgetfulness and loss of motivation to physical weakness and insomnia.

The issue, Needham says, is that although the trouble starts in the ICU, it only becomes clear once patients leave. “ICU doctors aren’t the ones dealing with this,” Needham said. “We need to build stronger bridges between critical care and other professions.” That’s where PICS comes in, a definition that exists explicitly to alert healthcare providers about the constellation of challenges many of these individuals face as they try to reenter “normal” life.
 

Defining the problem

As an ICU nurse at the Mayo Clinic in Rochester, Minnesota, Annie Johnson, ACNP-BC, knew lots about helping hospitalized patients, but she says she didn’t know anything about what to do after discharge – at least not until her own mother became a patient.

On the first day of retirement in October 2014, Johnson’s mother flatlined. Quick-thinking paramedics resuscitated her, and after several days in critical care, she was discharged. Since then, her heart has remained healthy. Johnson’s sister, who spent time worrying over her mother at the hospital, also had lingering effects. Both have since struggled, plagued by nightmares, flashbacks, and insomnia.

Johnson initially believed her mom’s and sister’s neuropsychiatric, post-ICU struggles were unique to her family. It was only a year later, at a seminar she was attending, that she first heard the words “post–intensive care syndrome.” Suddenly, Johnson had a name for her family’s experiences, and she began to create support groups and resources to help other families like hers.

“I thought of all the patients I had treated over the years who had been on ventilators for days and days and days. And if this happened to my mom after 48 hours, what must they be going through?” she asked.

Once physicians formally defined PICS, the Society for Critical Care Medicine helped create programs to educate ICU staff, patients, and families about potential post-discharge challenges. Researchers also began to investigate factors affecting post-ICU functioning. Follow-up studies of patients with delirium (ranging from general confusion about time and place to extreme agitation and violence) showed they had striking cognitive deficits. Problems with short-term memory, flexible thinking, and motivation plagued patients for years after their critical illness, similar to the physical deficiencies seen after ARDS. Delirium was one of the strongest risk factors for neuropsychiatric problems.

“Delirium is basically a stress test for the brain,” said Babar Khan, MD, a critical care specialist at Indiana University’s Regenstrief Institute, in Bloomington. But whether delirium accentuates preexisting cognitive difficulties or creates them afresh isn’t yet clear.

Sophia Wang, MD, a geriatric psychiatrist at Indiana University who works with many critical care patients, says patients who had experienced delirium in the ICU showed significant defects in memory and executive functioning long after their hospital stay. She points to a 2015 study that followed 47 ICU patients for a year post discharge. Among those who experienced delirium, brain volumes, as measured by MRI, were smaller at 3 months, something associated with cognitive problems at 1 year. Many struggled at work, and unemployment was common. Depression and posttraumatic stress compounded these difficulties. Among those with acute respiratory distress, ICU patients who are young, female, and unemployed are most likely to suffer from posttraumatic stress disorder after they are discharge.

Critical care medicine may have given these patients a second chance at life, Wang says, but the life they return to often looks nothing like the one they had before their illness.

Prolonged mechanical ventilation and the heavy sedation that often accompanies it are predictors of PICS severity. Some of these links could be explained by the gravity of the illness that landed someone in critical care, but others are more likely to be iatrogenic, says Gerald Weinhouse, MD, a pulmonology and critical care physician and co-director of the Critical Illness Recovery Program at the Brigham and Women’s Hospital in Boston. The involvement of loved ones at the patient’s bedside, however, improved the entire family’s outcome.

When Weinhouse saw those data, he and his colleagues founded a peer support program for ICU survivors. In a study published in 2019 in Critical Care Medicine, they identified six different models for peer support for those with PICS and their families, including both online and in-person approaches. An ongoing challenge for physicians, Weinhouse says, is getting patients to engage with these programs, given that their calendars are crowded with medical appointments and that they suffer from increased physical and mental disability.

Studies such as these led critical care physicians to form the ICU Liberation Collaborative to rethink critical care medicine. At Vanderbilt, Sevin and Jackson headed up one of the world’s first post-ICU clinics, which uses an interdisciplinary team to help patients maximize their functioning. They redesigned their critical care unit in a way that allows families to spend the night and that encourages patient mobility. Both Needham and Weinhouse continue tracking patient outcomes.

Even before the novel coronavirus struck, the United States — and the world — had begun to realize that graduating from the ICU was only the start of what was often an extensive recovery.
 

The long road back

When COVID-19 patients began flooding intensive care wards around the world, physicians scrambled to meet their complex and desperate acute medical needs. Over the past few months, physicians have focused on keeping these patients alive. “We’ve never seen anything like it ― not even during polio — with the sheer number of patients, all with respiratory distress,” Needham said.

But he and his colleagues know this is only the beginning.

“We’re aware that survivorship issues are coming. There’s going to be a wave of sick people who survived the coronavirus but are going to need more help,” Weinhouse said.

Intensivists have been drawing on PICS research in their fight to help COVID-19 patients. Work from the past few years has shown that although sedation is required during intubation itself, not everyone needs it while on a ventilator. Titrating down sedating medication helps reduce delirium, Wang says. Such medication has been shown to contribute to later cognitive problems. Needham’s studies showing that prolonged bedrest by ICU patients causes muscular atrophy has led him to encourage patients to move as much as possible. With the help of physical therapists, many patients on ventilators can be awake, alert, and moving around the ward.

One of the biggest challenges critical-care coronavirus patients face is prolonged isolation. The constant presence of a familiar face helps orient confused and delirious patients and provides emotional support during a frightening time. But because the immediate need for infection control outweighs these benefits, few hospitals allow visitors, especially for COVID-19 patients.

To address this, some units have been using video technology to allow loved ones to call in. At Johns Hopkins, physicians have also been relying on the expertise of occupational therapists (OTs). Needham says that one OT found that rubbing the hand and back of an agitated, delirious patient helped soothe and calm him better than many medications.

Ronan, who spent 5 days in intensive care, echoes that problem. She says she found the relative lack of human contact to be one of the most challenging parts of being in a bed on a COVID-19 ward. Separated from her husband and daughter, suffering from high fever and severe illness, she lost all track of time.

Her return home was difficult, too. Although her job as a home health nurse had prepared her on some level for the challenges she would face after discharge, Ronan says the hospital provided little practical help.

“Everything is so much harder at home, even little things like going to the bathroom,” she said. “I feel like I’m trying to bail out a sinking ship with a teacup.”

Khan and other physicians, aware of the challenges Ronan and others face once home, aim to create post-ICU clinics specifically for COVID-19 patients. They want to build what Khan calls a “one-stop shop” for all the support patients need to recover. Some of that can be provided via telehealth, which may also help ease the physical burden.

Because there’s so much physicians don’t know about the coronavirus, Johnson says, such clinics are not only a chance to help the sickest COVID-19 patients, they will also help researchers learn more about the virus and improve critical care for other illnesses.

Today, nearly 2 months after discharge, Ronan is back on the job but struggles with a persistent cough — likely due to the lung damage she sustained while ill. She has constant fatigue, as well as ongoing upset stomach from all the medications she took to reduce fever and body aches. When she dons a mask for work, the tangible reminder of her hospital stay sends her into a panic attack. Physically, she’s weaker than before.

Researchers are still trying to understand everything that Ronan and other COVID-19 patients need to move on with their lives after being in the ICU. Mysteries abound, but the ground laid by Sevin, Needham, Weinhouse, and others has provided a solid foundation on which to build.
 

This article first appeared on Medscape.com.

Treatment of patients with systemic lupus erythematosus and active lupus nephritis with belimumab (Benlysta) for 2 years with minimized background glucocorticoid treatment produced significantly better renal function, compared with control patients who only received standard therapy, in a randomized, multicenter trial with 446 evaluable patients, a finding that may help extend this treatment to a new group of lupus patients.

Sara Freeman/MDedge News

“The largest” treatment study of lupus nephritis reported to date showed that belimumab, approved by the Food and Drug Administration in 2011 for treating patients with systemic lupus erythematosus (SLE), administered at a standard dosage of 10 mg intravenously every 4 weeks, “significantly improved multiple lupus nephritis renal responses versus standard therapy alone while maintaining an acceptable safety profile,” Richard A. Furie, MD, said at the annual European Congress of Rheumatology, held online this year due to COVID-19.

The study’s primary endpoint was a composite measure that Dr. Furie and associates called the Primary Endpoint Renal Response, which required patients to have achieved a urinary protein-to-creatinine ratio of 0.7 or less (compared with an enrollment level of 1.0 or greater), an estimated glomerular filtration rate (eGFR) of at least 60 mL/min/1.73 kg/m² and no more than 20% below its preflare level, and continuation on the assigned treatment regimen. After 104 weeks on this treatment, which followed a 60-day induction phase that included treatment with a high-dose glucocorticoid, the percentages of patients who met the Primary Endpoint Renal Response criteria were 32% in the control arm who received standard treatment at the discretion of their treating clinicians plus placebo infusions and 43% in patients who received belimumab infusions in addition to their standard care. This calculated out to a 55% relative increase in this response with belimumab, a statistically significant result, reported Dr. Furie, professor of medicine at Hofstra University, Hempstead, N.Y., and chief of rheumatology at Northwell Health in Manhasset, N.Y.

Patients who received belimumab also had similar and statistically significant levels of improvement for several secondary endpoints, including one called Complete Renal Response, which required a protein-to-creatinine ratio of no greater than 0.5, an eGFR of at least 90 mL/min per 1.73 kg/m² and no more than 10% below its preflare level, and maintaining the assigned treatment. The Complete Renal Response after 104 weeks was 20% among control patients and 30% among those maintained on belimumab, a 74% relative improvement that was statistically significant. The total percentage of patients with any renal-related event after 104 weeks was 28% among the control patients and 16% among those who received belimumab, a statistically significant difference.

“The fact that the primary and all key secondary endpoints were successfully attained is a major accomplishment in lupus nephritis as well as in any SLE study,” Dr. Furie said in an interview. The study’s 2-year design “provided insight into the durability of the response,” and the steady divergence of the endpoint events in the two study arms beginning after about 24 weeks into the randomized phase “provided data regarding the rapidity of onset of action.” Collectively, the endpoints “mimic our real-life treatment goals: reduce disease activity, prevent flares, preserve renal function, lower steroid treatment, and do it all safely,” he concluded.

Results confirm benefit to subset of patients

“Belimumab is a safe and effective treatment for a significant subset of patients with lupus. We already knew that. Now we have even more confirmation,” commented Joan T. Merrill, MD, a professor of medicine at the University of Oklahoma Health Sciences Center and a rheumatologist who specializes in SLE at the Oklahoma Medical Research Foundation, both in Oklahoma City. “There have already been at least four international trials demonstrating belimumab’s efficacy in general lupus. Some patients in these earlier trials had nephritis, so it should not be surprising to see similar results in a trial restricted to patients with active nephritis, given the drug’s mechanism of action. Belimumab has repeatedly shown early and sustained benefits above what background treatments achieve, and belimumab has also proven to be safe to add to standard-of-care treatments,” she said in an interview.

The BLISS-LN (Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis) study enrolled patients at any of 118 centers in 20 countries, including the United States. All patients enrolled in the trial were adults with biopsy-confirmed, clinically active lupus nephritis and a urinary protein-to-creatinine ratio of at least 1.0, and need for induction therapy. The 60-day induction run-in phase began with high-dose glucocorticoids plus either cyclophosphamide or mycophenolate mofetil (CellCept), followed by maintenance on low-dose glucocorticoids and either azathioprine or mycophenolate mofetil. Nearly three-quarters of patients received mycophenolate mofetil–based induction. Once treatment with either belimumab or placebo began in the study’s main phase, the glucocorticoid dosage had to drop with tapering to no more than 10 mg/day within 24 weeks or the patient was considered a treatment failure.
 

Thoughts on current and future use of belimumab

The current labeled indication for belimumab is for “treatment of patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus who are receiving standard therapy,” an inclusive SLE population, but the label also adds this caveat: “Limitations of use: The efficacy of Benlysta has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus.” According to Dr. Furie’s report, GlaxoSmithKline, the company that markets belimumab, plans to seek a labeled indication for lupus nephritis for the drug during 2020.

“I doubt the drug is widely used as yet in clinical practice for lupus nephritis,” although it is being prescribed to selected SLE patients in current, routine practice, said Dr. Merrill, a coinvestigator on some belimumab studies. What also remains unknown is the efficacy of belimumab monotherapy. “We don’t know which subset of patients might benefit from belimumab alone,” she noted. Nor is it known whether belimumab treatment of patients with SLE but without lupus nephritis will forestall later development of lupus nephritis.

“With the introduction of the subcutaneous formulation a few years ago, there has been greater belimumab use” overall in patients with SLE, said Dr. Furie, and with a safety and efficacy record now established in five separate, reported studies in addition to the new BLISS-LN study: BLISS-52, BLISS-76, BLISS-SC, BLISS-NE ASIA, and PLUTO. “The pivotal studies [BLISS-52 and BLISS-76] were done in patients with SLE but without nephritis in need of aggressive induction therapy. About 15% of the trial cohorts had low-level renal involvement,” and post hoc analyses suggested that the benefit in those patients was similar to patients without renal involvement, which led to the BLISS-LN study. “In theory, no SLE patients with high-level nephritis should be on belimumab at this time,” based on its labeling, although some SLE patients with low-level renal disease may now receive the drug because they also have other affected organs, such as skin and joints, Dr. Furie said.

“These are encouraging results,” commented George K. Bertsias, MD, a rheumatologist and SLE specialist at the University of Crete in Heraklion, Greece. He particularly cited the “significant effect from add-on belimumab” on top of treatment with mycophenolate mofetil, an “established and effective treatment for lupus nephritis. The data provide additional evidence for the efficacy of belimumab in SLE, and also in lupus nephritis,” he said in an interview, and “having an official labeled indication for active nephritis will enhance use of the drug” in such patients. “Considering the favorable effects of the drug on SLE, especially preventing major flares, and on lupus nephritis it is possible that the drug will be particularly suitable for SLE patients who are at high risk for developing lupus nephritis, although such an effect remains to be determined.” Until now, belimumab has generally been prescribed to SLE patients who have disease manifestations in organs outside of the kidneys, he noted.

BLISS-LN was sponsored by GlaxoSmithKline. Dr. Furie is a consultant to and has received research funding from GlaxoSmithKline, and several of the study’s coauthors are employees of the company. Dr. Merrill has been a consultant to GlaxoSmithKline as well as to several other companies and has been a coinvestigator on belimumab studies. Dr. Bertsias has been a consultant to Novartis and has received research funding from GlaxoSmithKline.

mzoler@mdedge.com

SOURCE: Furie RA et al. Ann Rheum Dis. 2020 Jun;79[suppl 1]:103, Abstract OP0164.

Treatment of patients with systemic lupus erythematosus and active lupus nephritis with belimumab (Benlysta) for 2 years with minimized background glucocorticoid treatment produced significantly better renal function, compared with control patients who only received standard therapy, in a randomized, multicenter trial with 446 evaluable patients, a finding that may help extend this treatment to a new group of lupus patients.

Sara Freeman/MDedge News

“The largest” treatment study of lupus nephritis reported to date showed that belimumab, approved by the Food and Drug Administration in 2011 for treating patients with systemic lupus erythematosus (SLE), administered at a standard dosage of 10 mg intravenously every 4 weeks, “significantly improved multiple lupus nephritis renal responses versus standard therapy alone while maintaining an acceptable safety profile,” Richard A. Furie, MD, said at the annual European Congress of Rheumatology, held online this year due to COVID-19.

The study’s primary endpoint was a composite measure that Dr. Furie and associates called the Primary Endpoint Renal Response, which required patients to have achieved a urinary protein-to-creatinine ratio of 0.7 or less (compared with an enrollment level of 1.0 or greater), an estimated glomerular filtration rate (eGFR) of at least 60 mL/min/1.73 kg/m² and no more than 20% below its preflare level, and continuation on the assigned treatment regimen. After 104 weeks on this treatment, which followed a 60-day induction phase that included treatment with a high-dose glucocorticoid, the percentages of patients who met the Primary Endpoint Renal Response criteria were 32% in the control arm who received standard treatment at the discretion of their treating clinicians plus placebo infusions and 43% in patients who received belimumab infusions in addition to their standard care. This calculated out to a 55% relative increase in this response with belimumab, a statistically significant result, reported Dr. Furie, professor of medicine at Hofstra University, Hempstead, N.Y., and chief of rheumatology at Northwell Health in Manhasset, N.Y.

Patients who received belimumab also had similar and statistically significant levels of improvement for several secondary endpoints, including one called Complete Renal Response, which required a protein-to-creatinine ratio of no greater than 0.5, an eGFR of at least 90 mL/min per 1.73 kg/m² and no more than 10% below its preflare level, and maintaining the assigned treatment. The Complete Renal Response after 104 weeks was 20% among control patients and 30% among those maintained on belimumab, a 74% relative improvement that was statistically significant. The total percentage of patients with any renal-related event after 104 weeks was 28% among the control patients and 16% among those who received belimumab, a statistically significant difference.

“The fact that the primary and all key secondary endpoints were successfully attained is a major accomplishment in lupus nephritis as well as in any SLE study,” Dr. Furie said in an interview. The study’s 2-year design “provided insight into the durability of the response,” and the steady divergence of the endpoint events in the two study arms beginning after about 24 weeks into the randomized phase “provided data regarding the rapidity of onset of action.” Collectively, the endpoints “mimic our real-life treatment goals: reduce disease activity, prevent flares, preserve renal function, lower steroid treatment, and do it all safely,” he concluded.

Results confirm benefit to subset of patients

“Belimumab is a safe and effective treatment for a significant subset of patients with lupus. We already knew that. Now we have even more confirmation,” commented Joan T. Merrill, MD, a professor of medicine at the University of Oklahoma Health Sciences Center and a rheumatologist who specializes in SLE at the Oklahoma Medical Research Foundation, both in Oklahoma City. “There have already been at least four international trials demonstrating belimumab’s efficacy in general lupus. Some patients in these earlier trials had nephritis, so it should not be surprising to see similar results in a trial restricted to patients with active nephritis, given the drug’s mechanism of action. Belimumab has repeatedly shown early and sustained benefits above what background treatments achieve, and belimumab has also proven to be safe to add to standard-of-care treatments,” she said in an interview.

The BLISS-LN (Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis) study enrolled patients at any of 118 centers in 20 countries, including the United States. All patients enrolled in the trial were adults with biopsy-confirmed, clinically active lupus nephritis and a urinary protein-to-creatinine ratio of at least 1.0, and need for induction therapy. The 60-day induction run-in phase began with high-dose glucocorticoids plus either cyclophosphamide or mycophenolate mofetil (CellCept), followed by maintenance on low-dose glucocorticoids and either azathioprine or mycophenolate mofetil. Nearly three-quarters of patients received mycophenolate mofetil–based induction. Once treatment with either belimumab or placebo began in the study’s main phase, the glucocorticoid dosage had to drop with tapering to no more than 10 mg/day within 24 weeks or the patient was considered a treatment failure.
 

Thoughts on current and future use of belimumab

The current labeled indication for belimumab is for “treatment of patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus who are receiving standard therapy,” an inclusive SLE population, but the label also adds this caveat: “Limitations of use: The efficacy of Benlysta has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus.” According to Dr. Furie’s report, GlaxoSmithKline, the company that markets belimumab, plans to seek a labeled indication for lupus nephritis for the drug during 2020.

“I doubt the drug is widely used as yet in clinical practice for lupus nephritis,” although it is being prescribed to selected SLE patients in current, routine practice, said Dr. Merrill, a coinvestigator on some belimumab studies. What also remains unknown is the efficacy of belimumab monotherapy. “We don’t know which subset of patients might benefit from belimumab alone,” she noted. Nor is it known whether belimumab treatment of patients with SLE but without lupus nephritis will forestall later development of lupus nephritis.

“With the introduction of the subcutaneous formulation a few years ago, there has been greater belimumab use” overall in patients with SLE, said Dr. Furie, and with a safety and efficacy record now established in five separate, reported studies in addition to the new BLISS-LN study: BLISS-52, BLISS-76, BLISS-SC, BLISS-NE ASIA, and PLUTO. “The pivotal studies [BLISS-52 and BLISS-76] were done in patients with SLE but without nephritis in need of aggressive induction therapy. About 15% of the trial cohorts had low-level renal involvement,” and post hoc analyses suggested that the benefit in those patients was similar to patients without renal involvement, which led to the BLISS-LN study. “In theory, no SLE patients with high-level nephritis should be on belimumab at this time,” based on its labeling, although some SLE patients with low-level renal disease may now receive the drug because they also have other affected organs, such as skin and joints, Dr. Furie said.

“These are encouraging results,” commented George K. Bertsias, MD, a rheumatologist and SLE specialist at the University of Crete in Heraklion, Greece. He particularly cited the “significant effect from add-on belimumab” on top of treatment with mycophenolate mofetil, an “established and effective treatment for lupus nephritis. The data provide additional evidence for the efficacy of belimumab in SLE, and also in lupus nephritis,” he said in an interview, and “having an official labeled indication for active nephritis will enhance use of the drug” in such patients. “Considering the favorable effects of the drug on SLE, especially preventing major flares, and on lupus nephritis it is possible that the drug will be particularly suitable for SLE patients who are at high risk for developing lupus nephritis, although such an effect remains to be determined.” Until now, belimumab has generally been prescribed to SLE patients who have disease manifestations in organs outside of the kidneys, he noted.

BLISS-LN was sponsored by GlaxoSmithKline. Dr. Furie is a consultant to and has received research funding from GlaxoSmithKline, and several of the study’s coauthors are employees of the company. Dr. Merrill has been a consultant to GlaxoSmithKline as well as to several other companies and has been a coinvestigator on belimumab studies. Dr. Bertsias has been a consultant to Novartis and has received research funding from GlaxoSmithKline.

mzoler@mdedge.com

SOURCE: Furie RA et al. Ann Rheum Dis. 2020 Jun;79[suppl 1]:103, Abstract OP0164.

Treatment of patients with systemic lupus erythematosus and active lupus nephritis with belimumab (Benlysta) for 2 years with minimized background glucocorticoid treatment produced significantly better renal function, compared with control patients who only received standard therapy, in a randomized, multicenter trial with 446 evaluable patients, a finding that may help extend this treatment to a new group of lupus patients.

Sara Freeman/MDedge News

“The largest” treatment study of lupus nephritis reported to date showed that belimumab, approved by the Food and Drug Administration in 2011 for treating patients with systemic lupus erythematosus (SLE), administered at a standard dosage of 10 mg intravenously every 4 weeks, “significantly improved multiple lupus nephritis renal responses versus standard therapy alone while maintaining an acceptable safety profile,” Richard A. Furie, MD, said at the annual European Congress of Rheumatology, held online this year due to COVID-19.

The study’s primary endpoint was a composite measure that Dr. Furie and associates called the Primary Endpoint Renal Response, which required patients to have achieved a urinary protein-to-creatinine ratio of 0.7 or less (compared with an enrollment level of 1.0 or greater), an estimated glomerular filtration rate (eGFR) of at least 60 mL/min/1.73 kg/m² and no more than 20% below its preflare level, and continuation on the assigned treatment regimen. After 104 weeks on this treatment, which followed a 60-day induction phase that included treatment with a high-dose glucocorticoid, the percentages of patients who met the Primary Endpoint Renal Response criteria were 32% in the control arm who received standard treatment at the discretion of their treating clinicians plus placebo infusions and 43% in patients who received belimumab infusions in addition to their standard care. This calculated out to a 55% relative increase in this response with belimumab, a statistically significant result, reported Dr. Furie, professor of medicine at Hofstra University, Hempstead, N.Y., and chief of rheumatology at Northwell Health in Manhasset, N.Y.

Patients who received belimumab also had similar and statistically significant levels of improvement for several secondary endpoints, including one called Complete Renal Response, which required a protein-to-creatinine ratio of no greater than 0.5, an eGFR of at least 90 mL/min per 1.73 kg/m² and no more than 10% below its preflare level, and maintaining the assigned treatment. The Complete Renal Response after 104 weeks was 20% among control patients and 30% among those maintained on belimumab, a 74% relative improvement that was statistically significant. The total percentage of patients with any renal-related event after 104 weeks was 28% among the control patients and 16% among those who received belimumab, a statistically significant difference.

“The fact that the primary and all key secondary endpoints were successfully attained is a major accomplishment in lupus nephritis as well as in any SLE study,” Dr. Furie said in an interview. The study’s 2-year design “provided insight into the durability of the response,” and the steady divergence of the endpoint events in the two study arms beginning after about 24 weeks into the randomized phase “provided data regarding the rapidity of onset of action.” Collectively, the endpoints “mimic our real-life treatment goals: reduce disease activity, prevent flares, preserve renal function, lower steroid treatment, and do it all safely,” he concluded.

Results confirm benefit to subset of patients

“Belimumab is a safe and effective treatment for a significant subset of patients with lupus. We already knew that. Now we have even more confirmation,” commented Joan T. Merrill, MD, a professor of medicine at the University of Oklahoma Health Sciences Center and a rheumatologist who specializes in SLE at the Oklahoma Medical Research Foundation, both in Oklahoma City. “There have already been at least four international trials demonstrating belimumab’s efficacy in general lupus. Some patients in these earlier trials had nephritis, so it should not be surprising to see similar results in a trial restricted to patients with active nephritis, given the drug’s mechanism of action. Belimumab has repeatedly shown early and sustained benefits above what background treatments achieve, and belimumab has also proven to be safe to add to standard-of-care treatments,” she said in an interview.

The BLISS-LN (Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis) study enrolled patients at any of 118 centers in 20 countries, including the United States. All patients enrolled in the trial were adults with biopsy-confirmed, clinically active lupus nephritis and a urinary protein-to-creatinine ratio of at least 1.0, and need for induction therapy. The 60-day induction run-in phase began with high-dose glucocorticoids plus either cyclophosphamide or mycophenolate mofetil (CellCept), followed by maintenance on low-dose glucocorticoids and either azathioprine or mycophenolate mofetil. Nearly three-quarters of patients received mycophenolate mofetil–based induction. Once treatment with either belimumab or placebo began in the study’s main phase, the glucocorticoid dosage had to drop with tapering to no more than 10 mg/day within 24 weeks or the patient was considered a treatment failure.
 

Thoughts on current and future use of belimumab

The current labeled indication for belimumab is for “treatment of patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus who are receiving standard therapy,” an inclusive SLE population, but the label also adds this caveat: “Limitations of use: The efficacy of Benlysta has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus.” According to Dr. Furie’s report, GlaxoSmithKline, the company that markets belimumab, plans to seek a labeled indication for lupus nephritis for the drug during 2020.

“I doubt the drug is widely used as yet in clinical practice for lupus nephritis,” although it is being prescribed to selected SLE patients in current, routine practice, said Dr. Merrill, a coinvestigator on some belimumab studies. What also remains unknown is the efficacy of belimumab monotherapy. “We don’t know which subset of patients might benefit from belimumab alone,” she noted. Nor is it known whether belimumab treatment of patients with SLE but without lupus nephritis will forestall later development of lupus nephritis.

“With the introduction of the subcutaneous formulation a few years ago, there has been greater belimumab use” overall in patients with SLE, said Dr. Furie, and with a safety and efficacy record now established in five separate, reported studies in addition to the new BLISS-LN study: BLISS-52, BLISS-76, BLISS-SC, BLISS-NE ASIA, and PLUTO. “The pivotal studies [BLISS-52 and BLISS-76] were done in patients with SLE but without nephritis in need of aggressive induction therapy. About 15% of the trial cohorts had low-level renal involvement,” and post hoc analyses suggested that the benefit in those patients was similar to patients without renal involvement, which led to the BLISS-LN study. “In theory, no SLE patients with high-level nephritis should be on belimumab at this time,” based on its labeling, although some SLE patients with low-level renal disease may now receive the drug because they also have other affected organs, such as skin and joints, Dr. Furie said.

“These are encouraging results,” commented George K. Bertsias, MD, a rheumatologist and SLE specialist at the University of Crete in Heraklion, Greece. He particularly cited the “significant effect from add-on belimumab” on top of treatment with mycophenolate mofetil, an “established and effective treatment for lupus nephritis. The data provide additional evidence for the efficacy of belimumab in SLE, and also in lupus nephritis,” he said in an interview, and “having an official labeled indication for active nephritis will enhance use of the drug” in such patients. “Considering the favorable effects of the drug on SLE, especially preventing major flares, and on lupus nephritis it is possible that the drug will be particularly suitable for SLE patients who are at high risk for developing lupus nephritis, although such an effect remains to be determined.” Until now, belimumab has generally been prescribed to SLE patients who have disease manifestations in organs outside of the kidneys, he noted.

BLISS-LN was sponsored by GlaxoSmithKline. Dr. Furie is a consultant to and has received research funding from GlaxoSmithKline, and several of the study’s coauthors are employees of the company. Dr. Merrill has been a consultant to GlaxoSmithKline as well as to several other companies and has been a coinvestigator on belimumab studies. Dr. Bertsias has been a consultant to Novartis and has received research funding from GlaxoSmithKline.

mzoler@mdedge.com

SOURCE: Furie RA et al. Ann Rheum Dis. 2020 Jun;79[suppl 1]:103, Abstract OP0164.

The challenges posed by COVID-19 have crippled health care systems around the globe. By February 2020, the first outbreak in the United States had been set off in Washington State. We quickly became the world’s epicenter of the epidemic, with over 1.8 million patients and over 110,000 deaths.¹ The rapidity of spread and the severity of the disease created a tremendous strain on resources. It blindsided policymakers and hospital administrators, which left little time to react to the challenges placed on hospital operations all over the country.

The necessity of a new care model

Although health systems in the United States are adept in managing complications of common seasonal viral respiratory illnesses, COVID-19 presented an entirely different challenge with its significantly higher mortality rate. A respiratory disease turning into a multiorgan disease that causes debilitating cardiac, renal, neurological, hematological, and psychosocial complications² was not something we had experience managing effectively. Additional challenges included a massive surge of COVID-19 patients, a limited supply of personal protective equipment (PPE), an inadequate number of intensivists for managing the anticipated ventilated patients, and most importantly, the potential of losing some of our workforce if they became infected.

Based on the experiences in China and Italy, and various predictive models, the division of hospital medicine at Baystate Health quickly realized the necessity of a new model of care for COVID-19 patients. We came up with an elaborate plan to manage the disease burden and the strain on resources effectively. The measures we put in place could be broadly divided into three categories following the timeline of the disease: the preparatory phase, the execution phase, and the maintenance phase.
 

The preparatory phase: From “Hospitalists” to “COVIDists”

As in most hospitals around the country, hospitalists are the backbone of inpatient clinical operations at our health system. A focused group of 10 hospitalists who volunteered to take care of COVID-19 patients with a particular interest in the pandemic and experience in critical care were selected, and the term “COVIDists” was coined to refer to them.

COVIDists were trained in various treatment protocols and ongoing clinical trials. They were given refresher training in Advanced Cardiac Life Support (ACLS) and Fundamental Critical Care Support (FCCS) courses and were taught in critical care/ventilator management by the intensivists through rapid indoctrination in the ICU. All of them had their N-95 mask fitting updated and were trained in the safe donning and doffing of all kinds of PPE by PPE coaches. The palliative care team trained them in conducting end-of-life/code status discussions with a focus on being unable to speak with family members at the bedside. COVIDists were also assigned as Code Blue leaders for any “COVID code blue” in the hospital.

In addition to the rapid training course, COVID-related updates were disseminated daily using three different modalities: brief huddles at the start of the day with the COVIDists; a COVID-19 newsletter summarizing daily updates, new treatments, strategies, and policies; and a WhatsApp group for instantly broadcasting information to the COVIDists (Table 1).

The execution phase

All the hospitalized COVID-19 patients were grouped together to COVID units, and the COVIDists were deployed to those units geographically. COVIDists were given lighter than usual patient loads to deal with the extra time needed for donning and doffing of PPE and for coordination with specialists. COVIDists were almost the only clinicians physically visiting the patients in most cases, and they became the “eyes and ears” of specialists since the specialists were advised to minimize exposure and pursue telemedicine consults. The COVIDists were also undertaking the most challenging part of the care – talking to families about end-of-life issues and the futility of aggressive care in certain patients with preexisting conditions.

Some COVIDists were deployed to the ICU to work alongside the intensivists and became an invaluable resource in ICU management when the ICU census skyrocketed during the initial phase of the outbreak. This helped in tiding the health system over during the initial crisis. Within a short time, we shifted away from an early intubation strategy, and most of the ICU patients were managed in the intermediate care units on high flow oxygen along with the awake-proning protocol. The COVIDists exclusively managed these units. They led multidisciplinary rounds two times a day with the ICU, rapid response team (RRT), the palliative care team, and the nursing team. This step drastically decreased the number of intubations, RRT activations, reduced ICU census,³ and helped with hospital capacity and patient flow (Tables 2 and 3).

The maintenance phase

It is already 2 months since the first devising COVIDists. There is no difference in sick callouts between COVIDists and non-COVIDists. One COVIDist and one non-COVIDist contracted the disease, but none of them required hospitalization. Although we initially thought that COVIDists would be needed for only a short period of time, the evolution of the disease is showing signs that it might be prolonged over the next several months. Hence, we are planning to continue COVIDist service for at least the next 6 months and reevaluate the need.

Hospital medicine leadership checked on COVIDists daily in regard to their physical health and, more importantly, their mental well-being. They were offered the chance to be taken off the schedule if they felt burned out, but no one wanted to come off their scheduled service before finishing their shifts. BlueCross MA recognized one of the COVIDists, Raghuveer Rakasi, MD, as a “hero on the front line.”⁴ In Dr. Rakasi’s words, “We took a nosedive into something without knowing its depth, and aware that we could have fatalities among ourselves. We took up new roles, faced new challenges, learned new things every day, evolving every step of the way. We had to change the way we practice medicine, finding new ways to treat patients, and protecting the workforce by limiting patient exposure, prioritizing investigations.” He added that “we have to adapt to a new normal; we should be prepared for this to come in waves. Putting aside our political views, we should stand united 6 feet apart, with a mask covering our brave faces, frequently washing our helping hands to overcome these uncertain times.”
 

Conclusion

The creation of a focused group of hospitalists called COVIDists and providing them with structured and rapid training (in various aspects of clinical care of COVID-19 patients, critical care/ventilator management, efficient and safe use of PPE) and daily information dissemination allowed our health system to prepare for the large volume of COVID-19 patients. It also helped in preserving the larger hospital workforce for a possible future surge.

The rapid development and implementation of the COVIDist strategy succeeded because of the intrinsic motivation of the providers to improve the outcomes of this high-risk patient population and the close collaboration of the stakeholders. Our institution remains successful in managing the pandemic in Western Massachusetts, with reserve capacity remaining even during the peak of the epidemic. A large part of this was because of creating and training a pool of COVIDists.
 

Dr. Medarametla is medical director, clinical operations, in the division of hospital medicine at Baystate Health, and assistant professor at University of Massachusetts, Worcester. Readers can contact him at Venkatrao.MedarametlaMD@Baystatehealth.org. Dr. Prabhakaran is unit medical director, geriatrics unit, in the division of hospital medicine at Baystate Health and assistant professor at University of Massachusetts. Dr. Bryson is associate program director of the Internal Medicine Residency at Baystate Health and assistant professor at University of Massachusetts. Dr. Umar is medical director, clinical operations, in the division of hospital medicine at Baystate Health. Dr. Natanasabapathy is division chief of hospital medicine at Baystate Health and assistant professor at University of Massachusetts.

References

1. Centers for Disease Control and Prevention. Coronavirus Disease 2019 (COVID-19). Updated Jun 10, 2020. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html.

2. Zhou F et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: A retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-62.

3. Westafer LM et al. A transdisciplinary COVID-19 early respiratory intervention protocol: An implementation story. J Hosp Med. 2020 May 21;15(6):372-374.

4. Miller J. “Heroes on the front line: Dr. Raghuveer Rakasi.” Coverage. May 18, 2020. https://coverage.bluecrossma.com/article/heroes-front-line-dr-raghuveer-rakasi

The challenges posed by COVID-19 have crippled health care systems around the globe. By February 2020, the first outbreak in the United States had been set off in Washington State. We quickly became the world’s epicenter of the epidemic, with over 1.8 million patients and over 110,000 deaths.¹ The rapidity of spread and the severity of the disease created a tremendous strain on resources. It blindsided policymakers and hospital administrators, which left little time to react to the challenges placed on hospital operations all over the country.

The necessity of a new care model

Although health systems in the United States are adept in managing complications of common seasonal viral respiratory illnesses, COVID-19 presented an entirely different challenge with its significantly higher mortality rate. A respiratory disease turning into a multiorgan disease that causes debilitating cardiac, renal, neurological, hematological, and psychosocial complications² was not something we had experience managing effectively. Additional challenges included a massive surge of COVID-19 patients, a limited supply of personal protective equipment (PPE), an inadequate number of intensivists for managing the anticipated ventilated patients, and most importantly, the potential of losing some of our workforce if they became infected.

Based on the experiences in China and Italy, and various predictive models, the division of hospital medicine at Baystate Health quickly realized the necessity of a new model of care for COVID-19 patients. We came up with an elaborate plan to manage the disease burden and the strain on resources effectively. The measures we put in place could be broadly divided into three categories following the timeline of the disease: the preparatory phase, the execution phase, and the maintenance phase.
 

The preparatory phase: From “Hospitalists” to “COVIDists”

As in most hospitals around the country, hospitalists are the backbone of inpatient clinical operations at our health system. A focused group of 10 hospitalists who volunteered to take care of COVID-19 patients with a particular interest in the pandemic and experience in critical care were selected, and the term “COVIDists” was coined to refer to them.

COVIDists were trained in various treatment protocols and ongoing clinical trials. They were given refresher training in Advanced Cardiac Life Support (ACLS) and Fundamental Critical Care Support (FCCS) courses and were taught in critical care/ventilator management by the intensivists through rapid indoctrination in the ICU. All of them had their N-95 mask fitting updated and were trained in the safe donning and doffing of all kinds of PPE by PPE coaches. The palliative care team trained them in conducting end-of-life/code status discussions with a focus on being unable to speak with family members at the bedside. COVIDists were also assigned as Code Blue leaders for any “COVID code blue” in the hospital.

In addition to the rapid training course, COVID-related updates were disseminated daily using three different modalities: brief huddles at the start of the day with the COVIDists; a COVID-19 newsletter summarizing daily updates, new treatments, strategies, and policies; and a WhatsApp group for instantly broadcasting information to the COVIDists (Table 1).

The execution phase

All the hospitalized COVID-19 patients were grouped together to COVID units, and the COVIDists were deployed to those units geographically. COVIDists were given lighter than usual patient loads to deal with the extra time needed for donning and doffing of PPE and for coordination with specialists. COVIDists were almost the only clinicians physically visiting the patients in most cases, and they became the “eyes and ears” of specialists since the specialists were advised to minimize exposure and pursue telemedicine consults. The COVIDists were also undertaking the most challenging part of the care – talking to families about end-of-life issues and the futility of aggressive care in certain patients with preexisting conditions.

Some COVIDists were deployed to the ICU to work alongside the intensivists and became an invaluable resource in ICU management when the ICU census skyrocketed during the initial phase of the outbreak. This helped in tiding the health system over during the initial crisis. Within a short time, we shifted away from an early intubation strategy, and most of the ICU patients were managed in the intermediate care units on high flow oxygen along with the awake-proning protocol. The COVIDists exclusively managed these units. They led multidisciplinary rounds two times a day with the ICU, rapid response team (RRT), the palliative care team, and the nursing team. This step drastically decreased the number of intubations, RRT activations, reduced ICU census,³ and helped with hospital capacity and patient flow (Tables 2 and 3).

The maintenance phase

It is already 2 months since the first devising COVIDists. There is no difference in sick callouts between COVIDists and non-COVIDists. One COVIDist and one non-COVIDist contracted the disease, but none of them required hospitalization. Although we initially thought that COVIDists would be needed for only a short period of time, the evolution of the disease is showing signs that it might be prolonged over the next several months. Hence, we are planning to continue COVIDist service for at least the next 6 months and reevaluate the need.

Hospital medicine leadership checked on COVIDists daily in regard to their physical health and, more importantly, their mental well-being. They were offered the chance to be taken off the schedule if they felt burned out, but no one wanted to come off their scheduled service before finishing their shifts. BlueCross MA recognized one of the COVIDists, Raghuveer Rakasi, MD, as a “hero on the front line.”⁴ In Dr. Rakasi’s words, “We took a nosedive into something without knowing its depth, and aware that we could have fatalities among ourselves. We took up new roles, faced new challenges, learned new things every day, evolving every step of the way. We had to change the way we practice medicine, finding new ways to treat patients, and protecting the workforce by limiting patient exposure, prioritizing investigations.” He added that “we have to adapt to a new normal; we should be prepared for this to come in waves. Putting aside our political views, we should stand united 6 feet apart, with a mask covering our brave faces, frequently washing our helping hands to overcome these uncertain times.”
 

Conclusion

The creation of a focused group of hospitalists called COVIDists and providing them with structured and rapid training (in various aspects of clinical care of COVID-19 patients, critical care/ventilator management, efficient and safe use of PPE) and daily information dissemination allowed our health system to prepare for the large volume of COVID-19 patients. It also helped in preserving the larger hospital workforce for a possible future surge.

The rapid development and implementation of the COVIDist strategy succeeded because of the intrinsic motivation of the providers to improve the outcomes of this high-risk patient population and the close collaboration of the stakeholders. Our institution remains successful in managing the pandemic in Western Massachusetts, with reserve capacity remaining even during the peak of the epidemic. A large part of this was because of creating and training a pool of COVIDists.
 

Dr. Medarametla is medical director, clinical operations, in the division of hospital medicine at Baystate Health, and assistant professor at University of Massachusetts, Worcester. Readers can contact him at Venkatrao.MedarametlaMD@Baystatehealth.org. Dr. Prabhakaran is unit medical director, geriatrics unit, in the division of hospital medicine at Baystate Health and assistant professor at University of Massachusetts. Dr. Bryson is associate program director of the Internal Medicine Residency at Baystate Health and assistant professor at University of Massachusetts. Dr. Umar is medical director, clinical operations, in the division of hospital medicine at Baystate Health. Dr. Natanasabapathy is division chief of hospital medicine at Baystate Health and assistant professor at University of Massachusetts.

References

1. Centers for Disease Control and Prevention. Coronavirus Disease 2019 (COVID-19). Updated Jun 10, 2020. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html.

2. Zhou F et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: A retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-62.

3. Westafer LM et al. A transdisciplinary COVID-19 early respiratory intervention protocol: An implementation story. J Hosp Med. 2020 May 21;15(6):372-374.

4. Miller J. “Heroes on the front line: Dr. Raghuveer Rakasi.” Coverage. May 18, 2020. https://coverage.bluecrossma.com/article/heroes-front-line-dr-raghuveer-rakasi

The challenges posed by COVID-19 have crippled health care systems around the globe. By February 2020, the first outbreak in the United States had been set off in Washington State. We quickly became the world’s epicenter of the epidemic, with over 1.8 million patients and over 110,000 deaths.¹ The rapidity of spread and the severity of the disease created a tremendous strain on resources. It blindsided policymakers and hospital administrators, which left little time to react to the challenges placed on hospital operations all over the country.

The necessity of a new care model

Although health systems in the United States are adept in managing complications of common seasonal viral respiratory illnesses, COVID-19 presented an entirely different challenge with its significantly higher mortality rate. A respiratory disease turning into a multiorgan disease that causes debilitating cardiac, renal, neurological, hematological, and psychosocial complications² was not something we had experience managing effectively. Additional challenges included a massive surge of COVID-19 patients, a limited supply of personal protective equipment (PPE), an inadequate number of intensivists for managing the anticipated ventilated patients, and most importantly, the potential of losing some of our workforce if they became infected.

Based on the experiences in China and Italy, and various predictive models, the division of hospital medicine at Baystate Health quickly realized the necessity of a new model of care for COVID-19 patients. We came up with an elaborate plan to manage the disease burden and the strain on resources effectively. The measures we put in place could be broadly divided into three categories following the timeline of the disease: the preparatory phase, the execution phase, and the maintenance phase.
 

The preparatory phase: From “Hospitalists” to “COVIDists”

As in most hospitals around the country, hospitalists are the backbone of inpatient clinical operations at our health system. A focused group of 10 hospitalists who volunteered to take care of COVID-19 patients with a particular interest in the pandemic and experience in critical care were selected, and the term “COVIDists” was coined to refer to them.

COVIDists were trained in various treatment protocols and ongoing clinical trials. They were given refresher training in Advanced Cardiac Life Support (ACLS) and Fundamental Critical Care Support (FCCS) courses and were taught in critical care/ventilator management by the intensivists through rapid indoctrination in the ICU. All of them had their N-95 mask fitting updated and were trained in the safe donning and doffing of all kinds of PPE by PPE coaches. The palliative care team trained them in conducting end-of-life/code status discussions with a focus on being unable to speak with family members at the bedside. COVIDists were also assigned as Code Blue leaders for any “COVID code blue” in the hospital.

In addition to the rapid training course, COVID-related updates were disseminated daily using three different modalities: brief huddles at the start of the day with the COVIDists; a COVID-19 newsletter summarizing daily updates, new treatments, strategies, and policies; and a WhatsApp group for instantly broadcasting information to the COVIDists (Table 1).

The execution phase

All the hospitalized COVID-19 patients were grouped together to COVID units, and the COVIDists were deployed to those units geographically. COVIDists were given lighter than usual patient loads to deal with the extra time needed for donning and doffing of PPE and for coordination with specialists. COVIDists were almost the only clinicians physically visiting the patients in most cases, and they became the “eyes and ears” of specialists since the specialists were advised to minimize exposure and pursue telemedicine consults. The COVIDists were also undertaking the most challenging part of the care – talking to families about end-of-life issues and the futility of aggressive care in certain patients with preexisting conditions.

Some COVIDists were deployed to the ICU to work alongside the intensivists and became an invaluable resource in ICU management when the ICU census skyrocketed during the initial phase of the outbreak. This helped in tiding the health system over during the initial crisis. Within a short time, we shifted away from an early intubation strategy, and most of the ICU patients were managed in the intermediate care units on high flow oxygen along with the awake-proning protocol. The COVIDists exclusively managed these units. They led multidisciplinary rounds two times a day with the ICU, rapid response team (RRT), the palliative care team, and the nursing team. This step drastically decreased the number of intubations, RRT activations, reduced ICU census,³ and helped with hospital capacity and patient flow (Tables 2 and 3).

The maintenance phase

It is already 2 months since the first devising COVIDists. There is no difference in sick callouts between COVIDists and non-COVIDists. One COVIDist and one non-COVIDist contracted the disease, but none of them required hospitalization. Although we initially thought that COVIDists would be needed for only a short period of time, the evolution of the disease is showing signs that it might be prolonged over the next several months. Hence, we are planning to continue COVIDist service for at least the next 6 months and reevaluate the need.

Hospital medicine leadership checked on COVIDists daily in regard to their physical health and, more importantly, their mental well-being. They were offered the chance to be taken off the schedule if they felt burned out, but no one wanted to come off their scheduled service before finishing their shifts. BlueCross MA recognized one of the COVIDists, Raghuveer Rakasi, MD, as a “hero on the front line.”⁴ In Dr. Rakasi’s words, “We took a nosedive into something without knowing its depth, and aware that we could have fatalities among ourselves. We took up new roles, faced new challenges, learned new things every day, evolving every step of the way. We had to change the way we practice medicine, finding new ways to treat patients, and protecting the workforce by limiting patient exposure, prioritizing investigations.” He added that “we have to adapt to a new normal; we should be prepared for this to come in waves. Putting aside our political views, we should stand united 6 feet apart, with a mask covering our brave faces, frequently washing our helping hands to overcome these uncertain times.”
 

Conclusion

The creation of a focused group of hospitalists called COVIDists and providing them with structured and rapid training (in various aspects of clinical care of COVID-19 patients, critical care/ventilator management, efficient and safe use of PPE) and daily information dissemination allowed our health system to prepare for the large volume of COVID-19 patients. It also helped in preserving the larger hospital workforce for a possible future surge.

The rapid development and implementation of the COVIDist strategy succeeded because of the intrinsic motivation of the providers to improve the outcomes of this high-risk patient population and the close collaboration of the stakeholders. Our institution remains successful in managing the pandemic in Western Massachusetts, with reserve capacity remaining even during the peak of the epidemic. A large part of this was because of creating and training a pool of COVIDists.
 

Dr. Medarametla is medical director, clinical operations, in the division of hospital medicine at Baystate Health, and assistant professor at University of Massachusetts, Worcester. Readers can contact him at Venkatrao.MedarametlaMD@Baystatehealth.org. Dr. Prabhakaran is unit medical director, geriatrics unit, in the division of hospital medicine at Baystate Health and assistant professor at University of Massachusetts. Dr. Bryson is associate program director of the Internal Medicine Residency at Baystate Health and assistant professor at University of Massachusetts. Dr. Umar is medical director, clinical operations, in the division of hospital medicine at Baystate Health. Dr. Natanasabapathy is division chief of hospital medicine at Baystate Health and assistant professor at University of Massachusetts.

References

1. Centers for Disease Control and Prevention. Coronavirus Disease 2019 (COVID-19). Updated Jun 10, 2020. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html.

2. Zhou F et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: A retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-62.

3. Westafer LM et al. A transdisciplinary COVID-19 early respiratory intervention protocol: An implementation story. J Hosp Med. 2020 May 21;15(6):372-374.

4. Miller J. “Heroes on the front line: Dr. Raghuveer Rakasi.” Coverage. May 18, 2020. https://coverage.bluecrossma.com/article/heroes-front-line-dr-raghuveer-rakasi

Here are the stories our MDedge editors across specialties think you need to know about today:

Lung ultrasound works well in children with COVID-19

Lung ultrasound has “high concordance” with radiologic findings in children with COVID-19 and offers benefits over other imaging techniques, such as CT. “First, it may reduce the number of radiologic examinations, lowering the radiation exposure of the patients,” wrote Marco Denina, MD, and colleagues from the pediatric infectious diseases unit at Regina Margherita Children’s Hospital in Turin, Italy. “Secondly, when performed at the bedside, [lung ultrasound] allows for the reduction of the patient’s movement within the hospital; thus, it lowers the number of health care workers and medical devices exposed to [SARS-CoV-2].” The findings of the small, observational study were published in Pediatrics. Read more.

New hypertension definitions reveal preclampsia risk

Using the new clinical definitions of hypertension, pregnant women with even modest elevations in blood pressure are at increased risk for preeclampsia, according to results from a large retrospective cohort study. Elizabeth F. Sutton, PhD, of the University of Pittsburgh and colleagues looked at records from 18,162 women who had given birth to a single baby. The authors found preeclampsia risk increased with increasing blood pressure elevation. Among women with normal blood pressure before 20 weeks’ gestation, 5% had preeclampsia, while 7% of those with elevated blood pressure did, as did 12% of women with stage 1 hypertension and 30% of women with stage 2 hypertension. The increase in risk of preeclampsia was because of preterm preeclampsia in the women with elevated blood pressure. Preeclampsia researcher Mark Santillan, MD, PhD, of the University of Iowa in Iowa City, said in an interview that the results “open the door to considering these new blood pressure categories as a prognosticator” for preeclampsia. “This paper furthers the field by applying these new categories to hypertensive diseases in pregnancy, which are not well studied” in comparison to nonpregnant hypertensive states. Read more.

Face mask type matters when sterilizing

When sterilizing face masks, the type of mask and the method of sterilization have a bearing on subsequent filtration efficiency, according to new research published in JAMA Network Open. The greatest reduction in filtration efficiency after sterilization occurred with surgical face masks. With plasma vapor hydrogen peroxide (H2O2) sterilization, filtration efficiency of N95 and KN95 masks was maintained at more than 95%, but for surgical face masks, filtration efficiency was reduced to less than 95%. With chlorine dioxide (ClO2) sterilization, on the other hand, filtration efficiency was maintained at above 95% for N95 masks, but for KN95 and surgical face masks, filtration efficiency was reduced to less than 80%. Read more.

FDA approves first treatment for adult-onset Still’s disease

The Food and Drug Administration has expanded the indications for canakinumab (Ilaris) to include all patients with active Still’s disease older than 2 years, adding adult-onset Still’s disease (AOSD) to a previous approval for juvenile-onset Still’s disease, also known as systemic juvenile idiopathic arthritis (sJIA). That makes Ilaris the first approved treatment for AOSD. The results from a randomized, double-blind, placebo-controlled study of 36 patients with AOSD aged 22-70 years showed that the efficacy and safety data in AOSD were generally consistent with the results of a pooled analysis of sJIA patients, according to Novartis, which markets canakinumab. Read more.

Intranasal DHE shows promise in migraine

An intranasal form of dihydroergotamine (DHE) targeting the upper nasal region is safe and effective for the treatment of migraine, according to results from a phase 3 clinical trial. The new formulation could offer patients an at-home alternative to intramuscular infusions or intravenous injections currently used to deliver DHE. The STOP 301 phase 3 open-label safety and tolerability trial treated over 5,650 migraine attacks in 354 patients who self-administered INP104 for up to 52 weeks. They were provided up to three doses per week (1.45 mg in a dose of two puffs, one per nostril). A total of 66.3% of participants reported pain relief by 2 hours following a dose, and 38% had freedom from pain. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

Lung ultrasound works well in children with COVID-19

Lung ultrasound has “high concordance” with radiologic findings in children with COVID-19 and offers benefits over other imaging techniques, such as CT. “First, it may reduce the number of radiologic examinations, lowering the radiation exposure of the patients,” wrote Marco Denina, MD, and colleagues from the pediatric infectious diseases unit at Regina Margherita Children’s Hospital in Turin, Italy. “Secondly, when performed at the bedside, [lung ultrasound] allows for the reduction of the patient’s movement within the hospital; thus, it lowers the number of health care workers and medical devices exposed to [SARS-CoV-2].” The findings of the small, observational study were published in Pediatrics. Read more.

New hypertension definitions reveal preclampsia risk

Using the new clinical definitions of hypertension, pregnant women with even modest elevations in blood pressure are at increased risk for preeclampsia, according to results from a large retrospective cohort study. Elizabeth F. Sutton, PhD, of the University of Pittsburgh and colleagues looked at records from 18,162 women who had given birth to a single baby. The authors found preeclampsia risk increased with increasing blood pressure elevation. Among women with normal blood pressure before 20 weeks’ gestation, 5% had preeclampsia, while 7% of those with elevated blood pressure did, as did 12% of women with stage 1 hypertension and 30% of women with stage 2 hypertension. The increase in risk of preeclampsia was because of preterm preeclampsia in the women with elevated blood pressure. Preeclampsia researcher Mark Santillan, MD, PhD, of the University of Iowa in Iowa City, said in an interview that the results “open the door to considering these new blood pressure categories as a prognosticator” for preeclampsia. “This paper furthers the field by applying these new categories to hypertensive diseases in pregnancy, which are not well studied” in comparison to nonpregnant hypertensive states. Read more.

Face mask type matters when sterilizing

When sterilizing face masks, the type of mask and the method of sterilization have a bearing on subsequent filtration efficiency, according to new research published in JAMA Network Open. The greatest reduction in filtration efficiency after sterilization occurred with surgical face masks. With plasma vapor hydrogen peroxide (H2O2) sterilization, filtration efficiency of N95 and KN95 masks was maintained at more than 95%, but for surgical face masks, filtration efficiency was reduced to less than 95%. With chlorine dioxide (ClO2) sterilization, on the other hand, filtration efficiency was maintained at above 95% for N95 masks, but for KN95 and surgical face masks, filtration efficiency was reduced to less than 80%. Read more.

FDA approves first treatment for adult-onset Still’s disease

The Food and Drug Administration has expanded the indications for canakinumab (Ilaris) to include all patients with active Still’s disease older than 2 years, adding adult-onset Still’s disease (AOSD) to a previous approval for juvenile-onset Still’s disease, also known as systemic juvenile idiopathic arthritis (sJIA). That makes Ilaris the first approved treatment for AOSD. The results from a randomized, double-blind, placebo-controlled study of 36 patients with AOSD aged 22-70 years showed that the efficacy and safety data in AOSD were generally consistent with the results of a pooled analysis of sJIA patients, according to Novartis, which markets canakinumab. Read more.

Intranasal DHE shows promise in migraine

An intranasal form of dihydroergotamine (DHE) targeting the upper nasal region is safe and effective for the treatment of migraine, according to results from a phase 3 clinical trial. The new formulation could offer patients an at-home alternative to intramuscular infusions or intravenous injections currently used to deliver DHE. The STOP 301 phase 3 open-label safety and tolerability trial treated over 5,650 migraine attacks in 354 patients who self-administered INP104 for up to 52 weeks. They were provided up to three doses per week (1.45 mg in a dose of two puffs, one per nostril). A total of 66.3% of participants reported pain relief by 2 hours following a dose, and 38% had freedom from pain. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

Lung ultrasound works well in children with COVID-19

Lung ultrasound has “high concordance” with radiologic findings in children with COVID-19 and offers benefits over other imaging techniques, such as CT. “First, it may reduce the number of radiologic examinations, lowering the radiation exposure of the patients,” wrote Marco Denina, MD, and colleagues from the pediatric infectious diseases unit at Regina Margherita Children’s Hospital in Turin, Italy. “Secondly, when performed at the bedside, [lung ultrasound] allows for the reduction of the patient’s movement within the hospital; thus, it lowers the number of health care workers and medical devices exposed to [SARS-CoV-2].” The findings of the small, observational study were published in Pediatrics. Read more.

New hypertension definitions reveal preclampsia risk

Using the new clinical definitions of hypertension, pregnant women with even modest elevations in blood pressure are at increased risk for preeclampsia, according to results from a large retrospective cohort study. Elizabeth F. Sutton, PhD, of the University of Pittsburgh and colleagues looked at records from 18,162 women who had given birth to a single baby. The authors found preeclampsia risk increased with increasing blood pressure elevation. Among women with normal blood pressure before 20 weeks’ gestation, 5% had preeclampsia, while 7% of those with elevated blood pressure did, as did 12% of women with stage 1 hypertension and 30% of women with stage 2 hypertension. The increase in risk of preeclampsia was because of preterm preeclampsia in the women with elevated blood pressure. Preeclampsia researcher Mark Santillan, MD, PhD, of the University of Iowa in Iowa City, said in an interview that the results “open the door to considering these new blood pressure categories as a prognosticator” for preeclampsia. “This paper furthers the field by applying these new categories to hypertensive diseases in pregnancy, which are not well studied” in comparison to nonpregnant hypertensive states. Read more.

Face mask type matters when sterilizing

When sterilizing face masks, the type of mask and the method of sterilization have a bearing on subsequent filtration efficiency, according to new research published in JAMA Network Open. The greatest reduction in filtration efficiency after sterilization occurred with surgical face masks. With plasma vapor hydrogen peroxide (H2O2) sterilization, filtration efficiency of N95 and KN95 masks was maintained at more than 95%, but for surgical face masks, filtration efficiency was reduced to less than 95%. With chlorine dioxide (ClO2) sterilization, on the other hand, filtration efficiency was maintained at above 95% for N95 masks, but for KN95 and surgical face masks, filtration efficiency was reduced to less than 80%. Read more.

FDA approves first treatment for adult-onset Still’s disease

The Food and Drug Administration has expanded the indications for canakinumab (Ilaris) to include all patients with active Still’s disease older than 2 years, adding adult-onset Still’s disease (AOSD) to a previous approval for juvenile-onset Still’s disease, also known as systemic juvenile idiopathic arthritis (sJIA). That makes Ilaris the first approved treatment for AOSD. The results from a randomized, double-blind, placebo-controlled study of 36 patients with AOSD aged 22-70 years showed that the efficacy and safety data in AOSD were generally consistent with the results of a pooled analysis of sJIA patients, according to Novartis, which markets canakinumab. Read more.

Intranasal DHE shows promise in migraine

An intranasal form of dihydroergotamine (DHE) targeting the upper nasal region is safe and effective for the treatment of migraine, according to results from a phase 3 clinical trial. The new formulation could offer patients an at-home alternative to intramuscular infusions or intravenous injections currently used to deliver DHE. The STOP 301 phase 3 open-label safety and tolerability trial treated over 5,650 migraine attacks in 354 patients who self-administered INP104 for up to 52 weeks. They were provided up to three doses per week (1.45 mg in a dose of two puffs, one per nostril). A total of 66.3% of participants reported pain relief by 2 hours following a dose, and 38% had freedom from pain. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

A German registry is providing new insight into the characteristics and real-world diagnosis and management of rheumatic immune-related adverse events of cancer therapy. Its first findings were reported at the annual European Congress of Rheumatology, held online this year due to COVID-19.

“We have limited knowledge on the interrelationships between malignant and rheumatic diseases on both the clinical and molecular level, and we have a large unmet need for management guidelines in the case of the coincidence of both disease entities,” noted lead author Karolina Benesova, MD, of the department of hematology, oncology, and rheumatology at University Hospital Heidelberg (Germany).

The TRheuMa registry – Therapy-Induced Rheumatic Symptoms in Patients with Malignancy – is one of three registries in a multicenter observational project exploring various contexts between malignant and rheumatic diseases. Over its first 22 months, the registry recruited 69 patients having rheumatic symptoms as a result of immune checkpoint inhibitor therapy or other cancer therapies.
 

Registry findings

The largest shares of patients had non–small cell lung cancer (38%) or melanoma (33%), Dr. Benesova reported. The immune checkpoint inhibitors most commonly received were pembrolizumab (Keytruda), nivolumab (Opdivo), and ipilimumab (Yervoy).

The immune-related adverse events usually presented with symptoms of de novo spondyloarthritis or psoriatic arthritis (42%), late-onset RA (17%), or polymyalgia rheumatica (14%). But 16% of the patients were experiencing a flare of a preexisting rheumatic and musculoskeletal disease.

Laboratory findings differed somewhat from those of classical rheumatic and musculoskeletal diseases, according to Dr. Benesova. Specific findings were rare; in particular, most patients did not have detectable autoantibodies. However, 76% had an elevated C-reactive protein level and 39% had an elevated soluble CD25 level. In addition, nearly all patients (96%) undergoing joint ultrasound had pathologic findings.

“Based on our experiences from interdisciplinary care together with our local oncologists, we have developed a therapeutic algorithm for rheumatic immune-related adverse events,” she reported, noting that the algorithm is consistent with recently published recommendations in this area.

The large majority of patients were adequately treated with prednisone at a dose greater than 10 mg (40%) or at a dose of 10 mg or less with or without an NSAID (40%), while some received NSAID monotherapy (14%).

“We have a growing proportion of patients on conventional or biological [disease-modifying antirheumatic drugs],” Dr. Benesova noted. “These are mostly patients with preexisting rheumatic and musculoskeletal disease or highly suspected de novo classical rheumatic and musculoskeletal disease under checkpoint inhibitor therapy.”

Patients with melanoma having a rheumatic immune-related adverse event had a better response to their therapy than historical counterparts who did not have such events: 39% of the former had a complete response, relative to merely 4% of the latter.

Only a small proportion of patients overall (9%) had to discontinue immune checkpoint inhibitor therapy because of their adverse event, and some of them may be eligible for rechallenge if their cancer progresses, Dr. Benesova noted.

“There is still a lot to be done,” she stated, such as better elucidating the nature of these adverse events [whether transient side effects or a triggering of chronic rheumatic and musculoskeletal diseases], the need for a defensive treatment strategy, and the advisability of closer monitoring of high-risk patients given immune checkpoint inhibitors. “We are aiming at solving these questions in the next few years,” she concluded.

Findings in context

“Registries are important to gain prospective data on patient outcomes,” Sabina Sandigursky, MD, an instructor in the division of rheumatology at the Laura and Isaac Perlmutter Cancer Center at New York University, commented in an interview. “One must be careful, while interpreting these data, especially since they are not randomized, controlled trials.”

Patterns may differ at other centers, too, she pointed out. “The German registry reported a predominance of spondyloarthritis-like disease; however, our patients have a predominance of small-joint involvement. It is unclear what accounts for this difference.”

Individual institutions in North America are similarly collecting data on this patient population, with efforts underway to compile those data to provide a larger picture, according to Dr. Sandigursky.

“Many of the syndromes that we consider to be rheumatic immune-related adverse events have been well described by groups from the U.S., Canada, Australia, and European Union,” she concluded. “From this registry, we can observe how patients are being treated in real time since this information is largely consensus based.”

The study did not receive any specific funding. Dr. Benesova disclosed grant/research support from AbbVie, Novartis, Rheumaliga Baden-Wurttemberg, and the University of Heidelberg, and consultancies, speaker fees, and/or travel reimbursements from AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Medac, Merck Sharp & Dohme, Mundipharma, Novartis, Pfizer, Roche, and UCB. Some of her coauthors also disclosed financial relationships with industry. Dr. Sandigursky disclosed having no relevant conflicts of interest.

SOURCE: Benesova K et al. Ann Rheum Dis 2020;79[suppl 1]:168-9, Abstract OP0270.

A German registry is providing new insight into the characteristics and real-world diagnosis and management of rheumatic immune-related adverse events of cancer therapy. Its first findings were reported at the annual European Congress of Rheumatology, held online this year due to COVID-19.

“We have limited knowledge on the interrelationships between malignant and rheumatic diseases on both the clinical and molecular level, and we have a large unmet need for management guidelines in the case of the coincidence of both disease entities,” noted lead author Karolina Benesova, MD, of the department of hematology, oncology, and rheumatology at University Hospital Heidelberg (Germany).

The TRheuMa registry – Therapy-Induced Rheumatic Symptoms in Patients with Malignancy – is one of three registries in a multicenter observational project exploring various contexts between malignant and rheumatic diseases. Over its first 22 months, the registry recruited 69 patients having rheumatic symptoms as a result of immune checkpoint inhibitor therapy or other cancer therapies.
 

Registry findings

The largest shares of patients had non–small cell lung cancer (38%) or melanoma (33%), Dr. Benesova reported. The immune checkpoint inhibitors most commonly received were pembrolizumab (Keytruda), nivolumab (Opdivo), and ipilimumab (Yervoy).

The immune-related adverse events usually presented with symptoms of de novo spondyloarthritis or psoriatic arthritis (42%), late-onset RA (17%), or polymyalgia rheumatica (14%). But 16% of the patients were experiencing a flare of a preexisting rheumatic and musculoskeletal disease.

Laboratory findings differed somewhat from those of classical rheumatic and musculoskeletal diseases, according to Dr. Benesova. Specific findings were rare; in particular, most patients did not have detectable autoantibodies. However, 76% had an elevated C-reactive protein level and 39% had an elevated soluble CD25 level. In addition, nearly all patients (96%) undergoing joint ultrasound had pathologic findings.

“Based on our experiences from interdisciplinary care together with our local oncologists, we have developed a therapeutic algorithm for rheumatic immune-related adverse events,” she reported, noting that the algorithm is consistent with recently published recommendations in this area.

The large majority of patients were adequately treated with prednisone at a dose greater than 10 mg (40%) or at a dose of 10 mg or less with or without an NSAID (40%), while some received NSAID monotherapy (14%).

“We have a growing proportion of patients on conventional or biological [disease-modifying antirheumatic drugs],” Dr. Benesova noted. “These are mostly patients with preexisting rheumatic and musculoskeletal disease or highly suspected de novo classical rheumatic and musculoskeletal disease under checkpoint inhibitor therapy.”

Patients with melanoma having a rheumatic immune-related adverse event had a better response to their therapy than historical counterparts who did not have such events: 39% of the former had a complete response, relative to merely 4% of the latter.

Only a small proportion of patients overall (9%) had to discontinue immune checkpoint inhibitor therapy because of their adverse event, and some of them may be eligible for rechallenge if their cancer progresses, Dr. Benesova noted.

“There is still a lot to be done,” she stated, such as better elucidating the nature of these adverse events [whether transient side effects or a triggering of chronic rheumatic and musculoskeletal diseases], the need for a defensive treatment strategy, and the advisability of closer monitoring of high-risk patients given immune checkpoint inhibitors. “We are aiming at solving these questions in the next few years,” she concluded.

Findings in context

“Registries are important to gain prospective data on patient outcomes,” Sabina Sandigursky, MD, an instructor in the division of rheumatology at the Laura and Isaac Perlmutter Cancer Center at New York University, commented in an interview. “One must be careful, while interpreting these data, especially since they are not randomized, controlled trials.”

Patterns may differ at other centers, too, she pointed out. “The German registry reported a predominance of spondyloarthritis-like disease; however, our patients have a predominance of small-joint involvement. It is unclear what accounts for this difference.”

Individual institutions in North America are similarly collecting data on this patient population, with efforts underway to compile those data to provide a larger picture, according to Dr. Sandigursky.

“Many of the syndromes that we consider to be rheumatic immune-related adverse events have been well described by groups from the U.S., Canada, Australia, and European Union,” she concluded. “From this registry, we can observe how patients are being treated in real time since this information is largely consensus based.”

The study did not receive any specific funding. Dr. Benesova disclosed grant/research support from AbbVie, Novartis, Rheumaliga Baden-Wurttemberg, and the University of Heidelberg, and consultancies, speaker fees, and/or travel reimbursements from AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Medac, Merck Sharp & Dohme, Mundipharma, Novartis, Pfizer, Roche, and UCB. Some of her coauthors also disclosed financial relationships with industry. Dr. Sandigursky disclosed having no relevant conflicts of interest.

SOURCE: Benesova K et al. Ann Rheum Dis 2020;79[suppl 1]:168-9, Abstract OP0270.

A German registry is providing new insight into the characteristics and real-world diagnosis and management of rheumatic immune-related adverse events of cancer therapy. Its first findings were reported at the annual European Congress of Rheumatology, held online this year due to COVID-19.

“We have limited knowledge on the interrelationships between malignant and rheumatic diseases on both the clinical and molecular level, and we have a large unmet need for management guidelines in the case of the coincidence of both disease entities,” noted lead author Karolina Benesova, MD, of the department of hematology, oncology, and rheumatology at University Hospital Heidelberg (Germany).

The TRheuMa registry – Therapy-Induced Rheumatic Symptoms in Patients with Malignancy – is one of three registries in a multicenter observational project exploring various contexts between malignant and rheumatic diseases. Over its first 22 months, the registry recruited 69 patients having rheumatic symptoms as a result of immune checkpoint inhibitor therapy or other cancer therapies.
 

Registry findings

The largest shares of patients had non–small cell lung cancer (38%) or melanoma (33%), Dr. Benesova reported. The immune checkpoint inhibitors most commonly received were pembrolizumab (Keytruda), nivolumab (Opdivo), and ipilimumab (Yervoy).

The immune-related adverse events usually presented with symptoms of de novo spondyloarthritis or psoriatic arthritis (42%), late-onset RA (17%), or polymyalgia rheumatica (14%). But 16% of the patients were experiencing a flare of a preexisting rheumatic and musculoskeletal disease.

Laboratory findings differed somewhat from those of classical rheumatic and musculoskeletal diseases, according to Dr. Benesova. Specific findings were rare; in particular, most patients did not have detectable autoantibodies. However, 76% had an elevated C-reactive protein level and 39% had an elevated soluble CD25 level. In addition, nearly all patients (96%) undergoing joint ultrasound had pathologic findings.

“Based on our experiences from interdisciplinary care together with our local oncologists, we have developed a therapeutic algorithm for rheumatic immune-related adverse events,” she reported, noting that the algorithm is consistent with recently published recommendations in this area.

The large majority of patients were adequately treated with prednisone at a dose greater than 10 mg (40%) or at a dose of 10 mg or less with or without an NSAID (40%), while some received NSAID monotherapy (14%).

“We have a growing proportion of patients on conventional or biological [disease-modifying antirheumatic drugs],” Dr. Benesova noted. “These are mostly patients with preexisting rheumatic and musculoskeletal disease or highly suspected de novo classical rheumatic and musculoskeletal disease under checkpoint inhibitor therapy.”

Patients with melanoma having a rheumatic immune-related adverse event had a better response to their therapy than historical counterparts who did not have such events: 39% of the former had a complete response, relative to merely 4% of the latter.

Only a small proportion of patients overall (9%) had to discontinue immune checkpoint inhibitor therapy because of their adverse event, and some of them may be eligible for rechallenge if their cancer progresses, Dr. Benesova noted.

“There is still a lot to be done,” she stated, such as better elucidating the nature of these adverse events [whether transient side effects or a triggering of chronic rheumatic and musculoskeletal diseases], the need for a defensive treatment strategy, and the advisability of closer monitoring of high-risk patients given immune checkpoint inhibitors. “We are aiming at solving these questions in the next few years,” she concluded.

Findings in context

“Registries are important to gain prospective data on patient outcomes,” Sabina Sandigursky, MD, an instructor in the division of rheumatology at the Laura and Isaac Perlmutter Cancer Center at New York University, commented in an interview. “One must be careful, while interpreting these data, especially since they are not randomized, controlled trials.”

Patterns may differ at other centers, too, she pointed out. “The German registry reported a predominance of spondyloarthritis-like disease; however, our patients have a predominance of small-joint involvement. It is unclear what accounts for this difference.”

Individual institutions in North America are similarly collecting data on this patient population, with efforts underway to compile those data to provide a larger picture, according to Dr. Sandigursky.

“Many of the syndromes that we consider to be rheumatic immune-related adverse events have been well described by groups from the U.S., Canada, Australia, and European Union,” she concluded. “From this registry, we can observe how patients are being treated in real time since this information is largely consensus based.”

The study did not receive any specific funding. Dr. Benesova disclosed grant/research support from AbbVie, Novartis, Rheumaliga Baden-Wurttemberg, and the University of Heidelberg, and consultancies, speaker fees, and/or travel reimbursements from AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Medac, Merck Sharp & Dohme, Mundipharma, Novartis, Pfizer, Roche, and UCB. Some of her coauthors also disclosed financial relationships with industry. Dr. Sandigursky disclosed having no relevant conflicts of interest.

SOURCE: Benesova K et al. Ann Rheum Dis 2020;79[suppl 1]:168-9, Abstract OP0270.

I have an automatic preference for white people over black people. This isn’t my opinion; rather, it is my implicit bias test result. I didn’t believe it at first. Trying hard to not be biased, I took the test again and received the same outcome. My reaction – disbelief – is typical for those like me: White people who believe they are good human beings. I might be good, but that doesn’t mean I’m free of bias or exonerated from the harm being inflicted on people of color.

We’ve all watched in horror the acts of violence against blacks in the news. I was shocked and disgusted. It was easy to believe, however, that I am in no way complicit in the injustice and racism I was watching. I think I’m fair and without prejudice. I have never intentionally discriminated against someone. Wanting to help, I listened to my black colleagues, staff, and patients. What I learned made me uncomfortable.

Through all this news, I’d said little to my colleagues and friends. I cannot identify with how a black person has felt recently. What if I said the wrong thing or caused offense? The safe option is to say nothing. I learned that this is a common reaction and the least helpful. The advice from one black colleague was simple: “Just ask us.” Instead of ignoring the issue, she advised me to say: “I wonder what this experience has been like for you. Would you like to share?” And, if you mean it, to add, “I stand with you.” The latter should be followed by “What can I do to help?” Or, more powerfully, “What have I done that makes me complicit?”

Some of these conversations will be uncomfortable. If you want to help, then sit with that. Feeling uncomfortable might mean you are beginning to understand.

I also heard about the excellent book “White Fragility,” by Robin DiAngelo, PhD. In it, she argues that it is difficult for white people to talk about racism because of a tendency to react with defensiveness, guilt, and sometimes anger.

Many of the chapters in the book were easy to read because they didn’t apply to me: I don’t get angry in equity, inclusion, and diversity meetings. I don’t resent affirmative action programs. But then Dr. DiAngelo got me: I believed because I’m a good person and I have no intention of being racist, I’m absolved. Her argument was enlightening. Like all white people in the United States, I have benefited from white privilege. Yes, I’ve worked hard, but I also grew up in a white family with a college-educated father. That alone afforded me academic and financial advantages, which pushed me ahead. I’ve benefited from the status quo.

I have also failed to speak up when white friends carried on about how unnecessary affirmative action programs have become. I’ve sat with sealed lips when I’ve heard comments like “As a white male, it’s a lot harder to get into prestigious schools now.” Having no intention to harm doesn’t matter; plenty of harm is done unintentionally.

I also believed that because I have good intentions, I have no racial bias. I was wrong. The test I took online is an excellent tool to combat this blind spot. It was created by Harvard researchers and is available to everyone: Take a Test. It asks you to categorize faces as good or bad and records your tiny reaction times. Based on these and other questions, it provides feedback on your personal biases.

I was surprised that I have an implicit preference for white people over black people. That’s the point. Most of us are unaware of our biases and falsely believe we are free of them. I encourage you to take the test and learn about yourself. If the result makes you uncomfortable, then sit with it. Try not to be defensive, as I was, and accept that, even if you are a good person, you can become a better one.

Based on what I’ve learned and heard in the last few weeks, I’ve committed to a few things: To acknowledge the harm done to my black and brown colleagues and my complicity even by acts of omission. To not avoid uncomfortable feelings or uncomfortable conversations. As a leader, to use my organizational status to advocate. To stand by my partners of color not only in dramatic one-time marches but also against the everyday perpetrators of microaggressions. To create a safe space and invite my colleagues, staff, friends, and patients to share.

Standing up against racism is all our responsibility. As Dr. Martin Luther King Jr. reminds us: “In the end, we will remember not the words of our enemies, but the silence of our friends.”
 

Dr. Benabio is director of healthcare transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. He has no disclosures related to this column. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

I have an automatic preference for white people over black people. This isn’t my opinion; rather, it is my implicit bias test result. I didn’t believe it at first. Trying hard to not be biased, I took the test again and received the same outcome. My reaction – disbelief – is typical for those like me: White people who believe they are good human beings. I might be good, but that doesn’t mean I’m free of bias or exonerated from the harm being inflicted on people of color.

We’ve all watched in horror the acts of violence against blacks in the news. I was shocked and disgusted. It was easy to believe, however, that I am in no way complicit in the injustice and racism I was watching. I think I’m fair and without prejudice. I have never intentionally discriminated against someone. Wanting to help, I listened to my black colleagues, staff, and patients. What I learned made me uncomfortable.

Through all this news, I’d said little to my colleagues and friends. I cannot identify with how a black person has felt recently. What if I said the wrong thing or caused offense? The safe option is to say nothing. I learned that this is a common reaction and the least helpful. The advice from one black colleague was simple: “Just ask us.” Instead of ignoring the issue, she advised me to say: “I wonder what this experience has been like for you. Would you like to share?” And, if you mean it, to add, “I stand with you.” The latter should be followed by “What can I do to help?” Or, more powerfully, “What have I done that makes me complicit?”

Some of these conversations will be uncomfortable. If you want to help, then sit with that. Feeling uncomfortable might mean you are beginning to understand.

I also heard about the excellent book “White Fragility,” by Robin DiAngelo, PhD. In it, she argues that it is difficult for white people to talk about racism because of a tendency to react with defensiveness, guilt, and sometimes anger.

Many of the chapters in the book were easy to read because they didn’t apply to me: I don’t get angry in equity, inclusion, and diversity meetings. I don’t resent affirmative action programs. But then Dr. DiAngelo got me: I believed because I’m a good person and I have no intention of being racist, I’m absolved. Her argument was enlightening. Like all white people in the United States, I have benefited from white privilege. Yes, I’ve worked hard, but I also grew up in a white family with a college-educated father. That alone afforded me academic and financial advantages, which pushed me ahead. I’ve benefited from the status quo.

I have also failed to speak up when white friends carried on about how unnecessary affirmative action programs have become. I’ve sat with sealed lips when I’ve heard comments like “As a white male, it’s a lot harder to get into prestigious schools now.” Having no intention to harm doesn’t matter; plenty of harm is done unintentionally.

I also believed that because I have good intentions, I have no racial bias. I was wrong. The test I took online is an excellent tool to combat this blind spot. It was created by Harvard researchers and is available to everyone: Take a Test. It asks you to categorize faces as good or bad and records your tiny reaction times. Based on these and other questions, it provides feedback on your personal biases.

I was surprised that I have an implicit preference for white people over black people. That’s the point. Most of us are unaware of our biases and falsely believe we are free of them. I encourage you to take the test and learn about yourself. If the result makes you uncomfortable, then sit with it. Try not to be defensive, as I was, and accept that, even if you are a good person, you can become a better one.

Based on what I’ve learned and heard in the last few weeks, I’ve committed to a few things: To acknowledge the harm done to my black and brown colleagues and my complicity even by acts of omission. To not avoid uncomfortable feelings or uncomfortable conversations. As a leader, to use my organizational status to advocate. To stand by my partners of color not only in dramatic one-time marches but also against the everyday perpetrators of microaggressions. To create a safe space and invite my colleagues, staff, friends, and patients to share.

Standing up against racism is all our responsibility. As Dr. Martin Luther King Jr. reminds us: “In the end, we will remember not the words of our enemies, but the silence of our friends.”
 

Dr. Benabio is director of healthcare transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. He has no disclosures related to this column. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

I have an automatic preference for white people over black people. This isn’t my opinion; rather, it is my implicit bias test result. I didn’t believe it at first. Trying hard to not be biased, I took the test again and received the same outcome. My reaction – disbelief – is typical for those like me: White people who believe they are good human beings. I might be good, but that doesn’t mean I’m free of bias or exonerated from the harm being inflicted on people of color.

We’ve all watched in horror the acts of violence against blacks in the news. I was shocked and disgusted. It was easy to believe, however, that I am in no way complicit in the injustice and racism I was watching. I think I’m fair and without prejudice. I have never intentionally discriminated against someone. Wanting to help, I listened to my black colleagues, staff, and patients. What I learned made me uncomfortable.

Through all this news, I’d said little to my colleagues and friends. I cannot identify with how a black person has felt recently. What if I said the wrong thing or caused offense? The safe option is to say nothing. I learned that this is a common reaction and the least helpful. The advice from one black colleague was simple: “Just ask us.” Instead of ignoring the issue, she advised me to say: “I wonder what this experience has been like for you. Would you like to share?” And, if you mean it, to add, “I stand with you.” The latter should be followed by “What can I do to help?” Or, more powerfully, “What have I done that makes me complicit?”

Some of these conversations will be uncomfortable. If you want to help, then sit with that. Feeling uncomfortable might mean you are beginning to understand.

I also heard about the excellent book “White Fragility,” by Robin DiAngelo, PhD. In it, she argues that it is difficult for white people to talk about racism because of a tendency to react with defensiveness, guilt, and sometimes anger.

Many of the chapters in the book were easy to read because they didn’t apply to me: I don’t get angry in equity, inclusion, and diversity meetings. I don’t resent affirmative action programs. But then Dr. DiAngelo got me: I believed because I’m a good person and I have no intention of being racist, I’m absolved. Her argument was enlightening. Like all white people in the United States, I have benefited from white privilege. Yes, I’ve worked hard, but I also grew up in a white family with a college-educated father. That alone afforded me academic and financial advantages, which pushed me ahead. I’ve benefited from the status quo.

I have also failed to speak up when white friends carried on about how unnecessary affirmative action programs have become. I’ve sat with sealed lips when I’ve heard comments like “As a white male, it’s a lot harder to get into prestigious schools now.” Having no intention to harm doesn’t matter; plenty of harm is done unintentionally.

I also believed that because I have good intentions, I have no racial bias. I was wrong. The test I took online is an excellent tool to combat this blind spot. It was created by Harvard researchers and is available to everyone: Take a Test. It asks you to categorize faces as good or bad and records your tiny reaction times. Based on these and other questions, it provides feedback on your personal biases.

I was surprised that I have an implicit preference for white people over black people. That’s the point. Most of us are unaware of our biases and falsely believe we are free of them. I encourage you to take the test and learn about yourself. If the result makes you uncomfortable, then sit with it. Try not to be defensive, as I was, and accept that, even if you are a good person, you can become a better one.

Based on what I’ve learned and heard in the last few weeks, I’ve committed to a few things: To acknowledge the harm done to my black and brown colleagues and my complicity even by acts of omission. To not avoid uncomfortable feelings or uncomfortable conversations. As a leader, to use my organizational status to advocate. To stand by my partners of color not only in dramatic one-time marches but also against the everyday perpetrators of microaggressions. To create a safe space and invite my colleagues, staff, friends, and patients to share.

Standing up against racism is all our responsibility. As Dr. Martin Luther King Jr. reminds us: “In the end, we will remember not the words of our enemies, but the silence of our friends.”
 

Dr. Benabio is director of healthcare transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. He has no disclosures related to this column. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

Lung ultrasound has “high concordance” with radiologic findings in children with COVID-19, researchers wrote in Pediatrics.

They also noted the benefits that modality provides over other imaging techniques.

Marco Denina, MD, and colleagues from the pediatric infectious diseases unit at Regina Margherita Children’s Hospital in Turin, Italy, performed an observational study of eight children aged 0-17 years who were admitted to the hospital for COVID-19 between March 8 and 26, 2020. In seven of eight patients, the findings were concordant between imaging modalities; in the remaining patient, lung ultrasound (LUS) found an interstitial B-lines pattern that was not seen on radiography. In seven patients with pathologic ultrasound findings at baseline, the improvement or resolution of the subpleural consolidations or interstitial patterns was consistent with concomitant radiologic findings.

The authors cited the benefits of using point-of-care ultrasound instead of other modalities, such as CT. “First, it may reduce the number of radiologic examinations, lowering the radiation exposure of the patients,” they wrote. “Secondly, when performed at the bedside, LUS allows for the reduction of the patient’s movement within the hospital; thus, it lowers the number of health care workers and medical devices exposed to [SARS-CoV-2].”

One limitation of the study is the small sample size; however, the researchers felt the high concordance still suggests LUS is a reasonable method for COVID-19 patients.

There was no external funding for this study and the investigators had no relevant financial disclosures.

cpalmer@mdedge.com

SOURCE: Denina M et al. Pediatrics. 2020 Jun. doi: 10.1542/peds.2020-1157.

Lung ultrasound has “high concordance” with radiologic findings in children with COVID-19, researchers wrote in Pediatrics.

They also noted the benefits that modality provides over other imaging techniques.

Marco Denina, MD, and colleagues from the pediatric infectious diseases unit at Regina Margherita Children’s Hospital in Turin, Italy, performed an observational study of eight children aged 0-17 years who were admitted to the hospital for COVID-19 between March 8 and 26, 2020. In seven of eight patients, the findings were concordant between imaging modalities; in the remaining patient, lung ultrasound (LUS) found an interstitial B-lines pattern that was not seen on radiography. In seven patients with pathologic ultrasound findings at baseline, the improvement or resolution of the subpleural consolidations or interstitial patterns was consistent with concomitant radiologic findings.

The authors cited the benefits of using point-of-care ultrasound instead of other modalities, such as CT. “First, it may reduce the number of radiologic examinations, lowering the radiation exposure of the patients,” they wrote. “Secondly, when performed at the bedside, LUS allows for the reduction of the patient’s movement within the hospital; thus, it lowers the number of health care workers and medical devices exposed to [SARS-CoV-2].”

One limitation of the study is the small sample size; however, the researchers felt the high concordance still suggests LUS is a reasonable method for COVID-19 patients.

There was no external funding for this study and the investigators had no relevant financial disclosures.

cpalmer@mdedge.com

SOURCE: Denina M et al. Pediatrics. 2020 Jun. doi: 10.1542/peds.2020-1157.

Lung ultrasound has “high concordance” with radiologic findings in children with COVID-19, researchers wrote in Pediatrics.

They also noted the benefits that modality provides over other imaging techniques.

Marco Denina, MD, and colleagues from the pediatric infectious diseases unit at Regina Margherita Children’s Hospital in Turin, Italy, performed an observational study of eight children aged 0-17 years who were admitted to the hospital for COVID-19 between March 8 and 26, 2020. In seven of eight patients, the findings were concordant between imaging modalities; in the remaining patient, lung ultrasound (LUS) found an interstitial B-lines pattern that was not seen on radiography. In seven patients with pathologic ultrasound findings at baseline, the improvement or resolution of the subpleural consolidations or interstitial patterns was consistent with concomitant radiologic findings.

The authors cited the benefits of using point-of-care ultrasound instead of other modalities, such as CT. “First, it may reduce the number of radiologic examinations, lowering the radiation exposure of the patients,” they wrote. “Secondly, when performed at the bedside, LUS allows for the reduction of the patient’s movement within the hospital; thus, it lowers the number of health care workers and medical devices exposed to [SARS-CoV-2].”

One limitation of the study is the small sample size; however, the researchers felt the high concordance still suggests LUS is a reasonable method for COVID-19 patients.

There was no external funding for this study and the investigators had no relevant financial disclosures.

cpalmer@mdedge.com

SOURCE: Denina M et al. Pediatrics. 2020 Jun. doi: 10.1542/peds.2020-1157.

One might immediately think of the deaths of Eric Garner, George Floyd, or even the fictional character Radio Raheem from Spike Lee’s critically acclaimed film, “Do the Right Thing,” when they hear the words “I can’t breathe.” These words are a cry for help. The deaths of these unarmed black men is devastating and has led to a state of rage, palpable pain, and protest across the world.

However, in this moment, I am talking about the health inequity exposed by the COVID-19 pandemic. Whether it be acute respiratory distress syndrome (ARDS) secondary to severe COVID-19, or the subsequent hypercoagulable state of COVID-19 that leads to venous thromboembolism, many black people in this country are left breathless. Many black patients who had no employee-based health insurance also had no primary care physician to order a SARS-CoV2 PCR lab test for them. Many of these patients have preexisting conditions, such as asthma from living in redlined communities affected by environmental racism. Many grew up in food deserts, where no fresh-produce store was interested enough to set up shop in their neighborhoods. They have been eating fast food since early childhood, as a fast-food burger is still cheaper than a salad. The result is obesity, an epidemic that can lead to diabetes mellitus, hypertension that can lead to coronary artery disease, stroke, and end-stage renal disease. 

Earlier in my career, I once had a colleague gleefully tell me that all black people drank Kool-Aid while in discussion of the effects of high-sugar diets in our patients; this colleague was sure I would agree. Not all black people drink Kool-Aid. Secondary to my fear of the backlash that can come from the discomfort of “white fragility” that Robin DiAngelo describes in her New York Times bestseller by the same name, ”White Fragility: Why It’s So Hard for White People to Talk About Racism,” I refrained from expressing my own hurt, and I did not offer explicit correction. I, instead, took a serious pause. That pause, which lasted only minutes, seemed to last 400 years. It was a brief reflection of the 400 years of systemic racism seeping into everyday life. This included the circumstances that would lead to the health inequities that result in the health disparities from which many black patients suffer. It is that same systemic racism that could create two America’s in which my colleague might not have to know the historic context in which that question could be hurtful. I retorted with modified shock and a chuckle so that I could muster up enough strength to repeat what was said and leave it open for reflection. The goal was for my colleague to realize the obvious implicit bias that lingered, despite intention. The chuckle was also to cover my pain.

Whether we know it or not, we all carry some form of implicit bias, regardless of race, class, gender, ethnicity, sexual preference, or socioeconomic status. In this case, it is the same implicit bias that causes physicians to ignore some black patients when they have said that they are in pain. A groundbreaking April 2016 article in Proceedings of the National Academy of Sciences, “Racial Bias in Pain Assessment and Treatment Recommendations, and False Beliefs about Biological Differences Between Blacks and Whites” (doi: 10.1073/pnas.1516047113), revealed that racial disparities in pain assessment and treatment recommendations can be directly connected to the racial bias of the provider. It could be possible that this phenomenon has affected black patients who have walked into clinics and emergency departments and said, “I’m short of breath. I think that I might have coronavirus and need to be tested.” It may be that same implicit bias that has cut the air supply to a patient encounter. Instead of inquiring further, the patient might be met with minimum questions while their provider obtains their history and physical. Assumptions and blame on behavior and lack of personal responsibility secretly replace questions that could have been asked. Differentials between exacerbations and other etiologies are not explored. Could that patient have been sent home without a SARS-CoV2 polymerase chain reaction test? Well, what if the tests were in short supply? Sometimes they may have been sent home without a chest x-ray. In most cases, there are no funds to send them home with a pulse oximeter.

The act of assuming a person’s story that we consider to be one dimensional is always dangerous – and even more so during this pandemic. That person we can relate to – secondary to a cool pop culture moment, a TikTok song, or a negative stereotype – is not one dimensional. That assumption and that stereotype can make room for implicit bias. That same implicit bias is the knee on a neck of any marginalized patient. Implicit bias is the choke hold that slowly removes the light and life from a person who has a story, who has a family, and who has been an essential worker who can’t work from home. That person is telling us that they can’t breathe, but sometimes the only things seen are comorbidities through a misinformed or biased lens that suggest an assumed lack of personal responsibility. In a May 2020 New England Journal of Medicine perspective, “Racial health disparities and Covid-19” (doi: 10.1056/NEJMp2012910), Merlin Chowkwanyun, PhD, MPH, and Adolph L. Reed Jr., PhD, caution us against creating race-based explanations for presumed behavioral patterns.

Systemic racism has created the myth that the playing field has been leveled since the end of enslavement. It hasn’t. That black man, woman, or nonbinary person is telling you “I can’t breathe. I’m tired. I’m short of breath ... I have a cough ... I’m feeling weak these days, Doc.” However, implicit bias is still that knee that won’t let up. It has not let up. Communities with lower-income black and Hispanic patients have already seen local hospitals and frontline workers fight to save their lives while losing their own to COVID-19. We all witnessed the battle for scarce resources and PPE [personal protective equipment]. In contrast, some wealthy neighborhoods have occupants who most likely have access to a primary care physician and more testing centers.

As we reexamine ourselves and look at these cases of police brutality against unarmed black men, women, and children with the appropriate shame and outrage, let us reflect upon the privileges that we enjoy. Let us find our voice as we speak up for black lives. Let us look deeply into the history of medicine as it relates to black patients by reading “Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present” by Harriet A. Washington. Let us examine that painful legacy, which, while having moments of good intention, still carries the stain of indifference, racism, neglect, and even experimentation without informed consent.

Why should we do these things? Because some of our black patients have also yelled or whispered, “I can’t breathe,” and we were not always listening either.
 

Dr. Ajala is a hospitalist and associate site director for education at Grady Memorial Hospital in Atlanta. She is a member of the executive council for SHM’s Care for Vulnerable Populations special interest group.

One might immediately think of the deaths of Eric Garner, George Floyd, or even the fictional character Radio Raheem from Spike Lee’s critically acclaimed film, “Do the Right Thing,” when they hear the words “I can’t breathe.” These words are a cry for help. The deaths of these unarmed black men is devastating and has led to a state of rage, palpable pain, and protest across the world.

However, in this moment, I am talking about the health inequity exposed by the COVID-19 pandemic. Whether it be acute respiratory distress syndrome (ARDS) secondary to severe COVID-19, or the subsequent hypercoagulable state of COVID-19 that leads to venous thromboembolism, many black people in this country are left breathless. Many black patients who had no employee-based health insurance also had no primary care physician to order a SARS-CoV2 PCR lab test for them. Many of these patients have preexisting conditions, such as asthma from living in redlined communities affected by environmental racism. Many grew up in food deserts, where no fresh-produce store was interested enough to set up shop in their neighborhoods. They have been eating fast food since early childhood, as a fast-food burger is still cheaper than a salad. The result is obesity, an epidemic that can lead to diabetes mellitus, hypertension that can lead to coronary artery disease, stroke, and end-stage renal disease. 

Earlier in my career, I once had a colleague gleefully tell me that all black people drank Kool-Aid while in discussion of the effects of high-sugar diets in our patients; this colleague was sure I would agree. Not all black people drink Kool-Aid. Secondary to my fear of the backlash that can come from the discomfort of “white fragility” that Robin DiAngelo describes in her New York Times bestseller by the same name, ”White Fragility: Why It’s So Hard for White People to Talk About Racism,” I refrained from expressing my own hurt, and I did not offer explicit correction. I, instead, took a serious pause. That pause, which lasted only minutes, seemed to last 400 years. It was a brief reflection of the 400 years of systemic racism seeping into everyday life. This included the circumstances that would lead to the health inequities that result in the health disparities from which many black patients suffer. It is that same systemic racism that could create two America’s in which my colleague might not have to know the historic context in which that question could be hurtful. I retorted with modified shock and a chuckle so that I could muster up enough strength to repeat what was said and leave it open for reflection. The goal was for my colleague to realize the obvious implicit bias that lingered, despite intention. The chuckle was also to cover my pain.

Whether we know it or not, we all carry some form of implicit bias, regardless of race, class, gender, ethnicity, sexual preference, or socioeconomic status. In this case, it is the same implicit bias that causes physicians to ignore some black patients when they have said that they are in pain. A groundbreaking April 2016 article in Proceedings of the National Academy of Sciences, “Racial Bias in Pain Assessment and Treatment Recommendations, and False Beliefs about Biological Differences Between Blacks and Whites” (doi: 10.1073/pnas.1516047113), revealed that racial disparities in pain assessment and treatment recommendations can be directly connected to the racial bias of the provider. It could be possible that this phenomenon has affected black patients who have walked into clinics and emergency departments and said, “I’m short of breath. I think that I might have coronavirus and need to be tested.” It may be that same implicit bias that has cut the air supply to a patient encounter. Instead of inquiring further, the patient might be met with minimum questions while their provider obtains their history and physical. Assumptions and blame on behavior and lack of personal responsibility secretly replace questions that could have been asked. Differentials between exacerbations and other etiologies are not explored. Could that patient have been sent home without a SARS-CoV2 polymerase chain reaction test? Well, what if the tests were in short supply? Sometimes they may have been sent home without a chest x-ray. In most cases, there are no funds to send them home with a pulse oximeter.

The act of assuming a person’s story that we consider to be one dimensional is always dangerous – and even more so during this pandemic. That person we can relate to – secondary to a cool pop culture moment, a TikTok song, or a negative stereotype – is not one dimensional. That assumption and that stereotype can make room for implicit bias. That same implicit bias is the knee on a neck of any marginalized patient. Implicit bias is the choke hold that slowly removes the light and life from a person who has a story, who has a family, and who has been an essential worker who can’t work from home. That person is telling us that they can’t breathe, but sometimes the only things seen are comorbidities through a misinformed or biased lens that suggest an assumed lack of personal responsibility. In a May 2020 New England Journal of Medicine perspective, “Racial health disparities and Covid-19” (doi: 10.1056/NEJMp2012910), Merlin Chowkwanyun, PhD, MPH, and Adolph L. Reed Jr., PhD, caution us against creating race-based explanations for presumed behavioral patterns.

Systemic racism has created the myth that the playing field has been leveled since the end of enslavement. It hasn’t. That black man, woman, or nonbinary person is telling you “I can’t breathe. I’m tired. I’m short of breath ... I have a cough ... I’m feeling weak these days, Doc.” However, implicit bias is still that knee that won’t let up. It has not let up. Communities with lower-income black and Hispanic patients have already seen local hospitals and frontline workers fight to save their lives while losing their own to COVID-19. We all witnessed the battle for scarce resources and PPE [personal protective equipment]. In contrast, some wealthy neighborhoods have occupants who most likely have access to a primary care physician and more testing centers.

As we reexamine ourselves and look at these cases of police brutality against unarmed black men, women, and children with the appropriate shame and outrage, let us reflect upon the privileges that we enjoy. Let us find our voice as we speak up for black lives. Let us look deeply into the history of medicine as it relates to black patients by reading “Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present” by Harriet A. Washington. Let us examine that painful legacy, which, while having moments of good intention, still carries the stain of indifference, racism, neglect, and even experimentation without informed consent.

Why should we do these things? Because some of our black patients have also yelled or whispered, “I can’t breathe,” and we were not always listening either.
 

Dr. Ajala is a hospitalist and associate site director for education at Grady Memorial Hospital in Atlanta. She is a member of the executive council for SHM’s Care for Vulnerable Populations special interest group.

One might immediately think of the deaths of Eric Garner, George Floyd, or even the fictional character Radio Raheem from Spike Lee’s critically acclaimed film, “Do the Right Thing,” when they hear the words “I can’t breathe.” These words are a cry for help. The deaths of these unarmed black men is devastating and has led to a state of rage, palpable pain, and protest across the world.

However, in this moment, I am talking about the health inequity exposed by the COVID-19 pandemic. Whether it be acute respiratory distress syndrome (ARDS) secondary to severe COVID-19, or the subsequent hypercoagulable state of COVID-19 that leads to venous thromboembolism, many black people in this country are left breathless. Many black patients who had no employee-based health insurance also had no primary care physician to order a SARS-CoV2 PCR lab test for them. Many of these patients have preexisting conditions, such as asthma from living in redlined communities affected by environmental racism. Many grew up in food deserts, where no fresh-produce store was interested enough to set up shop in their neighborhoods. They have been eating fast food since early childhood, as a fast-food burger is still cheaper than a salad. The result is obesity, an epidemic that can lead to diabetes mellitus, hypertension that can lead to coronary artery disease, stroke, and end-stage renal disease. 

Earlier in my career, I once had a colleague gleefully tell me that all black people drank Kool-Aid while in discussion of the effects of high-sugar diets in our patients; this colleague was sure I would agree. Not all black people drink Kool-Aid. Secondary to my fear of the backlash that can come from the discomfort of “white fragility” that Robin DiAngelo describes in her New York Times bestseller by the same name, ”White Fragility: Why It’s So Hard for White People to Talk About Racism,” I refrained from expressing my own hurt, and I did not offer explicit correction. I, instead, took a serious pause. That pause, which lasted only minutes, seemed to last 400 years. It was a brief reflection of the 400 years of systemic racism seeping into everyday life. This included the circumstances that would lead to the health inequities that result in the health disparities from which many black patients suffer. It is that same systemic racism that could create two America’s in which my colleague might not have to know the historic context in which that question could be hurtful. I retorted with modified shock and a chuckle so that I could muster up enough strength to repeat what was said and leave it open for reflection. The goal was for my colleague to realize the obvious implicit bias that lingered, despite intention. The chuckle was also to cover my pain.

Whether we know it or not, we all carry some form of implicit bias, regardless of race, class, gender, ethnicity, sexual preference, or socioeconomic status. In this case, it is the same implicit bias that causes physicians to ignore some black patients when they have said that they are in pain. A groundbreaking April 2016 article in Proceedings of the National Academy of Sciences, “Racial Bias in Pain Assessment and Treatment Recommendations, and False Beliefs about Biological Differences Between Blacks and Whites” (doi: 10.1073/pnas.1516047113), revealed that racial disparities in pain assessment and treatment recommendations can be directly connected to the racial bias of the provider. It could be possible that this phenomenon has affected black patients who have walked into clinics and emergency departments and said, “I’m short of breath. I think that I might have coronavirus and need to be tested.” It may be that same implicit bias that has cut the air supply to a patient encounter. Instead of inquiring further, the patient might be met with minimum questions while their provider obtains their history and physical. Assumptions and blame on behavior and lack of personal responsibility secretly replace questions that could have been asked. Differentials between exacerbations and other etiologies are not explored. Could that patient have been sent home without a SARS-CoV2 polymerase chain reaction test? Well, what if the tests were in short supply? Sometimes they may have been sent home without a chest x-ray. In most cases, there are no funds to send them home with a pulse oximeter.

The act of assuming a person’s story that we consider to be one dimensional is always dangerous – and even more so during this pandemic. That person we can relate to – secondary to a cool pop culture moment, a TikTok song, or a negative stereotype – is not one dimensional. That assumption and that stereotype can make room for implicit bias. That same implicit bias is the knee on a neck of any marginalized patient. Implicit bias is the choke hold that slowly removes the light and life from a person who has a story, who has a family, and who has been an essential worker who can’t work from home. That person is telling us that they can’t breathe, but sometimes the only things seen are comorbidities through a misinformed or biased lens that suggest an assumed lack of personal responsibility. In a May 2020 New England Journal of Medicine perspective, “Racial health disparities and Covid-19” (doi: 10.1056/NEJMp2012910), Merlin Chowkwanyun, PhD, MPH, and Adolph L. Reed Jr., PhD, caution us against creating race-based explanations for presumed behavioral patterns.

Systemic racism has created the myth that the playing field has been leveled since the end of enslavement. It hasn’t. That black man, woman, or nonbinary person is telling you “I can’t breathe. I’m tired. I’m short of breath ... I have a cough ... I’m feeling weak these days, Doc.” However, implicit bias is still that knee that won’t let up. It has not let up. Communities with lower-income black and Hispanic patients have already seen local hospitals and frontline workers fight to save their lives while losing their own to COVID-19. We all witnessed the battle for scarce resources and PPE [personal protective equipment]. In contrast, some wealthy neighborhoods have occupants who most likely have access to a primary care physician and more testing centers.

As we reexamine ourselves and look at these cases of police brutality against unarmed black men, women, and children with the appropriate shame and outrage, let us reflect upon the privileges that we enjoy. Let us find our voice as we speak up for black lives. Let us look deeply into the history of medicine as it relates to black patients by reading “Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present” by Harriet A. Washington. Let us examine that painful legacy, which, while having moments of good intention, still carries the stain of indifference, racism, neglect, and even experimentation without informed consent.

Why should we do these things? Because some of our black patients have also yelled or whispered, “I can’t breathe,” and we were not always listening either.
 

Dr. Ajala is a hospitalist and associate site director for education at Grady Memorial Hospital in Atlanta. She is a member of the executive council for SHM’s Care for Vulnerable Populations special interest group.

The Food and Drug Administration has expanded the indications for canakinumab (Ilaris) to include all patients with active Still’s disease older than 2 years, adding adult-onset Still’s disease (AOSD) to a previous approval for juvenile-onset Still’s disease, also known as systemic juvenile idiopathic arthritis (sJIA), making it the first approved treatment for AOSD, according to an FDA announcement.

The approval comes under a Priority Review designation that used “comparable pharmacokinetic exposure and extrapolation of established efficacy of canakinumab in patients with sJIA, as well as the safety of canakinumab in patients with AOSD and other diseases,” the FDA said.

The results from a randomized, double-blind, placebo-controlled study of 36 patients with AOSD aged 22-70 years showed that the efficacy and safety data in AOSD were generally consistent with the results of a pooled analysis of sJIA patients, according to Novartis, which markets canakinumab.

AOSD and sJIA share certain similarities, such as fever, arthritis, rash, and elevated markers of inflammation, which has led to suspicion that they are part of a continuum rather than wholly distinct, according to the agency. In addition, the role of interleukin-1 is well established in both diseases and is blocked by canakinumab.

The most common side effects (occurring in greater than 10% of patients) in sJIA studies included infections, abdominal pain, and injection-site reactions. Serious infections (e.g., pneumonia, varicella, gastroenteritis, measles, sepsis, otitis media, sinusitis, adenovirus, lymph node abscess, pharyngitis) were observed in approximately 4%-5%, according to the full prescribing information.

Canakinumab is also approved for the periodic fever syndromes of cryopyrin-associated periodic syndromes in adults and children aged 4 years and older (including familial cold auto-inflammatory syndrome and Muckle-Wells syndrome), tumor necrosis factor receptor associated periodic syndrome in adult and pediatric patients, hyperimmunoglobulin D syndrome/mevalonate kinase deficiency in adult and pediatric patients, and familial Mediterranean fever in adult and pediatric patients.

cpalmer@mdedge.com

The Food and Drug Administration has expanded the indications for canakinumab (Ilaris) to include all patients with active Still’s disease older than 2 years, adding adult-onset Still’s disease (AOSD) to a previous approval for juvenile-onset Still’s disease, also known as systemic juvenile idiopathic arthritis (sJIA), making it the first approved treatment for AOSD, according to an FDA announcement.

The approval comes under a Priority Review designation that used “comparable pharmacokinetic exposure and extrapolation of established efficacy of canakinumab in patients with sJIA, as well as the safety of canakinumab in patients with AOSD and other diseases,” the FDA said.

The results from a randomized, double-blind, placebo-controlled study of 36 patients with AOSD aged 22-70 years showed that the efficacy and safety data in AOSD were generally consistent with the results of a pooled analysis of sJIA patients, according to Novartis, which markets canakinumab.

AOSD and sJIA share certain similarities, such as fever, arthritis, rash, and elevated markers of inflammation, which has led to suspicion that they are part of a continuum rather than wholly distinct, according to the agency. In addition, the role of interleukin-1 is well established in both diseases and is blocked by canakinumab.

The most common side effects (occurring in greater than 10% of patients) in sJIA studies included infections, abdominal pain, and injection-site reactions. Serious infections (e.g., pneumonia, varicella, gastroenteritis, measles, sepsis, otitis media, sinusitis, adenovirus, lymph node abscess, pharyngitis) were observed in approximately 4%-5%, according to the full prescribing information.

Canakinumab is also approved for the periodic fever syndromes of cryopyrin-associated periodic syndromes in adults and children aged 4 years and older (including familial cold auto-inflammatory syndrome and Muckle-Wells syndrome), tumor necrosis factor receptor associated periodic syndrome in adult and pediatric patients, hyperimmunoglobulin D syndrome/mevalonate kinase deficiency in adult and pediatric patients, and familial Mediterranean fever in adult and pediatric patients.

cpalmer@mdedge.com

The Food and Drug Administration has expanded the indications for canakinumab (Ilaris) to include all patients with active Still’s disease older than 2 years, adding adult-onset Still’s disease (AOSD) to a previous approval for juvenile-onset Still’s disease, also known as systemic juvenile idiopathic arthritis (sJIA), making it the first approved treatment for AOSD, according to an FDA announcement.

The approval comes under a Priority Review designation that used “comparable pharmacokinetic exposure and extrapolation of established efficacy of canakinumab in patients with sJIA, as well as the safety of canakinumab in patients with AOSD and other diseases,” the FDA said.

The results from a randomized, double-blind, placebo-controlled study of 36 patients with AOSD aged 22-70 years showed that the efficacy and safety data in AOSD were generally consistent with the results of a pooled analysis of sJIA patients, according to Novartis, which markets canakinumab.

AOSD and sJIA share certain similarities, such as fever, arthritis, rash, and elevated markers of inflammation, which has led to suspicion that they are part of a continuum rather than wholly distinct, according to the agency. In addition, the role of interleukin-1 is well established in both diseases and is blocked by canakinumab.

The most common side effects (occurring in greater than 10% of patients) in sJIA studies included infections, abdominal pain, and injection-site reactions. Serious infections (e.g., pneumonia, varicella, gastroenteritis, measles, sepsis, otitis media, sinusitis, adenovirus, lymph node abscess, pharyngitis) were observed in approximately 4%-5%, according to the full prescribing information.

Canakinumab is also approved for the periodic fever syndromes of cryopyrin-associated periodic syndromes in adults and children aged 4 years and older (including familial cold auto-inflammatory syndrome and Muckle-Wells syndrome), tumor necrosis factor receptor associated periodic syndrome in adult and pediatric patients, hyperimmunoglobulin D syndrome/mevalonate kinase deficiency in adult and pediatric patients, and familial Mediterranean fever in adult and pediatric patients.

cpalmer@mdedge.com

When sterilizing face masks, the type of face mask and the method of sterilization have a bearing on subsequent filtration efficiency, according to researchers. The greatest reduction in filtration efficiency after sterilization occurred with surgical face masks.

With plasma vapor hydrogen peroxide (H₂O₂) sterilization, filtration efficiency of N95 and KN95 masks was maintained at more than 95%, but for surgical face masks, filtration efficiency was reduced to less than 95%. With chlorine dioxide (ClO₂) sterilization, on the other hand, filtration efficiency was maintained at above 95% for N95 masks, but for KN95 and surgical face masks, filtration efficiency was reduced to less than 80%.

In a research letter published online June 15 in JAMA Network Open, researchers from the University of Oklahoma Health Sciences Center, Oklahoma City, report the results of a study of the two sterilization techniques on the pressure drop and filtration efficiency of N95, KN95, and surgical face masks.

“The H₂O₂ treatment showed a small effect on the overall filtration efficiency of the tested masks, but the ClO₂ treatment showed marked reduction in the overall filtration efficiency of the KN95s and surgical face masks. All pressure drop changes were within the acceptable range,” the researchers write.

The study did not evaluate the effect of repeated sterilizations on face masks.

Five masks of each type were sterilized with either H₂O₂ or ClO₂. Masks were then placed in a test chamber, and a salt aerosol was nebulized to assess both upstream and downstream filtration as well as pressure drop. The researchers used a mobility particle sizer to measure particle number concentration from 16.8 nm to 514 nm. An acceptable pressure drop was defined as a drop of less than 1.38 inches of water (35 mm) for inhalation.

Although pressure drop changes were within the acceptable range for all three mask types following sterilization with either method, H₂O₂ sterilization yielded the least reduction in filtration efficacy in all cases. After sterilization with H₂O₂, filtration efficiencies were 96.6%, 97.1%, and 91.6% for the N95s, KN95s, and the surgical face masks, respectively. In contrast, filtration efficiencies after ClO₂ sterilization were 95.1%, 76.2%, and 77.9%, respectively.

The researchers note that, although overall filtration efficiency was maintained with ClO₂ sterilization, there was a significant drop in efficiency with respect to particles of approximately 300 nm (0.3 microns) in size. For particles of that size, mean filtration efficiency decreased to 86.2% for N95s, 40.8% for KN95s, and 47.1% for surgical face masks.

The testing described in the report is “quite affordable at $350 per mask type, so it is hard to imagine any health care provider cannot set aside a small budget to conduct such an important test,” author Evan Floyd, PhD, told Medscape Medical News.

Given the high demand for effective face masks and the current risk for counterfeit products, Floyd suggested that individual facilities test all masks intended for use by healthcare workers before and after sterilization procedures.

“However, if for some reason testing is not an option, we would recommend sticking to established brands and suppliers, perhaps reach out to your state health department or a local representative of the strategic stockpile of PPE,” he noted.

The authors acknowledge that further studies using a larger sample size and a greater variety of masks, as well as studies to evaluate different sterilization techniques, are required. Further, “measuring the respirator’s filtration efficiency by aerosol size instead of only measuring the overall filtration efficiency” should also be considered. Such an approach would enable researchers to evaluate the degree to which masks protect against specific infectious agents.

This article first appeared on Medscape.com.

When sterilizing face masks, the type of face mask and the method of sterilization have a bearing on subsequent filtration efficiency, according to researchers. The greatest reduction in filtration efficiency after sterilization occurred with surgical face masks.

With plasma vapor hydrogen peroxide (H₂O₂) sterilization, filtration efficiency of N95 and KN95 masks was maintained at more than 95%, but for surgical face masks, filtration efficiency was reduced to less than 95%. With chlorine dioxide (ClO₂) sterilization, on the other hand, filtration efficiency was maintained at above 95% for N95 masks, but for KN95 and surgical face masks, filtration efficiency was reduced to less than 80%.

In a research letter published online June 15 in JAMA Network Open, researchers from the University of Oklahoma Health Sciences Center, Oklahoma City, report the results of a study of the two sterilization techniques on the pressure drop and filtration efficiency of N95, KN95, and surgical face masks.

“The H₂O₂ treatment showed a small effect on the overall filtration efficiency of the tested masks, but the ClO₂ treatment showed marked reduction in the overall filtration efficiency of the KN95s and surgical face masks. All pressure drop changes were within the acceptable range,” the researchers write.

The study did not evaluate the effect of repeated sterilizations on face masks.

Five masks of each type were sterilized with either H₂O₂ or ClO₂. Masks were then placed in a test chamber, and a salt aerosol was nebulized to assess both upstream and downstream filtration as well as pressure drop. The researchers used a mobility particle sizer to measure particle number concentration from 16.8 nm to 514 nm. An acceptable pressure drop was defined as a drop of less than 1.38 inches of water (35 mm) for inhalation.

Although pressure drop changes were within the acceptable range for all three mask types following sterilization with either method, H₂O₂ sterilization yielded the least reduction in filtration efficacy in all cases. After sterilization with H₂O₂, filtration efficiencies were 96.6%, 97.1%, and 91.6% for the N95s, KN95s, and the surgical face masks, respectively. In contrast, filtration efficiencies after ClO₂ sterilization were 95.1%, 76.2%, and 77.9%, respectively.

The researchers note that, although overall filtration efficiency was maintained with ClO₂ sterilization, there was a significant drop in efficiency with respect to particles of approximately 300 nm (0.3 microns) in size. For particles of that size, mean filtration efficiency decreased to 86.2% for N95s, 40.8% for KN95s, and 47.1% for surgical face masks.

The testing described in the report is “quite affordable at $350 per mask type, so it is hard to imagine any health care provider cannot set aside a small budget to conduct such an important test,” author Evan Floyd, PhD, told Medscape Medical News.

Given the high demand for effective face masks and the current risk for counterfeit products, Floyd suggested that individual facilities test all masks intended for use by healthcare workers before and after sterilization procedures.

“However, if for some reason testing is not an option, we would recommend sticking to established brands and suppliers, perhaps reach out to your state health department or a local representative of the strategic stockpile of PPE,” he noted.

The authors acknowledge that further studies using a larger sample size and a greater variety of masks, as well as studies to evaluate different sterilization techniques, are required. Further, “measuring the respirator’s filtration efficiency by aerosol size instead of only measuring the overall filtration efficiency” should also be considered. Such an approach would enable researchers to evaluate the degree to which masks protect against specific infectious agents.

This article first appeared on Medscape.com.

When sterilizing face masks, the type of face mask and the method of sterilization have a bearing on subsequent filtration efficiency, according to researchers. The greatest reduction in filtration efficiency after sterilization occurred with surgical face masks.

With plasma vapor hydrogen peroxide (H₂O₂) sterilization, filtration efficiency of N95 and KN95 masks was maintained at more than 95%, but for surgical face masks, filtration efficiency was reduced to less than 95%. With chlorine dioxide (ClO₂) sterilization, on the other hand, filtration efficiency was maintained at above 95% for N95 masks, but for KN95 and surgical face masks, filtration efficiency was reduced to less than 80%.

In a research letter published online June 15 in JAMA Network Open, researchers from the University of Oklahoma Health Sciences Center, Oklahoma City, report the results of a study of the two sterilization techniques on the pressure drop and filtration efficiency of N95, KN95, and surgical face masks.

“The H₂O₂ treatment showed a small effect on the overall filtration efficiency of the tested masks, but the ClO₂ treatment showed marked reduction in the overall filtration efficiency of the KN95s and surgical face masks. All pressure drop changes were within the acceptable range,” the researchers write.

The study did not evaluate the effect of repeated sterilizations on face masks.

Five masks of each type were sterilized with either H₂O₂ or ClO₂. Masks were then placed in a test chamber, and a salt aerosol was nebulized to assess both upstream and downstream filtration as well as pressure drop. The researchers used a mobility particle sizer to measure particle number concentration from 16.8 nm to 514 nm. An acceptable pressure drop was defined as a drop of less than 1.38 inches of water (35 mm) for inhalation.

Although pressure drop changes were within the acceptable range for all three mask types following sterilization with either method, H₂O₂ sterilization yielded the least reduction in filtration efficacy in all cases. After sterilization with H₂O₂, filtration efficiencies were 96.6%, 97.1%, and 91.6% for the N95s, KN95s, and the surgical face masks, respectively. In contrast, filtration efficiencies after ClO₂ sterilization were 95.1%, 76.2%, and 77.9%, respectively.

The researchers note that, although overall filtration efficiency was maintained with ClO₂ sterilization, there was a significant drop in efficiency with respect to particles of approximately 300 nm (0.3 microns) in size. For particles of that size, mean filtration efficiency decreased to 86.2% for N95s, 40.8% for KN95s, and 47.1% for surgical face masks.

The testing described in the report is “quite affordable at $350 per mask type, so it is hard to imagine any health care provider cannot set aside a small budget to conduct such an important test,” author Evan Floyd, PhD, told Medscape Medical News.

Given the high demand for effective face masks and the current risk for counterfeit products, Floyd suggested that individual facilities test all masks intended for use by healthcare workers before and after sterilization procedures.

“However, if for some reason testing is not an option, we would recommend sticking to established brands and suppliers, perhaps reach out to your state health department or a local representative of the strategic stockpile of PPE,” he noted.

The authors acknowledge that further studies using a larger sample size and a greater variety of masks, as well as studies to evaluate different sterilization techniques, are required. Further, “measuring the respirator’s filtration efficiency by aerosol size instead of only measuring the overall filtration efficiency” should also be considered. Such an approach would enable researchers to evaluate the degree to which masks protect against specific infectious agents.

This article first appeared on Medscape.com.