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CDC issues COVID-19 vaccine guidance for underlying conditions
The Centers for Disease Control and Prevention has issued updated guidance for people with underlying medical conditions who are considering getting the coronavirus vaccine.
“Adults of any age with certain underlying medical conditions are at increased risk for severe illness from the virus that causes COVID-19,” the CDC said in the guidance, posted on Dec. 26. “mRNA COVID-19 vaccines may be administered to people with underlying medical conditions provided they have not had a severe allergic reaction to any of the ingredients in the vaccine.”
Both the Pfizer and Moderna vaccines use mRNA, or messenger RNA.
The CDC guidance had specific information for people with HIV, weakened immune systems, and autoimmune conditions such as Guillain-Barré syndrome (GBS) and Bell’s palsy who are thinking of getting the vaccine.
People with HIV and weakened immune systems “may receive a COVID-19 vaccine. However, they should be aware of the limited safety data,” the CDC said.
There’s no information available yet about the safety of the vaccines for people with weakened immune systems. People with HIV were included in clinical trials, but “safety data specific to this group are not yet available at this time,” the CDC said.
Cases of Bell’s palsy, a temporary facial paralysis, were reported in people receiving the Pfizer and Moderna vaccines in clinical trials, the Food and Drug Administration said Dec. 17.
But the new CDC guidance said that the FDA “does not consider these to be above the rate expected in the general population. They have not concluded these cases were caused by vaccination. Therefore, persons who have previously had Bell’s palsy may receive an mRNA COVID-19 vaccine.”
Researchers have determined the vaccines are safe for people with GBS, a rare autoimmune disorder in which the body’s immune system attacks nerves just as they leave the spinal cord, the CDC said.
“To date, no cases of GBS have been reported following vaccination among participants in the mRNA COVID-19 vaccine clinical trials,” the CDC guidance said. “With few exceptions, the independent Advisory Committee on Immunization Practices general best practice guidelines for immunization do not include a history of GBS as a precaution to vaccination with other vaccines.”
For months, the CDC and other health authorities have said that people with certain medical conditions are at an increased risk of developing severe cases of COVID-19.
A version of this article first appeared on Medscape.com.
The Centers for Disease Control and Prevention has issued updated guidance for people with underlying medical conditions who are considering getting the coronavirus vaccine.
“Adults of any age with certain underlying medical conditions are at increased risk for severe illness from the virus that causes COVID-19,” the CDC said in the guidance, posted on Dec. 26. “mRNA COVID-19 vaccines may be administered to people with underlying medical conditions provided they have not had a severe allergic reaction to any of the ingredients in the vaccine.”
Both the Pfizer and Moderna vaccines use mRNA, or messenger RNA.
The CDC guidance had specific information for people with HIV, weakened immune systems, and autoimmune conditions such as Guillain-Barré syndrome (GBS) and Bell’s palsy who are thinking of getting the vaccine.
People with HIV and weakened immune systems “may receive a COVID-19 vaccine. However, they should be aware of the limited safety data,” the CDC said.
There’s no information available yet about the safety of the vaccines for people with weakened immune systems. People with HIV were included in clinical trials, but “safety data specific to this group are not yet available at this time,” the CDC said.
Cases of Bell’s palsy, a temporary facial paralysis, were reported in people receiving the Pfizer and Moderna vaccines in clinical trials, the Food and Drug Administration said Dec. 17.
But the new CDC guidance said that the FDA “does not consider these to be above the rate expected in the general population. They have not concluded these cases were caused by vaccination. Therefore, persons who have previously had Bell’s palsy may receive an mRNA COVID-19 vaccine.”
Researchers have determined the vaccines are safe for people with GBS, a rare autoimmune disorder in which the body’s immune system attacks nerves just as they leave the spinal cord, the CDC said.
“To date, no cases of GBS have been reported following vaccination among participants in the mRNA COVID-19 vaccine clinical trials,” the CDC guidance said. “With few exceptions, the independent Advisory Committee on Immunization Practices general best practice guidelines for immunization do not include a history of GBS as a precaution to vaccination with other vaccines.”
For months, the CDC and other health authorities have said that people with certain medical conditions are at an increased risk of developing severe cases of COVID-19.
A version of this article first appeared on Medscape.com.
The Centers for Disease Control and Prevention has issued updated guidance for people with underlying medical conditions who are considering getting the coronavirus vaccine.
“Adults of any age with certain underlying medical conditions are at increased risk for severe illness from the virus that causes COVID-19,” the CDC said in the guidance, posted on Dec. 26. “mRNA COVID-19 vaccines may be administered to people with underlying medical conditions provided they have not had a severe allergic reaction to any of the ingredients in the vaccine.”
Both the Pfizer and Moderna vaccines use mRNA, or messenger RNA.
The CDC guidance had specific information for people with HIV, weakened immune systems, and autoimmune conditions such as Guillain-Barré syndrome (GBS) and Bell’s palsy who are thinking of getting the vaccine.
People with HIV and weakened immune systems “may receive a COVID-19 vaccine. However, they should be aware of the limited safety data,” the CDC said.
There’s no information available yet about the safety of the vaccines for people with weakened immune systems. People with HIV were included in clinical trials, but “safety data specific to this group are not yet available at this time,” the CDC said.
Cases of Bell’s palsy, a temporary facial paralysis, were reported in people receiving the Pfizer and Moderna vaccines in clinical trials, the Food and Drug Administration said Dec. 17.
But the new CDC guidance said that the FDA “does not consider these to be above the rate expected in the general population. They have not concluded these cases were caused by vaccination. Therefore, persons who have previously had Bell’s palsy may receive an mRNA COVID-19 vaccine.”
Researchers have determined the vaccines are safe for people with GBS, a rare autoimmune disorder in which the body’s immune system attacks nerves just as they leave the spinal cord, the CDC said.
“To date, no cases of GBS have been reported following vaccination among participants in the mRNA COVID-19 vaccine clinical trials,” the CDC guidance said. “With few exceptions, the independent Advisory Committee on Immunization Practices general best practice guidelines for immunization do not include a history of GBS as a precaution to vaccination with other vaccines.”
For months, the CDC and other health authorities have said that people with certain medical conditions are at an increased risk of developing severe cases of COVID-19.
A version of this article first appeared on Medscape.com.
Scant risk for SARS-CoV-2 from hospital air
Everywhere they look within hospitals, researchers find RNA from SARS-CoV-2 in the air. But viable viruses typically are found only close to patients, according to a review of published studies.
The finding supports recommendations to use surgical masks in most parts of the hospital, reserving respirators (such as N95 or FFP2) for aerosol-generating procedures on patients’ respiratory tracts, said Gabriel Birgand, PhD, an infectious disease researcher at Imperial College London.
“When the virus is spreading a lot in the community, it’s probably more likely for you to be contaminated in your friends’ areas or in your building than in your work area, where you are well equipped and compliant with all the measures,” he said in an interview. “So it’s pretty good news.”
The systematic review by Dr. Birgand and colleagues was published in JAMA Network Open.
Recommended precautions to protect health care workers from SARS-CoV-2 infections remain controversial. Most authorities believe droplets are the primary route of transmission, which would mean surgical masks may be sufficient protection. But some research has suggested transmission by aerosols as well, making N95 respirators seem necessary. There is even disagreement about the definitions of the words “aerosol” and “droplet.”
To better understand where traces of the virus can be found in the air in hospitals, Dr. Birgand and colleagues analyzed all the studies they could find on the subject in English.
They identified 24 articles with original data. All of the studies used reverse transcription–polymerase chain reaction (PCR) tests to identify SARS-CoV-2 RNA. In five studies, attempts were also made to culture viable viruses. Three studies assessed the particle size relative to RNA concentration or viral titer.
Of 893 air samples across the 24 studies, 52.7% were taken from areas close to patients, 26.5% were taken in clinical areas, 13.7% in staff areas, 4.7% in public areas, and 2.4% in toilets or bathrooms.
Among those studies that quantified RNA, the median interquartile range of concentrations varied from 1.0 x 103 copies/m3 in clinical areas to 9.7 x 103 copies/m3 in toilets or bathrooms.
One study found an RNA concentration of 2.0 x 103 copies for particle sizes >4 mcm and 1.3 x 103 copies/m3 for particle sizes ≤4 mcm, both in patients’ rooms.
Three studies included viral cultures; of those, two resulted in positive cultures, both in a non-ICU setting. In one study, 3 of 39 samples were positive, and in the other, 4 of 4 were positive. Viral cultures in toilets, clinical areas, staff areas, and public areas were negative.
One of these studies assessed viral concentration and found that the median interquartile range was 4.8 tissue culture infectious dose (TCID50)/m3 for particles <1 mcm, 4.27 TCID50/m3 for particles 1-4 mcm, and 1.82 TCID50/m3 for particles >4 mcm.
Although viable viruses weren’t found in staff areas, the presence of viral RNA in places such as dining rooms and meeting rooms raises a concern, Dr. Birgand said.
“All of these staff areas are probably playing an important role in contamination,” he said. “It’s pretty easy to see when you are dining, you are not wearing a face mask, and it’s associated with a strong risk when there is a strong dissemination of the virus in the community.”
Studies on contact tracing among health care workers have also identified meeting rooms and dining rooms as the second most common source of infection after community contact, he said.
In general, the findings of the review correspond to epidemiologic studies, said Angela Rasmussen, PhD, a virologist with the Georgetown University Center for Global Health Science and Security, Washington, who was not involved in the review. “Absent aerosol-generating procedures, health care workers are largely not getting infected when they take droplet precautions.”
One reason may be that patients shed the most infectious viruses a couple of days before and after symptoms begin. By the time they’re hospitalized, they’re less likely to be contagious but may continue to shed viral RNA.
“We don’t really know the basis for the persistence of RNA being produced long after people have been infected and have recovered from the acute infection,” she said, “but it has been observed quite frequently.”
Although the virus cannot remain viable for very long in the air, remnants may still be detected in the form of RNA, Dr. Rasmussen said. In addition, hospitals often do a good job of ventilation.
She pointed out that it can be difficult to cultivate viruses in air samples because of contaminants such as bacteria and fungi. “That’s one of the limitations of a study like this. You’re not really sure if it’s because there’s no viable virus there or because you just aren’t able to collect samples that would allow you to determine that.”
Dr. Birgand and colleagues acknowledged other limitations. The studies they reviewed used different approaches to sampling. Different procedures may have been underway in the rooms being sampled, and factors such as temperature and humidity could have affected the results. In addition, the studies used different cycle thresholds for PCR positivity.
A version of this article first appeared on Medscape.com.
Everywhere they look within hospitals, researchers find RNA from SARS-CoV-2 in the air. But viable viruses typically are found only close to patients, according to a review of published studies.
The finding supports recommendations to use surgical masks in most parts of the hospital, reserving respirators (such as N95 or FFP2) for aerosol-generating procedures on patients’ respiratory tracts, said Gabriel Birgand, PhD, an infectious disease researcher at Imperial College London.
“When the virus is spreading a lot in the community, it’s probably more likely for you to be contaminated in your friends’ areas or in your building than in your work area, where you are well equipped and compliant with all the measures,” he said in an interview. “So it’s pretty good news.”
The systematic review by Dr. Birgand and colleagues was published in JAMA Network Open.
Recommended precautions to protect health care workers from SARS-CoV-2 infections remain controversial. Most authorities believe droplets are the primary route of transmission, which would mean surgical masks may be sufficient protection. But some research has suggested transmission by aerosols as well, making N95 respirators seem necessary. There is even disagreement about the definitions of the words “aerosol” and “droplet.”
To better understand where traces of the virus can be found in the air in hospitals, Dr. Birgand and colleagues analyzed all the studies they could find on the subject in English.
They identified 24 articles with original data. All of the studies used reverse transcription–polymerase chain reaction (PCR) tests to identify SARS-CoV-2 RNA. In five studies, attempts were also made to culture viable viruses. Three studies assessed the particle size relative to RNA concentration or viral titer.
Of 893 air samples across the 24 studies, 52.7% were taken from areas close to patients, 26.5% were taken in clinical areas, 13.7% in staff areas, 4.7% in public areas, and 2.4% in toilets or bathrooms.
Among those studies that quantified RNA, the median interquartile range of concentrations varied from 1.0 x 103 copies/m3 in clinical areas to 9.7 x 103 copies/m3 in toilets or bathrooms.
One study found an RNA concentration of 2.0 x 103 copies for particle sizes >4 mcm and 1.3 x 103 copies/m3 for particle sizes ≤4 mcm, both in patients’ rooms.
Three studies included viral cultures; of those, two resulted in positive cultures, both in a non-ICU setting. In one study, 3 of 39 samples were positive, and in the other, 4 of 4 were positive. Viral cultures in toilets, clinical areas, staff areas, and public areas were negative.
One of these studies assessed viral concentration and found that the median interquartile range was 4.8 tissue culture infectious dose (TCID50)/m3 for particles <1 mcm, 4.27 TCID50/m3 for particles 1-4 mcm, and 1.82 TCID50/m3 for particles >4 mcm.
Although viable viruses weren’t found in staff areas, the presence of viral RNA in places such as dining rooms and meeting rooms raises a concern, Dr. Birgand said.
“All of these staff areas are probably playing an important role in contamination,” he said. “It’s pretty easy to see when you are dining, you are not wearing a face mask, and it’s associated with a strong risk when there is a strong dissemination of the virus in the community.”
Studies on contact tracing among health care workers have also identified meeting rooms and dining rooms as the second most common source of infection after community contact, he said.
In general, the findings of the review correspond to epidemiologic studies, said Angela Rasmussen, PhD, a virologist with the Georgetown University Center for Global Health Science and Security, Washington, who was not involved in the review. “Absent aerosol-generating procedures, health care workers are largely not getting infected when they take droplet precautions.”
One reason may be that patients shed the most infectious viruses a couple of days before and after symptoms begin. By the time they’re hospitalized, they’re less likely to be contagious but may continue to shed viral RNA.
“We don’t really know the basis for the persistence of RNA being produced long after people have been infected and have recovered from the acute infection,” she said, “but it has been observed quite frequently.”
Although the virus cannot remain viable for very long in the air, remnants may still be detected in the form of RNA, Dr. Rasmussen said. In addition, hospitals often do a good job of ventilation.
She pointed out that it can be difficult to cultivate viruses in air samples because of contaminants such as bacteria and fungi. “That’s one of the limitations of a study like this. You’re not really sure if it’s because there’s no viable virus there or because you just aren’t able to collect samples that would allow you to determine that.”
Dr. Birgand and colleagues acknowledged other limitations. The studies they reviewed used different approaches to sampling. Different procedures may have been underway in the rooms being sampled, and factors such as temperature and humidity could have affected the results. In addition, the studies used different cycle thresholds for PCR positivity.
A version of this article first appeared on Medscape.com.
Everywhere they look within hospitals, researchers find RNA from SARS-CoV-2 in the air. But viable viruses typically are found only close to patients, according to a review of published studies.
The finding supports recommendations to use surgical masks in most parts of the hospital, reserving respirators (such as N95 or FFP2) for aerosol-generating procedures on patients’ respiratory tracts, said Gabriel Birgand, PhD, an infectious disease researcher at Imperial College London.
“When the virus is spreading a lot in the community, it’s probably more likely for you to be contaminated in your friends’ areas or in your building than in your work area, where you are well equipped and compliant with all the measures,” he said in an interview. “So it’s pretty good news.”
The systematic review by Dr. Birgand and colleagues was published in JAMA Network Open.
Recommended precautions to protect health care workers from SARS-CoV-2 infections remain controversial. Most authorities believe droplets are the primary route of transmission, which would mean surgical masks may be sufficient protection. But some research has suggested transmission by aerosols as well, making N95 respirators seem necessary. There is even disagreement about the definitions of the words “aerosol” and “droplet.”
To better understand where traces of the virus can be found in the air in hospitals, Dr. Birgand and colleagues analyzed all the studies they could find on the subject in English.
They identified 24 articles with original data. All of the studies used reverse transcription–polymerase chain reaction (PCR) tests to identify SARS-CoV-2 RNA. In five studies, attempts were also made to culture viable viruses. Three studies assessed the particle size relative to RNA concentration or viral titer.
Of 893 air samples across the 24 studies, 52.7% were taken from areas close to patients, 26.5% were taken in clinical areas, 13.7% in staff areas, 4.7% in public areas, and 2.4% in toilets or bathrooms.
Among those studies that quantified RNA, the median interquartile range of concentrations varied from 1.0 x 103 copies/m3 in clinical areas to 9.7 x 103 copies/m3 in toilets or bathrooms.
One study found an RNA concentration of 2.0 x 103 copies for particle sizes >4 mcm and 1.3 x 103 copies/m3 for particle sizes ≤4 mcm, both in patients’ rooms.
Three studies included viral cultures; of those, two resulted in positive cultures, both in a non-ICU setting. In one study, 3 of 39 samples were positive, and in the other, 4 of 4 were positive. Viral cultures in toilets, clinical areas, staff areas, and public areas were negative.
One of these studies assessed viral concentration and found that the median interquartile range was 4.8 tissue culture infectious dose (TCID50)/m3 for particles <1 mcm, 4.27 TCID50/m3 for particles 1-4 mcm, and 1.82 TCID50/m3 for particles >4 mcm.
Although viable viruses weren’t found in staff areas, the presence of viral RNA in places such as dining rooms and meeting rooms raises a concern, Dr. Birgand said.
“All of these staff areas are probably playing an important role in contamination,” he said. “It’s pretty easy to see when you are dining, you are not wearing a face mask, and it’s associated with a strong risk when there is a strong dissemination of the virus in the community.”
Studies on contact tracing among health care workers have also identified meeting rooms and dining rooms as the second most common source of infection after community contact, he said.
In general, the findings of the review correspond to epidemiologic studies, said Angela Rasmussen, PhD, a virologist with the Georgetown University Center for Global Health Science and Security, Washington, who was not involved in the review. “Absent aerosol-generating procedures, health care workers are largely not getting infected when they take droplet precautions.”
One reason may be that patients shed the most infectious viruses a couple of days before and after symptoms begin. By the time they’re hospitalized, they’re less likely to be contagious but may continue to shed viral RNA.
“We don’t really know the basis for the persistence of RNA being produced long after people have been infected and have recovered from the acute infection,” she said, “but it has been observed quite frequently.”
Although the virus cannot remain viable for very long in the air, remnants may still be detected in the form of RNA, Dr. Rasmussen said. In addition, hospitals often do a good job of ventilation.
She pointed out that it can be difficult to cultivate viruses in air samples because of contaminants such as bacteria and fungi. “That’s one of the limitations of a study like this. You’re not really sure if it’s because there’s no viable virus there or because you just aren’t able to collect samples that would allow you to determine that.”
Dr. Birgand and colleagues acknowledged other limitations. The studies they reviewed used different approaches to sampling. Different procedures may have been underway in the rooms being sampled, and factors such as temperature and humidity could have affected the results. In addition, the studies used different cycle thresholds for PCR positivity.
A version of this article first appeared on Medscape.com.
New resilience center targets traumatized health care workers
A physician assistant participating in a virtual workshop began to cry, confessing that she felt overwhelmed with guilt because New Yorkers were hailing her as a frontline hero in the pandemic. That was when Joe Ciavarro knew he was in the right place.
“She was saying all the things I could not verbalize because I, too, didn’t feel like I deserved all this praise and thousands of people cheering for us every evening when people were losing jobs, didn’t have money for food, and their loved ones were dying without family at their side,” says Mr. Ciavarro, a PA at Mount Sinai Medical Center in New York.
Mr. Ciavarro, who also manages 170 other PAs on two of Mount Sinai’s campuses in Manhattan, has been on the front lines since COVID-19 first hit; he lost a colleague and friend to suicide in September.
The mental anguish from his job prompted him to sign up for the resilience workshop offered by Mount Sinai’s Center for Stress, Resilience, and Personal Growth. The center – the first of its kind in North America – was launched in June to help health care workers like him cope with the intense psychological pressures they were facing. The weekly workshops became a safe place where Mr. Ciavarro and other staff members could share their darkest fears and learn ways to help them deal with their situation.
“It’s been grueling but we learned how to take care of ourselves so we can take care of our patients,” said Mr. Ciavarro. “This has become like a guided group therapy session on ways to manage and develop resilience. And I feel like my emotions are validated, knowing that others feel the same way.”
Caring for their own
Medical professionals treating patients with COVID-19 are in similar predicaments, and the psychological fallout is enormous: They’re exhausted by the seemingly never-ending patient load and staffing shortages, and haunted by fears for their own safety and that of their families. Studies in China, Canada, and Italy have revealed that a significant number of doctors and nurses in the early days of the pandemic experienced high levels of distress, depression, anxiety, nightmares, and insomnia.
after witnessing the deaths of so many patients who were alone, without family.
But the resilience workshop that Mr. Ciavarro attended offers some hope and is part of a multifaceted program that aims to be a model for other institutions and communities. The Mount Sinai health system already had some programs in place, including centers for 9/11 responders, for spirituality and health, and a wellness program to aid burned-out doctors. But the leadership at Mount Sinai, which includes psychiatrist Dennis Charney, MD, dean of the medical school and a leading expert on PTSD, knew early in the pandemic that emotional and psychological distress would plague health care workers, according to Deborah Marin, MD, director of the new center.
“We decided to quickly put in place a program that we could do virtually, with workshops and apps, that would give access to several services above and beyond what was already going on,” says Dr. Marin, a professor of psychiatry at the Icahn School of Medicine at Mount Sinai, New York, who also directs their center for spirituality and health.
The key components include a comprehensive screening tool that helps doctors at the center identify which potential participants are most at risk. Participants build personal inventories that detail the intensity of work-related exposures, personal or family stressors that have arisen because of the pandemic, or any mental health conditions or substance abuse problems that may make staff members more vulnerable.
The weekly workshops led by trained staff are designed to give participants the tools to foster resilience and process their experiences. Online apps provide feedback on their progress and engage them with video and other resources around meditation, relaxation, and resilience techniques.
In addition, all 40,000 members of the Mount Sinai staff are eligible for up to 14 one-on-one sessions with psychologists and psychiatrists who specialize in treating trauma.
“That’s highly unusual – to offer this at no cost to everyone,” said Dr. Marin. “We also have a treatment service that is specifically focused on behavioral health care, so people can learn better coping strategies, and we also have social workers to provide coaching.”
While the center doesn’t have specific numbers on how many nurses, physicians, and other staff have participated in treatment, they have trained over 70 peer leaders for their five workshops that home in on the most important factors of resilience.
“We’ve gotten enthusiastic responses from PAs and nurses,” said Craig Katz, MD, an expert in disaster psychiatry at Mount Sinai and a workshop moderator. Physicians have been slower to get on board. “Doctors are a tough nut to crack – it’s largely a culture where they may burn out but don’t want to talk about it. And asking for help is a hard transition for physicians to make.”
How to protect in midst of trauma
In formulating the program’s platform, Mount Sinai experts drew upon their extensive experience aiding 9/11 responders at the World Trade Center (WTC), as well as their system-wide wellness program that aids demoralized and burned-out physicians. While the reach of the pandemic is much broader than 9/11, experts see some commonalities in conditions that emerge after traumatic events, and they also discovered what can help.
“We learned from our WTC experience about what are protective factors – what are the social supports that buffer against depression, anxiety, and PTSD,” said Jonathan DePierro, PhD, clinical director of CSRPG and a psychologist at the Mount Sinai WTC Mental Health Program. “We also learned that people who have more prolonged exposures are at greater risk of developing mental health difficulties.”
The program itself reflects these lessons – and that’s why it’s open to all employees, not just medical professionals. Housekeepers, security staffers, even construction workers are also dealing with their lives being in danger. “That wasn’t in their job description,” said Dr. DePierro. “These people tend to have fewer social and economic resources, make less money and have fewer structural supports, which makes them even more vulnerable.”
Dr. Charney’s strategies on building resilience became a bible of sorts for the workshops, according to Dr. Katz, who authored the training curriculum. Sessions deal with how to build up reservoirs of realistic optimism, keep gratitude journals, find spiritual meaning in their lives, maintain physical wellness and create networks of social support. The workshops are meant to help participants create action plans, to reach out for support in their social networks, and keep the focus on the positives.
The goal is to give demoralized health care workers a renewed sense of competence. “The resilience workshop is a launching point to get people to show up and talk,” said Dr. Katz. “And if we do that, we’ve accomplished a lot just getting people in the door.”
The center will also have a research component to identify what works and what doesn’t so their platform can provide a template for other institutions; Dr. Marin said they’ve gotten inquiries about the program from major hospital systems in Michigan and California. They’ll also conduct longitudinal research to determine what lingering problems persist among healthcare workers over time.
Since the center opened its virtual doors, the curriculum has also been altered in response to feedback from the support staff, many of whom live in the community that surrounds Mount Sinai in northern Manhattan, which is largely lower-income Latinx and Black individuals. Workshop materials have been translated into Spanish and now feature people who reflect a more diverse set of experiences.
“Many of our employees and the population we serve identify as non-White so we’ve been doing outreach with a lot of the local unions,” said Dr. Marin. “Our next step is to take what we’re doing and work with local community organizations.”
A version of this article first appeared on Medscape.com.
A physician assistant participating in a virtual workshop began to cry, confessing that she felt overwhelmed with guilt because New Yorkers were hailing her as a frontline hero in the pandemic. That was when Joe Ciavarro knew he was in the right place.
“She was saying all the things I could not verbalize because I, too, didn’t feel like I deserved all this praise and thousands of people cheering for us every evening when people were losing jobs, didn’t have money for food, and their loved ones were dying without family at their side,” says Mr. Ciavarro, a PA at Mount Sinai Medical Center in New York.
Mr. Ciavarro, who also manages 170 other PAs on two of Mount Sinai’s campuses in Manhattan, has been on the front lines since COVID-19 first hit; he lost a colleague and friend to suicide in September.
The mental anguish from his job prompted him to sign up for the resilience workshop offered by Mount Sinai’s Center for Stress, Resilience, and Personal Growth. The center – the first of its kind in North America – was launched in June to help health care workers like him cope with the intense psychological pressures they were facing. The weekly workshops became a safe place where Mr. Ciavarro and other staff members could share their darkest fears and learn ways to help them deal with their situation.
“It’s been grueling but we learned how to take care of ourselves so we can take care of our patients,” said Mr. Ciavarro. “This has become like a guided group therapy session on ways to manage and develop resilience. And I feel like my emotions are validated, knowing that others feel the same way.”
Caring for their own
Medical professionals treating patients with COVID-19 are in similar predicaments, and the psychological fallout is enormous: They’re exhausted by the seemingly never-ending patient load and staffing shortages, and haunted by fears for their own safety and that of their families. Studies in China, Canada, and Italy have revealed that a significant number of doctors and nurses in the early days of the pandemic experienced high levels of distress, depression, anxiety, nightmares, and insomnia.
after witnessing the deaths of so many patients who were alone, without family.
But the resilience workshop that Mr. Ciavarro attended offers some hope and is part of a multifaceted program that aims to be a model for other institutions and communities. The Mount Sinai health system already had some programs in place, including centers for 9/11 responders, for spirituality and health, and a wellness program to aid burned-out doctors. But the leadership at Mount Sinai, which includes psychiatrist Dennis Charney, MD, dean of the medical school and a leading expert on PTSD, knew early in the pandemic that emotional and psychological distress would plague health care workers, according to Deborah Marin, MD, director of the new center.
“We decided to quickly put in place a program that we could do virtually, with workshops and apps, that would give access to several services above and beyond what was already going on,” says Dr. Marin, a professor of psychiatry at the Icahn School of Medicine at Mount Sinai, New York, who also directs their center for spirituality and health.
The key components include a comprehensive screening tool that helps doctors at the center identify which potential participants are most at risk. Participants build personal inventories that detail the intensity of work-related exposures, personal or family stressors that have arisen because of the pandemic, or any mental health conditions or substance abuse problems that may make staff members more vulnerable.
The weekly workshops led by trained staff are designed to give participants the tools to foster resilience and process their experiences. Online apps provide feedback on their progress and engage them with video and other resources around meditation, relaxation, and resilience techniques.
In addition, all 40,000 members of the Mount Sinai staff are eligible for up to 14 one-on-one sessions with psychologists and psychiatrists who specialize in treating trauma.
“That’s highly unusual – to offer this at no cost to everyone,” said Dr. Marin. “We also have a treatment service that is specifically focused on behavioral health care, so people can learn better coping strategies, and we also have social workers to provide coaching.”
While the center doesn’t have specific numbers on how many nurses, physicians, and other staff have participated in treatment, they have trained over 70 peer leaders for their five workshops that home in on the most important factors of resilience.
“We’ve gotten enthusiastic responses from PAs and nurses,” said Craig Katz, MD, an expert in disaster psychiatry at Mount Sinai and a workshop moderator. Physicians have been slower to get on board. “Doctors are a tough nut to crack – it’s largely a culture where they may burn out but don’t want to talk about it. And asking for help is a hard transition for physicians to make.”
How to protect in midst of trauma
In formulating the program’s platform, Mount Sinai experts drew upon their extensive experience aiding 9/11 responders at the World Trade Center (WTC), as well as their system-wide wellness program that aids demoralized and burned-out physicians. While the reach of the pandemic is much broader than 9/11, experts see some commonalities in conditions that emerge after traumatic events, and they also discovered what can help.
“We learned from our WTC experience about what are protective factors – what are the social supports that buffer against depression, anxiety, and PTSD,” said Jonathan DePierro, PhD, clinical director of CSRPG and a psychologist at the Mount Sinai WTC Mental Health Program. “We also learned that people who have more prolonged exposures are at greater risk of developing mental health difficulties.”
The program itself reflects these lessons – and that’s why it’s open to all employees, not just medical professionals. Housekeepers, security staffers, even construction workers are also dealing with their lives being in danger. “That wasn’t in their job description,” said Dr. DePierro. “These people tend to have fewer social and economic resources, make less money and have fewer structural supports, which makes them even more vulnerable.”
Dr. Charney’s strategies on building resilience became a bible of sorts for the workshops, according to Dr. Katz, who authored the training curriculum. Sessions deal with how to build up reservoirs of realistic optimism, keep gratitude journals, find spiritual meaning in their lives, maintain physical wellness and create networks of social support. The workshops are meant to help participants create action plans, to reach out for support in their social networks, and keep the focus on the positives.
The goal is to give demoralized health care workers a renewed sense of competence. “The resilience workshop is a launching point to get people to show up and talk,” said Dr. Katz. “And if we do that, we’ve accomplished a lot just getting people in the door.”
The center will also have a research component to identify what works and what doesn’t so their platform can provide a template for other institutions; Dr. Marin said they’ve gotten inquiries about the program from major hospital systems in Michigan and California. They’ll also conduct longitudinal research to determine what lingering problems persist among healthcare workers over time.
Since the center opened its virtual doors, the curriculum has also been altered in response to feedback from the support staff, many of whom live in the community that surrounds Mount Sinai in northern Manhattan, which is largely lower-income Latinx and Black individuals. Workshop materials have been translated into Spanish and now feature people who reflect a more diverse set of experiences.
“Many of our employees and the population we serve identify as non-White so we’ve been doing outreach with a lot of the local unions,” said Dr. Marin. “Our next step is to take what we’re doing and work with local community organizations.”
A version of this article first appeared on Medscape.com.
A physician assistant participating in a virtual workshop began to cry, confessing that she felt overwhelmed with guilt because New Yorkers were hailing her as a frontline hero in the pandemic. That was when Joe Ciavarro knew he was in the right place.
“She was saying all the things I could not verbalize because I, too, didn’t feel like I deserved all this praise and thousands of people cheering for us every evening when people were losing jobs, didn’t have money for food, and their loved ones were dying without family at their side,” says Mr. Ciavarro, a PA at Mount Sinai Medical Center in New York.
Mr. Ciavarro, who also manages 170 other PAs on two of Mount Sinai’s campuses in Manhattan, has been on the front lines since COVID-19 first hit; he lost a colleague and friend to suicide in September.
The mental anguish from his job prompted him to sign up for the resilience workshop offered by Mount Sinai’s Center for Stress, Resilience, and Personal Growth. The center – the first of its kind in North America – was launched in June to help health care workers like him cope with the intense psychological pressures they were facing. The weekly workshops became a safe place where Mr. Ciavarro and other staff members could share their darkest fears and learn ways to help them deal with their situation.
“It’s been grueling but we learned how to take care of ourselves so we can take care of our patients,” said Mr. Ciavarro. “This has become like a guided group therapy session on ways to manage and develop resilience. And I feel like my emotions are validated, knowing that others feel the same way.”
Caring for their own
Medical professionals treating patients with COVID-19 are in similar predicaments, and the psychological fallout is enormous: They’re exhausted by the seemingly never-ending patient load and staffing shortages, and haunted by fears for their own safety and that of their families. Studies in China, Canada, and Italy have revealed that a significant number of doctors and nurses in the early days of the pandemic experienced high levels of distress, depression, anxiety, nightmares, and insomnia.
after witnessing the deaths of so many patients who were alone, without family.
But the resilience workshop that Mr. Ciavarro attended offers some hope and is part of a multifaceted program that aims to be a model for other institutions and communities. The Mount Sinai health system already had some programs in place, including centers for 9/11 responders, for spirituality and health, and a wellness program to aid burned-out doctors. But the leadership at Mount Sinai, which includes psychiatrist Dennis Charney, MD, dean of the medical school and a leading expert on PTSD, knew early in the pandemic that emotional and psychological distress would plague health care workers, according to Deborah Marin, MD, director of the new center.
“We decided to quickly put in place a program that we could do virtually, with workshops and apps, that would give access to several services above and beyond what was already going on,” says Dr. Marin, a professor of psychiatry at the Icahn School of Medicine at Mount Sinai, New York, who also directs their center for spirituality and health.
The key components include a comprehensive screening tool that helps doctors at the center identify which potential participants are most at risk. Participants build personal inventories that detail the intensity of work-related exposures, personal or family stressors that have arisen because of the pandemic, or any mental health conditions or substance abuse problems that may make staff members more vulnerable.
The weekly workshops led by trained staff are designed to give participants the tools to foster resilience and process their experiences. Online apps provide feedback on their progress and engage them with video and other resources around meditation, relaxation, and resilience techniques.
In addition, all 40,000 members of the Mount Sinai staff are eligible for up to 14 one-on-one sessions with psychologists and psychiatrists who specialize in treating trauma.
“That’s highly unusual – to offer this at no cost to everyone,” said Dr. Marin. “We also have a treatment service that is specifically focused on behavioral health care, so people can learn better coping strategies, and we also have social workers to provide coaching.”
While the center doesn’t have specific numbers on how many nurses, physicians, and other staff have participated in treatment, they have trained over 70 peer leaders for their five workshops that home in on the most important factors of resilience.
“We’ve gotten enthusiastic responses from PAs and nurses,” said Craig Katz, MD, an expert in disaster psychiatry at Mount Sinai and a workshop moderator. Physicians have been slower to get on board. “Doctors are a tough nut to crack – it’s largely a culture where they may burn out but don’t want to talk about it. And asking for help is a hard transition for physicians to make.”
How to protect in midst of trauma
In formulating the program’s platform, Mount Sinai experts drew upon their extensive experience aiding 9/11 responders at the World Trade Center (WTC), as well as their system-wide wellness program that aids demoralized and burned-out physicians. While the reach of the pandemic is much broader than 9/11, experts see some commonalities in conditions that emerge after traumatic events, and they also discovered what can help.
“We learned from our WTC experience about what are protective factors – what are the social supports that buffer against depression, anxiety, and PTSD,” said Jonathan DePierro, PhD, clinical director of CSRPG and a psychologist at the Mount Sinai WTC Mental Health Program. “We also learned that people who have more prolonged exposures are at greater risk of developing mental health difficulties.”
The program itself reflects these lessons – and that’s why it’s open to all employees, not just medical professionals. Housekeepers, security staffers, even construction workers are also dealing with their lives being in danger. “That wasn’t in their job description,” said Dr. DePierro. “These people tend to have fewer social and economic resources, make less money and have fewer structural supports, which makes them even more vulnerable.”
Dr. Charney’s strategies on building resilience became a bible of sorts for the workshops, according to Dr. Katz, who authored the training curriculum. Sessions deal with how to build up reservoirs of realistic optimism, keep gratitude journals, find spiritual meaning in their lives, maintain physical wellness and create networks of social support. The workshops are meant to help participants create action plans, to reach out for support in their social networks, and keep the focus on the positives.
The goal is to give demoralized health care workers a renewed sense of competence. “The resilience workshop is a launching point to get people to show up and talk,” said Dr. Katz. “And if we do that, we’ve accomplished a lot just getting people in the door.”
The center will also have a research component to identify what works and what doesn’t so their platform can provide a template for other institutions; Dr. Marin said they’ve gotten inquiries about the program from major hospital systems in Michigan and California. They’ll also conduct longitudinal research to determine what lingering problems persist among healthcare workers over time.
Since the center opened its virtual doors, the curriculum has also been altered in response to feedback from the support staff, many of whom live in the community that surrounds Mount Sinai in northern Manhattan, which is largely lower-income Latinx and Black individuals. Workshop materials have been translated into Spanish and now feature people who reflect a more diverse set of experiences.
“Many of our employees and the population we serve identify as non-White so we’ve been doing outreach with a lot of the local unions,” said Dr. Marin. “Our next step is to take what we’re doing and work with local community organizations.”
A version of this article first appeared on Medscape.com.
Intense intervention may boost addiction program retention
An intense and assertive “won’t take no for an answer” approach is effective for engaging in treatment young adults with substance abuse who have been in and out of various recovery programs for years, new research suggests.
The Youth Opioid Recovery Support (YORS) program is a team effort that includes home delivery of the prescribed medication, family engagement, assertive outreach, and contingency management.
In a new study of 42 patients in recovery for substance use disorder (SUD), those who were treated with extended-release naltrexone or extended-release buprenorphine plus YORS received more outpatient doses of their medication, and rates of opioid relapse at 12 and 24 weeks were lower compared with their peers who received only treatment as usual.
“ coinvestigator Marc Fishman, MD, director of the Maryland Treatment Centers, Johns Hopkins University, Baltimore, said in an interview.
The findings were presented at the virtual American Academy of Addiction Psychiatry 31st Annual Meeting.
Treatment barriers
Young adults with SUD are difficult to reach, which leads to decreased addiction program retention, decreased medication adherence, early drop out, waxing and waning motivation, and worse outcomes, compared with older adults with SUD, Dr. Fishman said.
In July, positive results from a pilot trial conducted by the investigators of YORS were published online in Addiction.
In that study, 41 young adults aged 18-26 years who intended to undergo treatment for SUD with extended-release naltrexone were randomly assigned to also undergo YORS or treatment as usual, which consisted of a standard referral to outpatient care following an inpatient stay.
The primary outcomes were number of medication doses received over 24 weeks and relapse to opioid use, which was defined as 10 or more days of use within 28 days at 24 weeks.
Participants in the YORS group received more doses of extended-release naltrexone (mean, 4.28; standard deviation, 2.3) than participants in the treatment-as-usual group (mean, 0.70; SD, 1.2; P < .01).
In the YORS group, rates of relapse at both 12 and 24 weeks were lower, and there were fewer overall days of opioid use.
For the current study, the investigators wanted to test whether there was a possible effect when patients were given a choice of medication. In the earlier trial, patients did not have a choice – they had to take extended-release naltrexone. In this study, they could opt for it or extended-release buprenorphine.
The researchers recruited 22 young adults (aged 18-26 years) from their inpatient clinic to participate. Half the patients chose to take extended-release naltrexone, and the other half chose extended-release buprenorphine.
The groups were then compared to a historical group of 20 patients who received treatment as usual and served as the control group.
Positive outcomes
As in the first study, outcomes in the new study were better with YORS.
All participants who underwent YORS received more outpatient medication doses at 12 weeks and 24 weeks than those who received treatment as usual (1.91 vs. 0.40 and 3.76 vs. 0.70, respectively; P < .001).
For the YORS group, rates of opioid relapse were lower at 12 weeks (27.3% vs. 75.0%) and at 24 weeks (52.9% vs. 95.0%; P < .01.)
All components of YORS work together to improve retention, Dr. Fishman noted. Patients do much better if a relative such as a mother, father, or grandmother is closely involved, he added.
Also important is drug delivery.
“In some ways, this is similar to the assertive community treatment, or ACT, for schizophrenia. Like substance use disorder, schizophrenia requires long-acting injectable antipsychotics. When that is delivered to the patient through an organized delivery service like YORS, it improves outcomes,” said Dr. Fishman.
SUD is a chronic, relapsing illness in which an individual’s judgment is impaired, he added.
“ACT has become a relatively standard feature of treatment in most communities in this country and internationally and is sustainable under public sector funding, so it’s not an impossible leap to say it could be done. But it will not be cheap,” Dr. Fishman said.
Removing barriers
In a comment, Serra Akyar, MD, a psychiatry resident at Northwell Health’s Staten Island University Hospital, New York, said that the YORS program may appear to be labor intensive.
“However, the combination of medication-assisted treatment and support are essential to the treatment of opioid use disorder, especially for young adults. Developing effective interventions for young adults is particularly important, given the plasticity of their brains,” said Dr. Akyar, who was not involved with the research.
Inability to access medication and a lack of a supportive environment, both in everyday life and in regards to therapy, are barriers to successful treatment, she noted.
“The YORS intervention aims to remove these barriers to further enhance engagement to care through a combination of medication delivery and family engagement and assertive outreach via text messaging, a modality presumed to be well received by youth,” Dr. Akyar said.
Despite having a limited sample size, the study shows how a comprehensive intervention can have a large impact on the maintenance of medication adherence and reduction of relapse in young adults, she added.
“Its early success is encouraging and warrants further study on a larger scale to determine long-term effectiveness, overall costs and feasibility, generalizability, and whether certain independent factors exist that may predict medication adherence and reduction of relapse,” she said.
Wraparound support
The study is also a significant reminder that the opioid crisis has affected the young adult population, who are very vulnerable to OUD, said Jose Vito, MD, child, adolescent, and addiction psychiatrist at New York University.
“The study made me realize the importance of the four components of YORS, which were the outreach, family involvement, home delivery, and monetary incentives,” Dr. Vito said in an interview.
All of these components, in addition to extended-release naltrexone or extended-release buprenorphine, “have contributed to lower rates of opioid relapse, and the relapses are much later in the course of treatment if they do occur,” he said.
Overall, the findings demonstrate the importance of not giving up on these youths, he noted.
“Programs like YORS that provide wraparound support can help alleviate the opioid health care crisis by keeping these young adults in treatment,” Dr. Vito concluded.
The study was funded by the University of Maryland Center for Addiction Research, Education, and Service. Dr. Fishman has a financial relationship with Alkermes.
A version of this article first appeared on Medscape.com.
An intense and assertive “won’t take no for an answer” approach is effective for engaging in treatment young adults with substance abuse who have been in and out of various recovery programs for years, new research suggests.
The Youth Opioid Recovery Support (YORS) program is a team effort that includes home delivery of the prescribed medication, family engagement, assertive outreach, and contingency management.
In a new study of 42 patients in recovery for substance use disorder (SUD), those who were treated with extended-release naltrexone or extended-release buprenorphine plus YORS received more outpatient doses of their medication, and rates of opioid relapse at 12 and 24 weeks were lower compared with their peers who received only treatment as usual.
“ coinvestigator Marc Fishman, MD, director of the Maryland Treatment Centers, Johns Hopkins University, Baltimore, said in an interview.
The findings were presented at the virtual American Academy of Addiction Psychiatry 31st Annual Meeting.
Treatment barriers
Young adults with SUD are difficult to reach, which leads to decreased addiction program retention, decreased medication adherence, early drop out, waxing and waning motivation, and worse outcomes, compared with older adults with SUD, Dr. Fishman said.
In July, positive results from a pilot trial conducted by the investigators of YORS were published online in Addiction.
In that study, 41 young adults aged 18-26 years who intended to undergo treatment for SUD with extended-release naltrexone were randomly assigned to also undergo YORS or treatment as usual, which consisted of a standard referral to outpatient care following an inpatient stay.
The primary outcomes were number of medication doses received over 24 weeks and relapse to opioid use, which was defined as 10 or more days of use within 28 days at 24 weeks.
Participants in the YORS group received more doses of extended-release naltrexone (mean, 4.28; standard deviation, 2.3) than participants in the treatment-as-usual group (mean, 0.70; SD, 1.2; P < .01).
In the YORS group, rates of relapse at both 12 and 24 weeks were lower, and there were fewer overall days of opioid use.
For the current study, the investigators wanted to test whether there was a possible effect when patients were given a choice of medication. In the earlier trial, patients did not have a choice – they had to take extended-release naltrexone. In this study, they could opt for it or extended-release buprenorphine.
The researchers recruited 22 young adults (aged 18-26 years) from their inpatient clinic to participate. Half the patients chose to take extended-release naltrexone, and the other half chose extended-release buprenorphine.
The groups were then compared to a historical group of 20 patients who received treatment as usual and served as the control group.
Positive outcomes
As in the first study, outcomes in the new study were better with YORS.
All participants who underwent YORS received more outpatient medication doses at 12 weeks and 24 weeks than those who received treatment as usual (1.91 vs. 0.40 and 3.76 vs. 0.70, respectively; P < .001).
For the YORS group, rates of opioid relapse were lower at 12 weeks (27.3% vs. 75.0%) and at 24 weeks (52.9% vs. 95.0%; P < .01.)
All components of YORS work together to improve retention, Dr. Fishman noted. Patients do much better if a relative such as a mother, father, or grandmother is closely involved, he added.
Also important is drug delivery.
“In some ways, this is similar to the assertive community treatment, or ACT, for schizophrenia. Like substance use disorder, schizophrenia requires long-acting injectable antipsychotics. When that is delivered to the patient through an organized delivery service like YORS, it improves outcomes,” said Dr. Fishman.
SUD is a chronic, relapsing illness in which an individual’s judgment is impaired, he added.
“ACT has become a relatively standard feature of treatment in most communities in this country and internationally and is sustainable under public sector funding, so it’s not an impossible leap to say it could be done. But it will not be cheap,” Dr. Fishman said.
Removing barriers
In a comment, Serra Akyar, MD, a psychiatry resident at Northwell Health’s Staten Island University Hospital, New York, said that the YORS program may appear to be labor intensive.
“However, the combination of medication-assisted treatment and support are essential to the treatment of opioid use disorder, especially for young adults. Developing effective interventions for young adults is particularly important, given the plasticity of their brains,” said Dr. Akyar, who was not involved with the research.
Inability to access medication and a lack of a supportive environment, both in everyday life and in regards to therapy, are barriers to successful treatment, she noted.
“The YORS intervention aims to remove these barriers to further enhance engagement to care through a combination of medication delivery and family engagement and assertive outreach via text messaging, a modality presumed to be well received by youth,” Dr. Akyar said.
Despite having a limited sample size, the study shows how a comprehensive intervention can have a large impact on the maintenance of medication adherence and reduction of relapse in young adults, she added.
“Its early success is encouraging and warrants further study on a larger scale to determine long-term effectiveness, overall costs and feasibility, generalizability, and whether certain independent factors exist that may predict medication adherence and reduction of relapse,” she said.
Wraparound support
The study is also a significant reminder that the opioid crisis has affected the young adult population, who are very vulnerable to OUD, said Jose Vito, MD, child, adolescent, and addiction psychiatrist at New York University.
“The study made me realize the importance of the four components of YORS, which were the outreach, family involvement, home delivery, and monetary incentives,” Dr. Vito said in an interview.
All of these components, in addition to extended-release naltrexone or extended-release buprenorphine, “have contributed to lower rates of opioid relapse, and the relapses are much later in the course of treatment if they do occur,” he said.
Overall, the findings demonstrate the importance of not giving up on these youths, he noted.
“Programs like YORS that provide wraparound support can help alleviate the opioid health care crisis by keeping these young adults in treatment,” Dr. Vito concluded.
The study was funded by the University of Maryland Center for Addiction Research, Education, and Service. Dr. Fishman has a financial relationship with Alkermes.
A version of this article first appeared on Medscape.com.
An intense and assertive “won’t take no for an answer” approach is effective for engaging in treatment young adults with substance abuse who have been in and out of various recovery programs for years, new research suggests.
The Youth Opioid Recovery Support (YORS) program is a team effort that includes home delivery of the prescribed medication, family engagement, assertive outreach, and contingency management.
In a new study of 42 patients in recovery for substance use disorder (SUD), those who were treated with extended-release naltrexone or extended-release buprenorphine plus YORS received more outpatient doses of their medication, and rates of opioid relapse at 12 and 24 weeks were lower compared with their peers who received only treatment as usual.
“ coinvestigator Marc Fishman, MD, director of the Maryland Treatment Centers, Johns Hopkins University, Baltimore, said in an interview.
The findings were presented at the virtual American Academy of Addiction Psychiatry 31st Annual Meeting.
Treatment barriers
Young adults with SUD are difficult to reach, which leads to decreased addiction program retention, decreased medication adherence, early drop out, waxing and waning motivation, and worse outcomes, compared with older adults with SUD, Dr. Fishman said.
In July, positive results from a pilot trial conducted by the investigators of YORS were published online in Addiction.
In that study, 41 young adults aged 18-26 years who intended to undergo treatment for SUD with extended-release naltrexone were randomly assigned to also undergo YORS or treatment as usual, which consisted of a standard referral to outpatient care following an inpatient stay.
The primary outcomes were number of medication doses received over 24 weeks and relapse to opioid use, which was defined as 10 or more days of use within 28 days at 24 weeks.
Participants in the YORS group received more doses of extended-release naltrexone (mean, 4.28; standard deviation, 2.3) than participants in the treatment-as-usual group (mean, 0.70; SD, 1.2; P < .01).
In the YORS group, rates of relapse at both 12 and 24 weeks were lower, and there were fewer overall days of opioid use.
For the current study, the investigators wanted to test whether there was a possible effect when patients were given a choice of medication. In the earlier trial, patients did not have a choice – they had to take extended-release naltrexone. In this study, they could opt for it or extended-release buprenorphine.
The researchers recruited 22 young adults (aged 18-26 years) from their inpatient clinic to participate. Half the patients chose to take extended-release naltrexone, and the other half chose extended-release buprenorphine.
The groups were then compared to a historical group of 20 patients who received treatment as usual and served as the control group.
Positive outcomes
As in the first study, outcomes in the new study were better with YORS.
All participants who underwent YORS received more outpatient medication doses at 12 weeks and 24 weeks than those who received treatment as usual (1.91 vs. 0.40 and 3.76 vs. 0.70, respectively; P < .001).
For the YORS group, rates of opioid relapse were lower at 12 weeks (27.3% vs. 75.0%) and at 24 weeks (52.9% vs. 95.0%; P < .01.)
All components of YORS work together to improve retention, Dr. Fishman noted. Patients do much better if a relative such as a mother, father, or grandmother is closely involved, he added.
Also important is drug delivery.
“In some ways, this is similar to the assertive community treatment, or ACT, for schizophrenia. Like substance use disorder, schizophrenia requires long-acting injectable antipsychotics. When that is delivered to the patient through an organized delivery service like YORS, it improves outcomes,” said Dr. Fishman.
SUD is a chronic, relapsing illness in which an individual’s judgment is impaired, he added.
“ACT has become a relatively standard feature of treatment in most communities in this country and internationally and is sustainable under public sector funding, so it’s not an impossible leap to say it could be done. But it will not be cheap,” Dr. Fishman said.
Removing barriers
In a comment, Serra Akyar, MD, a psychiatry resident at Northwell Health’s Staten Island University Hospital, New York, said that the YORS program may appear to be labor intensive.
“However, the combination of medication-assisted treatment and support are essential to the treatment of opioid use disorder, especially for young adults. Developing effective interventions for young adults is particularly important, given the plasticity of their brains,” said Dr. Akyar, who was not involved with the research.
Inability to access medication and a lack of a supportive environment, both in everyday life and in regards to therapy, are barriers to successful treatment, she noted.
“The YORS intervention aims to remove these barriers to further enhance engagement to care through a combination of medication delivery and family engagement and assertive outreach via text messaging, a modality presumed to be well received by youth,” Dr. Akyar said.
Despite having a limited sample size, the study shows how a comprehensive intervention can have a large impact on the maintenance of medication adherence and reduction of relapse in young adults, she added.
“Its early success is encouraging and warrants further study on a larger scale to determine long-term effectiveness, overall costs and feasibility, generalizability, and whether certain independent factors exist that may predict medication adherence and reduction of relapse,” she said.
Wraparound support
The study is also a significant reminder that the opioid crisis has affected the young adult population, who are very vulnerable to OUD, said Jose Vito, MD, child, adolescent, and addiction psychiatrist at New York University.
“The study made me realize the importance of the four components of YORS, which were the outreach, family involvement, home delivery, and monetary incentives,” Dr. Vito said in an interview.
All of these components, in addition to extended-release naltrexone or extended-release buprenorphine, “have contributed to lower rates of opioid relapse, and the relapses are much later in the course of treatment if they do occur,” he said.
Overall, the findings demonstrate the importance of not giving up on these youths, he noted.
“Programs like YORS that provide wraparound support can help alleviate the opioid health care crisis by keeping these young adults in treatment,” Dr. Vito concluded.
The study was funded by the University of Maryland Center for Addiction Research, Education, and Service. Dr. Fishman has a financial relationship with Alkermes.
A version of this article first appeared on Medscape.com.
Does daily inhaler monitoring improve asthma outcomes in children?
Among children with moderate or severe persistent asthma, a randomized trial suggests.
But the intervention also may lead to more ED visits and increased hospitalization rates.
“We improved asthma symptom control but did not reduce health care use,” Ruchi S. Gupta, MD, MPH, and colleagues, wrote in a study published in Pediatrics.
The monitoring system alerted clinicians when a patient used a short-acting beta-agonist more than four times in a day. It could be that the “alerts enabled providers to detect asthma exacerbation virtually and refer for clinically appropriate care that included directing children to the ED,” the authors suggested. It also is possible that the intervention led caregivers to be more vigilant about symptoms and more empowered to seek care.
Adherence to preventive regimens
Many patients with asthma need to use preventive medications such as daily inhaled corticosteroids to control symptoms. Researchers have developed sensor-based inhaler monitoring interventions to improve treatment adherence, but the effectiveness of these interventions in improving asthma outcomes in urban and minority populations is unclear.
To assess the effectiveness of a clinically integrated, sensor-based inhaler monitoring intervention on improving asthma symptom control and related outcomes in children, Dr. Gupta, of Northwestern University and Ann & Robert H. Lurie Children’s Hospital of Chicago, and colleagues conducted a randomized, unblinded study, known as the Improving Technology-Assisted Recording of Asthma Control in Children (iTRACC) trial. They included 252 children: 127 in the control group and 125 in the intervention group.
Patients in the intervention group received Propeller Health’s Food and Drug Administration–cleared inhaler sensors for inhaled corticosteroids and short-acting beta-agonists. Caregivers could use a mobile application and clinicians could use a Web portal to track patients’ medication use. The app featured personalized insights, educational content, encouragement, surveys, and care team services.
Researchers recruited caregivers and children from five Chicago clinics for the study, which was conducted between 2016 and 2018. They included children aged 4-17 years who had a prescription for daily inhaled corticosteroids for at least 1 year before enrollment. In addition, participants had at least 1 exacerbation requiring oral corticosteroids in the previous year. They excluded children with other respiratory conditions. They also excluded participants who did not speak English because the app was available only in English.
“Sensors monitored inhaled medication use, capturing the date, time, and number of uses, and transmitted this information via Bluetooth to a paired smartphone and the provider portal in real-time,” the authors said.
Clinicians were alerted to call participants if a patient missed inhaled corticosteroid doses for 4 continuous days or used more than 4 short-acting beta-agonist doses per day. Clinicians could help guide asthma management, schedule an appointment, refill medications, and address technical difficulties with the sensors.
The intervention and control groups had similar baseline characteristics. About one-third of the patients were female, and the mean age was 9.3 years. In the control group, 28% identified as Hispanic, and 33% identified as non-Hispanic Black. In the intervention group, 40% identified as Hispanic, and 23% identified as non-Hispanic Black. About 59% reported Medicaid insurance. The intervention and control arms completed electronic surveys at 1, 3, 6, 9, and 12 months.
Average Asthma Control Test score increased from 19 to 22 in the intervention group, compared with an increase from 19 to 20 in the control group. Adjusted rates of emergency department visits and hospitalizations were greater in the intervention group (incidence rate ratios, 2.2 and 3.4, respectively). A measure of caregiver quality of life was greater in the intervention group, although the difference was not significant.
During the trial, more caregivers in the intervention group reported asthma attacks for which steroids were prescribed by a medical office (73% vs. 35%).
Some participants had to manually enter the number of daily puffs into the app because their inhalers were incompatible with the sensors. In addition, some data were missing because of incomplete or missing survey responses and sensor failure over time. “The number of intervention participants with actively transmitting sensors decreased from 102 at baseline to 56 at 12 months,” Dr. Gupta and associates noted.
Important area of research
“One interesting finding of this study is the increase in health care use in the intervention group to nearly twice as many emergency department (ED) visits and three times as many hospitalizations as the control group over 12 months,” Rachelle R. Ramsey, PhD, and Theresa W. Guilbert, MD, MS, of the University of Cincinnati, wrote in a related commentary. “Although it is plausible that, as the authors suggest, greater asthma knowledge and monitoring may have led to increased vigilance of asthma symptoms, it seems that this would have only led to an increase in ED visits but not hospitalizations.”
The mixture of objective electronic monitoring and subjective self-reported adherence may complicate interpretation of the results, they added.
“Overall, this article underscores the feasibility and importance of sensor-based electronic monitoring of adherence in pediatric asthma and encourages future research in this area,” Dr. Ramsey and Dr. Guilbert said.
The trial was supported by the UnitedHealth Group. Dr. Gupta has received grants from the National Institutes of Health, Rho, and other organizations, and has served as a medical consultant and adviser for a variety of companies. Dr. Ramsey is supported by the NIH. Dr. Guilbert reported fees from the American Board of Pediatrics, the Pediatric Pulmonary Subboard, and some pharmaceutical companies, plus grants from the NIH, grants and personal fees from Sanofi, Regeneron, and AstraZeneca, and royalties from UpToDate.
SOURCE: Gupta RS et al. Pediatrics. 2020 Dec 22. doi: 10.1542/peds.2020-1330.
Among children with moderate or severe persistent asthma, a randomized trial suggests.
But the intervention also may lead to more ED visits and increased hospitalization rates.
“We improved asthma symptom control but did not reduce health care use,” Ruchi S. Gupta, MD, MPH, and colleagues, wrote in a study published in Pediatrics.
The monitoring system alerted clinicians when a patient used a short-acting beta-agonist more than four times in a day. It could be that the “alerts enabled providers to detect asthma exacerbation virtually and refer for clinically appropriate care that included directing children to the ED,” the authors suggested. It also is possible that the intervention led caregivers to be more vigilant about symptoms and more empowered to seek care.
Adherence to preventive regimens
Many patients with asthma need to use preventive medications such as daily inhaled corticosteroids to control symptoms. Researchers have developed sensor-based inhaler monitoring interventions to improve treatment adherence, but the effectiveness of these interventions in improving asthma outcomes in urban and minority populations is unclear.
To assess the effectiveness of a clinically integrated, sensor-based inhaler monitoring intervention on improving asthma symptom control and related outcomes in children, Dr. Gupta, of Northwestern University and Ann & Robert H. Lurie Children’s Hospital of Chicago, and colleagues conducted a randomized, unblinded study, known as the Improving Technology-Assisted Recording of Asthma Control in Children (iTRACC) trial. They included 252 children: 127 in the control group and 125 in the intervention group.
Patients in the intervention group received Propeller Health’s Food and Drug Administration–cleared inhaler sensors for inhaled corticosteroids and short-acting beta-agonists. Caregivers could use a mobile application and clinicians could use a Web portal to track patients’ medication use. The app featured personalized insights, educational content, encouragement, surveys, and care team services.
Researchers recruited caregivers and children from five Chicago clinics for the study, which was conducted between 2016 and 2018. They included children aged 4-17 years who had a prescription for daily inhaled corticosteroids for at least 1 year before enrollment. In addition, participants had at least 1 exacerbation requiring oral corticosteroids in the previous year. They excluded children with other respiratory conditions. They also excluded participants who did not speak English because the app was available only in English.
“Sensors monitored inhaled medication use, capturing the date, time, and number of uses, and transmitted this information via Bluetooth to a paired smartphone and the provider portal in real-time,” the authors said.
Clinicians were alerted to call participants if a patient missed inhaled corticosteroid doses for 4 continuous days or used more than 4 short-acting beta-agonist doses per day. Clinicians could help guide asthma management, schedule an appointment, refill medications, and address technical difficulties with the sensors.
The intervention and control groups had similar baseline characteristics. About one-third of the patients were female, and the mean age was 9.3 years. In the control group, 28% identified as Hispanic, and 33% identified as non-Hispanic Black. In the intervention group, 40% identified as Hispanic, and 23% identified as non-Hispanic Black. About 59% reported Medicaid insurance. The intervention and control arms completed electronic surveys at 1, 3, 6, 9, and 12 months.
Average Asthma Control Test score increased from 19 to 22 in the intervention group, compared with an increase from 19 to 20 in the control group. Adjusted rates of emergency department visits and hospitalizations were greater in the intervention group (incidence rate ratios, 2.2 and 3.4, respectively). A measure of caregiver quality of life was greater in the intervention group, although the difference was not significant.
During the trial, more caregivers in the intervention group reported asthma attacks for which steroids were prescribed by a medical office (73% vs. 35%).
Some participants had to manually enter the number of daily puffs into the app because their inhalers were incompatible with the sensors. In addition, some data were missing because of incomplete or missing survey responses and sensor failure over time. “The number of intervention participants with actively transmitting sensors decreased from 102 at baseline to 56 at 12 months,” Dr. Gupta and associates noted.
Important area of research
“One interesting finding of this study is the increase in health care use in the intervention group to nearly twice as many emergency department (ED) visits and three times as many hospitalizations as the control group over 12 months,” Rachelle R. Ramsey, PhD, and Theresa W. Guilbert, MD, MS, of the University of Cincinnati, wrote in a related commentary. “Although it is plausible that, as the authors suggest, greater asthma knowledge and monitoring may have led to increased vigilance of asthma symptoms, it seems that this would have only led to an increase in ED visits but not hospitalizations.”
The mixture of objective electronic monitoring and subjective self-reported adherence may complicate interpretation of the results, they added.
“Overall, this article underscores the feasibility and importance of sensor-based electronic monitoring of adherence in pediatric asthma and encourages future research in this area,” Dr. Ramsey and Dr. Guilbert said.
The trial was supported by the UnitedHealth Group. Dr. Gupta has received grants from the National Institutes of Health, Rho, and other organizations, and has served as a medical consultant and adviser for a variety of companies. Dr. Ramsey is supported by the NIH. Dr. Guilbert reported fees from the American Board of Pediatrics, the Pediatric Pulmonary Subboard, and some pharmaceutical companies, plus grants from the NIH, grants and personal fees from Sanofi, Regeneron, and AstraZeneca, and royalties from UpToDate.
SOURCE: Gupta RS et al. Pediatrics. 2020 Dec 22. doi: 10.1542/peds.2020-1330.
Among children with moderate or severe persistent asthma, a randomized trial suggests.
But the intervention also may lead to more ED visits and increased hospitalization rates.
“We improved asthma symptom control but did not reduce health care use,” Ruchi S. Gupta, MD, MPH, and colleagues, wrote in a study published in Pediatrics.
The monitoring system alerted clinicians when a patient used a short-acting beta-agonist more than four times in a day. It could be that the “alerts enabled providers to detect asthma exacerbation virtually and refer for clinically appropriate care that included directing children to the ED,” the authors suggested. It also is possible that the intervention led caregivers to be more vigilant about symptoms and more empowered to seek care.
Adherence to preventive regimens
Many patients with asthma need to use preventive medications such as daily inhaled corticosteroids to control symptoms. Researchers have developed sensor-based inhaler monitoring interventions to improve treatment adherence, but the effectiveness of these interventions in improving asthma outcomes in urban and minority populations is unclear.
To assess the effectiveness of a clinically integrated, sensor-based inhaler monitoring intervention on improving asthma symptom control and related outcomes in children, Dr. Gupta, of Northwestern University and Ann & Robert H. Lurie Children’s Hospital of Chicago, and colleagues conducted a randomized, unblinded study, known as the Improving Technology-Assisted Recording of Asthma Control in Children (iTRACC) trial. They included 252 children: 127 in the control group and 125 in the intervention group.
Patients in the intervention group received Propeller Health’s Food and Drug Administration–cleared inhaler sensors for inhaled corticosteroids and short-acting beta-agonists. Caregivers could use a mobile application and clinicians could use a Web portal to track patients’ medication use. The app featured personalized insights, educational content, encouragement, surveys, and care team services.
Researchers recruited caregivers and children from five Chicago clinics for the study, which was conducted between 2016 and 2018. They included children aged 4-17 years who had a prescription for daily inhaled corticosteroids for at least 1 year before enrollment. In addition, participants had at least 1 exacerbation requiring oral corticosteroids in the previous year. They excluded children with other respiratory conditions. They also excluded participants who did not speak English because the app was available only in English.
“Sensors monitored inhaled medication use, capturing the date, time, and number of uses, and transmitted this information via Bluetooth to a paired smartphone and the provider portal in real-time,” the authors said.
Clinicians were alerted to call participants if a patient missed inhaled corticosteroid doses for 4 continuous days or used more than 4 short-acting beta-agonist doses per day. Clinicians could help guide asthma management, schedule an appointment, refill medications, and address technical difficulties with the sensors.
The intervention and control groups had similar baseline characteristics. About one-third of the patients were female, and the mean age was 9.3 years. In the control group, 28% identified as Hispanic, and 33% identified as non-Hispanic Black. In the intervention group, 40% identified as Hispanic, and 23% identified as non-Hispanic Black. About 59% reported Medicaid insurance. The intervention and control arms completed electronic surveys at 1, 3, 6, 9, and 12 months.
Average Asthma Control Test score increased from 19 to 22 in the intervention group, compared with an increase from 19 to 20 in the control group. Adjusted rates of emergency department visits and hospitalizations were greater in the intervention group (incidence rate ratios, 2.2 and 3.4, respectively). A measure of caregiver quality of life was greater in the intervention group, although the difference was not significant.
During the trial, more caregivers in the intervention group reported asthma attacks for which steroids were prescribed by a medical office (73% vs. 35%).
Some participants had to manually enter the number of daily puffs into the app because their inhalers were incompatible with the sensors. In addition, some data were missing because of incomplete or missing survey responses and sensor failure over time. “The number of intervention participants with actively transmitting sensors decreased from 102 at baseline to 56 at 12 months,” Dr. Gupta and associates noted.
Important area of research
“One interesting finding of this study is the increase in health care use in the intervention group to nearly twice as many emergency department (ED) visits and three times as many hospitalizations as the control group over 12 months,” Rachelle R. Ramsey, PhD, and Theresa W. Guilbert, MD, MS, of the University of Cincinnati, wrote in a related commentary. “Although it is plausible that, as the authors suggest, greater asthma knowledge and monitoring may have led to increased vigilance of asthma symptoms, it seems that this would have only led to an increase in ED visits but not hospitalizations.”
The mixture of objective electronic monitoring and subjective self-reported adherence may complicate interpretation of the results, they added.
“Overall, this article underscores the feasibility and importance of sensor-based electronic monitoring of adherence in pediatric asthma and encourages future research in this area,” Dr. Ramsey and Dr. Guilbert said.
The trial was supported by the UnitedHealth Group. Dr. Gupta has received grants from the National Institutes of Health, Rho, and other organizations, and has served as a medical consultant and adviser for a variety of companies. Dr. Ramsey is supported by the NIH. Dr. Guilbert reported fees from the American Board of Pediatrics, the Pediatric Pulmonary Subboard, and some pharmaceutical companies, plus grants from the NIH, grants and personal fees from Sanofi, Regeneron, and AstraZeneca, and royalties from UpToDate.
SOURCE: Gupta RS et al. Pediatrics. 2020 Dec 22. doi: 10.1542/peds.2020-1330.
FROM PEDIATRICS
HPV vaccine appears effective for treating warts, particularly in children
The human papillomavirus (HPV) vaccine, recommended by the Centers for Disease Control and Prevention for the prevention of HPV-associated genital warts and neoplasia, appears to be an effective and perhaps underappreciated treatment of existing cutaneous warts, according to expert speaking at the annual Coastal Dermatology symposium, held virtually.
, but a recently published review provides strong evidence that this is a practical clinical strategy, according to Theodore Rosen, MD, professor of dermatology at Baylor College of Medicine, Houston.
“Clearly, if you have someone, particularly a youngster, and you’re having trouble getting rid of their warts and they are age 9 years or above – and they need the vaccine anyhow – that’s a win-win proposition,” Dr. Rosen said.
The current nonavalent HPV vaccine is approved for individuals from age 9 to age 45. Although the CDC recommends routine vaccination at age 11 or 12 years, it allows earlier vaccination within the label.
The recently published and updated evidence of a benefit from treatment comes from a systematic literature review. For the review, 63 articles were drawn from the PubMed and Cochrane databases. The studies yielded 4,439 patients with cutaneous warts at the time they received the HPV vaccine or who specifically received vaccine as a treatment strategy.
As has been suggested previously in the case series and in a limited number of prospective studies, the majority of warts, including cutaneous warts and anogenital warts, resolved following vaccine administration.
“Mostly these were common warts, plantar warts, and flat warts,” Dr. Rosen said, but the paper also reported successful treatment of recurrent respiratory papillomatosis, squamous cell carcinomas, and basal cell carcinomas.
Case reports and small studies associating HPV vaccine with successful resolution of warts are easy to find in the literature. For example, 60% of patients achieved a complete response and 30% a partial response to HPV vaccine in one small prospective study of 26 patients with genital warts. Following vaccination, no recurrences were observed after a median follow-up of more than 8 months.
In the review paper, most of the cases involved patients who received the quadrivalent HPV vaccine, Dr. Rosen noted. Only one received the updated nonavalent vaccine, which, in addition to protection against the 6, 11, 16, and 18 subtypes extends protection to subtypes 31, 33, 45, 52, and 58.
“You would expect the nonavalent vaccine to provide the same protection. It is the same vaccine. It just offers activity against more subtypes,” Dr. Rosen said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education. He reported that he personally has used the nonavalent vaccine successfully to treat a cutaneous wart.
The nonavalent vaccine can be administered in just two doses for those who receive the first dose before age 15. In others, it is given in three doses at 1- to 2-month intervals, according to Dr. Rosen. He said the efficacy for preventing genital warts and most HPV-related neoplasia exceeds 90%, although it is lower for penile and anal cancer. The protection extends for at least 10 years, but he said that he believes that it is likely to be longer.
“The HPV vaccine is really, really safe,” Dr. Rosen said. Besides injection-site reactions, the most common adverse event is syncope. For this reason, patients are advised to stay seated for 30 minutes after administration.
There is some evidence for cross-immunity for HPV subtypes not covered by the vaccine, particularly among children, Dr. Rosen commented. Citing the review article, he said that, although almost all HPV-associated warts resolve in children when treated with the vaccine, response is somewhat lower in adolescents and further reduced in adults.
In an interview, the senior author of the recent literature review, Natasha A. Mesinkovska, MD, PhD, associate professor of dermatology, University of California, Irvine, agreed with Dr. Rosen about the value of HPV vaccine for patients not responding to conventional therapies for HPV-related cutaneous warts.
“I think HPV vaccine is an excellent option for those patients, even older ones at 45 years of age if cost is not an issue,” she said. She did offer a caveat. In a recent statement from the International Papillomavirus Society (IPVS) on a world shortage of HPV vaccine, it was estimated that supplies might be limited for the next 3-5 years.
Given this shortage, “obtaining them currently may prove to be difficult,” she cautioned.
This publication and Global Academy for Medical Education are owned by the same parent company.
The human papillomavirus (HPV) vaccine, recommended by the Centers for Disease Control and Prevention for the prevention of HPV-associated genital warts and neoplasia, appears to be an effective and perhaps underappreciated treatment of existing cutaneous warts, according to expert speaking at the annual Coastal Dermatology symposium, held virtually.
, but a recently published review provides strong evidence that this is a practical clinical strategy, according to Theodore Rosen, MD, professor of dermatology at Baylor College of Medicine, Houston.
“Clearly, if you have someone, particularly a youngster, and you’re having trouble getting rid of their warts and they are age 9 years or above – and they need the vaccine anyhow – that’s a win-win proposition,” Dr. Rosen said.
The current nonavalent HPV vaccine is approved for individuals from age 9 to age 45. Although the CDC recommends routine vaccination at age 11 or 12 years, it allows earlier vaccination within the label.
The recently published and updated evidence of a benefit from treatment comes from a systematic literature review. For the review, 63 articles were drawn from the PubMed and Cochrane databases. The studies yielded 4,439 patients with cutaneous warts at the time they received the HPV vaccine or who specifically received vaccine as a treatment strategy.
As has been suggested previously in the case series and in a limited number of prospective studies, the majority of warts, including cutaneous warts and anogenital warts, resolved following vaccine administration.
“Mostly these were common warts, plantar warts, and flat warts,” Dr. Rosen said, but the paper also reported successful treatment of recurrent respiratory papillomatosis, squamous cell carcinomas, and basal cell carcinomas.
Case reports and small studies associating HPV vaccine with successful resolution of warts are easy to find in the literature. For example, 60% of patients achieved a complete response and 30% a partial response to HPV vaccine in one small prospective study of 26 patients with genital warts. Following vaccination, no recurrences were observed after a median follow-up of more than 8 months.
In the review paper, most of the cases involved patients who received the quadrivalent HPV vaccine, Dr. Rosen noted. Only one received the updated nonavalent vaccine, which, in addition to protection against the 6, 11, 16, and 18 subtypes extends protection to subtypes 31, 33, 45, 52, and 58.
“You would expect the nonavalent vaccine to provide the same protection. It is the same vaccine. It just offers activity against more subtypes,” Dr. Rosen said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education. He reported that he personally has used the nonavalent vaccine successfully to treat a cutaneous wart.
The nonavalent vaccine can be administered in just two doses for those who receive the first dose before age 15. In others, it is given in three doses at 1- to 2-month intervals, according to Dr. Rosen. He said the efficacy for preventing genital warts and most HPV-related neoplasia exceeds 90%, although it is lower for penile and anal cancer. The protection extends for at least 10 years, but he said that he believes that it is likely to be longer.
“The HPV vaccine is really, really safe,” Dr. Rosen said. Besides injection-site reactions, the most common adverse event is syncope. For this reason, patients are advised to stay seated for 30 minutes after administration.
There is some evidence for cross-immunity for HPV subtypes not covered by the vaccine, particularly among children, Dr. Rosen commented. Citing the review article, he said that, although almost all HPV-associated warts resolve in children when treated with the vaccine, response is somewhat lower in adolescents and further reduced in adults.
In an interview, the senior author of the recent literature review, Natasha A. Mesinkovska, MD, PhD, associate professor of dermatology, University of California, Irvine, agreed with Dr. Rosen about the value of HPV vaccine for patients not responding to conventional therapies for HPV-related cutaneous warts.
“I think HPV vaccine is an excellent option for those patients, even older ones at 45 years of age if cost is not an issue,” she said. She did offer a caveat. In a recent statement from the International Papillomavirus Society (IPVS) on a world shortage of HPV vaccine, it was estimated that supplies might be limited for the next 3-5 years.
Given this shortage, “obtaining them currently may prove to be difficult,” she cautioned.
This publication and Global Academy for Medical Education are owned by the same parent company.
The human papillomavirus (HPV) vaccine, recommended by the Centers for Disease Control and Prevention for the prevention of HPV-associated genital warts and neoplasia, appears to be an effective and perhaps underappreciated treatment of existing cutaneous warts, according to expert speaking at the annual Coastal Dermatology symposium, held virtually.
, but a recently published review provides strong evidence that this is a practical clinical strategy, according to Theodore Rosen, MD, professor of dermatology at Baylor College of Medicine, Houston.
“Clearly, if you have someone, particularly a youngster, and you’re having trouble getting rid of their warts and they are age 9 years or above – and they need the vaccine anyhow – that’s a win-win proposition,” Dr. Rosen said.
The current nonavalent HPV vaccine is approved for individuals from age 9 to age 45. Although the CDC recommends routine vaccination at age 11 or 12 years, it allows earlier vaccination within the label.
The recently published and updated evidence of a benefit from treatment comes from a systematic literature review. For the review, 63 articles were drawn from the PubMed and Cochrane databases. The studies yielded 4,439 patients with cutaneous warts at the time they received the HPV vaccine or who specifically received vaccine as a treatment strategy.
As has been suggested previously in the case series and in a limited number of prospective studies, the majority of warts, including cutaneous warts and anogenital warts, resolved following vaccine administration.
“Mostly these were common warts, plantar warts, and flat warts,” Dr. Rosen said, but the paper also reported successful treatment of recurrent respiratory papillomatosis, squamous cell carcinomas, and basal cell carcinomas.
Case reports and small studies associating HPV vaccine with successful resolution of warts are easy to find in the literature. For example, 60% of patients achieved a complete response and 30% a partial response to HPV vaccine in one small prospective study of 26 patients with genital warts. Following vaccination, no recurrences were observed after a median follow-up of more than 8 months.
In the review paper, most of the cases involved patients who received the quadrivalent HPV vaccine, Dr. Rosen noted. Only one received the updated nonavalent vaccine, which, in addition to protection against the 6, 11, 16, and 18 subtypes extends protection to subtypes 31, 33, 45, 52, and 58.
“You would expect the nonavalent vaccine to provide the same protection. It is the same vaccine. It just offers activity against more subtypes,” Dr. Rosen said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education. He reported that he personally has used the nonavalent vaccine successfully to treat a cutaneous wart.
The nonavalent vaccine can be administered in just two doses for those who receive the first dose before age 15. In others, it is given in three doses at 1- to 2-month intervals, according to Dr. Rosen. He said the efficacy for preventing genital warts and most HPV-related neoplasia exceeds 90%, although it is lower for penile and anal cancer. The protection extends for at least 10 years, but he said that he believes that it is likely to be longer.
“The HPV vaccine is really, really safe,” Dr. Rosen said. Besides injection-site reactions, the most common adverse event is syncope. For this reason, patients are advised to stay seated for 30 minutes after administration.
There is some evidence for cross-immunity for HPV subtypes not covered by the vaccine, particularly among children, Dr. Rosen commented. Citing the review article, he said that, although almost all HPV-associated warts resolve in children when treated with the vaccine, response is somewhat lower in adolescents and further reduced in adults.
In an interview, the senior author of the recent literature review, Natasha A. Mesinkovska, MD, PhD, associate professor of dermatology, University of California, Irvine, agreed with Dr. Rosen about the value of HPV vaccine for patients not responding to conventional therapies for HPV-related cutaneous warts.
“I think HPV vaccine is an excellent option for those patients, even older ones at 45 years of age if cost is not an issue,” she said. She did offer a caveat. In a recent statement from the International Papillomavirus Society (IPVS) on a world shortage of HPV vaccine, it was estimated that supplies might be limited for the next 3-5 years.
Given this shortage, “obtaining them currently may prove to be difficult,” she cautioned.
This publication and Global Academy for Medical Education are owned by the same parent company.
FROM COASTAL DERM
Expert picks top pediatric dermatology studies of 2020
Lawrence F. Eichenfield, MD, said at the annual Coastal Dermatology Symposium, held virtually.
Dr. Eichenfield, professor of dermatology and pediatrics, at the University of California, San Diego, presented a list of studies, some of which resulted in approvals of pediatric indications in 2020, that he believes deserve attention.
Crisaborole
Crisaborole ointment, 2% is now approved for topical treatment of children aged as young as 3 months, based on the results of the CrisADe CARE1 phase 4 study. In this open-label study of infants aged from 3 months to under 2 years with mild to moderate AD, treated with crisaborole twice a day for 28 days, the mean reduction from baseline in the Eczema Area and Severity Index (EASI) score was 49.6% on day 15 and 57.5% on day 29. The most common side effects were erythema and application-site pain, but neither occurred in more than 4% of patients. The discontinuation rate was less than 3%.
When the indication for treatment of young children down to age 3 months (from 24 months) was granted by the Food and Drug Administration in March 2020, crisaborole, a phosphodiesterase-4 inhibitor, became the only nonsteroidal approved for treatment of AD in children aged younger than 2 years, Dr. Eichenfield pointed out.
Tacrolimus
The topical calcineurin inhibitor tacrolimus (Protopic) poses no detectable risk of cancer in children treated for AD, according to a prospective, multinational study that followed nearly 8,000 children with AD who used topical tacrolimus for at least 6 weeks over 10 years. With 44,469 person-years of follow-up in a population with at least 6 weeks of exposure to tacrolimus, there were six confirmed cancers, a rate not different than background rates, and no lymphomas.
“I have always tried to educate my patients about the potential use of the topical calcineurin inhibitors while reassuring them that the data did not support significant risk,” Dr. Eichenfield said. However, a large set of data reconfirming a low risk of cancer, although not definitive, “are really nice to have.”
Ruxolitinib
For treatment of AD in children aged as young as 12 years, a cream formulation of ruxolitinib, a Janus kinase 1/JAK2 inhibitor, met its primary outcomes in the phase 3 TRuE AD1 and TRuE AD2 trials. (These data are not yet published but were presented at the Revolutionizing Atopic Dermatitis virtual symposium in April 2020.) The primary endpoint of 75% EASI clearance (EASI-75) was achieved in approximately 62% of patients treated with the 1.5% dose of ruxolitinib twice daily. This was a highly significant advantage over vehicle in both studies (P < .0001).
The EASI-75 rates at 8 weeks for the 0.75% formulation, at 56% and 51.5% for the TRuE AD1 and TRuE AD2 trials, respectively, were lower but also superior (P < .0001) to the 24.6% and 14.4% response rates on vehicle, respectively.
Emphasizing a consistent benefit on multiple secondary endpoints, including the “really early itch decrease,” Dr. Eichenfield described the phase 3 data as “really excellent results.” The data have not yet led to FDA approval of ruxolitinib for AD, but approval seems likely. Dr. Eichenfield noted that other drugs in the same class, such as abrocitinib and upadacitinib, have also demonstrated promising efficacy in children aged 12 years or older.
Dupilumab
Dupilumab, an interleukin-4 receptor alpha antagonist, was approved in May, 2020, for the treatment of AD in children ages 6-11 years, on the basis of a recently published phase 3, randomized, placebo-controlled trial that enrolled children aged between 6 and 11 years, comparing dupilumab and topical corticosteroids and placebo plus topical corticosteroids. Severe involvement was an entry criterion.
At 16 weeks, an EASI-75 response was achieved by 67% of the group randomized to 200 mg of dupilumab administered every 2 weeks and 70% of the group randomized to 300 mg every 4 weeks versus 27% of those randomized to placebo. More patients in the dupilumab arms developed conjunctivitis (10.8% vs. 4.7%) and had injection-site reactions (8.5% vs. 3.5%), but the monoclonal antibody was otherwise well tolerated and safe.
These data suggest that younger patients with severe disease “do, if anything, better than adults,” Dr. Eichenfield said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education. He cautioned that avoiding live vaccines, which is recommended in patients on dupilumab, “is likely more of an issue in children.”
Ixekizumab
Ixekizumab has been approved for pediatric patients aged as young as 6 years who are eligible for systemic therapy on the basis of a phase 3 trial. For the primary endpoint of 75% clearance on the Psoriasis Area and Severity Index, the response rates were 89% for the IL-17 inhibitor administered every 4 weeks and 25% for placebo. The study also associated ixekizumab with a significant improvement in quality of life.
The availability of more targeted therapies for children are likely. In Europe, secukinumab, another IL-17 inhibitor, was approved for treatment in pediatric patients this past summer, Dr. Eichenfield noted. These data are not yet published, but he expects targeted therapies to join a growing list of biologics already approved in children.
For drugs with established efficacy and safety, he advised, “look at your pediatric psoriasis patients and don’t be wimpy.” In children with poorly controlled psoriasis, he concluded these drugs have been associated with improved quality of life.
In November 2019, the American Academy of Dermatology and National Psoriasis Foundation published psoriasis management guidelines for children. Not all of the most recently approved therapies are included in these guidelines, which are the first to provide specific recommendations for children, but Dr. Eichenfield also included this publication among his top picks for important contributions to the pediatric dermatology literature in 2020.
Dr. Eichenfield reported financial relationships with 20 pharmaceutical companies that manufacture dermatologic products, including those for the diseases he discussed.
This publication and Global Academy for Medical Education are owned by the same parent company.
Lawrence F. Eichenfield, MD, said at the annual Coastal Dermatology Symposium, held virtually.
Dr. Eichenfield, professor of dermatology and pediatrics, at the University of California, San Diego, presented a list of studies, some of which resulted in approvals of pediatric indications in 2020, that he believes deserve attention.
Crisaborole
Crisaborole ointment, 2% is now approved for topical treatment of children aged as young as 3 months, based on the results of the CrisADe CARE1 phase 4 study. In this open-label study of infants aged from 3 months to under 2 years with mild to moderate AD, treated with crisaborole twice a day for 28 days, the mean reduction from baseline in the Eczema Area and Severity Index (EASI) score was 49.6% on day 15 and 57.5% on day 29. The most common side effects were erythema and application-site pain, but neither occurred in more than 4% of patients. The discontinuation rate was less than 3%.
When the indication for treatment of young children down to age 3 months (from 24 months) was granted by the Food and Drug Administration in March 2020, crisaborole, a phosphodiesterase-4 inhibitor, became the only nonsteroidal approved for treatment of AD in children aged younger than 2 years, Dr. Eichenfield pointed out.
Tacrolimus
The topical calcineurin inhibitor tacrolimus (Protopic) poses no detectable risk of cancer in children treated for AD, according to a prospective, multinational study that followed nearly 8,000 children with AD who used topical tacrolimus for at least 6 weeks over 10 years. With 44,469 person-years of follow-up in a population with at least 6 weeks of exposure to tacrolimus, there were six confirmed cancers, a rate not different than background rates, and no lymphomas.
“I have always tried to educate my patients about the potential use of the topical calcineurin inhibitors while reassuring them that the data did not support significant risk,” Dr. Eichenfield said. However, a large set of data reconfirming a low risk of cancer, although not definitive, “are really nice to have.”
Ruxolitinib
For treatment of AD in children aged as young as 12 years, a cream formulation of ruxolitinib, a Janus kinase 1/JAK2 inhibitor, met its primary outcomes in the phase 3 TRuE AD1 and TRuE AD2 trials. (These data are not yet published but were presented at the Revolutionizing Atopic Dermatitis virtual symposium in April 2020.) The primary endpoint of 75% EASI clearance (EASI-75) was achieved in approximately 62% of patients treated with the 1.5% dose of ruxolitinib twice daily. This was a highly significant advantage over vehicle in both studies (P < .0001).
The EASI-75 rates at 8 weeks for the 0.75% formulation, at 56% and 51.5% for the TRuE AD1 and TRuE AD2 trials, respectively, were lower but also superior (P < .0001) to the 24.6% and 14.4% response rates on vehicle, respectively.
Emphasizing a consistent benefit on multiple secondary endpoints, including the “really early itch decrease,” Dr. Eichenfield described the phase 3 data as “really excellent results.” The data have not yet led to FDA approval of ruxolitinib for AD, but approval seems likely. Dr. Eichenfield noted that other drugs in the same class, such as abrocitinib and upadacitinib, have also demonstrated promising efficacy in children aged 12 years or older.
Dupilumab
Dupilumab, an interleukin-4 receptor alpha antagonist, was approved in May, 2020, for the treatment of AD in children ages 6-11 years, on the basis of a recently published phase 3, randomized, placebo-controlled trial that enrolled children aged between 6 and 11 years, comparing dupilumab and topical corticosteroids and placebo plus topical corticosteroids. Severe involvement was an entry criterion.
At 16 weeks, an EASI-75 response was achieved by 67% of the group randomized to 200 mg of dupilumab administered every 2 weeks and 70% of the group randomized to 300 mg every 4 weeks versus 27% of those randomized to placebo. More patients in the dupilumab arms developed conjunctivitis (10.8% vs. 4.7%) and had injection-site reactions (8.5% vs. 3.5%), but the monoclonal antibody was otherwise well tolerated and safe.
These data suggest that younger patients with severe disease “do, if anything, better than adults,” Dr. Eichenfield said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education. He cautioned that avoiding live vaccines, which is recommended in patients on dupilumab, “is likely more of an issue in children.”
Ixekizumab
Ixekizumab has been approved for pediatric patients aged as young as 6 years who are eligible for systemic therapy on the basis of a phase 3 trial. For the primary endpoint of 75% clearance on the Psoriasis Area and Severity Index, the response rates were 89% for the IL-17 inhibitor administered every 4 weeks and 25% for placebo. The study also associated ixekizumab with a significant improvement in quality of life.
The availability of more targeted therapies for children are likely. In Europe, secukinumab, another IL-17 inhibitor, was approved for treatment in pediatric patients this past summer, Dr. Eichenfield noted. These data are not yet published, but he expects targeted therapies to join a growing list of biologics already approved in children.
For drugs with established efficacy and safety, he advised, “look at your pediatric psoriasis patients and don’t be wimpy.” In children with poorly controlled psoriasis, he concluded these drugs have been associated with improved quality of life.
In November 2019, the American Academy of Dermatology and National Psoriasis Foundation published psoriasis management guidelines for children. Not all of the most recently approved therapies are included in these guidelines, which are the first to provide specific recommendations for children, but Dr. Eichenfield also included this publication among his top picks for important contributions to the pediatric dermatology literature in 2020.
Dr. Eichenfield reported financial relationships with 20 pharmaceutical companies that manufacture dermatologic products, including those for the diseases he discussed.
This publication and Global Academy for Medical Education are owned by the same parent company.
Lawrence F. Eichenfield, MD, said at the annual Coastal Dermatology Symposium, held virtually.
Dr. Eichenfield, professor of dermatology and pediatrics, at the University of California, San Diego, presented a list of studies, some of which resulted in approvals of pediatric indications in 2020, that he believes deserve attention.
Crisaborole
Crisaborole ointment, 2% is now approved for topical treatment of children aged as young as 3 months, based on the results of the CrisADe CARE1 phase 4 study. In this open-label study of infants aged from 3 months to under 2 years with mild to moderate AD, treated with crisaborole twice a day for 28 days, the mean reduction from baseline in the Eczema Area and Severity Index (EASI) score was 49.6% on day 15 and 57.5% on day 29. The most common side effects were erythema and application-site pain, but neither occurred in more than 4% of patients. The discontinuation rate was less than 3%.
When the indication for treatment of young children down to age 3 months (from 24 months) was granted by the Food and Drug Administration in March 2020, crisaborole, a phosphodiesterase-4 inhibitor, became the only nonsteroidal approved for treatment of AD in children aged younger than 2 years, Dr. Eichenfield pointed out.
Tacrolimus
The topical calcineurin inhibitor tacrolimus (Protopic) poses no detectable risk of cancer in children treated for AD, according to a prospective, multinational study that followed nearly 8,000 children with AD who used topical tacrolimus for at least 6 weeks over 10 years. With 44,469 person-years of follow-up in a population with at least 6 weeks of exposure to tacrolimus, there were six confirmed cancers, a rate not different than background rates, and no lymphomas.
“I have always tried to educate my patients about the potential use of the topical calcineurin inhibitors while reassuring them that the data did not support significant risk,” Dr. Eichenfield said. However, a large set of data reconfirming a low risk of cancer, although not definitive, “are really nice to have.”
Ruxolitinib
For treatment of AD in children aged as young as 12 years, a cream formulation of ruxolitinib, a Janus kinase 1/JAK2 inhibitor, met its primary outcomes in the phase 3 TRuE AD1 and TRuE AD2 trials. (These data are not yet published but were presented at the Revolutionizing Atopic Dermatitis virtual symposium in April 2020.) The primary endpoint of 75% EASI clearance (EASI-75) was achieved in approximately 62% of patients treated with the 1.5% dose of ruxolitinib twice daily. This was a highly significant advantage over vehicle in both studies (P < .0001).
The EASI-75 rates at 8 weeks for the 0.75% formulation, at 56% and 51.5% for the TRuE AD1 and TRuE AD2 trials, respectively, were lower but also superior (P < .0001) to the 24.6% and 14.4% response rates on vehicle, respectively.
Emphasizing a consistent benefit on multiple secondary endpoints, including the “really early itch decrease,” Dr. Eichenfield described the phase 3 data as “really excellent results.” The data have not yet led to FDA approval of ruxolitinib for AD, but approval seems likely. Dr. Eichenfield noted that other drugs in the same class, such as abrocitinib and upadacitinib, have also demonstrated promising efficacy in children aged 12 years or older.
Dupilumab
Dupilumab, an interleukin-4 receptor alpha antagonist, was approved in May, 2020, for the treatment of AD in children ages 6-11 years, on the basis of a recently published phase 3, randomized, placebo-controlled trial that enrolled children aged between 6 and 11 years, comparing dupilumab and topical corticosteroids and placebo plus topical corticosteroids. Severe involvement was an entry criterion.
At 16 weeks, an EASI-75 response was achieved by 67% of the group randomized to 200 mg of dupilumab administered every 2 weeks and 70% of the group randomized to 300 mg every 4 weeks versus 27% of those randomized to placebo. More patients in the dupilumab arms developed conjunctivitis (10.8% vs. 4.7%) and had injection-site reactions (8.5% vs. 3.5%), but the monoclonal antibody was otherwise well tolerated and safe.
These data suggest that younger patients with severe disease “do, if anything, better than adults,” Dr. Eichenfield said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education. He cautioned that avoiding live vaccines, which is recommended in patients on dupilumab, “is likely more of an issue in children.”
Ixekizumab
Ixekizumab has been approved for pediatric patients aged as young as 6 years who are eligible for systemic therapy on the basis of a phase 3 trial. For the primary endpoint of 75% clearance on the Psoriasis Area and Severity Index, the response rates were 89% for the IL-17 inhibitor administered every 4 weeks and 25% for placebo. The study also associated ixekizumab with a significant improvement in quality of life.
The availability of more targeted therapies for children are likely. In Europe, secukinumab, another IL-17 inhibitor, was approved for treatment in pediatric patients this past summer, Dr. Eichenfield noted. These data are not yet published, but he expects targeted therapies to join a growing list of biologics already approved in children.
For drugs with established efficacy and safety, he advised, “look at your pediatric psoriasis patients and don’t be wimpy.” In children with poorly controlled psoriasis, he concluded these drugs have been associated with improved quality of life.
In November 2019, the American Academy of Dermatology and National Psoriasis Foundation published psoriasis management guidelines for children. Not all of the most recently approved therapies are included in these guidelines, which are the first to provide specific recommendations for children, but Dr. Eichenfield also included this publication among his top picks for important contributions to the pediatric dermatology literature in 2020.
Dr. Eichenfield reported financial relationships with 20 pharmaceutical companies that manufacture dermatologic products, including those for the diseases he discussed.
This publication and Global Academy for Medical Education are owned by the same parent company.
FROM COASTAL DERM
Getting closer to a lifesaving RSV vaccine
Louis Bont, MD, PhD, provided an overview of the most recent developments in the complex respiratory syncytial virus (RSV) vaccine landscape at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year.
RSV imposes significant burden worldwide, with 33 million patients, 3 million hospitalizations, and at least 120,000 deaths, reported Dr. Bont of the Wilhelmina Children’s Hospital, University Medical Centre, Utrecht, the Netherlands. Of those deaths, more than 50% are in infants younger than 5 months, and “about 99% of the children dying from RSV live in low- and middle-income countries.”
“There are high-risk populations, such as children with prematurity, congenital heart disease, lung disease, and Down syndrome, but about 73% of all children who are hospitalized for RSV infection were previously healthy children,” Dr. Bont explained. “So, we need to find a solution for all children to prevent RSV infection.”
As observed by Nienke Scheltema in a Lancet Global Health article, population distributions of RSV infection mortality show that, regardless of whether children have comorbidities or they are previously healthy, most children die at a very young age, Dr. Bont explained. These data suggest “that a maternal vaccine or an antibody prophylaxis approach from birth onwards or during the first RSV season is the solution for the problem.”
The path to developing an RSV vaccine has now narrowed its focus onto a structural element of RSV, the prefusion F protein. This shift started with the discovery by Jason McLellan (Science, 2013 [two papers]) that there are two variants of the RSV F-fusion protein: the very stable postfusion conformation and the prefusion active conformation, a metastable protein that exists for a “fraction of a second,” Dr. Bont said.
“The interesting thing is that epitopes that are visible at the prefusion, metastable state … induce highly neutralizing antibodies, whereas epitopes at the postfusion conformation do not,” Dr. Bont explained. “So, by stabilizing the prefusion state, we start inducing neutralizing antibodies that will protect against severe RSV infection, and this is the basic concept of all the vaccine developments currently ongoing.”
These RSV vaccine developments fall into five approach types: live-attenuated or chimeric vaccines, vector-based vaccines, monoclonal antibodies, particle-based vaccines, and subunit or protein-based vaccines.
One breakthrough, which was presented at last year’s ESPID meeting, is the monoclonal antibody nirsevimab. In addition to being nine times more potent than the broadly used antibody palivizumab, it is also more stable; whereas many antibodies have a half-life of 3 weeks, nirsevimab has a half-life of 100 days. “The idea is that a single injection at the start of the RSV season protects children in the first RSV season of their life, a dangerous episode for them.” Dr. Bont explained. The originators, AstraZeneca and Sanofi Pasteur, have “the vision that every child on this planet should receive a single injection with this antibody in the first season,” he explained.
Studies of nanoparticle-based maternal vaccines have also revealed interesting results: Although a phase 3 trial investigating such vaccines didn’t achieve its primary endpoint, “interestingly, 15% of all RSV infections were mild, and only 2% were very severe and leading to hypoxemia,” Dr. Bont noted. “But if we look at vaccine efficacy, we see the opposite – the vaccine was not very efficacious to prevent mild disease, but very efficacious to prevent severe hypoxemia; actually, this is exactly what you would like to see in a vaccine.”
Investigations into live-attenuated and vector-based vaccines have been promising as well, Dr. Bont shared. Studies of live-attenuated vaccines suggest they have a future and that we can move onto their next phase of clinical development, and a study investigating adenoviral vector-based vaccines has demonstrated safety, efficacy, and immunogenicity, though it has also shown that we should anticipate some side effects when using them.
Simple subunit vaccines for RSV are also being explored – a study of DS-Cav1, a stabilized prefusion F subunit protein candidate vaccine, has shown that it has a superior functional profile, compared with previous pre-F subunit vaccines. However, it seemed to be more efficacious against strains of RSV A than strains of RSV B, the dominant strain.
Dr. Bont also discussed exciting work by Sesterhenn et al., in which they used a computer-based program to develop their own vaccine. Using their in-depth knowledge of the RSV prefusion F protein and a computer program, Sesterhenn et al. developed a trivalent vaccine, produced it, and showed – both in vitro and in monkeys – that such vaccines can work up to the level of preclinical in vivo experiments.
“We can now make vaccines behind our computer,” Dr. Bont declared. “And the system doesn’t only work for RSV vaccines, but also for other pathogens – as long as you have an in-depth molecular knowledge of the target epitope,” he added.
Joanne Wildenbeest, MD, PhD, at the Utrecht University, the Netherlands commented: “Lower respiratory tract infections due to RSV are among the leading causes of death worldwide in children under the age of 5, especially young infants. The recent advances in the development of a vaccine and passive immunization are important steps towards the goal to reduce childhood mortality due to RSV worldwide. Since RSV-related mortality is mainly seen in developing countries it is important that, once a vaccine has been approved, it will also be made easily available to these countries.”
Dr. Bont reported the following disclosures: ReSViNET (a nonprofit foundation); investigator-initiated studies with the Bill & Melinda Gates Foundation, AbbVie, MedImmune, and MeMed; participation with Pfizer, Regeneron, and Janssen; and consultancy with GlaxoSmithKline, Ablynx, Novavax, and Janssen.
Louis Bont, MD, PhD, provided an overview of the most recent developments in the complex respiratory syncytial virus (RSV) vaccine landscape at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year.
RSV imposes significant burden worldwide, with 33 million patients, 3 million hospitalizations, and at least 120,000 deaths, reported Dr. Bont of the Wilhelmina Children’s Hospital, University Medical Centre, Utrecht, the Netherlands. Of those deaths, more than 50% are in infants younger than 5 months, and “about 99% of the children dying from RSV live in low- and middle-income countries.”
“There are high-risk populations, such as children with prematurity, congenital heart disease, lung disease, and Down syndrome, but about 73% of all children who are hospitalized for RSV infection were previously healthy children,” Dr. Bont explained. “So, we need to find a solution for all children to prevent RSV infection.”
As observed by Nienke Scheltema in a Lancet Global Health article, population distributions of RSV infection mortality show that, regardless of whether children have comorbidities or they are previously healthy, most children die at a very young age, Dr. Bont explained. These data suggest “that a maternal vaccine or an antibody prophylaxis approach from birth onwards or during the first RSV season is the solution for the problem.”
The path to developing an RSV vaccine has now narrowed its focus onto a structural element of RSV, the prefusion F protein. This shift started with the discovery by Jason McLellan (Science, 2013 [two papers]) that there are two variants of the RSV F-fusion protein: the very stable postfusion conformation and the prefusion active conformation, a metastable protein that exists for a “fraction of a second,” Dr. Bont said.
“The interesting thing is that epitopes that are visible at the prefusion, metastable state … induce highly neutralizing antibodies, whereas epitopes at the postfusion conformation do not,” Dr. Bont explained. “So, by stabilizing the prefusion state, we start inducing neutralizing antibodies that will protect against severe RSV infection, and this is the basic concept of all the vaccine developments currently ongoing.”
These RSV vaccine developments fall into five approach types: live-attenuated or chimeric vaccines, vector-based vaccines, monoclonal antibodies, particle-based vaccines, and subunit or protein-based vaccines.
One breakthrough, which was presented at last year’s ESPID meeting, is the monoclonal antibody nirsevimab. In addition to being nine times more potent than the broadly used antibody palivizumab, it is also more stable; whereas many antibodies have a half-life of 3 weeks, nirsevimab has a half-life of 100 days. “The idea is that a single injection at the start of the RSV season protects children in the first RSV season of their life, a dangerous episode for them.” Dr. Bont explained. The originators, AstraZeneca and Sanofi Pasteur, have “the vision that every child on this planet should receive a single injection with this antibody in the first season,” he explained.
Studies of nanoparticle-based maternal vaccines have also revealed interesting results: Although a phase 3 trial investigating such vaccines didn’t achieve its primary endpoint, “interestingly, 15% of all RSV infections were mild, and only 2% were very severe and leading to hypoxemia,” Dr. Bont noted. “But if we look at vaccine efficacy, we see the opposite – the vaccine was not very efficacious to prevent mild disease, but very efficacious to prevent severe hypoxemia; actually, this is exactly what you would like to see in a vaccine.”
Investigations into live-attenuated and vector-based vaccines have been promising as well, Dr. Bont shared. Studies of live-attenuated vaccines suggest they have a future and that we can move onto their next phase of clinical development, and a study investigating adenoviral vector-based vaccines has demonstrated safety, efficacy, and immunogenicity, though it has also shown that we should anticipate some side effects when using them.
Simple subunit vaccines for RSV are also being explored – a study of DS-Cav1, a stabilized prefusion F subunit protein candidate vaccine, has shown that it has a superior functional profile, compared with previous pre-F subunit vaccines. However, it seemed to be more efficacious against strains of RSV A than strains of RSV B, the dominant strain.
Dr. Bont also discussed exciting work by Sesterhenn et al., in which they used a computer-based program to develop their own vaccine. Using their in-depth knowledge of the RSV prefusion F protein and a computer program, Sesterhenn et al. developed a trivalent vaccine, produced it, and showed – both in vitro and in monkeys – that such vaccines can work up to the level of preclinical in vivo experiments.
“We can now make vaccines behind our computer,” Dr. Bont declared. “And the system doesn’t only work for RSV vaccines, but also for other pathogens – as long as you have an in-depth molecular knowledge of the target epitope,” he added.
Joanne Wildenbeest, MD, PhD, at the Utrecht University, the Netherlands commented: “Lower respiratory tract infections due to RSV are among the leading causes of death worldwide in children under the age of 5, especially young infants. The recent advances in the development of a vaccine and passive immunization are important steps towards the goal to reduce childhood mortality due to RSV worldwide. Since RSV-related mortality is mainly seen in developing countries it is important that, once a vaccine has been approved, it will also be made easily available to these countries.”
Dr. Bont reported the following disclosures: ReSViNET (a nonprofit foundation); investigator-initiated studies with the Bill & Melinda Gates Foundation, AbbVie, MedImmune, and MeMed; participation with Pfizer, Regeneron, and Janssen; and consultancy with GlaxoSmithKline, Ablynx, Novavax, and Janssen.
Louis Bont, MD, PhD, provided an overview of the most recent developments in the complex respiratory syncytial virus (RSV) vaccine landscape at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year.
RSV imposes significant burden worldwide, with 33 million patients, 3 million hospitalizations, and at least 120,000 deaths, reported Dr. Bont of the Wilhelmina Children’s Hospital, University Medical Centre, Utrecht, the Netherlands. Of those deaths, more than 50% are in infants younger than 5 months, and “about 99% of the children dying from RSV live in low- and middle-income countries.”
“There are high-risk populations, such as children with prematurity, congenital heart disease, lung disease, and Down syndrome, but about 73% of all children who are hospitalized for RSV infection were previously healthy children,” Dr. Bont explained. “So, we need to find a solution for all children to prevent RSV infection.”
As observed by Nienke Scheltema in a Lancet Global Health article, population distributions of RSV infection mortality show that, regardless of whether children have comorbidities or they are previously healthy, most children die at a very young age, Dr. Bont explained. These data suggest “that a maternal vaccine or an antibody prophylaxis approach from birth onwards or during the first RSV season is the solution for the problem.”
The path to developing an RSV vaccine has now narrowed its focus onto a structural element of RSV, the prefusion F protein. This shift started with the discovery by Jason McLellan (Science, 2013 [two papers]) that there are two variants of the RSV F-fusion protein: the very stable postfusion conformation and the prefusion active conformation, a metastable protein that exists for a “fraction of a second,” Dr. Bont said.
“The interesting thing is that epitopes that are visible at the prefusion, metastable state … induce highly neutralizing antibodies, whereas epitopes at the postfusion conformation do not,” Dr. Bont explained. “So, by stabilizing the prefusion state, we start inducing neutralizing antibodies that will protect against severe RSV infection, and this is the basic concept of all the vaccine developments currently ongoing.”
These RSV vaccine developments fall into five approach types: live-attenuated or chimeric vaccines, vector-based vaccines, monoclonal antibodies, particle-based vaccines, and subunit or protein-based vaccines.
One breakthrough, which was presented at last year’s ESPID meeting, is the monoclonal antibody nirsevimab. In addition to being nine times more potent than the broadly used antibody palivizumab, it is also more stable; whereas many antibodies have a half-life of 3 weeks, nirsevimab has a half-life of 100 days. “The idea is that a single injection at the start of the RSV season protects children in the first RSV season of their life, a dangerous episode for them.” Dr. Bont explained. The originators, AstraZeneca and Sanofi Pasteur, have “the vision that every child on this planet should receive a single injection with this antibody in the first season,” he explained.
Studies of nanoparticle-based maternal vaccines have also revealed interesting results: Although a phase 3 trial investigating such vaccines didn’t achieve its primary endpoint, “interestingly, 15% of all RSV infections were mild, and only 2% were very severe and leading to hypoxemia,” Dr. Bont noted. “But if we look at vaccine efficacy, we see the opposite – the vaccine was not very efficacious to prevent mild disease, but very efficacious to prevent severe hypoxemia; actually, this is exactly what you would like to see in a vaccine.”
Investigations into live-attenuated and vector-based vaccines have been promising as well, Dr. Bont shared. Studies of live-attenuated vaccines suggest they have a future and that we can move onto their next phase of clinical development, and a study investigating adenoviral vector-based vaccines has demonstrated safety, efficacy, and immunogenicity, though it has also shown that we should anticipate some side effects when using them.
Simple subunit vaccines for RSV are also being explored – a study of DS-Cav1, a stabilized prefusion F subunit protein candidate vaccine, has shown that it has a superior functional profile, compared with previous pre-F subunit vaccines. However, it seemed to be more efficacious against strains of RSV A than strains of RSV B, the dominant strain.
Dr. Bont also discussed exciting work by Sesterhenn et al., in which they used a computer-based program to develop their own vaccine. Using their in-depth knowledge of the RSV prefusion F protein and a computer program, Sesterhenn et al. developed a trivalent vaccine, produced it, and showed – both in vitro and in monkeys – that such vaccines can work up to the level of preclinical in vivo experiments.
“We can now make vaccines behind our computer,” Dr. Bont declared. “And the system doesn’t only work for RSV vaccines, but also for other pathogens – as long as you have an in-depth molecular knowledge of the target epitope,” he added.
Joanne Wildenbeest, MD, PhD, at the Utrecht University, the Netherlands commented: “Lower respiratory tract infections due to RSV are among the leading causes of death worldwide in children under the age of 5, especially young infants. The recent advances in the development of a vaccine and passive immunization are important steps towards the goal to reduce childhood mortality due to RSV worldwide. Since RSV-related mortality is mainly seen in developing countries it is important that, once a vaccine has been approved, it will also be made easily available to these countries.”
Dr. Bont reported the following disclosures: ReSViNET (a nonprofit foundation); investigator-initiated studies with the Bill & Melinda Gates Foundation, AbbVie, MedImmune, and MeMed; participation with Pfizer, Regeneron, and Janssen; and consultancy with GlaxoSmithKline, Ablynx, Novavax, and Janssen.
FROM ESPID 2020
Analysis characterizes common wound microbes in epidermolysis bullosa
– in a retrospective analysis of over 700 wound cultures from 158 patients across the United States and Canada.
The findings from the EB Clinical Characterization and Outcomes Database speak to the value of surveillance cultures with routine testing for microbial resistance – including mupirocin resistance – and to the importance of antibiotic stewardship not only for oral antibiotics but for topicals as well, according to Laura E. Levin, MD, and Kimberly D. Morel, MD, of the departments of dermatology and pediatrics, Columbia University Irving Medical Center, New York, the lead and senior authors, respectively, of the paper recently published in Pediatric Dermatology.
Almost all of the 158 patients with at least one wound culture recorded in the database from the period of 2001-2018 had one or more positive culture results. Of 152 patients with positive cultures, 131 (86%) were positive for SA and 56 (37%) and 34 (22%) were positive for PA and GAS, respectively. Other bacteria isolated included Corynebacterium spp and Proteus spp. Nearly half (47%) of patients with SA-positive cultures had methicillin-resistant SA, and 68% had methicillin-susceptible SA. (Some patients grew both MSSA and MRSA at different points in time.)
Mupirocin-susceptibility testing was performed at only some of the 13 participating centers. Of 15 patients whose cultures had recorded SA mupirocin-susceptibility testing, 11 had cultures positive for mupirocin-susceptible SA and 6 (40%) had mupirocin-resistant SA isolates (2 patients grew both). Of these six patients, half had isolates that were also methicillin-resistant.
Mupirocin, a topical antibiotic, has been a cornerstone of decolonization regimens for MSSA and MRSA, but resistance has been demonstrated in other research as well and is not specific to EB, wrote Dr. Levin, Dr. Morel, and coauthors.
“Pediatric dermatologists often rely on topical antimicrobials in the treatment of patients’ open wounds to both prevent and treat infection, depending on the clinical scenario,” and surveillance cultures with routine testing for mupirocin resistance can help guide antibiotic choice and management strategies, Dr. Levin said in an interview.
More broadly, she added, “it’s helpful to know what bacteria are routinely colonizing wounds, not causing infection, versus those that are more likely to be associated with infection, chronic wounds, or the risk of developing skin cancer ... [to know] which wounds need to be treated more aggressively.”
A subset of patients with EB have been known to be at risk for squamous cell carcinoma, and research is implicating certain bacteria “as contributing to wound inflammation,” Dr. Morel said in an interview.
SCC was reported in 23 out of 717 patients in the database – but fewer than half of the patients with SCC had recorded wound cultures. The small numbers precluded the identification of microbes that may confer significant risk.
Correlating particular microbes with clinical features also will take more research. About half (57%) of the patients with recorded wound cultures had wounds with purulent exudate or other features of clinical infection. However, the presence or absence of clinical signs of infection was not temporally correlated with culture results in the database.
The 158 patients with recorded wound cultures had a mean age of 12.8 years and represented a range of EB subtypes.
PA was present in the wounds of patients as young as 1 month old, the authors noted. Investigators are “looking to further study PA and characterize clinical features ... to understand more about this microbe and its impact on patients with EB,” Dr. Morel said.
In the meantime, the analysis reaffirms the importance of antibiotic stewardship. Mupirocin is labeled to be used three times a day for a short period of time, but “tends to be prescribed and used less judiciously than intended,” Dr. Morel said. “It’s important [not to overuse it]. We have seen that patients’ culture results become sensitive to mupirocin again in the future when they avoid it for a period of time.”
The work was supported by the EB Research Partnership and EB Medical Research Foundation, as well as an NIH/NCATS grant. No investigator disclosures were listed.
SOURCE: Pediatr Dermatol. 2020 Nov 28. doi: 10.1111/pde.14444.
– in a retrospective analysis of over 700 wound cultures from 158 patients across the United States and Canada.
The findings from the EB Clinical Characterization and Outcomes Database speak to the value of surveillance cultures with routine testing for microbial resistance – including mupirocin resistance – and to the importance of antibiotic stewardship not only for oral antibiotics but for topicals as well, according to Laura E. Levin, MD, and Kimberly D. Morel, MD, of the departments of dermatology and pediatrics, Columbia University Irving Medical Center, New York, the lead and senior authors, respectively, of the paper recently published in Pediatric Dermatology.
Almost all of the 158 patients with at least one wound culture recorded in the database from the period of 2001-2018 had one or more positive culture results. Of 152 patients with positive cultures, 131 (86%) were positive for SA and 56 (37%) and 34 (22%) were positive for PA and GAS, respectively. Other bacteria isolated included Corynebacterium spp and Proteus spp. Nearly half (47%) of patients with SA-positive cultures had methicillin-resistant SA, and 68% had methicillin-susceptible SA. (Some patients grew both MSSA and MRSA at different points in time.)
Mupirocin-susceptibility testing was performed at only some of the 13 participating centers. Of 15 patients whose cultures had recorded SA mupirocin-susceptibility testing, 11 had cultures positive for mupirocin-susceptible SA and 6 (40%) had mupirocin-resistant SA isolates (2 patients grew both). Of these six patients, half had isolates that were also methicillin-resistant.
Mupirocin, a topical antibiotic, has been a cornerstone of decolonization regimens for MSSA and MRSA, but resistance has been demonstrated in other research as well and is not specific to EB, wrote Dr. Levin, Dr. Morel, and coauthors.
“Pediatric dermatologists often rely on topical antimicrobials in the treatment of patients’ open wounds to both prevent and treat infection, depending on the clinical scenario,” and surveillance cultures with routine testing for mupirocin resistance can help guide antibiotic choice and management strategies, Dr. Levin said in an interview.
More broadly, she added, “it’s helpful to know what bacteria are routinely colonizing wounds, not causing infection, versus those that are more likely to be associated with infection, chronic wounds, or the risk of developing skin cancer ... [to know] which wounds need to be treated more aggressively.”
A subset of patients with EB have been known to be at risk for squamous cell carcinoma, and research is implicating certain bacteria “as contributing to wound inflammation,” Dr. Morel said in an interview.
SCC was reported in 23 out of 717 patients in the database – but fewer than half of the patients with SCC had recorded wound cultures. The small numbers precluded the identification of microbes that may confer significant risk.
Correlating particular microbes with clinical features also will take more research. About half (57%) of the patients with recorded wound cultures had wounds with purulent exudate or other features of clinical infection. However, the presence or absence of clinical signs of infection was not temporally correlated with culture results in the database.
The 158 patients with recorded wound cultures had a mean age of 12.8 years and represented a range of EB subtypes.
PA was present in the wounds of patients as young as 1 month old, the authors noted. Investigators are “looking to further study PA and characterize clinical features ... to understand more about this microbe and its impact on patients with EB,” Dr. Morel said.
In the meantime, the analysis reaffirms the importance of antibiotic stewardship. Mupirocin is labeled to be used three times a day for a short period of time, but “tends to be prescribed and used less judiciously than intended,” Dr. Morel said. “It’s important [not to overuse it]. We have seen that patients’ culture results become sensitive to mupirocin again in the future when they avoid it for a period of time.”
The work was supported by the EB Research Partnership and EB Medical Research Foundation, as well as an NIH/NCATS grant. No investigator disclosures were listed.
SOURCE: Pediatr Dermatol. 2020 Nov 28. doi: 10.1111/pde.14444.
– in a retrospective analysis of over 700 wound cultures from 158 patients across the United States and Canada.
The findings from the EB Clinical Characterization and Outcomes Database speak to the value of surveillance cultures with routine testing for microbial resistance – including mupirocin resistance – and to the importance of antibiotic stewardship not only for oral antibiotics but for topicals as well, according to Laura E. Levin, MD, and Kimberly D. Morel, MD, of the departments of dermatology and pediatrics, Columbia University Irving Medical Center, New York, the lead and senior authors, respectively, of the paper recently published in Pediatric Dermatology.
Almost all of the 158 patients with at least one wound culture recorded in the database from the period of 2001-2018 had one or more positive culture results. Of 152 patients with positive cultures, 131 (86%) were positive for SA and 56 (37%) and 34 (22%) were positive for PA and GAS, respectively. Other bacteria isolated included Corynebacterium spp and Proteus spp. Nearly half (47%) of patients with SA-positive cultures had methicillin-resistant SA, and 68% had methicillin-susceptible SA. (Some patients grew both MSSA and MRSA at different points in time.)
Mupirocin-susceptibility testing was performed at only some of the 13 participating centers. Of 15 patients whose cultures had recorded SA mupirocin-susceptibility testing, 11 had cultures positive for mupirocin-susceptible SA and 6 (40%) had mupirocin-resistant SA isolates (2 patients grew both). Of these six patients, half had isolates that were also methicillin-resistant.
Mupirocin, a topical antibiotic, has been a cornerstone of decolonization regimens for MSSA and MRSA, but resistance has been demonstrated in other research as well and is not specific to EB, wrote Dr. Levin, Dr. Morel, and coauthors.
“Pediatric dermatologists often rely on topical antimicrobials in the treatment of patients’ open wounds to both prevent and treat infection, depending on the clinical scenario,” and surveillance cultures with routine testing for mupirocin resistance can help guide antibiotic choice and management strategies, Dr. Levin said in an interview.
More broadly, she added, “it’s helpful to know what bacteria are routinely colonizing wounds, not causing infection, versus those that are more likely to be associated with infection, chronic wounds, or the risk of developing skin cancer ... [to know] which wounds need to be treated more aggressively.”
A subset of patients with EB have been known to be at risk for squamous cell carcinoma, and research is implicating certain bacteria “as contributing to wound inflammation,” Dr. Morel said in an interview.
SCC was reported in 23 out of 717 patients in the database – but fewer than half of the patients with SCC had recorded wound cultures. The small numbers precluded the identification of microbes that may confer significant risk.
Correlating particular microbes with clinical features also will take more research. About half (57%) of the patients with recorded wound cultures had wounds with purulent exudate or other features of clinical infection. However, the presence or absence of clinical signs of infection was not temporally correlated with culture results in the database.
The 158 patients with recorded wound cultures had a mean age of 12.8 years and represented a range of EB subtypes.
PA was present in the wounds of patients as young as 1 month old, the authors noted. Investigators are “looking to further study PA and characterize clinical features ... to understand more about this microbe and its impact on patients with EB,” Dr. Morel said.
In the meantime, the analysis reaffirms the importance of antibiotic stewardship. Mupirocin is labeled to be used three times a day for a short period of time, but “tends to be prescribed and used less judiciously than intended,” Dr. Morel said. “It’s important [not to overuse it]. We have seen that patients’ culture results become sensitive to mupirocin again in the future when they avoid it for a period of time.”
The work was supported by the EB Research Partnership and EB Medical Research Foundation, as well as an NIH/NCATS grant. No investigator disclosures were listed.
SOURCE: Pediatr Dermatol. 2020 Nov 28. doi: 10.1111/pde.14444.
FROM PEDIATRIC DERMATOLOGY
Disparities in child abuse evaluation arise from implicit bias
according to research discussed by Tiffani J. Johnson, MD, an assistant professor of emergency medicine at the University of California, Davis.
“These disparities in child abuse evaluation and reporting are bidirectional,” she said. “We also recognize that abuse is more likely to be unrecognized in White children.”
Dr. Johnson presented data on the health disparities in child abuse reporting in a session at the annual meeting of the American Academy of Pediatrics, held virtually this year. Health care disparities, as defined by the National Academy of Sciences, refers to differences in the quality of care between minority and nonminority populations that are not caused by clinical appropriateness, access, need, or patient preference, she explained. Instead, they result from discrimination, bias, stereotyping, and uncertainty.
Disparities lead to harm in all children
For example, a 2018 systematic review found that Black and other non-White children were significantly more likely than White children to be evaluated with a skeletal survey. In one of the studies included, at a large urban academic center, Black and Latinx children with accidental fractures were 8.75 times more likely to undergo a skeletal survey than White children and 4.3 times more likely to be reported to child protective services.
“And let me emphasize that these are children who were ultimately found to have accidental fractures,” Dr. Johnson said.
Meanwhile, in an analysis of known cases of head trauma, researchers found that abuse was missed in 37% of White children, compared with 19% of non-White children.
“These only represent the tip of the iceberg as a true number of cases of abuse may never really be detected because some cases are still unknown,” Dr. Johnson told attendees. And the harm of these disparities runs in both directions.
“Failing to diagnose abuse in White children clearly puts them at increased risk for return visits and return evaluations for repeated abuse by the perpetrators,” she said. But harm also can result from overreporting and investigation, including psychological trauma and a waste of limited resources. Overinvestigation also can erode family-physician relationships and perpetuate distrust of medical care in communities of color.
Yet at the same time, it’s clear that Black children, adolescents, and young adults are not protected from harm in society more generally, when at home, where they learn, or where they play, Dr. Johnson said, referencing the deaths of Breonna Taylor and Tamir Rice as examples.
“And now we’re seeing increased evidence that children are not protected in the health care center when we think about the many disparities that have been identified in the care and outcomes of children, including the disproportionality in terms of child abuse evaluation and referrals,” Dr. Johnson said.
Racism is a root cause of that harm to Black children, she said, as the systemic structure of opportunities unfairly disadvantages some individuals and communities while unfairly advantaging others, thereby “sapping the strength of the whole society through the waste of human resources.”
Tonya Chaffee, MD, MPH, a clinical professor of health sciences at the University of California, San Francisco, who attended the session, said she particularly appreciated “seeing data on which racial/ethnic populations have child abuse reports made and the disparities that exist that are similar to what we are noticing in our own institution.”
Role of individual-level implicit bias and racism
While institutional and structural racism play a substantial role in health care disparities, Dr. Johnson focused primarily on the impact of personal racism when it comes to child abuse evaluations, through overt discrimination, explicit bias, implicit bias, and stigmatization. The most challenging of these to identify and acknowledge is often implicit bias, a tendency to believe, even unconsciously, that some people or ideas are better than others, which results in unfair treatment.
For example, a 2016 study found that half of medical students and residents held at least one biological belief about differences between Black and White individuals that was actually false, such as Black people having more pain tolerance or stronger bones than White people, which then affected treatment recommendations.
“Implicit bias refers to our attitudes that lie below the surface, but they can still influence our behaviors,” Dr. Johnson explained. She encouraged providers to take the implicit bias test online to learn about their own unrecognized implicit biases. These biases have a hand in influencing decisions particularly in fast-paced environments where cognitive load is high – such as EDs, where many child abuse evaluations occur.
For example, in one study Dr. Johnson led, the researchers measured implicit bias in participants before and after an ED shift to assess how cognitive load affected bias. They found that participants who care for more than 10 patients, the average score for implicit bias increased.
Similarly, “when the ED was more overcrowded, there was also increased bias at the end of the shift, compared to the beginning of the shift,” Dr. Johnson said. She asked clinicians to take into consideration that at the start of the shift, they may feel well rested and freshly caffeinated, able to suppress or overcome the biases that they know they have.
“But our biases [are] more likely to come into play with every subsequent decision that we make throughout the day when we’re engaged in clinical encounters,” such as who does and does not receive a skeletal survey or get referred to child protective services, she said.
In another study where she hypothesized that resident physicians would have less bias on the child race implicit bias test than on the adult race one, Dr. Johnson reported that 85% of 91 residents working in an ED had an implicit pro-White/anti-Black bias in the test on adult race, but an even higher bias score – 91% – with child race.
Research has found that even children’s names can conjure implicit bias when it comes to stereotypically “White-sounding” names versus stereotypically “Black-sounding names.”
The implicit bias among clinicians extends beyond care of different children. Research has also identified association between higher implicit bias scores and less interpersonal treatment, less supportive communication, less patient-centered communication, poorer patient ratings of satisfaction, and greater patient-reported difficulty with following recommendations, Dr. Johnson said.
“I want you to think about that because I know that when we’re engaging with parents and making decisions about whether or not we’re going to do a skeletal survey or report someone for it, there is a lot of subjectivity that comes into play with how you’re interacting with families,” Dr. Johnson said. Those verbal and nonverbal cues may be triggering to parents, which then affects your interaction with them. Further, research shows that these biases may impact treatment decisions as well.
Personal-mediated racism also shows up in the use of stigmatizing language, Dr. Johnson said.
“When providers read stigmatizing language in the patient’s medical records, it was associated with them having more negative attitudes about that patient,” which then influenced their clinical decision-making, she said. “So when providers got primed with stigmatizing language, they subsequently had less aggressive pain management for those patients.”
Clinical implications for patient care
Dr. Johnson encouraged attendees to be careful about the language and tone they use in communicating with other health care providers and during documentation in medical records. Disparities in child abuse evaluation and reporting tend to be greater in EDs with more subjective conditions, whereas disparities are lower in departments with more established protocols.
She recommended several changes to practice that can reduce the impact of implicit bias. Universal screening for child abuse can increase how many injuries are found, but usually at the cost of increased resources and radiation. Another option is use of validated clinical decision support rules to identify who is at high or low risk for maltreatment, something Dr. Johnson is working on in her research.
But it’s also important for individual providers to confront their personal biases. Evidence-based strategies for reducing bias include perspective taking, focusing on common identities with patients, using counter-stereotypical imaging, seeking increased opportunity for cross-cultural contact, and mindfulness meditation.
“When you interact with people of different backgrounds, it helps to reduce the impact of stereotypes in society about those individuals,” Dr. Johnson told attendees. It’s also important to recognize how diversity in your clinical team can reduce bias.
“We need to work with our institutions to confront racial biases in child abuse reporting and develop quality improvement projects to ensure reporting is done objectively,” Dr. Chaffee said in an interview after attending the session. “This will require training and likely policy changes, including how reports are made to child welfare and/or the police moving forward.”
according to research discussed by Tiffani J. Johnson, MD, an assistant professor of emergency medicine at the University of California, Davis.
“These disparities in child abuse evaluation and reporting are bidirectional,” she said. “We also recognize that abuse is more likely to be unrecognized in White children.”
Dr. Johnson presented data on the health disparities in child abuse reporting in a session at the annual meeting of the American Academy of Pediatrics, held virtually this year. Health care disparities, as defined by the National Academy of Sciences, refers to differences in the quality of care between minority and nonminority populations that are not caused by clinical appropriateness, access, need, or patient preference, she explained. Instead, they result from discrimination, bias, stereotyping, and uncertainty.
Disparities lead to harm in all children
For example, a 2018 systematic review found that Black and other non-White children were significantly more likely than White children to be evaluated with a skeletal survey. In one of the studies included, at a large urban academic center, Black and Latinx children with accidental fractures were 8.75 times more likely to undergo a skeletal survey than White children and 4.3 times more likely to be reported to child protective services.
“And let me emphasize that these are children who were ultimately found to have accidental fractures,” Dr. Johnson said.
Meanwhile, in an analysis of known cases of head trauma, researchers found that abuse was missed in 37% of White children, compared with 19% of non-White children.
“These only represent the tip of the iceberg as a true number of cases of abuse may never really be detected because some cases are still unknown,” Dr. Johnson told attendees. And the harm of these disparities runs in both directions.
“Failing to diagnose abuse in White children clearly puts them at increased risk for return visits and return evaluations for repeated abuse by the perpetrators,” she said. But harm also can result from overreporting and investigation, including psychological trauma and a waste of limited resources. Overinvestigation also can erode family-physician relationships and perpetuate distrust of medical care in communities of color.
Yet at the same time, it’s clear that Black children, adolescents, and young adults are not protected from harm in society more generally, when at home, where they learn, or where they play, Dr. Johnson said, referencing the deaths of Breonna Taylor and Tamir Rice as examples.
“And now we’re seeing increased evidence that children are not protected in the health care center when we think about the many disparities that have been identified in the care and outcomes of children, including the disproportionality in terms of child abuse evaluation and referrals,” Dr. Johnson said.
Racism is a root cause of that harm to Black children, she said, as the systemic structure of opportunities unfairly disadvantages some individuals and communities while unfairly advantaging others, thereby “sapping the strength of the whole society through the waste of human resources.”
Tonya Chaffee, MD, MPH, a clinical professor of health sciences at the University of California, San Francisco, who attended the session, said she particularly appreciated “seeing data on which racial/ethnic populations have child abuse reports made and the disparities that exist that are similar to what we are noticing in our own institution.”
Role of individual-level implicit bias and racism
While institutional and structural racism play a substantial role in health care disparities, Dr. Johnson focused primarily on the impact of personal racism when it comes to child abuse evaluations, through overt discrimination, explicit bias, implicit bias, and stigmatization. The most challenging of these to identify and acknowledge is often implicit bias, a tendency to believe, even unconsciously, that some people or ideas are better than others, which results in unfair treatment.
For example, a 2016 study found that half of medical students and residents held at least one biological belief about differences between Black and White individuals that was actually false, such as Black people having more pain tolerance or stronger bones than White people, which then affected treatment recommendations.
“Implicit bias refers to our attitudes that lie below the surface, but they can still influence our behaviors,” Dr. Johnson explained. She encouraged providers to take the implicit bias test online to learn about their own unrecognized implicit biases. These biases have a hand in influencing decisions particularly in fast-paced environments where cognitive load is high – such as EDs, where many child abuse evaluations occur.
For example, in one study Dr. Johnson led, the researchers measured implicit bias in participants before and after an ED shift to assess how cognitive load affected bias. They found that participants who care for more than 10 patients, the average score for implicit bias increased.
Similarly, “when the ED was more overcrowded, there was also increased bias at the end of the shift, compared to the beginning of the shift,” Dr. Johnson said. She asked clinicians to take into consideration that at the start of the shift, they may feel well rested and freshly caffeinated, able to suppress or overcome the biases that they know they have.
“But our biases [are] more likely to come into play with every subsequent decision that we make throughout the day when we’re engaged in clinical encounters,” such as who does and does not receive a skeletal survey or get referred to child protective services, she said.
In another study where she hypothesized that resident physicians would have less bias on the child race implicit bias test than on the adult race one, Dr. Johnson reported that 85% of 91 residents working in an ED had an implicit pro-White/anti-Black bias in the test on adult race, but an even higher bias score – 91% – with child race.
Research has found that even children’s names can conjure implicit bias when it comes to stereotypically “White-sounding” names versus stereotypically “Black-sounding names.”
The implicit bias among clinicians extends beyond care of different children. Research has also identified association between higher implicit bias scores and less interpersonal treatment, less supportive communication, less patient-centered communication, poorer patient ratings of satisfaction, and greater patient-reported difficulty with following recommendations, Dr. Johnson said.
“I want you to think about that because I know that when we’re engaging with parents and making decisions about whether or not we’re going to do a skeletal survey or report someone for it, there is a lot of subjectivity that comes into play with how you’re interacting with families,” Dr. Johnson said. Those verbal and nonverbal cues may be triggering to parents, which then affects your interaction with them. Further, research shows that these biases may impact treatment decisions as well.
Personal-mediated racism also shows up in the use of stigmatizing language, Dr. Johnson said.
“When providers read stigmatizing language in the patient’s medical records, it was associated with them having more negative attitudes about that patient,” which then influenced their clinical decision-making, she said. “So when providers got primed with stigmatizing language, they subsequently had less aggressive pain management for those patients.”
Clinical implications for patient care
Dr. Johnson encouraged attendees to be careful about the language and tone they use in communicating with other health care providers and during documentation in medical records. Disparities in child abuse evaluation and reporting tend to be greater in EDs with more subjective conditions, whereas disparities are lower in departments with more established protocols.
She recommended several changes to practice that can reduce the impact of implicit bias. Universal screening for child abuse can increase how many injuries are found, but usually at the cost of increased resources and radiation. Another option is use of validated clinical decision support rules to identify who is at high or low risk for maltreatment, something Dr. Johnson is working on in her research.
But it’s also important for individual providers to confront their personal biases. Evidence-based strategies for reducing bias include perspective taking, focusing on common identities with patients, using counter-stereotypical imaging, seeking increased opportunity for cross-cultural contact, and mindfulness meditation.
“When you interact with people of different backgrounds, it helps to reduce the impact of stereotypes in society about those individuals,” Dr. Johnson told attendees. It’s also important to recognize how diversity in your clinical team can reduce bias.
“We need to work with our institutions to confront racial biases in child abuse reporting and develop quality improvement projects to ensure reporting is done objectively,” Dr. Chaffee said in an interview after attending the session. “This will require training and likely policy changes, including how reports are made to child welfare and/or the police moving forward.”
according to research discussed by Tiffani J. Johnson, MD, an assistant professor of emergency medicine at the University of California, Davis.
“These disparities in child abuse evaluation and reporting are bidirectional,” she said. “We also recognize that abuse is more likely to be unrecognized in White children.”
Dr. Johnson presented data on the health disparities in child abuse reporting in a session at the annual meeting of the American Academy of Pediatrics, held virtually this year. Health care disparities, as defined by the National Academy of Sciences, refers to differences in the quality of care between minority and nonminority populations that are not caused by clinical appropriateness, access, need, or patient preference, she explained. Instead, they result from discrimination, bias, stereotyping, and uncertainty.
Disparities lead to harm in all children
For example, a 2018 systematic review found that Black and other non-White children were significantly more likely than White children to be evaluated with a skeletal survey. In one of the studies included, at a large urban academic center, Black and Latinx children with accidental fractures were 8.75 times more likely to undergo a skeletal survey than White children and 4.3 times more likely to be reported to child protective services.
“And let me emphasize that these are children who were ultimately found to have accidental fractures,” Dr. Johnson said.
Meanwhile, in an analysis of known cases of head trauma, researchers found that abuse was missed in 37% of White children, compared with 19% of non-White children.
“These only represent the tip of the iceberg as a true number of cases of abuse may never really be detected because some cases are still unknown,” Dr. Johnson told attendees. And the harm of these disparities runs in both directions.
“Failing to diagnose abuse in White children clearly puts them at increased risk for return visits and return evaluations for repeated abuse by the perpetrators,” she said. But harm also can result from overreporting and investigation, including psychological trauma and a waste of limited resources. Overinvestigation also can erode family-physician relationships and perpetuate distrust of medical care in communities of color.
Yet at the same time, it’s clear that Black children, adolescents, and young adults are not protected from harm in society more generally, when at home, where they learn, or where they play, Dr. Johnson said, referencing the deaths of Breonna Taylor and Tamir Rice as examples.
“And now we’re seeing increased evidence that children are not protected in the health care center when we think about the many disparities that have been identified in the care and outcomes of children, including the disproportionality in terms of child abuse evaluation and referrals,” Dr. Johnson said.
Racism is a root cause of that harm to Black children, she said, as the systemic structure of opportunities unfairly disadvantages some individuals and communities while unfairly advantaging others, thereby “sapping the strength of the whole society through the waste of human resources.”
Tonya Chaffee, MD, MPH, a clinical professor of health sciences at the University of California, San Francisco, who attended the session, said she particularly appreciated “seeing data on which racial/ethnic populations have child abuse reports made and the disparities that exist that are similar to what we are noticing in our own institution.”
Role of individual-level implicit bias and racism
While institutional and structural racism play a substantial role in health care disparities, Dr. Johnson focused primarily on the impact of personal racism when it comes to child abuse evaluations, through overt discrimination, explicit bias, implicit bias, and stigmatization. The most challenging of these to identify and acknowledge is often implicit bias, a tendency to believe, even unconsciously, that some people or ideas are better than others, which results in unfair treatment.
For example, a 2016 study found that half of medical students and residents held at least one biological belief about differences between Black and White individuals that was actually false, such as Black people having more pain tolerance or stronger bones than White people, which then affected treatment recommendations.
“Implicit bias refers to our attitudes that lie below the surface, but they can still influence our behaviors,” Dr. Johnson explained. She encouraged providers to take the implicit bias test online to learn about their own unrecognized implicit biases. These biases have a hand in influencing decisions particularly in fast-paced environments where cognitive load is high – such as EDs, where many child abuse evaluations occur.
For example, in one study Dr. Johnson led, the researchers measured implicit bias in participants before and after an ED shift to assess how cognitive load affected bias. They found that participants who care for more than 10 patients, the average score for implicit bias increased.
Similarly, “when the ED was more overcrowded, there was also increased bias at the end of the shift, compared to the beginning of the shift,” Dr. Johnson said. She asked clinicians to take into consideration that at the start of the shift, they may feel well rested and freshly caffeinated, able to suppress or overcome the biases that they know they have.
“But our biases [are] more likely to come into play with every subsequent decision that we make throughout the day when we’re engaged in clinical encounters,” such as who does and does not receive a skeletal survey or get referred to child protective services, she said.
In another study where she hypothesized that resident physicians would have less bias on the child race implicit bias test than on the adult race one, Dr. Johnson reported that 85% of 91 residents working in an ED had an implicit pro-White/anti-Black bias in the test on adult race, but an even higher bias score – 91% – with child race.
Research has found that even children’s names can conjure implicit bias when it comes to stereotypically “White-sounding” names versus stereotypically “Black-sounding names.”
The implicit bias among clinicians extends beyond care of different children. Research has also identified association between higher implicit bias scores and less interpersonal treatment, less supportive communication, less patient-centered communication, poorer patient ratings of satisfaction, and greater patient-reported difficulty with following recommendations, Dr. Johnson said.
“I want you to think about that because I know that when we’re engaging with parents and making decisions about whether or not we’re going to do a skeletal survey or report someone for it, there is a lot of subjectivity that comes into play with how you’re interacting with families,” Dr. Johnson said. Those verbal and nonverbal cues may be triggering to parents, which then affects your interaction with them. Further, research shows that these biases may impact treatment decisions as well.
Personal-mediated racism also shows up in the use of stigmatizing language, Dr. Johnson said.
“When providers read stigmatizing language in the patient’s medical records, it was associated with them having more negative attitudes about that patient,” which then influenced their clinical decision-making, she said. “So when providers got primed with stigmatizing language, they subsequently had less aggressive pain management for those patients.”
Clinical implications for patient care
Dr. Johnson encouraged attendees to be careful about the language and tone they use in communicating with other health care providers and during documentation in medical records. Disparities in child abuse evaluation and reporting tend to be greater in EDs with more subjective conditions, whereas disparities are lower in departments with more established protocols.
She recommended several changes to practice that can reduce the impact of implicit bias. Universal screening for child abuse can increase how many injuries are found, but usually at the cost of increased resources and radiation. Another option is use of validated clinical decision support rules to identify who is at high or low risk for maltreatment, something Dr. Johnson is working on in her research.
But it’s also important for individual providers to confront their personal biases. Evidence-based strategies for reducing bias include perspective taking, focusing on common identities with patients, using counter-stereotypical imaging, seeking increased opportunity for cross-cultural contact, and mindfulness meditation.
“When you interact with people of different backgrounds, it helps to reduce the impact of stereotypes in society about those individuals,” Dr. Johnson told attendees. It’s also important to recognize how diversity in your clinical team can reduce bias.
“We need to work with our institutions to confront racial biases in child abuse reporting and develop quality improvement projects to ensure reporting is done objectively,” Dr. Chaffee said in an interview after attending the session. “This will require training and likely policy changes, including how reports are made to child welfare and/or the police moving forward.”
FROM AAP 2020