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Mayo Clinic fires 700 employees for refusing COVID vaccine

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Mon, 01/10/2022 - 10:27

 

The Mayo Clinic fired 700 employees this week who didn’t comply with its COVID-19 vaccine mandate.

The medical center, which is Minnesota’s largest employer, has major campuses in Arizona, Florida, and Minnesota and operates hospitals in Iowa and Wisconsin.

Employees had until Jan. 3 to get vaccinated or receive approval for an exemption. On Jan. 4, the hospital fired those who didn’t meet the requirement, according to Action News Jax, a CBS affiliate in Florida.

The 700 employees make up about 1% of Mayo Clinic’s 73,000-person workforce. So far, none of the employees at the campus in Jacksonville, Fla., have been affected, the news outlet reported.

“Florida staff who are not in compliance with our vaccination program remain employed pending the outcome of litigation related to the Centers for Medicare & Medicaid Services requirements,” a Mayo Clinic spokesperson told Action News Jax.

The federal government and Florida remain at odds over vaccine mandates, and several lawsuits are winding through the court system. Florida Gov. Ron DeSantis signed legislation in November that bans private Florida employers from requiring all employees to get vaccinated and calls for various exemption options, according to The Florida Times-Union. The state law clashes with a federal rule that requires vaccinations for all health care workers at hospitals that receive Medicare and Medicaid funding.

The Mayo Clinic mandate required employees to receive at least one COVID-19 vaccine dose and not be “overdue” for a second dose, according to the statement. Only medical and religious exemptions were allowed, and most medical and religious exemptions were approved.

“While Mayo Clinic is saddened to lose valuable employees, we need to take all steps necessary to keep our patients, workforce, visitors, and communities safe,” Mayo Clinic wrote in its statement. “If individuals released from employment choose to get vaccinated at a later date, the opportunity exists for them to apply and return to Mayo Clinic for future job openings.”

With the latest surge in COVID-19 cases from the Omicron variant, the Mayo Clinic also encouraged unvaccinated people to get a shot and those who are eligible for a booster to get one “as soon as possible.”

“Based on science and data, it’s clear that vaccination keeps people out of the hospital and saves lives,” according to the statement. “That’s true for everyone in our communities – and it’s especially true for the many patients with serious or complex diseases who seek care at Mayo Clinic each day.”

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

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The Mayo Clinic fired 700 employees this week who didn’t comply with its COVID-19 vaccine mandate.

The medical center, which is Minnesota’s largest employer, has major campuses in Arizona, Florida, and Minnesota and operates hospitals in Iowa and Wisconsin.

Employees had until Jan. 3 to get vaccinated or receive approval for an exemption. On Jan. 4, the hospital fired those who didn’t meet the requirement, according to Action News Jax, a CBS affiliate in Florida.

The 700 employees make up about 1% of Mayo Clinic’s 73,000-person workforce. So far, none of the employees at the campus in Jacksonville, Fla., have been affected, the news outlet reported.

“Florida staff who are not in compliance with our vaccination program remain employed pending the outcome of litigation related to the Centers for Medicare & Medicaid Services requirements,” a Mayo Clinic spokesperson told Action News Jax.

The federal government and Florida remain at odds over vaccine mandates, and several lawsuits are winding through the court system. Florida Gov. Ron DeSantis signed legislation in November that bans private Florida employers from requiring all employees to get vaccinated and calls for various exemption options, according to The Florida Times-Union. The state law clashes with a federal rule that requires vaccinations for all health care workers at hospitals that receive Medicare and Medicaid funding.

The Mayo Clinic mandate required employees to receive at least one COVID-19 vaccine dose and not be “overdue” for a second dose, according to the statement. Only medical and religious exemptions were allowed, and most medical and religious exemptions were approved.

“While Mayo Clinic is saddened to lose valuable employees, we need to take all steps necessary to keep our patients, workforce, visitors, and communities safe,” Mayo Clinic wrote in its statement. “If individuals released from employment choose to get vaccinated at a later date, the opportunity exists for them to apply and return to Mayo Clinic for future job openings.”

With the latest surge in COVID-19 cases from the Omicron variant, the Mayo Clinic also encouraged unvaccinated people to get a shot and those who are eligible for a booster to get one “as soon as possible.”

“Based on science and data, it’s clear that vaccination keeps people out of the hospital and saves lives,” according to the statement. “That’s true for everyone in our communities – and it’s especially true for the many patients with serious or complex diseases who seek care at Mayo Clinic each day.”

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

 

The Mayo Clinic fired 700 employees this week who didn’t comply with its COVID-19 vaccine mandate.

The medical center, which is Minnesota’s largest employer, has major campuses in Arizona, Florida, and Minnesota and operates hospitals in Iowa and Wisconsin.

Employees had until Jan. 3 to get vaccinated or receive approval for an exemption. On Jan. 4, the hospital fired those who didn’t meet the requirement, according to Action News Jax, a CBS affiliate in Florida.

The 700 employees make up about 1% of Mayo Clinic’s 73,000-person workforce. So far, none of the employees at the campus in Jacksonville, Fla., have been affected, the news outlet reported.

“Florida staff who are not in compliance with our vaccination program remain employed pending the outcome of litigation related to the Centers for Medicare & Medicaid Services requirements,” a Mayo Clinic spokesperson told Action News Jax.

The federal government and Florida remain at odds over vaccine mandates, and several lawsuits are winding through the court system. Florida Gov. Ron DeSantis signed legislation in November that bans private Florida employers from requiring all employees to get vaccinated and calls for various exemption options, according to The Florida Times-Union. The state law clashes with a federal rule that requires vaccinations for all health care workers at hospitals that receive Medicare and Medicaid funding.

The Mayo Clinic mandate required employees to receive at least one COVID-19 vaccine dose and not be “overdue” for a second dose, according to the statement. Only medical and religious exemptions were allowed, and most medical and religious exemptions were approved.

“While Mayo Clinic is saddened to lose valuable employees, we need to take all steps necessary to keep our patients, workforce, visitors, and communities safe,” Mayo Clinic wrote in its statement. “If individuals released from employment choose to get vaccinated at a later date, the opportunity exists for them to apply and return to Mayo Clinic for future job openings.”

With the latest surge in COVID-19 cases from the Omicron variant, the Mayo Clinic also encouraged unvaccinated people to get a shot and those who are eligible for a booster to get one “as soon as possible.”

“Based on science and data, it’s clear that vaccination keeps people out of the hospital and saves lives,” according to the statement. “That’s true for everyone in our communities – and it’s especially true for the many patients with serious or complex diseases who seek care at Mayo Clinic each day.”

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

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Fossilized blood proteins from child illness may cause chalky teeth

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Fri, 01/07/2022 - 09:55

 

FROM FRONTIERS IN PHYSIOLOGY

Researchers have identified a potential cause of molar hypomineralization (MH), or “chalky teeth,” an underrecognized condition affecting one in five children worldwide. The discovery could lead to preventive medical therapies to reduce dental caries and extractions, they said.

According to a team led by biochemist Michael J. Hubbard, BDS, PhD, professor in the department of medicine, dentistry, and health sciences at the University of Melbourne, the “groundbreaking” research found that the failure of enamel to adequately harden is associated with exposure to serum albumin while teeth are developing. The blood protein “poisons” the growth of mineral crystals rather than injure the cells that deposit enamel, they reported.

The investigators, including researchers from Chile, said their findings hold promise for better clinical management of MH and open a new door into research on the broader pathogenesis and causes of the condition.

“We hope this breakthrough will eventually lead to medical prevention of MH, prompting global health benefits including major reductions in childhood tooth decay,” they wrote in an article published online Dec. 21 in Frontiers in Physiology.
 

More than cosmetic

Chalky teeth, characterized by discolored enamel spots, are not merely a cosmetic problem. The condition can lead to severe toothache, painful eating, tooth decay, and even abscesses and extractions. Although its triggers have eluded dental research for a century, Dr. Hubbard’s group said fossilized blood proteins such as albumin in the tooth appear to be at least one cause.

Biochemical evidence indicates that serum albumin surrounding developing teeth is normally excluded from enamel, Dr. Hubbard said in an interview. “Given that albumin binds strongly to hydroxyapatite-based mineral and blocks its growth, we infer that the epithelial barrier – the enamel-forming cells termed ameloblasts and normally responsible for excluding albumin – must break down in places in response to medical triggers.”

This breach enables localized infiltration of albumin, which then blocks further hardening of soft, immature enamel, leading to residual spots or patches of chalky enamel once the tooth eventually erupts into the mouth. “In other words, we infer that chalky enamel spots coincide with localized breaches of an epithelial barrier that are triggered by yet-to-be determined systemic insults,” he said.

Joseph Brofsky, DMD, section head of pediatric dentistry at North Shore LIJ Cohen Children’s Medical Center of New York, in Queens, agreed that that the definitive cause of MH has evaded identification for a hundred years. However, he expressed skepticism about the fossilized blood protein hypothesis.

“That’s a long shot. It’s a possibility, and I’m not ruling it out, but we’re not 100% sure,” said Dr. Brofsky, who was not involved in the research.

In his experience, MH is somewhat less prevalent in the United States, affecting about 1 in 10 children here, which is about half the global rate. “But it’s a problem, and we wish it would go away, but before we know beyond a reasonable doubt what causes this condition, it’s going to be hard to stop it.”

Most cases of MH involve hypomineralization of the 6-year molars, the first adult molars to erupt, but the process starts at birth. “For 6-year molars, normal hardening of dental enamel takes place from the early postnatal period through infancy,” Dr. Hubbard said.

The 2-year and 12-year molars are affected about half as frequently as their 6-year counterparts, “so this extends the medical-risk window out to early school days, and slightly back to the perinatal period for the 12-year and 2-year molars, respectively,” he said.

A critical question is which childhood illnesses are most likely to set the stage for MH, he added. “Forty-plus years of epidemiology have failed to nail a specific cause or causal association. But given the high prevalence of MH – 20% in otherwise healthy kids – naturally we suspect some common illnesses are the culprits,” he said. “But which diseases, which medications, and which combinations?”

Dr. Hubbard’s advice to pediatricians is to be alert to MH: “If you’re inspecting a child’s throat, then why not look at their back teeth, too – particularly when they’re getting their new molars at 2, 6, and 12 years?”

The study was supported by the Melbourne Research Unit for Facial Disorders Department of Pharmacology & Therapeutics, Department of Paediatrics, and Faculty of Medicine, Dentistry, and Health Sciences at the University of Melbourne. The authors and Dr. Brofsky have disclosed no relevant financial relationships.

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

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FROM FRONTIERS IN PHYSIOLOGY

Researchers have identified a potential cause of molar hypomineralization (MH), or “chalky teeth,” an underrecognized condition affecting one in five children worldwide. The discovery could lead to preventive medical therapies to reduce dental caries and extractions, they said.

According to a team led by biochemist Michael J. Hubbard, BDS, PhD, professor in the department of medicine, dentistry, and health sciences at the University of Melbourne, the “groundbreaking” research found that the failure of enamel to adequately harden is associated with exposure to serum albumin while teeth are developing. The blood protein “poisons” the growth of mineral crystals rather than injure the cells that deposit enamel, they reported.

The investigators, including researchers from Chile, said their findings hold promise for better clinical management of MH and open a new door into research on the broader pathogenesis and causes of the condition.

“We hope this breakthrough will eventually lead to medical prevention of MH, prompting global health benefits including major reductions in childhood tooth decay,” they wrote in an article published online Dec. 21 in Frontiers in Physiology.
 

More than cosmetic

Chalky teeth, characterized by discolored enamel spots, are not merely a cosmetic problem. The condition can lead to severe toothache, painful eating, tooth decay, and even abscesses and extractions. Although its triggers have eluded dental research for a century, Dr. Hubbard’s group said fossilized blood proteins such as albumin in the tooth appear to be at least one cause.

Biochemical evidence indicates that serum albumin surrounding developing teeth is normally excluded from enamel, Dr. Hubbard said in an interview. “Given that albumin binds strongly to hydroxyapatite-based mineral and blocks its growth, we infer that the epithelial barrier – the enamel-forming cells termed ameloblasts and normally responsible for excluding albumin – must break down in places in response to medical triggers.”

This breach enables localized infiltration of albumin, which then blocks further hardening of soft, immature enamel, leading to residual spots or patches of chalky enamel once the tooth eventually erupts into the mouth. “In other words, we infer that chalky enamel spots coincide with localized breaches of an epithelial barrier that are triggered by yet-to-be determined systemic insults,” he said.

Joseph Brofsky, DMD, section head of pediatric dentistry at North Shore LIJ Cohen Children’s Medical Center of New York, in Queens, agreed that that the definitive cause of MH has evaded identification for a hundred years. However, he expressed skepticism about the fossilized blood protein hypothesis.

“That’s a long shot. It’s a possibility, and I’m not ruling it out, but we’re not 100% sure,” said Dr. Brofsky, who was not involved in the research.

In his experience, MH is somewhat less prevalent in the United States, affecting about 1 in 10 children here, which is about half the global rate. “But it’s a problem, and we wish it would go away, but before we know beyond a reasonable doubt what causes this condition, it’s going to be hard to stop it.”

Most cases of MH involve hypomineralization of the 6-year molars, the first adult molars to erupt, but the process starts at birth. “For 6-year molars, normal hardening of dental enamel takes place from the early postnatal period through infancy,” Dr. Hubbard said.

The 2-year and 12-year molars are affected about half as frequently as their 6-year counterparts, “so this extends the medical-risk window out to early school days, and slightly back to the perinatal period for the 12-year and 2-year molars, respectively,” he said.

A critical question is which childhood illnesses are most likely to set the stage for MH, he added. “Forty-plus years of epidemiology have failed to nail a specific cause or causal association. But given the high prevalence of MH – 20% in otherwise healthy kids – naturally we suspect some common illnesses are the culprits,” he said. “But which diseases, which medications, and which combinations?”

Dr. Hubbard’s advice to pediatricians is to be alert to MH: “If you’re inspecting a child’s throat, then why not look at their back teeth, too – particularly when they’re getting their new molars at 2, 6, and 12 years?”

The study was supported by the Melbourne Research Unit for Facial Disorders Department of Pharmacology & Therapeutics, Department of Paediatrics, and Faculty of Medicine, Dentistry, and Health Sciences at the University of Melbourne. The authors and Dr. Brofsky have disclosed no relevant financial relationships.

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

 

FROM FRONTIERS IN PHYSIOLOGY

Researchers have identified a potential cause of molar hypomineralization (MH), or “chalky teeth,” an underrecognized condition affecting one in five children worldwide. The discovery could lead to preventive medical therapies to reduce dental caries and extractions, they said.

According to a team led by biochemist Michael J. Hubbard, BDS, PhD, professor in the department of medicine, dentistry, and health sciences at the University of Melbourne, the “groundbreaking” research found that the failure of enamel to adequately harden is associated with exposure to serum albumin while teeth are developing. The blood protein “poisons” the growth of mineral crystals rather than injure the cells that deposit enamel, they reported.

The investigators, including researchers from Chile, said their findings hold promise for better clinical management of MH and open a new door into research on the broader pathogenesis and causes of the condition.

“We hope this breakthrough will eventually lead to medical prevention of MH, prompting global health benefits including major reductions in childhood tooth decay,” they wrote in an article published online Dec. 21 in Frontiers in Physiology.
 

More than cosmetic

Chalky teeth, characterized by discolored enamel spots, are not merely a cosmetic problem. The condition can lead to severe toothache, painful eating, tooth decay, and even abscesses and extractions. Although its triggers have eluded dental research for a century, Dr. Hubbard’s group said fossilized blood proteins such as albumin in the tooth appear to be at least one cause.

Biochemical evidence indicates that serum albumin surrounding developing teeth is normally excluded from enamel, Dr. Hubbard said in an interview. “Given that albumin binds strongly to hydroxyapatite-based mineral and blocks its growth, we infer that the epithelial barrier – the enamel-forming cells termed ameloblasts and normally responsible for excluding albumin – must break down in places in response to medical triggers.”

This breach enables localized infiltration of albumin, which then blocks further hardening of soft, immature enamel, leading to residual spots or patches of chalky enamel once the tooth eventually erupts into the mouth. “In other words, we infer that chalky enamel spots coincide with localized breaches of an epithelial barrier that are triggered by yet-to-be determined systemic insults,” he said.

Joseph Brofsky, DMD, section head of pediatric dentistry at North Shore LIJ Cohen Children’s Medical Center of New York, in Queens, agreed that that the definitive cause of MH has evaded identification for a hundred years. However, he expressed skepticism about the fossilized blood protein hypothesis.

“That’s a long shot. It’s a possibility, and I’m not ruling it out, but we’re not 100% sure,” said Dr. Brofsky, who was not involved in the research.

In his experience, MH is somewhat less prevalent in the United States, affecting about 1 in 10 children here, which is about half the global rate. “But it’s a problem, and we wish it would go away, but before we know beyond a reasonable doubt what causes this condition, it’s going to be hard to stop it.”

Most cases of MH involve hypomineralization of the 6-year molars, the first adult molars to erupt, but the process starts at birth. “For 6-year molars, normal hardening of dental enamel takes place from the early postnatal period through infancy,” Dr. Hubbard said.

The 2-year and 12-year molars are affected about half as frequently as their 6-year counterparts, “so this extends the medical-risk window out to early school days, and slightly back to the perinatal period for the 12-year and 2-year molars, respectively,” he said.

A critical question is which childhood illnesses are most likely to set the stage for MH, he added. “Forty-plus years of epidemiology have failed to nail a specific cause or causal association. But given the high prevalence of MH – 20% in otherwise healthy kids – naturally we suspect some common illnesses are the culprits,” he said. “But which diseases, which medications, and which combinations?”

Dr. Hubbard’s advice to pediatricians is to be alert to MH: “If you’re inspecting a child’s throat, then why not look at their back teeth, too – particularly when they’re getting their new molars at 2, 6, and 12 years?”

The study was supported by the Melbourne Research Unit for Facial Disorders Department of Pharmacology & Therapeutics, Department of Paediatrics, and Faculty of Medicine, Dentistry, and Health Sciences at the University of Melbourne. The authors and Dr. Brofsky have disclosed no relevant financial relationships.

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

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Effective alternatives to psychotherapy for borderline personality disorder

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Fri, 01/07/2022 - 08:48

 

Early interventions that focus on clinical case management and psychiatric care, and not necessarily on individual psychotherapy, are effective for young patients with borderline personality disorder (BPD), new research suggests.

Findings from the Monitoring Outcomes of Borderline Personality Disorder in Youth (MOBY) trial also showed improved psychosocial functioning and reduced suicide ideation with these therapies.

Dr. John M. Oldham

The results suggest that, contrary to common belief, psychotherapy is not the only effective approach for early BPD, lead author Andrew M. Chanen, PhD, director of clinical programs and services and head of personality disorder research at Orygen, Melbourne, told this news organization.

“We can say that early diagnosis and early treatment is effective, and the treatment doesn’t need to involve individual psychotherapy but does need to involve clinical case management and psychiatric care,” said Dr. Chanen, a professorial fellow at the Centre for Youth Mental Health, University of Melbourne.

The findings were published online in JAMA Psychiatry.
 

Extreme sensitivity

Patients with BPD have “extreme sensitivity to interpersonal slights” and often exhibit intense and volatile emotions and impulsive behavior, Dr. Chanen noted. Many will self-harm, abuse drugs, or attempt suicide; the suicide rate among patients with BPD is 8%-10%.

The condition is typically diagnosed in puberty or early adulthood, affecting about 3% of young people and a little more than 1% of adults.

Because of their aggression and interpersonal difficulties, patients with BPD are often discriminated against by health professionals and end up not getting treated, said Dr. Chanen.

Those who are treated often receive individual psychotherapy, such as dialectical behavior therapy (DBT). That type of therapy, which teaches healthy ways to cope with stress and regulate emotions, is very effective, Dr. Chanen said.

The MOBY trial examined three treatment approaches: the Helping Young People Early (HYPE) model, HYPE combined with weekly “befriending,” and a general youth mental health service (YMHS) model combined with befriending.

A key element of HYPE is cognitive analytic therapy, a psychotherapy program focused on understanding problematic self-management and interpersonal relationship patterns. The model includes clinical case management, such as attending to housing, vocational and educational issues, other mental health needs, and physical health needs.

In the second model, the psychotherapy of the HYPE program was replaced with befriending, which involves chatting with a patient about neutral topics such as sports and avoiding emotionally loaded topics such as interpersonal problems.

For YMHS plus befriending, experts trained in treating young people, but not specialized in treating BPD, were involved in managing patients.

‘High satisfaction’

Researchers randomly assigned 139 participants aged 15-25 years (80.6% women; mean age, 19.1 years) with BPD to one of the treatment arms. Of these, 128 (92.1%) were included in the intent-to-treat analysis.

The primary endpoint was psychosocial functioning, as measured by the Inventory of Interpersonal Problems Circumplex Version and the Social Adjustment Scale–Self-Report. Secondary endpoints included suicidal ideation, suicide attempts, nonsuicidal self-injury, depression, substance use, and treatment satisfaction.

The investigators reported group averages, but the study’s noninferiority design did not allow for determining if one treatment had superior efficacy.

All groups improved significantly on the primary endpoint. At 12 months, there was a mean 28.91-point (23.8%) drop in interpersonal problems and a mean 0.55-point (19.3%) drop in social adjustment scores.

For secondary outcomes, mean improvements at 12 months ranged from 40.7% (17.64 points) on the depression scale to 52.7% (6.22 points) for suicide ideation.

“The only area where the treatment didn’t really have an impact was substance use,” said Dr. Chanen. “Satisfaction was high for all three interventions throughout the study, and it’s hard to improve on high satisfaction.”

 

 

‘Turns things upside down’

That patients across all groups had marked and sustained improvements “in ways you wouldn’t expect for BPD” supports the conclusion that the interventions had a true effect, Dr. Chanen said.

The results suggest early diagnosis and “a not very complicated treatment [will] drastically improve the lives of these young people,” he added.

They also imply there are effective alternatives to psychotherapy, which many individuals in the field insist is the only way to treat BPD. “This study turns things upside down and says actually it’s not. It’s the basics of treatment that are important,” Dr. Chanen said.

When a patient presents at the emergency department following a severe overdose, “it’s a reflex” for clinicians to refer that person to a psychotherapy program. “The problem is, these programs are not plentiful enough to be able to service the needs of this group,” Dr. Chanen noted.

On the other hand, the skills for clinical case management and psychiatric care “are available throughout the mental health systems,” he added.

The researchers are planning another analysis to determine whether age and sex predict better outcomes in these patients with BPD.
 

Unique contribution

Commenting for this news organization, John M. Oldham, MD, distinguished emeritus professor, Baylor College of Medicine, Houston, said a “unique and important contribution” of the study is the focus on early intervention.

“The general standard approach in psychiatry and the diagnostic world has been to not even consider anything until after somebody is 18 years of age, which is a mistake because these kids can become quite impaired earlier than that,” he said.

Dr. Oldham, who was not involved with the research, chaired the American Psychiatric Association workgroup that developed the 2001 evidence-based practice guideline for treating BPD, which recommended psychotherapy as the primary treatment. The guideline was last updated in 2005 – and another update is currently being developed, he noted.

There is an emerging trend toward “good psychiatric management” that focuses on level of functioning rather than on a specific strategy requiring a certificate of training that “not many people out there have,” said Dr. Oldham.

“You’re not going to make much headway with these kids if you’re going to be searching around for a DBT-certified therapist. What you need is to bring them in, get them to trust you, and in a sense be a kind of overall behavioral medicine navigator for them,” he added.

Dr. Oldham noted that, although the primary study outcome improved between 19% and 24%, “that means three-quarters of the people didn’t improve.”

He also pointed out this was only a 1-year trial. “Sometimes treatment for people with a personality disorder such as borderline takes a lot longer than that,” Dr. Oldham concluded.

The trial was funded by the National Health and Medical Research Council. Dr. Chanen reports receiving grants from the Australian government’s National Health and Medical Research Council during the conduct of the study and other support from the Helping Young People Early (HYPE) translational program outside the submitted work. He and another investigator cofounded and lead the HYPE clinical program, a government-funded program with continuous support, and the HYPE translational program, a not-for-profit training program. Dr. Oldham reported no relevant financial relationships.

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

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Early interventions that focus on clinical case management and psychiatric care, and not necessarily on individual psychotherapy, are effective for young patients with borderline personality disorder (BPD), new research suggests.

Findings from the Monitoring Outcomes of Borderline Personality Disorder in Youth (MOBY) trial also showed improved psychosocial functioning and reduced suicide ideation with these therapies.

Dr. John M. Oldham

The results suggest that, contrary to common belief, psychotherapy is not the only effective approach for early BPD, lead author Andrew M. Chanen, PhD, director of clinical programs and services and head of personality disorder research at Orygen, Melbourne, told this news organization.

“We can say that early diagnosis and early treatment is effective, and the treatment doesn’t need to involve individual psychotherapy but does need to involve clinical case management and psychiatric care,” said Dr. Chanen, a professorial fellow at the Centre for Youth Mental Health, University of Melbourne.

The findings were published online in JAMA Psychiatry.
 

Extreme sensitivity

Patients with BPD have “extreme sensitivity to interpersonal slights” and often exhibit intense and volatile emotions and impulsive behavior, Dr. Chanen noted. Many will self-harm, abuse drugs, or attempt suicide; the suicide rate among patients with BPD is 8%-10%.

The condition is typically diagnosed in puberty or early adulthood, affecting about 3% of young people and a little more than 1% of adults.

Because of their aggression and interpersonal difficulties, patients with BPD are often discriminated against by health professionals and end up not getting treated, said Dr. Chanen.

Those who are treated often receive individual psychotherapy, such as dialectical behavior therapy (DBT). That type of therapy, which teaches healthy ways to cope with stress and regulate emotions, is very effective, Dr. Chanen said.

The MOBY trial examined three treatment approaches: the Helping Young People Early (HYPE) model, HYPE combined with weekly “befriending,” and a general youth mental health service (YMHS) model combined with befriending.

A key element of HYPE is cognitive analytic therapy, a psychotherapy program focused on understanding problematic self-management and interpersonal relationship patterns. The model includes clinical case management, such as attending to housing, vocational and educational issues, other mental health needs, and physical health needs.

In the second model, the psychotherapy of the HYPE program was replaced with befriending, which involves chatting with a patient about neutral topics such as sports and avoiding emotionally loaded topics such as interpersonal problems.

For YMHS plus befriending, experts trained in treating young people, but not specialized in treating BPD, were involved in managing patients.

‘High satisfaction’

Researchers randomly assigned 139 participants aged 15-25 years (80.6% women; mean age, 19.1 years) with BPD to one of the treatment arms. Of these, 128 (92.1%) were included in the intent-to-treat analysis.

The primary endpoint was psychosocial functioning, as measured by the Inventory of Interpersonal Problems Circumplex Version and the Social Adjustment Scale–Self-Report. Secondary endpoints included suicidal ideation, suicide attempts, nonsuicidal self-injury, depression, substance use, and treatment satisfaction.

The investigators reported group averages, but the study’s noninferiority design did not allow for determining if one treatment had superior efficacy.

All groups improved significantly on the primary endpoint. At 12 months, there was a mean 28.91-point (23.8%) drop in interpersonal problems and a mean 0.55-point (19.3%) drop in social adjustment scores.

For secondary outcomes, mean improvements at 12 months ranged from 40.7% (17.64 points) on the depression scale to 52.7% (6.22 points) for suicide ideation.

“The only area where the treatment didn’t really have an impact was substance use,” said Dr. Chanen. “Satisfaction was high for all three interventions throughout the study, and it’s hard to improve on high satisfaction.”

 

 

‘Turns things upside down’

That patients across all groups had marked and sustained improvements “in ways you wouldn’t expect for BPD” supports the conclusion that the interventions had a true effect, Dr. Chanen said.

The results suggest early diagnosis and “a not very complicated treatment [will] drastically improve the lives of these young people,” he added.

They also imply there are effective alternatives to psychotherapy, which many individuals in the field insist is the only way to treat BPD. “This study turns things upside down and says actually it’s not. It’s the basics of treatment that are important,” Dr. Chanen said.

When a patient presents at the emergency department following a severe overdose, “it’s a reflex” for clinicians to refer that person to a psychotherapy program. “The problem is, these programs are not plentiful enough to be able to service the needs of this group,” Dr. Chanen noted.

On the other hand, the skills for clinical case management and psychiatric care “are available throughout the mental health systems,” he added.

The researchers are planning another analysis to determine whether age and sex predict better outcomes in these patients with BPD.
 

Unique contribution

Commenting for this news organization, John M. Oldham, MD, distinguished emeritus professor, Baylor College of Medicine, Houston, said a “unique and important contribution” of the study is the focus on early intervention.

“The general standard approach in psychiatry and the diagnostic world has been to not even consider anything until after somebody is 18 years of age, which is a mistake because these kids can become quite impaired earlier than that,” he said.

Dr. Oldham, who was not involved with the research, chaired the American Psychiatric Association workgroup that developed the 2001 evidence-based practice guideline for treating BPD, which recommended psychotherapy as the primary treatment. The guideline was last updated in 2005 – and another update is currently being developed, he noted.

There is an emerging trend toward “good psychiatric management” that focuses on level of functioning rather than on a specific strategy requiring a certificate of training that “not many people out there have,” said Dr. Oldham.

“You’re not going to make much headway with these kids if you’re going to be searching around for a DBT-certified therapist. What you need is to bring them in, get them to trust you, and in a sense be a kind of overall behavioral medicine navigator for them,” he added.

Dr. Oldham noted that, although the primary study outcome improved between 19% and 24%, “that means three-quarters of the people didn’t improve.”

He also pointed out this was only a 1-year trial. “Sometimes treatment for people with a personality disorder such as borderline takes a lot longer than that,” Dr. Oldham concluded.

The trial was funded by the National Health and Medical Research Council. Dr. Chanen reports receiving grants from the Australian government’s National Health and Medical Research Council during the conduct of the study and other support from the Helping Young People Early (HYPE) translational program outside the submitted work. He and another investigator cofounded and lead the HYPE clinical program, a government-funded program with continuous support, and the HYPE translational program, a not-for-profit training program. Dr. Oldham reported no relevant financial relationships.

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

 

Early interventions that focus on clinical case management and psychiatric care, and not necessarily on individual psychotherapy, are effective for young patients with borderline personality disorder (BPD), new research suggests.

Findings from the Monitoring Outcomes of Borderline Personality Disorder in Youth (MOBY) trial also showed improved psychosocial functioning and reduced suicide ideation with these therapies.

Dr. John M. Oldham

The results suggest that, contrary to common belief, psychotherapy is not the only effective approach for early BPD, lead author Andrew M. Chanen, PhD, director of clinical programs and services and head of personality disorder research at Orygen, Melbourne, told this news organization.

“We can say that early diagnosis and early treatment is effective, and the treatment doesn’t need to involve individual psychotherapy but does need to involve clinical case management and psychiatric care,” said Dr. Chanen, a professorial fellow at the Centre for Youth Mental Health, University of Melbourne.

The findings were published online in JAMA Psychiatry.
 

Extreme sensitivity

Patients with BPD have “extreme sensitivity to interpersonal slights” and often exhibit intense and volatile emotions and impulsive behavior, Dr. Chanen noted. Many will self-harm, abuse drugs, or attempt suicide; the suicide rate among patients with BPD is 8%-10%.

The condition is typically diagnosed in puberty or early adulthood, affecting about 3% of young people and a little more than 1% of adults.

Because of their aggression and interpersonal difficulties, patients with BPD are often discriminated against by health professionals and end up not getting treated, said Dr. Chanen.

Those who are treated often receive individual psychotherapy, such as dialectical behavior therapy (DBT). That type of therapy, which teaches healthy ways to cope with stress and regulate emotions, is very effective, Dr. Chanen said.

The MOBY trial examined three treatment approaches: the Helping Young People Early (HYPE) model, HYPE combined with weekly “befriending,” and a general youth mental health service (YMHS) model combined with befriending.

A key element of HYPE is cognitive analytic therapy, a psychotherapy program focused on understanding problematic self-management and interpersonal relationship patterns. The model includes clinical case management, such as attending to housing, vocational and educational issues, other mental health needs, and physical health needs.

In the second model, the psychotherapy of the HYPE program was replaced with befriending, which involves chatting with a patient about neutral topics such as sports and avoiding emotionally loaded topics such as interpersonal problems.

For YMHS plus befriending, experts trained in treating young people, but not specialized in treating BPD, were involved in managing patients.

‘High satisfaction’

Researchers randomly assigned 139 participants aged 15-25 years (80.6% women; mean age, 19.1 years) with BPD to one of the treatment arms. Of these, 128 (92.1%) were included in the intent-to-treat analysis.

The primary endpoint was psychosocial functioning, as measured by the Inventory of Interpersonal Problems Circumplex Version and the Social Adjustment Scale–Self-Report. Secondary endpoints included suicidal ideation, suicide attempts, nonsuicidal self-injury, depression, substance use, and treatment satisfaction.

The investigators reported group averages, but the study’s noninferiority design did not allow for determining if one treatment had superior efficacy.

All groups improved significantly on the primary endpoint. At 12 months, there was a mean 28.91-point (23.8%) drop in interpersonal problems and a mean 0.55-point (19.3%) drop in social adjustment scores.

For secondary outcomes, mean improvements at 12 months ranged from 40.7% (17.64 points) on the depression scale to 52.7% (6.22 points) for suicide ideation.

“The only area where the treatment didn’t really have an impact was substance use,” said Dr. Chanen. “Satisfaction was high for all three interventions throughout the study, and it’s hard to improve on high satisfaction.”

 

 

‘Turns things upside down’

That patients across all groups had marked and sustained improvements “in ways you wouldn’t expect for BPD” supports the conclusion that the interventions had a true effect, Dr. Chanen said.

The results suggest early diagnosis and “a not very complicated treatment [will] drastically improve the lives of these young people,” he added.

They also imply there are effective alternatives to psychotherapy, which many individuals in the field insist is the only way to treat BPD. “This study turns things upside down and says actually it’s not. It’s the basics of treatment that are important,” Dr. Chanen said.

When a patient presents at the emergency department following a severe overdose, “it’s a reflex” for clinicians to refer that person to a psychotherapy program. “The problem is, these programs are not plentiful enough to be able to service the needs of this group,” Dr. Chanen noted.

On the other hand, the skills for clinical case management and psychiatric care “are available throughout the mental health systems,” he added.

The researchers are planning another analysis to determine whether age and sex predict better outcomes in these patients with BPD.
 

Unique contribution

Commenting for this news organization, John M. Oldham, MD, distinguished emeritus professor, Baylor College of Medicine, Houston, said a “unique and important contribution” of the study is the focus on early intervention.

“The general standard approach in psychiatry and the diagnostic world has been to not even consider anything until after somebody is 18 years of age, which is a mistake because these kids can become quite impaired earlier than that,” he said.

Dr. Oldham, who was not involved with the research, chaired the American Psychiatric Association workgroup that developed the 2001 evidence-based practice guideline for treating BPD, which recommended psychotherapy as the primary treatment. The guideline was last updated in 2005 – and another update is currently being developed, he noted.

There is an emerging trend toward “good psychiatric management” that focuses on level of functioning rather than on a specific strategy requiring a certificate of training that “not many people out there have,” said Dr. Oldham.

“You’re not going to make much headway with these kids if you’re going to be searching around for a DBT-certified therapist. What you need is to bring them in, get them to trust you, and in a sense be a kind of overall behavioral medicine navigator for them,” he added.

Dr. Oldham noted that, although the primary study outcome improved between 19% and 24%, “that means three-quarters of the people didn’t improve.”

He also pointed out this was only a 1-year trial. “Sometimes treatment for people with a personality disorder such as borderline takes a lot longer than that,” Dr. Oldham concluded.

The trial was funded by the National Health and Medical Research Council. Dr. Chanen reports receiving grants from the Australian government’s National Health and Medical Research Council during the conduct of the study and other support from the Helping Young People Early (HYPE) translational program outside the submitted work. He and another investigator cofounded and lead the HYPE clinical program, a government-funded program with continuous support, and the HYPE translational program, a not-for-profit training program. Dr. Oldham reported no relevant financial relationships.

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

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My favorite physical exam pearls

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Changed
Thu, 01/06/2022 - 13:59

 

I would like to start the new year off by returning to the past – when the physical exam was emphasized and utilized in decision making. I think a big reason that its use has diminished in recent years is due to the physical exam not having been emphasized in training.

For those seeking to increase their comfort with conducting the physical exam, below are several methods I have found helpful to use in practice.
 

Examining the pharynx

We were usually taught to ask the patient to say ahhh, with or without a nasty tongue depressor.

Dr. Douglas S. Paauw

When I was on my pediatrics rotation, I was taught to ask the patients to roar like a lion, which always gave a nice look at their posterior pharynx. The kids also really liked doing this, but it might seem a little strange to ask adults to do this.

A technique I have found that works well with adults is to ask them to yawn. I have found that this get me a great look at the pharynx for about half of my patients.
 

Auscultatory percussion for pleural effusions

Guarino and colleagues described a technique that is easily mastered and very effective for determining the presence of pleural effusions.1 It involves placing the stethoscope 3 cm below the last rib in the mid clavicular line and tapping from the apex down to the last rib.

For patients without effusion, a sharp change to a loud percussion note will occur at the last rib.

If the patient has an effusion, the loud percussion note will start at the top of the effusion.

This method was remarkably successful at finding pleural effusions. In the study, Dr. Guarino found a sensitivity of 96% and a specificity of 100%.
 

Physical exam for anemia

Look at the nails and see if they look pale. How can we do this?

The first step is to know what your own hematocrit is. You can then compare the color of your nail to that of the patient.

If you have a normal hematocrit and the patient’s nail bed color is lighter than yours, the patient likely has anemia. If you do this frequently, you will get good at estimating hematocrit. This is especially important if you do not have labs readily available.

Another way to assess for anemia is to look at the color tint of the lower conjunctiva. The best way to look for this is to look at whether there is a generous amount of visible capillaries in the lower conjunctiva. Patients without anemia have a darker red color because of these vessels, whereas patients with anemia are a lighter pink.

Strobach and colleagues2 looked at both nail bed rubor and color tint of the lower conjunctiva and found that both reliably predicted presence and degree of anemia.

 

 

Determining if clubbing is present

Most physicians are aware of Shamroth sign, and use it to evaluate for clubbing. Shamroth sign is the loss of the diamond that is created by placing the back surfaces of opposite terminal phalanges together.

I have found that it’s easier to diagnose mild clubbing by looking at the finger in profile. If the ratio of the distal phalangeal depth compared to the depth across the distal interphalangeal joint is greater than 1:1, then clubbing is present.3

Pearls

1. Have the patient try yawning to better see the pharynx without using a tongue blade.

2. Try the technique of auscultatory percussion to be more accurate at picking up pleural effusions.

3. Know your hematocrit, so you can better use color shade to assess for anemia.

4. Try looking at fingers in profile to pick up clubbing.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as 3rd-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Guarino JR and Guarino JC. Auscultatory percussion: A simple method to detect pleural effusion. J Gen Intern Med. 1994 Feb;9(2):71-4.

2. Strobach RS et al. The value of the physical examination in the diagnosis of anemia. Correlation of the physical findings and the hemoglobin concentration. Arch Intern Med. 1988 Apr;148(4):831-2.

3. Spicknall KE et al. Clubbing: an update on diagnosis, differential diagnosis, pathophysiology, and clinical relevance. J Am Acad Dermatol. 2005 Jun;52(6):1020-8.

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I would like to start the new year off by returning to the past – when the physical exam was emphasized and utilized in decision making. I think a big reason that its use has diminished in recent years is due to the physical exam not having been emphasized in training.

For those seeking to increase their comfort with conducting the physical exam, below are several methods I have found helpful to use in practice.
 

Examining the pharynx

We were usually taught to ask the patient to say ahhh, with or without a nasty tongue depressor.

Dr. Douglas S. Paauw

When I was on my pediatrics rotation, I was taught to ask the patients to roar like a lion, which always gave a nice look at their posterior pharynx. The kids also really liked doing this, but it might seem a little strange to ask adults to do this.

A technique I have found that works well with adults is to ask them to yawn. I have found that this get me a great look at the pharynx for about half of my patients.
 

Auscultatory percussion for pleural effusions

Guarino and colleagues described a technique that is easily mastered and very effective for determining the presence of pleural effusions.1 It involves placing the stethoscope 3 cm below the last rib in the mid clavicular line and tapping from the apex down to the last rib.

For patients without effusion, a sharp change to a loud percussion note will occur at the last rib.

If the patient has an effusion, the loud percussion note will start at the top of the effusion.

This method was remarkably successful at finding pleural effusions. In the study, Dr. Guarino found a sensitivity of 96% and a specificity of 100%.
 

Physical exam for anemia

Look at the nails and see if they look pale. How can we do this?

The first step is to know what your own hematocrit is. You can then compare the color of your nail to that of the patient.

If you have a normal hematocrit and the patient’s nail bed color is lighter than yours, the patient likely has anemia. If you do this frequently, you will get good at estimating hematocrit. This is especially important if you do not have labs readily available.

Another way to assess for anemia is to look at the color tint of the lower conjunctiva. The best way to look for this is to look at whether there is a generous amount of visible capillaries in the lower conjunctiva. Patients without anemia have a darker red color because of these vessels, whereas patients with anemia are a lighter pink.

Strobach and colleagues2 looked at both nail bed rubor and color tint of the lower conjunctiva and found that both reliably predicted presence and degree of anemia.

 

 

Determining if clubbing is present

Most physicians are aware of Shamroth sign, and use it to evaluate for clubbing. Shamroth sign is the loss of the diamond that is created by placing the back surfaces of opposite terminal phalanges together.

I have found that it’s easier to diagnose mild clubbing by looking at the finger in profile. If the ratio of the distal phalangeal depth compared to the depth across the distal interphalangeal joint is greater than 1:1, then clubbing is present.3

Pearls

1. Have the patient try yawning to better see the pharynx without using a tongue blade.

2. Try the technique of auscultatory percussion to be more accurate at picking up pleural effusions.

3. Know your hematocrit, so you can better use color shade to assess for anemia.

4. Try looking at fingers in profile to pick up clubbing.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as 3rd-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Guarino JR and Guarino JC. Auscultatory percussion: A simple method to detect pleural effusion. J Gen Intern Med. 1994 Feb;9(2):71-4.

2. Strobach RS et al. The value of the physical examination in the diagnosis of anemia. Correlation of the physical findings and the hemoglobin concentration. Arch Intern Med. 1988 Apr;148(4):831-2.

3. Spicknall KE et al. Clubbing: an update on diagnosis, differential diagnosis, pathophysiology, and clinical relevance. J Am Acad Dermatol. 2005 Jun;52(6):1020-8.

 

I would like to start the new year off by returning to the past – when the physical exam was emphasized and utilized in decision making. I think a big reason that its use has diminished in recent years is due to the physical exam not having been emphasized in training.

For those seeking to increase their comfort with conducting the physical exam, below are several methods I have found helpful to use in practice.
 

Examining the pharynx

We were usually taught to ask the patient to say ahhh, with or without a nasty tongue depressor.

Dr. Douglas S. Paauw

When I was on my pediatrics rotation, I was taught to ask the patients to roar like a lion, which always gave a nice look at their posterior pharynx. The kids also really liked doing this, but it might seem a little strange to ask adults to do this.

A technique I have found that works well with adults is to ask them to yawn. I have found that this get me a great look at the pharynx for about half of my patients.
 

Auscultatory percussion for pleural effusions

Guarino and colleagues described a technique that is easily mastered and very effective for determining the presence of pleural effusions.1 It involves placing the stethoscope 3 cm below the last rib in the mid clavicular line and tapping from the apex down to the last rib.

For patients without effusion, a sharp change to a loud percussion note will occur at the last rib.

If the patient has an effusion, the loud percussion note will start at the top of the effusion.

This method was remarkably successful at finding pleural effusions. In the study, Dr. Guarino found a sensitivity of 96% and a specificity of 100%.
 

Physical exam for anemia

Look at the nails and see if they look pale. How can we do this?

The first step is to know what your own hematocrit is. You can then compare the color of your nail to that of the patient.

If you have a normal hematocrit and the patient’s nail bed color is lighter than yours, the patient likely has anemia. If you do this frequently, you will get good at estimating hematocrit. This is especially important if you do not have labs readily available.

Another way to assess for anemia is to look at the color tint of the lower conjunctiva. The best way to look for this is to look at whether there is a generous amount of visible capillaries in the lower conjunctiva. Patients without anemia have a darker red color because of these vessels, whereas patients with anemia are a lighter pink.

Strobach and colleagues2 looked at both nail bed rubor and color tint of the lower conjunctiva and found that both reliably predicted presence and degree of anemia.

 

 

Determining if clubbing is present

Most physicians are aware of Shamroth sign, and use it to evaluate for clubbing. Shamroth sign is the loss of the diamond that is created by placing the back surfaces of opposite terminal phalanges together.

I have found that it’s easier to diagnose mild clubbing by looking at the finger in profile. If the ratio of the distal phalangeal depth compared to the depth across the distal interphalangeal joint is greater than 1:1, then clubbing is present.3

Pearls

1. Have the patient try yawning to better see the pharynx without using a tongue blade.

2. Try the technique of auscultatory percussion to be more accurate at picking up pleural effusions.

3. Know your hematocrit, so you can better use color shade to assess for anemia.

4. Try looking at fingers in profile to pick up clubbing.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as 3rd-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Guarino JR and Guarino JC. Auscultatory percussion: A simple method to detect pleural effusion. J Gen Intern Med. 1994 Feb;9(2):71-4.

2. Strobach RS et al. The value of the physical examination in the diagnosis of anemia. Correlation of the physical findings and the hemoglobin concentration. Arch Intern Med. 1988 Apr;148(4):831-2.

3. Spicknall KE et al. Clubbing: an update on diagnosis, differential diagnosis, pathophysiology, and clinical relevance. J Am Acad Dermatol. 2005 Jun;52(6):1020-8.

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First ‘flurona’ cases reported in the U.S.

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Thu, 01/06/2022 - 13:27

 

Health authorities in California, Texas, and Kansas have reported cases of “flurona,” in which people have seasonal flu and COVID-19 at the same time.

The first known case was detected in Israel, but until the first week of January no cases had been reported in the United States.

In Los Angeles, a teenaged boy tested positive for both illnesses at a COVID testing site in Brentwood, the Los Angeles Times reported. The child’s mother tested positive for COVID the next day.

“This is the first one that we’re aware of,” Steve Farzam, chief operating officer of 911 COVID Testing, told the LA Times. “In and of itself, it’s not overly concerning; however, it is concerning and can be problematic for someone who has pre-existing medical conditions, anyone who is immunocompromised.”

The teen and his family of five had just returned from vacation in Cabo San Lucas, Mexico. All said they tested negative before the trip, but they tested again when they got home because one of the children had a runny nose, Mr. Farzam said.

The boy, who had not been vaccinated for COVID or the flu, doesn’t have serious symptoms and is recovering at home.

In Houston, a 17-year-old boy, his siblings, and his father felt sick a few days before Christmas and went in for testing, TV station KTRK reported. The teen tested positive for both the flu and COVID.

“I ended up getting tested the day before Christmas for strep throat, flu and COVID,” the teenager, Alec Zierlein, told KTRK. “I didn’t think I had any of the three. It felt like a mild cold.”

Health officials reported Jan. 5 that a flurona case was detected in Hays, Kan., TV station WIBW reported. The patient was being treated in the ICU. No other details were provided. In Israel, flurona was first found in an unvaccinated pregnant woman at Rabin Medical Center in Petach Tikva, according to the Times of Israel. She tested positive for both viruses when she arrived at the medical center, and doctors double-checked to confirm her diagnosis. The woman had mild symptoms and was released in good condition, the news outlet reported.

Public health officials in Israel said they are concerned that an increase in both viruses at the same time could lead to many hospitalizations.

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

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Health authorities in California, Texas, and Kansas have reported cases of “flurona,” in which people have seasonal flu and COVID-19 at the same time.

The first known case was detected in Israel, but until the first week of January no cases had been reported in the United States.

In Los Angeles, a teenaged boy tested positive for both illnesses at a COVID testing site in Brentwood, the Los Angeles Times reported. The child’s mother tested positive for COVID the next day.

“This is the first one that we’re aware of,” Steve Farzam, chief operating officer of 911 COVID Testing, told the LA Times. “In and of itself, it’s not overly concerning; however, it is concerning and can be problematic for someone who has pre-existing medical conditions, anyone who is immunocompromised.”

The teen and his family of five had just returned from vacation in Cabo San Lucas, Mexico. All said they tested negative before the trip, but they tested again when they got home because one of the children had a runny nose, Mr. Farzam said.

The boy, who had not been vaccinated for COVID or the flu, doesn’t have serious symptoms and is recovering at home.

In Houston, a 17-year-old boy, his siblings, and his father felt sick a few days before Christmas and went in for testing, TV station KTRK reported. The teen tested positive for both the flu and COVID.

“I ended up getting tested the day before Christmas for strep throat, flu and COVID,” the teenager, Alec Zierlein, told KTRK. “I didn’t think I had any of the three. It felt like a mild cold.”

Health officials reported Jan. 5 that a flurona case was detected in Hays, Kan., TV station WIBW reported. The patient was being treated in the ICU. No other details were provided. In Israel, flurona was first found in an unvaccinated pregnant woman at Rabin Medical Center in Petach Tikva, according to the Times of Israel. She tested positive for both viruses when she arrived at the medical center, and doctors double-checked to confirm her diagnosis. The woman had mild symptoms and was released in good condition, the news outlet reported.

Public health officials in Israel said they are concerned that an increase in both viruses at the same time could lead to many hospitalizations.

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

 

Health authorities in California, Texas, and Kansas have reported cases of “flurona,” in which people have seasonal flu and COVID-19 at the same time.

The first known case was detected in Israel, but until the first week of January no cases had been reported in the United States.

In Los Angeles, a teenaged boy tested positive for both illnesses at a COVID testing site in Brentwood, the Los Angeles Times reported. The child’s mother tested positive for COVID the next day.

“This is the first one that we’re aware of,” Steve Farzam, chief operating officer of 911 COVID Testing, told the LA Times. “In and of itself, it’s not overly concerning; however, it is concerning and can be problematic for someone who has pre-existing medical conditions, anyone who is immunocompromised.”

The teen and his family of five had just returned from vacation in Cabo San Lucas, Mexico. All said they tested negative before the trip, but they tested again when they got home because one of the children had a runny nose, Mr. Farzam said.

The boy, who had not been vaccinated for COVID or the flu, doesn’t have serious symptoms and is recovering at home.

In Houston, a 17-year-old boy, his siblings, and his father felt sick a few days before Christmas and went in for testing, TV station KTRK reported. The teen tested positive for both the flu and COVID.

“I ended up getting tested the day before Christmas for strep throat, flu and COVID,” the teenager, Alec Zierlein, told KTRK. “I didn’t think I had any of the three. It felt like a mild cold.”

Health officials reported Jan. 5 that a flurona case was detected in Hays, Kan., TV station WIBW reported. The patient was being treated in the ICU. No other details were provided. In Israel, flurona was first found in an unvaccinated pregnant woman at Rabin Medical Center in Petach Tikva, according to the Times of Israel. She tested positive for both viruses when she arrived at the medical center, and doctors double-checked to confirm her diagnosis. The woman had mild symptoms and was released in good condition, the news outlet reported.

Public health officials in Israel said they are concerned that an increase in both viruses at the same time could lead to many hospitalizations.

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

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Pneumonia in infancy predicts respiratory problems in early childhood

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Thu, 01/06/2022 - 13:39

 

Preschoolers who experienced community-acquired pneumonia in infancy were significantly more likely than were those with no history of pneumonia to develop chronic respiratory disorders, based on data from approximately 7,000 individuals.

“Lower respiratory tract infections (LRTI) during the first years of life cause injury to the rapidly developing lung at its most critical stage,” wrote Rotem Lapidot, MD, of Boston University, and colleagues. Previous research has linked pneumonia with subsequent chronic cough, bronchitis, and recurrent pneumonia in children, but data are needed to assess the impact of early community-acquired pneumonia (CAP) on respiratory health in otherwise healthy infants, the researchers said.

In a retrospective matched cohort study published in Respiratory Medicine , the researchers identified 1,343 infants who had CAP in the first 2 years of life, and 6,715 controls, using a large electronic health records dataset (Optum EHR dataset) for the period from Jan. 2011 through June 2018.

The primary outcomes were the development of any chronic respiratory disorders, reactive airway disease, and CAP hospitalizations between ages 2 and 5 years. Infants in the CAP group were otherwise healthy; those with congenital or other conditions that might predispose them to pneumonia were excluded. Baseline characteristics were similar between the CAP patients and controls.
 

Future risk

Overall, the rates per 100 patient-years for any chronic respiratory disorder were 11.6 for CAP patients versus 4.9 for controls (relative risk, 2.4). Rates for reactive airway disease and CAP hospitalization were 6.1 versus 1.9 per 100 patient-years (RR, 3.2) and 1.0 versus 0.2 per 100 patient-years (RR, 6.3) for the CAP patients and controls, respectively.

The distribution of CAP etiology of CAP in infants at the first hospitalization was 20% bacterial, 27% viral, and 53% unspecified. The relative rates of later respiratory illness were similar across etiologies of the initial hospitalization for CAP, which support the association between infant CAP and later respiratory disease, the researchers said.

Nearly all (97%) of the CAP patients had only one qualifying hospitalization for CAP before 2 years of age, and the mean age at the first hospitalization was 8.9 months. “Rates and relative rates of any chronic respiratory disorder, and our composite for reactive airway disease, increased with age at which the initial CAP hospitalization occurred,” and were highest for children hospitalized at close to 2 years of age, the researchers noted.
 

Persistent inflammation?

“Our findings add to the evolving hypothesis that persistent inflammation following pneumonia creates an increased risk for subsequent respiratory disease and exacerbations of underlying disease,” the researchers wrote.

The study findings were limited by several factors, including the potential for misclassification of some infants with and without underlying conditions, reliance on discharge information for etiology, and possible lack of generalizability to other populations, the researchers noted.

However, the results indicate an increased risk for respiratory illness in early childhood among infants with CAP, and support the need for greater attention to CAP prevention and for strategies to reduce inflammation after pneumonia, they said. “Further study is needed to confirm the long-term consequences of infant CAP and the underlying mechanisms that lead to such long-term sequelae,” they concluded.

Dr. Lapidot and several coauthors disclosed ties with Pfizer, the study sponsor.

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

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Preschoolers who experienced community-acquired pneumonia in infancy were significantly more likely than were those with no history of pneumonia to develop chronic respiratory disorders, based on data from approximately 7,000 individuals.

“Lower respiratory tract infections (LRTI) during the first years of life cause injury to the rapidly developing lung at its most critical stage,” wrote Rotem Lapidot, MD, of Boston University, and colleagues. Previous research has linked pneumonia with subsequent chronic cough, bronchitis, and recurrent pneumonia in children, but data are needed to assess the impact of early community-acquired pneumonia (CAP) on respiratory health in otherwise healthy infants, the researchers said.

In a retrospective matched cohort study published in Respiratory Medicine , the researchers identified 1,343 infants who had CAP in the first 2 years of life, and 6,715 controls, using a large electronic health records dataset (Optum EHR dataset) for the period from Jan. 2011 through June 2018.

The primary outcomes were the development of any chronic respiratory disorders, reactive airway disease, and CAP hospitalizations between ages 2 and 5 years. Infants in the CAP group were otherwise healthy; those with congenital or other conditions that might predispose them to pneumonia were excluded. Baseline characteristics were similar between the CAP patients and controls.
 

Future risk

Overall, the rates per 100 patient-years for any chronic respiratory disorder were 11.6 for CAP patients versus 4.9 for controls (relative risk, 2.4). Rates for reactive airway disease and CAP hospitalization were 6.1 versus 1.9 per 100 patient-years (RR, 3.2) and 1.0 versus 0.2 per 100 patient-years (RR, 6.3) for the CAP patients and controls, respectively.

The distribution of CAP etiology of CAP in infants at the first hospitalization was 20% bacterial, 27% viral, and 53% unspecified. The relative rates of later respiratory illness were similar across etiologies of the initial hospitalization for CAP, which support the association between infant CAP and later respiratory disease, the researchers said.

Nearly all (97%) of the CAP patients had only one qualifying hospitalization for CAP before 2 years of age, and the mean age at the first hospitalization was 8.9 months. “Rates and relative rates of any chronic respiratory disorder, and our composite for reactive airway disease, increased with age at which the initial CAP hospitalization occurred,” and were highest for children hospitalized at close to 2 years of age, the researchers noted.
 

Persistent inflammation?

“Our findings add to the evolving hypothesis that persistent inflammation following pneumonia creates an increased risk for subsequent respiratory disease and exacerbations of underlying disease,” the researchers wrote.

The study findings were limited by several factors, including the potential for misclassification of some infants with and without underlying conditions, reliance on discharge information for etiology, and possible lack of generalizability to other populations, the researchers noted.

However, the results indicate an increased risk for respiratory illness in early childhood among infants with CAP, and support the need for greater attention to CAP prevention and for strategies to reduce inflammation after pneumonia, they said. “Further study is needed to confirm the long-term consequences of infant CAP and the underlying mechanisms that lead to such long-term sequelae,” they concluded.

Dr. Lapidot and several coauthors disclosed ties with Pfizer, the study sponsor.

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

 

Preschoolers who experienced community-acquired pneumonia in infancy were significantly more likely than were those with no history of pneumonia to develop chronic respiratory disorders, based on data from approximately 7,000 individuals.

“Lower respiratory tract infections (LRTI) during the first years of life cause injury to the rapidly developing lung at its most critical stage,” wrote Rotem Lapidot, MD, of Boston University, and colleagues. Previous research has linked pneumonia with subsequent chronic cough, bronchitis, and recurrent pneumonia in children, but data are needed to assess the impact of early community-acquired pneumonia (CAP) on respiratory health in otherwise healthy infants, the researchers said.

In a retrospective matched cohort study published in Respiratory Medicine , the researchers identified 1,343 infants who had CAP in the first 2 years of life, and 6,715 controls, using a large electronic health records dataset (Optum EHR dataset) for the period from Jan. 2011 through June 2018.

The primary outcomes were the development of any chronic respiratory disorders, reactive airway disease, and CAP hospitalizations between ages 2 and 5 years. Infants in the CAP group were otherwise healthy; those with congenital or other conditions that might predispose them to pneumonia were excluded. Baseline characteristics were similar between the CAP patients and controls.
 

Future risk

Overall, the rates per 100 patient-years for any chronic respiratory disorder were 11.6 for CAP patients versus 4.9 for controls (relative risk, 2.4). Rates for reactive airway disease and CAP hospitalization were 6.1 versus 1.9 per 100 patient-years (RR, 3.2) and 1.0 versus 0.2 per 100 patient-years (RR, 6.3) for the CAP patients and controls, respectively.

The distribution of CAP etiology of CAP in infants at the first hospitalization was 20% bacterial, 27% viral, and 53% unspecified. The relative rates of later respiratory illness were similar across etiologies of the initial hospitalization for CAP, which support the association between infant CAP and later respiratory disease, the researchers said.

Nearly all (97%) of the CAP patients had only one qualifying hospitalization for CAP before 2 years of age, and the mean age at the first hospitalization was 8.9 months. “Rates and relative rates of any chronic respiratory disorder, and our composite for reactive airway disease, increased with age at which the initial CAP hospitalization occurred,” and were highest for children hospitalized at close to 2 years of age, the researchers noted.
 

Persistent inflammation?

“Our findings add to the evolving hypothesis that persistent inflammation following pneumonia creates an increased risk for subsequent respiratory disease and exacerbations of underlying disease,” the researchers wrote.

The study findings were limited by several factors, including the potential for misclassification of some infants with and without underlying conditions, reliance on discharge information for etiology, and possible lack of generalizability to other populations, the researchers noted.

However, the results indicate an increased risk for respiratory illness in early childhood among infants with CAP, and support the need for greater attention to CAP prevention and for strategies to reduce inflammation after pneumonia, they said. “Further study is needed to confirm the long-term consequences of infant CAP and the underlying mechanisms that lead to such long-term sequelae,” they concluded.

Dr. Lapidot and several coauthors disclosed ties with Pfizer, the study sponsor.

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

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Docs refused to pay the cyber attack ransom – and suffered

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Ransomware attacks are driving some small practices out of business.

Michigan-based Brookside ENT and Hearing Center, a two-physician practice, closed its doors in 2019 after a ransomware attack. The criminals locked their computer system and files and then demanded a $6,500 ransom to restore access. The practice took the advice of law enforcement and refused to pay. The attackers wiped the computer systems clean – destroying all patient records, appointment schedules, and financial information. Rather than rebuild the entire practice, the two doctors took early retirement.

Wood Ranch Medical, in Simi, Calif., a small primary care practice, decided to shut its doors in 2019 after a ransomware attack damaged its servers and backup files, which affected more than 5,000 patient records. The criminals demanded a ransom to restore the technology and records, but the owners refused to pay. They couldn’t rebuild the system without the backup files, so they shuttered their business.

Several large practices have also been attacked by ransomware, including Imperial Health in Louisiana in 2019, that may have compromised more than 110,000 records. The practice didn’t pay the ransom and had access to its backup files and the resources to rebuild its computer systems and stay in business.

Medical practices of all sizes have experienced ransomware attacks. More than 551 health care ransomware attacks were reported to the U.S. Department of Health and Human Services’ Office of Civil Rights in 2021 (as of Nov. 30), and over 40 million individuals faced exposure of their protected health information.

All it takes is one employee clicking on a link or embedded file in an email to launch malware. A vicious code locks the electronic health record (EHR) system, and your practice grinds to a halt.

Cyber criminals demand a ransom in bitcoin to unlock the files. They may even threaten to post private patient data publicly or sell it on the dark web to get you to pay up.

But, is paying a ransom necessary or wise? What other steps should you take? Here’s what cyber security experts say criminals look for in targets, how they infiltrate and attack, and how you should respond and prevent future attacks.
 

How does it happen?

Email is a popular way for criminals to hack into a system. Criminals often research company websites and impersonate a company executive and send a legitimate-looking “phishing” email to employees hoping that someone will click on it and launch a malware attack.

Recently, cyber criminals found an easier way to infiltrate that doesn’t require identifying targets to gain access, said Drex DeFord, executive health care strategist at CrowdStrike, a cybersecurity technology company in Sunnyvale, Calif.

“Instead of hacking into the system, cyber criminals are just logging in. Most likely, they have acquired a user’s credentials (username/password) from another source – possibly purchasing it from the dark web, the part of the Internet that criminals use, through an ‘access broker,’ an organization that specializes in collecting and selling these kinds of credentials,” said Mr. DeFord.

After a ransomware attack last August on Eskenazi Health in Indianapolis, forensic investigators discovered that the criminals had logged into the IT system in May and had disabled security protections that could have detected their presence before they launched their cyber attack, according to a statement.
 

 

 

Responding to a ransomware attack

When employees or the IT department suspect a ransomware attack is underway, cyber experts recommend isolating the “infected” part of the network, shutting down the computer system to prevent further damage, and securing backups.

Soon afterward, cyber criminals typically communicate their ransom demands electronically with instructions for payment. One practice described seeing a “skull and bones image” on its laptops with a link to instructions to pay the ransom demand in bitcoin.

Although you never want to pay criminals, it’s ultimately a business decision that every organization that’s affected by ransomware has to make, said Kathy Hughes, chief information security officer at Northwell Health in New York. “They need to weigh the cost and impact from paying a ransom against what they are able to recover, how long will it take, and how much will it cost,” she said.

While it may be tempting to pay a small ransom, such as $5,000, cyber experts warn that it doesn’t guarantee full access to the original data. About one-third (34%) of health care organizations whose data were encrypted paid the ransom to get their data back, according to a June 2021 HHS Report on Ransomware Trends. However, only 69% of the encrypted data was restored, the report states.

Criminals may also demand another payment, called “double extortion,” by threatening to post any extracted private patient or employee data on the dark web, said Ms. Hughes.

Practices sometimes choose not to pay the ransom when they know they can restore the backup files and rebuild the system for less than the ransom amount. However, it can take weeks to rebuild a fully operational IT system; meanwhile, the organization is losing thousands of dollars in patient revenue.

Criminals may retaliate against a practice that doesn’t pay the ransom by wiping the hard drives clean or posting the extracted medical, financial, and demographic data of patients on the dark web. Patients whose information has been extracted have filed class-action lawsuits against medical practices and organizations such as Scripps Health, in San Diego, claiming that they should have done more to keep their private information safe.

Experts also advise reporting the attack to local law enforcement officials, who may have cyber security experts on staff who will come on site and investigate the nature of the attack. They may also request help from the FBI’s professional cyber security team.

Having a cyber insurance policy may help offset some of the costs of an attack. However, make sure you have a good cyber security program, advised Mr. DeFord.

He suggests that small practices partner with large health systems that can donate their cyber security technology and related services legally under the updated Stark safe harbor rules. Otherwise, they may not meet the insurer’s requirements, or they may have to pay significantly higher rates.
 

 

 

Who is an easy target?

Cyber criminals look for easy targets, said Ms. Hughes. “A lot of threat actors are not targeting a specific practice – they’re simply throwing out a net and looking for vulnerable systems on the Internet.”

Small medical practices are particularly vulnerable to ransomware attacks because they lack the resources to pay for dedicated IT or cyber security staff, said Ms. Hughes, who oversees security for more than 800 outpatient practices. They’re not replacing outdated or unsupported equipment, applying regular “patches” that fix, update, or improve operating systems, application software, and Internet browsers, or using password controls.

As large practices or health systems acquire medical practices with different EHR systems, security can be more challenging. “Our goal at Northwell is always to get them onto our standard platform, where we use best practices for technology and security controls,” Ms. Hughes said. “In the world of security, having fewer EHR systems is better so there are fewer things to watch, fewer systems to patch, and fewer servers to monitor. From our point of view, it makes sense to have a standardized and streamlined system.”

Still, some practices may feel strongly about using their EHR system, she said. When that happens, “We at least bring them up to our security standards by having them implement password controls and regular patches. We communicate and collaborate with them constantly to get them to a more secure posture.”

Cyber security lapses may have increased during the pandemic when practices had to pivot rapidly to allow administrative staff to work remotely and clinical staff to use telehealth with patients.

“In the rush to get people out of the building during the pandemic, health care organizations bent many of their own rules on remote access. As they moved quickly to new telehealth solutions, they skipped steps like auditing new vendors and cyber-testing new equipment and software. Many organizations are still cleaning up the security ‘exceptions’ they made earlier in the pandemic,” said Mr. DeFord.
 

Hackers are sophisticated criminals

“The version of a hacker a lot of us grew up with – someone in a basement hacking into your environment and possibly deploying ransomware – isn’t accurate,” said Mr. DeFord. What experts know now is that these cyber criminals operate more like companies that have hired, trained, and developed people to be stealth-like – getting inside your network without being detected.

“They are more sophisticated than the health care organizations they often target,” added Mr. DeFord. “Their developers write the encryption software; they use chatbots to make paying the ransom easy and refer to the people they ransom as clients, because it’s a lucrative business,” he said.

These groups also have specialized roles – one may come in and map your network’s vulnerabilities and sell that information to another group that is good at extracting data and that sells that information to another group that is good at setting off ransomware and negotiation, said Mr. DeFord. “By the time a ransomware attack occurs, we often find that the bad guys have owned the network for at least 6 months.”

Patient records are attractive targets because the information can be sold on the dark web, the part of the Internet that’s unavailable to search engines and requires an anonymous browser called Tor to gain access, said Ms. Hughes.

Criminals steal patient identifiers such as Social Security numbers and birth dates, payment or insurance information, as well as medical histories and prescription data. Other people buy the information for fraudulent purposes, such as filing false tax returns, obtaining medical services, and opening credit cards, said Ms. Hughes.

Lately, criminal gangs appear to be targeting the IT or EHR systems that practices rely on for clinical care and making them unavailable. By locking EHR files or databases and holding them for ransom, criminals hope practices will be more likely to pay, said Ms. Hughes.

They also don’t want to get caught, and this tactic “gets them in and out faster” than extracting and posting patient data, although criminals may use that as a threat to extort a ransom payment, she said.
 

 

 

Fines for lax privacy/security

Breaches of patient records have consequences that include being investigated by federal or state authorities for potential HIPAA privacy and security violations and fines. Recently, the HHS announced a $1.5 million settlement – the largest to date – with Athens Orthopedic Clinic, PA, in Georgia, for not complying with the HIPAA rules.

When breaches of 500 or more patient records occur, medical groups are required to notify the HHS Office of Civil Rights (OCR) within 60 days, as well as all the affected patients and the media. Some organizations offer free credit monitoring and identity theft protection services to their patients.

Information about the breaches, including company names and the number of affected individuals, is posted publicly on what cyber experts often call “OCR’s wall of shame.”
 

Strengthen your defenses

The FBI and the HHS warned health care professionals and organizations in 2020 about the threat of increasing cyber attacks and urged them to take precautions to protect their networks.

Here are five actions you can take:

  • Back-up your files to the cloud or off-site services and test that the restoration works.
  • Implement user training with simulated phishing attacks so the staff will recognize suspicious emails and avoid actions that could launch malware attacks.
  • Ensure strong password controls and that systems are regularly patched.
  • Require multifactor authentication for remote access to IT networks.
  • Set anti-virus/anti-malware programs to conduct regular scans of IT network assets using up-to-date signatures.

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

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Ransomware attacks are driving some small practices out of business.

Michigan-based Brookside ENT and Hearing Center, a two-physician practice, closed its doors in 2019 after a ransomware attack. The criminals locked their computer system and files and then demanded a $6,500 ransom to restore access. The practice took the advice of law enforcement and refused to pay. The attackers wiped the computer systems clean – destroying all patient records, appointment schedules, and financial information. Rather than rebuild the entire practice, the two doctors took early retirement.

Wood Ranch Medical, in Simi, Calif., a small primary care practice, decided to shut its doors in 2019 after a ransomware attack damaged its servers and backup files, which affected more than 5,000 patient records. The criminals demanded a ransom to restore the technology and records, but the owners refused to pay. They couldn’t rebuild the system without the backup files, so they shuttered their business.

Several large practices have also been attacked by ransomware, including Imperial Health in Louisiana in 2019, that may have compromised more than 110,000 records. The practice didn’t pay the ransom and had access to its backup files and the resources to rebuild its computer systems and stay in business.

Medical practices of all sizes have experienced ransomware attacks. More than 551 health care ransomware attacks were reported to the U.S. Department of Health and Human Services’ Office of Civil Rights in 2021 (as of Nov. 30), and over 40 million individuals faced exposure of their protected health information.

All it takes is one employee clicking on a link or embedded file in an email to launch malware. A vicious code locks the electronic health record (EHR) system, and your practice grinds to a halt.

Cyber criminals demand a ransom in bitcoin to unlock the files. They may even threaten to post private patient data publicly or sell it on the dark web to get you to pay up.

But, is paying a ransom necessary or wise? What other steps should you take? Here’s what cyber security experts say criminals look for in targets, how they infiltrate and attack, and how you should respond and prevent future attacks.
 

How does it happen?

Email is a popular way for criminals to hack into a system. Criminals often research company websites and impersonate a company executive and send a legitimate-looking “phishing” email to employees hoping that someone will click on it and launch a malware attack.

Recently, cyber criminals found an easier way to infiltrate that doesn’t require identifying targets to gain access, said Drex DeFord, executive health care strategist at CrowdStrike, a cybersecurity technology company in Sunnyvale, Calif.

“Instead of hacking into the system, cyber criminals are just logging in. Most likely, they have acquired a user’s credentials (username/password) from another source – possibly purchasing it from the dark web, the part of the Internet that criminals use, through an ‘access broker,’ an organization that specializes in collecting and selling these kinds of credentials,” said Mr. DeFord.

After a ransomware attack last August on Eskenazi Health in Indianapolis, forensic investigators discovered that the criminals had logged into the IT system in May and had disabled security protections that could have detected their presence before they launched their cyber attack, according to a statement.
 

 

 

Responding to a ransomware attack

When employees or the IT department suspect a ransomware attack is underway, cyber experts recommend isolating the “infected” part of the network, shutting down the computer system to prevent further damage, and securing backups.

Soon afterward, cyber criminals typically communicate their ransom demands electronically with instructions for payment. One practice described seeing a “skull and bones image” on its laptops with a link to instructions to pay the ransom demand in bitcoin.

Although you never want to pay criminals, it’s ultimately a business decision that every organization that’s affected by ransomware has to make, said Kathy Hughes, chief information security officer at Northwell Health in New York. “They need to weigh the cost and impact from paying a ransom against what they are able to recover, how long will it take, and how much will it cost,” she said.

While it may be tempting to pay a small ransom, such as $5,000, cyber experts warn that it doesn’t guarantee full access to the original data. About one-third (34%) of health care organizations whose data were encrypted paid the ransom to get their data back, according to a June 2021 HHS Report on Ransomware Trends. However, only 69% of the encrypted data was restored, the report states.

Criminals may also demand another payment, called “double extortion,” by threatening to post any extracted private patient or employee data on the dark web, said Ms. Hughes.

Practices sometimes choose not to pay the ransom when they know they can restore the backup files and rebuild the system for less than the ransom amount. However, it can take weeks to rebuild a fully operational IT system; meanwhile, the organization is losing thousands of dollars in patient revenue.

Criminals may retaliate against a practice that doesn’t pay the ransom by wiping the hard drives clean or posting the extracted medical, financial, and demographic data of patients on the dark web. Patients whose information has been extracted have filed class-action lawsuits against medical practices and organizations such as Scripps Health, in San Diego, claiming that they should have done more to keep their private information safe.

Experts also advise reporting the attack to local law enforcement officials, who may have cyber security experts on staff who will come on site and investigate the nature of the attack. They may also request help from the FBI’s professional cyber security team.

Having a cyber insurance policy may help offset some of the costs of an attack. However, make sure you have a good cyber security program, advised Mr. DeFord.

He suggests that small practices partner with large health systems that can donate their cyber security technology and related services legally under the updated Stark safe harbor rules. Otherwise, they may not meet the insurer’s requirements, or they may have to pay significantly higher rates.
 

 

 

Who is an easy target?

Cyber criminals look for easy targets, said Ms. Hughes. “A lot of threat actors are not targeting a specific practice – they’re simply throwing out a net and looking for vulnerable systems on the Internet.”

Small medical practices are particularly vulnerable to ransomware attacks because they lack the resources to pay for dedicated IT or cyber security staff, said Ms. Hughes, who oversees security for more than 800 outpatient practices. They’re not replacing outdated or unsupported equipment, applying regular “patches” that fix, update, or improve operating systems, application software, and Internet browsers, or using password controls.

As large practices or health systems acquire medical practices with different EHR systems, security can be more challenging. “Our goal at Northwell is always to get them onto our standard platform, where we use best practices for technology and security controls,” Ms. Hughes said. “In the world of security, having fewer EHR systems is better so there are fewer things to watch, fewer systems to patch, and fewer servers to monitor. From our point of view, it makes sense to have a standardized and streamlined system.”

Still, some practices may feel strongly about using their EHR system, she said. When that happens, “We at least bring them up to our security standards by having them implement password controls and regular patches. We communicate and collaborate with them constantly to get them to a more secure posture.”

Cyber security lapses may have increased during the pandemic when practices had to pivot rapidly to allow administrative staff to work remotely and clinical staff to use telehealth with patients.

“In the rush to get people out of the building during the pandemic, health care organizations bent many of their own rules on remote access. As they moved quickly to new telehealth solutions, they skipped steps like auditing new vendors and cyber-testing new equipment and software. Many organizations are still cleaning up the security ‘exceptions’ they made earlier in the pandemic,” said Mr. DeFord.
 

Hackers are sophisticated criminals

“The version of a hacker a lot of us grew up with – someone in a basement hacking into your environment and possibly deploying ransomware – isn’t accurate,” said Mr. DeFord. What experts know now is that these cyber criminals operate more like companies that have hired, trained, and developed people to be stealth-like – getting inside your network without being detected.

“They are more sophisticated than the health care organizations they often target,” added Mr. DeFord. “Their developers write the encryption software; they use chatbots to make paying the ransom easy and refer to the people they ransom as clients, because it’s a lucrative business,” he said.

These groups also have specialized roles – one may come in and map your network’s vulnerabilities and sell that information to another group that is good at extracting data and that sells that information to another group that is good at setting off ransomware and negotiation, said Mr. DeFord. “By the time a ransomware attack occurs, we often find that the bad guys have owned the network for at least 6 months.”

Patient records are attractive targets because the information can be sold on the dark web, the part of the Internet that’s unavailable to search engines and requires an anonymous browser called Tor to gain access, said Ms. Hughes.

Criminals steal patient identifiers such as Social Security numbers and birth dates, payment or insurance information, as well as medical histories and prescription data. Other people buy the information for fraudulent purposes, such as filing false tax returns, obtaining medical services, and opening credit cards, said Ms. Hughes.

Lately, criminal gangs appear to be targeting the IT or EHR systems that practices rely on for clinical care and making them unavailable. By locking EHR files or databases and holding them for ransom, criminals hope practices will be more likely to pay, said Ms. Hughes.

They also don’t want to get caught, and this tactic “gets them in and out faster” than extracting and posting patient data, although criminals may use that as a threat to extort a ransom payment, she said.
 

 

 

Fines for lax privacy/security

Breaches of patient records have consequences that include being investigated by federal or state authorities for potential HIPAA privacy and security violations and fines. Recently, the HHS announced a $1.5 million settlement – the largest to date – with Athens Orthopedic Clinic, PA, in Georgia, for not complying with the HIPAA rules.

When breaches of 500 or more patient records occur, medical groups are required to notify the HHS Office of Civil Rights (OCR) within 60 days, as well as all the affected patients and the media. Some organizations offer free credit monitoring and identity theft protection services to their patients.

Information about the breaches, including company names and the number of affected individuals, is posted publicly on what cyber experts often call “OCR’s wall of shame.”
 

Strengthen your defenses

The FBI and the HHS warned health care professionals and organizations in 2020 about the threat of increasing cyber attacks and urged them to take precautions to protect their networks.

Here are five actions you can take:

  • Back-up your files to the cloud or off-site services and test that the restoration works.
  • Implement user training with simulated phishing attacks so the staff will recognize suspicious emails and avoid actions that could launch malware attacks.
  • Ensure strong password controls and that systems are regularly patched.
  • Require multifactor authentication for remote access to IT networks.
  • Set anti-virus/anti-malware programs to conduct regular scans of IT network assets using up-to-date signatures.

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

 

Ransomware attacks are driving some small practices out of business.

Michigan-based Brookside ENT and Hearing Center, a two-physician practice, closed its doors in 2019 after a ransomware attack. The criminals locked their computer system and files and then demanded a $6,500 ransom to restore access. The practice took the advice of law enforcement and refused to pay. The attackers wiped the computer systems clean – destroying all patient records, appointment schedules, and financial information. Rather than rebuild the entire practice, the two doctors took early retirement.

Wood Ranch Medical, in Simi, Calif., a small primary care practice, decided to shut its doors in 2019 after a ransomware attack damaged its servers and backup files, which affected more than 5,000 patient records. The criminals demanded a ransom to restore the technology and records, but the owners refused to pay. They couldn’t rebuild the system without the backup files, so they shuttered their business.

Several large practices have also been attacked by ransomware, including Imperial Health in Louisiana in 2019, that may have compromised more than 110,000 records. The practice didn’t pay the ransom and had access to its backup files and the resources to rebuild its computer systems and stay in business.

Medical practices of all sizes have experienced ransomware attacks. More than 551 health care ransomware attacks were reported to the U.S. Department of Health and Human Services’ Office of Civil Rights in 2021 (as of Nov. 30), and over 40 million individuals faced exposure of their protected health information.

All it takes is one employee clicking on a link or embedded file in an email to launch malware. A vicious code locks the electronic health record (EHR) system, and your practice grinds to a halt.

Cyber criminals demand a ransom in bitcoin to unlock the files. They may even threaten to post private patient data publicly or sell it on the dark web to get you to pay up.

But, is paying a ransom necessary or wise? What other steps should you take? Here’s what cyber security experts say criminals look for in targets, how they infiltrate and attack, and how you should respond and prevent future attacks.
 

How does it happen?

Email is a popular way for criminals to hack into a system. Criminals often research company websites and impersonate a company executive and send a legitimate-looking “phishing” email to employees hoping that someone will click on it and launch a malware attack.

Recently, cyber criminals found an easier way to infiltrate that doesn’t require identifying targets to gain access, said Drex DeFord, executive health care strategist at CrowdStrike, a cybersecurity technology company in Sunnyvale, Calif.

“Instead of hacking into the system, cyber criminals are just logging in. Most likely, they have acquired a user’s credentials (username/password) from another source – possibly purchasing it from the dark web, the part of the Internet that criminals use, through an ‘access broker,’ an organization that specializes in collecting and selling these kinds of credentials,” said Mr. DeFord.

After a ransomware attack last August on Eskenazi Health in Indianapolis, forensic investigators discovered that the criminals had logged into the IT system in May and had disabled security protections that could have detected their presence before they launched their cyber attack, according to a statement.
 

 

 

Responding to a ransomware attack

When employees or the IT department suspect a ransomware attack is underway, cyber experts recommend isolating the “infected” part of the network, shutting down the computer system to prevent further damage, and securing backups.

Soon afterward, cyber criminals typically communicate their ransom demands electronically with instructions for payment. One practice described seeing a “skull and bones image” on its laptops with a link to instructions to pay the ransom demand in bitcoin.

Although you never want to pay criminals, it’s ultimately a business decision that every organization that’s affected by ransomware has to make, said Kathy Hughes, chief information security officer at Northwell Health in New York. “They need to weigh the cost and impact from paying a ransom against what they are able to recover, how long will it take, and how much will it cost,” she said.

While it may be tempting to pay a small ransom, such as $5,000, cyber experts warn that it doesn’t guarantee full access to the original data. About one-third (34%) of health care organizations whose data were encrypted paid the ransom to get their data back, according to a June 2021 HHS Report on Ransomware Trends. However, only 69% of the encrypted data was restored, the report states.

Criminals may also demand another payment, called “double extortion,” by threatening to post any extracted private patient or employee data on the dark web, said Ms. Hughes.

Practices sometimes choose not to pay the ransom when they know they can restore the backup files and rebuild the system for less than the ransom amount. However, it can take weeks to rebuild a fully operational IT system; meanwhile, the organization is losing thousands of dollars in patient revenue.

Criminals may retaliate against a practice that doesn’t pay the ransom by wiping the hard drives clean or posting the extracted medical, financial, and demographic data of patients on the dark web. Patients whose information has been extracted have filed class-action lawsuits against medical practices and organizations such as Scripps Health, in San Diego, claiming that they should have done more to keep their private information safe.

Experts also advise reporting the attack to local law enforcement officials, who may have cyber security experts on staff who will come on site and investigate the nature of the attack. They may also request help from the FBI’s professional cyber security team.

Having a cyber insurance policy may help offset some of the costs of an attack. However, make sure you have a good cyber security program, advised Mr. DeFord.

He suggests that small practices partner with large health systems that can donate their cyber security technology and related services legally under the updated Stark safe harbor rules. Otherwise, they may not meet the insurer’s requirements, or they may have to pay significantly higher rates.
 

 

 

Who is an easy target?

Cyber criminals look for easy targets, said Ms. Hughes. “A lot of threat actors are not targeting a specific practice – they’re simply throwing out a net and looking for vulnerable systems on the Internet.”

Small medical practices are particularly vulnerable to ransomware attacks because they lack the resources to pay for dedicated IT or cyber security staff, said Ms. Hughes, who oversees security for more than 800 outpatient practices. They’re not replacing outdated or unsupported equipment, applying regular “patches” that fix, update, or improve operating systems, application software, and Internet browsers, or using password controls.

As large practices or health systems acquire medical practices with different EHR systems, security can be more challenging. “Our goal at Northwell is always to get them onto our standard platform, where we use best practices for technology and security controls,” Ms. Hughes said. “In the world of security, having fewer EHR systems is better so there are fewer things to watch, fewer systems to patch, and fewer servers to monitor. From our point of view, it makes sense to have a standardized and streamlined system.”

Still, some practices may feel strongly about using their EHR system, she said. When that happens, “We at least bring them up to our security standards by having them implement password controls and regular patches. We communicate and collaborate with them constantly to get them to a more secure posture.”

Cyber security lapses may have increased during the pandemic when practices had to pivot rapidly to allow administrative staff to work remotely and clinical staff to use telehealth with patients.

“In the rush to get people out of the building during the pandemic, health care organizations bent many of their own rules on remote access. As they moved quickly to new telehealth solutions, they skipped steps like auditing new vendors and cyber-testing new equipment and software. Many organizations are still cleaning up the security ‘exceptions’ they made earlier in the pandemic,” said Mr. DeFord.
 

Hackers are sophisticated criminals

“The version of a hacker a lot of us grew up with – someone in a basement hacking into your environment and possibly deploying ransomware – isn’t accurate,” said Mr. DeFord. What experts know now is that these cyber criminals operate more like companies that have hired, trained, and developed people to be stealth-like – getting inside your network without being detected.

“They are more sophisticated than the health care organizations they often target,” added Mr. DeFord. “Their developers write the encryption software; they use chatbots to make paying the ransom easy and refer to the people they ransom as clients, because it’s a lucrative business,” he said.

These groups also have specialized roles – one may come in and map your network’s vulnerabilities and sell that information to another group that is good at extracting data and that sells that information to another group that is good at setting off ransomware and negotiation, said Mr. DeFord. “By the time a ransomware attack occurs, we often find that the bad guys have owned the network for at least 6 months.”

Patient records are attractive targets because the information can be sold on the dark web, the part of the Internet that’s unavailable to search engines and requires an anonymous browser called Tor to gain access, said Ms. Hughes.

Criminals steal patient identifiers such as Social Security numbers and birth dates, payment or insurance information, as well as medical histories and prescription data. Other people buy the information for fraudulent purposes, such as filing false tax returns, obtaining medical services, and opening credit cards, said Ms. Hughes.

Lately, criminal gangs appear to be targeting the IT or EHR systems that practices rely on for clinical care and making them unavailable. By locking EHR files or databases and holding them for ransom, criminals hope practices will be more likely to pay, said Ms. Hughes.

They also don’t want to get caught, and this tactic “gets them in and out faster” than extracting and posting patient data, although criminals may use that as a threat to extort a ransom payment, she said.
 

 

 

Fines for lax privacy/security

Breaches of patient records have consequences that include being investigated by federal or state authorities for potential HIPAA privacy and security violations and fines. Recently, the HHS announced a $1.5 million settlement – the largest to date – with Athens Orthopedic Clinic, PA, in Georgia, for not complying with the HIPAA rules.

When breaches of 500 or more patient records occur, medical groups are required to notify the HHS Office of Civil Rights (OCR) within 60 days, as well as all the affected patients and the media. Some organizations offer free credit monitoring and identity theft protection services to their patients.

Information about the breaches, including company names and the number of affected individuals, is posted publicly on what cyber experts often call “OCR’s wall of shame.”
 

Strengthen your defenses

The FBI and the HHS warned health care professionals and organizations in 2020 about the threat of increasing cyber attacks and urged them to take precautions to protect their networks.

Here are five actions you can take:

  • Back-up your files to the cloud or off-site services and test that the restoration works.
  • Implement user training with simulated phishing attacks so the staff will recognize suspicious emails and avoid actions that could launch malware attacks.
  • Ensure strong password controls and that systems are regularly patched.
  • Require multifactor authentication for remote access to IT networks.
  • Set anti-virus/anti-malware programs to conduct regular scans of IT network assets using up-to-date signatures.

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

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Could the Omicron surge hasten the transition from pandemic to endemic?

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Thu, 01/06/2022 - 14:46

The record-setting surge in COVID-19 cases nationwide – including more than one million new infections reported on Jan. 3 – raises questions about whether the higher Omicron variant transmissibility will accelerate a transition from pandemic to endemic disease.

Furthermore, does the steep increase in number of people testing positive for SARS-CoV-2 mean the United States could finally be achieving a meaningful level of “herd immunity”?

Infectious disease experts weigh in on these possibilities.
 

An endemic eventuality?

Whether the current surge will mean the predicted switch to endemic COVID-19 will come sooner “is very hard to predict,” Michael Lin, MD, MPH, told this news organization.

“It’s an open question,” he said, “if another highly transmissible variant will emerge.”

On a positive note, “at this point many more people have received their vaccinations or been infected. And over time, repeated infections have led to milder symptoms,” added Dr. Lin, hospital epidemiologist at Rush Medical College, Chicago.

“It could end up being a seasonal variant,” he said.

COVID-19 going endemic is “a real possibility, but unfortunately ... it doesn’t seem necessarily that we’re going to have the same predictable pattern we have with the flu,” said Eleftherios Mylonakis, MD, PhD, chief of infectious diseases for Lifespan and its affiliates at Rhode Island Hospital and Miriam Hospital in Providence.

“We have a number of other viruses that don’t follow the same annual pattern,” he said.  

Unknowns include how long individuals’ immune responses, including T-cell defenses, will last going forward.

A transition from pandemic to endemic is “not a light switch, and there are no metrics associated with what endemic means for COVID-19,” said Syra Madad, DHSc., MSc, MCP, an infectious disease epidemiologist at Harvard’s Belfer Center for Science and International Affairs, Boston.

“Instead, we should continue to focus on decreasing transmission rates and preventing our hospitals from getting overwhelmed,” she said.
 

A hastening to herd immunity?

“The short answer is yes,” Dr. Lin said when asked if the increased transmissibility and increased cases linked to the Omicron surge could get the U.S. closer to herd immunity.

“The twist in this whole story,” he said, “is the virus mutated enough to escape first-line immune defenses, specifically antibodies. That is why we are seeing breakthrough infections, even in highly vaccinated populations.”

Dr. Mylonakis was more skeptical regarding herd immunity.

“The concept of herd immunity with a rapidly evolving virus is very difficult” to address, he said.

One reason is the number of unknown factors, Dr. Mylonakis said. He predicted a clearer picture will emerge after the Omicrons surge subsides. Also, with so many people infected by the Omicron variant, immune protection should peak.

“People will have boosted immunity. Not everybody, unfortunately, because there are people who cannot really mount [a full immune response] because of age, because of immunosuppression, etc.,” said Dr. Mylonakis, who is also professor of infectious diseases at Brown University.

“But the majority of the population will be exposed and will mount some degree of immunity.”

Dr. Madad agreed. “The omicron variant will add much more immunity into our population by both the preferred pathway – which is through vaccination – as well as through those that are unvaccinated and get infected with omicron,” she said.

“The pathway to gain immunity from vaccination is the safest option, and already over 1 million doses of the COVID-19 vaccine are going into arms per day – this includes first, second, and additional doses like boosters,” added Dr. Madad, who is also senior director of the System-wide Special Pathogens Program at New York City Health and Hospitals.
 

 

 

A shorter, more intense surge?

The United Kingdom’s experience with COVID-19 has often served as a bellwether of what is likely to happen in the U.S. If that is the case with the Omicron surge, the peak should last about 4 weeks, Dr. Mylonakis said.

In other words, the accelerated spread of Omicron could mean this surge passes more quickly than Delta.

Furthermore, some evidence suggests neutralizing antibodies produced by Omicron infection remain effective against the Delta variant – thereby reducing the risk of Delta reinfections over time.

The ability to neutralize the Delta variant increased more than fourfold after a median 14 days, according to data from a preprint study posted Dec. 27 on MedRxiv.

At the same time, neutralization of the Omicron variant increased 14-fold as participants mounted an antibody response. The study was conducted in vaccinated and unvaccinated people infected by Omicron in South Africa shortly after symptoms started. It has yet to be peer reviewed.

Eric Topol, MD, editor-in-chief of Medscape, described the results as “especially good news” in a tweet.

The current surge could also mean enhanced protection in the future.

“As we look at getting to the other side of this Omicron wave, we will end up with more immunity,” Dr. Madad said. “And with more immunity means we’ll be better guarded against the next emerging variant.”

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

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The record-setting surge in COVID-19 cases nationwide – including more than one million new infections reported on Jan. 3 – raises questions about whether the higher Omicron variant transmissibility will accelerate a transition from pandemic to endemic disease.

Furthermore, does the steep increase in number of people testing positive for SARS-CoV-2 mean the United States could finally be achieving a meaningful level of “herd immunity”?

Infectious disease experts weigh in on these possibilities.
 

An endemic eventuality?

Whether the current surge will mean the predicted switch to endemic COVID-19 will come sooner “is very hard to predict,” Michael Lin, MD, MPH, told this news organization.

“It’s an open question,” he said, “if another highly transmissible variant will emerge.”

On a positive note, “at this point many more people have received their vaccinations or been infected. And over time, repeated infections have led to milder symptoms,” added Dr. Lin, hospital epidemiologist at Rush Medical College, Chicago.

“It could end up being a seasonal variant,” he said.

COVID-19 going endemic is “a real possibility, but unfortunately ... it doesn’t seem necessarily that we’re going to have the same predictable pattern we have with the flu,” said Eleftherios Mylonakis, MD, PhD, chief of infectious diseases for Lifespan and its affiliates at Rhode Island Hospital and Miriam Hospital in Providence.

“We have a number of other viruses that don’t follow the same annual pattern,” he said.  

Unknowns include how long individuals’ immune responses, including T-cell defenses, will last going forward.

A transition from pandemic to endemic is “not a light switch, and there are no metrics associated with what endemic means for COVID-19,” said Syra Madad, DHSc., MSc, MCP, an infectious disease epidemiologist at Harvard’s Belfer Center for Science and International Affairs, Boston.

“Instead, we should continue to focus on decreasing transmission rates and preventing our hospitals from getting overwhelmed,” she said.
 

A hastening to herd immunity?

“The short answer is yes,” Dr. Lin said when asked if the increased transmissibility and increased cases linked to the Omicron surge could get the U.S. closer to herd immunity.

“The twist in this whole story,” he said, “is the virus mutated enough to escape first-line immune defenses, specifically antibodies. That is why we are seeing breakthrough infections, even in highly vaccinated populations.”

Dr. Mylonakis was more skeptical regarding herd immunity.

“The concept of herd immunity with a rapidly evolving virus is very difficult” to address, he said.

One reason is the number of unknown factors, Dr. Mylonakis said. He predicted a clearer picture will emerge after the Omicrons surge subsides. Also, with so many people infected by the Omicron variant, immune protection should peak.

“People will have boosted immunity. Not everybody, unfortunately, because there are people who cannot really mount [a full immune response] because of age, because of immunosuppression, etc.,” said Dr. Mylonakis, who is also professor of infectious diseases at Brown University.

“But the majority of the population will be exposed and will mount some degree of immunity.”

Dr. Madad agreed. “The omicron variant will add much more immunity into our population by both the preferred pathway – which is through vaccination – as well as through those that are unvaccinated and get infected with omicron,” she said.

“The pathway to gain immunity from vaccination is the safest option, and already over 1 million doses of the COVID-19 vaccine are going into arms per day – this includes first, second, and additional doses like boosters,” added Dr. Madad, who is also senior director of the System-wide Special Pathogens Program at New York City Health and Hospitals.
 

 

 

A shorter, more intense surge?

The United Kingdom’s experience with COVID-19 has often served as a bellwether of what is likely to happen in the U.S. If that is the case with the Omicron surge, the peak should last about 4 weeks, Dr. Mylonakis said.

In other words, the accelerated spread of Omicron could mean this surge passes more quickly than Delta.

Furthermore, some evidence suggests neutralizing antibodies produced by Omicron infection remain effective against the Delta variant – thereby reducing the risk of Delta reinfections over time.

The ability to neutralize the Delta variant increased more than fourfold after a median 14 days, according to data from a preprint study posted Dec. 27 on MedRxiv.

At the same time, neutralization of the Omicron variant increased 14-fold as participants mounted an antibody response. The study was conducted in vaccinated and unvaccinated people infected by Omicron in South Africa shortly after symptoms started. It has yet to be peer reviewed.

Eric Topol, MD, editor-in-chief of Medscape, described the results as “especially good news” in a tweet.

The current surge could also mean enhanced protection in the future.

“As we look at getting to the other side of this Omicron wave, we will end up with more immunity,” Dr. Madad said. “And with more immunity means we’ll be better guarded against the next emerging variant.”

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

The record-setting surge in COVID-19 cases nationwide – including more than one million new infections reported on Jan. 3 – raises questions about whether the higher Omicron variant transmissibility will accelerate a transition from pandemic to endemic disease.

Furthermore, does the steep increase in number of people testing positive for SARS-CoV-2 mean the United States could finally be achieving a meaningful level of “herd immunity”?

Infectious disease experts weigh in on these possibilities.
 

An endemic eventuality?

Whether the current surge will mean the predicted switch to endemic COVID-19 will come sooner “is very hard to predict,” Michael Lin, MD, MPH, told this news organization.

“It’s an open question,” he said, “if another highly transmissible variant will emerge.”

On a positive note, “at this point many more people have received their vaccinations or been infected. And over time, repeated infections have led to milder symptoms,” added Dr. Lin, hospital epidemiologist at Rush Medical College, Chicago.

“It could end up being a seasonal variant,” he said.

COVID-19 going endemic is “a real possibility, but unfortunately ... it doesn’t seem necessarily that we’re going to have the same predictable pattern we have with the flu,” said Eleftherios Mylonakis, MD, PhD, chief of infectious diseases for Lifespan and its affiliates at Rhode Island Hospital and Miriam Hospital in Providence.

“We have a number of other viruses that don’t follow the same annual pattern,” he said.  

Unknowns include how long individuals’ immune responses, including T-cell defenses, will last going forward.

A transition from pandemic to endemic is “not a light switch, and there are no metrics associated with what endemic means for COVID-19,” said Syra Madad, DHSc., MSc, MCP, an infectious disease epidemiologist at Harvard’s Belfer Center for Science and International Affairs, Boston.

“Instead, we should continue to focus on decreasing transmission rates and preventing our hospitals from getting overwhelmed,” she said.
 

A hastening to herd immunity?

“The short answer is yes,” Dr. Lin said when asked if the increased transmissibility and increased cases linked to the Omicron surge could get the U.S. closer to herd immunity.

“The twist in this whole story,” he said, “is the virus mutated enough to escape first-line immune defenses, specifically antibodies. That is why we are seeing breakthrough infections, even in highly vaccinated populations.”

Dr. Mylonakis was more skeptical regarding herd immunity.

“The concept of herd immunity with a rapidly evolving virus is very difficult” to address, he said.

One reason is the number of unknown factors, Dr. Mylonakis said. He predicted a clearer picture will emerge after the Omicrons surge subsides. Also, with so many people infected by the Omicron variant, immune protection should peak.

“People will have boosted immunity. Not everybody, unfortunately, because there are people who cannot really mount [a full immune response] because of age, because of immunosuppression, etc.,” said Dr. Mylonakis, who is also professor of infectious diseases at Brown University.

“But the majority of the population will be exposed and will mount some degree of immunity.”

Dr. Madad agreed. “The omicron variant will add much more immunity into our population by both the preferred pathway – which is through vaccination – as well as through those that are unvaccinated and get infected with omicron,” she said.

“The pathway to gain immunity from vaccination is the safest option, and already over 1 million doses of the COVID-19 vaccine are going into arms per day – this includes first, second, and additional doses like boosters,” added Dr. Madad, who is also senior director of the System-wide Special Pathogens Program at New York City Health and Hospitals.
 

 

 

A shorter, more intense surge?

The United Kingdom’s experience with COVID-19 has often served as a bellwether of what is likely to happen in the U.S. If that is the case with the Omicron surge, the peak should last about 4 weeks, Dr. Mylonakis said.

In other words, the accelerated spread of Omicron could mean this surge passes more quickly than Delta.

Furthermore, some evidence suggests neutralizing antibodies produced by Omicron infection remain effective against the Delta variant – thereby reducing the risk of Delta reinfections over time.

The ability to neutralize the Delta variant increased more than fourfold after a median 14 days, according to data from a preprint study posted Dec. 27 on MedRxiv.

At the same time, neutralization of the Omicron variant increased 14-fold as participants mounted an antibody response. The study was conducted in vaccinated and unvaccinated people infected by Omicron in South Africa shortly after symptoms started. It has yet to be peer reviewed.

Eric Topol, MD, editor-in-chief of Medscape, described the results as “especially good news” in a tweet.

The current surge could also mean enhanced protection in the future.

“As we look at getting to the other side of this Omicron wave, we will end up with more immunity,” Dr. Madad said. “And with more immunity means we’ll be better guarded against the next emerging variant.”

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

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As Omicron surges, hospital beds fill, but ICUs less affected

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Thu, 01/06/2022 - 11:32

 

Hospitals across the United States are beginning to fill up with COVID-19 patients again, but a smaller proportion of cases are severe enough to move to intensive care or require mechanical ventilation.

So far, hospitalizations caused by the Omicron variant appear to be milder than in previous waves.

“We are seeing an increase in the number of hospitalizations,” Rahul Sharma, MD, emergency physician-in-chief for New York–Presbyterian/Weill Cornell Medicine, told the New York Times.

“We’re not sending as many patients to the ICU, we’re not intubating as many patients, and actually, most of our patients that are coming to the emergency department that do test positive are actually being discharged,” he said.

Most Omicron patients in ICUs are unvaccinated or have severely compromised immune systems, doctors told the newspaper.

Currently, about 113,000 COVID-19 patients are hospitalized across the country, according to the latest data from the Department of Health & Human Services. About 76% of inpatient beds are in use nationwide, with about 16% of inpatient beds in use for COVID-19.

Early data suggests that the Omicron variant may cause less severe disease. But it’s easier to catch the variant, so more people are getting the virus, including people who have some immunity through prior infection or vaccination, which is driving up hospitalization numbers.

In New York, for instance, COVID-19 hospitalizations have surpassed the peak of last winter’s surge, the newspaper reported. In addition, Maryland Gov. Larry Hogan declared a state of emergency on Jan. 4, noting that the state had more hospitalized COVID-19 patients than at any other time during the pandemic.

“We’re in truly crushed mode,” Gabe Kelen, MD, chair of the department of emergency medicine for the Johns Hopkins University, Baltimore, told the Times.

Earlier in the pandemic, hospitals faced challenges with stockpiling ventilators and personal protective equipment, doctors told the newspaper. Now they’re dealing with limits on hospital beds and staffing as health care workers test positive. The increase in COVID-19 cases has also come along with a rise in hospitalizations for other conditions such as heart attacks and strokes.

In response, some hospitals are considering cutting elective surgeries because of staff shortages and limited bed capacity, the newspaper reported. In the meantime, hospital staff and administrators are watching case numbers to see how high hospitalizations may soar because of the Omicron variant.

“How high will it go? Can’t tell you. Don’t know,” James Musser, MD, chair of pathology and genomic medicine at Houston Methodist, told the Times. “We’re all watching it, obviously, very, very closely.”

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

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Hospitals across the United States are beginning to fill up with COVID-19 patients again, but a smaller proportion of cases are severe enough to move to intensive care or require mechanical ventilation.

So far, hospitalizations caused by the Omicron variant appear to be milder than in previous waves.

“We are seeing an increase in the number of hospitalizations,” Rahul Sharma, MD, emergency physician-in-chief for New York–Presbyterian/Weill Cornell Medicine, told the New York Times.

“We’re not sending as many patients to the ICU, we’re not intubating as many patients, and actually, most of our patients that are coming to the emergency department that do test positive are actually being discharged,” he said.

Most Omicron patients in ICUs are unvaccinated or have severely compromised immune systems, doctors told the newspaper.

Currently, about 113,000 COVID-19 patients are hospitalized across the country, according to the latest data from the Department of Health & Human Services. About 76% of inpatient beds are in use nationwide, with about 16% of inpatient beds in use for COVID-19.

Early data suggests that the Omicron variant may cause less severe disease. But it’s easier to catch the variant, so more people are getting the virus, including people who have some immunity through prior infection or vaccination, which is driving up hospitalization numbers.

In New York, for instance, COVID-19 hospitalizations have surpassed the peak of last winter’s surge, the newspaper reported. In addition, Maryland Gov. Larry Hogan declared a state of emergency on Jan. 4, noting that the state had more hospitalized COVID-19 patients than at any other time during the pandemic.

“We’re in truly crushed mode,” Gabe Kelen, MD, chair of the department of emergency medicine for the Johns Hopkins University, Baltimore, told the Times.

Earlier in the pandemic, hospitals faced challenges with stockpiling ventilators and personal protective equipment, doctors told the newspaper. Now they’re dealing with limits on hospital beds and staffing as health care workers test positive. The increase in COVID-19 cases has also come along with a rise in hospitalizations for other conditions such as heart attacks and strokes.

In response, some hospitals are considering cutting elective surgeries because of staff shortages and limited bed capacity, the newspaper reported. In the meantime, hospital staff and administrators are watching case numbers to see how high hospitalizations may soar because of the Omicron variant.

“How high will it go? Can’t tell you. Don’t know,” James Musser, MD, chair of pathology and genomic medicine at Houston Methodist, told the Times. “We’re all watching it, obviously, very, very closely.”

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

 

Hospitals across the United States are beginning to fill up with COVID-19 patients again, but a smaller proportion of cases are severe enough to move to intensive care or require mechanical ventilation.

So far, hospitalizations caused by the Omicron variant appear to be milder than in previous waves.

“We are seeing an increase in the number of hospitalizations,” Rahul Sharma, MD, emergency physician-in-chief for New York–Presbyterian/Weill Cornell Medicine, told the New York Times.

“We’re not sending as many patients to the ICU, we’re not intubating as many patients, and actually, most of our patients that are coming to the emergency department that do test positive are actually being discharged,” he said.

Most Omicron patients in ICUs are unvaccinated or have severely compromised immune systems, doctors told the newspaper.

Currently, about 113,000 COVID-19 patients are hospitalized across the country, according to the latest data from the Department of Health & Human Services. About 76% of inpatient beds are in use nationwide, with about 16% of inpatient beds in use for COVID-19.

Early data suggests that the Omicron variant may cause less severe disease. But it’s easier to catch the variant, so more people are getting the virus, including people who have some immunity through prior infection or vaccination, which is driving up hospitalization numbers.

In New York, for instance, COVID-19 hospitalizations have surpassed the peak of last winter’s surge, the newspaper reported. In addition, Maryland Gov. Larry Hogan declared a state of emergency on Jan. 4, noting that the state had more hospitalized COVID-19 patients than at any other time during the pandemic.

“We’re in truly crushed mode,” Gabe Kelen, MD, chair of the department of emergency medicine for the Johns Hopkins University, Baltimore, told the Times.

Earlier in the pandemic, hospitals faced challenges with stockpiling ventilators and personal protective equipment, doctors told the newspaper. Now they’re dealing with limits on hospital beds and staffing as health care workers test positive. The increase in COVID-19 cases has also come along with a rise in hospitalizations for other conditions such as heart attacks and strokes.

In response, some hospitals are considering cutting elective surgeries because of staff shortages and limited bed capacity, the newspaper reported. In the meantime, hospital staff and administrators are watching case numbers to see how high hospitalizations may soar because of the Omicron variant.

“How high will it go? Can’t tell you. Don’t know,” James Musser, MD, chair of pathology and genomic medicine at Houston Methodist, told the Times. “We’re all watching it, obviously, very, very closely.”

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

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Longitudinal course of atopic dermatitis often overlooked, expert says

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Thu, 01/06/2022 - 10:28

 

In the opinion of Raj Chovatiya, MD, PhD, the longitudinal course of atopic dermatitis (AD) is an important yet overlooked clinical domain of the disease.

“We know that AD is associated with fluctuating severity, disease flares, long-term persistence, and periods of quiescence, but its longitudinal course is not routinely incorporated into guidelines or clinical trials,” Dr. Chovatiya, assistant professor in the department of dermatology at Northwestern University, Chicago, said during the Revolutionizing Atopic Dermatitis virtual symposium. “Understanding the long-term course may improve our ability to phenotype, prognosticate, and personalize our care.”

Dr. Raj Chovatiya

The classic view of AD is that it starts in early childhood, follows a waxing and waning course for a few years, and burns out by adulthood. “I think we all know that this is generally false,” he said. “This was largely based on anecdotal clinical experience and large cross-sectional studies, not ones that consider the heterogeneity of AD.”



Results from a large-scale, prospective study of 7,157 children enrolled in the Pediatric Eczema Elective Registry (PEER), suggests that AD commonly persists beyond adulthood. PEER was a phase IV postmarketing safety study of children aged 12-17 with moderate to severe AD who were exposed to topical pimecrolimus and who were surveyed every 6 months (JAMA Dermatol. 2014;150[6]:593-600). The researchers found that more persistent disease was associated with self-reported disease activity, many environmental exposures, White race, history of AD, and an annual household income of less than $50,000. By age 20, 50% reported at least one 6-month symptom- and medication-free period. “The important takeaway was that at every age, greater than 80% reported active AD as defined by symptoms or medication use, meaning that persistence was extremely high – much higher than what was originally thought,” Dr. Chovatiya said. “If you take a look at the literature before this study, many were retrospective analyses, and persistence was estimated to be in the 40%-60% range.”

International prospective studies have provided a more conservative estimate of persistence. For example, the German Multicenter Allergy Study followed 1,314 from birth through age 7 (J Allergy Clin Immunol. 2004;113[5]:925-31). Of these, 22% had AD within the first 2 years of life. Of these, 43% were in remission by age 3, while 38% had intermittent AD, and 19% had symptoms every year of the study. “Studies of other birth cohorts in the world came out suggesting that the rates of AD persistence ranges in the single digits to the teens,” Dr. Chovatiya said.

To reconcile these heterogeneous estimates of AD persistence, researchers conducted a systematic review and meta-analysis of 45 studies that included 110,651 subjects from 15 countries and spanned 434,992 patient-years (J Am Acad Dermatol. 2016;75:681-7.e11). They found that 80% of childhood AD had at least one observed period of disease clearance by 8 years of age. “Most importantly, less than 5% of childhood AD was persistent 20 years after diagnosis,” Dr. Chovatiya said. “However, interestingly, increased persistence was associated with later onset AD, more years of persistence, and more patient/caregiver-assessed disease.” He pointed out inherent limitations to all studies of AD persistence, including nonuniform methods of data collection, differing cohorts, different ways of diagnosing AD, different disease severity scales, and the fact that most don’t assess flares or recurrence beyond the initial period of disease clearance. “This can lead to a potential underestimation of longer-term persistence,” he said.

Childhood AD features unique predictors of persistence that may define AD trajectories. For example, in several existing studies, more persistent disease was associated with higher baseline severity, earlier-onset AD, personal history of atopy, family history of AD, AD genetic risk score (heritability, including common Filaggrin mutations), urban environment, non-White race, Hispanic ethnicity, female sex, lower household income, and overall poorer health status.

“When it comes to evaluating the longitudinal course of AD in clinical practice, consideration of fluctuation, persistence, and improvement over time may actually improve our clinical decision-making and help set realistic expectations for our patients,” Dr. Chovatiya said. “I think that AD classification can take a lesson from asthma. When we think about how our allergy colleagues think about asthma, it is commonly classified as intermittent, mild persistent, moderate persistent, and severe persistent. Those that have intermittent disease get reactive treatment, while those with persistent disease get proactive treatment. Similarly, AD could be classified as mild intermittent, mild persistent, moderate to severe intermittent and moderate to severe persistent.”

He concluded his presentation by recommending that the fluctuating course of AD be better captured in clinical trials. “Current randomized, controlled trials use validated measures of AD signs and symptoms as inclusion criteria and measures of efficacy,” he said. “Static assessments may confound treatment effects, and assessment of prespecified time points are somewhat arbitrary in the context of disease subsets.” He proposes studies that examine aggregate measures of long-term disease control, such as number of itch-free days, weeks with clear skin, and flares experienced. “Long-term control assessment in RCTs should include signs, symptoms, health-related quality of life, and a patient global domain over time to better understand how AD is doing in the long run,” he said.

Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arcutis, Arena, Incyte, Pfizer, Regeneron, and Sanofi Genzyme.

[email protected]

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In the opinion of Raj Chovatiya, MD, PhD, the longitudinal course of atopic dermatitis (AD) is an important yet overlooked clinical domain of the disease.

“We know that AD is associated with fluctuating severity, disease flares, long-term persistence, and periods of quiescence, but its longitudinal course is not routinely incorporated into guidelines or clinical trials,” Dr. Chovatiya, assistant professor in the department of dermatology at Northwestern University, Chicago, said during the Revolutionizing Atopic Dermatitis virtual symposium. “Understanding the long-term course may improve our ability to phenotype, prognosticate, and personalize our care.”

Dr. Raj Chovatiya

The classic view of AD is that it starts in early childhood, follows a waxing and waning course for a few years, and burns out by adulthood. “I think we all know that this is generally false,” he said. “This was largely based on anecdotal clinical experience and large cross-sectional studies, not ones that consider the heterogeneity of AD.”



Results from a large-scale, prospective study of 7,157 children enrolled in the Pediatric Eczema Elective Registry (PEER), suggests that AD commonly persists beyond adulthood. PEER was a phase IV postmarketing safety study of children aged 12-17 with moderate to severe AD who were exposed to topical pimecrolimus and who were surveyed every 6 months (JAMA Dermatol. 2014;150[6]:593-600). The researchers found that more persistent disease was associated with self-reported disease activity, many environmental exposures, White race, history of AD, and an annual household income of less than $50,000. By age 20, 50% reported at least one 6-month symptom- and medication-free period. “The important takeaway was that at every age, greater than 80% reported active AD as defined by symptoms or medication use, meaning that persistence was extremely high – much higher than what was originally thought,” Dr. Chovatiya said. “If you take a look at the literature before this study, many were retrospective analyses, and persistence was estimated to be in the 40%-60% range.”

International prospective studies have provided a more conservative estimate of persistence. For example, the German Multicenter Allergy Study followed 1,314 from birth through age 7 (J Allergy Clin Immunol. 2004;113[5]:925-31). Of these, 22% had AD within the first 2 years of life. Of these, 43% were in remission by age 3, while 38% had intermittent AD, and 19% had symptoms every year of the study. “Studies of other birth cohorts in the world came out suggesting that the rates of AD persistence ranges in the single digits to the teens,” Dr. Chovatiya said.

To reconcile these heterogeneous estimates of AD persistence, researchers conducted a systematic review and meta-analysis of 45 studies that included 110,651 subjects from 15 countries and spanned 434,992 patient-years (J Am Acad Dermatol. 2016;75:681-7.e11). They found that 80% of childhood AD had at least one observed period of disease clearance by 8 years of age. “Most importantly, less than 5% of childhood AD was persistent 20 years after diagnosis,” Dr. Chovatiya said. “However, interestingly, increased persistence was associated with later onset AD, more years of persistence, and more patient/caregiver-assessed disease.” He pointed out inherent limitations to all studies of AD persistence, including nonuniform methods of data collection, differing cohorts, different ways of diagnosing AD, different disease severity scales, and the fact that most don’t assess flares or recurrence beyond the initial period of disease clearance. “This can lead to a potential underestimation of longer-term persistence,” he said.

Childhood AD features unique predictors of persistence that may define AD trajectories. For example, in several existing studies, more persistent disease was associated with higher baseline severity, earlier-onset AD, personal history of atopy, family history of AD, AD genetic risk score (heritability, including common Filaggrin mutations), urban environment, non-White race, Hispanic ethnicity, female sex, lower household income, and overall poorer health status.

“When it comes to evaluating the longitudinal course of AD in clinical practice, consideration of fluctuation, persistence, and improvement over time may actually improve our clinical decision-making and help set realistic expectations for our patients,” Dr. Chovatiya said. “I think that AD classification can take a lesson from asthma. When we think about how our allergy colleagues think about asthma, it is commonly classified as intermittent, mild persistent, moderate persistent, and severe persistent. Those that have intermittent disease get reactive treatment, while those with persistent disease get proactive treatment. Similarly, AD could be classified as mild intermittent, mild persistent, moderate to severe intermittent and moderate to severe persistent.”

He concluded his presentation by recommending that the fluctuating course of AD be better captured in clinical trials. “Current randomized, controlled trials use validated measures of AD signs and symptoms as inclusion criteria and measures of efficacy,” he said. “Static assessments may confound treatment effects, and assessment of prespecified time points are somewhat arbitrary in the context of disease subsets.” He proposes studies that examine aggregate measures of long-term disease control, such as number of itch-free days, weeks with clear skin, and flares experienced. “Long-term control assessment in RCTs should include signs, symptoms, health-related quality of life, and a patient global domain over time to better understand how AD is doing in the long run,” he said.

Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arcutis, Arena, Incyte, Pfizer, Regeneron, and Sanofi Genzyme.

[email protected]

 

In the opinion of Raj Chovatiya, MD, PhD, the longitudinal course of atopic dermatitis (AD) is an important yet overlooked clinical domain of the disease.

“We know that AD is associated with fluctuating severity, disease flares, long-term persistence, and periods of quiescence, but its longitudinal course is not routinely incorporated into guidelines or clinical trials,” Dr. Chovatiya, assistant professor in the department of dermatology at Northwestern University, Chicago, said during the Revolutionizing Atopic Dermatitis virtual symposium. “Understanding the long-term course may improve our ability to phenotype, prognosticate, and personalize our care.”

Dr. Raj Chovatiya

The classic view of AD is that it starts in early childhood, follows a waxing and waning course for a few years, and burns out by adulthood. “I think we all know that this is generally false,” he said. “This was largely based on anecdotal clinical experience and large cross-sectional studies, not ones that consider the heterogeneity of AD.”



Results from a large-scale, prospective study of 7,157 children enrolled in the Pediatric Eczema Elective Registry (PEER), suggests that AD commonly persists beyond adulthood. PEER was a phase IV postmarketing safety study of children aged 12-17 with moderate to severe AD who were exposed to topical pimecrolimus and who were surveyed every 6 months (JAMA Dermatol. 2014;150[6]:593-600). The researchers found that more persistent disease was associated with self-reported disease activity, many environmental exposures, White race, history of AD, and an annual household income of less than $50,000. By age 20, 50% reported at least one 6-month symptom- and medication-free period. “The important takeaway was that at every age, greater than 80% reported active AD as defined by symptoms or medication use, meaning that persistence was extremely high – much higher than what was originally thought,” Dr. Chovatiya said. “If you take a look at the literature before this study, many were retrospective analyses, and persistence was estimated to be in the 40%-60% range.”

International prospective studies have provided a more conservative estimate of persistence. For example, the German Multicenter Allergy Study followed 1,314 from birth through age 7 (J Allergy Clin Immunol. 2004;113[5]:925-31). Of these, 22% had AD within the first 2 years of life. Of these, 43% were in remission by age 3, while 38% had intermittent AD, and 19% had symptoms every year of the study. “Studies of other birth cohorts in the world came out suggesting that the rates of AD persistence ranges in the single digits to the teens,” Dr. Chovatiya said.

To reconcile these heterogeneous estimates of AD persistence, researchers conducted a systematic review and meta-analysis of 45 studies that included 110,651 subjects from 15 countries and spanned 434,992 patient-years (J Am Acad Dermatol. 2016;75:681-7.e11). They found that 80% of childhood AD had at least one observed period of disease clearance by 8 years of age. “Most importantly, less than 5% of childhood AD was persistent 20 years after diagnosis,” Dr. Chovatiya said. “However, interestingly, increased persistence was associated with later onset AD, more years of persistence, and more patient/caregiver-assessed disease.” He pointed out inherent limitations to all studies of AD persistence, including nonuniform methods of data collection, differing cohorts, different ways of diagnosing AD, different disease severity scales, and the fact that most don’t assess flares or recurrence beyond the initial period of disease clearance. “This can lead to a potential underestimation of longer-term persistence,” he said.

Childhood AD features unique predictors of persistence that may define AD trajectories. For example, in several existing studies, more persistent disease was associated with higher baseline severity, earlier-onset AD, personal history of atopy, family history of AD, AD genetic risk score (heritability, including common Filaggrin mutations), urban environment, non-White race, Hispanic ethnicity, female sex, lower household income, and overall poorer health status.

“When it comes to evaluating the longitudinal course of AD in clinical practice, consideration of fluctuation, persistence, and improvement over time may actually improve our clinical decision-making and help set realistic expectations for our patients,” Dr. Chovatiya said. “I think that AD classification can take a lesson from asthma. When we think about how our allergy colleagues think about asthma, it is commonly classified as intermittent, mild persistent, moderate persistent, and severe persistent. Those that have intermittent disease get reactive treatment, while those with persistent disease get proactive treatment. Similarly, AD could be classified as mild intermittent, mild persistent, moderate to severe intermittent and moderate to severe persistent.”

He concluded his presentation by recommending that the fluctuating course of AD be better captured in clinical trials. “Current randomized, controlled trials use validated measures of AD signs and symptoms as inclusion criteria and measures of efficacy,” he said. “Static assessments may confound treatment effects, and assessment of prespecified time points are somewhat arbitrary in the context of disease subsets.” He proposes studies that examine aggregate measures of long-term disease control, such as number of itch-free days, weeks with clear skin, and flares experienced. “Long-term control assessment in RCTs should include signs, symptoms, health-related quality of life, and a patient global domain over time to better understand how AD is doing in the long run,” he said.

Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arcutis, Arena, Incyte, Pfizer, Regeneron, and Sanofi Genzyme.

[email protected]

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