MDedge Pediatrics

Interventional cardiologist Richard B. Zelman, MD, has filed a lawsuit against Cape Cod Hospital, Cape Cod Healthcare Inc., and its chief executive officer Michael K. Lauf, alleging that he was fired and maligned after raising concerns about poorly performed surgeries and poor ethical practices at the hospital.

Dr. Zelman, from Barnstable, Mass., has been affiliated with Cape Cod Hospital in Hyannis, Mass., for more than 30 years. He helped found the hospital’s Heart and Vascular Institute and has served as its medical director since 2018.

In his lawsuit filed Dec. 6, Dr. Zelman alleges that the defendants, under Mr. Lauf’s leadership, “placed profit above all else, including by prioritizing revenue generation over patient safety and public health.”

Dr. Zelman says the defendants supported him “to the extent his actions were profitable.”

Yet, when he raised patient safety concerns that harmed that bottom line, Dr. Zelman says the defendants retaliated against him, including by threatening his career and reputation and unlawfully terminating his employment with the hospital.

The complaint notes Dr. Zelman is bringing this action “to recover damages for violations of the Massachusetts Healthcare Provider Whistleblower Statute ... as well as for breach of contract and common law claims.”

Dr. Zelman’s complaint alleges the defendants refused to adequately address the “dangerous care and violations of the professional standards of practice” that he reported, “resulting in harmful and tragic consequences.”

It also alleges Mr. Lauf restricted the use of a cerebral protection device used in patients undergoing transcatheter aortic-valve replacement (TAVR) deemed to be at high risk for periprocedural stroke to only those patients whose insurance reimbursed at higher rates.

Dr. Zelman says he objected to this prohibition “in accordance with his contractual and ethical obligations to ensure treatment of patients without regard to their ability to pay.”

Dr. Zelman’s lawsuit further alleges that Mr. Lauf launched a “trumped-up” and “baseless, biased, and retaliatory sham” investigation against him.

In a statement sent to the Boston Globe, Cape Cod Hospital denied Dr. Zelman’s claims that the cardiologist was retaliated against for raising patient safety issues, or that the hospital didn’t take action to improve cardiac care at the facility.
 

Voiced concerns

In a statement sent to this news organization, Dr. Zelman, now in private practice, said, “Over the past 25 years, I have been instrumental in bringing advanced cardiac care to Cape Cod. My commitment has always been to delivering the same quality outcomes and safety as the academic centers in Boston.

“Unfortunately, over the past 5 years, there has been inadequate oversight by the hospital administration and problems have occurred that in my opinion have led to serious patient consequences,” Dr. Zelman stated.

He said he has “voiced concerns over several years and they have been ignored.”

He added that Cape Cod Hospital offered him a million-dollar contract as long as he agreed to immediately issue a written statement endorsing the quality and safety of the cardiac surgical program that no longer exists.

“No amount of money was going to buy my silence,” Dr. Zelman told this news organization.

In his lawsuit, Dr. Zelman is seeking an undisclosed amount in damages, including back and front pay, lost benefits, physical and emotional distress, and attorneys’ fees.

This news organization reached out to Cape Cod Hospital for comment but has not yet received a response.

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

Interventional cardiologist Richard B. Zelman, MD, has filed a lawsuit against Cape Cod Hospital, Cape Cod Healthcare Inc., and its chief executive officer Michael K. Lauf, alleging that he was fired and maligned after raising concerns about poorly performed surgeries and poor ethical practices at the hospital.

Dr. Zelman, from Barnstable, Mass., has been affiliated with Cape Cod Hospital in Hyannis, Mass., for more than 30 years. He helped found the hospital’s Heart and Vascular Institute and has served as its medical director since 2018.

In his lawsuit filed Dec. 6, Dr. Zelman alleges that the defendants, under Mr. Lauf’s leadership, “placed profit above all else, including by prioritizing revenue generation over patient safety and public health.”

Dr. Zelman says the defendants supported him “to the extent his actions were profitable.”

Yet, when he raised patient safety concerns that harmed that bottom line, Dr. Zelman says the defendants retaliated against him, including by threatening his career and reputation and unlawfully terminating his employment with the hospital.

The complaint notes Dr. Zelman is bringing this action “to recover damages for violations of the Massachusetts Healthcare Provider Whistleblower Statute ... as well as for breach of contract and common law claims.”

Dr. Zelman’s complaint alleges the defendants refused to adequately address the “dangerous care and violations of the professional standards of practice” that he reported, “resulting in harmful and tragic consequences.”

It also alleges Mr. Lauf restricted the use of a cerebral protection device used in patients undergoing transcatheter aortic-valve replacement (TAVR) deemed to be at high risk for periprocedural stroke to only those patients whose insurance reimbursed at higher rates.

Dr. Zelman says he objected to this prohibition “in accordance with his contractual and ethical obligations to ensure treatment of patients without regard to their ability to pay.”

Dr. Zelman’s lawsuit further alleges that Mr. Lauf launched a “trumped-up” and “baseless, biased, and retaliatory sham” investigation against him.

In a statement sent to the Boston Globe, Cape Cod Hospital denied Dr. Zelman’s claims that the cardiologist was retaliated against for raising patient safety issues, or that the hospital didn’t take action to improve cardiac care at the facility.
 

Voiced concerns

In a statement sent to this news organization, Dr. Zelman, now in private practice, said, “Over the past 25 years, I have been instrumental in bringing advanced cardiac care to Cape Cod. My commitment has always been to delivering the same quality outcomes and safety as the academic centers in Boston.

“Unfortunately, over the past 5 years, there has been inadequate oversight by the hospital administration and problems have occurred that in my opinion have led to serious patient consequences,” Dr. Zelman stated.

He said he has “voiced concerns over several years and they have been ignored.”

He added that Cape Cod Hospital offered him a million-dollar contract as long as he agreed to immediately issue a written statement endorsing the quality and safety of the cardiac surgical program that no longer exists.

“No amount of money was going to buy my silence,” Dr. Zelman told this news organization.

In his lawsuit, Dr. Zelman is seeking an undisclosed amount in damages, including back and front pay, lost benefits, physical and emotional distress, and attorneys’ fees.

This news organization reached out to Cape Cod Hospital for comment but has not yet received a response.

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

Interventional cardiologist Richard B. Zelman, MD, has filed a lawsuit against Cape Cod Hospital, Cape Cod Healthcare Inc., and its chief executive officer Michael K. Lauf, alleging that he was fired and maligned after raising concerns about poorly performed surgeries and poor ethical practices at the hospital.

Dr. Zelman, from Barnstable, Mass., has been affiliated with Cape Cod Hospital in Hyannis, Mass., for more than 30 years. He helped found the hospital’s Heart and Vascular Institute and has served as its medical director since 2018.

In his lawsuit filed Dec. 6, Dr. Zelman alleges that the defendants, under Mr. Lauf’s leadership, “placed profit above all else, including by prioritizing revenue generation over patient safety and public health.”

Dr. Zelman says the defendants supported him “to the extent his actions were profitable.”

Yet, when he raised patient safety concerns that harmed that bottom line, Dr. Zelman says the defendants retaliated against him, including by threatening his career and reputation and unlawfully terminating his employment with the hospital.

The complaint notes Dr. Zelman is bringing this action “to recover damages for violations of the Massachusetts Healthcare Provider Whistleblower Statute ... as well as for breach of contract and common law claims.”

Dr. Zelman’s complaint alleges the defendants refused to adequately address the “dangerous care and violations of the professional standards of practice” that he reported, “resulting in harmful and tragic consequences.”

It also alleges Mr. Lauf restricted the use of a cerebral protection device used in patients undergoing transcatheter aortic-valve replacement (TAVR) deemed to be at high risk for periprocedural stroke to only those patients whose insurance reimbursed at higher rates.

Dr. Zelman says he objected to this prohibition “in accordance with his contractual and ethical obligations to ensure treatment of patients without regard to their ability to pay.”

Dr. Zelman’s lawsuit further alleges that Mr. Lauf launched a “trumped-up” and “baseless, biased, and retaliatory sham” investigation against him.

In a statement sent to the Boston Globe, Cape Cod Hospital denied Dr. Zelman’s claims that the cardiologist was retaliated against for raising patient safety issues, or that the hospital didn’t take action to improve cardiac care at the facility.
 

Voiced concerns

In a statement sent to this news organization, Dr. Zelman, now in private practice, said, “Over the past 25 years, I have been instrumental in bringing advanced cardiac care to Cape Cod. My commitment has always been to delivering the same quality outcomes and safety as the academic centers in Boston.

“Unfortunately, over the past 5 years, there has been inadequate oversight by the hospital administration and problems have occurred that in my opinion have led to serious patient consequences,” Dr. Zelman stated.

He said he has “voiced concerns over several years and they have been ignored.”

He added that Cape Cod Hospital offered him a million-dollar contract as long as he agreed to immediately issue a written statement endorsing the quality and safety of the cardiac surgical program that no longer exists.

“No amount of money was going to buy my silence,” Dr. Zelman told this news organization.

In his lawsuit, Dr. Zelman is seeking an undisclosed amount in damages, including back and front pay, lost benefits, physical and emotional distress, and attorneys’ fees.

This news organization reached out to Cape Cod Hospital for comment but has not yet received a response.

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

NASHVILLE, TENN. – About 21% of teens newly diagnosed with epilepsy experience suicidal ideation, and the percentage jumps to 31% within 3 years, new research reveals.

“We hope these results inspire epileptologists and neurologists to both recognize and screen for suicide ideation and behaviors in their adolescent patients,” said study investigator Hadley Greenwood, a third-year medical student at New York University.

The new data should also encourage providers “to become more comfortable” providing support to patients, “be that by increasing their familiarity with prescribing different antidepressants or by being well versed in how to connect patients to resources within their community,” said Mr. Greenwood.

The findings were presented here at the annual meeting of the American Epilepsy Society.
 

Little research

Previous studies have reported on the prevalence of suicidality as well as depression and anxiety among adults with epilepsy. “We wanted to look at adolescents because there’s much less in the literature out there about psychiatric comorbidity, and specifically suicidality, in this population,” said Mr. Greenwood.

Researchers used data from the Human Epilepsy Project, a study that collected data from 34 sites in the United States, Canada, Europe, and Australia from 2012 to 2017.

From a cohort of more than 400 participants, researchers identified 67 patients aged 11-17 years who were enrolled within 4 months of starting treatment for focal epilepsy.

Participants completed the Columbia–Suicide Severity Rating Scale (C-SSRS) at enrollment and at follow-ups over 36 months. The C-SSRS measures suicidal ideation and severity, said Mr. Greenwood.

“It’s scaled from passive suicide ideation, such as thoughts of ‘I wish I were dead’ without active intent, all the way up to active suicidal ideation with a plan and intent.”

Researchers were able to distinguish individuals with passive suicide ideation from those with more serious intentions, said Mr. Greenwood. They used medical records to evaluate the prevalence of suicidal ideation and behavior.

The investigators found that more than one in five (20.9%) teens endorsed any lifetime suicide ideation. This, said Mr. Greenwood, is “roughly equivalent” to the prevalence reported earlier in the adult cohort of the Human Epilepsy Project (21.6%).
 

‘Striking’ rate

The fact that one in five adolescents had any lifetime suicide ideation is “definitely a striking number,” said Mr. Greenwood.

Researchers found that 15% of patients experienced active suicide ideation, 7.5% exhibited preparatory or suicidal behaviors, and 3% had made a prior suicide attempt.

All of these percentages increased at 3 years: Thirty-one percent for suicide ideation; 25% for active suicide behavior, 15% for preparatory or suicide behaviors, and 5% for prior suicide attempt.

The fact that nearly one in three adolescents endorsed suicide ideation at 3 years is another “striking” finding, said Mr. Greenwood.

Of the 53 adolescents who had never had suicide ideation at the time of enrollment, 7 endorsed new-onset suicide ideation in the follow-up period. Five of 14 who had had suicide ideation at some point prior to enrollment continued to endorse it.

“The value of the study is identifying the prevalence and identifying the significant number of adolescents with epilepsy who are endorsing either suicide ideation or suicidal behaviors,” said Mr. Greenwood.

The researchers found that among younger teens (aged 11–14 years) rates of suicide ideation were higher than among their older counterparts (aged 15–17 years).

The study does not shed light on the biological connection between epilepsy and suicidality, but Mr. Greenwood noted that prior research has suggested a bidirectional relationship.

“Depression and other psychiatric comorbidities might exist prior to epileptic activity and actually predispose to epileptic activity.”

Mr. Greenwood noted that suicide ideation has “spiked” recently across the general population, and so it’s difficult to compare the prevalence in her study with “today’s prevalence.”

However, other research generally shows that the suicide ideation rate in the general adolescent population is much lower than in teens with epilepsy.

Unique aspects of the current study are that it reports suicide ideation and behaviors at around the time of an epilepsy diagnosis and documents how suicidality progresses or resolves over time, said Mr. Greenwood.
 

Underdiagnosed, undertreated

Commenting on the research, Elizabeth Donner, MD, director of the comprehensive epilepsy program, Hospital for Sick Children, and associate professor, department of pediatrics, University of Toronto, said a “key point” from the study is that the suicidality rate among teens with epilepsy exceeds that of children not living with epilepsy.

“We are significantly underdiagnosing and undertreating the mental health comorbidities in epilepsy,” said Dr. Donner. “Epilepsy is a brain disease and so are mental health disorders, so it shouldn’t come as any surprise that they coexist in individuals with epilepsy.”

The new results contribute to what is already known about the significant mortality rates among persons with epilepsy, said Dr. Donner. She referred to a 2018 study that showed that people with epilepsy were 3.5 times more likely to die by suicide.

Other research has shown that people with epilepsy are 10 times more likely to die by drowning, mostly in the bathtub, said Dr. Donner.

“You would think that we’re educating these people about risks related to their epilepsy, but either the messages don’t get through, or they don’t know how to keep themselves safe,” she said.

“This needs to be seen in a bigger picture, and the bigger picture is we need to recognize comorbid mental health issues; we need to address them once recognized; and then we need to counsel and support people to live safely with their epilepsy.

The study received funding from the Epilepsy Study Consortium, Finding a Cure for Epilepsy and Seizures (FACES) and other related foundations, UCB, Pfizer, Eisai, Lundbeck, and Sunovion. Mr. Greenwood and Dr. Donner report no relevant financial relationships.

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

NASHVILLE, TENN. – About 21% of teens newly diagnosed with epilepsy experience suicidal ideation, and the percentage jumps to 31% within 3 years, new research reveals.

“We hope these results inspire epileptologists and neurologists to both recognize and screen for suicide ideation and behaviors in their adolescent patients,” said study investigator Hadley Greenwood, a third-year medical student at New York University.

The new data should also encourage providers “to become more comfortable” providing support to patients, “be that by increasing their familiarity with prescribing different antidepressants or by being well versed in how to connect patients to resources within their community,” said Mr. Greenwood.

The findings were presented here at the annual meeting of the American Epilepsy Society.
 

Little research

Previous studies have reported on the prevalence of suicidality as well as depression and anxiety among adults with epilepsy. “We wanted to look at adolescents because there’s much less in the literature out there about psychiatric comorbidity, and specifically suicidality, in this population,” said Mr. Greenwood.

Researchers used data from the Human Epilepsy Project, a study that collected data from 34 sites in the United States, Canada, Europe, and Australia from 2012 to 2017.

From a cohort of more than 400 participants, researchers identified 67 patients aged 11-17 years who were enrolled within 4 months of starting treatment for focal epilepsy.

Participants completed the Columbia–Suicide Severity Rating Scale (C-SSRS) at enrollment and at follow-ups over 36 months. The C-SSRS measures suicidal ideation and severity, said Mr. Greenwood.

“It’s scaled from passive suicide ideation, such as thoughts of ‘I wish I were dead’ without active intent, all the way up to active suicidal ideation with a plan and intent.”

Researchers were able to distinguish individuals with passive suicide ideation from those with more serious intentions, said Mr. Greenwood. They used medical records to evaluate the prevalence of suicidal ideation and behavior.

The investigators found that more than one in five (20.9%) teens endorsed any lifetime suicide ideation. This, said Mr. Greenwood, is “roughly equivalent” to the prevalence reported earlier in the adult cohort of the Human Epilepsy Project (21.6%).
 

‘Striking’ rate

The fact that one in five adolescents had any lifetime suicide ideation is “definitely a striking number,” said Mr. Greenwood.

Researchers found that 15% of patients experienced active suicide ideation, 7.5% exhibited preparatory or suicidal behaviors, and 3% had made a prior suicide attempt.

All of these percentages increased at 3 years: Thirty-one percent for suicide ideation; 25% for active suicide behavior, 15% for preparatory or suicide behaviors, and 5% for prior suicide attempt.

The fact that nearly one in three adolescents endorsed suicide ideation at 3 years is another “striking” finding, said Mr. Greenwood.

Of the 53 adolescents who had never had suicide ideation at the time of enrollment, 7 endorsed new-onset suicide ideation in the follow-up period. Five of 14 who had had suicide ideation at some point prior to enrollment continued to endorse it.

“The value of the study is identifying the prevalence and identifying the significant number of adolescents with epilepsy who are endorsing either suicide ideation or suicidal behaviors,” said Mr. Greenwood.

The researchers found that among younger teens (aged 11–14 years) rates of suicide ideation were higher than among their older counterparts (aged 15–17 years).

The study does not shed light on the biological connection between epilepsy and suicidality, but Mr. Greenwood noted that prior research has suggested a bidirectional relationship.

“Depression and other psychiatric comorbidities might exist prior to epileptic activity and actually predispose to epileptic activity.”

Mr. Greenwood noted that suicide ideation has “spiked” recently across the general population, and so it’s difficult to compare the prevalence in her study with “today’s prevalence.”

However, other research generally shows that the suicide ideation rate in the general adolescent population is much lower than in teens with epilepsy.

Unique aspects of the current study are that it reports suicide ideation and behaviors at around the time of an epilepsy diagnosis and documents how suicidality progresses or resolves over time, said Mr. Greenwood.
 

Underdiagnosed, undertreated

Commenting on the research, Elizabeth Donner, MD, director of the comprehensive epilepsy program, Hospital for Sick Children, and associate professor, department of pediatrics, University of Toronto, said a “key point” from the study is that the suicidality rate among teens with epilepsy exceeds that of children not living with epilepsy.

“We are significantly underdiagnosing and undertreating the mental health comorbidities in epilepsy,” said Dr. Donner. “Epilepsy is a brain disease and so are mental health disorders, so it shouldn’t come as any surprise that they coexist in individuals with epilepsy.”

The new results contribute to what is already known about the significant mortality rates among persons with epilepsy, said Dr. Donner. She referred to a 2018 study that showed that people with epilepsy were 3.5 times more likely to die by suicide.

Other research has shown that people with epilepsy are 10 times more likely to die by drowning, mostly in the bathtub, said Dr. Donner.

“You would think that we’re educating these people about risks related to their epilepsy, but either the messages don’t get through, or they don’t know how to keep themselves safe,” she said.

“This needs to be seen in a bigger picture, and the bigger picture is we need to recognize comorbid mental health issues; we need to address them once recognized; and then we need to counsel and support people to live safely with their epilepsy.

The study received funding from the Epilepsy Study Consortium, Finding a Cure for Epilepsy and Seizures (FACES) and other related foundations, UCB, Pfizer, Eisai, Lundbeck, and Sunovion. Mr. Greenwood and Dr. Donner report no relevant financial relationships.

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

NASHVILLE, TENN. – About 21% of teens newly diagnosed with epilepsy experience suicidal ideation, and the percentage jumps to 31% within 3 years, new research reveals.

“We hope these results inspire epileptologists and neurologists to both recognize and screen for suicide ideation and behaviors in their adolescent patients,” said study investigator Hadley Greenwood, a third-year medical student at New York University.

The new data should also encourage providers “to become more comfortable” providing support to patients, “be that by increasing their familiarity with prescribing different antidepressants or by being well versed in how to connect patients to resources within their community,” said Mr. Greenwood.

The findings were presented here at the annual meeting of the American Epilepsy Society.
 

Little research

Previous studies have reported on the prevalence of suicidality as well as depression and anxiety among adults with epilepsy. “We wanted to look at adolescents because there’s much less in the literature out there about psychiatric comorbidity, and specifically suicidality, in this population,” said Mr. Greenwood.

Researchers used data from the Human Epilepsy Project, a study that collected data from 34 sites in the United States, Canada, Europe, and Australia from 2012 to 2017.

From a cohort of more than 400 participants, researchers identified 67 patients aged 11-17 years who were enrolled within 4 months of starting treatment for focal epilepsy.

Participants completed the Columbia–Suicide Severity Rating Scale (C-SSRS) at enrollment and at follow-ups over 36 months. The C-SSRS measures suicidal ideation and severity, said Mr. Greenwood.

“It’s scaled from passive suicide ideation, such as thoughts of ‘I wish I were dead’ without active intent, all the way up to active suicidal ideation with a plan and intent.”

Researchers were able to distinguish individuals with passive suicide ideation from those with more serious intentions, said Mr. Greenwood. They used medical records to evaluate the prevalence of suicidal ideation and behavior.

The investigators found that more than one in five (20.9%) teens endorsed any lifetime suicide ideation. This, said Mr. Greenwood, is “roughly equivalent” to the prevalence reported earlier in the adult cohort of the Human Epilepsy Project (21.6%).
 

‘Striking’ rate

The fact that one in five adolescents had any lifetime suicide ideation is “definitely a striking number,” said Mr. Greenwood.

Researchers found that 15% of patients experienced active suicide ideation, 7.5% exhibited preparatory or suicidal behaviors, and 3% had made a prior suicide attempt.

All of these percentages increased at 3 years: Thirty-one percent for suicide ideation; 25% for active suicide behavior, 15% for preparatory or suicide behaviors, and 5% for prior suicide attempt.

The fact that nearly one in three adolescents endorsed suicide ideation at 3 years is another “striking” finding, said Mr. Greenwood.

Of the 53 adolescents who had never had suicide ideation at the time of enrollment, 7 endorsed new-onset suicide ideation in the follow-up period. Five of 14 who had had suicide ideation at some point prior to enrollment continued to endorse it.

“The value of the study is identifying the prevalence and identifying the significant number of adolescents with epilepsy who are endorsing either suicide ideation or suicidal behaviors,” said Mr. Greenwood.

The researchers found that among younger teens (aged 11–14 years) rates of suicide ideation were higher than among their older counterparts (aged 15–17 years).

The study does not shed light on the biological connection between epilepsy and suicidality, but Mr. Greenwood noted that prior research has suggested a bidirectional relationship.

“Depression and other psychiatric comorbidities might exist prior to epileptic activity and actually predispose to epileptic activity.”

Mr. Greenwood noted that suicide ideation has “spiked” recently across the general population, and so it’s difficult to compare the prevalence in her study with “today’s prevalence.”

However, other research generally shows that the suicide ideation rate in the general adolescent population is much lower than in teens with epilepsy.

Unique aspects of the current study are that it reports suicide ideation and behaviors at around the time of an epilepsy diagnosis and documents how suicidality progresses or resolves over time, said Mr. Greenwood.
 

Underdiagnosed, undertreated

Commenting on the research, Elizabeth Donner, MD, director of the comprehensive epilepsy program, Hospital for Sick Children, and associate professor, department of pediatrics, University of Toronto, said a “key point” from the study is that the suicidality rate among teens with epilepsy exceeds that of children not living with epilepsy.

“We are significantly underdiagnosing and undertreating the mental health comorbidities in epilepsy,” said Dr. Donner. “Epilepsy is a brain disease and so are mental health disorders, so it shouldn’t come as any surprise that they coexist in individuals with epilepsy.”

The new results contribute to what is already known about the significant mortality rates among persons with epilepsy, said Dr. Donner. She referred to a 2018 study that showed that people with epilepsy were 3.5 times more likely to die by suicide.

Other research has shown that people with epilepsy are 10 times more likely to die by drowning, mostly in the bathtub, said Dr. Donner.

“You would think that we’re educating these people about risks related to their epilepsy, but either the messages don’t get through, or they don’t know how to keep themselves safe,” she said.

“This needs to be seen in a bigger picture, and the bigger picture is we need to recognize comorbid mental health issues; we need to address them once recognized; and then we need to counsel and support people to live safely with their epilepsy.

The study received funding from the Epilepsy Study Consortium, Finding a Cure for Epilepsy and Seizures (FACES) and other related foundations, UCB, Pfizer, Eisai, Lundbeck, and Sunovion. Mr. Greenwood and Dr. Donner report no relevant financial relationships.

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

The dire shortage of pediatric hospital beds plaguing the nation in the fall of 2022 is a byproduct of financial decisions made by hospitals over the past decade, as they shuttered children’s wards, which often operate in the red, and expanded the number of beds available for more profitable endeavors like joint replacements and cancer care.

To cope with the flood of young patients sickened by a sweeping convergence of nasty bugs – especially respiratory syncytial virus, influenza, and coronavirus – medical centers nationwide have deployed triage tents, delayed elective surgeries, and transferred critically ill children out of state.

A major factor in the bed shortage is a years-long trend among hospitals of eliminating pediatric units, which tend to be less profitable than adult units, said Mark Wietecha, MS, MBA, CEO of the Children’s Hospital Association. Hospitals optimize revenue by striving to keep their beds 100% full – and filled with patients whose conditions command generous insurance reimbursements.

“It really has to do with dollars,” said Scott Krugman, MD, MS, vice chair of pediatrics at the Herman and Walter Samuelson Children’s Hospital at Sinai in Baltimore. “Hospitals rely on high-volume, high-reimbursement procedures from good payers to make money. There’s no incentive for hospitals to provide money-losing services.”

The number of pediatric inpatient units in hospitals fell 19% from 2008 to 2018, according to a study published in 2021 in the journal Pediatrics. Just this year, hospitals have closed pediatric units in Boston and Springfield, Mass.; Richmond, Va.; and Tulsa, Okla.

The current surge in dangerous respiratory illnesses among children is yet another example of how COVID-19 has upended the health care system. The lockdowns and isolation that marked the first years of the pandemic left kids largely unexposed – and still vulnerable – to viruses other than COVID for two winters, and doctors are now essentially treating multiple years’ worth of respiratory ailments.

The pandemic also accelerated changes in the health care industry that have left many communities with fewer hospital beds available for children who are acutely ill, along with fewer doctors and nurses to care for them.

When intensive care units were flooded with older COVID patients in 2020, some hospitals began using children’s beds to treat adults. Many of those pediatric beds haven’t been restored, said Daniel Rauch, MD, chair of the American Academy of Pediatrics’ committee on hospital care.

In addition, the relentless pace of the pandemic has spurred more than 230,000 health care providers – including doctors, nurses, and physician assistants – to quit. Before the pandemic, about 10% of nurses left their jobs every year; the rate has risen to about 20%, Dr. Wietecha said. He estimates that pediatric hospitals are unable to maintain as many as 10% of their beds because of staffing shortages.

“There is just not enough space for all the kids who need beds,” said Megan Ranney, MD, MPH, who works in several emergency departments in Providence, R.I., including Hasbro Children’s Hospital. The number of children seeking emergency care in recent weeks was 25% higher than the hospital’s previous record.

“We have doctors who are cleaning beds so we can get children into them faster,” said Dr. Ranney, a deputy dean at Brown University’s School of Public Health.

There’s not great money in treating kids. About 40% of U.S. children are covered by Medicaid, a joint federal-state program for low-income patients and people with disabilities. Base Medicaid rates are typically more than 20% below those paid by Medicare, the government insurance program for older adults, and are even lower when compared with private insurance. While specialty care for a range of common adult procedures, from knee and hip replacements to heart surgeries and cancer treatments, generates major profits for medical centers, hospitals complain they typically lose money on inpatient pediatric care.

When Tufts Children’s Hospital closed 41 pediatric beds this summer, hospital officials assured residents that young patients could receive care at nearby Boston Children’s Hospital. Now, Boston Children’s is delaying some elective surgeries to make room for kids who are acutely ill.

Dr. Rauch noted that children’s hospitals, which specialize in treating rare and serious conditions such as pediatric cancer, cystic fibrosis, and heart defects, simply aren’t designed to handle this season’s crush of kids acutely ill with respiratory bugs.

Even before the autumn’s viral trifecta, pediatric units were straining to absorb rising numbers of young people in acute mental distress. Stories abound of children in mental crises being marooned for weeks in emergency departments while awaiting transfer to a pediatric psychiatric unit. On a good day, Dr. Ranney said, 20% of pediatric emergency room beds at Hasbro Children’s Hospital are occupied by children experiencing mental health issues.

In hopes of adding pediatric capacity, the American Academy of Pediatrics joined the Children’s Hospital Association last month in calling on the White House to declare a national emergency due to child respiratory infections and provide additional resources to help cover the costs of care. The Biden administration has said that the flexibility hospital systems and providers have been given during the pandemic to sidestep certain staffing requirements also applies to RSV and flu.

Doernbecher Children’s Hospital at Oregon Health & Science University has shifted to “crisis standards of care,” enabling intensive care nurses to treat more patients than they’re usually assigned. Hospitals in Atlanta, Pittsburgh, and Aurora, Colorado, meanwhile, have resorted to treating young patients in overflow tents in parking lots.

Alex Kon, MD, a pediatric critical care physician at Community Medical Center in Missoula, Mont., said providers there have made plans to care for older kids in the adult intensive care unit, and to divert ambulances to other facilities when necessary. With only three pediatric ICUs in the state, that means young patients may be flown as far as Seattle or Spokane, Wash., or Idaho.

Hollis Lillard took her 1-year-old son, Calder, to an Army hospital in Northern Virginia last month after he experienced several days of fever, coughing, and labored breathing. They spent 7 anguished hours in the emergency room before the hospital found an open bed and transferred them by ambulance to Walter Reed National Military Medical Center in Maryland.

With proper therapy and instructions for home care, Calder’s virus was readily treatable: He recovered after he was given oxygen and treated with steroids, which fight inflammation, and albuterol, which counteracts bronchospasms. He was discharged the next day.

Although hospitalizations for RSV are falling, rates remain well above the norm for this time of year. And hospitals may not get much relief.

People can be infected with RSV more than once a year, and Dr. Krugman worries about a resurgence in the months to come. Because of the coronavirus, which competes with other viruses, “the usual seasonal pattern of viruses has gone out the window,” he said.

Like RSV, influenza arrived early this season. Both viruses usually peak around January. Three strains of flu are circulating and have caused an estimated 8.7 million illnesses, 78,000 hospitalizations, and 4,500 deaths, according to the Centers for Disease Control and Prevention.

Dr. Krugman doubts the health care industry will learn any quick lessons from the current crisis. “Unless there is a radical change in how we pay for pediatric hospital care,” Dr. Krugman said, “the bed shortage is only going to get worse.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

The dire shortage of pediatric hospital beds plaguing the nation in the fall of 2022 is a byproduct of financial decisions made by hospitals over the past decade, as they shuttered children’s wards, which often operate in the red, and expanded the number of beds available for more profitable endeavors like joint replacements and cancer care.

To cope with the flood of young patients sickened by a sweeping convergence of nasty bugs – especially respiratory syncytial virus, influenza, and coronavirus – medical centers nationwide have deployed triage tents, delayed elective surgeries, and transferred critically ill children out of state.

A major factor in the bed shortage is a years-long trend among hospitals of eliminating pediatric units, which tend to be less profitable than adult units, said Mark Wietecha, MS, MBA, CEO of the Children’s Hospital Association. Hospitals optimize revenue by striving to keep their beds 100% full – and filled with patients whose conditions command generous insurance reimbursements.

“It really has to do with dollars,” said Scott Krugman, MD, MS, vice chair of pediatrics at the Herman and Walter Samuelson Children’s Hospital at Sinai in Baltimore. “Hospitals rely on high-volume, high-reimbursement procedures from good payers to make money. There’s no incentive for hospitals to provide money-losing services.”

The number of pediatric inpatient units in hospitals fell 19% from 2008 to 2018, according to a study published in 2021 in the journal Pediatrics. Just this year, hospitals have closed pediatric units in Boston and Springfield, Mass.; Richmond, Va.; and Tulsa, Okla.

The current surge in dangerous respiratory illnesses among children is yet another example of how COVID-19 has upended the health care system. The lockdowns and isolation that marked the first years of the pandemic left kids largely unexposed – and still vulnerable – to viruses other than COVID for two winters, and doctors are now essentially treating multiple years’ worth of respiratory ailments.

The pandemic also accelerated changes in the health care industry that have left many communities with fewer hospital beds available for children who are acutely ill, along with fewer doctors and nurses to care for them.

When intensive care units were flooded with older COVID patients in 2020, some hospitals began using children’s beds to treat adults. Many of those pediatric beds haven’t been restored, said Daniel Rauch, MD, chair of the American Academy of Pediatrics’ committee on hospital care.

In addition, the relentless pace of the pandemic has spurred more than 230,000 health care providers – including doctors, nurses, and physician assistants – to quit. Before the pandemic, about 10% of nurses left their jobs every year; the rate has risen to about 20%, Dr. Wietecha said. He estimates that pediatric hospitals are unable to maintain as many as 10% of their beds because of staffing shortages.

“There is just not enough space for all the kids who need beds,” said Megan Ranney, MD, MPH, who works in several emergency departments in Providence, R.I., including Hasbro Children’s Hospital. The number of children seeking emergency care in recent weeks was 25% higher than the hospital’s previous record.

“We have doctors who are cleaning beds so we can get children into them faster,” said Dr. Ranney, a deputy dean at Brown University’s School of Public Health.

There’s not great money in treating kids. About 40% of U.S. children are covered by Medicaid, a joint federal-state program for low-income patients and people with disabilities. Base Medicaid rates are typically more than 20% below those paid by Medicare, the government insurance program for older adults, and are even lower when compared with private insurance. While specialty care for a range of common adult procedures, from knee and hip replacements to heart surgeries and cancer treatments, generates major profits for medical centers, hospitals complain they typically lose money on inpatient pediatric care.

When Tufts Children’s Hospital closed 41 pediatric beds this summer, hospital officials assured residents that young patients could receive care at nearby Boston Children’s Hospital. Now, Boston Children’s is delaying some elective surgeries to make room for kids who are acutely ill.

Dr. Rauch noted that children’s hospitals, which specialize in treating rare and serious conditions such as pediatric cancer, cystic fibrosis, and heart defects, simply aren’t designed to handle this season’s crush of kids acutely ill with respiratory bugs.

Even before the autumn’s viral trifecta, pediatric units were straining to absorb rising numbers of young people in acute mental distress. Stories abound of children in mental crises being marooned for weeks in emergency departments while awaiting transfer to a pediatric psychiatric unit. On a good day, Dr. Ranney said, 20% of pediatric emergency room beds at Hasbro Children’s Hospital are occupied by children experiencing mental health issues.

In hopes of adding pediatric capacity, the American Academy of Pediatrics joined the Children’s Hospital Association last month in calling on the White House to declare a national emergency due to child respiratory infections and provide additional resources to help cover the costs of care. The Biden administration has said that the flexibility hospital systems and providers have been given during the pandemic to sidestep certain staffing requirements also applies to RSV and flu.

Doernbecher Children’s Hospital at Oregon Health & Science University has shifted to “crisis standards of care,” enabling intensive care nurses to treat more patients than they’re usually assigned. Hospitals in Atlanta, Pittsburgh, and Aurora, Colorado, meanwhile, have resorted to treating young patients in overflow tents in parking lots.

Alex Kon, MD, a pediatric critical care physician at Community Medical Center in Missoula, Mont., said providers there have made plans to care for older kids in the adult intensive care unit, and to divert ambulances to other facilities when necessary. With only three pediatric ICUs in the state, that means young patients may be flown as far as Seattle or Spokane, Wash., or Idaho.

Hollis Lillard took her 1-year-old son, Calder, to an Army hospital in Northern Virginia last month after he experienced several days of fever, coughing, and labored breathing. They spent 7 anguished hours in the emergency room before the hospital found an open bed and transferred them by ambulance to Walter Reed National Military Medical Center in Maryland.

With proper therapy and instructions for home care, Calder’s virus was readily treatable: He recovered after he was given oxygen and treated with steroids, which fight inflammation, and albuterol, which counteracts bronchospasms. He was discharged the next day.

Although hospitalizations for RSV are falling, rates remain well above the norm for this time of year. And hospitals may not get much relief.

People can be infected with RSV more than once a year, and Dr. Krugman worries about a resurgence in the months to come. Because of the coronavirus, which competes with other viruses, “the usual seasonal pattern of viruses has gone out the window,” he said.

Like RSV, influenza arrived early this season. Both viruses usually peak around January. Three strains of flu are circulating and have caused an estimated 8.7 million illnesses, 78,000 hospitalizations, and 4,500 deaths, according to the Centers for Disease Control and Prevention.

Dr. Krugman doubts the health care industry will learn any quick lessons from the current crisis. “Unless there is a radical change in how we pay for pediatric hospital care,” Dr. Krugman said, “the bed shortage is only going to get worse.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

The dire shortage of pediatric hospital beds plaguing the nation in the fall of 2022 is a byproduct of financial decisions made by hospitals over the past decade, as they shuttered children’s wards, which often operate in the red, and expanded the number of beds available for more profitable endeavors like joint replacements and cancer care.

To cope with the flood of young patients sickened by a sweeping convergence of nasty bugs – especially respiratory syncytial virus, influenza, and coronavirus – medical centers nationwide have deployed triage tents, delayed elective surgeries, and transferred critically ill children out of state.

A major factor in the bed shortage is a years-long trend among hospitals of eliminating pediatric units, which tend to be less profitable than adult units, said Mark Wietecha, MS, MBA, CEO of the Children’s Hospital Association. Hospitals optimize revenue by striving to keep their beds 100% full – and filled with patients whose conditions command generous insurance reimbursements.

“It really has to do with dollars,” said Scott Krugman, MD, MS, vice chair of pediatrics at the Herman and Walter Samuelson Children’s Hospital at Sinai in Baltimore. “Hospitals rely on high-volume, high-reimbursement procedures from good payers to make money. There’s no incentive for hospitals to provide money-losing services.”

The number of pediatric inpatient units in hospitals fell 19% from 2008 to 2018, according to a study published in 2021 in the journal Pediatrics. Just this year, hospitals have closed pediatric units in Boston and Springfield, Mass.; Richmond, Va.; and Tulsa, Okla.

The current surge in dangerous respiratory illnesses among children is yet another example of how COVID-19 has upended the health care system. The lockdowns and isolation that marked the first years of the pandemic left kids largely unexposed – and still vulnerable – to viruses other than COVID for two winters, and doctors are now essentially treating multiple years’ worth of respiratory ailments.

The pandemic also accelerated changes in the health care industry that have left many communities with fewer hospital beds available for children who are acutely ill, along with fewer doctors and nurses to care for them.

When intensive care units were flooded with older COVID patients in 2020, some hospitals began using children’s beds to treat adults. Many of those pediatric beds haven’t been restored, said Daniel Rauch, MD, chair of the American Academy of Pediatrics’ committee on hospital care.

In addition, the relentless pace of the pandemic has spurred more than 230,000 health care providers – including doctors, nurses, and physician assistants – to quit. Before the pandemic, about 10% of nurses left their jobs every year; the rate has risen to about 20%, Dr. Wietecha said. He estimates that pediatric hospitals are unable to maintain as many as 10% of their beds because of staffing shortages.

“There is just not enough space for all the kids who need beds,” said Megan Ranney, MD, MPH, who works in several emergency departments in Providence, R.I., including Hasbro Children’s Hospital. The number of children seeking emergency care in recent weeks was 25% higher than the hospital’s previous record.

“We have doctors who are cleaning beds so we can get children into them faster,” said Dr. Ranney, a deputy dean at Brown University’s School of Public Health.

There’s not great money in treating kids. About 40% of U.S. children are covered by Medicaid, a joint federal-state program for low-income patients and people with disabilities. Base Medicaid rates are typically more than 20% below those paid by Medicare, the government insurance program for older adults, and are even lower when compared with private insurance. While specialty care for a range of common adult procedures, from knee and hip replacements to heart surgeries and cancer treatments, generates major profits for medical centers, hospitals complain they typically lose money on inpatient pediatric care.

When Tufts Children’s Hospital closed 41 pediatric beds this summer, hospital officials assured residents that young patients could receive care at nearby Boston Children’s Hospital. Now, Boston Children’s is delaying some elective surgeries to make room for kids who are acutely ill.

Dr. Rauch noted that children’s hospitals, which specialize in treating rare and serious conditions such as pediatric cancer, cystic fibrosis, and heart defects, simply aren’t designed to handle this season’s crush of kids acutely ill with respiratory bugs.

Even before the autumn’s viral trifecta, pediatric units were straining to absorb rising numbers of young people in acute mental distress. Stories abound of children in mental crises being marooned for weeks in emergency departments while awaiting transfer to a pediatric psychiatric unit. On a good day, Dr. Ranney said, 20% of pediatric emergency room beds at Hasbro Children’s Hospital are occupied by children experiencing mental health issues.

In hopes of adding pediatric capacity, the American Academy of Pediatrics joined the Children’s Hospital Association last month in calling on the White House to declare a national emergency due to child respiratory infections and provide additional resources to help cover the costs of care. The Biden administration has said that the flexibility hospital systems and providers have been given during the pandemic to sidestep certain staffing requirements also applies to RSV and flu.

Doernbecher Children’s Hospital at Oregon Health & Science University has shifted to “crisis standards of care,” enabling intensive care nurses to treat more patients than they’re usually assigned. Hospitals in Atlanta, Pittsburgh, and Aurora, Colorado, meanwhile, have resorted to treating young patients in overflow tents in parking lots.

Alex Kon, MD, a pediatric critical care physician at Community Medical Center in Missoula, Mont., said providers there have made plans to care for older kids in the adult intensive care unit, and to divert ambulances to other facilities when necessary. With only three pediatric ICUs in the state, that means young patients may be flown as far as Seattle or Spokane, Wash., or Idaho.

Hollis Lillard took her 1-year-old son, Calder, to an Army hospital in Northern Virginia last month after he experienced several days of fever, coughing, and labored breathing. They spent 7 anguished hours in the emergency room before the hospital found an open bed and transferred them by ambulance to Walter Reed National Military Medical Center in Maryland.

With proper therapy and instructions for home care, Calder’s virus was readily treatable: He recovered after he was given oxygen and treated with steroids, which fight inflammation, and albuterol, which counteracts bronchospasms. He was discharged the next day.

Although hospitalizations for RSV are falling, rates remain well above the norm for this time of year. And hospitals may not get much relief.

People can be infected with RSV more than once a year, and Dr. Krugman worries about a resurgence in the months to come. Because of the coronavirus, which competes with other viruses, “the usual seasonal pattern of viruses has gone out the window,” he said.

Like RSV, influenza arrived early this season. Both viruses usually peak around January. Three strains of flu are circulating and have caused an estimated 8.7 million illnesses, 78,000 hospitalizations, and 4,500 deaths, according to the Centers for Disease Control and Prevention.

Dr. Krugman doubts the health care industry will learn any quick lessons from the current crisis. “Unless there is a radical change in how we pay for pediatric hospital care,” Dr. Krugman said, “the bed shortage is only going to get worse.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Morality is often talked about in binary terms, black and white, right or wrong. That is how children 4-8 years old first conceive of it. Moral development progresses alongside motor, language, and social skills, but pediatricians typically do not screen for it or chart it. In adolescence, the ability for abstract thought develops and, once susceptibility to peer pressure lessens, nuances begin to shade the binary model. Honor codes become possible by the college years; scandals at colleges and military academies demonstrate that some 18- to 22-year-old young adults still lack that maturity. Lawrence Kohlberg, PhD, in the 1950s proposed a six-stage model of moral development and indicated that some people never achieve the upper stages.

Recently, neuroimaging research has demonstrated that the prefrontal cortex is still developing up to 25 years of age. Those data have ramifications for obtaining truly informed consent for medical procedures. Arbitrarily, driver’s licenses are issued at 16 years of age, the right to vote comes at age 18, and the purchase of alcohol allowed at age 21. Consent for medical care varies by state and by procedure. Treatment for general medical care, pregnancy, sexually transmitted infections, and mental health problems often have different age requirements. In some states, a 14-year-old can give consent for treatment of depression or pregnancy but cannot get a tattoo.

The rules for firearms are also complex and vary by state. Perhaps more important is the determination of medical, psychological, moral, and criminal conditions for which guns should be removed from someone’s access. Some states have created formalized red flag laws to accomplish this. Other states have informal procedures used by police and social workers rather than involving medical personnel. Recent gun-related tragedies at a St. Louis high school near me and at a Colorado Springs bar demonstrate deficiencies in the red flag approach, with multiple fatal consequences.

Some moral issues do not neatly fit the binary approach. There are many concerns that are better described by a paradigm that “all things are permissible but not everything is edifying.” Take as a model of this the consumption of alcohol. The risks of an occasional single drink are very small for most people. For some, one drink leads to binges of alcoholism. Others drink and drive. Over the centuries, various groups in various localities have counseled temperance. Some personally avoid alcohol to avoid leading others astray.

The United States from 1920 to 1933 carried out the national social experiment Prohibition that outlawed intoxicating beverages. Ultimately, the organized crime of black market alcohol production, distribution, and consumption was found to be worse than the disease. Alcohol use was again legalized. That is understandable. Still, I doubt Carrie Nation ever thought that the sponsorship of most major sporting events would rely heavily on beer and liquor companies. Legalization and promotion are two distinct acts.

A federal prohibition of marijuana since the 1950s similarly produced crime from drug dealing. It also induced many otherwise law-abiding citizens to be scofflaws. (I think the 55 mph national speed limit under President Nixon created greater numbers of scofflaws.) In my state recreational marijuana became legal as I write this column. But is that good? Wise? Edifying?

State lotteries were created partly to reduce the negative effects of the numbers games funding organized crime. That rationale is understandable, but why are states promoting the games with commercials and billion dollar payouts?

I find the “permissible but not edifying” paradigm helpful in many areas of medical ethics. The ethical concerns typically then fall into one of four categories: Slippery slope, bright lines, overuse, and conscientiously opting out. All are subspecies of the theme of going too far.

Oregon’s Death with Dignity Act was enacted 25 years ago. Nine other states now allow some form of medically assisted death. Most states prohibit it. As is now the case for abortion, medical care is typically legislated at the state level to reflect local values. Canada goes beyond assisted suicide and in the vast majority of cases employs active euthanasia with a physician pushing lethal drugs intravenously. That action is forbidden in the United States. Currently, euthanasia is involved in 10,000 deaths per year in Canada. A terminal illness is no longer needed; that requirement was ruled unconstitutional. By March 2023, intractable mental health problems will be eligible for the euthanasia cure in Canada. I have long considered myself a navigator of ethical slippery slopes because that is where the suffering people are. Canada has gone too far down this particular slope for my skill set.
 

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

Morality is often talked about in binary terms, black and white, right or wrong. That is how children 4-8 years old first conceive of it. Moral development progresses alongside motor, language, and social skills, but pediatricians typically do not screen for it or chart it. In adolescence, the ability for abstract thought develops and, once susceptibility to peer pressure lessens, nuances begin to shade the binary model. Honor codes become possible by the college years; scandals at colleges and military academies demonstrate that some 18- to 22-year-old young adults still lack that maturity. Lawrence Kohlberg, PhD, in the 1950s proposed a six-stage model of moral development and indicated that some people never achieve the upper stages.

Recently, neuroimaging research has demonstrated that the prefrontal cortex is still developing up to 25 years of age. Those data have ramifications for obtaining truly informed consent for medical procedures. Arbitrarily, driver’s licenses are issued at 16 years of age, the right to vote comes at age 18, and the purchase of alcohol allowed at age 21. Consent for medical care varies by state and by procedure. Treatment for general medical care, pregnancy, sexually transmitted infections, and mental health problems often have different age requirements. In some states, a 14-year-old can give consent for treatment of depression or pregnancy but cannot get a tattoo.

The rules for firearms are also complex and vary by state. Perhaps more important is the determination of medical, psychological, moral, and criminal conditions for which guns should be removed from someone’s access. Some states have created formalized red flag laws to accomplish this. Other states have informal procedures used by police and social workers rather than involving medical personnel. Recent gun-related tragedies at a St. Louis high school near me and at a Colorado Springs bar demonstrate deficiencies in the red flag approach, with multiple fatal consequences.

Some moral issues do not neatly fit the binary approach. There are many concerns that are better described by a paradigm that “all things are permissible but not everything is edifying.” Take as a model of this the consumption of alcohol. The risks of an occasional single drink are very small for most people. For some, one drink leads to binges of alcoholism. Others drink and drive. Over the centuries, various groups in various localities have counseled temperance. Some personally avoid alcohol to avoid leading others astray.

The United States from 1920 to 1933 carried out the national social experiment Prohibition that outlawed intoxicating beverages. Ultimately, the organized crime of black market alcohol production, distribution, and consumption was found to be worse than the disease. Alcohol use was again legalized. That is understandable. Still, I doubt Carrie Nation ever thought that the sponsorship of most major sporting events would rely heavily on beer and liquor companies. Legalization and promotion are two distinct acts.

A federal prohibition of marijuana since the 1950s similarly produced crime from drug dealing. It also induced many otherwise law-abiding citizens to be scofflaws. (I think the 55 mph national speed limit under President Nixon created greater numbers of scofflaws.) In my state recreational marijuana became legal as I write this column. But is that good? Wise? Edifying?

State lotteries were created partly to reduce the negative effects of the numbers games funding organized crime. That rationale is understandable, but why are states promoting the games with commercials and billion dollar payouts?

I find the “permissible but not edifying” paradigm helpful in many areas of medical ethics. The ethical concerns typically then fall into one of four categories: Slippery slope, bright lines, overuse, and conscientiously opting out. All are subspecies of the theme of going too far.

Oregon’s Death with Dignity Act was enacted 25 years ago. Nine other states now allow some form of medically assisted death. Most states prohibit it. As is now the case for abortion, medical care is typically legislated at the state level to reflect local values. Canada goes beyond assisted suicide and in the vast majority of cases employs active euthanasia with a physician pushing lethal drugs intravenously. That action is forbidden in the United States. Currently, euthanasia is involved in 10,000 deaths per year in Canada. A terminal illness is no longer needed; that requirement was ruled unconstitutional. By March 2023, intractable mental health problems will be eligible for the euthanasia cure in Canada. I have long considered myself a navigator of ethical slippery slopes because that is where the suffering people are. Canada has gone too far down this particular slope for my skill set.
 

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

Morality is often talked about in binary terms, black and white, right or wrong. That is how children 4-8 years old first conceive of it. Moral development progresses alongside motor, language, and social skills, but pediatricians typically do not screen for it or chart it. In adolescence, the ability for abstract thought develops and, once susceptibility to peer pressure lessens, nuances begin to shade the binary model. Honor codes become possible by the college years; scandals at colleges and military academies demonstrate that some 18- to 22-year-old young adults still lack that maturity. Lawrence Kohlberg, PhD, in the 1950s proposed a six-stage model of moral development and indicated that some people never achieve the upper stages.

Recently, neuroimaging research has demonstrated that the prefrontal cortex is still developing up to 25 years of age. Those data have ramifications for obtaining truly informed consent for medical procedures. Arbitrarily, driver’s licenses are issued at 16 years of age, the right to vote comes at age 18, and the purchase of alcohol allowed at age 21. Consent for medical care varies by state and by procedure. Treatment for general medical care, pregnancy, sexually transmitted infections, and mental health problems often have different age requirements. In some states, a 14-year-old can give consent for treatment of depression or pregnancy but cannot get a tattoo.

The rules for firearms are also complex and vary by state. Perhaps more important is the determination of medical, psychological, moral, and criminal conditions for which guns should be removed from someone’s access. Some states have created formalized red flag laws to accomplish this. Other states have informal procedures used by police and social workers rather than involving medical personnel. Recent gun-related tragedies at a St. Louis high school near me and at a Colorado Springs bar demonstrate deficiencies in the red flag approach, with multiple fatal consequences.

Some moral issues do not neatly fit the binary approach. There are many concerns that are better described by a paradigm that “all things are permissible but not everything is edifying.” Take as a model of this the consumption of alcohol. The risks of an occasional single drink are very small for most people. For some, one drink leads to binges of alcoholism. Others drink and drive. Over the centuries, various groups in various localities have counseled temperance. Some personally avoid alcohol to avoid leading others astray.

The United States from 1920 to 1933 carried out the national social experiment Prohibition that outlawed intoxicating beverages. Ultimately, the organized crime of black market alcohol production, distribution, and consumption was found to be worse than the disease. Alcohol use was again legalized. That is understandable. Still, I doubt Carrie Nation ever thought that the sponsorship of most major sporting events would rely heavily on beer and liquor companies. Legalization and promotion are two distinct acts.

A federal prohibition of marijuana since the 1950s similarly produced crime from drug dealing. It also induced many otherwise law-abiding citizens to be scofflaws. (I think the 55 mph national speed limit under President Nixon created greater numbers of scofflaws.) In my state recreational marijuana became legal as I write this column. But is that good? Wise? Edifying?

State lotteries were created partly to reduce the negative effects of the numbers games funding organized crime. That rationale is understandable, but why are states promoting the games with commercials and billion dollar payouts?

I find the “permissible but not edifying” paradigm helpful in many areas of medical ethics. The ethical concerns typically then fall into one of four categories: Slippery slope, bright lines, overuse, and conscientiously opting out. All are subspecies of the theme of going too far.

Oregon’s Death with Dignity Act was enacted 25 years ago. Nine other states now allow some form of medically assisted death. Most states prohibit it. As is now the case for abortion, medical care is typically legislated at the state level to reflect local values. Canada goes beyond assisted suicide and in the vast majority of cases employs active euthanasia with a physician pushing lethal drugs intravenously. That action is forbidden in the United States. Currently, euthanasia is involved in 10,000 deaths per year in Canada. A terminal illness is no longer needed; that requirement was ruled unconstitutional. By March 2023, intractable mental health problems will be eligible for the euthanasia cure in Canada. I have long considered myself a navigator of ethical slippery slopes because that is where the suffering people are. Canada has gone too far down this particular slope for my skill set.
 

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

Several years ago I visited my primary care provider in her new office. She had just left the practice where we had been coworkers for over a decade. I was “roomed” by Louise (not her real name) whom I had never met before. I assumed she had come with the new waiting room furniture. She took my vital signs, asked a few boilerplate questions, and told me that my PCP would be in shortly.

After our initial ping-pong match of how-are-things-going I mentioned to my old friend/PCP that I thought Louise needed to work on her person-to-person skills. She thanked me and said there were so many challenges in the new practice setting she hadn’t had a chance to work on staff training.

Courtesy Dr. William G. Wilkoff

When I returned 6 months later Louise was a different person. She appeared and sounded interested in who I was and left me in the room to wait feeling glad I had spoken up. I wasn’t surprised at the change, knowing my former coworker’s past history. I was confident that in time she would coach her new staff and continue to reinforce her message by setting an example by being a caring and concerned physician.

The old Louise certainly wasn’t a rude or unpleasant person but good customer service just didn’t come naturally to her. She thought she was doing a good job, at least as far as she understood what her job was supposed to be. On the whole spectrum of professional misbehavior she would barely warrant a pixel of color. Unfortunately, we are seeing and suffering through a surge of rude behavior and incivility not just in the medical community but across all segments of our society.

It is particularly troubling in health care, which has an organizational nonsystem that was initially paternalistic and male dominated but continues to be hierarchical even as gender stereotypes are becoming less rigid. Rudeness within a team, whether it is a medical office or a factory assembly line, can create a toxic work environment that can affect the quality of the product. In this case the end product is the health and wellness of our patients. While incivility within a team can occasionally be hidden from the patients, eventually it will surface and take its toll on the customer service component of the practice.

One wonders why so many of us are behaving rudely. Is it examples we see in the media, is it our political leaders, or is the pandemic a contributor? Has democracy run its course? Are we victims of our departure from organized religion? Do we need to reorganize our medical training to be less hierarchical? I don’t think there is any single cause nor do I believe we need to restructure our medical training system to remedy the situation. We will always need to transfer information and skills from people who have them to people who need to learn them. If there is a low-hanging fruit in the customer service orchard it is one person at a time deciding to behave in a civil manner toward fellow citizens.

While a colorful crop of political signs arrived in the run-up to the November election, recently, here on the midcoast of Maine, simple white-on-black signs have appeared saying “BE NICE.”

The good news is that being nice can be contagious. Simply think of that golden rule. Treat your patients/customers/coworkers as you would like to be treated yourself.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

Several years ago I visited my primary care provider in her new office. She had just left the practice where we had been coworkers for over a decade. I was “roomed” by Louise (not her real name) whom I had never met before. I assumed she had come with the new waiting room furniture. She took my vital signs, asked a few boilerplate questions, and told me that my PCP would be in shortly.

After our initial ping-pong match of how-are-things-going I mentioned to my old friend/PCP that I thought Louise needed to work on her person-to-person skills. She thanked me and said there were so many challenges in the new practice setting she hadn’t had a chance to work on staff training.

Courtesy Dr. William G. Wilkoff

When I returned 6 months later Louise was a different person. She appeared and sounded interested in who I was and left me in the room to wait feeling glad I had spoken up. I wasn’t surprised at the change, knowing my former coworker’s past history. I was confident that in time she would coach her new staff and continue to reinforce her message by setting an example by being a caring and concerned physician.

The old Louise certainly wasn’t a rude or unpleasant person but good customer service just didn’t come naturally to her. She thought she was doing a good job, at least as far as she understood what her job was supposed to be. On the whole spectrum of professional misbehavior she would barely warrant a pixel of color. Unfortunately, we are seeing and suffering through a surge of rude behavior and incivility not just in the medical community but across all segments of our society.

It is particularly troubling in health care, which has an organizational nonsystem that was initially paternalistic and male dominated but continues to be hierarchical even as gender stereotypes are becoming less rigid. Rudeness within a team, whether it is a medical office or a factory assembly line, can create a toxic work environment that can affect the quality of the product. In this case the end product is the health and wellness of our patients. While incivility within a team can occasionally be hidden from the patients, eventually it will surface and take its toll on the customer service component of the practice.

One wonders why so many of us are behaving rudely. Is it examples we see in the media, is it our political leaders, or is the pandemic a contributor? Has democracy run its course? Are we victims of our departure from organized religion? Do we need to reorganize our medical training to be less hierarchical? I don’t think there is any single cause nor do I believe we need to restructure our medical training system to remedy the situation. We will always need to transfer information and skills from people who have them to people who need to learn them. If there is a low-hanging fruit in the customer service orchard it is one person at a time deciding to behave in a civil manner toward fellow citizens.

While a colorful crop of political signs arrived in the run-up to the November election, recently, here on the midcoast of Maine, simple white-on-black signs have appeared saying “BE NICE.”

The good news is that being nice can be contagious. Simply think of that golden rule. Treat your patients/customers/coworkers as you would like to be treated yourself.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

Several years ago I visited my primary care provider in her new office. She had just left the practice where we had been coworkers for over a decade. I was “roomed” by Louise (not her real name) whom I had never met before. I assumed she had come with the new waiting room furniture. She took my vital signs, asked a few boilerplate questions, and told me that my PCP would be in shortly.

After our initial ping-pong match of how-are-things-going I mentioned to my old friend/PCP that I thought Louise needed to work on her person-to-person skills. She thanked me and said there were so many challenges in the new practice setting she hadn’t had a chance to work on staff training.

Courtesy Dr. William G. Wilkoff

When I returned 6 months later Louise was a different person. She appeared and sounded interested in who I was and left me in the room to wait feeling glad I had spoken up. I wasn’t surprised at the change, knowing my former coworker’s past history. I was confident that in time she would coach her new staff and continue to reinforce her message by setting an example by being a caring and concerned physician.

The old Louise certainly wasn’t a rude or unpleasant person but good customer service just didn’t come naturally to her. She thought she was doing a good job, at least as far as she understood what her job was supposed to be. On the whole spectrum of professional misbehavior she would barely warrant a pixel of color. Unfortunately, we are seeing and suffering through a surge of rude behavior and incivility not just in the medical community but across all segments of our society.

It is particularly troubling in health care, which has an organizational nonsystem that was initially paternalistic and male dominated but continues to be hierarchical even as gender stereotypes are becoming less rigid. Rudeness within a team, whether it is a medical office or a factory assembly line, can create a toxic work environment that can affect the quality of the product. In this case the end product is the health and wellness of our patients. While incivility within a team can occasionally be hidden from the patients, eventually it will surface and take its toll on the customer service component of the practice.

One wonders why so many of us are behaving rudely. Is it examples we see in the media, is it our political leaders, or is the pandemic a contributor? Has democracy run its course? Are we victims of our departure from organized religion? Do we need to reorganize our medical training to be less hierarchical? I don’t think there is any single cause nor do I believe we need to restructure our medical training system to remedy the situation. We will always need to transfer information and skills from people who have them to people who need to learn them. If there is a low-hanging fruit in the customer service orchard it is one person at a time deciding to behave in a civil manner toward fellow citizens.

While a colorful crop of political signs arrived in the run-up to the November election, recently, here on the midcoast of Maine, simple white-on-black signs have appeared saying “BE NICE.”

The good news is that being nice can be contagious. Simply think of that golden rule. Treat your patients/customers/coworkers as you would like to be treated yourself.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the division of medical ethics at New York University.

I want to talk about a paper that my colleagues in my division just published in Health Affairs. Amanda Zink, Lauren Taylor, and a couple of others wrote a very interesting piece, which I think has significance and importance for all those doing clinical care in American health care today.

As they pointed out, there’s a large amount of literature about what makes patients trust their doctor. There are many studies that show that, although patients sometimes have become more critical of the medical profession, in general they still try to trust their individual physician. Nurses remain in fairly high esteem among those who are getting hospital care.

What isn’t studied, as this paper properly points out, is, what can the doctor and the nurse do to trust the patient? How can that be assessed? Isn’t that just as important as saying that patients have to trust their doctors to do and comply with what they’re told?

What if doctors are afraid of violence? What if doctors are fearful that they can’t trust patients to listen, pay attention, or do what they’re being told? What if they think that patients are coming in with all kinds of disinformation, false information, or things they pick up on the Internet, so that even though you try your best to get across accurate and complete information about what to do about infectious diseases, taking care of a kid with strep throat, or whatever it might be, you’re thinking, Can I trust this patient to do what it is that I want them to do?

One particular problem that’s causing distrust is that more and more patients are showing stress and dependence on drugs and alcohol. That doesn’t make them less trustworthy per se, but it means they can’t regulate their own behavior as well.

That obviously has to be something that the physician or the nurse is thinking about. Is this person going to be able to contain anger? Is this person going to be able to handle bad news? Is this person going to deal with me when I tell them that some of the things they believe to be true about what’s good for their health care are false?

I think we have to really start to push administrators and people in positions of power to teach doctors and nurses how to defuse situations and how to make people more comfortable when they come in and the doctor suspects that they might be under the influence, impaired, or angry because of things they’ve seen on social media, whatever those might be – including concerns about racism, bigotry, and bias, which some patients are bringing into the clinic and the hospital setting.

We need more training. We’ve got to address this as a serious issue. What can we do to defuse situations where the doctor or the nurse rightly thinks that they can’t control or they can’t trust what the patient is thinking or how the patient might behave?

It’s also the case that I think we need more backup and quick access to security so that people feel safe and comfortable in providing care. We have to make sure that if you need someone to restrain a patient or to get somebody out of a situation, that they can get there quickly and respond rapidly, and that they know what to do to deescalate a situation.

It’s sad to say, but security in today’s health care world has to be something that we really test and check – not because we’re worried, as many places are, about a shooter entering the premises, which is its own bit of concern – but I’m just talking about when the doctor or the nurse says that this patient might be acting up, could get violent, or is someone I can’t trust.

My coauthors are basically saying that it’s not a one-way street. Yes, we have to figure out ways to make sure that our patients can trust what we say. Trust is absolutely the lubricant that makes health care flow. If patients don’t trust their doctors, they’re not going to do what they say. They’re not going to get their prescriptions filled. They’re not going to be compliant. They’re not going to try to lose weight or control their diabetes.

It also goes the other way. The doctor or the nurse has to trust the patient. They have to believe that they’re safe. They have to believe that the patient is capable of controlling themselves. They have to believe that the patient is capable of listening and hearing what they’re saying, and that they’re competent to follow up on instructions, including to come back if that’s what’s required.

Everybody has to feel secure in the environment in which they’re working. Security, sadly, has to be a priority if we’re going to have a health care workforce that really feels safe and comfortable dealing with a patient population that is increasingly aggressive and perhaps not as trustworthy.

That’s not news I like to read when my colleagues write it up, but it’s important and we have to take it seriously.
 

Dr. Caplan disclosed that he has served as a director, officer, partner, employee, adviser, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position), and is a contributing author and adviser for Medscape. A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the division of medical ethics at New York University.

I want to talk about a paper that my colleagues in my division just published in Health Affairs. Amanda Zink, Lauren Taylor, and a couple of others wrote a very interesting piece, which I think has significance and importance for all those doing clinical care in American health care today.

As they pointed out, there’s a large amount of literature about what makes patients trust their doctor. There are many studies that show that, although patients sometimes have become more critical of the medical profession, in general they still try to trust their individual physician. Nurses remain in fairly high esteem among those who are getting hospital care.

What isn’t studied, as this paper properly points out, is, what can the doctor and the nurse do to trust the patient? How can that be assessed? Isn’t that just as important as saying that patients have to trust their doctors to do and comply with what they’re told?

What if doctors are afraid of violence? What if doctors are fearful that they can’t trust patients to listen, pay attention, or do what they’re being told? What if they think that patients are coming in with all kinds of disinformation, false information, or things they pick up on the Internet, so that even though you try your best to get across accurate and complete information about what to do about infectious diseases, taking care of a kid with strep throat, or whatever it might be, you’re thinking, Can I trust this patient to do what it is that I want them to do?

One particular problem that’s causing distrust is that more and more patients are showing stress and dependence on drugs and alcohol. That doesn’t make them less trustworthy per se, but it means they can’t regulate their own behavior as well.

That obviously has to be something that the physician or the nurse is thinking about. Is this person going to be able to contain anger? Is this person going to be able to handle bad news? Is this person going to deal with me when I tell them that some of the things they believe to be true about what’s good for their health care are false?

I think we have to really start to push administrators and people in positions of power to teach doctors and nurses how to defuse situations and how to make people more comfortable when they come in and the doctor suspects that they might be under the influence, impaired, or angry because of things they’ve seen on social media, whatever those might be – including concerns about racism, bigotry, and bias, which some patients are bringing into the clinic and the hospital setting.

We need more training. We’ve got to address this as a serious issue. What can we do to defuse situations where the doctor or the nurse rightly thinks that they can’t control or they can’t trust what the patient is thinking or how the patient might behave?

It’s also the case that I think we need more backup and quick access to security so that people feel safe and comfortable in providing care. We have to make sure that if you need someone to restrain a patient or to get somebody out of a situation, that they can get there quickly and respond rapidly, and that they know what to do to deescalate a situation.

It’s sad to say, but security in today’s health care world has to be something that we really test and check – not because we’re worried, as many places are, about a shooter entering the premises, which is its own bit of concern – but I’m just talking about when the doctor or the nurse says that this patient might be acting up, could get violent, or is someone I can’t trust.

My coauthors are basically saying that it’s not a one-way street. Yes, we have to figure out ways to make sure that our patients can trust what we say. Trust is absolutely the lubricant that makes health care flow. If patients don’t trust their doctors, they’re not going to do what they say. They’re not going to get their prescriptions filled. They’re not going to be compliant. They’re not going to try to lose weight or control their diabetes.

It also goes the other way. The doctor or the nurse has to trust the patient. They have to believe that they’re safe. They have to believe that the patient is capable of controlling themselves. They have to believe that the patient is capable of listening and hearing what they’re saying, and that they’re competent to follow up on instructions, including to come back if that’s what’s required.

Everybody has to feel secure in the environment in which they’re working. Security, sadly, has to be a priority if we’re going to have a health care workforce that really feels safe and comfortable dealing with a patient population that is increasingly aggressive and perhaps not as trustworthy.

That’s not news I like to read when my colleagues write it up, but it’s important and we have to take it seriously.
 

Dr. Caplan disclosed that he has served as a director, officer, partner, employee, adviser, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position), and is a contributing author and adviser for Medscape. A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the division of medical ethics at New York University.

I want to talk about a paper that my colleagues in my division just published in Health Affairs. Amanda Zink, Lauren Taylor, and a couple of others wrote a very interesting piece, which I think has significance and importance for all those doing clinical care in American health care today.

As they pointed out, there’s a large amount of literature about what makes patients trust their doctor. There are many studies that show that, although patients sometimes have become more critical of the medical profession, in general they still try to trust their individual physician. Nurses remain in fairly high esteem among those who are getting hospital care.

What isn’t studied, as this paper properly points out, is, what can the doctor and the nurse do to trust the patient? How can that be assessed? Isn’t that just as important as saying that patients have to trust their doctors to do and comply with what they’re told?

What if doctors are afraid of violence? What if doctors are fearful that they can’t trust patients to listen, pay attention, or do what they’re being told? What if they think that patients are coming in with all kinds of disinformation, false information, or things they pick up on the Internet, so that even though you try your best to get across accurate and complete information about what to do about infectious diseases, taking care of a kid with strep throat, or whatever it might be, you’re thinking, Can I trust this patient to do what it is that I want them to do?

One particular problem that’s causing distrust is that more and more patients are showing stress and dependence on drugs and alcohol. That doesn’t make them less trustworthy per se, but it means they can’t regulate their own behavior as well.

That obviously has to be something that the physician or the nurse is thinking about. Is this person going to be able to contain anger? Is this person going to be able to handle bad news? Is this person going to deal with me when I tell them that some of the things they believe to be true about what’s good for their health care are false?

I think we have to really start to push administrators and people in positions of power to teach doctors and nurses how to defuse situations and how to make people more comfortable when they come in and the doctor suspects that they might be under the influence, impaired, or angry because of things they’ve seen on social media, whatever those might be – including concerns about racism, bigotry, and bias, which some patients are bringing into the clinic and the hospital setting.

We need more training. We’ve got to address this as a serious issue. What can we do to defuse situations where the doctor or the nurse rightly thinks that they can’t control or they can’t trust what the patient is thinking or how the patient might behave?

It’s also the case that I think we need more backup and quick access to security so that people feel safe and comfortable in providing care. We have to make sure that if you need someone to restrain a patient or to get somebody out of a situation, that they can get there quickly and respond rapidly, and that they know what to do to deescalate a situation.

It’s sad to say, but security in today’s health care world has to be something that we really test and check – not because we’re worried, as many places are, about a shooter entering the premises, which is its own bit of concern – but I’m just talking about when the doctor or the nurse says that this patient might be acting up, could get violent, or is someone I can’t trust.

My coauthors are basically saying that it’s not a one-way street. Yes, we have to figure out ways to make sure that our patients can trust what we say. Trust is absolutely the lubricant that makes health care flow. If patients don’t trust their doctors, they’re not going to do what they say. They’re not going to get their prescriptions filled. They’re not going to be compliant. They’re not going to try to lose weight or control their diabetes.

It also goes the other way. The doctor or the nurse has to trust the patient. They have to believe that they’re safe. They have to believe that the patient is capable of controlling themselves. They have to believe that the patient is capable of listening and hearing what they’re saying, and that they’re competent to follow up on instructions, including to come back if that’s what’s required.

Everybody has to feel secure in the environment in which they’re working. Security, sadly, has to be a priority if we’re going to have a health care workforce that really feels safe and comfortable dealing with a patient population that is increasingly aggressive and perhaps not as trustworthy.

That’s not news I like to read when my colleagues write it up, but it’s important and we have to take it seriously.
 

Dr. Caplan disclosed that he has served as a director, officer, partner, employee, adviser, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position), and is a contributing author and adviser for Medscape. A version of this article first appeared on Medscape.com.

First described in 2020 by researchers from the U.S. National Institutes of Health, VEXAS syndrome is a systemic autoinflammatory disease of undefined origin. Its name is an acronym: Vacuoles, E1 enzyme, X-linked, Autoinflammatory, Somatic. The prevalence of this syndrome is unknown, but it is not so rare. As it is an X-linked disease, men are predominantly affected.

First identification

The NIH team screened the exomes and genomes of 2,560 individuals. Of this group, 1,477 had been referred because of undiagnosed recurrent fevers, systemic inflammation, or both, and 1,083 were affected by atypical, unclassified disorders. The researchers identified 25 men with a somatic mutation in the ubiquitin-like modifier activating enzyme 1 (UBA1) gene, which is involved in the protein ubiquitylation system. This posttranslational modification has a pleiotropic function that likely explains the clinical heterogeneity seen in VEXAS patients: regulation of protein turnover, especially those involved in the cell cycle, cell death, and signal transduction. Ubiquitylation is also involved in nonproteolytic functions, such as assembly of multiprotein complexes, intracellular signaling, inflammatory signaling, and DNA repair.

Clinical presentation

The clinicobiological presentation of VEXAS syndrome is very heterogeneous. Typically, patients present with a systemic inflammatory disease with unexplained episodes of fever, involvement of the lungs, skin, blood vessels, and joints. Molecular diagnosis is made by the sequencing of UBA1.

Most patients present with the characteristic clinical signs of other inflammatory diseases, such as polyarteritis nodosa and recurrent polychondritis. But VEXAS patients are at high risk of developing hematologic conditions. Indeed, the following were seen among the 25 participants in the NIH study: macrocytic anemia (96%), venous thromboembolism (44%), myelodysplastic syndrome (24%), and multiple myeloma or monoclonal gammopathy of undetermined significance (20%).

In VEXAS patients, levels of serum inflammatory markers are increased. These markers include tumor necrosis factor, interleukin-8, interleukin-6, interferon-inducible protein-10, interferon-gamma, C-reactive protein. In addition, there is aberrant activation of innate immune-signaling pathways.

In a large-scale analysis of a multicenter case series of 116 French patients, researchers found that VEXAS syndrome primarily affected men. The disease was progressive, and onset occurred after age 50 years. These patients can be divided into three phenotypically distinct clusters on the basis of integration of clinical and biological data. In the 58 cases in which myelodysplastic syndrome was present, the mortality rates were higher. The researchers also reported that the UBA1 p.Met41L mutation was associated with a better prognosis.
 

Treatment data

VEXAS syndrome resists the classical therapeutic arsenal. Patients require high-dose glucocorticoids, and prognosis appears to be poor. The available treatment data are retrospective. Of the 25 participants in the NIH study, 40% died within 5 years from disease-related causes or complications related to treatment. Among the promising therapeutic avenues is the use of inhibitors of the Janus kinase pathway.

This article was translated from Univadis France. A version of this article appeared on Medscape.com.

First described in 2020 by researchers from the U.S. National Institutes of Health, VEXAS syndrome is a systemic autoinflammatory disease of undefined origin. Its name is an acronym: Vacuoles, E1 enzyme, X-linked, Autoinflammatory, Somatic. The prevalence of this syndrome is unknown, but it is not so rare. As it is an X-linked disease, men are predominantly affected.

First identification

The NIH team screened the exomes and genomes of 2,560 individuals. Of this group, 1,477 had been referred because of undiagnosed recurrent fevers, systemic inflammation, or both, and 1,083 were affected by atypical, unclassified disorders. The researchers identified 25 men with a somatic mutation in the ubiquitin-like modifier activating enzyme 1 (UBA1) gene, which is involved in the protein ubiquitylation system. This posttranslational modification has a pleiotropic function that likely explains the clinical heterogeneity seen in VEXAS patients: regulation of protein turnover, especially those involved in the cell cycle, cell death, and signal transduction. Ubiquitylation is also involved in nonproteolytic functions, such as assembly of multiprotein complexes, intracellular signaling, inflammatory signaling, and DNA repair.

Clinical presentation

The clinicobiological presentation of VEXAS syndrome is very heterogeneous. Typically, patients present with a systemic inflammatory disease with unexplained episodes of fever, involvement of the lungs, skin, blood vessels, and joints. Molecular diagnosis is made by the sequencing of UBA1.

Most patients present with the characteristic clinical signs of other inflammatory diseases, such as polyarteritis nodosa and recurrent polychondritis. But VEXAS patients are at high risk of developing hematologic conditions. Indeed, the following were seen among the 25 participants in the NIH study: macrocytic anemia (96%), venous thromboembolism (44%), myelodysplastic syndrome (24%), and multiple myeloma or monoclonal gammopathy of undetermined significance (20%).

In VEXAS patients, levels of serum inflammatory markers are increased. These markers include tumor necrosis factor, interleukin-8, interleukin-6, interferon-inducible protein-10, interferon-gamma, C-reactive protein. In addition, there is aberrant activation of innate immune-signaling pathways.

In a large-scale analysis of a multicenter case series of 116 French patients, researchers found that VEXAS syndrome primarily affected men. The disease was progressive, and onset occurred after age 50 years. These patients can be divided into three phenotypically distinct clusters on the basis of integration of clinical and biological data. In the 58 cases in which myelodysplastic syndrome was present, the mortality rates were higher. The researchers also reported that the UBA1 p.Met41L mutation was associated with a better prognosis.
 

Treatment data

VEXAS syndrome resists the classical therapeutic arsenal. Patients require high-dose glucocorticoids, and prognosis appears to be poor. The available treatment data are retrospective. Of the 25 participants in the NIH study, 40% died within 5 years from disease-related causes or complications related to treatment. Among the promising therapeutic avenues is the use of inhibitors of the Janus kinase pathway.

This article was translated from Univadis France. A version of this article appeared on Medscape.com.

First described in 2020 by researchers from the U.S. National Institutes of Health, VEXAS syndrome is a systemic autoinflammatory disease of undefined origin. Its name is an acronym: Vacuoles, E1 enzyme, X-linked, Autoinflammatory, Somatic. The prevalence of this syndrome is unknown, but it is not so rare. As it is an X-linked disease, men are predominantly affected.

First identification

The NIH team screened the exomes and genomes of 2,560 individuals. Of this group, 1,477 had been referred because of undiagnosed recurrent fevers, systemic inflammation, or both, and 1,083 were affected by atypical, unclassified disorders. The researchers identified 25 men with a somatic mutation in the ubiquitin-like modifier activating enzyme 1 (UBA1) gene, which is involved in the protein ubiquitylation system. This posttranslational modification has a pleiotropic function that likely explains the clinical heterogeneity seen in VEXAS patients: regulation of protein turnover, especially those involved in the cell cycle, cell death, and signal transduction. Ubiquitylation is also involved in nonproteolytic functions, such as assembly of multiprotein complexes, intracellular signaling, inflammatory signaling, and DNA repair.

Clinical presentation

The clinicobiological presentation of VEXAS syndrome is very heterogeneous. Typically, patients present with a systemic inflammatory disease with unexplained episodes of fever, involvement of the lungs, skin, blood vessels, and joints. Molecular diagnosis is made by the sequencing of UBA1.

Most patients present with the characteristic clinical signs of other inflammatory diseases, such as polyarteritis nodosa and recurrent polychondritis. But VEXAS patients are at high risk of developing hematologic conditions. Indeed, the following were seen among the 25 participants in the NIH study: macrocytic anemia (96%), venous thromboembolism (44%), myelodysplastic syndrome (24%), and multiple myeloma or monoclonal gammopathy of undetermined significance (20%).

In VEXAS patients, levels of serum inflammatory markers are increased. These markers include tumor necrosis factor, interleukin-8, interleukin-6, interferon-inducible protein-10, interferon-gamma, C-reactive protein. In addition, there is aberrant activation of innate immune-signaling pathways.

In a large-scale analysis of a multicenter case series of 116 French patients, researchers found that VEXAS syndrome primarily affected men. The disease was progressive, and onset occurred after age 50 years. These patients can be divided into three phenotypically distinct clusters on the basis of integration of clinical and biological data. In the 58 cases in which myelodysplastic syndrome was present, the mortality rates were higher. The researchers also reported that the UBA1 p.Met41L mutation was associated with a better prognosis.
 

Treatment data

VEXAS syndrome resists the classical therapeutic arsenal. Patients require high-dose glucocorticoids, and prognosis appears to be poor. The available treatment data are retrospective. Of the 25 participants in the NIH study, 40% died within 5 years from disease-related causes or complications related to treatment. Among the promising therapeutic avenues is the use of inhibitors of the Janus kinase pathway.

This article was translated from Univadis France. A version of this article appeared on Medscape.com.

Children and young adults who are exposed to a single CT scan of the head or neck before age 22 years are at significantly increased risk of developing a brain tumor, particularly glioma, after at least 5 years, according to results of the large EPI-CT study.

“Translation of our risk estimates to the clinical setting indicates that per 10,000 children who received one head CT examination, about one radiation-induced brain cancer is expected during the 5-15 years following the CT examination,” noted lead author Michael Hauptmann, PhD, from the Institute of Biostatistics and Registry Research, Brandenburg Medical School, Neuruppin, Germany, and coauthors.

“Next to the clinical benefit of most CT scans, there is a small risk of cancer from the radiation exposure,” Dr. Hauptmann told this news organization.

“So, CT examinations should only be used when necessary, and if they are used, the lowest achievable dose should be applied,” he said.

The study was published online in The Lancet Oncology.

“This is a thoughtful and well-conducted study by an outstanding multinational team of scientists that adds further weight to the growing body of evidence that has found exposure to CT scanning increases a child’s risk of developing brain cancer,” commented Rebecca Bindman-Smith, MD, from the University of California, San Francisco, who was not involved in the research.

“The results are real, and important,” she told this news organization, adding that “the authors were conservative in their assumptions, and performed a very large number of sensitivity analyses ... to check that the results were robust to a large range of assumptions – and the results changed relatively little.”

“I do not think there is enough awareness [about this risk],” Dr. Hauptmann said. “There is evidence that a nonnegligible number of CTs is unjustified according to guidelines, and there is evidence that doses vary substantially for the same CT between institutions in the same or different countries.”

Indeed, particularly in the United States, “we perform many CT scans in children and even more so in adults that are simply unnecessary,” agreed Dr. Bindman-Smith, who is professor of epidemiology and biostatistics at the University of California, San Francisco. “It is important for patients and providers to understand that nothing we do in medicine is risk free, including CT scanning. If a CT is necessary, the benefit almost certainly outweighs the risk. But if [not], then it should not be obtained. Both patients and providers must make thoroughly considered decisions before asking for or agreeing to a CT.”

She also pointed out that while this study evaluated the risk only for brain cancer, children who undergo head CTs are also at increased risk for leukemia.
 

Dose/response relationship

The study included 658,752 individuals from nine European countries and 276 hospitals. Each patient had received at least one CT scan between 1977 and 2014 before they turned 22 years of age. Eligibility requirements included their being alive at least 5 years after the first scan and that they had not previously been diagnosed with cancer or benign brain tumor.

The radiation dose absorbed to the brain and 33 other organs and tissues was estimated for each participant using a dose reconstruction model that included historical information on CT machine settings, questionnaire data, and Digital Imaging and Communication in Medicine header metadata. “Mean brain dose per head or neck CT examination increased from 1984 until about 1991, following the introduction of multislice CT scanners at which point thereafter the mean dose decreased and then stabilized around 2010,” note the authors.

During a median follow-up of 5.6 years (starting 5 years after the first scan), 165 brain cancers occurred, including 121 (73%) gliomas, as well as a variety of other morphologic changes.

The mean cumulative brain dose, which lagged by 5 years, was 47.4 mGy overall and 76.0 mGy among people with brain cancer.

“We observed a significant positive association between the cumulative number of head or neck CT examinations and the risk of all brain cancers combined (P < .0001), and of gliomas separately (P = .0002),” the team reports, adding that, for a brain dose of 38 mGy, which was the average dose per head or neck CT in 2012-2014, the relative risk of developing brain cancer was 1.5, compared with not undergoing a CT scan, and the excess absolute risk per 100,000 person-years was 1.1.

These findings “can be used to give the patients and their parents important information on the risks of CT examination to balance against the known benefits,” noted Nobuyuki Hamada, PhD, from the Central Research Institute of Electric Power Industry, Tokyo, and Lydia B. Zablotska, MD, PhD, from the University of California, San Francisco, writing in a linked commentary.

“In recent years, rates of CT use have been steady or declined, and various efforts (for instance, in terms of diagnostic reference levels) have been made to justify and optimize CT examinations. Such continued efforts, along with extended epidemiological investigations, would be needed to minimize the risk of brain cancer after pediatric CT examination,” they add.
 

Keeping dose to a minimum

The study’s finding of a dose-response relationship underscores the importance of keeping doses to a minimum, Dr. Bindman-Smith commented. “I do not believe we are doing this nearly enough,” she added.

“In the UCSF International CT Dose Registry, where we have collected CT scans from 165 hospitals on many millions of patients, we found that the average brain dose for a head CT in a 1-year-old is 42 mGy but that this dose varies tremendously, where some children receive a dose of 100 mGy.

“So, a second message is that not only should CT scans be justified and used judiciously, but also they should be optimized, meaning using the lowest dose possible. I personally think there should be regulatory oversight to ensure that patients receive the absolutely lowest doses possible,” she added. “My team at UCSF has written quality measures endorsed by the National Quality Forum as a start for setting explicit standards for how CT should be performed in order to ensure the cancer risks are as low as possible.”

The study was funded through the Belgian Cancer Registry; La Ligue contre le Cancer, L’Institut National du Cancer, France; the Ministry of Health, Labour and Welfare of Japan; the German Federal Ministry of Education and Research; Worldwide Cancer Research; the Dutch Cancer Society; the Research Council of Norway; Consejo de Seguridad Nuclear, Generalitat deCatalunya, Spain; the U.S. National Cancer Institute; the U.K. National Institute for Health Research; and Public Health England. Dr. Hauptmann has disclosed no relevant financial relationships. Other investigators’ relevant financial relationships are listed in the original article. Dr. Hamada and Dr. Zablotska disclosed no relevant financial relationships.

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

Children and young adults who are exposed to a single CT scan of the head or neck before age 22 years are at significantly increased risk of developing a brain tumor, particularly glioma, after at least 5 years, according to results of the large EPI-CT study.

“Translation of our risk estimates to the clinical setting indicates that per 10,000 children who received one head CT examination, about one radiation-induced brain cancer is expected during the 5-15 years following the CT examination,” noted lead author Michael Hauptmann, PhD, from the Institute of Biostatistics and Registry Research, Brandenburg Medical School, Neuruppin, Germany, and coauthors.

“Next to the clinical benefit of most CT scans, there is a small risk of cancer from the radiation exposure,” Dr. Hauptmann told this news organization.

“So, CT examinations should only be used when necessary, and if they are used, the lowest achievable dose should be applied,” he said.

The study was published online in The Lancet Oncology.

“This is a thoughtful and well-conducted study by an outstanding multinational team of scientists that adds further weight to the growing body of evidence that has found exposure to CT scanning increases a child’s risk of developing brain cancer,” commented Rebecca Bindman-Smith, MD, from the University of California, San Francisco, who was not involved in the research.

“The results are real, and important,” she told this news organization, adding that “the authors were conservative in their assumptions, and performed a very large number of sensitivity analyses ... to check that the results were robust to a large range of assumptions – and the results changed relatively little.”

“I do not think there is enough awareness [about this risk],” Dr. Hauptmann said. “There is evidence that a nonnegligible number of CTs is unjustified according to guidelines, and there is evidence that doses vary substantially for the same CT between institutions in the same or different countries.”

Indeed, particularly in the United States, “we perform many CT scans in children and even more so in adults that are simply unnecessary,” agreed Dr. Bindman-Smith, who is professor of epidemiology and biostatistics at the University of California, San Francisco. “It is important for patients and providers to understand that nothing we do in medicine is risk free, including CT scanning. If a CT is necessary, the benefit almost certainly outweighs the risk. But if [not], then it should not be obtained. Both patients and providers must make thoroughly considered decisions before asking for or agreeing to a CT.”

She also pointed out that while this study evaluated the risk only for brain cancer, children who undergo head CTs are also at increased risk for leukemia.
 

Dose/response relationship

The study included 658,752 individuals from nine European countries and 276 hospitals. Each patient had received at least one CT scan between 1977 and 2014 before they turned 22 years of age. Eligibility requirements included their being alive at least 5 years after the first scan and that they had not previously been diagnosed with cancer or benign brain tumor.

The radiation dose absorbed to the brain and 33 other organs and tissues was estimated for each participant using a dose reconstruction model that included historical information on CT machine settings, questionnaire data, and Digital Imaging and Communication in Medicine header metadata. “Mean brain dose per head or neck CT examination increased from 1984 until about 1991, following the introduction of multislice CT scanners at which point thereafter the mean dose decreased and then stabilized around 2010,” note the authors.

During a median follow-up of 5.6 years (starting 5 years after the first scan), 165 brain cancers occurred, including 121 (73%) gliomas, as well as a variety of other morphologic changes.

The mean cumulative brain dose, which lagged by 5 years, was 47.4 mGy overall and 76.0 mGy among people with brain cancer.

“We observed a significant positive association between the cumulative number of head or neck CT examinations and the risk of all brain cancers combined (P < .0001), and of gliomas separately (P = .0002),” the team reports, adding that, for a brain dose of 38 mGy, which was the average dose per head or neck CT in 2012-2014, the relative risk of developing brain cancer was 1.5, compared with not undergoing a CT scan, and the excess absolute risk per 100,000 person-years was 1.1.

These findings “can be used to give the patients and their parents important information on the risks of CT examination to balance against the known benefits,” noted Nobuyuki Hamada, PhD, from the Central Research Institute of Electric Power Industry, Tokyo, and Lydia B. Zablotska, MD, PhD, from the University of California, San Francisco, writing in a linked commentary.

“In recent years, rates of CT use have been steady or declined, and various efforts (for instance, in terms of diagnostic reference levels) have been made to justify and optimize CT examinations. Such continued efforts, along with extended epidemiological investigations, would be needed to minimize the risk of brain cancer after pediatric CT examination,” they add.
 

Keeping dose to a minimum

The study’s finding of a dose-response relationship underscores the importance of keeping doses to a minimum, Dr. Bindman-Smith commented. “I do not believe we are doing this nearly enough,” she added.

“In the UCSF International CT Dose Registry, where we have collected CT scans from 165 hospitals on many millions of patients, we found that the average brain dose for a head CT in a 1-year-old is 42 mGy but that this dose varies tremendously, where some children receive a dose of 100 mGy.

“So, a second message is that not only should CT scans be justified and used judiciously, but also they should be optimized, meaning using the lowest dose possible. I personally think there should be regulatory oversight to ensure that patients receive the absolutely lowest doses possible,” she added. “My team at UCSF has written quality measures endorsed by the National Quality Forum as a start for setting explicit standards for how CT should be performed in order to ensure the cancer risks are as low as possible.”

The study was funded through the Belgian Cancer Registry; La Ligue contre le Cancer, L’Institut National du Cancer, France; the Ministry of Health, Labour and Welfare of Japan; the German Federal Ministry of Education and Research; Worldwide Cancer Research; the Dutch Cancer Society; the Research Council of Norway; Consejo de Seguridad Nuclear, Generalitat deCatalunya, Spain; the U.S. National Cancer Institute; the U.K. National Institute for Health Research; and Public Health England. Dr. Hauptmann has disclosed no relevant financial relationships. Other investigators’ relevant financial relationships are listed in the original article. Dr. Hamada and Dr. Zablotska disclosed no relevant financial relationships.

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

Children and young adults who are exposed to a single CT scan of the head or neck before age 22 years are at significantly increased risk of developing a brain tumor, particularly glioma, after at least 5 years, according to results of the large EPI-CT study.

“Translation of our risk estimates to the clinical setting indicates that per 10,000 children who received one head CT examination, about one radiation-induced brain cancer is expected during the 5-15 years following the CT examination,” noted lead author Michael Hauptmann, PhD, from the Institute of Biostatistics and Registry Research, Brandenburg Medical School, Neuruppin, Germany, and coauthors.

“Next to the clinical benefit of most CT scans, there is a small risk of cancer from the radiation exposure,” Dr. Hauptmann told this news organization.

“So, CT examinations should only be used when necessary, and if they are used, the lowest achievable dose should be applied,” he said.

The study was published online in The Lancet Oncology.

“This is a thoughtful and well-conducted study by an outstanding multinational team of scientists that adds further weight to the growing body of evidence that has found exposure to CT scanning increases a child’s risk of developing brain cancer,” commented Rebecca Bindman-Smith, MD, from the University of California, San Francisco, who was not involved in the research.

“The results are real, and important,” she told this news organization, adding that “the authors were conservative in their assumptions, and performed a very large number of sensitivity analyses ... to check that the results were robust to a large range of assumptions – and the results changed relatively little.”

“I do not think there is enough awareness [about this risk],” Dr. Hauptmann said. “There is evidence that a nonnegligible number of CTs is unjustified according to guidelines, and there is evidence that doses vary substantially for the same CT between institutions in the same or different countries.”

Indeed, particularly in the United States, “we perform many CT scans in children and even more so in adults that are simply unnecessary,” agreed Dr. Bindman-Smith, who is professor of epidemiology and biostatistics at the University of California, San Francisco. “It is important for patients and providers to understand that nothing we do in medicine is risk free, including CT scanning. If a CT is necessary, the benefit almost certainly outweighs the risk. But if [not], then it should not be obtained. Both patients and providers must make thoroughly considered decisions before asking for or agreeing to a CT.”

She also pointed out that while this study evaluated the risk only for brain cancer, children who undergo head CTs are also at increased risk for leukemia.
 

Dose/response relationship

The study included 658,752 individuals from nine European countries and 276 hospitals. Each patient had received at least one CT scan between 1977 and 2014 before they turned 22 years of age. Eligibility requirements included their being alive at least 5 years after the first scan and that they had not previously been diagnosed with cancer or benign brain tumor.

The radiation dose absorbed to the brain and 33 other organs and tissues was estimated for each participant using a dose reconstruction model that included historical information on CT machine settings, questionnaire data, and Digital Imaging and Communication in Medicine header metadata. “Mean brain dose per head or neck CT examination increased from 1984 until about 1991, following the introduction of multislice CT scanners at which point thereafter the mean dose decreased and then stabilized around 2010,” note the authors.

During a median follow-up of 5.6 years (starting 5 years after the first scan), 165 brain cancers occurred, including 121 (73%) gliomas, as well as a variety of other morphologic changes.

The mean cumulative brain dose, which lagged by 5 years, was 47.4 mGy overall and 76.0 mGy among people with brain cancer.

“We observed a significant positive association between the cumulative number of head or neck CT examinations and the risk of all brain cancers combined (P < .0001), and of gliomas separately (P = .0002),” the team reports, adding that, for a brain dose of 38 mGy, which was the average dose per head or neck CT in 2012-2014, the relative risk of developing brain cancer was 1.5, compared with not undergoing a CT scan, and the excess absolute risk per 100,000 person-years was 1.1.

These findings “can be used to give the patients and their parents important information on the risks of CT examination to balance against the known benefits,” noted Nobuyuki Hamada, PhD, from the Central Research Institute of Electric Power Industry, Tokyo, and Lydia B. Zablotska, MD, PhD, from the University of California, San Francisco, writing in a linked commentary.

“In recent years, rates of CT use have been steady or declined, and various efforts (for instance, in terms of diagnostic reference levels) have been made to justify and optimize CT examinations. Such continued efforts, along with extended epidemiological investigations, would be needed to minimize the risk of brain cancer after pediatric CT examination,” they add.
 

Keeping dose to a minimum

The study’s finding of a dose-response relationship underscores the importance of keeping doses to a minimum, Dr. Bindman-Smith commented. “I do not believe we are doing this nearly enough,” she added.

“In the UCSF International CT Dose Registry, where we have collected CT scans from 165 hospitals on many millions of patients, we found that the average brain dose for a head CT in a 1-year-old is 42 mGy but that this dose varies tremendously, where some children receive a dose of 100 mGy.

“So, a second message is that not only should CT scans be justified and used judiciously, but also they should be optimized, meaning using the lowest dose possible. I personally think there should be regulatory oversight to ensure that patients receive the absolutely lowest doses possible,” she added. “My team at UCSF has written quality measures endorsed by the National Quality Forum as a start for setting explicit standards for how CT should be performed in order to ensure the cancer risks are as low as possible.”

The study was funded through the Belgian Cancer Registry; La Ligue contre le Cancer, L’Institut National du Cancer, France; the Ministry of Health, Labour and Welfare of Japan; the German Federal Ministry of Education and Research; Worldwide Cancer Research; the Dutch Cancer Society; the Research Council of Norway; Consejo de Seguridad Nuclear, Generalitat deCatalunya, Spain; the U.S. National Cancer Institute; the U.K. National Institute for Health Research; and Public Health England. Dr. Hauptmann has disclosed no relevant financial relationships. Other investigators’ relevant financial relationships are listed in the original article. Dr. Hamada and Dr. Zablotska disclosed no relevant financial relationships.

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

The U.S. Food and Drug Administration has cleared the Dexcom G7 continuous glucose monitoring (CGM) system for people with all types of diabetes aged 2 years and older and for use during pregnancy.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The G7 has several improvements over the current G6 model, including a 60% smaller size, a 30-minute warm-up period (compared with 2 hours), an all-in-one sensor and transmitter (as opposed to the two separate devices), a mean absolute relative difference (compared with a standard, an assessment of accuracy) of 8.2% (compared with 12.8%), a 12-hour grace period (in contrast to the G6’s hard shutoff), and a redesigned mobile app.

It is indicated for wear on the back of the upper arm for people aged 2 years and older or the upper buttocks for ages 2-17 years old.

As an “integrated” CGM, the G7 has the capacity to work as part of automated insulin delivery systems, but that will require further FDA action. “Dexcom is working closely with its insulin pump partners to integrate Dexcom G7 into current and future automated insulin delivery systems as quickly as possible,” the company said in a statement.

Like the G6, it requires no fingersticks, scanning, or calibration. It provides real-time glucose readings every 5 minutes to a compatible device, including Apple Watch and other digital health apps, and allows for remote monitoring of data by as many as 10 followers.

Dexcom expects to initiate a U.S. launch of Dexcom G7 in early 2023. To facilitate immediate access to G7 for as many users as possible, the company will have accessible cash pay options in place as the company transitions coverage with availability for G7, the statement says.

The Dexcom G7 was granted a CE Mark (Conformité Européenne) in March 2022, which means it is approved for use in people with diabetes aged 2 years and older, including pregnant women, in Europe.

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

The U.S. Food and Drug Administration has cleared the Dexcom G7 continuous glucose monitoring (CGM) system for people with all types of diabetes aged 2 years and older and for use during pregnancy.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The G7 has several improvements over the current G6 model, including a 60% smaller size, a 30-minute warm-up period (compared with 2 hours), an all-in-one sensor and transmitter (as opposed to the two separate devices), a mean absolute relative difference (compared with a standard, an assessment of accuracy) of 8.2% (compared with 12.8%), a 12-hour grace period (in contrast to the G6’s hard shutoff), and a redesigned mobile app.

It is indicated for wear on the back of the upper arm for people aged 2 years and older or the upper buttocks for ages 2-17 years old.

As an “integrated” CGM, the G7 has the capacity to work as part of automated insulin delivery systems, but that will require further FDA action. “Dexcom is working closely with its insulin pump partners to integrate Dexcom G7 into current and future automated insulin delivery systems as quickly as possible,” the company said in a statement.

Like the G6, it requires no fingersticks, scanning, or calibration. It provides real-time glucose readings every 5 minutes to a compatible device, including Apple Watch and other digital health apps, and allows for remote monitoring of data by as many as 10 followers.

Dexcom expects to initiate a U.S. launch of Dexcom G7 in early 2023. To facilitate immediate access to G7 for as many users as possible, the company will have accessible cash pay options in place as the company transitions coverage with availability for G7, the statement says.

The Dexcom G7 was granted a CE Mark (Conformité Européenne) in March 2022, which means it is approved for use in people with diabetes aged 2 years and older, including pregnant women, in Europe.

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

The U.S. Food and Drug Administration has cleared the Dexcom G7 continuous glucose monitoring (CGM) system for people with all types of diabetes aged 2 years and older and for use during pregnancy.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The G7 has several improvements over the current G6 model, including a 60% smaller size, a 30-minute warm-up period (compared with 2 hours), an all-in-one sensor and transmitter (as opposed to the two separate devices), a mean absolute relative difference (compared with a standard, an assessment of accuracy) of 8.2% (compared with 12.8%), a 12-hour grace period (in contrast to the G6’s hard shutoff), and a redesigned mobile app.

It is indicated for wear on the back of the upper arm for people aged 2 years and older or the upper buttocks for ages 2-17 years old.

As an “integrated” CGM, the G7 has the capacity to work as part of automated insulin delivery systems, but that will require further FDA action. “Dexcom is working closely with its insulin pump partners to integrate Dexcom G7 into current and future automated insulin delivery systems as quickly as possible,” the company said in a statement.

Like the G6, it requires no fingersticks, scanning, or calibration. It provides real-time glucose readings every 5 minutes to a compatible device, including Apple Watch and other digital health apps, and allows for remote monitoring of data by as many as 10 followers.

Dexcom expects to initiate a U.S. launch of Dexcom G7 in early 2023. To facilitate immediate access to G7 for as many users as possible, the company will have accessible cash pay options in place as the company transitions coverage with availability for G7, the statement says.

The Dexcom G7 was granted a CE Mark (Conformité Européenne) in March 2022, which means it is approved for use in people with diabetes aged 2 years and older, including pregnant women, in Europe.

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

NEW ORLEANS – A study aimed at improving outcomes and reducing toxicity of treatment for children and young adults with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma found that, contrary to long-held assumptions, high-dose methotrexate does not reduce the risk for central nervous system relapse.

The same study also addressed two other issues related to standard care for these patients: 1) the dosage of dexamethasone used during the first treatment phase (results of which had already been reported some years ago) and 2) the impact of omitting monthly pulses of dexamethasone and vincristine after initial treatment.

“The trial did not give us the answers we were looking for, but that’s why we do randomized trials, and at least we have one clear answer, which is that high-dose methotrexate does not seem to have benefit in reducing the risk of CNS relapse,” reported study investigator Ajay Vora, MSc, from Great Ormond Street Hospital, London.

Among 1,570 patients randomly assigned in one group of the UKALL2011 trial, 5-year rates of CNS relapse were identical at 5.6% for patients treated with either high-dose methotrexate or standard interim maintenance with oral mercaptopurine and oral and intrathecal methotrexate.

There was a hint, however, that high-dose methotrexate could have a beneficial effect by reducing relapses in bone marrow for some subgroups of patients with B-lineage disease after dexamethasone induction, Dr. Vora commented.

He was speaking at a press briefing at the annual meeting of the American Society of Hematology, prior to the presentation of the data by Amy A. Kirkwood, MSc, from the University College London Cancer Institute.

Reacting to the results, Cynthia E. Dunbar, MD, chief of the Translational Stem Cell Biology Branch at the National Heart, Lung, and Blood Institute in Bethesda, Md., emphasized that “in patients treated with the UKALL regimen, high doses of methotrexate did not reduce the rate of CNS relapse, contrary to our long-standing beliefs.”

“Going forward, patients can be spared the risk of high-dose methotrexate without increasing their risk of recurrence in the central nervous system,” she said.

“As researchers in hematology, we look at it as our duty to question the standard approaches that we use to treat patients, even those that we thought of as tried-and-true,” said briefing moderator Mikkael Sekeres, MD, of the Sylvester Comprehensive Cancer Center at the University of Miami. This is one of the abstracts that “challenge some of those standards and in fact reveal that in many cases, giving less therapy and being less restrictive is actually better for patients or at least no worse.”
 

Complex design

The UKALL2011 trial had a byzantine design, with the overarching goal of finding out which treatment and maintenance strategy best finds the sweet spot between efficacy and toxicity in children and young adults (up to age 25) with ALL and lymphoblastic lymphoma.

One question that was already answered, as investigators reported at the 2017 ASH annual meeting, came from the first randomization in the study, designed to see whether a shorter course of dexamethasone – 14 days versus the standard 28 days – could reduce induction toxicity. It did not.

Now, at ASH 2022, the investigators reported outcomes from the second phase of the trial, which included two randomizations: one comparing high-dose methotrexate with standard interim maintenance to reduce CNS relapse risk, and one to see whether forgoing pulses of vincristine/dexamethasone could reduce maintenance morbidity.

Patients were stratified by National Cancer Institute minimal residual disease (MRD) risk categories, cytogenetics, and end-of-induction MRD to receive one of three treatment regimens. Patients with MRD high risk, defined as MRD greater than 0.5% at the end of consolidation, were not eligible for second-phase randomization and instead received off-protocol therapies.The second randomization was factorial, stratified by NCI and MRD risk groups, resulting in four arms: high-dose methotrexate with or without pulses and standard interim maintenance with our without pulses.

Standard interim maintenance in this trial was 2 months of oral mercaptopurine/methotrexate monthly pulses and single intrathecal methotrexate in two of the regimens, as well as five doses of escalating intravenous methotrexate plus vincristine and two doses of pegylated asparaginase in the third.

High-dose methotrexate was given at a dose of 5 g/m² for four doses 2 weeks apart, low dose 6-mercaptopurine, plus two doses of pegylated asparaginase in one regimen only.
 

Equivocal conclusions

As noted above, CNS relapse, the primary endpoint for the interim maintenance randomization, did not differ between the groups, with identical 5-year relapse rates. Similarly, 5-year event-free survival (EFS) rates were 90.3% in the high-dose group and 89.5% in the standard group, a difference that was not statistically significant (P = .68).

There was, however, an interaction between the first (short- vs. standard-course dexamethasone) and the interim maintenance randomizations, indicating significantly inferior EFS outcomes for patients who had received the short dose of dexamethasone followed by high-dose methotrexate, especially among patients who did not receive pulses (P = .006).

An analysis of patients treated with standard dexamethasone showed that those who received high-dose methotrexate had a lower risk for bone marrow relapse, with a hazard ratio of 0.62 (P = .029), and trends, albeit nonsignificant, toward better EFS and overall survival.

In addition, the overall results suggested that steroid pulses could be safely omitted without leading to an increase in bone marrow relapses: the 5-year rates of bone marrow relapse were 10.2% with pulses and 12.2% without, although omitting pulses was associated with a slight but significant decrease in EFS overall (P = .01). The effect was attenuated among patients who had received standard-course dexamethasone and high-dose methotrexate. Leaving out the pulses also reduced rates of grade 3 or 4 adverse events, including febrile neutropenia, Ms. Kirkwood noted in her presentation.

The investigators plan to analyze quality-of-life outcomes related to dexamethasone-vincristine pulses to see whether doing so could tip the balance in favor of leaving them out of therapy, and they will continue to follow patients to see whether their findings hold.

UKALL2011 was funded by Children with Cancer UK, Blood Cancer UK, and Cancer Research UK. Ms. Kirkwood disclosed consulting for and receiving honoraria from Kite. Dr. Vora reported no relevant financial relationships.

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

NEW ORLEANS – A study aimed at improving outcomes and reducing toxicity of treatment for children and young adults with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma found that, contrary to long-held assumptions, high-dose methotrexate does not reduce the risk for central nervous system relapse.

The same study also addressed two other issues related to standard care for these patients: 1) the dosage of dexamethasone used during the first treatment phase (results of which had already been reported some years ago) and 2) the impact of omitting monthly pulses of dexamethasone and vincristine after initial treatment.

“The trial did not give us the answers we were looking for, but that’s why we do randomized trials, and at least we have one clear answer, which is that high-dose methotrexate does not seem to have benefit in reducing the risk of CNS relapse,” reported study investigator Ajay Vora, MSc, from Great Ormond Street Hospital, London.

Among 1,570 patients randomly assigned in one group of the UKALL2011 trial, 5-year rates of CNS relapse were identical at 5.6% for patients treated with either high-dose methotrexate or standard interim maintenance with oral mercaptopurine and oral and intrathecal methotrexate.

There was a hint, however, that high-dose methotrexate could have a beneficial effect by reducing relapses in bone marrow for some subgroups of patients with B-lineage disease after dexamethasone induction, Dr. Vora commented.

He was speaking at a press briefing at the annual meeting of the American Society of Hematology, prior to the presentation of the data by Amy A. Kirkwood, MSc, from the University College London Cancer Institute.

Reacting to the results, Cynthia E. Dunbar, MD, chief of the Translational Stem Cell Biology Branch at the National Heart, Lung, and Blood Institute in Bethesda, Md., emphasized that “in patients treated with the UKALL regimen, high doses of methotrexate did not reduce the rate of CNS relapse, contrary to our long-standing beliefs.”

“Going forward, patients can be spared the risk of high-dose methotrexate without increasing their risk of recurrence in the central nervous system,” she said.

“As researchers in hematology, we look at it as our duty to question the standard approaches that we use to treat patients, even those that we thought of as tried-and-true,” said briefing moderator Mikkael Sekeres, MD, of the Sylvester Comprehensive Cancer Center at the University of Miami. This is one of the abstracts that “challenge some of those standards and in fact reveal that in many cases, giving less therapy and being less restrictive is actually better for patients or at least no worse.”
 

Complex design

The UKALL2011 trial had a byzantine design, with the overarching goal of finding out which treatment and maintenance strategy best finds the sweet spot between efficacy and toxicity in children and young adults (up to age 25) with ALL and lymphoblastic lymphoma.

One question that was already answered, as investigators reported at the 2017 ASH annual meeting, came from the first randomization in the study, designed to see whether a shorter course of dexamethasone – 14 days versus the standard 28 days – could reduce induction toxicity. It did not.

Now, at ASH 2022, the investigators reported outcomes from the second phase of the trial, which included two randomizations: one comparing high-dose methotrexate with standard interim maintenance to reduce CNS relapse risk, and one to see whether forgoing pulses of vincristine/dexamethasone could reduce maintenance morbidity.

Patients were stratified by National Cancer Institute minimal residual disease (MRD) risk categories, cytogenetics, and end-of-induction MRD to receive one of three treatment regimens. Patients with MRD high risk, defined as MRD greater than 0.5% at the end of consolidation, were not eligible for second-phase randomization and instead received off-protocol therapies.The second randomization was factorial, stratified by NCI and MRD risk groups, resulting in four arms: high-dose methotrexate with or without pulses and standard interim maintenance with our without pulses.

Standard interim maintenance in this trial was 2 months of oral mercaptopurine/methotrexate monthly pulses and single intrathecal methotrexate in two of the regimens, as well as five doses of escalating intravenous methotrexate plus vincristine and two doses of pegylated asparaginase in the third.

High-dose methotrexate was given at a dose of 5 g/m² for four doses 2 weeks apart, low dose 6-mercaptopurine, plus two doses of pegylated asparaginase in one regimen only.
 

Equivocal conclusions

As noted above, CNS relapse, the primary endpoint for the interim maintenance randomization, did not differ between the groups, with identical 5-year relapse rates. Similarly, 5-year event-free survival (EFS) rates were 90.3% in the high-dose group and 89.5% in the standard group, a difference that was not statistically significant (P = .68).

There was, however, an interaction between the first (short- vs. standard-course dexamethasone) and the interim maintenance randomizations, indicating significantly inferior EFS outcomes for patients who had received the short dose of dexamethasone followed by high-dose methotrexate, especially among patients who did not receive pulses (P = .006).

An analysis of patients treated with standard dexamethasone showed that those who received high-dose methotrexate had a lower risk for bone marrow relapse, with a hazard ratio of 0.62 (P = .029), and trends, albeit nonsignificant, toward better EFS and overall survival.

In addition, the overall results suggested that steroid pulses could be safely omitted without leading to an increase in bone marrow relapses: the 5-year rates of bone marrow relapse were 10.2% with pulses and 12.2% without, although omitting pulses was associated with a slight but significant decrease in EFS overall (P = .01). The effect was attenuated among patients who had received standard-course dexamethasone and high-dose methotrexate. Leaving out the pulses also reduced rates of grade 3 or 4 adverse events, including febrile neutropenia, Ms. Kirkwood noted in her presentation.

The investigators plan to analyze quality-of-life outcomes related to dexamethasone-vincristine pulses to see whether doing so could tip the balance in favor of leaving them out of therapy, and they will continue to follow patients to see whether their findings hold.

UKALL2011 was funded by Children with Cancer UK, Blood Cancer UK, and Cancer Research UK. Ms. Kirkwood disclosed consulting for and receiving honoraria from Kite. Dr. Vora reported no relevant financial relationships.

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

NEW ORLEANS – A study aimed at improving outcomes and reducing toxicity of treatment for children and young adults with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma found that, contrary to long-held assumptions, high-dose methotrexate does not reduce the risk for central nervous system relapse.

The same study also addressed two other issues related to standard care for these patients: 1) the dosage of dexamethasone used during the first treatment phase (results of which had already been reported some years ago) and 2) the impact of omitting monthly pulses of dexamethasone and vincristine after initial treatment.

“The trial did not give us the answers we were looking for, but that’s why we do randomized trials, and at least we have one clear answer, which is that high-dose methotrexate does not seem to have benefit in reducing the risk of CNS relapse,” reported study investigator Ajay Vora, MSc, from Great Ormond Street Hospital, London.

Among 1,570 patients randomly assigned in one group of the UKALL2011 trial, 5-year rates of CNS relapse were identical at 5.6% for patients treated with either high-dose methotrexate or standard interim maintenance with oral mercaptopurine and oral and intrathecal methotrexate.

There was a hint, however, that high-dose methotrexate could have a beneficial effect by reducing relapses in bone marrow for some subgroups of patients with B-lineage disease after dexamethasone induction, Dr. Vora commented.

He was speaking at a press briefing at the annual meeting of the American Society of Hematology, prior to the presentation of the data by Amy A. Kirkwood, MSc, from the University College London Cancer Institute.

Reacting to the results, Cynthia E. Dunbar, MD, chief of the Translational Stem Cell Biology Branch at the National Heart, Lung, and Blood Institute in Bethesda, Md., emphasized that “in patients treated with the UKALL regimen, high doses of methotrexate did not reduce the rate of CNS relapse, contrary to our long-standing beliefs.”

“Going forward, patients can be spared the risk of high-dose methotrexate without increasing their risk of recurrence in the central nervous system,” she said.

“As researchers in hematology, we look at it as our duty to question the standard approaches that we use to treat patients, even those that we thought of as tried-and-true,” said briefing moderator Mikkael Sekeres, MD, of the Sylvester Comprehensive Cancer Center at the University of Miami. This is one of the abstracts that “challenge some of those standards and in fact reveal that in many cases, giving less therapy and being less restrictive is actually better for patients or at least no worse.”
 

Complex design

The UKALL2011 trial had a byzantine design, with the overarching goal of finding out which treatment and maintenance strategy best finds the sweet spot between efficacy and toxicity in children and young adults (up to age 25) with ALL and lymphoblastic lymphoma.

One question that was already answered, as investigators reported at the 2017 ASH annual meeting, came from the first randomization in the study, designed to see whether a shorter course of dexamethasone – 14 days versus the standard 28 days – could reduce induction toxicity. It did not.

Now, at ASH 2022, the investigators reported outcomes from the second phase of the trial, which included two randomizations: one comparing high-dose methotrexate with standard interim maintenance to reduce CNS relapse risk, and one to see whether forgoing pulses of vincristine/dexamethasone could reduce maintenance morbidity.

Patients were stratified by National Cancer Institute minimal residual disease (MRD) risk categories, cytogenetics, and end-of-induction MRD to receive one of three treatment regimens. Patients with MRD high risk, defined as MRD greater than 0.5% at the end of consolidation, were not eligible for second-phase randomization and instead received off-protocol therapies.The second randomization was factorial, stratified by NCI and MRD risk groups, resulting in four arms: high-dose methotrexate with or without pulses and standard interim maintenance with our without pulses.

Standard interim maintenance in this trial was 2 months of oral mercaptopurine/methotrexate monthly pulses and single intrathecal methotrexate in two of the regimens, as well as five doses of escalating intravenous methotrexate plus vincristine and two doses of pegylated asparaginase in the third.

High-dose methotrexate was given at a dose of 5 g/m² for four doses 2 weeks apart, low dose 6-mercaptopurine, plus two doses of pegylated asparaginase in one regimen only.
 

Equivocal conclusions

As noted above, CNS relapse, the primary endpoint for the interim maintenance randomization, did not differ between the groups, with identical 5-year relapse rates. Similarly, 5-year event-free survival (EFS) rates were 90.3% in the high-dose group and 89.5% in the standard group, a difference that was not statistically significant (P = .68).

There was, however, an interaction between the first (short- vs. standard-course dexamethasone) and the interim maintenance randomizations, indicating significantly inferior EFS outcomes for patients who had received the short dose of dexamethasone followed by high-dose methotrexate, especially among patients who did not receive pulses (P = .006).

An analysis of patients treated with standard dexamethasone showed that those who received high-dose methotrexate had a lower risk for bone marrow relapse, with a hazard ratio of 0.62 (P = .029), and trends, albeit nonsignificant, toward better EFS and overall survival.

In addition, the overall results suggested that steroid pulses could be safely omitted without leading to an increase in bone marrow relapses: the 5-year rates of bone marrow relapse were 10.2% with pulses and 12.2% without, although omitting pulses was associated with a slight but significant decrease in EFS overall (P = .01). The effect was attenuated among patients who had received standard-course dexamethasone and high-dose methotrexate. Leaving out the pulses also reduced rates of grade 3 or 4 adverse events, including febrile neutropenia, Ms. Kirkwood noted in her presentation.

The investigators plan to analyze quality-of-life outcomes related to dexamethasone-vincristine pulses to see whether doing so could tip the balance in favor of leaving them out of therapy, and they will continue to follow patients to see whether their findings hold.

UKALL2011 was funded by Children with Cancer UK, Blood Cancer UK, and Cancer Research UK. Ms. Kirkwood disclosed consulting for and receiving honoraria from Kite. Dr. Vora reported no relevant financial relationships.

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