MDedge Pediatrics

Since the COVID-19 pandemic started more than 3 years ago, the longer-lasting effects of SARS-CoV-2 infection have continued to reveal themselves. Approximately 28% of Americans report having ever experienced post-COVID conditions, such as brain fog, postexertional malaise, and joint pain, and 11% say they are still experiencing these long-term effects. Now, new research is showing that people who have had COVID are more likely to newly develop an autoimmune disease. Exactly why this is happening is less clear, experts say.

Two preprint studies and one study published in a peer-reviewed journal provide strong evidence that patients who have been infected with SARS-CoV-2 are at elevated risk of developing an autoimmune disease. The studies retrospectively reviewed medical records from three countries and compared the incidence of new-onset autoimmune disease among patients who had polymerase chain reaction–confirmed COVID-19 and those who had never been diagnosed with the virus.

A study analyzing the health records of 3.8 million U.S. patients – more than 888,460 with confirmed COVID-19 – found that the COVID-19 group was two to three times as likely to develop various autoimmune diseases, such as rheumatoid arthritis, systemic lupus erythematosus, and systemic sclerosis. A U.K. preprint study that included more than 458,000 people with confirmed COVID found that those who had previously been infected with SARS-CoV-2 were 22% more likely to develop an autoimmune disease compared with the control group. In this cohort, the diseases most strongly associated with COVID-19 were type 1 diabetes, inflammatory bowel disease, and psoriasis. A preprint study from German researchers found that COVID-19 patients were almost 43% more likely to develop an autoimmune disease, compared with those who had never been infected. COVID-19 was most strongly linked to vasculitis.
 

These large studies are telling us, “Yes, this link is there, so we have to accept it,” Sonia Sharma, PhD, of the Center for Autoimmunity and Inflammation at the La Jolla (Calif.) Institute for Immunology, told this news organization. But this is not the first time that autoimmune diseases have been linked to previous infections.

La Jolla Institute for Immunology

Researchers have known for decades that Epstein-Barr virus infection is linked to several autoimmune diseases, including systemic lupus erythematosus, multiple sclerosis, and rheumatoid arthritis. More recent research suggests the virus may activate certain genes associated with these immune disorders. Hepatitis C virus can induce cryoglobulinemia, and infection with cytomegalovirus has been implicated in several autoimmune diseases. Bacterial infections have also been linked to autoimmunity, such as group A streptococcus and rheumatic fever, as well as salmonella and reactive arthritis, to name only a few.

“In a way, this isn’t necessarily a new concept to physicians, particularly rheumatologists,” said Jeffrey A. Sparks, MD, a rheumatologist at Brigham and Women’s Hospital in Boston. “There’s a fine line between appropriately clearing an infection and the body overreacting and setting off a cascade where the immune system is chronically overactive that can manifest as an autoimmune disease,” he told this news organization.

A dysregulated response to infection

It takes the immune system a week or two to develop antigen-specific antibodies to a new pathogen. But for patients with serious infections – in this instance, COVID-19 – that’s time they don’t have. Therefore, the immune system has an alternative pathway, called extrafollicular activation, that creates fast-acting antibodies, explained Matthew Woodruff, PhD, an instructor of immunology and rheumatology at Emory University, Atlanta.

Emory University School of Medicine

The trade-off is that these antibodies are not as specific and can target the body’s own tissues. This dysregulation of antibody selection is generally short lived and fades when more targeted antibodies are produced and take over, but in some cases, this process can lead to high levels of self-targeting antibodies that can harm the body’s organs and tissues. Research also suggests that for patients who experience long COVID, the same autoantibodies that drive the initial immune response are detectable in the body months after infection, though it is not known whether these lingering immune cells cause these longer-lasting symptoms.

“If you have a virus that causes hyperinflammation plus organ damage, that is a recipe for disaster,” Dr. Sharma said. “It’s a recipe for autoantibodies and autoreactive T cells that down the road can attack the body’s own tissues, especially in people whose immune system is trained in such a way to cause self-reactivity,” she added.

This hyperinflammation can result in rare but serious complications, such as multisystem inflammatory syndrome in children and adults, which can occur 2-6 weeks after SARS-CoV-2 infection. But even in these patients with severe illness, organ-specific complications tend to resolve in 6 months with “no significant sequelae 1 year after diagnosis,” according to the Centers for Disease Control and Prevention. And while long COVID can last for a year or longer, data suggest that symptoms do eventually resolve for most people. What is not clear is why acute autoimmunity triggered by COVID-19 can become a chronic condition in certain patients.
 

Predisposition to autoimmunity

P. J. Utz, MD, PhD, professor of immunology and rheumatology at Stanford (Calif.) University, said that people who develop autoimmune disease after SARS-CoV-2 infection may have already been predisposed toward autoimmunity. Especially for autoimmune diseases such as type 1 diabetes and lupus, autoantibodies can appear and circulate in the body for more than a decade in some people before they present with any clinical symptoms. “Their immune system is primed such that if they get infected with something – or they have some other environmental trigger that maybe we don’t know about yet – that is enough to then push them over the edge so that they get full-blown autoimmunity,” he said. What is not known is whether these patients’ conditions would have advanced to true clinical disease had they not been infected, he said.

Steve Fisch

He also noted that the presence of autoantibodies does not necessarily mean someone has autoimmune disease; healthy people can also have autoantibodies, and everyone develops them with age. “My advice would be, ‘Don’t lose sleep over this,’ “ he said.

Dr. Sparks agreed that while these retrospective studies did show an elevated risk of autoimmune disease after COVID-19, that risk appears to be relatively small. “As a practicing rheumatologist, we aren’t seeing a stampede of patients with new-onset rheumatic diseases,” he said. “It’s not like we’re overwhelmed with autoimmune patients, even though almost everyone’s had COVID. So, if there is a risk, it’s very modest.”

Dr. Sparks is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the R. Bruce and Joan M. Mickey Research Scholar Fund, and the Llura Gund Award for Rheumatoid Arthritis Research and Care. Dr. Utz receives research funding from Pfizer. Dr. Sharma and Dr. Woodruff have disclosed no relevant financial relationships.
 

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

Since the COVID-19 pandemic started more than 3 years ago, the longer-lasting effects of SARS-CoV-2 infection have continued to reveal themselves. Approximately 28% of Americans report having ever experienced post-COVID conditions, such as brain fog, postexertional malaise, and joint pain, and 11% say they are still experiencing these long-term effects. Now, new research is showing that people who have had COVID are more likely to newly develop an autoimmune disease. Exactly why this is happening is less clear, experts say.

Two preprint studies and one study published in a peer-reviewed journal provide strong evidence that patients who have been infected with SARS-CoV-2 are at elevated risk of developing an autoimmune disease. The studies retrospectively reviewed medical records from three countries and compared the incidence of new-onset autoimmune disease among patients who had polymerase chain reaction–confirmed COVID-19 and those who had never been diagnosed with the virus.

A study analyzing the health records of 3.8 million U.S. patients – more than 888,460 with confirmed COVID-19 – found that the COVID-19 group was two to three times as likely to develop various autoimmune diseases, such as rheumatoid arthritis, systemic lupus erythematosus, and systemic sclerosis. A U.K. preprint study that included more than 458,000 people with confirmed COVID found that those who had previously been infected with SARS-CoV-2 were 22% more likely to develop an autoimmune disease compared with the control group. In this cohort, the diseases most strongly associated with COVID-19 were type 1 diabetes, inflammatory bowel disease, and psoriasis. A preprint study from German researchers found that COVID-19 patients were almost 43% more likely to develop an autoimmune disease, compared with those who had never been infected. COVID-19 was most strongly linked to vasculitis.
 

These large studies are telling us, “Yes, this link is there, so we have to accept it,” Sonia Sharma, PhD, of the Center for Autoimmunity and Inflammation at the La Jolla (Calif.) Institute for Immunology, told this news organization. But this is not the first time that autoimmune diseases have been linked to previous infections.

La Jolla Institute for Immunology

Researchers have known for decades that Epstein-Barr virus infection is linked to several autoimmune diseases, including systemic lupus erythematosus, multiple sclerosis, and rheumatoid arthritis. More recent research suggests the virus may activate certain genes associated with these immune disorders. Hepatitis C virus can induce cryoglobulinemia, and infection with cytomegalovirus has been implicated in several autoimmune diseases. Bacterial infections have also been linked to autoimmunity, such as group A streptococcus and rheumatic fever, as well as salmonella and reactive arthritis, to name only a few.

“In a way, this isn’t necessarily a new concept to physicians, particularly rheumatologists,” said Jeffrey A. Sparks, MD, a rheumatologist at Brigham and Women’s Hospital in Boston. “There’s a fine line between appropriately clearing an infection and the body overreacting and setting off a cascade where the immune system is chronically overactive that can manifest as an autoimmune disease,” he told this news organization.

A dysregulated response to infection

It takes the immune system a week or two to develop antigen-specific antibodies to a new pathogen. But for patients with serious infections – in this instance, COVID-19 – that’s time they don’t have. Therefore, the immune system has an alternative pathway, called extrafollicular activation, that creates fast-acting antibodies, explained Matthew Woodruff, PhD, an instructor of immunology and rheumatology at Emory University, Atlanta.

Emory University School of Medicine

The trade-off is that these antibodies are not as specific and can target the body’s own tissues. This dysregulation of antibody selection is generally short lived and fades when more targeted antibodies are produced and take over, but in some cases, this process can lead to high levels of self-targeting antibodies that can harm the body’s organs and tissues. Research also suggests that for patients who experience long COVID, the same autoantibodies that drive the initial immune response are detectable in the body months after infection, though it is not known whether these lingering immune cells cause these longer-lasting symptoms.

“If you have a virus that causes hyperinflammation plus organ damage, that is a recipe for disaster,” Dr. Sharma said. “It’s a recipe for autoantibodies and autoreactive T cells that down the road can attack the body’s own tissues, especially in people whose immune system is trained in such a way to cause self-reactivity,” she added.

This hyperinflammation can result in rare but serious complications, such as multisystem inflammatory syndrome in children and adults, which can occur 2-6 weeks after SARS-CoV-2 infection. But even in these patients with severe illness, organ-specific complications tend to resolve in 6 months with “no significant sequelae 1 year after diagnosis,” according to the Centers for Disease Control and Prevention. And while long COVID can last for a year or longer, data suggest that symptoms do eventually resolve for most people. What is not clear is why acute autoimmunity triggered by COVID-19 can become a chronic condition in certain patients.
 

Predisposition to autoimmunity

P. J. Utz, MD, PhD, professor of immunology and rheumatology at Stanford (Calif.) University, said that people who develop autoimmune disease after SARS-CoV-2 infection may have already been predisposed toward autoimmunity. Especially for autoimmune diseases such as type 1 diabetes and lupus, autoantibodies can appear and circulate in the body for more than a decade in some people before they present with any clinical symptoms. “Their immune system is primed such that if they get infected with something – or they have some other environmental trigger that maybe we don’t know about yet – that is enough to then push them over the edge so that they get full-blown autoimmunity,” he said. What is not known is whether these patients’ conditions would have advanced to true clinical disease had they not been infected, he said.

Steve Fisch

He also noted that the presence of autoantibodies does not necessarily mean someone has autoimmune disease; healthy people can also have autoantibodies, and everyone develops them with age. “My advice would be, ‘Don’t lose sleep over this,’ “ he said.

Dr. Sparks agreed that while these retrospective studies did show an elevated risk of autoimmune disease after COVID-19, that risk appears to be relatively small. “As a practicing rheumatologist, we aren’t seeing a stampede of patients with new-onset rheumatic diseases,” he said. “It’s not like we’re overwhelmed with autoimmune patients, even though almost everyone’s had COVID. So, if there is a risk, it’s very modest.”

Dr. Sparks is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the R. Bruce and Joan M. Mickey Research Scholar Fund, and the Llura Gund Award for Rheumatoid Arthritis Research and Care. Dr. Utz receives research funding from Pfizer. Dr. Sharma and Dr. Woodruff have disclosed no relevant financial relationships.
 

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

Since the COVID-19 pandemic started more than 3 years ago, the longer-lasting effects of SARS-CoV-2 infection have continued to reveal themselves. Approximately 28% of Americans report having ever experienced post-COVID conditions, such as brain fog, postexertional malaise, and joint pain, and 11% say they are still experiencing these long-term effects. Now, new research is showing that people who have had COVID are more likely to newly develop an autoimmune disease. Exactly why this is happening is less clear, experts say.

Two preprint studies and one study published in a peer-reviewed journal provide strong evidence that patients who have been infected with SARS-CoV-2 are at elevated risk of developing an autoimmune disease. The studies retrospectively reviewed medical records from three countries and compared the incidence of new-onset autoimmune disease among patients who had polymerase chain reaction–confirmed COVID-19 and those who had never been diagnosed with the virus.

A study analyzing the health records of 3.8 million U.S. patients – more than 888,460 with confirmed COVID-19 – found that the COVID-19 group was two to three times as likely to develop various autoimmune diseases, such as rheumatoid arthritis, systemic lupus erythematosus, and systemic sclerosis. A U.K. preprint study that included more than 458,000 people with confirmed COVID found that those who had previously been infected with SARS-CoV-2 were 22% more likely to develop an autoimmune disease compared with the control group. In this cohort, the diseases most strongly associated with COVID-19 were type 1 diabetes, inflammatory bowel disease, and psoriasis. A preprint study from German researchers found that COVID-19 patients were almost 43% more likely to develop an autoimmune disease, compared with those who had never been infected. COVID-19 was most strongly linked to vasculitis.
 

These large studies are telling us, “Yes, this link is there, so we have to accept it,” Sonia Sharma, PhD, of the Center for Autoimmunity and Inflammation at the La Jolla (Calif.) Institute for Immunology, told this news organization. But this is not the first time that autoimmune diseases have been linked to previous infections.

La Jolla Institute for Immunology

Researchers have known for decades that Epstein-Barr virus infection is linked to several autoimmune diseases, including systemic lupus erythematosus, multiple sclerosis, and rheumatoid arthritis. More recent research suggests the virus may activate certain genes associated with these immune disorders. Hepatitis C virus can induce cryoglobulinemia, and infection with cytomegalovirus has been implicated in several autoimmune diseases. Bacterial infections have also been linked to autoimmunity, such as group A streptococcus and rheumatic fever, as well as salmonella and reactive arthritis, to name only a few.

“In a way, this isn’t necessarily a new concept to physicians, particularly rheumatologists,” said Jeffrey A. Sparks, MD, a rheumatologist at Brigham and Women’s Hospital in Boston. “There’s a fine line between appropriately clearing an infection and the body overreacting and setting off a cascade where the immune system is chronically overactive that can manifest as an autoimmune disease,” he told this news organization.

A dysregulated response to infection

It takes the immune system a week or two to develop antigen-specific antibodies to a new pathogen. But for patients with serious infections – in this instance, COVID-19 – that’s time they don’t have. Therefore, the immune system has an alternative pathway, called extrafollicular activation, that creates fast-acting antibodies, explained Matthew Woodruff, PhD, an instructor of immunology and rheumatology at Emory University, Atlanta.

Emory University School of Medicine

The trade-off is that these antibodies are not as specific and can target the body’s own tissues. This dysregulation of antibody selection is generally short lived and fades when more targeted antibodies are produced and take over, but in some cases, this process can lead to high levels of self-targeting antibodies that can harm the body’s organs and tissues. Research also suggests that for patients who experience long COVID, the same autoantibodies that drive the initial immune response are detectable in the body months after infection, though it is not known whether these lingering immune cells cause these longer-lasting symptoms.

“If you have a virus that causes hyperinflammation plus organ damage, that is a recipe for disaster,” Dr. Sharma said. “It’s a recipe for autoantibodies and autoreactive T cells that down the road can attack the body’s own tissues, especially in people whose immune system is trained in such a way to cause self-reactivity,” she added.

This hyperinflammation can result in rare but serious complications, such as multisystem inflammatory syndrome in children and adults, which can occur 2-6 weeks after SARS-CoV-2 infection. But even in these patients with severe illness, organ-specific complications tend to resolve in 6 months with “no significant sequelae 1 year after diagnosis,” according to the Centers for Disease Control and Prevention. And while long COVID can last for a year or longer, data suggest that symptoms do eventually resolve for most people. What is not clear is why acute autoimmunity triggered by COVID-19 can become a chronic condition in certain patients.
 

Predisposition to autoimmunity

P. J. Utz, MD, PhD, professor of immunology and rheumatology at Stanford (Calif.) University, said that people who develop autoimmune disease after SARS-CoV-2 infection may have already been predisposed toward autoimmunity. Especially for autoimmune diseases such as type 1 diabetes and lupus, autoantibodies can appear and circulate in the body for more than a decade in some people before they present with any clinical symptoms. “Their immune system is primed such that if they get infected with something – or they have some other environmental trigger that maybe we don’t know about yet – that is enough to then push them over the edge so that they get full-blown autoimmunity,” he said. What is not known is whether these patients’ conditions would have advanced to true clinical disease had they not been infected, he said.

Steve Fisch

He also noted that the presence of autoantibodies does not necessarily mean someone has autoimmune disease; healthy people can also have autoantibodies, and everyone develops them with age. “My advice would be, ‘Don’t lose sleep over this,’ “ he said.

Dr. Sparks agreed that while these retrospective studies did show an elevated risk of autoimmune disease after COVID-19, that risk appears to be relatively small. “As a practicing rheumatologist, we aren’t seeing a stampede of patients with new-onset rheumatic diseases,” he said. “It’s not like we’re overwhelmed with autoimmune patients, even though almost everyone’s had COVID. So, if there is a risk, it’s very modest.”

Dr. Sparks is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the R. Bruce and Joan M. Mickey Research Scholar Fund, and the Llura Gund Award for Rheumatoid Arthritis Research and Care. Dr. Utz receives research funding from Pfizer. Dr. Sharma and Dr. Woodruff have disclosed no relevant financial relationships.
 

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

WASHINGTON – A novel program for parents of highly dependent adult children reduces parental burden and anxiety in their offspring, a new pilot study shows.

Known as failure to launch (FTL) syndrome, the criteria for this condition include the absence of a neurodevelopmental, mental, or intellectual condition, difficulty adapting to the challenges of adulthood, and living with or at the expense of parents.

Results suggest that the program benefits families dealing with FTL, said study investigator Uri Berger, PhD, postdoctoral associate, Yale Child Study Center Anxiety and Mood Disorders Program, New Haven, Conn.

“If you encounter parents who are say 50-60 years old who have a child with FTL, you can tell them there’s something they can do; there’s work they can do even if their child is refusing to go to therapy,” he said.

The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
 

Anxious, isolated

Estimates suggest that there are 3.3 million physically able adults with FTL and that the disorder may be on the rise. These individuals often present with mental health symptoms including anxiety, depression, and suicidality, and tend to be socially isolated.

The investigators noted that intervening is often challenging because individuals with the syndrome are frequently noncompliant with therapy, and currently there is no standard of care.

“The longer you’re isolated, the harder it is getting out of your cocoon, and when these adult children get to the point where they seek help, they’re less likely to comply,” he said. However, he noted, this is not because they are lazy; it’s that they’re “very, very anxious.”

Parents and other family members are also negatively affected. Dr. Berger noted that 15% of parents of a child with FTL equate their caregiver burden with having a family member with a chronic physical illness. “It’s huge; parents go through hell and it’s very hard on them. Many believe it is their fault and they feel a lot of shame.”

Supportive Parenting for Anxious Childhood Emotions (SPACE) is a manualized, parent-based program for childhood anxiety and obsessive-compulsive disorder. It has been tested in clinical trials and found to be noninferior to cognitive behavioral therapy for childhood anxiety.

The research adapted it to treat FTL. SPACE-FTL focuses on reducing parents’ family accommodation (FA), a descriptor for a child’s excessive dependence on their parents to help them avoid anxiety-provoking situations.

The study examined the feasibility, acceptability, and treatment satisfaction and its effect on adult child psychopathology symptoms, parents’ FA, and the paternal burden of caring for adult children.

The study included parents (mean age, 59.46 years; 85% female) of 40 adult children with FTL (mean age, 23.51 years; 20% female) from across the United States.

Parents were randomized to a 13-week wait-list or the SPACE-FTL program, which involves 13-20 therapy sessions, depending on the need. The average number of sessions in the study was 15. The program has five key components:

• Providing information emphasizing FTL as not a character flaw but a problem with anxiety.
• Helping parents identify how they accommodate their child’s behavior, and facilitating an environment that encourages independence.
• Getting parents to show acceptance and confidence in their child who’s trying to overcome anxiety when, for example, they seek employment, instead of being overprotective and demanding.
• Focusing on change nonconfrontationally.
• Involving other family, community members, and professionals who can support the parent, child, or both.

The recruitment, treatment sessions, and assessments were all done online. Most participants rated the intervention as highly satisfactory on the Client Satisfaction Questionnaire (CSQ-8; mean score, 27.7 out of a maximum of 32). About 60% of the offspring no longer met full criteria for FTL (P < .001; Cohen’s D = 1.76).

All children of the wait-listed parents still met criteria for FTL.

FTL symptoms decreased significantly in the offspring of the intervention group, as seen in both in the Adult Entitled Dependence Scale (AED; P < .05; Cohen’s D = 0.84); and the Adaptive Behaviors Scale (ABS; P < .05; Cohen’s D = 0.70).

There was no change in anxiety as assessed by the Adult Behavior Checklist (ABCL). But Dr. Berger noted that child anxiety is difficult to assess through parental report.

“This population is self-isolating and parents sometimes don’t know what’s going on,” and ABCL measures may not be “as sensitive as we would have liked them to be,” Dr. Berger said.

Parental burden was significantly decreased as measured by the Zarit Burden Interview (ZBI; P < .05; Cohen’s D = 0.70). In addition, family accommodation decreased significantly as determined by the Family Accommodation Scale–Anxiety (FASA; P < .05; Cohen’s D = 0.70).
 

Innovative work

In a comment, Jonathan E. Alpert, MD, PhD, chair, department of psychiatry and behavioral sciences, and professor of psychiatry, neuroscience, and pediatrics, Albert Einstein College of Medicine, New York, described the program as “innovative.”

He noted that the SPACE-FTL approach provides parents with education and skills to reduce behaviors that reinforce their child’s avoidance of independent activities. Such behaviors “may inadvertently contribute to the adult child remaining stuck,” he said.

“Through its involvement of parents and use of a structured approach, SPACE-FTL is a very interesting step toward more evidence-based therapies.”

However, he noted that the number of study participants is still “very low” and further work is needed to better characterize this condition and develop effective therapies.

He noted that parents of adult children with FTL should not be judged or blamed. “They have been living with a worrisome problem for years and are simply doing their best to cope as any of us would do.”

In addition, he noted that some adult children aren’t capable of launching because of a serious mental illness or substance use disorder that needs treatment.

It’s unclear just how many adult children have FTL, as the condition lacks formal, agreed-upon clinical and research criteria and a reliable evidence base for treatment, Dr. Alpert said.

“Whatever the actual numbers of FTL, my anecdotal clinical experience suggests that it is a very common problem which is understudied.”

He added that the definitions of FTL should include cultural context. In some groups, it’s quite normal for adults in their 20s, 30s, or even older to live with their parents, Dr. Alpert said.

Dr. Berger and Dr. Albert report no relevant financial relationships.

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

WASHINGTON – A novel program for parents of highly dependent adult children reduces parental burden and anxiety in their offspring, a new pilot study shows.

Known as failure to launch (FTL) syndrome, the criteria for this condition include the absence of a neurodevelopmental, mental, or intellectual condition, difficulty adapting to the challenges of adulthood, and living with or at the expense of parents.

Results suggest that the program benefits families dealing with FTL, said study investigator Uri Berger, PhD, postdoctoral associate, Yale Child Study Center Anxiety and Mood Disorders Program, New Haven, Conn.

“If you encounter parents who are say 50-60 years old who have a child with FTL, you can tell them there’s something they can do; there’s work they can do even if their child is refusing to go to therapy,” he said.

The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
 

Anxious, isolated

Estimates suggest that there are 3.3 million physically able adults with FTL and that the disorder may be on the rise. These individuals often present with mental health symptoms including anxiety, depression, and suicidality, and tend to be socially isolated.

The investigators noted that intervening is often challenging because individuals with the syndrome are frequently noncompliant with therapy, and currently there is no standard of care.

“The longer you’re isolated, the harder it is getting out of your cocoon, and when these adult children get to the point where they seek help, they’re less likely to comply,” he said. However, he noted, this is not because they are lazy; it’s that they’re “very, very anxious.”

Parents and other family members are also negatively affected. Dr. Berger noted that 15% of parents of a child with FTL equate their caregiver burden with having a family member with a chronic physical illness. “It’s huge; parents go through hell and it’s very hard on them. Many believe it is their fault and they feel a lot of shame.”

Supportive Parenting for Anxious Childhood Emotions (SPACE) is a manualized, parent-based program for childhood anxiety and obsessive-compulsive disorder. It has been tested in clinical trials and found to be noninferior to cognitive behavioral therapy for childhood anxiety.

The research adapted it to treat FTL. SPACE-FTL focuses on reducing parents’ family accommodation (FA), a descriptor for a child’s excessive dependence on their parents to help them avoid anxiety-provoking situations.

The study examined the feasibility, acceptability, and treatment satisfaction and its effect on adult child psychopathology symptoms, parents’ FA, and the paternal burden of caring for adult children.

The study included parents (mean age, 59.46 years; 85% female) of 40 adult children with FTL (mean age, 23.51 years; 20% female) from across the United States.

Parents were randomized to a 13-week wait-list or the SPACE-FTL program, which involves 13-20 therapy sessions, depending on the need. The average number of sessions in the study was 15. The program has five key components:

• Providing information emphasizing FTL as not a character flaw but a problem with anxiety.
• Helping parents identify how they accommodate their child’s behavior, and facilitating an environment that encourages independence.
• Getting parents to show acceptance and confidence in their child who’s trying to overcome anxiety when, for example, they seek employment, instead of being overprotective and demanding.
• Focusing on change nonconfrontationally.
• Involving other family, community members, and professionals who can support the parent, child, or both.

The recruitment, treatment sessions, and assessments were all done online. Most participants rated the intervention as highly satisfactory on the Client Satisfaction Questionnaire (CSQ-8; mean score, 27.7 out of a maximum of 32). About 60% of the offspring no longer met full criteria for FTL (P < .001; Cohen’s D = 1.76).

All children of the wait-listed parents still met criteria for FTL.

FTL symptoms decreased significantly in the offspring of the intervention group, as seen in both in the Adult Entitled Dependence Scale (AED; P < .05; Cohen’s D = 0.84); and the Adaptive Behaviors Scale (ABS; P < .05; Cohen’s D = 0.70).

There was no change in anxiety as assessed by the Adult Behavior Checklist (ABCL). But Dr. Berger noted that child anxiety is difficult to assess through parental report.

“This population is self-isolating and parents sometimes don’t know what’s going on,” and ABCL measures may not be “as sensitive as we would have liked them to be,” Dr. Berger said.

Parental burden was significantly decreased as measured by the Zarit Burden Interview (ZBI; P < .05; Cohen’s D = 0.70). In addition, family accommodation decreased significantly as determined by the Family Accommodation Scale–Anxiety (FASA; P < .05; Cohen’s D = 0.70).
 

Innovative work

In a comment, Jonathan E. Alpert, MD, PhD, chair, department of psychiatry and behavioral sciences, and professor of psychiatry, neuroscience, and pediatrics, Albert Einstein College of Medicine, New York, described the program as “innovative.”

He noted that the SPACE-FTL approach provides parents with education and skills to reduce behaviors that reinforce their child’s avoidance of independent activities. Such behaviors “may inadvertently contribute to the adult child remaining stuck,” he said.

“Through its involvement of parents and use of a structured approach, SPACE-FTL is a very interesting step toward more evidence-based therapies.”

However, he noted that the number of study participants is still “very low” and further work is needed to better characterize this condition and develop effective therapies.

He noted that parents of adult children with FTL should not be judged or blamed. “They have been living with a worrisome problem for years and are simply doing their best to cope as any of us would do.”

In addition, he noted that some adult children aren’t capable of launching because of a serious mental illness or substance use disorder that needs treatment.

It’s unclear just how many adult children have FTL, as the condition lacks formal, agreed-upon clinical and research criteria and a reliable evidence base for treatment, Dr. Alpert said.

“Whatever the actual numbers of FTL, my anecdotal clinical experience suggests that it is a very common problem which is understudied.”

He added that the definitions of FTL should include cultural context. In some groups, it’s quite normal for adults in their 20s, 30s, or even older to live with their parents, Dr. Alpert said.

Dr. Berger and Dr. Albert report no relevant financial relationships.

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

WASHINGTON – A novel program for parents of highly dependent adult children reduces parental burden and anxiety in their offspring, a new pilot study shows.

Known as failure to launch (FTL) syndrome, the criteria for this condition include the absence of a neurodevelopmental, mental, or intellectual condition, difficulty adapting to the challenges of adulthood, and living with or at the expense of parents.

Results suggest that the program benefits families dealing with FTL, said study investigator Uri Berger, PhD, postdoctoral associate, Yale Child Study Center Anxiety and Mood Disorders Program, New Haven, Conn.

“If you encounter parents who are say 50-60 years old who have a child with FTL, you can tell them there’s something they can do; there’s work they can do even if their child is refusing to go to therapy,” he said.

The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
 

Anxious, isolated

Estimates suggest that there are 3.3 million physically able adults with FTL and that the disorder may be on the rise. These individuals often present with mental health symptoms including anxiety, depression, and suicidality, and tend to be socially isolated.

The investigators noted that intervening is often challenging because individuals with the syndrome are frequently noncompliant with therapy, and currently there is no standard of care.

“The longer you’re isolated, the harder it is getting out of your cocoon, and when these adult children get to the point where they seek help, they’re less likely to comply,” he said. However, he noted, this is not because they are lazy; it’s that they’re “very, very anxious.”

Parents and other family members are also negatively affected. Dr. Berger noted that 15% of parents of a child with FTL equate their caregiver burden with having a family member with a chronic physical illness. “It’s huge; parents go through hell and it’s very hard on them. Many believe it is their fault and they feel a lot of shame.”

Supportive Parenting for Anxious Childhood Emotions (SPACE) is a manualized, parent-based program for childhood anxiety and obsessive-compulsive disorder. It has been tested in clinical trials and found to be noninferior to cognitive behavioral therapy for childhood anxiety.

The research adapted it to treat FTL. SPACE-FTL focuses on reducing parents’ family accommodation (FA), a descriptor for a child’s excessive dependence on their parents to help them avoid anxiety-provoking situations.

The study examined the feasibility, acceptability, and treatment satisfaction and its effect on adult child psychopathology symptoms, parents’ FA, and the paternal burden of caring for adult children.

The study included parents (mean age, 59.46 years; 85% female) of 40 adult children with FTL (mean age, 23.51 years; 20% female) from across the United States.

Parents were randomized to a 13-week wait-list or the SPACE-FTL program, which involves 13-20 therapy sessions, depending on the need. The average number of sessions in the study was 15. The program has five key components:

• Providing information emphasizing FTL as not a character flaw but a problem with anxiety.
• Helping parents identify how they accommodate their child’s behavior, and facilitating an environment that encourages independence.
• Getting parents to show acceptance and confidence in their child who’s trying to overcome anxiety when, for example, they seek employment, instead of being overprotective and demanding.
• Focusing on change nonconfrontationally.
• Involving other family, community members, and professionals who can support the parent, child, or both.

The recruitment, treatment sessions, and assessments were all done online. Most participants rated the intervention as highly satisfactory on the Client Satisfaction Questionnaire (CSQ-8; mean score, 27.7 out of a maximum of 32). About 60% of the offspring no longer met full criteria for FTL (P < .001; Cohen’s D = 1.76).

All children of the wait-listed parents still met criteria for FTL.

FTL symptoms decreased significantly in the offspring of the intervention group, as seen in both in the Adult Entitled Dependence Scale (AED; P < .05; Cohen’s D = 0.84); and the Adaptive Behaviors Scale (ABS; P < .05; Cohen’s D = 0.70).

There was no change in anxiety as assessed by the Adult Behavior Checklist (ABCL). But Dr. Berger noted that child anxiety is difficult to assess through parental report.

“This population is self-isolating and parents sometimes don’t know what’s going on,” and ABCL measures may not be “as sensitive as we would have liked them to be,” Dr. Berger said.

Parental burden was significantly decreased as measured by the Zarit Burden Interview (ZBI; P < .05; Cohen’s D = 0.70). In addition, family accommodation decreased significantly as determined by the Family Accommodation Scale–Anxiety (FASA; P < .05; Cohen’s D = 0.70).
 

Innovative work

In a comment, Jonathan E. Alpert, MD, PhD, chair, department of psychiatry and behavioral sciences, and professor of psychiatry, neuroscience, and pediatrics, Albert Einstein College of Medicine, New York, described the program as “innovative.”

He noted that the SPACE-FTL approach provides parents with education and skills to reduce behaviors that reinforce their child’s avoidance of independent activities. Such behaviors “may inadvertently contribute to the adult child remaining stuck,” he said.

“Through its involvement of parents and use of a structured approach, SPACE-FTL is a very interesting step toward more evidence-based therapies.”

However, he noted that the number of study participants is still “very low” and further work is needed to better characterize this condition and develop effective therapies.

He noted that parents of adult children with FTL should not be judged or blamed. “They have been living with a worrisome problem for years and are simply doing their best to cope as any of us would do.”

In addition, he noted that some adult children aren’t capable of launching because of a serious mental illness or substance use disorder that needs treatment.

It’s unclear just how many adult children have FTL, as the condition lacks formal, agreed-upon clinical and research criteria and a reliable evidence base for treatment, Dr. Alpert said.

“Whatever the actual numbers of FTL, my anecdotal clinical experience suggests that it is a very common problem which is understudied.”

He added that the definitions of FTL should include cultural context. In some groups, it’s quite normal for adults in their 20s, 30s, or even older to live with their parents, Dr. Alpert said.

Dr. Berger and Dr. Albert report no relevant financial relationships.

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

WASHINGTON, D.C. – Remote monitoring of infant weight reduced the number of office visits among newborns, according to a new study presented at the Pediatric Academic Societies annual meeting.

The pilot trial compared the frequency of office visits for healthy babies born at 37 weeks’ gestation or later. One group of 20 infants had their weight monitored at home by parents, and another group of 20 infants received usual care, which included two in-person office visits over the first 6 weeks of life.

Researchers found that visits for infants in the intervention group decreased by 25% after the first week of life and by 23% after the second week.

The remote method can help alert physicians earlier to insufficient weight because parents report gains or losses three times a week over the 6 weeks, resulting in more data for providers. 

“You’re going to see fewer visits with people who have scales because the docs are getting the information they need, which is: ‘Is this baby doing okay or not?’ ” said Diane DiTomasso, PhD, RN, a professor at the University of Rhode Island, South Kingstown, who was not involved with the study. “I think it’s a very necessary study because, to my knowledge, nobody has done a randomized controlled trial on this topic.”

Keeping infants at home can also protect babies from infections they might catch in the clinic.

“There are a lot of other kids in an office setting, and kids like touching things,” said Anirudha Das, MD, MPH, a neonatologist at Cleveland Clinic Children’s and the lead author of the study. “When there are a lot of other kids, there are a lot of viruses. It’s a very dangerous environment.”

Parents in the intervention group were given scales and asked to enter their infant’s weight into a patient portal app three times per week for 6 weeks. Physicians then determined if in-office visits were necessary. 

The benefits of home weight checks can include helping to allow for breastfeeding for a longer duration. 

Weight is more closely monitored for breastfed infants. Waiting weeks for office checks can heighten parental anxiety and lead to prematurely stopping breastfeeding. With regular at-home checks, parents receive up-to-date information from physicians that can alleviate concerns and empower them with more control over the process, according to Dr. DiTomasso.

Breastfeeding is associated with a lower risk for cardiovascular disease, diabetes, obesity, cancer in later life, and a lower risk of breast cancer for breastfeeding parents.

Office weight checks can also alleviate a significant and unnecessary burden for parents, Dr. Das said.

“You shouldn’t have to put your baby in a car, possibly in freezing temperatures, hire someone to take care of your other kids, drive to the hospital, pay for parking, and walk to the office for a weight check,” Dr. Das said.

Dr. Das noted that, because of technical errors, parents weren’t able to use remote monitoring and had in-person visits during the first 5 days of life. The intervention group had more visits during that period than the usual-care group. 

The study was funded by the American Academy of Pediatrics. The authors and Dr. Das reported no relevant financial relationships.

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

WASHINGTON, D.C. – Remote monitoring of infant weight reduced the number of office visits among newborns, according to a new study presented at the Pediatric Academic Societies annual meeting.

The pilot trial compared the frequency of office visits for healthy babies born at 37 weeks’ gestation or later. One group of 20 infants had their weight monitored at home by parents, and another group of 20 infants received usual care, which included two in-person office visits over the first 6 weeks of life.

Researchers found that visits for infants in the intervention group decreased by 25% after the first week of life and by 23% after the second week.

The remote method can help alert physicians earlier to insufficient weight because parents report gains or losses three times a week over the 6 weeks, resulting in more data for providers. 

“You’re going to see fewer visits with people who have scales because the docs are getting the information they need, which is: ‘Is this baby doing okay or not?’ ” said Diane DiTomasso, PhD, RN, a professor at the University of Rhode Island, South Kingstown, who was not involved with the study. “I think it’s a very necessary study because, to my knowledge, nobody has done a randomized controlled trial on this topic.”

Keeping infants at home can also protect babies from infections they might catch in the clinic.

“There are a lot of other kids in an office setting, and kids like touching things,” said Anirudha Das, MD, MPH, a neonatologist at Cleveland Clinic Children’s and the lead author of the study. “When there are a lot of other kids, there are a lot of viruses. It’s a very dangerous environment.”

Parents in the intervention group were given scales and asked to enter their infant’s weight into a patient portal app three times per week for 6 weeks. Physicians then determined if in-office visits were necessary. 

The benefits of home weight checks can include helping to allow for breastfeeding for a longer duration. 

Weight is more closely monitored for breastfed infants. Waiting weeks for office checks can heighten parental anxiety and lead to prematurely stopping breastfeeding. With regular at-home checks, parents receive up-to-date information from physicians that can alleviate concerns and empower them with more control over the process, according to Dr. DiTomasso.

Breastfeeding is associated with a lower risk for cardiovascular disease, diabetes, obesity, cancer in later life, and a lower risk of breast cancer for breastfeeding parents.

Office weight checks can also alleviate a significant and unnecessary burden for parents, Dr. Das said.

“You shouldn’t have to put your baby in a car, possibly in freezing temperatures, hire someone to take care of your other kids, drive to the hospital, pay for parking, and walk to the office for a weight check,” Dr. Das said.

Dr. Das noted that, because of technical errors, parents weren’t able to use remote monitoring and had in-person visits during the first 5 days of life. The intervention group had more visits during that period than the usual-care group. 

The study was funded by the American Academy of Pediatrics. The authors and Dr. Das reported no relevant financial relationships.

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

WASHINGTON, D.C. – Remote monitoring of infant weight reduced the number of office visits among newborns, according to a new study presented at the Pediatric Academic Societies annual meeting.

The pilot trial compared the frequency of office visits for healthy babies born at 37 weeks’ gestation or later. One group of 20 infants had their weight monitored at home by parents, and another group of 20 infants received usual care, which included two in-person office visits over the first 6 weeks of life.

Researchers found that visits for infants in the intervention group decreased by 25% after the first week of life and by 23% after the second week.

The remote method can help alert physicians earlier to insufficient weight because parents report gains or losses three times a week over the 6 weeks, resulting in more data for providers. 

“You’re going to see fewer visits with people who have scales because the docs are getting the information they need, which is: ‘Is this baby doing okay or not?’ ” said Diane DiTomasso, PhD, RN, a professor at the University of Rhode Island, South Kingstown, who was not involved with the study. “I think it’s a very necessary study because, to my knowledge, nobody has done a randomized controlled trial on this topic.”

Keeping infants at home can also protect babies from infections they might catch in the clinic.

“There are a lot of other kids in an office setting, and kids like touching things,” said Anirudha Das, MD, MPH, a neonatologist at Cleveland Clinic Children’s and the lead author of the study. “When there are a lot of other kids, there are a lot of viruses. It’s a very dangerous environment.”

Parents in the intervention group were given scales and asked to enter their infant’s weight into a patient portal app three times per week for 6 weeks. Physicians then determined if in-office visits were necessary. 

The benefits of home weight checks can include helping to allow for breastfeeding for a longer duration. 

Weight is more closely monitored for breastfed infants. Waiting weeks for office checks can heighten parental anxiety and lead to prematurely stopping breastfeeding. With regular at-home checks, parents receive up-to-date information from physicians that can alleviate concerns and empower them with more control over the process, according to Dr. DiTomasso.

Breastfeeding is associated with a lower risk for cardiovascular disease, diabetes, obesity, cancer in later life, and a lower risk of breast cancer for breastfeeding parents.

Office weight checks can also alleviate a significant and unnecessary burden for parents, Dr. Das said.

“You shouldn’t have to put your baby in a car, possibly in freezing temperatures, hire someone to take care of your other kids, drive to the hospital, pay for parking, and walk to the office for a weight check,” Dr. Das said.

Dr. Das noted that, because of technical errors, parents weren’t able to use remote monitoring and had in-person visits during the first 5 days of life. The intervention group had more visits during that period than the usual-care group. 

The study was funded by the American Academy of Pediatrics. The authors and Dr. Das reported no relevant financial relationships.

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

A few weeks ago I asked what changes would have to occur to return urgent care to its former place under the umbrella of the primary care pediatrician. Several responses that I received and the recent story about screenings in this magazine (April 2023) have prompted me to ask the broader question of what is a pediatrician? More specifically, what is the role of a primary care pediatrician?

I think we can agree that a pediatrician is someone who has dedicated his or her training to learning about and then treating the diseases of children. There are pediatricians whose focus is on newborns. There are others who specialize by organ system or by the intensity of the disease (for example, hospitalists and ED physicians). In Great Britain, and to some extent Canada, “paediatricians” serve primarily as consultants to other health care providers. In this country, however, we tend to think of a pediatrician as a frontline primary care physician with general expertise in children. It is those providers (myself included) to whom I address my questions: “What is our role? What is our primary mission?” Are the expectations that we and others have for us realistic given the realities of 21st-century America? And, is our failure to meet some of those expectations contributing to our burnout?

Are we preventionists? I have always thought that one of the things that sets us apart from other specialties is our focus on prevention. We’ve done a pretty good job with infectious diseases thanks to vaccines and antibiotics. But, when I look at the children who grew to be obese adults under my care I have to say that I and my peers have done an abysmal job of prevention. And that is just one example.

Are we educators responsible for helping parents learn what we consider to be the best child-rearing practices? The Latin root of the word “doctor” means teacher. But, education done well is a very time-consuming process. How many of us have time in the office to really teach? Furthermore, some recent studies on managing vaccine deniers suggests that education doesn’t work with people who have long-held beliefs.

Are we data-entry clerks tasked with documenting our every professional step to validate our value to society and the correctness of our methods? It seems that there are some folks who believe we should be.

Are we screeners? TSA agents with white coats and stethoscopes responsible for screening the entire population for potential threats that weren’t obvious to our thoughtful history taking and careful physical examinations?

And finally, are we healers? If you haven’t already disabused yourself of that myth please take a moment to consider the number of cures you have orchestrated in the last 10 years.

The answer is that we can and maybe should be all of those things but we and those who advise us and support us must have reasonable expectations of how difficult it can be to be all those things to all of our patients in the real world of primary care pediatrics. We aren’t social engineers who can level every inequality nor can we orchestrate changes in a society that leans toward enabling unhealthy lifestyles.

The American Academy of Pediatrics must shoulder some of the blame for this discrepancy between expectations and reality. In the Pediatric News article on screening, Susan Kressly, MD, the chair of the American Academy of Pediatrics’s Section on Administration and Practice shares some common-sense observations on how screening can be applied thoughtfully. However, this isn’t how it is usually portrayed in the top-down rollout as each advocacy group releases its next best screening recommendations.

Faced with this clash or expectations I have always chosen to think small. I live in a small town in a small state. I look at each patient and each family, one at a time, with its strengths and its vulnerabilities as a given. I try to educate and prevent as their needs and my time allows. I screen when something makes me feel uncomfortable. Long ago I retired my aspirations as a healer and instead have focussed on being a soother.

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 [email protected].

A few weeks ago I asked what changes would have to occur to return urgent care to its former place under the umbrella of the primary care pediatrician. Several responses that I received and the recent story about screenings in this magazine (April 2023) have prompted me to ask the broader question of what is a pediatrician? More specifically, what is the role of a primary care pediatrician?

I think we can agree that a pediatrician is someone who has dedicated his or her training to learning about and then treating the diseases of children. There are pediatricians whose focus is on newborns. There are others who specialize by organ system or by the intensity of the disease (for example, hospitalists and ED physicians). In Great Britain, and to some extent Canada, “paediatricians” serve primarily as consultants to other health care providers. In this country, however, we tend to think of a pediatrician as a frontline primary care physician with general expertise in children. It is those providers (myself included) to whom I address my questions: “What is our role? What is our primary mission?” Are the expectations that we and others have for us realistic given the realities of 21st-century America? And, is our failure to meet some of those expectations contributing to our burnout?

Are we preventionists? I have always thought that one of the things that sets us apart from other specialties is our focus on prevention. We’ve done a pretty good job with infectious diseases thanks to vaccines and antibiotics. But, when I look at the children who grew to be obese adults under my care I have to say that I and my peers have done an abysmal job of prevention. And that is just one example.

Are we educators responsible for helping parents learn what we consider to be the best child-rearing practices? The Latin root of the word “doctor” means teacher. But, education done well is a very time-consuming process. How many of us have time in the office to really teach? Furthermore, some recent studies on managing vaccine deniers suggests that education doesn’t work with people who have long-held beliefs.

Are we data-entry clerks tasked with documenting our every professional step to validate our value to society and the correctness of our methods? It seems that there are some folks who believe we should be.

Are we screeners? TSA agents with white coats and stethoscopes responsible for screening the entire population for potential threats that weren’t obvious to our thoughtful history taking and careful physical examinations?

And finally, are we healers? If you haven’t already disabused yourself of that myth please take a moment to consider the number of cures you have orchestrated in the last 10 years.

The answer is that we can and maybe should be all of those things but we and those who advise us and support us must have reasonable expectations of how difficult it can be to be all those things to all of our patients in the real world of primary care pediatrics. We aren’t social engineers who can level every inequality nor can we orchestrate changes in a society that leans toward enabling unhealthy lifestyles.

The American Academy of Pediatrics must shoulder some of the blame for this discrepancy between expectations and reality. In the Pediatric News article on screening, Susan Kressly, MD, the chair of the American Academy of Pediatrics’s Section on Administration and Practice shares some common-sense observations on how screening can be applied thoughtfully. However, this isn’t how it is usually portrayed in the top-down rollout as each advocacy group releases its next best screening recommendations.

Faced with this clash or expectations I have always chosen to think small. I live in a small town in a small state. I look at each patient and each family, one at a time, with its strengths and its vulnerabilities as a given. I try to educate and prevent as their needs and my time allows. I screen when something makes me feel uncomfortable. Long ago I retired my aspirations as a healer and instead have focussed on being a soother.

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 [email protected].

A few weeks ago I asked what changes would have to occur to return urgent care to its former place under the umbrella of the primary care pediatrician. Several responses that I received and the recent story about screenings in this magazine (April 2023) have prompted me to ask the broader question of what is a pediatrician? More specifically, what is the role of a primary care pediatrician?

I think we can agree that a pediatrician is someone who has dedicated his or her training to learning about and then treating the diseases of children. There are pediatricians whose focus is on newborns. There are others who specialize by organ system or by the intensity of the disease (for example, hospitalists and ED physicians). In Great Britain, and to some extent Canada, “paediatricians” serve primarily as consultants to other health care providers. In this country, however, we tend to think of a pediatrician as a frontline primary care physician with general expertise in children. It is those providers (myself included) to whom I address my questions: “What is our role? What is our primary mission?” Are the expectations that we and others have for us realistic given the realities of 21st-century America? And, is our failure to meet some of those expectations contributing to our burnout?

Are we preventionists? I have always thought that one of the things that sets us apart from other specialties is our focus on prevention. We’ve done a pretty good job with infectious diseases thanks to vaccines and antibiotics. But, when I look at the children who grew to be obese adults under my care I have to say that I and my peers have done an abysmal job of prevention. And that is just one example.

Are we educators responsible for helping parents learn what we consider to be the best child-rearing practices? The Latin root of the word “doctor” means teacher. But, education done well is a very time-consuming process. How many of us have time in the office to really teach? Furthermore, some recent studies on managing vaccine deniers suggests that education doesn’t work with people who have long-held beliefs.

Are we data-entry clerks tasked with documenting our every professional step to validate our value to society and the correctness of our methods? It seems that there are some folks who believe we should be.

Are we screeners? TSA agents with white coats and stethoscopes responsible for screening the entire population for potential threats that weren’t obvious to our thoughtful history taking and careful physical examinations?

And finally, are we healers? If you haven’t already disabused yourself of that myth please take a moment to consider the number of cures you have orchestrated in the last 10 years.

The answer is that we can and maybe should be all of those things but we and those who advise us and support us must have reasonable expectations of how difficult it can be to be all those things to all of our patients in the real world of primary care pediatrics. We aren’t social engineers who can level every inequality nor can we orchestrate changes in a society that leans toward enabling unhealthy lifestyles.

The American Academy of Pediatrics must shoulder some of the blame for this discrepancy between expectations and reality. In the Pediatric News article on screening, Susan Kressly, MD, the chair of the American Academy of Pediatrics’s Section on Administration and Practice shares some common-sense observations on how screening can be applied thoughtfully. However, this isn’t how it is usually portrayed in the top-down rollout as each advocacy group releases its next best screening recommendations.

Faced with this clash or expectations I have always chosen to think small. I live in a small town in a small state. I look at each patient and each family, one at a time, with its strengths and its vulnerabilities as a given. I try to educate and prevent as their needs and my time allows. I screen when something makes me feel uncomfortable. Long ago I retired my aspirations as a healer and instead have focussed on being a soother.

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 [email protected].

Would closed-loop systems be a good option for young patients with type 1 diabetes?

International and French recommendations on closed-loop systems state that the use of an “artificial pancreas” should be reserved for adults who are fully engaged with their treatment. This means that young patients, especially adolescents, who are less likely to comply with treatment and are more likely to experience suboptimal blood glucose control, are often excluded from the use of such systems for managing their diabetes.

Several recent studies seem to call this approach into question.

One such study, which was presented at a Francophone Diabetes Society conference and was published in Nature Communications, showed that adolescents with poorly controlled diabetes who were equipped with closed-loop systems gained IQ points and reasoning capacity and experienced a reduction in edematous tissue in the brain cortex. Furthermore, with the closed-loop system, patients spent 13% more time in a target range, and there was a significant reduction in time spent in hyperglycemia.

In the same vein, a small prospective study published in Diabetes Care showed that the closed-loop system with the Minimed 780G pump improved glycemic control for 20 young patients with type 1 diabetes aged 13-25 years whose diabetes was poorly controlled (hemoglobin A1c ≥ 8.5%). At the end of the 3-month study period, the average A1c had decreased from 10.5% (±2.1%) to 7.6% (±1.1%), an average decrease of 2.9%. The time spent in target A1c, which was set from 0.70 g/L to 1.80 g/L, was increased by almost 40%.

With respect to very young children, a study published in The New England Journal of Medicine also showed a favorable risk-benefit ratio for closed-loop systems. The trial, which enrolled 102 children aged 2 years to less than 6 years who had type 1 diabetes, showed that the amount of time that the glucose level was within the target range during the 13-week study period was higher (+3 hours) for those who had been randomly assigned to receive the hybrid closed-loop system (n = 68) than for those who had received the standard treatment (n = 34), either with an insulin pump or multiple daily injections or a Dexcom G6 continuous glucose monitoring device.

A previous study carried out by the Paris Public Hospital System had already shown that the French Diabeloop system could reduce episodes of hypoglycemia and achieve good glycemic control for prepubescent children (n = 21; aged 6-12 years) with type 1 diabetes in real-life conditions.

Eric Renard, MD, PhD, head of the department of endocrinology and diabetes at Lapeyronie Hospital in Montpellier, France, was not surprised at the findings from the study, especially in adolescents with poorly controlled diabetes.

“We have already seen studies in which those patients who had the most poorly controlled diabetes at the start were the ones who improved the most with the closed-loop system, by at least 20% in terms of time in target. These findings resonate with what I see in my clinic,” said Dr. Renard in an interview.

“In my experience, these young adolescents, who neglected their diabetes when they had no devices to help control it, when they had to inject themselves, et cetera ... well, they’re just not the same people when they’re put on a closed-loop system,” he added. “They rise to the challenge, and for the first time, they succeed without making a huge effort, since the algorithm does what they weren’t doing. It’s astonishing to see near-total engagement in these young people when explaining the technology to them and saying, ‘Let’s give it a go.’ These are the very same youngsters who didn’t want to hear about their diabetes in the past. They are delighted and once again involved in managing their condition.”

That’s why Dr. Renard recommends keeping an open mind when considering treatment options for young patients with poorly controlled type 1 diabetes.

“When young people have very poorly controlled diabetes, they risk having cardiovascular complications and damaging their retinas and kidneys,” he said. “If we can get them from 25% to 45% time in target, even if that hasn’t been easy to achieve, this will help save their blood vessels! The only thing we have to be careful of is that we don’t set up a closed-loop system in someone who doesn’t want one. But, if it can manage to spark the interest of a young patient, in most cases, it’s beneficial.”

This article was translated from the Medscape French edition. A version appeared on Medscape.com.

Would closed-loop systems be a good option for young patients with type 1 diabetes?

International and French recommendations on closed-loop systems state that the use of an “artificial pancreas” should be reserved for adults who are fully engaged with their treatment. This means that young patients, especially adolescents, who are less likely to comply with treatment and are more likely to experience suboptimal blood glucose control, are often excluded from the use of such systems for managing their diabetes.

Several recent studies seem to call this approach into question.

One such study, which was presented at a Francophone Diabetes Society conference and was published in Nature Communications, showed that adolescents with poorly controlled diabetes who were equipped with closed-loop systems gained IQ points and reasoning capacity and experienced a reduction in edematous tissue in the brain cortex. Furthermore, with the closed-loop system, patients spent 13% more time in a target range, and there was a significant reduction in time spent in hyperglycemia.

In the same vein, a small prospective study published in Diabetes Care showed that the closed-loop system with the Minimed 780G pump improved glycemic control for 20 young patients with type 1 diabetes aged 13-25 years whose diabetes was poorly controlled (hemoglobin A1c ≥ 8.5%). At the end of the 3-month study period, the average A1c had decreased from 10.5% (±2.1%) to 7.6% (±1.1%), an average decrease of 2.9%. The time spent in target A1c, which was set from 0.70 g/L to 1.80 g/L, was increased by almost 40%.

With respect to very young children, a study published in The New England Journal of Medicine also showed a favorable risk-benefit ratio for closed-loop systems. The trial, which enrolled 102 children aged 2 years to less than 6 years who had type 1 diabetes, showed that the amount of time that the glucose level was within the target range during the 13-week study period was higher (+3 hours) for those who had been randomly assigned to receive the hybrid closed-loop system (n = 68) than for those who had received the standard treatment (n = 34), either with an insulin pump or multiple daily injections or a Dexcom G6 continuous glucose monitoring device.

A previous study carried out by the Paris Public Hospital System had already shown that the French Diabeloop system could reduce episodes of hypoglycemia and achieve good glycemic control for prepubescent children (n = 21; aged 6-12 years) with type 1 diabetes in real-life conditions.

Eric Renard, MD, PhD, head of the department of endocrinology and diabetes at Lapeyronie Hospital in Montpellier, France, was not surprised at the findings from the study, especially in adolescents with poorly controlled diabetes.

“We have already seen studies in which those patients who had the most poorly controlled diabetes at the start were the ones who improved the most with the closed-loop system, by at least 20% in terms of time in target. These findings resonate with what I see in my clinic,” said Dr. Renard in an interview.

“In my experience, these young adolescents, who neglected their diabetes when they had no devices to help control it, when they had to inject themselves, et cetera ... well, they’re just not the same people when they’re put on a closed-loop system,” he added. “They rise to the challenge, and for the first time, they succeed without making a huge effort, since the algorithm does what they weren’t doing. It’s astonishing to see near-total engagement in these young people when explaining the technology to them and saying, ‘Let’s give it a go.’ These are the very same youngsters who didn’t want to hear about their diabetes in the past. They are delighted and once again involved in managing their condition.”

That’s why Dr. Renard recommends keeping an open mind when considering treatment options for young patients with poorly controlled type 1 diabetes.

“When young people have very poorly controlled diabetes, they risk having cardiovascular complications and damaging their retinas and kidneys,” he said. “If we can get them from 25% to 45% time in target, even if that hasn’t been easy to achieve, this will help save their blood vessels! The only thing we have to be careful of is that we don’t set up a closed-loop system in someone who doesn’t want one. But, if it can manage to spark the interest of a young patient, in most cases, it’s beneficial.”

This article was translated from the Medscape French edition. A version appeared on Medscape.com.

Would closed-loop systems be a good option for young patients with type 1 diabetes?

International and French recommendations on closed-loop systems state that the use of an “artificial pancreas” should be reserved for adults who are fully engaged with their treatment. This means that young patients, especially adolescents, who are less likely to comply with treatment and are more likely to experience suboptimal blood glucose control, are often excluded from the use of such systems for managing their diabetes.

Several recent studies seem to call this approach into question.

One such study, which was presented at a Francophone Diabetes Society conference and was published in Nature Communications, showed that adolescents with poorly controlled diabetes who were equipped with closed-loop systems gained IQ points and reasoning capacity and experienced a reduction in edematous tissue in the brain cortex. Furthermore, with the closed-loop system, patients spent 13% more time in a target range, and there was a significant reduction in time spent in hyperglycemia.

In the same vein, a small prospective study published in Diabetes Care showed that the closed-loop system with the Minimed 780G pump improved glycemic control for 20 young patients with type 1 diabetes aged 13-25 years whose diabetes was poorly controlled (hemoglobin A1c ≥ 8.5%). At the end of the 3-month study period, the average A1c had decreased from 10.5% (±2.1%) to 7.6% (±1.1%), an average decrease of 2.9%. The time spent in target A1c, which was set from 0.70 g/L to 1.80 g/L, was increased by almost 40%.

With respect to very young children, a study published in The New England Journal of Medicine also showed a favorable risk-benefit ratio for closed-loop systems. The trial, which enrolled 102 children aged 2 years to less than 6 years who had type 1 diabetes, showed that the amount of time that the glucose level was within the target range during the 13-week study period was higher (+3 hours) for those who had been randomly assigned to receive the hybrid closed-loop system (n = 68) than for those who had received the standard treatment (n = 34), either with an insulin pump or multiple daily injections or a Dexcom G6 continuous glucose monitoring device.

A previous study carried out by the Paris Public Hospital System had already shown that the French Diabeloop system could reduce episodes of hypoglycemia and achieve good glycemic control for prepubescent children (n = 21; aged 6-12 years) with type 1 diabetes in real-life conditions.

Eric Renard, MD, PhD, head of the department of endocrinology and diabetes at Lapeyronie Hospital in Montpellier, France, was not surprised at the findings from the study, especially in adolescents with poorly controlled diabetes.

“We have already seen studies in which those patients who had the most poorly controlled diabetes at the start were the ones who improved the most with the closed-loop system, by at least 20% in terms of time in target. These findings resonate with what I see in my clinic,” said Dr. Renard in an interview.

“In my experience, these young adolescents, who neglected their diabetes when they had no devices to help control it, when they had to inject themselves, et cetera ... well, they’re just not the same people when they’re put on a closed-loop system,” he added. “They rise to the challenge, and for the first time, they succeed without making a huge effort, since the algorithm does what they weren’t doing. It’s astonishing to see near-total engagement in these young people when explaining the technology to them and saying, ‘Let’s give it a go.’ These are the very same youngsters who didn’t want to hear about their diabetes in the past. They are delighted and once again involved in managing their condition.”

That’s why Dr. Renard recommends keeping an open mind when considering treatment options for young patients with poorly controlled type 1 diabetes.

“When young people have very poorly controlled diabetes, they risk having cardiovascular complications and damaging their retinas and kidneys,” he said. “If we can get them from 25% to 45% time in target, even if that hasn’t been easy to achieve, this will help save their blood vessels! The only thing we have to be careful of is that we don’t set up a closed-loop system in someone who doesn’t want one. But, if it can manage to spark the interest of a young patient, in most cases, it’s beneficial.”

This article was translated from the Medscape French edition. A version appeared on Medscape.com.

Prediction models that incorporate more than just treatment status could rank order heart transplant candidates by urgency more effectively than the current system, a modeling study suggests.

Since 2018, the U.S. heart transplant allocation system has ranked heart candidates according to six treatment-based “statuses” (up from three used previously), ignoring many objective patient characteristics, the authors write.

Their study showed no significant difference in survival between statuses four and six, and status five had lower survival than status four.

“We expected multivariable prediction models to outperform the six-status system when it comes to rank ordering patients by how likely they are to die on the wait list (medical urgency),” William F. Parker, MD, MS, PhD, of the University of Chicago, told this news organization.

“However, we were surprised to see that the statuses were out of order,” he said. “Status five patients are more urgent than status three or status four patients,” mainly because most are in renal failure and listed for multiorgan transplantation with a kidney.

Objective physiologic measurements, such as glomerular filtration rate (GFR), had high variable importance, offering a minimally invasive measurement with predictive power in assessing medical urgency. Therefore, including GFR and other variables such as extracorporeal membrane oxygenation (ECMO) could improve the accuracy of the allocation system in identifying the most medically urgent candidates, Dr. Parker and colleagues suggest.

The study was published online in JACC: Heart Failure.
 

‘Moderate ability’ to rank order

The investigators assessed the effectiveness of the standard six-status ranking system and several novel prediction models in identifying the most urgent heart transplant candidates. The primary outcome was death before receipt of a heart transplant.

The final data set contained 32,294 candidates (mean age, 53 years; 74%, men); 27,200 made up the prepolicy training set and 5,094 were included in the postpolicy test set.

The team evaluated the accuracy of the six-status system using Harrell’s C-index and log-rank tests of Kaplan-Meier estimated survival by status for candidates listed after the policy change (November 2018 to March 2020) in the Scientific Registry of Transplant Recipients data set.

They then developed Cox proportional hazards models and random survival forest models using prepolicy data (2010-2017). Predictor variables included age, diagnosis, laboratory measurements, hemodynamics, and supportive treatment at the time of listing.

They found that the six-status ranking at listing has had “moderate ability” to rank order candidates.

As Dr. Parker indicated, statuses four and six had no significant difference in survival, and status five had lower survival than status four.

The investigators’ multivariable prediction models derived with prepolicy data ranked candidates correctly more often than the six-status rankings. Objective physiologic measurements, such as GFR and ECMO, were identified as having significant importance with regard to ranking by urgency.

“The novel prediction models we developed … could be implemented by the Organ Procurement and Transplantation Network (OPTN) as allocation policy and would be better than the status quo,” Dr. Parker said. “However, I think we could do even better using the newer data collected after 2018.” 
 

Modifications underway

The OPTN Heart Transplantation Committee is currently working on developing a new framework for allocating deceased donor hearts called Continuous Distribution.

“The six-tiered system works well, and it better stratifies the most medically urgent candidates than the previous allocation framework,” the leadership of the United Network for Organ Sharing Heart Transplantation Committee, including Chair Richard C. Daly, MD, Mayo Clinic; Vice-Chair Jondavid Menteer, MD, University of Southern California, Los Angeles; and former Chair Shelley Hall, MD, Baylor University Medical Center, told this news organization.

“That said, it is always appropriate to review and adjust variables that affect the medical urgency attribute for heart allocation.”

The new framework will change how patients are prioritized, they said. “Continuous distribution will consider all patient factors, including medical urgency, together to determine the order of an organ offer, and no single factor will decide an organ match.

“The goal is to increase fairness by moving to a points-based allocation framework that allows candidates to be compared using a single score composed of multiple factors.

“Furthermore,” they added, “continuous distribution provides a framework that will allow modifications of the criteria defining medical urgency (and other attributes of allocation) to a finer degree than the current policy. … Once continuous distribution is in place and the OPTN has policy monitoring data, the committee may consider and model different ways of defining medical urgency.”

Kiran K. Khush, MD, of Stanford (Calif.) University School of Medicine, coauthor of a related commentary, elaborated. “The composite allocation score (CAS) will consist of a ‘points-based system,’ in which candidates will be assigned points based on (1) medical urgency, (2) anticipated posttransplant survival, (3) candidate biology (eg., special characteristics that may result in higher prioritization, such as blood type O and allosensitization), (4) access (eg., prior living donor, pediatric patient), and (5) placement efficacy (travel, proximity).”

Candidates will be assigned points based on these categories, and will be rank ordered for each donor offer.

Dr. Khush and colleagues propose that a multivariable model – such as the ones described in the study – would be the best way to assign points for medical urgency.

“This system will be more equitable than the current system,” Dr. Khush said, “because it will better prioritize the sickest candidates while improving access for patients who are currently at a disadvantage [for example, blood O, highly sensitized patients], and will also remove artificial geographic boundaries [for example, the current 500-mile rule for heart allocation].”
 

Going further

Jesse D. Schold, PhD, of the University of Colorado at Denver, Aurora, raises concerns about other aspects of the heart allocation system in another related commentary.

“One big issue with our data in transplantation … is that, while it is very comprehensive for capturing transplant candidates and recipients, there is no data collection for patients and processes of care for patients prior to wait list placement,” he told this news organization. This phase of care is subject to wide variation in practice, he said, “and is likely as important as any to patients – the ability to be referred, evaluated, and placed on a waiting list.”

Report cards that measure quality of care after wait list placement ignore key phases prior to wait list placement, he said. “This may have the unintended consequences of limiting access to care and to the waiting list for patients perceived to be at higher risk, or the use of higher-risk donors, despite their potential survival advantage.

“In contrast,” he said, “quality report cards that incentivize treatment for all patients who may benefit would likely have a greater beneficial impact on patients with end-organ disease.”

There is also significant risk of underlying differences in patient populations between centers, despite the use of multivariable models, he added. This heterogeneity “may not be reflected accurately in the report cards [which] have significant impact for regulatory review, private payer contracting, and center reputation.”

Some of these concerns may be addressed in the new OPTN Modernization Initiative, according to David Bowman, a public affairs specialist at the Health Resources and Services Administration. One of the goals of the initiative “is to ensure that the OPTN Board of Directors is high functioning, has greater independence, and represents the diversity of communities served by the OPTN,” he told this news organization. “Strengthened governance will lead to effective policy development and implementation, and enhanced transparency and accountability of the process.”

Addressing another concern about the system, Savitri Fedson, MD, of the Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, wonders in a related editorial whether organ donors and recipients should know more about each other, and if so, could that reverse the ongoing downward trend in organ acceptance?

Although some organizations are in favor of sharing more information, Dr. Fedson notes that “less information may have the greater benefit.” She writes, “We might realize that the simplest approach is often the best: a fulsome thank you for the donor’s gift that is willingly given to a stranger without expectation of payment, and on the recipient side, the knowledge that an organ is of good quality.

“The transplant patient can be comforted with the understanding that the risk of disease transmission, while not zero, is low, and that their survival following acceptance of an organ is better than languishing on a waiting list.”

The study received no commercial funding. Dr. Parker, Dr. Khush, Dr. Schold, and Dr. Fedson report no relevant financial relationships.

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

Prediction models that incorporate more than just treatment status could rank order heart transplant candidates by urgency more effectively than the current system, a modeling study suggests.

Since 2018, the U.S. heart transplant allocation system has ranked heart candidates according to six treatment-based “statuses” (up from three used previously), ignoring many objective patient characteristics, the authors write.

Their study showed no significant difference in survival between statuses four and six, and status five had lower survival than status four.

“We expected multivariable prediction models to outperform the six-status system when it comes to rank ordering patients by how likely they are to die on the wait list (medical urgency),” William F. Parker, MD, MS, PhD, of the University of Chicago, told this news organization.

“However, we were surprised to see that the statuses were out of order,” he said. “Status five patients are more urgent than status three or status four patients,” mainly because most are in renal failure and listed for multiorgan transplantation with a kidney.

Objective physiologic measurements, such as glomerular filtration rate (GFR), had high variable importance, offering a minimally invasive measurement with predictive power in assessing medical urgency. Therefore, including GFR and other variables such as extracorporeal membrane oxygenation (ECMO) could improve the accuracy of the allocation system in identifying the most medically urgent candidates, Dr. Parker and colleagues suggest.

The study was published online in JACC: Heart Failure.
 

‘Moderate ability’ to rank order

The investigators assessed the effectiveness of the standard six-status ranking system and several novel prediction models in identifying the most urgent heart transplant candidates. The primary outcome was death before receipt of a heart transplant.

The final data set contained 32,294 candidates (mean age, 53 years; 74%, men); 27,200 made up the prepolicy training set and 5,094 were included in the postpolicy test set.

The team evaluated the accuracy of the six-status system using Harrell’s C-index and log-rank tests of Kaplan-Meier estimated survival by status for candidates listed after the policy change (November 2018 to March 2020) in the Scientific Registry of Transplant Recipients data set.

They then developed Cox proportional hazards models and random survival forest models using prepolicy data (2010-2017). Predictor variables included age, diagnosis, laboratory measurements, hemodynamics, and supportive treatment at the time of listing.

They found that the six-status ranking at listing has had “moderate ability” to rank order candidates.

As Dr. Parker indicated, statuses four and six had no significant difference in survival, and status five had lower survival than status four.

The investigators’ multivariable prediction models derived with prepolicy data ranked candidates correctly more often than the six-status rankings. Objective physiologic measurements, such as GFR and ECMO, were identified as having significant importance with regard to ranking by urgency.

“The novel prediction models we developed … could be implemented by the Organ Procurement and Transplantation Network (OPTN) as allocation policy and would be better than the status quo,” Dr. Parker said. “However, I think we could do even better using the newer data collected after 2018.” 
 

Modifications underway

The OPTN Heart Transplantation Committee is currently working on developing a new framework for allocating deceased donor hearts called Continuous Distribution.

“The six-tiered system works well, and it better stratifies the most medically urgent candidates than the previous allocation framework,” the leadership of the United Network for Organ Sharing Heart Transplantation Committee, including Chair Richard C. Daly, MD, Mayo Clinic; Vice-Chair Jondavid Menteer, MD, University of Southern California, Los Angeles; and former Chair Shelley Hall, MD, Baylor University Medical Center, told this news organization.

“That said, it is always appropriate to review and adjust variables that affect the medical urgency attribute for heart allocation.”

The new framework will change how patients are prioritized, they said. “Continuous distribution will consider all patient factors, including medical urgency, together to determine the order of an organ offer, and no single factor will decide an organ match.

“The goal is to increase fairness by moving to a points-based allocation framework that allows candidates to be compared using a single score composed of multiple factors.

“Furthermore,” they added, “continuous distribution provides a framework that will allow modifications of the criteria defining medical urgency (and other attributes of allocation) to a finer degree than the current policy. … Once continuous distribution is in place and the OPTN has policy monitoring data, the committee may consider and model different ways of defining medical urgency.”

Kiran K. Khush, MD, of Stanford (Calif.) University School of Medicine, coauthor of a related commentary, elaborated. “The composite allocation score (CAS) will consist of a ‘points-based system,’ in which candidates will be assigned points based on (1) medical urgency, (2) anticipated posttransplant survival, (3) candidate biology (eg., special characteristics that may result in higher prioritization, such as blood type O and allosensitization), (4) access (eg., prior living donor, pediatric patient), and (5) placement efficacy (travel, proximity).”

Candidates will be assigned points based on these categories, and will be rank ordered for each donor offer.

Dr. Khush and colleagues propose that a multivariable model – such as the ones described in the study – would be the best way to assign points for medical urgency.

“This system will be more equitable than the current system,” Dr. Khush said, “because it will better prioritize the sickest candidates while improving access for patients who are currently at a disadvantage [for example, blood O, highly sensitized patients], and will also remove artificial geographic boundaries [for example, the current 500-mile rule for heart allocation].”
 

Going further

Jesse D. Schold, PhD, of the University of Colorado at Denver, Aurora, raises concerns about other aspects of the heart allocation system in another related commentary.

“One big issue with our data in transplantation … is that, while it is very comprehensive for capturing transplant candidates and recipients, there is no data collection for patients and processes of care for patients prior to wait list placement,” he told this news organization. This phase of care is subject to wide variation in practice, he said, “and is likely as important as any to patients – the ability to be referred, evaluated, and placed on a waiting list.”

Report cards that measure quality of care after wait list placement ignore key phases prior to wait list placement, he said. “This may have the unintended consequences of limiting access to care and to the waiting list for patients perceived to be at higher risk, or the use of higher-risk donors, despite their potential survival advantage.

“In contrast,” he said, “quality report cards that incentivize treatment for all patients who may benefit would likely have a greater beneficial impact on patients with end-organ disease.”

There is also significant risk of underlying differences in patient populations between centers, despite the use of multivariable models, he added. This heterogeneity “may not be reflected accurately in the report cards [which] have significant impact for regulatory review, private payer contracting, and center reputation.”

Some of these concerns may be addressed in the new OPTN Modernization Initiative, according to David Bowman, a public affairs specialist at the Health Resources and Services Administration. One of the goals of the initiative “is to ensure that the OPTN Board of Directors is high functioning, has greater independence, and represents the diversity of communities served by the OPTN,” he told this news organization. “Strengthened governance will lead to effective policy development and implementation, and enhanced transparency and accountability of the process.”

Addressing another concern about the system, Savitri Fedson, MD, of the Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, wonders in a related editorial whether organ donors and recipients should know more about each other, and if so, could that reverse the ongoing downward trend in organ acceptance?

Although some organizations are in favor of sharing more information, Dr. Fedson notes that “less information may have the greater benefit.” She writes, “We might realize that the simplest approach is often the best: a fulsome thank you for the donor’s gift that is willingly given to a stranger without expectation of payment, and on the recipient side, the knowledge that an organ is of good quality.

“The transplant patient can be comforted with the understanding that the risk of disease transmission, while not zero, is low, and that their survival following acceptance of an organ is better than languishing on a waiting list.”

The study received no commercial funding. Dr. Parker, Dr. Khush, Dr. Schold, and Dr. Fedson report no relevant financial relationships.

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

Prediction models that incorporate more than just treatment status could rank order heart transplant candidates by urgency more effectively than the current system, a modeling study suggests.

Since 2018, the U.S. heart transplant allocation system has ranked heart candidates according to six treatment-based “statuses” (up from three used previously), ignoring many objective patient characteristics, the authors write.

Their study showed no significant difference in survival between statuses four and six, and status five had lower survival than status four.

“We expected multivariable prediction models to outperform the six-status system when it comes to rank ordering patients by how likely they are to die on the wait list (medical urgency),” William F. Parker, MD, MS, PhD, of the University of Chicago, told this news organization.

“However, we were surprised to see that the statuses were out of order,” he said. “Status five patients are more urgent than status three or status four patients,” mainly because most are in renal failure and listed for multiorgan transplantation with a kidney.

Objective physiologic measurements, such as glomerular filtration rate (GFR), had high variable importance, offering a minimally invasive measurement with predictive power in assessing medical urgency. Therefore, including GFR and other variables such as extracorporeal membrane oxygenation (ECMO) could improve the accuracy of the allocation system in identifying the most medically urgent candidates, Dr. Parker and colleagues suggest.

The study was published online in JACC: Heart Failure.
 

‘Moderate ability’ to rank order

The investigators assessed the effectiveness of the standard six-status ranking system and several novel prediction models in identifying the most urgent heart transplant candidates. The primary outcome was death before receipt of a heart transplant.

The final data set contained 32,294 candidates (mean age, 53 years; 74%, men); 27,200 made up the prepolicy training set and 5,094 were included in the postpolicy test set.

The team evaluated the accuracy of the six-status system using Harrell’s C-index and log-rank tests of Kaplan-Meier estimated survival by status for candidates listed after the policy change (November 2018 to March 2020) in the Scientific Registry of Transplant Recipients data set.

They then developed Cox proportional hazards models and random survival forest models using prepolicy data (2010-2017). Predictor variables included age, diagnosis, laboratory measurements, hemodynamics, and supportive treatment at the time of listing.

They found that the six-status ranking at listing has had “moderate ability” to rank order candidates.

As Dr. Parker indicated, statuses four and six had no significant difference in survival, and status five had lower survival than status four.

The investigators’ multivariable prediction models derived with prepolicy data ranked candidates correctly more often than the six-status rankings. Objective physiologic measurements, such as GFR and ECMO, were identified as having significant importance with regard to ranking by urgency.

“The novel prediction models we developed … could be implemented by the Organ Procurement and Transplantation Network (OPTN) as allocation policy and would be better than the status quo,” Dr. Parker said. “However, I think we could do even better using the newer data collected after 2018.” 
 

Modifications underway

The OPTN Heart Transplantation Committee is currently working on developing a new framework for allocating deceased donor hearts called Continuous Distribution.

“The six-tiered system works well, and it better stratifies the most medically urgent candidates than the previous allocation framework,” the leadership of the United Network for Organ Sharing Heart Transplantation Committee, including Chair Richard C. Daly, MD, Mayo Clinic; Vice-Chair Jondavid Menteer, MD, University of Southern California, Los Angeles; and former Chair Shelley Hall, MD, Baylor University Medical Center, told this news organization.

“That said, it is always appropriate to review and adjust variables that affect the medical urgency attribute for heart allocation.”

The new framework will change how patients are prioritized, they said. “Continuous distribution will consider all patient factors, including medical urgency, together to determine the order of an organ offer, and no single factor will decide an organ match.

“The goal is to increase fairness by moving to a points-based allocation framework that allows candidates to be compared using a single score composed of multiple factors.

“Furthermore,” they added, “continuous distribution provides a framework that will allow modifications of the criteria defining medical urgency (and other attributes of allocation) to a finer degree than the current policy. … Once continuous distribution is in place and the OPTN has policy monitoring data, the committee may consider and model different ways of defining medical urgency.”

Kiran K. Khush, MD, of Stanford (Calif.) University School of Medicine, coauthor of a related commentary, elaborated. “The composite allocation score (CAS) will consist of a ‘points-based system,’ in which candidates will be assigned points based on (1) medical urgency, (2) anticipated posttransplant survival, (3) candidate biology (eg., special characteristics that may result in higher prioritization, such as blood type O and allosensitization), (4) access (eg., prior living donor, pediatric patient), and (5) placement efficacy (travel, proximity).”

Candidates will be assigned points based on these categories, and will be rank ordered for each donor offer.

Dr. Khush and colleagues propose that a multivariable model – such as the ones described in the study – would be the best way to assign points for medical urgency.

“This system will be more equitable than the current system,” Dr. Khush said, “because it will better prioritize the sickest candidates while improving access for patients who are currently at a disadvantage [for example, blood O, highly sensitized patients], and will also remove artificial geographic boundaries [for example, the current 500-mile rule for heart allocation].”
 

Going further

Jesse D. Schold, PhD, of the University of Colorado at Denver, Aurora, raises concerns about other aspects of the heart allocation system in another related commentary.

“One big issue with our data in transplantation … is that, while it is very comprehensive for capturing transplant candidates and recipients, there is no data collection for patients and processes of care for patients prior to wait list placement,” he told this news organization. This phase of care is subject to wide variation in practice, he said, “and is likely as important as any to patients – the ability to be referred, evaluated, and placed on a waiting list.”

Report cards that measure quality of care after wait list placement ignore key phases prior to wait list placement, he said. “This may have the unintended consequences of limiting access to care and to the waiting list for patients perceived to be at higher risk, or the use of higher-risk donors, despite their potential survival advantage.

“In contrast,” he said, “quality report cards that incentivize treatment for all patients who may benefit would likely have a greater beneficial impact on patients with end-organ disease.”

There is also significant risk of underlying differences in patient populations between centers, despite the use of multivariable models, he added. This heterogeneity “may not be reflected accurately in the report cards [which] have significant impact for regulatory review, private payer contracting, and center reputation.”

Some of these concerns may be addressed in the new OPTN Modernization Initiative, according to David Bowman, a public affairs specialist at the Health Resources and Services Administration. One of the goals of the initiative “is to ensure that the OPTN Board of Directors is high functioning, has greater independence, and represents the diversity of communities served by the OPTN,” he told this news organization. “Strengthened governance will lead to effective policy development and implementation, and enhanced transparency and accountability of the process.”

Addressing another concern about the system, Savitri Fedson, MD, of the Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, wonders in a related editorial whether organ donors and recipients should know more about each other, and if so, could that reverse the ongoing downward trend in organ acceptance?

Although some organizations are in favor of sharing more information, Dr. Fedson notes that “less information may have the greater benefit.” She writes, “We might realize that the simplest approach is often the best: a fulsome thank you for the donor’s gift that is willingly given to a stranger without expectation of payment, and on the recipient side, the knowledge that an organ is of good quality.

“The transplant patient can be comforted with the understanding that the risk of disease transmission, while not zero, is low, and that their survival following acceptance of an organ is better than languishing on a waiting list.”

The study received no commercial funding. Dr. Parker, Dr. Khush, Dr. Schold, and Dr. Fedson report no relevant financial relationships.

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

Taking a swing against arthritis

Osteoarthritis is a tough disease to manage. Exercise helps ease the stiffness and pain of the joints, but at the same time, the disease makes it difficult to do that beneficial exercise. Even a relatively simple activity like jogging can hurt more than it helps. If only there were a low-impact exercise that was incredibly popular among the generally older population who are likely to have arthritis.

We love a good golf study here at LOTME, and a group of Australian and U.K. researchers have provided. Osteoarthritis affects 2 million people in the land down under, making it the most common source of disability there. In that population, only 64% reported their physical health to be good, very good, or excellent. Among the 459 golfers with OA that the study authors surveyed, however, the percentage reporting good health rose to more than 90%.

jacoblund/Getty Images

A similar story emerged when they looked at mental health. Nearly a quarter of nongolfers with OA reported high or very high levels of psychological distress, compared with just 8% of golfers. This pattern of improved physical and mental health remained when the researchers looked at the general, non-OA population.

This isn’t the first time golf’s been connected with improved health, and previous studies have shown golf to reduce the risks of cardiovascular disease, diabetes, and obesity, among other things. Just walking one 18-hole round significantly exceeds the CDC’s recommended 150 minutes of physical activity per week. Go out multiple times a week – leaving the cart and beer at home, American golfers – and you’ll be fit for a lifetime.

The golfers on our staff, however, are still waiting for those mental health benefits to kick in. Because when we’re adding up our scorecard after that string of four double bogeys to end the round, we’re most definitely thinking: “Yes, this sport is reducing my psychological distress. I am having fun right now.”
 

Battle of the sexes’ intestines

There are, we’re sure you’ve noticed, some differences between males and females. Females, for one thing, have longer small intestines than males. Everybody knows that, right? You didn’t know? Really? … Really?

Afif Ramdhasuma/Unsplash

Well, then, we’re guessing you haven’t read “Hidden diversity: Comparative functional morphology of humans and other species” by Erin A. McKenney, PhD, of North Carolina State University, Raleigh, and associates, which just appeared in PeerJ. We couldn’t put it down, even in the shower – a real page-turner/scroller. (It’s a great way to clean a phone, for those who also like to scroll, text, or talk on the toilet.)

The researchers got out their rulers, calipers, and string and took many measurements of the digestive systems of 45 human cadavers (21 female and 24 male), which were compared with data from 10 rats, 10 pigs, and 10 bullfrogs, which had been collected (the measurements, not the animals) by undergraduate students enrolled in a comparative anatomy laboratory course at the university.

There was little intestinal-length variation among the four-legged subjects, but when it comes to humans, females have “consistently and significantly longer small intestines than males,” the investigators noted.

The women’s small intestines, almost 14 feet long on average, were about a foot longer than the men’s, which suggests that women are better able to extract nutrients from food and “supports the canalization hypothesis, which posits that women are better able to survive during periods of stress,” coauthor Amanda Hale said in a written statement from the school. The way to a man’s heart may be through his stomach, but the way to a woman’s heart is through her duodenum, it seems.

Fascinating stuff, to be sure, but the thing that really caught our eye in the PeerJ article was the authors’ suggestion “that organs behave independently of one another, both within and across species.” Organs behaving independently? A somewhat ominous concept, no doubt, but it does explain a lot of the sounds we hear coming from our guts, which can get pretty frightening, especially on chili night.
 

Dog walking is dangerous business

Yes, you did read that right. A lot of strange things can send you to the emergency department. Go ahead and add dog walking onto that list.

Investigators from Johns Hopkins University estimate that over 422,000 adults presented to U.S. emergency departments with leash-dependent dog walking-related injuries between 2001 and 2020.

freestocks/Unsplash

With almost 53% of U.S. households owning at least one dog in 2021-2022 in the wake of the COVID pet boom, this kind of occurrence is becoming more common than you think. The annual number of dog-walking injuries more than quadrupled from 7,300 to 32,000 over the course of the study, and the researchers link that spike to the promotion of dog walking for fitness, along with the boost of ownership itself.

The most common injuries listed in the National Electronic Injury Surveillance System database were finger fracture, traumatic brain injury, and shoulder sprain or strain. These mostly involved falls from being pulled, tripped, or tangled up in the leash while walking. For those aged 65 years and older, traumatic brain injury and hip fracture were the most common.

Women were 50% more likely to sustain a fracture than were men, and dog owners aged 65 and older were three times as likely to fall, twice as likely to get a fracture, and 60% more likely to have brain injury than were younger people. Now, that’s not to say younger people don’t also get hurt. After all, dogs aren’t ageists. The researchers have that data but it’s coming out later.

Meanwhile, the pitfalls involved with just trying to get our daily steps in while letting Muffin do her business have us on the lookout for random squirrels.

Taking a swing against arthritis

Osteoarthritis is a tough disease to manage. Exercise helps ease the stiffness and pain of the joints, but at the same time, the disease makes it difficult to do that beneficial exercise. Even a relatively simple activity like jogging can hurt more than it helps. If only there were a low-impact exercise that was incredibly popular among the generally older population who are likely to have arthritis.

We love a good golf study here at LOTME, and a group of Australian and U.K. researchers have provided. Osteoarthritis affects 2 million people in the land down under, making it the most common source of disability there. In that population, only 64% reported their physical health to be good, very good, or excellent. Among the 459 golfers with OA that the study authors surveyed, however, the percentage reporting good health rose to more than 90%.

jacoblund/Getty Images

A similar story emerged when they looked at mental health. Nearly a quarter of nongolfers with OA reported high or very high levels of psychological distress, compared with just 8% of golfers. This pattern of improved physical and mental health remained when the researchers looked at the general, non-OA population.

This isn’t the first time golf’s been connected with improved health, and previous studies have shown golf to reduce the risks of cardiovascular disease, diabetes, and obesity, among other things. Just walking one 18-hole round significantly exceeds the CDC’s recommended 150 minutes of physical activity per week. Go out multiple times a week – leaving the cart and beer at home, American golfers – and you’ll be fit for a lifetime.

The golfers on our staff, however, are still waiting for those mental health benefits to kick in. Because when we’re adding up our scorecard after that string of four double bogeys to end the round, we’re most definitely thinking: “Yes, this sport is reducing my psychological distress. I am having fun right now.”
 

Battle of the sexes’ intestines

There are, we’re sure you’ve noticed, some differences between males and females. Females, for one thing, have longer small intestines than males. Everybody knows that, right? You didn’t know? Really? … Really?

Afif Ramdhasuma/Unsplash

Well, then, we’re guessing you haven’t read “Hidden diversity: Comparative functional morphology of humans and other species” by Erin A. McKenney, PhD, of North Carolina State University, Raleigh, and associates, which just appeared in PeerJ. We couldn’t put it down, even in the shower – a real page-turner/scroller. (It’s a great way to clean a phone, for those who also like to scroll, text, or talk on the toilet.)

The researchers got out their rulers, calipers, and string and took many measurements of the digestive systems of 45 human cadavers (21 female and 24 male), which were compared with data from 10 rats, 10 pigs, and 10 bullfrogs, which had been collected (the measurements, not the animals) by undergraduate students enrolled in a comparative anatomy laboratory course at the university.

There was little intestinal-length variation among the four-legged subjects, but when it comes to humans, females have “consistently and significantly longer small intestines than males,” the investigators noted.

The women’s small intestines, almost 14 feet long on average, were about a foot longer than the men’s, which suggests that women are better able to extract nutrients from food and “supports the canalization hypothesis, which posits that women are better able to survive during periods of stress,” coauthor Amanda Hale said in a written statement from the school. The way to a man’s heart may be through his stomach, but the way to a woman’s heart is through her duodenum, it seems.

Fascinating stuff, to be sure, but the thing that really caught our eye in the PeerJ article was the authors’ suggestion “that organs behave independently of one another, both within and across species.” Organs behaving independently? A somewhat ominous concept, no doubt, but it does explain a lot of the sounds we hear coming from our guts, which can get pretty frightening, especially on chili night.
 

Dog walking is dangerous business

Yes, you did read that right. A lot of strange things can send you to the emergency department. Go ahead and add dog walking onto that list.

Investigators from Johns Hopkins University estimate that over 422,000 adults presented to U.S. emergency departments with leash-dependent dog walking-related injuries between 2001 and 2020.

freestocks/Unsplash

With almost 53% of U.S. households owning at least one dog in 2021-2022 in the wake of the COVID pet boom, this kind of occurrence is becoming more common than you think. The annual number of dog-walking injuries more than quadrupled from 7,300 to 32,000 over the course of the study, and the researchers link that spike to the promotion of dog walking for fitness, along with the boost of ownership itself.

The most common injuries listed in the National Electronic Injury Surveillance System database were finger fracture, traumatic brain injury, and shoulder sprain or strain. These mostly involved falls from being pulled, tripped, or tangled up in the leash while walking. For those aged 65 years and older, traumatic brain injury and hip fracture were the most common.

Women were 50% more likely to sustain a fracture than were men, and dog owners aged 65 and older were three times as likely to fall, twice as likely to get a fracture, and 60% more likely to have brain injury than were younger people. Now, that’s not to say younger people don’t also get hurt. After all, dogs aren’t ageists. The researchers have that data but it’s coming out later.

Meanwhile, the pitfalls involved with just trying to get our daily steps in while letting Muffin do her business have us on the lookout for random squirrels.

Taking a swing against arthritis

Osteoarthritis is a tough disease to manage. Exercise helps ease the stiffness and pain of the joints, but at the same time, the disease makes it difficult to do that beneficial exercise. Even a relatively simple activity like jogging can hurt more than it helps. If only there were a low-impact exercise that was incredibly popular among the generally older population who are likely to have arthritis.

We love a good golf study here at LOTME, and a group of Australian and U.K. researchers have provided. Osteoarthritis affects 2 million people in the land down under, making it the most common source of disability there. In that population, only 64% reported their physical health to be good, very good, or excellent. Among the 459 golfers with OA that the study authors surveyed, however, the percentage reporting good health rose to more than 90%.

jacoblund/Getty Images

A similar story emerged when they looked at mental health. Nearly a quarter of nongolfers with OA reported high or very high levels of psychological distress, compared with just 8% of golfers. This pattern of improved physical and mental health remained when the researchers looked at the general, non-OA population.

This isn’t the first time golf’s been connected with improved health, and previous studies have shown golf to reduce the risks of cardiovascular disease, diabetes, and obesity, among other things. Just walking one 18-hole round significantly exceeds the CDC’s recommended 150 minutes of physical activity per week. Go out multiple times a week – leaving the cart and beer at home, American golfers – and you’ll be fit for a lifetime.

The golfers on our staff, however, are still waiting for those mental health benefits to kick in. Because when we’re adding up our scorecard after that string of four double bogeys to end the round, we’re most definitely thinking: “Yes, this sport is reducing my psychological distress. I am having fun right now.”
 

Battle of the sexes’ intestines

There are, we’re sure you’ve noticed, some differences between males and females. Females, for one thing, have longer small intestines than males. Everybody knows that, right? You didn’t know? Really? … Really?

Afif Ramdhasuma/Unsplash

Well, then, we’re guessing you haven’t read “Hidden diversity: Comparative functional morphology of humans and other species” by Erin A. McKenney, PhD, of North Carolina State University, Raleigh, and associates, which just appeared in PeerJ. We couldn’t put it down, even in the shower – a real page-turner/scroller. (It’s a great way to clean a phone, for those who also like to scroll, text, or talk on the toilet.)

The researchers got out their rulers, calipers, and string and took many measurements of the digestive systems of 45 human cadavers (21 female and 24 male), which were compared with data from 10 rats, 10 pigs, and 10 bullfrogs, which had been collected (the measurements, not the animals) by undergraduate students enrolled in a comparative anatomy laboratory course at the university.

There was little intestinal-length variation among the four-legged subjects, but when it comes to humans, females have “consistently and significantly longer small intestines than males,” the investigators noted.

The women’s small intestines, almost 14 feet long on average, were about a foot longer than the men’s, which suggests that women are better able to extract nutrients from food and “supports the canalization hypothesis, which posits that women are better able to survive during periods of stress,” coauthor Amanda Hale said in a written statement from the school. The way to a man’s heart may be through his stomach, but the way to a woman’s heart is through her duodenum, it seems.

Fascinating stuff, to be sure, but the thing that really caught our eye in the PeerJ article was the authors’ suggestion “that organs behave independently of one another, both within and across species.” Organs behaving independently? A somewhat ominous concept, no doubt, but it does explain a lot of the sounds we hear coming from our guts, which can get pretty frightening, especially on chili night.
 

Dog walking is dangerous business

Yes, you did read that right. A lot of strange things can send you to the emergency department. Go ahead and add dog walking onto that list.

Investigators from Johns Hopkins University estimate that over 422,000 adults presented to U.S. emergency departments with leash-dependent dog walking-related injuries between 2001 and 2020.

freestocks/Unsplash

With almost 53% of U.S. households owning at least one dog in 2021-2022 in the wake of the COVID pet boom, this kind of occurrence is becoming more common than you think. The annual number of dog-walking injuries more than quadrupled from 7,300 to 32,000 over the course of the study, and the researchers link that spike to the promotion of dog walking for fitness, along with the boost of ownership itself.

The most common injuries listed in the National Electronic Injury Surveillance System database were finger fracture, traumatic brain injury, and shoulder sprain or strain. These mostly involved falls from being pulled, tripped, or tangled up in the leash while walking. For those aged 65 years and older, traumatic brain injury and hip fracture were the most common.

Women were 50% more likely to sustain a fracture than were men, and dog owners aged 65 and older were three times as likely to fall, twice as likely to get a fracture, and 60% more likely to have brain injury than were younger people. Now, that’s not to say younger people don’t also get hurt. After all, dogs aren’t ageists. The researchers have that data but it’s coming out later.

Meanwhile, the pitfalls involved with just trying to get our daily steps in while letting Muffin do her business have us on the lookout for random squirrels.

Exposure to four or more CT scans before age 18 years is associated with more than double the risk for certain cancers into early adulthood, data indicate.
 

In a population-based case-control study that included more than 85,000 participants, researchers found a ninefold increased risk of intracranial tumors among children who received four or more CT scans.

The results “indicate that judicious CT usage and radiation-reducing techniques should be advocated,” Yu-Hsuan Joni Shao, PhD, professor of biomedical informatics at Taipei (Taiwan) Medical University, and colleagues wrote.

The study was published in the Canadian Medical Association Journal.
 

Dose-response relationship

The investigators used the National Health Insurance Research Database in Taiwan to identify 7,807 patients under age 25 years with intracranial tumors (grades I-IV), leukemia, non-Hodgkin lymphomas, or Hodgkin lymphomas that had been diagnosed in a 14-year span between the years 2000 and 2013. They matched each case with 10 control participants without cancer by sex, date of birth, and date of entry into the cohort.

Radiation exposure was calculated for each patient according to number and type of CT scans received and an estimated organ-specific cumulative dose based on previously published models. The investigators excluded patients from the analysis if they had a diagnosis of any malignant disease before the study period or if they had any cancer-predisposing conditions, such as Down syndrome (which entails an increased risk of leukemia) or immunodeficiency (which may require multiple CT scans).

Compared with no exposure, exposure to a single pediatric CT scan was not associated with increased cancer risk. Exposure to two to three CT scans, however, was associated with an increased risk for intracranial tumour (adjusted odds ratio, 2.36), but not for leukemia, non-Hodgkin lymphoma, or Hodgkin lymphoma.  Exposure to four or more CT scans was associated with increased risk for intracranial tumor (aOR, 9.01), leukemia (aOR, 4.80), and non-Hodgkin lymphoma (aOR, 6.76), but not for Hodgkin lymphoma.

The researchers also found a dose-response relationship. Participants in the top quintile of cumulative brain radiation dose had a significantly higher risk for intracranial tumor, compared with nonexposed participants (aOR, 3.61), although this relationship was not seen with the other cancers.

Age at exposure was also a significant factor. Children exposed to four or more CT scans at or before age 6 years had the highest risk for cancer (aOR, 22.95), followed by the same number of scans in those aged 7-12 years (aOR, 5.69) and those aged 13-18 years (aOR, 3.20).

The authors noted that, although these cancers are uncommon in children, “our work reinforces the importance of radiation protection strategies, addressed by the International Atomic Energy Agency. Unnecessary CT scans should be avoided, and special attention should be paid to patients who require repeated CT scans. Parents and pediatric patients should be well informed on risks and benefits before radiological procedures and encouraged to participate in decision-making around imaging.”
 

True risks underestimated?  

Commenting on the findings, Rebecca Smith-Bindman, MD, a radiologist at the University of California, San Francisco, and an expert on the impact of CT scans on patient outcomes, said that she trusts the authors’ overall findings. But “because of the direction of their biases,” the study design “doesn’t let me accept their conclusion that one CT does not elevate the risk.

“It’s an interesting study that found the risk of brain cancer is more than doubled in children who undergo two or more CT scans, but in many ways, their assumptions will underestimate the true risk,” said Dr. Smith-Bindman, who is a professor of epidemiology and biostatistics at UCSF. She said reasons for this include the fact that the investigators used estimated, rather than actual radiation doses; that their estimates “reflect doses far lower than we have found actually occur in clinical practice”; that they do not differentiate between a low-dose or a high-dose CT; and that that they include a long, 3-year lag during which leukemia can develop after a CT scan.

“They did a lot of really well-done adjustments to ensure that they were not overestimating risk,” said Dr. Smith-Bindman. “They made sure to delete children who had cancer susceptibility syndrome, they included a lag of 3 years, assuming that there could be hidden cancers for up to 3 years after the first imaging study when they might have had a preexisting cancer. These are decisions that ensure that any cancer risk they find is real, but it also means that the risks that are estimated are almost certainly an underestimate of the true risks.”

The study was conducted without external funding. The authors declared no relevant financial relationships. Dr. Smith-Bindman is a cofounder of Alara Imaging, a company focused on collecting and reporting radiation dose information associated with CT.

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

Exposure to four or more CT scans before age 18 years is associated with more than double the risk for certain cancers into early adulthood, data indicate.
 

In a population-based case-control study that included more than 85,000 participants, researchers found a ninefold increased risk of intracranial tumors among children who received four or more CT scans.

The results “indicate that judicious CT usage and radiation-reducing techniques should be advocated,” Yu-Hsuan Joni Shao, PhD, professor of biomedical informatics at Taipei (Taiwan) Medical University, and colleagues wrote.

The study was published in the Canadian Medical Association Journal.
 

Dose-response relationship

The investigators used the National Health Insurance Research Database in Taiwan to identify 7,807 patients under age 25 years with intracranial tumors (grades I-IV), leukemia, non-Hodgkin lymphomas, or Hodgkin lymphomas that had been diagnosed in a 14-year span between the years 2000 and 2013. They matched each case with 10 control participants without cancer by sex, date of birth, and date of entry into the cohort.

Radiation exposure was calculated for each patient according to number and type of CT scans received and an estimated organ-specific cumulative dose based on previously published models. The investigators excluded patients from the analysis if they had a diagnosis of any malignant disease before the study period or if they had any cancer-predisposing conditions, such as Down syndrome (which entails an increased risk of leukemia) or immunodeficiency (which may require multiple CT scans).

Compared with no exposure, exposure to a single pediatric CT scan was not associated with increased cancer risk. Exposure to two to three CT scans, however, was associated with an increased risk for intracranial tumour (adjusted odds ratio, 2.36), but not for leukemia, non-Hodgkin lymphoma, or Hodgkin lymphoma.  Exposure to four or more CT scans was associated with increased risk for intracranial tumor (aOR, 9.01), leukemia (aOR, 4.80), and non-Hodgkin lymphoma (aOR, 6.76), but not for Hodgkin lymphoma.

The researchers also found a dose-response relationship. Participants in the top quintile of cumulative brain radiation dose had a significantly higher risk for intracranial tumor, compared with nonexposed participants (aOR, 3.61), although this relationship was not seen with the other cancers.

Age at exposure was also a significant factor. Children exposed to four or more CT scans at or before age 6 years had the highest risk for cancer (aOR, 22.95), followed by the same number of scans in those aged 7-12 years (aOR, 5.69) and those aged 13-18 years (aOR, 3.20).

The authors noted that, although these cancers are uncommon in children, “our work reinforces the importance of radiation protection strategies, addressed by the International Atomic Energy Agency. Unnecessary CT scans should be avoided, and special attention should be paid to patients who require repeated CT scans. Parents and pediatric patients should be well informed on risks and benefits before radiological procedures and encouraged to participate in decision-making around imaging.”
 

True risks underestimated?  

Commenting on the findings, Rebecca Smith-Bindman, MD, a radiologist at the University of California, San Francisco, and an expert on the impact of CT scans on patient outcomes, said that she trusts the authors’ overall findings. But “because of the direction of their biases,” the study design “doesn’t let me accept their conclusion that one CT does not elevate the risk.

“It’s an interesting study that found the risk of brain cancer is more than doubled in children who undergo two or more CT scans, but in many ways, their assumptions will underestimate the true risk,” said Dr. Smith-Bindman, who is a professor of epidemiology and biostatistics at UCSF. She said reasons for this include the fact that the investigators used estimated, rather than actual radiation doses; that their estimates “reflect doses far lower than we have found actually occur in clinical practice”; that they do not differentiate between a low-dose or a high-dose CT; and that that they include a long, 3-year lag during which leukemia can develop after a CT scan.

“They did a lot of really well-done adjustments to ensure that they were not overestimating risk,” said Dr. Smith-Bindman. “They made sure to delete children who had cancer susceptibility syndrome, they included a lag of 3 years, assuming that there could be hidden cancers for up to 3 years after the first imaging study when they might have had a preexisting cancer. These are decisions that ensure that any cancer risk they find is real, but it also means that the risks that are estimated are almost certainly an underestimate of the true risks.”

The study was conducted without external funding. The authors declared no relevant financial relationships. Dr. Smith-Bindman is a cofounder of Alara Imaging, a company focused on collecting and reporting radiation dose information associated with CT.

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

Exposure to four or more CT scans before age 18 years is associated with more than double the risk for certain cancers into early adulthood, data indicate.
 

In a population-based case-control study that included more than 85,000 participants, researchers found a ninefold increased risk of intracranial tumors among children who received four or more CT scans.

The results “indicate that judicious CT usage and radiation-reducing techniques should be advocated,” Yu-Hsuan Joni Shao, PhD, professor of biomedical informatics at Taipei (Taiwan) Medical University, and colleagues wrote.

The study was published in the Canadian Medical Association Journal.
 

Dose-response relationship

The investigators used the National Health Insurance Research Database in Taiwan to identify 7,807 patients under age 25 years with intracranial tumors (grades I-IV), leukemia, non-Hodgkin lymphomas, or Hodgkin lymphomas that had been diagnosed in a 14-year span between the years 2000 and 2013. They matched each case with 10 control participants without cancer by sex, date of birth, and date of entry into the cohort.

Radiation exposure was calculated for each patient according to number and type of CT scans received and an estimated organ-specific cumulative dose based on previously published models. The investigators excluded patients from the analysis if they had a diagnosis of any malignant disease before the study period or if they had any cancer-predisposing conditions, such as Down syndrome (which entails an increased risk of leukemia) or immunodeficiency (which may require multiple CT scans).

Compared with no exposure, exposure to a single pediatric CT scan was not associated with increased cancer risk. Exposure to two to three CT scans, however, was associated with an increased risk for intracranial tumour (adjusted odds ratio, 2.36), but not for leukemia, non-Hodgkin lymphoma, or Hodgkin lymphoma.  Exposure to four or more CT scans was associated with increased risk for intracranial tumor (aOR, 9.01), leukemia (aOR, 4.80), and non-Hodgkin lymphoma (aOR, 6.76), but not for Hodgkin lymphoma.

The researchers also found a dose-response relationship. Participants in the top quintile of cumulative brain radiation dose had a significantly higher risk for intracranial tumor, compared with nonexposed participants (aOR, 3.61), although this relationship was not seen with the other cancers.

Age at exposure was also a significant factor. Children exposed to four or more CT scans at or before age 6 years had the highest risk for cancer (aOR, 22.95), followed by the same number of scans in those aged 7-12 years (aOR, 5.69) and those aged 13-18 years (aOR, 3.20).

The authors noted that, although these cancers are uncommon in children, “our work reinforces the importance of radiation protection strategies, addressed by the International Atomic Energy Agency. Unnecessary CT scans should be avoided, and special attention should be paid to patients who require repeated CT scans. Parents and pediatric patients should be well informed on risks and benefits before radiological procedures and encouraged to participate in decision-making around imaging.”
 

True risks underestimated?  

Commenting on the findings, Rebecca Smith-Bindman, MD, a radiologist at the University of California, San Francisco, and an expert on the impact of CT scans on patient outcomes, said that she trusts the authors’ overall findings. But “because of the direction of their biases,” the study design “doesn’t let me accept their conclusion that one CT does not elevate the risk.

“It’s an interesting study that found the risk of brain cancer is more than doubled in children who undergo two or more CT scans, but in many ways, their assumptions will underestimate the true risk,” said Dr. Smith-Bindman, who is a professor of epidemiology and biostatistics at UCSF. She said reasons for this include the fact that the investigators used estimated, rather than actual radiation doses; that their estimates “reflect doses far lower than we have found actually occur in clinical practice”; that they do not differentiate between a low-dose or a high-dose CT; and that that they include a long, 3-year lag during which leukemia can develop after a CT scan.

“They did a lot of really well-done adjustments to ensure that they were not overestimating risk,” said Dr. Smith-Bindman. “They made sure to delete children who had cancer susceptibility syndrome, they included a lag of 3 years, assuming that there could be hidden cancers for up to 3 years after the first imaging study when they might have had a preexisting cancer. These are decisions that ensure that any cancer risk they find is real, but it also means that the risks that are estimated are almost certainly an underestimate of the true risks.”

The study was conducted without external funding. The authors declared no relevant financial relationships. Dr. Smith-Bindman is a cofounder of Alara Imaging, a company focused on collecting and reporting radiation dose information associated with CT.

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

The vast majority of melatonin gummies sold in the United States may contain up to 347% more melatonin than is listed on the label, and some products also contain cannabidiol. New data may explain the recent massive jump in pediatric hospitalizations.
 

Thenvestigators found that consuming some products as directed could expose consumers, including children, to doses that are 40-130 times greater than what’s recommended.

“The results were quite shocking,” lead researcher Pieter Cohen, MD, with Harvard Medical School, Boston, and Cambridge Health Alliance, Somerville, Mass., said in an interview.

“Melatonin gummies contained up to 347% more melatonin than what was listed on the label, and some products also contained cannabidiol; in one brand of melatonin gummies, there was zero melatonin, just CBD,” Dr. Cohen said.

The study was published online in JAMA.
 

530% jump in pediatric hospitalizations

Melatonin products are not approved by the Food and Drug Administration but are sold over the counter or online.

Previous research from JAMA has shown the use of melatonin has increased over the past 2 decades among people of all ages.

With increased use has come a spike in reports of melatonin overdose, calls to poison control centers, and related ED visits for children.

Federal data show the number of U.S. children who unintentionally ingested melatonin supplements jumped 530% from 2012 to 2021. More than 4,000 of the reported ingestions led to a hospital stay; 287 children required intensive care, and two children died.

It was unclear why melatonin supplements were causing these harms, which led Dr. Cohen’s team to analyze 25 unique brands of “melatonin” gummies purchased online.

One product didn’t contain any melatonin but did contain 31.3 mg of CBD.

In the remaining products, the quantity of melatonin ranged from 1.3 mg to 13.1 mg per serving. The actual quantity of melatonin ranged from 74% to 347% of the labeled quantity, the researchers found.

They note that for a young adult who takes as little as 0.1-0.3 mg of melatonin, plasma concentrations can increase into the normal night-time range.

Of the 25 products (88%) analyzed, 22 were inaccurately labeled, and only 3 (12%) contained a quantity of melatonin that was within 10% (plus or minus) of the declared quantity.

Five products listed CBD as an ingredient. The listed quantity ranged from 10.6 mg to 31.3 mg per serving, although the actual quantity of CBD ranged from 104% to 118% of the labeled quantity.
 

Inquire about use in kids

A limitation of the study is that only one sample of each brand was analyzed, and only gummies were analyzed. It is not known whether the results are generalizable to melatonin products sold as tablets and capsules in the United States or whether the quantity of melatonin within an individual brand may vary from batch to batch.

A recent study from Canada showed similar results. In an analysis of 16 Canadian melatonin brands, the actual dose of melatonin ranged from 17% to 478% of the declared quantity.

It’s estimated that more than 1% of all U.S. children use melatonin supplements, most commonly for sleep, stress, and relaxation.

“Given new research as to the excessive quantities of melatonin in gummies, caution should be used if considering their use,” said Dr. Cohen.

“It’s important to inquire about melatonin use when caring for children, particularly when parents express concerns about their child’s sleep,” he added.

The American Academy of Sleep Medicine recently issued a health advisory encouraging parents to talk to a health care professional before giving melatonin or any supplement to children.
 

Children don’t need melatonin

Commenting on the study, Michael Breus, PhD, clinical psychologist and founder of TheSleepDoctor.com, agreed that analyzing only one sample of each brand is a key limitation “because supplements are made in batches, and gummies in particular are difficult to distribute the active ingredient evenly.

“But even with that being said, 88% of them were labeled incorrectly, so even if there were a few single-sample issues, I kind of doubt its all of them,” Dr. Breus said.

“Kids as a general rule do not need melatonin. Their brains make almost four times the necessary amount already. If you start giving kids pills to help them sleep, then they start to have a pill problem, causing another issue,” Dr. Breus added.

“Most children’s falling asleep and staying sleep issues can be treated with behavioral measures like cognitive-behavioral therapy for insomnia,” he said.

The study had no specific funding. Dr. Cohen has received research support from Consumers Union and PEW Charitable Trusts and royalties from UptoDate. Dr. Breus disclosed no relevant financial relationships.

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

The vast majority of melatonin gummies sold in the United States may contain up to 347% more melatonin than is listed on the label, and some products also contain cannabidiol. New data may explain the recent massive jump in pediatric hospitalizations.
 

Thenvestigators found that consuming some products as directed could expose consumers, including children, to doses that are 40-130 times greater than what’s recommended.

“The results were quite shocking,” lead researcher Pieter Cohen, MD, with Harvard Medical School, Boston, and Cambridge Health Alliance, Somerville, Mass., said in an interview.

“Melatonin gummies contained up to 347% more melatonin than what was listed on the label, and some products also contained cannabidiol; in one brand of melatonin gummies, there was zero melatonin, just CBD,” Dr. Cohen said.

The study was published online in JAMA.
 

530% jump in pediatric hospitalizations

Melatonin products are not approved by the Food and Drug Administration but are sold over the counter or online.

Previous research from JAMA has shown the use of melatonin has increased over the past 2 decades among people of all ages.

With increased use has come a spike in reports of melatonin overdose, calls to poison control centers, and related ED visits for children.

Federal data show the number of U.S. children who unintentionally ingested melatonin supplements jumped 530% from 2012 to 2021. More than 4,000 of the reported ingestions led to a hospital stay; 287 children required intensive care, and two children died.

It was unclear why melatonin supplements were causing these harms, which led Dr. Cohen’s team to analyze 25 unique brands of “melatonin” gummies purchased online.

One product didn’t contain any melatonin but did contain 31.3 mg of CBD.

In the remaining products, the quantity of melatonin ranged from 1.3 mg to 13.1 mg per serving. The actual quantity of melatonin ranged from 74% to 347% of the labeled quantity, the researchers found.

They note that for a young adult who takes as little as 0.1-0.3 mg of melatonin, plasma concentrations can increase into the normal night-time range.

Of the 25 products (88%) analyzed, 22 were inaccurately labeled, and only 3 (12%) contained a quantity of melatonin that was within 10% (plus or minus) of the declared quantity.

Five products listed CBD as an ingredient. The listed quantity ranged from 10.6 mg to 31.3 mg per serving, although the actual quantity of CBD ranged from 104% to 118% of the labeled quantity.
 

Inquire about use in kids

A limitation of the study is that only one sample of each brand was analyzed, and only gummies were analyzed. It is not known whether the results are generalizable to melatonin products sold as tablets and capsules in the United States or whether the quantity of melatonin within an individual brand may vary from batch to batch.

A recent study from Canada showed similar results. In an analysis of 16 Canadian melatonin brands, the actual dose of melatonin ranged from 17% to 478% of the declared quantity.

It’s estimated that more than 1% of all U.S. children use melatonin supplements, most commonly for sleep, stress, and relaxation.

“Given new research as to the excessive quantities of melatonin in gummies, caution should be used if considering their use,” said Dr. Cohen.

“It’s important to inquire about melatonin use when caring for children, particularly when parents express concerns about their child’s sleep,” he added.

The American Academy of Sleep Medicine recently issued a health advisory encouraging parents to talk to a health care professional before giving melatonin or any supplement to children.
 

Children don’t need melatonin

Commenting on the study, Michael Breus, PhD, clinical psychologist and founder of TheSleepDoctor.com, agreed that analyzing only one sample of each brand is a key limitation “because supplements are made in batches, and gummies in particular are difficult to distribute the active ingredient evenly.

“But even with that being said, 88% of them were labeled incorrectly, so even if there were a few single-sample issues, I kind of doubt its all of them,” Dr. Breus said.

“Kids as a general rule do not need melatonin. Their brains make almost four times the necessary amount already. If you start giving kids pills to help them sleep, then they start to have a pill problem, causing another issue,” Dr. Breus added.

“Most children’s falling asleep and staying sleep issues can be treated with behavioral measures like cognitive-behavioral therapy for insomnia,” he said.

The study had no specific funding. Dr. Cohen has received research support from Consumers Union and PEW Charitable Trusts and royalties from UptoDate. Dr. Breus disclosed no relevant financial relationships.

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

The vast majority of melatonin gummies sold in the United States may contain up to 347% more melatonin than is listed on the label, and some products also contain cannabidiol. New data may explain the recent massive jump in pediatric hospitalizations.
 

Thenvestigators found that consuming some products as directed could expose consumers, including children, to doses that are 40-130 times greater than what’s recommended.

“The results were quite shocking,” lead researcher Pieter Cohen, MD, with Harvard Medical School, Boston, and Cambridge Health Alliance, Somerville, Mass., said in an interview.

“Melatonin gummies contained up to 347% more melatonin than what was listed on the label, and some products also contained cannabidiol; in one brand of melatonin gummies, there was zero melatonin, just CBD,” Dr. Cohen said.

The study was published online in JAMA.
 

530% jump in pediatric hospitalizations

Melatonin products are not approved by the Food and Drug Administration but are sold over the counter or online.

Previous research from JAMA has shown the use of melatonin has increased over the past 2 decades among people of all ages.

With increased use has come a spike in reports of melatonin overdose, calls to poison control centers, and related ED visits for children.

Federal data show the number of U.S. children who unintentionally ingested melatonin supplements jumped 530% from 2012 to 2021. More than 4,000 of the reported ingestions led to a hospital stay; 287 children required intensive care, and two children died.

It was unclear why melatonin supplements were causing these harms, which led Dr. Cohen’s team to analyze 25 unique brands of “melatonin” gummies purchased online.

One product didn’t contain any melatonin but did contain 31.3 mg of CBD.

In the remaining products, the quantity of melatonin ranged from 1.3 mg to 13.1 mg per serving. The actual quantity of melatonin ranged from 74% to 347% of the labeled quantity, the researchers found.

They note that for a young adult who takes as little as 0.1-0.3 mg of melatonin, plasma concentrations can increase into the normal night-time range.

Of the 25 products (88%) analyzed, 22 were inaccurately labeled, and only 3 (12%) contained a quantity of melatonin that was within 10% (plus or minus) of the declared quantity.

Five products listed CBD as an ingredient. The listed quantity ranged from 10.6 mg to 31.3 mg per serving, although the actual quantity of CBD ranged from 104% to 118% of the labeled quantity.
 

Inquire about use in kids

A limitation of the study is that only one sample of each brand was analyzed, and only gummies were analyzed. It is not known whether the results are generalizable to melatonin products sold as tablets and capsules in the United States or whether the quantity of melatonin within an individual brand may vary from batch to batch.

A recent study from Canada showed similar results. In an analysis of 16 Canadian melatonin brands, the actual dose of melatonin ranged from 17% to 478% of the declared quantity.

It’s estimated that more than 1% of all U.S. children use melatonin supplements, most commonly for sleep, stress, and relaxation.

“Given new research as to the excessive quantities of melatonin in gummies, caution should be used if considering their use,” said Dr. Cohen.

“It’s important to inquire about melatonin use when caring for children, particularly when parents express concerns about their child’s sleep,” he added.

The American Academy of Sleep Medicine recently issued a health advisory encouraging parents to talk to a health care professional before giving melatonin or any supplement to children.
 

Children don’t need melatonin

Commenting on the study, Michael Breus, PhD, clinical psychologist and founder of TheSleepDoctor.com, agreed that analyzing only one sample of each brand is a key limitation “because supplements are made in batches, and gummies in particular are difficult to distribute the active ingredient evenly.

“But even with that being said, 88% of them were labeled incorrectly, so even if there were a few single-sample issues, I kind of doubt its all of them,” Dr. Breus said.

“Kids as a general rule do not need melatonin. Their brains make almost four times the necessary amount already. If you start giving kids pills to help them sleep, then they start to have a pill problem, causing another issue,” Dr. Breus added.

“Most children’s falling asleep and staying sleep issues can be treated with behavioral measures like cognitive-behavioral therapy for insomnia,” he said.

The study had no specific funding. Dr. Cohen has received research support from Consumers Union and PEW Charitable Trusts and royalties from UptoDate. Dr. Breus disclosed no relevant financial relationships.

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

Abdul Moiz Hafiz, MD, was flabbergasted when he received a phone call from his institution’s credentialing office telling him that he was not certified for interventional cardiology – even though he had passed that exam in 2016.

Dr. Hafiz, who directs the Advanced Structural Heart Disease Program at Southern Illinois University, phoned the American Board of Internal Medicine (ABIM), where he learned that to restore his credentials, he would need to pay $1,225 in maintenance of certification (MOC) fees.

Like Dr. Hafiz, many physicians have been dismayed to learn that the ABIM is now listing as “not certified” physicians who have passed board exams but have not paid annual MOC fees of $220 per year for the first certificate and $120 for each additional certificate.

Even doctors who are participating in mandatory continuing education outside the ABIM’s auspices are finding themselves listed as “not certified.” Some physicians learned of the policy change only after applying for hospital privileges or for jobs that require ABIM certification.

Now that increasing numbers of physicians are employed by hospitals and health care organizations that require ABIM certification, many doctors have no option but to pony up the fees if they want to continue to practice medicine.

“We have no say in the matter,” said Dr. Hafiz, “and there’s no appeal process.”

The change affects nearly 330,000 physicians. Responses to the policy on Twitter included accusations of extortion and denunciations of the ABIM’s “money grab policies.”

Sunil Rao, MD, director of interventional cardiology at NYU Langone Health and president of the Society for Cardiovascular Angiography and Interventions (SCAI), has heard from many SCAI members who had experiences similar to Dr. Hafiz’s. While Dr. Rao describes some of the Twitter outrage as “emotional,” he does acknowledge that the ABIM’s moves appear to be financially motivated.

“The issue here was that as soon as they paid the fee, all of a sudden, ABIM flipped the switch and said they were certified,” he said. “It certainly sounds like a purely financial kind of structure.”

Richard Baron, MD, president and CEO of the ABIM, said doctors are misunderstanding the policy change.

“No doctor loses certification solely for failure to pay fees,” Dr. Baron told this news organization. “What caused them to be reported as not certified was that we didn’t have evidence that they had met program requirements. They could say, ‘But I did meet program requirements, you just didn’t know it.’ To which our answer would be, for us to know it, we have to process them. And our policy is that we don’t process them unless you are current on your fees.”

This is not the first time ABIM policies have alienated physicians.

Last year, the ABIM raised its MOC fees from $165 to $220. That also prompted a wave of outrage. Other grievances go further back. At one time, being board certified was a lifetime credential. However, in 1990 the ABIM made periodic recertification mandatory.

The process, which came to be known as “maintenance of certification,” had to be completed every 10 years, and fees were charged for each certification. At that point, said Dr. Baron, the relationship between the ABIM and physicians changed from a one-time interaction to a career-long relationship. He advises doctors to check in periodically on their portal page at the ABIM or download the app so they will always know their status.

Many physicians would prefer not to be bound to a lifetime relationship with the ABIM. There is an alternative licensing board, the National Board of Physicians and Surgeons (NBPAS), but it is accepted by only a limited number of hospitals.

“Until the NBPAS gains wide recognition,” said Dr. Hafiz, “the ABIM is going to continue to have basically a monopoly over the market.”

The value of MOC itself has been called into question. “There are no direct data supporting the value of the MOC process in either improving care, making patient care safer, or making patient care higher quality,” said Dr. Rao. This feeds frustration in a clinical community already dealing with onerous training requirements and expensive board certification exams and adds to the perception that it is a purely financial transaction, he said. (Studies examining whether the MOC system improves patient care have shown mixed results.)

The true value of the ABIM to physicians, Dr. Baron contends, is that the organization is an independent third party that differentiates those doctors from people who don’t have their skills, training, and expertise. “In these days, where anyone can be an ‘expert’ on the Internet, that’s more valuable than ever before,” he said.
 

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

Abdul Moiz Hafiz, MD, was flabbergasted when he received a phone call from his institution’s credentialing office telling him that he was not certified for interventional cardiology – even though he had passed that exam in 2016.

Dr. Hafiz, who directs the Advanced Structural Heart Disease Program at Southern Illinois University, phoned the American Board of Internal Medicine (ABIM), where he learned that to restore his credentials, he would need to pay $1,225 in maintenance of certification (MOC) fees.

Like Dr. Hafiz, many physicians have been dismayed to learn that the ABIM is now listing as “not certified” physicians who have passed board exams but have not paid annual MOC fees of $220 per year for the first certificate and $120 for each additional certificate.

Even doctors who are participating in mandatory continuing education outside the ABIM’s auspices are finding themselves listed as “not certified.” Some physicians learned of the policy change only after applying for hospital privileges or for jobs that require ABIM certification.

Now that increasing numbers of physicians are employed by hospitals and health care organizations that require ABIM certification, many doctors have no option but to pony up the fees if they want to continue to practice medicine.

“We have no say in the matter,” said Dr. Hafiz, “and there’s no appeal process.”

The change affects nearly 330,000 physicians. Responses to the policy on Twitter included accusations of extortion and denunciations of the ABIM’s “money grab policies.”

Sunil Rao, MD, director of interventional cardiology at NYU Langone Health and president of the Society for Cardiovascular Angiography and Interventions (SCAI), has heard from many SCAI members who had experiences similar to Dr. Hafiz’s. While Dr. Rao describes some of the Twitter outrage as “emotional,” he does acknowledge that the ABIM’s moves appear to be financially motivated.

“The issue here was that as soon as they paid the fee, all of a sudden, ABIM flipped the switch and said they were certified,” he said. “It certainly sounds like a purely financial kind of structure.”

Richard Baron, MD, president and CEO of the ABIM, said doctors are misunderstanding the policy change.

“No doctor loses certification solely for failure to pay fees,” Dr. Baron told this news organization. “What caused them to be reported as not certified was that we didn’t have evidence that they had met program requirements. They could say, ‘But I did meet program requirements, you just didn’t know it.’ To which our answer would be, for us to know it, we have to process them. And our policy is that we don’t process them unless you are current on your fees.”

This is not the first time ABIM policies have alienated physicians.

Last year, the ABIM raised its MOC fees from $165 to $220. That also prompted a wave of outrage. Other grievances go further back. At one time, being board certified was a lifetime credential. However, in 1990 the ABIM made periodic recertification mandatory.

The process, which came to be known as “maintenance of certification,” had to be completed every 10 years, and fees were charged for each certification. At that point, said Dr. Baron, the relationship between the ABIM and physicians changed from a one-time interaction to a career-long relationship. He advises doctors to check in periodically on their portal page at the ABIM or download the app so they will always know their status.

Many physicians would prefer not to be bound to a lifetime relationship with the ABIM. There is an alternative licensing board, the National Board of Physicians and Surgeons (NBPAS), but it is accepted by only a limited number of hospitals.

“Until the NBPAS gains wide recognition,” said Dr. Hafiz, “the ABIM is going to continue to have basically a monopoly over the market.”

The value of MOC itself has been called into question. “There are no direct data supporting the value of the MOC process in either improving care, making patient care safer, or making patient care higher quality,” said Dr. Rao. This feeds frustration in a clinical community already dealing with onerous training requirements and expensive board certification exams and adds to the perception that it is a purely financial transaction, he said. (Studies examining whether the MOC system improves patient care have shown mixed results.)

The true value of the ABIM to physicians, Dr. Baron contends, is that the organization is an independent third party that differentiates those doctors from people who don’t have their skills, training, and expertise. “In these days, where anyone can be an ‘expert’ on the Internet, that’s more valuable than ever before,” he said.
 

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

Abdul Moiz Hafiz, MD, was flabbergasted when he received a phone call from his institution’s credentialing office telling him that he was not certified for interventional cardiology – even though he had passed that exam in 2016.

Dr. Hafiz, who directs the Advanced Structural Heart Disease Program at Southern Illinois University, phoned the American Board of Internal Medicine (ABIM), where he learned that to restore his credentials, he would need to pay $1,225 in maintenance of certification (MOC) fees.

Like Dr. Hafiz, many physicians have been dismayed to learn that the ABIM is now listing as “not certified” physicians who have passed board exams but have not paid annual MOC fees of $220 per year for the first certificate and $120 for each additional certificate.

Even doctors who are participating in mandatory continuing education outside the ABIM’s auspices are finding themselves listed as “not certified.” Some physicians learned of the policy change only after applying for hospital privileges or for jobs that require ABIM certification.

Now that increasing numbers of physicians are employed by hospitals and health care organizations that require ABIM certification, many doctors have no option but to pony up the fees if they want to continue to practice medicine.

“We have no say in the matter,” said Dr. Hafiz, “and there’s no appeal process.”

The change affects nearly 330,000 physicians. Responses to the policy on Twitter included accusations of extortion and denunciations of the ABIM’s “money grab policies.”

Sunil Rao, MD, director of interventional cardiology at NYU Langone Health and president of the Society for Cardiovascular Angiography and Interventions (SCAI), has heard from many SCAI members who had experiences similar to Dr. Hafiz’s. While Dr. Rao describes some of the Twitter outrage as “emotional,” he does acknowledge that the ABIM’s moves appear to be financially motivated.

“The issue here was that as soon as they paid the fee, all of a sudden, ABIM flipped the switch and said they were certified,” he said. “It certainly sounds like a purely financial kind of structure.”

Richard Baron, MD, president and CEO of the ABIM, said doctors are misunderstanding the policy change.

“No doctor loses certification solely for failure to pay fees,” Dr. Baron told this news organization. “What caused them to be reported as not certified was that we didn’t have evidence that they had met program requirements. They could say, ‘But I did meet program requirements, you just didn’t know it.’ To which our answer would be, for us to know it, we have to process them. And our policy is that we don’t process them unless you are current on your fees.”

This is not the first time ABIM policies have alienated physicians.

Last year, the ABIM raised its MOC fees from $165 to $220. That also prompted a wave of outrage. Other grievances go further back. At one time, being board certified was a lifetime credential. However, in 1990 the ABIM made periodic recertification mandatory.

The process, which came to be known as “maintenance of certification,” had to be completed every 10 years, and fees were charged for each certification. At that point, said Dr. Baron, the relationship between the ABIM and physicians changed from a one-time interaction to a career-long relationship. He advises doctors to check in periodically on their portal page at the ABIM or download the app so they will always know their status.

Many physicians would prefer not to be bound to a lifetime relationship with the ABIM. There is an alternative licensing board, the National Board of Physicians and Surgeons (NBPAS), but it is accepted by only a limited number of hospitals.

“Until the NBPAS gains wide recognition,” said Dr. Hafiz, “the ABIM is going to continue to have basically a monopoly over the market.”

The value of MOC itself has been called into question. “There are no direct data supporting the value of the MOC process in either improving care, making patient care safer, or making patient care higher quality,” said Dr. Rao. This feeds frustration in a clinical community already dealing with onerous training requirements and expensive board certification exams and adds to the perception that it is a purely financial transaction, he said. (Studies examining whether the MOC system improves patient care have shown mixed results.)

The true value of the ABIM to physicians, Dr. Baron contends, is that the organization is an independent third party that differentiates those doctors from people who don’t have their skills, training, and expertise. “In these days, where anyone can be an ‘expert’ on the Internet, that’s more valuable than ever before,” he said.
 

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