Vasculitis of the coronary arteries is a well-recognized acute complication of Kawasaki disease, but the long-term risk of cardiovascular (CV) sequelae does not appear to be clinically meaningful for most patients, according to results from an analysis of data presented at the annual meeting of the Canadian Rheumatology Association.

For patients and parents, these data provide “a message of reassurance,” according to Jennifer J.Y. Lee, MD, a pediatric rheumatologist affiliated with the Hospital for Sick Children, Toronto.

The long-term outcomes were characterized as reassuring even though rates of hypertension, major adverse cardiac events (MACE), and death from CV events were higher in patients with Kawasaki disease relative to controls in a retrospective data-linkage study. In fact, these differences were highly statistically significant, but the absolute differences were extremely small.

For this analysis, the 1,174 patients diagnosed with Kawasaki disease at Dr. Lee’s institution between 1991 and 2008 were compared in a 10:1 ratio to 11,740 controls matched for factors such as age, sex, ethnicity, and geographic region. The median follow-up period was 20 years, and the maximum was 28 years.
 

Adjusted CV risks are significant

In an adjusted Cox proportional hazard ratio model, patients in the Kawasaki group had a more than twofold increase in risk for hypertension (aHR, 2.3; P < .0001) and all-cause mortality (aHR, 2.5; P = .009). They also had more than a 10-fold increase in risk for MACE (aHR, 10.3; P < .0001).

These statistics belie the clinical relevance, according to Dr. Lee. Because of the very low rates of all the measured events in both groups, there was just one more case of hypertension per 1,250 patient-years of follow-up, one more case of MACE per 833 patient-years of follow-up, and one more death for 3,846 patient years of follow-up.

Moreover, when these outcomes were graphed over time, most events occurred during the acute period or in the initial years of follow-up.

“There was not a constant increase in risk of these outcomes over time for patients with Kawasaki disease relative to the controls,” Dr. Lee reported. “The long-term prognosis for Kawasaki patients remains favorable.”

European group reports similar results

Similar results from a single-center experience were published 3 years ago. In that study, 207 Kawasaki patients treated at the University of Lausanne (Switzerland) were followed for 30 years. Complications after the acute phase were characterized as “rare.”

For example, only three patients (1.4%) had a subsequent episode of myocardial ischemia. All three had developed a coronary aneurysm during the acute phase of Kawasaki disease. The authors of that study reported that children who had not received immunoglobulins during the acute phase or who developed Kawasaki disease outside of the usual age range were more likely to have subsequent events, such as disease recurrence.

Other studies of long-term CV outcomes in patients with Kawasaki disease generally show similar data, according to James T. Gaensbauer, MD, a pediatric infectious disease specialist at the Mayo Clinic, Rochester, Minn.

“I generally agree with the premise that major complications are rare when you compare a cohort of patients with Kawasaki disease with the general population,” Dr. Gaensbauer said. However, he added, “I do not think you can say no one needs to worry.”
 

Severity of acute disease might matter

During the acute phase of Kawasaki disease, the arterial damage varies. As suggested in the University of Lausanne follow-up, patients with significant coronary aneurysms do appear to be at greater risk of long-term complications. Dr. Gaensbauer cited a statement from the American Heart Association that noted a higher risk of CV sequelae from Kawasaki disease with a greater or more severe coronary aneurysm or in the face of other evidence of damage to the arterial tree.

“The clinical course within the first 2 years of Kawasaki disease appears to be important for risk of CV complications after this time,” Dr. Gaensbauer said.

The absolute risk of CV events in patients with a more complicated acute course of Kawasaki disease remains incompletely understood, but Dr. Gaensbauer said that there are several sets of data, including these new data from the Hospital for Sick Children, that suggest that the overall prognosis is good. However, he cautioned that this reassurance does not necessarily apply to children with a difficult acute course.

According to the 2017 AHA statement on Kawasaki disease, risk stratification based on echocardiography and other measures after the acute phase of Kawasaki disease are reasonable to determine if long-term follow-up is needed. In those without abnormalities, it is reasonable to forgo further cardiology assessment.

Dr. Lee and Dr. Gaensbauer reported having no potential conflicts of interest.

Vasculitis of the coronary arteries is a well-recognized acute complication of Kawasaki disease, but the long-term risk of cardiovascular (CV) sequelae does not appear to be clinically meaningful for most patients, according to results from an analysis of data presented at the annual meeting of the Canadian Rheumatology Association.

For patients and parents, these data provide “a message of reassurance,” according to Jennifer J.Y. Lee, MD, a pediatric rheumatologist affiliated with the Hospital for Sick Children, Toronto.

The long-term outcomes were characterized as reassuring even though rates of hypertension, major adverse cardiac events (MACE), and death from CV events were higher in patients with Kawasaki disease relative to controls in a retrospective data-linkage study. In fact, these differences were highly statistically significant, but the absolute differences were extremely small.

For this analysis, the 1,174 patients diagnosed with Kawasaki disease at Dr. Lee’s institution between 1991 and 2008 were compared in a 10:1 ratio to 11,740 controls matched for factors such as age, sex, ethnicity, and geographic region. The median follow-up period was 20 years, and the maximum was 28 years.
 

Adjusted CV risks are significant

In an adjusted Cox proportional hazard ratio model, patients in the Kawasaki group had a more than twofold increase in risk for hypertension (aHR, 2.3; P < .0001) and all-cause mortality (aHR, 2.5; P = .009). They also had more than a 10-fold increase in risk for MACE (aHR, 10.3; P < .0001).

These statistics belie the clinical relevance, according to Dr. Lee. Because of the very low rates of all the measured events in both groups, there was just one more case of hypertension per 1,250 patient-years of follow-up, one more case of MACE per 833 patient-years of follow-up, and one more death for 3,846 patient years of follow-up.

Moreover, when these outcomes were graphed over time, most events occurred during the acute period or in the initial years of follow-up.

“There was not a constant increase in risk of these outcomes over time for patients with Kawasaki disease relative to the controls,” Dr. Lee reported. “The long-term prognosis for Kawasaki patients remains favorable.”

European group reports similar results

Similar results from a single-center experience were published 3 years ago. In that study, 207 Kawasaki patients treated at the University of Lausanne (Switzerland) were followed for 30 years. Complications after the acute phase were characterized as “rare.”

For example, only three patients (1.4%) had a subsequent episode of myocardial ischemia. All three had developed a coronary aneurysm during the acute phase of Kawasaki disease. The authors of that study reported that children who had not received immunoglobulins during the acute phase or who developed Kawasaki disease outside of the usual age range were more likely to have subsequent events, such as disease recurrence.

Other studies of long-term CV outcomes in patients with Kawasaki disease generally show similar data, according to James T. Gaensbauer, MD, a pediatric infectious disease specialist at the Mayo Clinic, Rochester, Minn.

“I generally agree with the premise that major complications are rare when you compare a cohort of patients with Kawasaki disease with the general population,” Dr. Gaensbauer said. However, he added, “I do not think you can say no one needs to worry.”
 

Severity of acute disease might matter

During the acute phase of Kawasaki disease, the arterial damage varies. As suggested in the University of Lausanne follow-up, patients with significant coronary aneurysms do appear to be at greater risk of long-term complications. Dr. Gaensbauer cited a statement from the American Heart Association that noted a higher risk of CV sequelae from Kawasaki disease with a greater or more severe coronary aneurysm or in the face of other evidence of damage to the arterial tree.

“The clinical course within the first 2 years of Kawasaki disease appears to be important for risk of CV complications after this time,” Dr. Gaensbauer said.

The absolute risk of CV events in patients with a more complicated acute course of Kawasaki disease remains incompletely understood, but Dr. Gaensbauer said that there are several sets of data, including these new data from the Hospital for Sick Children, that suggest that the overall prognosis is good. However, he cautioned that this reassurance does not necessarily apply to children with a difficult acute course.

According to the 2017 AHA statement on Kawasaki disease, risk stratification based on echocardiography and other measures after the acute phase of Kawasaki disease are reasonable to determine if long-term follow-up is needed. In those without abnormalities, it is reasonable to forgo further cardiology assessment.

Dr. Lee and Dr. Gaensbauer reported having no potential conflicts of interest.

Vasculitis of the coronary arteries is a well-recognized acute complication of Kawasaki disease, but the long-term risk of cardiovascular (CV) sequelae does not appear to be clinically meaningful for most patients, according to results from an analysis of data presented at the annual meeting of the Canadian Rheumatology Association.

For patients and parents, these data provide “a message of reassurance,” according to Jennifer J.Y. Lee, MD, a pediatric rheumatologist affiliated with the Hospital for Sick Children, Toronto.

The long-term outcomes were characterized as reassuring even though rates of hypertension, major adverse cardiac events (MACE), and death from CV events were higher in patients with Kawasaki disease relative to controls in a retrospective data-linkage study. In fact, these differences were highly statistically significant, but the absolute differences were extremely small.

For this analysis, the 1,174 patients diagnosed with Kawasaki disease at Dr. Lee’s institution between 1991 and 2008 were compared in a 10:1 ratio to 11,740 controls matched for factors such as age, sex, ethnicity, and geographic region. The median follow-up period was 20 years, and the maximum was 28 years.
 

Adjusted CV risks are significant

In an adjusted Cox proportional hazard ratio model, patients in the Kawasaki group had a more than twofold increase in risk for hypertension (aHR, 2.3; P < .0001) and all-cause mortality (aHR, 2.5; P = .009). They also had more than a 10-fold increase in risk for MACE (aHR, 10.3; P < .0001).

These statistics belie the clinical relevance, according to Dr. Lee. Because of the very low rates of all the measured events in both groups, there was just one more case of hypertension per 1,250 patient-years of follow-up, one more case of MACE per 833 patient-years of follow-up, and one more death for 3,846 patient years of follow-up.

Moreover, when these outcomes were graphed over time, most events occurred during the acute period or in the initial years of follow-up.

“There was not a constant increase in risk of these outcomes over time for patients with Kawasaki disease relative to the controls,” Dr. Lee reported. “The long-term prognosis for Kawasaki patients remains favorable.”

European group reports similar results

Similar results from a single-center experience were published 3 years ago. In that study, 207 Kawasaki patients treated at the University of Lausanne (Switzerland) were followed for 30 years. Complications after the acute phase were characterized as “rare.”

For example, only three patients (1.4%) had a subsequent episode of myocardial ischemia. All three had developed a coronary aneurysm during the acute phase of Kawasaki disease. The authors of that study reported that children who had not received immunoglobulins during the acute phase or who developed Kawasaki disease outside of the usual age range were more likely to have subsequent events, such as disease recurrence.

Other studies of long-term CV outcomes in patients with Kawasaki disease generally show similar data, according to James T. Gaensbauer, MD, a pediatric infectious disease specialist at the Mayo Clinic, Rochester, Minn.

“I generally agree with the premise that major complications are rare when you compare a cohort of patients with Kawasaki disease with the general population,” Dr. Gaensbauer said. However, he added, “I do not think you can say no one needs to worry.”
 

Severity of acute disease might matter

During the acute phase of Kawasaki disease, the arterial damage varies. As suggested in the University of Lausanne follow-up, patients with significant coronary aneurysms do appear to be at greater risk of long-term complications. Dr. Gaensbauer cited a statement from the American Heart Association that noted a higher risk of CV sequelae from Kawasaki disease with a greater or more severe coronary aneurysm or in the face of other evidence of damage to the arterial tree.

“The clinical course within the first 2 years of Kawasaki disease appears to be important for risk of CV complications after this time,” Dr. Gaensbauer said.

The absolute risk of CV events in patients with a more complicated acute course of Kawasaki disease remains incompletely understood, but Dr. Gaensbauer said that there are several sets of data, including these new data from the Hospital for Sick Children, that suggest that the overall prognosis is good. However, he cautioned that this reassurance does not necessarily apply to children with a difficult acute course.

According to the 2017 AHA statement on Kawasaki disease, risk stratification based on echocardiography and other measures after the acute phase of Kawasaki disease are reasonable to determine if long-term follow-up is needed. In those without abnormalities, it is reasonable to forgo further cardiology assessment.

Dr. Lee and Dr. Gaensbauer reported having no potential conflicts of interest.

Long COVID continues to be a moving target – continuously evolving and still surprising doctors and patients who have sometimes incapacitating long-term symptoms.

Little about the disorder seems predictable at this point. People can have long COVID after asymptomatic, mild, or severe COVID-19, for example. And when a person gets long COVID – also known as long-haul COVID – symptoms can vary widely.

To address all the uncertainty, the New York State Department of Health gathered experts in primary care, pediatrics, physical medicine, rehabilitation, and pulmonology to answer some pressing questions.

New York in 2020 was the first epicenter of the pandemic in the United States, making it also the center of the long COVID epidemic, says Emily Lutterloh, MD, director of the Division of Epidemiology at the New York State Department of Health.
 

What do you do when you’re seeing a patient with long COVID for the first time?

The first exam varies because there are so many different ways long COVID presents itself, says Benjamin Abramoff, MD, a physical medicine and rehabilitation specialist at Penn Medicine in Philadelphia.

I’ve now been seriously ill with #LongCovid for 11 months. I was never hospitalized. I didn’t even have a “mild” covid case. Instead, I developed Long Covid from an asymptomatic infection.

I’m far from unique. Up to 1/5 of asymptomatic patients go on to have long-term symptoms.

— Ravi Veriah Jacques (@RaviHVJ) February 3, 2022

Assessing their previous and current care also helps to direct their ongoing management, says Zijian Chen, MD, medical director of the Center for Post-COVID Care at Mount Sinai Health System in New York.
 

Can vaccination help people with long COVID?

Anything that we can do to help prevent people from being critically ill or being hospitalized with COVID-19 is helpful to prevent long COVID, says Dr. Abramoff, who is also director of the long COVID clinic at the University of Pennsylvania, Philadelphia.

“So that’s something I always discuss with patients. In some research, sometimes patients do feel better after the vaccine,” he says.
 

What kind of therapies do you find helpful for your patients?

Rehabilitation is a key part of recovery from long COVID, Dr. Abramoff says. “It is very important to make this very patient-specific.”

“We have patients that are working. They’re already going to the gym in some cases but don’t feel like they have the same endurance,” he says. “And then we have patients who are so crippled by their fatigue that they can’t get out of bed.”
 

1/ What is #LongCOVID?!

A disabling malady from ongoing inflammation, autoimmunity, & potential viral reservoirs (GI, brain?)

NEW DATA: The Lungs “light up” on special MRI Scans 3 to 9 months later in patients never hospitalized for COVID.https://t.co/I2kyZ4cK5F pic.twitter.com/dL1P67L2DK

— WesElyMD (@WesElyMD) February 2, 2022

An exercise program can help people who have long COVID.

“There’s a big role for therapy services in the recovery of these patients,” says John Baratta, MD, of the department of physical medicine and rehabilitation at the University of North Carolina at Chapel Hill.

But the limited number of long COVID clinics can mean some people are unable to get to therapists trained on the needs of patients with lingering COVID symptoms. Educating community physical and occupational therapists is one solution.
 

How long does it take for people with long COVID to recover and get back to 100% if they can?

Specific numbers aren’t really available, Dr. Baratta says.

“But I can tell you the general trend that I see is that a lot of patients have a gradual improvement of symptoms. The slow but steady improvement with time may be the body’s natural healing process, a result of medical interventions, or both.”

It can help to reassure people with long COVID that they will not be discharged from care until they feel they’ve maximized their health, says Sharagim Kemp, DO, medical director of the COVID Recovery Program for Nuvance Health, a health system in New York and Connecticut.

It’s essential to set realistic recovery expectations and tell patients that not everyone will return to 100% of their pre-COVID functioning, she says.

“Once we are able to help them reset their expectations, there’s almost an accelerated recovery because they are not putting that pressure on themselves anymore,” Dr. Kemp says.
 

What are the most common symptoms you’re seeing in long COVID?

It’s helpful to think of long COVID as a very broad umbrella term, Dr. Abramoff says.

Echoing what many others have observed, fatigue, cognitive dysfunction or “brain fog,“ and shortness of breath or troubled breathing appear to be the most common symptoms, he says.

Some reported vague symptoms, Dr. Kemp says.

People may go to the doctor “not even realizing that they had COVID. That’s one of the important points here – to have a high index of suspicion for patients who come in with multiple symptoms,” she says.

For this reason, patients can report symptoms that don’t necessarily fit into any specialty, says Sarah J. Ryan, MD, an internal medicine doctor at Columbia University Irving Medical Center in New York. People say they are “just not themselves” or they are tired after their COVID-19 recovery.
 

Is there a connection between severe COVID cases and severe long COVID?

“It’s not like that at all. I would say that more than 80% of the patients that we see had mild to moderate illness and they were not hospitalized,” Dr. Baratta says.

Long COVID is a bit different in children and teenagers, says Ixsy Ramirez, MD, a pediatric pulmonologist at University of Michigan Health, Ann Arbor. Most patients in the long COVID clinic at the University of Michigan were previously healthy, and not children with asthma or other lung conditions as one might expect. In fact, many are student athletes, or were before they had long COVID.

In this population, shortness of breath is most common, followed by chest pain and fatigue. Unfortunately, the symptoms are so serious for many kids that their performance is limited, even if they can return to competitive play.
 

Are there defined criteria you use to diagnose long COVID? How do you give someone a diagnosis?

That’s an ever-evolving question, Dr. Kemp says. The generally accepted definition centers on persistent or new symptoms 4 weeks or more after the original COVID-19 illness, but there are exceptions.

Researchers are working on lab tests to help confirm the diagnosis. But without a definitive blood biomarker, getting to the diagnosis requires “some thorough detective work,” Dr. Ryan says.
 

Do you bring in mental health providers to help with treatment?

“We focus on mental health quite a bit actually,” says, Dr. Chen, cofounder of his institution’s COVID recovery clinic. Mount Sinai offers one-on-one and group mental health services, for example.

“Personally, I’ve seen patients that I did not expect to have such severe mental health changes” with long COVID.
 

One of the most powerful accounts and testimonies I have seen on what most #LongCovid patients experience when interacting with their doctors.

“I did not fit in a box, so they chose not to see me, even worse they made me feel like it was my fault for not fitting in their box” pic.twitter.com/7GQLBucuO5

— charlos (@loscharlos) February 3, 2022

Examples include severe depression, cases of acute psychosis, hallucinations, and other problems “that are really unexpected after a viral illness.”

Stony Brook University Hospital in New York has a long COVID clinic staffed by multiple primary care doctors who do exams and refer patients to services. A bonus of offering psychological services to all post-COVID patients is doctors get a more complete picture of each person and a better understanding of what they are going through, says Abigail Chua, MD, a pulmonologist at Stony Brook.

Some empathy is essential, Dr. Baratta says. “It’s important to recognize that a lot of these patients present with a sense of grief or loss for their prior life.”
 

What does the future hold?

A simple test to diagnose long COVID, combined with an effective treatment that helps people feel better within a week, would be ideal, Dr. Abramoff says.

“That would be lovely. But you know, we’re just not at that point.”

And it would be helpful to start identifying subtypes of long COVID so diagnosis and treatment can be more targeted, Dr. Abramoff says. Otherwise, “It’s going to be a very challenging approach to try to treat all of our patients with long COVID symptoms the same way.”

Good clinical trials likewise are needed to address all the subtleties of long COVID.

A number of long COVID centers are collaborating on research to find out more, Dr. Chen says. Actions include setting up a bank of tissue samples from people with long COVID so researchers can continue to figure out the condition.

One goal, Dr. Chen says, would be the ability to treat long COVID rather than just its symptoms.

Long COVID emphasizes the need to prevent people from getting COVID in the first place, Dr. Ramirez says. This will continue to be important, particularly when some people dismiss the seriousness of COVID, comparing it to a cold if they get it. That attitude discounts the large number of people who unfortunately go on to develop long-term, often debilitating, symptoms.

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

Long COVID continues to be a moving target – continuously evolving and still surprising doctors and patients who have sometimes incapacitating long-term symptoms.

Little about the disorder seems predictable at this point. People can have long COVID after asymptomatic, mild, or severe COVID-19, for example. And when a person gets long COVID – also known as long-haul COVID – symptoms can vary widely.

To address all the uncertainty, the New York State Department of Health gathered experts in primary care, pediatrics, physical medicine, rehabilitation, and pulmonology to answer some pressing questions.

New York in 2020 was the first epicenter of the pandemic in the United States, making it also the center of the long COVID epidemic, says Emily Lutterloh, MD, director of the Division of Epidemiology at the New York State Department of Health.
 

What do you do when you’re seeing a patient with long COVID for the first time?

The first exam varies because there are so many different ways long COVID presents itself, says Benjamin Abramoff, MD, a physical medicine and rehabilitation specialist at Penn Medicine in Philadelphia.

I’ve now been seriously ill with #LongCovid for 11 months. I was never hospitalized. I didn’t even have a “mild” covid case. Instead, I developed Long Covid from an asymptomatic infection.

I’m far from unique. Up to 1/5 of asymptomatic patients go on to have long-term symptoms.

— Ravi Veriah Jacques (@RaviHVJ) February 3, 2022

Assessing their previous and current care also helps to direct their ongoing management, says Zijian Chen, MD, medical director of the Center for Post-COVID Care at Mount Sinai Health System in New York.
 

Can vaccination help people with long COVID?

Anything that we can do to help prevent people from being critically ill or being hospitalized with COVID-19 is helpful to prevent long COVID, says Dr. Abramoff, who is also director of the long COVID clinic at the University of Pennsylvania, Philadelphia.

“So that’s something I always discuss with patients. In some research, sometimes patients do feel better after the vaccine,” he says.
 

What kind of therapies do you find helpful for your patients?

Rehabilitation is a key part of recovery from long COVID, Dr. Abramoff says. “It is very important to make this very patient-specific.”

“We have patients that are working. They’re already going to the gym in some cases but don’t feel like they have the same endurance,” he says. “And then we have patients who are so crippled by their fatigue that they can’t get out of bed.”
 

1/ What is #LongCOVID?!

A disabling malady from ongoing inflammation, autoimmunity, & potential viral reservoirs (GI, brain?)

NEW DATA: The Lungs “light up” on special MRI Scans 3 to 9 months later in patients never hospitalized for COVID.https://t.co/I2kyZ4cK5F pic.twitter.com/dL1P67L2DK

— WesElyMD (@WesElyMD) February 2, 2022

An exercise program can help people who have long COVID.

“There’s a big role for therapy services in the recovery of these patients,” says John Baratta, MD, of the department of physical medicine and rehabilitation at the University of North Carolina at Chapel Hill.

But the limited number of long COVID clinics can mean some people are unable to get to therapists trained on the needs of patients with lingering COVID symptoms. Educating community physical and occupational therapists is one solution.
 

How long does it take for people with long COVID to recover and get back to 100% if they can?

Specific numbers aren’t really available, Dr. Baratta says.

“But I can tell you the general trend that I see is that a lot of patients have a gradual improvement of symptoms. The slow but steady improvement with time may be the body’s natural healing process, a result of medical interventions, or both.”

It can help to reassure people with long COVID that they will not be discharged from care until they feel they’ve maximized their health, says Sharagim Kemp, DO, medical director of the COVID Recovery Program for Nuvance Health, a health system in New York and Connecticut.

It’s essential to set realistic recovery expectations and tell patients that not everyone will return to 100% of their pre-COVID functioning, she says.

“Once we are able to help them reset their expectations, there’s almost an accelerated recovery because they are not putting that pressure on themselves anymore,” Dr. Kemp says.
 

What are the most common symptoms you’re seeing in long COVID?

It’s helpful to think of long COVID as a very broad umbrella term, Dr. Abramoff says.

Echoing what many others have observed, fatigue, cognitive dysfunction or “brain fog,“ and shortness of breath or troubled breathing appear to be the most common symptoms, he says.

Some reported vague symptoms, Dr. Kemp says.

People may go to the doctor “not even realizing that they had COVID. That’s one of the important points here – to have a high index of suspicion for patients who come in with multiple symptoms,” she says.

For this reason, patients can report symptoms that don’t necessarily fit into any specialty, says Sarah J. Ryan, MD, an internal medicine doctor at Columbia University Irving Medical Center in New York. People say they are “just not themselves” or they are tired after their COVID-19 recovery.
 

Is there a connection between severe COVID cases and severe long COVID?

“It’s not like that at all. I would say that more than 80% of the patients that we see had mild to moderate illness and they were not hospitalized,” Dr. Baratta says.

Long COVID is a bit different in children and teenagers, says Ixsy Ramirez, MD, a pediatric pulmonologist at University of Michigan Health, Ann Arbor. Most patients in the long COVID clinic at the University of Michigan were previously healthy, and not children with asthma or other lung conditions as one might expect. In fact, many are student athletes, or were before they had long COVID.

In this population, shortness of breath is most common, followed by chest pain and fatigue. Unfortunately, the symptoms are so serious for many kids that their performance is limited, even if they can return to competitive play.
 

Are there defined criteria you use to diagnose long COVID? How do you give someone a diagnosis?

That’s an ever-evolving question, Dr. Kemp says. The generally accepted definition centers on persistent or new symptoms 4 weeks or more after the original COVID-19 illness, but there are exceptions.

Researchers are working on lab tests to help confirm the diagnosis. But without a definitive blood biomarker, getting to the diagnosis requires “some thorough detective work,” Dr. Ryan says.
 

Do you bring in mental health providers to help with treatment?

“We focus on mental health quite a bit actually,” says, Dr. Chen, cofounder of his institution’s COVID recovery clinic. Mount Sinai offers one-on-one and group mental health services, for example.

“Personally, I’ve seen patients that I did not expect to have such severe mental health changes” with long COVID.
 

One of the most powerful accounts and testimonies I have seen on what most #LongCovid patients experience when interacting with their doctors.

“I did not fit in a box, so they chose not to see me, even worse they made me feel like it was my fault for not fitting in their box” pic.twitter.com/7GQLBucuO5

— charlos (@loscharlos) February 3, 2022

Examples include severe depression, cases of acute psychosis, hallucinations, and other problems “that are really unexpected after a viral illness.”

Stony Brook University Hospital in New York has a long COVID clinic staffed by multiple primary care doctors who do exams and refer patients to services. A bonus of offering psychological services to all post-COVID patients is doctors get a more complete picture of each person and a better understanding of what they are going through, says Abigail Chua, MD, a pulmonologist at Stony Brook.

Some empathy is essential, Dr. Baratta says. “It’s important to recognize that a lot of these patients present with a sense of grief or loss for their prior life.”
 

What does the future hold?

A simple test to diagnose long COVID, combined with an effective treatment that helps people feel better within a week, would be ideal, Dr. Abramoff says.

“That would be lovely. But you know, we’re just not at that point.”

And it would be helpful to start identifying subtypes of long COVID so diagnosis and treatment can be more targeted, Dr. Abramoff says. Otherwise, “It’s going to be a very challenging approach to try to treat all of our patients with long COVID symptoms the same way.”

Good clinical trials likewise are needed to address all the subtleties of long COVID.

A number of long COVID centers are collaborating on research to find out more, Dr. Chen says. Actions include setting up a bank of tissue samples from people with long COVID so researchers can continue to figure out the condition.

One goal, Dr. Chen says, would be the ability to treat long COVID rather than just its symptoms.

Long COVID emphasizes the need to prevent people from getting COVID in the first place, Dr. Ramirez says. This will continue to be important, particularly when some people dismiss the seriousness of COVID, comparing it to a cold if they get it. That attitude discounts the large number of people who unfortunately go on to develop long-term, often debilitating, symptoms.

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

Long COVID continues to be a moving target – continuously evolving and still surprising doctors and patients who have sometimes incapacitating long-term symptoms.

Little about the disorder seems predictable at this point. People can have long COVID after asymptomatic, mild, or severe COVID-19, for example. And when a person gets long COVID – also known as long-haul COVID – symptoms can vary widely.

To address all the uncertainty, the New York State Department of Health gathered experts in primary care, pediatrics, physical medicine, rehabilitation, and pulmonology to answer some pressing questions.

New York in 2020 was the first epicenter of the pandemic in the United States, making it also the center of the long COVID epidemic, says Emily Lutterloh, MD, director of the Division of Epidemiology at the New York State Department of Health.
 

What do you do when you’re seeing a patient with long COVID for the first time?

The first exam varies because there are so many different ways long COVID presents itself, says Benjamin Abramoff, MD, a physical medicine and rehabilitation specialist at Penn Medicine in Philadelphia.

I’ve now been seriously ill with #LongCovid for 11 months. I was never hospitalized. I didn’t even have a “mild” covid case. Instead, I developed Long Covid from an asymptomatic infection.

I’m far from unique. Up to 1/5 of asymptomatic patients go on to have long-term symptoms.

— Ravi Veriah Jacques (@RaviHVJ) February 3, 2022

Assessing their previous and current care also helps to direct their ongoing management, says Zijian Chen, MD, medical director of the Center for Post-COVID Care at Mount Sinai Health System in New York.
 

Can vaccination help people with long COVID?

Anything that we can do to help prevent people from being critically ill or being hospitalized with COVID-19 is helpful to prevent long COVID, says Dr. Abramoff, who is also director of the long COVID clinic at the University of Pennsylvania, Philadelphia.

“So that’s something I always discuss with patients. In some research, sometimes patients do feel better after the vaccine,” he says.
 

What kind of therapies do you find helpful for your patients?

Rehabilitation is a key part of recovery from long COVID, Dr. Abramoff says. “It is very important to make this very patient-specific.”

“We have patients that are working. They’re already going to the gym in some cases but don’t feel like they have the same endurance,” he says. “And then we have patients who are so crippled by their fatigue that they can’t get out of bed.”
 

1/ What is #LongCOVID?!

A disabling malady from ongoing inflammation, autoimmunity, & potential viral reservoirs (GI, brain?)

NEW DATA: The Lungs “light up” on special MRI Scans 3 to 9 months later in patients never hospitalized for COVID.https://t.co/I2kyZ4cK5F pic.twitter.com/dL1P67L2DK

— WesElyMD (@WesElyMD) February 2, 2022

An exercise program can help people who have long COVID.

“There’s a big role for therapy services in the recovery of these patients,” says John Baratta, MD, of the department of physical medicine and rehabilitation at the University of North Carolina at Chapel Hill.

But the limited number of long COVID clinics can mean some people are unable to get to therapists trained on the needs of patients with lingering COVID symptoms. Educating community physical and occupational therapists is one solution.
 

How long does it take for people with long COVID to recover and get back to 100% if they can?

Specific numbers aren’t really available, Dr. Baratta says.

“But I can tell you the general trend that I see is that a lot of patients have a gradual improvement of symptoms. The slow but steady improvement with time may be the body’s natural healing process, a result of medical interventions, or both.”

It can help to reassure people with long COVID that they will not be discharged from care until they feel they’ve maximized their health, says Sharagim Kemp, DO, medical director of the COVID Recovery Program for Nuvance Health, a health system in New York and Connecticut.

It’s essential to set realistic recovery expectations and tell patients that not everyone will return to 100% of their pre-COVID functioning, she says.

“Once we are able to help them reset their expectations, there’s almost an accelerated recovery because they are not putting that pressure on themselves anymore,” Dr. Kemp says.
 

What are the most common symptoms you’re seeing in long COVID?

It’s helpful to think of long COVID as a very broad umbrella term, Dr. Abramoff says.

Echoing what many others have observed, fatigue, cognitive dysfunction or “brain fog,“ and shortness of breath or troubled breathing appear to be the most common symptoms, he says.

Some reported vague symptoms, Dr. Kemp says.

People may go to the doctor “not even realizing that they had COVID. That’s one of the important points here – to have a high index of suspicion for patients who come in with multiple symptoms,” she says.

For this reason, patients can report symptoms that don’t necessarily fit into any specialty, says Sarah J. Ryan, MD, an internal medicine doctor at Columbia University Irving Medical Center in New York. People say they are “just not themselves” or they are tired after their COVID-19 recovery.
 

Is there a connection between severe COVID cases and severe long COVID?

“It’s not like that at all. I would say that more than 80% of the patients that we see had mild to moderate illness and they were not hospitalized,” Dr. Baratta says.

Long COVID is a bit different in children and teenagers, says Ixsy Ramirez, MD, a pediatric pulmonologist at University of Michigan Health, Ann Arbor. Most patients in the long COVID clinic at the University of Michigan were previously healthy, and not children with asthma or other lung conditions as one might expect. In fact, many are student athletes, or were before they had long COVID.

In this population, shortness of breath is most common, followed by chest pain and fatigue. Unfortunately, the symptoms are so serious for many kids that their performance is limited, even if they can return to competitive play.
 

Are there defined criteria you use to diagnose long COVID? How do you give someone a diagnosis?

That’s an ever-evolving question, Dr. Kemp says. The generally accepted definition centers on persistent or new symptoms 4 weeks or more after the original COVID-19 illness, but there are exceptions.

Researchers are working on lab tests to help confirm the diagnosis. But without a definitive blood biomarker, getting to the diagnosis requires “some thorough detective work,” Dr. Ryan says.
 

Do you bring in mental health providers to help with treatment?

“We focus on mental health quite a bit actually,” says, Dr. Chen, cofounder of his institution’s COVID recovery clinic. Mount Sinai offers one-on-one and group mental health services, for example.

“Personally, I’ve seen patients that I did not expect to have such severe mental health changes” with long COVID.
 

One of the most powerful accounts and testimonies I have seen on what most #LongCovid patients experience when interacting with their doctors.

“I did not fit in a box, so they chose not to see me, even worse they made me feel like it was my fault for not fitting in their box” pic.twitter.com/7GQLBucuO5

— charlos (@loscharlos) February 3, 2022

Examples include severe depression, cases of acute psychosis, hallucinations, and other problems “that are really unexpected after a viral illness.”

Stony Brook University Hospital in New York has a long COVID clinic staffed by multiple primary care doctors who do exams and refer patients to services. A bonus of offering psychological services to all post-COVID patients is doctors get a more complete picture of each person and a better understanding of what they are going through, says Abigail Chua, MD, a pulmonologist at Stony Brook.

Some empathy is essential, Dr. Baratta says. “It’s important to recognize that a lot of these patients present with a sense of grief or loss for their prior life.”
 

What does the future hold?

A simple test to diagnose long COVID, combined with an effective treatment that helps people feel better within a week, would be ideal, Dr. Abramoff says.

“That would be lovely. But you know, we’re just not at that point.”

And it would be helpful to start identifying subtypes of long COVID so diagnosis and treatment can be more targeted, Dr. Abramoff says. Otherwise, “It’s going to be a very challenging approach to try to treat all of our patients with long COVID symptoms the same way.”

Good clinical trials likewise are needed to address all the subtleties of long COVID.

A number of long COVID centers are collaborating on research to find out more, Dr. Chen says. Actions include setting up a bank of tissue samples from people with long COVID so researchers can continue to figure out the condition.

One goal, Dr. Chen says, would be the ability to treat long COVID rather than just its symptoms.

Long COVID emphasizes the need to prevent people from getting COVID in the first place, Dr. Ramirez says. This will continue to be important, particularly when some people dismiss the seriousness of COVID, comparing it to a cold if they get it. That attitude discounts the large number of people who unfortunately go on to develop long-term, often debilitating, symptoms.

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

She was a 20-year-old barista when we first met, working her way through college.

I was a newly minted attending physician. I’d stopped at the place she worked for coffee on the way to my office. When I got up to the front she was wearing sunglasses and apologized for them. She said she was having bad headaches, and couldn’t get into a doctor she’d been referred to. Feeling bad for her, and needing patients, I handed her my card.

She showed up a few days later, a little nervous as she’d never met a “regular” outside the coffee place before, and had brought her sister along for support.

She was back last week. Now she’s head of human resources for the same chain of local coffee shops. She’s married, with kids, a mortgage, and a minivan.

We were talking about our chance meeting and reminiscing. Her migraines had taken a few medication trials to control, but after a year or 2 we’d found the right one for her and she’s been on it since.

Like many of my longtime patients, she moved past calling me “doctor” long ago. Our one to two visits a year are now more social than medical, chatting about our kids, dogs, and lives.

The same passage of time that brings us from grade school, to medical school, to medical practice takes others along with it. We may not see the changes of days, but when they drop by only once a year it’s obvious. Just like the way we don’t see daily changes in family and friends, but when we look at old pictures we’re shocked by how different they (not to mention ourselves) look.

We all follow the same course around the sun, usually facing the same milestones and similar memories on the trip. Our long-term patients, like distant relatives, may only come by infrequently, so the changes are greater. I’m sure they say the same things about me. “I saw Dr. Block today; boy, he’s really gone gray.”

I don’t mind that (too much) anymore. My thinning, graying, hair (I hope) makes me look a little more distinguished, although my complete lack of fashion sense more than goes the other way.

The river only goes in one direction, carrying us, our patients, and our families, all along with it. We often lose track of time’s effects on us until we see the changes it has brought to another.

It’s always a good reminder to pause and remember to enjoy the ride.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

She was a 20-year-old barista when we first met, working her way through college.

I was a newly minted attending physician. I’d stopped at the place she worked for coffee on the way to my office. When I got up to the front she was wearing sunglasses and apologized for them. She said she was having bad headaches, and couldn’t get into a doctor she’d been referred to. Feeling bad for her, and needing patients, I handed her my card.

She showed up a few days later, a little nervous as she’d never met a “regular” outside the coffee place before, and had brought her sister along for support.

She was back last week. Now she’s head of human resources for the same chain of local coffee shops. She’s married, with kids, a mortgage, and a minivan.

We were talking about our chance meeting and reminiscing. Her migraines had taken a few medication trials to control, but after a year or 2 we’d found the right one for her and she’s been on it since.

Like many of my longtime patients, she moved past calling me “doctor” long ago. Our one to two visits a year are now more social than medical, chatting about our kids, dogs, and lives.

The same passage of time that brings us from grade school, to medical school, to medical practice takes others along with it. We may not see the changes of days, but when they drop by only once a year it’s obvious. Just like the way we don’t see daily changes in family and friends, but when we look at old pictures we’re shocked by how different they (not to mention ourselves) look.

We all follow the same course around the sun, usually facing the same milestones and similar memories on the trip. Our long-term patients, like distant relatives, may only come by infrequently, so the changes are greater. I’m sure they say the same things about me. “I saw Dr. Block today; boy, he’s really gone gray.”

I don’t mind that (too much) anymore. My thinning, graying, hair (I hope) makes me look a little more distinguished, although my complete lack of fashion sense more than goes the other way.

The river only goes in one direction, carrying us, our patients, and our families, all along with it. We often lose track of time’s effects on us until we see the changes it has brought to another.

It’s always a good reminder to pause and remember to enjoy the ride.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

She was a 20-year-old barista when we first met, working her way through college.

I was a newly minted attending physician. I’d stopped at the place she worked for coffee on the way to my office. When I got up to the front she was wearing sunglasses and apologized for them. She said she was having bad headaches, and couldn’t get into a doctor she’d been referred to. Feeling bad for her, and needing patients, I handed her my card.

She showed up a few days later, a little nervous as she’d never met a “regular” outside the coffee place before, and had brought her sister along for support.

She was back last week. Now she’s head of human resources for the same chain of local coffee shops. She’s married, with kids, a mortgage, and a minivan.

We were talking about our chance meeting and reminiscing. Her migraines had taken a few medication trials to control, but after a year or 2 we’d found the right one for her and she’s been on it since.

Like many of my longtime patients, she moved past calling me “doctor” long ago. Our one to two visits a year are now more social than medical, chatting about our kids, dogs, and lives.

The same passage of time that brings us from grade school, to medical school, to medical practice takes others along with it. We may not see the changes of days, but when they drop by only once a year it’s obvious. Just like the way we don’t see daily changes in family and friends, but when we look at old pictures we’re shocked by how different they (not to mention ourselves) look.

We all follow the same course around the sun, usually facing the same milestones and similar memories on the trip. Our long-term patients, like distant relatives, may only come by infrequently, so the changes are greater. I’m sure they say the same things about me. “I saw Dr. Block today; boy, he’s really gone gray.”

I don’t mind that (too much) anymore. My thinning, graying, hair (I hope) makes me look a little more distinguished, although my complete lack of fashion sense more than goes the other way.

The river only goes in one direction, carrying us, our patients, and our families, all along with it. We often lose track of time’s effects on us until we see the changes it has brought to another.

It’s always a good reminder to pause and remember to enjoy the ride.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Two illicit drugs are contributing to a sharp rise in fentanyl-related deaths, a new study from the Centers for Disease Control and Prevention shows.

Para-fluorofentanyl, a schedule I substance often found in heroin packets and counterfeit pills, is making a comeback on the illicit drug market, Jordan Trecki, PhD, and associates reported in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report (2022 Jan 28;71[4]:153-5). U.S. medical examiner reports and national law enforcement seizure data point to a rise in encounters of this drug along with metonitazene, a benzimidazole-opioid, in combination with fentanyl.

On their own, para-fluorofentanyl and metonitazene can kill the user through respiratory depression. Combinations of these substances and other opioids, including fentanyl-related compounds or adulterants, “pose an even greater potential harm to the patient than previously observed,” reported Dr. Trecki, a pharmacologist affiliated with the Drug Enforcement Administration, and colleagues.

Opioids contribute to about 75% of all U.S. drug overdose deaths, which rose by 28.5% during 2020-2021, according to the National Center for Health Statistics. And fentanyl is replacing heroin as the primary drug of use, said addiction specialist Brian Fuehrlein, MD, PhD, in an interview.

“For patients with stimulant use disorder and even cannabis use disorder, fentanyl is becoming more and more common as an adulterant in those substances, often resulting in inadvertent use. Hence, fentanyl and fentanyl-like drugs and fentanyl analogues are becoming increasingly common and important,” said Dr. Fuehrlein, director of the psychiatric emergency room at the VA Connecticut Healthcare System. He was not involved with the MMWR study.
 

Tennessee data reflect national problem

Recent data from a medical examiner in Knoxville, Tenn., illustrate what might be happening nationwide with those two emerging substances.

Over the last 2 years, the Knox County Regional Forensic Center has identified para-fluorofentanyl in the toxicology results of drug overdose victims, and metonitazene – either on its own or in combination with fentanyl and para-fluorofentanyl. Fentanyl appeared in 562 or 73% of 770 unintentional drug overdose deaths from November 2020 to August 2021. Forty-eight of these cases involved para-fluorofentanyl, and 26 involved metonitazene.

“Although the percentage of law enforcement encounters with these substances in Tennessee decreased relative to the national total percentage within this time frame, the increase in encounters both within Tennessee and nationally reflect an increased distribution of para-fluorofentanyl and metonitazene throughout the United States,” the authors reported.
 

How to identify substances, manage overdoses

The authors encouraged physicians, labs, and medical examiners to be on the lookout for these two substances either in the emergency department or when identifying the cause of drug overdose deaths.

They also advised that stronger opioids, such as fentanyl, para-fluorofentanyl, metonitazene, or other benzimidazoles may warrant additional doses of the opioid-reversal drug naloxone.

While he hasn’t personally seen any of these drugs in his practice, “I would assume that these are on the rise due to inexpensive cost to manufacture and potency of effect,” said Dr. Fuehrlein, also an associate professor of psychiatry at Yale University, New Haven, Conn.

The need for additional naloxone to manage acute overdoses is a key takeaway of the MMWR paper, he added. Clinicians should also educate patients about harm reduction strategies to avoid overdose death when using potentially powerful and unknown drugs. “Things like start low and go slow, buy from the same supplier, do not use opioids with alcohol or benzos, have Narcan available, do not use alone, etc.”

Dr. Fuehrlein had no disclosures.

Two illicit drugs are contributing to a sharp rise in fentanyl-related deaths, a new study from the Centers for Disease Control and Prevention shows.

Para-fluorofentanyl, a schedule I substance often found in heroin packets and counterfeit pills, is making a comeback on the illicit drug market, Jordan Trecki, PhD, and associates reported in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report (2022 Jan 28;71[4]:153-5). U.S. medical examiner reports and national law enforcement seizure data point to a rise in encounters of this drug along with metonitazene, a benzimidazole-opioid, in combination with fentanyl.

On their own, para-fluorofentanyl and metonitazene can kill the user through respiratory depression. Combinations of these substances and other opioids, including fentanyl-related compounds or adulterants, “pose an even greater potential harm to the patient than previously observed,” reported Dr. Trecki, a pharmacologist affiliated with the Drug Enforcement Administration, and colleagues.

Opioids contribute to about 75% of all U.S. drug overdose deaths, which rose by 28.5% during 2020-2021, according to the National Center for Health Statistics. And fentanyl is replacing heroin as the primary drug of use, said addiction specialist Brian Fuehrlein, MD, PhD, in an interview.

“For patients with stimulant use disorder and even cannabis use disorder, fentanyl is becoming more and more common as an adulterant in those substances, often resulting in inadvertent use. Hence, fentanyl and fentanyl-like drugs and fentanyl analogues are becoming increasingly common and important,” said Dr. Fuehrlein, director of the psychiatric emergency room at the VA Connecticut Healthcare System. He was not involved with the MMWR study.
 

Tennessee data reflect national problem

Recent data from a medical examiner in Knoxville, Tenn., illustrate what might be happening nationwide with those two emerging substances.

Over the last 2 years, the Knox County Regional Forensic Center has identified para-fluorofentanyl in the toxicology results of drug overdose victims, and metonitazene – either on its own or in combination with fentanyl and para-fluorofentanyl. Fentanyl appeared in 562 or 73% of 770 unintentional drug overdose deaths from November 2020 to August 2021. Forty-eight of these cases involved para-fluorofentanyl, and 26 involved metonitazene.

“Although the percentage of law enforcement encounters with these substances in Tennessee decreased relative to the national total percentage within this time frame, the increase in encounters both within Tennessee and nationally reflect an increased distribution of para-fluorofentanyl and metonitazene throughout the United States,” the authors reported.
 

How to identify substances, manage overdoses

The authors encouraged physicians, labs, and medical examiners to be on the lookout for these two substances either in the emergency department or when identifying the cause of drug overdose deaths.

They also advised that stronger opioids, such as fentanyl, para-fluorofentanyl, metonitazene, or other benzimidazoles may warrant additional doses of the opioid-reversal drug naloxone.

While he hasn’t personally seen any of these drugs in his practice, “I would assume that these are on the rise due to inexpensive cost to manufacture and potency of effect,” said Dr. Fuehrlein, also an associate professor of psychiatry at Yale University, New Haven, Conn.

The need for additional naloxone to manage acute overdoses is a key takeaway of the MMWR paper, he added. Clinicians should also educate patients about harm reduction strategies to avoid overdose death when using potentially powerful and unknown drugs. “Things like start low and go slow, buy from the same supplier, do not use opioids with alcohol or benzos, have Narcan available, do not use alone, etc.”

Dr. Fuehrlein had no disclosures.

Two illicit drugs are contributing to a sharp rise in fentanyl-related deaths, a new study from the Centers for Disease Control and Prevention shows.

Para-fluorofentanyl, a schedule I substance often found in heroin packets and counterfeit pills, is making a comeback on the illicit drug market, Jordan Trecki, PhD, and associates reported in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report (2022 Jan 28;71[4]:153-5). U.S. medical examiner reports and national law enforcement seizure data point to a rise in encounters of this drug along with metonitazene, a benzimidazole-opioid, in combination with fentanyl.

On their own, para-fluorofentanyl and metonitazene can kill the user through respiratory depression. Combinations of these substances and other opioids, including fentanyl-related compounds or adulterants, “pose an even greater potential harm to the patient than previously observed,” reported Dr. Trecki, a pharmacologist affiliated with the Drug Enforcement Administration, and colleagues.

Opioids contribute to about 75% of all U.S. drug overdose deaths, which rose by 28.5% during 2020-2021, according to the National Center for Health Statistics. And fentanyl is replacing heroin as the primary drug of use, said addiction specialist Brian Fuehrlein, MD, PhD, in an interview.

“For patients with stimulant use disorder and even cannabis use disorder, fentanyl is becoming more and more common as an adulterant in those substances, often resulting in inadvertent use. Hence, fentanyl and fentanyl-like drugs and fentanyl analogues are becoming increasingly common and important,” said Dr. Fuehrlein, director of the psychiatric emergency room at the VA Connecticut Healthcare System. He was not involved with the MMWR study.
 

Tennessee data reflect national problem

Recent data from a medical examiner in Knoxville, Tenn., illustrate what might be happening nationwide with those two emerging substances.

Over the last 2 years, the Knox County Regional Forensic Center has identified para-fluorofentanyl in the toxicology results of drug overdose victims, and metonitazene – either on its own or in combination with fentanyl and para-fluorofentanyl. Fentanyl appeared in 562 or 73% of 770 unintentional drug overdose deaths from November 2020 to August 2021. Forty-eight of these cases involved para-fluorofentanyl, and 26 involved metonitazene.

“Although the percentage of law enforcement encounters with these substances in Tennessee decreased relative to the national total percentage within this time frame, the increase in encounters both within Tennessee and nationally reflect an increased distribution of para-fluorofentanyl and metonitazene throughout the United States,” the authors reported.
 

How to identify substances, manage overdoses

The authors encouraged physicians, labs, and medical examiners to be on the lookout for these two substances either in the emergency department or when identifying the cause of drug overdose deaths.

They also advised that stronger opioids, such as fentanyl, para-fluorofentanyl, metonitazene, or other benzimidazoles may warrant additional doses of the opioid-reversal drug naloxone.

While he hasn’t personally seen any of these drugs in his practice, “I would assume that these are on the rise due to inexpensive cost to manufacture and potency of effect,” said Dr. Fuehrlein, also an associate professor of psychiatry at Yale University, New Haven, Conn.

The need for additional naloxone to manage acute overdoses is a key takeaway of the MMWR paper, he added. Clinicians should also educate patients about harm reduction strategies to avoid overdose death when using potentially powerful and unknown drugs. “Things like start low and go slow, buy from the same supplier, do not use opioids with alcohol or benzos, have Narcan available, do not use alone, etc.”

Dr. Fuehrlein had no disclosures.

Patients undergoing bowel prep for colonoscopy had significantly greater decreases in potassium after prep with sodium phosphate, compared with those whose prep involved polyethylene glycol, based on data from a meta-analysis of more than 2,000 patients.

Electrolyte disturbances, though rare, represent a serious adverse event associated with bowel preparation, and the prevalence remains unclear, Atsushi Sakuraba, MD, of the University of Chicago said in an interview. Dr. Sakuraba, who was not involved in the study, said he was surprised by some of the study findings. “The incidence and degree of hypokalemia associated with sodium phosphate bowel preparation was greater than what I would have thought.”

Authors of the current analysis, led by Ankie Reumkens, MD, of Maastricht (the Netherlands) University Medical Center, noted in Digestive Endoscopy that the severity of adverse events is not directly related to the degree of electrolyte disturbance. “Electrolyte disturbances may vary from asymptomatic via mild and moderate symptoms (i.e., muscle weakness, constipation, nausea, and vomiting), to severe symptoms (i.e., paralysis, seizures, cardiac arrhythmias, coma, and death).” Although current guidelines do not include recommendations for electrolyte measurement, the European Society of Gastrointestinal Endoscopy recommends against routine use of sodium phosphate (NaP) despite a low level of evidence. Although polyethylene glycol (PEG) is the preferred choice for older patients and in patients with renal impairment, heart failure, and inflammatory bowel disease, the investigators noted that NaP and picosulfate with magnesium titrate (SPMC) have been associated with higher patient tolerance and compliance.

Bowel preparation solutions are available in high-volume versions that include high-volume PEG, while low-volume options include low-volume PEG, NaP, and SPMC; despite the variety of choices, bowel preparations of any type may cause electrolyte disturbances, and their extent, magnitude, and risk factors have not been well studied.

In their systemic review and meta-analysis, the researchers examined the pooled prevalence of electrolyte disturbances; the primary endpoint was the pooled prevalence of hypokalemia, hyponatremia, hyperphosphatemia, and hypocalcemia after bowel preparation, and the changes in mean potassium values. The review was based on 13 studies published between Jan. 1, 1995, and July 1, 2021, with a total of 2,386 patients.

Overall, hypokalemia occurred in 17.2 % of patients who underwent NaP for bowel preparation versus 4.8% of those who underwent PEG. Hyponatremia occurred in 0.9% of NaP patients versus3.3% of PEG patients; hyperphosphatemia occurred in 37.3% and 0.65% of NaP and PEG patients, respectively; and hypocalcemia occurred in 15.6% and 8.1% of NaP and PEG patients, respectively.

Pharmacokinetics may explain the increased disturbances in electrolyte balance with NaP, the researchers noted.

“PEG is iso-osmotic with plasma, causing no net absorption or excretion of water or ions,” they said, but “NaP is highly osmotic and therefore results in fluid shifts from the systemic compartment to the gastrointestinal tract.”

The study findings were limited by several factors including the potential underreporting of the prevalence of electrolyte disturbances, the exclusion of patients with renal insufficiency, heart failure, and bowel problems, and the incomplete data on bowel cleansing scores and adverse events, the researchers noted. More data on the prevalences of electrolyte disturbances after low-volume bowel preparations are needed to inform evidence-based recommendations, especially in light of the increased numbers of colonoscopies and increasing numbers of older patients and patients with comorbidities.

From a clinical practice perspective, Dr. Sakuraba agreed with the authors’ conclusion that the results support the recommendations of some current guidelines against the routine use of sodium phosphate for bowel preparation, even if the number of included studies was small.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Sakuraba had no financial conflicts to disclose.

Patients undergoing bowel prep for colonoscopy had significantly greater decreases in potassium after prep with sodium phosphate, compared with those whose prep involved polyethylene glycol, based on data from a meta-analysis of more than 2,000 patients.

Electrolyte disturbances, though rare, represent a serious adverse event associated with bowel preparation, and the prevalence remains unclear, Atsushi Sakuraba, MD, of the University of Chicago said in an interview. Dr. Sakuraba, who was not involved in the study, said he was surprised by some of the study findings. “The incidence and degree of hypokalemia associated with sodium phosphate bowel preparation was greater than what I would have thought.”

Authors of the current analysis, led by Ankie Reumkens, MD, of Maastricht (the Netherlands) University Medical Center, noted in Digestive Endoscopy that the severity of adverse events is not directly related to the degree of electrolyte disturbance. “Electrolyte disturbances may vary from asymptomatic via mild and moderate symptoms (i.e., muscle weakness, constipation, nausea, and vomiting), to severe symptoms (i.e., paralysis, seizures, cardiac arrhythmias, coma, and death).” Although current guidelines do not include recommendations for electrolyte measurement, the European Society of Gastrointestinal Endoscopy recommends against routine use of sodium phosphate (NaP) despite a low level of evidence. Although polyethylene glycol (PEG) is the preferred choice for older patients and in patients with renal impairment, heart failure, and inflammatory bowel disease, the investigators noted that NaP and picosulfate with magnesium titrate (SPMC) have been associated with higher patient tolerance and compliance.

Bowel preparation solutions are available in high-volume versions that include high-volume PEG, while low-volume options include low-volume PEG, NaP, and SPMC; despite the variety of choices, bowel preparations of any type may cause electrolyte disturbances, and their extent, magnitude, and risk factors have not been well studied.

In their systemic review and meta-analysis, the researchers examined the pooled prevalence of electrolyte disturbances; the primary endpoint was the pooled prevalence of hypokalemia, hyponatremia, hyperphosphatemia, and hypocalcemia after bowel preparation, and the changes in mean potassium values. The review was based on 13 studies published between Jan. 1, 1995, and July 1, 2021, with a total of 2,386 patients.

Overall, hypokalemia occurred in 17.2 % of patients who underwent NaP for bowel preparation versus 4.8% of those who underwent PEG. Hyponatremia occurred in 0.9% of NaP patients versus3.3% of PEG patients; hyperphosphatemia occurred in 37.3% and 0.65% of NaP and PEG patients, respectively; and hypocalcemia occurred in 15.6% and 8.1% of NaP and PEG patients, respectively.

Pharmacokinetics may explain the increased disturbances in electrolyte balance with NaP, the researchers noted.

“PEG is iso-osmotic with plasma, causing no net absorption or excretion of water or ions,” they said, but “NaP is highly osmotic and therefore results in fluid shifts from the systemic compartment to the gastrointestinal tract.”

The study findings were limited by several factors including the potential underreporting of the prevalence of electrolyte disturbances, the exclusion of patients with renal insufficiency, heart failure, and bowel problems, and the incomplete data on bowel cleansing scores and adverse events, the researchers noted. More data on the prevalences of electrolyte disturbances after low-volume bowel preparations are needed to inform evidence-based recommendations, especially in light of the increased numbers of colonoscopies and increasing numbers of older patients and patients with comorbidities.

From a clinical practice perspective, Dr. Sakuraba agreed with the authors’ conclusion that the results support the recommendations of some current guidelines against the routine use of sodium phosphate for bowel preparation, even if the number of included studies was small.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Sakuraba had no financial conflicts to disclose.

Patients undergoing bowel prep for colonoscopy had significantly greater decreases in potassium after prep with sodium phosphate, compared with those whose prep involved polyethylene glycol, based on data from a meta-analysis of more than 2,000 patients.

Electrolyte disturbances, though rare, represent a serious adverse event associated with bowel preparation, and the prevalence remains unclear, Atsushi Sakuraba, MD, of the University of Chicago said in an interview. Dr. Sakuraba, who was not involved in the study, said he was surprised by some of the study findings. “The incidence and degree of hypokalemia associated with sodium phosphate bowel preparation was greater than what I would have thought.”

Authors of the current analysis, led by Ankie Reumkens, MD, of Maastricht (the Netherlands) University Medical Center, noted in Digestive Endoscopy that the severity of adverse events is not directly related to the degree of electrolyte disturbance. “Electrolyte disturbances may vary from asymptomatic via mild and moderate symptoms (i.e., muscle weakness, constipation, nausea, and vomiting), to severe symptoms (i.e., paralysis, seizures, cardiac arrhythmias, coma, and death).” Although current guidelines do not include recommendations for electrolyte measurement, the European Society of Gastrointestinal Endoscopy recommends against routine use of sodium phosphate (NaP) despite a low level of evidence. Although polyethylene glycol (PEG) is the preferred choice for older patients and in patients with renal impairment, heart failure, and inflammatory bowel disease, the investigators noted that NaP and picosulfate with magnesium titrate (SPMC) have been associated with higher patient tolerance and compliance.

Bowel preparation solutions are available in high-volume versions that include high-volume PEG, while low-volume options include low-volume PEG, NaP, and SPMC; despite the variety of choices, bowel preparations of any type may cause electrolyte disturbances, and their extent, magnitude, and risk factors have not been well studied.

In their systemic review and meta-analysis, the researchers examined the pooled prevalence of electrolyte disturbances; the primary endpoint was the pooled prevalence of hypokalemia, hyponatremia, hyperphosphatemia, and hypocalcemia after bowel preparation, and the changes in mean potassium values. The review was based on 13 studies published between Jan. 1, 1995, and July 1, 2021, with a total of 2,386 patients.

Overall, hypokalemia occurred in 17.2 % of patients who underwent NaP for bowel preparation versus 4.8% of those who underwent PEG. Hyponatremia occurred in 0.9% of NaP patients versus3.3% of PEG patients; hyperphosphatemia occurred in 37.3% and 0.65% of NaP and PEG patients, respectively; and hypocalcemia occurred in 15.6% and 8.1% of NaP and PEG patients, respectively.

Pharmacokinetics may explain the increased disturbances in electrolyte balance with NaP, the researchers noted.

“PEG is iso-osmotic with plasma, causing no net absorption or excretion of water or ions,” they said, but “NaP is highly osmotic and therefore results in fluid shifts from the systemic compartment to the gastrointestinal tract.”

The study findings were limited by several factors including the potential underreporting of the prevalence of electrolyte disturbances, the exclusion of patients with renal insufficiency, heart failure, and bowel problems, and the incomplete data on bowel cleansing scores and adverse events, the researchers noted. More data on the prevalences of electrolyte disturbances after low-volume bowel preparations are needed to inform evidence-based recommendations, especially in light of the increased numbers of colonoscopies and increasing numbers of older patients and patients with comorbidities.

From a clinical practice perspective, Dr. Sakuraba agreed with the authors’ conclusion that the results support the recommendations of some current guidelines against the routine use of sodium phosphate for bowel preparation, even if the number of included studies was small.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Sakuraba had no financial conflicts to disclose.

To the Editor:

With a steady increase in dermatology publications over recent decades, there is an expanding pool of evidence to address clinical questions.¹ Residency training is the time when appraising the medical literature and practicing evidence-based medicine is most honed. Evidence-based medicine is an essential component of Practice-based Learning and Improvement, a required core competency of the Accreditation Council for Graduate Medical Education.² Assimilation of new research evidence is traditionally taught through didactics and journal club discussions in residency.

However, at a time when the demand for information overwhelms safeguards that exist to evaluate its quality, it is more important than ever to be equipped with the proper tools to critically appraise novel literature. Beyond accepting a scientific article at face value, physicians must learn to ask targeted questions of the study design, results, and clinical relevance. These questions change based on the type of study, and organizations such as the Oxford Centre for Evidence-Based Medicine provide guidance through critical appraisal worksheets.³

To investigate the utility of using guided questions to evaluate the reliability, significance, and applicability of clinical evidence, we beta tested a novel web-based application in an academic dermatology setting to design and run a journal club for residents. Six dermatology residents participated in this institutional review board–approved study comprised of 3 phases: (1) independent article appraisal through the web-based application, (2) group discussion, and (3) anonymous postsurvey.

Using this platform, we uploaded a recent article into the interactive reader, which contained an integrated tool for appraisal based on specific questions. Because the article described the results of a randomized clinical trial, we used questions from the Centre for Evidence-Based Medicine’s Randomised Controlled Trials Critical Appraisal Worksheet, which has a series of questions to evaluate internal validity, results, and external validity and applicability.³

Residents used the platform to independently read the article, highlight areas of the text that corresponded to 8 critical appraisal questions, and answer yes or no to these questions. Based on residents’ answers, a final appraisal score (on a scale of 1% to 100%) was generated. Simultaneously, the attending dermatologist leading the journal club (C.W.) also completed the assignment to establish an expert score.

Scores from the residents’ independent appraisal ranged from 75% to 100% (mean, 85.4%). Upon discussing the article in a group setting, the residents established a consensus score of 75%. This consensus score matched the expert score, which suggested to us that both independently reviewing the article using guided questions and conducting a group debriefing were necessary to match the expert level of critical appraisal.

Of note, the residents’ average independent appraisal score was higher than both the consensus and expert scores, indicating that the residents evaluated the article less critically on their own. With more practice using this method, it is possible that the precision and accuracy of the residents’ critical appraisal of scientific articles will improve.

In the postsurvey, we asked residents about the critical appraisal of the medical literature. All residents agreed that evaluating the quality of evidence when reading a scientific article was somewhat important or very important to them; however, only 2 of 6 evaluated the quality of evidence all the time, and the other 4 did so half of the time or less than half of the time.

When critically appraising articles, 2 of 6 residents used specific rubrics half of the time; 4 of 6 less than half of the time. Most important, 5 of 6 residents agreed that the quality of evidence affected their management decisions more than half of the time or all of the time. Although it is clear that residents value evidence-based medicine and understand the importance of evaluating the quality of evidence, doing so currently might not be simple or practical.

An organized framework for appraising articles would streamline the process. Five of 6 residents agreed that the use of specific questions as a guide made it easier to appraise an article for the quality of its evidence. Four of 6 residents found that juxtaposing specific questions with the interactive reader was helpful; 5 of 6 agreed that they would use a web-based journal club platform if given the option.

Lastly, 5 of 6 residents agreed that if such a tool were available, a platform containing all major dermatology publications in an interactive reader format, along with relevant appraisal questions on the side, would be useful.

This pilot study augmented the typical journal club experience by emphasizing goal-directed reading and the importance of analyzing the quality of evidence. The combination of independent appraisal of an article using targeted questions and a group debrief led to better understanding of the evidence and its clinical applicability. The COVID-19 pandemic may be a better time than ever to explore innovative ways to teach evidence-based medicine in residency training.

To the Editor:

With a steady increase in dermatology publications over recent decades, there is an expanding pool of evidence to address clinical questions.¹ Residency training is the time when appraising the medical literature and practicing evidence-based medicine is most honed. Evidence-based medicine is an essential component of Practice-based Learning and Improvement, a required core competency of the Accreditation Council for Graduate Medical Education.² Assimilation of new research evidence is traditionally taught through didactics and journal club discussions in residency.

However, at a time when the demand for information overwhelms safeguards that exist to evaluate its quality, it is more important than ever to be equipped with the proper tools to critically appraise novel literature. Beyond accepting a scientific article at face value, physicians must learn to ask targeted questions of the study design, results, and clinical relevance. These questions change based on the type of study, and organizations such as the Oxford Centre for Evidence-Based Medicine provide guidance through critical appraisal worksheets.³

To investigate the utility of using guided questions to evaluate the reliability, significance, and applicability of clinical evidence, we beta tested a novel web-based application in an academic dermatology setting to design and run a journal club for residents. Six dermatology residents participated in this institutional review board–approved study comprised of 3 phases: (1) independent article appraisal through the web-based application, (2) group discussion, and (3) anonymous postsurvey.

Using this platform, we uploaded a recent article into the interactive reader, which contained an integrated tool for appraisal based on specific questions. Because the article described the results of a randomized clinical trial, we used questions from the Centre for Evidence-Based Medicine’s Randomised Controlled Trials Critical Appraisal Worksheet, which has a series of questions to evaluate internal validity, results, and external validity and applicability.³

Residents used the platform to independently read the article, highlight areas of the text that corresponded to 8 critical appraisal questions, and answer yes or no to these questions. Based on residents’ answers, a final appraisal score (on a scale of 1% to 100%) was generated. Simultaneously, the attending dermatologist leading the journal club (C.W.) also completed the assignment to establish an expert score.

Scores from the residents’ independent appraisal ranged from 75% to 100% (mean, 85.4%). Upon discussing the article in a group setting, the residents established a consensus score of 75%. This consensus score matched the expert score, which suggested to us that both independently reviewing the article using guided questions and conducting a group debriefing were necessary to match the expert level of critical appraisal.

Of note, the residents’ average independent appraisal score was higher than both the consensus and expert scores, indicating that the residents evaluated the article less critically on their own. With more practice using this method, it is possible that the precision and accuracy of the residents’ critical appraisal of scientific articles will improve.

In the postsurvey, we asked residents about the critical appraisal of the medical literature. All residents agreed that evaluating the quality of evidence when reading a scientific article was somewhat important or very important to them; however, only 2 of 6 evaluated the quality of evidence all the time, and the other 4 did so half of the time or less than half of the time.

When critically appraising articles, 2 of 6 residents used specific rubrics half of the time; 4 of 6 less than half of the time. Most important, 5 of 6 residents agreed that the quality of evidence affected their management decisions more than half of the time or all of the time. Although it is clear that residents value evidence-based medicine and understand the importance of evaluating the quality of evidence, doing so currently might not be simple or practical.

An organized framework for appraising articles would streamline the process. Five of 6 residents agreed that the use of specific questions as a guide made it easier to appraise an article for the quality of its evidence. Four of 6 residents found that juxtaposing specific questions with the interactive reader was helpful; 5 of 6 agreed that they would use a web-based journal club platform if given the option.

Lastly, 5 of 6 residents agreed that if such a tool were available, a platform containing all major dermatology publications in an interactive reader format, along with relevant appraisal questions on the side, would be useful.

This pilot study augmented the typical journal club experience by emphasizing goal-directed reading and the importance of analyzing the quality of evidence. The combination of independent appraisal of an article using targeted questions and a group debrief led to better understanding of the evidence and its clinical applicability. The COVID-19 pandemic may be a better time than ever to explore innovative ways to teach evidence-based medicine in residency training.

To the Editor:

With a steady increase in dermatology publications over recent decades, there is an expanding pool of evidence to address clinical questions.¹ Residency training is the time when appraising the medical literature and practicing evidence-based medicine is most honed. Evidence-based medicine is an essential component of Practice-based Learning and Improvement, a required core competency of the Accreditation Council for Graduate Medical Education.² Assimilation of new research evidence is traditionally taught through didactics and journal club discussions in residency.

However, at a time when the demand for information overwhelms safeguards that exist to evaluate its quality, it is more important than ever to be equipped with the proper tools to critically appraise novel literature. Beyond accepting a scientific article at face value, physicians must learn to ask targeted questions of the study design, results, and clinical relevance. These questions change based on the type of study, and organizations such as the Oxford Centre for Evidence-Based Medicine provide guidance through critical appraisal worksheets.³

To investigate the utility of using guided questions to evaluate the reliability, significance, and applicability of clinical evidence, we beta tested a novel web-based application in an academic dermatology setting to design and run a journal club for residents. Six dermatology residents participated in this institutional review board–approved study comprised of 3 phases: (1) independent article appraisal through the web-based application, (2) group discussion, and (3) anonymous postsurvey.

Using this platform, we uploaded a recent article into the interactive reader, which contained an integrated tool for appraisal based on specific questions. Because the article described the results of a randomized clinical trial, we used questions from the Centre for Evidence-Based Medicine’s Randomised Controlled Trials Critical Appraisal Worksheet, which has a series of questions to evaluate internal validity, results, and external validity and applicability.³

Residents used the platform to independently read the article, highlight areas of the text that corresponded to 8 critical appraisal questions, and answer yes or no to these questions. Based on residents’ answers, a final appraisal score (on a scale of 1% to 100%) was generated. Simultaneously, the attending dermatologist leading the journal club (C.W.) also completed the assignment to establish an expert score.

Scores from the residents’ independent appraisal ranged from 75% to 100% (mean, 85.4%). Upon discussing the article in a group setting, the residents established a consensus score of 75%. This consensus score matched the expert score, which suggested to us that both independently reviewing the article using guided questions and conducting a group debriefing were necessary to match the expert level of critical appraisal.

Of note, the residents’ average independent appraisal score was higher than both the consensus and expert scores, indicating that the residents evaluated the article less critically on their own. With more practice using this method, it is possible that the precision and accuracy of the residents’ critical appraisal of scientific articles will improve.

In the postsurvey, we asked residents about the critical appraisal of the medical literature. All residents agreed that evaluating the quality of evidence when reading a scientific article was somewhat important or very important to them; however, only 2 of 6 evaluated the quality of evidence all the time, and the other 4 did so half of the time or less than half of the time.

When critically appraising articles, 2 of 6 residents used specific rubrics half of the time; 4 of 6 less than half of the time. Most important, 5 of 6 residents agreed that the quality of evidence affected their management decisions more than half of the time or all of the time. Although it is clear that residents value evidence-based medicine and understand the importance of evaluating the quality of evidence, doing so currently might not be simple or practical.

An organized framework for appraising articles would streamline the process. Five of 6 residents agreed that the use of specific questions as a guide made it easier to appraise an article for the quality of its evidence. Four of 6 residents found that juxtaposing specific questions with the interactive reader was helpful; 5 of 6 agreed that they would use a web-based journal club platform if given the option.

Lastly, 5 of 6 residents agreed that if such a tool were available, a platform containing all major dermatology publications in an interactive reader format, along with relevant appraisal questions on the side, would be useful.

This pilot study augmented the typical journal club experience by emphasizing goal-directed reading and the importance of analyzing the quality of evidence. The combination of independent appraisal of an article using targeted questions and a group debrief led to better understanding of the evidence and its clinical applicability. The COVID-19 pandemic may be a better time than ever to explore innovative ways to teach evidence-based medicine in residency training.

Media coverage of transgender health care judged to be “negative” was associated with a drop of around 30% in referral rates to gender identity clinics in Sweden among young people under age 19, a new study indicates.

Malin Indremo, MS, from the department of neuroscience, Uppsala (Sweden) University, and colleagues explored the effect of the documentaries, “The Trans Train and Teenage Girls,” which they explain was a “Swedish public service television show” representing “investigative journalism.” The two-part documentary series was aired in Sweden in April 2019 and October 2019, respectively, and is now available in English on YouTube.

In their article, published online in JAMA Network Open, the authors said they consider “The Trans Train” programs to be “negative” media coverage because the “documentaries addressed the distinct increase among adolescents referred to gender identity clinics in recent years. Two young adults who regretted their transition and parents of transgender individuals who questioned the clinics’ assessments of their children were interviewed, and concerns were raised about whether gender-confirming treatments are based on sufficient scientific evidence.”

The programs, they suggest, may have influenced and jeopardized young transgender individuals’ access to transgender-specific health care.

Stella O’Malley, a U.K.-based psychotherapist specializing in transgender care and executive director of Genspect, an international organization that provides support to the parents of young people who are questioning their gender, expressed her disappointment with the study’s conclusions.

“I’m really surprised and disappointed that the researchers believe that negative coverage is the reason for a drop in referrals when it is more accurate to say that the information provided by ‘The Trans Train’ documentaries was concerning and suggests that further critical analysis and a review needs to be carried out on the clinics in question,” she said in an interview.

Ms. O’Malley herself made a documentary for Channel 4 in the United Kingdom, broadcast in 2018, called: “Trans Kids: It’s Time to Talk.”
 

Rapidly increasing numbers of youth, especially girls, question gender

As Ms. Indremo and coauthors explained – and as has been widely reported by this news organization – “the number of referrals to gender identity clinics have rapidly increased worldwide” in recent years, and this “has been especially prominent in adolescents and young adults.”

In addition, they acknowledged, “there has been a shift in gender ratio, with a preponderance toward individuals who were assigned female at birth (AFAB).”

This was the topic of “The Trans Train” programs, and in fact, following their broadcast, Ms. Indremo and colleagues noted that “an intense debate in national media [in Sweden] arose from the documentaries.”

Their research aimed to explore the association between both “positive” and “negative” media coverage and the number of referrals to gender identity clinics for young people (under aged 19) respectively. Data from the six gender clinics in Sweden were included between January 2017 and December 2019.

In the period studied, the clinics received 1,784 referrals, including 613 referrals in 2017, 663 referrals in 2018, and 508 referrals in 2019.

From the age-specific data that included 1,674 referrals, 359 individuals (21.4%) were younger than 13 years and 1,315 individuals (78.6%) were aged 13-18 years. From the assigned sex-specific data that included 1,435 referrals, 1,034 individuals (72.1%) were AFAB and 401 individuals (27.9%) were assigned male at birth (AMAB). Information on sex assigned at birth was lacking from one clinic, which was excluded from the analysis.

When they examined data for the 3 months following the airing of the first part of “The Trans Train” documentary series (in April 2019), they found that referrals to gender clinics fell by 25.4% overall, compared with the 3 months before part 1 was screened. Specifically, they fell by 25.3% for young people aged 13-18 years and by 32.2% for those born female.

In the extended analyses of 6 months following part 1, a decrease of total referrals by 30.7% was observed, while referrals for AFAB individuals decreased by 37.4% and referrals for individuals aged 13-18 years decreased by 27.7%. A decrease of referrals by 41.7% for children aged younger than 13 years was observed in the 6-month analysis, as well as a decrease of 8.2% among AMAB individuals.

“The Trans Train” documentaries, Ms. Indremo and colleagues said, “were criticized for being negatively biased and giving an oversimplified picture of transgender health care.”
 

Did the nature of the trans train documentaries influence referrals?

In an invited commentary published in JAMA Network Open, Ken C. Pang, PhD, from the Murdoch Children’s Research Institute, Melbourne, and colleagues noted: “Although the mechanisms underlying this decrease [in referrals] were not formally explored in their study, the authors reasonably speculated that both parents and referring health professionals may have been less likely to support a child or adolescent’s attendance at a specialist pediatric gender clinic following the documentaries.”

Dr. Pang and colleagues went on to say it is “the ... responsibility of media organizations in ensuring that stories depicting health care for transgender and gender diverse (TGD) young people are fair, balanced, nuanced, and accurate.”

Often, media reports have “fallen short of these standards and lacked the voices of TGD young people who have benefited from gender-affirming care or the perspectives of health professionals with expertise in providing such care,” they added.

“For example, some [media reports] have suggested that the growing number of referrals to such clinics is not owing to greater awareness of gender diversity and empowerment of TGD young people but is instead being driven by other factors such as peer influence, while others have warned that the use of gender-affirming hormonal interventions in TGD young people represents an undue risk,” they continue.

Ms. Indremo and colleagues didn’t see any drop-in referrals after the second part of the series, aired in October 2019, but they say this was likely because referrals were “already lowered” by the airing of the first part of the documentaries.

Nor did they see an increase in referrals following what they say was a “positive” media event in the form of a story about a professional Swedish handball player who announced the decision to quit his career to seek care for gender dysphoria.

“One may assume that a single news event is not significant enough to influence referral counts,” they suggested, noting also that Sweden represents “a society where there is already a relatively high level of awareness of gender identity issues.”

“Our results point to a differential association of media attention depending on the tone of the media content,” they observed.

Dr. Pang and coauthors noted it would be “helpful to examine whether similar media coverage in other countries has been associated with similar decreases in referral numbers and whether particular types of media stories are more prone to having this association.”
 

Parents and doctors debate treatment of gender dysphoria

In Sweden, custodians’ permission as well as custodians’ help is needed for minors to access care for gender dysphoria, said Ms. Indremo and coauthors. “It is possible that the content of the documentaries contributed to a higher custodian barrier to having their children referred for assessment, believing it may not be in the best interest of their child. This would highly impact young transgender individuals’ possibilities to access care.” 

They also acknowledge that health care practitioners who refer young people to specialist clinics might also have been influenced by the documentaries, noting “some commentators argued that all treatments for gender dysphoria be stopped, and that ‘all health care given at the gender identity clinics was an experiment lacking scientific basis.’ ”

In April 2021, Angela Sämfjord, MD, child and adolescent psychiatrist at Sahlgrenska University Hospital, Gothenburg, Sweden, who started a child and adolescent clinic – the Lundstrom Gender Clinic – told this news organization she had reevaluated her approach even prior to “The Trans Train” documentaries and had resigned in 2018 because of her own fears about the lack of evidence for hormonal and surgical treatments of youth with gender dysphoria.

Following the debate that ensued after the airing of “The Trans Train” programs, the Swedish National Board of Health and Welfare published new recommendations in March 2021, which reflected a significant change in direction for the evaluation of gender dysphoria in minors, emphasizing the requirement for a thorough mental health assessment.

And in May 2021, Karolinska Children’s Hospital, which houses one of the leading gender identity clinics in Sweden, announced it would stop the routine medical treatment of children with gender dysphoria under the age of 18, which meant a total ban on the prescribing of puberty blockers and cross-sex hormones to minors. Such treatment could henceforth only be carried out within the setting of a clinical trial approved by the EPM (Ethical Review Agency/Swedish Institutional Review Board), it said.

The remaining five gender identity clinics in Sweden decided upon their own rules, but in general, they have become much more cautious regarding medical treatment of minors within the past year. Also, there is a desire in Sweden to reduce the number of gender identity clinics for minors from the current six to perhaps a maximum of three nationwide.

However, neither Ms. Indremo and colleagues nor Dr. Pang and colleagues mentioned the subsequent change to the Swedish NBHW recommendations on evaluation of gender dysphoria in minors in JAMA articles.

New NBHW recommendations about medical treatment of gender dysphoria with puberty blockers and cross-sex hormones for minors were due to be issued in 2021 but have been delayed.
 

Debate in other countries

Sweden is not alone in discussing this issue. In 2020, Finland became the first country in the world to issue new guidelines that concluded there is a lack of quality evidence to support the use of hormonal interventions in adolescents with gender dysphoria.

This issue has been hotly debated in the United Kingdom – not least with the Keira Bell court case and two National Institute for Health and Clinical Excellence evidence reviews concluding there is a lack of data to support the use of puberty-blocking agents and “cross-sex” hormones in youth with gender dysphoria.

And a number of U.S. states are attempting to outlaw the medical and surgical treatment of gender dysphoria in minors. Even health care professionals who have been treating young people with gender dysphoria for years – some of whom are transgender themselves – have started to speak out and are questioning what they call “sloppy care” given to many such youth.

Indeed, a recent survey shows that detransitioners – individuals who suffer from gender dysphoria, transition to the opposite sex but then regret their decision and detransition – are getting short shrift when it comes to care, with over half of the 100 surveyed saying they feel they did not receive adequate evaluation from a doctor or mental health professional before starting to transition.

And new draft standards of care for treating people with gender dysphoria by the World Professional Association for Transgender Health have drawn criticism from experts.
 

‘First do no harm’

In their conclusion, Dr. Pang and coauthors said that, with respect to the media coverage of young people with gender dysphoria, “who are, after all, one of the most vulnerable subgroups within our society, perhaps our media should recall one of the core tenets of health care and ensure their stories ‘first, do no harm.’”

However, in a commentary recently published in Child and Adolescent Mental Health, Alison Clayton, MBBS, from the University of Melbourne, and coauthors again pointed out that evidence reviews of the use of puberty blockers in young people with gender dysphoria show “there is very low certainty of the benefits of puberty blockers, an unknown risk of harm, and there is need for more rigorous research.”

“The clinically prudent thing to do, if we aim to ‘first, do no harm,’ is to proceed with extreme caution, especially given the rapidly rising case numbers and novel gender dysphoria presentations,” Clayton and colleagues concluded.

Ms. Indremo and coauthors reported no relevant financial relationships. Dr. Pang reported being a member of the Australian Professional Association for Trans Health and its research committee. One commentary coauthor has reported being a member of WPATH.

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

Media coverage of transgender health care judged to be “negative” was associated with a drop of around 30% in referral rates to gender identity clinics in Sweden among young people under age 19, a new study indicates.

Malin Indremo, MS, from the department of neuroscience, Uppsala (Sweden) University, and colleagues explored the effect of the documentaries, “The Trans Train and Teenage Girls,” which they explain was a “Swedish public service television show” representing “investigative journalism.” The two-part documentary series was aired in Sweden in April 2019 and October 2019, respectively, and is now available in English on YouTube.

In their article, published online in JAMA Network Open, the authors said they consider “The Trans Train” programs to be “negative” media coverage because the “documentaries addressed the distinct increase among adolescents referred to gender identity clinics in recent years. Two young adults who regretted their transition and parents of transgender individuals who questioned the clinics’ assessments of their children were interviewed, and concerns were raised about whether gender-confirming treatments are based on sufficient scientific evidence.”

The programs, they suggest, may have influenced and jeopardized young transgender individuals’ access to transgender-specific health care.

Stella O’Malley, a U.K.-based psychotherapist specializing in transgender care and executive director of Genspect, an international organization that provides support to the parents of young people who are questioning their gender, expressed her disappointment with the study’s conclusions.

“I’m really surprised and disappointed that the researchers believe that negative coverage is the reason for a drop in referrals when it is more accurate to say that the information provided by ‘The Trans Train’ documentaries was concerning and suggests that further critical analysis and a review needs to be carried out on the clinics in question,” she said in an interview.

Ms. O’Malley herself made a documentary for Channel 4 in the United Kingdom, broadcast in 2018, called: “Trans Kids: It’s Time to Talk.”
 

Rapidly increasing numbers of youth, especially girls, question gender

As Ms. Indremo and coauthors explained – and as has been widely reported by this news organization – “the number of referrals to gender identity clinics have rapidly increased worldwide” in recent years, and this “has been especially prominent in adolescents and young adults.”

In addition, they acknowledged, “there has been a shift in gender ratio, with a preponderance toward individuals who were assigned female at birth (AFAB).”

This was the topic of “The Trans Train” programs, and in fact, following their broadcast, Ms. Indremo and colleagues noted that “an intense debate in national media [in Sweden] arose from the documentaries.”

Their research aimed to explore the association between both “positive” and “negative” media coverage and the number of referrals to gender identity clinics for young people (under aged 19) respectively. Data from the six gender clinics in Sweden were included between January 2017 and December 2019.

In the period studied, the clinics received 1,784 referrals, including 613 referrals in 2017, 663 referrals in 2018, and 508 referrals in 2019.

From the age-specific data that included 1,674 referrals, 359 individuals (21.4%) were younger than 13 years and 1,315 individuals (78.6%) were aged 13-18 years. From the assigned sex-specific data that included 1,435 referrals, 1,034 individuals (72.1%) were AFAB and 401 individuals (27.9%) were assigned male at birth (AMAB). Information on sex assigned at birth was lacking from one clinic, which was excluded from the analysis.

When they examined data for the 3 months following the airing of the first part of “The Trans Train” documentary series (in April 2019), they found that referrals to gender clinics fell by 25.4% overall, compared with the 3 months before part 1 was screened. Specifically, they fell by 25.3% for young people aged 13-18 years and by 32.2% for those born female.

In the extended analyses of 6 months following part 1, a decrease of total referrals by 30.7% was observed, while referrals for AFAB individuals decreased by 37.4% and referrals for individuals aged 13-18 years decreased by 27.7%. A decrease of referrals by 41.7% for children aged younger than 13 years was observed in the 6-month analysis, as well as a decrease of 8.2% among AMAB individuals.

“The Trans Train” documentaries, Ms. Indremo and colleagues said, “were criticized for being negatively biased and giving an oversimplified picture of transgender health care.”
 

Did the nature of the trans train documentaries influence referrals?

In an invited commentary published in JAMA Network Open, Ken C. Pang, PhD, from the Murdoch Children’s Research Institute, Melbourne, and colleagues noted: “Although the mechanisms underlying this decrease [in referrals] were not formally explored in their study, the authors reasonably speculated that both parents and referring health professionals may have been less likely to support a child or adolescent’s attendance at a specialist pediatric gender clinic following the documentaries.”

Dr. Pang and colleagues went on to say it is “the ... responsibility of media organizations in ensuring that stories depicting health care for transgender and gender diverse (TGD) young people are fair, balanced, nuanced, and accurate.”

Often, media reports have “fallen short of these standards and lacked the voices of TGD young people who have benefited from gender-affirming care or the perspectives of health professionals with expertise in providing such care,” they added.

“For example, some [media reports] have suggested that the growing number of referrals to such clinics is not owing to greater awareness of gender diversity and empowerment of TGD young people but is instead being driven by other factors such as peer influence, while others have warned that the use of gender-affirming hormonal interventions in TGD young people represents an undue risk,” they continue.

Ms. Indremo and colleagues didn’t see any drop-in referrals after the second part of the series, aired in October 2019, but they say this was likely because referrals were “already lowered” by the airing of the first part of the documentaries.

Nor did they see an increase in referrals following what they say was a “positive” media event in the form of a story about a professional Swedish handball player who announced the decision to quit his career to seek care for gender dysphoria.

“One may assume that a single news event is not significant enough to influence referral counts,” they suggested, noting also that Sweden represents “a society where there is already a relatively high level of awareness of gender identity issues.”

“Our results point to a differential association of media attention depending on the tone of the media content,” they observed.

Dr. Pang and coauthors noted it would be “helpful to examine whether similar media coverage in other countries has been associated with similar decreases in referral numbers and whether particular types of media stories are more prone to having this association.”
 

Parents and doctors debate treatment of gender dysphoria

In Sweden, custodians’ permission as well as custodians’ help is needed for minors to access care for gender dysphoria, said Ms. Indremo and coauthors. “It is possible that the content of the documentaries contributed to a higher custodian barrier to having their children referred for assessment, believing it may not be in the best interest of their child. This would highly impact young transgender individuals’ possibilities to access care.” 

They also acknowledge that health care practitioners who refer young people to specialist clinics might also have been influenced by the documentaries, noting “some commentators argued that all treatments for gender dysphoria be stopped, and that ‘all health care given at the gender identity clinics was an experiment lacking scientific basis.’ ”

In April 2021, Angela Sämfjord, MD, child and adolescent psychiatrist at Sahlgrenska University Hospital, Gothenburg, Sweden, who started a child and adolescent clinic – the Lundstrom Gender Clinic – told this news organization she had reevaluated her approach even prior to “The Trans Train” documentaries and had resigned in 2018 because of her own fears about the lack of evidence for hormonal and surgical treatments of youth with gender dysphoria.

Following the debate that ensued after the airing of “The Trans Train” programs, the Swedish National Board of Health and Welfare published new recommendations in March 2021, which reflected a significant change in direction for the evaluation of gender dysphoria in minors, emphasizing the requirement for a thorough mental health assessment.

And in May 2021, Karolinska Children’s Hospital, which houses one of the leading gender identity clinics in Sweden, announced it would stop the routine medical treatment of children with gender dysphoria under the age of 18, which meant a total ban on the prescribing of puberty blockers and cross-sex hormones to minors. Such treatment could henceforth only be carried out within the setting of a clinical trial approved by the EPM (Ethical Review Agency/Swedish Institutional Review Board), it said.

The remaining five gender identity clinics in Sweden decided upon their own rules, but in general, they have become much more cautious regarding medical treatment of minors within the past year. Also, there is a desire in Sweden to reduce the number of gender identity clinics for minors from the current six to perhaps a maximum of three nationwide.

However, neither Ms. Indremo and colleagues nor Dr. Pang and colleagues mentioned the subsequent change to the Swedish NBHW recommendations on evaluation of gender dysphoria in minors in JAMA articles.

New NBHW recommendations about medical treatment of gender dysphoria with puberty blockers and cross-sex hormones for minors were due to be issued in 2021 but have been delayed.
 

Debate in other countries

Sweden is not alone in discussing this issue. In 2020, Finland became the first country in the world to issue new guidelines that concluded there is a lack of quality evidence to support the use of hormonal interventions in adolescents with gender dysphoria.

This issue has been hotly debated in the United Kingdom – not least with the Keira Bell court case and two National Institute for Health and Clinical Excellence evidence reviews concluding there is a lack of data to support the use of puberty-blocking agents and “cross-sex” hormones in youth with gender dysphoria.

And a number of U.S. states are attempting to outlaw the medical and surgical treatment of gender dysphoria in minors. Even health care professionals who have been treating young people with gender dysphoria for years – some of whom are transgender themselves – have started to speak out and are questioning what they call “sloppy care” given to many such youth.

Indeed, a recent survey shows that detransitioners – individuals who suffer from gender dysphoria, transition to the opposite sex but then regret their decision and detransition – are getting short shrift when it comes to care, with over half of the 100 surveyed saying they feel they did not receive adequate evaluation from a doctor or mental health professional before starting to transition.

And new draft standards of care for treating people with gender dysphoria by the World Professional Association for Transgender Health have drawn criticism from experts.
 

‘First do no harm’

In their conclusion, Dr. Pang and coauthors said that, with respect to the media coverage of young people with gender dysphoria, “who are, after all, one of the most vulnerable subgroups within our society, perhaps our media should recall one of the core tenets of health care and ensure their stories ‘first, do no harm.’”

However, in a commentary recently published in Child and Adolescent Mental Health, Alison Clayton, MBBS, from the University of Melbourne, and coauthors again pointed out that evidence reviews of the use of puberty blockers in young people with gender dysphoria show “there is very low certainty of the benefits of puberty blockers, an unknown risk of harm, and there is need for more rigorous research.”

“The clinically prudent thing to do, if we aim to ‘first, do no harm,’ is to proceed with extreme caution, especially given the rapidly rising case numbers and novel gender dysphoria presentations,” Clayton and colleagues concluded.

Ms. Indremo and coauthors reported no relevant financial relationships. Dr. Pang reported being a member of the Australian Professional Association for Trans Health and its research committee. One commentary coauthor has reported being a member of WPATH.

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

Media coverage of transgender health care judged to be “negative” was associated with a drop of around 30% in referral rates to gender identity clinics in Sweden among young people under age 19, a new study indicates.

Malin Indremo, MS, from the department of neuroscience, Uppsala (Sweden) University, and colleagues explored the effect of the documentaries, “The Trans Train and Teenage Girls,” which they explain was a “Swedish public service television show” representing “investigative journalism.” The two-part documentary series was aired in Sweden in April 2019 and October 2019, respectively, and is now available in English on YouTube.

In their article, published online in JAMA Network Open, the authors said they consider “The Trans Train” programs to be “negative” media coverage because the “documentaries addressed the distinct increase among adolescents referred to gender identity clinics in recent years. Two young adults who regretted their transition and parents of transgender individuals who questioned the clinics’ assessments of their children were interviewed, and concerns were raised about whether gender-confirming treatments are based on sufficient scientific evidence.”

The programs, they suggest, may have influenced and jeopardized young transgender individuals’ access to transgender-specific health care.

Stella O’Malley, a U.K.-based psychotherapist specializing in transgender care and executive director of Genspect, an international organization that provides support to the parents of young people who are questioning their gender, expressed her disappointment with the study’s conclusions.

“I’m really surprised and disappointed that the researchers believe that negative coverage is the reason for a drop in referrals when it is more accurate to say that the information provided by ‘The Trans Train’ documentaries was concerning and suggests that further critical analysis and a review needs to be carried out on the clinics in question,” she said in an interview.

Ms. O’Malley herself made a documentary for Channel 4 in the United Kingdom, broadcast in 2018, called: “Trans Kids: It’s Time to Talk.”
 

Rapidly increasing numbers of youth, especially girls, question gender

As Ms. Indremo and coauthors explained – and as has been widely reported by this news organization – “the number of referrals to gender identity clinics have rapidly increased worldwide” in recent years, and this “has been especially prominent in adolescents and young adults.”

In addition, they acknowledged, “there has been a shift in gender ratio, with a preponderance toward individuals who were assigned female at birth (AFAB).”

This was the topic of “The Trans Train” programs, and in fact, following their broadcast, Ms. Indremo and colleagues noted that “an intense debate in national media [in Sweden] arose from the documentaries.”

Their research aimed to explore the association between both “positive” and “negative” media coverage and the number of referrals to gender identity clinics for young people (under aged 19) respectively. Data from the six gender clinics in Sweden were included between January 2017 and December 2019.

In the period studied, the clinics received 1,784 referrals, including 613 referrals in 2017, 663 referrals in 2018, and 508 referrals in 2019.

From the age-specific data that included 1,674 referrals, 359 individuals (21.4%) were younger than 13 years and 1,315 individuals (78.6%) were aged 13-18 years. From the assigned sex-specific data that included 1,435 referrals, 1,034 individuals (72.1%) were AFAB and 401 individuals (27.9%) were assigned male at birth (AMAB). Information on sex assigned at birth was lacking from one clinic, which was excluded from the analysis.

When they examined data for the 3 months following the airing of the first part of “The Trans Train” documentary series (in April 2019), they found that referrals to gender clinics fell by 25.4% overall, compared with the 3 months before part 1 was screened. Specifically, they fell by 25.3% for young people aged 13-18 years and by 32.2% for those born female.

In the extended analyses of 6 months following part 1, a decrease of total referrals by 30.7% was observed, while referrals for AFAB individuals decreased by 37.4% and referrals for individuals aged 13-18 years decreased by 27.7%. A decrease of referrals by 41.7% for children aged younger than 13 years was observed in the 6-month analysis, as well as a decrease of 8.2% among AMAB individuals.

“The Trans Train” documentaries, Ms. Indremo and colleagues said, “were criticized for being negatively biased and giving an oversimplified picture of transgender health care.”
 

Did the nature of the trans train documentaries influence referrals?

In an invited commentary published in JAMA Network Open, Ken C. Pang, PhD, from the Murdoch Children’s Research Institute, Melbourne, and colleagues noted: “Although the mechanisms underlying this decrease [in referrals] were not formally explored in their study, the authors reasonably speculated that both parents and referring health professionals may have been less likely to support a child or adolescent’s attendance at a specialist pediatric gender clinic following the documentaries.”

Dr. Pang and colleagues went on to say it is “the ... responsibility of media organizations in ensuring that stories depicting health care for transgender and gender diverse (TGD) young people are fair, balanced, nuanced, and accurate.”

Often, media reports have “fallen short of these standards and lacked the voices of TGD young people who have benefited from gender-affirming care or the perspectives of health professionals with expertise in providing such care,” they added.

“For example, some [media reports] have suggested that the growing number of referrals to such clinics is not owing to greater awareness of gender diversity and empowerment of TGD young people but is instead being driven by other factors such as peer influence, while others have warned that the use of gender-affirming hormonal interventions in TGD young people represents an undue risk,” they continue.

Ms. Indremo and colleagues didn’t see any drop-in referrals after the second part of the series, aired in October 2019, but they say this was likely because referrals were “already lowered” by the airing of the first part of the documentaries.

Nor did they see an increase in referrals following what they say was a “positive” media event in the form of a story about a professional Swedish handball player who announced the decision to quit his career to seek care for gender dysphoria.

“One may assume that a single news event is not significant enough to influence referral counts,” they suggested, noting also that Sweden represents “a society where there is already a relatively high level of awareness of gender identity issues.”

“Our results point to a differential association of media attention depending on the tone of the media content,” they observed.

Dr. Pang and coauthors noted it would be “helpful to examine whether similar media coverage in other countries has been associated with similar decreases in referral numbers and whether particular types of media stories are more prone to having this association.”
 

Parents and doctors debate treatment of gender dysphoria

In Sweden, custodians’ permission as well as custodians’ help is needed for minors to access care for gender dysphoria, said Ms. Indremo and coauthors. “It is possible that the content of the documentaries contributed to a higher custodian barrier to having their children referred for assessment, believing it may not be in the best interest of their child. This would highly impact young transgender individuals’ possibilities to access care.” 

They also acknowledge that health care practitioners who refer young people to specialist clinics might also have been influenced by the documentaries, noting “some commentators argued that all treatments for gender dysphoria be stopped, and that ‘all health care given at the gender identity clinics was an experiment lacking scientific basis.’ ”

In April 2021, Angela Sämfjord, MD, child and adolescent psychiatrist at Sahlgrenska University Hospital, Gothenburg, Sweden, who started a child and adolescent clinic – the Lundstrom Gender Clinic – told this news organization she had reevaluated her approach even prior to “The Trans Train” documentaries and had resigned in 2018 because of her own fears about the lack of evidence for hormonal and surgical treatments of youth with gender dysphoria.

Following the debate that ensued after the airing of “The Trans Train” programs, the Swedish National Board of Health and Welfare published new recommendations in March 2021, which reflected a significant change in direction for the evaluation of gender dysphoria in minors, emphasizing the requirement for a thorough mental health assessment.

And in May 2021, Karolinska Children’s Hospital, which houses one of the leading gender identity clinics in Sweden, announced it would stop the routine medical treatment of children with gender dysphoria under the age of 18, which meant a total ban on the prescribing of puberty blockers and cross-sex hormones to minors. Such treatment could henceforth only be carried out within the setting of a clinical trial approved by the EPM (Ethical Review Agency/Swedish Institutional Review Board), it said.

The remaining five gender identity clinics in Sweden decided upon their own rules, but in general, they have become much more cautious regarding medical treatment of minors within the past year. Also, there is a desire in Sweden to reduce the number of gender identity clinics for minors from the current six to perhaps a maximum of three nationwide.

However, neither Ms. Indremo and colleagues nor Dr. Pang and colleagues mentioned the subsequent change to the Swedish NBHW recommendations on evaluation of gender dysphoria in minors in JAMA articles.

New NBHW recommendations about medical treatment of gender dysphoria with puberty blockers and cross-sex hormones for minors were due to be issued in 2021 but have been delayed.
 

Debate in other countries

Sweden is not alone in discussing this issue. In 2020, Finland became the first country in the world to issue new guidelines that concluded there is a lack of quality evidence to support the use of hormonal interventions in adolescents with gender dysphoria.

This issue has been hotly debated in the United Kingdom – not least with the Keira Bell court case and two National Institute for Health and Clinical Excellence evidence reviews concluding there is a lack of data to support the use of puberty-blocking agents and “cross-sex” hormones in youth with gender dysphoria.

And a number of U.S. states are attempting to outlaw the medical and surgical treatment of gender dysphoria in minors. Even health care professionals who have been treating young people with gender dysphoria for years – some of whom are transgender themselves – have started to speak out and are questioning what they call “sloppy care” given to many such youth.

Indeed, a recent survey shows that detransitioners – individuals who suffer from gender dysphoria, transition to the opposite sex but then regret their decision and detransition – are getting short shrift when it comes to care, with over half of the 100 surveyed saying they feel they did not receive adequate evaluation from a doctor or mental health professional before starting to transition.

And new draft standards of care for treating people with gender dysphoria by the World Professional Association for Transgender Health have drawn criticism from experts.
 

‘First do no harm’

In their conclusion, Dr. Pang and coauthors said that, with respect to the media coverage of young people with gender dysphoria, “who are, after all, one of the most vulnerable subgroups within our society, perhaps our media should recall one of the core tenets of health care and ensure their stories ‘first, do no harm.’”

However, in a commentary recently published in Child and Adolescent Mental Health, Alison Clayton, MBBS, from the University of Melbourne, and coauthors again pointed out that evidence reviews of the use of puberty blockers in young people with gender dysphoria show “there is very low certainty of the benefits of puberty blockers, an unknown risk of harm, and there is need for more rigorous research.”

“The clinically prudent thing to do, if we aim to ‘first, do no harm,’ is to proceed with extreme caution, especially given the rapidly rising case numbers and novel gender dysphoria presentations,” Clayton and colleagues concluded.

Ms. Indremo and coauthors reported no relevant financial relationships. Dr. Pang reported being a member of the Australian Professional Association for Trans Health and its research committee. One commentary coauthor has reported being a member of WPATH.

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

The Diagnosis: Desmoplastic Spitz Nevus

Desmoplastic Spitz nevus is a rare variant of Spitz nevus that commonly presents as a red to brown papule on the head, neck, or extremities. It is pertinent to review the histologic features of this neoplasm, as it can be confused with other more sinister entities such as spitzoid melanoma. Histologically, there is a dermal infiltrate of melanocytes containing eosinophilic cytoplasm and vesicular nuclei. Junctional involvement is rare, and there should be no pagetoid spread.¹ This entity features abundant stromal fibrosis formed by dense collagen bundles, low cellular density, and polygonal-shaped melanocytes, which helps to differentiate it from melanoma.^2,3 In a retrospective study comparing the characteristics of desmoplastic Spitz nevi with desmoplastic melanoma, desmoplastic Spitz nevi histologically were more symmetric and circumscribed with greater melanocytic maturation and adnexal structure involvement.³ Although this entity demonstrates maturation from the superficial to the deep dermis, it also may feature deep dermal vascular proliferation.⁴ S-100 and SRY-related HMG box 10, SOX-10, are noted to be positive in desmoplastic Spitz nevi, which can help to differentiate it from nonmelanocytic entities (Figure 1).

Although spitzoid lesions can be ambiguous and difficult even for experts to classify, spitzoid melanoma tends to have a high Breslow thickness, high cell density, marked atypia, and an increased nucleus to cytoplasm ratio.⁵ Additionally, desmoplastic melanoma was found to more often display “melanocytic junctional nests associated with discohesive cells, variations in size and shape of the nests, lentiginous melanocytic proliferation, actinic elastosis, pagetoid spread, dermal mitosis, perineural involvement and brisk inflammatory infiltrate.”³ Given the challenge of histologically separating desmoplastic Spitz nevi from melanoma, immunostaining can be useful. For example, Hilliard et al⁶ used a p16 antibody to differentiate desmoplastic Spitz nevi from desmoplastic melanoma, finding that most desmoplastic melanomas (81.8%; n=11) were negative for p16, whereas all desmoplastic Spitz nevi were at least moderately positive. However, another study re-evaluated the utility of p16 in desmoplastic melanoma and found that 72.7% (16/22) were at least focally reactive for the immunostain.⁷ Thus, caution must be exercised when using p16.

PReferentially expressed Antigen in MElanoma (PRAME) is a newer nuclear immunohistochemical marker that tends to be positive in melanomas and negative in nevi. Desmoplastic Spitz nevi would be expected to be negative for PRAME, while desmoplastic melanoma may be positive; however, this marker seems to be less effective in desmoplastic melanoma than in most other subtypes of the malignancy. In one study, only 35% (n=20) of desmoplastic melanomas were positive for PRAME.⁸ Likewise, another study showed that some benign Spitz nevi may diffusely express PRAME.⁹ As such, PRAME should be used prudently.

For cases in which immunohistochemistry is equivocal, molecular testing may aid in differentiating Spitz nevi from melanoma. For example, comparative genomic hybridization has revealed an increased copy number of chromosome 11p in approximately 20% of Spitz nevi cases¹⁰; this finding is not seen in melanoma. Mutation analyses of HRas proto-oncogene, GTPase, HRAS; B-Raf proto-oncogene, serine/threonine kinase, BRAF; and NRAS proto-oncogene, GTPase, NRAS, also have shown some promise in distinguishing spitzoid lesions from melanoma, but these analyses may be oversimplified.¹¹ Fluorescence in situ hybridization (FISH) is another diagnostic modality that has been studied to differentiate benign nevi from melanoma. One study challenged the utility of FISH, reporting 7 of 15 desmoplastic melanomas tested positive compared to 0 of 15 sclerotic melanocytic nevi.¹² Thus, negative FISH cannot reliably rule out melanoma. Ultimately, a combination of immunostains along with FISH or another genetic study would prove to be most effective in ruling out melanoma in difficult cases. Even then, a dermatopathologist may be faced with a degree of uncertainty.

Cellular blue nevi predominantly affect adults younger than 40 years and commonly are seen on the buttocks.¹³ This benign neoplasm demonstrates areas that are distinctly sclerotic as well as those that are cellular in nature.¹⁴ This entity demonstrates a well-circumscribed dermal growth pattern with 2 main populations of cells. The sclerotic portion of the cellular blue nevus mimics that of the blue nevus in that it is noted superficially with irregular margins. The cellular aspect of the nevus features spindle cells contained within well-circumscribed nodules (Figure 2). Stromal melanophages are not uncommon, and some can be observed adjacent to nerve fibers. Although this blue nevus variant displays features of the common blue nevus, its melanocytes track along adnexal and neurovascular structures similar to the deep penetrating nevus and the desmoplastic Spitz nevus. However, these melanocytes are variable in morphology and can appear on a spectrum spanning from pale and lightly pigmented to clear.¹⁵

The breast is the most common site of origin of tumor metastasis to the skin. These cutaneous metastases can vary in both their clinical and histological presentations. For example, cutaneous metastatic breast adenocarcinoma often can present clinically as pink-violaceous papules and plaques on the breast or on other parts of the body. Histologically, it can demonstrate a varying degree of patterns such as collagen infiltration by single cells, cords, tubules, and sheets of atypical cells (Figure 3) that can be observed together in areas of mucin or can form glandular structures.16 Metastatic breast carcinoma is noted to be positive for gross cystic disease fluid protein-15, estrogen receptor, and cytokeratin 7, which can help differentiate this entity from other tumors of glandular origin.¹⁶ Although rare, primary melanoma of the breast has been reported in the literature.^17,18 These malignant melanocytic lesions easily could be differentiated from other breast tumors such as adenocarcinoma using immunohistochemical staining patterns.

Deep penetrating nevi most often are observed clinically as blue, brown, or black papules or nodules on the head or neck.¹⁹ Histologically, this lesion features a wedge-shaped infiltrate of deep dermal melanocytes with oval nuclei. It commonly extends to the reticular dermis or further into the subcutis (Figure 4).^20,21 This neoplasm frequently tracks along adnexal and neurovascular structures, resulting in a plexiform appearance.²² The adnexal involvement of deep penetrating nevi is a shared feature with desmoplastic Spitz nevi. The presence of any number of melanophages is characteristic of this lesion.²³ Lastly, there is a well-documented association between β-catenin mutations and deep penetrating nevi.²⁴ Multicentric reticulohistiocytosis (MRH) is a rare form of non-Langerhans cell histiocytosis that has the pathognomonic clinical finding of pink-red papules (coral beading) with a predilection for acral surfaces. Histology of affected skin reveals a dermal infiltrate of ground glass as well as eosinophilic histiocytes that most often stain positive for CD68 and human alveolar macrophage 56 but negative for S-100 and CD1a (Figure 5).²⁵ Although MRH is rare, negative staining for S-100 could serve as a useful diagnostic clue to differentiate it from other entities that are positive for S-100, such as the desmoplastic Spitz nevus. Arthritis mutilans is a potential complication of MRH, but a reported association with an underlying malignancy is seen in approximately 25% of cases.²⁶ Thus, the cutaneous, rheumatologic, and oncologic implications of this disease help to distinguish it from other differential diagnoses that may be considered.

The Diagnosis: Desmoplastic Spitz Nevus

Desmoplastic Spitz nevus is a rare variant of Spitz nevus that commonly presents as a red to brown papule on the head, neck, or extremities. It is pertinent to review the histologic features of this neoplasm, as it can be confused with other more sinister entities such as spitzoid melanoma. Histologically, there is a dermal infiltrate of melanocytes containing eosinophilic cytoplasm and vesicular nuclei. Junctional involvement is rare, and there should be no pagetoid spread.¹ This entity features abundant stromal fibrosis formed by dense collagen bundles, low cellular density, and polygonal-shaped melanocytes, which helps to differentiate it from melanoma.^2,3 In a retrospective study comparing the characteristics of desmoplastic Spitz nevi with desmoplastic melanoma, desmoplastic Spitz nevi histologically were more symmetric and circumscribed with greater melanocytic maturation and adnexal structure involvement.³ Although this entity demonstrates maturation from the superficial to the deep dermis, it also may feature deep dermal vascular proliferation.⁴ S-100 and SRY-related HMG box 10, SOX-10, are noted to be positive in desmoplastic Spitz nevi, which can help to differentiate it from nonmelanocytic entities (Figure 1).

Although spitzoid lesions can be ambiguous and difficult even for experts to classify, spitzoid melanoma tends to have a high Breslow thickness, high cell density, marked atypia, and an increased nucleus to cytoplasm ratio.⁵ Additionally, desmoplastic melanoma was found to more often display “melanocytic junctional nests associated with discohesive cells, variations in size and shape of the nests, lentiginous melanocytic proliferation, actinic elastosis, pagetoid spread, dermal mitosis, perineural involvement and brisk inflammatory infiltrate.”³ Given the challenge of histologically separating desmoplastic Spitz nevi from melanoma, immunostaining can be useful. For example, Hilliard et al⁶ used a p16 antibody to differentiate desmoplastic Spitz nevi from desmoplastic melanoma, finding that most desmoplastic melanomas (81.8%; n=11) were negative for p16, whereas all desmoplastic Spitz nevi were at least moderately positive. However, another study re-evaluated the utility of p16 in desmoplastic melanoma and found that 72.7% (16/22) were at least focally reactive for the immunostain.⁷ Thus, caution must be exercised when using p16.

PReferentially expressed Antigen in MElanoma (PRAME) is a newer nuclear immunohistochemical marker that tends to be positive in melanomas and negative in nevi. Desmoplastic Spitz nevi would be expected to be negative for PRAME, while desmoplastic melanoma may be positive; however, this marker seems to be less effective in desmoplastic melanoma than in most other subtypes of the malignancy. In one study, only 35% (n=20) of desmoplastic melanomas were positive for PRAME.⁸ Likewise, another study showed that some benign Spitz nevi may diffusely express PRAME.⁹ As such, PRAME should be used prudently.

For cases in which immunohistochemistry is equivocal, molecular testing may aid in differentiating Spitz nevi from melanoma. For example, comparative genomic hybridization has revealed an increased copy number of chromosome 11p in approximately 20% of Spitz nevi cases¹⁰; this finding is not seen in melanoma. Mutation analyses of HRas proto-oncogene, GTPase, HRAS; B-Raf proto-oncogene, serine/threonine kinase, BRAF; and NRAS proto-oncogene, GTPase, NRAS, also have shown some promise in distinguishing spitzoid lesions from melanoma, but these analyses may be oversimplified.¹¹ Fluorescence in situ hybridization (FISH) is another diagnostic modality that has been studied to differentiate benign nevi from melanoma. One study challenged the utility of FISH, reporting 7 of 15 desmoplastic melanomas tested positive compared to 0 of 15 sclerotic melanocytic nevi.¹² Thus, negative FISH cannot reliably rule out melanoma. Ultimately, a combination of immunostains along with FISH or another genetic study would prove to be most effective in ruling out melanoma in difficult cases. Even then, a dermatopathologist may be faced with a degree of uncertainty.

Cellular blue nevi predominantly affect adults younger than 40 years and commonly are seen on the buttocks.¹³ This benign neoplasm demonstrates areas that are distinctly sclerotic as well as those that are cellular in nature.¹⁴ This entity demonstrates a well-circumscribed dermal growth pattern with 2 main populations of cells. The sclerotic portion of the cellular blue nevus mimics that of the blue nevus in that it is noted superficially with irregular margins. The cellular aspect of the nevus features spindle cells contained within well-circumscribed nodules (Figure 2). Stromal melanophages are not uncommon, and some can be observed adjacent to nerve fibers. Although this blue nevus variant displays features of the common blue nevus, its melanocytes track along adnexal and neurovascular structures similar to the deep penetrating nevus and the desmoplastic Spitz nevus. However, these melanocytes are variable in morphology and can appear on a spectrum spanning from pale and lightly pigmented to clear.¹⁵

The breast is the most common site of origin of tumor metastasis to the skin. These cutaneous metastases can vary in both their clinical and histological presentations. For example, cutaneous metastatic breast adenocarcinoma often can present clinically as pink-violaceous papules and plaques on the breast or on other parts of the body. Histologically, it can demonstrate a varying degree of patterns such as collagen infiltration by single cells, cords, tubules, and sheets of atypical cells (Figure 3) that can be observed together in areas of mucin or can form glandular structures.16 Metastatic breast carcinoma is noted to be positive for gross cystic disease fluid protein-15, estrogen receptor, and cytokeratin 7, which can help differentiate this entity from other tumors of glandular origin.¹⁶ Although rare, primary melanoma of the breast has been reported in the literature.^17,18 These malignant melanocytic lesions easily could be differentiated from other breast tumors such as adenocarcinoma using immunohistochemical staining patterns.

Deep penetrating nevi most often are observed clinically as blue, brown, or black papules or nodules on the head or neck.¹⁹ Histologically, this lesion features a wedge-shaped infiltrate of deep dermal melanocytes with oval nuclei. It commonly extends to the reticular dermis or further into the subcutis (Figure 4).^20,21 This neoplasm frequently tracks along adnexal and neurovascular structures, resulting in a plexiform appearance.²² The adnexal involvement of deep penetrating nevi is a shared feature with desmoplastic Spitz nevi. The presence of any number of melanophages is characteristic of this lesion.²³ Lastly, there is a well-documented association between β-catenin mutations and deep penetrating nevi.²⁴ Multicentric reticulohistiocytosis (MRH) is a rare form of non-Langerhans cell histiocytosis that has the pathognomonic clinical finding of pink-red papules (coral beading) with a predilection for acral surfaces. Histology of affected skin reveals a dermal infiltrate of ground glass as well as eosinophilic histiocytes that most often stain positive for CD68 and human alveolar macrophage 56 but negative for S-100 and CD1a (Figure 5).²⁵ Although MRH is rare, negative staining for S-100 could serve as a useful diagnostic clue to differentiate it from other entities that are positive for S-100, such as the desmoplastic Spitz nevus. Arthritis mutilans is a potential complication of MRH, but a reported association with an underlying malignancy is seen in approximately 25% of cases.²⁶ Thus, the cutaneous, rheumatologic, and oncologic implications of this disease help to distinguish it from other differential diagnoses that may be considered.

The Diagnosis: Desmoplastic Spitz Nevus

Desmoplastic Spitz nevus is a rare variant of Spitz nevus that commonly presents as a red to brown papule on the head, neck, or extremities. It is pertinent to review the histologic features of this neoplasm, as it can be confused with other more sinister entities such as spitzoid melanoma. Histologically, there is a dermal infiltrate of melanocytes containing eosinophilic cytoplasm and vesicular nuclei. Junctional involvement is rare, and there should be no pagetoid spread.¹ This entity features abundant stromal fibrosis formed by dense collagen bundles, low cellular density, and polygonal-shaped melanocytes, which helps to differentiate it from melanoma.^2,3 In a retrospective study comparing the characteristics of desmoplastic Spitz nevi with desmoplastic melanoma, desmoplastic Spitz nevi histologically were more symmetric and circumscribed with greater melanocytic maturation and adnexal structure involvement.³ Although this entity demonstrates maturation from the superficial to the deep dermis, it also may feature deep dermal vascular proliferation.⁴ S-100 and SRY-related HMG box 10, SOX-10, are noted to be positive in desmoplastic Spitz nevi, which can help to differentiate it from nonmelanocytic entities (Figure 1).

Although spitzoid lesions can be ambiguous and difficult even for experts to classify, spitzoid melanoma tends to have a high Breslow thickness, high cell density, marked atypia, and an increased nucleus to cytoplasm ratio.⁵ Additionally, desmoplastic melanoma was found to more often display “melanocytic junctional nests associated with discohesive cells, variations in size and shape of the nests, lentiginous melanocytic proliferation, actinic elastosis, pagetoid spread, dermal mitosis, perineural involvement and brisk inflammatory infiltrate.”³ Given the challenge of histologically separating desmoplastic Spitz nevi from melanoma, immunostaining can be useful. For example, Hilliard et al⁶ used a p16 antibody to differentiate desmoplastic Spitz nevi from desmoplastic melanoma, finding that most desmoplastic melanomas (81.8%; n=11) were negative for p16, whereas all desmoplastic Spitz nevi were at least moderately positive. However, another study re-evaluated the utility of p16 in desmoplastic melanoma and found that 72.7% (16/22) were at least focally reactive for the immunostain.⁷ Thus, caution must be exercised when using p16.

PReferentially expressed Antigen in MElanoma (PRAME) is a newer nuclear immunohistochemical marker that tends to be positive in melanomas and negative in nevi. Desmoplastic Spitz nevi would be expected to be negative for PRAME, while desmoplastic melanoma may be positive; however, this marker seems to be less effective in desmoplastic melanoma than in most other subtypes of the malignancy. In one study, only 35% (n=20) of desmoplastic melanomas were positive for PRAME.⁸ Likewise, another study showed that some benign Spitz nevi may diffusely express PRAME.⁹ As such, PRAME should be used prudently.

For cases in which immunohistochemistry is equivocal, molecular testing may aid in differentiating Spitz nevi from melanoma. For example, comparative genomic hybridization has revealed an increased copy number of chromosome 11p in approximately 20% of Spitz nevi cases¹⁰; this finding is not seen in melanoma. Mutation analyses of HRas proto-oncogene, GTPase, HRAS; B-Raf proto-oncogene, serine/threonine kinase, BRAF; and NRAS proto-oncogene, GTPase, NRAS, also have shown some promise in distinguishing spitzoid lesions from melanoma, but these analyses may be oversimplified.¹¹ Fluorescence in situ hybridization (FISH) is another diagnostic modality that has been studied to differentiate benign nevi from melanoma. One study challenged the utility of FISH, reporting 7 of 15 desmoplastic melanomas tested positive compared to 0 of 15 sclerotic melanocytic nevi.¹² Thus, negative FISH cannot reliably rule out melanoma. Ultimately, a combination of immunostains along with FISH or another genetic study would prove to be most effective in ruling out melanoma in difficult cases. Even then, a dermatopathologist may be faced with a degree of uncertainty.

Cellular blue nevi predominantly affect adults younger than 40 years and commonly are seen on the buttocks.¹³ This benign neoplasm demonstrates areas that are distinctly sclerotic as well as those that are cellular in nature.¹⁴ This entity demonstrates a well-circumscribed dermal growth pattern with 2 main populations of cells. The sclerotic portion of the cellular blue nevus mimics that of the blue nevus in that it is noted superficially with irregular margins. The cellular aspect of the nevus features spindle cells contained within well-circumscribed nodules (Figure 2). Stromal melanophages are not uncommon, and some can be observed adjacent to nerve fibers. Although this blue nevus variant displays features of the common blue nevus, its melanocytes track along adnexal and neurovascular structures similar to the deep penetrating nevus and the desmoplastic Spitz nevus. However, these melanocytes are variable in morphology and can appear on a spectrum spanning from pale and lightly pigmented to clear.¹⁵

The breast is the most common site of origin of tumor metastasis to the skin. These cutaneous metastases can vary in both their clinical and histological presentations. For example, cutaneous metastatic breast adenocarcinoma often can present clinically as pink-violaceous papules and plaques on the breast or on other parts of the body. Histologically, it can demonstrate a varying degree of patterns such as collagen infiltration by single cells, cords, tubules, and sheets of atypical cells (Figure 3) that can be observed together in areas of mucin or can form glandular structures.16 Metastatic breast carcinoma is noted to be positive for gross cystic disease fluid protein-15, estrogen receptor, and cytokeratin 7, which can help differentiate this entity from other tumors of glandular origin.¹⁶ Although rare, primary melanoma of the breast has been reported in the literature.^17,18 These malignant melanocytic lesions easily could be differentiated from other breast tumors such as adenocarcinoma using immunohistochemical staining patterns.

Deep penetrating nevi most often are observed clinically as blue, brown, or black papules or nodules on the head or neck.¹⁹ Histologically, this lesion features a wedge-shaped infiltrate of deep dermal melanocytes with oval nuclei. It commonly extends to the reticular dermis or further into the subcutis (Figure 4).^20,21 This neoplasm frequently tracks along adnexal and neurovascular structures, resulting in a plexiform appearance.²² The adnexal involvement of deep penetrating nevi is a shared feature with desmoplastic Spitz nevi. The presence of any number of melanophages is characteristic of this lesion.²³ Lastly, there is a well-documented association between β-catenin mutations and deep penetrating nevi.²⁴ Multicentric reticulohistiocytosis (MRH) is a rare form of non-Langerhans cell histiocytosis that has the pathognomonic clinical finding of pink-red papules (coral beading) with a predilection for acral surfaces. Histology of affected skin reveals a dermal infiltrate of ground glass as well as eosinophilic histiocytes that most often stain positive for CD68 and human alveolar macrophage 56 but negative for S-100 and CD1a (Figure 5).²⁵ Although MRH is rare, negative staining for S-100 could serve as a useful diagnostic clue to differentiate it from other entities that are positive for S-100, such as the desmoplastic Spitz nevus. Arthritis mutilans is a potential complication of MRH, but a reported association with an underlying malignancy is seen in approximately 25% of cases.²⁶ Thus, the cutaneous, rheumatologic, and oncologic implications of this disease help to distinguish it from other differential diagnoses that may be considered.

A breakthrough neuromodulation system rapidly restores motor function in patients with a severe spinal cord injury (SCI), new research shows.

The study demonstrated that an epidural electrical stimulation (EES) system developed specifically for spinal cord injuries enabled three men with complete paralysis to stand, walk, cycle, swim, and move their torso within 1 day.

“Thanks to this technology, we have been able to target individuals with the most serious spinal cord injury, meaning those with clinically complete spinal cord injury, with no sensation and no movement in the legs,” Grégoire Courtine, PhD, professor of neuroscience and neurotechnology at the Swiss Federal Institute of Technology, University Hospital Lausanne (Switzerland), and the University of Lausanne, told reporters attending a press briefing.

The study was published online Feb. 7, 2022, in Nature Medicine.
 

More rapid, precise, effective

SCIs involve severed connections between the brain and extremities. To compensate for these lost connections, researchers have investigated stem cell therapy, brain-machine interfaces, and powered exoskeletons.

However, these approaches aren’t yet ready for prime time.

In the meantime, researchers discovered even patients with a “complete” injury may have low-functioning connections and started investigating epidural stimulators designed to treat chronic pain. Recent studies – including three published in 2018 – showed promise for these pain-related stimulators in patients with incomplete SCI.

But using such “repurposed” technology meant the electrode array was relatively narrow and short, “so we could not target all the regions of the spinal cord involving control of leg and trunk movements,” said Dr. Courtine. With the newer technology “we are much more precise, effective, and more rapid in delivering therapy.”

To develop this new approach, the researchers designed a paddle lead with an arrangement of electrodes that targets sacral, lumbar, and low-thoracic dorsal roots involved in leg and trunk movements. They also established a personalized computational framework that allows for optimal surgical placement of this paddle lead.

In addition, they developed software that renders the configuration of individualized activity–dependent stimulation programs rapid, simple, and predictable.

They tested these neurotechnologies in three men with complete sensorimotor paralysis as part of an ongoing clinical trial. The participants, aged 29, 32, and 41 years, suffered an SCI from a motor bike accident 3, 9, and 1 year before enrollment.

All three patients exhibited complete sensorimotor paralysis. They were unable to take any step, and muscles remained quiescent during these attempts.

A neurosurgeon implanted electrodes along the spinal cord of study subjects. Wires from these electrodes were connected to a neurostimulator implanted under the skin in the abdomen.

The men can select different activity-based programs from a tablet that sends signals to the implanted device.
 

Personalized approach

Within a single day of the surgery, the participants were able to stand, walk, cycle, swim, and control trunk movements.

“It was not perfect at the very beginning, but they could train very early on to have a more fluid gait,” said study investigator neurosurgeon Joceylyne Bloch, MD, associate professor, University of Lausanne and University Hospital Lausanne.

At this stage, not all paralyzed patients are eligible for the procedure. Dr. Bloch explained that at least 6 cm of healthy spinal cord under the lesion is needed to implant the electrodes.

“There’s a huge variability of spinal cord anatomy between individuals. That’s why it’s important to study each person individually and to have individual models in order to be precise.”

Researchers envision having “a library of electrode arrays,” added Dr. Courtine. With preoperative imaging of the individual’s spinal cord, “the neurosurgeon can select the more appropriate electrode array for that specific patient.”

Dr. Courtine noted recovery of sensation with the system differs from one individual to another. One study participant, Michel Roccati, now 30, told the briefing he feels a contraction in his muscle during the stimulation.

Currently, only individuals whose injury is more than a year old are included in the study to ensure patients have “a stable lesion” and reached “a plateau of recovery,” said Dr. Bloch. However, animal models show intervening earlier might boost the benefits.

A patient’s age can influence the outcome, as younger patients are likely in better condition and more motivated than older patients, said Dr. Bloch. However, she noted patients closing in on 50 years have responded well to the therapy.

Such stimulation systems may prove useful in treating conditions typically associated with SCI, such as hypertension and bladder control, and perhaps also in patients with Parkinson’s disease, said Dr. Courtine.

The researchers plan to conduct another study that will include a next-generation pulse generator with features that make the stimulation even more effective and user friendly. A voice recognition system could eventually be connected to the system.

“The next step is a minicomputer that you implant in the body that communicates in real time with an external iPhone,” said Dr. Courtine.

ONWARD Medical, which developed the technology, has received a breakthrough device designation from the Food and Drug Administration. The company is in discussions with the FDA to carry out a clinical trial of the device in the United States.
 

A ‘huge step forward’

Peter J. Grahn, PhD, assistant professor, department of physical medicine and rehabilitation and department of neurologic surgery, Mayo Clinic, Rochester, Minn., an author of one of the 2018 studies, said this technology “is a huge step forward” and “really pushes the field.”

Compared with the device used in his study that’s designed to treat neuropathic pain, this new system “is much more capable of dynamic stimulation,” said Dr. Grahn. “You can tailor the stimulation based on which area of the spinal cord you want to target during a specific function.”

There has been “a lot of hope and hype” recently around stem cells and biological molecules that were supposed to be “magic pills” to cure spinal cord dysfunction, said Dr. Grahn. “I don’t think this is one of those.”

However, he questioned the researchers’ use of the word “walking.”

“They say independent stepping or walking is restored on day 1, but the graphs show day 1 function is having over 60% of their body weight supported when they’re taking these steps,” he said.

In addition, the “big question” is how this technology can “be distilled down” into an approach “applicable across rehabilitation centers,” said Dr. Grahn.

The study was supported by numerous organizations, including ONWARD Medical. Dr. Courtine and Dr. Bloch hold various patents in relation with the present work. Dr. Courtine is a consultant with ONWARD Medical, and he and Dr. Bloch are shareholders of ONWARD Medical, a company with direct relationships with the presented work. Dr. Grahn reported no relevant financial relationships.

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

A breakthrough neuromodulation system rapidly restores motor function in patients with a severe spinal cord injury (SCI), new research shows.

The study demonstrated that an epidural electrical stimulation (EES) system developed specifically for spinal cord injuries enabled three men with complete paralysis to stand, walk, cycle, swim, and move their torso within 1 day.

“Thanks to this technology, we have been able to target individuals with the most serious spinal cord injury, meaning those with clinically complete spinal cord injury, with no sensation and no movement in the legs,” Grégoire Courtine, PhD, professor of neuroscience and neurotechnology at the Swiss Federal Institute of Technology, University Hospital Lausanne (Switzerland), and the University of Lausanne, told reporters attending a press briefing.

The study was published online Feb. 7, 2022, in Nature Medicine.
 

More rapid, precise, effective

SCIs involve severed connections between the brain and extremities. To compensate for these lost connections, researchers have investigated stem cell therapy, brain-machine interfaces, and powered exoskeletons.

However, these approaches aren’t yet ready for prime time.

In the meantime, researchers discovered even patients with a “complete” injury may have low-functioning connections and started investigating epidural stimulators designed to treat chronic pain. Recent studies – including three published in 2018 – showed promise for these pain-related stimulators in patients with incomplete SCI.

But using such “repurposed” technology meant the electrode array was relatively narrow and short, “so we could not target all the regions of the spinal cord involving control of leg and trunk movements,” said Dr. Courtine. With the newer technology “we are much more precise, effective, and more rapid in delivering therapy.”

To develop this new approach, the researchers designed a paddle lead with an arrangement of electrodes that targets sacral, lumbar, and low-thoracic dorsal roots involved in leg and trunk movements. They also established a personalized computational framework that allows for optimal surgical placement of this paddle lead.

In addition, they developed software that renders the configuration of individualized activity–dependent stimulation programs rapid, simple, and predictable.

They tested these neurotechnologies in three men with complete sensorimotor paralysis as part of an ongoing clinical trial. The participants, aged 29, 32, and 41 years, suffered an SCI from a motor bike accident 3, 9, and 1 year before enrollment.

All three patients exhibited complete sensorimotor paralysis. They were unable to take any step, and muscles remained quiescent during these attempts.

A neurosurgeon implanted electrodes along the spinal cord of study subjects. Wires from these electrodes were connected to a neurostimulator implanted under the skin in the abdomen.

The men can select different activity-based programs from a tablet that sends signals to the implanted device.
 

Personalized approach

Within a single day of the surgery, the participants were able to stand, walk, cycle, swim, and control trunk movements.

“It was not perfect at the very beginning, but they could train very early on to have a more fluid gait,” said study investigator neurosurgeon Joceylyne Bloch, MD, associate professor, University of Lausanne and University Hospital Lausanne.

At this stage, not all paralyzed patients are eligible for the procedure. Dr. Bloch explained that at least 6 cm of healthy spinal cord under the lesion is needed to implant the electrodes.

“There’s a huge variability of spinal cord anatomy between individuals. That’s why it’s important to study each person individually and to have individual models in order to be precise.”

Researchers envision having “a library of electrode arrays,” added Dr. Courtine. With preoperative imaging of the individual’s spinal cord, “the neurosurgeon can select the more appropriate electrode array for that specific patient.”

Dr. Courtine noted recovery of sensation with the system differs from one individual to another. One study participant, Michel Roccati, now 30, told the briefing he feels a contraction in his muscle during the stimulation.

Currently, only individuals whose injury is more than a year old are included in the study to ensure patients have “a stable lesion” and reached “a plateau of recovery,” said Dr. Bloch. However, animal models show intervening earlier might boost the benefits.

A patient’s age can influence the outcome, as younger patients are likely in better condition and more motivated than older patients, said Dr. Bloch. However, she noted patients closing in on 50 years have responded well to the therapy.

Such stimulation systems may prove useful in treating conditions typically associated with SCI, such as hypertension and bladder control, and perhaps also in patients with Parkinson’s disease, said Dr. Courtine.

The researchers plan to conduct another study that will include a next-generation pulse generator with features that make the stimulation even more effective and user friendly. A voice recognition system could eventually be connected to the system.

“The next step is a minicomputer that you implant in the body that communicates in real time with an external iPhone,” said Dr. Courtine.

ONWARD Medical, which developed the technology, has received a breakthrough device designation from the Food and Drug Administration. The company is in discussions with the FDA to carry out a clinical trial of the device in the United States.
 

A ‘huge step forward’

Peter J. Grahn, PhD, assistant professor, department of physical medicine and rehabilitation and department of neurologic surgery, Mayo Clinic, Rochester, Minn., an author of one of the 2018 studies, said this technology “is a huge step forward” and “really pushes the field.”

Compared with the device used in his study that’s designed to treat neuropathic pain, this new system “is much more capable of dynamic stimulation,” said Dr. Grahn. “You can tailor the stimulation based on which area of the spinal cord you want to target during a specific function.”

There has been “a lot of hope and hype” recently around stem cells and biological molecules that were supposed to be “magic pills” to cure spinal cord dysfunction, said Dr. Grahn. “I don’t think this is one of those.”

However, he questioned the researchers’ use of the word “walking.”

“They say independent stepping or walking is restored on day 1, but the graphs show day 1 function is having over 60% of their body weight supported when they’re taking these steps,” he said.

In addition, the “big question” is how this technology can “be distilled down” into an approach “applicable across rehabilitation centers,” said Dr. Grahn.

The study was supported by numerous organizations, including ONWARD Medical. Dr. Courtine and Dr. Bloch hold various patents in relation with the present work. Dr. Courtine is a consultant with ONWARD Medical, and he and Dr. Bloch are shareholders of ONWARD Medical, a company with direct relationships with the presented work. Dr. Grahn reported no relevant financial relationships.

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

A breakthrough neuromodulation system rapidly restores motor function in patients with a severe spinal cord injury (SCI), new research shows.

The study demonstrated that an epidural electrical stimulation (EES) system developed specifically for spinal cord injuries enabled three men with complete paralysis to stand, walk, cycle, swim, and move their torso within 1 day.

“Thanks to this technology, we have been able to target individuals with the most serious spinal cord injury, meaning those with clinically complete spinal cord injury, with no sensation and no movement in the legs,” Grégoire Courtine, PhD, professor of neuroscience and neurotechnology at the Swiss Federal Institute of Technology, University Hospital Lausanne (Switzerland), and the University of Lausanne, told reporters attending a press briefing.

The study was published online Feb. 7, 2022, in Nature Medicine.
 

More rapid, precise, effective

SCIs involve severed connections between the brain and extremities. To compensate for these lost connections, researchers have investigated stem cell therapy, brain-machine interfaces, and powered exoskeletons.

However, these approaches aren’t yet ready for prime time.

In the meantime, researchers discovered even patients with a “complete” injury may have low-functioning connections and started investigating epidural stimulators designed to treat chronic pain. Recent studies – including three published in 2018 – showed promise for these pain-related stimulators in patients with incomplete SCI.

But using such “repurposed” technology meant the electrode array was relatively narrow and short, “so we could not target all the regions of the spinal cord involving control of leg and trunk movements,” said Dr. Courtine. With the newer technology “we are much more precise, effective, and more rapid in delivering therapy.”

To develop this new approach, the researchers designed a paddle lead with an arrangement of electrodes that targets sacral, lumbar, and low-thoracic dorsal roots involved in leg and trunk movements. They also established a personalized computational framework that allows for optimal surgical placement of this paddle lead.

In addition, they developed software that renders the configuration of individualized activity–dependent stimulation programs rapid, simple, and predictable.

They tested these neurotechnologies in three men with complete sensorimotor paralysis as part of an ongoing clinical trial. The participants, aged 29, 32, and 41 years, suffered an SCI from a motor bike accident 3, 9, and 1 year before enrollment.

All three patients exhibited complete sensorimotor paralysis. They were unable to take any step, and muscles remained quiescent during these attempts.

A neurosurgeon implanted electrodes along the spinal cord of study subjects. Wires from these electrodes were connected to a neurostimulator implanted under the skin in the abdomen.

The men can select different activity-based programs from a tablet that sends signals to the implanted device.
 

Personalized approach

Within a single day of the surgery, the participants were able to stand, walk, cycle, swim, and control trunk movements.

“It was not perfect at the very beginning, but they could train very early on to have a more fluid gait,” said study investigator neurosurgeon Joceylyne Bloch, MD, associate professor, University of Lausanne and University Hospital Lausanne.

At this stage, not all paralyzed patients are eligible for the procedure. Dr. Bloch explained that at least 6 cm of healthy spinal cord under the lesion is needed to implant the electrodes.

“There’s a huge variability of spinal cord anatomy between individuals. That’s why it’s important to study each person individually and to have individual models in order to be precise.”

Researchers envision having “a library of electrode arrays,” added Dr. Courtine. With preoperative imaging of the individual’s spinal cord, “the neurosurgeon can select the more appropriate electrode array for that specific patient.”

Dr. Courtine noted recovery of sensation with the system differs from one individual to another. One study participant, Michel Roccati, now 30, told the briefing he feels a contraction in his muscle during the stimulation.

Currently, only individuals whose injury is more than a year old are included in the study to ensure patients have “a stable lesion” and reached “a plateau of recovery,” said Dr. Bloch. However, animal models show intervening earlier might boost the benefits.

A patient’s age can influence the outcome, as younger patients are likely in better condition and more motivated than older patients, said Dr. Bloch. However, she noted patients closing in on 50 years have responded well to the therapy.

Such stimulation systems may prove useful in treating conditions typically associated with SCI, such as hypertension and bladder control, and perhaps also in patients with Parkinson’s disease, said Dr. Courtine.

The researchers plan to conduct another study that will include a next-generation pulse generator with features that make the stimulation even more effective and user friendly. A voice recognition system could eventually be connected to the system.

“The next step is a minicomputer that you implant in the body that communicates in real time with an external iPhone,” said Dr. Courtine.

ONWARD Medical, which developed the technology, has received a breakthrough device designation from the Food and Drug Administration. The company is in discussions with the FDA to carry out a clinical trial of the device in the United States.
 

A ‘huge step forward’

Peter J. Grahn, PhD, assistant professor, department of physical medicine and rehabilitation and department of neurologic surgery, Mayo Clinic, Rochester, Minn., an author of one of the 2018 studies, said this technology “is a huge step forward” and “really pushes the field.”

Compared with the device used in his study that’s designed to treat neuropathic pain, this new system “is much more capable of dynamic stimulation,” said Dr. Grahn. “You can tailor the stimulation based on which area of the spinal cord you want to target during a specific function.”

There has been “a lot of hope and hype” recently around stem cells and biological molecules that were supposed to be “magic pills” to cure spinal cord dysfunction, said Dr. Grahn. “I don’t think this is one of those.”

However, he questioned the researchers’ use of the word “walking.”

“They say independent stepping or walking is restored on day 1, but the graphs show day 1 function is having over 60% of their body weight supported when they’re taking these steps,” he said.

In addition, the “big question” is how this technology can “be distilled down” into an approach “applicable across rehabilitation centers,” said Dr. Grahn.

The study was supported by numerous organizations, including ONWARD Medical. Dr. Courtine and Dr. Bloch hold various patents in relation with the present work. Dr. Courtine is a consultant with ONWARD Medical, and he and Dr. Bloch are shareholders of ONWARD Medical, a company with direct relationships with the presented work. Dr. Grahn reported no relevant financial relationships.

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

On November 2, 2021, the Centers for Medicare & Medicaid Services (CMS) released its final rule for the 2022 Medicare Physician Fee Schedule (PFS) and the Quality Payment Program (QPP).^1,2 These guidelines contain updates that will remarkably impact the field of medicine—and dermatology in particular—in 2022. This article will walk you through some of the updates most relevant to dermatology and how they may affect your practice.

Process for the Final Rule

The CMS releases an annual rule for the PFS and QPP. The interim rule generally is released over the summer with preliminary guidelines for the upcoming payment year. There is then a period of open comment where those affected by these changes, including physicians and medical associations, can submit comments to support what has been proposed or advocate for any changes. This input is then reviewed, and a final rule generally is published in the fall.

For this calendar year, the interim 2022 rule was released on July 13, 2021,³ and included many of guidelines that will be discussed in more detail in this article. Many associations that represent medicine overall and specifically dermatology, including the American Medical Association and the American Academy of Dermatology, submitted comments in response to these proposals.^4,5

PFS Conversion Factor

The PFS conversion factor is updated annually to ensure budget neutrality in the setting of changes in relative value units. For 2022, the PFS conversion factor is $34.6062, representing a reduction of approximately $0.29 from the 2021 PFS conversion factor of $34.8931.⁶ This reduction does not take into account other payment adjustments due to legislative changes.

In combination, these changes previously were estimated to represent an overall payment cut of 10% or higher for dermatology, with those practitioners doing more procedural work or dermatopathology likely being impacted more heavily. However, with the passing of the Protecting Medicare and American Farmers from Sequester Cuts Act, it is estimated that the reductions in payment to dermatology will begin at 0.75% and reach 2.75% in the second half of the year with the phased-in reinstatement of the Medicare sequester.^4,5,7

Clinical Labor Pricing Updates

Starting in 2022, the CMS will utilize updated wage rates from the US Bureau of Labor Statistics to revise clinical labor costs over a 4-year period. Clinical labor rates are important, as they are used to calculate practice expense within the PFS. These clinical labor rates were last updated in 2002.⁸ Median wage data, as opposed to mean data, from the US Bureau of Labor Statistics will be utilized to calculate the updated clinical labor rates.

A multiyear implementation plan was put into place by CMS due to multiple concerns, including that current wage rates are inadequate and may not reflect current labor rate information. Additionally, comments on this proposal voiced concern that updating the supply and equipment pricing without updating the clinical labor pricing could create distortions in the allocation of direct practice expense, which also factored into the implementation of a multiyear plan.⁸

Evaluation and Management Visits

The biggest update in this area primarily is related to refining policies for split (shared) evaluation and management (E/M) visits and teaching physician activities. Split E/M visits are defined by the CMS as visits provided in the facility setting by a physician and nonphysician practitioner in the same group, with the visit billed by whomever provides the substantive portion of the visit. For 2022, the term substantive portion will be defined by the CMS as history, physical examination, medical decision-making, or more than half of the total time; for 2023, it will be defined as more than half of the total time spent.³ A split visit also can apply to an E/M visit provided in part by both a teaching physician and resident. Split visits can be reported for new or established patients. For proper reimbursement, the 2 practitioners who performed the services must be documented in the medical record, and the practitioner who provided the substantive portion must sign and date the encounter in the medical record. Additionally, the CMS has indicated the modifier FS must be included on the claim to indicate the split visit.⁹

For dermatologists who act as teaching physicians, it is important to note that many of the existing CMS policies for billing E/M services are still in place, specifically that if a resident participates in a service in a teaching setting, the teaching physician can bill for the service only if they are present for the key or critical portion of the service. A primary care exception does exist, in which teaching physicians at certain teaching hospital primary care centers can bill for some services performed independently by a resident without the physical presence of the teaching physician; however, this often is not applicable within dermatology.

With updated outpatient E/M guidelines, if time is being selected to bill, only the time that the teaching physician was present can be included to determine the overall E/M level.

Billing for Physician Assistant Services

Currently Medicare can only make payments to the employer or independent contractor of a physician assistant (PA); however, starting January 1, 2022, the CMS has authorized Medicare to make direct payments to PAs for qualifying professional services, in the same manner that nurse practitioners can currently bill. This also will allow PAs to incorporate as a group and bill Medicare for PA services. This stems from a congressional mandate within the Consolidated Appropriations Act of 2021.⁸ As a result, in states where PAs can practice independently, they can opt out of physician-led care teams and furnish services independently, including dermatologic services.

Several changes were made to the Merit-Based Incentive Payment System (MIPS). Some of these changes include:

• Increase the MIPS performance threshold to 75 points from 60 points.
• Set the performance threshold at 89 points.
• Reduce the quality performance category weight from 40% to 30% of the final MIPS score.
• Increase the cost performance category weight from 20% to 30% of the final MIPS score.
• The extreme and uncontrollable circumstances application also has been extended to the end of 2022, allowing those remarkably impacted by the COVID-19 public health emergency to request for reweighting on any or all MIPS performance categories.

Cost Measures and MIPS Value Pathways

The melanoma resection cost measure will be implemented in 2022, representing the first dermatology cost measure, which will include the cost to Medicare over a 1-year period for all patient care for the excision of a melanoma. Although cost measures will be part of the MIPS value pathways (MVPs) reporting, dermatology currently is not part of the MVP; however, with the CMS moving forward with an initial set of MVPs that physicians can voluntarily report on in 2023, there is a possibility that dermatology will be asked to be part of the program in the future.¹⁰

Final Thoughts

There are many upcoming changes as part of the 2022 final rule, including to the conversion factor, E/M split visits, PA billing, and the QPP. Advocacy in these areas to the CMS and lawmakers, either directly or through dermatologic and other medical societies, is critical to help influence eventual recommendations.

On November 2, 2021, the Centers for Medicare & Medicaid Services (CMS) released its final rule for the 2022 Medicare Physician Fee Schedule (PFS) and the Quality Payment Program (QPP).^1,2 These guidelines contain updates that will remarkably impact the field of medicine—and dermatology in particular—in 2022. This article will walk you through some of the updates most relevant to dermatology and how they may affect your practice.

Process for the Final Rule

The CMS releases an annual rule for the PFS and QPP. The interim rule generally is released over the summer with preliminary guidelines for the upcoming payment year. There is then a period of open comment where those affected by these changes, including physicians and medical associations, can submit comments to support what has been proposed or advocate for any changes. This input is then reviewed, and a final rule generally is published in the fall.

For this calendar year, the interim 2022 rule was released on July 13, 2021,³ and included many of guidelines that will be discussed in more detail in this article. Many associations that represent medicine overall and specifically dermatology, including the American Medical Association and the American Academy of Dermatology, submitted comments in response to these proposals.^4,5

PFS Conversion Factor

The PFS conversion factor is updated annually to ensure budget neutrality in the setting of changes in relative value units. For 2022, the PFS conversion factor is $34.6062, representing a reduction of approximately $0.29 from the 2021 PFS conversion factor of $34.8931.⁶ This reduction does not take into account other payment adjustments due to legislative changes.

In combination, these changes previously were estimated to represent an overall payment cut of 10% or higher for dermatology, with those practitioners doing more procedural work or dermatopathology likely being impacted more heavily. However, with the passing of the Protecting Medicare and American Farmers from Sequester Cuts Act, it is estimated that the reductions in payment to dermatology will begin at 0.75% and reach 2.75% in the second half of the year with the phased-in reinstatement of the Medicare sequester.^4,5,7

Clinical Labor Pricing Updates

Starting in 2022, the CMS will utilize updated wage rates from the US Bureau of Labor Statistics to revise clinical labor costs over a 4-year period. Clinical labor rates are important, as they are used to calculate practice expense within the PFS. These clinical labor rates were last updated in 2002.⁸ Median wage data, as opposed to mean data, from the US Bureau of Labor Statistics will be utilized to calculate the updated clinical labor rates.

A multiyear implementation plan was put into place by CMS due to multiple concerns, including that current wage rates are inadequate and may not reflect current labor rate information. Additionally, comments on this proposal voiced concern that updating the supply and equipment pricing without updating the clinical labor pricing could create distortions in the allocation of direct practice expense, which also factored into the implementation of a multiyear plan.⁸

Evaluation and Management Visits

The biggest update in this area primarily is related to refining policies for split (shared) evaluation and management (E/M) visits and teaching physician activities. Split E/M visits are defined by the CMS as visits provided in the facility setting by a physician and nonphysician practitioner in the same group, with the visit billed by whomever provides the substantive portion of the visit. For 2022, the term substantive portion will be defined by the CMS as history, physical examination, medical decision-making, or more than half of the total time; for 2023, it will be defined as more than half of the total time spent.³ A split visit also can apply to an E/M visit provided in part by both a teaching physician and resident. Split visits can be reported for new or established patients. For proper reimbursement, the 2 practitioners who performed the services must be documented in the medical record, and the practitioner who provided the substantive portion must sign and date the encounter in the medical record. Additionally, the CMS has indicated the modifier FS must be included on the claim to indicate the split visit.⁹

For dermatologists who act as teaching physicians, it is important to note that many of the existing CMS policies for billing E/M services are still in place, specifically that if a resident participates in a service in a teaching setting, the teaching physician can bill for the service only if they are present for the key or critical portion of the service. A primary care exception does exist, in which teaching physicians at certain teaching hospital primary care centers can bill for some services performed independently by a resident without the physical presence of the teaching physician; however, this often is not applicable within dermatology.

With updated outpatient E/M guidelines, if time is being selected to bill, only the time that the teaching physician was present can be included to determine the overall E/M level.

Billing for Physician Assistant Services

Currently Medicare can only make payments to the employer or independent contractor of a physician assistant (PA); however, starting January 1, 2022, the CMS has authorized Medicare to make direct payments to PAs for qualifying professional services, in the same manner that nurse practitioners can currently bill. This also will allow PAs to incorporate as a group and bill Medicare for PA services. This stems from a congressional mandate within the Consolidated Appropriations Act of 2021.⁸ As a result, in states where PAs can practice independently, they can opt out of physician-led care teams and furnish services independently, including dermatologic services.

Several changes were made to the Merit-Based Incentive Payment System (MIPS). Some of these changes include:

• Increase the MIPS performance threshold to 75 points from 60 points.
• Set the performance threshold at 89 points.
• Reduce the quality performance category weight from 40% to 30% of the final MIPS score.
• Increase the cost performance category weight from 20% to 30% of the final MIPS score.
• The extreme and uncontrollable circumstances application also has been extended to the end of 2022, allowing those remarkably impacted by the COVID-19 public health emergency to request for reweighting on any or all MIPS performance categories.

Cost Measures and MIPS Value Pathways

The melanoma resection cost measure will be implemented in 2022, representing the first dermatology cost measure, which will include the cost to Medicare over a 1-year period for all patient care for the excision of a melanoma. Although cost measures will be part of the MIPS value pathways (MVPs) reporting, dermatology currently is not part of the MVP; however, with the CMS moving forward with an initial set of MVPs that physicians can voluntarily report on in 2023, there is a possibility that dermatology will be asked to be part of the program in the future.¹⁰

Final Thoughts

There are many upcoming changes as part of the 2022 final rule, including to the conversion factor, E/M split visits, PA billing, and the QPP. Advocacy in these areas to the CMS and lawmakers, either directly or through dermatologic and other medical societies, is critical to help influence eventual recommendations.

On November 2, 2021, the Centers for Medicare & Medicaid Services (CMS) released its final rule for the 2022 Medicare Physician Fee Schedule (PFS) and the Quality Payment Program (QPP).^1,2 These guidelines contain updates that will remarkably impact the field of medicine—and dermatology in particular—in 2022. This article will walk you through some of the updates most relevant to dermatology and how they may affect your practice.

Process for the Final Rule

The CMS releases an annual rule for the PFS and QPP. The interim rule generally is released over the summer with preliminary guidelines for the upcoming payment year. There is then a period of open comment where those affected by these changes, including physicians and medical associations, can submit comments to support what has been proposed or advocate for any changes. This input is then reviewed, and a final rule generally is published in the fall.

For this calendar year, the interim 2022 rule was released on July 13, 2021,³ and included many of guidelines that will be discussed in more detail in this article. Many associations that represent medicine overall and specifically dermatology, including the American Medical Association and the American Academy of Dermatology, submitted comments in response to these proposals.^4,5

PFS Conversion Factor

The PFS conversion factor is updated annually to ensure budget neutrality in the setting of changes in relative value units. For 2022, the PFS conversion factor is $34.6062, representing a reduction of approximately $0.29 from the 2021 PFS conversion factor of $34.8931.⁶ This reduction does not take into account other payment adjustments due to legislative changes.

In combination, these changes previously were estimated to represent an overall payment cut of 10% or higher for dermatology, with those practitioners doing more procedural work or dermatopathology likely being impacted more heavily. However, with the passing of the Protecting Medicare and American Farmers from Sequester Cuts Act, it is estimated that the reductions in payment to dermatology will begin at 0.75% and reach 2.75% in the second half of the year with the phased-in reinstatement of the Medicare sequester.^4,5,7

Clinical Labor Pricing Updates

Starting in 2022, the CMS will utilize updated wage rates from the US Bureau of Labor Statistics to revise clinical labor costs over a 4-year period. Clinical labor rates are important, as they are used to calculate practice expense within the PFS. These clinical labor rates were last updated in 2002.⁸ Median wage data, as opposed to mean data, from the US Bureau of Labor Statistics will be utilized to calculate the updated clinical labor rates.

A multiyear implementation plan was put into place by CMS due to multiple concerns, including that current wage rates are inadequate and may not reflect current labor rate information. Additionally, comments on this proposal voiced concern that updating the supply and equipment pricing without updating the clinical labor pricing could create distortions in the allocation of direct practice expense, which also factored into the implementation of a multiyear plan.⁸

Evaluation and Management Visits

The biggest update in this area primarily is related to refining policies for split (shared) evaluation and management (E/M) visits and teaching physician activities. Split E/M visits are defined by the CMS as visits provided in the facility setting by a physician and nonphysician practitioner in the same group, with the visit billed by whomever provides the substantive portion of the visit. For 2022, the term substantive portion will be defined by the CMS as history, physical examination, medical decision-making, or more than half of the total time; for 2023, it will be defined as more than half of the total time spent.³ A split visit also can apply to an E/M visit provided in part by both a teaching physician and resident. Split visits can be reported for new or established patients. For proper reimbursement, the 2 practitioners who performed the services must be documented in the medical record, and the practitioner who provided the substantive portion must sign and date the encounter in the medical record. Additionally, the CMS has indicated the modifier FS must be included on the claim to indicate the split visit.⁹

For dermatologists who act as teaching physicians, it is important to note that many of the existing CMS policies for billing E/M services are still in place, specifically that if a resident participates in a service in a teaching setting, the teaching physician can bill for the service only if they are present for the key or critical portion of the service. A primary care exception does exist, in which teaching physicians at certain teaching hospital primary care centers can bill for some services performed independently by a resident without the physical presence of the teaching physician; however, this often is not applicable within dermatology.

With updated outpatient E/M guidelines, if time is being selected to bill, only the time that the teaching physician was present can be included to determine the overall E/M level.

Billing for Physician Assistant Services

Currently Medicare can only make payments to the employer or independent contractor of a physician assistant (PA); however, starting January 1, 2022, the CMS has authorized Medicare to make direct payments to PAs for qualifying professional services, in the same manner that nurse practitioners can currently bill. This also will allow PAs to incorporate as a group and bill Medicare for PA services. This stems from a congressional mandate within the Consolidated Appropriations Act of 2021.⁸ As a result, in states where PAs can practice independently, they can opt out of physician-led care teams and furnish services independently, including dermatologic services.

Several changes were made to the Merit-Based Incentive Payment System (MIPS). Some of these changes include:

• Increase the MIPS performance threshold to 75 points from 60 points.
• Set the performance threshold at 89 points.
• Reduce the quality performance category weight from 40% to 30% of the final MIPS score.
• Increase the cost performance category weight from 20% to 30% of the final MIPS score.
• The extreme and uncontrollable circumstances application also has been extended to the end of 2022, allowing those remarkably impacted by the COVID-19 public health emergency to request for reweighting on any or all MIPS performance categories.

Cost Measures and MIPS Value Pathways

The melanoma resection cost measure will be implemented in 2022, representing the first dermatology cost measure, which will include the cost to Medicare over a 1-year period for all patient care for the excision of a melanoma. Although cost measures will be part of the MIPS value pathways (MVPs) reporting, dermatology currently is not part of the MVP; however, with the CMS moving forward with an initial set of MVPs that physicians can voluntarily report on in 2023, there is a possibility that dermatology will be asked to be part of the program in the future.¹⁰

Final Thoughts

There are many upcoming changes as part of the 2022 final rule, including to the conversion factor, E/M split visits, PA billing, and the QPP. Advocacy in these areas to the CMS and lawmakers, either directly or through dermatologic and other medical societies, is critical to help influence eventual recommendations.