The American Gastroenterological Association has developed a new index to help clinicians gauge the severity of eosinophilic esophagitis (EoE), offering a tool to physicians that experts say has been lacking in the field and should help better guide treatment.

The index – known as I-SEE, for Index of Severity for Eosinophilic Esophagitis – was developed after an exhaustive review of the literature, and allows clinicians to calculate a score based on symptoms, complications, endoscopy findings, and histology. It was published in Gastroenterology and the Journal of Allergy and Clinical Immunology.

University of North Carolina

How it works

The index divides criteria into three main categories: symptoms and complications, inflammatory features, and fibrostenotic features.

In the symptoms and complications category, points are assessed based on whether symptoms are weekly, daily, or several times a day and whether problems such as food impaction or esophageal perforations are present.

Inflammatory features include localized or diffuse edema or furrows on endoscopy and eosinophil counts.

Fibrostenotic scoring items include features such as rings or strictures and how constricting they are, as well as basal zone hyperplasia and lamina propria fibrosis.

Each feature is assigned a score of 1-15. An overall score of 0 points would be considered inactive disease; 1-6 is mildly active disease; 7-14 is moderately active disease; and 15 or more is severely active disease.

Someone with daily symptoms (2 points) and localized edema on endoscopy (1 point) and 15-60 eosinophils per high power field (1 point) would have a total of 4 points and be considered to have mildly active disease. Someone who is 18 years of age or older with daily symptoms (2 points), food impaction with an ED visit (2 points), diffuse edema on endoscopy (2 points), 15-60 eosinophils per high power field (1 point), basal zone hyperplasia (2 points), and rings or strictures on endoscopy that don’t permit passing a standard upper endoscope (15 points), would have 24 points and be considered to have severely active disease.

The index is only just starting to be tested with patient-level data, but the first results are promising, Dr. Dellon said. He hopes incorporating endoscopic and histologic features into the index will lead to wider evaluation of these indicators of severity because they have been shown to be important clinically.

Dr. Dellon said there is a plan to develop an app that will allow the index’s “usability” to be tested across a range of practice settings and disciplines. The index will also be evaluated in existing and prospectively collected datasets.

“This will help us understand the distribution of EoE patient severity in a number of settings, as well as how severity relates to posttreatment outcomes,” he said. “Ultimately, it is possible that I-SEE could be incorporated into electronic medical records systems.”
 

Simplifying clinical practice

Philip Katz, MD, professor of medicine in the gastroenterology division at Weill Cornell Medicine, New York, said the index could be a step forward in the care of EoE patients.

“The way all of us make choices for these patients and how we judge where they are in terms of the ‘severity’ of their disease is not ideal, by any means,” he said. “[This] appears to be a strong attempt to simplify what we’re currently doing now and put it all in one place.”

Ease of use will be important and his practice will be evaluating that, he said. He said he hopes that software will make it practical, possibly with the necessary information able to be imported straight from the electronic health record.

“We’ll do our best to use the system data in a way that the authors have suggested,” he said. “Basically, we’ll make our own opinions as data is gathered.”

He recommended that clinicians treating EoE try to use the index and assess its performance on their own, in addition to staying aware of data that’s collected elsewhere in the field. That way, collectively, the tool will have the maximum impact on improving patient care.

“[The researchers who developed the tool] are people who have dedicated a substantial portion of their professional careers to studying this disease and are comfortable that this is a tool that will offer more value than what we’re currently doing,” he said. “Chances are, this will be much better than what we currently have.”

This new tool was developed as part of AGA’s EoE initiative: Eosinophilic Esophagitis: Expand, Optimize, Excel. View additional resources at eoe.gastro.org.

The index was developed as part of a conference that was supported by a grant from Takeda. This conference was also funded in part by the division of intramural research at National Institute of Allergy and Infectious Diseases/National Institutes of Health and supported by CEGIR (U54 AI117804). All activities and products resulting from this conference were independently developed with no involvement or input from the funder. The authors disclosed relationships with various industry entities, including Takeda. None of the other relationships were relevant to this work. Dr. Katz consults with Phathom, Sebela Pharmaceuticals, and AstraZeneca.

This article was updated on June 7, 2022.

The American Gastroenterological Association has developed a new index to help clinicians gauge the severity of eosinophilic esophagitis (EoE), offering a tool to physicians that experts say has been lacking in the field and should help better guide treatment.

The index – known as I-SEE, for Index of Severity for Eosinophilic Esophagitis – was developed after an exhaustive review of the literature, and allows clinicians to calculate a score based on symptoms, complications, endoscopy findings, and histology. It was published in Gastroenterology and the Journal of Allergy and Clinical Immunology.

University of North Carolina

How it works

The index divides criteria into three main categories: symptoms and complications, inflammatory features, and fibrostenotic features.

In the symptoms and complications category, points are assessed based on whether symptoms are weekly, daily, or several times a day and whether problems such as food impaction or esophageal perforations are present.

Inflammatory features include localized or diffuse edema or furrows on endoscopy and eosinophil counts.

Fibrostenotic scoring items include features such as rings or strictures and how constricting they are, as well as basal zone hyperplasia and lamina propria fibrosis.

Each feature is assigned a score of 1-15. An overall score of 0 points would be considered inactive disease; 1-6 is mildly active disease; 7-14 is moderately active disease; and 15 or more is severely active disease.

Someone with daily symptoms (2 points) and localized edema on endoscopy (1 point) and 15-60 eosinophils per high power field (1 point) would have a total of 4 points and be considered to have mildly active disease. Someone who is 18 years of age or older with daily symptoms (2 points), food impaction with an ED visit (2 points), diffuse edema on endoscopy (2 points), 15-60 eosinophils per high power field (1 point), basal zone hyperplasia (2 points), and rings or strictures on endoscopy that don’t permit passing a standard upper endoscope (15 points), would have 24 points and be considered to have severely active disease.

The index is only just starting to be tested with patient-level data, but the first results are promising, Dr. Dellon said. He hopes incorporating endoscopic and histologic features into the index will lead to wider evaluation of these indicators of severity because they have been shown to be important clinically.

Dr. Dellon said there is a plan to develop an app that will allow the index’s “usability” to be tested across a range of practice settings and disciplines. The index will also be evaluated in existing and prospectively collected datasets.

“This will help us understand the distribution of EoE patient severity in a number of settings, as well as how severity relates to posttreatment outcomes,” he said. “Ultimately, it is possible that I-SEE could be incorporated into electronic medical records systems.”
 

Simplifying clinical practice

Philip Katz, MD, professor of medicine in the gastroenterology division at Weill Cornell Medicine, New York, said the index could be a step forward in the care of EoE patients.

“The way all of us make choices for these patients and how we judge where they are in terms of the ‘severity’ of their disease is not ideal, by any means,” he said. “[This] appears to be a strong attempt to simplify what we’re currently doing now and put it all in one place.”

Ease of use will be important and his practice will be evaluating that, he said. He said he hopes that software will make it practical, possibly with the necessary information able to be imported straight from the electronic health record.

“We’ll do our best to use the system data in a way that the authors have suggested,” he said. “Basically, we’ll make our own opinions as data is gathered.”

He recommended that clinicians treating EoE try to use the index and assess its performance on their own, in addition to staying aware of data that’s collected elsewhere in the field. That way, collectively, the tool will have the maximum impact on improving patient care.

“[The researchers who developed the tool] are people who have dedicated a substantial portion of their professional careers to studying this disease and are comfortable that this is a tool that will offer more value than what we’re currently doing,” he said. “Chances are, this will be much better than what we currently have.”

This new tool was developed as part of AGA’s EoE initiative: Eosinophilic Esophagitis: Expand, Optimize, Excel. View additional resources at eoe.gastro.org.

The index was developed as part of a conference that was supported by a grant from Takeda. This conference was also funded in part by the division of intramural research at National Institute of Allergy and Infectious Diseases/National Institutes of Health and supported by CEGIR (U54 AI117804). All activities and products resulting from this conference were independently developed with no involvement or input from the funder. The authors disclosed relationships with various industry entities, including Takeda. None of the other relationships were relevant to this work. Dr. Katz consults with Phathom, Sebela Pharmaceuticals, and AstraZeneca.

This article was updated on June 7, 2022.

The American Gastroenterological Association has developed a new index to help clinicians gauge the severity of eosinophilic esophagitis (EoE), offering a tool to physicians that experts say has been lacking in the field and should help better guide treatment.

The index – known as I-SEE, for Index of Severity for Eosinophilic Esophagitis – was developed after an exhaustive review of the literature, and allows clinicians to calculate a score based on symptoms, complications, endoscopy findings, and histology. It was published in Gastroenterology and the Journal of Allergy and Clinical Immunology.

University of North Carolina

How it works

The index divides criteria into three main categories: symptoms and complications, inflammatory features, and fibrostenotic features.

In the symptoms and complications category, points are assessed based on whether symptoms are weekly, daily, or several times a day and whether problems such as food impaction or esophageal perforations are present.

Inflammatory features include localized or diffuse edema or furrows on endoscopy and eosinophil counts.

Fibrostenotic scoring items include features such as rings or strictures and how constricting they are, as well as basal zone hyperplasia and lamina propria fibrosis.

Each feature is assigned a score of 1-15. An overall score of 0 points would be considered inactive disease; 1-6 is mildly active disease; 7-14 is moderately active disease; and 15 or more is severely active disease.

Someone with daily symptoms (2 points) and localized edema on endoscopy (1 point) and 15-60 eosinophils per high power field (1 point) would have a total of 4 points and be considered to have mildly active disease. Someone who is 18 years of age or older with daily symptoms (2 points), food impaction with an ED visit (2 points), diffuse edema on endoscopy (2 points), 15-60 eosinophils per high power field (1 point), basal zone hyperplasia (2 points), and rings or strictures on endoscopy that don’t permit passing a standard upper endoscope (15 points), would have 24 points and be considered to have severely active disease.

The index is only just starting to be tested with patient-level data, but the first results are promising, Dr. Dellon said. He hopes incorporating endoscopic and histologic features into the index will lead to wider evaluation of these indicators of severity because they have been shown to be important clinically.

Dr. Dellon said there is a plan to develop an app that will allow the index’s “usability” to be tested across a range of practice settings and disciplines. The index will also be evaluated in existing and prospectively collected datasets.

“This will help us understand the distribution of EoE patient severity in a number of settings, as well as how severity relates to posttreatment outcomes,” he said. “Ultimately, it is possible that I-SEE could be incorporated into electronic medical records systems.”
 

Simplifying clinical practice

Philip Katz, MD, professor of medicine in the gastroenterology division at Weill Cornell Medicine, New York, said the index could be a step forward in the care of EoE patients.

“The way all of us make choices for these patients and how we judge where they are in terms of the ‘severity’ of their disease is not ideal, by any means,” he said. “[This] appears to be a strong attempt to simplify what we’re currently doing now and put it all in one place.”

Ease of use will be important and his practice will be evaluating that, he said. He said he hopes that software will make it practical, possibly with the necessary information able to be imported straight from the electronic health record.

“We’ll do our best to use the system data in a way that the authors have suggested,” he said. “Basically, we’ll make our own opinions as data is gathered.”

He recommended that clinicians treating EoE try to use the index and assess its performance on their own, in addition to staying aware of data that’s collected elsewhere in the field. That way, collectively, the tool will have the maximum impact on improving patient care.

“[The researchers who developed the tool] are people who have dedicated a substantial portion of their professional careers to studying this disease and are comfortable that this is a tool that will offer more value than what we’re currently doing,” he said. “Chances are, this will be much better than what we currently have.”

This new tool was developed as part of AGA’s EoE initiative: Eosinophilic Esophagitis: Expand, Optimize, Excel. View additional resources at eoe.gastro.org.

The index was developed as part of a conference that was supported by a grant from Takeda. This conference was also funded in part by the division of intramural research at National Institute of Allergy and Infectious Diseases/National Institutes of Health and supported by CEGIR (U54 AI117804). All activities and products resulting from this conference were independently developed with no involvement or input from the funder. The authors disclosed relationships with various industry entities, including Takeda. None of the other relationships were relevant to this work. Dr. Katz consults with Phathom, Sebela Pharmaceuticals, and AstraZeneca.

This article was updated on June 7, 2022.

The U.S. Food and Drug Administration has approved a label extension for oral risdiplam (Evrysdi, Genentech) to include presymptomatic infants younger than 2 months old with spinal muscular atrophy (SMA).

As previously reported, the FDA first approved oral risdiplam for SMA in children older than age 2 years in 2020.

The FDA expanded the indication for risdiplam to include babies younger than 2 months old because of interim safety and efficacy data from the ongoing RAINBOWFISH study. It includes 25 babies from birth to 6 weeks of age at first dose, all of whom have genetically diagnosed SMA but are not yet presenting with symptoms.

After 12 months of risdiplam treatment, the majority of presymptomatic infants with SMA reached key motor milestones, Genentech said in a news release.

Of the six babies with two or three copies of the SMN2 gene, all were able to sit after 1 year of active treatment, roughly two-thirds could stand, and half could walk independently.

All babies were alive at 12 months without permanent ventilation.

“The approval of Evrysdi for presymptomatic babies is particularly important, as early treatment of SMA, before symptoms start to arise, can help babies to achieve motor milestones,” Richard Finkel, MD, principal investigator of the trial, said in the release.

“With the inclusion of SMA in newborn screening programs, this approval provides the opportunity to start treating at home with Evrysdi soon after the diagnosis is confirmed,” added Dr. Finkel, who is director of the experimental neuroscience program, St. Jude Children’s Research Hospital, Memphis.
 

From newborns to older adults?

SMA is a rare and often fatal genetic disease that causes muscle weakness and progressive loss of movement.

SMA, which affects about 1 in 10,000 babies, is caused by a mutation in the survival motor neuron 1 (SMN1) gene. The gene encodes the SMN protein, which is critical for the maintenance and function of motor neurons.

Risdiplam is an orally administered, centrally and peripherally distributed small molecule that modulates survival motor neuron 2 (SMN2) premessenger RNA splicing to increase SMN protein levels.

As part of the label extension, the prescribing information for risdiplam has also been updated to include 2-year pooled data from parts 1 and 2 of the FIREFISH study, which demonstrated long-term efficacy and safety in symptomatic infants with Type 1 SMA, the company noted.

“Because of its efficacy in multiple settings, Evrysdi is now available for people with SMA, from presymptomatic newborns to older adults,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, said in the release. 

“We are proud of this achievement, which has the potential to make a real difference to those living with SMA and their caregivers,” Dr. Garraway added.

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

The U.S. Food and Drug Administration has approved a label extension for oral risdiplam (Evrysdi, Genentech) to include presymptomatic infants younger than 2 months old with spinal muscular atrophy (SMA).

As previously reported, the FDA first approved oral risdiplam for SMA in children older than age 2 years in 2020.

The FDA expanded the indication for risdiplam to include babies younger than 2 months old because of interim safety and efficacy data from the ongoing RAINBOWFISH study. It includes 25 babies from birth to 6 weeks of age at first dose, all of whom have genetically diagnosed SMA but are not yet presenting with symptoms.

After 12 months of risdiplam treatment, the majority of presymptomatic infants with SMA reached key motor milestones, Genentech said in a news release.

Of the six babies with two or three copies of the SMN2 gene, all were able to sit after 1 year of active treatment, roughly two-thirds could stand, and half could walk independently.

All babies were alive at 12 months without permanent ventilation.

“The approval of Evrysdi for presymptomatic babies is particularly important, as early treatment of SMA, before symptoms start to arise, can help babies to achieve motor milestones,” Richard Finkel, MD, principal investigator of the trial, said in the release.

“With the inclusion of SMA in newborn screening programs, this approval provides the opportunity to start treating at home with Evrysdi soon after the diagnosis is confirmed,” added Dr. Finkel, who is director of the experimental neuroscience program, St. Jude Children’s Research Hospital, Memphis.
 

From newborns to older adults?

SMA is a rare and often fatal genetic disease that causes muscle weakness and progressive loss of movement.

SMA, which affects about 1 in 10,000 babies, is caused by a mutation in the survival motor neuron 1 (SMN1) gene. The gene encodes the SMN protein, which is critical for the maintenance and function of motor neurons.

Risdiplam is an orally administered, centrally and peripherally distributed small molecule that modulates survival motor neuron 2 (SMN2) premessenger RNA splicing to increase SMN protein levels.

As part of the label extension, the prescribing information for risdiplam has also been updated to include 2-year pooled data from parts 1 and 2 of the FIREFISH study, which demonstrated long-term efficacy and safety in symptomatic infants with Type 1 SMA, the company noted.

“Because of its efficacy in multiple settings, Evrysdi is now available for people with SMA, from presymptomatic newborns to older adults,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, said in the release. 

“We are proud of this achievement, which has the potential to make a real difference to those living with SMA and their caregivers,” Dr. Garraway added.

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

The U.S. Food and Drug Administration has approved a label extension for oral risdiplam (Evrysdi, Genentech) to include presymptomatic infants younger than 2 months old with spinal muscular atrophy (SMA).

As previously reported, the FDA first approved oral risdiplam for SMA in children older than age 2 years in 2020.

The FDA expanded the indication for risdiplam to include babies younger than 2 months old because of interim safety and efficacy data from the ongoing RAINBOWFISH study. It includes 25 babies from birth to 6 weeks of age at first dose, all of whom have genetically diagnosed SMA but are not yet presenting with symptoms.

After 12 months of risdiplam treatment, the majority of presymptomatic infants with SMA reached key motor milestones, Genentech said in a news release.

Of the six babies with two or three copies of the SMN2 gene, all were able to sit after 1 year of active treatment, roughly two-thirds could stand, and half could walk independently.

All babies were alive at 12 months without permanent ventilation.

“The approval of Evrysdi for presymptomatic babies is particularly important, as early treatment of SMA, before symptoms start to arise, can help babies to achieve motor milestones,” Richard Finkel, MD, principal investigator of the trial, said in the release.

“With the inclusion of SMA in newborn screening programs, this approval provides the opportunity to start treating at home with Evrysdi soon after the diagnosis is confirmed,” added Dr. Finkel, who is director of the experimental neuroscience program, St. Jude Children’s Research Hospital, Memphis.
 

From newborns to older adults?

SMA is a rare and often fatal genetic disease that causes muscle weakness and progressive loss of movement.

SMA, which affects about 1 in 10,000 babies, is caused by a mutation in the survival motor neuron 1 (SMN1) gene. The gene encodes the SMN protein, which is critical for the maintenance and function of motor neurons.

Risdiplam is an orally administered, centrally and peripherally distributed small molecule that modulates survival motor neuron 2 (SMN2) premessenger RNA splicing to increase SMN protein levels.

As part of the label extension, the prescribing information for risdiplam has also been updated to include 2-year pooled data from parts 1 and 2 of the FIREFISH study, which demonstrated long-term efficacy and safety in symptomatic infants with Type 1 SMA, the company noted.

“Because of its efficacy in multiple settings, Evrysdi is now available for people with SMA, from presymptomatic newborns to older adults,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, said in the release. 

“We are proud of this achievement, which has the potential to make a real difference to those living with SMA and their caregivers,” Dr. Garraway added.

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

Learning that a family member has cancer can be devastating enough. Waiting to find out whether a loved one can afford their treatment takes the concern to another level.

That was the case for health policy expert Stacie B. Dusetzina, PhD, when her mother was diagnosed with metastatic breast cancer.

“There is this period where you are waiting to learn more about the cancer type and treatment options, and, of course, what might be covered by your health plan,” Dr. Dusetzina, an associate professor at Vanderbilt University Medical Center, Nashville, Tenn., said in an interview. “Knowing as much as I do about coverage for prescription drugs in Medicare Part D, I was worried we would be in a situation where my mom had to spend over $15,000 out-of-pocket every year for one of these drugs.”

That $15,000 would have taken a large chunk of her retirement income and could make treatment unaffordable down the line.

This situation is hardly unique.

Many patients with cancer who rely on Medicare Part D face an impossible choice: “Your money or your life,” Dr. Dusetzina said.

In a recent perspective in the New England Journal of Medicine, Dr. Dusetzina detailed how subtle variations in people’s cancer type can have major implications for their out-of-pocket drug costs.

The difference in cost comes down to whether drugs are delivered as pills or infusions. Oral agents are almost always covered under a health plan’s pharmacy benefit (Medicare Part D), while physician-administered drugs are covered under the medical benefit (Medicare Part B).

According to Dr. Dusetzina, Medicare beneficiaries can face substantial, possibly “unlimited,” out-of-pocket costs for drugs covered under Part D if they don’t qualify for low-income subsidies. On the other hand, most beneficiaries receiving physician-administered drugs covered under Part B have supplemental coverage, which reduces or eliminates out-of-pocket costs.

Dr. Dusetzina broke down the expected first fill and yearly out-of-pocket costs associated with 10 oral cancer drugs covered under Part D. These costs ranged from $3,100 to $3,392 for a first fill and $10,592 to $14,067 for one year.

In a candid Twitter thread, Dr. Dusetzina opened up more about the issues highlighted in her piece: “This paper is about #PartD and Cancer. It is also about #pharmacoequity ... This is about how screwed you are if you need cancer treatment and your treatment happens to be covered by #PartD and not #PartB.”

“This is ARBITRARY and INEQUITABLE,” she added.

What’s “arbitrary,” Dr. Dusetzina explains, is that a rather small, chance distinction in cancer type or subtype can be the difference between affording and not affording treatment – and potentially between life and death.

Take the drug costs for two similar patients with breast cancer.

Patient A has hormone receptor–positive, human epidermal growth factor receptor type 2 (HER2)–negative breast cancer and thus would likely receive first-line therapy with two oral agents: an aromatase inhibitor and cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, most often palbociclib (Ibrance).

For palbociclib alone, out-of-pocket costs would come to $3,100 for the first fill and nearly $10,600 over a year for a Part D beneficiary who doesn’t qualify for low-income subsidies.

Now take patient B who has HER2–positive metastatic breast cancer. This person would likely receive first-line treatment with trastuzumab (Herceptin), pertuzumab (Perjeta), and a taxane – a combination covered under Part B, which would be subject to an out-of-pocket cap or covered with limited or no cost sharing.

This difference in cancer subtype leaves some patients “paying substantially more for their cancer treatment than others, despite the same goal of extending or improving their lives,” Dr. Dusetzina writes.

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

Learning that a family member has cancer can be devastating enough. Waiting to find out whether a loved one can afford their treatment takes the concern to another level.

That was the case for health policy expert Stacie B. Dusetzina, PhD, when her mother was diagnosed with metastatic breast cancer.

“There is this period where you are waiting to learn more about the cancer type and treatment options, and, of course, what might be covered by your health plan,” Dr. Dusetzina, an associate professor at Vanderbilt University Medical Center, Nashville, Tenn., said in an interview. “Knowing as much as I do about coverage for prescription drugs in Medicare Part D, I was worried we would be in a situation where my mom had to spend over $15,000 out-of-pocket every year for one of these drugs.”

That $15,000 would have taken a large chunk of her retirement income and could make treatment unaffordable down the line.

This situation is hardly unique.

Many patients with cancer who rely on Medicare Part D face an impossible choice: “Your money or your life,” Dr. Dusetzina said.

In a recent perspective in the New England Journal of Medicine, Dr. Dusetzina detailed how subtle variations in people’s cancer type can have major implications for their out-of-pocket drug costs.

The difference in cost comes down to whether drugs are delivered as pills or infusions. Oral agents are almost always covered under a health plan’s pharmacy benefit (Medicare Part D), while physician-administered drugs are covered under the medical benefit (Medicare Part B).

According to Dr. Dusetzina, Medicare beneficiaries can face substantial, possibly “unlimited,” out-of-pocket costs for drugs covered under Part D if they don’t qualify for low-income subsidies. On the other hand, most beneficiaries receiving physician-administered drugs covered under Part B have supplemental coverage, which reduces or eliminates out-of-pocket costs.

Dr. Dusetzina broke down the expected first fill and yearly out-of-pocket costs associated with 10 oral cancer drugs covered under Part D. These costs ranged from $3,100 to $3,392 for a first fill and $10,592 to $14,067 for one year.

In a candid Twitter thread, Dr. Dusetzina opened up more about the issues highlighted in her piece: “This paper is about #PartD and Cancer. It is also about #pharmacoequity ... This is about how screwed you are if you need cancer treatment and your treatment happens to be covered by #PartD and not #PartB.”

“This is ARBITRARY and INEQUITABLE,” she added.

What’s “arbitrary,” Dr. Dusetzina explains, is that a rather small, chance distinction in cancer type or subtype can be the difference between affording and not affording treatment – and potentially between life and death.

Take the drug costs for two similar patients with breast cancer.

Patient A has hormone receptor–positive, human epidermal growth factor receptor type 2 (HER2)–negative breast cancer and thus would likely receive first-line therapy with two oral agents: an aromatase inhibitor and cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, most often palbociclib (Ibrance).

For palbociclib alone, out-of-pocket costs would come to $3,100 for the first fill and nearly $10,600 over a year for a Part D beneficiary who doesn’t qualify for low-income subsidies.

Now take patient B who has HER2–positive metastatic breast cancer. This person would likely receive first-line treatment with trastuzumab (Herceptin), pertuzumab (Perjeta), and a taxane – a combination covered under Part B, which would be subject to an out-of-pocket cap or covered with limited or no cost sharing.

This difference in cancer subtype leaves some patients “paying substantially more for their cancer treatment than others, despite the same goal of extending or improving their lives,” Dr. Dusetzina writes.

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

Learning that a family member has cancer can be devastating enough. Waiting to find out whether a loved one can afford their treatment takes the concern to another level.

That was the case for health policy expert Stacie B. Dusetzina, PhD, when her mother was diagnosed with metastatic breast cancer.

“There is this period where you are waiting to learn more about the cancer type and treatment options, and, of course, what might be covered by your health plan,” Dr. Dusetzina, an associate professor at Vanderbilt University Medical Center, Nashville, Tenn., said in an interview. “Knowing as much as I do about coverage for prescription drugs in Medicare Part D, I was worried we would be in a situation where my mom had to spend over $15,000 out-of-pocket every year for one of these drugs.”

That $15,000 would have taken a large chunk of her retirement income and could make treatment unaffordable down the line.

This situation is hardly unique.

Many patients with cancer who rely on Medicare Part D face an impossible choice: “Your money or your life,” Dr. Dusetzina said.

In a recent perspective in the New England Journal of Medicine, Dr. Dusetzina detailed how subtle variations in people’s cancer type can have major implications for their out-of-pocket drug costs.

The difference in cost comes down to whether drugs are delivered as pills or infusions. Oral agents are almost always covered under a health plan’s pharmacy benefit (Medicare Part D), while physician-administered drugs are covered under the medical benefit (Medicare Part B).

According to Dr. Dusetzina, Medicare beneficiaries can face substantial, possibly “unlimited,” out-of-pocket costs for drugs covered under Part D if they don’t qualify for low-income subsidies. On the other hand, most beneficiaries receiving physician-administered drugs covered under Part B have supplemental coverage, which reduces or eliminates out-of-pocket costs.

Dr. Dusetzina broke down the expected first fill and yearly out-of-pocket costs associated with 10 oral cancer drugs covered under Part D. These costs ranged from $3,100 to $3,392 for a first fill and $10,592 to $14,067 for one year.

In a candid Twitter thread, Dr. Dusetzina opened up more about the issues highlighted in her piece: “This paper is about #PartD and Cancer. It is also about #pharmacoequity ... This is about how screwed you are if you need cancer treatment and your treatment happens to be covered by #PartD and not #PartB.”

“This is ARBITRARY and INEQUITABLE,” she added.

What’s “arbitrary,” Dr. Dusetzina explains, is that a rather small, chance distinction in cancer type or subtype can be the difference between affording and not affording treatment – and potentially between life and death.

Take the drug costs for two similar patients with breast cancer.

Patient A has hormone receptor–positive, human epidermal growth factor receptor type 2 (HER2)–negative breast cancer and thus would likely receive first-line therapy with two oral agents: an aromatase inhibitor and cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, most often palbociclib (Ibrance).

For palbociclib alone, out-of-pocket costs would come to $3,100 for the first fill and nearly $10,600 over a year for a Part D beneficiary who doesn’t qualify for low-income subsidies.

Now take patient B who has HER2–positive metastatic breast cancer. This person would likely receive first-line treatment with trastuzumab (Herceptin), pertuzumab (Perjeta), and a taxane – a combination covered under Part B, which would be subject to an out-of-pocket cap or covered with limited or no cost sharing.

This difference in cancer subtype leaves some patients “paying substantially more for their cancer treatment than others, despite the same goal of extending or improving their lives,” Dr. Dusetzina writes.

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

A wearable patch that delivers electrical stimulation to the perineum may postpone premature ejaculation, according to research presented at the annual meeting of the American Urological Association. The disposable device appears to work by helping men contract the muscles in the pelvic floor, allowing them to postpone climax.

Among 34 men with a lifelong history of premature ejaculation, average intravaginal ejaculatory latency time – the time from vaginal penetration to ejaculation – increased from about 67 seconds at baseline to 123 seconds when they used the device.

Another 17 participants received a sham treatment – stimulation they could feel but that did not activate muscles. In this group, time to ejaculation increased from 63 seconds to 81 seconds.

The longer duration with active treatment was statistically significant (P < .0001), whereas the increase in the control group was not (P = .1653), said Ege Can Serefoglu, MD, a researcher at Biruni University, Istanbul, and editor-in-chief of the International Journal of Impotence Research.

Dr. Serefoglu is a member of the scientific advisory board for Virility Medical, a company in Hod Hasharon, Israel, that is developing the stimulator. Marketed as vPatch, the device is expected to be available in 2023, Dr. Serefoglu said. It was cleared by the Food and Drug Administration in November and has CE-mark approval in Europe, according to the company.
 

Common problem, limited options

Research shows that 20%-30% of men are not happy with their time to ejaculation, Dr. Serefoglu said.

The International Society for Sexual Medicine defines premature ejaculation as ejaculation which always or almost always occurs within about 1 minute of penetration, the patient is unable to delay this occurrence, and the condition causes personal distress.

“Unfortunately, in spite of its high prevalence we do not really have any satisfying treatment options,” Dr. Serefoglu said.

Topical anesthetics may be used to decrease the sensitivity of the glans penis, and selective serotonin reuptake inhibitors may help delay ejaculation. But these options have limited efficacy and low adherence, he said.

Preclinical studies have shown that injection of botulinum toxin into the bulbospongiosus muscles is associated with a dose-dependent increase in ejaculation latency in rats.

Data on ClinicalTrials.gov show that this approach also may increase ejaculation latency in men, Dr. Serefoglu said. Although investigators found no safety concerns, drugmaker Allergan made a strategic business decision to stop developing this treatment approach, according to the registration entry for the study.

The idea for vPatch came from researchers wondering if instead of paralyzing the muscles with botulinum toxin, they used electrical stimulation to cause contraction of those muscles, Dr. Serefoglu said. A smaller proof-of-concept study demonstrated the feasibility and safety of this technique.

To further assess the safety and efficacy of a transcutaneous perineal electrical stimulator for the treatment of premature ejaculation, investigators conducted the randomized, double-blind, sham-controlled trial at Rambam Medical Centre, Haifa, Israel, and Villa Donatello Clinic, Florence, Italy.

The trial included males with premature ejaculation aged 18-60 years. Their female partners measured IELT using a stopwatch during four sexual intercourse sessions before treatment, and four times on treatment, at home.

In addition to the increased time to ejaculation, perceived control over ejaculation, satisfaction with sexual intercourse, personal distress related to ejaculation, and interpersonal difficulty related to ejaculation all significantly improved with vPatch, the researchers found.

Of participants who received active treatment, 73.5% reported a subjective sense of improvement versus 41.2% of the control group.
 

Potential reactions

No serious adverse events were observed, Dr. Serefoglu reported. Potential adverse reactions include redness, discomfort, and localized pain, according to the company’s website.

Men should not use vPatch if they have been diagnosed with pelvic cancer, or if they have an implanted electronic device, diabetes with peripheral neuropathy, or perineal dermatologic diseases, irritations, or lesions. Other precautions include avoiding use of the vPatch in water or humid environments. The device has not been tested on use with a pregnant partner.

The disposable patches are meant for one-time use. “The miniaturized perineal stimulation device may become an on-demand, drug-free therapeutic option,” Dr. Serefoglu said.

Combining electrical stimulation with other treatment approaches may provide additional benefit, said Bradley Schwartz, DO, professor and chairman of urology at Southern Illinois University, Springfield, who moderated the session at the AUA meeting at which the results of the study were presented.

“You go from 1 to 2 minutes just with this device,” Dr. Schwartz said. “If you went from 2 to 3 minutes, you would essentially be tripling their pleasure or their time, which might make a significant difference.”

Serefoglu agreed that combining the stimulator with other treatment approaches such as topical anesthetics could increase patient satisfaction.

Comoderator Kelly Healy, MD, assistant professor of urology at Columbia University Medical Center, New York, highlighted a direction for future research: examining outcomes according to different types of relationships, as well as partner satisfaction.

“That is a perfect question that should also be considered in the future trials,” Dr. Serefoglu said. “This was mainly focused on the man’s satisfaction. But men are trying to delay their ejaculation to satisfy their partner.”

Dr. Serefoglu is on the scientific advisory board for Virility Medical, which sponsored the study. Dr. Healy had no disclosures. Dr. Schwartz disclosed ties to Cook Medical.

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

A wearable patch that delivers electrical stimulation to the perineum may postpone premature ejaculation, according to research presented at the annual meeting of the American Urological Association. The disposable device appears to work by helping men contract the muscles in the pelvic floor, allowing them to postpone climax.

Among 34 men with a lifelong history of premature ejaculation, average intravaginal ejaculatory latency time – the time from vaginal penetration to ejaculation – increased from about 67 seconds at baseline to 123 seconds when they used the device.

Another 17 participants received a sham treatment – stimulation they could feel but that did not activate muscles. In this group, time to ejaculation increased from 63 seconds to 81 seconds.

The longer duration with active treatment was statistically significant (P < .0001), whereas the increase in the control group was not (P = .1653), said Ege Can Serefoglu, MD, a researcher at Biruni University, Istanbul, and editor-in-chief of the International Journal of Impotence Research.

Dr. Serefoglu is a member of the scientific advisory board for Virility Medical, a company in Hod Hasharon, Israel, that is developing the stimulator. Marketed as vPatch, the device is expected to be available in 2023, Dr. Serefoglu said. It was cleared by the Food and Drug Administration in November and has CE-mark approval in Europe, according to the company.
 

Common problem, limited options

Research shows that 20%-30% of men are not happy with their time to ejaculation, Dr. Serefoglu said.

The International Society for Sexual Medicine defines premature ejaculation as ejaculation which always or almost always occurs within about 1 minute of penetration, the patient is unable to delay this occurrence, and the condition causes personal distress.

“Unfortunately, in spite of its high prevalence we do not really have any satisfying treatment options,” Dr. Serefoglu said.

Topical anesthetics may be used to decrease the sensitivity of the glans penis, and selective serotonin reuptake inhibitors may help delay ejaculation. But these options have limited efficacy and low adherence, he said.

Preclinical studies have shown that injection of botulinum toxin into the bulbospongiosus muscles is associated with a dose-dependent increase in ejaculation latency in rats.

Data on ClinicalTrials.gov show that this approach also may increase ejaculation latency in men, Dr. Serefoglu said. Although investigators found no safety concerns, drugmaker Allergan made a strategic business decision to stop developing this treatment approach, according to the registration entry for the study.

The idea for vPatch came from researchers wondering if instead of paralyzing the muscles with botulinum toxin, they used electrical stimulation to cause contraction of those muscles, Dr. Serefoglu said. A smaller proof-of-concept study demonstrated the feasibility and safety of this technique.

To further assess the safety and efficacy of a transcutaneous perineal electrical stimulator for the treatment of premature ejaculation, investigators conducted the randomized, double-blind, sham-controlled trial at Rambam Medical Centre, Haifa, Israel, and Villa Donatello Clinic, Florence, Italy.

The trial included males with premature ejaculation aged 18-60 years. Their female partners measured IELT using a stopwatch during four sexual intercourse sessions before treatment, and four times on treatment, at home.

In addition to the increased time to ejaculation, perceived control over ejaculation, satisfaction with sexual intercourse, personal distress related to ejaculation, and interpersonal difficulty related to ejaculation all significantly improved with vPatch, the researchers found.

Of participants who received active treatment, 73.5% reported a subjective sense of improvement versus 41.2% of the control group.
 

Potential reactions

No serious adverse events were observed, Dr. Serefoglu reported. Potential adverse reactions include redness, discomfort, and localized pain, according to the company’s website.

Men should not use vPatch if they have been diagnosed with pelvic cancer, or if they have an implanted electronic device, diabetes with peripheral neuropathy, or perineal dermatologic diseases, irritations, or lesions. Other precautions include avoiding use of the vPatch in water or humid environments. The device has not been tested on use with a pregnant partner.

The disposable patches are meant for one-time use. “The miniaturized perineal stimulation device may become an on-demand, drug-free therapeutic option,” Dr. Serefoglu said.

Combining electrical stimulation with other treatment approaches may provide additional benefit, said Bradley Schwartz, DO, professor and chairman of urology at Southern Illinois University, Springfield, who moderated the session at the AUA meeting at which the results of the study were presented.

“You go from 1 to 2 minutes just with this device,” Dr. Schwartz said. “If you went from 2 to 3 minutes, you would essentially be tripling their pleasure or their time, which might make a significant difference.”

Serefoglu agreed that combining the stimulator with other treatment approaches such as topical anesthetics could increase patient satisfaction.

Comoderator Kelly Healy, MD, assistant professor of urology at Columbia University Medical Center, New York, highlighted a direction for future research: examining outcomes according to different types of relationships, as well as partner satisfaction.

“That is a perfect question that should also be considered in the future trials,” Dr. Serefoglu said. “This was mainly focused on the man’s satisfaction. But men are trying to delay their ejaculation to satisfy their partner.”

Dr. Serefoglu is on the scientific advisory board for Virility Medical, which sponsored the study. Dr. Healy had no disclosures. Dr. Schwartz disclosed ties to Cook Medical.

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

A wearable patch that delivers electrical stimulation to the perineum may postpone premature ejaculation, according to research presented at the annual meeting of the American Urological Association. The disposable device appears to work by helping men contract the muscles in the pelvic floor, allowing them to postpone climax.

Among 34 men with a lifelong history of premature ejaculation, average intravaginal ejaculatory latency time – the time from vaginal penetration to ejaculation – increased from about 67 seconds at baseline to 123 seconds when they used the device.

Another 17 participants received a sham treatment – stimulation they could feel but that did not activate muscles. In this group, time to ejaculation increased from 63 seconds to 81 seconds.

The longer duration with active treatment was statistically significant (P < .0001), whereas the increase in the control group was not (P = .1653), said Ege Can Serefoglu, MD, a researcher at Biruni University, Istanbul, and editor-in-chief of the International Journal of Impotence Research.

Dr. Serefoglu is a member of the scientific advisory board for Virility Medical, a company in Hod Hasharon, Israel, that is developing the stimulator. Marketed as vPatch, the device is expected to be available in 2023, Dr. Serefoglu said. It was cleared by the Food and Drug Administration in November and has CE-mark approval in Europe, according to the company.
 

Common problem, limited options

Research shows that 20%-30% of men are not happy with their time to ejaculation, Dr. Serefoglu said.

The International Society for Sexual Medicine defines premature ejaculation as ejaculation which always or almost always occurs within about 1 minute of penetration, the patient is unable to delay this occurrence, and the condition causes personal distress.

“Unfortunately, in spite of its high prevalence we do not really have any satisfying treatment options,” Dr. Serefoglu said.

Topical anesthetics may be used to decrease the sensitivity of the glans penis, and selective serotonin reuptake inhibitors may help delay ejaculation. But these options have limited efficacy and low adherence, he said.

Preclinical studies have shown that injection of botulinum toxin into the bulbospongiosus muscles is associated with a dose-dependent increase in ejaculation latency in rats.

Data on ClinicalTrials.gov show that this approach also may increase ejaculation latency in men, Dr. Serefoglu said. Although investigators found no safety concerns, drugmaker Allergan made a strategic business decision to stop developing this treatment approach, according to the registration entry for the study.

The idea for vPatch came from researchers wondering if instead of paralyzing the muscles with botulinum toxin, they used electrical stimulation to cause contraction of those muscles, Dr. Serefoglu said. A smaller proof-of-concept study demonstrated the feasibility and safety of this technique.

To further assess the safety and efficacy of a transcutaneous perineal electrical stimulator for the treatment of premature ejaculation, investigators conducted the randomized, double-blind, sham-controlled trial at Rambam Medical Centre, Haifa, Israel, and Villa Donatello Clinic, Florence, Italy.

The trial included males with premature ejaculation aged 18-60 years. Their female partners measured IELT using a stopwatch during four sexual intercourse sessions before treatment, and four times on treatment, at home.

In addition to the increased time to ejaculation, perceived control over ejaculation, satisfaction with sexual intercourse, personal distress related to ejaculation, and interpersonal difficulty related to ejaculation all significantly improved with vPatch, the researchers found.

Of participants who received active treatment, 73.5% reported a subjective sense of improvement versus 41.2% of the control group.
 

Potential reactions

No serious adverse events were observed, Dr. Serefoglu reported. Potential adverse reactions include redness, discomfort, and localized pain, according to the company’s website.

Men should not use vPatch if they have been diagnosed with pelvic cancer, or if they have an implanted electronic device, diabetes with peripheral neuropathy, or perineal dermatologic diseases, irritations, or lesions. Other precautions include avoiding use of the vPatch in water or humid environments. The device has not been tested on use with a pregnant partner.

The disposable patches are meant for one-time use. “The miniaturized perineal stimulation device may become an on-demand, drug-free therapeutic option,” Dr. Serefoglu said.

Combining electrical stimulation with other treatment approaches may provide additional benefit, said Bradley Schwartz, DO, professor and chairman of urology at Southern Illinois University, Springfield, who moderated the session at the AUA meeting at which the results of the study were presented.

“You go from 1 to 2 minutes just with this device,” Dr. Schwartz said. “If you went from 2 to 3 minutes, you would essentially be tripling their pleasure or their time, which might make a significant difference.”

Serefoglu agreed that combining the stimulator with other treatment approaches such as topical anesthetics could increase patient satisfaction.

Comoderator Kelly Healy, MD, assistant professor of urology at Columbia University Medical Center, New York, highlighted a direction for future research: examining outcomes according to different types of relationships, as well as partner satisfaction.

“That is a perfect question that should also be considered in the future trials,” Dr. Serefoglu said. “This was mainly focused on the man’s satisfaction. But men are trying to delay their ejaculation to satisfy their partner.”

Dr. Serefoglu is on the scientific advisory board for Virility Medical, which sponsored the study. Dr. Healy had no disclosures. Dr. Schwartz disclosed ties to Cook Medical.

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

Headache medicine expert Joel Saper, MD once saw the formation of the United Council for Neurologic Subspecialties as a sign of progress in the field. In 2005, he even helped write their first certification exam for headache medicine.

Now he’s calling fraud.

After Dr. Saper’s initial 10-year certification expired, he paid $1,800 to take a recertification test. Passing this, he earned another decade of diplomate status; or so he thought, until a couple years later, when he received word from the UCNS.

“They were changing the rules,” Dr. Saper said in an interview. “The 10-year certificate was no longer valid. You had to go through another process.”

That process, known as continuous certification, has become the new standard among medical boards. In contrast with a more conventional recertification process that depends upon high-fee, high-stakes exams taken years apart, continuous certification typically involves a relatively small annual fee coupled with online reading and assessments designed to ensure familiarity with advances in the field.

It’s not just the physicians that need to study up. Medical boards are under pressure to ensure that they are maintaining retention, a potentially challenging task with approximately 200 medical certifying boards in the United States competing for attention, and in some cases, credibility.

Pivots to new systems of recertification have been a particular flash point among physicians. In 2015, a Newsweek article described how a group of “nationally known physicians revolted against the American Board of Internal Medicine” after the board “attempted to expand its program for recertifying doctors, adding boatloads of requirements and fees to be paid by physicians.”

In response, ABIM attacked both the journalist and Newsweek, citing a conflict of interest (the journalist was married to a doctor). The journalist went on to uncover some uncomfortable statistics, including the fact that, over a 5-year period, the ABIM Foundation lost $39.8 million while paying senior administrators $125.7 million. Such revelations have likely added to a collective skepticism about medical boards and their motives.
 

The changing landscape of recertification

According to Brenda Riggott, executive director of the UCNS, the switch to continuous certification was driven by a need to keep up with new standards.

“We really found the landscape of maintaining medical certifications in general was changing,” Ms. Riggott said, highlighting how the UCNS “evaluated 13 different continuous certification models being administered by medical boards” before settling upon the present model.

Continuous certification with the UCNS now requires a $175 annual fee. Each year, diplomates read 10 journal articles, then take a 25-question online quiz to demonstrate their understanding.

“It’s really about patient care,” Ms. Riggott said in an interview. “Medicine changes rapidly. And there are a lot of advances. Evaluating that once a decade is really not enough to verify that somebody is maintaining their skills, their knowledge.”

Dr. Saper, a clinical professor of neurology at Michigan State University, East Lansing, and founder-director of the Michigan Head Pain and Neurological Institute, Ann Arbor, had no inherent qualm with transitioning to this newer process, but he did take umbrage at its execution, since his UCNS certificate still had about 7 years until expiry.

He said the UCNS should have honored existing certificates through their stated duration, citing precedent set by the American Academy of Neurology. When the AAN transitioned from lifetime board certification to a periodic recertification process, they honored the lifetime status of those who already held it, according to Dr. Saper.

“[The AAN] looked at those of us who had been boarded under the premise that we were going to be lifetime boarded ... and they said: ‘We’re going to grandfather you ... because that was the rule under which you took your initial exams.’ ... That’s what UCNS should have done,” Dr. Saper said.
 

A compromise

Under pressure from Dr. Saper and others, UCNS compromised by endorsing 10-year diplomates until the 5-year mark.

Alan Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, and the editor-in-chief of Neurology Reviews, was among those who spoke up, only to see the duration of his certification cut in half.

“UCNS obviously realized that they had been wrong,” Dr. Rapoport said, referring to the compromise they made.

At the 5-year mark, physicians who didn’t adopt the new system were deleted from the UCNS online database, eliminating “the only way the public would know whether or not we were certified. This was after UCNS told us we would stay on the list with a note next to our name suggesting our certification was incomplete. They did not care that this might have hurt our reputations,” Dr. Rapoport said.

“To this day, no refunds, partial or full, have been given for the $1,800 we paid for the privilege of sitting for the exam, or for our time studying, or for the expenses accrued from canceling a day in the office and traveling to a testing center,” Dr. Rapoport said. “I did not want the money back; I wanted the certification promised to me. Since they have removed my name from this list, they do owe me the $1,800. They say they do not return their fees if you fail. How about if you pass and they remove you from their list?”

Yet he went on to make clear that the real issue is the principle of the matter. “This is not about money,” Dr. Rapoport said. “This is about what is fair and right.”

“The UCNS issued me a certificate for 10 years of certification in headache medicine; it is unethical and unlawful to break that contract and grant me only 5 years. Worse, they removed my name as though I do not exist. Along with Dr. Saper, I was one of the doctors that spent time and effort to advance headache medicine from October 1979, when I became a headache specialist, to today. I supported the principles of UCNS and took the first exam. I became the President of the International Headache Society and traveled the world promoting headache medicine; and this is how I am treated. Who can respect this type of certification, or this organization?”

Dr. Saper agreed: “It’s not about the money. It’s about the commitment. It’s very fraudulent.”

After the UCNS decision, Dr. Rapoport and Dr. Saper sought legal counsel, but ultimately decided not to sue the UCNS because of the lengthy process it would entail and the cost, estimated to be over $100,000.

“Our lawyers said: ‘It’s going to be years to get through it. You’ll probably win in the end, because it was fraudulent behavior,’ ” Dr. Saper said.
 

A different viewpoint

Ms. Riggott offered a different viewpoint: Nobody was guaranteed 10 years of certification.

“People do not pay for certification [from the UCNS],” Ms. Riggott said. “They pay to sit for an exam. It’s an exam administration fee. That can be construed as: ‘They paid for 10 years.’ They did not. They paid to sit for an exam. There are people who pay for an exam, and they don’t pass it, and they’re not certified. They don’t get a refund. That’s just the way high-stakes certification exams go.”

Dr. Saper and Dr. Rapoport see it differently. “The inherent reason any of us sit for an exam is to get certified.” Dr. Rapoport added. “Ms. Riggott is not being honest. There was an implied contract that if we passed, we would be granted a 10-year certification because that was what we did previously and that is what they told us would happen. Why would they have sent me this nice certificate for 10 more years of certification if she were telling the truth?”

Courtesy Dr. Alan M. Rapoport

Profits over promises

Dr. Rapoport estimates that many other neurologists had their certificates cut short and were dropped from this official list, some of them eminent members of the field, including David Watson, MD, professor and chair of neurology at West Virginia University Rockefeller Neuroscience Institute, Morgantown, and Robert Cowan, MD, professor of neurology and chief of the division of headache medicine at Stanford (Calif.) University.

“It is troubling when the organizations charged with maintaining the integrity of our specialization do not act with integrity,” Dr. Watson said. “The UCNS chose profits over promises and has refused to meaningfully engage with those of us whom they have wronged. What was once a point of pride for me (being in the second class of certified headache medicine diplomates) has become a meaningless piece of paper. This makes me sad.”

Dr. Cowan said the UCNS actions angered him while affirming his lifelong skepticism of clubs. “I was very sorry, but not surprised, to see the UCNS change the rules when the opportunity to make more money presented itself, and not surprised they did not honor their contracts. UCNS is just another scam like Best Doctors in the US and similar hypes. Neither are worth another dime of my money nor the time spent discussing them. One thing more: I have no quarrel with efforts to encourage keeping up with the field, although no one I know needs codification or direction as to which articles should be read. My outrage comes when responsible behavior is used as an excuse to line the pockets of dishonest, immoral individuals. I’m done.”

According to Ms. Riggott, the UCNS continuous certification process continues to evolve based on feedback from diplomates. She noted that “change is hard,” although the challenges of the transition appear to be paying off. “Initial retention for continuing certification is much higher than we would have expected from a high-stakes recertification exam,” she said. “So we are very, very happy about that.”
 

Proprietary tests drive revenue

According to Katie Collins, executive director of the National Board of Physicians and Surgeons, proprietary tests are a key revenue driver for medical boards, casting doubt on their educational motives.

“This isn’t really about maintaining their education, it’s really about having control over what they learn,” Ms. Collins said. “And unfortunately, physicians no longer have control over what they learn.”

NBPAS was formed largely in response to physicians dissatisfied with this situation. For $189 every 2 years, plus $25 for a paper certificate, NBPAS recertifies doctors originally credentialed by the American Board of Medical Specialties or the American Osteopathic Association.

Instead of making physicians take proprietary tests, NBPAS requires them to earn 50 hours of Accreditation Council for Continuing Medical Education–accredited CME every 2 years. Physicians can select where they seek this credit, giving them the agency to “pick and choose where they want to learn more,” Ms. Collins said, noting that this allows physicians to address personal knowledge gaps, instead of mastering the prescriptive lessons issued by other boards.

While this benefits physicians, Ms. Collins added, it also reduces the bottom line.

NBPAS is a “true 501(c)(3),” she said. “We have money for rainy days, but certainly not millions. We don’t have anything close to a million in savings.” Most medical boards are making millions on top of their services, she said. “That’s not for me to rein in, but it’s for me to point out.”

Noah Rosen, MD, associate professor of neurology and psychiatry at Northwell Health, Great Neck, N.Y., and former UCNS board member, said the UCNS was not motivated by money when they decided to switch to continuous recertification.

“The UCNS budget is publicly available,” Dr. Rosen said in an interview. “This is not a money-making organization,” he added, noting that the UCNS has “been basically operating on a breakeven budget,” and that certification “is not really a money-making proposition.”

Public IRS filings from 2019 and 2020 suggest a slightly different picture. In 2019, the UCNS reported net income of $72,256. In 2020, the inaugural year of the continuous certification program, net income jumped almost fivefold to $349,108. Over the same period, total assets held by the UCNS rose from $1.97 million to $2.37 million.

For comparison, NBPAS controls approximately $500,000 in total assets. The ABIM? Just shy of $72 million.
 

Recertification highlights a generational gap

Dr. Rosen, who was not a voting board member when the UCNS decided to switch to continuous certification, suggested that the transition could have been handled more effectively.

“I think Dr. Rapoport speaks to the frustration of how they made the transition, and that it could have been done in a way that recognizes people that held the certificate in a better way,” Dr. Rosen said.

He said that the departure of Dr. Rapoport and other neurologists from the UCNS points to another trend in the certification space. “I do think it brings up a deeper issue: What’s the value of certification? Dr. Rapoport and other people have brought up the question: What actually does this certificate bring you, if it’s not recognized by the federal government, and actually is not recognized by a lot of state governments, as well, as an official certification?”

He said the answer could depend on age.

“There seems to be a difference between younger people entering into the field and people that are more established in the field already,” Dr. Rosen said. “Younger people entering the field, they see certification as a distinction, something that separates them from the experiences and maybe every other neurologist.”

Ms. Collins independently pointed out the same generational gap. She noted that when the ABMS changed their maintenance model from lifelong to periodic in 2000, approximately 60% of their physicians had to change with the times, while the remainder did not.

“They grandfathered the other 40% – the older, probably more Caucasian male physicians,” she said. “It’s just the field. It’s evolved, it’s become more diverse. They created a divide in the physician community about what is the best means to maintain your board.”

In response to these comments, and despite his negative experiences with the UCNS, Dr. Rapoport emphasized that he still places high value on subspecialty certification.

“I care a lot about certification and that is why I decided to study for and take the only exam offered at the time,” he said, “I do not need it to continue my practice in headache medicine. No one asks me if I am certified in headache medicine. My patients are referred to me because of my reputation. But I have always sought the highest level of certification I could get. What UCNS has done is to cheapen the value of their certification.”

Dr. Rosen and Ms. Collins highlighted the other side of the same conclusion: For younger physicians, board certifications are more of a career consideration than they are for older physicians, as they could mean the difference between landing or losing a job.

“The American Board of Medical Specialties and [their] 24 member boards have really woven board certification into a requirement for employment for hospital privileges and for reimbursement,” Ms. Collins said.

And so, the practical value of board certification may depend most on the tenure of the person holding paper.

“I have not gone back to get any further certification [from the UCNS],” Dr. Saper said.

Even if his name has been removed from the UCNS register, he pointed out that his printed certificate still shows it’s valid until October 31st, 2026: “If anybody asks: ‘Are you certified?’ I say: ‘Here’s my certificate.’ ”

Courtesy Joel R. Saper, MD

Headache medicine expert Joel Saper, MD once saw the formation of the United Council for Neurologic Subspecialties as a sign of progress in the field. In 2005, he even helped write their first certification exam for headache medicine.

Now he’s calling fraud.

After Dr. Saper’s initial 10-year certification expired, he paid $1,800 to take a recertification test. Passing this, he earned another decade of diplomate status; or so he thought, until a couple years later, when he received word from the UCNS.

“They were changing the rules,” Dr. Saper said in an interview. “The 10-year certificate was no longer valid. You had to go through another process.”

That process, known as continuous certification, has become the new standard among medical boards. In contrast with a more conventional recertification process that depends upon high-fee, high-stakes exams taken years apart, continuous certification typically involves a relatively small annual fee coupled with online reading and assessments designed to ensure familiarity with advances in the field.

It’s not just the physicians that need to study up. Medical boards are under pressure to ensure that they are maintaining retention, a potentially challenging task with approximately 200 medical certifying boards in the United States competing for attention, and in some cases, credibility.

Pivots to new systems of recertification have been a particular flash point among physicians. In 2015, a Newsweek article described how a group of “nationally known physicians revolted against the American Board of Internal Medicine” after the board “attempted to expand its program for recertifying doctors, adding boatloads of requirements and fees to be paid by physicians.”

In response, ABIM attacked both the journalist and Newsweek, citing a conflict of interest (the journalist was married to a doctor). The journalist went on to uncover some uncomfortable statistics, including the fact that, over a 5-year period, the ABIM Foundation lost $39.8 million while paying senior administrators $125.7 million. Such revelations have likely added to a collective skepticism about medical boards and their motives.
 

The changing landscape of recertification

According to Brenda Riggott, executive director of the UCNS, the switch to continuous certification was driven by a need to keep up with new standards.

“We really found the landscape of maintaining medical certifications in general was changing,” Ms. Riggott said, highlighting how the UCNS “evaluated 13 different continuous certification models being administered by medical boards” before settling upon the present model.

Continuous certification with the UCNS now requires a $175 annual fee. Each year, diplomates read 10 journal articles, then take a 25-question online quiz to demonstrate their understanding.

“It’s really about patient care,” Ms. Riggott said in an interview. “Medicine changes rapidly. And there are a lot of advances. Evaluating that once a decade is really not enough to verify that somebody is maintaining their skills, their knowledge.”

Dr. Saper, a clinical professor of neurology at Michigan State University, East Lansing, and founder-director of the Michigan Head Pain and Neurological Institute, Ann Arbor, had no inherent qualm with transitioning to this newer process, but he did take umbrage at its execution, since his UCNS certificate still had about 7 years until expiry.

He said the UCNS should have honored existing certificates through their stated duration, citing precedent set by the American Academy of Neurology. When the AAN transitioned from lifetime board certification to a periodic recertification process, they honored the lifetime status of those who already held it, according to Dr. Saper.

“[The AAN] looked at those of us who had been boarded under the premise that we were going to be lifetime boarded ... and they said: ‘We’re going to grandfather you ... because that was the rule under which you took your initial exams.’ ... That’s what UCNS should have done,” Dr. Saper said.
 

A compromise

Under pressure from Dr. Saper and others, UCNS compromised by endorsing 10-year diplomates until the 5-year mark.

Alan Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, and the editor-in-chief of Neurology Reviews, was among those who spoke up, only to see the duration of his certification cut in half.

“UCNS obviously realized that they had been wrong,” Dr. Rapoport said, referring to the compromise they made.

At the 5-year mark, physicians who didn’t adopt the new system were deleted from the UCNS online database, eliminating “the only way the public would know whether or not we were certified. This was after UCNS told us we would stay on the list with a note next to our name suggesting our certification was incomplete. They did not care that this might have hurt our reputations,” Dr. Rapoport said.

“To this day, no refunds, partial or full, have been given for the $1,800 we paid for the privilege of sitting for the exam, or for our time studying, or for the expenses accrued from canceling a day in the office and traveling to a testing center,” Dr. Rapoport said. “I did not want the money back; I wanted the certification promised to me. Since they have removed my name from this list, they do owe me the $1,800. They say they do not return their fees if you fail. How about if you pass and they remove you from their list?”

Yet he went on to make clear that the real issue is the principle of the matter. “This is not about money,” Dr. Rapoport said. “This is about what is fair and right.”

“The UCNS issued me a certificate for 10 years of certification in headache medicine; it is unethical and unlawful to break that contract and grant me only 5 years. Worse, they removed my name as though I do not exist. Along with Dr. Saper, I was one of the doctors that spent time and effort to advance headache medicine from October 1979, when I became a headache specialist, to today. I supported the principles of UCNS and took the first exam. I became the President of the International Headache Society and traveled the world promoting headache medicine; and this is how I am treated. Who can respect this type of certification, or this organization?”

Dr. Saper agreed: “It’s not about the money. It’s about the commitment. It’s very fraudulent.”

After the UCNS decision, Dr. Rapoport and Dr. Saper sought legal counsel, but ultimately decided not to sue the UCNS because of the lengthy process it would entail and the cost, estimated to be over $100,000.

“Our lawyers said: ‘It’s going to be years to get through it. You’ll probably win in the end, because it was fraudulent behavior,’ ” Dr. Saper said.
 

A different viewpoint

Ms. Riggott offered a different viewpoint: Nobody was guaranteed 10 years of certification.

“People do not pay for certification [from the UCNS],” Ms. Riggott said. “They pay to sit for an exam. It’s an exam administration fee. That can be construed as: ‘They paid for 10 years.’ They did not. They paid to sit for an exam. There are people who pay for an exam, and they don’t pass it, and they’re not certified. They don’t get a refund. That’s just the way high-stakes certification exams go.”

Dr. Saper and Dr. Rapoport see it differently. “The inherent reason any of us sit for an exam is to get certified.” Dr. Rapoport added. “Ms. Riggott is not being honest. There was an implied contract that if we passed, we would be granted a 10-year certification because that was what we did previously and that is what they told us would happen. Why would they have sent me this nice certificate for 10 more years of certification if she were telling the truth?”

Courtesy Dr. Alan M. Rapoport

Profits over promises

Dr. Rapoport estimates that many other neurologists had their certificates cut short and were dropped from this official list, some of them eminent members of the field, including David Watson, MD, professor and chair of neurology at West Virginia University Rockefeller Neuroscience Institute, Morgantown, and Robert Cowan, MD, professor of neurology and chief of the division of headache medicine at Stanford (Calif.) University.

“It is troubling when the organizations charged with maintaining the integrity of our specialization do not act with integrity,” Dr. Watson said. “The UCNS chose profits over promises and has refused to meaningfully engage with those of us whom they have wronged. What was once a point of pride for me (being in the second class of certified headache medicine diplomates) has become a meaningless piece of paper. This makes me sad.”

Dr. Cowan said the UCNS actions angered him while affirming his lifelong skepticism of clubs. “I was very sorry, but not surprised, to see the UCNS change the rules when the opportunity to make more money presented itself, and not surprised they did not honor their contracts. UCNS is just another scam like Best Doctors in the US and similar hypes. Neither are worth another dime of my money nor the time spent discussing them. One thing more: I have no quarrel with efforts to encourage keeping up with the field, although no one I know needs codification or direction as to which articles should be read. My outrage comes when responsible behavior is used as an excuse to line the pockets of dishonest, immoral individuals. I’m done.”

According to Ms. Riggott, the UCNS continuous certification process continues to evolve based on feedback from diplomates. She noted that “change is hard,” although the challenges of the transition appear to be paying off. “Initial retention for continuing certification is much higher than we would have expected from a high-stakes recertification exam,” she said. “So we are very, very happy about that.”
 

Proprietary tests drive revenue

According to Katie Collins, executive director of the National Board of Physicians and Surgeons, proprietary tests are a key revenue driver for medical boards, casting doubt on their educational motives.

“This isn’t really about maintaining their education, it’s really about having control over what they learn,” Ms. Collins said. “And unfortunately, physicians no longer have control over what they learn.”

NBPAS was formed largely in response to physicians dissatisfied with this situation. For $189 every 2 years, plus $25 for a paper certificate, NBPAS recertifies doctors originally credentialed by the American Board of Medical Specialties or the American Osteopathic Association.

Instead of making physicians take proprietary tests, NBPAS requires them to earn 50 hours of Accreditation Council for Continuing Medical Education–accredited CME every 2 years. Physicians can select where they seek this credit, giving them the agency to “pick and choose where they want to learn more,” Ms. Collins said, noting that this allows physicians to address personal knowledge gaps, instead of mastering the prescriptive lessons issued by other boards.

While this benefits physicians, Ms. Collins added, it also reduces the bottom line.

NBPAS is a “true 501(c)(3),” she said. “We have money for rainy days, but certainly not millions. We don’t have anything close to a million in savings.” Most medical boards are making millions on top of their services, she said. “That’s not for me to rein in, but it’s for me to point out.”

Noah Rosen, MD, associate professor of neurology and psychiatry at Northwell Health, Great Neck, N.Y., and former UCNS board member, said the UCNS was not motivated by money when they decided to switch to continuous recertification.

“The UCNS budget is publicly available,” Dr. Rosen said in an interview. “This is not a money-making organization,” he added, noting that the UCNS has “been basically operating on a breakeven budget,” and that certification “is not really a money-making proposition.”

Public IRS filings from 2019 and 2020 suggest a slightly different picture. In 2019, the UCNS reported net income of $72,256. In 2020, the inaugural year of the continuous certification program, net income jumped almost fivefold to $349,108. Over the same period, total assets held by the UCNS rose from $1.97 million to $2.37 million.

For comparison, NBPAS controls approximately $500,000 in total assets. The ABIM? Just shy of $72 million.
 

Recertification highlights a generational gap

Dr. Rosen, who was not a voting board member when the UCNS decided to switch to continuous certification, suggested that the transition could have been handled more effectively.

“I think Dr. Rapoport speaks to the frustration of how they made the transition, and that it could have been done in a way that recognizes people that held the certificate in a better way,” Dr. Rosen said.

He said that the departure of Dr. Rapoport and other neurologists from the UCNS points to another trend in the certification space. “I do think it brings up a deeper issue: What’s the value of certification? Dr. Rapoport and other people have brought up the question: What actually does this certificate bring you, if it’s not recognized by the federal government, and actually is not recognized by a lot of state governments, as well, as an official certification?”

He said the answer could depend on age.

“There seems to be a difference between younger people entering into the field and people that are more established in the field already,” Dr. Rosen said. “Younger people entering the field, they see certification as a distinction, something that separates them from the experiences and maybe every other neurologist.”

Ms. Collins independently pointed out the same generational gap. She noted that when the ABMS changed their maintenance model from lifelong to periodic in 2000, approximately 60% of their physicians had to change with the times, while the remainder did not.

“They grandfathered the other 40% – the older, probably more Caucasian male physicians,” she said. “It’s just the field. It’s evolved, it’s become more diverse. They created a divide in the physician community about what is the best means to maintain your board.”

In response to these comments, and despite his negative experiences with the UCNS, Dr. Rapoport emphasized that he still places high value on subspecialty certification.

“I care a lot about certification and that is why I decided to study for and take the only exam offered at the time,” he said, “I do not need it to continue my practice in headache medicine. No one asks me if I am certified in headache medicine. My patients are referred to me because of my reputation. But I have always sought the highest level of certification I could get. What UCNS has done is to cheapen the value of their certification.”

Dr. Rosen and Ms. Collins highlighted the other side of the same conclusion: For younger physicians, board certifications are more of a career consideration than they are for older physicians, as they could mean the difference between landing or losing a job.

“The American Board of Medical Specialties and [their] 24 member boards have really woven board certification into a requirement for employment for hospital privileges and for reimbursement,” Ms. Collins said.

And so, the practical value of board certification may depend most on the tenure of the person holding paper.

“I have not gone back to get any further certification [from the UCNS],” Dr. Saper said.

Even if his name has been removed from the UCNS register, he pointed out that his printed certificate still shows it’s valid until October 31st, 2026: “If anybody asks: ‘Are you certified?’ I say: ‘Here’s my certificate.’ ”

Courtesy Joel R. Saper, MD

Headache medicine expert Joel Saper, MD once saw the formation of the United Council for Neurologic Subspecialties as a sign of progress in the field. In 2005, he even helped write their first certification exam for headache medicine.

Now he’s calling fraud.

After Dr. Saper’s initial 10-year certification expired, he paid $1,800 to take a recertification test. Passing this, he earned another decade of diplomate status; or so he thought, until a couple years later, when he received word from the UCNS.

“They were changing the rules,” Dr. Saper said in an interview. “The 10-year certificate was no longer valid. You had to go through another process.”

That process, known as continuous certification, has become the new standard among medical boards. In contrast with a more conventional recertification process that depends upon high-fee, high-stakes exams taken years apart, continuous certification typically involves a relatively small annual fee coupled with online reading and assessments designed to ensure familiarity with advances in the field.

It’s not just the physicians that need to study up. Medical boards are under pressure to ensure that they are maintaining retention, a potentially challenging task with approximately 200 medical certifying boards in the United States competing for attention, and in some cases, credibility.

Pivots to new systems of recertification have been a particular flash point among physicians. In 2015, a Newsweek article described how a group of “nationally known physicians revolted against the American Board of Internal Medicine” after the board “attempted to expand its program for recertifying doctors, adding boatloads of requirements and fees to be paid by physicians.”

In response, ABIM attacked both the journalist and Newsweek, citing a conflict of interest (the journalist was married to a doctor). The journalist went on to uncover some uncomfortable statistics, including the fact that, over a 5-year period, the ABIM Foundation lost $39.8 million while paying senior administrators $125.7 million. Such revelations have likely added to a collective skepticism about medical boards and their motives.
 

The changing landscape of recertification

According to Brenda Riggott, executive director of the UCNS, the switch to continuous certification was driven by a need to keep up with new standards.

“We really found the landscape of maintaining medical certifications in general was changing,” Ms. Riggott said, highlighting how the UCNS “evaluated 13 different continuous certification models being administered by medical boards” before settling upon the present model.

Continuous certification with the UCNS now requires a $175 annual fee. Each year, diplomates read 10 journal articles, then take a 25-question online quiz to demonstrate their understanding.

“It’s really about patient care,” Ms. Riggott said in an interview. “Medicine changes rapidly. And there are a lot of advances. Evaluating that once a decade is really not enough to verify that somebody is maintaining their skills, their knowledge.”

Dr. Saper, a clinical professor of neurology at Michigan State University, East Lansing, and founder-director of the Michigan Head Pain and Neurological Institute, Ann Arbor, had no inherent qualm with transitioning to this newer process, but he did take umbrage at its execution, since his UCNS certificate still had about 7 years until expiry.

He said the UCNS should have honored existing certificates through their stated duration, citing precedent set by the American Academy of Neurology. When the AAN transitioned from lifetime board certification to a periodic recertification process, they honored the lifetime status of those who already held it, according to Dr. Saper.

“[The AAN] looked at those of us who had been boarded under the premise that we were going to be lifetime boarded ... and they said: ‘We’re going to grandfather you ... because that was the rule under which you took your initial exams.’ ... That’s what UCNS should have done,” Dr. Saper said.
 

A compromise

Under pressure from Dr. Saper and others, UCNS compromised by endorsing 10-year diplomates until the 5-year mark.

Alan Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, and the editor-in-chief of Neurology Reviews, was among those who spoke up, only to see the duration of his certification cut in half.

“UCNS obviously realized that they had been wrong,” Dr. Rapoport said, referring to the compromise they made.

At the 5-year mark, physicians who didn’t adopt the new system were deleted from the UCNS online database, eliminating “the only way the public would know whether or not we were certified. This was after UCNS told us we would stay on the list with a note next to our name suggesting our certification was incomplete. They did not care that this might have hurt our reputations,” Dr. Rapoport said.

“To this day, no refunds, partial or full, have been given for the $1,800 we paid for the privilege of sitting for the exam, or for our time studying, or for the expenses accrued from canceling a day in the office and traveling to a testing center,” Dr. Rapoport said. “I did not want the money back; I wanted the certification promised to me. Since they have removed my name from this list, they do owe me the $1,800. They say they do not return their fees if you fail. How about if you pass and they remove you from their list?”

Yet he went on to make clear that the real issue is the principle of the matter. “This is not about money,” Dr. Rapoport said. “This is about what is fair and right.”

“The UCNS issued me a certificate for 10 years of certification in headache medicine; it is unethical and unlawful to break that contract and grant me only 5 years. Worse, they removed my name as though I do not exist. Along with Dr. Saper, I was one of the doctors that spent time and effort to advance headache medicine from October 1979, when I became a headache specialist, to today. I supported the principles of UCNS and took the first exam. I became the President of the International Headache Society and traveled the world promoting headache medicine; and this is how I am treated. Who can respect this type of certification, or this organization?”

Dr. Saper agreed: “It’s not about the money. It’s about the commitment. It’s very fraudulent.”

After the UCNS decision, Dr. Rapoport and Dr. Saper sought legal counsel, but ultimately decided not to sue the UCNS because of the lengthy process it would entail and the cost, estimated to be over $100,000.

“Our lawyers said: ‘It’s going to be years to get through it. You’ll probably win in the end, because it was fraudulent behavior,’ ” Dr. Saper said.
 

A different viewpoint

Ms. Riggott offered a different viewpoint: Nobody was guaranteed 10 years of certification.

“People do not pay for certification [from the UCNS],” Ms. Riggott said. “They pay to sit for an exam. It’s an exam administration fee. That can be construed as: ‘They paid for 10 years.’ They did not. They paid to sit for an exam. There are people who pay for an exam, and they don’t pass it, and they’re not certified. They don’t get a refund. That’s just the way high-stakes certification exams go.”

Dr. Saper and Dr. Rapoport see it differently. “The inherent reason any of us sit for an exam is to get certified.” Dr. Rapoport added. “Ms. Riggott is not being honest. There was an implied contract that if we passed, we would be granted a 10-year certification because that was what we did previously and that is what they told us would happen. Why would they have sent me this nice certificate for 10 more years of certification if she were telling the truth?”

Courtesy Dr. Alan M. Rapoport

Profits over promises

Dr. Rapoport estimates that many other neurologists had their certificates cut short and were dropped from this official list, some of them eminent members of the field, including David Watson, MD, professor and chair of neurology at West Virginia University Rockefeller Neuroscience Institute, Morgantown, and Robert Cowan, MD, professor of neurology and chief of the division of headache medicine at Stanford (Calif.) University.

“It is troubling when the organizations charged with maintaining the integrity of our specialization do not act with integrity,” Dr. Watson said. “The UCNS chose profits over promises and has refused to meaningfully engage with those of us whom they have wronged. What was once a point of pride for me (being in the second class of certified headache medicine diplomates) has become a meaningless piece of paper. This makes me sad.”

Dr. Cowan said the UCNS actions angered him while affirming his lifelong skepticism of clubs. “I was very sorry, but not surprised, to see the UCNS change the rules when the opportunity to make more money presented itself, and not surprised they did not honor their contracts. UCNS is just another scam like Best Doctors in the US and similar hypes. Neither are worth another dime of my money nor the time spent discussing them. One thing more: I have no quarrel with efforts to encourage keeping up with the field, although no one I know needs codification or direction as to which articles should be read. My outrage comes when responsible behavior is used as an excuse to line the pockets of dishonest, immoral individuals. I’m done.”

According to Ms. Riggott, the UCNS continuous certification process continues to evolve based on feedback from diplomates. She noted that “change is hard,” although the challenges of the transition appear to be paying off. “Initial retention for continuing certification is much higher than we would have expected from a high-stakes recertification exam,” she said. “So we are very, very happy about that.”
 

Proprietary tests drive revenue

According to Katie Collins, executive director of the National Board of Physicians and Surgeons, proprietary tests are a key revenue driver for medical boards, casting doubt on their educational motives.

“This isn’t really about maintaining their education, it’s really about having control over what they learn,” Ms. Collins said. “And unfortunately, physicians no longer have control over what they learn.”

NBPAS was formed largely in response to physicians dissatisfied with this situation. For $189 every 2 years, plus $25 for a paper certificate, NBPAS recertifies doctors originally credentialed by the American Board of Medical Specialties or the American Osteopathic Association.

Instead of making physicians take proprietary tests, NBPAS requires them to earn 50 hours of Accreditation Council for Continuing Medical Education–accredited CME every 2 years. Physicians can select where they seek this credit, giving them the agency to “pick and choose where they want to learn more,” Ms. Collins said, noting that this allows physicians to address personal knowledge gaps, instead of mastering the prescriptive lessons issued by other boards.

While this benefits physicians, Ms. Collins added, it also reduces the bottom line.

NBPAS is a “true 501(c)(3),” she said. “We have money for rainy days, but certainly not millions. We don’t have anything close to a million in savings.” Most medical boards are making millions on top of their services, she said. “That’s not for me to rein in, but it’s for me to point out.”

Noah Rosen, MD, associate professor of neurology and psychiatry at Northwell Health, Great Neck, N.Y., and former UCNS board member, said the UCNS was not motivated by money when they decided to switch to continuous recertification.

“The UCNS budget is publicly available,” Dr. Rosen said in an interview. “This is not a money-making organization,” he added, noting that the UCNS has “been basically operating on a breakeven budget,” and that certification “is not really a money-making proposition.”

Public IRS filings from 2019 and 2020 suggest a slightly different picture. In 2019, the UCNS reported net income of $72,256. In 2020, the inaugural year of the continuous certification program, net income jumped almost fivefold to $349,108. Over the same period, total assets held by the UCNS rose from $1.97 million to $2.37 million.

For comparison, NBPAS controls approximately $500,000 in total assets. The ABIM? Just shy of $72 million.
 

Recertification highlights a generational gap

Dr. Rosen, who was not a voting board member when the UCNS decided to switch to continuous certification, suggested that the transition could have been handled more effectively.

“I think Dr. Rapoport speaks to the frustration of how they made the transition, and that it could have been done in a way that recognizes people that held the certificate in a better way,” Dr. Rosen said.

He said that the departure of Dr. Rapoport and other neurologists from the UCNS points to another trend in the certification space. “I do think it brings up a deeper issue: What’s the value of certification? Dr. Rapoport and other people have brought up the question: What actually does this certificate bring you, if it’s not recognized by the federal government, and actually is not recognized by a lot of state governments, as well, as an official certification?”

He said the answer could depend on age.

“There seems to be a difference between younger people entering into the field and people that are more established in the field already,” Dr. Rosen said. “Younger people entering the field, they see certification as a distinction, something that separates them from the experiences and maybe every other neurologist.”

Ms. Collins independently pointed out the same generational gap. She noted that when the ABMS changed their maintenance model from lifelong to periodic in 2000, approximately 60% of their physicians had to change with the times, while the remainder did not.

“They grandfathered the other 40% – the older, probably more Caucasian male physicians,” she said. “It’s just the field. It’s evolved, it’s become more diverse. They created a divide in the physician community about what is the best means to maintain your board.”

In response to these comments, and despite his negative experiences with the UCNS, Dr. Rapoport emphasized that he still places high value on subspecialty certification.

“I care a lot about certification and that is why I decided to study for and take the only exam offered at the time,” he said, “I do not need it to continue my practice in headache medicine. No one asks me if I am certified in headache medicine. My patients are referred to me because of my reputation. But I have always sought the highest level of certification I could get. What UCNS has done is to cheapen the value of their certification.”

Dr. Rosen and Ms. Collins highlighted the other side of the same conclusion: For younger physicians, board certifications are more of a career consideration than they are for older physicians, as they could mean the difference between landing or losing a job.

“The American Board of Medical Specialties and [their] 24 member boards have really woven board certification into a requirement for employment for hospital privileges and for reimbursement,” Ms. Collins said.

And so, the practical value of board certification may depend most on the tenure of the person holding paper.

“I have not gone back to get any further certification [from the UCNS],” Dr. Saper said.

Even if his name has been removed from the UCNS register, he pointed out that his printed certificate still shows it’s valid until October 31st, 2026: “If anybody asks: ‘Are you certified?’ I say: ‘Here’s my certificate.’ ”

Courtesy Joel R. Saper, MD

Time-restricted eating reduced cardiovascular risk among older breast cancer survivors, a single-group feasibility study suggests.

The results show a 15% relative decline in cardiovascular risk, measured using the Framingham Risk Score, among at-risk breast cancer survivors (BCS) after only 8 weeks of following a time-restricted eating regimen, reported Amy A. Kirkham, PhD, assistant professor of kinesiology and physical education, University of Toronto, and colleagues.

“Time-restricted eating also significantly decreased visceral adipose tissue (VAT), which our team has previously found to accumulate rapidly with cardiotoxic treatment and predict later cardiac events among BCS,” the researchers add.

The findings were published online in the Journal of the American College of Cardiology: Cardiac Onco.

Physical activity is one of the main modalities for lowering cardiovascular risk, but it is not feasible for everyone because of physical limitations and other factors, noted Dr. Kirkham.

“I became interested in time-restricted eating when I came across the literature, which has really exploded in the last 5 years, showing that it can reduce the number of cardiovascular risk factors,” she said in an interview.

“However, most of these populations studied have had cardiometabolic conditions, like obesity, type 2 diabetes, prediabetes, and metabolic syndrome, and no one has looked at this” in either the population specifically at high risk for cardiovascular disease or in patients with overt cardiovascular disease, she said.

This approach is easy for patients to follow and is much simpler than many of the other dietary patterns, noted Dr. Kirkham. “It simply consists of having a start time or end time to your eating, so it is easy to prescribe,” she said. “You can see how that is much easier for a doctor to explain to a patient than trying to explain how to meet the physical activity guidelines each week.”

“This particular study definitely shows that time-restricted eating can decrease the calorie intake, and I think by decreasing the calorie intake you definitely would improve the body weight, which has numerous benefits irrespective of how we arrive at the end goal which is including the cardiovascular risk factors,” said Ajay Vallakati, MBBS, physician and clinical assistant professor of internal medicine, the Ohio State University, Columbus, commenting on the study.

“I think time-restricted eating is a tool we should look at, and a bigger study would help us to recommend this for our patients,” Dr. Vallakati told this news organization.

The study involved 22 participants. Mean age was 66 years. Mean body mass index was 31 ± 5 kg/m². In the cohort, 91% of participants were taking aromatase inhibitors and tamoxifen at the time of the study, and 50% underwent left-sided radiation.

The study group included breast cancer survivors who had risk factors for cardiovascular disease mortality, including completion of cardiotoxic therapy, like anthracyclines, within 1-6 years, obesity/overweight, and older age, defined as 60 years of age or older.

Participants were allowed to eat freely between 12 PM and 8 PM on weekdays and any time during weekends. Outside of the allotted hours, they could only drink black coffee, water, or black tea for the 8-week study period. They were not under any other physical activity or dietary restrictions.

All were provided with behavioral support, such as check-in phone calls with the research team at 1-, 3-, and 6-week follow-up and pre-interventional calls from a registered dietitian. During weekdays, they also received automated text messages twice a day asking what time they started and stopped eating.

Irritability and headaches were among the transient, minor symptoms reported, the researchers say. The study group responded to nearly all of the text messages that they received from the researchers. The participants also followed through with the fast for a median 98% of the prescribed days by fasting for 16 or more hours.

The results showed that after 8 weeks, median Framingham cardiovascular risk declined from 10.9% to 8.6%, a 15% relative reduction (P = .037). Modifiable aspects of Framingham, such as systolic blood pressure, total cholesterol, and high-density lipoprotein, remained relatively consistent overall, however, suggesting variation between individuals in the etiology of the risk decline.

Caloric intake fell by a median of 450 kcal, representing a relative reduction of about 22% (P < .001), they note.

The findings also showed a decline in median derived whole-body fat mass (–0.9 kg; P = .046), body mass (–1.0 kg; P = .025), and mean MRI-derived VAT (–5%; P = .009).

Other data showed that the average BMI remained the same (P = .10).

At the beginning of the study, 68% of the cohort was considered cardiometabolically unhealthy, given the benchmarks for pharmacologic preventive therapy of cardiovascular risk or metabolic syndrome based on Canadian Cardiovascular Society recommendations.

Notably, 53% of the cohort was no longer classified as meeting the criteria for metabolic syndrome or for the therapeutic treatment of cardiovascular risk after the intervention.

The study’s limitations include its short duration, selection bias, and that it did not involve a control group, the researchers acknowledge.

“Randomized controlled trials are needed to confirm these findings and to evaluate the health benefits, including potential health care cost savings and safety of longer-term time-restricted eating,” the researchers conclude.

Dr. Vallakati and Dr. Kirkham report no relevant conflicts of interest.

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

Time-restricted eating reduced cardiovascular risk among older breast cancer survivors, a single-group feasibility study suggests.

The results show a 15% relative decline in cardiovascular risk, measured using the Framingham Risk Score, among at-risk breast cancer survivors (BCS) after only 8 weeks of following a time-restricted eating regimen, reported Amy A. Kirkham, PhD, assistant professor of kinesiology and physical education, University of Toronto, and colleagues.

“Time-restricted eating also significantly decreased visceral adipose tissue (VAT), which our team has previously found to accumulate rapidly with cardiotoxic treatment and predict later cardiac events among BCS,” the researchers add.

The findings were published online in the Journal of the American College of Cardiology: Cardiac Onco.

Physical activity is one of the main modalities for lowering cardiovascular risk, but it is not feasible for everyone because of physical limitations and other factors, noted Dr. Kirkham.

“I became interested in time-restricted eating when I came across the literature, which has really exploded in the last 5 years, showing that it can reduce the number of cardiovascular risk factors,” she said in an interview.

“However, most of these populations studied have had cardiometabolic conditions, like obesity, type 2 diabetes, prediabetes, and metabolic syndrome, and no one has looked at this” in either the population specifically at high risk for cardiovascular disease or in patients with overt cardiovascular disease, she said.

This approach is easy for patients to follow and is much simpler than many of the other dietary patterns, noted Dr. Kirkham. “It simply consists of having a start time or end time to your eating, so it is easy to prescribe,” she said. “You can see how that is much easier for a doctor to explain to a patient than trying to explain how to meet the physical activity guidelines each week.”

“This particular study definitely shows that time-restricted eating can decrease the calorie intake, and I think by decreasing the calorie intake you definitely would improve the body weight, which has numerous benefits irrespective of how we arrive at the end goal which is including the cardiovascular risk factors,” said Ajay Vallakati, MBBS, physician and clinical assistant professor of internal medicine, the Ohio State University, Columbus, commenting on the study.

“I think time-restricted eating is a tool we should look at, and a bigger study would help us to recommend this for our patients,” Dr. Vallakati told this news organization.

The study involved 22 participants. Mean age was 66 years. Mean body mass index was 31 ± 5 kg/m². In the cohort, 91% of participants were taking aromatase inhibitors and tamoxifen at the time of the study, and 50% underwent left-sided radiation.

The study group included breast cancer survivors who had risk factors for cardiovascular disease mortality, including completion of cardiotoxic therapy, like anthracyclines, within 1-6 years, obesity/overweight, and older age, defined as 60 years of age or older.

Participants were allowed to eat freely between 12 PM and 8 PM on weekdays and any time during weekends. Outside of the allotted hours, they could only drink black coffee, water, or black tea for the 8-week study period. They were not under any other physical activity or dietary restrictions.

All were provided with behavioral support, such as check-in phone calls with the research team at 1-, 3-, and 6-week follow-up and pre-interventional calls from a registered dietitian. During weekdays, they also received automated text messages twice a day asking what time they started and stopped eating.

Irritability and headaches were among the transient, minor symptoms reported, the researchers say. The study group responded to nearly all of the text messages that they received from the researchers. The participants also followed through with the fast for a median 98% of the prescribed days by fasting for 16 or more hours.

The results showed that after 8 weeks, median Framingham cardiovascular risk declined from 10.9% to 8.6%, a 15% relative reduction (P = .037). Modifiable aspects of Framingham, such as systolic blood pressure, total cholesterol, and high-density lipoprotein, remained relatively consistent overall, however, suggesting variation between individuals in the etiology of the risk decline.

Caloric intake fell by a median of 450 kcal, representing a relative reduction of about 22% (P < .001), they note.

The findings also showed a decline in median derived whole-body fat mass (–0.9 kg; P = .046), body mass (–1.0 kg; P = .025), and mean MRI-derived VAT (–5%; P = .009).

Other data showed that the average BMI remained the same (P = .10).

At the beginning of the study, 68% of the cohort was considered cardiometabolically unhealthy, given the benchmarks for pharmacologic preventive therapy of cardiovascular risk or metabolic syndrome based on Canadian Cardiovascular Society recommendations.

Notably, 53% of the cohort was no longer classified as meeting the criteria for metabolic syndrome or for the therapeutic treatment of cardiovascular risk after the intervention.

The study’s limitations include its short duration, selection bias, and that it did not involve a control group, the researchers acknowledge.

“Randomized controlled trials are needed to confirm these findings and to evaluate the health benefits, including potential health care cost savings and safety of longer-term time-restricted eating,” the researchers conclude.

Dr. Vallakati and Dr. Kirkham report no relevant conflicts of interest.

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

Time-restricted eating reduced cardiovascular risk among older breast cancer survivors, a single-group feasibility study suggests.

The results show a 15% relative decline in cardiovascular risk, measured using the Framingham Risk Score, among at-risk breast cancer survivors (BCS) after only 8 weeks of following a time-restricted eating regimen, reported Amy A. Kirkham, PhD, assistant professor of kinesiology and physical education, University of Toronto, and colleagues.

“Time-restricted eating also significantly decreased visceral adipose tissue (VAT), which our team has previously found to accumulate rapidly with cardiotoxic treatment and predict later cardiac events among BCS,” the researchers add.

The findings were published online in the Journal of the American College of Cardiology: Cardiac Onco.

Physical activity is one of the main modalities for lowering cardiovascular risk, but it is not feasible for everyone because of physical limitations and other factors, noted Dr. Kirkham.

“I became interested in time-restricted eating when I came across the literature, which has really exploded in the last 5 years, showing that it can reduce the number of cardiovascular risk factors,” she said in an interview.

“However, most of these populations studied have had cardiometabolic conditions, like obesity, type 2 diabetes, prediabetes, and metabolic syndrome, and no one has looked at this” in either the population specifically at high risk for cardiovascular disease or in patients with overt cardiovascular disease, she said.

This approach is easy for patients to follow and is much simpler than many of the other dietary patterns, noted Dr. Kirkham. “It simply consists of having a start time or end time to your eating, so it is easy to prescribe,” she said. “You can see how that is much easier for a doctor to explain to a patient than trying to explain how to meet the physical activity guidelines each week.”

“This particular study definitely shows that time-restricted eating can decrease the calorie intake, and I think by decreasing the calorie intake you definitely would improve the body weight, which has numerous benefits irrespective of how we arrive at the end goal which is including the cardiovascular risk factors,” said Ajay Vallakati, MBBS, physician and clinical assistant professor of internal medicine, the Ohio State University, Columbus, commenting on the study.

“I think time-restricted eating is a tool we should look at, and a bigger study would help us to recommend this for our patients,” Dr. Vallakati told this news organization.

The study involved 22 participants. Mean age was 66 years. Mean body mass index was 31 ± 5 kg/m². In the cohort, 91% of participants were taking aromatase inhibitors and tamoxifen at the time of the study, and 50% underwent left-sided radiation.

The study group included breast cancer survivors who had risk factors for cardiovascular disease mortality, including completion of cardiotoxic therapy, like anthracyclines, within 1-6 years, obesity/overweight, and older age, defined as 60 years of age or older.

Participants were allowed to eat freely between 12 PM and 8 PM on weekdays and any time during weekends. Outside of the allotted hours, they could only drink black coffee, water, or black tea for the 8-week study period. They were not under any other physical activity or dietary restrictions.

All were provided with behavioral support, such as check-in phone calls with the research team at 1-, 3-, and 6-week follow-up and pre-interventional calls from a registered dietitian. During weekdays, they also received automated text messages twice a day asking what time they started and stopped eating.

Irritability and headaches were among the transient, minor symptoms reported, the researchers say. The study group responded to nearly all of the text messages that they received from the researchers. The participants also followed through with the fast for a median 98% of the prescribed days by fasting for 16 or more hours.

The results showed that after 8 weeks, median Framingham cardiovascular risk declined from 10.9% to 8.6%, a 15% relative reduction (P = .037). Modifiable aspects of Framingham, such as systolic blood pressure, total cholesterol, and high-density lipoprotein, remained relatively consistent overall, however, suggesting variation between individuals in the etiology of the risk decline.

Caloric intake fell by a median of 450 kcal, representing a relative reduction of about 22% (P < .001), they note.

The findings also showed a decline in median derived whole-body fat mass (–0.9 kg; P = .046), body mass (–1.0 kg; P = .025), and mean MRI-derived VAT (–5%; P = .009).

Other data showed that the average BMI remained the same (P = .10).

At the beginning of the study, 68% of the cohort was considered cardiometabolically unhealthy, given the benchmarks for pharmacologic preventive therapy of cardiovascular risk or metabolic syndrome based on Canadian Cardiovascular Society recommendations.

Notably, 53% of the cohort was no longer classified as meeting the criteria for metabolic syndrome or for the therapeutic treatment of cardiovascular risk after the intervention.

The study’s limitations include its short duration, selection bias, and that it did not involve a control group, the researchers acknowledge.

“Randomized controlled trials are needed to confirm these findings and to evaluate the health benefits, including potential health care cost savings and safety of longer-term time-restricted eating,” the researchers conclude.

Dr. Vallakati and Dr. Kirkham report no relevant conflicts of interest.

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

Babies of mothers who experience significant psychological distress during pregnancy showed evidence of altered brain development in utero and reduced cognitive outcomes at 18 months, based on data from a pair of studies including approximately 300 women.

In a longitudinal study published in JAMA Network Open, Yao Wu, PhD, of Children’s National Hospital, Washington, and colleagues recruited 97 healthy mother-infant dyads between January 2016 and October 2020 at a single center. Of these, 87 underwent two fetal brain imaging studies each, and 10 completed the first MRI visit, for a total of 184 fetal MRIs.

Neurodevelopment and social-emotional development for infants at 18 months of age was measured using the Bayley Scales of Infant and Toddler Development and Infant-Toddler Social and Emotional Assessment. The mean age of the mothers was 35 years; maternal distress was assessed between 24 and 40 weeks’ gestation using validated self-report questionnaires. Parenting stress was assessed at the 18-month infant testing using the Parenting Stress Index-Short Form.

Overall, prenatal maternal stress was negatively associated with infant cognitive performance (P = .01) at 18 months, mediated by fetal left hippocampal volume.

In addition, increased fetal cortical local gyrification index and sulcal depth measured during reported times of prenatal maternal distress were associated with significantly poorer social-emotional scores and competence scores at age 18 months. The beta coefficients for local gyrification index and sulcal depth were –54.62 and –14.22, respectively, for social-emotional and competence scores, –24.01 and –7.53, respectively; P values were P < .001, P < .002, P = .003, P < .001, respectively.

“Increased cortical gyrification has been suggested in children with dyslexia and autism, and sulcal depth has been associated with the severity of impaired performance on working memory and executive function in adults with schizophrenia,” the researchers wrote in their discussion of the findings.

The current study “extends our previous findings and suggests a critical role for disturbances in emerging fetal cerebral cortical folding development in mediating the association between prenatal maternal distress and neurodevelopmental problems that later manifest in infancy,” they explained.

The researchers also found that prenatal maternal anxiety, stress, and depression were positively associated with all measures of parenting stress at the 18-month testing visit.

The study findings were limited by several factors including the use of self-reports for both maternal distress and infant social-emotional assessment, despite the use of validated questionnaires, and the fact that assessment of maternal distress at specific times may not reflect the entire pregnancy, the researchers noted. Other potential limitations included the inability to use some MRI data because of fetal movement and the homogenous population of relatively highly educated women with access to health care that may not reflect other areas, they said.

“Identifying early brain developmental biomarkers may help improve the identification of infants at risk for later neurodevelopmental impairment who might benefit from early targeted interventions,” the researchers concluded.
 

Technology enhances health and disease models

The effect of the prenatal period on future well-being is recognized, but the current study makes “substantial contributions to prenatal programming science, with implications for ways to transform the prenatal care ecosystem for two-generation impact,” Catherine Monk, PhD, and Cristina R. Fernández, MD, both of Columbia University, New York, wrote in an accompanying editorial.

John Abbott/Columbia University

The developmental origins of health and disease (DOHaD) conceptual model introduced by Dr. David Barker in 1995 were later applied to show that maternal stress, depression, and anxiety affected child prenatal and future development, they said. However, the current study uses cutting-edge neuroscience to directly assess developing fetal brains. The finding of reduced cognitive functioning at 18 months associated with maternal stress is consistent with other findings, they noted.

“Finding an association between maternal prenatal stress and infant cognitive outcomes in the setting of what may be modest stress relative to that of a low-resourced or historically marginalized sample underscores the importance of this research; presumably, with higher stress, and greater social determinants of health burden, the effect sizes would be even greater and of greater concern,” they said.

However, studies such as the current one “have the potential to transform the prenatal and postpartum care ecosystems,” by encouraging a whole-person approach to the care of pregnant women, including attention to mental well-being and quality of life, they emphasized.
 

COVID-19 stress considerations

In a separate study published in Communications Medicine, Yuan-Chiao Lu, MD, also of Children’s National Hospital in Washington, and colleagues found a similar effect of maternal stress on fetal brain development.

The researchers imaged the brains of fetuses before and during the COVID-19 pandemic and interviewed mothers about any distress they experienced during pregnancy.

The study population included 65 women with known COVID-19 exposures who underwent 92 fetal MRIs and 137 prepandemic controls who underwent 182 fetal MRIs. Maternal distress was measured via the Spielberger State Anxiety Inventory, Spielberger Trait Anxiety Inventory, Perceived Stress Scale, and Edinburgh Postnatal Depression Scale.

Overall, scores on measures of stress and depression were significantly higher for women in the pandemic group compared with controls. Of the 173 women for whom maternal distress measures were available, 28% of the prepandemic group and 52% of the pandemic group met criteria for elevated maternal psychological distress, defined as above the threshold for distress on any one of the four measures.

After the researchers controlled for maternal distress, MRI data showed decreases in fetal white matter and in hippocampal and cerebellar volumes in fetuses in the pandemic group compared with controls.

Other signs of impaired brain development were similar to those seen in the JAMA Network Open study, including decreased cortical surface area and local gyrification index, as well as reduced sulcal depth in multiple brain lobes, indicating delayed cerebral cortical gyrification.

The second study was limited by a lack of data on other lifestyle changes during the pandemic that might influence maternal health and fetal development, the researchers noted. Other limitations were the possible lack of generalizability to a range of racial and ethnic populations and geographic areas outside of Washington, and the inability to control for unknown COVID-19 exposures or subclinical infections in controls, they said.

However, the results support findings from previous studies, and provide a unique opportunity to study the effect of prenatal stress on early development, as well as a chance to implement “novel and timely interventions,” the researchers wrote.

“Monitoring the COVID generation of infants for long-term cognitive and health outcomes after birth is warranted and currently underway,” and continued research may inform preventive strategies for pregnant women experiencing multiple stressors beyond the pandemic, they concluded.


 

Interpret pandemic effect with caution

“Research studies, as well as our own daily experiences, have made it abundantly clear that stress is on the rise as a consequence of the COVID-19 pandemic,” said editorial author Dr. Monk, who commented on the second study in an interview. “This is an important public health question: Early identification of pandemic effects on child development can help garner the necessary resources to intervene early, dramatically increasing the likelihood of improving that child’s developmental trajectory,” she said.

“The pandemic is an unprecedented experience that has widespread impact on people’s lives, how could it not also alter gestational biology and the developing brain? That being said, we need to be cautious in that we do not yet know the functional implications of these brain changes for longer-term development,” Dr. Monk said. “Also, we do not know what aspects of women’s pandemic-affected lives had an influence on fetal brain development. The authors found higher stress in pandemic versus nonpandemic women, but not evidence that distress was the mediating variable relating pregnancy during the pandemic to altered brain development,” she explained.

The take-home message for clinicians is to “provide your patients with realistic avenues for neurodevelopmental assessments of their children if they, or you, have concerns,” Dr. Monk said. “However, do not prejudge ‘pandemic babies,’ as not all children will be affected by these potential pandemic effects,” she emphasized. “It is possible to misjudge normal variation in children’s development and unnecessarily raise parents’ anxiety levels. Importantly, this period of brain plasticity means any needed intervention likely can have a big, ameliorating impact,” she added.

“We need follow-up studies looking at pandemic effects on prenatal and postnatal development and what factors protect the fetus and birthing person from the negative influences,” she said.

The JAMA study was supported by the National Institutes of Health and the A. James & Alice B. Clark Foundation. The study in Communications Medicine was supported by the National Institutes of Health, the Intellectual and Developmental Disabilities Research Center, and the A. James & Alice B. Clark Foundation. None of the researchers in either study disclosed conflicts of interest. Dr. Monk disclosed grants from the National Institutes of Health, the Bezos Family Foundation, and the Robin Hood Foundation outside the submitted work.

Babies of mothers who experience significant psychological distress during pregnancy showed evidence of altered brain development in utero and reduced cognitive outcomes at 18 months, based on data from a pair of studies including approximately 300 women.

In a longitudinal study published in JAMA Network Open, Yao Wu, PhD, of Children’s National Hospital, Washington, and colleagues recruited 97 healthy mother-infant dyads between January 2016 and October 2020 at a single center. Of these, 87 underwent two fetal brain imaging studies each, and 10 completed the first MRI visit, for a total of 184 fetal MRIs.

Neurodevelopment and social-emotional development for infants at 18 months of age was measured using the Bayley Scales of Infant and Toddler Development and Infant-Toddler Social and Emotional Assessment. The mean age of the mothers was 35 years; maternal distress was assessed between 24 and 40 weeks’ gestation using validated self-report questionnaires. Parenting stress was assessed at the 18-month infant testing using the Parenting Stress Index-Short Form.

Overall, prenatal maternal stress was negatively associated with infant cognitive performance (P = .01) at 18 months, mediated by fetal left hippocampal volume.

In addition, increased fetal cortical local gyrification index and sulcal depth measured during reported times of prenatal maternal distress were associated with significantly poorer social-emotional scores and competence scores at age 18 months. The beta coefficients for local gyrification index and sulcal depth were –54.62 and –14.22, respectively, for social-emotional and competence scores, –24.01 and –7.53, respectively; P values were P < .001, P < .002, P = .003, P < .001, respectively.

“Increased cortical gyrification has been suggested in children with dyslexia and autism, and sulcal depth has been associated with the severity of impaired performance on working memory and executive function in adults with schizophrenia,” the researchers wrote in their discussion of the findings.

The current study “extends our previous findings and suggests a critical role for disturbances in emerging fetal cerebral cortical folding development in mediating the association between prenatal maternal distress and neurodevelopmental problems that later manifest in infancy,” they explained.

The researchers also found that prenatal maternal anxiety, stress, and depression were positively associated with all measures of parenting stress at the 18-month testing visit.

The study findings were limited by several factors including the use of self-reports for both maternal distress and infant social-emotional assessment, despite the use of validated questionnaires, and the fact that assessment of maternal distress at specific times may not reflect the entire pregnancy, the researchers noted. Other potential limitations included the inability to use some MRI data because of fetal movement and the homogenous population of relatively highly educated women with access to health care that may not reflect other areas, they said.

“Identifying early brain developmental biomarkers may help improve the identification of infants at risk for later neurodevelopmental impairment who might benefit from early targeted interventions,” the researchers concluded.
 

Technology enhances health and disease models

The effect of the prenatal period on future well-being is recognized, but the current study makes “substantial contributions to prenatal programming science, with implications for ways to transform the prenatal care ecosystem for two-generation impact,” Catherine Monk, PhD, and Cristina R. Fernández, MD, both of Columbia University, New York, wrote in an accompanying editorial.

John Abbott/Columbia University

The developmental origins of health and disease (DOHaD) conceptual model introduced by Dr. David Barker in 1995 were later applied to show that maternal stress, depression, and anxiety affected child prenatal and future development, they said. However, the current study uses cutting-edge neuroscience to directly assess developing fetal brains. The finding of reduced cognitive functioning at 18 months associated with maternal stress is consistent with other findings, they noted.

“Finding an association between maternal prenatal stress and infant cognitive outcomes in the setting of what may be modest stress relative to that of a low-resourced or historically marginalized sample underscores the importance of this research; presumably, with higher stress, and greater social determinants of health burden, the effect sizes would be even greater and of greater concern,” they said.

However, studies such as the current one “have the potential to transform the prenatal and postpartum care ecosystems,” by encouraging a whole-person approach to the care of pregnant women, including attention to mental well-being and quality of life, they emphasized.
 

COVID-19 stress considerations

In a separate study published in Communications Medicine, Yuan-Chiao Lu, MD, also of Children’s National Hospital in Washington, and colleagues found a similar effect of maternal stress on fetal brain development.

The researchers imaged the brains of fetuses before and during the COVID-19 pandemic and interviewed mothers about any distress they experienced during pregnancy.

The study population included 65 women with known COVID-19 exposures who underwent 92 fetal MRIs and 137 prepandemic controls who underwent 182 fetal MRIs. Maternal distress was measured via the Spielberger State Anxiety Inventory, Spielberger Trait Anxiety Inventory, Perceived Stress Scale, and Edinburgh Postnatal Depression Scale.

Overall, scores on measures of stress and depression were significantly higher for women in the pandemic group compared with controls. Of the 173 women for whom maternal distress measures were available, 28% of the prepandemic group and 52% of the pandemic group met criteria for elevated maternal psychological distress, defined as above the threshold for distress on any one of the four measures.

After the researchers controlled for maternal distress, MRI data showed decreases in fetal white matter and in hippocampal and cerebellar volumes in fetuses in the pandemic group compared with controls.

Other signs of impaired brain development were similar to those seen in the JAMA Network Open study, including decreased cortical surface area and local gyrification index, as well as reduced sulcal depth in multiple brain lobes, indicating delayed cerebral cortical gyrification.

The second study was limited by a lack of data on other lifestyle changes during the pandemic that might influence maternal health and fetal development, the researchers noted. Other limitations were the possible lack of generalizability to a range of racial and ethnic populations and geographic areas outside of Washington, and the inability to control for unknown COVID-19 exposures or subclinical infections in controls, they said.

However, the results support findings from previous studies, and provide a unique opportunity to study the effect of prenatal stress on early development, as well as a chance to implement “novel and timely interventions,” the researchers wrote.

“Monitoring the COVID generation of infants for long-term cognitive and health outcomes after birth is warranted and currently underway,” and continued research may inform preventive strategies for pregnant women experiencing multiple stressors beyond the pandemic, they concluded.


 

Interpret pandemic effect with caution

“Research studies, as well as our own daily experiences, have made it abundantly clear that stress is on the rise as a consequence of the COVID-19 pandemic,” said editorial author Dr. Monk, who commented on the second study in an interview. “This is an important public health question: Early identification of pandemic effects on child development can help garner the necessary resources to intervene early, dramatically increasing the likelihood of improving that child’s developmental trajectory,” she said.

“The pandemic is an unprecedented experience that has widespread impact on people’s lives, how could it not also alter gestational biology and the developing brain? That being said, we need to be cautious in that we do not yet know the functional implications of these brain changes for longer-term development,” Dr. Monk said. “Also, we do not know what aspects of women’s pandemic-affected lives had an influence on fetal brain development. The authors found higher stress in pandemic versus nonpandemic women, but not evidence that distress was the mediating variable relating pregnancy during the pandemic to altered brain development,” she explained.

The take-home message for clinicians is to “provide your patients with realistic avenues for neurodevelopmental assessments of their children if they, or you, have concerns,” Dr. Monk said. “However, do not prejudge ‘pandemic babies,’ as not all children will be affected by these potential pandemic effects,” she emphasized. “It is possible to misjudge normal variation in children’s development and unnecessarily raise parents’ anxiety levels. Importantly, this period of brain plasticity means any needed intervention likely can have a big, ameliorating impact,” she added.

“We need follow-up studies looking at pandemic effects on prenatal and postnatal development and what factors protect the fetus and birthing person from the negative influences,” she said.

The JAMA study was supported by the National Institutes of Health and the A. James & Alice B. Clark Foundation. The study in Communications Medicine was supported by the National Institutes of Health, the Intellectual and Developmental Disabilities Research Center, and the A. James & Alice B. Clark Foundation. None of the researchers in either study disclosed conflicts of interest. Dr. Monk disclosed grants from the National Institutes of Health, the Bezos Family Foundation, and the Robin Hood Foundation outside the submitted work.

Babies of mothers who experience significant psychological distress during pregnancy showed evidence of altered brain development in utero and reduced cognitive outcomes at 18 months, based on data from a pair of studies including approximately 300 women.

In a longitudinal study published in JAMA Network Open, Yao Wu, PhD, of Children’s National Hospital, Washington, and colleagues recruited 97 healthy mother-infant dyads between January 2016 and October 2020 at a single center. Of these, 87 underwent two fetal brain imaging studies each, and 10 completed the first MRI visit, for a total of 184 fetal MRIs.

Neurodevelopment and social-emotional development for infants at 18 months of age was measured using the Bayley Scales of Infant and Toddler Development and Infant-Toddler Social and Emotional Assessment. The mean age of the mothers was 35 years; maternal distress was assessed between 24 and 40 weeks’ gestation using validated self-report questionnaires. Parenting stress was assessed at the 18-month infant testing using the Parenting Stress Index-Short Form.

Overall, prenatal maternal stress was negatively associated with infant cognitive performance (P = .01) at 18 months, mediated by fetal left hippocampal volume.

In addition, increased fetal cortical local gyrification index and sulcal depth measured during reported times of prenatal maternal distress were associated with significantly poorer social-emotional scores and competence scores at age 18 months. The beta coefficients for local gyrification index and sulcal depth were –54.62 and –14.22, respectively, for social-emotional and competence scores, –24.01 and –7.53, respectively; P values were P < .001, P < .002, P = .003, P < .001, respectively.

“Increased cortical gyrification has been suggested in children with dyslexia and autism, and sulcal depth has been associated with the severity of impaired performance on working memory and executive function in adults with schizophrenia,” the researchers wrote in their discussion of the findings.

The current study “extends our previous findings and suggests a critical role for disturbances in emerging fetal cerebral cortical folding development in mediating the association between prenatal maternal distress and neurodevelopmental problems that later manifest in infancy,” they explained.

The researchers also found that prenatal maternal anxiety, stress, and depression were positively associated with all measures of parenting stress at the 18-month testing visit.

The study findings were limited by several factors including the use of self-reports for both maternal distress and infant social-emotional assessment, despite the use of validated questionnaires, and the fact that assessment of maternal distress at specific times may not reflect the entire pregnancy, the researchers noted. Other potential limitations included the inability to use some MRI data because of fetal movement and the homogenous population of relatively highly educated women with access to health care that may not reflect other areas, they said.

“Identifying early brain developmental biomarkers may help improve the identification of infants at risk for later neurodevelopmental impairment who might benefit from early targeted interventions,” the researchers concluded.
 

Technology enhances health and disease models

The effect of the prenatal period on future well-being is recognized, but the current study makes “substantial contributions to prenatal programming science, with implications for ways to transform the prenatal care ecosystem for two-generation impact,” Catherine Monk, PhD, and Cristina R. Fernández, MD, both of Columbia University, New York, wrote in an accompanying editorial.

John Abbott/Columbia University

The developmental origins of health and disease (DOHaD) conceptual model introduced by Dr. David Barker in 1995 were later applied to show that maternal stress, depression, and anxiety affected child prenatal and future development, they said. However, the current study uses cutting-edge neuroscience to directly assess developing fetal brains. The finding of reduced cognitive functioning at 18 months associated with maternal stress is consistent with other findings, they noted.

“Finding an association between maternal prenatal stress and infant cognitive outcomes in the setting of what may be modest stress relative to that of a low-resourced or historically marginalized sample underscores the importance of this research; presumably, with higher stress, and greater social determinants of health burden, the effect sizes would be even greater and of greater concern,” they said.

However, studies such as the current one “have the potential to transform the prenatal and postpartum care ecosystems,” by encouraging a whole-person approach to the care of pregnant women, including attention to mental well-being and quality of life, they emphasized.
 

COVID-19 stress considerations

In a separate study published in Communications Medicine, Yuan-Chiao Lu, MD, also of Children’s National Hospital in Washington, and colleagues found a similar effect of maternal stress on fetal brain development.

The researchers imaged the brains of fetuses before and during the COVID-19 pandemic and interviewed mothers about any distress they experienced during pregnancy.

The study population included 65 women with known COVID-19 exposures who underwent 92 fetal MRIs and 137 prepandemic controls who underwent 182 fetal MRIs. Maternal distress was measured via the Spielberger State Anxiety Inventory, Spielberger Trait Anxiety Inventory, Perceived Stress Scale, and Edinburgh Postnatal Depression Scale.

Overall, scores on measures of stress and depression were significantly higher for women in the pandemic group compared with controls. Of the 173 women for whom maternal distress measures were available, 28% of the prepandemic group and 52% of the pandemic group met criteria for elevated maternal psychological distress, defined as above the threshold for distress on any one of the four measures.

After the researchers controlled for maternal distress, MRI data showed decreases in fetal white matter and in hippocampal and cerebellar volumes in fetuses in the pandemic group compared with controls.

Other signs of impaired brain development were similar to those seen in the JAMA Network Open study, including decreased cortical surface area and local gyrification index, as well as reduced sulcal depth in multiple brain lobes, indicating delayed cerebral cortical gyrification.

The second study was limited by a lack of data on other lifestyle changes during the pandemic that might influence maternal health and fetal development, the researchers noted. Other limitations were the possible lack of generalizability to a range of racial and ethnic populations and geographic areas outside of Washington, and the inability to control for unknown COVID-19 exposures or subclinical infections in controls, they said.

However, the results support findings from previous studies, and provide a unique opportunity to study the effect of prenatal stress on early development, as well as a chance to implement “novel and timely interventions,” the researchers wrote.

“Monitoring the COVID generation of infants for long-term cognitive and health outcomes after birth is warranted and currently underway,” and continued research may inform preventive strategies for pregnant women experiencing multiple stressors beyond the pandemic, they concluded.


 

Interpret pandemic effect with caution

“Research studies, as well as our own daily experiences, have made it abundantly clear that stress is on the rise as a consequence of the COVID-19 pandemic,” said editorial author Dr. Monk, who commented on the second study in an interview. “This is an important public health question: Early identification of pandemic effects on child development can help garner the necessary resources to intervene early, dramatically increasing the likelihood of improving that child’s developmental trajectory,” she said.

“The pandemic is an unprecedented experience that has widespread impact on people’s lives, how could it not also alter gestational biology and the developing brain? That being said, we need to be cautious in that we do not yet know the functional implications of these brain changes for longer-term development,” Dr. Monk said. “Also, we do not know what aspects of women’s pandemic-affected lives had an influence on fetal brain development. The authors found higher stress in pandemic versus nonpandemic women, but not evidence that distress was the mediating variable relating pregnancy during the pandemic to altered brain development,” she explained.

The take-home message for clinicians is to “provide your patients with realistic avenues for neurodevelopmental assessments of their children if they, or you, have concerns,” Dr. Monk said. “However, do not prejudge ‘pandemic babies,’ as not all children will be affected by these potential pandemic effects,” she emphasized. “It is possible to misjudge normal variation in children’s development and unnecessarily raise parents’ anxiety levels. Importantly, this period of brain plasticity means any needed intervention likely can have a big, ameliorating impact,” she added.

“We need follow-up studies looking at pandemic effects on prenatal and postnatal development and what factors protect the fetus and birthing person from the negative influences,” she said.

The JAMA study was supported by the National Institutes of Health and the A. James & Alice B. Clark Foundation. The study in Communications Medicine was supported by the National Institutes of Health, the Intellectual and Developmental Disabilities Research Center, and the A. James & Alice B. Clark Foundation. None of the researchers in either study disclosed conflicts of interest. Dr. Monk disclosed grants from the National Institutes of Health, the Bezos Family Foundation, and the Robin Hood Foundation outside the submitted work.

Less than 10% of parents followed recommended safe sleep practices for their infants aged 12 months and younger at both sleep onset and after nighttime waking, based on data from a survey of 1,500 parents published in Pediatrics.

Sleep-related death remains a major cause of infant mortality in the United States despite the early success of public health campaigns for safe sleep practices, such as “Back to Sleep,” and many parents persist in unsafe practices such as prone positioning and bed-sharing, Mersine A. Bryan, MD, of the University of Washington, Seattle, and colleagues wrote. “Though nighttime waking is common for infants, less attention has been paid to the safety of second-sleep practices.”

To examine the prevalence and safety of infant second-sleep practices, the researchers used a cross-sectional online survey to collect information on sleep practices from parents of infants aged 12 months and younger; 74% of the respondents were female, 65% were White, 12% were Black, and 17% were Hispanic. The mean age of the infants was 6.6 months, and 24% were aged 3 months and younger.

The survey included parent reports of three safe sleep practices based on the American Academy of Pediatrics 2016 Safe Infant Sleep Guidelines: supine infant sleep position, use of a separate sleep space (vs. bed sharing), and use of an approved surface/safe location (such as a bassinet, crib, cradle, or play yard vs. an adult bed).

Parents were asked to report sleep practices at sleep onset and at nighttime waking, and the researchers used a composite score to determine safe practices were met at each of these two time points.

Of the 1,500 participants, 581 (39%), reported any second-sleep practice. Of the 482 who reported on all three sleep practices at both time points, 29% met all three safe sleep criteria at sleep onset and 9% met all three safe sleep criteria at sleep onset and nighttime waking.

Of the parents who reported second sleep practices, 39% reported changes in practice after nighttime waking from sleep onset. Significantly more parents who switched practices between sleep onset and nighttime waking shifted from a safer to a less safe practice, the researchers noted.

For positioning, 67% of respondents overall reported placing infants on their backs at sleep onset. Among the 564 who reported a second sleep position, 42% placed infants on their backs again; 13% switched from supine to nonsupine positions and 7% changed from nonsupine to supine.

For sleep spaces, 72% of participants overall reported a separate sleep space for infants at sleep onset. Of the 508 who reported on second-sleep spaces, 54% kept infants in a separate space after nighttime waking, 18% shifted to a shared space after nighttime waking. Of those in shared spaces at sleep onset, 8% shifted to separate spaces after nighttime waking.

For sleep location, 71% of respondents overall used an approved sleep surface at sleep onset. Of the 560 who reported sleep location at both time points, 42% remained in a safe location after nighttime waking, while 30% were moved from a safe to an unsafe location, and 10% of those in an unsafe location were moved from an unsafe to a safe location.

In a multivariate analysis, the researchers examined the demographics associated with changes in sleep practice after nighttime waking. Parents younger than 25 years, first-time parents, those who identified as Black non-Hispanic or Hispanic, smokers, and those with preterm infants (less than 37 weeks’ gestation) were more likely to change sleep practices after nighttime waking. However, parents who reported a safe sleep practice at sleep onset were more likely to do so after nighttime waking.

“We hypothesize that expansion of existing strategies to promote infant safe sleep practices to include sleep practices after nighttime waking can have a positive impact on infant safe sleep,” the researchers wrote.

The study findings were limited by several factors including the use of an online survey, which limited the study population to those with internet and computer access, and the reliance on self-reports and only two time points, the researchers noted. Other limitations included the inclusion of only three of the AAP sleep recommendations, and the inclusion of only English speakers.

However, the results were strengthened by the large, diverse, and geographically representative sample of parents.

“When advising families about infant sleep, pediatricians should discuss nighttime wakings with parents because they are common and reinforce the need for safe sleep practices every time,” the researchers noted.
 

Increase opportunities for education

The current study is important because infants continue to die or experience life-long catastrophic health outcomes as a result of not following safe sleep practices, Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.

“I am not surprised by the study findings,” said Dr. Haut, who was not involved in the study. “As a pediatric nurse practitioner for over 35 years, I see infant sleep as a continuing challenge for families. In today’s fast-paced world, multiple priorities leave parents few resources for managing their own well-being, with adequate sleep being one health requirement that is often not met for them.”

To improve safe sleep practices, “it is imperative for health care providers in any setting to address safe sleep practices for infants and children,” said Dr. Haut. “In addition to safety, opportunity for adequate hours of sleep is also important.” She acknowledged that, “in the office setting, time is a huge barrier to completing comprehensive anticipatory guidance. When parents ask questions about sleep, they are often doing everything they can to physically make it through the night with a crying infant. Enforcing safe practices at this point is extremely difficult.”

However, some opportunities for safe sleep education include the prenatal period when parents can take time to listen and plan, not just for feeding preferences but for safe infant sleep practices, Dr. Haut noted.

“When sleep is a problem, families can be invited back to the office for additional counseling and education, which allows more time than within a scheduled health visit,” Dr. Haut emphasized. “Finally, enhanced public awareness is an aspect of learning. In my career I have seen the devastating results of suffocation while cosleeping as well as injuries from falling from a bed or inappropriate sleeping space, and other poor outcomes from inadequate support for safe sleep habits.”

As for additional research, studies are needed to include larger populations and “to further quantify positive outcomes of following safe sleeping practices,” said Dr. Haut. The results of these studies should be made available to the general public, not only to health care professionals. 

The study was supported by Seattle Children’s Research Institute. The researchers had no financial conflicts to disclose. Dr. Haut had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Less than 10% of parents followed recommended safe sleep practices for their infants aged 12 months and younger at both sleep onset and after nighttime waking, based on data from a survey of 1,500 parents published in Pediatrics.

Sleep-related death remains a major cause of infant mortality in the United States despite the early success of public health campaigns for safe sleep practices, such as “Back to Sleep,” and many parents persist in unsafe practices such as prone positioning and bed-sharing, Mersine A. Bryan, MD, of the University of Washington, Seattle, and colleagues wrote. “Though nighttime waking is common for infants, less attention has been paid to the safety of second-sleep practices.”

To examine the prevalence and safety of infant second-sleep practices, the researchers used a cross-sectional online survey to collect information on sleep practices from parents of infants aged 12 months and younger; 74% of the respondents were female, 65% were White, 12% were Black, and 17% were Hispanic. The mean age of the infants was 6.6 months, and 24% were aged 3 months and younger.

The survey included parent reports of three safe sleep practices based on the American Academy of Pediatrics 2016 Safe Infant Sleep Guidelines: supine infant sleep position, use of a separate sleep space (vs. bed sharing), and use of an approved surface/safe location (such as a bassinet, crib, cradle, or play yard vs. an adult bed).

Parents were asked to report sleep practices at sleep onset and at nighttime waking, and the researchers used a composite score to determine safe practices were met at each of these two time points.

Of the 1,500 participants, 581 (39%), reported any second-sleep practice. Of the 482 who reported on all three sleep practices at both time points, 29% met all three safe sleep criteria at sleep onset and 9% met all three safe sleep criteria at sleep onset and nighttime waking.

Of the parents who reported second sleep practices, 39% reported changes in practice after nighttime waking from sleep onset. Significantly more parents who switched practices between sleep onset and nighttime waking shifted from a safer to a less safe practice, the researchers noted.

For positioning, 67% of respondents overall reported placing infants on their backs at sleep onset. Among the 564 who reported a second sleep position, 42% placed infants on their backs again; 13% switched from supine to nonsupine positions and 7% changed from nonsupine to supine.

For sleep spaces, 72% of participants overall reported a separate sleep space for infants at sleep onset. Of the 508 who reported on second-sleep spaces, 54% kept infants in a separate space after nighttime waking, 18% shifted to a shared space after nighttime waking. Of those in shared spaces at sleep onset, 8% shifted to separate spaces after nighttime waking.

For sleep location, 71% of respondents overall used an approved sleep surface at sleep onset. Of the 560 who reported sleep location at both time points, 42% remained in a safe location after nighttime waking, while 30% were moved from a safe to an unsafe location, and 10% of those in an unsafe location were moved from an unsafe to a safe location.

In a multivariate analysis, the researchers examined the demographics associated with changes in sleep practice after nighttime waking. Parents younger than 25 years, first-time parents, those who identified as Black non-Hispanic or Hispanic, smokers, and those with preterm infants (less than 37 weeks’ gestation) were more likely to change sleep practices after nighttime waking. However, parents who reported a safe sleep practice at sleep onset were more likely to do so after nighttime waking.

“We hypothesize that expansion of existing strategies to promote infant safe sleep practices to include sleep practices after nighttime waking can have a positive impact on infant safe sleep,” the researchers wrote.

The study findings were limited by several factors including the use of an online survey, which limited the study population to those with internet and computer access, and the reliance on self-reports and only two time points, the researchers noted. Other limitations included the inclusion of only three of the AAP sleep recommendations, and the inclusion of only English speakers.

However, the results were strengthened by the large, diverse, and geographically representative sample of parents.

“When advising families about infant sleep, pediatricians should discuss nighttime wakings with parents because they are common and reinforce the need for safe sleep practices every time,” the researchers noted.
 

Increase opportunities for education

The current study is important because infants continue to die or experience life-long catastrophic health outcomes as a result of not following safe sleep practices, Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.

“I am not surprised by the study findings,” said Dr. Haut, who was not involved in the study. “As a pediatric nurse practitioner for over 35 years, I see infant sleep as a continuing challenge for families. In today’s fast-paced world, multiple priorities leave parents few resources for managing their own well-being, with adequate sleep being one health requirement that is often not met for them.”

To improve safe sleep practices, “it is imperative for health care providers in any setting to address safe sleep practices for infants and children,” said Dr. Haut. “In addition to safety, opportunity for adequate hours of sleep is also important.” She acknowledged that, “in the office setting, time is a huge barrier to completing comprehensive anticipatory guidance. When parents ask questions about sleep, they are often doing everything they can to physically make it through the night with a crying infant. Enforcing safe practices at this point is extremely difficult.”

However, some opportunities for safe sleep education include the prenatal period when parents can take time to listen and plan, not just for feeding preferences but for safe infant sleep practices, Dr. Haut noted.

“When sleep is a problem, families can be invited back to the office for additional counseling and education, which allows more time than within a scheduled health visit,” Dr. Haut emphasized. “Finally, enhanced public awareness is an aspect of learning. In my career I have seen the devastating results of suffocation while cosleeping as well as injuries from falling from a bed or inappropriate sleeping space, and other poor outcomes from inadequate support for safe sleep habits.”

As for additional research, studies are needed to include larger populations and “to further quantify positive outcomes of following safe sleeping practices,” said Dr. Haut. The results of these studies should be made available to the general public, not only to health care professionals. 

The study was supported by Seattle Children’s Research Institute. The researchers had no financial conflicts to disclose. Dr. Haut had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Less than 10% of parents followed recommended safe sleep practices for their infants aged 12 months and younger at both sleep onset and after nighttime waking, based on data from a survey of 1,500 parents published in Pediatrics.

Sleep-related death remains a major cause of infant mortality in the United States despite the early success of public health campaigns for safe sleep practices, such as “Back to Sleep,” and many parents persist in unsafe practices such as prone positioning and bed-sharing, Mersine A. Bryan, MD, of the University of Washington, Seattle, and colleagues wrote. “Though nighttime waking is common for infants, less attention has been paid to the safety of second-sleep practices.”

To examine the prevalence and safety of infant second-sleep practices, the researchers used a cross-sectional online survey to collect information on sleep practices from parents of infants aged 12 months and younger; 74% of the respondents were female, 65% were White, 12% were Black, and 17% were Hispanic. The mean age of the infants was 6.6 months, and 24% were aged 3 months and younger.

The survey included parent reports of three safe sleep practices based on the American Academy of Pediatrics 2016 Safe Infant Sleep Guidelines: supine infant sleep position, use of a separate sleep space (vs. bed sharing), and use of an approved surface/safe location (such as a bassinet, crib, cradle, or play yard vs. an adult bed).

Parents were asked to report sleep practices at sleep onset and at nighttime waking, and the researchers used a composite score to determine safe practices were met at each of these two time points.

Of the 1,500 participants, 581 (39%), reported any second-sleep practice. Of the 482 who reported on all three sleep practices at both time points, 29% met all three safe sleep criteria at sleep onset and 9% met all three safe sleep criteria at sleep onset and nighttime waking.

Of the parents who reported second sleep practices, 39% reported changes in practice after nighttime waking from sleep onset. Significantly more parents who switched practices between sleep onset and nighttime waking shifted from a safer to a less safe practice, the researchers noted.

For positioning, 67% of respondents overall reported placing infants on their backs at sleep onset. Among the 564 who reported a second sleep position, 42% placed infants on their backs again; 13% switched from supine to nonsupine positions and 7% changed from nonsupine to supine.

For sleep spaces, 72% of participants overall reported a separate sleep space for infants at sleep onset. Of the 508 who reported on second-sleep spaces, 54% kept infants in a separate space after nighttime waking, 18% shifted to a shared space after nighttime waking. Of those in shared spaces at sleep onset, 8% shifted to separate spaces after nighttime waking.

For sleep location, 71% of respondents overall used an approved sleep surface at sleep onset. Of the 560 who reported sleep location at both time points, 42% remained in a safe location after nighttime waking, while 30% were moved from a safe to an unsafe location, and 10% of those in an unsafe location were moved from an unsafe to a safe location.

In a multivariate analysis, the researchers examined the demographics associated with changes in sleep practice after nighttime waking. Parents younger than 25 years, first-time parents, those who identified as Black non-Hispanic or Hispanic, smokers, and those with preterm infants (less than 37 weeks’ gestation) were more likely to change sleep practices after nighttime waking. However, parents who reported a safe sleep practice at sleep onset were more likely to do so after nighttime waking.

“We hypothesize that expansion of existing strategies to promote infant safe sleep practices to include sleep practices after nighttime waking can have a positive impact on infant safe sleep,” the researchers wrote.

The study findings were limited by several factors including the use of an online survey, which limited the study population to those with internet and computer access, and the reliance on self-reports and only two time points, the researchers noted. Other limitations included the inclusion of only three of the AAP sleep recommendations, and the inclusion of only English speakers.

However, the results were strengthened by the large, diverse, and geographically representative sample of parents.

“When advising families about infant sleep, pediatricians should discuss nighttime wakings with parents because they are common and reinforce the need for safe sleep practices every time,” the researchers noted.
 

Increase opportunities for education

The current study is important because infants continue to die or experience life-long catastrophic health outcomes as a result of not following safe sleep practices, Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.

“I am not surprised by the study findings,” said Dr. Haut, who was not involved in the study. “As a pediatric nurse practitioner for over 35 years, I see infant sleep as a continuing challenge for families. In today’s fast-paced world, multiple priorities leave parents few resources for managing their own well-being, with adequate sleep being one health requirement that is often not met for them.”

To improve safe sleep practices, “it is imperative for health care providers in any setting to address safe sleep practices for infants and children,” said Dr. Haut. “In addition to safety, opportunity for adequate hours of sleep is also important.” She acknowledged that, “in the office setting, time is a huge barrier to completing comprehensive anticipatory guidance. When parents ask questions about sleep, they are often doing everything they can to physically make it through the night with a crying infant. Enforcing safe practices at this point is extremely difficult.”

However, some opportunities for safe sleep education include the prenatal period when parents can take time to listen and plan, not just for feeding preferences but for safe infant sleep practices, Dr. Haut noted.

“When sleep is a problem, families can be invited back to the office for additional counseling and education, which allows more time than within a scheduled health visit,” Dr. Haut emphasized. “Finally, enhanced public awareness is an aspect of learning. In my career I have seen the devastating results of suffocation while cosleeping as well as injuries from falling from a bed or inappropriate sleeping space, and other poor outcomes from inadequate support for safe sleep habits.”

As for additional research, studies are needed to include larger populations and “to further quantify positive outcomes of following safe sleeping practices,” said Dr. Haut. The results of these studies should be made available to the general public, not only to health care professionals. 

The study was supported by Seattle Children’s Research Institute. The researchers had no financial conflicts to disclose. Dr. Haut had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Here we go again, and again, and again.

There just aren’t enough tears, and before the bodies of 19 small children are identified, the political noise starts up. Mass shootings are a part of the American landscape, but when they happen at schools, we all feel a distinct sense of violation and gaping grief. Those children are so innocent, so deserving of a right to live their lives, hold their place with their families, create their own legacies, and die of natural causes at a ripe old age. And those children could have been our children. There was nothing special about them; they were just sent to school that day like every child who is sent to school every day.

Here is how the politics goes: The Republicans will blame the Democrats and the Democrats will blame the Republicans. Is Rachel Maddow at fault, or is it Tucker Carlson? Social media accounts blamed both of them for the racially motivated mass murder in a Buffalo grocery store on May 14.

Mass murders were previously defined as a shooting where four or more victims are killed, excluding the shooter, in a public place that is not related to the commission of another crime. In 2012, the definition was changed to include events with three victims. This definition excludes gang violence and the murder of family members.

When it comes to explaining mass murder, the camps divide: They are the result of some combination of mental illness, easy access to firearms, and terrorism and hate. For psychiatry, there is a unique place in the argument – half of all mass shooters have exhibited signs or symptoms of psychiatric illness, and for those who want to deflect the issue away from issues related to the regulation of firearms, it becomes easy to blame “mental illness,” as though that explains it all. Either the gunman “snapped” in such a way that no one could have predicted, or the mental health system is at fault for not preventing it.

There are many ways to be emotionally disturbed; mental illness is only one of them, and there is no psychiatric diagnosis that includes the symptom of shooting strangers, or shooting children. The vast majority of people, including nearly all psychiatrists, will never know someone who perpetrates a mass shooting. 

Can mental illness give us any insight into these senseless killings? Sometimes, but rarely. Take John Hinckley Jr., who shot President Ronald Reagan as a means to impress actress Jodie Foster. Sometimes these killings are motivated by delusional beliefs. But the planning and preparation that goes into most mass shootings involves a degree of organization and forethought that we don’t typically see in those with severe psychotic disorders.

The other psychological explanation that satisfies some of a nonmedical population is that these killers “just snap.” This, too, is a term that is not included in our diagnostic vocabulary, but it remains a way for some to explain that which can’t be explained. If mental illness, however, is the cause of mass murders, then more stringent gun control is unnecessary. Every state already has a mechanism to prevent those with criminal and specified psychiatric histories from buying legal firearms, and it may be inevitable that these screens are not perfect. 

The next line of political thinking moves to the psychiatric “if only.” If only there were more state hospital beds and if only it were easier to compel people with psychiatric disorders to get treatment against their will, then we could eliminate these crimes. The Virginia tech shooter was mandated to get outpatient psychiatric treatment after a brief hospitalization, yet he never went and there was no mechanism in place to track him.

In cases where a person with a psychotic illness has a history of repeated violent episodes after stopping medications, it does make sense to mandate treatment, not because they are likely to shoot strangers, but because some people do become violent when they are ill and mental illness is believed to play a role in 10% of murders.

Mass murders remain rare, and while advocates for legislation that would make it easier to mandate involuntary care have cited violence prevention as a reason, it is hard to imagine that we would force people to get care because they “might” commit such a crime – unless there was convincing evidence that someone was at risk of committing such a heinous act.

For those who oppose stronger gun control laws, the “what if” may circulate around the need for even more firearms. What if teachers carried guns? What if schools were more heavily policed? What if the criminals were made to be afraid?

We are left with the fact that other countries do not see these numbers of mass shooting events, yet mental illness is ubiquitous. While the presence of psychiatric disorders does little to explain school shootings, we still have no understanding of what motivated the Sandy Hook killer, and it remains to be seen what we will come to understand about the gunman in Uvalde, Texas.

Mental illness is not unique to the United States; however, the number of available firearms is. In a country of 323 million people (including children and people who live in institutions where they have no access to firearms), there are estimated to be over 400 million guns in the United States, 98% of which are owned by civilians. 

Hate crimes and terrorism are another explanation for mass murders. In these instances, the gunman makes his motive obvious: There are social media announcements, or the site of the shooting is a synagogue, a mosque, or a location where the victims are of a specific race or religion. But hate may come out of a psychotic illness, and easy access to firearms allows for these crimes to continue. 

Firearms are now the No. 1 cause of mortality in children. Very few of these deaths are the result of mass murders. Many more are from accidental deaths, targeted crime, or suicide. Still, school shootings rip at our hearts. Neither the victims nor their grieving families have any role in the act, and suffering leaves its mark on families, communities, and all of us.
 

Are there answers?

In many states, physicians can now request emergency removal of firearms from the home of someone who is both mentally ill and threatening either suicide or homicide. During the era when high-capacity firearms were banned, from 1994 to 2004, mass murders decreased in our country. While most gunmen use legal firearms they have purchased, I would contend that “smart guns” – firearms that allow only the legal owner to operate them based on biometrics – would prevent some mass shootings and many accidents, crimes, and suicides. Universal background checks and tracking gun purchases in the way we monitor controlled medications, or even Sudafed, might allow authorities to predict who might be at risk of committing these heinous acts.

In his newly released book, Trigger Points: Inside the Mission to Stop Mass Murders in America, journalist Mark Follman argues for a proactive community approach using threat assessment methods and providing wraparound services to those who are deemed to be at risk for violent acts. Mr. Follman’s voice is one of the few out there saying that these events are not random and are, in fact, preventable.

In psychiatry, we struggle with school shootings such as the one we just saw in Uvalde. Our own hearts ache as we hold our children close and empathize with the loss of strangers who have been through the unthinkable. We help our patients as they process their emotions. And we wonder whether any of our patients might ever do anything so horrific. The feelings get complicated, the sadness and anger intermingle while the frustration builds, and we are left with our fears and the hope that if that very rare person were to walk through our office door, we would know what to do.

Dr. Miller is a coauthor of Committed: The Battle Over Involuntary Psychiatric Care (Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore. A version of this article first appeared on Medscape.com.

Here we go again, and again, and again.

There just aren’t enough tears, and before the bodies of 19 small children are identified, the political noise starts up. Mass shootings are a part of the American landscape, but when they happen at schools, we all feel a distinct sense of violation and gaping grief. Those children are so innocent, so deserving of a right to live their lives, hold their place with their families, create their own legacies, and die of natural causes at a ripe old age. And those children could have been our children. There was nothing special about them; they were just sent to school that day like every child who is sent to school every day.

Here is how the politics goes: The Republicans will blame the Democrats and the Democrats will blame the Republicans. Is Rachel Maddow at fault, or is it Tucker Carlson? Social media accounts blamed both of them for the racially motivated mass murder in a Buffalo grocery store on May 14.

Mass murders were previously defined as a shooting where four or more victims are killed, excluding the shooter, in a public place that is not related to the commission of another crime. In 2012, the definition was changed to include events with three victims. This definition excludes gang violence and the murder of family members.

When it comes to explaining mass murder, the camps divide: They are the result of some combination of mental illness, easy access to firearms, and terrorism and hate. For psychiatry, there is a unique place in the argument – half of all mass shooters have exhibited signs or symptoms of psychiatric illness, and for those who want to deflect the issue away from issues related to the regulation of firearms, it becomes easy to blame “mental illness,” as though that explains it all. Either the gunman “snapped” in such a way that no one could have predicted, or the mental health system is at fault for not preventing it.

There are many ways to be emotionally disturbed; mental illness is only one of them, and there is no psychiatric diagnosis that includes the symptom of shooting strangers, or shooting children. The vast majority of people, including nearly all psychiatrists, will never know someone who perpetrates a mass shooting. 

Can mental illness give us any insight into these senseless killings? Sometimes, but rarely. Take John Hinckley Jr., who shot President Ronald Reagan as a means to impress actress Jodie Foster. Sometimes these killings are motivated by delusional beliefs. But the planning and preparation that goes into most mass shootings involves a degree of organization and forethought that we don’t typically see in those with severe psychotic disorders.

The other psychological explanation that satisfies some of a nonmedical population is that these killers “just snap.” This, too, is a term that is not included in our diagnostic vocabulary, but it remains a way for some to explain that which can’t be explained. If mental illness, however, is the cause of mass murders, then more stringent gun control is unnecessary. Every state already has a mechanism to prevent those with criminal and specified psychiatric histories from buying legal firearms, and it may be inevitable that these screens are not perfect. 

The next line of political thinking moves to the psychiatric “if only.” If only there were more state hospital beds and if only it were easier to compel people with psychiatric disorders to get treatment against their will, then we could eliminate these crimes. The Virginia tech shooter was mandated to get outpatient psychiatric treatment after a brief hospitalization, yet he never went and there was no mechanism in place to track him.

In cases where a person with a psychotic illness has a history of repeated violent episodes after stopping medications, it does make sense to mandate treatment, not because they are likely to shoot strangers, but because some people do become violent when they are ill and mental illness is believed to play a role in 10% of murders.

Mass murders remain rare, and while advocates for legislation that would make it easier to mandate involuntary care have cited violence prevention as a reason, it is hard to imagine that we would force people to get care because they “might” commit such a crime – unless there was convincing evidence that someone was at risk of committing such a heinous act.

For those who oppose stronger gun control laws, the “what if” may circulate around the need for even more firearms. What if teachers carried guns? What if schools were more heavily policed? What if the criminals were made to be afraid?

We are left with the fact that other countries do not see these numbers of mass shooting events, yet mental illness is ubiquitous. While the presence of psychiatric disorders does little to explain school shootings, we still have no understanding of what motivated the Sandy Hook killer, and it remains to be seen what we will come to understand about the gunman in Uvalde, Texas.

Mental illness is not unique to the United States; however, the number of available firearms is. In a country of 323 million people (including children and people who live in institutions where they have no access to firearms), there are estimated to be over 400 million guns in the United States, 98% of which are owned by civilians. 

Hate crimes and terrorism are another explanation for mass murders. In these instances, the gunman makes his motive obvious: There are social media announcements, or the site of the shooting is a synagogue, a mosque, or a location where the victims are of a specific race or religion. But hate may come out of a psychotic illness, and easy access to firearms allows for these crimes to continue. 

Firearms are now the No. 1 cause of mortality in children. Very few of these deaths are the result of mass murders. Many more are from accidental deaths, targeted crime, or suicide. Still, school shootings rip at our hearts. Neither the victims nor their grieving families have any role in the act, and suffering leaves its mark on families, communities, and all of us.
 

Are there answers?

In many states, physicians can now request emergency removal of firearms from the home of someone who is both mentally ill and threatening either suicide or homicide. During the era when high-capacity firearms were banned, from 1994 to 2004, mass murders decreased in our country. While most gunmen use legal firearms they have purchased, I would contend that “smart guns” – firearms that allow only the legal owner to operate them based on biometrics – would prevent some mass shootings and many accidents, crimes, and suicides. Universal background checks and tracking gun purchases in the way we monitor controlled medications, or even Sudafed, might allow authorities to predict who might be at risk of committing these heinous acts.

In his newly released book, Trigger Points: Inside the Mission to Stop Mass Murders in America, journalist Mark Follman argues for a proactive community approach using threat assessment methods and providing wraparound services to those who are deemed to be at risk for violent acts. Mr. Follman’s voice is one of the few out there saying that these events are not random and are, in fact, preventable.

In psychiatry, we struggle with school shootings such as the one we just saw in Uvalde. Our own hearts ache as we hold our children close and empathize with the loss of strangers who have been through the unthinkable. We help our patients as they process their emotions. And we wonder whether any of our patients might ever do anything so horrific. The feelings get complicated, the sadness and anger intermingle while the frustration builds, and we are left with our fears and the hope that if that very rare person were to walk through our office door, we would know what to do.

Dr. Miller is a coauthor of Committed: The Battle Over Involuntary Psychiatric Care (Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore. A version of this article first appeared on Medscape.com.

Here we go again, and again, and again.

There just aren’t enough tears, and before the bodies of 19 small children are identified, the political noise starts up. Mass shootings are a part of the American landscape, but when they happen at schools, we all feel a distinct sense of violation and gaping grief. Those children are so innocent, so deserving of a right to live their lives, hold their place with their families, create their own legacies, and die of natural causes at a ripe old age. And those children could have been our children. There was nothing special about them; they were just sent to school that day like every child who is sent to school every day.

Here is how the politics goes: The Republicans will blame the Democrats and the Democrats will blame the Republicans. Is Rachel Maddow at fault, or is it Tucker Carlson? Social media accounts blamed both of them for the racially motivated mass murder in a Buffalo grocery store on May 14.

Mass murders were previously defined as a shooting where four or more victims are killed, excluding the shooter, in a public place that is not related to the commission of another crime. In 2012, the definition was changed to include events with three victims. This definition excludes gang violence and the murder of family members.

When it comes to explaining mass murder, the camps divide: They are the result of some combination of mental illness, easy access to firearms, and terrorism and hate. For psychiatry, there is a unique place in the argument – half of all mass shooters have exhibited signs or symptoms of psychiatric illness, and for those who want to deflect the issue away from issues related to the regulation of firearms, it becomes easy to blame “mental illness,” as though that explains it all. Either the gunman “snapped” in such a way that no one could have predicted, or the mental health system is at fault for not preventing it.

There are many ways to be emotionally disturbed; mental illness is only one of them, and there is no psychiatric diagnosis that includes the symptom of shooting strangers, or shooting children. The vast majority of people, including nearly all psychiatrists, will never know someone who perpetrates a mass shooting. 

Can mental illness give us any insight into these senseless killings? Sometimes, but rarely. Take John Hinckley Jr., who shot President Ronald Reagan as a means to impress actress Jodie Foster. Sometimes these killings are motivated by delusional beliefs. But the planning and preparation that goes into most mass shootings involves a degree of organization and forethought that we don’t typically see in those with severe psychotic disorders.

The other psychological explanation that satisfies some of a nonmedical population is that these killers “just snap.” This, too, is a term that is not included in our diagnostic vocabulary, but it remains a way for some to explain that which can’t be explained. If mental illness, however, is the cause of mass murders, then more stringent gun control is unnecessary. Every state already has a mechanism to prevent those with criminal and specified psychiatric histories from buying legal firearms, and it may be inevitable that these screens are not perfect. 

The next line of political thinking moves to the psychiatric “if only.” If only there were more state hospital beds and if only it were easier to compel people with psychiatric disorders to get treatment against their will, then we could eliminate these crimes. The Virginia tech shooter was mandated to get outpatient psychiatric treatment after a brief hospitalization, yet he never went and there was no mechanism in place to track him.

In cases where a person with a psychotic illness has a history of repeated violent episodes after stopping medications, it does make sense to mandate treatment, not because they are likely to shoot strangers, but because some people do become violent when they are ill and mental illness is believed to play a role in 10% of murders.

Mass murders remain rare, and while advocates for legislation that would make it easier to mandate involuntary care have cited violence prevention as a reason, it is hard to imagine that we would force people to get care because they “might” commit such a crime – unless there was convincing evidence that someone was at risk of committing such a heinous act.

For those who oppose stronger gun control laws, the “what if” may circulate around the need for even more firearms. What if teachers carried guns? What if schools were more heavily policed? What if the criminals were made to be afraid?

We are left with the fact that other countries do not see these numbers of mass shooting events, yet mental illness is ubiquitous. While the presence of psychiatric disorders does little to explain school shootings, we still have no understanding of what motivated the Sandy Hook killer, and it remains to be seen what we will come to understand about the gunman in Uvalde, Texas.

Mental illness is not unique to the United States; however, the number of available firearms is. In a country of 323 million people (including children and people who live in institutions where they have no access to firearms), there are estimated to be over 400 million guns in the United States, 98% of which are owned by civilians. 

Hate crimes and terrorism are another explanation for mass murders. In these instances, the gunman makes his motive obvious: There are social media announcements, or the site of the shooting is a synagogue, a mosque, or a location where the victims are of a specific race or religion. But hate may come out of a psychotic illness, and easy access to firearms allows for these crimes to continue. 

Firearms are now the No. 1 cause of mortality in children. Very few of these deaths are the result of mass murders. Many more are from accidental deaths, targeted crime, or suicide. Still, school shootings rip at our hearts. Neither the victims nor their grieving families have any role in the act, and suffering leaves its mark on families, communities, and all of us.
 

Are there answers?

In many states, physicians can now request emergency removal of firearms from the home of someone who is both mentally ill and threatening either suicide or homicide. During the era when high-capacity firearms were banned, from 1994 to 2004, mass murders decreased in our country. While most gunmen use legal firearms they have purchased, I would contend that “smart guns” – firearms that allow only the legal owner to operate them based on biometrics – would prevent some mass shootings and many accidents, crimes, and suicides. Universal background checks and tracking gun purchases in the way we monitor controlled medications, or even Sudafed, might allow authorities to predict who might be at risk of committing these heinous acts.

In his newly released book, Trigger Points: Inside the Mission to Stop Mass Murders in America, journalist Mark Follman argues for a proactive community approach using threat assessment methods and providing wraparound services to those who are deemed to be at risk for violent acts. Mr. Follman’s voice is one of the few out there saying that these events are not random and are, in fact, preventable.

In psychiatry, we struggle with school shootings such as the one we just saw in Uvalde. Our own hearts ache as we hold our children close and empathize with the loss of strangers who have been through the unthinkable. We help our patients as they process their emotions. And we wonder whether any of our patients might ever do anything so horrific. The feelings get complicated, the sadness and anger intermingle while the frustration builds, and we are left with our fears and the hope that if that very rare person were to walk through our office door, we would know what to do.

Dr. Miller is a coauthor of Committed: The Battle Over Involuntary Psychiatric Care (Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore. A version of this article first appeared on Medscape.com.

A cohort study has found increases in mortality rates among women with non-endometrioid uterine carcinoma, despite incident rates that have stabilized. After correction with hysterectomy, mortality risk was about doubled for Black women, compared with White women, and these results could not be explained by differences in cancer subtype or cancer stage at diagnosis. Non-endometroid uterine carcinoma represents 15%-20% of uterine cancers diagnosed and carries a worse prognosis.

“We do not know why non-endometrioid subtypes are disproportionately increasing among all women, nor do we understand why they are so much more common among non-Hispanic Black women. We need more research to identify risk factors and exposures more specifically associated with non-endometrioid cancers to better understand the strong increases in this subtype among all women and the particularly high rates and recent increases in non-Hispanic black women,” said lead author Megan Clarke, PhD, MHS, the study’s lead author and a cancer epidemiologist with the National Cancer Institute.

The study was published online in JAMA Oncology.

“Physicians should be aware that both incidence and mortality rates of non-endometrioid cancers are on the rise. Because these subtypes are rarer than endometrioid uterine cancers, physicians may be less familiar with diagnosing and treating these aggressive types of cancers. Increasing awareness among clinicians and patients regarding the signs and symptoms of uterine cancer (such as postmenopausal bleeding) and the differences in histologic subtypes among racial and ethnic groups may promote earlier diagnosis and timely referral to appropriate treatment,” Dr. Clarke said.

Previous studies based on death certificates found increased mortality, especially in Black women, but they were limited by an inability to link mortality to tumor characteristics. To address this, the researchers linked mortality data to records of 208,587 women diagnosed with uterine cancer between 2000 and 2017, drawn from the U.S. Surveillance, Epidemiology, and End Results (SEER) Program.

Black women represented 9.7% of cases, but they suffered 17.7% of uterine cancer deaths. Overall, mortality from uterine corpus cancer increased by 1.8% per year (95% confidence interval, 1.5%-2.9%). Non-endometroid cancers increased at 2.7% per year (95% CI, 1.8%-3.6%), and this was higher in Asian (3.4%; 95% CI, 0.3%-6.6%), Black (3.5%; 95% CI, 2.2%-4.9%), Hispanic (6.7%; 95% CI, 1.9%-11.8%), and White women (1.5%; 95% CI, 0.6%-2.4%).

Mortality increased 1.8% per year overall for uterine cancer and 2.7% per year for non-endometrioid uterine cancer. There was no increase in mortality seen in endometrioid cancers.

“The concerning rise in deaths from non-endometrioid cancers warrants clinical attention. Our findings suggest that there may be several factors contributing to racial disparities in uterine cancer mortality. Higher mortality rates among non-Hispanic Black women are partly attributable to higher incidence of tumors with aggressive subtypes and advanced stages. However, non-Hispanic Black women in our study who were diagnosed with less aggressive subtypes and early-stage disease also had the highest mortality rates,” said Dr. Clarke.

That suggests that inequities of treatment and high-quality care may be at least partly to blame, since those factors are known to contribute to differences in uterine cancer outcomes. “Other factors including comorbidities, health care facility characteristics, treatment preferences and adherence, patient and provider communication, provider bias, discrimination and structural racism, and potential biologic differences in response to treatment need to be better understood in terms of how they influence racial disparities,” Dr. Clarke said.

Dr. Clarke reported no relevant disclosures.

A cohort study has found increases in mortality rates among women with non-endometrioid uterine carcinoma, despite incident rates that have stabilized. After correction with hysterectomy, mortality risk was about doubled for Black women, compared with White women, and these results could not be explained by differences in cancer subtype or cancer stage at diagnosis. Non-endometroid uterine carcinoma represents 15%-20% of uterine cancers diagnosed and carries a worse prognosis.

“We do not know why non-endometrioid subtypes are disproportionately increasing among all women, nor do we understand why they are so much more common among non-Hispanic Black women. We need more research to identify risk factors and exposures more specifically associated with non-endometrioid cancers to better understand the strong increases in this subtype among all women and the particularly high rates and recent increases in non-Hispanic black women,” said lead author Megan Clarke, PhD, MHS, the study’s lead author and a cancer epidemiologist with the National Cancer Institute.

The study was published online in JAMA Oncology.

“Physicians should be aware that both incidence and mortality rates of non-endometrioid cancers are on the rise. Because these subtypes are rarer than endometrioid uterine cancers, physicians may be less familiar with diagnosing and treating these aggressive types of cancers. Increasing awareness among clinicians and patients regarding the signs and symptoms of uterine cancer (such as postmenopausal bleeding) and the differences in histologic subtypes among racial and ethnic groups may promote earlier diagnosis and timely referral to appropriate treatment,” Dr. Clarke said.

Previous studies based on death certificates found increased mortality, especially in Black women, but they were limited by an inability to link mortality to tumor characteristics. To address this, the researchers linked mortality data to records of 208,587 women diagnosed with uterine cancer between 2000 and 2017, drawn from the U.S. Surveillance, Epidemiology, and End Results (SEER) Program.

Black women represented 9.7% of cases, but they suffered 17.7% of uterine cancer deaths. Overall, mortality from uterine corpus cancer increased by 1.8% per year (95% confidence interval, 1.5%-2.9%). Non-endometroid cancers increased at 2.7% per year (95% CI, 1.8%-3.6%), and this was higher in Asian (3.4%; 95% CI, 0.3%-6.6%), Black (3.5%; 95% CI, 2.2%-4.9%), Hispanic (6.7%; 95% CI, 1.9%-11.8%), and White women (1.5%; 95% CI, 0.6%-2.4%).

Mortality increased 1.8% per year overall for uterine cancer and 2.7% per year for non-endometrioid uterine cancer. There was no increase in mortality seen in endometrioid cancers.

“The concerning rise in deaths from non-endometrioid cancers warrants clinical attention. Our findings suggest that there may be several factors contributing to racial disparities in uterine cancer mortality. Higher mortality rates among non-Hispanic Black women are partly attributable to higher incidence of tumors with aggressive subtypes and advanced stages. However, non-Hispanic Black women in our study who were diagnosed with less aggressive subtypes and early-stage disease also had the highest mortality rates,” said Dr. Clarke.

That suggests that inequities of treatment and high-quality care may be at least partly to blame, since those factors are known to contribute to differences in uterine cancer outcomes. “Other factors including comorbidities, health care facility characteristics, treatment preferences and adherence, patient and provider communication, provider bias, discrimination and structural racism, and potential biologic differences in response to treatment need to be better understood in terms of how they influence racial disparities,” Dr. Clarke said.

Dr. Clarke reported no relevant disclosures.

A cohort study has found increases in mortality rates among women with non-endometrioid uterine carcinoma, despite incident rates that have stabilized. After correction with hysterectomy, mortality risk was about doubled for Black women, compared with White women, and these results could not be explained by differences in cancer subtype or cancer stage at diagnosis. Non-endometroid uterine carcinoma represents 15%-20% of uterine cancers diagnosed and carries a worse prognosis.

“We do not know why non-endometrioid subtypes are disproportionately increasing among all women, nor do we understand why they are so much more common among non-Hispanic Black women. We need more research to identify risk factors and exposures more specifically associated with non-endometrioid cancers to better understand the strong increases in this subtype among all women and the particularly high rates and recent increases in non-Hispanic black women,” said lead author Megan Clarke, PhD, MHS, the study’s lead author and a cancer epidemiologist with the National Cancer Institute.

The study was published online in JAMA Oncology.

“Physicians should be aware that both incidence and mortality rates of non-endometrioid cancers are on the rise. Because these subtypes are rarer than endometrioid uterine cancers, physicians may be less familiar with diagnosing and treating these aggressive types of cancers. Increasing awareness among clinicians and patients regarding the signs and symptoms of uterine cancer (such as postmenopausal bleeding) and the differences in histologic subtypes among racial and ethnic groups may promote earlier diagnosis and timely referral to appropriate treatment,” Dr. Clarke said.

Previous studies based on death certificates found increased mortality, especially in Black women, but they were limited by an inability to link mortality to tumor characteristics. To address this, the researchers linked mortality data to records of 208,587 women diagnosed with uterine cancer between 2000 and 2017, drawn from the U.S. Surveillance, Epidemiology, and End Results (SEER) Program.

Black women represented 9.7% of cases, but they suffered 17.7% of uterine cancer deaths. Overall, mortality from uterine corpus cancer increased by 1.8% per year (95% confidence interval, 1.5%-2.9%). Non-endometroid cancers increased at 2.7% per year (95% CI, 1.8%-3.6%), and this was higher in Asian (3.4%; 95% CI, 0.3%-6.6%), Black (3.5%; 95% CI, 2.2%-4.9%), Hispanic (6.7%; 95% CI, 1.9%-11.8%), and White women (1.5%; 95% CI, 0.6%-2.4%).

Mortality increased 1.8% per year overall for uterine cancer and 2.7% per year for non-endometrioid uterine cancer. There was no increase in mortality seen in endometrioid cancers.

“The concerning rise in deaths from non-endometrioid cancers warrants clinical attention. Our findings suggest that there may be several factors contributing to racial disparities in uterine cancer mortality. Higher mortality rates among non-Hispanic Black women are partly attributable to higher incidence of tumors with aggressive subtypes and advanced stages. However, non-Hispanic Black women in our study who were diagnosed with less aggressive subtypes and early-stage disease also had the highest mortality rates,” said Dr. Clarke.

That suggests that inequities of treatment and high-quality care may be at least partly to blame, since those factors are known to contribute to differences in uterine cancer outcomes. “Other factors including comorbidities, health care facility characteristics, treatment preferences and adherence, patient and provider communication, provider bias, discrimination and structural racism, and potential biologic differences in response to treatment need to be better understood in terms of how they influence racial disparities,” Dr. Clarke said.

Dr. Clarke reported no relevant disclosures.