The number of sentinel events in hospitals in the United States increased by 19% from 2021 to 2022, on the basis of new data from The Joint Commission.

Reporting sentinel events to The Joint Commission began in 1996 as a way to help health care organizations improve safety. The annual review is based on an aggregate database of reports analyzed each year, according to the review authors.

The Joint Commission defines a sentinel event as a patient safety event (not primarily related to the natural course of the patient’s illness or underlying condition) that reaches a patient and results in death, permanent harm (regardless of severity), or severe harm (regardless of duration).

Some of the specific events deemed sentinel include patient suicide while under care in a health care setting, unanticipated death of a full-term infant, homicide of any patient or staff member while on site at a health care organization, any intrapartum maternal death, severe maternal morbidity, sexual abuse or assault of any patient undergoing care in the health care setting, sexual abuse or assault of any staff member providing care, and physical assault of any patient or staff member in the health care setting.

Additional events considered sentinel are related to treatments and procedures. These include surgery in the wrong site; wrong patient or wrong procedure for a given patient; administration of blood or blood products incompatible with the patient that results in death, permanent harm, or severe harm; severe neonatal hyperbilirubinemia; and patient falls.

A total of 1,441 sentinel events were reported in 2022. Patient falls accounted for the majority (42%) of these events, continuing a trend in increasing rates of patient falls from previous years. Falls considered sentinel events were those resulting in any fracture, surgery, casting or traction, consultation or comfort care for neurologic or internal injury, the need for blood products, or death or permanent harm as a result of injuries sustained in the fall. The leading sentinel event types after falls included delay in treatment, unintended retention of a foreign object, and wrong surgery (6% for each). Other sentinel event types in the top 10 accounted for 5% or less of reports: suicide (5%), assault/rape/sexual assault/homicide (4%), fire/burns (3%), perinatal events (2%), self-harm (2%), and medication management (2%).

Overall, 20% of the 2022 events resulted in patient death, 6% in permanent harm or loss of function, 44% in severe temporary harm, and 13% in a need for additional care or an extended hospital stay.

The most common events that led to patient death were suicide (24%), treatment delays (21%), and patient falls (11%). Patient falls also accounted for nearly two-thirds of the events resulting in severe temporary harm (62%).

Most of the events (88%) occurred in hospital settings; of these, the most common were falls (45%), followed by the retention of foreign objects and incorrect surgeries (7% and 6%, respectively). Overall, 90% of sentinel events were reported by the health care organizations; the remaining 10% were reported by patients, families, or employees (current or former).

“Failures in communication, teamwork, and consistently following policies were leading causes for reported sentinel events,” the authors wrote. However, reporting sentinel events is voluntary; therefore “no conclusions should be drawn about the actual relative frequency of events or trends in events over time,” they noted.
 

Increased reporting may not reflect increased occurrence

“It is important to clarify that The Joint Commission saw an increase in reporting of sentinel events; whether this is indicative of an actual increase in occurrence of sentinel events across the country or not is difficult to say, as the reporting is voluntary,” said Haytham Kaafarani, MD, MPH, chief patient safety officer and medical director for The Joint Commission, in an interview.

“However, this is the highest number reported to The Joint Commission since the inception of the sentinel event policy: there were 547 health care organizations that reported sentinel events in 2022, compared to 500 in 2021 and 423 in 2020,” Dr. Kaafarani said. “Having said that, based on published literature, the COVID-19 pandemic stressed our health care systems in many ways including but not limited to staff shortage in times of increased needs, worsening of mental health conditions, and delay in presentation of non–COVID-related medical conditions during the pandemic,” he noted.

Dr. Kaafarani said that The Joint Commission was not surprised by the type of sentinel events reported, which has remained consistent with previous years.

However, The Joint Commission was surprised by the significant increase in the number of reported events, he said. “Since reporting is voluntarily, we welcome the increase in reporting of sentinel events, as it helps The Joint Commission better understand the patient safety landscape across the country, and better helps health care organizations during their difficult times.”

Based on the latest information, “The Joint Commission encourages health care organizations to create research that is focused on preventing patient falls in hospitals,” said Dr. Kaafarani. “With staff shortages reported within many health care organizations, it is now more essential than ever to establish systematic interventions to prevent patient falls and resultant harm.”

The review authors report no relevant financial relationships.

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

The number of sentinel events in hospitals in the United States increased by 19% from 2021 to 2022, on the basis of new data from The Joint Commission.

Reporting sentinel events to The Joint Commission began in 1996 as a way to help health care organizations improve safety. The annual review is based on an aggregate database of reports analyzed each year, according to the review authors.

The Joint Commission defines a sentinel event as a patient safety event (not primarily related to the natural course of the patient’s illness or underlying condition) that reaches a patient and results in death, permanent harm (regardless of severity), or severe harm (regardless of duration).

Some of the specific events deemed sentinel include patient suicide while under care in a health care setting, unanticipated death of a full-term infant, homicide of any patient or staff member while on site at a health care organization, any intrapartum maternal death, severe maternal morbidity, sexual abuse or assault of any patient undergoing care in the health care setting, sexual abuse or assault of any staff member providing care, and physical assault of any patient or staff member in the health care setting.

Additional events considered sentinel are related to treatments and procedures. These include surgery in the wrong site; wrong patient or wrong procedure for a given patient; administration of blood or blood products incompatible with the patient that results in death, permanent harm, or severe harm; severe neonatal hyperbilirubinemia; and patient falls.

A total of 1,441 sentinel events were reported in 2022. Patient falls accounted for the majority (42%) of these events, continuing a trend in increasing rates of patient falls from previous years. Falls considered sentinel events were those resulting in any fracture, surgery, casting or traction, consultation or comfort care for neurologic or internal injury, the need for blood products, or death or permanent harm as a result of injuries sustained in the fall. The leading sentinel event types after falls included delay in treatment, unintended retention of a foreign object, and wrong surgery (6% for each). Other sentinel event types in the top 10 accounted for 5% or less of reports: suicide (5%), assault/rape/sexual assault/homicide (4%), fire/burns (3%), perinatal events (2%), self-harm (2%), and medication management (2%).

Overall, 20% of the 2022 events resulted in patient death, 6% in permanent harm or loss of function, 44% in severe temporary harm, and 13% in a need for additional care or an extended hospital stay.

The most common events that led to patient death were suicide (24%), treatment delays (21%), and patient falls (11%). Patient falls also accounted for nearly two-thirds of the events resulting in severe temporary harm (62%).

Most of the events (88%) occurred in hospital settings; of these, the most common were falls (45%), followed by the retention of foreign objects and incorrect surgeries (7% and 6%, respectively). Overall, 90% of sentinel events were reported by the health care organizations; the remaining 10% were reported by patients, families, or employees (current or former).

“Failures in communication, teamwork, and consistently following policies were leading causes for reported sentinel events,” the authors wrote. However, reporting sentinel events is voluntary; therefore “no conclusions should be drawn about the actual relative frequency of events or trends in events over time,” they noted.
 

Increased reporting may not reflect increased occurrence

“It is important to clarify that The Joint Commission saw an increase in reporting of sentinel events; whether this is indicative of an actual increase in occurrence of sentinel events across the country or not is difficult to say, as the reporting is voluntary,” said Haytham Kaafarani, MD, MPH, chief patient safety officer and medical director for The Joint Commission, in an interview.

“However, this is the highest number reported to The Joint Commission since the inception of the sentinel event policy: there were 547 health care organizations that reported sentinel events in 2022, compared to 500 in 2021 and 423 in 2020,” Dr. Kaafarani said. “Having said that, based on published literature, the COVID-19 pandemic stressed our health care systems in many ways including but not limited to staff shortage in times of increased needs, worsening of mental health conditions, and delay in presentation of non–COVID-related medical conditions during the pandemic,” he noted.

Dr. Kaafarani said that The Joint Commission was not surprised by the type of sentinel events reported, which has remained consistent with previous years.

However, The Joint Commission was surprised by the significant increase in the number of reported events, he said. “Since reporting is voluntarily, we welcome the increase in reporting of sentinel events, as it helps The Joint Commission better understand the patient safety landscape across the country, and better helps health care organizations during their difficult times.”

Based on the latest information, “The Joint Commission encourages health care organizations to create research that is focused on preventing patient falls in hospitals,” said Dr. Kaafarani. “With staff shortages reported within many health care organizations, it is now more essential than ever to establish systematic interventions to prevent patient falls and resultant harm.”

The review authors report no relevant financial relationships.

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

The number of sentinel events in hospitals in the United States increased by 19% from 2021 to 2022, on the basis of new data from The Joint Commission.

Reporting sentinel events to The Joint Commission began in 1996 as a way to help health care organizations improve safety. The annual review is based on an aggregate database of reports analyzed each year, according to the review authors.

The Joint Commission defines a sentinel event as a patient safety event (not primarily related to the natural course of the patient’s illness or underlying condition) that reaches a patient and results in death, permanent harm (regardless of severity), or severe harm (regardless of duration).

Some of the specific events deemed sentinel include patient suicide while under care in a health care setting, unanticipated death of a full-term infant, homicide of any patient or staff member while on site at a health care organization, any intrapartum maternal death, severe maternal morbidity, sexual abuse or assault of any patient undergoing care in the health care setting, sexual abuse or assault of any staff member providing care, and physical assault of any patient or staff member in the health care setting.

Additional events considered sentinel are related to treatments and procedures. These include surgery in the wrong site; wrong patient or wrong procedure for a given patient; administration of blood or blood products incompatible with the patient that results in death, permanent harm, or severe harm; severe neonatal hyperbilirubinemia; and patient falls.

A total of 1,441 sentinel events were reported in 2022. Patient falls accounted for the majority (42%) of these events, continuing a trend in increasing rates of patient falls from previous years. Falls considered sentinel events were those resulting in any fracture, surgery, casting or traction, consultation or comfort care for neurologic or internal injury, the need for blood products, or death or permanent harm as a result of injuries sustained in the fall. The leading sentinel event types after falls included delay in treatment, unintended retention of a foreign object, and wrong surgery (6% for each). Other sentinel event types in the top 10 accounted for 5% or less of reports: suicide (5%), assault/rape/sexual assault/homicide (4%), fire/burns (3%), perinatal events (2%), self-harm (2%), and medication management (2%).

Overall, 20% of the 2022 events resulted in patient death, 6% in permanent harm or loss of function, 44% in severe temporary harm, and 13% in a need for additional care or an extended hospital stay.

The most common events that led to patient death were suicide (24%), treatment delays (21%), and patient falls (11%). Patient falls also accounted for nearly two-thirds of the events resulting in severe temporary harm (62%).

Most of the events (88%) occurred in hospital settings; of these, the most common were falls (45%), followed by the retention of foreign objects and incorrect surgeries (7% and 6%, respectively). Overall, 90% of sentinel events were reported by the health care organizations; the remaining 10% were reported by patients, families, or employees (current or former).

“Failures in communication, teamwork, and consistently following policies were leading causes for reported sentinel events,” the authors wrote. However, reporting sentinel events is voluntary; therefore “no conclusions should be drawn about the actual relative frequency of events or trends in events over time,” they noted.
 

Increased reporting may not reflect increased occurrence

“It is important to clarify that The Joint Commission saw an increase in reporting of sentinel events; whether this is indicative of an actual increase in occurrence of sentinel events across the country or not is difficult to say, as the reporting is voluntary,” said Haytham Kaafarani, MD, MPH, chief patient safety officer and medical director for The Joint Commission, in an interview.

“However, this is the highest number reported to The Joint Commission since the inception of the sentinel event policy: there were 547 health care organizations that reported sentinel events in 2022, compared to 500 in 2021 and 423 in 2020,” Dr. Kaafarani said. “Having said that, based on published literature, the COVID-19 pandemic stressed our health care systems in many ways including but not limited to staff shortage in times of increased needs, worsening of mental health conditions, and delay in presentation of non–COVID-related medical conditions during the pandemic,” he noted.

Dr. Kaafarani said that The Joint Commission was not surprised by the type of sentinel events reported, which has remained consistent with previous years.

However, The Joint Commission was surprised by the significant increase in the number of reported events, he said. “Since reporting is voluntarily, we welcome the increase in reporting of sentinel events, as it helps The Joint Commission better understand the patient safety landscape across the country, and better helps health care organizations during their difficult times.”

Based on the latest information, “The Joint Commission encourages health care organizations to create research that is focused on preventing patient falls in hospitals,” said Dr. Kaafarani. “With staff shortages reported within many health care organizations, it is now more essential than ever to establish systematic interventions to prevent patient falls and resultant harm.”

The review authors report no relevant financial relationships.

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

I imagine I am not alone when I tell you that my blood pressure rises every time I receive an email from CoverMyMeds, or worse, a phone call from a patient to tell me the pharmacist says I need to call their insurance company to get a medication authorized. Prior authorizations (PAs) are the bane of every physician’s existence.

Pharmacy benefit managers (PBMs) and insurers determine what treatment patients may have without regulation, accountability, liability, or transparency. They ask providers to jump through hoops, and no one oversees the placement of these hoops. The process puts patients at risk and sucks the joy from the practice of medicine.

In fall 2021, the legislative committee of the Maryland Psychiatric Society, with the help of Kathy Orellana and Tim Clement from the American Psychiatric Association, drafted a bill to modify the use of PAs. Unfortunately, the bill died in committee during the 2022 Maryland General Assembly legislative session.

Robert Herman, MD, who helped draft the initial legislation, was delighted when he learned that MedChi, the Maryland State Medical Society, had taken the proposed legislation and expanded it. “It was everything we wished for and more,” Dr. Herman said.

During this year’s legislative session, House Bill 305/Senate Bill 308, Health Insurance – Utilization Review – Revisions, was sponsored by 19 delegates and two senators. Fifty medical associations, including dentists and physical therapists, endorsed the bill. Many people, including Dr. Herman, testified before the Health and Government Operations Committee on Feb. 16.

Delegate Kenneth Kerr introduced the legislation to the committee.

“Before I begin, let me make two points. First, the bill does not do away with prior authorization or other utilization review techniques; rather, it tries to make a more balanced approach for both patients and physicians by attempting to reduce the volume that’s subject to prior authorization, by increasing transparency and communication, and by studying how the process can be improved overall. Second, we have over 50 organizations representing health care providers and patient advocacy organizations supporting this legislation. This is a systemic issue across the entire spectrum of healthcare,” said Mr. Kerr.

Mr. Kerr went on to say there were 81,143 denials for treatment in 2021. The three areas with the highest rate of denials were pharmacy, dental, and the combination of labs and radiology.

He further noted that, when consumers filed a complaint with the Maryland Insurance Administration, 72.4% of denials were reversed in 2022.

“This resulted in more benefits that could have, and should have, been given to the patient at the first request. These reversals indicate there is a problem,” Mr. Kerr said. He discussed increased administrative costs, the enormous workload burden this incurs, and the problem of burnout among medical providers.

The proposed legislation includes a ban on PA requirements for generic medications, for dose changes of previously authorized medication, and ends the requirement for yearly authorizations. It requires that a physician of the same specialty be on the panel that denies care and shortens the time periods allowed for responses and appeals.

Testimony began with those supporting the legislation. Doctors highlighted the harm inflicted on their patients by the PA process. An oncologist spoke of how it took weeks to get approval for chemotherapy for a patient with an aggressive cancer, a gastroenterologist discussed a patient who became ill and lost her job when successful treatment for inflammatory bowel disease was stopped while she waited for the yearly medication reapproval, and another physician told of a patient who died of an exacerbation of obstructive lung disease, also while awaiting a yearly reapproval for an effective medication.

A dentist spoke about how he was not authorized to place a crown on a patient’s tooth. Instead, he was instructed to try a filling first, and when the filling failed, he was told he would not be authorized to work on the same tooth twice in one year.

A physical therapist testified that PA was required every two to four sessions, and each request took up half of a session – a significant portion of time that was not used for treatment.

Three people testified in opposition to the bill. Matthew Celantano, executive director of the League of Life and Health Insurers of Maryland, called the legislation “drastic” and testified that the cost would be prohibitive.

“From our end, it’s important for you to hear that prior authorization is care coordination. It’s protection that keeps [patients] safe, but helps control skyrocketing health care costs,” said Mr. Celantano.

Deb Rivkin, vice president of government affairs for CareFirst Blue Cross Blue Shield, testified in favor of using better technology. She cited legislation under consideration in Virginia that would give clinicians more information about the specific medications that require PAs, price information, and real-time authorizations.

Finally, representing the Pharmaceutical Care Management Association, Heather Cascone testified about PAs for generic medications. Her testimony focused on prior authorization for generic medications. She claimed that “... by allowing unrestricted dispensing of generic drugs, or an override based on the subjective opinion of the prescriber, prior authorization can protect patients from drugs with a safety risk; they can catch things like drug-disease contraindications, dosage errors, pregnancy-related contraindications, and a variety of cost-savings protections.”

I found this testimony particularly difficult because the “protector” is generally not a physician and has neither seen, nor examined, the patient. The implication that patients need protection from their doctors who would be unaware aware that they are pregnant, or are ill, was offensive. It also implies that PBMs are lax by not requiring PA on all medications, ignoring the fact that patients often bypass such denials by paying out of pocket for treatment.

If this had been a high school debate, there would be no doubt the enthusiasm for the bill for HB305 was strong, the committee chair was eager, and the arguments in favor of the legislation robust. There are no public minutes for the subsequent meetings with stakeholders, and I was somewhat heartbroken to learn that once again, the bill died in committee.

Annette Hanson, MD, chair of the MPS legislative committee, remains optimistic for the future. “Since then, the APA [American Psychiatric Association] has taken our bill and used it as model legislation now being offered to other district branches. MPS has created something that is going to spread across the country. Change may be slow, but it is not inevitable. And when it happens, I want you to remember that it started here,” she said.

However, the pressure is on. A recent ProPublica article documented how Cigna rejects claims by the batch without ever reviewing them. Soon after that piece was published, it was announced that several of the large insurers, including Cigna, would be cutting back on PA demands. It remains to be seen whether this is a token move to placate legislators, and whether it will provide meaningful relief to physicians and patients. I remain skeptical.

In the meantime, physicians’ ability to help their patients remains compromised and administrative tasks consume valuable time. I have started to wonder whether there may be some other way to push this issue to action. PA is about cost containment, but perhaps there are other ways to economize.

Why do medications cost less in other countries? Why does a medication cost hundreds of dollars more at one pharmacy versus another? Why do medicines sometimes have a copay that is two or three times higher than the cash price? Why do some covered medications have copays of thousands of dollars a year? I wonder if physicians shouldn’t come together and collectively agree not to comply and refuse to complete PAs in organized rebellion.

The fear, of course, is that such an endeavor would hurt patients, but if we all agreed in concert, then for better or for worse, something would have to give. The existing system is already hurting everyone, and physicians, by agreeing to play this awful game, are complicit in letting insurers dictate the care our patients receive.

Dinah Miller, MD, is a coauthor of Committed: The Battle Over Involuntary Psychiatric Care (Johns Hopkins University Press, 2016) and has a private practice and is an assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore.

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

I imagine I am not alone when I tell you that my blood pressure rises every time I receive an email from CoverMyMeds, or worse, a phone call from a patient to tell me the pharmacist says I need to call their insurance company to get a medication authorized. Prior authorizations (PAs) are the bane of every physician’s existence.

Pharmacy benefit managers (PBMs) and insurers determine what treatment patients may have without regulation, accountability, liability, or transparency. They ask providers to jump through hoops, and no one oversees the placement of these hoops. The process puts patients at risk and sucks the joy from the practice of medicine.

In fall 2021, the legislative committee of the Maryland Psychiatric Society, with the help of Kathy Orellana and Tim Clement from the American Psychiatric Association, drafted a bill to modify the use of PAs. Unfortunately, the bill died in committee during the 2022 Maryland General Assembly legislative session.

Robert Herman, MD, who helped draft the initial legislation, was delighted when he learned that MedChi, the Maryland State Medical Society, had taken the proposed legislation and expanded it. “It was everything we wished for and more,” Dr. Herman said.

During this year’s legislative session, House Bill 305/Senate Bill 308, Health Insurance – Utilization Review – Revisions, was sponsored by 19 delegates and two senators. Fifty medical associations, including dentists and physical therapists, endorsed the bill. Many people, including Dr. Herman, testified before the Health and Government Operations Committee on Feb. 16.

Delegate Kenneth Kerr introduced the legislation to the committee.

“Before I begin, let me make two points. First, the bill does not do away with prior authorization or other utilization review techniques; rather, it tries to make a more balanced approach for both patients and physicians by attempting to reduce the volume that’s subject to prior authorization, by increasing transparency and communication, and by studying how the process can be improved overall. Second, we have over 50 organizations representing health care providers and patient advocacy organizations supporting this legislation. This is a systemic issue across the entire spectrum of healthcare,” said Mr. Kerr.

Mr. Kerr went on to say there were 81,143 denials for treatment in 2021. The three areas with the highest rate of denials were pharmacy, dental, and the combination of labs and radiology.

He further noted that, when consumers filed a complaint with the Maryland Insurance Administration, 72.4% of denials were reversed in 2022.

“This resulted in more benefits that could have, and should have, been given to the patient at the first request. These reversals indicate there is a problem,” Mr. Kerr said. He discussed increased administrative costs, the enormous workload burden this incurs, and the problem of burnout among medical providers.

The proposed legislation includes a ban on PA requirements for generic medications, for dose changes of previously authorized medication, and ends the requirement for yearly authorizations. It requires that a physician of the same specialty be on the panel that denies care and shortens the time periods allowed for responses and appeals.

Testimony began with those supporting the legislation. Doctors highlighted the harm inflicted on their patients by the PA process. An oncologist spoke of how it took weeks to get approval for chemotherapy for a patient with an aggressive cancer, a gastroenterologist discussed a patient who became ill and lost her job when successful treatment for inflammatory bowel disease was stopped while she waited for the yearly medication reapproval, and another physician told of a patient who died of an exacerbation of obstructive lung disease, also while awaiting a yearly reapproval for an effective medication.

A dentist spoke about how he was not authorized to place a crown on a patient’s tooth. Instead, he was instructed to try a filling first, and when the filling failed, he was told he would not be authorized to work on the same tooth twice in one year.

A physical therapist testified that PA was required every two to four sessions, and each request took up half of a session – a significant portion of time that was not used for treatment.

Three people testified in opposition to the bill. Matthew Celantano, executive director of the League of Life and Health Insurers of Maryland, called the legislation “drastic” and testified that the cost would be prohibitive.

“From our end, it’s important for you to hear that prior authorization is care coordination. It’s protection that keeps [patients] safe, but helps control skyrocketing health care costs,” said Mr. Celantano.

Deb Rivkin, vice president of government affairs for CareFirst Blue Cross Blue Shield, testified in favor of using better technology. She cited legislation under consideration in Virginia that would give clinicians more information about the specific medications that require PAs, price information, and real-time authorizations.

Finally, representing the Pharmaceutical Care Management Association, Heather Cascone testified about PAs for generic medications. Her testimony focused on prior authorization for generic medications. She claimed that “... by allowing unrestricted dispensing of generic drugs, or an override based on the subjective opinion of the prescriber, prior authorization can protect patients from drugs with a safety risk; they can catch things like drug-disease contraindications, dosage errors, pregnancy-related contraindications, and a variety of cost-savings protections.”

I found this testimony particularly difficult because the “protector” is generally not a physician and has neither seen, nor examined, the patient. The implication that patients need protection from their doctors who would be unaware aware that they are pregnant, or are ill, was offensive. It also implies that PBMs are lax by not requiring PA on all medications, ignoring the fact that patients often bypass such denials by paying out of pocket for treatment.

If this had been a high school debate, there would be no doubt the enthusiasm for the bill for HB305 was strong, the committee chair was eager, and the arguments in favor of the legislation robust. There are no public minutes for the subsequent meetings with stakeholders, and I was somewhat heartbroken to learn that once again, the bill died in committee.

Annette Hanson, MD, chair of the MPS legislative committee, remains optimistic for the future. “Since then, the APA [American Psychiatric Association] has taken our bill and used it as model legislation now being offered to other district branches. MPS has created something that is going to spread across the country. Change may be slow, but it is not inevitable. And when it happens, I want you to remember that it started here,” she said.

However, the pressure is on. A recent ProPublica article documented how Cigna rejects claims by the batch without ever reviewing them. Soon after that piece was published, it was announced that several of the large insurers, including Cigna, would be cutting back on PA demands. It remains to be seen whether this is a token move to placate legislators, and whether it will provide meaningful relief to physicians and patients. I remain skeptical.

In the meantime, physicians’ ability to help their patients remains compromised and administrative tasks consume valuable time. I have started to wonder whether there may be some other way to push this issue to action. PA is about cost containment, but perhaps there are other ways to economize.

Why do medications cost less in other countries? Why does a medication cost hundreds of dollars more at one pharmacy versus another? Why do medicines sometimes have a copay that is two or three times higher than the cash price? Why do some covered medications have copays of thousands of dollars a year? I wonder if physicians shouldn’t come together and collectively agree not to comply and refuse to complete PAs in organized rebellion.

The fear, of course, is that such an endeavor would hurt patients, but if we all agreed in concert, then for better or for worse, something would have to give. The existing system is already hurting everyone, and physicians, by agreeing to play this awful game, are complicit in letting insurers dictate the care our patients receive.

Dinah Miller, MD, is a coauthor of Committed: The Battle Over Involuntary Psychiatric Care (Johns Hopkins University Press, 2016) and has a private practice and is an assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore.

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

I imagine I am not alone when I tell you that my blood pressure rises every time I receive an email from CoverMyMeds, or worse, a phone call from a patient to tell me the pharmacist says I need to call their insurance company to get a medication authorized. Prior authorizations (PAs) are the bane of every physician’s existence.

Pharmacy benefit managers (PBMs) and insurers determine what treatment patients may have without regulation, accountability, liability, or transparency. They ask providers to jump through hoops, and no one oversees the placement of these hoops. The process puts patients at risk and sucks the joy from the practice of medicine.

In fall 2021, the legislative committee of the Maryland Psychiatric Society, with the help of Kathy Orellana and Tim Clement from the American Psychiatric Association, drafted a bill to modify the use of PAs. Unfortunately, the bill died in committee during the 2022 Maryland General Assembly legislative session.

Robert Herman, MD, who helped draft the initial legislation, was delighted when he learned that MedChi, the Maryland State Medical Society, had taken the proposed legislation and expanded it. “It was everything we wished for and more,” Dr. Herman said.

During this year’s legislative session, House Bill 305/Senate Bill 308, Health Insurance – Utilization Review – Revisions, was sponsored by 19 delegates and two senators. Fifty medical associations, including dentists and physical therapists, endorsed the bill. Many people, including Dr. Herman, testified before the Health and Government Operations Committee on Feb. 16.

Delegate Kenneth Kerr introduced the legislation to the committee.

“Before I begin, let me make two points. First, the bill does not do away with prior authorization or other utilization review techniques; rather, it tries to make a more balanced approach for both patients and physicians by attempting to reduce the volume that’s subject to prior authorization, by increasing transparency and communication, and by studying how the process can be improved overall. Second, we have over 50 organizations representing health care providers and patient advocacy organizations supporting this legislation. This is a systemic issue across the entire spectrum of healthcare,” said Mr. Kerr.

Mr. Kerr went on to say there were 81,143 denials for treatment in 2021. The three areas with the highest rate of denials were pharmacy, dental, and the combination of labs and radiology.

He further noted that, when consumers filed a complaint with the Maryland Insurance Administration, 72.4% of denials were reversed in 2022.

“This resulted in more benefits that could have, and should have, been given to the patient at the first request. These reversals indicate there is a problem,” Mr. Kerr said. He discussed increased administrative costs, the enormous workload burden this incurs, and the problem of burnout among medical providers.

The proposed legislation includes a ban on PA requirements for generic medications, for dose changes of previously authorized medication, and ends the requirement for yearly authorizations. It requires that a physician of the same specialty be on the panel that denies care and shortens the time periods allowed for responses and appeals.

Testimony began with those supporting the legislation. Doctors highlighted the harm inflicted on their patients by the PA process. An oncologist spoke of how it took weeks to get approval for chemotherapy for a patient with an aggressive cancer, a gastroenterologist discussed a patient who became ill and lost her job when successful treatment for inflammatory bowel disease was stopped while she waited for the yearly medication reapproval, and another physician told of a patient who died of an exacerbation of obstructive lung disease, also while awaiting a yearly reapproval for an effective medication.

A dentist spoke about how he was not authorized to place a crown on a patient’s tooth. Instead, he was instructed to try a filling first, and when the filling failed, he was told he would not be authorized to work on the same tooth twice in one year.

A physical therapist testified that PA was required every two to four sessions, and each request took up half of a session – a significant portion of time that was not used for treatment.

Three people testified in opposition to the bill. Matthew Celantano, executive director of the League of Life and Health Insurers of Maryland, called the legislation “drastic” and testified that the cost would be prohibitive.

“From our end, it’s important for you to hear that prior authorization is care coordination. It’s protection that keeps [patients] safe, but helps control skyrocketing health care costs,” said Mr. Celantano.

Deb Rivkin, vice president of government affairs for CareFirst Blue Cross Blue Shield, testified in favor of using better technology. She cited legislation under consideration in Virginia that would give clinicians more information about the specific medications that require PAs, price information, and real-time authorizations.

Finally, representing the Pharmaceutical Care Management Association, Heather Cascone testified about PAs for generic medications. Her testimony focused on prior authorization for generic medications. She claimed that “... by allowing unrestricted dispensing of generic drugs, or an override based on the subjective opinion of the prescriber, prior authorization can protect patients from drugs with a safety risk; they can catch things like drug-disease contraindications, dosage errors, pregnancy-related contraindications, and a variety of cost-savings protections.”

I found this testimony particularly difficult because the “protector” is generally not a physician and has neither seen, nor examined, the patient. The implication that patients need protection from their doctors who would be unaware aware that they are pregnant, or are ill, was offensive. It also implies that PBMs are lax by not requiring PA on all medications, ignoring the fact that patients often bypass such denials by paying out of pocket for treatment.

If this had been a high school debate, there would be no doubt the enthusiasm for the bill for HB305 was strong, the committee chair was eager, and the arguments in favor of the legislation robust. There are no public minutes for the subsequent meetings with stakeholders, and I was somewhat heartbroken to learn that once again, the bill died in committee.

Annette Hanson, MD, chair of the MPS legislative committee, remains optimistic for the future. “Since then, the APA [American Psychiatric Association] has taken our bill and used it as model legislation now being offered to other district branches. MPS has created something that is going to spread across the country. Change may be slow, but it is not inevitable. And when it happens, I want you to remember that it started here,” she said.

However, the pressure is on. A recent ProPublica article documented how Cigna rejects claims by the batch without ever reviewing them. Soon after that piece was published, it was announced that several of the large insurers, including Cigna, would be cutting back on PA demands. It remains to be seen whether this is a token move to placate legislators, and whether it will provide meaningful relief to physicians and patients. I remain skeptical.

In the meantime, physicians’ ability to help their patients remains compromised and administrative tasks consume valuable time. I have started to wonder whether there may be some other way to push this issue to action. PA is about cost containment, but perhaps there are other ways to economize.

Why do medications cost less in other countries? Why does a medication cost hundreds of dollars more at one pharmacy versus another? Why do medicines sometimes have a copay that is two or three times higher than the cash price? Why do some covered medications have copays of thousands of dollars a year? I wonder if physicians shouldn’t come together and collectively agree not to comply and refuse to complete PAs in organized rebellion.

The fear, of course, is that such an endeavor would hurt patients, but if we all agreed in concert, then for better or for worse, something would have to give. The existing system is already hurting everyone, and physicians, by agreeing to play this awful game, are complicit in letting insurers dictate the care our patients receive.

Dinah Miller, MD, is a coauthor of Committed: The Battle Over Involuntary Psychiatric Care (Johns Hopkins University Press, 2016) and has a private practice and is an assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore.

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

Current U.S., European, and Australian guidelines recommend 10-mm safety margins for radical excision of primary melanomas, but for patients with early-stage cutaneous melanoma in critical areas of the body, excision with 5-mm margins may not significantly increase risk for recurrence or melanoma-specific mortality (MSM), results of a retrospective study suggest.

Among 1,179 patients with stage T1a melanomas near the face, scalp, external genitalia, or other critical areas, the weighted 10-year local recurrence rate for patients who underwent resection with 10-mm margins was 5.7%, compared with 6.7% for those who had resections with 5-mm margins, a nonsignificant difference.

Weighted 10-year melanoma-specific mortality was 1.8% for patients treated with wide margins, vs. 4.2% for those treated with narrow margins, also a nonsignificant difference. Patients treated with narrow margins did have significantly fewer reconstructive surgeries than patients treated with wide margins, reported Andrea Maurichi, MD, and colleagues at the National Cancer Institute of Italy in Milan.

“Because this association was found in melanomas of the head and neck, acral, and genital sites, there is no plausible reason why it could not be extrapolated to other locations. The findings also support the need for prospective randomized clinical trials to definitively answer the important question about appropriate excision margins for T1a melanoma,” they wrote in the study, published online in JAMA Dermatology.

The authors also found, however, that Breslow thickness greater than 0.4 mm and mitotic rate greater than 1/mm­­² were associated with worse MSM, and that acral lentiginous melanoma, lentigo maligna melanoma, and increasing Breslow thickness were associated with a higher incidence of local recurrence.

A melanoma expert who was not involved in the study said that despite these findings, wider margins are always preferable.

“There is always a conversation around these general [critical] areas, but as a rule we try to get larger margins,” said Ryan J. Sullivan, MD, of Mass General Cancer Center in Boston.

In an interview, Dr. Sullivan said that the finding about lower frequency of reconstructive procedures in the narrow margins groups may be more of a concern for younger patients than for the elderly.

Study design

The investigators conducted a retrospective cohort study of consecutive patients aged 18 or older at the National Cancer Institute of Milan who were diagnosed with T1a cutaneous melanoma close to critical areas from 2001 through 2020.

Patients with primary cutaneous melanoma of the head and face areas with functional or cosmetic considerations, acral areas (plantar, palmar, digital and interdigital areas), external genitalia, or periumbilical and perineal areas were eligible for inclusion.

The cohort comprised 1,179 patients with a median age of 50 and equal sex distribution. Of these patients, 626 (53%) had a wide excision, of whom 434 had a linear repair, and 192 had a flap of graft reconstruction. The remaining 553 patients had narrow excisions, 491 with linear repair, and 62 with flap or graft reconstruction.

Analyses were adjusted to account for imbalances between the surgical groups.

The study was supported by the nonprofit foundation Emme Rouge. The authors and Dr. Sullivan reported having no relevant conflicts of interest to disclose.

Current U.S., European, and Australian guidelines recommend 10-mm safety margins for radical excision of primary melanomas, but for patients with early-stage cutaneous melanoma in critical areas of the body, excision with 5-mm margins may not significantly increase risk for recurrence or melanoma-specific mortality (MSM), results of a retrospective study suggest.

Among 1,179 patients with stage T1a melanomas near the face, scalp, external genitalia, or other critical areas, the weighted 10-year local recurrence rate for patients who underwent resection with 10-mm margins was 5.7%, compared with 6.7% for those who had resections with 5-mm margins, a nonsignificant difference.

Weighted 10-year melanoma-specific mortality was 1.8% for patients treated with wide margins, vs. 4.2% for those treated with narrow margins, also a nonsignificant difference. Patients treated with narrow margins did have significantly fewer reconstructive surgeries than patients treated with wide margins, reported Andrea Maurichi, MD, and colleagues at the National Cancer Institute of Italy in Milan.

“Because this association was found in melanomas of the head and neck, acral, and genital sites, there is no plausible reason why it could not be extrapolated to other locations. The findings also support the need for prospective randomized clinical trials to definitively answer the important question about appropriate excision margins for T1a melanoma,” they wrote in the study, published online in JAMA Dermatology.

The authors also found, however, that Breslow thickness greater than 0.4 mm and mitotic rate greater than 1/mm­­² were associated with worse MSM, and that acral lentiginous melanoma, lentigo maligna melanoma, and increasing Breslow thickness were associated with a higher incidence of local recurrence.

A melanoma expert who was not involved in the study said that despite these findings, wider margins are always preferable.

“There is always a conversation around these general [critical] areas, but as a rule we try to get larger margins,” said Ryan J. Sullivan, MD, of Mass General Cancer Center in Boston.

In an interview, Dr. Sullivan said that the finding about lower frequency of reconstructive procedures in the narrow margins groups may be more of a concern for younger patients than for the elderly.

Study design

The investigators conducted a retrospective cohort study of consecutive patients aged 18 or older at the National Cancer Institute of Milan who were diagnosed with T1a cutaneous melanoma close to critical areas from 2001 through 2020.

Patients with primary cutaneous melanoma of the head and face areas with functional or cosmetic considerations, acral areas (plantar, palmar, digital and interdigital areas), external genitalia, or periumbilical and perineal areas were eligible for inclusion.

The cohort comprised 1,179 patients with a median age of 50 and equal sex distribution. Of these patients, 626 (53%) had a wide excision, of whom 434 had a linear repair, and 192 had a flap of graft reconstruction. The remaining 553 patients had narrow excisions, 491 with linear repair, and 62 with flap or graft reconstruction.

Analyses were adjusted to account for imbalances between the surgical groups.

The study was supported by the nonprofit foundation Emme Rouge. The authors and Dr. Sullivan reported having no relevant conflicts of interest to disclose.

Current U.S., European, and Australian guidelines recommend 10-mm safety margins for radical excision of primary melanomas, but for patients with early-stage cutaneous melanoma in critical areas of the body, excision with 5-mm margins may not significantly increase risk for recurrence or melanoma-specific mortality (MSM), results of a retrospective study suggest.

Among 1,179 patients with stage T1a melanomas near the face, scalp, external genitalia, or other critical areas, the weighted 10-year local recurrence rate for patients who underwent resection with 10-mm margins was 5.7%, compared with 6.7% for those who had resections with 5-mm margins, a nonsignificant difference.

Weighted 10-year melanoma-specific mortality was 1.8% for patients treated with wide margins, vs. 4.2% for those treated with narrow margins, also a nonsignificant difference. Patients treated with narrow margins did have significantly fewer reconstructive surgeries than patients treated with wide margins, reported Andrea Maurichi, MD, and colleagues at the National Cancer Institute of Italy in Milan.

“Because this association was found in melanomas of the head and neck, acral, and genital sites, there is no plausible reason why it could not be extrapolated to other locations. The findings also support the need for prospective randomized clinical trials to definitively answer the important question about appropriate excision margins for T1a melanoma,” they wrote in the study, published online in JAMA Dermatology.

The authors also found, however, that Breslow thickness greater than 0.4 mm and mitotic rate greater than 1/mm­­² were associated with worse MSM, and that acral lentiginous melanoma, lentigo maligna melanoma, and increasing Breslow thickness were associated with a higher incidence of local recurrence.

A melanoma expert who was not involved in the study said that despite these findings, wider margins are always preferable.

“There is always a conversation around these general [critical] areas, but as a rule we try to get larger margins,” said Ryan J. Sullivan, MD, of Mass General Cancer Center in Boston.

In an interview, Dr. Sullivan said that the finding about lower frequency of reconstructive procedures in the narrow margins groups may be more of a concern for younger patients than for the elderly.

Study design

The investigators conducted a retrospective cohort study of consecutive patients aged 18 or older at the National Cancer Institute of Milan who were diagnosed with T1a cutaneous melanoma close to critical areas from 2001 through 2020.

Patients with primary cutaneous melanoma of the head and face areas with functional or cosmetic considerations, acral areas (plantar, palmar, digital and interdigital areas), external genitalia, or periumbilical and perineal areas were eligible for inclusion.

The cohort comprised 1,179 patients with a median age of 50 and equal sex distribution. Of these patients, 626 (53%) had a wide excision, of whom 434 had a linear repair, and 192 had a flap of graft reconstruction. The remaining 553 patients had narrow excisions, 491 with linear repair, and 62 with flap or graft reconstruction.

Analyses were adjusted to account for imbalances between the surgical groups.

The study was supported by the nonprofit foundation Emme Rouge. The authors and Dr. Sullivan reported having no relevant conflicts of interest to disclose.

With a federal judge’s recent ruling clouding the future availability of mifepristone for terminating pregnancies, attention has shifted to the efficacy of another abortion drug, misoprostol.

Experts said a misoprostol-only regimen for medical abortions is as safe as but not as effective as the combination of mifepristone and misoprostol. A misoprostol-only approach also comes with more pronounced side effects.

“Misoprostol only is a good alternative; it’s not the best alternative,” Beverly Gray, MD, associate professor in the department of obstetrics and Gynecology at Duke University, Durham, N.C., said during a video conference on April 12. “The best medication would be to use mifepristone and misoprostol together because they’re efficacious with fewer side effects.”

To medically terminate a pregnancy using the two-drug regimen, patients first take the progesterone blocker mifepristone, which ends the pregnancy. That is followed 24-48 hours later with misoprostol, which causes the uterus to expel the pregnancy tissue. Used in combination, the two drugs have an efficacy rate of 98% in terminating a pregnancy.

An alternative approach is a misoprostol-only regimen. Patients take multiple doses of the drug over the course of hours until the pregnancy passes. This method is considered effective and safe, although patients may experience more nausea, vomiting, diarrhea, bleeding, and cramping.

“It’s effective, but not as effective as the combination treatment,” said Mitchell D. Creinin, MD, professor in the department of obstetrics and gynecology at University of California, Davis. “It also requires much higher doses. To get misoprostol by itself to have relatively high efficacy, you have to use multiple doses. It causes significantly more side effects, and it’s less effective.”

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

With a federal judge’s recent ruling clouding the future availability of mifepristone for terminating pregnancies, attention has shifted to the efficacy of another abortion drug, misoprostol.

Experts said a misoprostol-only regimen for medical abortions is as safe as but not as effective as the combination of mifepristone and misoprostol. A misoprostol-only approach also comes with more pronounced side effects.

“Misoprostol only is a good alternative; it’s not the best alternative,” Beverly Gray, MD, associate professor in the department of obstetrics and Gynecology at Duke University, Durham, N.C., said during a video conference on April 12. “The best medication would be to use mifepristone and misoprostol together because they’re efficacious with fewer side effects.”

To medically terminate a pregnancy using the two-drug regimen, patients first take the progesterone blocker mifepristone, which ends the pregnancy. That is followed 24-48 hours later with misoprostol, which causes the uterus to expel the pregnancy tissue. Used in combination, the two drugs have an efficacy rate of 98% in terminating a pregnancy.

An alternative approach is a misoprostol-only regimen. Patients take multiple doses of the drug over the course of hours until the pregnancy passes. This method is considered effective and safe, although patients may experience more nausea, vomiting, diarrhea, bleeding, and cramping.

“It’s effective, but not as effective as the combination treatment,” said Mitchell D. Creinin, MD, professor in the department of obstetrics and gynecology at University of California, Davis. “It also requires much higher doses. To get misoprostol by itself to have relatively high efficacy, you have to use multiple doses. It causes significantly more side effects, and it’s less effective.”

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

With a federal judge’s recent ruling clouding the future availability of mifepristone for terminating pregnancies, attention has shifted to the efficacy of another abortion drug, misoprostol.

Experts said a misoprostol-only regimen for medical abortions is as safe as but not as effective as the combination of mifepristone and misoprostol. A misoprostol-only approach also comes with more pronounced side effects.

“Misoprostol only is a good alternative; it’s not the best alternative,” Beverly Gray, MD, associate professor in the department of obstetrics and Gynecology at Duke University, Durham, N.C., said during a video conference on April 12. “The best medication would be to use mifepristone and misoprostol together because they’re efficacious with fewer side effects.”

To medically terminate a pregnancy using the two-drug regimen, patients first take the progesterone blocker mifepristone, which ends the pregnancy. That is followed 24-48 hours later with misoprostol, which causes the uterus to expel the pregnancy tissue. Used in combination, the two drugs have an efficacy rate of 98% in terminating a pregnancy.

An alternative approach is a misoprostol-only regimen. Patients take multiple doses of the drug over the course of hours until the pregnancy passes. This method is considered effective and safe, although patients may experience more nausea, vomiting, diarrhea, bleeding, and cramping.

“It’s effective, but not as effective as the combination treatment,” said Mitchell D. Creinin, MD, professor in the department of obstetrics and gynecology at University of California, Davis. “It also requires much higher doses. To get misoprostol by itself to have relatively high efficacy, you have to use multiple doses. It causes significantly more side effects, and it’s less effective.”

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

NEW ORLEANS – Pediatric patients with rheumatologic diseases experience a particularly high prevalence of psychological distress and depression and anxiety symptoms, according to research presented at the Pediatric Rheumatology Symposium. Although this finding is not necessarily surprising, the extent to which depression and psychological distress impacts these young patients’ quality of life has led to greater research and innovation in seeking ways to identify, address, and treat depression and anxiety in children and adolescents with diseases such as juvenile idiopathic arthritis (JIA) or systemic lupus erythematosus (SLE).

Accordingly, other studies presented at the conference examined more efficient ways to screen adolescent patients for depression and assessed programs designed to improve symptoms. In fact, the American College of Rheumatology award for the top Quality, Health Services, and Education Research abstract at this year’s symposium went to Lauren Harper, MD, a pediatric rheumatology fellow at Nationwide Children’s Hospital, Columbus, whose research examined the effects of automating depression screening during check-in for adolescent patients with SLE. Her findings revealed that automation of screening increased detection of depression and suicidality, thereby increasing interventions and ultimately resulting in a reduction in depression prevalence.

Tara Haelle/MDedge News

“The key clinical takeaway is that mental health screening is really important – it affects our patients in so many different ways – and it’s very doable in your rheumatology clinic,” Dr. Harper said in an interview. “It’s also important because they’re coming to us very frequently, but they don’t see their PCP [primary care provider] very often, so we can’t leave screening to the PCPs.”

Two other studies assessed the effectiveness of a 6-week cognitive-behavioral intervention for youth called Treatment and Education Approach for Childhood-Onset Lupus (TEACH). One study found that remote delivery of TEACH resulted in improved mood symptoms and reduced fatigue, and another found the program particularly effective in improving mood for patients deemed “high risk” because of greater depression and fatigue symptoms.

The impact of growing mental health problems has been enormous both in the pediatric rheumatology population and society at large, Daria Sosna, MSc, a research coordinator at the University of Calgary (Alta.), said in an interview as she visited the research posters related to psychological stress and depression.

“We need to do something,” said Ms. Sosna, whose department is currently applying for funding to develop a research project to improve mental health outcomes in adolescents with lupus. “This population, specifically, has higher numbers than anyone else does because they have chronic illness” – and those issues need to be addressed.
 

High psychological stress levels

The study looking at psychological stress in pediatric rheumatology patients, led by Natalie Rosenwasser, MD, of Seattle Children’s Hospital, relied on cross-sectional data from patients enrolled in two Childhood Arthritis and Rheumatology Research Alliance sites, one in Utah and one in Seattle. The average age of the 71 patients who completed the surveys was 13, and the researchers reported the findings in two separate age groups: those aged 13-17, who completed the surveys themselves, and those aged 8-12, whose parents completed the surveys. Nearly all the patients (94.4%) had JIA, but one had lupus and three had juvenile dermatomyositis.

E+/Getty Images

The participants completed the Patient-Reported Outcomes Measurement Information System (PROMIS) for psychological stress, physical stress, and depressive symptoms. They also filled out the National Institutes of Health–Toolbox Perceived Stress survey, the 9-item Patient Health Questionnaire (PHQ-9), the Screen for Child Anxiety Related Disorders (SCARED), a visual analog scale for COVID-related distress, and a questionnaire asking about how receptive they were to mental health screening. The researchers determined that a score 1 standard deviation above the mean on the PROMIS and NIH-Toolbox assessments qualified as a high level of psychological stress.

“There are data that suggest that psychological stress can be a precursor to depression and anxiety, which raises the concern that not every patient who’s experiencing mental health symptoms is going to be picked up on traditional measures that meet that clinical threshold, but they may really need interventions to protect their mental health,” presenter Erin Treemarcki, DO, an assistant professor of pediatric rheumatology at the University of Utah, Salt Lake City, said in an interview. “Not every patient may necessarily need referral to a mental health specialist, but there are still potential interventions that we can do in the clinical setting to address mental health, which in turn can improve outcomes, including medication compliance and knowing how patients are feeling.”

More than one-third of the patients (39%) reported a high level of psychological stress, and 43% had elevated physical stress. Broken down by age, 26% of the teens and 15% of the younger patients reported high levels of perceived stress. The PROMIS only identified increased depressive symptoms in 26% of the participants, whereas more than half (54%) had a positive PHQ-9 depression screen. Furthermore, half the patients had SCARED scores (50%) that likely indicated anxiety disorder. Only 6% of patients reported severe stress specifically related to the pandemic, but most reported mild distress from the pandemic.

“Psychological stress was highly correlated with physical stress, perceived stress, depressive symptoms [PROMIS and PHQ-9], and anxiety,” the authors reported (P < .05). The authors next plan to expand their assessment to a third CARRA site and then explore the interaction between psychological distress and sociodemographic factors.

“There’s such an increase in mental health disorders right now, and we’re overwhelmed in general,” Ms. Sosna said in an interview. “There have to be interventions that approach this. We can use pharmacological approaches, we can use CBT, we can use a lot of these things that are very well established, and they’re absolutely fantastic, but we don’t necessarily have the resources or capabilities to do that all the time.”
 

Benefits of automated depression screening

To reduce the likelihood of depression screenings falling through the cracks during visits, Dr. Harper’s study assessed the impact of automating screens in an adolescent population. In her presentation, she noted previous research finding that nearly half of youth with lupus (47%) had depression, compared with 24% of adults with lupus. Pediatric patients have nearly three times the odds of depression and more than five times the odds of suicidal ideation, she told attendees. These mood disorders are correlated with greater physical disability, higher cardiovascular risk, more disease activity, higher risk of premature death, and decreased educational attainment, medication compliance, and quality of life.

Despite recommendations for depression screening from the U.S. Preventive Services Task Force and the American Academy of Pediatrics, only 2% of pediatric rheumatology patients are routinely screened for depression with a validated instrument, and only 7% of those with depressive symptoms are screened, according to a 2016 study that Dr. Harper cited. Yet the same study found that nearly all pediatric rheumatologists (95%) supported routine depression screening every 6-12 months. Hence her team’s decision to test whether automating screening improved their screening rates.

Their population included lupus patients aged 12 and older seen at Nationwide Children’s Hospital between 2014 and 2022. Initially, patients completed the PHQ-9 on paper, which was then transcribed into the electronic health record. The process became automated and administered on an iPad at every visit in 2022. Positive screens – those endorsing suicidality or with a score of at least 10 – caused an alert to pop up for clinicians during their workflow so that they would talk to the mental health team about the patient’s needs.

A total of 149 patients completed 529 screenings during the study’s 8 years. Only 1 patient completed a PHQ-9 in 2014, which increased to just 17 patients in 2017. Automation resulted in 225 screens (P < .01). Subsequently, positive screens increased from 0% in 2014 to 25%-30% in 2018-2021, but then fell to 12% in 2022 (P < .01). The median PHQ-9 score was 3; overall scores decreased as screening increased.

The overall incidence of positive screens during the study period was 20% and prevalence was 38%, the authors reported. Of the 10 automated alerts triggered by positive screens, 90% resulted in a meeting with a psychologist or social worker, and 90% completed a suicide risk assessment. The intrusive alert for clinicians requires them to acknowledge the alert, agreeing to initiate a risk assessment, before they can enter data into the patient’s chart.

The study findings reveal “that you can successfully screen a high-risk population using an automated, seamless process, and you can alert providers without too much disruption to their typical clinic flow,” Dr. Harper told attendees. “And all of these processes have led to sustainability for routine depression screening in our lupus clinic.”

Dr. Harper’s team next plans to expand the automated screenings to populations with other diseases, to add an automated screening for anxiety, and to explore how PHQ-9 scores correlate with disease activity.
 

Treating patients’ mental health

Another two other abstracts at the symposium looked at another option, the 6-week cognitive-behavioral TEACH program. Deborah Levy, MD, MS, an associate professor of pediatrics at the University of Toronto and the clinical director of rheumatology at The Hospital for Sick Children, and colleagues assessed the program’s success when delivered remotely to adolescent patients with lupus. Pilot testing with TEACH had already shown improvements in fatigue and mood, Dr. Levy told attendees, but barriers to in-person delivery limited its utility even before the pandemic, so this study aimed to determine a remote version’s feasibility and effects, compared with treatment as usual.

The randomized, controlled trial, led by Natoshia Cunningham, PhD, from Michigan State University, Grand Rapids, included 57 participants, aged 12-22, from seven U.S. and Canadian rheumatology sites. All had been diagnosed with childhood-onset SLE by age 18 and had elevated symptoms in fatigue, pain, or depression. A PROMIS Fatigue T score of 60 or greater indicated elevated fatigue scores, whereas a high pain score was at least a 3/10 on a visual analog scale, and a high depression T score was at least a 60 but not higher than 80 on the Children’s Depression Inventory–2 or the Beck Depression Inventory–II (depending on the patient’s age).

Patients with other chronic medical conditions, developmental delays, or untreated major psychiatric illness were excluded from the study, as were patients who were receiving overlapping treatment, such as cognitive-behavioral therapy for pain or mood. Thirty patients were randomly assigned to receive treatment as usual while 27 patients were assigned to participate in the remote TEACH program.

Nearly all the patients (94%) were female, but they were racially diverse, with 42% White, 28% Asian, 19% Black, 19% Hispanic, and 4% multiracial. The patients were an average 16 years old and had been diagnosed for a median 5 years. Three of the intervention’s six modules involved the caregivers or, for older patients, their partners if desired. The communication strategies taught in the program were also tailored to patients’ ages.

“All of these strategies are educational, cognitive, behavioral, mindfulness strategies that target fatigue [and] pain, and they also developed web content for participants to use on their own,” Dr. Levy told attendees.

The researchers had complete postassessment data from 88% of participants, but they also reported some of the statements made during qualitative interviews about the program’s feasibility.

“I think it makes people more aware of themselves to become a better version of themselves, whether that’s in their normal life or in handling a lupus kind of life,” one participant said about the program’s benefits. Another appreciated the “alternative ways of thinking,” including “being more mindful of my thoughts and how those kind of aggravate my stress.”

The quantitative findings revealed a statistically significant reduction in depressive symptoms and fatigue for TEACH participants, compared with treatment as usual. Mood scores fell by an average 13.7 points in the TEACH group, compared with a drop of 2.4 points in the treatment as usual group (P < .001). Scores for fatigue fell 9.16 points in the TEACH group and 2.93 in the control group (P = .003). No statistically significant difference showed up in pain scores between the groups, although pain, medication adherence, and disease activity did improve slightly more in the TEACH group.

In addition to the significant improvements in mood and fatigue, therefore, “completion of TEACH may be associated with improved medication adherence and disease activity versus treatment as usual,” Dr. Levy said.

A much smaller study authored by some of the same researchers also assessed TEACH’s impact not in remote form but in terms of its value specifically for adolescent patients with SLE and elevated depression and fatigue scores. Comparison of 6 high-risk patients with 10 low-risk patients who underwent TEACH suggested that the program was especially effective for improving depression in high-risk patients since these patients had a statistically significantly greater improvement in mood. Fatigue, pain, anxiety, quality of life, and disease activity scores did not statistically differ between the groups.

Authors of the automated depression screening study reported no disclosures or outside funding. The study assessing psychological distress was funded by a CARRA–Arthritis Foundation grant, and the authors reported no disclosures. The remote TEACH study was funded by a CARRA–Arthritis Foundation grant, and all but one author reported no disclosures. One author had disclosures with Janssen, Roche, and Sobi. The high-risk TEACH study was also funded by a CARRA grant, and the authors had no disclosures.

NEW ORLEANS – Pediatric patients with rheumatologic diseases experience a particularly high prevalence of psychological distress and depression and anxiety symptoms, according to research presented at the Pediatric Rheumatology Symposium. Although this finding is not necessarily surprising, the extent to which depression and psychological distress impacts these young patients’ quality of life has led to greater research and innovation in seeking ways to identify, address, and treat depression and anxiety in children and adolescents with diseases such as juvenile idiopathic arthritis (JIA) or systemic lupus erythematosus (SLE).

Accordingly, other studies presented at the conference examined more efficient ways to screen adolescent patients for depression and assessed programs designed to improve symptoms. In fact, the American College of Rheumatology award for the top Quality, Health Services, and Education Research abstract at this year’s symposium went to Lauren Harper, MD, a pediatric rheumatology fellow at Nationwide Children’s Hospital, Columbus, whose research examined the effects of automating depression screening during check-in for adolescent patients with SLE. Her findings revealed that automation of screening increased detection of depression and suicidality, thereby increasing interventions and ultimately resulting in a reduction in depression prevalence.

Tara Haelle/MDedge News

“The key clinical takeaway is that mental health screening is really important – it affects our patients in so many different ways – and it’s very doable in your rheumatology clinic,” Dr. Harper said in an interview. “It’s also important because they’re coming to us very frequently, but they don’t see their PCP [primary care provider] very often, so we can’t leave screening to the PCPs.”

Two other studies assessed the effectiveness of a 6-week cognitive-behavioral intervention for youth called Treatment and Education Approach for Childhood-Onset Lupus (TEACH). One study found that remote delivery of TEACH resulted in improved mood symptoms and reduced fatigue, and another found the program particularly effective in improving mood for patients deemed “high risk” because of greater depression and fatigue symptoms.

The impact of growing mental health problems has been enormous both in the pediatric rheumatology population and society at large, Daria Sosna, MSc, a research coordinator at the University of Calgary (Alta.), said in an interview as she visited the research posters related to psychological stress and depression.

“We need to do something,” said Ms. Sosna, whose department is currently applying for funding to develop a research project to improve mental health outcomes in adolescents with lupus. “This population, specifically, has higher numbers than anyone else does because they have chronic illness” – and those issues need to be addressed.
 

High psychological stress levels

The study looking at psychological stress in pediatric rheumatology patients, led by Natalie Rosenwasser, MD, of Seattle Children’s Hospital, relied on cross-sectional data from patients enrolled in two Childhood Arthritis and Rheumatology Research Alliance sites, one in Utah and one in Seattle. The average age of the 71 patients who completed the surveys was 13, and the researchers reported the findings in two separate age groups: those aged 13-17, who completed the surveys themselves, and those aged 8-12, whose parents completed the surveys. Nearly all the patients (94.4%) had JIA, but one had lupus and three had juvenile dermatomyositis.

E+/Getty Images

The participants completed the Patient-Reported Outcomes Measurement Information System (PROMIS) for psychological stress, physical stress, and depressive symptoms. They also filled out the National Institutes of Health–Toolbox Perceived Stress survey, the 9-item Patient Health Questionnaire (PHQ-9), the Screen for Child Anxiety Related Disorders (SCARED), a visual analog scale for COVID-related distress, and a questionnaire asking about how receptive they were to mental health screening. The researchers determined that a score 1 standard deviation above the mean on the PROMIS and NIH-Toolbox assessments qualified as a high level of psychological stress.

“There are data that suggest that psychological stress can be a precursor to depression and anxiety, which raises the concern that not every patient who’s experiencing mental health symptoms is going to be picked up on traditional measures that meet that clinical threshold, but they may really need interventions to protect their mental health,” presenter Erin Treemarcki, DO, an assistant professor of pediatric rheumatology at the University of Utah, Salt Lake City, said in an interview. “Not every patient may necessarily need referral to a mental health specialist, but there are still potential interventions that we can do in the clinical setting to address mental health, which in turn can improve outcomes, including medication compliance and knowing how patients are feeling.”

More than one-third of the patients (39%) reported a high level of psychological stress, and 43% had elevated physical stress. Broken down by age, 26% of the teens and 15% of the younger patients reported high levels of perceived stress. The PROMIS only identified increased depressive symptoms in 26% of the participants, whereas more than half (54%) had a positive PHQ-9 depression screen. Furthermore, half the patients had SCARED scores (50%) that likely indicated anxiety disorder. Only 6% of patients reported severe stress specifically related to the pandemic, but most reported mild distress from the pandemic.

“Psychological stress was highly correlated with physical stress, perceived stress, depressive symptoms [PROMIS and PHQ-9], and anxiety,” the authors reported (P < .05). The authors next plan to expand their assessment to a third CARRA site and then explore the interaction between psychological distress and sociodemographic factors.

“There’s such an increase in mental health disorders right now, and we’re overwhelmed in general,” Ms. Sosna said in an interview. “There have to be interventions that approach this. We can use pharmacological approaches, we can use CBT, we can use a lot of these things that are very well established, and they’re absolutely fantastic, but we don’t necessarily have the resources or capabilities to do that all the time.”
 

Benefits of automated depression screening

To reduce the likelihood of depression screenings falling through the cracks during visits, Dr. Harper’s study assessed the impact of automating screens in an adolescent population. In her presentation, she noted previous research finding that nearly half of youth with lupus (47%) had depression, compared with 24% of adults with lupus. Pediatric patients have nearly three times the odds of depression and more than five times the odds of suicidal ideation, she told attendees. These mood disorders are correlated with greater physical disability, higher cardiovascular risk, more disease activity, higher risk of premature death, and decreased educational attainment, medication compliance, and quality of life.

Despite recommendations for depression screening from the U.S. Preventive Services Task Force and the American Academy of Pediatrics, only 2% of pediatric rheumatology patients are routinely screened for depression with a validated instrument, and only 7% of those with depressive symptoms are screened, according to a 2016 study that Dr. Harper cited. Yet the same study found that nearly all pediatric rheumatologists (95%) supported routine depression screening every 6-12 months. Hence her team’s decision to test whether automating screening improved their screening rates.

Their population included lupus patients aged 12 and older seen at Nationwide Children’s Hospital between 2014 and 2022. Initially, patients completed the PHQ-9 on paper, which was then transcribed into the electronic health record. The process became automated and administered on an iPad at every visit in 2022. Positive screens – those endorsing suicidality or with a score of at least 10 – caused an alert to pop up for clinicians during their workflow so that they would talk to the mental health team about the patient’s needs.

A total of 149 patients completed 529 screenings during the study’s 8 years. Only 1 patient completed a PHQ-9 in 2014, which increased to just 17 patients in 2017. Automation resulted in 225 screens (P < .01). Subsequently, positive screens increased from 0% in 2014 to 25%-30% in 2018-2021, but then fell to 12% in 2022 (P < .01). The median PHQ-9 score was 3; overall scores decreased as screening increased.

The overall incidence of positive screens during the study period was 20% and prevalence was 38%, the authors reported. Of the 10 automated alerts triggered by positive screens, 90% resulted in a meeting with a psychologist or social worker, and 90% completed a suicide risk assessment. The intrusive alert for clinicians requires them to acknowledge the alert, agreeing to initiate a risk assessment, before they can enter data into the patient’s chart.

The study findings reveal “that you can successfully screen a high-risk population using an automated, seamless process, and you can alert providers without too much disruption to their typical clinic flow,” Dr. Harper told attendees. “And all of these processes have led to sustainability for routine depression screening in our lupus clinic.”

Dr. Harper’s team next plans to expand the automated screenings to populations with other diseases, to add an automated screening for anxiety, and to explore how PHQ-9 scores correlate with disease activity.
 

Treating patients’ mental health

Another two other abstracts at the symposium looked at another option, the 6-week cognitive-behavioral TEACH program. Deborah Levy, MD, MS, an associate professor of pediatrics at the University of Toronto and the clinical director of rheumatology at The Hospital for Sick Children, and colleagues assessed the program’s success when delivered remotely to adolescent patients with lupus. Pilot testing with TEACH had already shown improvements in fatigue and mood, Dr. Levy told attendees, but barriers to in-person delivery limited its utility even before the pandemic, so this study aimed to determine a remote version’s feasibility and effects, compared with treatment as usual.

The randomized, controlled trial, led by Natoshia Cunningham, PhD, from Michigan State University, Grand Rapids, included 57 participants, aged 12-22, from seven U.S. and Canadian rheumatology sites. All had been diagnosed with childhood-onset SLE by age 18 and had elevated symptoms in fatigue, pain, or depression. A PROMIS Fatigue T score of 60 or greater indicated elevated fatigue scores, whereas a high pain score was at least a 3/10 on a visual analog scale, and a high depression T score was at least a 60 but not higher than 80 on the Children’s Depression Inventory–2 or the Beck Depression Inventory–II (depending on the patient’s age).

Patients with other chronic medical conditions, developmental delays, or untreated major psychiatric illness were excluded from the study, as were patients who were receiving overlapping treatment, such as cognitive-behavioral therapy for pain or mood. Thirty patients were randomly assigned to receive treatment as usual while 27 patients were assigned to participate in the remote TEACH program.

Nearly all the patients (94%) were female, but they were racially diverse, with 42% White, 28% Asian, 19% Black, 19% Hispanic, and 4% multiracial. The patients were an average 16 years old and had been diagnosed for a median 5 years. Three of the intervention’s six modules involved the caregivers or, for older patients, their partners if desired. The communication strategies taught in the program were also tailored to patients’ ages.

“All of these strategies are educational, cognitive, behavioral, mindfulness strategies that target fatigue [and] pain, and they also developed web content for participants to use on their own,” Dr. Levy told attendees.

The researchers had complete postassessment data from 88% of participants, but they also reported some of the statements made during qualitative interviews about the program’s feasibility.

“I think it makes people more aware of themselves to become a better version of themselves, whether that’s in their normal life or in handling a lupus kind of life,” one participant said about the program’s benefits. Another appreciated the “alternative ways of thinking,” including “being more mindful of my thoughts and how those kind of aggravate my stress.”

The quantitative findings revealed a statistically significant reduction in depressive symptoms and fatigue for TEACH participants, compared with treatment as usual. Mood scores fell by an average 13.7 points in the TEACH group, compared with a drop of 2.4 points in the treatment as usual group (P < .001). Scores for fatigue fell 9.16 points in the TEACH group and 2.93 in the control group (P = .003). No statistically significant difference showed up in pain scores between the groups, although pain, medication adherence, and disease activity did improve slightly more in the TEACH group.

In addition to the significant improvements in mood and fatigue, therefore, “completion of TEACH may be associated with improved medication adherence and disease activity versus treatment as usual,” Dr. Levy said.

A much smaller study authored by some of the same researchers also assessed TEACH’s impact not in remote form but in terms of its value specifically for adolescent patients with SLE and elevated depression and fatigue scores. Comparison of 6 high-risk patients with 10 low-risk patients who underwent TEACH suggested that the program was especially effective for improving depression in high-risk patients since these patients had a statistically significantly greater improvement in mood. Fatigue, pain, anxiety, quality of life, and disease activity scores did not statistically differ between the groups.

Authors of the automated depression screening study reported no disclosures or outside funding. The study assessing psychological distress was funded by a CARRA–Arthritis Foundation grant, and the authors reported no disclosures. The remote TEACH study was funded by a CARRA–Arthritis Foundation grant, and all but one author reported no disclosures. One author had disclosures with Janssen, Roche, and Sobi. The high-risk TEACH study was also funded by a CARRA grant, and the authors had no disclosures.

NEW ORLEANS – Pediatric patients with rheumatologic diseases experience a particularly high prevalence of psychological distress and depression and anxiety symptoms, according to research presented at the Pediatric Rheumatology Symposium. Although this finding is not necessarily surprising, the extent to which depression and psychological distress impacts these young patients’ quality of life has led to greater research and innovation in seeking ways to identify, address, and treat depression and anxiety in children and adolescents with diseases such as juvenile idiopathic arthritis (JIA) or systemic lupus erythematosus (SLE).

Accordingly, other studies presented at the conference examined more efficient ways to screen adolescent patients for depression and assessed programs designed to improve symptoms. In fact, the American College of Rheumatology award for the top Quality, Health Services, and Education Research abstract at this year’s symposium went to Lauren Harper, MD, a pediatric rheumatology fellow at Nationwide Children’s Hospital, Columbus, whose research examined the effects of automating depression screening during check-in for adolescent patients with SLE. Her findings revealed that automation of screening increased detection of depression and suicidality, thereby increasing interventions and ultimately resulting in a reduction in depression prevalence.

Tara Haelle/MDedge News

“The key clinical takeaway is that mental health screening is really important – it affects our patients in so many different ways – and it’s very doable in your rheumatology clinic,” Dr. Harper said in an interview. “It’s also important because they’re coming to us very frequently, but they don’t see their PCP [primary care provider] very often, so we can’t leave screening to the PCPs.”

Two other studies assessed the effectiveness of a 6-week cognitive-behavioral intervention for youth called Treatment and Education Approach for Childhood-Onset Lupus (TEACH). One study found that remote delivery of TEACH resulted in improved mood symptoms and reduced fatigue, and another found the program particularly effective in improving mood for patients deemed “high risk” because of greater depression and fatigue symptoms.

The impact of growing mental health problems has been enormous both in the pediatric rheumatology population and society at large, Daria Sosna, MSc, a research coordinator at the University of Calgary (Alta.), said in an interview as she visited the research posters related to psychological stress and depression.

“We need to do something,” said Ms. Sosna, whose department is currently applying for funding to develop a research project to improve mental health outcomes in adolescents with lupus. “This population, specifically, has higher numbers than anyone else does because they have chronic illness” – and those issues need to be addressed.
 

High psychological stress levels

The study looking at psychological stress in pediatric rheumatology patients, led by Natalie Rosenwasser, MD, of Seattle Children’s Hospital, relied on cross-sectional data from patients enrolled in two Childhood Arthritis and Rheumatology Research Alliance sites, one in Utah and one in Seattle. The average age of the 71 patients who completed the surveys was 13, and the researchers reported the findings in two separate age groups: those aged 13-17, who completed the surveys themselves, and those aged 8-12, whose parents completed the surveys. Nearly all the patients (94.4%) had JIA, but one had lupus and three had juvenile dermatomyositis.

E+/Getty Images

The participants completed the Patient-Reported Outcomes Measurement Information System (PROMIS) for psychological stress, physical stress, and depressive symptoms. They also filled out the National Institutes of Health–Toolbox Perceived Stress survey, the 9-item Patient Health Questionnaire (PHQ-9), the Screen for Child Anxiety Related Disorders (SCARED), a visual analog scale for COVID-related distress, and a questionnaire asking about how receptive they were to mental health screening. The researchers determined that a score 1 standard deviation above the mean on the PROMIS and NIH-Toolbox assessments qualified as a high level of psychological stress.

“There are data that suggest that psychological stress can be a precursor to depression and anxiety, which raises the concern that not every patient who’s experiencing mental health symptoms is going to be picked up on traditional measures that meet that clinical threshold, but they may really need interventions to protect their mental health,” presenter Erin Treemarcki, DO, an assistant professor of pediatric rheumatology at the University of Utah, Salt Lake City, said in an interview. “Not every patient may necessarily need referral to a mental health specialist, but there are still potential interventions that we can do in the clinical setting to address mental health, which in turn can improve outcomes, including medication compliance and knowing how patients are feeling.”

More than one-third of the patients (39%) reported a high level of psychological stress, and 43% had elevated physical stress. Broken down by age, 26% of the teens and 15% of the younger patients reported high levels of perceived stress. The PROMIS only identified increased depressive symptoms in 26% of the participants, whereas more than half (54%) had a positive PHQ-9 depression screen. Furthermore, half the patients had SCARED scores (50%) that likely indicated anxiety disorder. Only 6% of patients reported severe stress specifically related to the pandemic, but most reported mild distress from the pandemic.

“Psychological stress was highly correlated with physical stress, perceived stress, depressive symptoms [PROMIS and PHQ-9], and anxiety,” the authors reported (P < .05). The authors next plan to expand their assessment to a third CARRA site and then explore the interaction between psychological distress and sociodemographic factors.

“There’s such an increase in mental health disorders right now, and we’re overwhelmed in general,” Ms. Sosna said in an interview. “There have to be interventions that approach this. We can use pharmacological approaches, we can use CBT, we can use a lot of these things that are very well established, and they’re absolutely fantastic, but we don’t necessarily have the resources or capabilities to do that all the time.”
 

Benefits of automated depression screening

To reduce the likelihood of depression screenings falling through the cracks during visits, Dr. Harper’s study assessed the impact of automating screens in an adolescent population. In her presentation, she noted previous research finding that nearly half of youth with lupus (47%) had depression, compared with 24% of adults with lupus. Pediatric patients have nearly three times the odds of depression and more than five times the odds of suicidal ideation, she told attendees. These mood disorders are correlated with greater physical disability, higher cardiovascular risk, more disease activity, higher risk of premature death, and decreased educational attainment, medication compliance, and quality of life.

Despite recommendations for depression screening from the U.S. Preventive Services Task Force and the American Academy of Pediatrics, only 2% of pediatric rheumatology patients are routinely screened for depression with a validated instrument, and only 7% of those with depressive symptoms are screened, according to a 2016 study that Dr. Harper cited. Yet the same study found that nearly all pediatric rheumatologists (95%) supported routine depression screening every 6-12 months. Hence her team’s decision to test whether automating screening improved their screening rates.

Their population included lupus patients aged 12 and older seen at Nationwide Children’s Hospital between 2014 and 2022. Initially, patients completed the PHQ-9 on paper, which was then transcribed into the electronic health record. The process became automated and administered on an iPad at every visit in 2022. Positive screens – those endorsing suicidality or with a score of at least 10 – caused an alert to pop up for clinicians during their workflow so that they would talk to the mental health team about the patient’s needs.

A total of 149 patients completed 529 screenings during the study’s 8 years. Only 1 patient completed a PHQ-9 in 2014, which increased to just 17 patients in 2017. Automation resulted in 225 screens (P < .01). Subsequently, positive screens increased from 0% in 2014 to 25%-30% in 2018-2021, but then fell to 12% in 2022 (P < .01). The median PHQ-9 score was 3; overall scores decreased as screening increased.

The overall incidence of positive screens during the study period was 20% and prevalence was 38%, the authors reported. Of the 10 automated alerts triggered by positive screens, 90% resulted in a meeting with a psychologist or social worker, and 90% completed a suicide risk assessment. The intrusive alert for clinicians requires them to acknowledge the alert, agreeing to initiate a risk assessment, before they can enter data into the patient’s chart.

The study findings reveal “that you can successfully screen a high-risk population using an automated, seamless process, and you can alert providers without too much disruption to their typical clinic flow,” Dr. Harper told attendees. “And all of these processes have led to sustainability for routine depression screening in our lupus clinic.”

Dr. Harper’s team next plans to expand the automated screenings to populations with other diseases, to add an automated screening for anxiety, and to explore how PHQ-9 scores correlate with disease activity.
 

Treating patients’ mental health

Another two other abstracts at the symposium looked at another option, the 6-week cognitive-behavioral TEACH program. Deborah Levy, MD, MS, an associate professor of pediatrics at the University of Toronto and the clinical director of rheumatology at The Hospital for Sick Children, and colleagues assessed the program’s success when delivered remotely to adolescent patients with lupus. Pilot testing with TEACH had already shown improvements in fatigue and mood, Dr. Levy told attendees, but barriers to in-person delivery limited its utility even before the pandemic, so this study aimed to determine a remote version’s feasibility and effects, compared with treatment as usual.

The randomized, controlled trial, led by Natoshia Cunningham, PhD, from Michigan State University, Grand Rapids, included 57 participants, aged 12-22, from seven U.S. and Canadian rheumatology sites. All had been diagnosed with childhood-onset SLE by age 18 and had elevated symptoms in fatigue, pain, or depression. A PROMIS Fatigue T score of 60 or greater indicated elevated fatigue scores, whereas a high pain score was at least a 3/10 on a visual analog scale, and a high depression T score was at least a 60 but not higher than 80 on the Children’s Depression Inventory–2 or the Beck Depression Inventory–II (depending on the patient’s age).

Patients with other chronic medical conditions, developmental delays, or untreated major psychiatric illness were excluded from the study, as were patients who were receiving overlapping treatment, such as cognitive-behavioral therapy for pain or mood. Thirty patients were randomly assigned to receive treatment as usual while 27 patients were assigned to participate in the remote TEACH program.

Nearly all the patients (94%) were female, but they were racially diverse, with 42% White, 28% Asian, 19% Black, 19% Hispanic, and 4% multiracial. The patients were an average 16 years old and had been diagnosed for a median 5 years. Three of the intervention’s six modules involved the caregivers or, for older patients, their partners if desired. The communication strategies taught in the program were also tailored to patients’ ages.

“All of these strategies are educational, cognitive, behavioral, mindfulness strategies that target fatigue [and] pain, and they also developed web content for participants to use on their own,” Dr. Levy told attendees.

The researchers had complete postassessment data from 88% of participants, but they also reported some of the statements made during qualitative interviews about the program’s feasibility.

“I think it makes people more aware of themselves to become a better version of themselves, whether that’s in their normal life or in handling a lupus kind of life,” one participant said about the program’s benefits. Another appreciated the “alternative ways of thinking,” including “being more mindful of my thoughts and how those kind of aggravate my stress.”

The quantitative findings revealed a statistically significant reduction in depressive symptoms and fatigue for TEACH participants, compared with treatment as usual. Mood scores fell by an average 13.7 points in the TEACH group, compared with a drop of 2.4 points in the treatment as usual group (P < .001). Scores for fatigue fell 9.16 points in the TEACH group and 2.93 in the control group (P = .003). No statistically significant difference showed up in pain scores between the groups, although pain, medication adherence, and disease activity did improve slightly more in the TEACH group.

In addition to the significant improvements in mood and fatigue, therefore, “completion of TEACH may be associated with improved medication adherence and disease activity versus treatment as usual,” Dr. Levy said.

A much smaller study authored by some of the same researchers also assessed TEACH’s impact not in remote form but in terms of its value specifically for adolescent patients with SLE and elevated depression and fatigue scores. Comparison of 6 high-risk patients with 10 low-risk patients who underwent TEACH suggested that the program was especially effective for improving depression in high-risk patients since these patients had a statistically significantly greater improvement in mood. Fatigue, pain, anxiety, quality of life, and disease activity scores did not statistically differ between the groups.

Authors of the automated depression screening study reported no disclosures or outside funding. The study assessing psychological distress was funded by a CARRA–Arthritis Foundation grant, and the authors reported no disclosures. The remote TEACH study was funded by a CARRA–Arthritis Foundation grant, and all but one author reported no disclosures. One author had disclosures with Janssen, Roche, and Sobi. The high-risk TEACH study was also funded by a CARRA grant, and the authors had no disclosures.

In 2014, after smoking cigarettes for 40 years, Kati Markowitz decided to switch to vaping. She had heard the newer electronic cigarettes might be less harmful. And, at the time, she said, she wasn’t aware of other options to try to quit smoking.

For 7 years, she vaped every day.

Then Ms. Markowitz received news she’d hoped never to hear: She had lung cancer. A nodule detected in a CT scan had grown. She was scheduled for treatment – the removal of an entire lobe from her right lung. But first, she said, her surgeon told her she had to quit vaping, which reduces the risk for post-operative complications and enables a healthy recovery.

Ms. Markowitz had thought switching to vaping would be less harmful than smoking cigarettes. Now, she no longer believes that’s true.

“Did I fool myself by hoping to get lucky and not have any bad repercussions? Yes, I did,” Ms. Markowitz said, adding that she wonders if vaping contributed to her lung cancer or if she’ll experience other negative health effects in the future.

Researchers are divided on if e-cigarettes are as effective in smoking cessation as other nicotine replacement therapies like gums and lozenges. They also say more research is needed on the long-term health impacts of vaping to ultimately determine if vapes are a safe replacement for cigarettes.

“There is scientific research to support vaping as a cessation tool, but we wouldn’t use it as a first line of defense because we still need longitudinal studies to understand the long-term risk of e-cigarettes,” said Monica Hanna, MPH, assistant director of the Nicotine and Tobacco Recovery Program at RWJBarnabas Health’s Institute for Prevention and Recovery, Eatontown, N.J. “We also need research to understand exactly how we could use e-cigarettes as a cessation device.”
 

Vaping to quit

The first prototypes of e-cigarettes were developed in the 1930s, although what are now known as vapes weren’t sold by manufacturers until the 2000s in the United States, following an invention by a former health official in China. The vape was touted by both researchers and manufacturers over the years of development as a way to quit smoking cigarettes.

The Consumer Advocates for Smoke-free Alternatives Association, a nonprofit group that supports vaping and accepts donations from the e-cigarette industry, has compiled more than 13,000 testimonials from people who say vaping helped them give up smoking.

Studies show mixed results that using vapes can help traditional smokers quit.

A November 2022 Cochrane review showed a “high certainty of evidence that people are more likely to stop smoking traditional cigarettes for at least 6 months using e-cigarettes, or ‘vapes,’ than using nicotine replacement therapies, such as patches and gums.” The meta-analysis examined 78 studies with more than 22,000 participants. And a 2019 study with 886 participants, published in the New England Journal Medicine, found smokers who tried vaping to quit were twice as likely after a year to have stopped smoking cigarettes than those who used nicotine replacement therapy.

“In terms of the global research, it’s pretty clear that vaping can help smokers quit,” said Peter Shields, MD, a professor in the department of internal medicine at The Ohio State University College of Medicine, Columbus, who specializes in the treatment of lung cancer.

But a 2013 study published in the Lancet, and another from the Lancet in 2019, found only a modest improvement in cessation outcomes when participants used e-cigarettes paired with patches, compared with patches alone.

“For a disruptive technology that was supposed to end combustible tobacco use, there seems very little large-scale disruption,” said Thomas Eissenberg, PhD, co-director of Virginia Commonwealth University’s Center for the Study of Tobacco Products, Richmond.

Michael Joseph Blaha, MD, MPH, director of clinical research at the Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease, Baltimore, pointed to research that shows a portion of people who start vaping to quit smoking end up using both products – or become so-called “dual” users.

“I do think there is fairly high-quality evidence that vaping can lead to more cessation, but at the tradeoff of more long-term dual users and more overall nicotine addiction,” Dr. Blaha said. “Vaping remains a third-line clinical tool after nicotine replacement therapy and FDA-approved cessation medications.”

The U.S. Food and Drug Administration has not approved any e-cigarette or vaping device for smoking cessation, like it has for patches and gums, which means manufacturers cannot market their products as helping tobacco smokers quit.

“There is potential for vaping as a cessation device, but the evidence so far is too small to say for sure that vaping is a more effective tool than others for combustible tobacco cessation,” Ms. Hanna, from RWJBarnabas Health’s Institute for Prevention and Recovery, said.
 

Reducing harm and improving health?

Vapes have also been touted as a boon to individual and public health since cigarette smoking is the leading cause of preventable disease and disability in the United States, responsible for more than 480,000 deaths per year in the U.S., according to the U.S. Centers for Disease Control and Prevention.

Quitting smoking lowers the risk of developing various cancers, heart disease, stroke, and other serious diseases. The aim of nicotine replacement therapy is to help smokers quit by gradually providing the body with smaller doses of nicotine over time, without exposing the body to toxic chemicals found in cigarettes.

“No one should say that e-cigarettes are safe, but compared to cigarettes, the data is consistent: They are not as harmful, and when a smoker switches, it’s better for them,” Dr. Shields said. “Like with other nicotine replacement therapies, if there is a risk that someone stops vaping and returns to smoking, I would rather have them as long-term vapers since it is generally considered to be less harmful than combustible tobacco.”

The FDA has allowed a handful of companies to market their electronic nicotine delivery systems as safer than traditional cigarettes by gaining approval through the Premarket Tobacco Product Applications process. In 2021, the agency announced its first PMTA authorization of an electronic cigarette to R.J. Reynolds for three of its tobacco-flavored vaping products. Regulators approved more products from three additional companies in 2022.

But the FDA has also denied others, including two products in 2023 from R.J. Reynolds, stating that, “the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health.”

Questions remain among some researchers on the effects of vaping if used long term. Data on the health effects of vapes are just beginning to emerge and are mainly from studies of animals or cells. Measuring health effects among vape users will entail decades more of study, since Americans only gained access to the products in the 2000s.

Dr. Eissenberg said vaping likely does not cause the same diseases as cigarette smoking, but that does not mean they are not harmful. Ingredients found in e-cigarettes, such as heated propylene glycol, vegetable glycerin, and flavors, have only been used as food ingredients. The potential diseases caused by vapes are still unknown, because inhaling these heated ingredients is new. He also said he had “no issue” with an adult smoker vaping to help them quit smoking – as long they do so for a short period.

“I am very concerned that long-term use in adults could lead to considerable disease and death,” Dr. Eissenberg said. “Simply put, the human lung evolved for one purpose: gas exchange of oxygen in, carbon dioxide out. Anything else that enters the lung is a challenge to the organ.”

But Kenneth Warner, PhD, dean emeritus at the University of Michigan School of Public Health, Ann Arbor, said breaking the addiction to traditional cigarettes could reduce high rates of lung cancer in lower income communities where rates of smoking are comparatively high.

About three times as many Americans smoked (12.6%) than vaped (4.7%) in 2021, but those who live in households with lower incomes are more likely to smoke. According to the CDC, use of tobacco is higher among adults who were uninsured (27.3%) or who had Medicaid coverage (28.6%) than among those with private insurance (16.4%). People with annual family incomes of less than $12,500 also are more likely to be diagnosed with lung cancer than those with family incomes of $50,000 or more. Public health researchers have attributed those disparities in part to higher rates of smoking in lower-income households.

Dr. Warner said many lower-income and other Americans may never quit smoking cigarettes because they believe making the switch to e-cigarettes will not benefit their health. A 2022 study, published in the American Journal of Preventive Medicine, found that the percent of Americans who thought vaping was more harmful than smoking quadrupled between 2018 and 2020, from 6.8% to 28.3%. A third of respondents thought vaping was as harmful as smoking.

“We’ve convinced a large percentage of the American public that vaping is as harmful as smoking when it could be helping people quit smoking,” Dr. Warner said. “People are dying right now.”

Ms. Markowitz did quit smoking by taking up vaping. But now she questions if her lung cancer prognosis would have been delayed, or even avoided, if she’d tried a traditional method like a lozenge or gum instead. She vaped once an hour for most of her 7 years of using the devices.

“For people who are trying to stop smoking, I would recommend something like the patch instead,” Ms. Markowitz said.

The Consumer Advocates for Smoke-free Alternatives receives funding from the vaping industry. Dr. Blaha, Dr. Eissenberg, Ms. Hanna, Dr. Shields, and Dr. Warner reported no funding from the tobacco or e-cigarette industry. Dr. Blaha and Dr. Warner receive tobacco-related research funding from the FDA. Dr. Warner is a member of the FDA’s Tobacco Products Scientific Advisory Committee.

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

In 2014, after smoking cigarettes for 40 years, Kati Markowitz decided to switch to vaping. She had heard the newer electronic cigarettes might be less harmful. And, at the time, she said, she wasn’t aware of other options to try to quit smoking.

For 7 years, she vaped every day.

Then Ms. Markowitz received news she’d hoped never to hear: She had lung cancer. A nodule detected in a CT scan had grown. She was scheduled for treatment – the removal of an entire lobe from her right lung. But first, she said, her surgeon told her she had to quit vaping, which reduces the risk for post-operative complications and enables a healthy recovery.

Ms. Markowitz had thought switching to vaping would be less harmful than smoking cigarettes. Now, she no longer believes that’s true.

“Did I fool myself by hoping to get lucky and not have any bad repercussions? Yes, I did,” Ms. Markowitz said, adding that she wonders if vaping contributed to her lung cancer or if she’ll experience other negative health effects in the future.

Researchers are divided on if e-cigarettes are as effective in smoking cessation as other nicotine replacement therapies like gums and lozenges. They also say more research is needed on the long-term health impacts of vaping to ultimately determine if vapes are a safe replacement for cigarettes.

“There is scientific research to support vaping as a cessation tool, but we wouldn’t use it as a first line of defense because we still need longitudinal studies to understand the long-term risk of e-cigarettes,” said Monica Hanna, MPH, assistant director of the Nicotine and Tobacco Recovery Program at RWJBarnabas Health’s Institute for Prevention and Recovery, Eatontown, N.J. “We also need research to understand exactly how we could use e-cigarettes as a cessation device.”
 

Vaping to quit

The first prototypes of e-cigarettes were developed in the 1930s, although what are now known as vapes weren’t sold by manufacturers until the 2000s in the United States, following an invention by a former health official in China. The vape was touted by both researchers and manufacturers over the years of development as a way to quit smoking cigarettes.

The Consumer Advocates for Smoke-free Alternatives Association, a nonprofit group that supports vaping and accepts donations from the e-cigarette industry, has compiled more than 13,000 testimonials from people who say vaping helped them give up smoking.

Studies show mixed results that using vapes can help traditional smokers quit.

A November 2022 Cochrane review showed a “high certainty of evidence that people are more likely to stop smoking traditional cigarettes for at least 6 months using e-cigarettes, or ‘vapes,’ than using nicotine replacement therapies, such as patches and gums.” The meta-analysis examined 78 studies with more than 22,000 participants. And a 2019 study with 886 participants, published in the New England Journal Medicine, found smokers who tried vaping to quit were twice as likely after a year to have stopped smoking cigarettes than those who used nicotine replacement therapy.

“In terms of the global research, it’s pretty clear that vaping can help smokers quit,” said Peter Shields, MD, a professor in the department of internal medicine at The Ohio State University College of Medicine, Columbus, who specializes in the treatment of lung cancer.

But a 2013 study published in the Lancet, and another from the Lancet in 2019, found only a modest improvement in cessation outcomes when participants used e-cigarettes paired with patches, compared with patches alone.

“For a disruptive technology that was supposed to end combustible tobacco use, there seems very little large-scale disruption,” said Thomas Eissenberg, PhD, co-director of Virginia Commonwealth University’s Center for the Study of Tobacco Products, Richmond.

Michael Joseph Blaha, MD, MPH, director of clinical research at the Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease, Baltimore, pointed to research that shows a portion of people who start vaping to quit smoking end up using both products – or become so-called “dual” users.

“I do think there is fairly high-quality evidence that vaping can lead to more cessation, but at the tradeoff of more long-term dual users and more overall nicotine addiction,” Dr. Blaha said. “Vaping remains a third-line clinical tool after nicotine replacement therapy and FDA-approved cessation medications.”

The U.S. Food and Drug Administration has not approved any e-cigarette or vaping device for smoking cessation, like it has for patches and gums, which means manufacturers cannot market their products as helping tobacco smokers quit.

“There is potential for vaping as a cessation device, but the evidence so far is too small to say for sure that vaping is a more effective tool than others for combustible tobacco cessation,” Ms. Hanna, from RWJBarnabas Health’s Institute for Prevention and Recovery, said.
 

Reducing harm and improving health?

Vapes have also been touted as a boon to individual and public health since cigarette smoking is the leading cause of preventable disease and disability in the United States, responsible for more than 480,000 deaths per year in the U.S., according to the U.S. Centers for Disease Control and Prevention.

Quitting smoking lowers the risk of developing various cancers, heart disease, stroke, and other serious diseases. The aim of nicotine replacement therapy is to help smokers quit by gradually providing the body with smaller doses of nicotine over time, without exposing the body to toxic chemicals found in cigarettes.

“No one should say that e-cigarettes are safe, but compared to cigarettes, the data is consistent: They are not as harmful, and when a smoker switches, it’s better for them,” Dr. Shields said. “Like with other nicotine replacement therapies, if there is a risk that someone stops vaping and returns to smoking, I would rather have them as long-term vapers since it is generally considered to be less harmful than combustible tobacco.”

The FDA has allowed a handful of companies to market their electronic nicotine delivery systems as safer than traditional cigarettes by gaining approval through the Premarket Tobacco Product Applications process. In 2021, the agency announced its first PMTA authorization of an electronic cigarette to R.J. Reynolds for three of its tobacco-flavored vaping products. Regulators approved more products from three additional companies in 2022.

But the FDA has also denied others, including two products in 2023 from R.J. Reynolds, stating that, “the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health.”

Questions remain among some researchers on the effects of vaping if used long term. Data on the health effects of vapes are just beginning to emerge and are mainly from studies of animals or cells. Measuring health effects among vape users will entail decades more of study, since Americans only gained access to the products in the 2000s.

Dr. Eissenberg said vaping likely does not cause the same diseases as cigarette smoking, but that does not mean they are not harmful. Ingredients found in e-cigarettes, such as heated propylene glycol, vegetable glycerin, and flavors, have only been used as food ingredients. The potential diseases caused by vapes are still unknown, because inhaling these heated ingredients is new. He also said he had “no issue” with an adult smoker vaping to help them quit smoking – as long they do so for a short period.

“I am very concerned that long-term use in adults could lead to considerable disease and death,” Dr. Eissenberg said. “Simply put, the human lung evolved for one purpose: gas exchange of oxygen in, carbon dioxide out. Anything else that enters the lung is a challenge to the organ.”

But Kenneth Warner, PhD, dean emeritus at the University of Michigan School of Public Health, Ann Arbor, said breaking the addiction to traditional cigarettes could reduce high rates of lung cancer in lower income communities where rates of smoking are comparatively high.

About three times as many Americans smoked (12.6%) than vaped (4.7%) in 2021, but those who live in households with lower incomes are more likely to smoke. According to the CDC, use of tobacco is higher among adults who were uninsured (27.3%) or who had Medicaid coverage (28.6%) than among those with private insurance (16.4%). People with annual family incomes of less than $12,500 also are more likely to be diagnosed with lung cancer than those with family incomes of $50,000 or more. Public health researchers have attributed those disparities in part to higher rates of smoking in lower-income households.

Dr. Warner said many lower-income and other Americans may never quit smoking cigarettes because they believe making the switch to e-cigarettes will not benefit their health. A 2022 study, published in the American Journal of Preventive Medicine, found that the percent of Americans who thought vaping was more harmful than smoking quadrupled between 2018 and 2020, from 6.8% to 28.3%. A third of respondents thought vaping was as harmful as smoking.

“We’ve convinced a large percentage of the American public that vaping is as harmful as smoking when it could be helping people quit smoking,” Dr. Warner said. “People are dying right now.”

Ms. Markowitz did quit smoking by taking up vaping. But now she questions if her lung cancer prognosis would have been delayed, or even avoided, if she’d tried a traditional method like a lozenge or gum instead. She vaped once an hour for most of her 7 years of using the devices.

“For people who are trying to stop smoking, I would recommend something like the patch instead,” Ms. Markowitz said.

The Consumer Advocates for Smoke-free Alternatives receives funding from the vaping industry. Dr. Blaha, Dr. Eissenberg, Ms. Hanna, Dr. Shields, and Dr. Warner reported no funding from the tobacco or e-cigarette industry. Dr. Blaha and Dr. Warner receive tobacco-related research funding from the FDA. Dr. Warner is a member of the FDA’s Tobacco Products Scientific Advisory Committee.

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

In 2014, after smoking cigarettes for 40 years, Kati Markowitz decided to switch to vaping. She had heard the newer electronic cigarettes might be less harmful. And, at the time, she said, she wasn’t aware of other options to try to quit smoking.

For 7 years, she vaped every day.

Then Ms. Markowitz received news she’d hoped never to hear: She had lung cancer. A nodule detected in a CT scan had grown. She was scheduled for treatment – the removal of an entire lobe from her right lung. But first, she said, her surgeon told her she had to quit vaping, which reduces the risk for post-operative complications and enables a healthy recovery.

Ms. Markowitz had thought switching to vaping would be less harmful than smoking cigarettes. Now, she no longer believes that’s true.

“Did I fool myself by hoping to get lucky and not have any bad repercussions? Yes, I did,” Ms. Markowitz said, adding that she wonders if vaping contributed to her lung cancer or if she’ll experience other negative health effects in the future.

Researchers are divided on if e-cigarettes are as effective in smoking cessation as other nicotine replacement therapies like gums and lozenges. They also say more research is needed on the long-term health impacts of vaping to ultimately determine if vapes are a safe replacement for cigarettes.

“There is scientific research to support vaping as a cessation tool, but we wouldn’t use it as a first line of defense because we still need longitudinal studies to understand the long-term risk of e-cigarettes,” said Monica Hanna, MPH, assistant director of the Nicotine and Tobacco Recovery Program at RWJBarnabas Health’s Institute for Prevention and Recovery, Eatontown, N.J. “We also need research to understand exactly how we could use e-cigarettes as a cessation device.”
 

Vaping to quit

The first prototypes of e-cigarettes were developed in the 1930s, although what are now known as vapes weren’t sold by manufacturers until the 2000s in the United States, following an invention by a former health official in China. The vape was touted by both researchers and manufacturers over the years of development as a way to quit smoking cigarettes.

The Consumer Advocates for Smoke-free Alternatives Association, a nonprofit group that supports vaping and accepts donations from the e-cigarette industry, has compiled more than 13,000 testimonials from people who say vaping helped them give up smoking.

Studies show mixed results that using vapes can help traditional smokers quit.

A November 2022 Cochrane review showed a “high certainty of evidence that people are more likely to stop smoking traditional cigarettes for at least 6 months using e-cigarettes, or ‘vapes,’ than using nicotine replacement therapies, such as patches and gums.” The meta-analysis examined 78 studies with more than 22,000 participants. And a 2019 study with 886 participants, published in the New England Journal Medicine, found smokers who tried vaping to quit were twice as likely after a year to have stopped smoking cigarettes than those who used nicotine replacement therapy.

“In terms of the global research, it’s pretty clear that vaping can help smokers quit,” said Peter Shields, MD, a professor in the department of internal medicine at The Ohio State University College of Medicine, Columbus, who specializes in the treatment of lung cancer.

But a 2013 study published in the Lancet, and another from the Lancet in 2019, found only a modest improvement in cessation outcomes when participants used e-cigarettes paired with patches, compared with patches alone.

“For a disruptive technology that was supposed to end combustible tobacco use, there seems very little large-scale disruption,” said Thomas Eissenberg, PhD, co-director of Virginia Commonwealth University’s Center for the Study of Tobacco Products, Richmond.

Michael Joseph Blaha, MD, MPH, director of clinical research at the Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease, Baltimore, pointed to research that shows a portion of people who start vaping to quit smoking end up using both products – or become so-called “dual” users.

“I do think there is fairly high-quality evidence that vaping can lead to more cessation, but at the tradeoff of more long-term dual users and more overall nicotine addiction,” Dr. Blaha said. “Vaping remains a third-line clinical tool after nicotine replacement therapy and FDA-approved cessation medications.”

The U.S. Food and Drug Administration has not approved any e-cigarette or vaping device for smoking cessation, like it has for patches and gums, which means manufacturers cannot market their products as helping tobacco smokers quit.

“There is potential for vaping as a cessation device, but the evidence so far is too small to say for sure that vaping is a more effective tool than others for combustible tobacco cessation,” Ms. Hanna, from RWJBarnabas Health’s Institute for Prevention and Recovery, said.
 

Reducing harm and improving health?

Vapes have also been touted as a boon to individual and public health since cigarette smoking is the leading cause of preventable disease and disability in the United States, responsible for more than 480,000 deaths per year in the U.S., according to the U.S. Centers for Disease Control and Prevention.

Quitting smoking lowers the risk of developing various cancers, heart disease, stroke, and other serious diseases. The aim of nicotine replacement therapy is to help smokers quit by gradually providing the body with smaller doses of nicotine over time, without exposing the body to toxic chemicals found in cigarettes.

“No one should say that e-cigarettes are safe, but compared to cigarettes, the data is consistent: They are not as harmful, and when a smoker switches, it’s better for them,” Dr. Shields said. “Like with other nicotine replacement therapies, if there is a risk that someone stops vaping and returns to smoking, I would rather have them as long-term vapers since it is generally considered to be less harmful than combustible tobacco.”

The FDA has allowed a handful of companies to market their electronic nicotine delivery systems as safer than traditional cigarettes by gaining approval through the Premarket Tobacco Product Applications process. In 2021, the agency announced its first PMTA authorization of an electronic cigarette to R.J. Reynolds for three of its tobacco-flavored vaping products. Regulators approved more products from three additional companies in 2022.

But the FDA has also denied others, including two products in 2023 from R.J. Reynolds, stating that, “the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health.”

Questions remain among some researchers on the effects of vaping if used long term. Data on the health effects of vapes are just beginning to emerge and are mainly from studies of animals or cells. Measuring health effects among vape users will entail decades more of study, since Americans only gained access to the products in the 2000s.

Dr. Eissenberg said vaping likely does not cause the same diseases as cigarette smoking, but that does not mean they are not harmful. Ingredients found in e-cigarettes, such as heated propylene glycol, vegetable glycerin, and flavors, have only been used as food ingredients. The potential diseases caused by vapes are still unknown, because inhaling these heated ingredients is new. He also said he had “no issue” with an adult smoker vaping to help them quit smoking – as long they do so for a short period.

“I am very concerned that long-term use in adults could lead to considerable disease and death,” Dr. Eissenberg said. “Simply put, the human lung evolved for one purpose: gas exchange of oxygen in, carbon dioxide out. Anything else that enters the lung is a challenge to the organ.”

But Kenneth Warner, PhD, dean emeritus at the University of Michigan School of Public Health, Ann Arbor, said breaking the addiction to traditional cigarettes could reduce high rates of lung cancer in lower income communities where rates of smoking are comparatively high.

About three times as many Americans smoked (12.6%) than vaped (4.7%) in 2021, but those who live in households with lower incomes are more likely to smoke. According to the CDC, use of tobacco is higher among adults who were uninsured (27.3%) or who had Medicaid coverage (28.6%) than among those with private insurance (16.4%). People with annual family incomes of less than $12,500 also are more likely to be diagnosed with lung cancer than those with family incomes of $50,000 or more. Public health researchers have attributed those disparities in part to higher rates of smoking in lower-income households.

Dr. Warner said many lower-income and other Americans may never quit smoking cigarettes because they believe making the switch to e-cigarettes will not benefit their health. A 2022 study, published in the American Journal of Preventive Medicine, found that the percent of Americans who thought vaping was more harmful than smoking quadrupled between 2018 and 2020, from 6.8% to 28.3%. A third of respondents thought vaping was as harmful as smoking.

“We’ve convinced a large percentage of the American public that vaping is as harmful as smoking when it could be helping people quit smoking,” Dr. Warner said. “People are dying right now.”

Ms. Markowitz did quit smoking by taking up vaping. But now she questions if her lung cancer prognosis would have been delayed, or even avoided, if she’d tried a traditional method like a lozenge or gum instead. She vaped once an hour for most of her 7 years of using the devices.

“For people who are trying to stop smoking, I would recommend something like the patch instead,” Ms. Markowitz said.

The Consumer Advocates for Smoke-free Alternatives receives funding from the vaping industry. Dr. Blaha, Dr. Eissenberg, Ms. Hanna, Dr. Shields, and Dr. Warner reported no funding from the tobacco or e-cigarette industry. Dr. Blaha and Dr. Warner receive tobacco-related research funding from the FDA. Dr. Warner is a member of the FDA’s Tobacco Products Scientific Advisory Committee.

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

Life expectancy in New York City fell to 78 years from 2019 to 2020, a 4.6-year drop mostly caused by the COVID-19 pandemic, NYC Health said in releasing its annual summary of vital statistics. 

Non-White demographic groups had the highest drops. Life expectancy fell to 73 years for Black New Yorkers (a 5.5-year drop from 2019) and 77.3 years for Hispanic/Latino New Yorkers (a 6-year drop.) For White New Yorkers life expectancy only fell to 80.1 years (about a 3-year drop.)

Overall, the city had a mortality rate of 241.3 deaths per 100,000 population in 2020. That’s even higher than the 228.9 deaths per 100,000 reported during the 2018 influenza pandemic, NYC Health said in a news release. 

“The sharp decline in life expectancy from 2019 was largely due to the COVID-19 pandemic,” said NYC Health Commissioner Ashwin Vasan, MD.

Another factor was a 42.2% rise in unintentional drug overdoses from 2019 to 2020. Again, racial disparities were highlighted, with the drug-related death rate highest among Black New Yorkers.

The pandemic also affected the premature death rate, meaning deaths before age 65. That rate went up 48.8% from 2019 to 2020. In the 8 previous years, from 2011 to 2019, it fell 8.6%“New Yorkers’ lifespans are falling, on top of years of relative flattening before COVID, and that cannot continue,” Dr. Vasan said in a news release. 

“It is the great challenge of our time, our city, and our Department to lay out an agenda for the next era of public health, to reverse these trends, and set us out on a new path where all New Yorkers can lead healthier, longer lives,” Dr. Vasan said.

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

Life expectancy in New York City fell to 78 years from 2019 to 2020, a 4.6-year drop mostly caused by the COVID-19 pandemic, NYC Health said in releasing its annual summary of vital statistics. 

Non-White demographic groups had the highest drops. Life expectancy fell to 73 years for Black New Yorkers (a 5.5-year drop from 2019) and 77.3 years for Hispanic/Latino New Yorkers (a 6-year drop.) For White New Yorkers life expectancy only fell to 80.1 years (about a 3-year drop.)

Overall, the city had a mortality rate of 241.3 deaths per 100,000 population in 2020. That’s even higher than the 228.9 deaths per 100,000 reported during the 2018 influenza pandemic, NYC Health said in a news release. 

“The sharp decline in life expectancy from 2019 was largely due to the COVID-19 pandemic,” said NYC Health Commissioner Ashwin Vasan, MD.

Another factor was a 42.2% rise in unintentional drug overdoses from 2019 to 2020. Again, racial disparities were highlighted, with the drug-related death rate highest among Black New Yorkers.

The pandemic also affected the premature death rate, meaning deaths before age 65. That rate went up 48.8% from 2019 to 2020. In the 8 previous years, from 2011 to 2019, it fell 8.6%“New Yorkers’ lifespans are falling, on top of years of relative flattening before COVID, and that cannot continue,” Dr. Vasan said in a news release. 

“It is the great challenge of our time, our city, and our Department to lay out an agenda for the next era of public health, to reverse these trends, and set us out on a new path where all New Yorkers can lead healthier, longer lives,” Dr. Vasan said.

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

Life expectancy in New York City fell to 78 years from 2019 to 2020, a 4.6-year drop mostly caused by the COVID-19 pandemic, NYC Health said in releasing its annual summary of vital statistics. 

Non-White demographic groups had the highest drops. Life expectancy fell to 73 years for Black New Yorkers (a 5.5-year drop from 2019) and 77.3 years for Hispanic/Latino New Yorkers (a 6-year drop.) For White New Yorkers life expectancy only fell to 80.1 years (about a 3-year drop.)

Overall, the city had a mortality rate of 241.3 deaths per 100,000 population in 2020. That’s even higher than the 228.9 deaths per 100,000 reported during the 2018 influenza pandemic, NYC Health said in a news release. 

“The sharp decline in life expectancy from 2019 was largely due to the COVID-19 pandemic,” said NYC Health Commissioner Ashwin Vasan, MD.

Another factor was a 42.2% rise in unintentional drug overdoses from 2019 to 2020. Again, racial disparities were highlighted, with the drug-related death rate highest among Black New Yorkers.

The pandemic also affected the premature death rate, meaning deaths before age 65. That rate went up 48.8% from 2019 to 2020. In the 8 previous years, from 2011 to 2019, it fell 8.6%“New Yorkers’ lifespans are falling, on top of years of relative flattening before COVID, and that cannot continue,” Dr. Vasan said in a news release. 

“It is the great challenge of our time, our city, and our Department to lay out an agenda for the next era of public health, to reverse these trends, and set us out on a new path where all New Yorkers can lead healthier, longer lives,” Dr. Vasan said.

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

PHOENIX – During the incidental treatment of melanocytic nevi during laser hair removal, common clinical changes include regression and decreased size, while common histologic changes include mild atypia and thermal damage, according to results from a systematic review of literature on the topic. To date, no severe cases of severe dysplasia or melanoma have been reported.

“That’s reassuring,” study author Ahuva Cices, MD, said in an interview at the annual conference of the American Society for Laser Medicine and Surgery, where she presented the results during an abstract session. “But, with that in mind, we want to avoid treating nevi with laser hair removal to avoid changes that could be concerning. We also recommend baseline skin exams so we know what we’re looking at before we start treating with lasers, and any changes can be recognized from that baseline status. It’s important to keep an eye out for changes and always be evaluating.”

Doug Brunk/MDedge News

In December of 2022, Dr. Cices, chief dermatology resident at Mount Sinai Health System, New York, searched PubMed for articles that evaluated changes in melanocytic nevi after laser hair removal procedures. She used the search terms “nevi laser hair removal,” “nevi diode,” “nevi long pulse alexandrite,” “nevi long pulse neodymium doped yttrium aluminum garnet,” and “melanoma laser hair removal,” and limited the analysis to English language patient-based reports that discussed incidental treatment of melanocytic nevi while undergoing hair removal with a laser.

Reports excluded from the analysis were those that focused on changes following hair removal with nonlaser devices such as intense pulsed light (IPL), those evaluating nonmelanocytic nevi such as Becker’s nevus or nevus of Ota, and those evaluating the intentional ablation or removal of melanocytic lesions.

The search yielded 10 relevant studies for systematic review: seven case reports or series and three observational trials, two of which were prospective and one retrospective.

The results of the review, according to Dr. Cices, revealed that clinical and dermoscopic changes were noted to present as early as 15 days after treatment and persist to the maximum follow up time, at 3 years. Commonly reported changes included regression, decreased size, laser-induced asymmetry, bleaching, darkening, and altered pattern on dermoscopy. Histologic changes included mild atypia, thermal damage, scar formation, and regression.

“Although some of the clinical and dermoscopic alterations may be concerning for malignancy, to our knowledge, there are no documented cases of malignant transformation of nevi following treatment with laser hair removal,” she wrote in the abstract.

Dr. Cices acknowledged certain limitations of the systematic review, including the low number of relevant reports and their generally small sample size, many of which were limited to single cases.

Omar A. Ibrahimi, MD, PhD, medical director of the Connecticut Skin Institute, Stamford, who was asked to comment on the review, characterized the findings as important because laser hair removal is such a commonly performed procedure.

While the study is limited by the small number of studies on the subject matter, “it brings up an important discussion,” Dr. Ibrahimi said in an interview. “Generally speaking, we know that most hair removal lasers do indeed target melanin pigment and can be absorbed by melanocytes. While the wavelengths used for LHR [laser hair removal] will not result in DNA damage or cause mutations that can lead to melanoma, they can sometimes alter the appearance of pigmented lesions and that may change the dermatologist’s ability to monitor them for atypia,” he noted.

“For that reason, I would recommend all patients see a dermatologist for evaluation of their nevi prior to any treatments and they consider very carefully where they get their laser treatments. If they have any atypical pigmented lesions, then that information should be disclosed with the person performing the laser hair removal procedure particularly if there are lesions that are being specifically monitored.”

Dr. Cices reported having no disclosures. Dr. Ibrahimi disclosed that he is a member of the advisory board for Accure Acne, AbbVie, Cutera, Lutronic, Blueberry Therapeutics, Cytrellis, and Quthero. He also holds stock in many device and pharmaceutical companies.

PHOENIX – During the incidental treatment of melanocytic nevi during laser hair removal, common clinical changes include regression and decreased size, while common histologic changes include mild atypia and thermal damage, according to results from a systematic review of literature on the topic. To date, no severe cases of severe dysplasia or melanoma have been reported.

“That’s reassuring,” study author Ahuva Cices, MD, said in an interview at the annual conference of the American Society for Laser Medicine and Surgery, where she presented the results during an abstract session. “But, with that in mind, we want to avoid treating nevi with laser hair removal to avoid changes that could be concerning. We also recommend baseline skin exams so we know what we’re looking at before we start treating with lasers, and any changes can be recognized from that baseline status. It’s important to keep an eye out for changes and always be evaluating.”

Doug Brunk/MDedge News

In December of 2022, Dr. Cices, chief dermatology resident at Mount Sinai Health System, New York, searched PubMed for articles that evaluated changes in melanocytic nevi after laser hair removal procedures. She used the search terms “nevi laser hair removal,” “nevi diode,” “nevi long pulse alexandrite,” “nevi long pulse neodymium doped yttrium aluminum garnet,” and “melanoma laser hair removal,” and limited the analysis to English language patient-based reports that discussed incidental treatment of melanocytic nevi while undergoing hair removal with a laser.

Reports excluded from the analysis were those that focused on changes following hair removal with nonlaser devices such as intense pulsed light (IPL), those evaluating nonmelanocytic nevi such as Becker’s nevus or nevus of Ota, and those evaluating the intentional ablation or removal of melanocytic lesions.

The search yielded 10 relevant studies for systematic review: seven case reports or series and three observational trials, two of which were prospective and one retrospective.

The results of the review, according to Dr. Cices, revealed that clinical and dermoscopic changes were noted to present as early as 15 days after treatment and persist to the maximum follow up time, at 3 years. Commonly reported changes included regression, decreased size, laser-induced asymmetry, bleaching, darkening, and altered pattern on dermoscopy. Histologic changes included mild atypia, thermal damage, scar formation, and regression.

“Although some of the clinical and dermoscopic alterations may be concerning for malignancy, to our knowledge, there are no documented cases of malignant transformation of nevi following treatment with laser hair removal,” she wrote in the abstract.

Dr. Cices acknowledged certain limitations of the systematic review, including the low number of relevant reports and their generally small sample size, many of which were limited to single cases.

Omar A. Ibrahimi, MD, PhD, medical director of the Connecticut Skin Institute, Stamford, who was asked to comment on the review, characterized the findings as important because laser hair removal is such a commonly performed procedure.

While the study is limited by the small number of studies on the subject matter, “it brings up an important discussion,” Dr. Ibrahimi said in an interview. “Generally speaking, we know that most hair removal lasers do indeed target melanin pigment and can be absorbed by melanocytes. While the wavelengths used for LHR [laser hair removal] will not result in DNA damage or cause mutations that can lead to melanoma, they can sometimes alter the appearance of pigmented lesions and that may change the dermatologist’s ability to monitor them for atypia,” he noted.

“For that reason, I would recommend all patients see a dermatologist for evaluation of their nevi prior to any treatments and they consider very carefully where they get their laser treatments. If they have any atypical pigmented lesions, then that information should be disclosed with the person performing the laser hair removal procedure particularly if there are lesions that are being specifically monitored.”

Dr. Cices reported having no disclosures. Dr. Ibrahimi disclosed that he is a member of the advisory board for Accure Acne, AbbVie, Cutera, Lutronic, Blueberry Therapeutics, Cytrellis, and Quthero. He also holds stock in many device and pharmaceutical companies.

PHOENIX – During the incidental treatment of melanocytic nevi during laser hair removal, common clinical changes include regression and decreased size, while common histologic changes include mild atypia and thermal damage, according to results from a systematic review of literature on the topic. To date, no severe cases of severe dysplasia or melanoma have been reported.

“That’s reassuring,” study author Ahuva Cices, MD, said in an interview at the annual conference of the American Society for Laser Medicine and Surgery, where she presented the results during an abstract session. “But, with that in mind, we want to avoid treating nevi with laser hair removal to avoid changes that could be concerning. We also recommend baseline skin exams so we know what we’re looking at before we start treating with lasers, and any changes can be recognized from that baseline status. It’s important to keep an eye out for changes and always be evaluating.”

Doug Brunk/MDedge News

In December of 2022, Dr. Cices, chief dermatology resident at Mount Sinai Health System, New York, searched PubMed for articles that evaluated changes in melanocytic nevi after laser hair removal procedures. She used the search terms “nevi laser hair removal,” “nevi diode,” “nevi long pulse alexandrite,” “nevi long pulse neodymium doped yttrium aluminum garnet,” and “melanoma laser hair removal,” and limited the analysis to English language patient-based reports that discussed incidental treatment of melanocytic nevi while undergoing hair removal with a laser.

Reports excluded from the analysis were those that focused on changes following hair removal with nonlaser devices such as intense pulsed light (IPL), those evaluating nonmelanocytic nevi such as Becker’s nevus or nevus of Ota, and those evaluating the intentional ablation or removal of melanocytic lesions.

The search yielded 10 relevant studies for systematic review: seven case reports or series and three observational trials, two of which were prospective and one retrospective.

The results of the review, according to Dr. Cices, revealed that clinical and dermoscopic changes were noted to present as early as 15 days after treatment and persist to the maximum follow up time, at 3 years. Commonly reported changes included regression, decreased size, laser-induced asymmetry, bleaching, darkening, and altered pattern on dermoscopy. Histologic changes included mild atypia, thermal damage, scar formation, and regression.

“Although some of the clinical and dermoscopic alterations may be concerning for malignancy, to our knowledge, there are no documented cases of malignant transformation of nevi following treatment with laser hair removal,” she wrote in the abstract.

Dr. Cices acknowledged certain limitations of the systematic review, including the low number of relevant reports and their generally small sample size, many of which were limited to single cases.

Omar A. Ibrahimi, MD, PhD, medical director of the Connecticut Skin Institute, Stamford, who was asked to comment on the review, characterized the findings as important because laser hair removal is such a commonly performed procedure.

While the study is limited by the small number of studies on the subject matter, “it brings up an important discussion,” Dr. Ibrahimi said in an interview. “Generally speaking, we know that most hair removal lasers do indeed target melanin pigment and can be absorbed by melanocytes. While the wavelengths used for LHR [laser hair removal] will not result in DNA damage or cause mutations that can lead to melanoma, they can sometimes alter the appearance of pigmented lesions and that may change the dermatologist’s ability to monitor them for atypia,” he noted.

“For that reason, I would recommend all patients see a dermatologist for evaluation of their nevi prior to any treatments and they consider very carefully where they get their laser treatments. If they have any atypical pigmented lesions, then that information should be disclosed with the person performing the laser hair removal procedure particularly if there are lesions that are being specifically monitored.”

Dr. Cices reported having no disclosures. Dr. Ibrahimi disclosed that he is a member of the advisory board for Accure Acne, AbbVie, Cutera, Lutronic, Blueberry Therapeutics, Cytrellis, and Quthero. He also holds stock in many device and pharmaceutical companies.

Both pain relief and neurological improvements persisted in patients with diabetic neuropathy 2 years after they began receiving treatment with 10 kHz of spinal cord stimulation, according to research that released early, prior to its presentation at the annual meeting of the American Academy of Neurology.

The data represents the longest follow-up available for spinal cord stimulation at a frequency higher than the 60 Hz initially approved for diabetic neuropathy by the Food and Drug Administration, according to lead author Erika A. Petersen, MD, a professor of neurosurgery and the residency program director at the University of Arkansas for Medical Sciences, Little Rock.

University of Arkansas

“You would expect that somebody who continues to have diabetes for 24 months and has neuropathy would have worse neuropathy after 2 years, and what we’re seeing is that people were stable or better in terms of their nerve function at 2 years,” Dr. Petersen said in an interview. “So that’s really revolutionary.”
 

Encouraging preliminary findings

The findings are “promising and preliminary,” John D. Markman, MD, a professor in neurology and neurosurgery, vice chair for clinical research, and director of the Translational Pain Research Program at the University of Rochester (N.Y.) Medical Center, said in an interview. Dr. Markman, who was not involved in this study, said that, though the results are encouraging, it’s “less clear how much of [the pain improvement] is due to what we would consider to be on-target, pain-relieving benefit from stimulation versus other factors like expectation.” The crossover rate and amount of reduction in pain intensity are promising, but “I think that excitement is weighed against the fact that this is an open-label study.”

An underused treatment

Although spinal cord stimulation has been around since the late 1960s, its use only picked up steam in the 2000s, when it became more frequently used to treat chronic nerve damage related to neuropathic pain syndromes, Dr. Petersen explained. The FDA approved the treatment’s new indication for diabetic neuropathy in 2015, and data from Abbott and Medtronic have shown benefits from spinal cord stimulation at 60 Hz, but some patients are uncomfortable with the vibration or tingling feelings the devices can cause at that frequency.

“They describe creepy crawlies or ants crawling over the feet, or pins and needles, and painful sensitivity,” Dr. Petersen said. “You create a vibration feeling in the same zone where they already have those feelings of buzzing and pain and vibration, and it’s sometimes actually even more uncomfortable and less satisfying to them in terms of relief” with the spinal cord stimulation at 60 Hz, she said, “so there’s a lot of attrition in terms of who will actually use it.”

At 10 kHz, however, “people don’t feel any vibration or tingling associated with it; it just jams the signal of the pain,” she said. The difference between the frequencies is like that between “a lifeguard whistle and a dog whistle.”
 

Testing high-frequency stimulation

The new findings included the 24-month follow-up data from a randomized controlled trial that assessed the effectiveness of high-frequency spinal cord stimulation for painful diabetic neuropathy. The original 216 participants enrolled in the trial had diabetic neuropathy symptoms for at least 12 months and either could no not tolerate or did not respond to medications. Enrollment criteria also included lower-limb pain intensity of at least 5 on a 0-10 visual analogy scale and hemoglobin A1c of no more than 10%.

For the first 6 months of the trial – before crossover was offered – participants were randomly assigned to receive either 10 kHz of spinal cord stimulation along with conventional medical management or to receive conventional medical management alone. The 6-month data from 187 patients, as reported in April 2021 in JAMA Neurology, revealed that 79% of those receiving spinal cord stimulation experienced at least 50% improved pain relief without worsening of their baseline neurologic deficits, compared with only 5% of those receiving only conventional treatments.

Average pain levels increased 2% in the control participants compared with a decrease of 76% in those with the spinal cord stimulation devices. In addition, 62% of the patients receiving spinal cord stimulation demonstration neurologic improvement in reflexes, strength, movement and sensation, compared with 3% of those in the control group. The study’s findings led the FDA to approve the device using 10 kHz.

At 6 months, 93% of control patients crossed over to receiving spinal cord stimulation while none with the devices opted to stop their spinal cord stimulation. The 12-month data revealed that 85% of those receiving spinal cord stimulation experienced at least 50% pain relief, with the average pain relief at 74%. Patients also reported statistically significant improved quality of life as well as less interference with sleep, mood, and daily activities from pain.

Two years after baseline, patients’ pain relief was maintained with average 80% improvement, and 66% of patients showed neurologic improvement since baseline. Though no patients had devices removed because of ineffectiveness, five patients’ devices were removed because of infection while infections in three other patients resolved.

“Being able to offer something that is not a pharmaceutical, without the side effects, that shows an even longer durability to that response is a really important finding at this point,” Dr. Petersen said.
 

Surgical considerations

Among the estimated 37 million Americans with type 1 or 2 diabetes, approximately one quarter of them experience some level of painful diabetic neuropathy, but medication and other medical management strategies are not always adequate in treating their pain. After a 1-week trial of spinal cord stimulation, the devices are implanted under the skin and rechargeable through the skin for up to 10 years, after which they can be replaced.

An appropriate candidate for spinal cord stimulation would be someone for whom existing non-invasive pain relief options, including medications, are ineffective or intolerable, Dr. Petersen and Dr. Markman both said. An adequate trial of medication is not “one size fits all” and will vary by each patient, added Dr. Markman, who is also interested in whether this study’s participants were able to have a reduction in use of pain relief medications.

“I think there’s a significant number of patients out there who can benefit from this, so I think that’s why it’s promising and exciting,” Dr. Markman said. “I do think it’s important to see if this actually allows them to be on less medication or whether stimulation turns out to be another treatment in addition to their baseline treatments.” The challenge is identifying “which patients are most likely to be benefiting from this and which are most likely to be harmed.”

Aside from infection from implantation, other possible risks include pain at the battery site and, in rare cases, a need for reoperation because of migration of the leads, he said.
 

Improvement in symptom severity and quality of life

After the wound from the implant has completely healed, Dr. Petersen said patients using the devices do not have any activity restrictions outside of magnetic interference, such as MRIs. “I’ve had people go back-country kayaking, scuba diving, fishing with their grandkids, all sorts of all sorts of things. If patients need to go through a scanner of any kind, they should ask whether it’s safe for pacemakers since these devices are like a “pacemaker for pain.

“I had a patient bring solar chargers with him so that he could recharge his battery in the backwoods while kayaking because that’s the level of improvement in pain that he got – from barely being able to walk down the hall to feeling comfortable being off the grid and active again,” Dr. Petersen said. “Those kinds of improvements in quality of life are massive.”

The study findings may also suggest that spinal cord stimulation can benefit a broader population of patients experiencing neuropathic pain, Dr. Markman said.

“There’s an extraordinary unmet need for treatments for neuropathy, and one important question here is the extent to which diabetic peripheral neuropathy and the response that we’re seeing here is a proxy for a broader effect across many neuropathies that are caused by other conditions other than diabetes,” Dr. Markman said. “There’s a lot of reason to think that this will be helpful not just for diabetes-related neuropathic pain, but for other types of neuropathic pain that have similar clinical presentations or clinical symptom patterns to diabetic peripheral neuropathy.”

The study was funded by Nevro, who manufactures the devices. Dr. Petersen and Dr. Markman both reported consulting with, receiving support from, holding stock options with, and serving on the data safety monitoring boards and advisory boards of numerous pharmaceutical companies.

Both pain relief and neurological improvements persisted in patients with diabetic neuropathy 2 years after they began receiving treatment with 10 kHz of spinal cord stimulation, according to research that released early, prior to its presentation at the annual meeting of the American Academy of Neurology.

The data represents the longest follow-up available for spinal cord stimulation at a frequency higher than the 60 Hz initially approved for diabetic neuropathy by the Food and Drug Administration, according to lead author Erika A. Petersen, MD, a professor of neurosurgery and the residency program director at the University of Arkansas for Medical Sciences, Little Rock.

University of Arkansas

“You would expect that somebody who continues to have diabetes for 24 months and has neuropathy would have worse neuropathy after 2 years, and what we’re seeing is that people were stable or better in terms of their nerve function at 2 years,” Dr. Petersen said in an interview. “So that’s really revolutionary.”
 

Encouraging preliminary findings

The findings are “promising and preliminary,” John D. Markman, MD, a professor in neurology and neurosurgery, vice chair for clinical research, and director of the Translational Pain Research Program at the University of Rochester (N.Y.) Medical Center, said in an interview. Dr. Markman, who was not involved in this study, said that, though the results are encouraging, it’s “less clear how much of [the pain improvement] is due to what we would consider to be on-target, pain-relieving benefit from stimulation versus other factors like expectation.” The crossover rate and amount of reduction in pain intensity are promising, but “I think that excitement is weighed against the fact that this is an open-label study.”

An underused treatment

Although spinal cord stimulation has been around since the late 1960s, its use only picked up steam in the 2000s, when it became more frequently used to treat chronic nerve damage related to neuropathic pain syndromes, Dr. Petersen explained. The FDA approved the treatment’s new indication for diabetic neuropathy in 2015, and data from Abbott and Medtronic have shown benefits from spinal cord stimulation at 60 Hz, but some patients are uncomfortable with the vibration or tingling feelings the devices can cause at that frequency.

“They describe creepy crawlies or ants crawling over the feet, or pins and needles, and painful sensitivity,” Dr. Petersen said. “You create a vibration feeling in the same zone where they already have those feelings of buzzing and pain and vibration, and it’s sometimes actually even more uncomfortable and less satisfying to them in terms of relief” with the spinal cord stimulation at 60 Hz, she said, “so there’s a lot of attrition in terms of who will actually use it.”

At 10 kHz, however, “people don’t feel any vibration or tingling associated with it; it just jams the signal of the pain,” she said. The difference between the frequencies is like that between “a lifeguard whistle and a dog whistle.”
 

Testing high-frequency stimulation

The new findings included the 24-month follow-up data from a randomized controlled trial that assessed the effectiveness of high-frequency spinal cord stimulation for painful diabetic neuropathy. The original 216 participants enrolled in the trial had diabetic neuropathy symptoms for at least 12 months and either could no not tolerate or did not respond to medications. Enrollment criteria also included lower-limb pain intensity of at least 5 on a 0-10 visual analogy scale and hemoglobin A1c of no more than 10%.

For the first 6 months of the trial – before crossover was offered – participants were randomly assigned to receive either 10 kHz of spinal cord stimulation along with conventional medical management or to receive conventional medical management alone. The 6-month data from 187 patients, as reported in April 2021 in JAMA Neurology, revealed that 79% of those receiving spinal cord stimulation experienced at least 50% improved pain relief without worsening of their baseline neurologic deficits, compared with only 5% of those receiving only conventional treatments.

Average pain levels increased 2% in the control participants compared with a decrease of 76% in those with the spinal cord stimulation devices. In addition, 62% of the patients receiving spinal cord stimulation demonstration neurologic improvement in reflexes, strength, movement and sensation, compared with 3% of those in the control group. The study’s findings led the FDA to approve the device using 10 kHz.

At 6 months, 93% of control patients crossed over to receiving spinal cord stimulation while none with the devices opted to stop their spinal cord stimulation. The 12-month data revealed that 85% of those receiving spinal cord stimulation experienced at least 50% pain relief, with the average pain relief at 74%. Patients also reported statistically significant improved quality of life as well as less interference with sleep, mood, and daily activities from pain.

Two years after baseline, patients’ pain relief was maintained with average 80% improvement, and 66% of patients showed neurologic improvement since baseline. Though no patients had devices removed because of ineffectiveness, five patients’ devices were removed because of infection while infections in three other patients resolved.

“Being able to offer something that is not a pharmaceutical, without the side effects, that shows an even longer durability to that response is a really important finding at this point,” Dr. Petersen said.
 

Surgical considerations

Among the estimated 37 million Americans with type 1 or 2 diabetes, approximately one quarter of them experience some level of painful diabetic neuropathy, but medication and other medical management strategies are not always adequate in treating their pain. After a 1-week trial of spinal cord stimulation, the devices are implanted under the skin and rechargeable through the skin for up to 10 years, after which they can be replaced.

An appropriate candidate for spinal cord stimulation would be someone for whom existing non-invasive pain relief options, including medications, are ineffective or intolerable, Dr. Petersen and Dr. Markman both said. An adequate trial of medication is not “one size fits all” and will vary by each patient, added Dr. Markman, who is also interested in whether this study’s participants were able to have a reduction in use of pain relief medications.

“I think there’s a significant number of patients out there who can benefit from this, so I think that’s why it’s promising and exciting,” Dr. Markman said. “I do think it’s important to see if this actually allows them to be on less medication or whether stimulation turns out to be another treatment in addition to their baseline treatments.” The challenge is identifying “which patients are most likely to be benefiting from this and which are most likely to be harmed.”

Aside from infection from implantation, other possible risks include pain at the battery site and, in rare cases, a need for reoperation because of migration of the leads, he said.
 

Improvement in symptom severity and quality of life

After the wound from the implant has completely healed, Dr. Petersen said patients using the devices do not have any activity restrictions outside of magnetic interference, such as MRIs. “I’ve had people go back-country kayaking, scuba diving, fishing with their grandkids, all sorts of all sorts of things. If patients need to go through a scanner of any kind, they should ask whether it’s safe for pacemakers since these devices are like a “pacemaker for pain.

“I had a patient bring solar chargers with him so that he could recharge his battery in the backwoods while kayaking because that’s the level of improvement in pain that he got – from barely being able to walk down the hall to feeling comfortable being off the grid and active again,” Dr. Petersen said. “Those kinds of improvements in quality of life are massive.”

The study findings may also suggest that spinal cord stimulation can benefit a broader population of patients experiencing neuropathic pain, Dr. Markman said.

“There’s an extraordinary unmet need for treatments for neuropathy, and one important question here is the extent to which diabetic peripheral neuropathy and the response that we’re seeing here is a proxy for a broader effect across many neuropathies that are caused by other conditions other than diabetes,” Dr. Markman said. “There’s a lot of reason to think that this will be helpful not just for diabetes-related neuropathic pain, but for other types of neuropathic pain that have similar clinical presentations or clinical symptom patterns to diabetic peripheral neuropathy.”

The study was funded by Nevro, who manufactures the devices. Dr. Petersen and Dr. Markman both reported consulting with, receiving support from, holding stock options with, and serving on the data safety monitoring boards and advisory boards of numerous pharmaceutical companies.

Both pain relief and neurological improvements persisted in patients with diabetic neuropathy 2 years after they began receiving treatment with 10 kHz of spinal cord stimulation, according to research that released early, prior to its presentation at the annual meeting of the American Academy of Neurology.

The data represents the longest follow-up available for spinal cord stimulation at a frequency higher than the 60 Hz initially approved for diabetic neuropathy by the Food and Drug Administration, according to lead author Erika A. Petersen, MD, a professor of neurosurgery and the residency program director at the University of Arkansas for Medical Sciences, Little Rock.

University of Arkansas

“You would expect that somebody who continues to have diabetes for 24 months and has neuropathy would have worse neuropathy after 2 years, and what we’re seeing is that people were stable or better in terms of their nerve function at 2 years,” Dr. Petersen said in an interview. “So that’s really revolutionary.”
 

Encouraging preliminary findings

The findings are “promising and preliminary,” John D. Markman, MD, a professor in neurology and neurosurgery, vice chair for clinical research, and director of the Translational Pain Research Program at the University of Rochester (N.Y.) Medical Center, said in an interview. Dr. Markman, who was not involved in this study, said that, though the results are encouraging, it’s “less clear how much of [the pain improvement] is due to what we would consider to be on-target, pain-relieving benefit from stimulation versus other factors like expectation.” The crossover rate and amount of reduction in pain intensity are promising, but “I think that excitement is weighed against the fact that this is an open-label study.”

An underused treatment

Although spinal cord stimulation has been around since the late 1960s, its use only picked up steam in the 2000s, when it became more frequently used to treat chronic nerve damage related to neuropathic pain syndromes, Dr. Petersen explained. The FDA approved the treatment’s new indication for diabetic neuropathy in 2015, and data from Abbott and Medtronic have shown benefits from spinal cord stimulation at 60 Hz, but some patients are uncomfortable with the vibration or tingling feelings the devices can cause at that frequency.

“They describe creepy crawlies or ants crawling over the feet, or pins and needles, and painful sensitivity,” Dr. Petersen said. “You create a vibration feeling in the same zone where they already have those feelings of buzzing and pain and vibration, and it’s sometimes actually even more uncomfortable and less satisfying to them in terms of relief” with the spinal cord stimulation at 60 Hz, she said, “so there’s a lot of attrition in terms of who will actually use it.”

At 10 kHz, however, “people don’t feel any vibration or tingling associated with it; it just jams the signal of the pain,” she said. The difference between the frequencies is like that between “a lifeguard whistle and a dog whistle.”
 

Testing high-frequency stimulation

The new findings included the 24-month follow-up data from a randomized controlled trial that assessed the effectiveness of high-frequency spinal cord stimulation for painful diabetic neuropathy. The original 216 participants enrolled in the trial had diabetic neuropathy symptoms for at least 12 months and either could no not tolerate or did not respond to medications. Enrollment criteria also included lower-limb pain intensity of at least 5 on a 0-10 visual analogy scale and hemoglobin A1c of no more than 10%.

For the first 6 months of the trial – before crossover was offered – participants were randomly assigned to receive either 10 kHz of spinal cord stimulation along with conventional medical management or to receive conventional medical management alone. The 6-month data from 187 patients, as reported in April 2021 in JAMA Neurology, revealed that 79% of those receiving spinal cord stimulation experienced at least 50% improved pain relief without worsening of their baseline neurologic deficits, compared with only 5% of those receiving only conventional treatments.

Average pain levels increased 2% in the control participants compared with a decrease of 76% in those with the spinal cord stimulation devices. In addition, 62% of the patients receiving spinal cord stimulation demonstration neurologic improvement in reflexes, strength, movement and sensation, compared with 3% of those in the control group. The study’s findings led the FDA to approve the device using 10 kHz.

At 6 months, 93% of control patients crossed over to receiving spinal cord stimulation while none with the devices opted to stop their spinal cord stimulation. The 12-month data revealed that 85% of those receiving spinal cord stimulation experienced at least 50% pain relief, with the average pain relief at 74%. Patients also reported statistically significant improved quality of life as well as less interference with sleep, mood, and daily activities from pain.

Two years after baseline, patients’ pain relief was maintained with average 80% improvement, and 66% of patients showed neurologic improvement since baseline. Though no patients had devices removed because of ineffectiveness, five patients’ devices were removed because of infection while infections in three other patients resolved.

“Being able to offer something that is not a pharmaceutical, without the side effects, that shows an even longer durability to that response is a really important finding at this point,” Dr. Petersen said.
 

Surgical considerations

Among the estimated 37 million Americans with type 1 or 2 diabetes, approximately one quarter of them experience some level of painful diabetic neuropathy, but medication and other medical management strategies are not always adequate in treating their pain. After a 1-week trial of spinal cord stimulation, the devices are implanted under the skin and rechargeable through the skin for up to 10 years, after which they can be replaced.

An appropriate candidate for spinal cord stimulation would be someone for whom existing non-invasive pain relief options, including medications, are ineffective or intolerable, Dr. Petersen and Dr. Markman both said. An adequate trial of medication is not “one size fits all” and will vary by each patient, added Dr. Markman, who is also interested in whether this study’s participants were able to have a reduction in use of pain relief medications.

“I think there’s a significant number of patients out there who can benefit from this, so I think that’s why it’s promising and exciting,” Dr. Markman said. “I do think it’s important to see if this actually allows them to be on less medication or whether stimulation turns out to be another treatment in addition to their baseline treatments.” The challenge is identifying “which patients are most likely to be benefiting from this and which are most likely to be harmed.”

Aside from infection from implantation, other possible risks include pain at the battery site and, in rare cases, a need for reoperation because of migration of the leads, he said.
 

Improvement in symptom severity and quality of life

After the wound from the implant has completely healed, Dr. Petersen said patients using the devices do not have any activity restrictions outside of magnetic interference, such as MRIs. “I’ve had people go back-country kayaking, scuba diving, fishing with their grandkids, all sorts of all sorts of things. If patients need to go through a scanner of any kind, they should ask whether it’s safe for pacemakers since these devices are like a “pacemaker for pain.

“I had a patient bring solar chargers with him so that he could recharge his battery in the backwoods while kayaking because that’s the level of improvement in pain that he got – from barely being able to walk down the hall to feeling comfortable being off the grid and active again,” Dr. Petersen said. “Those kinds of improvements in quality of life are massive.”

The study findings may also suggest that spinal cord stimulation can benefit a broader population of patients experiencing neuropathic pain, Dr. Markman said.

“There’s an extraordinary unmet need for treatments for neuropathy, and one important question here is the extent to which diabetic peripheral neuropathy and the response that we’re seeing here is a proxy for a broader effect across many neuropathies that are caused by other conditions other than diabetes,” Dr. Markman said. “There’s a lot of reason to think that this will be helpful not just for diabetes-related neuropathic pain, but for other types of neuropathic pain that have similar clinical presentations or clinical symptom patterns to diabetic peripheral neuropathy.”

The study was funded by Nevro, who manufactures the devices. Dr. Petersen and Dr. Markman both reported consulting with, receiving support from, holding stock options with, and serving on the data safety monitoring boards and advisory boards of numerous pharmaceutical companies.

A new study has shown a substantial variation in the blood pressure response to various antihypertensive medications between individuals, raising the possibility of future personalized therapy.

“We found that using the optimal antihypertensive drug for a particular patient resulted in an average of a 4.4 mm Hg greater reduction of blood pressure compared with a random choice of the other drugs. That is quite a substantial difference, and could be equivalent to adding in another drug,” lead author Johan Sundström, MD, Uppsala (Sweden) University Hospital, told this news organization.

Vishnu Kumar/Thinkstock

“These preliminary findings suggest that some people may be better treated with one antihypertensive drug rather than another. This is opening up the field of hypertension for personalized medicine,” he added.

The study was published online in the Journal of the American Medical Association.

The authors noted that despite global access to multiple classes of highly effective blood pressure-lowering drugs, only one in four women and one in five men with hypertension reach treatment targets. While most hypertension guidelines advocate combination pharmacotherapy, many patients in routine care continue to be treated with monotherapy, with adverse effects and nonadherence being important clinical problems.

“One drug often does not give enough blood pressure reduction, but patients are often reluctant to up-titrate to two drugs,” Dr. Sundström said. “While we know that the four recommended classes of antihypertensives lower blood pressure equally well on average, we don’t know if their efficacy is the same in individual patients.

“We wondered whether there could be different optimal drugs for different people, and if we could identify the optimal drug for each person then maybe more patients could get to target levels with just one drug,” he said.

The researchers conducted a randomized, double-blind, repeated crossover trial at an outpatient research clinic in Sweden, studying 280 men and women with grade 1 hypertension at low risk for cardiovascular events.

Each participant was scheduled for 2 months’ treatment in random order with each of four different classes of antihypertensive drugs: an ACE inhibitor, lisinopril; an angiotensin II blocker, candesartan; a thiazide diuretic, hydrochlorothiazide; a calcium channel blocker, amlodipine.

There were then repeated treatment periods for two drug classes to try to account for any effect of a particular event that might have affected the blood pressure at one point in time. Ambulatory daytime systolic blood pressure was measured at the end of each treatment period.

Results showed that variation in systolic blood pressure was large between treatments on average, between participants on average, within participants taking the same treatment, and between treatments in the same participant.

Overall, personalized treatment using the optimal single-drug therapy led to a 4.4–mm Hg lower systolic blood pressure in the trial population than a random choice of any of the other drug classes.

Taking into consideration that lisinopril was found to be on average the most efficacious of the drugs at the selected doses, personalized treatment compared with lisinopril still led to a 3.1–mm Hg improvement in systolic blood pressure.

The researchers noted that the mean additional blood pressure reduction achievable by using the optimal agent was of a magnitude twice that achieved by doubling the dose of a first drug, and more than half that of adding a second drug on average.

While there were only small differences between certain drugs (e.g., candesartan vs. lisinopril; amlodipine vs. hydrochlorothiazide), for all other comparisons tested, the choice was important, with particularly large gains to be made by personalizing the choice between candesartan vs. amlodipine and between lisinopril vs. amlodipine.

In addition, some people showed very large differences in response to different drugs, whereas others did not have much difference at all.
 

How to identify the optimal drug?

“The million-dollar question is how we identify the best drug for each individual patient,” Dr. Sundström said. “This study has opened Pandora’s box. We now need to figure out how to go forward and how we tailor treatment in each patient.”

In the study, the researchers suggest that personalizing therapy could be achieved either by identifying the phenotypic characteristics that are associated with enhanced response to one treatment vs. another or by directly measuring the individual’s responses to a series of treatments to ascertain which is most effective.

Addressing the first scenario, Dr. Sundström explained: “We can analyze the characteristics of patients who did best on each drug. There are many variables we can look at here such as age, diet, baseline blood pressure, exercise levels, smoking status, race, body weight, salt intake, and findings from genetic tests. We are going to try to look into these to see if we can find any predictors of response to various different drugs.”

For the second strategy, he suggested that patients starting pharmacologic therapy could try a few different treatments. “For example, we could give patients two different drugs and ask them to alternate treatment periods with each of them and measure their blood pressure with a home monitoring kit and record adverse effects.”

Nonadherence “is such a big problem with antihypertensives,” he added. “This approach may allow patients to be more empowered when choosing the right treatment, which should help adherence in the longer term.”
 

‘Proof-of-principle’

Commenting on the study in an accompanying editorial, Robert M. Carey, MD, University of Virginia Health System, Charlottesville, wrote: “At this stage, the findings are more theoretical than immediately practical for the implementation of personalized antihypertensive drug therapy, but the study does provide proof-of-principle and the authors suggest a few scenarios in which a personalized approach could be used in the future.”

He said the practical ramifications of personally targeted therapy remain unclear, given that determination of an individual’s response to a series of short test treatments before selecting long-term therapy may be considered too cumbersome, and currently few phenotypic markers are currently available that would be likely to accurately predict the individual response to a particular therapy.

Dr. Carey concluded that the results of this study “encourage the further pursuit of larger randomized trials using similar repeated crossover designs to validate this concept and eventually in trials with longer follow-up data to determine whether there is improvement in long-term clinical outcomes compared with current strategies.”

He added that the results support the possibility that personalized medical treatment of hypertension “may ultimately supplement or even supplant the current method of antihypertensive drug decision-making in the future.”

This study was supported by the Swedish Research Council; Kjell and Märta Beijer Foundation; and Anders Wiklöf. Dr. Sundström reported owning stock in Symptoms Europe AB and Anagram Kommunikation AB. Coauthor Emil Hagström, MD, PhD, reported receiving grants from Pfizer and Amgen and personal fees from Amgen, Novo Nordisk, Bayer, AstraZeneca, Amarin, and Novartis. Coauthor Ollie Östlund, PhD, reported fees from Uppsala University paid to his institution, Uppsala Clinical Research Center, for its participation in the PHYSIC trial during the conduct of the study. Dr. Carey reports no relevant financial relationships.
 

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

A new study has shown a substantial variation in the blood pressure response to various antihypertensive medications between individuals, raising the possibility of future personalized therapy.

“We found that using the optimal antihypertensive drug for a particular patient resulted in an average of a 4.4 mm Hg greater reduction of blood pressure compared with a random choice of the other drugs. That is quite a substantial difference, and could be equivalent to adding in another drug,” lead author Johan Sundström, MD, Uppsala (Sweden) University Hospital, told this news organization.

Vishnu Kumar/Thinkstock

“These preliminary findings suggest that some people may be better treated with one antihypertensive drug rather than another. This is opening up the field of hypertension for personalized medicine,” he added.

The study was published online in the Journal of the American Medical Association.

The authors noted that despite global access to multiple classes of highly effective blood pressure-lowering drugs, only one in four women and one in five men with hypertension reach treatment targets. While most hypertension guidelines advocate combination pharmacotherapy, many patients in routine care continue to be treated with monotherapy, with adverse effects and nonadherence being important clinical problems.

“One drug often does not give enough blood pressure reduction, but patients are often reluctant to up-titrate to two drugs,” Dr. Sundström said. “While we know that the four recommended classes of antihypertensives lower blood pressure equally well on average, we don’t know if their efficacy is the same in individual patients.

“We wondered whether there could be different optimal drugs for different people, and if we could identify the optimal drug for each person then maybe more patients could get to target levels with just one drug,” he said.

The researchers conducted a randomized, double-blind, repeated crossover trial at an outpatient research clinic in Sweden, studying 280 men and women with grade 1 hypertension at low risk for cardiovascular events.

Each participant was scheduled for 2 months’ treatment in random order with each of four different classes of antihypertensive drugs: an ACE inhibitor, lisinopril; an angiotensin II blocker, candesartan; a thiazide diuretic, hydrochlorothiazide; a calcium channel blocker, amlodipine.

There were then repeated treatment periods for two drug classes to try to account for any effect of a particular event that might have affected the blood pressure at one point in time. Ambulatory daytime systolic blood pressure was measured at the end of each treatment period.

Results showed that variation in systolic blood pressure was large between treatments on average, between participants on average, within participants taking the same treatment, and between treatments in the same participant.

Overall, personalized treatment using the optimal single-drug therapy led to a 4.4–mm Hg lower systolic blood pressure in the trial population than a random choice of any of the other drug classes.

Taking into consideration that lisinopril was found to be on average the most efficacious of the drugs at the selected doses, personalized treatment compared with lisinopril still led to a 3.1–mm Hg improvement in systolic blood pressure.

The researchers noted that the mean additional blood pressure reduction achievable by using the optimal agent was of a magnitude twice that achieved by doubling the dose of a first drug, and more than half that of adding a second drug on average.

While there were only small differences between certain drugs (e.g., candesartan vs. lisinopril; amlodipine vs. hydrochlorothiazide), for all other comparisons tested, the choice was important, with particularly large gains to be made by personalizing the choice between candesartan vs. amlodipine and between lisinopril vs. amlodipine.

In addition, some people showed very large differences in response to different drugs, whereas others did not have much difference at all.
 

How to identify the optimal drug?

“The million-dollar question is how we identify the best drug for each individual patient,” Dr. Sundström said. “This study has opened Pandora’s box. We now need to figure out how to go forward and how we tailor treatment in each patient.”

In the study, the researchers suggest that personalizing therapy could be achieved either by identifying the phenotypic characteristics that are associated with enhanced response to one treatment vs. another or by directly measuring the individual’s responses to a series of treatments to ascertain which is most effective.

Addressing the first scenario, Dr. Sundström explained: “We can analyze the characteristics of patients who did best on each drug. There are many variables we can look at here such as age, diet, baseline blood pressure, exercise levels, smoking status, race, body weight, salt intake, and findings from genetic tests. We are going to try to look into these to see if we can find any predictors of response to various different drugs.”

For the second strategy, he suggested that patients starting pharmacologic therapy could try a few different treatments. “For example, we could give patients two different drugs and ask them to alternate treatment periods with each of them and measure their blood pressure with a home monitoring kit and record adverse effects.”

Nonadherence “is such a big problem with antihypertensives,” he added. “This approach may allow patients to be more empowered when choosing the right treatment, which should help adherence in the longer term.”
 

‘Proof-of-principle’

Commenting on the study in an accompanying editorial, Robert M. Carey, MD, University of Virginia Health System, Charlottesville, wrote: “At this stage, the findings are more theoretical than immediately practical for the implementation of personalized antihypertensive drug therapy, but the study does provide proof-of-principle and the authors suggest a few scenarios in which a personalized approach could be used in the future.”

He said the practical ramifications of personally targeted therapy remain unclear, given that determination of an individual’s response to a series of short test treatments before selecting long-term therapy may be considered too cumbersome, and currently few phenotypic markers are currently available that would be likely to accurately predict the individual response to a particular therapy.

Dr. Carey concluded that the results of this study “encourage the further pursuit of larger randomized trials using similar repeated crossover designs to validate this concept and eventually in trials with longer follow-up data to determine whether there is improvement in long-term clinical outcomes compared with current strategies.”

He added that the results support the possibility that personalized medical treatment of hypertension “may ultimately supplement or even supplant the current method of antihypertensive drug decision-making in the future.”

This study was supported by the Swedish Research Council; Kjell and Märta Beijer Foundation; and Anders Wiklöf. Dr. Sundström reported owning stock in Symptoms Europe AB and Anagram Kommunikation AB. Coauthor Emil Hagström, MD, PhD, reported receiving grants from Pfizer and Amgen and personal fees from Amgen, Novo Nordisk, Bayer, AstraZeneca, Amarin, and Novartis. Coauthor Ollie Östlund, PhD, reported fees from Uppsala University paid to his institution, Uppsala Clinical Research Center, for its participation in the PHYSIC trial during the conduct of the study. Dr. Carey reports no relevant financial relationships.
 

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

A new study has shown a substantial variation in the blood pressure response to various antihypertensive medications between individuals, raising the possibility of future personalized therapy.

“We found that using the optimal antihypertensive drug for a particular patient resulted in an average of a 4.4 mm Hg greater reduction of blood pressure compared with a random choice of the other drugs. That is quite a substantial difference, and could be equivalent to adding in another drug,” lead author Johan Sundström, MD, Uppsala (Sweden) University Hospital, told this news organization.

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“These preliminary findings suggest that some people may be better treated with one antihypertensive drug rather than another. This is opening up the field of hypertension for personalized medicine,” he added.

The study was published online in the Journal of the American Medical Association.

The authors noted that despite global access to multiple classes of highly effective blood pressure-lowering drugs, only one in four women and one in five men with hypertension reach treatment targets. While most hypertension guidelines advocate combination pharmacotherapy, many patients in routine care continue to be treated with monotherapy, with adverse effects and nonadherence being important clinical problems.

“One drug often does not give enough blood pressure reduction, but patients are often reluctant to up-titrate to two drugs,” Dr. Sundström said. “While we know that the four recommended classes of antihypertensives lower blood pressure equally well on average, we don’t know if their efficacy is the same in individual patients.

“We wondered whether there could be different optimal drugs for different people, and if we could identify the optimal drug for each person then maybe more patients could get to target levels with just one drug,” he said.

The researchers conducted a randomized, double-blind, repeated crossover trial at an outpatient research clinic in Sweden, studying 280 men and women with grade 1 hypertension at low risk for cardiovascular events.

Each participant was scheduled for 2 months’ treatment in random order with each of four different classes of antihypertensive drugs: an ACE inhibitor, lisinopril; an angiotensin II blocker, candesartan; a thiazide diuretic, hydrochlorothiazide; a calcium channel blocker, amlodipine.

There were then repeated treatment periods for two drug classes to try to account for any effect of a particular event that might have affected the blood pressure at one point in time. Ambulatory daytime systolic blood pressure was measured at the end of each treatment period.

Results showed that variation in systolic blood pressure was large between treatments on average, between participants on average, within participants taking the same treatment, and between treatments in the same participant.

Overall, personalized treatment using the optimal single-drug therapy led to a 4.4–mm Hg lower systolic blood pressure in the trial population than a random choice of any of the other drug classes.

Taking into consideration that lisinopril was found to be on average the most efficacious of the drugs at the selected doses, personalized treatment compared with lisinopril still led to a 3.1–mm Hg improvement in systolic blood pressure.

The researchers noted that the mean additional blood pressure reduction achievable by using the optimal agent was of a magnitude twice that achieved by doubling the dose of a first drug, and more than half that of adding a second drug on average.

While there were only small differences between certain drugs (e.g., candesartan vs. lisinopril; amlodipine vs. hydrochlorothiazide), for all other comparisons tested, the choice was important, with particularly large gains to be made by personalizing the choice between candesartan vs. amlodipine and between lisinopril vs. amlodipine.

In addition, some people showed very large differences in response to different drugs, whereas others did not have much difference at all.
 

How to identify the optimal drug?

“The million-dollar question is how we identify the best drug for each individual patient,” Dr. Sundström said. “This study has opened Pandora’s box. We now need to figure out how to go forward and how we tailor treatment in each patient.”

In the study, the researchers suggest that personalizing therapy could be achieved either by identifying the phenotypic characteristics that are associated with enhanced response to one treatment vs. another or by directly measuring the individual’s responses to a series of treatments to ascertain which is most effective.

Addressing the first scenario, Dr. Sundström explained: “We can analyze the characteristics of patients who did best on each drug. There are many variables we can look at here such as age, diet, baseline blood pressure, exercise levels, smoking status, race, body weight, salt intake, and findings from genetic tests. We are going to try to look into these to see if we can find any predictors of response to various different drugs.”

For the second strategy, he suggested that patients starting pharmacologic therapy could try a few different treatments. “For example, we could give patients two different drugs and ask them to alternate treatment periods with each of them and measure their blood pressure with a home monitoring kit and record adverse effects.”

Nonadherence “is such a big problem with antihypertensives,” he added. “This approach may allow patients to be more empowered when choosing the right treatment, which should help adherence in the longer term.”
 

‘Proof-of-principle’

Commenting on the study in an accompanying editorial, Robert M. Carey, MD, University of Virginia Health System, Charlottesville, wrote: “At this stage, the findings are more theoretical than immediately practical for the implementation of personalized antihypertensive drug therapy, but the study does provide proof-of-principle and the authors suggest a few scenarios in which a personalized approach could be used in the future.”

He said the practical ramifications of personally targeted therapy remain unclear, given that determination of an individual’s response to a series of short test treatments before selecting long-term therapy may be considered too cumbersome, and currently few phenotypic markers are currently available that would be likely to accurately predict the individual response to a particular therapy.

Dr. Carey concluded that the results of this study “encourage the further pursuit of larger randomized trials using similar repeated crossover designs to validate this concept and eventually in trials with longer follow-up data to determine whether there is improvement in long-term clinical outcomes compared with current strategies.”

He added that the results support the possibility that personalized medical treatment of hypertension “may ultimately supplement or even supplant the current method of antihypertensive drug decision-making in the future.”

This study was supported by the Swedish Research Council; Kjell and Märta Beijer Foundation; and Anders Wiklöf. Dr. Sundström reported owning stock in Symptoms Europe AB and Anagram Kommunikation AB. Coauthor Emil Hagström, MD, PhD, reported receiving grants from Pfizer and Amgen and personal fees from Amgen, Novo Nordisk, Bayer, AstraZeneca, Amarin, and Novartis. Coauthor Ollie Östlund, PhD, reported fees from Uppsala University paid to his institution, Uppsala Clinical Research Center, for its participation in the PHYSIC trial during the conduct of the study. Dr. Carey reports no relevant financial relationships.
 

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