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Fed Pract
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gaming
gambling
compulsive behaviors
ammunition
assault rifle
black jack
Boko Haram
bondage
child abuse
cocaine
Daech
drug paraphernalia
explosion
gun
human trafficking
ISIL
ISIS
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Islamic state
mixed martial arts
MMA
molestation
national rifle association
NRA
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pedophilia
poker
porn
pornography
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recreational drug
sex slave rings
slot machine
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Texas hold 'em
UFC
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bunges
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butt
butt fuck
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buttfucked
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cock sucker
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A peer-reviewed clinical journal serving healthcare professionals working with the Department of Veterans Affairs, the Department of Defense, and the Public Health Service.

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New Therapy Brings Hope for Dry AMD Vision Loss

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Tue, 01/14/2025 - 08:46

A new light therapy device could be a game-changer for millions at risk of vision loss. The Food and Drug Administration (FDA) has approved a first-of-its-kind treatment for dry age-related macular degeneration (AMD), a leading cause of blindness in adults over 55.

Developed by LumiThera, the device showed promising results in a clinical trial, marking it as the first effective therapy for AMD. Approved under the FDA’s “De Novo” process, the treatment offers hope where no similar options existed.

The LumiThera study, done at 10 retinal centers in the United States, assessed the safety and effectiveness of the system on the eyes of 100 people over a 24-month period. The data collected during the trial was then analyzed over a 13-month period. 

The trial found that LumiThera’s Valeda Light Delivery System significantly reduced the risk of vision loss and the start of geographic atrophy in dry AMD. More than 58% of the people studied reported improvements in their sight after the therapy. 

Geographic atrophy is a treacherous hallmark of late-stage dry AMD, in which cells in the center of the eye’s retina — called the macula — die, which can cause severe vision loss in advanced forms of the disease.

LumiThera’s system is the first treatment authorized by the FDA for vision loss from dry AMD. AMD is a leading cause of irreversible blindness or vision loss in people over 60. Around 20 million people in the United States have AMD, with dry AMD accounting for 90% of diagnosed cases. It’s considered “dry” because it doesn’t involve the growth of abnormal blood vessels, the way the “wet” form of AMD does.

The percentage of people with dry AMD who lose their vision depends on how severe the disease is and whether it becomes the wet form, which is more severe than the dry form. The wet form is marked by blood vessels leaking into the macula and the loss of central vision. Around 10%-15% of dry AMD cases become the wet form. 

During a presentation in 2024 at a meeting of the American Society of Retina Specialists, Eleonora Lad, MD, PhD, vice chair of ophthalmology clinical research at Duke University Medical Center, said the treatment — known as “photobiomodulation” (PBM) — is the first to deliver “meaningful effects” in dry AMD.

But how does PBM work, and what specifically improved in the eyes of the people in the study to help combat the disease?

 

Specific Wavelengths of Light Improve Cellular Function

Until now, taking nutritional supplements (vitamin C, vitamin E, lutein, zeaxanthin, zinc, and copper) was among the most common ways of treating dry AMD. The efficacy with this combo of nutritional supplements was established by the Age-Related Eye Disease Study 2 (AREDS2). The supplements help lower the risk of advanced dry AMD and wet AMD. 

There are also recently approved eye injections for dry AMD, such as the drugs Syfovre and Izervay, to treat later stages of the disease. But while both Syfovre and Izervay can slow the progression of geographic atrophy by about 14%-20%, patients receiving either drug have a higher risk of getting wet AMD, and the treatments are invasive. The drugs must be injected directly into the middle of the eye around once per month. 

PBM works by delivering specific wavelengths of light to the retina that help cells in retinal tissue, increasing energy production by mitochondria in eye cells, decreasing inflammation, and increasing nutrients and oxygen for cells. This improves cell survival in dry AMD and could slow the disease or stop it from reaching later stages.

Several eye disorders may be partly caused by oxidative stress and impaired mitochondrial function. The wavelength of light used in PBM stimulates an enzyme in eye cells that is key to healthy cellular function and vision. 

Research has shown that PBM prevents oxidative stress, which damages retinal pigment epithelial cells and could lead to AMD.

 

More Study Is Needed

PBM has been around for decades and has been promoted as a treatment for dementia, smoking cessation, spinal cord injury, and wound healing, along with AMD. 

“Google photobiomodulation or light therapy, and you’ll find it’s supposed to fix everything ... people try to sell it for everything, and that’s because they own the equipment, and they’re looking to recoup their costs,” said Jason M. Miller, MD, PhD, a retinal disease specialist at the Kellogg Eye Center at the University of Michigan School of Medicine, Ann Arbor.

He said more rigorous and larger trials are need before PBM therapy should gain wider FDA approval.

The FDA’s De Novo approval process is for medical devices that have designs that are unlike others already on the market. To get full approval from the FDA, a new drug or device must be assessed in a clinical trial that involves more people than the 100 or so that LumiThera used in its trial. For example, phase 3 trials for drugs usually involve 1,000-3,000 people.

Syfovre’s phase 3 clinical trials involved 1,258 patients. 

Research has shown that perceptions of visual acuity could also color the study results in a way that distorts the actual effectiveness of treatment, the way the placebo effect works. Some people in studies may simply think their vision is improving because they know they’re getting treatment. 

In a 2022 study, researchers showed that people in a trial who were given a placebo with the expectation the treatment would work reported a more favorable response to treatment than those who received a “nocebo” they were told wouldn’t work. 

The sensitivity of response to the placebo/nocebo treatments were shown to rely on the expectations caused by the experiment, and the study’s findings provided evidence that “both ocular accommodation and stereoacuity can be influenced by manipulating expectations and belief about the efficacy of an inert treatment.”

“The placebo effect in medicine is just rampant. It accounts for, in some trials, 30%-40% of an effect. ... I would have a hard time buying this device right now. I don’t want to say it’s ineffective, I just want more data,” said Miller.

A version of this article appeared on WebMD.com.

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A new light therapy device could be a game-changer for millions at risk of vision loss. The Food and Drug Administration (FDA) has approved a first-of-its-kind treatment for dry age-related macular degeneration (AMD), a leading cause of blindness in adults over 55.

Developed by LumiThera, the device showed promising results in a clinical trial, marking it as the first effective therapy for AMD. Approved under the FDA’s “De Novo” process, the treatment offers hope where no similar options existed.

The LumiThera study, done at 10 retinal centers in the United States, assessed the safety and effectiveness of the system on the eyes of 100 people over a 24-month period. The data collected during the trial was then analyzed over a 13-month period. 

The trial found that LumiThera’s Valeda Light Delivery System significantly reduced the risk of vision loss and the start of geographic atrophy in dry AMD. More than 58% of the people studied reported improvements in their sight after the therapy. 

Geographic atrophy is a treacherous hallmark of late-stage dry AMD, in which cells in the center of the eye’s retina — called the macula — die, which can cause severe vision loss in advanced forms of the disease.

LumiThera’s system is the first treatment authorized by the FDA for vision loss from dry AMD. AMD is a leading cause of irreversible blindness or vision loss in people over 60. Around 20 million people in the United States have AMD, with dry AMD accounting for 90% of diagnosed cases. It’s considered “dry” because it doesn’t involve the growth of abnormal blood vessels, the way the “wet” form of AMD does.

The percentage of people with dry AMD who lose their vision depends on how severe the disease is and whether it becomes the wet form, which is more severe than the dry form. The wet form is marked by blood vessels leaking into the macula and the loss of central vision. Around 10%-15% of dry AMD cases become the wet form. 

During a presentation in 2024 at a meeting of the American Society of Retina Specialists, Eleonora Lad, MD, PhD, vice chair of ophthalmology clinical research at Duke University Medical Center, said the treatment — known as “photobiomodulation” (PBM) — is the first to deliver “meaningful effects” in dry AMD.

But how does PBM work, and what specifically improved in the eyes of the people in the study to help combat the disease?

 

Specific Wavelengths of Light Improve Cellular Function

Until now, taking nutritional supplements (vitamin C, vitamin E, lutein, zeaxanthin, zinc, and copper) was among the most common ways of treating dry AMD. The efficacy with this combo of nutritional supplements was established by the Age-Related Eye Disease Study 2 (AREDS2). The supplements help lower the risk of advanced dry AMD and wet AMD. 

There are also recently approved eye injections for dry AMD, such as the drugs Syfovre and Izervay, to treat later stages of the disease. But while both Syfovre and Izervay can slow the progression of geographic atrophy by about 14%-20%, patients receiving either drug have a higher risk of getting wet AMD, and the treatments are invasive. The drugs must be injected directly into the middle of the eye around once per month. 

PBM works by delivering specific wavelengths of light to the retina that help cells in retinal tissue, increasing energy production by mitochondria in eye cells, decreasing inflammation, and increasing nutrients and oxygen for cells. This improves cell survival in dry AMD and could slow the disease or stop it from reaching later stages.

Several eye disorders may be partly caused by oxidative stress and impaired mitochondrial function. The wavelength of light used in PBM stimulates an enzyme in eye cells that is key to healthy cellular function and vision. 

Research has shown that PBM prevents oxidative stress, which damages retinal pigment epithelial cells and could lead to AMD.

 

More Study Is Needed

PBM has been around for decades and has been promoted as a treatment for dementia, smoking cessation, spinal cord injury, and wound healing, along with AMD. 

“Google photobiomodulation or light therapy, and you’ll find it’s supposed to fix everything ... people try to sell it for everything, and that’s because they own the equipment, and they’re looking to recoup their costs,” said Jason M. Miller, MD, PhD, a retinal disease specialist at the Kellogg Eye Center at the University of Michigan School of Medicine, Ann Arbor.

He said more rigorous and larger trials are need before PBM therapy should gain wider FDA approval.

The FDA’s De Novo approval process is for medical devices that have designs that are unlike others already on the market. To get full approval from the FDA, a new drug or device must be assessed in a clinical trial that involves more people than the 100 or so that LumiThera used in its trial. For example, phase 3 trials for drugs usually involve 1,000-3,000 people.

Syfovre’s phase 3 clinical trials involved 1,258 patients. 

Research has shown that perceptions of visual acuity could also color the study results in a way that distorts the actual effectiveness of treatment, the way the placebo effect works. Some people in studies may simply think their vision is improving because they know they’re getting treatment. 

In a 2022 study, researchers showed that people in a trial who were given a placebo with the expectation the treatment would work reported a more favorable response to treatment than those who received a “nocebo” they were told wouldn’t work. 

The sensitivity of response to the placebo/nocebo treatments were shown to rely on the expectations caused by the experiment, and the study’s findings provided evidence that “both ocular accommodation and stereoacuity can be influenced by manipulating expectations and belief about the efficacy of an inert treatment.”

“The placebo effect in medicine is just rampant. It accounts for, in some trials, 30%-40% of an effect. ... I would have a hard time buying this device right now. I don’t want to say it’s ineffective, I just want more data,” said Miller.

A version of this article appeared on WebMD.com.

A new light therapy device could be a game-changer for millions at risk of vision loss. The Food and Drug Administration (FDA) has approved a first-of-its-kind treatment for dry age-related macular degeneration (AMD), a leading cause of blindness in adults over 55.

Developed by LumiThera, the device showed promising results in a clinical trial, marking it as the first effective therapy for AMD. Approved under the FDA’s “De Novo” process, the treatment offers hope where no similar options existed.

The LumiThera study, done at 10 retinal centers in the United States, assessed the safety and effectiveness of the system on the eyes of 100 people over a 24-month period. The data collected during the trial was then analyzed over a 13-month period. 

The trial found that LumiThera’s Valeda Light Delivery System significantly reduced the risk of vision loss and the start of geographic atrophy in dry AMD. More than 58% of the people studied reported improvements in their sight after the therapy. 

Geographic atrophy is a treacherous hallmark of late-stage dry AMD, in which cells in the center of the eye’s retina — called the macula — die, which can cause severe vision loss in advanced forms of the disease.

LumiThera’s system is the first treatment authorized by the FDA for vision loss from dry AMD. AMD is a leading cause of irreversible blindness or vision loss in people over 60. Around 20 million people in the United States have AMD, with dry AMD accounting for 90% of diagnosed cases. It’s considered “dry” because it doesn’t involve the growth of abnormal blood vessels, the way the “wet” form of AMD does.

The percentage of people with dry AMD who lose their vision depends on how severe the disease is and whether it becomes the wet form, which is more severe than the dry form. The wet form is marked by blood vessels leaking into the macula and the loss of central vision. Around 10%-15% of dry AMD cases become the wet form. 

During a presentation in 2024 at a meeting of the American Society of Retina Specialists, Eleonora Lad, MD, PhD, vice chair of ophthalmology clinical research at Duke University Medical Center, said the treatment — known as “photobiomodulation” (PBM) — is the first to deliver “meaningful effects” in dry AMD.

But how does PBM work, and what specifically improved in the eyes of the people in the study to help combat the disease?

 

Specific Wavelengths of Light Improve Cellular Function

Until now, taking nutritional supplements (vitamin C, vitamin E, lutein, zeaxanthin, zinc, and copper) was among the most common ways of treating dry AMD. The efficacy with this combo of nutritional supplements was established by the Age-Related Eye Disease Study 2 (AREDS2). The supplements help lower the risk of advanced dry AMD and wet AMD. 

There are also recently approved eye injections for dry AMD, such as the drugs Syfovre and Izervay, to treat later stages of the disease. But while both Syfovre and Izervay can slow the progression of geographic atrophy by about 14%-20%, patients receiving either drug have a higher risk of getting wet AMD, and the treatments are invasive. The drugs must be injected directly into the middle of the eye around once per month. 

PBM works by delivering specific wavelengths of light to the retina that help cells in retinal tissue, increasing energy production by mitochondria in eye cells, decreasing inflammation, and increasing nutrients and oxygen for cells. This improves cell survival in dry AMD and could slow the disease or stop it from reaching later stages.

Several eye disorders may be partly caused by oxidative stress and impaired mitochondrial function. The wavelength of light used in PBM stimulates an enzyme in eye cells that is key to healthy cellular function and vision. 

Research has shown that PBM prevents oxidative stress, which damages retinal pigment epithelial cells and could lead to AMD.

 

More Study Is Needed

PBM has been around for decades and has been promoted as a treatment for dementia, smoking cessation, spinal cord injury, and wound healing, along with AMD. 

“Google photobiomodulation or light therapy, and you’ll find it’s supposed to fix everything ... people try to sell it for everything, and that’s because they own the equipment, and they’re looking to recoup their costs,” said Jason M. Miller, MD, PhD, a retinal disease specialist at the Kellogg Eye Center at the University of Michigan School of Medicine, Ann Arbor.

He said more rigorous and larger trials are need before PBM therapy should gain wider FDA approval.

The FDA’s De Novo approval process is for medical devices that have designs that are unlike others already on the market. To get full approval from the FDA, a new drug or device must be assessed in a clinical trial that involves more people than the 100 or so that LumiThera used in its trial. For example, phase 3 trials for drugs usually involve 1,000-3,000 people.

Syfovre’s phase 3 clinical trials involved 1,258 patients. 

Research has shown that perceptions of visual acuity could also color the study results in a way that distorts the actual effectiveness of treatment, the way the placebo effect works. Some people in studies may simply think their vision is improving because they know they’re getting treatment. 

In a 2022 study, researchers showed that people in a trial who were given a placebo with the expectation the treatment would work reported a more favorable response to treatment than those who received a “nocebo” they were told wouldn’t work. 

The sensitivity of response to the placebo/nocebo treatments were shown to rely on the expectations caused by the experiment, and the study’s findings provided evidence that “both ocular accommodation and stereoacuity can be influenced by manipulating expectations and belief about the efficacy of an inert treatment.”

“The placebo effect in medicine is just rampant. It accounts for, in some trials, 30%-40% of an effect. ... I would have a hard time buying this device right now. I don’t want to say it’s ineffective, I just want more data,” said Miller.

A version of this article appeared on WebMD.com.

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Areas of Hope Offered in 2024 VA Suicide Report

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Suicide was the 12th-leading cause of death for veterans in 2022. However, fewer veterans died by suicide in 2022 than in 12 of the previous 14 years, according to the 2024 National Veteran Suicide Prevention Annual Report released by the US Department of Veterans Affairs (VA).

The review is the most comprehensive national report on veteran suicide and is based on verified data from the Centers for Disease Control and US Department of Defense from 2001-2022, or the most recent years the VA has data.

The report states that 6407 veterans died by suicide in 2022, 3 more than the year before. For comparison, 41,484 nonveteran US adults died by suicide in 2022, 1476 more than 2021. It is important to assess suicide mortality rates in the context of population changes, the report cautions. From 2001-2022, the veteran population dropped from 25.8 million to 18.5 million, a 28.4% decrease. During that same period, the nonveteran US adult population increased from 186.5 million to 242.4 million, a 30.0% jump. 

On average, 131 US adults died by suicide each day in 2022: 18 veterans and 114 nonveterans. Among all US adults, including veterans, the average number of suicides per day rose from 81 per day in 2001 to 131 per day in 2022. The average number of veteran suicides per day rose from 16.5 in 2001 to 17.6 in 2022. 

“Hope serves an important role within suicide prevention efforts,” the VA said. “Within the challenges faced in 2022, key areas of hope emerged.”

Among those key findings are a 24.1% decrease in age-adjusted suicide rates, a 37% suicide rate reduction among individuals who received VA homeless program services, 3.8% suicide rate decrease in veterans aged 18 to 34 years, and considerable drops in suicide rates for veterans with Veterans Health Administration mental health diagnoses of anxiety (36.1%), depression (34.5%), posttraumatic stress disorder (31.6%), and alcohol use disorder (13.7%).

Eliminating veteran suicide is VA’s top clinical priority and a critical aspect of the strategy for reducing military and veteran suicide. Since 2022, VA has worked aggressively to expand support, including offering no-cost health care to veterans in suicidal crisis; launching the 988 (then press 1) hotline, qualified responders through the Veterans Crisis Line; expanding firearm suicide prevention efforts; and encouraging veterans to reach out for help through a national veteran suicide prevention awareness campaign

“There is nothing more important to VA than ending veteran suicide,“ said Secretary of Veterans Affairs Denis McDonough. “We will learn from this report to better serve veterans and save lives.”

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Suicide was the 12th-leading cause of death for veterans in 2022. However, fewer veterans died by suicide in 2022 than in 12 of the previous 14 years, according to the 2024 National Veteran Suicide Prevention Annual Report released by the US Department of Veterans Affairs (VA).

The review is the most comprehensive national report on veteran suicide and is based on verified data from the Centers for Disease Control and US Department of Defense from 2001-2022, or the most recent years the VA has data.

The report states that 6407 veterans died by suicide in 2022, 3 more than the year before. For comparison, 41,484 nonveteran US adults died by suicide in 2022, 1476 more than 2021. It is important to assess suicide mortality rates in the context of population changes, the report cautions. From 2001-2022, the veteran population dropped from 25.8 million to 18.5 million, a 28.4% decrease. During that same period, the nonveteran US adult population increased from 186.5 million to 242.4 million, a 30.0% jump. 

On average, 131 US adults died by suicide each day in 2022: 18 veterans and 114 nonveterans. Among all US adults, including veterans, the average number of suicides per day rose from 81 per day in 2001 to 131 per day in 2022. The average number of veteran suicides per day rose from 16.5 in 2001 to 17.6 in 2022. 

“Hope serves an important role within suicide prevention efforts,” the VA said. “Within the challenges faced in 2022, key areas of hope emerged.”

Among those key findings are a 24.1% decrease in age-adjusted suicide rates, a 37% suicide rate reduction among individuals who received VA homeless program services, 3.8% suicide rate decrease in veterans aged 18 to 34 years, and considerable drops in suicide rates for veterans with Veterans Health Administration mental health diagnoses of anxiety (36.1%), depression (34.5%), posttraumatic stress disorder (31.6%), and alcohol use disorder (13.7%).

Eliminating veteran suicide is VA’s top clinical priority and a critical aspect of the strategy for reducing military and veteran suicide. Since 2022, VA has worked aggressively to expand support, including offering no-cost health care to veterans in suicidal crisis; launching the 988 (then press 1) hotline, qualified responders through the Veterans Crisis Line; expanding firearm suicide prevention efforts; and encouraging veterans to reach out for help through a national veteran suicide prevention awareness campaign

“There is nothing more important to VA than ending veteran suicide,“ said Secretary of Veterans Affairs Denis McDonough. “We will learn from this report to better serve veterans and save lives.”

Suicide was the 12th-leading cause of death for veterans in 2022. However, fewer veterans died by suicide in 2022 than in 12 of the previous 14 years, according to the 2024 National Veteran Suicide Prevention Annual Report released by the US Department of Veterans Affairs (VA).

The review is the most comprehensive national report on veteran suicide and is based on verified data from the Centers for Disease Control and US Department of Defense from 2001-2022, or the most recent years the VA has data.

The report states that 6407 veterans died by suicide in 2022, 3 more than the year before. For comparison, 41,484 nonveteran US adults died by suicide in 2022, 1476 more than 2021. It is important to assess suicide mortality rates in the context of population changes, the report cautions. From 2001-2022, the veteran population dropped from 25.8 million to 18.5 million, a 28.4% decrease. During that same period, the nonveteran US adult population increased from 186.5 million to 242.4 million, a 30.0% jump. 

On average, 131 US adults died by suicide each day in 2022: 18 veterans and 114 nonveterans. Among all US adults, including veterans, the average number of suicides per day rose from 81 per day in 2001 to 131 per day in 2022. The average number of veteran suicides per day rose from 16.5 in 2001 to 17.6 in 2022. 

“Hope serves an important role within suicide prevention efforts,” the VA said. “Within the challenges faced in 2022, key areas of hope emerged.”

Among those key findings are a 24.1% decrease in age-adjusted suicide rates, a 37% suicide rate reduction among individuals who received VA homeless program services, 3.8% suicide rate decrease in veterans aged 18 to 34 years, and considerable drops in suicide rates for veterans with Veterans Health Administration mental health diagnoses of anxiety (36.1%), depression (34.5%), posttraumatic stress disorder (31.6%), and alcohol use disorder (13.7%).

Eliminating veteran suicide is VA’s top clinical priority and a critical aspect of the strategy for reducing military and veteran suicide. Since 2022, VA has worked aggressively to expand support, including offering no-cost health care to veterans in suicidal crisis; launching the 988 (then press 1) hotline, qualified responders through the Veterans Crisis Line; expanding firearm suicide prevention efforts; and encouraging veterans to reach out for help through a national veteran suicide prevention awareness campaign

“There is nothing more important to VA than ending veteran suicide,“ said Secretary of Veterans Affairs Denis McDonough. “We will learn from this report to better serve veterans and save lives.”

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Does Watch and Wait Increase Distant Metastasis Risk in Rectal Cancer?

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TOPLINE:

Patients with rectal cancer managed by watch and wait and subsequent local regrowth have a higher risk for distant metastases than those undergoing immediate surgery. The new study highlights the importance of timely surgical intervention to improve distant metastases–free survival rates.

METHODOLOGY:

  • Organ preservation has become an attractive alternative to surgery for patients with rectal cancer who achieve a clinical complete response after neoadjuvant therapy, with the risk for local regrowth after initial clinical complete response being around 25%-30%.
  • The new study aimed to compare the risk for distant metastases between patients with local regrowth after watch and wait and patients with near-complete pathologic response managed by total mesorectal excision.
  • A total of 508 patients with local regrowth were included from the International Watch & Wait Database, and 893 patients with near-complete pathologic response were included from the Spanish Rectal Cancer Project.
  • The primary endpoint was distant metastases–free survival at 3 years from the decision to watch and wait or total mesorectal excision, and the secondary endpoints included possible risk factors associated with distant metastases.

TAKEAWAY:

  • Patients with local regrowth had a significantly higher rate of distant metastases (rate, 22.8% vs 10.2%; P ≤.001) than those with near-complete pathologic response managed by total mesorectal excision.
  • Distant metastases–free survival at 3 years was significantly worse for patients with local regrowth (rate, 75% vs 87%; P < .001).
  • Independent risk factors for distant metastases included local regrowth (vs total mesorectal excision at reassessment; P = .001), ypT3-4 status (P = .016), and ypN+ status (P = .001) at the time of surgery.
  • Patients with local regrowth had worse distant metastases–free survival across all pathologic stages than those managed by total mesorectal excision.

IN PRACTICE:

“Patients with local regrowth appear to have a higher risk for subsequent distant metastases development than patients with near-complete pathologic response managed by total mesorectal excision at restaging irrespective of final pathology,” the authors wrote.

SOURCE:

This study was led by Laura M. Fernandez, MD, of the Champalimaud Foundation in Lisbon, Portugal. It was published online in Journal of Clinical Oncology.

LIMITATIONS:

This study’s limitations included the heterogeneity in defining clinical complete response and the decision to watch and wait across different institutions. The majority of patients did not receive total neoadjuvant therapy regimens, which may have affected the generalizability of the findings. The study had a considerable amount of follow-up losses, which could have introduced bias.

DISCLOSURES:

This study was supported by the European Society of Surgical Oncology, the Champalimaud Foundation, the Bas Mulder Award, the Alpe d’HuZes Foundation, the Dutch Cancer Society, the European Research Council Advanced Grant, and the National Institute of Health and Research Manchester Biomedical Research Centre. Fernandez disclosed receiving grants from Johnson & Johnson. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE:

Patients with rectal cancer managed by watch and wait and subsequent local regrowth have a higher risk for distant metastases than those undergoing immediate surgery. The new study highlights the importance of timely surgical intervention to improve distant metastases–free survival rates.

METHODOLOGY:

  • Organ preservation has become an attractive alternative to surgery for patients with rectal cancer who achieve a clinical complete response after neoadjuvant therapy, with the risk for local regrowth after initial clinical complete response being around 25%-30%.
  • The new study aimed to compare the risk for distant metastases between patients with local regrowth after watch and wait and patients with near-complete pathologic response managed by total mesorectal excision.
  • A total of 508 patients with local regrowth were included from the International Watch & Wait Database, and 893 patients with near-complete pathologic response were included from the Spanish Rectal Cancer Project.
  • The primary endpoint was distant metastases–free survival at 3 years from the decision to watch and wait or total mesorectal excision, and the secondary endpoints included possible risk factors associated with distant metastases.

TAKEAWAY:

  • Patients with local regrowth had a significantly higher rate of distant metastases (rate, 22.8% vs 10.2%; P ≤.001) than those with near-complete pathologic response managed by total mesorectal excision.
  • Distant metastases–free survival at 3 years was significantly worse for patients with local regrowth (rate, 75% vs 87%; P < .001).
  • Independent risk factors for distant metastases included local regrowth (vs total mesorectal excision at reassessment; P = .001), ypT3-4 status (P = .016), and ypN+ status (P = .001) at the time of surgery.
  • Patients with local regrowth had worse distant metastases–free survival across all pathologic stages than those managed by total mesorectal excision.

IN PRACTICE:

“Patients with local regrowth appear to have a higher risk for subsequent distant metastases development than patients with near-complete pathologic response managed by total mesorectal excision at restaging irrespective of final pathology,” the authors wrote.

SOURCE:

This study was led by Laura M. Fernandez, MD, of the Champalimaud Foundation in Lisbon, Portugal. It was published online in Journal of Clinical Oncology.

LIMITATIONS:

This study’s limitations included the heterogeneity in defining clinical complete response and the decision to watch and wait across different institutions. The majority of patients did not receive total neoadjuvant therapy regimens, which may have affected the generalizability of the findings. The study had a considerable amount of follow-up losses, which could have introduced bias.

DISCLOSURES:

This study was supported by the European Society of Surgical Oncology, the Champalimaud Foundation, the Bas Mulder Award, the Alpe d’HuZes Foundation, the Dutch Cancer Society, the European Research Council Advanced Grant, and the National Institute of Health and Research Manchester Biomedical Research Centre. Fernandez disclosed receiving grants from Johnson & Johnson. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Patients with rectal cancer managed by watch and wait and subsequent local regrowth have a higher risk for distant metastases than those undergoing immediate surgery. The new study highlights the importance of timely surgical intervention to improve distant metastases–free survival rates.

METHODOLOGY:

  • Organ preservation has become an attractive alternative to surgery for patients with rectal cancer who achieve a clinical complete response after neoadjuvant therapy, with the risk for local regrowth after initial clinical complete response being around 25%-30%.
  • The new study aimed to compare the risk for distant metastases between patients with local regrowth after watch and wait and patients with near-complete pathologic response managed by total mesorectal excision.
  • A total of 508 patients with local regrowth were included from the International Watch & Wait Database, and 893 patients with near-complete pathologic response were included from the Spanish Rectal Cancer Project.
  • The primary endpoint was distant metastases–free survival at 3 years from the decision to watch and wait or total mesorectal excision, and the secondary endpoints included possible risk factors associated with distant metastases.

TAKEAWAY:

  • Patients with local regrowth had a significantly higher rate of distant metastases (rate, 22.8% vs 10.2%; P ≤.001) than those with near-complete pathologic response managed by total mesorectal excision.
  • Distant metastases–free survival at 3 years was significantly worse for patients with local regrowth (rate, 75% vs 87%; P < .001).
  • Independent risk factors for distant metastases included local regrowth (vs total mesorectal excision at reassessment; P = .001), ypT3-4 status (P = .016), and ypN+ status (P = .001) at the time of surgery.
  • Patients with local regrowth had worse distant metastases–free survival across all pathologic stages than those managed by total mesorectal excision.

IN PRACTICE:

“Patients with local regrowth appear to have a higher risk for subsequent distant metastases development than patients with near-complete pathologic response managed by total mesorectal excision at restaging irrespective of final pathology,” the authors wrote.

SOURCE:

This study was led by Laura M. Fernandez, MD, of the Champalimaud Foundation in Lisbon, Portugal. It was published online in Journal of Clinical Oncology.

LIMITATIONS:

This study’s limitations included the heterogeneity in defining clinical complete response and the decision to watch and wait across different institutions. The majority of patients did not receive total neoadjuvant therapy regimens, which may have affected the generalizability of the findings. The study had a considerable amount of follow-up losses, which could have introduced bias.

DISCLOSURES:

This study was supported by the European Society of Surgical Oncology, the Champalimaud Foundation, the Bas Mulder Award, the Alpe d’HuZes Foundation, the Dutch Cancer Society, the European Research Council Advanced Grant, and the National Institute of Health and Research Manchester Biomedical Research Centre. Fernandez disclosed receiving grants from Johnson & Johnson. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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Break the Itch-Scratch Cycle to Treat Prurigo Nodularis

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Break the Itch-Scratch Cycle to Treat Prurigo Nodularis

Prurigo nodularis (PN) is a chronic inflammatory skin condition characterized by firm hyperkeratotic nodules that develops when patients persistently scratch or rub intensely itchy areas of the skin. This potent itch-scratch cycle can be traced back to a dysfunctional interplay between cutaneous nerve fibers and the local immune environment.1-3 Pruritis lasting at least 6 weeks is a hallmark symptom of PN and can be accompanied by pain and/or a burning sensation.4 The lesions are symmetrically distributed in areas that are easy to scratch (eg, arms, legs, trunk), typically sparing the face, palms, and soles; however, facial lesions have been reported in pediatric patients with PN, who also are more likely to have back, hand, and foot involvement.5,6

PN can greatly affect patients’ quality of life, leading to increased rates of depression and anxiety.7-9 Patients with severe symptoms also report increased sleep disturbance, distraction from work, selfconsciousness leading to social isolation, and missed days of work/school.9 In one study, patients with PN reported missing at least 1 day of work, school, training, or learning; giving up a leisure activity or sport; or refusing an invitation to dinner or a party in the past 3 months due to the disease.10

FDP042016_F
Epidemiology

PN has a prevalence of 72 per 100,000 individuals in the United States, most commonly affecting adults aged 51 to 65 years and disproportionately affecting African American and female patients.11-13 Most patients with PN experience a 2-year delay in diagnosis after initial onset of symptoms. 10 Adults with PN have an increased likelihood of having other dermatologic conditions, including atopic dermatitis (AD) and psoriasis.11 Nearly two-thirds of pediatric patients with PN present with AD, and those with AD showed more resistance to first-line treatment options.5

Key Clinical Features

Compared to White patients, who typically present with lesions that appear erythematous or pink, patients with darker skin tones may present with hyperpigmented nodules that are larger and darker.12 The pruritic nodules often show signs of scratching or picking (eg, excoriations, lichenification, and angulated erosions).4

Worth Noting

Diagnosis of PN is made clinically, but skin biopsy may be helpful to rule out alternative diseases. Histologically, the hairy palm sign may be present in addition to other histologic features commonly associated with excessive scratching or rubbing of the skin.

Patients with PN have a high risk for HIV, which is not surprising considering HIV is a known systemic cause of generalized chronic pruritus. Other associations include type 2 diabetes mellitus and thyroid, kidney, and liver disease. 11,13 Workup for patients with PN should include a complete blood count with differential; liver and renal function testing; and testing for C-reactive protein, thyroid-stimulating hormone, and lactate dehydrogenase.4,14 Hemoglobin A1c and HIV testing as well as a hepatitis panel should be considered when appropriate. Because generalized pruritus may be a sign of malignancy, chest radiography and lymph node and abdominal ultrasonography should be performed in patients who have experienced itch for less than 1 year along with B symptoms (fever, night sweats, ≥ 10% weight loss over 6 months, fatigue).14 Frequent scratching can disrupt the skin barrier, contributing to the increased risk for skin infections.13 All patients with a suspected PN diagnosis also should undergo screening for depression and anxiety, as patients with PN are at an increased risk for these conditions.4

Treatment of PN starts with breaking the itch-scratch cycle by addressing the underlying cause of the pruritus. Therapies are focused on addressing the immunologic and neural components of the disease. Topical treatments include moderate to strong corticosteroids, calcineurin inhibitors (tacrolimus or pimecrolimus), capsaicin, and antipruritic emollients. Systemic agents include phototherapy (narrow-band UVB or excimer laser), gabapentin, pregabalin, paroxetine, and amitriptyline to address the neural component of itch. Methotrexate or cyclosporine can be used to address the immunologic component of PN and diminish the itch. That said, methotrexate and cyclosporine often are inadequate to control pruritus. 10 Of note, sedating antihistamines are not effective in treating itch in PN but can be used as an adjuvant therapy for sleep disturbances in these patients.15

The only drugs currently approved by the US Food and Drug Administration to treat PN are the biologics dupilumab (targeting the IL-4 receptor) approved in 2022 and nemolizumab (targeting the IL-31 receptor) approved in 2024.16-18 The evidence that these injectable biologics work is heartening in a condition that has historically been very challenging to treat.16,18 It should be noted that the high cost of these 2 medications can restrict access to care for patients who are uninsured or underinsured.

Resolution of a prurigo nodule may result in a hyperpigmented macule taking months to years to fade.

Health Disparity Highlight

Patients with PN have a considerable comorbidity burden, negative impact on quality of life, and increased health care utilization rates.12 PN is 3.4 times more common in Black patients than White patients.13 Black patients with PN have increased mortality, higher health care utilization rates, and increased systemic inflammation compared to White patients.12,19,20

References
  1. Cevikbas F, Wang X, Akiyama T, et al. A sensory neuron– expressed IL-31 receptor mediates T helper cell–dependent itch: involvement of TRPV1 and TRPA1. J Allergy Clin Immunol. 2014;133:448-460.
  2. Lou H, Lu J, Choi EB, et al. Expression of IL-22 in the skin causes Th2-biased immunity, epidermal barrier dysfunction, and pruritus via stimulating epithelial Th2 cytokines and the GRP pathway. J Immunol. 2017;198:2543-2555.
  3. Sutaria N, Adawi W, Goldberg R, et al. Itch: pathogenesis and treatment. J Am Acad Dermatol. 2022;86:17-34.
  4. Elmariah S, Kim B, Berger T, et al. Practical approaches for diagnosis and management of prurigo nodularis: United States expert panel consensus. J Am Acad Dermatol. 2021;84:747-760.
  5. Kyvayko R, Fachler-Sharp T, Greenberger S, et al. Characterization of paediatric prurigo nodularis: a multicentre retrospective, observational study. Acta Derm Venereol. 2024;104:adv15771.
  6. Aggarwal P, Choi J, Sutaria N, et al. Clinical characteristics and disease burden in prurigo nodularis. Clin Exp Dermatol. 2021;46:1277-1284.
  7. Whang KA, Le TK, Khanna R, et al. Health-related quality of life and economic burden of prurigo nodularis. J Am Acad Dermatol. 2022;86:573-580.
  8. Jørgensen KM, Egeberg A, Gislason GH, et al. Anxiety, depression and suicide in patients with prurigo nodularis. J Eur Acad Dermatol Venereol. 2017;31:E106-E107.
  9. Rodriguez D, Kwatra SG, Dias-Barbosa C, et al. Patient perspectives on living with severe prurigo nodularis. JAMA Dermatol. 2023;159:1205-1212.
  10. Misery L, Patras de Campaigno C, Taieb C, et al. Impact of chronic prurigo nodularis on daily life and stigmatization. J Eur Acad Dermatol Venereol. 2023;37:E908-E909.
  11. Huang AH, Canner JK, Khanna R, et al. Real-world prevalence of prurigo nodularis and burden of associated diseases. J Invest Dermatol. 2020;140:480-483.e4.
  12. Sutaria N, Adawi W, Brown I, et al. Racial disparities in mortality among patients with prurigo nodularis: a multicenter cohort study. J Am Acad Dermatol. 2022;82:487- 490.
  13. Boozalis E, Tang O, Patel S, et al. Ethnic differences and comorbidities of 909 prurigo nodularis patients. J Am Acad Dermatol. 2018;79:714-719.e3.
  14. Müller S, Zeidler C, Ständer S. Chronic prurigo including prurigo nodularis: new insights and treatments. Am J Clin Dermatol. 2024;25:15-33.
  15. Williams KA, Roh YS, Brown I, et al. Pathophysiology, diagnosis, and pharmacological treatment of prurigo nodularis. Expert Rev Clin Pharmacol. 2021;14:67-77.
  16. Kwatra SG, Yosipovitch G, Legat FJ, et al. Phase 3 trial of nemolizumab in patients with prurigo nodularis. N Engl J Med. 2023;389:1579-1589.
  17. Beck KM, Yang EJ, Sekhon S, et al. Dupilumab treatment for generalized prurigo nodularis. JAMA Dermatol. 2019;155:118-120.
  18. Yosipovitch G, Mollanazar N, Ständer S, et al. Dupilumab in patients with prurigo nodularis: two randomized, double- blind, placebo- controlled phase 3 trials. Nat Med. 2023;29:1180-1190.
  19. Wongvibulsin S, Sutaria N, Williams KA, et al. A nationwide study of prurigo nodularis: disease burden and healthcare utilization in the United States. J Invest Dermatol. 2021;141:2530-2533.e1.
  20. Sutaria N, Alphonse MP, Marani M, et al. Cluster analysis of circulating plasma biomarkers in prurigo nodularis reveals a distinct systemic inflammatory signature in African Americans. J Invest Dermatol. 2022;142:1300-1308.e3.
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Prurigo nodularis (PN) is a chronic inflammatory skin condition characterized by firm hyperkeratotic nodules that develops when patients persistently scratch or rub intensely itchy areas of the skin. This potent itch-scratch cycle can be traced back to a dysfunctional interplay between cutaneous nerve fibers and the local immune environment.1-3 Pruritis lasting at least 6 weeks is a hallmark symptom of PN and can be accompanied by pain and/or a burning sensation.4 The lesions are symmetrically distributed in areas that are easy to scratch (eg, arms, legs, trunk), typically sparing the face, palms, and soles; however, facial lesions have been reported in pediatric patients with PN, who also are more likely to have back, hand, and foot involvement.5,6

PN can greatly affect patients’ quality of life, leading to increased rates of depression and anxiety.7-9 Patients with severe symptoms also report increased sleep disturbance, distraction from work, selfconsciousness leading to social isolation, and missed days of work/school.9 In one study, patients with PN reported missing at least 1 day of work, school, training, or learning; giving up a leisure activity or sport; or refusing an invitation to dinner or a party in the past 3 months due to the disease.10

FDP042016_F
Epidemiology

PN has a prevalence of 72 per 100,000 individuals in the United States, most commonly affecting adults aged 51 to 65 years and disproportionately affecting African American and female patients.11-13 Most patients with PN experience a 2-year delay in diagnosis after initial onset of symptoms. 10 Adults with PN have an increased likelihood of having other dermatologic conditions, including atopic dermatitis (AD) and psoriasis.11 Nearly two-thirds of pediatric patients with PN present with AD, and those with AD showed more resistance to first-line treatment options.5

Key Clinical Features

Compared to White patients, who typically present with lesions that appear erythematous or pink, patients with darker skin tones may present with hyperpigmented nodules that are larger and darker.12 The pruritic nodules often show signs of scratching or picking (eg, excoriations, lichenification, and angulated erosions).4

Worth Noting

Diagnosis of PN is made clinically, but skin biopsy may be helpful to rule out alternative diseases. Histologically, the hairy palm sign may be present in addition to other histologic features commonly associated with excessive scratching or rubbing of the skin.

Patients with PN have a high risk for HIV, which is not surprising considering HIV is a known systemic cause of generalized chronic pruritus. Other associations include type 2 diabetes mellitus and thyroid, kidney, and liver disease. 11,13 Workup for patients with PN should include a complete blood count with differential; liver and renal function testing; and testing for C-reactive protein, thyroid-stimulating hormone, and lactate dehydrogenase.4,14 Hemoglobin A1c and HIV testing as well as a hepatitis panel should be considered when appropriate. Because generalized pruritus may be a sign of malignancy, chest radiography and lymph node and abdominal ultrasonography should be performed in patients who have experienced itch for less than 1 year along with B symptoms (fever, night sweats, ≥ 10% weight loss over 6 months, fatigue).14 Frequent scratching can disrupt the skin barrier, contributing to the increased risk for skin infections.13 All patients with a suspected PN diagnosis also should undergo screening for depression and anxiety, as patients with PN are at an increased risk for these conditions.4

Treatment of PN starts with breaking the itch-scratch cycle by addressing the underlying cause of the pruritus. Therapies are focused on addressing the immunologic and neural components of the disease. Topical treatments include moderate to strong corticosteroids, calcineurin inhibitors (tacrolimus or pimecrolimus), capsaicin, and antipruritic emollients. Systemic agents include phototherapy (narrow-band UVB or excimer laser), gabapentin, pregabalin, paroxetine, and amitriptyline to address the neural component of itch. Methotrexate or cyclosporine can be used to address the immunologic component of PN and diminish the itch. That said, methotrexate and cyclosporine often are inadequate to control pruritus. 10 Of note, sedating antihistamines are not effective in treating itch in PN but can be used as an adjuvant therapy for sleep disturbances in these patients.15

The only drugs currently approved by the US Food and Drug Administration to treat PN are the biologics dupilumab (targeting the IL-4 receptor) approved in 2022 and nemolizumab (targeting the IL-31 receptor) approved in 2024.16-18 The evidence that these injectable biologics work is heartening in a condition that has historically been very challenging to treat.16,18 It should be noted that the high cost of these 2 medications can restrict access to care for patients who are uninsured or underinsured.

Resolution of a prurigo nodule may result in a hyperpigmented macule taking months to years to fade.

Health Disparity Highlight

Patients with PN have a considerable comorbidity burden, negative impact on quality of life, and increased health care utilization rates.12 PN is 3.4 times more common in Black patients than White patients.13 Black patients with PN have increased mortality, higher health care utilization rates, and increased systemic inflammation compared to White patients.12,19,20

Prurigo nodularis (PN) is a chronic inflammatory skin condition characterized by firm hyperkeratotic nodules that develops when patients persistently scratch or rub intensely itchy areas of the skin. This potent itch-scratch cycle can be traced back to a dysfunctional interplay between cutaneous nerve fibers and the local immune environment.1-3 Pruritis lasting at least 6 weeks is a hallmark symptom of PN and can be accompanied by pain and/or a burning sensation.4 The lesions are symmetrically distributed in areas that are easy to scratch (eg, arms, legs, trunk), typically sparing the face, palms, and soles; however, facial lesions have been reported in pediatric patients with PN, who also are more likely to have back, hand, and foot involvement.5,6

PN can greatly affect patients’ quality of life, leading to increased rates of depression and anxiety.7-9 Patients with severe symptoms also report increased sleep disturbance, distraction from work, selfconsciousness leading to social isolation, and missed days of work/school.9 In one study, patients with PN reported missing at least 1 day of work, school, training, or learning; giving up a leisure activity or sport; or refusing an invitation to dinner or a party in the past 3 months due to the disease.10

FDP042016_F
Epidemiology

PN has a prevalence of 72 per 100,000 individuals in the United States, most commonly affecting adults aged 51 to 65 years and disproportionately affecting African American and female patients.11-13 Most patients with PN experience a 2-year delay in diagnosis after initial onset of symptoms. 10 Adults with PN have an increased likelihood of having other dermatologic conditions, including atopic dermatitis (AD) and psoriasis.11 Nearly two-thirds of pediatric patients with PN present with AD, and those with AD showed more resistance to first-line treatment options.5

Key Clinical Features

Compared to White patients, who typically present with lesions that appear erythematous or pink, patients with darker skin tones may present with hyperpigmented nodules that are larger and darker.12 The pruritic nodules often show signs of scratching or picking (eg, excoriations, lichenification, and angulated erosions).4

Worth Noting

Diagnosis of PN is made clinically, but skin biopsy may be helpful to rule out alternative diseases. Histologically, the hairy palm sign may be present in addition to other histologic features commonly associated with excessive scratching or rubbing of the skin.

Patients with PN have a high risk for HIV, which is not surprising considering HIV is a known systemic cause of generalized chronic pruritus. Other associations include type 2 diabetes mellitus and thyroid, kidney, and liver disease. 11,13 Workup for patients with PN should include a complete blood count with differential; liver and renal function testing; and testing for C-reactive protein, thyroid-stimulating hormone, and lactate dehydrogenase.4,14 Hemoglobin A1c and HIV testing as well as a hepatitis panel should be considered when appropriate. Because generalized pruritus may be a sign of malignancy, chest radiography and lymph node and abdominal ultrasonography should be performed in patients who have experienced itch for less than 1 year along with B symptoms (fever, night sweats, ≥ 10% weight loss over 6 months, fatigue).14 Frequent scratching can disrupt the skin barrier, contributing to the increased risk for skin infections.13 All patients with a suspected PN diagnosis also should undergo screening for depression and anxiety, as patients with PN are at an increased risk for these conditions.4

Treatment of PN starts with breaking the itch-scratch cycle by addressing the underlying cause of the pruritus. Therapies are focused on addressing the immunologic and neural components of the disease. Topical treatments include moderate to strong corticosteroids, calcineurin inhibitors (tacrolimus or pimecrolimus), capsaicin, and antipruritic emollients. Systemic agents include phototherapy (narrow-band UVB or excimer laser), gabapentin, pregabalin, paroxetine, and amitriptyline to address the neural component of itch. Methotrexate or cyclosporine can be used to address the immunologic component of PN and diminish the itch. That said, methotrexate and cyclosporine often are inadequate to control pruritus. 10 Of note, sedating antihistamines are not effective in treating itch in PN but can be used as an adjuvant therapy for sleep disturbances in these patients.15

The only drugs currently approved by the US Food and Drug Administration to treat PN are the biologics dupilumab (targeting the IL-4 receptor) approved in 2022 and nemolizumab (targeting the IL-31 receptor) approved in 2024.16-18 The evidence that these injectable biologics work is heartening in a condition that has historically been very challenging to treat.16,18 It should be noted that the high cost of these 2 medications can restrict access to care for patients who are uninsured or underinsured.

Resolution of a prurigo nodule may result in a hyperpigmented macule taking months to years to fade.

Health Disparity Highlight

Patients with PN have a considerable comorbidity burden, negative impact on quality of life, and increased health care utilization rates.12 PN is 3.4 times more common in Black patients than White patients.13 Black patients with PN have increased mortality, higher health care utilization rates, and increased systemic inflammation compared to White patients.12,19,20

References
  1. Cevikbas F, Wang X, Akiyama T, et al. A sensory neuron– expressed IL-31 receptor mediates T helper cell–dependent itch: involvement of TRPV1 and TRPA1. J Allergy Clin Immunol. 2014;133:448-460.
  2. Lou H, Lu J, Choi EB, et al. Expression of IL-22 in the skin causes Th2-biased immunity, epidermal barrier dysfunction, and pruritus via stimulating epithelial Th2 cytokines and the GRP pathway. J Immunol. 2017;198:2543-2555.
  3. Sutaria N, Adawi W, Goldberg R, et al. Itch: pathogenesis and treatment. J Am Acad Dermatol. 2022;86:17-34.
  4. Elmariah S, Kim B, Berger T, et al. Practical approaches for diagnosis and management of prurigo nodularis: United States expert panel consensus. J Am Acad Dermatol. 2021;84:747-760.
  5. Kyvayko R, Fachler-Sharp T, Greenberger S, et al. Characterization of paediatric prurigo nodularis: a multicentre retrospective, observational study. Acta Derm Venereol. 2024;104:adv15771.
  6. Aggarwal P, Choi J, Sutaria N, et al. Clinical characteristics and disease burden in prurigo nodularis. Clin Exp Dermatol. 2021;46:1277-1284.
  7. Whang KA, Le TK, Khanna R, et al. Health-related quality of life and economic burden of prurigo nodularis. J Am Acad Dermatol. 2022;86:573-580.
  8. Jørgensen KM, Egeberg A, Gislason GH, et al. Anxiety, depression and suicide in patients with prurigo nodularis. J Eur Acad Dermatol Venereol. 2017;31:E106-E107.
  9. Rodriguez D, Kwatra SG, Dias-Barbosa C, et al. Patient perspectives on living with severe prurigo nodularis. JAMA Dermatol. 2023;159:1205-1212.
  10. Misery L, Patras de Campaigno C, Taieb C, et al. Impact of chronic prurigo nodularis on daily life and stigmatization. J Eur Acad Dermatol Venereol. 2023;37:E908-E909.
  11. Huang AH, Canner JK, Khanna R, et al. Real-world prevalence of prurigo nodularis and burden of associated diseases. J Invest Dermatol. 2020;140:480-483.e4.
  12. Sutaria N, Adawi W, Brown I, et al. Racial disparities in mortality among patients with prurigo nodularis: a multicenter cohort study. J Am Acad Dermatol. 2022;82:487- 490.
  13. Boozalis E, Tang O, Patel S, et al. Ethnic differences and comorbidities of 909 prurigo nodularis patients. J Am Acad Dermatol. 2018;79:714-719.e3.
  14. Müller S, Zeidler C, Ständer S. Chronic prurigo including prurigo nodularis: new insights and treatments. Am J Clin Dermatol. 2024;25:15-33.
  15. Williams KA, Roh YS, Brown I, et al. Pathophysiology, diagnosis, and pharmacological treatment of prurigo nodularis. Expert Rev Clin Pharmacol. 2021;14:67-77.
  16. Kwatra SG, Yosipovitch G, Legat FJ, et al. Phase 3 trial of nemolizumab in patients with prurigo nodularis. N Engl J Med. 2023;389:1579-1589.
  17. Beck KM, Yang EJ, Sekhon S, et al. Dupilumab treatment for generalized prurigo nodularis. JAMA Dermatol. 2019;155:118-120.
  18. Yosipovitch G, Mollanazar N, Ständer S, et al. Dupilumab in patients with prurigo nodularis: two randomized, double- blind, placebo- controlled phase 3 trials. Nat Med. 2023;29:1180-1190.
  19. Wongvibulsin S, Sutaria N, Williams KA, et al. A nationwide study of prurigo nodularis: disease burden and healthcare utilization in the United States. J Invest Dermatol. 2021;141:2530-2533.e1.
  20. Sutaria N, Alphonse MP, Marani M, et al. Cluster analysis of circulating plasma biomarkers in prurigo nodularis reveals a distinct systemic inflammatory signature in African Americans. J Invest Dermatol. 2022;142:1300-1308.e3.
References
  1. Cevikbas F, Wang X, Akiyama T, et al. A sensory neuron– expressed IL-31 receptor mediates T helper cell–dependent itch: involvement of TRPV1 and TRPA1. J Allergy Clin Immunol. 2014;133:448-460.
  2. Lou H, Lu J, Choi EB, et al. Expression of IL-22 in the skin causes Th2-biased immunity, epidermal barrier dysfunction, and pruritus via stimulating epithelial Th2 cytokines and the GRP pathway. J Immunol. 2017;198:2543-2555.
  3. Sutaria N, Adawi W, Goldberg R, et al. Itch: pathogenesis and treatment. J Am Acad Dermatol. 2022;86:17-34.
  4. Elmariah S, Kim B, Berger T, et al. Practical approaches for diagnosis and management of prurigo nodularis: United States expert panel consensus. J Am Acad Dermatol. 2021;84:747-760.
  5. Kyvayko R, Fachler-Sharp T, Greenberger S, et al. Characterization of paediatric prurigo nodularis: a multicentre retrospective, observational study. Acta Derm Venereol. 2024;104:adv15771.
  6. Aggarwal P, Choi J, Sutaria N, et al. Clinical characteristics and disease burden in prurigo nodularis. Clin Exp Dermatol. 2021;46:1277-1284.
  7. Whang KA, Le TK, Khanna R, et al. Health-related quality of life and economic burden of prurigo nodularis. J Am Acad Dermatol. 2022;86:573-580.
  8. Jørgensen KM, Egeberg A, Gislason GH, et al. Anxiety, depression and suicide in patients with prurigo nodularis. J Eur Acad Dermatol Venereol. 2017;31:E106-E107.
  9. Rodriguez D, Kwatra SG, Dias-Barbosa C, et al. Patient perspectives on living with severe prurigo nodularis. JAMA Dermatol. 2023;159:1205-1212.
  10. Misery L, Patras de Campaigno C, Taieb C, et al. Impact of chronic prurigo nodularis on daily life and stigmatization. J Eur Acad Dermatol Venereol. 2023;37:E908-E909.
  11. Huang AH, Canner JK, Khanna R, et al. Real-world prevalence of prurigo nodularis and burden of associated diseases. J Invest Dermatol. 2020;140:480-483.e4.
  12. Sutaria N, Adawi W, Brown I, et al. Racial disparities in mortality among patients with prurigo nodularis: a multicenter cohort study. J Am Acad Dermatol. 2022;82:487- 490.
  13. Boozalis E, Tang O, Patel S, et al. Ethnic differences and comorbidities of 909 prurigo nodularis patients. J Am Acad Dermatol. 2018;79:714-719.e3.
  14. Müller S, Zeidler C, Ständer S. Chronic prurigo including prurigo nodularis: new insights and treatments. Am J Clin Dermatol. 2024;25:15-33.
  15. Williams KA, Roh YS, Brown I, et al. Pathophysiology, diagnosis, and pharmacological treatment of prurigo nodularis. Expert Rev Clin Pharmacol. 2021;14:67-77.
  16. Kwatra SG, Yosipovitch G, Legat FJ, et al. Phase 3 trial of nemolizumab in patients with prurigo nodularis. N Engl J Med. 2023;389:1579-1589.
  17. Beck KM, Yang EJ, Sekhon S, et al. Dupilumab treatment for generalized prurigo nodularis. JAMA Dermatol. 2019;155:118-120.
  18. Yosipovitch G, Mollanazar N, Ständer S, et al. Dupilumab in patients with prurigo nodularis: two randomized, double- blind, placebo- controlled phase 3 trials. Nat Med. 2023;29:1180-1190.
  19. Wongvibulsin S, Sutaria N, Williams KA, et al. A nationwide study of prurigo nodularis: disease burden and healthcare utilization in the United States. J Invest Dermatol. 2021;141:2530-2533.e1.
  20. Sutaria N, Alphonse MP, Marani M, et al. Cluster analysis of circulating plasma biomarkers in prurigo nodularis reveals a distinct systemic inflammatory signature in African Americans. J Invest Dermatol. 2022;142:1300-1308.e3.
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Improving Interprofessional Neurology Training Using Tele-Education

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Improving Interprofessional Neurology Training Using Tele-Education

Neurologic disorders are major causes of death and disability. Globally, the burden of neurologic disorders continues to increase. The prevalence of disabling neurologic disorders significantly increases with age. As people live longer, health care systems will face increasing demands for treatment, rehabilitation, and support services for neurologic disorders. The scarcity of established modifiable risks for most of the neurologic burden demonstrates how new knowledge is required to develop effective prevention and treatment strategies.1

A single-center study for chronic headache at a rural institution found that, when combined with public education, clinician education not only can increase access to care but also reduce specialist overuse, hospitalizations, polypharmacy, and emergency department visits.2 A predicted shortage of neurologists has sparked increased interest in the field and individual neurology educators are helping fuel its popularity.3-5

TELE-EDUCATION

Educating the next generation of health professionals is 1 of 4 statutory missions of the US Department of Veterans Affairs (VA).6 Tele-education (also known as telelearning and distance learning) deviates from traditional in-person classroom settings, in which the lecture has been a core pedagogic method.7 Audio, video, and online technologies provide health education and can overcome geographic barriers for rural and remote clinicians.8 Recent technological improvements have allowed for inexpensive and efficient dissemination of educational materials, including video lectures, podcasts, online modules, assessment materials, and even entire curricula.9

There has been an increase in the awareness of the parallel curriculum involving self-directed and asynchronous learning opportunities. 10 Several studies report knowledge gained via tele-education is comparable to conventional classroom learning.11-13 A systematic review of e-learning perceptions among health care students suggested benefits (eg, learning flexibility, pedagogical design, online interactions, basic computer skills, and access to technology) and drawbacks (eg, limited acquisition of clinical skills, internet connection problems, and issues with using educational platforms).1

The COVID-19 pandemic forced an abrupt cessation of traditional in-person education, forcing educational institutions and medical organizations to transition to telelearning. Solutions in the education field appeared during the pandemic, such as videoconferencing, social media, and telemedicine, that effectively addressed the sudden cessation of in-person medical education.15

Graduate medical education in neurology residency programs served as an experimental set up for tele-education during the pandemic. Residents from neurology training programs outlined the benefits of a volunteer lecturer-based online didactic program that was established to meet this need, which included exposure to subspeciality topics, access to subspecialist experts not available within the department, exposure to different pedagogic methods, interaction with members of other educational institutions and training programs, career development opportunities, and the potential for forming a community of learning.16

Not all recent educational developments are technology-based. For example, instruction focused on specific patient experiences, and learning processes that emphasize problem solving and personal responsibility over specific knowledge have been successful in neurology.17,18 Departments and institutions must be creative in finding ways to fund continuing education, especially when budgets are limited.19

ANNUAL NEUROLOGY SEMINAR

An annual Veterans Health Administration (VHA) neurology seminar began in 2019 as a 1-day in-person event. Neurologists at the Michael E. DeBakey VA Medical Center in Houston presented in 50-minute sessions. Nonspecialist clinical personnel and neurology clinicians attended the event. Attendees requested making the presentations widely available and regularly repeating the seminar.

The second neurology seminar took place during the COVID-19 pandemic. It was conducted online and advertised across the Veterans Integrated Services Network (VISN) 16. The 1-day program had 204 participants who were primarily nurses (59%) and physicians (21%); 94% agreed with the program objectives (Table 1). Participants could earn CME credits for the 7 presentations primarily by VHA experts.

FDP042053_T1

Based on feedback and a needs assessment, the program expanded in 2021 and 2022. With support from the national VHA neurology office and VHA Employee Education System (EES), the Institute for Learning, Education, and Development (ILEAD), the feedback identified topics that resonate with VHA clinicians. Neurological disorders in the fields of stroke, dementia, and headache were included since veterans with these disorders regularly visit primary care, geriatrics, mental health, and other clinical offices. Updates provided in the diagnosis and treatment of common neurological disorders were well received. Almost all speakers were VHA clinicians, which allowed them to focus on topics relevant to clinical practice at the VHA.

Attendance has increased annually. In 2021, 550 clinicians registered (52% nurses) and 433 completed the postseminar survey (Table 2). In 2022, 635 participants registered and 342 completed evaluations, including attendees from other federal agencies who were invited to participate via EES TRAIN (Training Finder Real-time Affiliate Integrated Network). Forty-seven participants from other federal agencies, including the US Department of Defense, National Institute of Health, and Centers for Disease Control and Prevention, completed the feedback evaluation via TRAIN (Table 3). Participants report high levels of satisfaction each year (mean of 4.5 on a 5-point scale). Respondents preferred conventional lecture presentation and case-based discussions for the teaching format and dementia was the most requested topic for future seminars (Table 4).

FDP042053_T2FDP042053_T3FDP042053_T4

The content of each seminar was designed to include . 1 topic relevant to current clinical practice. The 2020 seminar covered topics of cerebrovascular complications of COVID- 19 and living well with neurodegenerative disease in the COVID-19 era. In 2021, the seminar included COVID-19 and neurologic manifestations. In 2022, topics included trends in stroke rehabilitation. In addition, ≥ 1 session addressed neurologic issues within the VHA. In 2020, the VA Deputy National Director of Neurology presented on the VHA stroke systems of care. In 2021, there was a presentation on traumatic brain injury (TBI) in the military. In 2022, sessions covered long term neurologic consequences of TBI and use of telemedicine for neurologic disorders. Feedback on the sessions were positive (eAppendix, available at doi:10.12788/fp.0545).

FDP042053_APP

At the request of the participants, individual presentations were shared via email by the course director and speakers. In collaboration with the EES, each session was recorded and the 2022 seminar was made available to registrants in TMS and EES TRAIN and via the VHA Neurology SharePoint.

DISCUSSION

The annual VHA neurology seminar is a 1-day neurology conference that provides education to general neurologists and other clinicians caring for patients with neurologic disorders. It is the first of its kind neurology education program in the VHA covering most subspecialties in neurology and aims at improving neurologic patient care and access through education. Sessions have covered stroke, epilepsy, sleep, amyotrophic lateral sclerosis, neuropathy, dementia, movement disorders and Parkinson disease, headaches, multiple sclerosis, neurorehabilitation, and telehealth.

The seminar has transitioned from an inperson meeting to a virtual format, making neurology education more convenient and accessible. The virtual format provides the means to increase educational collaborations and share lecture platforms with other federal agencies. The program offers CME credits at no cost to government employees. Recorded lectures can also be asynchronously viewed from the Neurology SharePoint without the ability to earn CME credits. These recordings may be used to educate trainees as well.

The seminar aims to educate all health care professionals caring for patients with neurologic disorders. It aims to eliminate neurophobia, the fear of neural sciences and clinical neurology, and help general practitioners, especially in rural areas, take care of patients with neurologic disorders. The seminars introduce general practitioners to VHA neurology experts; the epilepsy, headache multiple sclerosis, and Parkinson disease centers of excellence; and the national programs for telestroke and teleneurology.

Education Support in the VHA

The EES/ILEAD provides a wide variety of learning opportunities to VHA employees on a broad range of topics, making it one of the largest medical education programs in the country. Pharmacists, social workers, psychologists, therapists, nurses, physician assistants, and physicians have access to certified training opportunities to gain knowledge and skills needed to provide high-quality, veteran-centered care.

A review of geriatrics learning activities through the EES found > 15,000 lectures from 1999 to 2009 for > 300,000 attendees.20 To our knowledge, a review of neurology-related learning activities offered by the EES/ILEAD has not been completed, but the study on geriatrics shows that a similar review would be feasible, given the integrated education system, and helpful in identifying what topics are covered, formats are used, and participants are engaged in neurology education at the VHA. This is a future project planned by the neurology education workgroup.

The EES/ILEAD arranged CME credit for the VHA Neurology Seminar and assisted in organizing an online event with > 500 attendees. Technology support and tools provided by EES during the virtual seminar, such as polling and chat features, kept the audience engaged. Other specialties may similarly value a virtual, all-day seminar format that is efficient and can encourage increased participation from practitioners, nurses, and clinicians.

Future Growth

We plan to increase future participation in the annual neurology seminar with primary care, geriatrics, neurology, and other specialties by instituting an improved and earlier marketing strategy. This includes working with the VHA neurology office to inform neurology practitioners as well as other program offices in the VHA. We intend to host the seminar the same day every year to make it easy for attendees to plan accordingly. In the future we may consider hybrid in-person and virtual modalities if feasible. We plan to focus on reaching out to other government agencies through platforms like TRAIN and the American Academy of Neurology government sections. Securing funding, administrative staff, and protected time in the future may help expand the program further.

Limitations

While a virtual format offers several advantages, using it removes the feel of an in-person meeting, which could be viewed by some attendees as a limitation. The other challenges and drawbacks of transitioning to the virtual platform for a national meeting are similar to those reported in the literature: time zone differences, internet issues, and participants having difficulty using certain online platforms. Attendance could also be limited by scheduling conflicts.16 Despite a large audience attending the seminar, many clinicians do not get protected time from their institutions. Institutional and leadership support at national and local levels will likely improve participation and help participants earn CME credits. While we are still doing a preliminary needs assessment, a formal needs assessment across federal governmental organizations will be helpful.

CONCLUSIONS

The annual VHA neurology seminar promotes interprofessional education, introduces neurology subspecialty centers of excellence, improves access to renowned neurology experts, and provides neurology-related updates through a VHA lens. The program not only provides educational updates to neurology clinicians, but also increases the confidence of non-neurology clinicians called to care for veterans with neurological disorders in their respective clinics.

References
  1. GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990- 2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019;18(5):459-480. doi:10.1016/S1474-4422(18)30499-X
  2. Baker V, Hack N. Improving access to care for patients with migraine in a remote Pacific population. Neurol Clin Pract. 2020;10(5):444-448. doi:10.1212/CPJ.0000000000000774
  3. Gutmann L, Cahill C, Jordan JT, et al. Characteristics of graduating US allopathic medical students pursuing a career in neurology. Neurology. 2019;92(17):e2051-e2063. doi:10.1212/WNL.0000000000007369
  4. Jordan JT, Cahill C, Ostendorf T, et al. Attracting neurology’s next generation: a qualitative study of specialty choice and perceptions. Neurology. 2020;95(8):e1080- e1090. doi:10.1212/WNL.0000000000009461
  5. Minen MT, Kaplan K, Akter S, et al. Understanding how to strengthen the neurology pipeline with insights from undergraduate neuroscience students. Neurology 2022;98(8):314-323. doi:10.1212/WNL.0000000000013259
  6. US Department of Veterans Affairs, Office of Academic Affiliations. To Educate for VA and the Nation. Updated August 1, 2024. Accessed August 15, 2024. https://www.va.gov/oaa/
  7. Schaefer SM, Dominguez M, Moeller JJ. The future of the lecture in neurology education. Semin Neurol. 2018;38(4):418-427. doi:10.1055/s-0038-1667042
  8. Curran VR. Tele-education. J Telemed Telecare. 2006;12(2):57-63. doi:10.1258/135763306776084400
  9. Lau KHV, Lakhan SE, Achike F. New media, technology and neurology education. Semin Neurol. 2018;38(4):457- 464. doi:10.1055/s-0038-1666985
  10. Quirk M, Chumley H. The adaptive medical curriculum: a model for continuous improvement. Med Teach. 2018;40(8):786-790. doi:10.1080/0142159X.2018.1484896
  11. Brockfeld T, Müller B, de Laffolie J. Video versus live lecture courses: a comparative evaluation of lecture types and results. Med Educ Online. 2018;23(1):1555434. doi:10.1080/10872981.2018.1555434
  12. Davis J, Crabb S, Rogers E, Zamora J, Khan K. Computer-based teaching is as good as face to face lecture-based teaching of evidence based medicine: a randomized controlled trial. Med Teach. 2008;30(3):302-307. doi:10.1080/01421590701784349
  13. Markova T, Roth LM, Monsur J. Synchronous distance learning as an effective and feasible method for delivering residency didactics. Fam Med. 2005;37(8):570-575.
  14. Naciri A, Radid M, Kharbach A, Chemsi G. E-learning in health professions education during the COVID-19 pandemic: a systematic review. J Educ Eval Health Prof. 2021;18:27. doi:10.3352/jeehp.2021.18.27
  15. Dedeilia A, Sotiropoulos MG, Hanrahan JG, Janga D, Dedeilias P, Sideris M. Medical and surgical education challenges and innovations in the COVID-19 era: a systematic review. In Vivo. 2020;34(3 Suppl):1603-1611. doi:10.21873/invivo.11950
  16. Weber DJ, Albert DVF, Aravamuthan BR, Bernson-Leung ME, Bhatti D, Milligan TA. Training in neurology: rapid implementation of cross-institutional neurology resident education in the time of COVID-19. Neurology. 2020;95(19):883-886. doi:10.1212/WNL.0000000000010753
  17. Frey J, Neeley B, Umer A, et al. Training in neurology: neuro day: an innovative curriculum connecting medical students with patients. Neurology. 2021;96(10):e1482- e1486. doi:10.1212/WNL.0000000000010859
  18. Schwartzstein RM, Dienstag JL, King RW, et al. The Harvard Medical School Pathways Curriculum: reimagining developmentally appropriate medical education for contemporary learners. Acad Med. 2020;95(11):1687-1695. doi:10.1097/ACM.0000000000003270
  19. Greer DM, Moeller J, Torres DR, et al. Funding the educational mission in neurology. Neurology. 2021;96(12):574- 582. doi:10.1212/WNL.0000000000011635
  20. Thielke S, Tumosa N, Lindenfeld R, Shay K. Geriatric focused educational offerings in the Department of Veterans Affairs from 1999 to 2009. Gerontol Geriatr Educ. 2011;32(1):38-53. doi:10.1080/02701960.2011.550214
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Fariha Jamal, MDa,b; Amtul Farheen, MDc,d; Christine Rizk, MDa,b

Author affiliations:
aMichael E. DeBakey Veterans Affairs Medical Center, Houston, Texas
bBaylor College of Medicine, Houston, Texas
cG.V. (Sonny) Montgomery Department of Veterans Affairs Medical Center, Jackson, Mississippi
dUniversity of Mississippi, Oxford

Author disclosures: The authors report no actual or potential conflicts of interest regarding this article.

Correspondence: Fariha Jamal ([email protected])

Fed Pract. 2025;42(1). Published online January 16. doi:10.12788/fp.0545

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Author and Disclosure Information

Fariha Jamal, MDa,b; Amtul Farheen, MDc,d; Christine Rizk, MDa,b

Author affiliations:
aMichael E. DeBakey Veterans Affairs Medical Center, Houston, Texas
bBaylor College of Medicine, Houston, Texas
cG.V. (Sonny) Montgomery Department of Veterans Affairs Medical Center, Jackson, Mississippi
dUniversity of Mississippi, Oxford

Author disclosures: The authors report no actual or potential conflicts of interest regarding this article.

Correspondence: Fariha Jamal ([email protected])

Fed Pract. 2025;42(1). Published online January 16. doi:10.12788/fp.0545

Author and Disclosure Information

Fariha Jamal, MDa,b; Amtul Farheen, MDc,d; Christine Rizk, MDa,b

Author affiliations:
aMichael E. DeBakey Veterans Affairs Medical Center, Houston, Texas
bBaylor College of Medicine, Houston, Texas
cG.V. (Sonny) Montgomery Department of Veterans Affairs Medical Center, Jackson, Mississippi
dUniversity of Mississippi, Oxford

Author disclosures: The authors report no actual or potential conflicts of interest regarding this article.

Correspondence: Fariha Jamal ([email protected])

Fed Pract. 2025;42(1). Published online January 16. doi:10.12788/fp.0545

Article PDF
Article PDF

Neurologic disorders are major causes of death and disability. Globally, the burden of neurologic disorders continues to increase. The prevalence of disabling neurologic disorders significantly increases with age. As people live longer, health care systems will face increasing demands for treatment, rehabilitation, and support services for neurologic disorders. The scarcity of established modifiable risks for most of the neurologic burden demonstrates how new knowledge is required to develop effective prevention and treatment strategies.1

A single-center study for chronic headache at a rural institution found that, when combined with public education, clinician education not only can increase access to care but also reduce specialist overuse, hospitalizations, polypharmacy, and emergency department visits.2 A predicted shortage of neurologists has sparked increased interest in the field and individual neurology educators are helping fuel its popularity.3-5

TELE-EDUCATION

Educating the next generation of health professionals is 1 of 4 statutory missions of the US Department of Veterans Affairs (VA).6 Tele-education (also known as telelearning and distance learning) deviates from traditional in-person classroom settings, in which the lecture has been a core pedagogic method.7 Audio, video, and online technologies provide health education and can overcome geographic barriers for rural and remote clinicians.8 Recent technological improvements have allowed for inexpensive and efficient dissemination of educational materials, including video lectures, podcasts, online modules, assessment materials, and even entire curricula.9

There has been an increase in the awareness of the parallel curriculum involving self-directed and asynchronous learning opportunities. 10 Several studies report knowledge gained via tele-education is comparable to conventional classroom learning.11-13 A systematic review of e-learning perceptions among health care students suggested benefits (eg, learning flexibility, pedagogical design, online interactions, basic computer skills, and access to technology) and drawbacks (eg, limited acquisition of clinical skills, internet connection problems, and issues with using educational platforms).1

The COVID-19 pandemic forced an abrupt cessation of traditional in-person education, forcing educational institutions and medical organizations to transition to telelearning. Solutions in the education field appeared during the pandemic, such as videoconferencing, social media, and telemedicine, that effectively addressed the sudden cessation of in-person medical education.15

Graduate medical education in neurology residency programs served as an experimental set up for tele-education during the pandemic. Residents from neurology training programs outlined the benefits of a volunteer lecturer-based online didactic program that was established to meet this need, which included exposure to subspeciality topics, access to subspecialist experts not available within the department, exposure to different pedagogic methods, interaction with members of other educational institutions and training programs, career development opportunities, and the potential for forming a community of learning.16

Not all recent educational developments are technology-based. For example, instruction focused on specific patient experiences, and learning processes that emphasize problem solving and personal responsibility over specific knowledge have been successful in neurology.17,18 Departments and institutions must be creative in finding ways to fund continuing education, especially when budgets are limited.19

ANNUAL NEUROLOGY SEMINAR

An annual Veterans Health Administration (VHA) neurology seminar began in 2019 as a 1-day in-person event. Neurologists at the Michael E. DeBakey VA Medical Center in Houston presented in 50-minute sessions. Nonspecialist clinical personnel and neurology clinicians attended the event. Attendees requested making the presentations widely available and regularly repeating the seminar.

The second neurology seminar took place during the COVID-19 pandemic. It was conducted online and advertised across the Veterans Integrated Services Network (VISN) 16. The 1-day program had 204 participants who were primarily nurses (59%) and physicians (21%); 94% agreed with the program objectives (Table 1). Participants could earn CME credits for the 7 presentations primarily by VHA experts.

FDP042053_T1

Based on feedback and a needs assessment, the program expanded in 2021 and 2022. With support from the national VHA neurology office and VHA Employee Education System (EES), the Institute for Learning, Education, and Development (ILEAD), the feedback identified topics that resonate with VHA clinicians. Neurological disorders in the fields of stroke, dementia, and headache were included since veterans with these disorders regularly visit primary care, geriatrics, mental health, and other clinical offices. Updates provided in the diagnosis and treatment of common neurological disorders were well received. Almost all speakers were VHA clinicians, which allowed them to focus on topics relevant to clinical practice at the VHA.

Attendance has increased annually. In 2021, 550 clinicians registered (52% nurses) and 433 completed the postseminar survey (Table 2). In 2022, 635 participants registered and 342 completed evaluations, including attendees from other federal agencies who were invited to participate via EES TRAIN (Training Finder Real-time Affiliate Integrated Network). Forty-seven participants from other federal agencies, including the US Department of Defense, National Institute of Health, and Centers for Disease Control and Prevention, completed the feedback evaluation via TRAIN (Table 3). Participants report high levels of satisfaction each year (mean of 4.5 on a 5-point scale). Respondents preferred conventional lecture presentation and case-based discussions for the teaching format and dementia was the most requested topic for future seminars (Table 4).

FDP042053_T2FDP042053_T3FDP042053_T4

The content of each seminar was designed to include . 1 topic relevant to current clinical practice. The 2020 seminar covered topics of cerebrovascular complications of COVID- 19 and living well with neurodegenerative disease in the COVID-19 era. In 2021, the seminar included COVID-19 and neurologic manifestations. In 2022, topics included trends in stroke rehabilitation. In addition, ≥ 1 session addressed neurologic issues within the VHA. In 2020, the VA Deputy National Director of Neurology presented on the VHA stroke systems of care. In 2021, there was a presentation on traumatic brain injury (TBI) in the military. In 2022, sessions covered long term neurologic consequences of TBI and use of telemedicine for neurologic disorders. Feedback on the sessions were positive (eAppendix, available at doi:10.12788/fp.0545).

FDP042053_APP

At the request of the participants, individual presentations were shared via email by the course director and speakers. In collaboration with the EES, each session was recorded and the 2022 seminar was made available to registrants in TMS and EES TRAIN and via the VHA Neurology SharePoint.

DISCUSSION

The annual VHA neurology seminar is a 1-day neurology conference that provides education to general neurologists and other clinicians caring for patients with neurologic disorders. It is the first of its kind neurology education program in the VHA covering most subspecialties in neurology and aims at improving neurologic patient care and access through education. Sessions have covered stroke, epilepsy, sleep, amyotrophic lateral sclerosis, neuropathy, dementia, movement disorders and Parkinson disease, headaches, multiple sclerosis, neurorehabilitation, and telehealth.

The seminar has transitioned from an inperson meeting to a virtual format, making neurology education more convenient and accessible. The virtual format provides the means to increase educational collaborations and share lecture platforms with other federal agencies. The program offers CME credits at no cost to government employees. Recorded lectures can also be asynchronously viewed from the Neurology SharePoint without the ability to earn CME credits. These recordings may be used to educate trainees as well.

The seminar aims to educate all health care professionals caring for patients with neurologic disorders. It aims to eliminate neurophobia, the fear of neural sciences and clinical neurology, and help general practitioners, especially in rural areas, take care of patients with neurologic disorders. The seminars introduce general practitioners to VHA neurology experts; the epilepsy, headache multiple sclerosis, and Parkinson disease centers of excellence; and the national programs for telestroke and teleneurology.

Education Support in the VHA

The EES/ILEAD provides a wide variety of learning opportunities to VHA employees on a broad range of topics, making it one of the largest medical education programs in the country. Pharmacists, social workers, psychologists, therapists, nurses, physician assistants, and physicians have access to certified training opportunities to gain knowledge and skills needed to provide high-quality, veteran-centered care.

A review of geriatrics learning activities through the EES found > 15,000 lectures from 1999 to 2009 for > 300,000 attendees.20 To our knowledge, a review of neurology-related learning activities offered by the EES/ILEAD has not been completed, but the study on geriatrics shows that a similar review would be feasible, given the integrated education system, and helpful in identifying what topics are covered, formats are used, and participants are engaged in neurology education at the VHA. This is a future project planned by the neurology education workgroup.

The EES/ILEAD arranged CME credit for the VHA Neurology Seminar and assisted in organizing an online event with > 500 attendees. Technology support and tools provided by EES during the virtual seminar, such as polling and chat features, kept the audience engaged. Other specialties may similarly value a virtual, all-day seminar format that is efficient and can encourage increased participation from practitioners, nurses, and clinicians.

Future Growth

We plan to increase future participation in the annual neurology seminar with primary care, geriatrics, neurology, and other specialties by instituting an improved and earlier marketing strategy. This includes working with the VHA neurology office to inform neurology practitioners as well as other program offices in the VHA. We intend to host the seminar the same day every year to make it easy for attendees to plan accordingly. In the future we may consider hybrid in-person and virtual modalities if feasible. We plan to focus on reaching out to other government agencies through platforms like TRAIN and the American Academy of Neurology government sections. Securing funding, administrative staff, and protected time in the future may help expand the program further.

Limitations

While a virtual format offers several advantages, using it removes the feel of an in-person meeting, which could be viewed by some attendees as a limitation. The other challenges and drawbacks of transitioning to the virtual platform for a national meeting are similar to those reported in the literature: time zone differences, internet issues, and participants having difficulty using certain online platforms. Attendance could also be limited by scheduling conflicts.16 Despite a large audience attending the seminar, many clinicians do not get protected time from their institutions. Institutional and leadership support at national and local levels will likely improve participation and help participants earn CME credits. While we are still doing a preliminary needs assessment, a formal needs assessment across federal governmental organizations will be helpful.

CONCLUSIONS

The annual VHA neurology seminar promotes interprofessional education, introduces neurology subspecialty centers of excellence, improves access to renowned neurology experts, and provides neurology-related updates through a VHA lens. The program not only provides educational updates to neurology clinicians, but also increases the confidence of non-neurology clinicians called to care for veterans with neurological disorders in their respective clinics.

Neurologic disorders are major causes of death and disability. Globally, the burden of neurologic disorders continues to increase. The prevalence of disabling neurologic disorders significantly increases with age. As people live longer, health care systems will face increasing demands for treatment, rehabilitation, and support services for neurologic disorders. The scarcity of established modifiable risks for most of the neurologic burden demonstrates how new knowledge is required to develop effective prevention and treatment strategies.1

A single-center study for chronic headache at a rural institution found that, when combined with public education, clinician education not only can increase access to care but also reduce specialist overuse, hospitalizations, polypharmacy, and emergency department visits.2 A predicted shortage of neurologists has sparked increased interest in the field and individual neurology educators are helping fuel its popularity.3-5

TELE-EDUCATION

Educating the next generation of health professionals is 1 of 4 statutory missions of the US Department of Veterans Affairs (VA).6 Tele-education (also known as telelearning and distance learning) deviates from traditional in-person classroom settings, in which the lecture has been a core pedagogic method.7 Audio, video, and online technologies provide health education and can overcome geographic barriers for rural and remote clinicians.8 Recent technological improvements have allowed for inexpensive and efficient dissemination of educational materials, including video lectures, podcasts, online modules, assessment materials, and even entire curricula.9

There has been an increase in the awareness of the parallel curriculum involving self-directed and asynchronous learning opportunities. 10 Several studies report knowledge gained via tele-education is comparable to conventional classroom learning.11-13 A systematic review of e-learning perceptions among health care students suggested benefits (eg, learning flexibility, pedagogical design, online interactions, basic computer skills, and access to technology) and drawbacks (eg, limited acquisition of clinical skills, internet connection problems, and issues with using educational platforms).1

The COVID-19 pandemic forced an abrupt cessation of traditional in-person education, forcing educational institutions and medical organizations to transition to telelearning. Solutions in the education field appeared during the pandemic, such as videoconferencing, social media, and telemedicine, that effectively addressed the sudden cessation of in-person medical education.15

Graduate medical education in neurology residency programs served as an experimental set up for tele-education during the pandemic. Residents from neurology training programs outlined the benefits of a volunteer lecturer-based online didactic program that was established to meet this need, which included exposure to subspeciality topics, access to subspecialist experts not available within the department, exposure to different pedagogic methods, interaction with members of other educational institutions and training programs, career development opportunities, and the potential for forming a community of learning.16

Not all recent educational developments are technology-based. For example, instruction focused on specific patient experiences, and learning processes that emphasize problem solving and personal responsibility over specific knowledge have been successful in neurology.17,18 Departments and institutions must be creative in finding ways to fund continuing education, especially when budgets are limited.19

ANNUAL NEUROLOGY SEMINAR

An annual Veterans Health Administration (VHA) neurology seminar began in 2019 as a 1-day in-person event. Neurologists at the Michael E. DeBakey VA Medical Center in Houston presented in 50-minute sessions. Nonspecialist clinical personnel and neurology clinicians attended the event. Attendees requested making the presentations widely available and regularly repeating the seminar.

The second neurology seminar took place during the COVID-19 pandemic. It was conducted online and advertised across the Veterans Integrated Services Network (VISN) 16. The 1-day program had 204 participants who were primarily nurses (59%) and physicians (21%); 94% agreed with the program objectives (Table 1). Participants could earn CME credits for the 7 presentations primarily by VHA experts.

FDP042053_T1

Based on feedback and a needs assessment, the program expanded in 2021 and 2022. With support from the national VHA neurology office and VHA Employee Education System (EES), the Institute for Learning, Education, and Development (ILEAD), the feedback identified topics that resonate with VHA clinicians. Neurological disorders in the fields of stroke, dementia, and headache were included since veterans with these disorders regularly visit primary care, geriatrics, mental health, and other clinical offices. Updates provided in the diagnosis and treatment of common neurological disorders were well received. Almost all speakers were VHA clinicians, which allowed them to focus on topics relevant to clinical practice at the VHA.

Attendance has increased annually. In 2021, 550 clinicians registered (52% nurses) and 433 completed the postseminar survey (Table 2). In 2022, 635 participants registered and 342 completed evaluations, including attendees from other federal agencies who were invited to participate via EES TRAIN (Training Finder Real-time Affiliate Integrated Network). Forty-seven participants from other federal agencies, including the US Department of Defense, National Institute of Health, and Centers for Disease Control and Prevention, completed the feedback evaluation via TRAIN (Table 3). Participants report high levels of satisfaction each year (mean of 4.5 on a 5-point scale). Respondents preferred conventional lecture presentation and case-based discussions for the teaching format and dementia was the most requested topic for future seminars (Table 4).

FDP042053_T2FDP042053_T3FDP042053_T4

The content of each seminar was designed to include . 1 topic relevant to current clinical practice. The 2020 seminar covered topics of cerebrovascular complications of COVID- 19 and living well with neurodegenerative disease in the COVID-19 era. In 2021, the seminar included COVID-19 and neurologic manifestations. In 2022, topics included trends in stroke rehabilitation. In addition, ≥ 1 session addressed neurologic issues within the VHA. In 2020, the VA Deputy National Director of Neurology presented on the VHA stroke systems of care. In 2021, there was a presentation on traumatic brain injury (TBI) in the military. In 2022, sessions covered long term neurologic consequences of TBI and use of telemedicine for neurologic disorders. Feedback on the sessions were positive (eAppendix, available at doi:10.12788/fp.0545).

FDP042053_APP

At the request of the participants, individual presentations were shared via email by the course director and speakers. In collaboration with the EES, each session was recorded and the 2022 seminar was made available to registrants in TMS and EES TRAIN and via the VHA Neurology SharePoint.

DISCUSSION

The annual VHA neurology seminar is a 1-day neurology conference that provides education to general neurologists and other clinicians caring for patients with neurologic disorders. It is the first of its kind neurology education program in the VHA covering most subspecialties in neurology and aims at improving neurologic patient care and access through education. Sessions have covered stroke, epilepsy, sleep, amyotrophic lateral sclerosis, neuropathy, dementia, movement disorders and Parkinson disease, headaches, multiple sclerosis, neurorehabilitation, and telehealth.

The seminar has transitioned from an inperson meeting to a virtual format, making neurology education more convenient and accessible. The virtual format provides the means to increase educational collaborations and share lecture platforms with other federal agencies. The program offers CME credits at no cost to government employees. Recorded lectures can also be asynchronously viewed from the Neurology SharePoint without the ability to earn CME credits. These recordings may be used to educate trainees as well.

The seminar aims to educate all health care professionals caring for patients with neurologic disorders. It aims to eliminate neurophobia, the fear of neural sciences and clinical neurology, and help general practitioners, especially in rural areas, take care of patients with neurologic disorders. The seminars introduce general practitioners to VHA neurology experts; the epilepsy, headache multiple sclerosis, and Parkinson disease centers of excellence; and the national programs for telestroke and teleneurology.

Education Support in the VHA

The EES/ILEAD provides a wide variety of learning opportunities to VHA employees on a broad range of topics, making it one of the largest medical education programs in the country. Pharmacists, social workers, psychologists, therapists, nurses, physician assistants, and physicians have access to certified training opportunities to gain knowledge and skills needed to provide high-quality, veteran-centered care.

A review of geriatrics learning activities through the EES found > 15,000 lectures from 1999 to 2009 for > 300,000 attendees.20 To our knowledge, a review of neurology-related learning activities offered by the EES/ILEAD has not been completed, but the study on geriatrics shows that a similar review would be feasible, given the integrated education system, and helpful in identifying what topics are covered, formats are used, and participants are engaged in neurology education at the VHA. This is a future project planned by the neurology education workgroup.

The EES/ILEAD arranged CME credit for the VHA Neurology Seminar and assisted in organizing an online event with > 500 attendees. Technology support and tools provided by EES during the virtual seminar, such as polling and chat features, kept the audience engaged. Other specialties may similarly value a virtual, all-day seminar format that is efficient and can encourage increased participation from practitioners, nurses, and clinicians.

Future Growth

We plan to increase future participation in the annual neurology seminar with primary care, geriatrics, neurology, and other specialties by instituting an improved and earlier marketing strategy. This includes working with the VHA neurology office to inform neurology practitioners as well as other program offices in the VHA. We intend to host the seminar the same day every year to make it easy for attendees to plan accordingly. In the future we may consider hybrid in-person and virtual modalities if feasible. We plan to focus on reaching out to other government agencies through platforms like TRAIN and the American Academy of Neurology government sections. Securing funding, administrative staff, and protected time in the future may help expand the program further.

Limitations

While a virtual format offers several advantages, using it removes the feel of an in-person meeting, which could be viewed by some attendees as a limitation. The other challenges and drawbacks of transitioning to the virtual platform for a national meeting are similar to those reported in the literature: time zone differences, internet issues, and participants having difficulty using certain online platforms. Attendance could also be limited by scheduling conflicts.16 Despite a large audience attending the seminar, many clinicians do not get protected time from their institutions. Institutional and leadership support at national and local levels will likely improve participation and help participants earn CME credits. While we are still doing a preliminary needs assessment, a formal needs assessment across federal governmental organizations will be helpful.

CONCLUSIONS

The annual VHA neurology seminar promotes interprofessional education, introduces neurology subspecialty centers of excellence, improves access to renowned neurology experts, and provides neurology-related updates through a VHA lens. The program not only provides educational updates to neurology clinicians, but also increases the confidence of non-neurology clinicians called to care for veterans with neurological disorders in their respective clinics.

References
  1. GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990- 2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019;18(5):459-480. doi:10.1016/S1474-4422(18)30499-X
  2. Baker V, Hack N. Improving access to care for patients with migraine in a remote Pacific population. Neurol Clin Pract. 2020;10(5):444-448. doi:10.1212/CPJ.0000000000000774
  3. Gutmann L, Cahill C, Jordan JT, et al. Characteristics of graduating US allopathic medical students pursuing a career in neurology. Neurology. 2019;92(17):e2051-e2063. doi:10.1212/WNL.0000000000007369
  4. Jordan JT, Cahill C, Ostendorf T, et al. Attracting neurology’s next generation: a qualitative study of specialty choice and perceptions. Neurology. 2020;95(8):e1080- e1090. doi:10.1212/WNL.0000000000009461
  5. Minen MT, Kaplan K, Akter S, et al. Understanding how to strengthen the neurology pipeline with insights from undergraduate neuroscience students. Neurology 2022;98(8):314-323. doi:10.1212/WNL.0000000000013259
  6. US Department of Veterans Affairs, Office of Academic Affiliations. To Educate for VA and the Nation. Updated August 1, 2024. Accessed August 15, 2024. https://www.va.gov/oaa/
  7. Schaefer SM, Dominguez M, Moeller JJ. The future of the lecture in neurology education. Semin Neurol. 2018;38(4):418-427. doi:10.1055/s-0038-1667042
  8. Curran VR. Tele-education. J Telemed Telecare. 2006;12(2):57-63. doi:10.1258/135763306776084400
  9. Lau KHV, Lakhan SE, Achike F. New media, technology and neurology education. Semin Neurol. 2018;38(4):457- 464. doi:10.1055/s-0038-1666985
  10. Quirk M, Chumley H. The adaptive medical curriculum: a model for continuous improvement. Med Teach. 2018;40(8):786-790. doi:10.1080/0142159X.2018.1484896
  11. Brockfeld T, Müller B, de Laffolie J. Video versus live lecture courses: a comparative evaluation of lecture types and results. Med Educ Online. 2018;23(1):1555434. doi:10.1080/10872981.2018.1555434
  12. Davis J, Crabb S, Rogers E, Zamora J, Khan K. Computer-based teaching is as good as face to face lecture-based teaching of evidence based medicine: a randomized controlled trial. Med Teach. 2008;30(3):302-307. doi:10.1080/01421590701784349
  13. Markova T, Roth LM, Monsur J. Synchronous distance learning as an effective and feasible method for delivering residency didactics. Fam Med. 2005;37(8):570-575.
  14. Naciri A, Radid M, Kharbach A, Chemsi G. E-learning in health professions education during the COVID-19 pandemic: a systematic review. J Educ Eval Health Prof. 2021;18:27. doi:10.3352/jeehp.2021.18.27
  15. Dedeilia A, Sotiropoulos MG, Hanrahan JG, Janga D, Dedeilias P, Sideris M. Medical and surgical education challenges and innovations in the COVID-19 era: a systematic review. In Vivo. 2020;34(3 Suppl):1603-1611. doi:10.21873/invivo.11950
  16. Weber DJ, Albert DVF, Aravamuthan BR, Bernson-Leung ME, Bhatti D, Milligan TA. Training in neurology: rapid implementation of cross-institutional neurology resident education in the time of COVID-19. Neurology. 2020;95(19):883-886. doi:10.1212/WNL.0000000000010753
  17. Frey J, Neeley B, Umer A, et al. Training in neurology: neuro day: an innovative curriculum connecting medical students with patients. Neurology. 2021;96(10):e1482- e1486. doi:10.1212/WNL.0000000000010859
  18. Schwartzstein RM, Dienstag JL, King RW, et al. The Harvard Medical School Pathways Curriculum: reimagining developmentally appropriate medical education for contemporary learners. Acad Med. 2020;95(11):1687-1695. doi:10.1097/ACM.0000000000003270
  19. Greer DM, Moeller J, Torres DR, et al. Funding the educational mission in neurology. Neurology. 2021;96(12):574- 582. doi:10.1212/WNL.0000000000011635
  20. Thielke S, Tumosa N, Lindenfeld R, Shay K. Geriatric focused educational offerings in the Department of Veterans Affairs from 1999 to 2009. Gerontol Geriatr Educ. 2011;32(1):38-53. doi:10.1080/02701960.2011.550214
References
  1. GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990- 2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019;18(5):459-480. doi:10.1016/S1474-4422(18)30499-X
  2. Baker V, Hack N. Improving access to care for patients with migraine in a remote Pacific population. Neurol Clin Pract. 2020;10(5):444-448. doi:10.1212/CPJ.0000000000000774
  3. Gutmann L, Cahill C, Jordan JT, et al. Characteristics of graduating US allopathic medical students pursuing a career in neurology. Neurology. 2019;92(17):e2051-e2063. doi:10.1212/WNL.0000000000007369
  4. Jordan JT, Cahill C, Ostendorf T, et al. Attracting neurology’s next generation: a qualitative study of specialty choice and perceptions. Neurology. 2020;95(8):e1080- e1090. doi:10.1212/WNL.0000000000009461
  5. Minen MT, Kaplan K, Akter S, et al. Understanding how to strengthen the neurology pipeline with insights from undergraduate neuroscience students. Neurology 2022;98(8):314-323. doi:10.1212/WNL.0000000000013259
  6. US Department of Veterans Affairs, Office of Academic Affiliations. To Educate for VA and the Nation. Updated August 1, 2024. Accessed August 15, 2024. https://www.va.gov/oaa/
  7. Schaefer SM, Dominguez M, Moeller JJ. The future of the lecture in neurology education. Semin Neurol. 2018;38(4):418-427. doi:10.1055/s-0038-1667042
  8. Curran VR. Tele-education. J Telemed Telecare. 2006;12(2):57-63. doi:10.1258/135763306776084400
  9. Lau KHV, Lakhan SE, Achike F. New media, technology and neurology education. Semin Neurol. 2018;38(4):457- 464. doi:10.1055/s-0038-1666985
  10. Quirk M, Chumley H. The adaptive medical curriculum: a model for continuous improvement. Med Teach. 2018;40(8):786-790. doi:10.1080/0142159X.2018.1484896
  11. Brockfeld T, Müller B, de Laffolie J. Video versus live lecture courses: a comparative evaluation of lecture types and results. Med Educ Online. 2018;23(1):1555434. doi:10.1080/10872981.2018.1555434
  12. Davis J, Crabb S, Rogers E, Zamora J, Khan K. Computer-based teaching is as good as face to face lecture-based teaching of evidence based medicine: a randomized controlled trial. Med Teach. 2008;30(3):302-307. doi:10.1080/01421590701784349
  13. Markova T, Roth LM, Monsur J. Synchronous distance learning as an effective and feasible method for delivering residency didactics. Fam Med. 2005;37(8):570-575.
  14. Naciri A, Radid M, Kharbach A, Chemsi G. E-learning in health professions education during the COVID-19 pandemic: a systematic review. J Educ Eval Health Prof. 2021;18:27. doi:10.3352/jeehp.2021.18.27
  15. Dedeilia A, Sotiropoulos MG, Hanrahan JG, Janga D, Dedeilias P, Sideris M. Medical and surgical education challenges and innovations in the COVID-19 era: a systematic review. In Vivo. 2020;34(3 Suppl):1603-1611. doi:10.21873/invivo.11950
  16. Weber DJ, Albert DVF, Aravamuthan BR, Bernson-Leung ME, Bhatti D, Milligan TA. Training in neurology: rapid implementation of cross-institutional neurology resident education in the time of COVID-19. Neurology. 2020;95(19):883-886. doi:10.1212/WNL.0000000000010753
  17. Frey J, Neeley B, Umer A, et al. Training in neurology: neuro day: an innovative curriculum connecting medical students with patients. Neurology. 2021;96(10):e1482- e1486. doi:10.1212/WNL.0000000000010859
  18. Schwartzstein RM, Dienstag JL, King RW, et al. The Harvard Medical School Pathways Curriculum: reimagining developmentally appropriate medical education for contemporary learners. Acad Med. 2020;95(11):1687-1695. doi:10.1097/ACM.0000000000003270
  19. Greer DM, Moeller J, Torres DR, et al. Funding the educational mission in neurology. Neurology. 2021;96(12):574- 582. doi:10.1212/WNL.0000000000011635
  20. Thielke S, Tumosa N, Lindenfeld R, Shay K. Geriatric focused educational offerings in the Department of Veterans Affairs from 1999 to 2009. Gerontol Geriatr Educ. 2011;32(1):38-53. doi:10.1080/02701960.2011.550214
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Development of an Integrative Medicine Rotation for Family Medicine and Preventive Medicine Residency

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Development of an Integrative Medicine Rotation for Family Medicine and Preventive Medicine Residency

Integrative medicine or complementary alternative medicine (IM/CAM) is increasingly being recognized as an integral part of optimal health and healing. IM/CAM “reaffirms the importance of the relationship between practitioner and patient, focuses on the whole person, is informed by evidence, and makes use of all appropriate therapeutic approaches, healthcare professionals and disciplines.”1 IM/CAM encompasses a wide range of therapies, conceptual frameworks, and health care-related professions, such as acupuncture, massage, dietary supplements, mindfulness, yoga, meditation and guided imagery.1 Research has found that 30% to 98% of patients with chronic conditions seek IM/CAM therapies.1-3

Despite the high prevalence of patients utilizing IM/CAM therapies and the National Institutes of Health grants for IM/CAM education, implementation of IM/CAM instruction in graduate medical education programs remains inconsistent.1 Barriers cited by programs include a lack of IM/CAM experts in the program, faculty training, competing financial resources, and an already full resident education schedule.4 As a result, many physicians have limited or no training in IM/CAM.1,5

The US Department of Veterans Affairs (VA) offers IM/CAM health programs to veterans and caregivers as part of its whole health care initiative.6 Several VA health care systems have adopted whole health and IM/CAM through programs for mental health integration into primary care; women’s health; integrative pain care; geriatrics, through adoption of Age-Friendly Health Systems standards; and nutrition and physical activity.7-13 The VA provides training to more medical students than any other health system: > 95% of US medical schools are affiliated with a VA medical center (VAMC).14 As part of the training mission, VA seeks to encourage students of diverse professions to consider careers in the VA.14

Residency is a time for newly licensed physicians to acquire additional experience and training to translate knowledge and skills acquired during medical school directly to patient care.15 However, residency curricula have limited time to incorporate IM/CAM training. Residency training is also physically and psychosocially demanding, often resulting in inadequate self-care, poor work-life balance, and disrupted sleep.16-18 Resident wellness is at a historic low, resulting in high rates of burnout during training.4,15

Residency programs are required to provide wellness education; however, most programs include minimal content.19 Despite high rates of burnout, formal curricula on the topic have not been established. 20 IM/CAM education also can provide a path for residents to learn about and engage in mindfulness-based training or cognitive stress reduction for self-care.

INTEGRATIVE WHOLE HEALTH ROTATION

In 2017, the Baltimore Geriatric Research Education and Clinical Center (GRECC) established an IM/whole health residency rotation and created a structured curriculum incorporating self-assessment, active reflection, and self-care to complement training in specific IM/CAM modalities for residents in family medicine. The curriculum evaluated how this training improved residents’ perceptions of IM/CAM and how it personally and professionally impacted the practice of self-care as a strategy to decrease burnout. We hypothesized that this structured experience would increase IM/CAM knowledge among clinicians while promoting the importance and practice of self-care to reduce burnout.

The 2-week IM/CAM curriculum was developed by University of Maryland School of Medicine faculty in partnership with the Baltimore GRECC and staff at the VA Maryland Health Care System. The curriculum was designed to expose residents to the 8 components of the whole health Circle of Health (moving the body; surroundings; personal development; food and drink; recharge; family, friends, and coworkers; spirit and soul; and power of the mind) in addition to IM/ CAM modalities the VA is mandated to offer to veterans (acupuncture, chiropractic, meditation, massage therapy, biofeedback, clinical hypnosis, guided imagery, yoga, and tai chi).21 Twelve residents (1 preventive medicine and 11 third-year family medicine residents) rotated individually throughout the year as part of their behavioral health block rotation. All residents completed the 2-week curriculum as their schedules allowed. The curriculum consisted of didactics sessions and activities at the Baltimore, Loch Raven, and Perry Point VAMCs. Residents completed evaluations before and after the rotation. The experience described in this article by the residents and the survey data were collected from the 2018/2019 training year. A rotation syllabus, competencies adapted from Locke and colleagues and skills residents obtain during this rotation that support these competencies, as well as a resident sample schedule were developed (eAppendix is available at doi:10.12788/fp.0544).1

FDP042035_App
Rotation Overview

for each resident were built around instructional opportunities, which included 1-on-1 didactics, direct observation of treatment modalities, and personal reflection of the residents’ self-care practices. While each resident’s rotation schedule varied slightly due to their schedules, the foundational instruction elements were the same. Didactic session themes included an overview of IM/CAM, nutrition, narrative medicine, pain psychology, music therapy, chaplain services, motor-cognitive training, and exercise guidelines. Assigned readings, including peer-reviewed literature on IM/CAM therapies, complemented all sessions. Residents created an evidence-supported integrative treatment plan for a patient with a condition of interest to them.

Residents observed clinician-led veteran group sessions on IM/CAM treatment modalities, including guided meditation, mindfulness and relaxation, self-awareness, living well with chronic pain, tai chi, drumming for health and balance, anger management, recovery group, acceptance and commitment therapy, and Gerofit exercise. The group classes allowed residents to actively participate in the activity or discussion. Residents also shadowed VA clinicians in sleep, pain, nutrition, acupuncture, and mental health clinics.

Residents were encouraged to practice self-care during the 2-week rotation. The rotation schedule built in free time, including a 1-hour daily lunch period, for residents to consider their own health habits, complete a personal health inventory, and try self-care activities outlined on the syllabus with links to resources. These resources also served as educational materials that residents could share with patients. All materials, including didactic lectures, journal articles and self-care resources, were provided to each resident through a free online course to ensure residents had access throughout and following completion of the rotation. This content, including the rotation evaluation metrics, is available upon request from the corresponding author.

Evaluations

Residents completed a survey before and after the rotation to measure IM/CAM knowledge and application and self-care/ burnout perceptions. Residents were asked to evaluate rotation sessions and comment on whether this rotation benefited them personally and professionally (Table 1). Descriptive statistics were analyzed using Microsoft Excel. Given the small sample size and lack of statistical power, only mean survey results are reported in this article. Because this opportunity is specific to the University of Maryland School of Medicine and the proposed project was part of ordinary educational practice, the study was deemed not human subject research by the University of Maryland Institutional Review Board (HP-00089256).

FDP042035_T1

Perceptions and attitudes toward IM/CAM were assessed using a survey designed by the University of Minnesota Academic Health Center. It included 18 items scored on a 5-point semantic rating scale (1, strongly disagree; 5, strongly agree).22 Residents rated their level of agreement with statements reflecting both positive (eg, clinical care should integrate the best of conventional and CAM practices) and negative (eg, CAM is a threat to public health) views. Three questions adapted from the NHIS Adult Complementary Health Questionnaire and UC Irvine Survey of Health Care Use and Practice assessed the use of IM/CAM resources.23,24

Resident knowledge and application of IM/CAM were measured using a case study designed by the course faculty. The case listed a chief complaint of nerve pain, with a history of chronic pain, neuropathic pain, anxiety, chronic fatigue, depression, insomnia, posttraumatic stress disorder, history of present illness, past surgical history, medication list, review of symptoms, laboratory values, and physical examination. The residents completed an assessment before and after the rotation. Residents rated their confidence in the diagnosis and treatment of 8 medical conditions using a 5-point semantic rating scale (Table 2). Self-care importance and selfcare frequency were measured by a variety of means, including 3 survey questions, the Five Facet Mindfulness Questionnaire, 2 prompts on a 7-point semantic scale, and a slightly modified version of the validated Perceived Stress Scale.25-28

FDP042035_T2
Survey Results

Residents gave the rotation positive feedback with a mean score of 8.5 out of 10. They reported the beneficial impact of seeing the nontraditional and nonpharmacological practices in treating patients, chronic pain management team approaches, and enjoyed being able to participate in group classes with patients. Many residents expressed a desire for a longer rotation to have more time to experience the behavioral health-focused sessions. Residents also requested additional information on nutritional supplements/natural medicines, battlefield acupuncture training and osteopathic manipulative therapy practices. All residents reported the rotation personally and/or professionally benefited them (Appendix).

Given the sample of 12 residents, values are presented as prerotation to postrotation comparisons without statistical analysis. There was a trend towards an increase in the reported use and recommendation of 26 modalities of nonconventional therapies following the rotation. There was also a slight increase in resource knowledge and use of these resources, and residents reported accessing more types of resources. Mean scores of the case study to gauge knowledge and application of IM increased from 7.5 at baseline to 11.0 after the rotation. Resident confidence in diagnosis increased for all 8 conditions, but confidence in treatment only increased for 4 conditions.

Results of self-care importance, self-care frequency and mindfulness were consistent baseline to postrotation. The mean time residents spent regularly practicing self-care during a work week increased slightly while feelings of burnout decreased. The perceived stress scale average score decreased from 13.4 at baseline to 10.5 after rotation.

DISCUSSION

The implementation of an IM residency rotation that incorporates whole health and interprofessional practices demonstrated improved perception and increased use of IM/CAM resources and knowledge among a small sample of third-year residents. Residents reported they had a positive experience participating in the rotation and gained knowledge, resources, and skills they felt confident discussing with their patients.

Many studies reported favorable attitudes and perceptions of IM/CAM use among physicians, but few have assessed these measures while implementing a training curriculum.3,4,22 Gardiner and colleagues reported on the perception and use of IM resources among family medicine residents.4 The study found that while 58% of all residents reported IM/CAM as an important part of their training, only 60% reported they received it or had specific learning objectives in their curriculum. 4 The program outlined in this study and previous research illustrate that physicians recognize the importance of IM/CAM education in training programs, but most were unaware of the resources available or did not feel comfortable counseling patients about most IM/CAM applications.

Residents in this program slightly increased their use of IM/CAM to diagnose and treat medical conditions after the rotation. A study by Wahner-Roedler and colleagues assessed physician knowledge regarding common IM/CAM therapies.3 On average, physicians only felt knowledgeable and comfortable counseling patients for 3 of 13 listed treatments/techniques and few natural herbal treatments. The study also found that most physicians had difficulty accessing IM/CAM information at their institution despite having free access to electronic databases. However, this study only assessed physician attitudes of IM/CAM and did not include an educational component to increase their knowledge of the modalities.3 This evaluation supports the need for interventions like the program described in this article that provide physicians with access to evidence-based resources combined with the applied experiences to increase their comfort within this growing field.

Though the sample size in this study was small, its results support existing research indicating that clinicians view selfcare as important. Many residents were already using a self-care plan at baseline, but there was slight increase in the practice of self-care during the rotation and a slight decrease in burnout. Previous research reflects high rates of burnout and relatively poor quality of life among primary care physicians.15 Burnout is associated with lower quality of care, lower patient satisfaction and contributes to medical errors. Studies suggest as many as 60% of primary care physicians report symptoms of burnout, which negatively affected the quality of patient care they provide.15

Despite the profound effects burnout has on physicians and patient care, a standardized wellness education or self-care tool kit is not currently available. The University of Massachusetts recently introduced a pilot program to promote resident wellness that demonstrated favorable results.15 A meta-analysis of physicians and medical trainees found decreases in anxiety and symptoms of anxiety as well as a decrease in burnout among participants in cognitive, behavioral and mindfulness interventions.29 However, unlike our program, these programs focused solely on the well-being of medical trainees, residents, and physicians and didn’t focus on the patient-clinician interactions. Given the impact on patient care, there is a need to develop and implement additional programs like our residency rotation that promote health and wellness among physicians while also evaluating how physicians may translate these skills to patient education.

While this program st i l l exists for third-year residents at Baltimore GRECC, it has significantly changed since the COVID-19 pandemic. For about the first 6 months of the pandemic, when physical distancing requirements were in place, family medicine trainees were not able to rotate. Upon return to the facility, many group classes were cancelled and some clinicians no longer offered the sessions. The rotation has evolved to a hybrid format, where many group classes for veteran patients are offered virtually, and residents observe a mix of virtual and in-person shadowing opportunities. Our formal evaluation included administering the survey and occurred from July 2018 to July 2019 but wasn’t implemented upon return to post-COVID activities due to the inconsistent experiences offered to residents over the past few years. Future research should evaluate the impact of this hybrid program on the clinicians and explore dissemination to other VAMCs and their academic affiliates.

Limitations

Project recruitment was limited to 11 family medicine and 1 preventive medicine resident. Perceptions, use of IM/CAM, and knowledge about IM/CAM could be considerably different in different departments with varying schedules, hours worked, and patient volumes. Secondly, the survey was conducted 2 weeks apart. Indications of self-care and burnout may not reflect long-term effects, adoption, or maintenance. Future research should include longer follow up to examine how this type of educational activity may impact burnout rates of physicians following the completion of residency, as well as changes in perspectives of IM/CAM while practicing as a physician. Trainees were exposed to a wide range of health care professions, but additional research is needed regarding medical resident perceptions of the roles of specific professions in a collaborative health care team.30,31

CONCLUSIONS

The residency rotation program illustrates the benefits of establishing a standardized IM/CAM rotation that includes self-care resources in family medicine programs to adequately train clinicians to practice wellness and promote it to their patients. The results of this project suggest this type of training will help residents assess the literature to better counsel patients on IM/CAM options while also providing strategies for maintaining optimal health and well-being for health care professionals. Broadening and shifting the scope of medicine from treatment to prevention, personal wellness, and optimal healing should be a top priority.

References
  1. Locke AB, Gordon A, Guerrera MP, Gardiner P, Lebensohn P. Recommended integrative medicine competencies for family medicine residents. Explore (NY). 2013;9(5):308-313. doi:10.1016/j.explore.2013.06.005
  2. Eisenberg DM, Davis RB, Ettner SL, et al. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA. 1998;280(18):1569-1575. doi:10.1001/jama.280.18.1569
  3. Wahner-Roedler DL, Vincent A, Elkin PL, Loehrer LL, Cha SS, Bauer BA. Physicians’ attitudes toward complementary and alternative medicine and their knowledge of specific therapies: a survey at an academic medical center. Evid Based Complement Alternat Med. 2006;3(4):495-501. doi:10.1093/ecam/nel036
  4. Gardiner P, Filippelli AC, Lebensohn P, Bonakdar R. Family medicine residency program directors attitudes and knowledge of family medicine CAM competencies. Explore (NY). 2013;9(5):299-307. doi:10.1016/j.explore.2013.06.002
  5. Sierpina V, Levine R, Astin J, Tan A. Use of mind-body therapies in psychiatry and family medicine faculty and residents: attitudes, barriers, and gender differences. Explore (NY). 2007;3(2):129-135. doi:10.1016/j.explore.2006.12.001
  6. Krist AH, South-Paul J, Meisnere M, eds. Achieving Whole Health: A New Approach for Veterans and the Nation. The National Academies Press; 2023.
  7. Bokhour BG, DeFaccio R, Gaj L, et al. Changes in patientreported outcomes associated with receiving whole health in the Veteran Health Administration (VHA)’s National Demonstration Project. J Gen Intern Med. 2024;39(1):84-94. doi:10.1007/s11606-023-08376-0
  8. Courtney RE, Schadegg MJ, Bolton R, Smith S, Harden SM. Using a whole health approach to build biopsychosocial- spiritual personal health plans for veterans with chronic pain. Pain Manag Nurs. 2024;25(1):69-74. doi:10.1016/j.pmn.2023.09.010
  9. Gabrielian S, Jones AL, Hoge AE, et al. Enhancing primary care experiences for homeless patients with serious mental illness: results from a national survey. J Prim Care Community Health. 2021;12:2150132721993654. doi:10.1177/2150132721993654
  10. Matthieu MM, Church KA, Taylor LD, et al. Integrating the age-friendly health systems movement in Veterans Health Administration: national advance care planning via group visits and the 4Ms framework. Health Soc Work. 2023;48(4):277-280. doi:10.1093/hsw/hlad022
  11. Meisler AW, Gianoli MO, Na PJ, Pietrzak RH. Functional disability in US military veterans: the importance of integrated whole health initiatives. Prim Care Companion CNS Disord. 2023;25(4):22m03461. doi:10.4088/PCC.22m03461
  12. Ortmeyer HK, Giffuni J, Etchberger D, Katzel L. The role of companion dogs in the VA Maryland Health Care System Whole Health(y) GeroFit Program. Animals (Basel). 2023;13(19):3047. doi:10.3390/ani13193047
  13. Sullivan MB, Hill K, Ballengee LA, et al. Remotely delivered psychologically informed mindful movement physical therapy for pain care: a framework for operationalization. Glob Adv Integr Med Health. 2023;12:27536130231209751. doi:10.1177/27536130231209751
  14. (OAA) OoAA. 75th Anniversary: Passion to learn. Power to heal. Washington DC.: US Department of Veterans Affairs; 2021. https://content.yudu.com/web/448fx/0A448g9/75thAnniversary2021/html/index.html?page=24&origin=reader
  15. Runyan C, Savageau JA, Potts S, Weinreb L. Impact of a family medicine resident wellness curriculum: a feasibility study. Med Educ Online. 2016;21:30648. doi:10.3402/meo.v21.30648
  16. Lafreniere JP, Rios R, Packer H, Ghazarian S, Wright SM, Levine RB. Burned out at the bedside: patient perceptions of physician burnout in an internal medicine resident continuity clinic. J Gen Intern Med. 2016;31(2):203-208. doi:10.1007/s11606-015-3503-3
  17. Freedy JR, Staley C, Mims LD, et al. Social, individual, and environmental characteristics of family medicine resident burnout: a CERA study. Fam Med. 2022;54(4):270-276. doi:10.22454/FamMed.2022.526799
  18. Alrishan MA, Alshammari SA. Prevalence of sleep deprivation and its effect on the performance of family medicine residents in Riyadh, Saudi Arabia. J Family Community Med. 2020;27(2):125-130. doi:10.4103/jfcm.JFCM_9_20
  19. ACGME. ACGME Program Requirements for Graduate Medical Education in Family Medicine. https://www.acgme.org/globalassets/pfassets/programrequirements/120_familymedicine_2024.pdf
  20. Nene Y, Tadi P. Resident Burnout. In: StatPearls; 2023.
  21. Bokhour BG, Haun JN, Hyde J, Charns M, Kligler B. Transforming the veterans affairs to a whole health system of care: time for action and research. Med Care. 2020;58(4):295-300. doi:10.1097/MLF.0000000000001316
  22. Kreitzer MJ, Mitten D, Harris I, Shandeling J. Attitudes toward CAM among medical, nursing, and pharmacy faculty and students: a comparative analysis. Altern Ther Health Med. 2002;8(6):44-53.
  23. Clarke TC, Black LI, Stussman BJ, Barnes PM, Nahin RL. Trends in the use of complementary health approaches among adults: United States, 2002-2012. Natl Health Stat Report. 2015(79):1-16.
  24. Nguyen J, Liu MA, Patel RJ, Tahara K, Nguyen AL. Use and interest in complementary and alternative medicine among college students seeking healthcare at a university campus student health center. Complement Ther Clin Pract. 2016;24:103-108. doi:10.1016/j.ctcp.2016.06.001
  25. Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006;13(1):27-45. doi:10.1177/1073191105283504
  26. Baer RA, Smith GT, Lykins E, et al. Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment. 2008;15(3):329-342. doi:10.1177/1073191107313003
  27. West CP, Dyrbye LN, Sloan JA, Shanafelt TD. Single item measures of emotional exhaustion and depersonalization are useful for assessing burnout in medical professionals. J Gen Intern Med. 2009;24(12):1318- 1321. doi:10.1007/s11606-009-1129-z
  28. Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983;24(4):385-396.
  29. Regehr C, Glancy D, Pitts A, LeBlanc VR. Interventions to reduce the consequences of stress in physicians: a review and meta-analysis. J Nerv Ment Dis. 2014;202(5):353-359. doi:10.1097/NMD.0000000000000130
  30. Visser CLF, Ket JCF, Croiset G, Kusurkar RA. Perceptions of residents, medical and nursing students about interprofessional education: a systematic review of the quantitative and qualitative literature. BMC Med Educ. 2017;17(1):77. doi:10.1186/s12909-017-0909-0
  31. Lingard L, Espin S, Evans C, Hawryluck L. The rules of the game: interprofessional collaboration on the intensive care unit team. Crit Care. 2004;8(6):R403-408. doi:10.1186/cc2958
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Marissa Khajavi, MD, MPHa; Delia Chiaramonte, MD, MSb,c; Beth Hogans, MD, PhDd,e; Jacob Blumenthal, MD, FACPa,d; Leslie Katzel, MD, PhDa,d; Jeffrey Beans, MPH, MBAd; Jamie Giffuni, MAd; Elizabeth A. Dennis, PhD, RDa,d

Author affiliations:
aUniversity of Maryland School of Medicine, Baltimore 
bIntegrative Palliative Institute, Baltimore, Maryland 
cUniversity of Maryland School of Pharmacy, Baltimore 
dGeriatrics Research, Education, and Clinical Center, Veterans Affairs Maryland Health Care System, Baltimore 
eThe Johns Hopkins School of Medicine, Baltimore, Maryland

Author disclosures: Dr. Hogans serves as Director-at-Large of the American Academy of Pain Medicine and receives royalties from the American Academy of Neurology. The other authors report no actual or potential conflicts of interest with regard to this article.

Correspondence: Elizabeth Dennis (elizabeth.dennis@ som.umaryland.edu)

Fed Pract. 2025;42(1). Published online January 15. doi:10.12788/fp.0544

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Marissa Khajavi, MD, MPHa; Delia Chiaramonte, MD, MSb,c; Beth Hogans, MD, PhDd,e; Jacob Blumenthal, MD, FACPa,d; Leslie Katzel, MD, PhDa,d; Jeffrey Beans, MPH, MBAd; Jamie Giffuni, MAd; Elizabeth A. Dennis, PhD, RDa,d

Author affiliations:
aUniversity of Maryland School of Medicine, Baltimore 
bIntegrative Palliative Institute, Baltimore, Maryland 
cUniversity of Maryland School of Pharmacy, Baltimore 
dGeriatrics Research, Education, and Clinical Center, Veterans Affairs Maryland Health Care System, Baltimore 
eThe Johns Hopkins School of Medicine, Baltimore, Maryland

Author disclosures: Dr. Hogans serves as Director-at-Large of the American Academy of Pain Medicine and receives royalties from the American Academy of Neurology. The other authors report no actual or potential conflicts of interest with regard to this article.

Correspondence: Elizabeth Dennis (elizabeth.dennis@ som.umaryland.edu)

Fed Pract. 2025;42(1). Published online January 15. doi:10.12788/fp.0544

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Marissa Khajavi, MD, MPHa; Delia Chiaramonte, MD, MSb,c; Beth Hogans, MD, PhDd,e; Jacob Blumenthal, MD, FACPa,d; Leslie Katzel, MD, PhDa,d; Jeffrey Beans, MPH, MBAd; Jamie Giffuni, MAd; Elizabeth A. Dennis, PhD, RDa,d

Author affiliations:
aUniversity of Maryland School of Medicine, Baltimore 
bIntegrative Palliative Institute, Baltimore, Maryland 
cUniversity of Maryland School of Pharmacy, Baltimore 
dGeriatrics Research, Education, and Clinical Center, Veterans Affairs Maryland Health Care System, Baltimore 
eThe Johns Hopkins School of Medicine, Baltimore, Maryland

Author disclosures: Dr. Hogans serves as Director-at-Large of the American Academy of Pain Medicine and receives royalties from the American Academy of Neurology. The other authors report no actual or potential conflicts of interest with regard to this article.

Correspondence: Elizabeth Dennis (elizabeth.dennis@ som.umaryland.edu)

Fed Pract. 2025;42(1). Published online January 15. doi:10.12788/fp.0544

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Integrative medicine or complementary alternative medicine (IM/CAM) is increasingly being recognized as an integral part of optimal health and healing. IM/CAM “reaffirms the importance of the relationship between practitioner and patient, focuses on the whole person, is informed by evidence, and makes use of all appropriate therapeutic approaches, healthcare professionals and disciplines.”1 IM/CAM encompasses a wide range of therapies, conceptual frameworks, and health care-related professions, such as acupuncture, massage, dietary supplements, mindfulness, yoga, meditation and guided imagery.1 Research has found that 30% to 98% of patients with chronic conditions seek IM/CAM therapies.1-3

Despite the high prevalence of patients utilizing IM/CAM therapies and the National Institutes of Health grants for IM/CAM education, implementation of IM/CAM instruction in graduate medical education programs remains inconsistent.1 Barriers cited by programs include a lack of IM/CAM experts in the program, faculty training, competing financial resources, and an already full resident education schedule.4 As a result, many physicians have limited or no training in IM/CAM.1,5

The US Department of Veterans Affairs (VA) offers IM/CAM health programs to veterans and caregivers as part of its whole health care initiative.6 Several VA health care systems have adopted whole health and IM/CAM through programs for mental health integration into primary care; women’s health; integrative pain care; geriatrics, through adoption of Age-Friendly Health Systems standards; and nutrition and physical activity.7-13 The VA provides training to more medical students than any other health system: > 95% of US medical schools are affiliated with a VA medical center (VAMC).14 As part of the training mission, VA seeks to encourage students of diverse professions to consider careers in the VA.14

Residency is a time for newly licensed physicians to acquire additional experience and training to translate knowledge and skills acquired during medical school directly to patient care.15 However, residency curricula have limited time to incorporate IM/CAM training. Residency training is also physically and psychosocially demanding, often resulting in inadequate self-care, poor work-life balance, and disrupted sleep.16-18 Resident wellness is at a historic low, resulting in high rates of burnout during training.4,15

Residency programs are required to provide wellness education; however, most programs include minimal content.19 Despite high rates of burnout, formal curricula on the topic have not been established. 20 IM/CAM education also can provide a path for residents to learn about and engage in mindfulness-based training or cognitive stress reduction for self-care.

INTEGRATIVE WHOLE HEALTH ROTATION

In 2017, the Baltimore Geriatric Research Education and Clinical Center (GRECC) established an IM/whole health residency rotation and created a structured curriculum incorporating self-assessment, active reflection, and self-care to complement training in specific IM/CAM modalities for residents in family medicine. The curriculum evaluated how this training improved residents’ perceptions of IM/CAM and how it personally and professionally impacted the practice of self-care as a strategy to decrease burnout. We hypothesized that this structured experience would increase IM/CAM knowledge among clinicians while promoting the importance and practice of self-care to reduce burnout.

The 2-week IM/CAM curriculum was developed by University of Maryland School of Medicine faculty in partnership with the Baltimore GRECC and staff at the VA Maryland Health Care System. The curriculum was designed to expose residents to the 8 components of the whole health Circle of Health (moving the body; surroundings; personal development; food and drink; recharge; family, friends, and coworkers; spirit and soul; and power of the mind) in addition to IM/ CAM modalities the VA is mandated to offer to veterans (acupuncture, chiropractic, meditation, massage therapy, biofeedback, clinical hypnosis, guided imagery, yoga, and tai chi).21 Twelve residents (1 preventive medicine and 11 third-year family medicine residents) rotated individually throughout the year as part of their behavioral health block rotation. All residents completed the 2-week curriculum as their schedules allowed. The curriculum consisted of didactics sessions and activities at the Baltimore, Loch Raven, and Perry Point VAMCs. Residents completed evaluations before and after the rotation. The experience described in this article by the residents and the survey data were collected from the 2018/2019 training year. A rotation syllabus, competencies adapted from Locke and colleagues and skills residents obtain during this rotation that support these competencies, as well as a resident sample schedule were developed (eAppendix is available at doi:10.12788/fp.0544).1

FDP042035_App
Rotation Overview

for each resident were built around instructional opportunities, which included 1-on-1 didactics, direct observation of treatment modalities, and personal reflection of the residents’ self-care practices. While each resident’s rotation schedule varied slightly due to their schedules, the foundational instruction elements were the same. Didactic session themes included an overview of IM/CAM, nutrition, narrative medicine, pain psychology, music therapy, chaplain services, motor-cognitive training, and exercise guidelines. Assigned readings, including peer-reviewed literature on IM/CAM therapies, complemented all sessions. Residents created an evidence-supported integrative treatment plan for a patient with a condition of interest to them.

Residents observed clinician-led veteran group sessions on IM/CAM treatment modalities, including guided meditation, mindfulness and relaxation, self-awareness, living well with chronic pain, tai chi, drumming for health and balance, anger management, recovery group, acceptance and commitment therapy, and Gerofit exercise. The group classes allowed residents to actively participate in the activity or discussion. Residents also shadowed VA clinicians in sleep, pain, nutrition, acupuncture, and mental health clinics.

Residents were encouraged to practice self-care during the 2-week rotation. The rotation schedule built in free time, including a 1-hour daily lunch period, for residents to consider their own health habits, complete a personal health inventory, and try self-care activities outlined on the syllabus with links to resources. These resources also served as educational materials that residents could share with patients. All materials, including didactic lectures, journal articles and self-care resources, were provided to each resident through a free online course to ensure residents had access throughout and following completion of the rotation. This content, including the rotation evaluation metrics, is available upon request from the corresponding author.

Evaluations

Residents completed a survey before and after the rotation to measure IM/CAM knowledge and application and self-care/ burnout perceptions. Residents were asked to evaluate rotation sessions and comment on whether this rotation benefited them personally and professionally (Table 1). Descriptive statistics were analyzed using Microsoft Excel. Given the small sample size and lack of statistical power, only mean survey results are reported in this article. Because this opportunity is specific to the University of Maryland School of Medicine and the proposed project was part of ordinary educational practice, the study was deemed not human subject research by the University of Maryland Institutional Review Board (HP-00089256).

FDP042035_T1

Perceptions and attitudes toward IM/CAM were assessed using a survey designed by the University of Minnesota Academic Health Center. It included 18 items scored on a 5-point semantic rating scale (1, strongly disagree; 5, strongly agree).22 Residents rated their level of agreement with statements reflecting both positive (eg, clinical care should integrate the best of conventional and CAM practices) and negative (eg, CAM is a threat to public health) views. Three questions adapted from the NHIS Adult Complementary Health Questionnaire and UC Irvine Survey of Health Care Use and Practice assessed the use of IM/CAM resources.23,24

Resident knowledge and application of IM/CAM were measured using a case study designed by the course faculty. The case listed a chief complaint of nerve pain, with a history of chronic pain, neuropathic pain, anxiety, chronic fatigue, depression, insomnia, posttraumatic stress disorder, history of present illness, past surgical history, medication list, review of symptoms, laboratory values, and physical examination. The residents completed an assessment before and after the rotation. Residents rated their confidence in the diagnosis and treatment of 8 medical conditions using a 5-point semantic rating scale (Table 2). Self-care importance and selfcare frequency were measured by a variety of means, including 3 survey questions, the Five Facet Mindfulness Questionnaire, 2 prompts on a 7-point semantic scale, and a slightly modified version of the validated Perceived Stress Scale.25-28

FDP042035_T2
Survey Results

Residents gave the rotation positive feedback with a mean score of 8.5 out of 10. They reported the beneficial impact of seeing the nontraditional and nonpharmacological practices in treating patients, chronic pain management team approaches, and enjoyed being able to participate in group classes with patients. Many residents expressed a desire for a longer rotation to have more time to experience the behavioral health-focused sessions. Residents also requested additional information on nutritional supplements/natural medicines, battlefield acupuncture training and osteopathic manipulative therapy practices. All residents reported the rotation personally and/or professionally benefited them (Appendix).

Given the sample of 12 residents, values are presented as prerotation to postrotation comparisons without statistical analysis. There was a trend towards an increase in the reported use and recommendation of 26 modalities of nonconventional therapies following the rotation. There was also a slight increase in resource knowledge and use of these resources, and residents reported accessing more types of resources. Mean scores of the case study to gauge knowledge and application of IM increased from 7.5 at baseline to 11.0 after the rotation. Resident confidence in diagnosis increased for all 8 conditions, but confidence in treatment only increased for 4 conditions.

Results of self-care importance, self-care frequency and mindfulness were consistent baseline to postrotation. The mean time residents spent regularly practicing self-care during a work week increased slightly while feelings of burnout decreased. The perceived stress scale average score decreased from 13.4 at baseline to 10.5 after rotation.

DISCUSSION

The implementation of an IM residency rotation that incorporates whole health and interprofessional practices demonstrated improved perception and increased use of IM/CAM resources and knowledge among a small sample of third-year residents. Residents reported they had a positive experience participating in the rotation and gained knowledge, resources, and skills they felt confident discussing with their patients.

Many studies reported favorable attitudes and perceptions of IM/CAM use among physicians, but few have assessed these measures while implementing a training curriculum.3,4,22 Gardiner and colleagues reported on the perception and use of IM resources among family medicine residents.4 The study found that while 58% of all residents reported IM/CAM as an important part of their training, only 60% reported they received it or had specific learning objectives in their curriculum. 4 The program outlined in this study and previous research illustrate that physicians recognize the importance of IM/CAM education in training programs, but most were unaware of the resources available or did not feel comfortable counseling patients about most IM/CAM applications.

Residents in this program slightly increased their use of IM/CAM to diagnose and treat medical conditions after the rotation. A study by Wahner-Roedler and colleagues assessed physician knowledge regarding common IM/CAM therapies.3 On average, physicians only felt knowledgeable and comfortable counseling patients for 3 of 13 listed treatments/techniques and few natural herbal treatments. The study also found that most physicians had difficulty accessing IM/CAM information at their institution despite having free access to electronic databases. However, this study only assessed physician attitudes of IM/CAM and did not include an educational component to increase their knowledge of the modalities.3 This evaluation supports the need for interventions like the program described in this article that provide physicians with access to evidence-based resources combined with the applied experiences to increase their comfort within this growing field.

Though the sample size in this study was small, its results support existing research indicating that clinicians view selfcare as important. Many residents were already using a self-care plan at baseline, but there was slight increase in the practice of self-care during the rotation and a slight decrease in burnout. Previous research reflects high rates of burnout and relatively poor quality of life among primary care physicians.15 Burnout is associated with lower quality of care, lower patient satisfaction and contributes to medical errors. Studies suggest as many as 60% of primary care physicians report symptoms of burnout, which negatively affected the quality of patient care they provide.15

Despite the profound effects burnout has on physicians and patient care, a standardized wellness education or self-care tool kit is not currently available. The University of Massachusetts recently introduced a pilot program to promote resident wellness that demonstrated favorable results.15 A meta-analysis of physicians and medical trainees found decreases in anxiety and symptoms of anxiety as well as a decrease in burnout among participants in cognitive, behavioral and mindfulness interventions.29 However, unlike our program, these programs focused solely on the well-being of medical trainees, residents, and physicians and didn’t focus on the patient-clinician interactions. Given the impact on patient care, there is a need to develop and implement additional programs like our residency rotation that promote health and wellness among physicians while also evaluating how physicians may translate these skills to patient education.

While this program st i l l exists for third-year residents at Baltimore GRECC, it has significantly changed since the COVID-19 pandemic. For about the first 6 months of the pandemic, when physical distancing requirements were in place, family medicine trainees were not able to rotate. Upon return to the facility, many group classes were cancelled and some clinicians no longer offered the sessions. The rotation has evolved to a hybrid format, where many group classes for veteran patients are offered virtually, and residents observe a mix of virtual and in-person shadowing opportunities. Our formal evaluation included administering the survey and occurred from July 2018 to July 2019 but wasn’t implemented upon return to post-COVID activities due to the inconsistent experiences offered to residents over the past few years. Future research should evaluate the impact of this hybrid program on the clinicians and explore dissemination to other VAMCs and their academic affiliates.

Limitations

Project recruitment was limited to 11 family medicine and 1 preventive medicine resident. Perceptions, use of IM/CAM, and knowledge about IM/CAM could be considerably different in different departments with varying schedules, hours worked, and patient volumes. Secondly, the survey was conducted 2 weeks apart. Indications of self-care and burnout may not reflect long-term effects, adoption, or maintenance. Future research should include longer follow up to examine how this type of educational activity may impact burnout rates of physicians following the completion of residency, as well as changes in perspectives of IM/CAM while practicing as a physician. Trainees were exposed to a wide range of health care professions, but additional research is needed regarding medical resident perceptions of the roles of specific professions in a collaborative health care team.30,31

CONCLUSIONS

The residency rotation program illustrates the benefits of establishing a standardized IM/CAM rotation that includes self-care resources in family medicine programs to adequately train clinicians to practice wellness and promote it to their patients. The results of this project suggest this type of training will help residents assess the literature to better counsel patients on IM/CAM options while also providing strategies for maintaining optimal health and well-being for health care professionals. Broadening and shifting the scope of medicine from treatment to prevention, personal wellness, and optimal healing should be a top priority.

Integrative medicine or complementary alternative medicine (IM/CAM) is increasingly being recognized as an integral part of optimal health and healing. IM/CAM “reaffirms the importance of the relationship between practitioner and patient, focuses on the whole person, is informed by evidence, and makes use of all appropriate therapeutic approaches, healthcare professionals and disciplines.”1 IM/CAM encompasses a wide range of therapies, conceptual frameworks, and health care-related professions, such as acupuncture, massage, dietary supplements, mindfulness, yoga, meditation and guided imagery.1 Research has found that 30% to 98% of patients with chronic conditions seek IM/CAM therapies.1-3

Despite the high prevalence of patients utilizing IM/CAM therapies and the National Institutes of Health grants for IM/CAM education, implementation of IM/CAM instruction in graduate medical education programs remains inconsistent.1 Barriers cited by programs include a lack of IM/CAM experts in the program, faculty training, competing financial resources, and an already full resident education schedule.4 As a result, many physicians have limited or no training in IM/CAM.1,5

The US Department of Veterans Affairs (VA) offers IM/CAM health programs to veterans and caregivers as part of its whole health care initiative.6 Several VA health care systems have adopted whole health and IM/CAM through programs for mental health integration into primary care; women’s health; integrative pain care; geriatrics, through adoption of Age-Friendly Health Systems standards; and nutrition and physical activity.7-13 The VA provides training to more medical students than any other health system: > 95% of US medical schools are affiliated with a VA medical center (VAMC).14 As part of the training mission, VA seeks to encourage students of diverse professions to consider careers in the VA.14

Residency is a time for newly licensed physicians to acquire additional experience and training to translate knowledge and skills acquired during medical school directly to patient care.15 However, residency curricula have limited time to incorporate IM/CAM training. Residency training is also physically and psychosocially demanding, often resulting in inadequate self-care, poor work-life balance, and disrupted sleep.16-18 Resident wellness is at a historic low, resulting in high rates of burnout during training.4,15

Residency programs are required to provide wellness education; however, most programs include minimal content.19 Despite high rates of burnout, formal curricula on the topic have not been established. 20 IM/CAM education also can provide a path for residents to learn about and engage in mindfulness-based training or cognitive stress reduction for self-care.

INTEGRATIVE WHOLE HEALTH ROTATION

In 2017, the Baltimore Geriatric Research Education and Clinical Center (GRECC) established an IM/whole health residency rotation and created a structured curriculum incorporating self-assessment, active reflection, and self-care to complement training in specific IM/CAM modalities for residents in family medicine. The curriculum evaluated how this training improved residents’ perceptions of IM/CAM and how it personally and professionally impacted the practice of self-care as a strategy to decrease burnout. We hypothesized that this structured experience would increase IM/CAM knowledge among clinicians while promoting the importance and practice of self-care to reduce burnout.

The 2-week IM/CAM curriculum was developed by University of Maryland School of Medicine faculty in partnership with the Baltimore GRECC and staff at the VA Maryland Health Care System. The curriculum was designed to expose residents to the 8 components of the whole health Circle of Health (moving the body; surroundings; personal development; food and drink; recharge; family, friends, and coworkers; spirit and soul; and power of the mind) in addition to IM/ CAM modalities the VA is mandated to offer to veterans (acupuncture, chiropractic, meditation, massage therapy, biofeedback, clinical hypnosis, guided imagery, yoga, and tai chi).21 Twelve residents (1 preventive medicine and 11 third-year family medicine residents) rotated individually throughout the year as part of their behavioral health block rotation. All residents completed the 2-week curriculum as their schedules allowed. The curriculum consisted of didactics sessions and activities at the Baltimore, Loch Raven, and Perry Point VAMCs. Residents completed evaluations before and after the rotation. The experience described in this article by the residents and the survey data were collected from the 2018/2019 training year. A rotation syllabus, competencies adapted from Locke and colleagues and skills residents obtain during this rotation that support these competencies, as well as a resident sample schedule were developed (eAppendix is available at doi:10.12788/fp.0544).1

FDP042035_App
Rotation Overview

for each resident were built around instructional opportunities, which included 1-on-1 didactics, direct observation of treatment modalities, and personal reflection of the residents’ self-care practices. While each resident’s rotation schedule varied slightly due to their schedules, the foundational instruction elements were the same. Didactic session themes included an overview of IM/CAM, nutrition, narrative medicine, pain psychology, music therapy, chaplain services, motor-cognitive training, and exercise guidelines. Assigned readings, including peer-reviewed literature on IM/CAM therapies, complemented all sessions. Residents created an evidence-supported integrative treatment plan for a patient with a condition of interest to them.

Residents observed clinician-led veteran group sessions on IM/CAM treatment modalities, including guided meditation, mindfulness and relaxation, self-awareness, living well with chronic pain, tai chi, drumming for health and balance, anger management, recovery group, acceptance and commitment therapy, and Gerofit exercise. The group classes allowed residents to actively participate in the activity or discussion. Residents also shadowed VA clinicians in sleep, pain, nutrition, acupuncture, and mental health clinics.

Residents were encouraged to practice self-care during the 2-week rotation. The rotation schedule built in free time, including a 1-hour daily lunch period, for residents to consider their own health habits, complete a personal health inventory, and try self-care activities outlined on the syllabus with links to resources. These resources also served as educational materials that residents could share with patients. All materials, including didactic lectures, journal articles and self-care resources, were provided to each resident through a free online course to ensure residents had access throughout and following completion of the rotation. This content, including the rotation evaluation metrics, is available upon request from the corresponding author.

Evaluations

Residents completed a survey before and after the rotation to measure IM/CAM knowledge and application and self-care/ burnout perceptions. Residents were asked to evaluate rotation sessions and comment on whether this rotation benefited them personally and professionally (Table 1). Descriptive statistics were analyzed using Microsoft Excel. Given the small sample size and lack of statistical power, only mean survey results are reported in this article. Because this opportunity is specific to the University of Maryland School of Medicine and the proposed project was part of ordinary educational practice, the study was deemed not human subject research by the University of Maryland Institutional Review Board (HP-00089256).

FDP042035_T1

Perceptions and attitudes toward IM/CAM were assessed using a survey designed by the University of Minnesota Academic Health Center. It included 18 items scored on a 5-point semantic rating scale (1, strongly disagree; 5, strongly agree).22 Residents rated their level of agreement with statements reflecting both positive (eg, clinical care should integrate the best of conventional and CAM practices) and negative (eg, CAM is a threat to public health) views. Three questions adapted from the NHIS Adult Complementary Health Questionnaire and UC Irvine Survey of Health Care Use and Practice assessed the use of IM/CAM resources.23,24

Resident knowledge and application of IM/CAM were measured using a case study designed by the course faculty. The case listed a chief complaint of nerve pain, with a history of chronic pain, neuropathic pain, anxiety, chronic fatigue, depression, insomnia, posttraumatic stress disorder, history of present illness, past surgical history, medication list, review of symptoms, laboratory values, and physical examination. The residents completed an assessment before and after the rotation. Residents rated their confidence in the diagnosis and treatment of 8 medical conditions using a 5-point semantic rating scale (Table 2). Self-care importance and selfcare frequency were measured by a variety of means, including 3 survey questions, the Five Facet Mindfulness Questionnaire, 2 prompts on a 7-point semantic scale, and a slightly modified version of the validated Perceived Stress Scale.25-28

FDP042035_T2
Survey Results

Residents gave the rotation positive feedback with a mean score of 8.5 out of 10. They reported the beneficial impact of seeing the nontraditional and nonpharmacological practices in treating patients, chronic pain management team approaches, and enjoyed being able to participate in group classes with patients. Many residents expressed a desire for a longer rotation to have more time to experience the behavioral health-focused sessions. Residents also requested additional information on nutritional supplements/natural medicines, battlefield acupuncture training and osteopathic manipulative therapy practices. All residents reported the rotation personally and/or professionally benefited them (Appendix).

Given the sample of 12 residents, values are presented as prerotation to postrotation comparisons without statistical analysis. There was a trend towards an increase in the reported use and recommendation of 26 modalities of nonconventional therapies following the rotation. There was also a slight increase in resource knowledge and use of these resources, and residents reported accessing more types of resources. Mean scores of the case study to gauge knowledge and application of IM increased from 7.5 at baseline to 11.0 after the rotation. Resident confidence in diagnosis increased for all 8 conditions, but confidence in treatment only increased for 4 conditions.

Results of self-care importance, self-care frequency and mindfulness were consistent baseline to postrotation. The mean time residents spent regularly practicing self-care during a work week increased slightly while feelings of burnout decreased. The perceived stress scale average score decreased from 13.4 at baseline to 10.5 after rotation.

DISCUSSION

The implementation of an IM residency rotation that incorporates whole health and interprofessional practices demonstrated improved perception and increased use of IM/CAM resources and knowledge among a small sample of third-year residents. Residents reported they had a positive experience participating in the rotation and gained knowledge, resources, and skills they felt confident discussing with their patients.

Many studies reported favorable attitudes and perceptions of IM/CAM use among physicians, but few have assessed these measures while implementing a training curriculum.3,4,22 Gardiner and colleagues reported on the perception and use of IM resources among family medicine residents.4 The study found that while 58% of all residents reported IM/CAM as an important part of their training, only 60% reported they received it or had specific learning objectives in their curriculum. 4 The program outlined in this study and previous research illustrate that physicians recognize the importance of IM/CAM education in training programs, but most were unaware of the resources available or did not feel comfortable counseling patients about most IM/CAM applications.

Residents in this program slightly increased their use of IM/CAM to diagnose and treat medical conditions after the rotation. A study by Wahner-Roedler and colleagues assessed physician knowledge regarding common IM/CAM therapies.3 On average, physicians only felt knowledgeable and comfortable counseling patients for 3 of 13 listed treatments/techniques and few natural herbal treatments. The study also found that most physicians had difficulty accessing IM/CAM information at their institution despite having free access to electronic databases. However, this study only assessed physician attitudes of IM/CAM and did not include an educational component to increase their knowledge of the modalities.3 This evaluation supports the need for interventions like the program described in this article that provide physicians with access to evidence-based resources combined with the applied experiences to increase their comfort within this growing field.

Though the sample size in this study was small, its results support existing research indicating that clinicians view selfcare as important. Many residents were already using a self-care plan at baseline, but there was slight increase in the practice of self-care during the rotation and a slight decrease in burnout. Previous research reflects high rates of burnout and relatively poor quality of life among primary care physicians.15 Burnout is associated with lower quality of care, lower patient satisfaction and contributes to medical errors. Studies suggest as many as 60% of primary care physicians report symptoms of burnout, which negatively affected the quality of patient care they provide.15

Despite the profound effects burnout has on physicians and patient care, a standardized wellness education or self-care tool kit is not currently available. The University of Massachusetts recently introduced a pilot program to promote resident wellness that demonstrated favorable results.15 A meta-analysis of physicians and medical trainees found decreases in anxiety and symptoms of anxiety as well as a decrease in burnout among participants in cognitive, behavioral and mindfulness interventions.29 However, unlike our program, these programs focused solely on the well-being of medical trainees, residents, and physicians and didn’t focus on the patient-clinician interactions. Given the impact on patient care, there is a need to develop and implement additional programs like our residency rotation that promote health and wellness among physicians while also evaluating how physicians may translate these skills to patient education.

While this program st i l l exists for third-year residents at Baltimore GRECC, it has significantly changed since the COVID-19 pandemic. For about the first 6 months of the pandemic, when physical distancing requirements were in place, family medicine trainees were not able to rotate. Upon return to the facility, many group classes were cancelled and some clinicians no longer offered the sessions. The rotation has evolved to a hybrid format, where many group classes for veteran patients are offered virtually, and residents observe a mix of virtual and in-person shadowing opportunities. Our formal evaluation included administering the survey and occurred from July 2018 to July 2019 but wasn’t implemented upon return to post-COVID activities due to the inconsistent experiences offered to residents over the past few years. Future research should evaluate the impact of this hybrid program on the clinicians and explore dissemination to other VAMCs and their academic affiliates.

Limitations

Project recruitment was limited to 11 family medicine and 1 preventive medicine resident. Perceptions, use of IM/CAM, and knowledge about IM/CAM could be considerably different in different departments with varying schedules, hours worked, and patient volumes. Secondly, the survey was conducted 2 weeks apart. Indications of self-care and burnout may not reflect long-term effects, adoption, or maintenance. Future research should include longer follow up to examine how this type of educational activity may impact burnout rates of physicians following the completion of residency, as well as changes in perspectives of IM/CAM while practicing as a physician. Trainees were exposed to a wide range of health care professions, but additional research is needed regarding medical resident perceptions of the roles of specific professions in a collaborative health care team.30,31

CONCLUSIONS

The residency rotation program illustrates the benefits of establishing a standardized IM/CAM rotation that includes self-care resources in family medicine programs to adequately train clinicians to practice wellness and promote it to their patients. The results of this project suggest this type of training will help residents assess the literature to better counsel patients on IM/CAM options while also providing strategies for maintaining optimal health and well-being for health care professionals. Broadening and shifting the scope of medicine from treatment to prevention, personal wellness, and optimal healing should be a top priority.

References
  1. Locke AB, Gordon A, Guerrera MP, Gardiner P, Lebensohn P. Recommended integrative medicine competencies for family medicine residents. Explore (NY). 2013;9(5):308-313. doi:10.1016/j.explore.2013.06.005
  2. Eisenberg DM, Davis RB, Ettner SL, et al. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA. 1998;280(18):1569-1575. doi:10.1001/jama.280.18.1569
  3. Wahner-Roedler DL, Vincent A, Elkin PL, Loehrer LL, Cha SS, Bauer BA. Physicians’ attitudes toward complementary and alternative medicine and their knowledge of specific therapies: a survey at an academic medical center. Evid Based Complement Alternat Med. 2006;3(4):495-501. doi:10.1093/ecam/nel036
  4. Gardiner P, Filippelli AC, Lebensohn P, Bonakdar R. Family medicine residency program directors attitudes and knowledge of family medicine CAM competencies. Explore (NY). 2013;9(5):299-307. doi:10.1016/j.explore.2013.06.002
  5. Sierpina V, Levine R, Astin J, Tan A. Use of mind-body therapies in psychiatry and family medicine faculty and residents: attitudes, barriers, and gender differences. Explore (NY). 2007;3(2):129-135. doi:10.1016/j.explore.2006.12.001
  6. Krist AH, South-Paul J, Meisnere M, eds. Achieving Whole Health: A New Approach for Veterans and the Nation. The National Academies Press; 2023.
  7. Bokhour BG, DeFaccio R, Gaj L, et al. Changes in patientreported outcomes associated with receiving whole health in the Veteran Health Administration (VHA)’s National Demonstration Project. J Gen Intern Med. 2024;39(1):84-94. doi:10.1007/s11606-023-08376-0
  8. Courtney RE, Schadegg MJ, Bolton R, Smith S, Harden SM. Using a whole health approach to build biopsychosocial- spiritual personal health plans for veterans with chronic pain. Pain Manag Nurs. 2024;25(1):69-74. doi:10.1016/j.pmn.2023.09.010
  9. Gabrielian S, Jones AL, Hoge AE, et al. Enhancing primary care experiences for homeless patients with serious mental illness: results from a national survey. J Prim Care Community Health. 2021;12:2150132721993654. doi:10.1177/2150132721993654
  10. Matthieu MM, Church KA, Taylor LD, et al. Integrating the age-friendly health systems movement in Veterans Health Administration: national advance care planning via group visits and the 4Ms framework. Health Soc Work. 2023;48(4):277-280. doi:10.1093/hsw/hlad022
  11. Meisler AW, Gianoli MO, Na PJ, Pietrzak RH. Functional disability in US military veterans: the importance of integrated whole health initiatives. Prim Care Companion CNS Disord. 2023;25(4):22m03461. doi:10.4088/PCC.22m03461
  12. Ortmeyer HK, Giffuni J, Etchberger D, Katzel L. The role of companion dogs in the VA Maryland Health Care System Whole Health(y) GeroFit Program. Animals (Basel). 2023;13(19):3047. doi:10.3390/ani13193047
  13. Sullivan MB, Hill K, Ballengee LA, et al. Remotely delivered psychologically informed mindful movement physical therapy for pain care: a framework for operationalization. Glob Adv Integr Med Health. 2023;12:27536130231209751. doi:10.1177/27536130231209751
  14. (OAA) OoAA. 75th Anniversary: Passion to learn. Power to heal. Washington DC.: US Department of Veterans Affairs; 2021. https://content.yudu.com/web/448fx/0A448g9/75thAnniversary2021/html/index.html?page=24&origin=reader
  15. Runyan C, Savageau JA, Potts S, Weinreb L. Impact of a family medicine resident wellness curriculum: a feasibility study. Med Educ Online. 2016;21:30648. doi:10.3402/meo.v21.30648
  16. Lafreniere JP, Rios R, Packer H, Ghazarian S, Wright SM, Levine RB. Burned out at the bedside: patient perceptions of physician burnout in an internal medicine resident continuity clinic. J Gen Intern Med. 2016;31(2):203-208. doi:10.1007/s11606-015-3503-3
  17. Freedy JR, Staley C, Mims LD, et al. Social, individual, and environmental characteristics of family medicine resident burnout: a CERA study. Fam Med. 2022;54(4):270-276. doi:10.22454/FamMed.2022.526799
  18. Alrishan MA, Alshammari SA. Prevalence of sleep deprivation and its effect on the performance of family medicine residents in Riyadh, Saudi Arabia. J Family Community Med. 2020;27(2):125-130. doi:10.4103/jfcm.JFCM_9_20
  19. ACGME. ACGME Program Requirements for Graduate Medical Education in Family Medicine. https://www.acgme.org/globalassets/pfassets/programrequirements/120_familymedicine_2024.pdf
  20. Nene Y, Tadi P. Resident Burnout. In: StatPearls; 2023.
  21. Bokhour BG, Haun JN, Hyde J, Charns M, Kligler B. Transforming the veterans affairs to a whole health system of care: time for action and research. Med Care. 2020;58(4):295-300. doi:10.1097/MLF.0000000000001316
  22. Kreitzer MJ, Mitten D, Harris I, Shandeling J. Attitudes toward CAM among medical, nursing, and pharmacy faculty and students: a comparative analysis. Altern Ther Health Med. 2002;8(6):44-53.
  23. Clarke TC, Black LI, Stussman BJ, Barnes PM, Nahin RL. Trends in the use of complementary health approaches among adults: United States, 2002-2012. Natl Health Stat Report. 2015(79):1-16.
  24. Nguyen J, Liu MA, Patel RJ, Tahara K, Nguyen AL. Use and interest in complementary and alternative medicine among college students seeking healthcare at a university campus student health center. Complement Ther Clin Pract. 2016;24:103-108. doi:10.1016/j.ctcp.2016.06.001
  25. Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006;13(1):27-45. doi:10.1177/1073191105283504
  26. Baer RA, Smith GT, Lykins E, et al. Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment. 2008;15(3):329-342. doi:10.1177/1073191107313003
  27. West CP, Dyrbye LN, Sloan JA, Shanafelt TD. Single item measures of emotional exhaustion and depersonalization are useful for assessing burnout in medical professionals. J Gen Intern Med. 2009;24(12):1318- 1321. doi:10.1007/s11606-009-1129-z
  28. Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983;24(4):385-396.
  29. Regehr C, Glancy D, Pitts A, LeBlanc VR. Interventions to reduce the consequences of stress in physicians: a review and meta-analysis. J Nerv Ment Dis. 2014;202(5):353-359. doi:10.1097/NMD.0000000000000130
  30. Visser CLF, Ket JCF, Croiset G, Kusurkar RA. Perceptions of residents, medical and nursing students about interprofessional education: a systematic review of the quantitative and qualitative literature. BMC Med Educ. 2017;17(1):77. doi:10.1186/s12909-017-0909-0
  31. Lingard L, Espin S, Evans C, Hawryluck L. The rules of the game: interprofessional collaboration on the intensive care unit team. Crit Care. 2004;8(6):R403-408. doi:10.1186/cc2958
References
  1. Locke AB, Gordon A, Guerrera MP, Gardiner P, Lebensohn P. Recommended integrative medicine competencies for family medicine residents. Explore (NY). 2013;9(5):308-313. doi:10.1016/j.explore.2013.06.005
  2. Eisenberg DM, Davis RB, Ettner SL, et al. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA. 1998;280(18):1569-1575. doi:10.1001/jama.280.18.1569
  3. Wahner-Roedler DL, Vincent A, Elkin PL, Loehrer LL, Cha SS, Bauer BA. Physicians’ attitudes toward complementary and alternative medicine and their knowledge of specific therapies: a survey at an academic medical center. Evid Based Complement Alternat Med. 2006;3(4):495-501. doi:10.1093/ecam/nel036
  4. Gardiner P, Filippelli AC, Lebensohn P, Bonakdar R. Family medicine residency program directors attitudes and knowledge of family medicine CAM competencies. Explore (NY). 2013;9(5):299-307. doi:10.1016/j.explore.2013.06.002
  5. Sierpina V, Levine R, Astin J, Tan A. Use of mind-body therapies in psychiatry and family medicine faculty and residents: attitudes, barriers, and gender differences. Explore (NY). 2007;3(2):129-135. doi:10.1016/j.explore.2006.12.001
  6. Krist AH, South-Paul J, Meisnere M, eds. Achieving Whole Health: A New Approach for Veterans and the Nation. The National Academies Press; 2023.
  7. Bokhour BG, DeFaccio R, Gaj L, et al. Changes in patientreported outcomes associated with receiving whole health in the Veteran Health Administration (VHA)’s National Demonstration Project. J Gen Intern Med. 2024;39(1):84-94. doi:10.1007/s11606-023-08376-0
  8. Courtney RE, Schadegg MJ, Bolton R, Smith S, Harden SM. Using a whole health approach to build biopsychosocial- spiritual personal health plans for veterans with chronic pain. Pain Manag Nurs. 2024;25(1):69-74. doi:10.1016/j.pmn.2023.09.010
  9. Gabrielian S, Jones AL, Hoge AE, et al. Enhancing primary care experiences for homeless patients with serious mental illness: results from a national survey. J Prim Care Community Health. 2021;12:2150132721993654. doi:10.1177/2150132721993654
  10. Matthieu MM, Church KA, Taylor LD, et al. Integrating the age-friendly health systems movement in Veterans Health Administration: national advance care planning via group visits and the 4Ms framework. Health Soc Work. 2023;48(4):277-280. doi:10.1093/hsw/hlad022
  11. Meisler AW, Gianoli MO, Na PJ, Pietrzak RH. Functional disability in US military veterans: the importance of integrated whole health initiatives. Prim Care Companion CNS Disord. 2023;25(4):22m03461. doi:10.4088/PCC.22m03461
  12. Ortmeyer HK, Giffuni J, Etchberger D, Katzel L. The role of companion dogs in the VA Maryland Health Care System Whole Health(y) GeroFit Program. Animals (Basel). 2023;13(19):3047. doi:10.3390/ani13193047
  13. Sullivan MB, Hill K, Ballengee LA, et al. Remotely delivered psychologically informed mindful movement physical therapy for pain care: a framework for operationalization. Glob Adv Integr Med Health. 2023;12:27536130231209751. doi:10.1177/27536130231209751
  14. (OAA) OoAA. 75th Anniversary: Passion to learn. Power to heal. Washington DC.: US Department of Veterans Affairs; 2021. https://content.yudu.com/web/448fx/0A448g9/75thAnniversary2021/html/index.html?page=24&origin=reader
  15. Runyan C, Savageau JA, Potts S, Weinreb L. Impact of a family medicine resident wellness curriculum: a feasibility study. Med Educ Online. 2016;21:30648. doi:10.3402/meo.v21.30648
  16. Lafreniere JP, Rios R, Packer H, Ghazarian S, Wright SM, Levine RB. Burned out at the bedside: patient perceptions of physician burnout in an internal medicine resident continuity clinic. J Gen Intern Med. 2016;31(2):203-208. doi:10.1007/s11606-015-3503-3
  17. Freedy JR, Staley C, Mims LD, et al. Social, individual, and environmental characteristics of family medicine resident burnout: a CERA study. Fam Med. 2022;54(4):270-276. doi:10.22454/FamMed.2022.526799
  18. Alrishan MA, Alshammari SA. Prevalence of sleep deprivation and its effect on the performance of family medicine residents in Riyadh, Saudi Arabia. J Family Community Med. 2020;27(2):125-130. doi:10.4103/jfcm.JFCM_9_20
  19. ACGME. ACGME Program Requirements for Graduate Medical Education in Family Medicine. https://www.acgme.org/globalassets/pfassets/programrequirements/120_familymedicine_2024.pdf
  20. Nene Y, Tadi P. Resident Burnout. In: StatPearls; 2023.
  21. Bokhour BG, Haun JN, Hyde J, Charns M, Kligler B. Transforming the veterans affairs to a whole health system of care: time for action and research. Med Care. 2020;58(4):295-300. doi:10.1097/MLF.0000000000001316
  22. Kreitzer MJ, Mitten D, Harris I, Shandeling J. Attitudes toward CAM among medical, nursing, and pharmacy faculty and students: a comparative analysis. Altern Ther Health Med. 2002;8(6):44-53.
  23. Clarke TC, Black LI, Stussman BJ, Barnes PM, Nahin RL. Trends in the use of complementary health approaches among adults: United States, 2002-2012. Natl Health Stat Report. 2015(79):1-16.
  24. Nguyen J, Liu MA, Patel RJ, Tahara K, Nguyen AL. Use and interest in complementary and alternative medicine among college students seeking healthcare at a university campus student health center. Complement Ther Clin Pract. 2016;24:103-108. doi:10.1016/j.ctcp.2016.06.001
  25. Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006;13(1):27-45. doi:10.1177/1073191105283504
  26. Baer RA, Smith GT, Lykins E, et al. Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment. 2008;15(3):329-342. doi:10.1177/1073191107313003
  27. West CP, Dyrbye LN, Sloan JA, Shanafelt TD. Single item measures of emotional exhaustion and depersonalization are useful for assessing burnout in medical professionals. J Gen Intern Med. 2009;24(12):1318- 1321. doi:10.1007/s11606-009-1129-z
  28. Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983;24(4):385-396.
  29. Regehr C, Glancy D, Pitts A, LeBlanc VR. Interventions to reduce the consequences of stress in physicians: a review and meta-analysis. J Nerv Ment Dis. 2014;202(5):353-359. doi:10.1097/NMD.0000000000000130
  30. Visser CLF, Ket JCF, Croiset G, Kusurkar RA. Perceptions of residents, medical and nursing students about interprofessional education: a systematic review of the quantitative and qualitative literature. BMC Med Educ. 2017;17(1):77. doi:10.1186/s12909-017-0909-0
  31. Lingard L, Espin S, Evans C, Hawryluck L. The rules of the game: interprofessional collaboration on the intensive care unit team. Crit Care. 2004;8(6):R403-408. doi:10.1186/cc2958
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Pharmacist-Led Deprescribing of Aspirin for Primary Prevention of Cardiovascular Disease Among Geriatric Veterans

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Pharmacist-Led Deprescribing of Aspirin for Primary Prevention of Cardiovascular Disease Among Geriatric Veterans

Low-dose aspirin commonly is used for the prevention of cardiovascular disease (CVD) but is associated with an increased risk of major bleeding.1 The use of aspirin for primary prevention is largely extrapolated from clinical trials showing benefit in the secondary prevention of myocardial infarction and ischemic stroke. However, results from the Aspirin in Reducing Events in the Elderly (ASPREE) trial challenged this practice.2 The ASPREE trial, conducted in the United States and Australia from 2010 to 2014, sought to determine whether daily 100 mg aspirin, was superior to placebo in promoting disability-free survival among older adults. Participants were aged ≥ 70 years (≥ 65 years for Hispanic and Black US participants), living in the community, and were free from preexisting CVD, cerebrovascular disease, or any chronic condition likely to limit survival to < 5 years. The study found no significant difference in the primary endpoints of death, dementia, or persistent physical disability, but there was a significantly higher risk of major hemorrhage in the aspirin group (3.8% vs 2.8%; hazard ratio, 1.38; 95% CI, 1.18-1.62; P < .001).

Several medical societies have updated their guideline recommendations for aspirin for primary prevention of CVD. The 2022 United States Public Service Task Force (USPSTF) provides a grade C recommendation (at least moderate certainty that the net benefit is small) to consider low-dose aspirin for the primary prevention of CVD on an individual patient basis for adults aged 40 to 59 years who have a ≥ 10% 10-year CVD risk. For adults aged ≥ 60 years, the USPSTF recommendation is grade D (moderate or high certainty that the practice has no net benefit or that harms outweigh the benefits) for low-dose aspirin use.1,3 The American College of Cardiology and American Heart Association (ACC/AHA) recommend considering low-dose aspirin for primary prevention of atherosclerotic cardiovascular disease (ASCVD) among select adults aged 40 to 70 years at higher CVD risk but not at increased risk of bleeding.4 The American Diabetes Association (ADA) recommends low-dose aspirin for primary prevention of CVD in patients with diabetes and additional risk factors such as family history of premature ASCVD, hypertension, dyslipidemia, smoking, or chronic kidney disease, and who are not at higher risk of bleeding.5 The ADA standards also caution against the use of aspirin as primary prevention in patients aged > 70 years. Low-dose aspirin use is not recommended for the primary prevention of CVD in older adults or adults of any age who are at increased risk of bleeding.

Recent literature using the US Department of Veterans Affairs (VA) Corporate Data Warehouse database confirms 86,555 of 1.8 million veterans aged > 70 years (5%) were taking low-dose aspirin for primary prevention of ASCVD despite guideline recommendations.6 Higher risk of gastrointestinal and other major bleeding from low-dose aspirin has been reported in the literature.1 Major bleeds represent a significant burden to the health care system with an estimated mean $13,093 cost for gastrointestinal bleed hospitalization.7

Considering the large scale aspirin use without appropriate indication within the veteran population, the risk of adverse effects, and the significant cost to patients and the health care system, it is imperative to determine the best approach to efficiently deprescribe aspirin for primary prevention among geriatric patients. Deprescribing refers to the systematic and supervised process of dose reduction or drug discontinuation with the goal of improving health and/or reducing the risk of adverse effects.8 During patient visits, primary care practitioners (PCPs) have opportunities to discontinue aspirin, but these encounters are time-limited and deprescribing might be secondary to more acute primary care needs. The shortage of PCPs is expected to worsen in coming years, which could further reduce their availability to assess inappropriate aspirin use.9

VA clinical pharmacist practitioners (CPPs) serve as medication experts and work autonomously under a broad scope of practice as part of the patient aligned care team.10-12 CPPs can free up time for PCPs and facilitate deprescribing efforts, especially for older adults. One retrospective cohort study conducted at a VA medical center found that CPPs deprescribed more potentially inappropriate medications among individuals aged ≥ 80 years compared with usual care with PCPs (26.8% vs 16.1%; P < .001).12,13 An aspirin deprescribing protocol conducted in 2022 resulted in nearly half of veterans aged ≥ 70 years contacted by phone agreeing to stop aspirin. Although this study supports the role pharmacists can play in reducing aspirin use in accordance with guidelines, the authors acknowledge that their interventions had a mean time of 12 minutes per patient and would require workflow changes.14 The purpose of this study is to evaluate the efficiency of aspirin deprescribing through 2 approaches: direct deprescribing by pharmacists using populationlevel review compared with clinicians following a pharmacist-led education.

Methods

This was a single-center quality improvement cohort study at the Durham VA Health Care System (DVAHCS) in North Carolina. Patients included were aged ≥ 70 years without known ASCVD who received care at any of 3 DVAHCS community-based outpatient clinics and prescribed aspirin. Patient data was obtained using the VIONE (Deprescribing Dashboard called Vital, Important, Optional, Not indicated, and Every medication has a specific indication or diagnosis) dashboard.15 VIONE was developed to identify potentially inappropriate medications (PIMs) that are eligible to deprescribe based on Beers Criteria, Screening Tool of Older Personsf Prescriptions criteria, and common clinical scenarios when clinicians determine the risk outweighs the benefit to continue a specific medication. 16,17 VIONE is used to reduce polypharmacy and improve patient safety, comfort, and medication adherence. Aspirin for patients aged ≥ 70 years without a history of ASCVD is a PIM identified by VIONE. Patients aged ≥ 70 years were chosen as an inclusion criteria in this study to match the ASPREE trial inclusion criteria and age inclusion criteria in the VIONE dashboard for aspirin deprescribing.2 Patient lists were generated for these potentially inappropriate aspirin prescriptions for 3 months before clinician staff education presentations, the day of the presentations, and 3 months after.

The primary endpoint was the number of veterans with aspirin deprescribed directly by 2 pharmacists over 12 weeks, divided by total patient care time spent, compared with the change in number of veterans with aspirin deprescribed by any DVAHCS physician, nurse practitioner, physician assistant, or CPP over 12 weeks, divided by the total pharmacist time spent on PCP education. Secondary endpoints were the number of aspirin orders discontinued by pharmacists and CPPs, the number of aspirin orders discontinued 12 weeks before pharmacist-led education compared with the number of aspirin orders discontinued 12 weeks after CPP-led education, average and median pharmacist time spent per patient encounter, and time of direct patient encounters vs time spent on PCP education.

Pharmacists reviewed each patient who met the inclusion criteria from the list generated by VIONE on December 1, 2022, for aspirin appropriateness according to the ACC/AHA and USPSTF guidelines, with the goal to discontinue aspirin for primary prevention of ASCVD and no other indications.1,4 Pharmacists documented their visits using VIONE methodology in the Computerized Patient Record System (CPRS) using a polypharmacy review note. CPPs contacted patients who were taking aspirin for primary prevention by unscheduled telephone call to assess for aspirin adherence, undocumented history of ASCVD, cardiovascular risk factors, and history of bleeding. Aspirin was discontinued if patients met guideline criteria recommendations and agreed to discontinuation. Risk-benefit discussions were completed when patients without known ASCVD were considered high risk because the ACC/AHA guidelines mention there is insufficient evidence of safety and efficacy of aspirin for primary prevention for patients with other known ASCVD risk factors (eg, strong family history of premature myocardial infarction, inability to achieve lipid, blood pressure, or glucose targets, or significant elevation in coronary artery calcium score).

High risk was defined as family history of premature ASCVD (in a male first-degree relative aged < 55 years or a female first-degree relative aged < 65 years), most recent blood pressure or 2 blood pressure results in the last 12 months > 160/100 mm Hg, recent hemoglobin A1c > 9%, and/or low-density lipoprotein > 190 mg/dL or not prescribed an indicated statin.3 Aspirin was continued or discontinued according to patient preference after the personalized risk-benefit discussion.

For patients with a clinical indication for aspirin use other than ASCVD (eg, atrial fibrillation not on anticoagulation, venous thromboembolism prophylaxis, carotid artery disease), CPPs documented their assessment and when appropriate deferred to the PCP for consideration of stopping aspirin. For patients with undocumented ASCVD, CPPs added their ASCVD history to their problem list and aspirin was continued. PCPs were notified by alert when aspirin was discontinued and when patients could not be reached by telephone.

presented a review of recent guideline updates and supporting literature at 2 online staff meetings. The education sessions lasted about 10 minutes and were presented to PCPs across 3 community-based outpatient clinics. An estimated 40 minutes were spent creating the PowerPoint education materials, seeking feedback, making edits, and answering questions or emails from PCPs after the presentation. During the presentation, pharmacists encouraged PCPs to discontinue aspirin (active VA prescriptions and reported over-the-counter use) for primary prevention of ASCVD in patients aged ≥ 70 years during their upcoming appointments and consider risk factors recommended by the ACC/AHA guidelines when applicable. PCPs were notified that CPPs planned to start a population review for discontinuing active VA aspirin prescriptions on December 1, 2022. The primary endpoint and secondary endpoints were analyzed using descriptive statistics. All data were analyzed using Microsoft Excel.

 

FDP042022_F1

Results

A total of 868 patients aged ≥ 70 years with active prescriptions for aspirin were identified on December 1, 2022. After applying inclusion and exclusion criteria for the pharmacist population review, 224 patients were included for cohort final analysis (Figure). All 868 patients were eligible for the CPP intervention. Primary reasons for exclusion from the CPP population included over-thecounter aspirin and a history of ASCVD in the patient’s problem list. All patients were male, with a mean (SD) age of 75 (4.4) years (Table 1). Most patients were prescribed aspirin, 81 mg daily (n = 220; 98%).

FDP042022_T1

 

The direct CPP deprescribing intervention resulted in 2 aspirin prescriptions discontinued per hour of pharmacist time and 67 aspirin prescriptions discontinued per hour of pharmacist time via the PCP education intervention. CPPs discontinued 66 aspirin orders in the 12 weeks before the PCP education sessions. A total of 230 aspirin prescriptions were discontinued in the 12 weeks following the PCP education sessions, with 97 discontinued directly by CPPs and 133 discontinued by PCPs. The PCP education session yielded an additional 67 discontinued aspirin orders compared with the 12 weeks before the education sessions (Table 2).

FDP042022_T2

The CPP direct deprescribing intervention took about 48.3 hours, accounting for health record review and time interacting with patients. The PCP education intervention took about 60 minutes, which included time for preparing and delivering education materials (Table 3). CPP deprescribing encounter types, interventions, and related subcategories, and other identified indications to continue aspirin are listed in Table 4.

FDP042022_T3FDP042022_T4

Discussion

Compared with direct deprescribing by pharmacists, the PCP education intervention was more efficient based on number of aspirin orders discontinued by pharmacist time. PCPs discontinued twice as many aspirin prescriptions in the 12 weeks after pharmacist-led education compared with the 12 weeks before.

Patients were primarily contacted by telephone (73%) for deprescribing. Among the 163 patients reached by phone and encouraged to discontinue aspirin, 97 patients (60%) accepted the recommendation, which was similar to the acceptance rates found in the literature (48% to 55%).14,18 Although many veterans continued taking aspirin (78%), most had indications for its continued use, such as a history of ASCVD, atrial fibrillation without anticoagulation, and carotid artery stenosis, and complex comorbidities that required further discussion with their PCP. Less common uses for aspirin were identified through CPRS review or patient reports included cerebral small vessel disease without history of ASCVD, subclavian artery stenosis, thrombocytosis, bioprosthetic valve replacement, giant cell arteritis, rheumatoid arthritis, and prevention of second eye involvement of ischemic optic neuropathy.

to describe the benefit of clinical pharmacy services for deprescribing aspirin for primary prevention of ASCVD through PCP education. Previously published literature has assessed alternative ways to identify or discontinue PIMs—including aspirin—among geriatric patients. One study evaluated the use of marking inappropriate aspirin prescriptions in the electronic health database, leading to a significant reduction in incidence of inappropriate aspirin prescribing; however, it did not assess changes in discontinuation rates of existing aspirin prescriptions.19 The previous VA pharmacist aspirin deprescribing protocol demonstrated pharmacists’ aptitude at discontinuing aspirin for primary prevention but only used direct patient contact and did not compare efficiency with other methods, including PCP education.14

This quality improvement project contributes new data to the existing literature to support the use of clinical pharmacists to discontinue aspirin for primary prevention and suggests a strong role for pharmacists as educators on clinical guidelines, in addition to their roles directly deprescribing PIMs in clinical practice. This study is further strengthened by its use of VIONE, which previously has demonstrated effectiveness in deprescribing a variety of PIMs in primary care settings.20

Despite using VIONE for generating a list of patients eligible for deprescription, our CPRS review found that this list was frequently inaccurate. For example, a small portion of patients were on the VIONE generated list indicating they had no ASCVD history, but had transient ischemic attack listed in their problem lists. Patient problem lists often were missing documented ASCVD history that was revealed by patient interview or CPRS review. It is possible that patients interviewed might have omitted relevant ASCVD history because of low health literacy, conditions affecting memory, or use of health care services outside the VA system.

There were several instances of aspirin used for other non-ASCVD indications, such as primary stroke prevention in atrial fibrillation. The ACC/AHA atrial fibrillation guidelines previously provided a Class IIb recommendation (benefit is greater than risk but additional studies are needed) for considering no antithrombic therapy or treatment with oral anticoagulant or aspirin for nonvalvular atrial fibrillation with CHA2DS2-VASc (Congestive heart failure, Hypertension, Age [> 65 y, 1 point; > 75 y, 2 points], Diabetes, previous Stroke/transient ischemic attack [2 points]) score of 1.21 The ACC/ AHA guidelines were updated in 2023 to recommend against antiplatelet therapy as an alternative to anticoagulation for reducing cardioembolic stroke risk among patients with atrial fibrillation with no indication for antiplatelet therapy because of risk of harm.22 If a patient has no risk factors for stroke, aspirin is not recommended to prevent thromboembolic events because of a lack of benefit. Interventions from this quality improvement study were completed before the 2023 atrial fibrillation guideline was published and therefore in this study aspirin was not discontinued when used for atrial fibrillation. Aspirin use for atrial fibrillation might benefit from similar discontinuation efforts analyzed within this study. Beyond atrial fibrillation, major guidelines do not comment on the use of aspirin for any other indications in the absence of clinical ASCVD.

Limitations

This study is limited by the lack of clinical consensus for complex patients and demonstrates the importance of individualized patient assessment when considering discontinuing aspirin. Because of the project’s relatively short intervention period, aspirin deprescribing rates could decrease over time and repeated education efforts might be necessary to see lasting impact. Health care professionals from services outside of primary care also might have discontinued aspirin during the study period unrelated to the education and these discontinued aspirin prescriptions could contribute to the higher rate observed among PCPs. This study included a specific population cohort of male, US veterans and might not reflect other populations where these interventions could be implemented.

The measurement of time spent by pharmacists and PCPs is an additional limitation. Although it is expected that PCPs attempt to discontinue aspirin during their existing patient care appointments, the time spent during visits was not measured or documented. Direct deprescribing by pharmacist CPRS review required a significant amount of time and could be a barrier to successful intervention by CPPs in patient aligned care teams.

To reduce the time pharmacists spent completing CPRS reviews, an aspirin deprescribing clinical reminder tool could be used to assess use and appropriate indication quickly during any primary care visit led by a PCP or CPP. In addition, it is recommended that pharmacists regularly educate health care professionals on guideline recommendations for aspirin use among geriatric patients. Future studies of the incidence of major cardiovascular events after aspirin deprescribing among geriatric patients and a longitudinal cost/benefit analysis could support these initiatives.

Conclusions

In this study, pharmacists successfully deprescribed inappropriate medications, such as aspirin. However, pharmacist-led PCP education is more efficient compared with direct deprescribing using a population-level review. PCP education requires less time and could allow ambulatory care pharmacists to spend more time on other direct patient care interventions to improve quality and access to care in primary care clinics. This study’s results further support the role of pharmacists in deprescribing PIMs for older adults and the use of a deprescribing tool, such as VIONE, in a primary care setting.

References
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  18. Draeger C, Lodhi F, Geissinger N, Larson T, Griesbach S. Interdisciplinary deprescribing of aspirin through prescriber education and provision of patient-specific recommendations. WMJ. 2022;121(3):220-225
  19. de Lusignan S, Hinton W, Seidu S, et al. Dashboards to reduce inappropriate prescribing of metformin and aspirin: A quality assurance programme in a primary care sentinel network. Prim Care Diabetes. 2021;15(6):1075-1079. doi:10.1016/j.pcd.2021.06.003
  20. Nelson MW, Downs TN, Puglisi GM, Simpkins BA, Collier AS. Use of a deprescribing tool in an interdisciplinary primary-care patient-aligned care team. Sr Care Pharm. 2022;37(1):34-43. doi:10.4140/TCP.n.2022.34
  21. January CT, Wann LS, Alpert JS, et al. 2014 AHA/ ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014;130(23):e199-e267. doi:10.1161/CIR.0000000000000041
  22. Joglar JA, Chung MK, Armbruster AL, et al. 2023 ACC/ AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines Circulation. 2024;149(1):e1- e156. doi:10.1161/CIR.0000000000001193
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Shelby Koen, PharmD, BCPSa; Matthew Cavaletto, PharmD, BCACPa,b; Lindsay Garris, PharmD, BCPS, BCACPa; Jennie Hewitt, PharmD, BCACPa

Author affiliations: aDurham Veterans Affairs Health Care System, North Carolina
bVeterans Affairs Northern Indiana Health Care System, Fort Wayne, Indiana

Author disclosures: The authors report no actual or potential conflicts of interest with regard to this article.

Correspondence: Shelby Koen ([email protected])

Fed Pract. 2025;42(1). Published online January 16. doi:10.12788/fp.0537

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Shelby Koen, PharmD, BCPSa; Matthew Cavaletto, PharmD, BCACPa,b; Lindsay Garris, PharmD, BCPS, BCACPa; Jennie Hewitt, PharmD, BCACPa

Author affiliations: aDurham Veterans Affairs Health Care System, North Carolina
bVeterans Affairs Northern Indiana Health Care System, Fort Wayne, Indiana

Author disclosures: The authors report no actual or potential conflicts of interest with regard to this article.

Correspondence: Shelby Koen ([email protected])

Fed Pract. 2025;42(1). Published online January 16. doi:10.12788/fp.0537

Author and Disclosure Information

Shelby Koen, PharmD, BCPSa; Matthew Cavaletto, PharmD, BCACPa,b; Lindsay Garris, PharmD, BCPS, BCACPa; Jennie Hewitt, PharmD, BCACPa

Author affiliations: aDurham Veterans Affairs Health Care System, North Carolina
bVeterans Affairs Northern Indiana Health Care System, Fort Wayne, Indiana

Author disclosures: The authors report no actual or potential conflicts of interest with regard to this article.

Correspondence: Shelby Koen ([email protected])

Fed Pract. 2025;42(1). Published online January 16. doi:10.12788/fp.0537

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Article PDF

Low-dose aspirin commonly is used for the prevention of cardiovascular disease (CVD) but is associated with an increased risk of major bleeding.1 The use of aspirin for primary prevention is largely extrapolated from clinical trials showing benefit in the secondary prevention of myocardial infarction and ischemic stroke. However, results from the Aspirin in Reducing Events in the Elderly (ASPREE) trial challenged this practice.2 The ASPREE trial, conducted in the United States and Australia from 2010 to 2014, sought to determine whether daily 100 mg aspirin, was superior to placebo in promoting disability-free survival among older adults. Participants were aged ≥ 70 years (≥ 65 years for Hispanic and Black US participants), living in the community, and were free from preexisting CVD, cerebrovascular disease, or any chronic condition likely to limit survival to < 5 years. The study found no significant difference in the primary endpoints of death, dementia, or persistent physical disability, but there was a significantly higher risk of major hemorrhage in the aspirin group (3.8% vs 2.8%; hazard ratio, 1.38; 95% CI, 1.18-1.62; P < .001).

Several medical societies have updated their guideline recommendations for aspirin for primary prevention of CVD. The 2022 United States Public Service Task Force (USPSTF) provides a grade C recommendation (at least moderate certainty that the net benefit is small) to consider low-dose aspirin for the primary prevention of CVD on an individual patient basis for adults aged 40 to 59 years who have a ≥ 10% 10-year CVD risk. For adults aged ≥ 60 years, the USPSTF recommendation is grade D (moderate or high certainty that the practice has no net benefit or that harms outweigh the benefits) for low-dose aspirin use.1,3 The American College of Cardiology and American Heart Association (ACC/AHA) recommend considering low-dose aspirin for primary prevention of atherosclerotic cardiovascular disease (ASCVD) among select adults aged 40 to 70 years at higher CVD risk but not at increased risk of bleeding.4 The American Diabetes Association (ADA) recommends low-dose aspirin for primary prevention of CVD in patients with diabetes and additional risk factors such as family history of premature ASCVD, hypertension, dyslipidemia, smoking, or chronic kidney disease, and who are not at higher risk of bleeding.5 The ADA standards also caution against the use of aspirin as primary prevention in patients aged > 70 years. Low-dose aspirin use is not recommended for the primary prevention of CVD in older adults or adults of any age who are at increased risk of bleeding.

Recent literature using the US Department of Veterans Affairs (VA) Corporate Data Warehouse database confirms 86,555 of 1.8 million veterans aged > 70 years (5%) were taking low-dose aspirin for primary prevention of ASCVD despite guideline recommendations.6 Higher risk of gastrointestinal and other major bleeding from low-dose aspirin has been reported in the literature.1 Major bleeds represent a significant burden to the health care system with an estimated mean $13,093 cost for gastrointestinal bleed hospitalization.7

Considering the large scale aspirin use without appropriate indication within the veteran population, the risk of adverse effects, and the significant cost to patients and the health care system, it is imperative to determine the best approach to efficiently deprescribe aspirin for primary prevention among geriatric patients. Deprescribing refers to the systematic and supervised process of dose reduction or drug discontinuation with the goal of improving health and/or reducing the risk of adverse effects.8 During patient visits, primary care practitioners (PCPs) have opportunities to discontinue aspirin, but these encounters are time-limited and deprescribing might be secondary to more acute primary care needs. The shortage of PCPs is expected to worsen in coming years, which could further reduce their availability to assess inappropriate aspirin use.9

VA clinical pharmacist practitioners (CPPs) serve as medication experts and work autonomously under a broad scope of practice as part of the patient aligned care team.10-12 CPPs can free up time for PCPs and facilitate deprescribing efforts, especially for older adults. One retrospective cohort study conducted at a VA medical center found that CPPs deprescribed more potentially inappropriate medications among individuals aged ≥ 80 years compared with usual care with PCPs (26.8% vs 16.1%; P < .001).12,13 An aspirin deprescribing protocol conducted in 2022 resulted in nearly half of veterans aged ≥ 70 years contacted by phone agreeing to stop aspirin. Although this study supports the role pharmacists can play in reducing aspirin use in accordance with guidelines, the authors acknowledge that their interventions had a mean time of 12 minutes per patient and would require workflow changes.14 The purpose of this study is to evaluate the efficiency of aspirin deprescribing through 2 approaches: direct deprescribing by pharmacists using populationlevel review compared with clinicians following a pharmacist-led education.

Methods

This was a single-center quality improvement cohort study at the Durham VA Health Care System (DVAHCS) in North Carolina. Patients included were aged ≥ 70 years without known ASCVD who received care at any of 3 DVAHCS community-based outpatient clinics and prescribed aspirin. Patient data was obtained using the VIONE (Deprescribing Dashboard called Vital, Important, Optional, Not indicated, and Every medication has a specific indication or diagnosis) dashboard.15 VIONE was developed to identify potentially inappropriate medications (PIMs) that are eligible to deprescribe based on Beers Criteria, Screening Tool of Older Personsf Prescriptions criteria, and common clinical scenarios when clinicians determine the risk outweighs the benefit to continue a specific medication. 16,17 VIONE is used to reduce polypharmacy and improve patient safety, comfort, and medication adherence. Aspirin for patients aged ≥ 70 years without a history of ASCVD is a PIM identified by VIONE. Patients aged ≥ 70 years were chosen as an inclusion criteria in this study to match the ASPREE trial inclusion criteria and age inclusion criteria in the VIONE dashboard for aspirin deprescribing.2 Patient lists were generated for these potentially inappropriate aspirin prescriptions for 3 months before clinician staff education presentations, the day of the presentations, and 3 months after.

The primary endpoint was the number of veterans with aspirin deprescribed directly by 2 pharmacists over 12 weeks, divided by total patient care time spent, compared with the change in number of veterans with aspirin deprescribed by any DVAHCS physician, nurse practitioner, physician assistant, or CPP over 12 weeks, divided by the total pharmacist time spent on PCP education. Secondary endpoints were the number of aspirin orders discontinued by pharmacists and CPPs, the number of aspirin orders discontinued 12 weeks before pharmacist-led education compared with the number of aspirin orders discontinued 12 weeks after CPP-led education, average and median pharmacist time spent per patient encounter, and time of direct patient encounters vs time spent on PCP education.

Pharmacists reviewed each patient who met the inclusion criteria from the list generated by VIONE on December 1, 2022, for aspirin appropriateness according to the ACC/AHA and USPSTF guidelines, with the goal to discontinue aspirin for primary prevention of ASCVD and no other indications.1,4 Pharmacists documented their visits using VIONE methodology in the Computerized Patient Record System (CPRS) using a polypharmacy review note. CPPs contacted patients who were taking aspirin for primary prevention by unscheduled telephone call to assess for aspirin adherence, undocumented history of ASCVD, cardiovascular risk factors, and history of bleeding. Aspirin was discontinued if patients met guideline criteria recommendations and agreed to discontinuation. Risk-benefit discussions were completed when patients without known ASCVD were considered high risk because the ACC/AHA guidelines mention there is insufficient evidence of safety and efficacy of aspirin for primary prevention for patients with other known ASCVD risk factors (eg, strong family history of premature myocardial infarction, inability to achieve lipid, blood pressure, or glucose targets, or significant elevation in coronary artery calcium score).

High risk was defined as family history of premature ASCVD (in a male first-degree relative aged < 55 years or a female first-degree relative aged < 65 years), most recent blood pressure or 2 blood pressure results in the last 12 months > 160/100 mm Hg, recent hemoglobin A1c > 9%, and/or low-density lipoprotein > 190 mg/dL or not prescribed an indicated statin.3 Aspirin was continued or discontinued according to patient preference after the personalized risk-benefit discussion.

For patients with a clinical indication for aspirin use other than ASCVD (eg, atrial fibrillation not on anticoagulation, venous thromboembolism prophylaxis, carotid artery disease), CPPs documented their assessment and when appropriate deferred to the PCP for consideration of stopping aspirin. For patients with undocumented ASCVD, CPPs added their ASCVD history to their problem list and aspirin was continued. PCPs were notified by alert when aspirin was discontinued and when patients could not be reached by telephone.

presented a review of recent guideline updates and supporting literature at 2 online staff meetings. The education sessions lasted about 10 minutes and were presented to PCPs across 3 community-based outpatient clinics. An estimated 40 minutes were spent creating the PowerPoint education materials, seeking feedback, making edits, and answering questions or emails from PCPs after the presentation. During the presentation, pharmacists encouraged PCPs to discontinue aspirin (active VA prescriptions and reported over-the-counter use) for primary prevention of ASCVD in patients aged ≥ 70 years during their upcoming appointments and consider risk factors recommended by the ACC/AHA guidelines when applicable. PCPs were notified that CPPs planned to start a population review for discontinuing active VA aspirin prescriptions on December 1, 2022. The primary endpoint and secondary endpoints were analyzed using descriptive statistics. All data were analyzed using Microsoft Excel.

 

FDP042022_F1

Results

A total of 868 patients aged ≥ 70 years with active prescriptions for aspirin were identified on December 1, 2022. After applying inclusion and exclusion criteria for the pharmacist population review, 224 patients were included for cohort final analysis (Figure). All 868 patients were eligible for the CPP intervention. Primary reasons for exclusion from the CPP population included over-thecounter aspirin and a history of ASCVD in the patient’s problem list. All patients were male, with a mean (SD) age of 75 (4.4) years (Table 1). Most patients were prescribed aspirin, 81 mg daily (n = 220; 98%).

FDP042022_T1

 

The direct CPP deprescribing intervention resulted in 2 aspirin prescriptions discontinued per hour of pharmacist time and 67 aspirin prescriptions discontinued per hour of pharmacist time via the PCP education intervention. CPPs discontinued 66 aspirin orders in the 12 weeks before the PCP education sessions. A total of 230 aspirin prescriptions were discontinued in the 12 weeks following the PCP education sessions, with 97 discontinued directly by CPPs and 133 discontinued by PCPs. The PCP education session yielded an additional 67 discontinued aspirin orders compared with the 12 weeks before the education sessions (Table 2).

FDP042022_T2

The CPP direct deprescribing intervention took about 48.3 hours, accounting for health record review and time interacting with patients. The PCP education intervention took about 60 minutes, which included time for preparing and delivering education materials (Table 3). CPP deprescribing encounter types, interventions, and related subcategories, and other identified indications to continue aspirin are listed in Table 4.

FDP042022_T3FDP042022_T4

Discussion

Compared with direct deprescribing by pharmacists, the PCP education intervention was more efficient based on number of aspirin orders discontinued by pharmacist time. PCPs discontinued twice as many aspirin prescriptions in the 12 weeks after pharmacist-led education compared with the 12 weeks before.

Patients were primarily contacted by telephone (73%) for deprescribing. Among the 163 patients reached by phone and encouraged to discontinue aspirin, 97 patients (60%) accepted the recommendation, which was similar to the acceptance rates found in the literature (48% to 55%).14,18 Although many veterans continued taking aspirin (78%), most had indications for its continued use, such as a history of ASCVD, atrial fibrillation without anticoagulation, and carotid artery stenosis, and complex comorbidities that required further discussion with their PCP. Less common uses for aspirin were identified through CPRS review or patient reports included cerebral small vessel disease without history of ASCVD, subclavian artery stenosis, thrombocytosis, bioprosthetic valve replacement, giant cell arteritis, rheumatoid arthritis, and prevention of second eye involvement of ischemic optic neuropathy.

to describe the benefit of clinical pharmacy services for deprescribing aspirin for primary prevention of ASCVD through PCP education. Previously published literature has assessed alternative ways to identify or discontinue PIMs—including aspirin—among geriatric patients. One study evaluated the use of marking inappropriate aspirin prescriptions in the electronic health database, leading to a significant reduction in incidence of inappropriate aspirin prescribing; however, it did not assess changes in discontinuation rates of existing aspirin prescriptions.19 The previous VA pharmacist aspirin deprescribing protocol demonstrated pharmacists’ aptitude at discontinuing aspirin for primary prevention but only used direct patient contact and did not compare efficiency with other methods, including PCP education.14

This quality improvement project contributes new data to the existing literature to support the use of clinical pharmacists to discontinue aspirin for primary prevention and suggests a strong role for pharmacists as educators on clinical guidelines, in addition to their roles directly deprescribing PIMs in clinical practice. This study is further strengthened by its use of VIONE, which previously has demonstrated effectiveness in deprescribing a variety of PIMs in primary care settings.20

Despite using VIONE for generating a list of patients eligible for deprescription, our CPRS review found that this list was frequently inaccurate. For example, a small portion of patients were on the VIONE generated list indicating they had no ASCVD history, but had transient ischemic attack listed in their problem lists. Patient problem lists often were missing documented ASCVD history that was revealed by patient interview or CPRS review. It is possible that patients interviewed might have omitted relevant ASCVD history because of low health literacy, conditions affecting memory, or use of health care services outside the VA system.

There were several instances of aspirin used for other non-ASCVD indications, such as primary stroke prevention in atrial fibrillation. The ACC/AHA atrial fibrillation guidelines previously provided a Class IIb recommendation (benefit is greater than risk but additional studies are needed) for considering no antithrombic therapy or treatment with oral anticoagulant or aspirin for nonvalvular atrial fibrillation with CHA2DS2-VASc (Congestive heart failure, Hypertension, Age [> 65 y, 1 point; > 75 y, 2 points], Diabetes, previous Stroke/transient ischemic attack [2 points]) score of 1.21 The ACC/ AHA guidelines were updated in 2023 to recommend against antiplatelet therapy as an alternative to anticoagulation for reducing cardioembolic stroke risk among patients with atrial fibrillation with no indication for antiplatelet therapy because of risk of harm.22 If a patient has no risk factors for stroke, aspirin is not recommended to prevent thromboembolic events because of a lack of benefit. Interventions from this quality improvement study were completed before the 2023 atrial fibrillation guideline was published and therefore in this study aspirin was not discontinued when used for atrial fibrillation. Aspirin use for atrial fibrillation might benefit from similar discontinuation efforts analyzed within this study. Beyond atrial fibrillation, major guidelines do not comment on the use of aspirin for any other indications in the absence of clinical ASCVD.

Limitations

This study is limited by the lack of clinical consensus for complex patients and demonstrates the importance of individualized patient assessment when considering discontinuing aspirin. Because of the project’s relatively short intervention period, aspirin deprescribing rates could decrease over time and repeated education efforts might be necessary to see lasting impact. Health care professionals from services outside of primary care also might have discontinued aspirin during the study period unrelated to the education and these discontinued aspirin prescriptions could contribute to the higher rate observed among PCPs. This study included a specific population cohort of male, US veterans and might not reflect other populations where these interventions could be implemented.

The measurement of time spent by pharmacists and PCPs is an additional limitation. Although it is expected that PCPs attempt to discontinue aspirin during their existing patient care appointments, the time spent during visits was not measured or documented. Direct deprescribing by pharmacist CPRS review required a significant amount of time and could be a barrier to successful intervention by CPPs in patient aligned care teams.

To reduce the time pharmacists spent completing CPRS reviews, an aspirin deprescribing clinical reminder tool could be used to assess use and appropriate indication quickly during any primary care visit led by a PCP or CPP. In addition, it is recommended that pharmacists regularly educate health care professionals on guideline recommendations for aspirin use among geriatric patients. Future studies of the incidence of major cardiovascular events after aspirin deprescribing among geriatric patients and a longitudinal cost/benefit analysis could support these initiatives.

Conclusions

In this study, pharmacists successfully deprescribed inappropriate medications, such as aspirin. However, pharmacist-led PCP education is more efficient compared with direct deprescribing using a population-level review. PCP education requires less time and could allow ambulatory care pharmacists to spend more time on other direct patient care interventions to improve quality and access to care in primary care clinics. This study’s results further support the role of pharmacists in deprescribing PIMs for older adults and the use of a deprescribing tool, such as VIONE, in a primary care setting.

Low-dose aspirin commonly is used for the prevention of cardiovascular disease (CVD) but is associated with an increased risk of major bleeding.1 The use of aspirin for primary prevention is largely extrapolated from clinical trials showing benefit in the secondary prevention of myocardial infarction and ischemic stroke. However, results from the Aspirin in Reducing Events in the Elderly (ASPREE) trial challenged this practice.2 The ASPREE trial, conducted in the United States and Australia from 2010 to 2014, sought to determine whether daily 100 mg aspirin, was superior to placebo in promoting disability-free survival among older adults. Participants were aged ≥ 70 years (≥ 65 years for Hispanic and Black US participants), living in the community, and were free from preexisting CVD, cerebrovascular disease, or any chronic condition likely to limit survival to < 5 years. The study found no significant difference in the primary endpoints of death, dementia, or persistent physical disability, but there was a significantly higher risk of major hemorrhage in the aspirin group (3.8% vs 2.8%; hazard ratio, 1.38; 95% CI, 1.18-1.62; P < .001).

Several medical societies have updated their guideline recommendations for aspirin for primary prevention of CVD. The 2022 United States Public Service Task Force (USPSTF) provides a grade C recommendation (at least moderate certainty that the net benefit is small) to consider low-dose aspirin for the primary prevention of CVD on an individual patient basis for adults aged 40 to 59 years who have a ≥ 10% 10-year CVD risk. For adults aged ≥ 60 years, the USPSTF recommendation is grade D (moderate or high certainty that the practice has no net benefit or that harms outweigh the benefits) for low-dose aspirin use.1,3 The American College of Cardiology and American Heart Association (ACC/AHA) recommend considering low-dose aspirin for primary prevention of atherosclerotic cardiovascular disease (ASCVD) among select adults aged 40 to 70 years at higher CVD risk but not at increased risk of bleeding.4 The American Diabetes Association (ADA) recommends low-dose aspirin for primary prevention of CVD in patients with diabetes and additional risk factors such as family history of premature ASCVD, hypertension, dyslipidemia, smoking, or chronic kidney disease, and who are not at higher risk of bleeding.5 The ADA standards also caution against the use of aspirin as primary prevention in patients aged > 70 years. Low-dose aspirin use is not recommended for the primary prevention of CVD in older adults or adults of any age who are at increased risk of bleeding.

Recent literature using the US Department of Veterans Affairs (VA) Corporate Data Warehouse database confirms 86,555 of 1.8 million veterans aged > 70 years (5%) were taking low-dose aspirin for primary prevention of ASCVD despite guideline recommendations.6 Higher risk of gastrointestinal and other major bleeding from low-dose aspirin has been reported in the literature.1 Major bleeds represent a significant burden to the health care system with an estimated mean $13,093 cost for gastrointestinal bleed hospitalization.7

Considering the large scale aspirin use without appropriate indication within the veteran population, the risk of adverse effects, and the significant cost to patients and the health care system, it is imperative to determine the best approach to efficiently deprescribe aspirin for primary prevention among geriatric patients. Deprescribing refers to the systematic and supervised process of dose reduction or drug discontinuation with the goal of improving health and/or reducing the risk of adverse effects.8 During patient visits, primary care practitioners (PCPs) have opportunities to discontinue aspirin, but these encounters are time-limited and deprescribing might be secondary to more acute primary care needs. The shortage of PCPs is expected to worsen in coming years, which could further reduce their availability to assess inappropriate aspirin use.9

VA clinical pharmacist practitioners (CPPs) serve as medication experts and work autonomously under a broad scope of practice as part of the patient aligned care team.10-12 CPPs can free up time for PCPs and facilitate deprescribing efforts, especially for older adults. One retrospective cohort study conducted at a VA medical center found that CPPs deprescribed more potentially inappropriate medications among individuals aged ≥ 80 years compared with usual care with PCPs (26.8% vs 16.1%; P < .001).12,13 An aspirin deprescribing protocol conducted in 2022 resulted in nearly half of veterans aged ≥ 70 years contacted by phone agreeing to stop aspirin. Although this study supports the role pharmacists can play in reducing aspirin use in accordance with guidelines, the authors acknowledge that their interventions had a mean time of 12 minutes per patient and would require workflow changes.14 The purpose of this study is to evaluate the efficiency of aspirin deprescribing through 2 approaches: direct deprescribing by pharmacists using populationlevel review compared with clinicians following a pharmacist-led education.

Methods

This was a single-center quality improvement cohort study at the Durham VA Health Care System (DVAHCS) in North Carolina. Patients included were aged ≥ 70 years without known ASCVD who received care at any of 3 DVAHCS community-based outpatient clinics and prescribed aspirin. Patient data was obtained using the VIONE (Deprescribing Dashboard called Vital, Important, Optional, Not indicated, and Every medication has a specific indication or diagnosis) dashboard.15 VIONE was developed to identify potentially inappropriate medications (PIMs) that are eligible to deprescribe based on Beers Criteria, Screening Tool of Older Personsf Prescriptions criteria, and common clinical scenarios when clinicians determine the risk outweighs the benefit to continue a specific medication. 16,17 VIONE is used to reduce polypharmacy and improve patient safety, comfort, and medication adherence. Aspirin for patients aged ≥ 70 years without a history of ASCVD is a PIM identified by VIONE. Patients aged ≥ 70 years were chosen as an inclusion criteria in this study to match the ASPREE trial inclusion criteria and age inclusion criteria in the VIONE dashboard for aspirin deprescribing.2 Patient lists were generated for these potentially inappropriate aspirin prescriptions for 3 months before clinician staff education presentations, the day of the presentations, and 3 months after.

The primary endpoint was the number of veterans with aspirin deprescribed directly by 2 pharmacists over 12 weeks, divided by total patient care time spent, compared with the change in number of veterans with aspirin deprescribed by any DVAHCS physician, nurse practitioner, physician assistant, or CPP over 12 weeks, divided by the total pharmacist time spent on PCP education. Secondary endpoints were the number of aspirin orders discontinued by pharmacists and CPPs, the number of aspirin orders discontinued 12 weeks before pharmacist-led education compared with the number of aspirin orders discontinued 12 weeks after CPP-led education, average and median pharmacist time spent per patient encounter, and time of direct patient encounters vs time spent on PCP education.

Pharmacists reviewed each patient who met the inclusion criteria from the list generated by VIONE on December 1, 2022, for aspirin appropriateness according to the ACC/AHA and USPSTF guidelines, with the goal to discontinue aspirin for primary prevention of ASCVD and no other indications.1,4 Pharmacists documented their visits using VIONE methodology in the Computerized Patient Record System (CPRS) using a polypharmacy review note. CPPs contacted patients who were taking aspirin for primary prevention by unscheduled telephone call to assess for aspirin adherence, undocumented history of ASCVD, cardiovascular risk factors, and history of bleeding. Aspirin was discontinued if patients met guideline criteria recommendations and agreed to discontinuation. Risk-benefit discussions were completed when patients without known ASCVD were considered high risk because the ACC/AHA guidelines mention there is insufficient evidence of safety and efficacy of aspirin for primary prevention for patients with other known ASCVD risk factors (eg, strong family history of premature myocardial infarction, inability to achieve lipid, blood pressure, or glucose targets, or significant elevation in coronary artery calcium score).

High risk was defined as family history of premature ASCVD (in a male first-degree relative aged < 55 years or a female first-degree relative aged < 65 years), most recent blood pressure or 2 blood pressure results in the last 12 months > 160/100 mm Hg, recent hemoglobin A1c > 9%, and/or low-density lipoprotein > 190 mg/dL or not prescribed an indicated statin.3 Aspirin was continued or discontinued according to patient preference after the personalized risk-benefit discussion.

For patients with a clinical indication for aspirin use other than ASCVD (eg, atrial fibrillation not on anticoagulation, venous thromboembolism prophylaxis, carotid artery disease), CPPs documented their assessment and when appropriate deferred to the PCP for consideration of stopping aspirin. For patients with undocumented ASCVD, CPPs added their ASCVD history to their problem list and aspirin was continued. PCPs were notified by alert when aspirin was discontinued and when patients could not be reached by telephone.

presented a review of recent guideline updates and supporting literature at 2 online staff meetings. The education sessions lasted about 10 minutes and were presented to PCPs across 3 community-based outpatient clinics. An estimated 40 minutes were spent creating the PowerPoint education materials, seeking feedback, making edits, and answering questions or emails from PCPs after the presentation. During the presentation, pharmacists encouraged PCPs to discontinue aspirin (active VA prescriptions and reported over-the-counter use) for primary prevention of ASCVD in patients aged ≥ 70 years during their upcoming appointments and consider risk factors recommended by the ACC/AHA guidelines when applicable. PCPs were notified that CPPs planned to start a population review for discontinuing active VA aspirin prescriptions on December 1, 2022. The primary endpoint and secondary endpoints were analyzed using descriptive statistics. All data were analyzed using Microsoft Excel.

 

FDP042022_F1

Results

A total of 868 patients aged ≥ 70 years with active prescriptions for aspirin were identified on December 1, 2022. After applying inclusion and exclusion criteria for the pharmacist population review, 224 patients were included for cohort final analysis (Figure). All 868 patients were eligible for the CPP intervention. Primary reasons for exclusion from the CPP population included over-thecounter aspirin and a history of ASCVD in the patient’s problem list. All patients were male, with a mean (SD) age of 75 (4.4) years (Table 1). Most patients were prescribed aspirin, 81 mg daily (n = 220; 98%).

FDP042022_T1

 

The direct CPP deprescribing intervention resulted in 2 aspirin prescriptions discontinued per hour of pharmacist time and 67 aspirin prescriptions discontinued per hour of pharmacist time via the PCP education intervention. CPPs discontinued 66 aspirin orders in the 12 weeks before the PCP education sessions. A total of 230 aspirin prescriptions were discontinued in the 12 weeks following the PCP education sessions, with 97 discontinued directly by CPPs and 133 discontinued by PCPs. The PCP education session yielded an additional 67 discontinued aspirin orders compared with the 12 weeks before the education sessions (Table 2).

FDP042022_T2

The CPP direct deprescribing intervention took about 48.3 hours, accounting for health record review and time interacting with patients. The PCP education intervention took about 60 minutes, which included time for preparing and delivering education materials (Table 3). CPP deprescribing encounter types, interventions, and related subcategories, and other identified indications to continue aspirin are listed in Table 4.

FDP042022_T3FDP042022_T4

Discussion

Compared with direct deprescribing by pharmacists, the PCP education intervention was more efficient based on number of aspirin orders discontinued by pharmacist time. PCPs discontinued twice as many aspirin prescriptions in the 12 weeks after pharmacist-led education compared with the 12 weeks before.

Patients were primarily contacted by telephone (73%) for deprescribing. Among the 163 patients reached by phone and encouraged to discontinue aspirin, 97 patients (60%) accepted the recommendation, which was similar to the acceptance rates found in the literature (48% to 55%).14,18 Although many veterans continued taking aspirin (78%), most had indications for its continued use, such as a history of ASCVD, atrial fibrillation without anticoagulation, and carotid artery stenosis, and complex comorbidities that required further discussion with their PCP. Less common uses for aspirin were identified through CPRS review or patient reports included cerebral small vessel disease without history of ASCVD, subclavian artery stenosis, thrombocytosis, bioprosthetic valve replacement, giant cell arteritis, rheumatoid arthritis, and prevention of second eye involvement of ischemic optic neuropathy.

to describe the benefit of clinical pharmacy services for deprescribing aspirin for primary prevention of ASCVD through PCP education. Previously published literature has assessed alternative ways to identify or discontinue PIMs—including aspirin—among geriatric patients. One study evaluated the use of marking inappropriate aspirin prescriptions in the electronic health database, leading to a significant reduction in incidence of inappropriate aspirin prescribing; however, it did not assess changes in discontinuation rates of existing aspirin prescriptions.19 The previous VA pharmacist aspirin deprescribing protocol demonstrated pharmacists’ aptitude at discontinuing aspirin for primary prevention but only used direct patient contact and did not compare efficiency with other methods, including PCP education.14

This quality improvement project contributes new data to the existing literature to support the use of clinical pharmacists to discontinue aspirin for primary prevention and suggests a strong role for pharmacists as educators on clinical guidelines, in addition to their roles directly deprescribing PIMs in clinical practice. This study is further strengthened by its use of VIONE, which previously has demonstrated effectiveness in deprescribing a variety of PIMs in primary care settings.20

Despite using VIONE for generating a list of patients eligible for deprescription, our CPRS review found that this list was frequently inaccurate. For example, a small portion of patients were on the VIONE generated list indicating they had no ASCVD history, but had transient ischemic attack listed in their problem lists. Patient problem lists often were missing documented ASCVD history that was revealed by patient interview or CPRS review. It is possible that patients interviewed might have omitted relevant ASCVD history because of low health literacy, conditions affecting memory, or use of health care services outside the VA system.

There were several instances of aspirin used for other non-ASCVD indications, such as primary stroke prevention in atrial fibrillation. The ACC/AHA atrial fibrillation guidelines previously provided a Class IIb recommendation (benefit is greater than risk but additional studies are needed) for considering no antithrombic therapy or treatment with oral anticoagulant or aspirin for nonvalvular atrial fibrillation with CHA2DS2-VASc (Congestive heart failure, Hypertension, Age [> 65 y, 1 point; > 75 y, 2 points], Diabetes, previous Stroke/transient ischemic attack [2 points]) score of 1.21 The ACC/ AHA guidelines were updated in 2023 to recommend against antiplatelet therapy as an alternative to anticoagulation for reducing cardioembolic stroke risk among patients with atrial fibrillation with no indication for antiplatelet therapy because of risk of harm.22 If a patient has no risk factors for stroke, aspirin is not recommended to prevent thromboembolic events because of a lack of benefit. Interventions from this quality improvement study were completed before the 2023 atrial fibrillation guideline was published and therefore in this study aspirin was not discontinued when used for atrial fibrillation. Aspirin use for atrial fibrillation might benefit from similar discontinuation efforts analyzed within this study. Beyond atrial fibrillation, major guidelines do not comment on the use of aspirin for any other indications in the absence of clinical ASCVD.

Limitations

This study is limited by the lack of clinical consensus for complex patients and demonstrates the importance of individualized patient assessment when considering discontinuing aspirin. Because of the project’s relatively short intervention period, aspirin deprescribing rates could decrease over time and repeated education efforts might be necessary to see lasting impact. Health care professionals from services outside of primary care also might have discontinued aspirin during the study period unrelated to the education and these discontinued aspirin prescriptions could contribute to the higher rate observed among PCPs. This study included a specific population cohort of male, US veterans and might not reflect other populations where these interventions could be implemented.

The measurement of time spent by pharmacists and PCPs is an additional limitation. Although it is expected that PCPs attempt to discontinue aspirin during their existing patient care appointments, the time spent during visits was not measured or documented. Direct deprescribing by pharmacist CPRS review required a significant amount of time and could be a barrier to successful intervention by CPPs in patient aligned care teams.

To reduce the time pharmacists spent completing CPRS reviews, an aspirin deprescribing clinical reminder tool could be used to assess use and appropriate indication quickly during any primary care visit led by a PCP or CPP. In addition, it is recommended that pharmacists regularly educate health care professionals on guideline recommendations for aspirin use among geriatric patients. Future studies of the incidence of major cardiovascular events after aspirin deprescribing among geriatric patients and a longitudinal cost/benefit analysis could support these initiatives.

Conclusions

In this study, pharmacists successfully deprescribed inappropriate medications, such as aspirin. However, pharmacist-led PCP education is more efficient compared with direct deprescribing using a population-level review. PCP education requires less time and could allow ambulatory care pharmacists to spend more time on other direct patient care interventions to improve quality and access to care in primary care clinics. This study’s results further support the role of pharmacists in deprescribing PIMs for older adults and the use of a deprescribing tool, such as VIONE, in a primary care setting.

References
  1. US Preventive Services Task Force; Davidson KW, Barry MJ, et al. Aspirin use to prevent cardiovascular disease: US Preventive Services Task Force recommendation statement. JAMA. 2022;327(16):1577-1584. doi:10.1001/jama.2022.4983
  2. McNeil JJ, Nelson MR, Woods RL, et al. Effect of aspirin on all-cause mortality in the healthy elderly. N Engl J Med. 2018;379(16):1519-1528. doi:10.1056/NEJMoa1803955
  3. Barry MJ, Wolff TA, Pbert L, et al. Putting evidence into practice: an update on the US Preventive Services Task Force methods for developing recommendations for preventive services. Ann Fam Med. 2023;21(2):165-171. doi:10.1370/afm.2946
  4. Arnett DK, Blumenthal RS, Albert MA, et al. 2019 ACC/ AHA Guideline on the Primary Prevention of Cardiovascular Disease: A report of the American College of Cardiology/ American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;140(11):e596-e646. doi:10.1161/CIR.0000000000000678
  5. American Diabetes Association Professional Practice Committee. 10. Cardiovascular disease and risk management: Standards of care in diabetes-2024. Diabetes Care. 2024;47(Suppl 1):S179-S218. doi:10.2337/dc24-S010
  6. Ong SY, Chui P, Bhargava A, Justice A, Hauser RG. Estimating aspirin overuse for primary prevention of atherosclerotic cardiovascular disease (from a nationwide healthcare system). Am J Cardiol. 2020;137:25-30. doi:10.1016/j.amjcard.2020.09.042
  7. Weiss AJ, Jiang HJ. Overview of clinical conditions with frequent and costly hospital readmissions by payer, 2018. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Agency for Healthcare Research and Quality (US); July 20, 2021.
  8. Krishnaswami A, Steinman MA, Goyal P, et al. Deprescribing in older adults with cardiovascular disease. J Am Coll Cardiol. 2019;73(20):2584-2595. doi:10.1016/j.jacc.2019.03.467
  9. Association of American Medical Colleges. The complexities of physician supply and demand: projections from 2019 to 2034. Accessed March 17, 2024. https://www.aamc.org/media/54681/download
  10. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1108.07(1): General pharmacy service requirements. November 28, 2022. Accessed March 17, 2024. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=10045
  11. US Department of Veterans Affairs, Veterans Health Administration. VHA Handbook 1108.11(3): Clinical pharmacy services. July 1, 2015. Accessed March 17, 2024. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3120
  12. US Department of Veterans Affairs. Clinical pharmacist practitioner (CPP) to improve access to and quality of care August 2021. August 2021. Accessed May 19, 2023. https://www.pbm.va.gov/PBM/CPPO/Documents/ExternalFactSheet_OptimizingtheCPPToImproveAccess_508.pdf
  13. Ammerman CA, Simpkins BA, Warman N, Downs TN. Potentially inappropriate medications in older adults: Deprescribing with a clinical pharmacist. J Am Geriatr Soc. 2019;67(1):115-118. doi:10.1111/jgs.15623
  14. Rothbauer K, Siodlak M, Dreischmeier E, Ranola TS, Welch L. Evaluation of a pharmacist-driven ambulatory aspirin deprescribing protocol. Fed Pract. 2022;39(suppl 5):S37- S41a. doi:10.12788/fp.0294
  15. US Department of Veterans Affairs. VIONE changes the way VA handles prescriptions. January 25, 2020. Accessed May 21, 2023. https://news.va.gov/70709/vione-changes-way-va-handles-prescriptions/
  16. 2023 American Geriatrics Society Beers Criteria Update Expert Panel. American Geriatrics Society 2023 updated AGS Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2023;71(7):2052- 2081. doi:10.1111/jgs.18372
  17. O’Mahony D, Cherubini A, Guiteras AR, et al. STOPP/ START criteria for potentially inappropriate prescribing in older people: version 3. Eur Geriatr Med. 2023;14(4):625- 632. doi:10.1007/s41999-023-00777-y
  18. Draeger C, Lodhi F, Geissinger N, Larson T, Griesbach S. Interdisciplinary deprescribing of aspirin through prescriber education and provision of patient-specific recommendations. WMJ. 2022;121(3):220-225
  19. de Lusignan S, Hinton W, Seidu S, et al. Dashboards to reduce inappropriate prescribing of metformin and aspirin: A quality assurance programme in a primary care sentinel network. Prim Care Diabetes. 2021;15(6):1075-1079. doi:10.1016/j.pcd.2021.06.003
  20. Nelson MW, Downs TN, Puglisi GM, Simpkins BA, Collier AS. Use of a deprescribing tool in an interdisciplinary primary-care patient-aligned care team. Sr Care Pharm. 2022;37(1):34-43. doi:10.4140/TCP.n.2022.34
  21. January CT, Wann LS, Alpert JS, et al. 2014 AHA/ ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014;130(23):e199-e267. doi:10.1161/CIR.0000000000000041
  22. Joglar JA, Chung MK, Armbruster AL, et al. 2023 ACC/ AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines Circulation. 2024;149(1):e1- e156. doi:10.1161/CIR.0000000000001193
References
  1. US Preventive Services Task Force; Davidson KW, Barry MJ, et al. Aspirin use to prevent cardiovascular disease: US Preventive Services Task Force recommendation statement. JAMA. 2022;327(16):1577-1584. doi:10.1001/jama.2022.4983
  2. McNeil JJ, Nelson MR, Woods RL, et al. Effect of aspirin on all-cause mortality in the healthy elderly. N Engl J Med. 2018;379(16):1519-1528. doi:10.1056/NEJMoa1803955
  3. Barry MJ, Wolff TA, Pbert L, et al. Putting evidence into practice: an update on the US Preventive Services Task Force methods for developing recommendations for preventive services. Ann Fam Med. 2023;21(2):165-171. doi:10.1370/afm.2946
  4. Arnett DK, Blumenthal RS, Albert MA, et al. 2019 ACC/ AHA Guideline on the Primary Prevention of Cardiovascular Disease: A report of the American College of Cardiology/ American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;140(11):e596-e646. doi:10.1161/CIR.0000000000000678
  5. American Diabetes Association Professional Practice Committee. 10. Cardiovascular disease and risk management: Standards of care in diabetes-2024. Diabetes Care. 2024;47(Suppl 1):S179-S218. doi:10.2337/dc24-S010
  6. Ong SY, Chui P, Bhargava A, Justice A, Hauser RG. Estimating aspirin overuse for primary prevention of atherosclerotic cardiovascular disease (from a nationwide healthcare system). Am J Cardiol. 2020;137:25-30. doi:10.1016/j.amjcard.2020.09.042
  7. Weiss AJ, Jiang HJ. Overview of clinical conditions with frequent and costly hospital readmissions by payer, 2018. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Agency for Healthcare Research and Quality (US); July 20, 2021.
  8. Krishnaswami A, Steinman MA, Goyal P, et al. Deprescribing in older adults with cardiovascular disease. J Am Coll Cardiol. 2019;73(20):2584-2595. doi:10.1016/j.jacc.2019.03.467
  9. Association of American Medical Colleges. The complexities of physician supply and demand: projections from 2019 to 2034. Accessed March 17, 2024. https://www.aamc.org/media/54681/download
  10. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1108.07(1): General pharmacy service requirements. November 28, 2022. Accessed March 17, 2024. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=10045
  11. US Department of Veterans Affairs, Veterans Health Administration. VHA Handbook 1108.11(3): Clinical pharmacy services. July 1, 2015. Accessed March 17, 2024. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3120
  12. US Department of Veterans Affairs. Clinical pharmacist practitioner (CPP) to improve access to and quality of care August 2021. August 2021. Accessed May 19, 2023. https://www.pbm.va.gov/PBM/CPPO/Documents/ExternalFactSheet_OptimizingtheCPPToImproveAccess_508.pdf
  13. Ammerman CA, Simpkins BA, Warman N, Downs TN. Potentially inappropriate medications in older adults: Deprescribing with a clinical pharmacist. J Am Geriatr Soc. 2019;67(1):115-118. doi:10.1111/jgs.15623
  14. Rothbauer K, Siodlak M, Dreischmeier E, Ranola TS, Welch L. Evaluation of a pharmacist-driven ambulatory aspirin deprescribing protocol. Fed Pract. 2022;39(suppl 5):S37- S41a. doi:10.12788/fp.0294
  15. US Department of Veterans Affairs. VIONE changes the way VA handles prescriptions. January 25, 2020. Accessed May 21, 2023. https://news.va.gov/70709/vione-changes-way-va-handles-prescriptions/
  16. 2023 American Geriatrics Society Beers Criteria Update Expert Panel. American Geriatrics Society 2023 updated AGS Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2023;71(7):2052- 2081. doi:10.1111/jgs.18372
  17. O’Mahony D, Cherubini A, Guiteras AR, et al. STOPP/ START criteria for potentially inappropriate prescribing in older people: version 3. Eur Geriatr Med. 2023;14(4):625- 632. doi:10.1007/s41999-023-00777-y
  18. Draeger C, Lodhi F, Geissinger N, Larson T, Griesbach S. Interdisciplinary deprescribing of aspirin through prescriber education and provision of patient-specific recommendations. WMJ. 2022;121(3):220-225
  19. de Lusignan S, Hinton W, Seidu S, et al. Dashboards to reduce inappropriate prescribing of metformin and aspirin: A quality assurance programme in a primary care sentinel network. Prim Care Diabetes. 2021;15(6):1075-1079. doi:10.1016/j.pcd.2021.06.003
  20. Nelson MW, Downs TN, Puglisi GM, Simpkins BA, Collier AS. Use of a deprescribing tool in an interdisciplinary primary-care patient-aligned care team. Sr Care Pharm. 2022;37(1):34-43. doi:10.4140/TCP.n.2022.34
  21. January CT, Wann LS, Alpert JS, et al. 2014 AHA/ ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014;130(23):e199-e267. doi:10.1161/CIR.0000000000000041
  22. Joglar JA, Chung MK, Armbruster AL, et al. 2023 ACC/ AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines Circulation. 2024;149(1):e1- e156. doi:10.1161/CIR.0000000000001193
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Pharmacist-Led Deprescribing of Aspirin for Primary Prevention of Cardiovascular Disease Among Geriatric Veterans

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Donepezil Shows Promise in TBI Recovery

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Tue, 01/14/2025 - 09:00

TOPLINE:

Donepezil was associated with improved verbal memory and enhanced recall and processing speed, compared with placebo, in patients with severe traumatic brain injury (TBI), with a favorable safety profile despite mild to moderate gastrointestinal side effects.

METHODOLOGY:

  • A four-site, randomized, parallel-group, double-blind, placebo-controlled, 10-week clinical trial (MEMRI-TBI-D) was conducted between 2013 and 2019 to evaluate the efficacy of donepezil for verbal memory impairments following severe TBI.
  • 75 adults (75% men; mean age, 37 years) with complicated mild, moderate, or severe nonpenetrating TBI at least 6 months prior to study participation were included and randomly assigned to receive donepezil (n = 37) or placebo (n = 38).
  • Participants received 5 mg donepezil daily or matching placebo for 2 weeks, then donepezil at 10 mg daily or matching placebo for 8 weeks; treatment was discontinued at 10 weeks, with an additional 4-week observation period.
  • Verbal memory was assessed using the Hopkins Verbal Learning Test–Revised (HVLT-R). The primary outcome measure was verbal learning, evaluated through the HVLT-R total recall (ie, Total Trials 1-3) score.

TAKEAWAY:

  • Compared with placebo, donepezil was associated with significantly greater improvements in verbal learning in both modified intent-to-treat and per-protocol analyses (P = .034 and .036, respectively).
  • Treatment-responder rates were significantly higher in the donepezil group than in the placebo group (42 vs 18%; P = .03), with donepezil responders showing significant improvements in delayed recall and processing speed.
  • Although there were no serious adverse events in either group, treatment-emergent adverse events were significantly more common in the donepezil group vs placebo (46% vs 8%; P < .001). No serious adverse events occurred in either group.
  • Diarrhea and nausea were significantly more common in the donepezil group than in the placebo group (Fisher’s exact test: diarrhea, P = .03; nausea, P = .01).

IN PRACTICE:

“This study demonstrates the efficacy of donepezil on severe, persistent verbal memory impairments after predominantly severe TBI, with significant benefit for a subset of persons with such injuries, as well as a relatively favorable safety and tolerability profile,” the investigators wrote.

SOURCE:

The study was led by David B. Arciniegas, MD, University of Colorado School of Medicine, Aurora. It was published online in The Journal of Neuropsychiatry and Clinical Neurosciences.

LIMITATIONS:

The study included a relatively small sample with predominantly severe TBI requiring hospitalization and inpatient rehabilitation. The sample characteristics limit the generalizability of the findings to persons with other severities of TBI, other types of memory impairments, or more complex neuropsychiatric presentations. The study population had an average of 14 years of education, making generalizability to individuals with lower education levels uncertain. Additionally, while measures of information processing speed and immediate auditory attention were included, specific measures of sustained or selective attention were not, making it difficult to rule out improvements in higher-level attention as potential contributors to the observed verbal memory performance improvements.

DISCLOSURES:

The study was funded by the National Institute on Disability, Independent Living, and Rehabilitation Research, with in-kind support from TIRR Memorial Hermann. Four authors disclosed various financial and professional affiliations, including advisory roles with pharmaceutical and diagnostic companies, support from institutional awards, and involvement in programs funded by external organizations. One author served as the editor of The Journal of Neuropsychiatry and Clinical Neurosciences, with an independent editor overseeing the review and publication process for this article.

This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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TOPLINE:

Donepezil was associated with improved verbal memory and enhanced recall and processing speed, compared with placebo, in patients with severe traumatic brain injury (TBI), with a favorable safety profile despite mild to moderate gastrointestinal side effects.

METHODOLOGY:

  • A four-site, randomized, parallel-group, double-blind, placebo-controlled, 10-week clinical trial (MEMRI-TBI-D) was conducted between 2013 and 2019 to evaluate the efficacy of donepezil for verbal memory impairments following severe TBI.
  • 75 adults (75% men; mean age, 37 years) with complicated mild, moderate, or severe nonpenetrating TBI at least 6 months prior to study participation were included and randomly assigned to receive donepezil (n = 37) or placebo (n = 38).
  • Participants received 5 mg donepezil daily or matching placebo for 2 weeks, then donepezil at 10 mg daily or matching placebo for 8 weeks; treatment was discontinued at 10 weeks, with an additional 4-week observation period.
  • Verbal memory was assessed using the Hopkins Verbal Learning Test–Revised (HVLT-R). The primary outcome measure was verbal learning, evaluated through the HVLT-R total recall (ie, Total Trials 1-3) score.

TAKEAWAY:

  • Compared with placebo, donepezil was associated with significantly greater improvements in verbal learning in both modified intent-to-treat and per-protocol analyses (P = .034 and .036, respectively).
  • Treatment-responder rates were significantly higher in the donepezil group than in the placebo group (42 vs 18%; P = .03), with donepezil responders showing significant improvements in delayed recall and processing speed.
  • Although there were no serious adverse events in either group, treatment-emergent adverse events were significantly more common in the donepezil group vs placebo (46% vs 8%; P < .001). No serious adverse events occurred in either group.
  • Diarrhea and nausea were significantly more common in the donepezil group than in the placebo group (Fisher’s exact test: diarrhea, P = .03; nausea, P = .01).

IN PRACTICE:

“This study demonstrates the efficacy of donepezil on severe, persistent verbal memory impairments after predominantly severe TBI, with significant benefit for a subset of persons with such injuries, as well as a relatively favorable safety and tolerability profile,” the investigators wrote.

SOURCE:

The study was led by David B. Arciniegas, MD, University of Colorado School of Medicine, Aurora. It was published online in The Journal of Neuropsychiatry and Clinical Neurosciences.

LIMITATIONS:

The study included a relatively small sample with predominantly severe TBI requiring hospitalization and inpatient rehabilitation. The sample characteristics limit the generalizability of the findings to persons with other severities of TBI, other types of memory impairments, or more complex neuropsychiatric presentations. The study population had an average of 14 years of education, making generalizability to individuals with lower education levels uncertain. Additionally, while measures of information processing speed and immediate auditory attention were included, specific measures of sustained or selective attention were not, making it difficult to rule out improvements in higher-level attention as potential contributors to the observed verbal memory performance improvements.

DISCLOSURES:

The study was funded by the National Institute on Disability, Independent Living, and Rehabilitation Research, with in-kind support from TIRR Memorial Hermann. Four authors disclosed various financial and professional affiliations, including advisory roles with pharmaceutical and diagnostic companies, support from institutional awards, and involvement in programs funded by external organizations. One author served as the editor of The Journal of Neuropsychiatry and Clinical Neurosciences, with an independent editor overseeing the review and publication process for this article.

This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Donepezil was associated with improved verbal memory and enhanced recall and processing speed, compared with placebo, in patients with severe traumatic brain injury (TBI), with a favorable safety profile despite mild to moderate gastrointestinal side effects.

METHODOLOGY:

  • A four-site, randomized, parallel-group, double-blind, placebo-controlled, 10-week clinical trial (MEMRI-TBI-D) was conducted between 2013 and 2019 to evaluate the efficacy of donepezil for verbal memory impairments following severe TBI.
  • 75 adults (75% men; mean age, 37 years) with complicated mild, moderate, or severe nonpenetrating TBI at least 6 months prior to study participation were included and randomly assigned to receive donepezil (n = 37) or placebo (n = 38).
  • Participants received 5 mg donepezil daily or matching placebo for 2 weeks, then donepezil at 10 mg daily or matching placebo for 8 weeks; treatment was discontinued at 10 weeks, with an additional 4-week observation period.
  • Verbal memory was assessed using the Hopkins Verbal Learning Test–Revised (HVLT-R). The primary outcome measure was verbal learning, evaluated through the HVLT-R total recall (ie, Total Trials 1-3) score.

TAKEAWAY:

  • Compared with placebo, donepezil was associated with significantly greater improvements in verbal learning in both modified intent-to-treat and per-protocol analyses (P = .034 and .036, respectively).
  • Treatment-responder rates were significantly higher in the donepezil group than in the placebo group (42 vs 18%; P = .03), with donepezil responders showing significant improvements in delayed recall and processing speed.
  • Although there were no serious adverse events in either group, treatment-emergent adverse events were significantly more common in the donepezil group vs placebo (46% vs 8%; P < .001). No serious adverse events occurred in either group.
  • Diarrhea and nausea were significantly more common in the donepezil group than in the placebo group (Fisher’s exact test: diarrhea, P = .03; nausea, P = .01).

IN PRACTICE:

“This study demonstrates the efficacy of donepezil on severe, persistent verbal memory impairments after predominantly severe TBI, with significant benefit for a subset of persons with such injuries, as well as a relatively favorable safety and tolerability profile,” the investigators wrote.

SOURCE:

The study was led by David B. Arciniegas, MD, University of Colorado School of Medicine, Aurora. It was published online in The Journal of Neuropsychiatry and Clinical Neurosciences.

LIMITATIONS:

The study included a relatively small sample with predominantly severe TBI requiring hospitalization and inpatient rehabilitation. The sample characteristics limit the generalizability of the findings to persons with other severities of TBI, other types of memory impairments, or more complex neuropsychiatric presentations. The study population had an average of 14 years of education, making generalizability to individuals with lower education levels uncertain. Additionally, while measures of information processing speed and immediate auditory attention were included, specific measures of sustained or selective attention were not, making it difficult to rule out improvements in higher-level attention as potential contributors to the observed verbal memory performance improvements.

DISCLOSURES:

The study was funded by the National Institute on Disability, Independent Living, and Rehabilitation Research, with in-kind support from TIRR Memorial Hermann. Four authors disclosed various financial and professional affiliations, including advisory roles with pharmaceutical and diagnostic companies, support from institutional awards, and involvement in programs funded by external organizations. One author served as the editor of The Journal of Neuropsychiatry and Clinical Neurosciences, with an independent editor overseeing the review and publication process for this article.

This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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AI-Aided Colonoscopy’s ‘Intelligent’ Module Ups Polyp Detection

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Results from the British COLO-DETECT trial add to the growing body of evidence supporting the use of artificial intelligence (AI)–aided colonoscopy to increase premalignant colorectal polyp detection in routine colonoscopy practice.

Colin J. Rees, a professor of gastroenterology in the Faculty of Medical Sciences at Newcastle University in Newcastle upon Tyne, England, and colleagues compared the real-world clinical effectiveness of computer-aided detection (CADe)–assisted colonoscopy using an “intelligent” module with that of standard colonoscopy in a study in The Lancet Gastroenterology & Hepatology.

They found the GI Genius Intelligent Endoscopy Module (Medtronic) increased the mean number of adenomas detected per procedure and the adenoma detection rate, especially for small, flat (type 0-IIa) polyps, and sessile serrated lesions, which are more likely to be missed.

“Missed sessile serrated lesions disproportionately increase the risk of post-colonoscopy colorectal cancer, thus the adoption of GI Genius into routine colonoscopy practice could not only increase polyp detection but also reduce the incidence of post-colonoscopy colorectal cancer,” the investigators wrote.

“AI is going to have a major impact upon most aspects of healthcare. Some areas of medical practice are now well established, and some are still in evolution,” Rees, who is also president of the British Society of Gastroenterology, said in an interview. “Within gastroenterology, the role of AI in endoscopic diagnostics is also evolving. The COLO-DETECT trial demonstrates that AI increases detection of lesions, and work is ongoing to see how AI might help with characterization and other elements of endoscopic practice.”

 

Study Details

The multicenter, open-label, parallel-arm, pragmatic randomized controlled trial was conducted at 12 National Health Service hospitals in England. The study cohort consisted of adults ≥ 18 years undergoing colorectal cancer (CRC) screening or colonoscopy for gastrointestinal symptom surveillance owing to personal or family history.

Recruiting staff, participants, and colonoscopists were unmasked to allocation, whereas histopathologists, cochief investigators, and trial statisticians were masked.

CADe-assisted colonoscopy consisted of standard colonoscopy plus the GI Genius module active for at least the entire inspection phase of colonoscope withdrawal.

The primary outcome was mean adenomas per procedure (total number of adenomas detected divided by total number of procedures). The key secondary outcome was adenoma detection rate (proportion of colonoscopies with at least one adenoma).

From March 2021 to April 2023, the investigators recruited 2032 participants, 55.7% men, with a mean cohort age of 62.4 years and randomly assigned them to CADe-assisted colonoscopy (n = 1015) or to standard colonoscopy (n = 1017). Of these, 60.6% were undergoing screening and 39.4% had symptomatic indications.

Mean adenomas per procedure were 1.56 (SD, 2.82; n = 1001 participants with data) in the CADe-assisted group vs 1.21 (n = 1009) in the standard group, for an adjusted mean difference of 0.36 (95% CI, 0.14-0.57; adjusted incidence rate ratio, 1.30; 95% CI, 1.15-1.47; P < .0001).

Adenomas were detected in 555 (56.6%) of 980 participants in the CADe-assisted group vs 477 (48.4%) of 986 in the standard group, representing a proportion difference of 8.3% (95% CI, 3.9-12.7; adjusted odds ratio, 1.47; 95% CI, 1.21-1.78; P < .0001).

As to safety, adverse events were numerically comparable in both the intervention and control groups, with overall events 25 vs 19 and serious events 4 vs 6. On independent review, no adverse events in the CADe-assisted colonoscopy group were related to GI Genius.

 

Dr. Nabil M. Mansour

Offering a US perspective on the study, Nabil M. Mansour, MD, an associate professor and director of the McNair General GI Clinic at Baylor College of Medicine in Houston, Texas, said GI Genius and other CADe systems represent a significant advance over standard colonoscopy for identifying premalignant polyps. “While the data have been mixed, most studies, particularly randomized controlled trials have shown significant improvements with CADe in detection both terms of in adenomas per colonoscopy and reductions in adenoma miss rate,” he said in an interview.

He added that the main utility of CADe is for asymptomatic patients undergoing average-risk screening and surveillance colonoscopy for CRC screening and prevention, as well as for those with positive stool-based screening tests, “though there is no downside to using it in symptomatic patients as well.” Though AI colonoscopy likely still stands at < 50% of endoscopy centers overall, and is used mainly at academic centers, his clinic has been using it for the past year.

The main question, Mansour cautioned, is whether increased detection of small polyps will actually reduce CRC incidence or mortality, and it will likely be several years before clear, concrete data can answer that.

“Most studies have shown the improvement in adenoma detection is mainly for diminutive polyps < 5 mm in diameter, but whether that will actually translate to substantive improvements in hard outcomes is as yet unknown,” he said. “But if gastroenterologists are interested in doing everything they can today to help improve detection rates and lower miss rates of premalignant polyps, serious consideration should be given to adopting the use of CADe in practice.”

This study was supported by Medtronic. Rees reported receiving grant funding from ARC Medical, Norgine, Medtronic, 3-D Matrix, and Olympus Medical, and has been an expert witness for ARC Medical. Other authors disclosed receiving research funding, honoraria, or travel expenses from Medtronic or other private companies. Mansour had no competing interests to declare.

A version of this article appeared on Medscape.com.

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Results from the British COLO-DETECT trial add to the growing body of evidence supporting the use of artificial intelligence (AI)–aided colonoscopy to increase premalignant colorectal polyp detection in routine colonoscopy practice.

Colin J. Rees, a professor of gastroenterology in the Faculty of Medical Sciences at Newcastle University in Newcastle upon Tyne, England, and colleagues compared the real-world clinical effectiveness of computer-aided detection (CADe)–assisted colonoscopy using an “intelligent” module with that of standard colonoscopy in a study in The Lancet Gastroenterology & Hepatology.

They found the GI Genius Intelligent Endoscopy Module (Medtronic) increased the mean number of adenomas detected per procedure and the adenoma detection rate, especially for small, flat (type 0-IIa) polyps, and sessile serrated lesions, which are more likely to be missed.

“Missed sessile serrated lesions disproportionately increase the risk of post-colonoscopy colorectal cancer, thus the adoption of GI Genius into routine colonoscopy practice could not only increase polyp detection but also reduce the incidence of post-colonoscopy colorectal cancer,” the investigators wrote.

“AI is going to have a major impact upon most aspects of healthcare. Some areas of medical practice are now well established, and some are still in evolution,” Rees, who is also president of the British Society of Gastroenterology, said in an interview. “Within gastroenterology, the role of AI in endoscopic diagnostics is also evolving. The COLO-DETECT trial demonstrates that AI increases detection of lesions, and work is ongoing to see how AI might help with characterization and other elements of endoscopic practice.”

 

Study Details

The multicenter, open-label, parallel-arm, pragmatic randomized controlled trial was conducted at 12 National Health Service hospitals in England. The study cohort consisted of adults ≥ 18 years undergoing colorectal cancer (CRC) screening or colonoscopy for gastrointestinal symptom surveillance owing to personal or family history.

Recruiting staff, participants, and colonoscopists were unmasked to allocation, whereas histopathologists, cochief investigators, and trial statisticians were masked.

CADe-assisted colonoscopy consisted of standard colonoscopy plus the GI Genius module active for at least the entire inspection phase of colonoscope withdrawal.

The primary outcome was mean adenomas per procedure (total number of adenomas detected divided by total number of procedures). The key secondary outcome was adenoma detection rate (proportion of colonoscopies with at least one adenoma).

From March 2021 to April 2023, the investigators recruited 2032 participants, 55.7% men, with a mean cohort age of 62.4 years and randomly assigned them to CADe-assisted colonoscopy (n = 1015) or to standard colonoscopy (n = 1017). Of these, 60.6% were undergoing screening and 39.4% had symptomatic indications.

Mean adenomas per procedure were 1.56 (SD, 2.82; n = 1001 participants with data) in the CADe-assisted group vs 1.21 (n = 1009) in the standard group, for an adjusted mean difference of 0.36 (95% CI, 0.14-0.57; adjusted incidence rate ratio, 1.30; 95% CI, 1.15-1.47; P < .0001).

Adenomas were detected in 555 (56.6%) of 980 participants in the CADe-assisted group vs 477 (48.4%) of 986 in the standard group, representing a proportion difference of 8.3% (95% CI, 3.9-12.7; adjusted odds ratio, 1.47; 95% CI, 1.21-1.78; P < .0001).

As to safety, adverse events were numerically comparable in both the intervention and control groups, with overall events 25 vs 19 and serious events 4 vs 6. On independent review, no adverse events in the CADe-assisted colonoscopy group were related to GI Genius.

 

Dr. Nabil M. Mansour

Offering a US perspective on the study, Nabil M. Mansour, MD, an associate professor and director of the McNair General GI Clinic at Baylor College of Medicine in Houston, Texas, said GI Genius and other CADe systems represent a significant advance over standard colonoscopy for identifying premalignant polyps. “While the data have been mixed, most studies, particularly randomized controlled trials have shown significant improvements with CADe in detection both terms of in adenomas per colonoscopy and reductions in adenoma miss rate,” he said in an interview.

He added that the main utility of CADe is for asymptomatic patients undergoing average-risk screening and surveillance colonoscopy for CRC screening and prevention, as well as for those with positive stool-based screening tests, “though there is no downside to using it in symptomatic patients as well.” Though AI colonoscopy likely still stands at < 50% of endoscopy centers overall, and is used mainly at academic centers, his clinic has been using it for the past year.

The main question, Mansour cautioned, is whether increased detection of small polyps will actually reduce CRC incidence or mortality, and it will likely be several years before clear, concrete data can answer that.

“Most studies have shown the improvement in adenoma detection is mainly for diminutive polyps < 5 mm in diameter, but whether that will actually translate to substantive improvements in hard outcomes is as yet unknown,” he said. “But if gastroenterologists are interested in doing everything they can today to help improve detection rates and lower miss rates of premalignant polyps, serious consideration should be given to adopting the use of CADe in practice.”

This study was supported by Medtronic. Rees reported receiving grant funding from ARC Medical, Norgine, Medtronic, 3-D Matrix, and Olympus Medical, and has been an expert witness for ARC Medical. Other authors disclosed receiving research funding, honoraria, or travel expenses from Medtronic or other private companies. Mansour had no competing interests to declare.

A version of this article appeared on Medscape.com.

Results from the British COLO-DETECT trial add to the growing body of evidence supporting the use of artificial intelligence (AI)–aided colonoscopy to increase premalignant colorectal polyp detection in routine colonoscopy practice.

Colin J. Rees, a professor of gastroenterology in the Faculty of Medical Sciences at Newcastle University in Newcastle upon Tyne, England, and colleagues compared the real-world clinical effectiveness of computer-aided detection (CADe)–assisted colonoscopy using an “intelligent” module with that of standard colonoscopy in a study in The Lancet Gastroenterology & Hepatology.

They found the GI Genius Intelligent Endoscopy Module (Medtronic) increased the mean number of adenomas detected per procedure and the adenoma detection rate, especially for small, flat (type 0-IIa) polyps, and sessile serrated lesions, which are more likely to be missed.

“Missed sessile serrated lesions disproportionately increase the risk of post-colonoscopy colorectal cancer, thus the adoption of GI Genius into routine colonoscopy practice could not only increase polyp detection but also reduce the incidence of post-colonoscopy colorectal cancer,” the investigators wrote.

“AI is going to have a major impact upon most aspects of healthcare. Some areas of medical practice are now well established, and some are still in evolution,” Rees, who is also president of the British Society of Gastroenterology, said in an interview. “Within gastroenterology, the role of AI in endoscopic diagnostics is also evolving. The COLO-DETECT trial demonstrates that AI increases detection of lesions, and work is ongoing to see how AI might help with characterization and other elements of endoscopic practice.”

 

Study Details

The multicenter, open-label, parallel-arm, pragmatic randomized controlled trial was conducted at 12 National Health Service hospitals in England. The study cohort consisted of adults ≥ 18 years undergoing colorectal cancer (CRC) screening or colonoscopy for gastrointestinal symptom surveillance owing to personal or family history.

Recruiting staff, participants, and colonoscopists were unmasked to allocation, whereas histopathologists, cochief investigators, and trial statisticians were masked.

CADe-assisted colonoscopy consisted of standard colonoscopy plus the GI Genius module active for at least the entire inspection phase of colonoscope withdrawal.

The primary outcome was mean adenomas per procedure (total number of adenomas detected divided by total number of procedures). The key secondary outcome was adenoma detection rate (proportion of colonoscopies with at least one adenoma).

From March 2021 to April 2023, the investigators recruited 2032 participants, 55.7% men, with a mean cohort age of 62.4 years and randomly assigned them to CADe-assisted colonoscopy (n = 1015) or to standard colonoscopy (n = 1017). Of these, 60.6% were undergoing screening and 39.4% had symptomatic indications.

Mean adenomas per procedure were 1.56 (SD, 2.82; n = 1001 participants with data) in the CADe-assisted group vs 1.21 (n = 1009) in the standard group, for an adjusted mean difference of 0.36 (95% CI, 0.14-0.57; adjusted incidence rate ratio, 1.30; 95% CI, 1.15-1.47; P < .0001).

Adenomas were detected in 555 (56.6%) of 980 participants in the CADe-assisted group vs 477 (48.4%) of 986 in the standard group, representing a proportion difference of 8.3% (95% CI, 3.9-12.7; adjusted odds ratio, 1.47; 95% CI, 1.21-1.78; P < .0001).

As to safety, adverse events were numerically comparable in both the intervention and control groups, with overall events 25 vs 19 and serious events 4 vs 6. On independent review, no adverse events in the CADe-assisted colonoscopy group were related to GI Genius.

 

Dr. Nabil M. Mansour

Offering a US perspective on the study, Nabil M. Mansour, MD, an associate professor and director of the McNair General GI Clinic at Baylor College of Medicine in Houston, Texas, said GI Genius and other CADe systems represent a significant advance over standard colonoscopy for identifying premalignant polyps. “While the data have been mixed, most studies, particularly randomized controlled trials have shown significant improvements with CADe in detection both terms of in adenomas per colonoscopy and reductions in adenoma miss rate,” he said in an interview.

He added that the main utility of CADe is for asymptomatic patients undergoing average-risk screening and surveillance colonoscopy for CRC screening and prevention, as well as for those with positive stool-based screening tests, “though there is no downside to using it in symptomatic patients as well.” Though AI colonoscopy likely still stands at < 50% of endoscopy centers overall, and is used mainly at academic centers, his clinic has been using it for the past year.

The main question, Mansour cautioned, is whether increased detection of small polyps will actually reduce CRC incidence or mortality, and it will likely be several years before clear, concrete data can answer that.

“Most studies have shown the improvement in adenoma detection is mainly for diminutive polyps < 5 mm in diameter, but whether that will actually translate to substantive improvements in hard outcomes is as yet unknown,” he said. “But if gastroenterologists are interested in doing everything they can today to help improve detection rates and lower miss rates of premalignant polyps, serious consideration should be given to adopting the use of CADe in practice.”

This study was supported by Medtronic. Rees reported receiving grant funding from ARC Medical, Norgine, Medtronic, 3-D Matrix, and Olympus Medical, and has been an expert witness for ARC Medical. Other authors disclosed receiving research funding, honoraria, or travel expenses from Medtronic or other private companies. Mansour had no competing interests to declare.

A version of this article appeared on Medscape.com.

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