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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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Best definition of malnutrition varies by cancer type

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For patients undergoing major oncologic surgery, the best definition of malnutrition used to assess postoperative risk varies by cancer type, results of a retrospective study suggest.

Dr. Nicholas P. McKenna

The current, one-size-fits-all approach to nutritional status leads to both undertreatment and overtreatment of malnutrition, as well as inaccurate estimations of postoperative risk, reported lead study author Nicholas P. McKenna, MD, of the Mayo Clinic in Rochester, Minn., and colleagues.

“Assessing nutritional status is important because it impacts preoperative planning, particularly with respect to the use of prehabilitation,” the investigators wrote. Their report is in the Journal of the American College of Surgeons. They noted that while prehabilitation has been shown to reduce postoperative risk among those who need it, identification of these patients is an area that needs improvement.

With this in mind, Dr. McKenna and colleagues analyzed 205,840 major oncologic operations, with data drawn from the American College of Surgeons National Surgical Quality Improvement (NSQIP) database.

The researchers evaluated patients’ nutritional status using three techniques: the NSQIP method, the European Society for Clinical Nutrition and Metabolism (ESPEN) definitions, and the World Health Organization body mass index (BMI) classification system.

Combining these three assessments led to seven hierarchical nutritional status categories:

  • Severe malnutrition – BMI less than 18.5 kg/m2 and greater than 10% weight loss
  • ESPEN 1 – BMI 18.5-20 kg/m2 (if younger than 70 years) or less than 22 kg/m2 (if 70 years or older) plus greater than 10% weight loss
  • ESPEN 2 – BMI less than 18.5 kg/m2
  • NSQIP – BMI greater than 20 kg/m2 (if younger than 70 years) or 22 kg/m2 (if 70 years or older) plus greater than 10% weight loss
  • Mild malnutrition – BMI 18.5-20 kg/m2 (if younger than 70 years) or less than 22 kg/m2 (if 70 years or older)
  • Obese – BMI at least 30 kg/m2
  • No malnutrition.

The study’s primary outcomes were 30-day mortality and 30-day morbidity. The latter included a variety of complications, such as deep incisional surgical site infection, septic shock, and acute renal failure. Demographic and clinical factors were included in multivariate analyses.
 

Results

Most of the operations involved patients with colorectal cancer (74%), followed by pancreatic (10%), lung (9%), gastric (3%), esophageal (3%), and liver (2%) cancer.

Across all patients, 16% fell into one of five malnutrition categories: mild malnutrition (6%), NSQIP (6%), ESPEN 2 (2%), ESPEN 1 (1%), or severe malnutrition (0.6%). The remainder of patients were either obese (31%) or had normal nutritional status (54%).

Malnutrition was most common among patients with pancreatic cancer (28%) and least common among those with colorectal cancer (14%).

Aligning with previous research, this study showed that nutritional status was associated with postoperative risk. Mortality risk was highest among patients with severe malnutrition, and morbidity was most common in the severe and ESPEN 1 groups (P less than .0001 for both).

While the spectrum of classifications appeared accurate across the population, multivariable models for mortality and morbidity revealed an interaction between cancer type and malnutrition definition (P less than .0001 for both), which suggested the most accurate definition of malnutrition differed from one type of cancer to another.

Specifically, a classification of severe malnutrition was most predictive of mortality among patients with esophageal or colorectal cancer. ESPEN 1 was most predictive of mortality for patients with gastric or lung cancer, and NSQIP was most predictive for those with liver cancer.

For predicting morbidity, severe malnutrition was most accurate among patients with colorectal cancer, whereas ESPEN 1 was better suited for gastric and lung cancer.
 

 

 

Interpreting and applying the results

“The biggest takeaway is that the optimal definition of malnutrition varies by cancer type,” Dr. McKenna said in an interview.

He went on to explain that weight loss is a particularly important indicator of malnutrition for patients with esophageal or gastric cancer. “These are the cancers that more commonly undergo neoadjuvant chemotherapy,” he noted.

The other major finding, Dr. McKenna said, offers some perspective on short-term versus long-term risk.

“Most people consider obesity a negative prognostic factor,” he said. “But in terms of operative risk, it’s kind of a neutral effect. It doesn’t really affect the short-term outcomes of an operation.”

Still, Dr. McKenna warned that a visual assessment of patient body condition is not enough to predict postoperative risk. Instead, he recommended accurate height and weight measurements during annual and preoperative exams. He also noted that more patients are at risk than clinicians may suspect.

“Even definitions that didn’t previously exist, such as mild malnutrition, had a somewhat negative effect within colorectal cancer and esophageal cancer,” Dr. McKenna said. “So these are patients who previously probably would be considered pretty healthy, but there is probably some room to improve their nutritional status.”

While the study revealed that different types of cancer should have unique tools for measuring nutritional status, development of these systems will require more research concerning prehabilitation outcomes, according to Dr. McKenna. In the meantime, he highlighted a point of action in the clinic.

“We think, overall, especially with the rise of neoadjuvant chemotherapy upfront, before surgery, that identifying patients at risk before they start neoadjuvant chemotherapy is going to be important,” he said. “They are the ones who really need to be targeted.”

There was no external funding for this study, and the investigators reported no conflicts of interest.
 

SOURCE: McKenna NP et al. J Am Coll Surg. 2020 Feb 26. doi: 10.1016/j.jamcollsurg.2019.12.034.

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For patients undergoing major oncologic surgery, the best definition of malnutrition used to assess postoperative risk varies by cancer type, results of a retrospective study suggest.

Dr. Nicholas P. McKenna

The current, one-size-fits-all approach to nutritional status leads to both undertreatment and overtreatment of malnutrition, as well as inaccurate estimations of postoperative risk, reported lead study author Nicholas P. McKenna, MD, of the Mayo Clinic in Rochester, Minn., and colleagues.

“Assessing nutritional status is important because it impacts preoperative planning, particularly with respect to the use of prehabilitation,” the investigators wrote. Their report is in the Journal of the American College of Surgeons. They noted that while prehabilitation has been shown to reduce postoperative risk among those who need it, identification of these patients is an area that needs improvement.

With this in mind, Dr. McKenna and colleagues analyzed 205,840 major oncologic operations, with data drawn from the American College of Surgeons National Surgical Quality Improvement (NSQIP) database.

The researchers evaluated patients’ nutritional status using three techniques: the NSQIP method, the European Society for Clinical Nutrition and Metabolism (ESPEN) definitions, and the World Health Organization body mass index (BMI) classification system.

Combining these three assessments led to seven hierarchical nutritional status categories:

  • Severe malnutrition – BMI less than 18.5 kg/m2 and greater than 10% weight loss
  • ESPEN 1 – BMI 18.5-20 kg/m2 (if younger than 70 years) or less than 22 kg/m2 (if 70 years or older) plus greater than 10% weight loss
  • ESPEN 2 – BMI less than 18.5 kg/m2
  • NSQIP – BMI greater than 20 kg/m2 (if younger than 70 years) or 22 kg/m2 (if 70 years or older) plus greater than 10% weight loss
  • Mild malnutrition – BMI 18.5-20 kg/m2 (if younger than 70 years) or less than 22 kg/m2 (if 70 years or older)
  • Obese – BMI at least 30 kg/m2
  • No malnutrition.

The study’s primary outcomes were 30-day mortality and 30-day morbidity. The latter included a variety of complications, such as deep incisional surgical site infection, septic shock, and acute renal failure. Demographic and clinical factors were included in multivariate analyses.
 

Results

Most of the operations involved patients with colorectal cancer (74%), followed by pancreatic (10%), lung (9%), gastric (3%), esophageal (3%), and liver (2%) cancer.

Across all patients, 16% fell into one of five malnutrition categories: mild malnutrition (6%), NSQIP (6%), ESPEN 2 (2%), ESPEN 1 (1%), or severe malnutrition (0.6%). The remainder of patients were either obese (31%) or had normal nutritional status (54%).

Malnutrition was most common among patients with pancreatic cancer (28%) and least common among those with colorectal cancer (14%).

Aligning with previous research, this study showed that nutritional status was associated with postoperative risk. Mortality risk was highest among patients with severe malnutrition, and morbidity was most common in the severe and ESPEN 1 groups (P less than .0001 for both).

While the spectrum of classifications appeared accurate across the population, multivariable models for mortality and morbidity revealed an interaction between cancer type and malnutrition definition (P less than .0001 for both), which suggested the most accurate definition of malnutrition differed from one type of cancer to another.

Specifically, a classification of severe malnutrition was most predictive of mortality among patients with esophageal or colorectal cancer. ESPEN 1 was most predictive of mortality for patients with gastric or lung cancer, and NSQIP was most predictive for those with liver cancer.

For predicting morbidity, severe malnutrition was most accurate among patients with colorectal cancer, whereas ESPEN 1 was better suited for gastric and lung cancer.
 

 

 

Interpreting and applying the results

“The biggest takeaway is that the optimal definition of malnutrition varies by cancer type,” Dr. McKenna said in an interview.

He went on to explain that weight loss is a particularly important indicator of malnutrition for patients with esophageal or gastric cancer. “These are the cancers that more commonly undergo neoadjuvant chemotherapy,” he noted.

The other major finding, Dr. McKenna said, offers some perspective on short-term versus long-term risk.

“Most people consider obesity a negative prognostic factor,” he said. “But in terms of operative risk, it’s kind of a neutral effect. It doesn’t really affect the short-term outcomes of an operation.”

Still, Dr. McKenna warned that a visual assessment of patient body condition is not enough to predict postoperative risk. Instead, he recommended accurate height and weight measurements during annual and preoperative exams. He also noted that more patients are at risk than clinicians may suspect.

“Even definitions that didn’t previously exist, such as mild malnutrition, had a somewhat negative effect within colorectal cancer and esophageal cancer,” Dr. McKenna said. “So these are patients who previously probably would be considered pretty healthy, but there is probably some room to improve their nutritional status.”

While the study revealed that different types of cancer should have unique tools for measuring nutritional status, development of these systems will require more research concerning prehabilitation outcomes, according to Dr. McKenna. In the meantime, he highlighted a point of action in the clinic.

“We think, overall, especially with the rise of neoadjuvant chemotherapy upfront, before surgery, that identifying patients at risk before they start neoadjuvant chemotherapy is going to be important,” he said. “They are the ones who really need to be targeted.”

There was no external funding for this study, and the investigators reported no conflicts of interest.
 

SOURCE: McKenna NP et al. J Am Coll Surg. 2020 Feb 26. doi: 10.1016/j.jamcollsurg.2019.12.034.

For patients undergoing major oncologic surgery, the best definition of malnutrition used to assess postoperative risk varies by cancer type, results of a retrospective study suggest.

Dr. Nicholas P. McKenna

The current, one-size-fits-all approach to nutritional status leads to both undertreatment and overtreatment of malnutrition, as well as inaccurate estimations of postoperative risk, reported lead study author Nicholas P. McKenna, MD, of the Mayo Clinic in Rochester, Minn., and colleagues.

“Assessing nutritional status is important because it impacts preoperative planning, particularly with respect to the use of prehabilitation,” the investigators wrote. Their report is in the Journal of the American College of Surgeons. They noted that while prehabilitation has been shown to reduce postoperative risk among those who need it, identification of these patients is an area that needs improvement.

With this in mind, Dr. McKenna and colleagues analyzed 205,840 major oncologic operations, with data drawn from the American College of Surgeons National Surgical Quality Improvement (NSQIP) database.

The researchers evaluated patients’ nutritional status using three techniques: the NSQIP method, the European Society for Clinical Nutrition and Metabolism (ESPEN) definitions, and the World Health Organization body mass index (BMI) classification system.

Combining these three assessments led to seven hierarchical nutritional status categories:

  • Severe malnutrition – BMI less than 18.5 kg/m2 and greater than 10% weight loss
  • ESPEN 1 – BMI 18.5-20 kg/m2 (if younger than 70 years) or less than 22 kg/m2 (if 70 years or older) plus greater than 10% weight loss
  • ESPEN 2 – BMI less than 18.5 kg/m2
  • NSQIP – BMI greater than 20 kg/m2 (if younger than 70 years) or 22 kg/m2 (if 70 years or older) plus greater than 10% weight loss
  • Mild malnutrition – BMI 18.5-20 kg/m2 (if younger than 70 years) or less than 22 kg/m2 (if 70 years or older)
  • Obese – BMI at least 30 kg/m2
  • No malnutrition.

The study’s primary outcomes were 30-day mortality and 30-day morbidity. The latter included a variety of complications, such as deep incisional surgical site infection, septic shock, and acute renal failure. Demographic and clinical factors were included in multivariate analyses.
 

Results

Most of the operations involved patients with colorectal cancer (74%), followed by pancreatic (10%), lung (9%), gastric (3%), esophageal (3%), and liver (2%) cancer.

Across all patients, 16% fell into one of five malnutrition categories: mild malnutrition (6%), NSQIP (6%), ESPEN 2 (2%), ESPEN 1 (1%), or severe malnutrition (0.6%). The remainder of patients were either obese (31%) or had normal nutritional status (54%).

Malnutrition was most common among patients with pancreatic cancer (28%) and least common among those with colorectal cancer (14%).

Aligning with previous research, this study showed that nutritional status was associated with postoperative risk. Mortality risk was highest among patients with severe malnutrition, and morbidity was most common in the severe and ESPEN 1 groups (P less than .0001 for both).

While the spectrum of classifications appeared accurate across the population, multivariable models for mortality and morbidity revealed an interaction between cancer type and malnutrition definition (P less than .0001 for both), which suggested the most accurate definition of malnutrition differed from one type of cancer to another.

Specifically, a classification of severe malnutrition was most predictive of mortality among patients with esophageal or colorectal cancer. ESPEN 1 was most predictive of mortality for patients with gastric or lung cancer, and NSQIP was most predictive for those with liver cancer.

For predicting morbidity, severe malnutrition was most accurate among patients with colorectal cancer, whereas ESPEN 1 was better suited for gastric and lung cancer.
 

 

 

Interpreting and applying the results

“The biggest takeaway is that the optimal definition of malnutrition varies by cancer type,” Dr. McKenna said in an interview.

He went on to explain that weight loss is a particularly important indicator of malnutrition for patients with esophageal or gastric cancer. “These are the cancers that more commonly undergo neoadjuvant chemotherapy,” he noted.

The other major finding, Dr. McKenna said, offers some perspective on short-term versus long-term risk.

“Most people consider obesity a negative prognostic factor,” he said. “But in terms of operative risk, it’s kind of a neutral effect. It doesn’t really affect the short-term outcomes of an operation.”

Still, Dr. McKenna warned that a visual assessment of patient body condition is not enough to predict postoperative risk. Instead, he recommended accurate height and weight measurements during annual and preoperative exams. He also noted that more patients are at risk than clinicians may suspect.

“Even definitions that didn’t previously exist, such as mild malnutrition, had a somewhat negative effect within colorectal cancer and esophageal cancer,” Dr. McKenna said. “So these are patients who previously probably would be considered pretty healthy, but there is probably some room to improve their nutritional status.”

While the study revealed that different types of cancer should have unique tools for measuring nutritional status, development of these systems will require more research concerning prehabilitation outcomes, according to Dr. McKenna. In the meantime, he highlighted a point of action in the clinic.

“We think, overall, especially with the rise of neoadjuvant chemotherapy upfront, before surgery, that identifying patients at risk before they start neoadjuvant chemotherapy is going to be important,” he said. “They are the ones who really need to be targeted.”

There was no external funding for this study, and the investigators reported no conflicts of interest.
 

SOURCE: McKenna NP et al. J Am Coll Surg. 2020 Feb 26. doi: 10.1016/j.jamcollsurg.2019.12.034.

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Telehealth seen as a key tool to help fight COVID-19

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Telehealth is increasingly being viewed as a key way to help fight the COVID-19 outbreak in the United States. Recognizing the potential of this technology to slow the spread of the disease, the House of Representatives included a provision in an $8.3 billion emergency response bill it approved today that would temporarily lift restrictions on Medicare telehealth coverage to assist in the efforts to contain the virus.

Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention (CDC), said that hospitals should be prepared to use telehealth as one of their tools in fighting the outbreak, according to a recent news release from the American Hospital Association (AHA).

Congress is responding to that need by including the service in the new coronavirus legislation now headed to the Senate, after the funding bill was approved in a 415-2 vote by the House.

The bill empowers the Secretary of Health and Human Services (HHS) to “waive or modify application of certain Medicare requirements with respect to telehealth services furnished during certain emergency periods.”

While the measure adds telehealth to the waiver authority that the HHS secretary currently has during national emergencies, it’s only for the coronavirus crisis in this case, Krista Drobac, executive director of the Alliance for Connected Care, told Medscape Medical News.

The waiver would apply to originating sites of telehealth visits, she noted. Thus Medicare coverage of telemedicine would be expanded beyond rural areas.

In addition, the waiver would allow coverage of virtual visits conducted on smartphones with audio and video capabilities. A “qualified provider,” as defined by the legislation, would be a practitioner who has an established relationship with the patient or who is in the same practice as the provider who has that relationship.

An advantage of telehealth, proponents say, is that it can enable people who believe they have COVID-19 to be seen at home rather than visit offices or emergency departments (EDs) where they might spread the disease or be in proximity to others who have it.

In an editorial published March 2 in Modern Healthcare, medical directors from Stanford Medicine, MedStar Health, and Intermountain Healthcare also noted that telehealth can give patients 24/7 access to care, allow surveillance of patients at risk while keeping them at home, ensure that treatment in hospitals is reserved for high-need patients, and enable providers to triage and screen more patients than can be handled in brick-and-mortar care settings.

However, telehealth screening would allow physicians only to judge whether a patient’s symptoms might be indicative of COVID-19, the Alliance for Connected Care, a telehealth advocacy group, noted in a letter to Congressional leaders. Patients would still have to be seen in person to be tested for the disease.

The group, which represents technology companies, health insurers, pharmacies, and other healthcare players, has been lobbying Congress to include telehealth in federal funds to combat the outbreak.

The American Telemedicine Association (ATA) also supports this goal, ATA President Joseph Kvedar, MD, told Medscape Medical News. And the authors of the Modern Healthcare editorial also advocated for this legislative solution. Because the fatality rate for COVID-19 is significantly higher for older people than for other age groups, they noted, telehealth should be an economically viable option for all seniors.

The Centers for Medicare and Medicaid Services (CMS) long covered telemedicine only in rural areas and only when initiated in healthcare settings. Recently, however, CMS loosened its approach to some extent. Virtual “check-in visits” can now be initiated from any location, including home, to determine whether a Medicare patient needs to be seen in the office. In addition, CMS allows Medicare Advantage plans to offer telemedicine as a core benefit.

 

 

Are healthcare systems prepared?

Some large healthcare systems such as Stanford, MedStar, and Intermountain are already using telehealth to diagnose and treat patients who have traditional influenza. Telehealth providers at Stanford estimate that almost 50% of these patients are being prescribed the antiviral drug Tamiflu.

It’s unclear whether other healthcare systems are this well prepared to offer telehealth on a large scale. But, according to an AHA survey, Kvedar noted, three quarters of AHA members are engaged in some form of telehealth.

Drobac said “it wouldn’t require too much effort” to ramp up a wide-scale telehealth program that could help reduce the impact of the outbreak. “The technology is there,” she noted. “You need a HIPAA-compliant telehealth platform, but there are so many out there.”

Kvedar agreed. To begin with, he said, hospitals might sequester patients who visit the ED with COVID-19 symptoms in a video-equipped “isolation room.” Staff members could then do the patient intake from a different location in the hospital.

He admitted that this approach would be infeasible if a lot of patients arrived in EDs with coronavirus symptoms. However, Kvedar noted, “All the tools are in place to go well beyond that. American Well, Teladoc, and others are all offering ways to get out in front of this. There are plenty of vendors out there, and most people have a connected cell phone that you can do a video call on.”

Hospital leaders would have to decide whether to embrace telehealth, which would mean less use of services in their institutions, he said. “But it would be for the greater good of the public.”

Kvedar recalled that there was some use of telehealth in the New York area after 9/11. Telehealth was also used in the aftermath of Hurricane Katrina in 2005. But the ATA president, who is also vice president of connected health at Partners HealthCare in Boston, noted that the COVID-19 outbreak is the first public health emergency to occur in the era of Skype and smartphones.

If Congress does ultimately authorize CMS to cover telehealth across the board during this emergency, might that lead to a permanent change in Medicare coverage policy? Kvedar wouldn’t venture an opinion. “However, the current CMS leadership has been incredibly telehealth friendly,” he said. “So it’s possible they would [embrace a lifting of restrictions]. As patients get a sense of this modality of care and how convenient it is for them, they’ll start asking for more.”

Meanwhile, he said, the telehealth opportunity goes beyond video visits with doctors to mitigate the outbreak. Telehealth data could also be used to track disease spread, similar to how researchers have studied Google searches to predict the spread of the flu, he noted.

Teladoc, a major telehealth vendor, recently told stock analysts it’s already working with the CDC on disease surveillance, according to a report in FierceHealthcare.

This article first appeared on Medscape.com.

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Telehealth is increasingly being viewed as a key way to help fight the COVID-19 outbreak in the United States. Recognizing the potential of this technology to slow the spread of the disease, the House of Representatives included a provision in an $8.3 billion emergency response bill it approved today that would temporarily lift restrictions on Medicare telehealth coverage to assist in the efforts to contain the virus.

Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention (CDC), said that hospitals should be prepared to use telehealth as one of their tools in fighting the outbreak, according to a recent news release from the American Hospital Association (AHA).

Congress is responding to that need by including the service in the new coronavirus legislation now headed to the Senate, after the funding bill was approved in a 415-2 vote by the House.

The bill empowers the Secretary of Health and Human Services (HHS) to “waive or modify application of certain Medicare requirements with respect to telehealth services furnished during certain emergency periods.”

While the measure adds telehealth to the waiver authority that the HHS secretary currently has during national emergencies, it’s only for the coronavirus crisis in this case, Krista Drobac, executive director of the Alliance for Connected Care, told Medscape Medical News.

The waiver would apply to originating sites of telehealth visits, she noted. Thus Medicare coverage of telemedicine would be expanded beyond rural areas.

In addition, the waiver would allow coverage of virtual visits conducted on smartphones with audio and video capabilities. A “qualified provider,” as defined by the legislation, would be a practitioner who has an established relationship with the patient or who is in the same practice as the provider who has that relationship.

An advantage of telehealth, proponents say, is that it can enable people who believe they have COVID-19 to be seen at home rather than visit offices or emergency departments (EDs) where they might spread the disease or be in proximity to others who have it.

In an editorial published March 2 in Modern Healthcare, medical directors from Stanford Medicine, MedStar Health, and Intermountain Healthcare also noted that telehealth can give patients 24/7 access to care, allow surveillance of patients at risk while keeping them at home, ensure that treatment in hospitals is reserved for high-need patients, and enable providers to triage and screen more patients than can be handled in brick-and-mortar care settings.

However, telehealth screening would allow physicians only to judge whether a patient’s symptoms might be indicative of COVID-19, the Alliance for Connected Care, a telehealth advocacy group, noted in a letter to Congressional leaders. Patients would still have to be seen in person to be tested for the disease.

The group, which represents technology companies, health insurers, pharmacies, and other healthcare players, has been lobbying Congress to include telehealth in federal funds to combat the outbreak.

The American Telemedicine Association (ATA) also supports this goal, ATA President Joseph Kvedar, MD, told Medscape Medical News. And the authors of the Modern Healthcare editorial also advocated for this legislative solution. Because the fatality rate for COVID-19 is significantly higher for older people than for other age groups, they noted, telehealth should be an economically viable option for all seniors.

The Centers for Medicare and Medicaid Services (CMS) long covered telemedicine only in rural areas and only when initiated in healthcare settings. Recently, however, CMS loosened its approach to some extent. Virtual “check-in visits” can now be initiated from any location, including home, to determine whether a Medicare patient needs to be seen in the office. In addition, CMS allows Medicare Advantage plans to offer telemedicine as a core benefit.

 

 

Are healthcare systems prepared?

Some large healthcare systems such as Stanford, MedStar, and Intermountain are already using telehealth to diagnose and treat patients who have traditional influenza. Telehealth providers at Stanford estimate that almost 50% of these patients are being prescribed the antiviral drug Tamiflu.

It’s unclear whether other healthcare systems are this well prepared to offer telehealth on a large scale. But, according to an AHA survey, Kvedar noted, three quarters of AHA members are engaged in some form of telehealth.

Drobac said “it wouldn’t require too much effort” to ramp up a wide-scale telehealth program that could help reduce the impact of the outbreak. “The technology is there,” she noted. “You need a HIPAA-compliant telehealth platform, but there are so many out there.”

Kvedar agreed. To begin with, he said, hospitals might sequester patients who visit the ED with COVID-19 symptoms in a video-equipped “isolation room.” Staff members could then do the patient intake from a different location in the hospital.

He admitted that this approach would be infeasible if a lot of patients arrived in EDs with coronavirus symptoms. However, Kvedar noted, “All the tools are in place to go well beyond that. American Well, Teladoc, and others are all offering ways to get out in front of this. There are plenty of vendors out there, and most people have a connected cell phone that you can do a video call on.”

Hospital leaders would have to decide whether to embrace telehealth, which would mean less use of services in their institutions, he said. “But it would be for the greater good of the public.”

Kvedar recalled that there was some use of telehealth in the New York area after 9/11. Telehealth was also used in the aftermath of Hurricane Katrina in 2005. But the ATA president, who is also vice president of connected health at Partners HealthCare in Boston, noted that the COVID-19 outbreak is the first public health emergency to occur in the era of Skype and smartphones.

If Congress does ultimately authorize CMS to cover telehealth across the board during this emergency, might that lead to a permanent change in Medicare coverage policy? Kvedar wouldn’t venture an opinion. “However, the current CMS leadership has been incredibly telehealth friendly,” he said. “So it’s possible they would [embrace a lifting of restrictions]. As patients get a sense of this modality of care and how convenient it is for them, they’ll start asking for more.”

Meanwhile, he said, the telehealth opportunity goes beyond video visits with doctors to mitigate the outbreak. Telehealth data could also be used to track disease spread, similar to how researchers have studied Google searches to predict the spread of the flu, he noted.

Teladoc, a major telehealth vendor, recently told stock analysts it’s already working with the CDC on disease surveillance, according to a report in FierceHealthcare.

This article first appeared on Medscape.com.

Telehealth is increasingly being viewed as a key way to help fight the COVID-19 outbreak in the United States. Recognizing the potential of this technology to slow the spread of the disease, the House of Representatives included a provision in an $8.3 billion emergency response bill it approved today that would temporarily lift restrictions on Medicare telehealth coverage to assist in the efforts to contain the virus.

Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention (CDC), said that hospitals should be prepared to use telehealth as one of their tools in fighting the outbreak, according to a recent news release from the American Hospital Association (AHA).

Congress is responding to that need by including the service in the new coronavirus legislation now headed to the Senate, after the funding bill was approved in a 415-2 vote by the House.

The bill empowers the Secretary of Health and Human Services (HHS) to “waive or modify application of certain Medicare requirements with respect to telehealth services furnished during certain emergency periods.”

While the measure adds telehealth to the waiver authority that the HHS secretary currently has during national emergencies, it’s only for the coronavirus crisis in this case, Krista Drobac, executive director of the Alliance for Connected Care, told Medscape Medical News.

The waiver would apply to originating sites of telehealth visits, she noted. Thus Medicare coverage of telemedicine would be expanded beyond rural areas.

In addition, the waiver would allow coverage of virtual visits conducted on smartphones with audio and video capabilities. A “qualified provider,” as defined by the legislation, would be a practitioner who has an established relationship with the patient or who is in the same practice as the provider who has that relationship.

An advantage of telehealth, proponents say, is that it can enable people who believe they have COVID-19 to be seen at home rather than visit offices or emergency departments (EDs) where they might spread the disease or be in proximity to others who have it.

In an editorial published March 2 in Modern Healthcare, medical directors from Stanford Medicine, MedStar Health, and Intermountain Healthcare also noted that telehealth can give patients 24/7 access to care, allow surveillance of patients at risk while keeping them at home, ensure that treatment in hospitals is reserved for high-need patients, and enable providers to triage and screen more patients than can be handled in brick-and-mortar care settings.

However, telehealth screening would allow physicians only to judge whether a patient’s symptoms might be indicative of COVID-19, the Alliance for Connected Care, a telehealth advocacy group, noted in a letter to Congressional leaders. Patients would still have to be seen in person to be tested for the disease.

The group, which represents technology companies, health insurers, pharmacies, and other healthcare players, has been lobbying Congress to include telehealth in federal funds to combat the outbreak.

The American Telemedicine Association (ATA) also supports this goal, ATA President Joseph Kvedar, MD, told Medscape Medical News. And the authors of the Modern Healthcare editorial also advocated for this legislative solution. Because the fatality rate for COVID-19 is significantly higher for older people than for other age groups, they noted, telehealth should be an economically viable option for all seniors.

The Centers for Medicare and Medicaid Services (CMS) long covered telemedicine only in rural areas and only when initiated in healthcare settings. Recently, however, CMS loosened its approach to some extent. Virtual “check-in visits” can now be initiated from any location, including home, to determine whether a Medicare patient needs to be seen in the office. In addition, CMS allows Medicare Advantage plans to offer telemedicine as a core benefit.

 

 

Are healthcare systems prepared?

Some large healthcare systems such as Stanford, MedStar, and Intermountain are already using telehealth to diagnose and treat patients who have traditional influenza. Telehealth providers at Stanford estimate that almost 50% of these patients are being prescribed the antiviral drug Tamiflu.

It’s unclear whether other healthcare systems are this well prepared to offer telehealth on a large scale. But, according to an AHA survey, Kvedar noted, three quarters of AHA members are engaged in some form of telehealth.

Drobac said “it wouldn’t require too much effort” to ramp up a wide-scale telehealth program that could help reduce the impact of the outbreak. “The technology is there,” she noted. “You need a HIPAA-compliant telehealth platform, but there are so many out there.”

Kvedar agreed. To begin with, he said, hospitals might sequester patients who visit the ED with COVID-19 symptoms in a video-equipped “isolation room.” Staff members could then do the patient intake from a different location in the hospital.

He admitted that this approach would be infeasible if a lot of patients arrived in EDs with coronavirus symptoms. However, Kvedar noted, “All the tools are in place to go well beyond that. American Well, Teladoc, and others are all offering ways to get out in front of this. There are plenty of vendors out there, and most people have a connected cell phone that you can do a video call on.”

Hospital leaders would have to decide whether to embrace telehealth, which would mean less use of services in their institutions, he said. “But it would be for the greater good of the public.”

Kvedar recalled that there was some use of telehealth in the New York area after 9/11. Telehealth was also used in the aftermath of Hurricane Katrina in 2005. But the ATA president, who is also vice president of connected health at Partners HealthCare in Boston, noted that the COVID-19 outbreak is the first public health emergency to occur in the era of Skype and smartphones.

If Congress does ultimately authorize CMS to cover telehealth across the board during this emergency, might that lead to a permanent change in Medicare coverage policy? Kvedar wouldn’t venture an opinion. “However, the current CMS leadership has been incredibly telehealth friendly,” he said. “So it’s possible they would [embrace a lifting of restrictions]. As patients get a sense of this modality of care and how convenient it is for them, they’ll start asking for more.”

Meanwhile, he said, the telehealth opportunity goes beyond video visits with doctors to mitigate the outbreak. Telehealth data could also be used to track disease spread, similar to how researchers have studied Google searches to predict the spread of the flu, he noted.

Teladoc, a major telehealth vendor, recently told stock analysts it’s already working with the CDC on disease surveillance, according to a report in FierceHealthcare.

This article first appeared on Medscape.com.

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A Nervous Recipient of a “Tongue Lashing”

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A veteran with a history of mental illness and drug and alcohol misuse developed a bleeding lesion on his tongue, which raised concerns of self-injury.

Self-injurious behaviors are common and can be either volitional or unintentional. Often people who perform these behaviors receive “tongue lashings” from family, friends, and loved ones. We recently treated a patient whose lesion in the oral cavity was thought to be caused by some form of self-injury, though the prognosis clearly depended on the true culprit. It is important for clinicians to identify the cause of the injury when encountering patients with oral cavity lesions.

Case Presentation

A 40-year-old white male with a medical history of bipolar disorder, posttraumatic stress disorder, polysubstance abuse, and recently diagnosed temporomandibular joint (TMJ) syndrome was seen in outpatient primary care for a bleeding lesion in his mouth for the past 3 weeks. The lesion was under the surface of his right tongue. He first noted the lesion after he had burned himself tasting some homemade rice pudding while under the influence of marijuana. The next day, an impression was taken of his mouth by a dental assistant who was fitting him for an oral appliance for his TMJ syndrome; according to his history, she did not perform a visual inspection of his mouth nor could he recall his last dental examination. He had neither lost weight nor experienced dysphagia. He was not taking any prescribed medications, had an 8 pack-year history of smoking cigarettes, and had smoked crack cocaine intermittently for several years. The also patient had chewed one-half tin per day of chewing tobacco for 5 years, though he had quit 7 years before presentation. He was consuming 6 alcoholic drinks daily and had no history of chewing betel nuts.

On physical examination, the patient seemed extremely anxious, but his vital signs were unremarkable. The nasal dorsum was straight, and the nares were widely patent. There were no suspicious cutaneous lesions noted of the face, head, trunk, or extremities. The salivary glands were soft and showed no lesions or masses within the parotid or submandibular glands bilaterally. There was no obvious obstruction of Stenson or Wharton ducts bilaterally. He had normal lips and oral competence. The dentition was noted to be fair.

A nonfriable, 1.5 cm-wide lesion was found on the ventral surface of the right tongue (Figure 1). The tongue was mobile. The mouth floor was soft and without evidence of masses or lesions. The tonsils, tonsillar pillars, palate, and base of tongue did not show any concerning lesions or masses. The neck revealed a nonenlarged thyroid and no lymphadenopathy. The remainder of the examination was unremarkable.

Diagnosis

Given his risk factors of alcohol use disorder and a history of both inhaled and chewing tobacco, oral squamous cell carcinoma (SCC) was considered. The differential diagnosis also included pyogenic granuloma, mucocele, sublingual fibroma, and metastasis to the oral soft tissue. Due to its implications with respect to morbidity and mortality, we thought it necessary to rule out SCC of the oral cavity. SCC comprises more than 90% of oral malignancies, and tobacco-related products, alcohol, and human papilloma virus are well-established risk factors.1

 

 

Pyogenic granuloma, also known as eruptive hemangioma and lobular capillary hemangioma, is a relatively common benign lesion of the skin and mucosal surfaces that often presents as a solitary, rapidly enlarging papule or nodule that is extremely friable.2 Interestingly, pyogenic granuloma is a misnomer, since it is neither infectious in origin nor granulomatous when visualized under the microscope and is thought to arise from an exuberant tissue response to localized irritation or trauma. An individual lesion can range in size from a few millimeters to a few centimeters and generally reaches its maximum size within a matter of weeks; they often arise at sites of minor trauma.3 While the pathogenesis of pyogenic granuloma has not been clearly established, it seems to be related to an imbalance of angiogenesis secondary to overexpression of vascular endothelial growth factor and basic fibroblast growth factor.4 While they can occur at any age, pyogenic granulomas are frequently seen in pediatric patients and during pregnancy.

A fibroma, also known as an irritation fibroma, is one of the more common fibrous tumorlike growths and is often caused by trauma or irritation. It usually presents as a smooth-surfaced, painless solid lesion, though it can be nodular and histopathologically shows collagen and connective tissue.5 While fibromas can occur anywhere in the oral cavity, they commonly arise on the buccal mucosa along the plane of occlusion between the maxillary and mandibular teeth.

Mucoceles are the most common benign lesions in the mouth and are commonly found on the lower lip and are mucus-filled cavities, arising from the accumulation of mucus from trauma or lip-biting and alteration of minor salivary glands.6 Our patient’s rapid evolution and history of trauma were consistent with a mucocele. Although the lower lip is the most common site of involvement, mucoceles also occur on the tongue, cheek, palate, and mouth floor.Metastases to the oral cavity are rare and comprise only 1% of all oral cavity malignancies.7 Although most commonly seen in the jaw, nearly one-third of oral cavity metastases are in the soft tissue.8 They generally occur late in the course of disease, and the time between appearance and death is usually short.8 Our patient’s lack of known primary malignancy and lack of weight loss rendered this diagnosis unlikely.

   

Other possibilities include peripheral giant cell granuloma, a reactive hyperplastic lesion of the oral cavity originating from the periosteum or periodontal membrane following local irritation or chronic trauma,9 and peripheral ossifying fibroma, a reactive soft tissue growth usually seen on the interdental papilla.10

Surgical excision was performed and revealed reactive epidermal hyperplasia, ulceration, granulation tissue formation, and marked inflammation with reactive changes. There was no evidence of malignancy and was interpreted as consistent with pyogenic granuloma (Figures 2 and 3) likely due to the trauma from the thermal burn or poor dentition.

 

Management

The patient was relieved to be informed of the diagnosis of an unusual presentation of pyogenic granuloma with no evidence of cancer. Current treatment strategies for pyogenic granuloma include surgical excision, shave excision with cautery, cryotherapy, sclerotherapy, carbon dioxide or pulsed dye laser, as well as expectant management. However, recurrence after initial treatment can occur, with lower recurrence rates occurring with surgical excision.11

Although we wouldn’t state that we gave the patient a “tongue-lashing,” we strongly advised him that he return to his dentist and abstain from tobacco products, alcohol, illicit drugs, and taste-testing scalding food directly from the pot.

References

1. Khot KP, Deshmane S, Choudhari S. Human papilloma virus in oral squamous cell carcinoma-the enigma unraveled. Clin J Dent Res. 2016;19(1):17-23.

2. Bolognia JL, Jorizzo JL, Rapini RP, eds. Neoplasms of the skin. In: Bolognia JL, Jorizzo JL, Rapini RP, eds. Dermatology. Vol 2. St. Louis, MO: Mosby; 2007:1627-1901.

3. Tatusov M, Reddy S, Federman DG. Pyogenic granuloma: yet another motorcycle peril. Postgrad Med. 2012;124(6):124-126.

4. Yuan K, Jin YT, Lin MT. The detection and comparison of angiogenesis-associated factors in pyogenic granuloma by immunohistochemistry. J Periodontol. 2000;71(5):701-709.

5. Krishnan V, Shunmugavelu K. A clinical challenging situation of intra oral fibroma mimicking pyogenic granuloma. J Pan African Med. 2015;22(1):263.

6. Nallasivam KU, Sudha BR. Oral mucocele: review of literature and a case report. J Pharm Bioallied Sci. 2015;7(suppl 2):S731-S733.

7. Zachariades N. Neoplasms metastatic to the mouth, jaws, and surrounding tissues. J Craniomaxillofac Surg. 1989;17(6):283-290.

8. Irani S. Metastasis to the oral soft tissues: a review of 412 cases. J Int Soc Prev Community Dent. 2016;6(5):393-401.

9. Shadman N, Ebrahimi SF, Jafari S, Eslami M. Peripheral giant cell granuloma: a review of 123 cases. Dent Res J (Isfahan). 2009;6(1):47-50.

10. Poonacha KS, Shigli AL, Shirol D. Peripheral ossifying fibroma: a clinical report. Contemp Clin Dent. 2010;1(1):54-56.

11. Gilmore A, Kelsberg G, Safranek G. Clinical inquiries. What’s the best treatment for pyogenic granuloma? J Fam Pract. 2010;59(1):40-42.

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Daniel Federman is the Acting Chief of Medicine at the VA Connecticut Healthcare System in West Haven, Connecticut. William Ackley is an Internal Medicine Resident, and Rebecca Baldassarri is a Pathologist, both at Yale University School of Medicine in New Haven. Correspondence: Daniel Federman ([email protected])

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

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Daniel Federman is the Acting Chief of Medicine at the VA Connecticut Healthcare System in West Haven, Connecticut. William Ackley is an Internal Medicine Resident, and Rebecca Baldassarri is a Pathologist, both at Yale University School of Medicine in New Haven. Correspondence: Daniel Federman ([email protected])

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Daniel Federman is the Acting Chief of Medicine at the VA Connecticut Healthcare System in West Haven, Connecticut. William Ackley is an Internal Medicine Resident, and Rebecca Baldassarri is a Pathologist, both at Yale University School of Medicine in New Haven. Correspondence: Daniel Federman ([email protected])

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

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A veteran with a history of mental illness and drug and alcohol misuse developed a bleeding lesion on his tongue, which raised concerns of self-injury.
A veteran with a history of mental illness and drug and alcohol misuse developed a bleeding lesion on his tongue, which raised concerns of self-injury.

Self-injurious behaviors are common and can be either volitional or unintentional. Often people who perform these behaviors receive “tongue lashings” from family, friends, and loved ones. We recently treated a patient whose lesion in the oral cavity was thought to be caused by some form of self-injury, though the prognosis clearly depended on the true culprit. It is important for clinicians to identify the cause of the injury when encountering patients with oral cavity lesions.

Case Presentation

A 40-year-old white male with a medical history of bipolar disorder, posttraumatic stress disorder, polysubstance abuse, and recently diagnosed temporomandibular joint (TMJ) syndrome was seen in outpatient primary care for a bleeding lesion in his mouth for the past 3 weeks. The lesion was under the surface of his right tongue. He first noted the lesion after he had burned himself tasting some homemade rice pudding while under the influence of marijuana. The next day, an impression was taken of his mouth by a dental assistant who was fitting him for an oral appliance for his TMJ syndrome; according to his history, she did not perform a visual inspection of his mouth nor could he recall his last dental examination. He had neither lost weight nor experienced dysphagia. He was not taking any prescribed medications, had an 8 pack-year history of smoking cigarettes, and had smoked crack cocaine intermittently for several years. The also patient had chewed one-half tin per day of chewing tobacco for 5 years, though he had quit 7 years before presentation. He was consuming 6 alcoholic drinks daily and had no history of chewing betel nuts.

On physical examination, the patient seemed extremely anxious, but his vital signs were unremarkable. The nasal dorsum was straight, and the nares were widely patent. There were no suspicious cutaneous lesions noted of the face, head, trunk, or extremities. The salivary glands were soft and showed no lesions or masses within the parotid or submandibular glands bilaterally. There was no obvious obstruction of Stenson or Wharton ducts bilaterally. He had normal lips and oral competence. The dentition was noted to be fair.

A nonfriable, 1.5 cm-wide lesion was found on the ventral surface of the right tongue (Figure 1). The tongue was mobile. The mouth floor was soft and without evidence of masses or lesions. The tonsils, tonsillar pillars, palate, and base of tongue did not show any concerning lesions or masses. The neck revealed a nonenlarged thyroid and no lymphadenopathy. The remainder of the examination was unremarkable.

Diagnosis

Given his risk factors of alcohol use disorder and a history of both inhaled and chewing tobacco, oral squamous cell carcinoma (SCC) was considered. The differential diagnosis also included pyogenic granuloma, mucocele, sublingual fibroma, and metastasis to the oral soft tissue. Due to its implications with respect to morbidity and mortality, we thought it necessary to rule out SCC of the oral cavity. SCC comprises more than 90% of oral malignancies, and tobacco-related products, alcohol, and human papilloma virus are well-established risk factors.1

 

 

Pyogenic granuloma, also known as eruptive hemangioma and lobular capillary hemangioma, is a relatively common benign lesion of the skin and mucosal surfaces that often presents as a solitary, rapidly enlarging papule or nodule that is extremely friable.2 Interestingly, pyogenic granuloma is a misnomer, since it is neither infectious in origin nor granulomatous when visualized under the microscope and is thought to arise from an exuberant tissue response to localized irritation or trauma. An individual lesion can range in size from a few millimeters to a few centimeters and generally reaches its maximum size within a matter of weeks; they often arise at sites of minor trauma.3 While the pathogenesis of pyogenic granuloma has not been clearly established, it seems to be related to an imbalance of angiogenesis secondary to overexpression of vascular endothelial growth factor and basic fibroblast growth factor.4 While they can occur at any age, pyogenic granulomas are frequently seen in pediatric patients and during pregnancy.

A fibroma, also known as an irritation fibroma, is one of the more common fibrous tumorlike growths and is often caused by trauma or irritation. It usually presents as a smooth-surfaced, painless solid lesion, though it can be nodular and histopathologically shows collagen and connective tissue.5 While fibromas can occur anywhere in the oral cavity, they commonly arise on the buccal mucosa along the plane of occlusion between the maxillary and mandibular teeth.

Mucoceles are the most common benign lesions in the mouth and are commonly found on the lower lip and are mucus-filled cavities, arising from the accumulation of mucus from trauma or lip-biting and alteration of minor salivary glands.6 Our patient’s rapid evolution and history of trauma were consistent with a mucocele. Although the lower lip is the most common site of involvement, mucoceles also occur on the tongue, cheek, palate, and mouth floor.Metastases to the oral cavity are rare and comprise only 1% of all oral cavity malignancies.7 Although most commonly seen in the jaw, nearly one-third of oral cavity metastases are in the soft tissue.8 They generally occur late in the course of disease, and the time between appearance and death is usually short.8 Our patient’s lack of known primary malignancy and lack of weight loss rendered this diagnosis unlikely.

   

Other possibilities include peripheral giant cell granuloma, a reactive hyperplastic lesion of the oral cavity originating from the periosteum or periodontal membrane following local irritation or chronic trauma,9 and peripheral ossifying fibroma, a reactive soft tissue growth usually seen on the interdental papilla.10

Surgical excision was performed and revealed reactive epidermal hyperplasia, ulceration, granulation tissue formation, and marked inflammation with reactive changes. There was no evidence of malignancy and was interpreted as consistent with pyogenic granuloma (Figures 2 and 3) likely due to the trauma from the thermal burn or poor dentition.

 

Management

The patient was relieved to be informed of the diagnosis of an unusual presentation of pyogenic granuloma with no evidence of cancer. Current treatment strategies for pyogenic granuloma include surgical excision, shave excision with cautery, cryotherapy, sclerotherapy, carbon dioxide or pulsed dye laser, as well as expectant management. However, recurrence after initial treatment can occur, with lower recurrence rates occurring with surgical excision.11

Although we wouldn’t state that we gave the patient a “tongue-lashing,” we strongly advised him that he return to his dentist and abstain from tobacco products, alcohol, illicit drugs, and taste-testing scalding food directly from the pot.

Self-injurious behaviors are common and can be either volitional or unintentional. Often people who perform these behaviors receive “tongue lashings” from family, friends, and loved ones. We recently treated a patient whose lesion in the oral cavity was thought to be caused by some form of self-injury, though the prognosis clearly depended on the true culprit. It is important for clinicians to identify the cause of the injury when encountering patients with oral cavity lesions.

Case Presentation

A 40-year-old white male with a medical history of bipolar disorder, posttraumatic stress disorder, polysubstance abuse, and recently diagnosed temporomandibular joint (TMJ) syndrome was seen in outpatient primary care for a bleeding lesion in his mouth for the past 3 weeks. The lesion was under the surface of his right tongue. He first noted the lesion after he had burned himself tasting some homemade rice pudding while under the influence of marijuana. The next day, an impression was taken of his mouth by a dental assistant who was fitting him for an oral appliance for his TMJ syndrome; according to his history, she did not perform a visual inspection of his mouth nor could he recall his last dental examination. He had neither lost weight nor experienced dysphagia. He was not taking any prescribed medications, had an 8 pack-year history of smoking cigarettes, and had smoked crack cocaine intermittently for several years. The also patient had chewed one-half tin per day of chewing tobacco for 5 years, though he had quit 7 years before presentation. He was consuming 6 alcoholic drinks daily and had no history of chewing betel nuts.

On physical examination, the patient seemed extremely anxious, but his vital signs were unremarkable. The nasal dorsum was straight, and the nares were widely patent. There were no suspicious cutaneous lesions noted of the face, head, trunk, or extremities. The salivary glands were soft and showed no lesions or masses within the parotid or submandibular glands bilaterally. There was no obvious obstruction of Stenson or Wharton ducts bilaterally. He had normal lips and oral competence. The dentition was noted to be fair.

A nonfriable, 1.5 cm-wide lesion was found on the ventral surface of the right tongue (Figure 1). The tongue was mobile. The mouth floor was soft and without evidence of masses or lesions. The tonsils, tonsillar pillars, palate, and base of tongue did not show any concerning lesions or masses. The neck revealed a nonenlarged thyroid and no lymphadenopathy. The remainder of the examination was unremarkable.

Diagnosis

Given his risk factors of alcohol use disorder and a history of both inhaled and chewing tobacco, oral squamous cell carcinoma (SCC) was considered. The differential diagnosis also included pyogenic granuloma, mucocele, sublingual fibroma, and metastasis to the oral soft tissue. Due to its implications with respect to morbidity and mortality, we thought it necessary to rule out SCC of the oral cavity. SCC comprises more than 90% of oral malignancies, and tobacco-related products, alcohol, and human papilloma virus are well-established risk factors.1

 

 

Pyogenic granuloma, also known as eruptive hemangioma and lobular capillary hemangioma, is a relatively common benign lesion of the skin and mucosal surfaces that often presents as a solitary, rapidly enlarging papule or nodule that is extremely friable.2 Interestingly, pyogenic granuloma is a misnomer, since it is neither infectious in origin nor granulomatous when visualized under the microscope and is thought to arise from an exuberant tissue response to localized irritation or trauma. An individual lesion can range in size from a few millimeters to a few centimeters and generally reaches its maximum size within a matter of weeks; they often arise at sites of minor trauma.3 While the pathogenesis of pyogenic granuloma has not been clearly established, it seems to be related to an imbalance of angiogenesis secondary to overexpression of vascular endothelial growth factor and basic fibroblast growth factor.4 While they can occur at any age, pyogenic granulomas are frequently seen in pediatric patients and during pregnancy.

A fibroma, also known as an irritation fibroma, is one of the more common fibrous tumorlike growths and is often caused by trauma or irritation. It usually presents as a smooth-surfaced, painless solid lesion, though it can be nodular and histopathologically shows collagen and connective tissue.5 While fibromas can occur anywhere in the oral cavity, they commonly arise on the buccal mucosa along the plane of occlusion between the maxillary and mandibular teeth.

Mucoceles are the most common benign lesions in the mouth and are commonly found on the lower lip and are mucus-filled cavities, arising from the accumulation of mucus from trauma or lip-biting and alteration of minor salivary glands.6 Our patient’s rapid evolution and history of trauma were consistent with a mucocele. Although the lower lip is the most common site of involvement, mucoceles also occur on the tongue, cheek, palate, and mouth floor.Metastases to the oral cavity are rare and comprise only 1% of all oral cavity malignancies.7 Although most commonly seen in the jaw, nearly one-third of oral cavity metastases are in the soft tissue.8 They generally occur late in the course of disease, and the time between appearance and death is usually short.8 Our patient’s lack of known primary malignancy and lack of weight loss rendered this diagnosis unlikely.

   

Other possibilities include peripheral giant cell granuloma, a reactive hyperplastic lesion of the oral cavity originating from the periosteum or periodontal membrane following local irritation or chronic trauma,9 and peripheral ossifying fibroma, a reactive soft tissue growth usually seen on the interdental papilla.10

Surgical excision was performed and revealed reactive epidermal hyperplasia, ulceration, granulation tissue formation, and marked inflammation with reactive changes. There was no evidence of malignancy and was interpreted as consistent with pyogenic granuloma (Figures 2 and 3) likely due to the trauma from the thermal burn or poor dentition.

 

Management

The patient was relieved to be informed of the diagnosis of an unusual presentation of pyogenic granuloma with no evidence of cancer. Current treatment strategies for pyogenic granuloma include surgical excision, shave excision with cautery, cryotherapy, sclerotherapy, carbon dioxide or pulsed dye laser, as well as expectant management. However, recurrence after initial treatment can occur, with lower recurrence rates occurring with surgical excision.11

Although we wouldn’t state that we gave the patient a “tongue-lashing,” we strongly advised him that he return to his dentist and abstain from tobacco products, alcohol, illicit drugs, and taste-testing scalding food directly from the pot.

References

1. Khot KP, Deshmane S, Choudhari S. Human papilloma virus in oral squamous cell carcinoma-the enigma unraveled. Clin J Dent Res. 2016;19(1):17-23.

2. Bolognia JL, Jorizzo JL, Rapini RP, eds. Neoplasms of the skin. In: Bolognia JL, Jorizzo JL, Rapini RP, eds. Dermatology. Vol 2. St. Louis, MO: Mosby; 2007:1627-1901.

3. Tatusov M, Reddy S, Federman DG. Pyogenic granuloma: yet another motorcycle peril. Postgrad Med. 2012;124(6):124-126.

4. Yuan K, Jin YT, Lin MT. The detection and comparison of angiogenesis-associated factors in pyogenic granuloma by immunohistochemistry. J Periodontol. 2000;71(5):701-709.

5. Krishnan V, Shunmugavelu K. A clinical challenging situation of intra oral fibroma mimicking pyogenic granuloma. J Pan African Med. 2015;22(1):263.

6. Nallasivam KU, Sudha BR. Oral mucocele: review of literature and a case report. J Pharm Bioallied Sci. 2015;7(suppl 2):S731-S733.

7. Zachariades N. Neoplasms metastatic to the mouth, jaws, and surrounding tissues. J Craniomaxillofac Surg. 1989;17(6):283-290.

8. Irani S. Metastasis to the oral soft tissues: a review of 412 cases. J Int Soc Prev Community Dent. 2016;6(5):393-401.

9. Shadman N, Ebrahimi SF, Jafari S, Eslami M. Peripheral giant cell granuloma: a review of 123 cases. Dent Res J (Isfahan). 2009;6(1):47-50.

10. Poonacha KS, Shigli AL, Shirol D. Peripheral ossifying fibroma: a clinical report. Contemp Clin Dent. 2010;1(1):54-56.

11. Gilmore A, Kelsberg G, Safranek G. Clinical inquiries. What’s the best treatment for pyogenic granuloma? J Fam Pract. 2010;59(1):40-42.

References

1. Khot KP, Deshmane S, Choudhari S. Human papilloma virus in oral squamous cell carcinoma-the enigma unraveled. Clin J Dent Res. 2016;19(1):17-23.

2. Bolognia JL, Jorizzo JL, Rapini RP, eds. Neoplasms of the skin. In: Bolognia JL, Jorizzo JL, Rapini RP, eds. Dermatology. Vol 2. St. Louis, MO: Mosby; 2007:1627-1901.

3. Tatusov M, Reddy S, Federman DG. Pyogenic granuloma: yet another motorcycle peril. Postgrad Med. 2012;124(6):124-126.

4. Yuan K, Jin YT, Lin MT. The detection and comparison of angiogenesis-associated factors in pyogenic granuloma by immunohistochemistry. J Periodontol. 2000;71(5):701-709.

5. Krishnan V, Shunmugavelu K. A clinical challenging situation of intra oral fibroma mimicking pyogenic granuloma. J Pan African Med. 2015;22(1):263.

6. Nallasivam KU, Sudha BR. Oral mucocele: review of literature and a case report. J Pharm Bioallied Sci. 2015;7(suppl 2):S731-S733.

7. Zachariades N. Neoplasms metastatic to the mouth, jaws, and surrounding tissues. J Craniomaxillofac Surg. 1989;17(6):283-290.

8. Irani S. Metastasis to the oral soft tissues: a review of 412 cases. J Int Soc Prev Community Dent. 2016;6(5):393-401.

9. Shadman N, Ebrahimi SF, Jafari S, Eslami M. Peripheral giant cell granuloma: a review of 123 cases. Dent Res J (Isfahan). 2009;6(1):47-50.

10. Poonacha KS, Shigli AL, Shirol D. Peripheral ossifying fibroma: a clinical report. Contemp Clin Dent. 2010;1(1):54-56.

11. Gilmore A, Kelsberg G, Safranek G. Clinical inquiries. What’s the best treatment for pyogenic granuloma? J Fam Pract. 2010;59(1):40-42.

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Refractive Outcomes for Cataract Surgery With Toric Intraocular Lenses at a Veterans Affairs Medical Center

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Cataract surgery is one of the most common ambulatory procedures performed in the US.1-3 With the aging of the US population, the number of Americans with cataracts is projected to increase from 24.4 million in 2010 to 38.7 million in 2030.4

Approximately 20% of all cataract patients have preoperative astigmatism of > 1.5 diopters (D), underscoring the importance of training residents in the placement of toric intraocular lenses (IOLs).5 However, the implantation of toric IOLs is more challenging than monofocal IOLs, requiring precise surgical alignment of the IOL.6 Successful toric IOL implantation also requires accurate calculation of the IOL cylinder power and target axis of alignment. It is unclear which toric IOL calculation formula offers the most accurate refractive predictions, and practitioners have designed strategies to apply different formulae depending on the biometric dimensions of the target eye.7-9

Previous studies of resident-performed cataract surgery using toric IOLs6,10-13 and studies that compare the performance of the Barrett and Holladay toric formulae have been limited by their small sample sizes (< 107 eyes).7,14-16 Moreover, none of the studies that evaluate the comparative effectiveness of these biometric formulae were conducted at a teaching hospital.7,14-16

Given the added complexity of toric IOL placement and variable surgical experience of residents as ophthalmologists-in-training, it is important to assess outcomes in teaching hospitals.13 The primary aims of this study were to assess the visual and refractive outcomes of cataract surgery using toric IOLs in a US Department of Veterans Affairs (VA) teaching hospital and to compare the relative accuracy of the Holladay 2 or Barrett toric biometric formulae in predicting postoperative refraction outcomes.

Methods

The Providence VA Medical Center (PVAMC) Institutional Review Board approved this study. This retrospective chart review included patients with cataract and corneal astigmatism who underwent cataract surgery using Acrysof toric IOLs, model SN6AT (Alcon) at the PVAMC teaching hospital between November 2013 and May 2018.

Only 1 eye was included from each study subject to avoid compounding of data with the use of bilateral eyes.17 In addition, bilateral cataract surgery was only performed on some patients at the PVAMC, so including both eyes from eligible patients would disproportionately weigh those patients’ outcomes. If both eyes had cataract surgery and their postoperative visual acuities were unequal, we chose the eye with the better postoperative visual acuity since refraction accuracy decreases with worsening best-corrected visual acuity (BCVA). If both eyes had cataract surgery and the postoperative visual acuity was the same, the first operated eye was chosen.17,18

Exclusion criteria included worse than 20/40 BCVA, posterior capsular rupture, sulcus IOL, history of corneal disease, history of refractive surgery (laser-assisted in situ keratomileusis [LASIK]/photorefractive keratectomy [PRK]), axial length not measurable by the Lenstar optical biometer (Haag-Streit USA), or no postoperative refraction within 3 weeks to 4 months.19,20

Patient age, race/ethnicity, gender, preoperative refraction, preoperative BCVA, postoperative refraction, postoperative BCVA, and IOL power were recorded from patient charts (Table 1). Preoperative and postoperative refractive values were converted to spherical equivalents. The preoperative biometry and most of the postoperative refractions were performed by experienced technicians certified by the Joint Commission on Allied Health Personnel in Ophthalmology. The main outcomes for the assessment of surgeries included the postoperative BCVA, postoperative spherical equivalent refraction, and postoperative residual refractive astigmatism.

Axial length (AL), preoperative anterior chamber depth (ACD), preoperative flat corneal front power (K1), preoperative steep corneal front power (K2), lens thickness, horizontal white-to-white (WTW) corneal diameter, and central corneal thickness (CCT) were recorded from the Lenstar biometric device. Predicted postoperative refractions for the Holladay 2 formula were calculated using Holladay IOL Consultant software (Holladay Consulting). Predicted postoperative refractions for the Barrett toric IOL formula were calculated using the online Barrett toric formula calculator.21 Since previous studies have shown that both the Holladay and Barrett formulae account for posterior corneal astigmatism, a comparison of refractive outcomes in eyes with against-the-rule astigmatism vs with-the-rule astigmatism was not performed.14 An estimated standardized value for surgically-induced astigmatism was entered into both formulae; 0.3 diopter (D) was chosen based on previously published averages.22-24

A formula’s prediction error is defined as the predicted postoperative refraction minus the actual postoperative refraction. The mean absolute prediction error (MAE), defined as the mean of the absolute values of the prediction errors, and the median absolute prediction error (MedAE), defined as the median of the absolute values of the prediction errors, were used to assess the overall accuracy of each formula. Also, the percentages of eyes with postoperative refraction within ≥ 0.25 D, ≥ 0.50 D, and ≥ 1.0 D were calculated for both formulae. Two-tailed t tests were performed to compare the MAE between the formulae. Subgroup analyses were performed for short eyes (AL < 22 mm), medium length eyes (AL = 22-25 mm), and long eyes (AL > 25 mm). Statistical analysis was performed using STATA 11 (STATA Corp). The preoperative corneal astigmatism and postoperative refractive astigmatism of all the cases were compared in double-angle plots to assess how well the toric IOL neutralized the corneal astigmatism.

 

 

Results

Of 325 charts reviewed during the study period, 34 patients were excluded due to lack of postoperative refraction within the designated follow-up period, 5 for worse than 20/40 postoperative BCVA (4 had preexisting ocular disease), 2 for complications, and 1 for missing data. We included 283 eyes from 283 patients in the final study. Resident ophthalmologists were the primary surgeons in 87.6% (248/283) of the cases.

The median postoperative BCVA was 20/20, and 92% of patients had a postoperative BCVA of 20/25 or better. The prediction outcomes of the toric SN6AT IOLs are shown in Table 2. The Barrett toric formula had a lower MAE than the Holladay 2 formula, but this difference was not statistically significant. The Barrett toric formula also predicted a higher percentage of eyes with postoperative refraction within ≥ 0.25 D (53.2%), ≥ 0.5 D (77.3%), and ≥ 1.0 D (96.1%). For both formulae, > 95% of eyes had prediction errors that fell within 1.0 D.

While the Barrett formula demonstrated a lower MAE in all 3 AL groups, no statistically significant differences were found between the Barrett and Holladay formulae (P = .94, P = .49, and P = .08 for short, medium, and long eyes, respectively). Both formulae produced the lowest MAE in the long AL group: Barrett had a MAE of 0.221 D and Holladay 2 had one of 0.329 D. The Barrett formula produced its highest percentage of eyes with prediction errors falling within 0.25 D and 0.5 D in the long AL group. In comparison, both formulae had the highest MAEs in the short AL group (Barrett toric, 0.598 D; Holladay 2, 0.613 D) and produced the lowest percentage of eyes with prediction errors falling within ≥ 0.25 D and ≥ 0.5 D in the short AL group.

A cumulative histogram of the preoperative corneal and postoperative refractive astigmatism magnitude is shown in Figure 1. The same data are presented as double-angle plots in the Appendix, which shows that the centroid values for preoperative corneal astigmatism were greatlyreduced when compared with the postoperative refractive astigmatism (mean absolute value of 1.77 D ≥ 0.73 D to 0.5 D ≥ 0.50 D).

Preoperative corneal astigmatism and postoperative refractive astigmatism were compared since preoperative refractive astigmatism has noncorneal contributions, including lenticular astigmatism, and there is minimal expected change between preoperative and postoperative corneal astigmatism.14 For comparison, double-angle plots of postoperative refractive astigmatism prediction errors for the Holladay and Barrett formulae are shown in Figure 2.

    

Discussion

To our knowledge, this is the largest study of resident-performed cataract surgery using toric IOLs, the largest study that compared the performance of the Barrett toric and Holladay 2 formulae, and the first that compared these formulae in a teaching hospital setting. This study found no significant difference in the predictive accuracy of the Barrett and Holladay 2 biometric formulae for cataract surgery using toric IOLs. In addition, our refractive outcomes were consistent with the results of previous toric IOL outcome studies conducted in teaching and nonteaching hospital settings.6,10-13

 

 

In 4 previous studies that compared the MAE of the Barrett and Holladay formulae for toric IOLs, the Barrett formula produced a lower MAE than the Holladay 2 formula.7,14-16 However, this difference was significant in only 2 of the studies, which had sample sizes of only 68 and 107 eyes.14,16 Furthermore, the Barrett toric formula produced the lower MAE for the entire AL range, though this was not statistically significant at our sample size. In addition, both formulae produced the lowest MAE in the long AL group and the highest MAE in the short AL group. The unique anatomy and high IOL power needed in short eyes may explain the challenges in attaining accurate IOL power predictions in this AL group.19,25

Limitations

The sample size of this study may have prevented us from detecting statistically significant differences in the performance of the Barrett and Holladay formulae. However, our findings are consistent with studies that compare the accuracy of these formulae in teaching and nonteaching hospital settings. Second, the study was conducted at a VA hospital, and a high proportion of patients were male; thus, our findings may not be generalizable to patients who receive cataract surgery with toric IOLs in other settings.

Conclusions

In a single VA teaching hospital, the Barrett and Holladay 2 biometric formulae provide similar refractive predictions for cataract surgery using toric IOLs. Larger studies would be necessary to detect smaller differences in the relative performance of the biometric formulae.

References

1. Schein OD, Cassard SD, Tielsch JM, Gower EW. Cataract surgery among Medicare beneficiaries. Ophthalmic Epidemiol. 2012;19(5):257-264.

2. Congdon N, O’Colmain B, Klaver CC, et al. Causes and prevalence of visual impairment among adults in the United States. Arch Ophthalmol. 2004;122(4):477-485.

3. Congdon N, Vingerling JR, Klein BE, et al. Prevalence of cataract and pseudophakia/aphakia among adults in the United States. Arch Ophthalmol. 2004;122(4):487-494.

4. National Eye Institute. Cataract tables: cataract defined. https://www.nei.nih.gov/learn-about-eye-health/resources-for-health-educators/eye-health-data-and-statistics/cataract-data-and-statistics/cataract-tables. Updated February 7, 2020. Accessed February 10, 2020.

5. Ostri C, Falck L, Boberg-Ans G, Kessel L. The need for toric intra-ocular lens implantation in public ophthalmology departments. Acta Ophthalmol. 2015;93(5):e396-e397.

6. Sundy M, McKnight D, Eck C, Rieger F 3rd. Visual acuity outcomes of toric lens implantation in patients undergoing cataract surgery at a residency training program. Mo Med. 2016;113(1):40-43.

7. Ferreira TB, Ribeiro P, Ribeiro FJ, O’Neill JG. Comparison of methodologies using estimated or measured values of total corneal astigmatism for toric intraocular lens power calculation. J Refract Surg. 2017;33(12):794-800.

8. Reitblat O, Levy A, Kleinmann G, Abulafia A, Assia EI. Effect of posterior corneal astigmatism on power calculation and alignment of toric intraocular lenses: comparison of methodologies. J Cataract Refract Surg. 2016;42(2):217-225.

9. Aristodemou P, Knox Cartwright NE, Sparrow JM, Johnston RL. Formula choice: Hoffer Q, Holladay 1, or SRK/T and refractive outcomes in 8108 eyes after cataract surgery with biometry by partial coherence interferometry. J Cataract Refract Surg. 2011;37(1):63-71.

10. Moreira HR, Hatch KM, Greenberg PB. Benchmarking outcomes in resident-performed cataract surgery with toric intraocular lenses [published correction appears in: Clin Experiment Ophthalmol. 2013;41(8):819]. Clin Exp Ophthalmol. 2013;41(6):624-626.

11. Retzlaff JA, Sanders DR, Kraff MC. Development of the SRK/T intraocular lens implant power calculation formula [published correction appears in: J Cataract Refract Surg. 1990;16(4):528]. J Cataract Refract Surg. 1990;16(3):333-340.

12. Roensch MA, Charton JW, Blomquist PH, Aggarwal NK, McCulley JP. Resident experience with toric and multifocal intraocular lenses in a public county hospital system. J Cataract Refract Surg. 2012;38(5):793-798.

13. Pouyeh B, Galor A, Junk AK, et al. Surgical and refractive outcomes of cataract surgery with toric intraocular lens implantation at a resident-teaching institution. J Cataract Refract Surg. 2011;37(9):1623-1628.

14. Ferreira TB, Ribeiro P, Ribeiro FJ, O’Neill JG. Comparison of astigmatic prediction errors associated with new calculation methods for toric intraocular lenses. J Cataract Refract Surg. 2017;43(3):340-347.

15. Abulafia A, Hill WE, Franchina M, Barrett GD. Comparison of methods to predict residual astigmatism after intraocular lens implantation. J Refract Surg. 2015;31(10):699-707.

16. Abulafia A, Barrett GD, Kleinmann G, et al. Prediction of refractive outcomes with toric intraocular lens implantation. J Cataract Refract Surg. 2015;41(5):936-944.

17. Wang Q, Jiang W, Lin T, Wu X, Lin H, Chen W. Meta-analysis of accuracy of intraocular lens power calculation formulas in short eyes. Clin Exp Ophthalmol. 2018;46(4):356-363.

18. Melles RB, Holladay JT, Chang WJ. Accuracy of intraocular lens calculation formulas. Ophthalmology. 2018;125(2):169-178.

19. Hoffer KJ. The Hoffer Q formula: a comparison of theoretic and regression formulas. J Cataract Refract Surg. 1993;19(6):700-712.

20. Cooke DL, Cooke TL. Comparison of 9 intraocular lens power calculation formulas. J Cataract Refract Surg. 2016;42(8):1157-1164.

21. American Society of Cataract and Refractive Surgery. Barrett toric calculator. www.ascrs.org/barrett-toric-calculator. Accessed February 5, 2020.

22. Holladay JT, Pettit G. Improving toric intraocular lens calculations using total surgically induced astigmatism for a 2.5 mm temporal incision. J Cataract Refract Surg. 2019;45(3):272-283.

23. Canovas C, Alarcon A, Rosén R, et al. New algorithm for toric intraocular lens power calculation considering the posterior corneal astigmatism. J Cataract Refract Surg. 2018;44(2):168-174.

24. Visser N, Berendschot TT, Bauer NJ, Nuijts RM. Vector analysis of corneal and refractive astigmatism changes following toric pseudophakic and toric phakic IOL implantation. Invest Ophthalmol Vis Sci. 2012;53(4):1865-1873.

25. Narváez J, Zimmerman G, Stulting RD, Chang DH. Accuracy of intraocular lens power prediction using the Hoffer Q, Holladay 1, Holladay 2, and SRK/T formulas. J Cataract Refract Surg. 2006;32(12):2050-2053.

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Elaine Tran and Kevin Tang are Medical Students; David Rivera and Jorge Rivera are Clinical Assistant Professors of Surgery (Ophthalmology); and Paul Greenberg is a Professor of Surgery (Ophthalmology); all at the Warren Alpert Medical School of Brown University in Providence, Rhode Island. Allison Chen is an Ophthalmology Resident at the Shiley Eye Institute, University of California San Diego Health in La Jolla. Michael Chen is a Student at Harvard University in Cambridge, Massachusetts. David Rivera and Jorge Rivera are Staff Ophthalmologists, and Paul Greenberg is Chief of Ophthalmology; all at the Providence Veterans Affairs Medical Center in Rhode Island.
Correspondence: Paul Greenberg ([email protected])

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The authors report no actual or potential conflicts of interest for this article.

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Elaine Tran and Kevin Tang are Medical Students; David Rivera and Jorge Rivera are Clinical Assistant Professors of Surgery (Ophthalmology); and Paul Greenberg is a Professor of Surgery (Ophthalmology); all at the Warren Alpert Medical School of Brown University in Providence, Rhode Island. Allison Chen is an Ophthalmology Resident at the Shiley Eye Institute, University of California San Diego Health in La Jolla. Michael Chen is a Student at Harvard University in Cambridge, Massachusetts. David Rivera and Jorge Rivera are Staff Ophthalmologists, and Paul Greenberg is Chief of Ophthalmology; all at the Providence Veterans Affairs Medical Center in Rhode Island.
Correspondence: Paul Greenberg ([email protected])

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

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The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

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Elaine Tran and Kevin Tang are Medical Students; David Rivera and Jorge Rivera are Clinical Assistant Professors of Surgery (Ophthalmology); and Paul Greenberg is a Professor of Surgery (Ophthalmology); all at the Warren Alpert Medical School of Brown University in Providence, Rhode Island. Allison Chen is an Ophthalmology Resident at the Shiley Eye Institute, University of California San Diego Health in La Jolla. Michael Chen is a Student at Harvard University in Cambridge, Massachusetts. David Rivera and Jorge Rivera are Staff Ophthalmologists, and Paul Greenberg is Chief of Ophthalmology; all at the Providence Veterans Affairs Medical Center in Rhode Island.
Correspondence: Paul Greenberg ([email protected])

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

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

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Related Articles

Cataract surgery is one of the most common ambulatory procedures performed in the US.1-3 With the aging of the US population, the number of Americans with cataracts is projected to increase from 24.4 million in 2010 to 38.7 million in 2030.4

Approximately 20% of all cataract patients have preoperative astigmatism of > 1.5 diopters (D), underscoring the importance of training residents in the placement of toric intraocular lenses (IOLs).5 However, the implantation of toric IOLs is more challenging than monofocal IOLs, requiring precise surgical alignment of the IOL.6 Successful toric IOL implantation also requires accurate calculation of the IOL cylinder power and target axis of alignment. It is unclear which toric IOL calculation formula offers the most accurate refractive predictions, and practitioners have designed strategies to apply different formulae depending on the biometric dimensions of the target eye.7-9

Previous studies of resident-performed cataract surgery using toric IOLs6,10-13 and studies that compare the performance of the Barrett and Holladay toric formulae have been limited by their small sample sizes (< 107 eyes).7,14-16 Moreover, none of the studies that evaluate the comparative effectiveness of these biometric formulae were conducted at a teaching hospital.7,14-16

Given the added complexity of toric IOL placement and variable surgical experience of residents as ophthalmologists-in-training, it is important to assess outcomes in teaching hospitals.13 The primary aims of this study were to assess the visual and refractive outcomes of cataract surgery using toric IOLs in a US Department of Veterans Affairs (VA) teaching hospital and to compare the relative accuracy of the Holladay 2 or Barrett toric biometric formulae in predicting postoperative refraction outcomes.

Methods

The Providence VA Medical Center (PVAMC) Institutional Review Board approved this study. This retrospective chart review included patients with cataract and corneal astigmatism who underwent cataract surgery using Acrysof toric IOLs, model SN6AT (Alcon) at the PVAMC teaching hospital between November 2013 and May 2018.

Only 1 eye was included from each study subject to avoid compounding of data with the use of bilateral eyes.17 In addition, bilateral cataract surgery was only performed on some patients at the PVAMC, so including both eyes from eligible patients would disproportionately weigh those patients’ outcomes. If both eyes had cataract surgery and their postoperative visual acuities were unequal, we chose the eye with the better postoperative visual acuity since refraction accuracy decreases with worsening best-corrected visual acuity (BCVA). If both eyes had cataract surgery and the postoperative visual acuity was the same, the first operated eye was chosen.17,18

Exclusion criteria included worse than 20/40 BCVA, posterior capsular rupture, sulcus IOL, history of corneal disease, history of refractive surgery (laser-assisted in situ keratomileusis [LASIK]/photorefractive keratectomy [PRK]), axial length not measurable by the Lenstar optical biometer (Haag-Streit USA), or no postoperative refraction within 3 weeks to 4 months.19,20

Patient age, race/ethnicity, gender, preoperative refraction, preoperative BCVA, postoperative refraction, postoperative BCVA, and IOL power were recorded from patient charts (Table 1). Preoperative and postoperative refractive values were converted to spherical equivalents. The preoperative biometry and most of the postoperative refractions were performed by experienced technicians certified by the Joint Commission on Allied Health Personnel in Ophthalmology. The main outcomes for the assessment of surgeries included the postoperative BCVA, postoperative spherical equivalent refraction, and postoperative residual refractive astigmatism.

Axial length (AL), preoperative anterior chamber depth (ACD), preoperative flat corneal front power (K1), preoperative steep corneal front power (K2), lens thickness, horizontal white-to-white (WTW) corneal diameter, and central corneal thickness (CCT) were recorded from the Lenstar biometric device. Predicted postoperative refractions for the Holladay 2 formula were calculated using Holladay IOL Consultant software (Holladay Consulting). Predicted postoperative refractions for the Barrett toric IOL formula were calculated using the online Barrett toric formula calculator.21 Since previous studies have shown that both the Holladay and Barrett formulae account for posterior corneal astigmatism, a comparison of refractive outcomes in eyes with against-the-rule astigmatism vs with-the-rule astigmatism was not performed.14 An estimated standardized value for surgically-induced astigmatism was entered into both formulae; 0.3 diopter (D) was chosen based on previously published averages.22-24

A formula’s prediction error is defined as the predicted postoperative refraction minus the actual postoperative refraction. The mean absolute prediction error (MAE), defined as the mean of the absolute values of the prediction errors, and the median absolute prediction error (MedAE), defined as the median of the absolute values of the prediction errors, were used to assess the overall accuracy of each formula. Also, the percentages of eyes with postoperative refraction within ≥ 0.25 D, ≥ 0.50 D, and ≥ 1.0 D were calculated for both formulae. Two-tailed t tests were performed to compare the MAE between the formulae. Subgroup analyses were performed for short eyes (AL < 22 mm), medium length eyes (AL = 22-25 mm), and long eyes (AL > 25 mm). Statistical analysis was performed using STATA 11 (STATA Corp). The preoperative corneal astigmatism and postoperative refractive astigmatism of all the cases were compared in double-angle plots to assess how well the toric IOL neutralized the corneal astigmatism.

 

 

Results

Of 325 charts reviewed during the study period, 34 patients were excluded due to lack of postoperative refraction within the designated follow-up period, 5 for worse than 20/40 postoperative BCVA (4 had preexisting ocular disease), 2 for complications, and 1 for missing data. We included 283 eyes from 283 patients in the final study. Resident ophthalmologists were the primary surgeons in 87.6% (248/283) of the cases.

The median postoperative BCVA was 20/20, and 92% of patients had a postoperative BCVA of 20/25 or better. The prediction outcomes of the toric SN6AT IOLs are shown in Table 2. The Barrett toric formula had a lower MAE than the Holladay 2 formula, but this difference was not statistically significant. The Barrett toric formula also predicted a higher percentage of eyes with postoperative refraction within ≥ 0.25 D (53.2%), ≥ 0.5 D (77.3%), and ≥ 1.0 D (96.1%). For both formulae, > 95% of eyes had prediction errors that fell within 1.0 D.

While the Barrett formula demonstrated a lower MAE in all 3 AL groups, no statistically significant differences were found between the Barrett and Holladay formulae (P = .94, P = .49, and P = .08 for short, medium, and long eyes, respectively). Both formulae produced the lowest MAE in the long AL group: Barrett had a MAE of 0.221 D and Holladay 2 had one of 0.329 D. The Barrett formula produced its highest percentage of eyes with prediction errors falling within 0.25 D and 0.5 D in the long AL group. In comparison, both formulae had the highest MAEs in the short AL group (Barrett toric, 0.598 D; Holladay 2, 0.613 D) and produced the lowest percentage of eyes with prediction errors falling within ≥ 0.25 D and ≥ 0.5 D in the short AL group.

A cumulative histogram of the preoperative corneal and postoperative refractive astigmatism magnitude is shown in Figure 1. The same data are presented as double-angle plots in the Appendix, which shows that the centroid values for preoperative corneal astigmatism were greatlyreduced when compared with the postoperative refractive astigmatism (mean absolute value of 1.77 D ≥ 0.73 D to 0.5 D ≥ 0.50 D).

Preoperative corneal astigmatism and postoperative refractive astigmatism were compared since preoperative refractive astigmatism has noncorneal contributions, including lenticular astigmatism, and there is minimal expected change between preoperative and postoperative corneal astigmatism.14 For comparison, double-angle plots of postoperative refractive astigmatism prediction errors for the Holladay and Barrett formulae are shown in Figure 2.

    

Discussion

To our knowledge, this is the largest study of resident-performed cataract surgery using toric IOLs, the largest study that compared the performance of the Barrett toric and Holladay 2 formulae, and the first that compared these formulae in a teaching hospital setting. This study found no significant difference in the predictive accuracy of the Barrett and Holladay 2 biometric formulae for cataract surgery using toric IOLs. In addition, our refractive outcomes were consistent with the results of previous toric IOL outcome studies conducted in teaching and nonteaching hospital settings.6,10-13

 

 

In 4 previous studies that compared the MAE of the Barrett and Holladay formulae for toric IOLs, the Barrett formula produced a lower MAE than the Holladay 2 formula.7,14-16 However, this difference was significant in only 2 of the studies, which had sample sizes of only 68 and 107 eyes.14,16 Furthermore, the Barrett toric formula produced the lower MAE for the entire AL range, though this was not statistically significant at our sample size. In addition, both formulae produced the lowest MAE in the long AL group and the highest MAE in the short AL group. The unique anatomy and high IOL power needed in short eyes may explain the challenges in attaining accurate IOL power predictions in this AL group.19,25

Limitations

The sample size of this study may have prevented us from detecting statistically significant differences in the performance of the Barrett and Holladay formulae. However, our findings are consistent with studies that compare the accuracy of these formulae in teaching and nonteaching hospital settings. Second, the study was conducted at a VA hospital, and a high proportion of patients were male; thus, our findings may not be generalizable to patients who receive cataract surgery with toric IOLs in other settings.

Conclusions

In a single VA teaching hospital, the Barrett and Holladay 2 biometric formulae provide similar refractive predictions for cataract surgery using toric IOLs. Larger studies would be necessary to detect smaller differences in the relative performance of the biometric formulae.

Cataract surgery is one of the most common ambulatory procedures performed in the US.1-3 With the aging of the US population, the number of Americans with cataracts is projected to increase from 24.4 million in 2010 to 38.7 million in 2030.4

Approximately 20% of all cataract patients have preoperative astigmatism of > 1.5 diopters (D), underscoring the importance of training residents in the placement of toric intraocular lenses (IOLs).5 However, the implantation of toric IOLs is more challenging than monofocal IOLs, requiring precise surgical alignment of the IOL.6 Successful toric IOL implantation also requires accurate calculation of the IOL cylinder power and target axis of alignment. It is unclear which toric IOL calculation formula offers the most accurate refractive predictions, and practitioners have designed strategies to apply different formulae depending on the biometric dimensions of the target eye.7-9

Previous studies of resident-performed cataract surgery using toric IOLs6,10-13 and studies that compare the performance of the Barrett and Holladay toric formulae have been limited by their small sample sizes (< 107 eyes).7,14-16 Moreover, none of the studies that evaluate the comparative effectiveness of these biometric formulae were conducted at a teaching hospital.7,14-16

Given the added complexity of toric IOL placement and variable surgical experience of residents as ophthalmologists-in-training, it is important to assess outcomes in teaching hospitals.13 The primary aims of this study were to assess the visual and refractive outcomes of cataract surgery using toric IOLs in a US Department of Veterans Affairs (VA) teaching hospital and to compare the relative accuracy of the Holladay 2 or Barrett toric biometric formulae in predicting postoperative refraction outcomes.

Methods

The Providence VA Medical Center (PVAMC) Institutional Review Board approved this study. This retrospective chart review included patients with cataract and corneal astigmatism who underwent cataract surgery using Acrysof toric IOLs, model SN6AT (Alcon) at the PVAMC teaching hospital between November 2013 and May 2018.

Only 1 eye was included from each study subject to avoid compounding of data with the use of bilateral eyes.17 In addition, bilateral cataract surgery was only performed on some patients at the PVAMC, so including both eyes from eligible patients would disproportionately weigh those patients’ outcomes. If both eyes had cataract surgery and their postoperative visual acuities were unequal, we chose the eye with the better postoperative visual acuity since refraction accuracy decreases with worsening best-corrected visual acuity (BCVA). If both eyes had cataract surgery and the postoperative visual acuity was the same, the first operated eye was chosen.17,18

Exclusion criteria included worse than 20/40 BCVA, posterior capsular rupture, sulcus IOL, history of corneal disease, history of refractive surgery (laser-assisted in situ keratomileusis [LASIK]/photorefractive keratectomy [PRK]), axial length not measurable by the Lenstar optical biometer (Haag-Streit USA), or no postoperative refraction within 3 weeks to 4 months.19,20

Patient age, race/ethnicity, gender, preoperative refraction, preoperative BCVA, postoperative refraction, postoperative BCVA, and IOL power were recorded from patient charts (Table 1). Preoperative and postoperative refractive values were converted to spherical equivalents. The preoperative biometry and most of the postoperative refractions were performed by experienced technicians certified by the Joint Commission on Allied Health Personnel in Ophthalmology. The main outcomes for the assessment of surgeries included the postoperative BCVA, postoperative spherical equivalent refraction, and postoperative residual refractive astigmatism.

Axial length (AL), preoperative anterior chamber depth (ACD), preoperative flat corneal front power (K1), preoperative steep corneal front power (K2), lens thickness, horizontal white-to-white (WTW) corneal diameter, and central corneal thickness (CCT) were recorded from the Lenstar biometric device. Predicted postoperative refractions for the Holladay 2 formula were calculated using Holladay IOL Consultant software (Holladay Consulting). Predicted postoperative refractions for the Barrett toric IOL formula were calculated using the online Barrett toric formula calculator.21 Since previous studies have shown that both the Holladay and Barrett formulae account for posterior corneal astigmatism, a comparison of refractive outcomes in eyes with against-the-rule astigmatism vs with-the-rule astigmatism was not performed.14 An estimated standardized value for surgically-induced astigmatism was entered into both formulae; 0.3 diopter (D) was chosen based on previously published averages.22-24

A formula’s prediction error is defined as the predicted postoperative refraction minus the actual postoperative refraction. The mean absolute prediction error (MAE), defined as the mean of the absolute values of the prediction errors, and the median absolute prediction error (MedAE), defined as the median of the absolute values of the prediction errors, were used to assess the overall accuracy of each formula. Also, the percentages of eyes with postoperative refraction within ≥ 0.25 D, ≥ 0.50 D, and ≥ 1.0 D were calculated for both formulae. Two-tailed t tests were performed to compare the MAE between the formulae. Subgroup analyses were performed for short eyes (AL < 22 mm), medium length eyes (AL = 22-25 mm), and long eyes (AL > 25 mm). Statistical analysis was performed using STATA 11 (STATA Corp). The preoperative corneal astigmatism and postoperative refractive astigmatism of all the cases were compared in double-angle plots to assess how well the toric IOL neutralized the corneal astigmatism.

 

 

Results

Of 325 charts reviewed during the study period, 34 patients were excluded due to lack of postoperative refraction within the designated follow-up period, 5 for worse than 20/40 postoperative BCVA (4 had preexisting ocular disease), 2 for complications, and 1 for missing data. We included 283 eyes from 283 patients in the final study. Resident ophthalmologists were the primary surgeons in 87.6% (248/283) of the cases.

The median postoperative BCVA was 20/20, and 92% of patients had a postoperative BCVA of 20/25 or better. The prediction outcomes of the toric SN6AT IOLs are shown in Table 2. The Barrett toric formula had a lower MAE than the Holladay 2 formula, but this difference was not statistically significant. The Barrett toric formula also predicted a higher percentage of eyes with postoperative refraction within ≥ 0.25 D (53.2%), ≥ 0.5 D (77.3%), and ≥ 1.0 D (96.1%). For both formulae, > 95% of eyes had prediction errors that fell within 1.0 D.

While the Barrett formula demonstrated a lower MAE in all 3 AL groups, no statistically significant differences were found between the Barrett and Holladay formulae (P = .94, P = .49, and P = .08 for short, medium, and long eyes, respectively). Both formulae produced the lowest MAE in the long AL group: Barrett had a MAE of 0.221 D and Holladay 2 had one of 0.329 D. The Barrett formula produced its highest percentage of eyes with prediction errors falling within 0.25 D and 0.5 D in the long AL group. In comparison, both formulae had the highest MAEs in the short AL group (Barrett toric, 0.598 D; Holladay 2, 0.613 D) and produced the lowest percentage of eyes with prediction errors falling within ≥ 0.25 D and ≥ 0.5 D in the short AL group.

A cumulative histogram of the preoperative corneal and postoperative refractive astigmatism magnitude is shown in Figure 1. The same data are presented as double-angle plots in the Appendix, which shows that the centroid values for preoperative corneal astigmatism were greatlyreduced when compared with the postoperative refractive astigmatism (mean absolute value of 1.77 D ≥ 0.73 D to 0.5 D ≥ 0.50 D).

Preoperative corneal astigmatism and postoperative refractive astigmatism were compared since preoperative refractive astigmatism has noncorneal contributions, including lenticular astigmatism, and there is minimal expected change between preoperative and postoperative corneal astigmatism.14 For comparison, double-angle plots of postoperative refractive astigmatism prediction errors for the Holladay and Barrett formulae are shown in Figure 2.

    

Discussion

To our knowledge, this is the largest study of resident-performed cataract surgery using toric IOLs, the largest study that compared the performance of the Barrett toric and Holladay 2 formulae, and the first that compared these formulae in a teaching hospital setting. This study found no significant difference in the predictive accuracy of the Barrett and Holladay 2 biometric formulae for cataract surgery using toric IOLs. In addition, our refractive outcomes were consistent with the results of previous toric IOL outcome studies conducted in teaching and nonteaching hospital settings.6,10-13

 

 

In 4 previous studies that compared the MAE of the Barrett and Holladay formulae for toric IOLs, the Barrett formula produced a lower MAE than the Holladay 2 formula.7,14-16 However, this difference was significant in only 2 of the studies, which had sample sizes of only 68 and 107 eyes.14,16 Furthermore, the Barrett toric formula produced the lower MAE for the entire AL range, though this was not statistically significant at our sample size. In addition, both formulae produced the lowest MAE in the long AL group and the highest MAE in the short AL group. The unique anatomy and high IOL power needed in short eyes may explain the challenges in attaining accurate IOL power predictions in this AL group.19,25

Limitations

The sample size of this study may have prevented us from detecting statistically significant differences in the performance of the Barrett and Holladay formulae. However, our findings are consistent with studies that compare the accuracy of these formulae in teaching and nonteaching hospital settings. Second, the study was conducted at a VA hospital, and a high proportion of patients were male; thus, our findings may not be generalizable to patients who receive cataract surgery with toric IOLs in other settings.

Conclusions

In a single VA teaching hospital, the Barrett and Holladay 2 biometric formulae provide similar refractive predictions for cataract surgery using toric IOLs. Larger studies would be necessary to detect smaller differences in the relative performance of the biometric formulae.

References

1. Schein OD, Cassard SD, Tielsch JM, Gower EW. Cataract surgery among Medicare beneficiaries. Ophthalmic Epidemiol. 2012;19(5):257-264.

2. Congdon N, O’Colmain B, Klaver CC, et al. Causes and prevalence of visual impairment among adults in the United States. Arch Ophthalmol. 2004;122(4):477-485.

3. Congdon N, Vingerling JR, Klein BE, et al. Prevalence of cataract and pseudophakia/aphakia among adults in the United States. Arch Ophthalmol. 2004;122(4):487-494.

4. National Eye Institute. Cataract tables: cataract defined. https://www.nei.nih.gov/learn-about-eye-health/resources-for-health-educators/eye-health-data-and-statistics/cataract-data-and-statistics/cataract-tables. Updated February 7, 2020. Accessed February 10, 2020.

5. Ostri C, Falck L, Boberg-Ans G, Kessel L. The need for toric intra-ocular lens implantation in public ophthalmology departments. Acta Ophthalmol. 2015;93(5):e396-e397.

6. Sundy M, McKnight D, Eck C, Rieger F 3rd. Visual acuity outcomes of toric lens implantation in patients undergoing cataract surgery at a residency training program. Mo Med. 2016;113(1):40-43.

7. Ferreira TB, Ribeiro P, Ribeiro FJ, O’Neill JG. Comparison of methodologies using estimated or measured values of total corneal astigmatism for toric intraocular lens power calculation. J Refract Surg. 2017;33(12):794-800.

8. Reitblat O, Levy A, Kleinmann G, Abulafia A, Assia EI. Effect of posterior corneal astigmatism on power calculation and alignment of toric intraocular lenses: comparison of methodologies. J Cataract Refract Surg. 2016;42(2):217-225.

9. Aristodemou P, Knox Cartwright NE, Sparrow JM, Johnston RL. Formula choice: Hoffer Q, Holladay 1, or SRK/T and refractive outcomes in 8108 eyes after cataract surgery with biometry by partial coherence interferometry. J Cataract Refract Surg. 2011;37(1):63-71.

10. Moreira HR, Hatch KM, Greenberg PB. Benchmarking outcomes in resident-performed cataract surgery with toric intraocular lenses [published correction appears in: Clin Experiment Ophthalmol. 2013;41(8):819]. Clin Exp Ophthalmol. 2013;41(6):624-626.

11. Retzlaff JA, Sanders DR, Kraff MC. Development of the SRK/T intraocular lens implant power calculation formula [published correction appears in: J Cataract Refract Surg. 1990;16(4):528]. J Cataract Refract Surg. 1990;16(3):333-340.

12. Roensch MA, Charton JW, Blomquist PH, Aggarwal NK, McCulley JP. Resident experience with toric and multifocal intraocular lenses in a public county hospital system. J Cataract Refract Surg. 2012;38(5):793-798.

13. Pouyeh B, Galor A, Junk AK, et al. Surgical and refractive outcomes of cataract surgery with toric intraocular lens implantation at a resident-teaching institution. J Cataract Refract Surg. 2011;37(9):1623-1628.

14. Ferreira TB, Ribeiro P, Ribeiro FJ, O’Neill JG. Comparison of astigmatic prediction errors associated with new calculation methods for toric intraocular lenses. J Cataract Refract Surg. 2017;43(3):340-347.

15. Abulafia A, Hill WE, Franchina M, Barrett GD. Comparison of methods to predict residual astigmatism after intraocular lens implantation. J Refract Surg. 2015;31(10):699-707.

16. Abulafia A, Barrett GD, Kleinmann G, et al. Prediction of refractive outcomes with toric intraocular lens implantation. J Cataract Refract Surg. 2015;41(5):936-944.

17. Wang Q, Jiang W, Lin T, Wu X, Lin H, Chen W. Meta-analysis of accuracy of intraocular lens power calculation formulas in short eyes. Clin Exp Ophthalmol. 2018;46(4):356-363.

18. Melles RB, Holladay JT, Chang WJ. Accuracy of intraocular lens calculation formulas. Ophthalmology. 2018;125(2):169-178.

19. Hoffer KJ. The Hoffer Q formula: a comparison of theoretic and regression formulas. J Cataract Refract Surg. 1993;19(6):700-712.

20. Cooke DL, Cooke TL. Comparison of 9 intraocular lens power calculation formulas. J Cataract Refract Surg. 2016;42(8):1157-1164.

21. American Society of Cataract and Refractive Surgery. Barrett toric calculator. www.ascrs.org/barrett-toric-calculator. Accessed February 5, 2020.

22. Holladay JT, Pettit G. Improving toric intraocular lens calculations using total surgically induced astigmatism for a 2.5 mm temporal incision. J Cataract Refract Surg. 2019;45(3):272-283.

23. Canovas C, Alarcon A, Rosén R, et al. New algorithm for toric intraocular lens power calculation considering the posterior corneal astigmatism. J Cataract Refract Surg. 2018;44(2):168-174.

24. Visser N, Berendschot TT, Bauer NJ, Nuijts RM. Vector analysis of corneal and refractive astigmatism changes following toric pseudophakic and toric phakic IOL implantation. Invest Ophthalmol Vis Sci. 2012;53(4):1865-1873.

25. Narváez J, Zimmerman G, Stulting RD, Chang DH. Accuracy of intraocular lens power prediction using the Hoffer Q, Holladay 1, Holladay 2, and SRK/T formulas. J Cataract Refract Surg. 2006;32(12):2050-2053.

References

1. Schein OD, Cassard SD, Tielsch JM, Gower EW. Cataract surgery among Medicare beneficiaries. Ophthalmic Epidemiol. 2012;19(5):257-264.

2. Congdon N, O’Colmain B, Klaver CC, et al. Causes and prevalence of visual impairment among adults in the United States. Arch Ophthalmol. 2004;122(4):477-485.

3. Congdon N, Vingerling JR, Klein BE, et al. Prevalence of cataract and pseudophakia/aphakia among adults in the United States. Arch Ophthalmol. 2004;122(4):487-494.

4. National Eye Institute. Cataract tables: cataract defined. https://www.nei.nih.gov/learn-about-eye-health/resources-for-health-educators/eye-health-data-and-statistics/cataract-data-and-statistics/cataract-tables. Updated February 7, 2020. Accessed February 10, 2020.

5. Ostri C, Falck L, Boberg-Ans G, Kessel L. The need for toric intra-ocular lens implantation in public ophthalmology departments. Acta Ophthalmol. 2015;93(5):e396-e397.

6. Sundy M, McKnight D, Eck C, Rieger F 3rd. Visual acuity outcomes of toric lens implantation in patients undergoing cataract surgery at a residency training program. Mo Med. 2016;113(1):40-43.

7. Ferreira TB, Ribeiro P, Ribeiro FJ, O’Neill JG. Comparison of methodologies using estimated or measured values of total corneal astigmatism for toric intraocular lens power calculation. J Refract Surg. 2017;33(12):794-800.

8. Reitblat O, Levy A, Kleinmann G, Abulafia A, Assia EI. Effect of posterior corneal astigmatism on power calculation and alignment of toric intraocular lenses: comparison of methodologies. J Cataract Refract Surg. 2016;42(2):217-225.

9. Aristodemou P, Knox Cartwright NE, Sparrow JM, Johnston RL. Formula choice: Hoffer Q, Holladay 1, or SRK/T and refractive outcomes in 8108 eyes after cataract surgery with biometry by partial coherence interferometry. J Cataract Refract Surg. 2011;37(1):63-71.

10. Moreira HR, Hatch KM, Greenberg PB. Benchmarking outcomes in resident-performed cataract surgery with toric intraocular lenses [published correction appears in: Clin Experiment Ophthalmol. 2013;41(8):819]. Clin Exp Ophthalmol. 2013;41(6):624-626.

11. Retzlaff JA, Sanders DR, Kraff MC. Development of the SRK/T intraocular lens implant power calculation formula [published correction appears in: J Cataract Refract Surg. 1990;16(4):528]. J Cataract Refract Surg. 1990;16(3):333-340.

12. Roensch MA, Charton JW, Blomquist PH, Aggarwal NK, McCulley JP. Resident experience with toric and multifocal intraocular lenses in a public county hospital system. J Cataract Refract Surg. 2012;38(5):793-798.

13. Pouyeh B, Galor A, Junk AK, et al. Surgical and refractive outcomes of cataract surgery with toric intraocular lens implantation at a resident-teaching institution. J Cataract Refract Surg. 2011;37(9):1623-1628.

14. Ferreira TB, Ribeiro P, Ribeiro FJ, O’Neill JG. Comparison of astigmatic prediction errors associated with new calculation methods for toric intraocular lenses. J Cataract Refract Surg. 2017;43(3):340-347.

15. Abulafia A, Hill WE, Franchina M, Barrett GD. Comparison of methods to predict residual astigmatism after intraocular lens implantation. J Refract Surg. 2015;31(10):699-707.

16. Abulafia A, Barrett GD, Kleinmann G, et al. Prediction of refractive outcomes with toric intraocular lens implantation. J Cataract Refract Surg. 2015;41(5):936-944.

17. Wang Q, Jiang W, Lin T, Wu X, Lin H, Chen W. Meta-analysis of accuracy of intraocular lens power calculation formulas in short eyes. Clin Exp Ophthalmol. 2018;46(4):356-363.

18. Melles RB, Holladay JT, Chang WJ. Accuracy of intraocular lens calculation formulas. Ophthalmology. 2018;125(2):169-178.

19. Hoffer KJ. The Hoffer Q formula: a comparison of theoretic and regression formulas. J Cataract Refract Surg. 1993;19(6):700-712.

20. Cooke DL, Cooke TL. Comparison of 9 intraocular lens power calculation formulas. J Cataract Refract Surg. 2016;42(8):1157-1164.

21. American Society of Cataract and Refractive Surgery. Barrett toric calculator. www.ascrs.org/barrett-toric-calculator. Accessed February 5, 2020.

22. Holladay JT, Pettit G. Improving toric intraocular lens calculations using total surgically induced astigmatism for a 2.5 mm temporal incision. J Cataract Refract Surg. 2019;45(3):272-283.

23. Canovas C, Alarcon A, Rosén R, et al. New algorithm for toric intraocular lens power calculation considering the posterior corneal astigmatism. J Cataract Refract Surg. 2018;44(2):168-174.

24. Visser N, Berendschot TT, Bauer NJ, Nuijts RM. Vector analysis of corneal and refractive astigmatism changes following toric pseudophakic and toric phakic IOL implantation. Invest Ophthalmol Vis Sci. 2012;53(4):1865-1873.

25. Narváez J, Zimmerman G, Stulting RD, Chang DH. Accuracy of intraocular lens power prediction using the Hoffer Q, Holladay 1, Holladay 2, and SRK/T formulas. J Cataract Refract Surg. 2006;32(12):2050-2053.

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Demographic Profile and Service-Connection Trends of Posttraumatic Stress Disorder and Traumatic Brain Injury in US Veterans Pre- and Post-9/11

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The nature of combat and associated injuries in Operation Iraqi Freedom (OIF), Operation Enduring Freedom (OEF), Operation New Dawn (OND), and Afghanistan War is different from previous conflicts. Multiple protracted deployments with infrequent breaks after September 11, 2001 (9/11) have further compounded the problem.

Posttraumatic stress disorder (PTSD) and traumatic brain injury (TBI) are the signature wounds of recent wars, with a higher incidence among the veterans of OEF and OIF compared with those from previous conflicts.1,2 More than 2.7 million who served in Iraq and Afghanistan suffer from PTSD.3,4 Symptoms of PTSD may appear within the first 3 months after exposure to a traumatic event or after many months and, in some cases, after a delay of many years and continue for life.5 Although delayed onset of PTSD in the absence of prior symptoms is rare,6,7 its incidence rises with increasing frequency of exposure to traumatic events8,9 and over time.10

According to the Brain Injury Association of America, TBI is “an alteration in brain function, or other evidence of brain pathology, caused by an external force.”8 TBI is often associated with increased risk of PTSD, depression, and posttraumatic headache,11-13 which may lead to broader cognitive, somatic, neurobiological, and psychosocial dysfunctions.14-17 According to Veterans Health Administration (VHA) data, 201,435 veterans from all eras enrolled with the US Department of Veterans Affairs (VA) have a diagnosis associated with TBI and 56,695 OEF/OIF veterans have been evaluated for a TBI-related condition.2 According to the Defense and Veterans Brain Injury Center (DVBIC), > 361,000 veterans have been diagnosed with TBI, with a peak of 32,000 cases in 2011.1,18 Moreover, the reported incidence and prevalence of PTSD and TBI among US veterans are not consistent. The incidence of PTSD has been estimated at 15% to 20% in recent wars3,19 compared with 10% to 30% in previous wars.3,19,20

When PTSD or TBI is deemed “related” to military service, the veteran may receive a service-connected disability rating ranging from 0% (no life-interfering symptoms due to injury) to 100% (totally disabling injury). The percentage of service connection associated with an injury is a quantifiable measure of the debilitating effect of injury on the individual. A significant majority (94%) of those who seek mental health services and treatment at VHA clinics apply for PTSD-related disability benefits.21 The estimated cost related to PTSD/TBI service-connected pensions is $20.28 billion per year and approximately $514 billion over 50 years.22 The cost of VA and Social Security disability payments combined with health care costs and treatment of PTSD is estimated to exceed $1 trillion over the next 30 years.22

The National Vietnam Veterans Readjustment Study (NVVRS) provided valuable information on prevalence rates of PTSD and other postwar psychological problems.23 Meanwhile, there have been no recent large-scale studies to compare the demographics of veterans diagnosed with PTSD and TBI who served prior to and after 9/11. A better understanding of demographic changes is considered essential for designing and tailoring therapeutic interventions to manage the rising cost.22

The present study focused on identifying changing trends in the demographics of veterans who served prior to and after 9/11 and who received a VA inpatient or outpatient diagnosis of PTSD and/or TBI. Specifically, this study addressed the changes in demographics of veterans with PTSD, TBI, or PTSD+TBI seen at the VHA clinics between December 1,1998 and May 31, 2014 (before and after September 11, 2001) for diagnosis, treatment and health care policy issues.

 

 

Methods

This study was approved by the Kansas City VA Medical Center Institutional Review Board. VHA data from the Corporate Data Warehouse (CDW) and the National Patient Care Database were extracted using the VA Informatics and Computing Infrastructure (VINCI) workspace. CDW uses a unique identifier to identify veterans across treatment episodes at more than 1,400 VHA centers organized under 21 Veterans Integrated Service Networks (VISNs). These sources of VA data are widely used for retrospective longitudinal studies.

Study Population

The study population consisted of 1,339,937 veterans with a VA inpatient/outpatient diagnosis of PTSD or TBI using International Statistical Classification of Diseases and Related Health Problems, Ninth Revision (ICD-9) codes between December 1, 1998 and May 31, 2014. Demographic (gender classification, race, ethnicity, marital status, age at date of data extraction, and date of death if indicated), service-connection disability rating, and geographic distribution within VISN data on each veteran were then extracted.

Veterans in the cohort were assigned to 1 of 4 US military services period groups. The pre-9/11 group included veterans who entered and left the military prior to September 11, 2001. This group mostly included veterans from World War II, Korean War, Vietnam War, and the first Gulf War (1990-1991). The post-9/11 group included veterans who first entered military services after September 11, 2001. The overlap group included veterans who entered military services prior to 9/11, remained in service and left after September 11, 2001. The reentered group included veterans who entered and left service prior to September 11, 2001, and then reentered military service after September 11, 2001 (Figure 1). Using ICD-9 codes, veterans also were placed into the following categories: PTSD alone (ICD-9 309.81 only), TBI alone (ICD-9 850.0-859.9, V15.52), and PTSD+TBI (any combination of ICD-9 codes from the other categories).

 

Statistical Analysis 

Descriptive statistics were applied using proportions and means. Relationships between variables were examined using χ2 tests, t tests, analysis of variance, and nonparametric tests. All hypotheses were 2-sided at 95% CI. Results are presented as absolute numbers.

Results

PTSD only (n = 1,132,356, 85%) was the predominant diagnosis category followed by PTSD+TBI (n = 106,792, 8%) and TBI only (n = 100,789, 7%) (Figure 2). Most of the veterans in the study served pre-9/11 (77%), followed by post-9/11 (15%); 7% were in the overlap group, and 1% in the reentered group (Table 1). It is notable that the proportion of veterans diagnosed with PTSD decreased from pre-9/11 (88%) to post-9/11 (71%), overlap (77%), and reentered (74%) service periods. Increases were noted in those with PTSD+TBI diagnosis category from pre-9/11 (4%) to post-9/11 (23%), overlap (17%), and reentered (22%) service periods (Figure 3). In general, the relative distribution of diagnostic categories in all the service periods showed a similar trend, with the majority of veterans diagnosed with PTSD only. Across all service periods, significantly smaller proportions of veterans were diagnosed with TBI only (P < .001).

   

Distribution by Gender and Age

The cohort was 92% male (n = 1,239,295), but there was a marked increase in the percentage of nonmale veterans in post-9/11 groups. Study population ages ranged from 18 to 99 years based on date of birth to the date data were obtained; or date of birth to date of death, for those who were reported deceased at the time the data were obtained. The average (SD) ages for veterans in the pre-9/11 group were significantly older (66.3 [11.2] years) compared with the ages of veterans in the post-9/11 group (36.1 [8.7] years), the overlap group (41.4 [8.2] years), and the reentered group (46.9 [9.2] years), respectively.

 

 

Distribution by Race and Marital Status

The cohort identified as 65.7% white and 18.2% African American with much smaller percentages of Asians, American Indian/Alaska Natives (AI/AN) and Native Hawaiian/Pacific Islanders (Table 2). The relative proportion of AI/AN and Native Hawaiian/Pacific Islanders remained constant across all groups, whereas the number of Asians diagnosed with PTSD, TBI, or PTSD+TBI increased in the post-9/11 group. The number of African Americans diagnosed with PTSD, TBI, or both markedly increased in the overlap and reentered groups when compared with the pre-9/11 group, yet it went down in the post-9/11/group.

Half the cohort identified themselves as married (n = 675,145) (Table 3). A slightly larger proportion of those diagnosed with PTSD alone were married (51.7%), compared with those diagnosed with TBI only (40.3%), or PTSD+TBI (45.8%). Veterans in the post-9/11 group were less likely to identify as married (45.2%) compared with the pre-9/11 (51.2%), overlap (52.6%), or reentered (53.2%) groups. Divorce rates among pre-9/11 group, overlap group, and reentered group were higher compared with that of the post-9/11 group in all diagnosis categories.

Geographic Distribution

Veterans diagnosed with PTSD, TBI, or both were not evenly distributed across the VISNs VISNs 7, 8, 10, and 22 treated the most veterans, whereas VISN 9 and 15 treated the fewest. Taken together, the top 3 VISNs accounted for 27% to 28% of the total while lowest 3 accounted for 8% to 9% of the total cohort.

 

Service-Connected Disability

Of 1,339,937 veterans in the cohort, 1,067,691 had a service-connected disability rating for PTSD and/or TBI. Most were diagnosed with PTSD (n = 923,523, 86.5%) followed by both PTSD+TBI (n = 94,051, 8.8%). Three-quarters of the veterans with a service-connected disability were in the pre-9/11 group. Nearly 80% of veterans with a service-connected disability rating had a rating of > 50%. The average (SD) age of veterans with PTSD+TBI and a > 50% service-connected disability was 66.3 (11.2) years in the pre-9/11 group compared with 36.1 (8.7) years in the post-9/11 group.

Discussion

The demographic profile of veterans diagnosed with PTSD+TBI has changed across the service periods covered in this study. Compared with pre-9/11 veterans, the post-9/11 cohort: (1) higher percentage were diagnosed with PTSD+TBI; (2) higher proportion were nonmale veterans; (3) included more young veterans with > 50% service-connected disability; (4) were more racially diverse; and (5) were less likely to be married and divorced and more likely to be self-identified as single. Additionally, data revealed that veterans tended to locate more to some geographic regions than to others.

The nature of the warfare has changed remarkably over the past few decades. Gunshot wounds accounted for 65% of all injuries in World War I, 35% during Vietnam War, and 16% to 23% in the First Gulf War.24 In post-9/11 military conflicts, 81% of injuries were explosion related.24,25 Although improvements in personal protective gear and battlefield trauma care led to increased survival, several factors may have contributed to increased reporting of TBI, which peaked in 2011 at 32,000 cases.24-26

 

 

Increases in PTSD Diagnosis

Increasing media awareness, mandatory battlefield concussion screening programs instituted by the US Department of Defense (DoD), and stressful conditions that exacerbate mild TBI (mTBI) may have all contributed to the increase in numbers of veterans seeking evaluations and being diagnosed with PTSD and/or TBI in the post-9/11 groups. Additionally, the 2007 National Defense Authorization Act requested the Secretary of Defense to develop a comprehensive, systematic approach for the identification, treatment, disposition, and documentation of TBI in combat and peacetime. By a conservative estimate, significant numbers of veterans will continue to be seen for mTBI at about 20,000 new cases per year.25-27

More frequent diagnosis of mTBI may have contributed to the increase in veterans diagnosed with PTSD+TBI in the post-9/11 groups. A recent study found that almost 44% of US Army infantry soldiers in Iraq did not lose consciousness but reported symptoms consistent with TBI.14 Compared with veterans of previous wars, veterans of the post-9/11 conflicts (OIF, OED, and OND) have experienced multiple, protracted deployments with infrequent breaks that can have a cumulative effect on the development of PTSD.8-10

The findings from the NVVRS study led to creation of specialized PTSD programs in the late 1980s. Since then, there has been an explosion of knowledge and awareness about PTSD, TBI, and the associated service-connected disability ratings and benefits, leading to an increased number of veterans seeking care for PTSD. For example, media coverage of the 50th anniversary of the D-day celebrations resulted in a surge of World War II veterans seeking treatment for PTSD and a surge of Vietnam veterans sought treatment for PTSD during the wars in Iraq and Afghanistan.28 An increased number of veterans reporting PTSD symptoms prompted the DoD to increase screening for PTSD, and to encourage service members to seek treatment when appropriate.

The VA has instituted training programs for clinicians and psychologists to screen and provide care for PTSD. Beginning in 2007, the VA implemented mandatory TBI screening for all veterans who served in combat operations and separated from active-duty service after September 11, 2001. The 4-question screen identifies veterans who are at increased risk of TBI and who experience symptoms that may be related to specific event(s).29 A positive screen does not diagnose TBI but rather indicates a need for further evaluation, which may or may not be responsible for inflated reporting of TBI. Renewed research also has led providers to recognize and study PTSD resulting from noncombat trauma and moral injury. The possibility of delayed onset also drives up the number of veterans diagnosed with PTSD.5-7

Prevalence

A wide variability exists in the reported prevalence of PTSD among US war veterans with estimates ranging from 15% to 20% of veterans from recent conflicts3,20 and 10% to 30% of veterans from previous wars.3,19 These rates are higher than estimates from allied forces from other countries.19 Meta-analyses suggest that the prevalence of PTSD is 2% to 15% among Vietnam War veterans, 1% to 13% among first (pre-9/11) Gulf War veterans, 4% to 17% among OEF/OIF/OND veterans; these veterans have a lifetime prevalence of 6% to 31%.3,11,19,30-38 The prevalence of PTSD is 2 to 4 times higher among the US veterans19,39 when compared with that of civilians.40,41 According to one study, concomitant PTSD and TBI appears to be much higher in US war veterans (4%-17%) compared with United Kingdom Iraq War veterans (3%-6%).19

 

 

This study’s finding of an increase in nonmale soldiers with PTSD and/or TBI was not surprising. There is a paucity of data on the effect of war zone exposure on women veterans. Recently, women have been more actively involved in combat roles with 41,000 women deployed to a combat zone. Results of this study indicate a 2- to 3-fold increase in veterans identifying themselves as nonmale in post-9/11 groups with a higher proportion diagnosed with either PTSD alone or PTSD and TBI. Women are at a higher risk for PTSD than are men due in part to exposure to abuse/trauma prior to deployment, experience of higher rates of discrimination, and/or sexual assault.31-33 One study involving First Gulf War female veterans reported higher precombat psychiatric histories as well as higher rates of physical and sexual abuse when compared with that of men.31

In this study, the average age of veterans adjudicated and compensated for PTSD and/or TBI pre-9/11, was 66 years compared with 36 years for post-9/11 veterans. Sixty-six percent of veterans from the post-9/11 group had ≥ 50% service-connected disability at age 36 years; 75% of veterans from the overlap group had ≥ 50% service-connected disability at age 41 years; and 76% veterans from the reentered group had ≥ 50% service-connected disability at age 46 years. Younger age at diagnosis and higher rates of disability not only pose unique challenges for veterans and family members, but also suggest implications for career prospects, family earnings, loss of productivity, and disease-adjusted life years. Also noted in the results, this younger cohort has a higher percentage of single/unmarried veterans, suggesting familial support systems may be more parental than spousal. Treatment for this younger cohort will likely need to focus on early and sustained rehabilitation that can be integrated with career plans.

For treatment to be effective, there must be evidence for veterans enrolling, remaining, and reporting benefits from the treatment. Limited research has shown currently advocated evidence-based therapies to have low enrollment rates, high drop-out rates, and mixed outcomes.42

Results showing a gradual increase in the proportion of nonwhite, non-African American veterans diagnosed with PTSD alone, TBI alone, or both, likely reflect the changing demographic profile of the US as well as the Army. However, the reason that more African Americans were diagnosed with PTSD and/or TBI in the overlap and reentered groups when compared with the pre-9/11 group could not be ascertained. It is possible that more veterans identified themselves as African Americans as evident from a decrease in the number of veterans in the unknown category post-9/11 when compared with the pre-9/11 group. In 2016, the American Community Survey showed that Hispanic and African American veterans were more likely to use VA health care and other benefits than were any other racial group.40 Improved screening for PTSD and TBI diagnoses, increased awareness, and education about the availability of VA services and benefits may have contributed to the increased use of VA benefits in these groups.

Data from this study are concordant with data from the National Center for Veterans Analysis and Statistics reporting on the younger age of diagnosis and higher rates of initial service-connected disability in veterans with PTSD and PTSD+TBI.43 One study analyzing records from 1999 to 2004 showed that the number of PTSD cases grew by 79.5%, resulting in 148.7% increase in benefits payment from $1.7 billion to $4.3 billion per year.44 In contrast, the compensation cost for all other disability categories increased by only 41.7% over this period. This study also revealed that while veterans with PTSD represented only 8.7% of compensation recipients, they received 20.5% of all compensation payments, driven in large part by an increase in > 50% service-connected disability ratings.44

Thus, from financial as well as treatment points of view, the change in the demographic profile of the veteran must be considered when developing PTSD treatment strategies. While treatment in the past focused solely on addressing trauma-associated psychiatric issues, TBI and PTSD association will likely shift the focus to concurrent psychiatric and physical symptomology. Similarly, PTSD/TBI treatment modalities must consider that the profile of post-9/11 service members includes more women, younger age, and a greater racial diversity. For instance, younger age for a disabled veteran brings additional challenges, including reliance on parental or buddy support systems vs a spousal support system, integrating career with treatment, selecting geographic locations that can support both career and treatment, sustaining rehabilitation over time. The treatment needs of a 35-year-old soldier with PTSD and/or TBI, whether male or female, Asian or African American are likely to be very different from the treatment needs of a 65-year-old white male. Newer treatment approaches will have to address the needs of all soldiers.

 

 

Limitations

Our study may underestimate the actual PTSD and/or TBI disease burden because of the social stigma associated with diagnosis, military culture, limitations in data collection.45-50 In addition, in this retrospective database cohort study, we considered and tried to minimize the impact of any of the usual potential limitations, including (1) accuracy of data quality and linkage; (2) identifying cohort appropriately (study groups); (3) defining endpoints clearly to avoid misclassifications; and (4) incorporating all important confounders. We identified veterans utilizing medical services at VA hospitals during a defined period and diagnosed with PTSD and TBI using ICD-9 codes and divided in 4 well-defined groups. In addition, another limitation of our study is to not accurately capture the veterans who have alternative health coverage and may choose not to enroll and/or participate in VA health care. In addition, some service members leaving war zones may not disclose or downplay the mental health symptoms to avoid any delay in their return home.

Conclusions

This study highlights the changing profile of the soldier diagnosed with PTSD and/or TBI who served pre-9/11 compared with that of those who served post-9/11. Treatment modalities must address the changes in warfare and demographics of US service members. Future treatment will need to focus more on concurrent PTSD/TBI therapies, the needs of younger soldiers, the needs of women injured in combat, and the needs of a more racially and ethnically diverse population. Severe injuries at a younger age will require early detection and rehabilitation for return to optimum functioning over a lifetime. The current study underscores a need for identifying the gaps in ongoing programs and services, developing alternatives, and implementing improved systems of care. More studies are needed to identify the cost implications and the effectiveness of current therapies for PTSD and/or TBI.

Acknowledgments

This study was supported by VA Medical Center and Midwest BioMedical Research Foundation (MBRF), Kansas City, Missouri. The manuscript received support, in part, from NIH-RO1 DK107490. These agencies did not participate in the design/conduct of the study or, in the interpretation of the data.

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Author and Disclosure Information

Hemant Thakur is a Psychiatrist, Olurinde Oni is a Research Associate, Vikas Singh is a staff Neurologist, Rishi Sharma worked as a Research Fellow, Mukut Sharma is a Senior Research Scientist, Douglas Burns is a Research Biologist, and Ram Sharma is Chief of Research; all at the Kansas City VA Medical Center in Missouri. Mary Oehlert is a Psychologist at the Eastern Kansas Healthcare System VA Medical Center in Leavenworth.
Correspondence: Hemant Thakur ([email protected])

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

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Hemant Thakur is a Psychiatrist, Olurinde Oni is a Research Associate, Vikas Singh is a staff Neurologist, Rishi Sharma worked as a Research Fellow, Mukut Sharma is a Senior Research Scientist, Douglas Burns is a Research Biologist, and Ram Sharma is Chief of Research; all at the Kansas City VA Medical Center in Missouri. Mary Oehlert is a Psychologist at the Eastern Kansas Healthcare System VA Medical Center in Leavenworth.
Correspondence: Hemant Thakur ([email protected])

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

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Author and Disclosure Information

Hemant Thakur is a Psychiatrist, Olurinde Oni is a Research Associate, Vikas Singh is a staff Neurologist, Rishi Sharma worked as a Research Fellow, Mukut Sharma is a Senior Research Scientist, Douglas Burns is a Research Biologist, and Ram Sharma is Chief of Research; all at the Kansas City VA Medical Center in Missouri. Mary Oehlert is a Psychologist at the Eastern Kansas Healthcare System VA Medical Center in Leavenworth.
Correspondence: Hemant Thakur ([email protected])

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

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The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

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Related Articles

The nature of combat and associated injuries in Operation Iraqi Freedom (OIF), Operation Enduring Freedom (OEF), Operation New Dawn (OND), and Afghanistan War is different from previous conflicts. Multiple protracted deployments with infrequent breaks after September 11, 2001 (9/11) have further compounded the problem.

Posttraumatic stress disorder (PTSD) and traumatic brain injury (TBI) are the signature wounds of recent wars, with a higher incidence among the veterans of OEF and OIF compared with those from previous conflicts.1,2 More than 2.7 million who served in Iraq and Afghanistan suffer from PTSD.3,4 Symptoms of PTSD may appear within the first 3 months after exposure to a traumatic event or after many months and, in some cases, after a delay of many years and continue for life.5 Although delayed onset of PTSD in the absence of prior symptoms is rare,6,7 its incidence rises with increasing frequency of exposure to traumatic events8,9 and over time.10

According to the Brain Injury Association of America, TBI is “an alteration in brain function, or other evidence of brain pathology, caused by an external force.”8 TBI is often associated with increased risk of PTSD, depression, and posttraumatic headache,11-13 which may lead to broader cognitive, somatic, neurobiological, and psychosocial dysfunctions.14-17 According to Veterans Health Administration (VHA) data, 201,435 veterans from all eras enrolled with the US Department of Veterans Affairs (VA) have a diagnosis associated with TBI and 56,695 OEF/OIF veterans have been evaluated for a TBI-related condition.2 According to the Defense and Veterans Brain Injury Center (DVBIC), > 361,000 veterans have been diagnosed with TBI, with a peak of 32,000 cases in 2011.1,18 Moreover, the reported incidence and prevalence of PTSD and TBI among US veterans are not consistent. The incidence of PTSD has been estimated at 15% to 20% in recent wars3,19 compared with 10% to 30% in previous wars.3,19,20

When PTSD or TBI is deemed “related” to military service, the veteran may receive a service-connected disability rating ranging from 0% (no life-interfering symptoms due to injury) to 100% (totally disabling injury). The percentage of service connection associated with an injury is a quantifiable measure of the debilitating effect of injury on the individual. A significant majority (94%) of those who seek mental health services and treatment at VHA clinics apply for PTSD-related disability benefits.21 The estimated cost related to PTSD/TBI service-connected pensions is $20.28 billion per year and approximately $514 billion over 50 years.22 The cost of VA and Social Security disability payments combined with health care costs and treatment of PTSD is estimated to exceed $1 trillion over the next 30 years.22

The National Vietnam Veterans Readjustment Study (NVVRS) provided valuable information on prevalence rates of PTSD and other postwar psychological problems.23 Meanwhile, there have been no recent large-scale studies to compare the demographics of veterans diagnosed with PTSD and TBI who served prior to and after 9/11. A better understanding of demographic changes is considered essential for designing and tailoring therapeutic interventions to manage the rising cost.22

The present study focused on identifying changing trends in the demographics of veterans who served prior to and after 9/11 and who received a VA inpatient or outpatient diagnosis of PTSD and/or TBI. Specifically, this study addressed the changes in demographics of veterans with PTSD, TBI, or PTSD+TBI seen at the VHA clinics between December 1,1998 and May 31, 2014 (before and after September 11, 2001) for diagnosis, treatment and health care policy issues.

 

 

Methods

This study was approved by the Kansas City VA Medical Center Institutional Review Board. VHA data from the Corporate Data Warehouse (CDW) and the National Patient Care Database were extracted using the VA Informatics and Computing Infrastructure (VINCI) workspace. CDW uses a unique identifier to identify veterans across treatment episodes at more than 1,400 VHA centers organized under 21 Veterans Integrated Service Networks (VISNs). These sources of VA data are widely used for retrospective longitudinal studies.

Study Population

The study population consisted of 1,339,937 veterans with a VA inpatient/outpatient diagnosis of PTSD or TBI using International Statistical Classification of Diseases and Related Health Problems, Ninth Revision (ICD-9) codes between December 1, 1998 and May 31, 2014. Demographic (gender classification, race, ethnicity, marital status, age at date of data extraction, and date of death if indicated), service-connection disability rating, and geographic distribution within VISN data on each veteran were then extracted.

Veterans in the cohort were assigned to 1 of 4 US military services period groups. The pre-9/11 group included veterans who entered and left the military prior to September 11, 2001. This group mostly included veterans from World War II, Korean War, Vietnam War, and the first Gulf War (1990-1991). The post-9/11 group included veterans who first entered military services after September 11, 2001. The overlap group included veterans who entered military services prior to 9/11, remained in service and left after September 11, 2001. The reentered group included veterans who entered and left service prior to September 11, 2001, and then reentered military service after September 11, 2001 (Figure 1). Using ICD-9 codes, veterans also were placed into the following categories: PTSD alone (ICD-9 309.81 only), TBI alone (ICD-9 850.0-859.9, V15.52), and PTSD+TBI (any combination of ICD-9 codes from the other categories).

 

Statistical Analysis 

Descriptive statistics were applied using proportions and means. Relationships between variables were examined using χ2 tests, t tests, analysis of variance, and nonparametric tests. All hypotheses were 2-sided at 95% CI. Results are presented as absolute numbers.

Results

PTSD only (n = 1,132,356, 85%) was the predominant diagnosis category followed by PTSD+TBI (n = 106,792, 8%) and TBI only (n = 100,789, 7%) (Figure 2). Most of the veterans in the study served pre-9/11 (77%), followed by post-9/11 (15%); 7% were in the overlap group, and 1% in the reentered group (Table 1). It is notable that the proportion of veterans diagnosed with PTSD decreased from pre-9/11 (88%) to post-9/11 (71%), overlap (77%), and reentered (74%) service periods. Increases were noted in those with PTSD+TBI diagnosis category from pre-9/11 (4%) to post-9/11 (23%), overlap (17%), and reentered (22%) service periods (Figure 3). In general, the relative distribution of diagnostic categories in all the service periods showed a similar trend, with the majority of veterans diagnosed with PTSD only. Across all service periods, significantly smaller proportions of veterans were diagnosed with TBI only (P < .001).

   

Distribution by Gender and Age

The cohort was 92% male (n = 1,239,295), but there was a marked increase in the percentage of nonmale veterans in post-9/11 groups. Study population ages ranged from 18 to 99 years based on date of birth to the date data were obtained; or date of birth to date of death, for those who were reported deceased at the time the data were obtained. The average (SD) ages for veterans in the pre-9/11 group were significantly older (66.3 [11.2] years) compared with the ages of veterans in the post-9/11 group (36.1 [8.7] years), the overlap group (41.4 [8.2] years), and the reentered group (46.9 [9.2] years), respectively.

 

 

Distribution by Race and Marital Status

The cohort identified as 65.7% white and 18.2% African American with much smaller percentages of Asians, American Indian/Alaska Natives (AI/AN) and Native Hawaiian/Pacific Islanders (Table 2). The relative proportion of AI/AN and Native Hawaiian/Pacific Islanders remained constant across all groups, whereas the number of Asians diagnosed with PTSD, TBI, or PTSD+TBI increased in the post-9/11 group. The number of African Americans diagnosed with PTSD, TBI, or both markedly increased in the overlap and reentered groups when compared with the pre-9/11 group, yet it went down in the post-9/11/group.

Half the cohort identified themselves as married (n = 675,145) (Table 3). A slightly larger proportion of those diagnosed with PTSD alone were married (51.7%), compared with those diagnosed with TBI only (40.3%), or PTSD+TBI (45.8%). Veterans in the post-9/11 group were less likely to identify as married (45.2%) compared with the pre-9/11 (51.2%), overlap (52.6%), or reentered (53.2%) groups. Divorce rates among pre-9/11 group, overlap group, and reentered group were higher compared with that of the post-9/11 group in all diagnosis categories.

Geographic Distribution

Veterans diagnosed with PTSD, TBI, or both were not evenly distributed across the VISNs VISNs 7, 8, 10, and 22 treated the most veterans, whereas VISN 9 and 15 treated the fewest. Taken together, the top 3 VISNs accounted for 27% to 28% of the total while lowest 3 accounted for 8% to 9% of the total cohort.

 

Service-Connected Disability

Of 1,339,937 veterans in the cohort, 1,067,691 had a service-connected disability rating for PTSD and/or TBI. Most were diagnosed with PTSD (n = 923,523, 86.5%) followed by both PTSD+TBI (n = 94,051, 8.8%). Three-quarters of the veterans with a service-connected disability were in the pre-9/11 group. Nearly 80% of veterans with a service-connected disability rating had a rating of > 50%. The average (SD) age of veterans with PTSD+TBI and a > 50% service-connected disability was 66.3 (11.2) years in the pre-9/11 group compared with 36.1 (8.7) years in the post-9/11 group.

Discussion

The demographic profile of veterans diagnosed with PTSD+TBI has changed across the service periods covered in this study. Compared with pre-9/11 veterans, the post-9/11 cohort: (1) higher percentage were diagnosed with PTSD+TBI; (2) higher proportion were nonmale veterans; (3) included more young veterans with > 50% service-connected disability; (4) were more racially diverse; and (5) were less likely to be married and divorced and more likely to be self-identified as single. Additionally, data revealed that veterans tended to locate more to some geographic regions than to others.

The nature of the warfare has changed remarkably over the past few decades. Gunshot wounds accounted for 65% of all injuries in World War I, 35% during Vietnam War, and 16% to 23% in the First Gulf War.24 In post-9/11 military conflicts, 81% of injuries were explosion related.24,25 Although improvements in personal protective gear and battlefield trauma care led to increased survival, several factors may have contributed to increased reporting of TBI, which peaked in 2011 at 32,000 cases.24-26

 

 

Increases in PTSD Diagnosis

Increasing media awareness, mandatory battlefield concussion screening programs instituted by the US Department of Defense (DoD), and stressful conditions that exacerbate mild TBI (mTBI) may have all contributed to the increase in numbers of veterans seeking evaluations and being diagnosed with PTSD and/or TBI in the post-9/11 groups. Additionally, the 2007 National Defense Authorization Act requested the Secretary of Defense to develop a comprehensive, systematic approach for the identification, treatment, disposition, and documentation of TBI in combat and peacetime. By a conservative estimate, significant numbers of veterans will continue to be seen for mTBI at about 20,000 new cases per year.25-27

More frequent diagnosis of mTBI may have contributed to the increase in veterans diagnosed with PTSD+TBI in the post-9/11 groups. A recent study found that almost 44% of US Army infantry soldiers in Iraq did not lose consciousness but reported symptoms consistent with TBI.14 Compared with veterans of previous wars, veterans of the post-9/11 conflicts (OIF, OED, and OND) have experienced multiple, protracted deployments with infrequent breaks that can have a cumulative effect on the development of PTSD.8-10

The findings from the NVVRS study led to creation of specialized PTSD programs in the late 1980s. Since then, there has been an explosion of knowledge and awareness about PTSD, TBI, and the associated service-connected disability ratings and benefits, leading to an increased number of veterans seeking care for PTSD. For example, media coverage of the 50th anniversary of the D-day celebrations resulted in a surge of World War II veterans seeking treatment for PTSD and a surge of Vietnam veterans sought treatment for PTSD during the wars in Iraq and Afghanistan.28 An increased number of veterans reporting PTSD symptoms prompted the DoD to increase screening for PTSD, and to encourage service members to seek treatment when appropriate.

The VA has instituted training programs for clinicians and psychologists to screen and provide care for PTSD. Beginning in 2007, the VA implemented mandatory TBI screening for all veterans who served in combat operations and separated from active-duty service after September 11, 2001. The 4-question screen identifies veterans who are at increased risk of TBI and who experience symptoms that may be related to specific event(s).29 A positive screen does not diagnose TBI but rather indicates a need for further evaluation, which may or may not be responsible for inflated reporting of TBI. Renewed research also has led providers to recognize and study PTSD resulting from noncombat trauma and moral injury. The possibility of delayed onset also drives up the number of veterans diagnosed with PTSD.5-7

Prevalence

A wide variability exists in the reported prevalence of PTSD among US war veterans with estimates ranging from 15% to 20% of veterans from recent conflicts3,20 and 10% to 30% of veterans from previous wars.3,19 These rates are higher than estimates from allied forces from other countries.19 Meta-analyses suggest that the prevalence of PTSD is 2% to 15% among Vietnam War veterans, 1% to 13% among first (pre-9/11) Gulf War veterans, 4% to 17% among OEF/OIF/OND veterans; these veterans have a lifetime prevalence of 6% to 31%.3,11,19,30-38 The prevalence of PTSD is 2 to 4 times higher among the US veterans19,39 when compared with that of civilians.40,41 According to one study, concomitant PTSD and TBI appears to be much higher in US war veterans (4%-17%) compared with United Kingdom Iraq War veterans (3%-6%).19

 

 

This study’s finding of an increase in nonmale soldiers with PTSD and/or TBI was not surprising. There is a paucity of data on the effect of war zone exposure on women veterans. Recently, women have been more actively involved in combat roles with 41,000 women deployed to a combat zone. Results of this study indicate a 2- to 3-fold increase in veterans identifying themselves as nonmale in post-9/11 groups with a higher proportion diagnosed with either PTSD alone or PTSD and TBI. Women are at a higher risk for PTSD than are men due in part to exposure to abuse/trauma prior to deployment, experience of higher rates of discrimination, and/or sexual assault.31-33 One study involving First Gulf War female veterans reported higher precombat psychiatric histories as well as higher rates of physical and sexual abuse when compared with that of men.31

In this study, the average age of veterans adjudicated and compensated for PTSD and/or TBI pre-9/11, was 66 years compared with 36 years for post-9/11 veterans. Sixty-six percent of veterans from the post-9/11 group had ≥ 50% service-connected disability at age 36 years; 75% of veterans from the overlap group had ≥ 50% service-connected disability at age 41 years; and 76% veterans from the reentered group had ≥ 50% service-connected disability at age 46 years. Younger age at diagnosis and higher rates of disability not only pose unique challenges for veterans and family members, but also suggest implications for career prospects, family earnings, loss of productivity, and disease-adjusted life years. Also noted in the results, this younger cohort has a higher percentage of single/unmarried veterans, suggesting familial support systems may be more parental than spousal. Treatment for this younger cohort will likely need to focus on early and sustained rehabilitation that can be integrated with career plans.

For treatment to be effective, there must be evidence for veterans enrolling, remaining, and reporting benefits from the treatment. Limited research has shown currently advocated evidence-based therapies to have low enrollment rates, high drop-out rates, and mixed outcomes.42

Results showing a gradual increase in the proportion of nonwhite, non-African American veterans diagnosed with PTSD alone, TBI alone, or both, likely reflect the changing demographic profile of the US as well as the Army. However, the reason that more African Americans were diagnosed with PTSD and/or TBI in the overlap and reentered groups when compared with the pre-9/11 group could not be ascertained. It is possible that more veterans identified themselves as African Americans as evident from a decrease in the number of veterans in the unknown category post-9/11 when compared with the pre-9/11 group. In 2016, the American Community Survey showed that Hispanic and African American veterans were more likely to use VA health care and other benefits than were any other racial group.40 Improved screening for PTSD and TBI diagnoses, increased awareness, and education about the availability of VA services and benefits may have contributed to the increased use of VA benefits in these groups.

Data from this study are concordant with data from the National Center for Veterans Analysis and Statistics reporting on the younger age of diagnosis and higher rates of initial service-connected disability in veterans with PTSD and PTSD+TBI.43 One study analyzing records from 1999 to 2004 showed that the number of PTSD cases grew by 79.5%, resulting in 148.7% increase in benefits payment from $1.7 billion to $4.3 billion per year.44 In contrast, the compensation cost for all other disability categories increased by only 41.7% over this period. This study also revealed that while veterans with PTSD represented only 8.7% of compensation recipients, they received 20.5% of all compensation payments, driven in large part by an increase in > 50% service-connected disability ratings.44

Thus, from financial as well as treatment points of view, the change in the demographic profile of the veteran must be considered when developing PTSD treatment strategies. While treatment in the past focused solely on addressing trauma-associated psychiatric issues, TBI and PTSD association will likely shift the focus to concurrent psychiatric and physical symptomology. Similarly, PTSD/TBI treatment modalities must consider that the profile of post-9/11 service members includes more women, younger age, and a greater racial diversity. For instance, younger age for a disabled veteran brings additional challenges, including reliance on parental or buddy support systems vs a spousal support system, integrating career with treatment, selecting geographic locations that can support both career and treatment, sustaining rehabilitation over time. The treatment needs of a 35-year-old soldier with PTSD and/or TBI, whether male or female, Asian or African American are likely to be very different from the treatment needs of a 65-year-old white male. Newer treatment approaches will have to address the needs of all soldiers.

 

 

Limitations

Our study may underestimate the actual PTSD and/or TBI disease burden because of the social stigma associated with diagnosis, military culture, limitations in data collection.45-50 In addition, in this retrospective database cohort study, we considered and tried to minimize the impact of any of the usual potential limitations, including (1) accuracy of data quality and linkage; (2) identifying cohort appropriately (study groups); (3) defining endpoints clearly to avoid misclassifications; and (4) incorporating all important confounders. We identified veterans utilizing medical services at VA hospitals during a defined period and diagnosed with PTSD and TBI using ICD-9 codes and divided in 4 well-defined groups. In addition, another limitation of our study is to not accurately capture the veterans who have alternative health coverage and may choose not to enroll and/or participate in VA health care. In addition, some service members leaving war zones may not disclose or downplay the mental health symptoms to avoid any delay in their return home.

Conclusions

This study highlights the changing profile of the soldier diagnosed with PTSD and/or TBI who served pre-9/11 compared with that of those who served post-9/11. Treatment modalities must address the changes in warfare and demographics of US service members. Future treatment will need to focus more on concurrent PTSD/TBI therapies, the needs of younger soldiers, the needs of women injured in combat, and the needs of a more racially and ethnically diverse population. Severe injuries at a younger age will require early detection and rehabilitation for return to optimum functioning over a lifetime. The current study underscores a need for identifying the gaps in ongoing programs and services, developing alternatives, and implementing improved systems of care. More studies are needed to identify the cost implications and the effectiveness of current therapies for PTSD and/or TBI.

Acknowledgments

This study was supported by VA Medical Center and Midwest BioMedical Research Foundation (MBRF), Kansas City, Missouri. The manuscript received support, in part, from NIH-RO1 DK107490. These agencies did not participate in the design/conduct of the study or, in the interpretation of the data.

The nature of combat and associated injuries in Operation Iraqi Freedom (OIF), Operation Enduring Freedom (OEF), Operation New Dawn (OND), and Afghanistan War is different from previous conflicts. Multiple protracted deployments with infrequent breaks after September 11, 2001 (9/11) have further compounded the problem.

Posttraumatic stress disorder (PTSD) and traumatic brain injury (TBI) are the signature wounds of recent wars, with a higher incidence among the veterans of OEF and OIF compared with those from previous conflicts.1,2 More than 2.7 million who served in Iraq and Afghanistan suffer from PTSD.3,4 Symptoms of PTSD may appear within the first 3 months after exposure to a traumatic event or after many months and, in some cases, after a delay of many years and continue for life.5 Although delayed onset of PTSD in the absence of prior symptoms is rare,6,7 its incidence rises with increasing frequency of exposure to traumatic events8,9 and over time.10

According to the Brain Injury Association of America, TBI is “an alteration in brain function, or other evidence of brain pathology, caused by an external force.”8 TBI is often associated with increased risk of PTSD, depression, and posttraumatic headache,11-13 which may lead to broader cognitive, somatic, neurobiological, and psychosocial dysfunctions.14-17 According to Veterans Health Administration (VHA) data, 201,435 veterans from all eras enrolled with the US Department of Veterans Affairs (VA) have a diagnosis associated with TBI and 56,695 OEF/OIF veterans have been evaluated for a TBI-related condition.2 According to the Defense and Veterans Brain Injury Center (DVBIC), > 361,000 veterans have been diagnosed with TBI, with a peak of 32,000 cases in 2011.1,18 Moreover, the reported incidence and prevalence of PTSD and TBI among US veterans are not consistent. The incidence of PTSD has been estimated at 15% to 20% in recent wars3,19 compared with 10% to 30% in previous wars.3,19,20

When PTSD or TBI is deemed “related” to military service, the veteran may receive a service-connected disability rating ranging from 0% (no life-interfering symptoms due to injury) to 100% (totally disabling injury). The percentage of service connection associated with an injury is a quantifiable measure of the debilitating effect of injury on the individual. A significant majority (94%) of those who seek mental health services and treatment at VHA clinics apply for PTSD-related disability benefits.21 The estimated cost related to PTSD/TBI service-connected pensions is $20.28 billion per year and approximately $514 billion over 50 years.22 The cost of VA and Social Security disability payments combined with health care costs and treatment of PTSD is estimated to exceed $1 trillion over the next 30 years.22

The National Vietnam Veterans Readjustment Study (NVVRS) provided valuable information on prevalence rates of PTSD and other postwar psychological problems.23 Meanwhile, there have been no recent large-scale studies to compare the demographics of veterans diagnosed with PTSD and TBI who served prior to and after 9/11. A better understanding of demographic changes is considered essential for designing and tailoring therapeutic interventions to manage the rising cost.22

The present study focused on identifying changing trends in the demographics of veterans who served prior to and after 9/11 and who received a VA inpatient or outpatient diagnosis of PTSD and/or TBI. Specifically, this study addressed the changes in demographics of veterans with PTSD, TBI, or PTSD+TBI seen at the VHA clinics between December 1,1998 and May 31, 2014 (before and after September 11, 2001) for diagnosis, treatment and health care policy issues.

 

 

Methods

This study was approved by the Kansas City VA Medical Center Institutional Review Board. VHA data from the Corporate Data Warehouse (CDW) and the National Patient Care Database were extracted using the VA Informatics and Computing Infrastructure (VINCI) workspace. CDW uses a unique identifier to identify veterans across treatment episodes at more than 1,400 VHA centers organized under 21 Veterans Integrated Service Networks (VISNs). These sources of VA data are widely used for retrospective longitudinal studies.

Study Population

The study population consisted of 1,339,937 veterans with a VA inpatient/outpatient diagnosis of PTSD or TBI using International Statistical Classification of Diseases and Related Health Problems, Ninth Revision (ICD-9) codes between December 1, 1998 and May 31, 2014. Demographic (gender classification, race, ethnicity, marital status, age at date of data extraction, and date of death if indicated), service-connection disability rating, and geographic distribution within VISN data on each veteran were then extracted.

Veterans in the cohort were assigned to 1 of 4 US military services period groups. The pre-9/11 group included veterans who entered and left the military prior to September 11, 2001. This group mostly included veterans from World War II, Korean War, Vietnam War, and the first Gulf War (1990-1991). The post-9/11 group included veterans who first entered military services after September 11, 2001. The overlap group included veterans who entered military services prior to 9/11, remained in service and left after September 11, 2001. The reentered group included veterans who entered and left service prior to September 11, 2001, and then reentered military service after September 11, 2001 (Figure 1). Using ICD-9 codes, veterans also were placed into the following categories: PTSD alone (ICD-9 309.81 only), TBI alone (ICD-9 850.0-859.9, V15.52), and PTSD+TBI (any combination of ICD-9 codes from the other categories).

 

Statistical Analysis 

Descriptive statistics were applied using proportions and means. Relationships between variables were examined using χ2 tests, t tests, analysis of variance, and nonparametric tests. All hypotheses were 2-sided at 95% CI. Results are presented as absolute numbers.

Results

PTSD only (n = 1,132,356, 85%) was the predominant diagnosis category followed by PTSD+TBI (n = 106,792, 8%) and TBI only (n = 100,789, 7%) (Figure 2). Most of the veterans in the study served pre-9/11 (77%), followed by post-9/11 (15%); 7% were in the overlap group, and 1% in the reentered group (Table 1). It is notable that the proportion of veterans diagnosed with PTSD decreased from pre-9/11 (88%) to post-9/11 (71%), overlap (77%), and reentered (74%) service periods. Increases were noted in those with PTSD+TBI diagnosis category from pre-9/11 (4%) to post-9/11 (23%), overlap (17%), and reentered (22%) service periods (Figure 3). In general, the relative distribution of diagnostic categories in all the service periods showed a similar trend, with the majority of veterans diagnosed with PTSD only. Across all service periods, significantly smaller proportions of veterans were diagnosed with TBI only (P < .001).

   

Distribution by Gender and Age

The cohort was 92% male (n = 1,239,295), but there was a marked increase in the percentage of nonmale veterans in post-9/11 groups. Study population ages ranged from 18 to 99 years based on date of birth to the date data were obtained; or date of birth to date of death, for those who were reported deceased at the time the data were obtained. The average (SD) ages for veterans in the pre-9/11 group were significantly older (66.3 [11.2] years) compared with the ages of veterans in the post-9/11 group (36.1 [8.7] years), the overlap group (41.4 [8.2] years), and the reentered group (46.9 [9.2] years), respectively.

 

 

Distribution by Race and Marital Status

The cohort identified as 65.7% white and 18.2% African American with much smaller percentages of Asians, American Indian/Alaska Natives (AI/AN) and Native Hawaiian/Pacific Islanders (Table 2). The relative proportion of AI/AN and Native Hawaiian/Pacific Islanders remained constant across all groups, whereas the number of Asians diagnosed with PTSD, TBI, or PTSD+TBI increased in the post-9/11 group. The number of African Americans diagnosed with PTSD, TBI, or both markedly increased in the overlap and reentered groups when compared with the pre-9/11 group, yet it went down in the post-9/11/group.

Half the cohort identified themselves as married (n = 675,145) (Table 3). A slightly larger proportion of those diagnosed with PTSD alone were married (51.7%), compared with those diagnosed with TBI only (40.3%), or PTSD+TBI (45.8%). Veterans in the post-9/11 group were less likely to identify as married (45.2%) compared with the pre-9/11 (51.2%), overlap (52.6%), or reentered (53.2%) groups. Divorce rates among pre-9/11 group, overlap group, and reentered group were higher compared with that of the post-9/11 group in all diagnosis categories.

Geographic Distribution

Veterans diagnosed with PTSD, TBI, or both were not evenly distributed across the VISNs VISNs 7, 8, 10, and 22 treated the most veterans, whereas VISN 9 and 15 treated the fewest. Taken together, the top 3 VISNs accounted for 27% to 28% of the total while lowest 3 accounted for 8% to 9% of the total cohort.

 

Service-Connected Disability

Of 1,339,937 veterans in the cohort, 1,067,691 had a service-connected disability rating for PTSD and/or TBI. Most were diagnosed with PTSD (n = 923,523, 86.5%) followed by both PTSD+TBI (n = 94,051, 8.8%). Three-quarters of the veterans with a service-connected disability were in the pre-9/11 group. Nearly 80% of veterans with a service-connected disability rating had a rating of > 50%. The average (SD) age of veterans with PTSD+TBI and a > 50% service-connected disability was 66.3 (11.2) years in the pre-9/11 group compared with 36.1 (8.7) years in the post-9/11 group.

Discussion

The demographic profile of veterans diagnosed with PTSD+TBI has changed across the service periods covered in this study. Compared with pre-9/11 veterans, the post-9/11 cohort: (1) higher percentage were diagnosed with PTSD+TBI; (2) higher proportion were nonmale veterans; (3) included more young veterans with > 50% service-connected disability; (4) were more racially diverse; and (5) were less likely to be married and divorced and more likely to be self-identified as single. Additionally, data revealed that veterans tended to locate more to some geographic regions than to others.

The nature of the warfare has changed remarkably over the past few decades. Gunshot wounds accounted for 65% of all injuries in World War I, 35% during Vietnam War, and 16% to 23% in the First Gulf War.24 In post-9/11 military conflicts, 81% of injuries were explosion related.24,25 Although improvements in personal protective gear and battlefield trauma care led to increased survival, several factors may have contributed to increased reporting of TBI, which peaked in 2011 at 32,000 cases.24-26

 

 

Increases in PTSD Diagnosis

Increasing media awareness, mandatory battlefield concussion screening programs instituted by the US Department of Defense (DoD), and stressful conditions that exacerbate mild TBI (mTBI) may have all contributed to the increase in numbers of veterans seeking evaluations and being diagnosed with PTSD and/or TBI in the post-9/11 groups. Additionally, the 2007 National Defense Authorization Act requested the Secretary of Defense to develop a comprehensive, systematic approach for the identification, treatment, disposition, and documentation of TBI in combat and peacetime. By a conservative estimate, significant numbers of veterans will continue to be seen for mTBI at about 20,000 new cases per year.25-27

More frequent diagnosis of mTBI may have contributed to the increase in veterans diagnosed with PTSD+TBI in the post-9/11 groups. A recent study found that almost 44% of US Army infantry soldiers in Iraq did not lose consciousness but reported symptoms consistent with TBI.14 Compared with veterans of previous wars, veterans of the post-9/11 conflicts (OIF, OED, and OND) have experienced multiple, protracted deployments with infrequent breaks that can have a cumulative effect on the development of PTSD.8-10

The findings from the NVVRS study led to creation of specialized PTSD programs in the late 1980s. Since then, there has been an explosion of knowledge and awareness about PTSD, TBI, and the associated service-connected disability ratings and benefits, leading to an increased number of veterans seeking care for PTSD. For example, media coverage of the 50th anniversary of the D-day celebrations resulted in a surge of World War II veterans seeking treatment for PTSD and a surge of Vietnam veterans sought treatment for PTSD during the wars in Iraq and Afghanistan.28 An increased number of veterans reporting PTSD symptoms prompted the DoD to increase screening for PTSD, and to encourage service members to seek treatment when appropriate.

The VA has instituted training programs for clinicians and psychologists to screen and provide care for PTSD. Beginning in 2007, the VA implemented mandatory TBI screening for all veterans who served in combat operations and separated from active-duty service after September 11, 2001. The 4-question screen identifies veterans who are at increased risk of TBI and who experience symptoms that may be related to specific event(s).29 A positive screen does not diagnose TBI but rather indicates a need for further evaluation, which may or may not be responsible for inflated reporting of TBI. Renewed research also has led providers to recognize and study PTSD resulting from noncombat trauma and moral injury. The possibility of delayed onset also drives up the number of veterans diagnosed with PTSD.5-7

Prevalence

A wide variability exists in the reported prevalence of PTSD among US war veterans with estimates ranging from 15% to 20% of veterans from recent conflicts3,20 and 10% to 30% of veterans from previous wars.3,19 These rates are higher than estimates from allied forces from other countries.19 Meta-analyses suggest that the prevalence of PTSD is 2% to 15% among Vietnam War veterans, 1% to 13% among first (pre-9/11) Gulf War veterans, 4% to 17% among OEF/OIF/OND veterans; these veterans have a lifetime prevalence of 6% to 31%.3,11,19,30-38 The prevalence of PTSD is 2 to 4 times higher among the US veterans19,39 when compared with that of civilians.40,41 According to one study, concomitant PTSD and TBI appears to be much higher in US war veterans (4%-17%) compared with United Kingdom Iraq War veterans (3%-6%).19

 

 

This study’s finding of an increase in nonmale soldiers with PTSD and/or TBI was not surprising. There is a paucity of data on the effect of war zone exposure on women veterans. Recently, women have been more actively involved in combat roles with 41,000 women deployed to a combat zone. Results of this study indicate a 2- to 3-fold increase in veterans identifying themselves as nonmale in post-9/11 groups with a higher proportion diagnosed with either PTSD alone or PTSD and TBI. Women are at a higher risk for PTSD than are men due in part to exposure to abuse/trauma prior to deployment, experience of higher rates of discrimination, and/or sexual assault.31-33 One study involving First Gulf War female veterans reported higher precombat psychiatric histories as well as higher rates of physical and sexual abuse when compared with that of men.31

In this study, the average age of veterans adjudicated and compensated for PTSD and/or TBI pre-9/11, was 66 years compared with 36 years for post-9/11 veterans. Sixty-six percent of veterans from the post-9/11 group had ≥ 50% service-connected disability at age 36 years; 75% of veterans from the overlap group had ≥ 50% service-connected disability at age 41 years; and 76% veterans from the reentered group had ≥ 50% service-connected disability at age 46 years. Younger age at diagnosis and higher rates of disability not only pose unique challenges for veterans and family members, but also suggest implications for career prospects, family earnings, loss of productivity, and disease-adjusted life years. Also noted in the results, this younger cohort has a higher percentage of single/unmarried veterans, suggesting familial support systems may be more parental than spousal. Treatment for this younger cohort will likely need to focus on early and sustained rehabilitation that can be integrated with career plans.

For treatment to be effective, there must be evidence for veterans enrolling, remaining, and reporting benefits from the treatment. Limited research has shown currently advocated evidence-based therapies to have low enrollment rates, high drop-out rates, and mixed outcomes.42

Results showing a gradual increase in the proportion of nonwhite, non-African American veterans diagnosed with PTSD alone, TBI alone, or both, likely reflect the changing demographic profile of the US as well as the Army. However, the reason that more African Americans were diagnosed with PTSD and/or TBI in the overlap and reentered groups when compared with the pre-9/11 group could not be ascertained. It is possible that more veterans identified themselves as African Americans as evident from a decrease in the number of veterans in the unknown category post-9/11 when compared with the pre-9/11 group. In 2016, the American Community Survey showed that Hispanic and African American veterans were more likely to use VA health care and other benefits than were any other racial group.40 Improved screening for PTSD and TBI diagnoses, increased awareness, and education about the availability of VA services and benefits may have contributed to the increased use of VA benefits in these groups.

Data from this study are concordant with data from the National Center for Veterans Analysis and Statistics reporting on the younger age of diagnosis and higher rates of initial service-connected disability in veterans with PTSD and PTSD+TBI.43 One study analyzing records from 1999 to 2004 showed that the number of PTSD cases grew by 79.5%, resulting in 148.7% increase in benefits payment from $1.7 billion to $4.3 billion per year.44 In contrast, the compensation cost for all other disability categories increased by only 41.7% over this period. This study also revealed that while veterans with PTSD represented only 8.7% of compensation recipients, they received 20.5% of all compensation payments, driven in large part by an increase in > 50% service-connected disability ratings.44

Thus, from financial as well as treatment points of view, the change in the demographic profile of the veteran must be considered when developing PTSD treatment strategies. While treatment in the past focused solely on addressing trauma-associated psychiatric issues, TBI and PTSD association will likely shift the focus to concurrent psychiatric and physical symptomology. Similarly, PTSD/TBI treatment modalities must consider that the profile of post-9/11 service members includes more women, younger age, and a greater racial diversity. For instance, younger age for a disabled veteran brings additional challenges, including reliance on parental or buddy support systems vs a spousal support system, integrating career with treatment, selecting geographic locations that can support both career and treatment, sustaining rehabilitation over time. The treatment needs of a 35-year-old soldier with PTSD and/or TBI, whether male or female, Asian or African American are likely to be very different from the treatment needs of a 65-year-old white male. Newer treatment approaches will have to address the needs of all soldiers.

 

 

Limitations

Our study may underestimate the actual PTSD and/or TBI disease burden because of the social stigma associated with diagnosis, military culture, limitations in data collection.45-50 In addition, in this retrospective database cohort study, we considered and tried to minimize the impact of any of the usual potential limitations, including (1) accuracy of data quality and linkage; (2) identifying cohort appropriately (study groups); (3) defining endpoints clearly to avoid misclassifications; and (4) incorporating all important confounders. We identified veterans utilizing medical services at VA hospitals during a defined period and diagnosed with PTSD and TBI using ICD-9 codes and divided in 4 well-defined groups. In addition, another limitation of our study is to not accurately capture the veterans who have alternative health coverage and may choose not to enroll and/or participate in VA health care. In addition, some service members leaving war zones may not disclose or downplay the mental health symptoms to avoid any delay in their return home.

Conclusions

This study highlights the changing profile of the soldier diagnosed with PTSD and/or TBI who served pre-9/11 compared with that of those who served post-9/11. Treatment modalities must address the changes in warfare and demographics of US service members. Future treatment will need to focus more on concurrent PTSD/TBI therapies, the needs of younger soldiers, the needs of women injured in combat, and the needs of a more racially and ethnically diverse population. Severe injuries at a younger age will require early detection and rehabilitation for return to optimum functioning over a lifetime. The current study underscores a need for identifying the gaps in ongoing programs and services, developing alternatives, and implementing improved systems of care. More studies are needed to identify the cost implications and the effectiveness of current therapies for PTSD and/or TBI.

Acknowledgments

This study was supported by VA Medical Center and Midwest BioMedical Research Foundation (MBRF), Kansas City, Missouri. The manuscript received support, in part, from NIH-RO1 DK107490. These agencies did not participate in the design/conduct of the study or, in the interpretation of the data.

References

1. Bagalman E. Traumatic brain injury among veterans. http://www.ncsl.org/documents/statefed/health/TBI_Vets2013.pdf. Published January 4, 2013. Accessed February 3, 2020.

2. Veterans Health Administration, Support Service Center. Workload files fiscal year 2008-fiscal year 2012. [Source not verified.]

3. Tanielian T, Jaycox LH, eds. Invisible Wounds of War: Psychological and Cognitive Injuries, Their Consequences, and Services to Assist Recovery. Santa Monica, CA: RAND Corporation; 2008.

4. Bagalman E. Health care for veterans: traumatic brain injury. https://fas.org/sgp/crs/misc/R40941.pdf. Published March 9, 2015. Accessed February 4, 2020.

5. Ikin JF, Sim MR, McKenzie DP, et al. Anxiety, post-traumatic stress disorder and depression in Korean War veterans 50 years after the war. Br J Psychiatry. 2007;190(6):475-483.

6. Andrews B, Brewin CR, Philpott R, Stewart L. Delayed-onset posttraumatic stress disorder: a systematic review of the evidence. Am J Psychiatry. 2007;164(9):1319-1326.

7. Frueh BC, Grubaugh AL, Yeager DE, Magruder KM. Delayed-onset post-traumatic stress disorder among war veterans in primary care clinics. Br J Psychiatry. 2009;194(6):515-520.

8. McAllister TW. Neurobiological consequences of traumatic brain injury. Dialogues Clin Neurosci. 2011;13(3):287-300.

9. Schlenger WE, Kulka RA, Fairbank JA, et al. The prevalence of posttraumatic stress disorder in the Vietnam generation: a multimethod, multisource assessment of psychiatric disorder. J Trauma Stress. 1992;5(3):333-363.

10. Friedman MJ, Resick PA, Bryant RA, Strain J, Horowitz M, Spiegel D. Classification of trauma and stressor-related disorders in DSM-5. Depress Anxiety. 2011;28(9):737-749.

11. Lew HL, Otis JD, Tun C, Kerns RD, Clark ME, Cifu DX. Prevalence of chronic pain, posttraumatic stress disorder, and persistent postconcussive symptoms in OIF/OEF veterans: polytrauma clinical triad. J Rehabil Res Dev. 2009;46(6):697-702.

12. Carlson K, Kehle S, Meis L, et al. The Assessment and Treatment of Individuals with History of Traumatic Brain Injury and Post-Traumatic Stress Disorder: A Systematic Review of the Evidence. Washington, DC: US Department of Veterans Affairs; 2009.

13. Gironda RJ, Clark ME, Ruff RL, et al. Traumatic brain injury, polytrauma, and pain: challenges and treatment strategies for the polytrauma rehabilitation. Rehabil Psychol. 2009;54(3):247-258. 

14. Hoge CW, McGurk D, Thomas JL, Cox AL, Engel CC, Castro CA. Mild traumatic brain injury in U.S. soldiers returning from Iraq. N Engl J Med. 2008;358(5):453-463.

15. Bazarian JJ, Cernak I, Noble-Haeusslein L, Potolicchio S, Temkin N. Long-term neurologic outcomes after traumatic brain injury. J Head Trauma Rehabil. 2009;24(6):439-451.

16. Peskind ER, Brody D, Cernak I, McKee A, Ruff RL. Military- and sports-related mild traumatic brain injury: clinical presentation, management, and long-term consequences. J Clin Psychiatry. 2013;74(2):180-188.

17. Riggio S. Traumatic brain injury and its neurobehavioral sequelae. Neurol Clin. 2011;29(1):35-47, vii.

18. Helmick KM, Spells CA, Malik SZ, Davies CA, Marion DW, Hinds SR. Traumatic brain injury in the US military: epidemiology and key clinical and research programs. Brain Imaging Behav. 2015;9(3):358-366.

19. Richardson LK, Frueh BC, Acierno R. Prevalence estimates of combat-related post-traumatic stress disorder: critical review. Aust N Z J Psychiatry. 2010;44(1):4-19.

20. Thompson WW, Gottesman II, Zalewski C. Reconciling disparate prevalence rates of PTSD in large samples of US male Vietnam veterans and their controls. BMC Psychiatry. 2006;6:19.

21. Frueh BC, Elhai JD, Gold PB, et al Disability compensation seeking among veterans evaluated for posttraumatic stress disorder. Psychiatr Serv. 2003;54(1):84-91.

22. Thakur H, Oni O, Singh V, et al. Increases in the service connection disability and treatment costs associated with posttraumatic stress disorder and/or traumatic brain injury in United States veterans pre- and post-9/11: the strong need for a novel therapeutic approach. Epidemiology (Sunnyvale). 2018;8(4):353.

23. Schlenger WE, Kulka RA, Fairbank JA, et al. The prevalence of post-traumatic stress disorder in the Vietnam generation: a multimethod, multisource assessment of psychiatric disorder. J Trauma Stress. 1992;5(3):333-363.

24. Belmont PJ, Schoenfeld AJ, Goodman G. Epidemiology of combat wounds in Operation Iraqi Freedom and Operation Enduring Freedom: orthopaedic burden of disease. J Surg Orthop Adv. 2010;19(1):2-7.

25. Owens BD, Kragh JG Jr, Wenke JC, Macaitis J, Wade CE, Holcomb JB. Combat wounds in Operation Iraqi Freedom and Operation Enduring Freedom. J Trauma. 2008;64(2):295-299.

26. Defense Health Agency, Defense and Veterans Brain Injury Center. DOD worldwide numbers for TBI since 2000. https://dvbic.dcoe.mil/dod-worldwide-numbers-tbi. Updated February 14, 2020. Accessed February 14, 2020.

27. Armed Forces Health Surveillance Center. Deployment-related conditions of special surveillance interest, U.S. armed forces, by month and service, January 2003-December 2012 (data as of 22 January 2013). MSMR. 2013;20(1):16-19.

28. Harvey JH, Stein SK, Scott PK. Fifty years of grief: accounts and reported psychological reactions of Normandy invasion veterans. J Narrative Life History. 1995;5(4):321-332.

29. US Department of Veterans Affairs. Polytrauma/TBI system of care. https://www.polytrauma.va.gov/system-of-care/index.asp. Updated June 3, 2015. Accessed February 4, 2020.

30. Wolfe J, Erickson DJ, Sharkansky EJ, King DW, King LA. Course and predictors of posttraumatic stress disorder among Gulf War veterans: a prospective analysis. J Consult Clin Psychol. 1999;67(4):520-528.

31. Breslau N, Davis GC, Peterson EL, Schultz L. Psychiatric sequelae of posttraumatic stress disorder in women. Arch Gen Psychiatry. 1997;54(1):81-87.

32. Kessler RC, Sonnega A, Bromet E, Hughes M, Nelson CB. Posttraumatic stress disorder in the National Comorbidity Survey. Arch Gen Psychiatry. 1995;52(12):1048-1060.

33. Wolfe J, Kimerling R. Gender issues in the assessment of posttraumatic stress disorder. In: Wilson J, Keane TM, eds. Assessing Psychological Trauma and PTSD. New York: Guilford; 2004:192-238.

34. Engel CC Jr, Engel AL, Campbell SJ, McFall ME, Russo J, Katon W. Posttraumatic stress disorder symptoms and precombat sexual and physical abuse in Desert Storm veterans. J Nerv Ment Dis. 1993;181(11):683-688.

35. US Department of Veterans Affairs, National Center for Veterans Analysis and Statistics. Profile of veterans: 2016 data from the American Community Survey. https://www.va.gov/vetdata/docs/SpecialReports/Profile_of_Veterans_2016.pdf. Published February 2018. Accessed February 4, 2020.

36. US Department of Commerce Economics and Statistics Administration, US Census Bureau, Geography Division. 2010 population distribution in the United States and Puerto Rico. https://www2.census.gov/geo/maps/dc10_thematic/2010_Nighttime_PopDist/2010_Nighttime_PopDist_Page_Map.pdf. Accessed February 4, 2020.

37. Cifu DX, Taylor BC, Carne WF, et al. Traumatic brain injury, posttraumatic stress disorder, and pain diagnoses in OIF/OEF/OND veterans. J Rehabil Res Dev. 2013;50(9):1169-1176.

38. Dohrenwend BP, Turner JB, Turse NA, Adams BG, Koenen KC, Marshall R. The psychological risks of Vietnam for U.S. veterans: a revisit with new data and methods. Science. 2006;313(5789):979-982.

39. Magruder KM, Frueh BC, Knapp RG, et al. Prevalence of posttraumatic stress disorder in Veterans Affairs primary care clinics. Gen Hosp Psychiatry. 2005;27(3):169-179.

40. Norris FH. Epidemiology of trauma: frequency and impact of different potentially traumatic events on different demographic groups. J Consult Clin Psychol. 1992;60(3):409-418.

41. Resnick HS, Kilpatrick DG, Dansky BS, Saunders BE, Best CL. Prevalence of civilian trauma and posttraumatic stress disorder in a representative national sample of women. J Consult Clin Psychol. 1993;61(6):984-991.

42. Najavits LM. The problem of dropout from “gold standard” PTSD therapies. F1000Prime Rep. 2015;7:43.

43. US Department of Veterans Affairs, National Center for Veterans Analysis and Statistics. Trends in veterans with a service-connected disability: 1985 to 2014. https://www.va.gov/vetdata/docs/QuickFacts/SCD_trends_FINAL_2014.PDF. Published June 2015. Accessed February 4, 2020.

44. US Department of Veterans Affairs, Office of Inspector General. Review of state variances in VA disability compensation payments. Report 05-00765-137. https://www.va.gov/oig/52/reports/2005/VAOIG-05-00765-137.pdf. Published May 19, 2015. Accessed February 4, 2020.

45. McNally RJ. Progress and controversy in the study of posttraumatic stress disorder. Annu Rev Psychol. 2003;54:229-252.

46. Freeman T, Powell M, Kimbrell T. Measuring symptom exaggeration in veterans with chronic posttraumatic stress disorder. Psychiatry Res. 2008;158(3):374-380.

47. Frueh BC, Elhai JD, Grubaugh AL, et al. Documented combat exposure of US veterans seeking treatment for combat-related post-traumatic stress disorder. Br J Psychiatry. 2005;186(6):467-475.

48. Frueh BC, Hamner MB, Cahill SP, Gold PB, Hamlin KL. Apparent symptom overreporting in combat veterans evaluated for PTSD. Clin Psychol Rev. 2000;20(7):853-885.

49. Sparr L, Pankratz LD. Factitious posttraumatic stress disorder. Am J Psychiatry. 1983;140(8):1016-1019.

50. Baggaley M. ‘Military Munchausen’s’: assessment of factitious claims of military service in psychiatric patients. Psychiatr Bull. 1998;22(3):153-154.

References

1. Bagalman E. Traumatic brain injury among veterans. http://www.ncsl.org/documents/statefed/health/TBI_Vets2013.pdf. Published January 4, 2013. Accessed February 3, 2020.

2. Veterans Health Administration, Support Service Center. Workload files fiscal year 2008-fiscal year 2012. [Source not verified.]

3. Tanielian T, Jaycox LH, eds. Invisible Wounds of War: Psychological and Cognitive Injuries, Their Consequences, and Services to Assist Recovery. Santa Monica, CA: RAND Corporation; 2008.

4. Bagalman E. Health care for veterans: traumatic brain injury. https://fas.org/sgp/crs/misc/R40941.pdf. Published March 9, 2015. Accessed February 4, 2020.

5. Ikin JF, Sim MR, McKenzie DP, et al. Anxiety, post-traumatic stress disorder and depression in Korean War veterans 50 years after the war. Br J Psychiatry. 2007;190(6):475-483.

6. Andrews B, Brewin CR, Philpott R, Stewart L. Delayed-onset posttraumatic stress disorder: a systematic review of the evidence. Am J Psychiatry. 2007;164(9):1319-1326.

7. Frueh BC, Grubaugh AL, Yeager DE, Magruder KM. Delayed-onset post-traumatic stress disorder among war veterans in primary care clinics. Br J Psychiatry. 2009;194(6):515-520.

8. McAllister TW. Neurobiological consequences of traumatic brain injury. Dialogues Clin Neurosci. 2011;13(3):287-300.

9. Schlenger WE, Kulka RA, Fairbank JA, et al. The prevalence of posttraumatic stress disorder in the Vietnam generation: a multimethod, multisource assessment of psychiatric disorder. J Trauma Stress. 1992;5(3):333-363.

10. Friedman MJ, Resick PA, Bryant RA, Strain J, Horowitz M, Spiegel D. Classification of trauma and stressor-related disorders in DSM-5. Depress Anxiety. 2011;28(9):737-749.

11. Lew HL, Otis JD, Tun C, Kerns RD, Clark ME, Cifu DX. Prevalence of chronic pain, posttraumatic stress disorder, and persistent postconcussive symptoms in OIF/OEF veterans: polytrauma clinical triad. J Rehabil Res Dev. 2009;46(6):697-702.

12. Carlson K, Kehle S, Meis L, et al. The Assessment and Treatment of Individuals with History of Traumatic Brain Injury and Post-Traumatic Stress Disorder: A Systematic Review of the Evidence. Washington, DC: US Department of Veterans Affairs; 2009.

13. Gironda RJ, Clark ME, Ruff RL, et al. Traumatic brain injury, polytrauma, and pain: challenges and treatment strategies for the polytrauma rehabilitation. Rehabil Psychol. 2009;54(3):247-258. 

14. Hoge CW, McGurk D, Thomas JL, Cox AL, Engel CC, Castro CA. Mild traumatic brain injury in U.S. soldiers returning from Iraq. N Engl J Med. 2008;358(5):453-463.

15. Bazarian JJ, Cernak I, Noble-Haeusslein L, Potolicchio S, Temkin N. Long-term neurologic outcomes after traumatic brain injury. J Head Trauma Rehabil. 2009;24(6):439-451.

16. Peskind ER, Brody D, Cernak I, McKee A, Ruff RL. Military- and sports-related mild traumatic brain injury: clinical presentation, management, and long-term consequences. J Clin Psychiatry. 2013;74(2):180-188.

17. Riggio S. Traumatic brain injury and its neurobehavioral sequelae. Neurol Clin. 2011;29(1):35-47, vii.

18. Helmick KM, Spells CA, Malik SZ, Davies CA, Marion DW, Hinds SR. Traumatic brain injury in the US military: epidemiology and key clinical and research programs. Brain Imaging Behav. 2015;9(3):358-366.

19. Richardson LK, Frueh BC, Acierno R. Prevalence estimates of combat-related post-traumatic stress disorder: critical review. Aust N Z J Psychiatry. 2010;44(1):4-19.

20. Thompson WW, Gottesman II, Zalewski C. Reconciling disparate prevalence rates of PTSD in large samples of US male Vietnam veterans and their controls. BMC Psychiatry. 2006;6:19.

21. Frueh BC, Elhai JD, Gold PB, et al Disability compensation seeking among veterans evaluated for posttraumatic stress disorder. Psychiatr Serv. 2003;54(1):84-91.

22. Thakur H, Oni O, Singh V, et al. Increases in the service connection disability and treatment costs associated with posttraumatic stress disorder and/or traumatic brain injury in United States veterans pre- and post-9/11: the strong need for a novel therapeutic approach. Epidemiology (Sunnyvale). 2018;8(4):353.

23. Schlenger WE, Kulka RA, Fairbank JA, et al. The prevalence of post-traumatic stress disorder in the Vietnam generation: a multimethod, multisource assessment of psychiatric disorder. J Trauma Stress. 1992;5(3):333-363.

24. Belmont PJ, Schoenfeld AJ, Goodman G. Epidemiology of combat wounds in Operation Iraqi Freedom and Operation Enduring Freedom: orthopaedic burden of disease. J Surg Orthop Adv. 2010;19(1):2-7.

25. Owens BD, Kragh JG Jr, Wenke JC, Macaitis J, Wade CE, Holcomb JB. Combat wounds in Operation Iraqi Freedom and Operation Enduring Freedom. J Trauma. 2008;64(2):295-299.

26. Defense Health Agency, Defense and Veterans Brain Injury Center. DOD worldwide numbers for TBI since 2000. https://dvbic.dcoe.mil/dod-worldwide-numbers-tbi. Updated February 14, 2020. Accessed February 14, 2020.

27. Armed Forces Health Surveillance Center. Deployment-related conditions of special surveillance interest, U.S. armed forces, by month and service, January 2003-December 2012 (data as of 22 January 2013). MSMR. 2013;20(1):16-19.

28. Harvey JH, Stein SK, Scott PK. Fifty years of grief: accounts and reported psychological reactions of Normandy invasion veterans. J Narrative Life History. 1995;5(4):321-332.

29. US Department of Veterans Affairs. Polytrauma/TBI system of care. https://www.polytrauma.va.gov/system-of-care/index.asp. Updated June 3, 2015. Accessed February 4, 2020.

30. Wolfe J, Erickson DJ, Sharkansky EJ, King DW, King LA. Course and predictors of posttraumatic stress disorder among Gulf War veterans: a prospective analysis. J Consult Clin Psychol. 1999;67(4):520-528.

31. Breslau N, Davis GC, Peterson EL, Schultz L. Psychiatric sequelae of posttraumatic stress disorder in women. Arch Gen Psychiatry. 1997;54(1):81-87.

32. Kessler RC, Sonnega A, Bromet E, Hughes M, Nelson CB. Posttraumatic stress disorder in the National Comorbidity Survey. Arch Gen Psychiatry. 1995;52(12):1048-1060.

33. Wolfe J, Kimerling R. Gender issues in the assessment of posttraumatic stress disorder. In: Wilson J, Keane TM, eds. Assessing Psychological Trauma and PTSD. New York: Guilford; 2004:192-238.

34. Engel CC Jr, Engel AL, Campbell SJ, McFall ME, Russo J, Katon W. Posttraumatic stress disorder symptoms and precombat sexual and physical abuse in Desert Storm veterans. J Nerv Ment Dis. 1993;181(11):683-688.

35. US Department of Veterans Affairs, National Center for Veterans Analysis and Statistics. Profile of veterans: 2016 data from the American Community Survey. https://www.va.gov/vetdata/docs/SpecialReports/Profile_of_Veterans_2016.pdf. Published February 2018. Accessed February 4, 2020.

36. US Department of Commerce Economics and Statistics Administration, US Census Bureau, Geography Division. 2010 population distribution in the United States and Puerto Rico. https://www2.census.gov/geo/maps/dc10_thematic/2010_Nighttime_PopDist/2010_Nighttime_PopDist_Page_Map.pdf. Accessed February 4, 2020.

37. Cifu DX, Taylor BC, Carne WF, et al. Traumatic brain injury, posttraumatic stress disorder, and pain diagnoses in OIF/OEF/OND veterans. J Rehabil Res Dev. 2013;50(9):1169-1176.

38. Dohrenwend BP, Turner JB, Turse NA, Adams BG, Koenen KC, Marshall R. The psychological risks of Vietnam for U.S. veterans: a revisit with new data and methods. Science. 2006;313(5789):979-982.

39. Magruder KM, Frueh BC, Knapp RG, et al. Prevalence of posttraumatic stress disorder in Veterans Affairs primary care clinics. Gen Hosp Psychiatry. 2005;27(3):169-179.

40. Norris FH. Epidemiology of trauma: frequency and impact of different potentially traumatic events on different demographic groups. J Consult Clin Psychol. 1992;60(3):409-418.

41. Resnick HS, Kilpatrick DG, Dansky BS, Saunders BE, Best CL. Prevalence of civilian trauma and posttraumatic stress disorder in a representative national sample of women. J Consult Clin Psychol. 1993;61(6):984-991.

42. Najavits LM. The problem of dropout from “gold standard” PTSD therapies. F1000Prime Rep. 2015;7:43.

43. US Department of Veterans Affairs, National Center for Veterans Analysis and Statistics. Trends in veterans with a service-connected disability: 1985 to 2014. https://www.va.gov/vetdata/docs/QuickFacts/SCD_trends_FINAL_2014.PDF. Published June 2015. Accessed February 4, 2020.

44. US Department of Veterans Affairs, Office of Inspector General. Review of state variances in VA disability compensation payments. Report 05-00765-137. https://www.va.gov/oig/52/reports/2005/VAOIG-05-00765-137.pdf. Published May 19, 2015. Accessed February 4, 2020.

45. McNally RJ. Progress and controversy in the study of posttraumatic stress disorder. Annu Rev Psychol. 2003;54:229-252.

46. Freeman T, Powell M, Kimbrell T. Measuring symptom exaggeration in veterans with chronic posttraumatic stress disorder. Psychiatry Res. 2008;158(3):374-380.

47. Frueh BC, Elhai JD, Grubaugh AL, et al. Documented combat exposure of US veterans seeking treatment for combat-related post-traumatic stress disorder. Br J Psychiatry. 2005;186(6):467-475.

48. Frueh BC, Hamner MB, Cahill SP, Gold PB, Hamlin KL. Apparent symptom overreporting in combat veterans evaluated for PTSD. Clin Psychol Rev. 2000;20(7):853-885.

49. Sparr L, Pankratz LD. Factitious posttraumatic stress disorder. Am J Psychiatry. 1983;140(8):1016-1019.

50. Baggaley M. ‘Military Munchausen’s’: assessment of factitious claims of military service in psychiatric patients. Psychiatr Bull. 1998;22(3):153-154.

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Small Bowel Obstruction in a Surgically Naïve Abdomen

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Finding the cause of small bowel obstructions can lead to the discovery of important and treatable underlying disease.

A 53-year-old male veteran with a history of heavy tobacco and alcohol use presented with abdominal pain, emesis, and no bowel movements for 2 days. He had no history of surgical procedures, malignancies, diverticulitis, inflammatory bowel disease, traveling abroad, parasitic infections, tuberculosis exposure, or hospital admissions for abdominal pain. He reported experiencing no flushing, diarrhea, or cardiac symptoms. His medical history included hypertension, depression, and osteoarthritis. His vital signs were within normal limits.

A physical examination revealed a distended abdomen with mild tenderness. He had no inguinal or ventral hernias. He also had no abnormal skin lesions. A rectal examination did not reveal any masses or blood. His laboratory values were normal. X-ray and computed tomography (CT) scan revealed dilated loops of proximal small bowel, mild wall thickening in a segment of the midileum, and narrowing of the distal small bowel suggestive of a partial small bowel obstruction (Figure 1). A 1-cm nonspecific omental nodule also was seen on the CT scan, but no enlarged lymph nodes or mesenteric calcifications were seen. There was no thickening of the terminal ileum.

The patient underwent an exploratory laparotomy, which revealed no adhesions. In the midileum there was an area of thickened bowel with some nodularity associated with the thickness, but no discrete mass. In the mesentery there were multiple hard, white, calcified nodules, with the majority clustered near the thickened ileal segment. There also was a 1-cm hard, peritoneal mass on the anterior abdominal wall. The segment of thickened ileum, the adjacent mesentery, and the peritoneal nodule were resected.

Pathologic examination of the resected tissue showed immunohistochemical stains that were positive for CD79a, CD10, and BCL-2 and negative for CD23, CD5, and CD3. Nineteen mesenteric lymph nodes were negative for malignancy. The postoperative staging positron emission tomography (PET) scan did not reveal any fluorodeoxyglucose avid masses anywhere else, and bone marrow biopsy showed no infiltration.

  • What is your diagnosis?
  • How would you treat this patient?
     

     

Diagnosis

Based on the pathologic examination of the resected tissue and immunohistochemical stains, this patient was diagnosed with malignant non-Hodgkin B-cell lymphoma, follicular type, grade 1. PET scan and bone marrow biopsy revealed no other lesions, making this a primary lymphoma of the small intestine. The resected tissue showed negative margins and negative lymph nodes, indicating the full extent of the patient’s tumor was removed. He then underwent nasogastric tube decompression and IV fluid resuscitation. Two days later, he had a large bowel movement, and his abdominal pain resolved. He was provided the treatment options of observation only, radiation therapy, or rituximab treatment. Based on the high risk of enteritis following radiation therapy, the patient elected for observation only, with a repeat scan in 6 months. He also was counseled on alcohol and tobacco cessation. At the 6-month oncology follow-up, the patient showed no evidence of disease recurrence.

Discussion

Small bowel obstruction accounts for about 350,000 hospitalizations annually in the US.1 The incidence is equal in men and women and can present at any age.2,3 Patients typically present nonspecifically, with intermittent, colicky abdominal pain, nausea, vomiting, and constipation.2 A physical examination may reveal abdominal distention, rigidity, and hypoactive or absent bowel sounds.1 The 2 most common etiologies of small bowel obstruction are adhesions from prior abdominal surgery (65%) and incarcerated inguinal hernias (10%).1 However, in a patient presenting with a small bowel obstruction in a surgically naïve abdomen with no hernias, a more detailed history covering current malignancies, past hospital admissions for abdominal pains, pelvic inflammatory disease, diverticulitis, inflammatory bowel disease, and risks for parasite infection must be taken. The differential should include intraluminal causes, including small bowel malignancy, which accounts for 5% of small bowel obstructions,1 as well as extraluminal causes, including adhesions from diverticulitis, Meckel diverticulum, Ladd bands, and undiagnosed prior appendicitis.

 

 

To provide a tissue diagnosis and definitive treatment, surgical exploration was needed for this patient. Exploratory laparotomy revealed an area of thickened ileum and calcified nodules in its mesentery. Pathologic examination of the resected tissue revealed large lymphoid nodules in a follicular pattern with coarse chromatin (Figure 2). Taken together with the immunohistochemical stains, this was consistent with malignant B-cell non-Hodgkin lymphoma, follicular type, grade 1.

Small bowel malignancy accounts for > 5% of all gastrointestinal tumors.4 Of these, small bowel neuroendocrine tumors are the most common, followed by adenocarcinomas, lymphomas, and stromal tumors.4 Primary follicular lymphoma (PFL) is a B-cell non-Hodgkin lymphoma, and comprises between 3.8% and 11% of gastrointestinal lymphomas, commonly in the duodenum and terminal ileum.5

PFL typically occurs in middle-aged females and can be difficult to diagnose, as most patients are asymptomatic or present with unspecified abdominal pain. Many are diagnosed incidentally when endoscopy biopsies are performed for other reasons.4,5 Histologically, PFL is composed of a mixed population of small (centrocytes) and large (centroblasts) lymphoid cells, with higher proportions of centroblasts corresponding to a higher grade lymphoma.6 The classic immunophenotype of PFL shows coexpression of CD79a (or CD20), CD10, and BCL-2; however, in rare cases, low-grade PFL may stain negative for BCL-2 and have diminished staining for CD10 in interfollicular areas.7

PFL generally carries a favorable prognosis. Most patients achieving complete disease regression or stable disease following treatment and a low recurrence rate. Treatment can include surgical resection, radiation, rituximab therapy, chemotherapy, or observation.8 Patient also should be counseled in alcohol and tobacco cessation to reduce recurrence risk.

Other small bowel malignancies may present as small bowel obstructions as well. Neuroendocrine tumors and adenocarcinomas are both more common than small bowel lymphomas and can present as small bowel obstruction. However, neuroendocrine tumors are derived from serotonin-expressing enterochromaffin cells of the midgut and often present with classic carcinoid syndrome symptoms, including diarrhea, flushing, and right heart fibrosis, which the patient lacked.9 Immunohistology of small bowel adenocarcinoma often shows expression of MUC1 or MUC5AC with tumor markers CEA and CA 19-9.10

Primary intestinal melanoma, another small bowel malignancy, is extremely rare. More commonly, the etiology of intestinal melanoma is cutaneous melanoma that metastasizes to the gastrointestinal tract.11 This patient had no skin lesions to suggest metastatic melanoma. With intestinal melanoma, immunohistochemical evaluation may show S-100, the most sensitive marker for melanoma, or HMB-45, MART-1/Melan-A, tyrosinase, and MITF.12

Conclusion

This case is notable because it highlights the importance of examining the cause of small bowel obstruction in a surgically naïve abdomen, as exploration led to the discovery and curative treatment of a primary intestinal malignancy. It also underscores the nonspecific presentation that PFLs of the small intestine can have and the importance of understanding the different histopathology and immunohistochemical profiles of small bowel malignancies.

References

1. Rami Reddy SR, Cappell MS. A systematic review of the clinical presentation, diagnosis, and treatment of small bowel obstruction. Curr Gastroenterol Rep. 2017;19(6):28.

2. Smith DA, Nehring SM. Bowel obstruction. https://www.ncbi.nlm.nih.gov/books/NBK441975. Updated November 12, 2019. Accessed February 6, 2020.

3. Popoola D, Lou MA, Mansour AY, Sims EH. Small bowel obstruction: review of nine years of experience. J Natl Med Assoc. 1984;76(11):1089-1094.

4. Bilimoria KY, Bentrem DJ, Wayne JD, Ko CY, Bennett CL, Talamonti MS. Small bowel cancer in the United States: changes in epidemiology, treatment, and survival over the last 20 years. Ann Surg. 2009;249(1):63-71.

5. Freedman AS. Clinical presentation and diagnosis of primary gastrointestinal lymphomas. https://www.uptodate.com/contents/clinical-presentation-and-diagnosis-of-primary-gastrointestinal-lymphomas. Updated March 26, 2019. Accessed February 6, 2020.

6. Moy BT, Wilmot J, Ballesteros E, Forouhar F, Vaziri H. Primary follicular lymphoma of the gastrointestinal tract: casereport and review. J Gastrointest Cancer. 2016;47(3):255-263.

7. Choi SM, Betz BL, Perry AM. Follicular lymphoma diagnostic caveats and updates. Arch Pathol Lab Med. 2018;142(11):1330-1340.

8. Schmatz AI, Streubel B, Kretschmer-Chott E, et al. Primary follicular lymphoma of the duodenum is a distinct mucosal/submucosal variant of follicular lymphoma: a retrospective study of 63 cases. J Clin Oncol. 2011;29(11):1445-1451.

9. Grin A, Streutker CJ. Neuroendocrine tumors of the luminal gastrointestinal tract. Arch Pathol Lab Med. 2015;139(6):750-756.

10. Chang H-K, Yu E, Kim J, et al; Korean Small Intestinal Cancer Study Group. Adenocarcinoma of the small intestine: a multi-institutional study of 197 surgically resected cases. Hum Pathol. 2010;41(8):1087-1096.

11. Lens M, Bataille V, Krivokapic Z. Melanoma of the small intestine. Lancet Oncol. 2009;10(5):516-521.

12. Ohsie SJ, Sarantopoulos GP, Cochran AJ, Binder SW. Immunohistochemical characteristics of melanoma. J Cutan Pathol. 2008;35(5):433-444.

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Rohit Gupta is a Medical Student at Baylor College of Medicine in Houston, Texas. SreyRam Kuy is Deputy Chief Medical Officer of Veterans Integrated Service Network 16 in Houston, Texas.
Correspondence: Rohit Gupta ([email protected])

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

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Rohit Gupta is a Medical Student at Baylor College of Medicine in Houston, Texas. SreyRam Kuy is Deputy Chief Medical Officer of Veterans Integrated Service Network 16 in Houston, Texas.
Correspondence: Rohit Gupta ([email protected])

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

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

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Correspondence: Rohit Gupta ([email protected])

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

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

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Related Articles
Finding the cause of small bowel obstructions can lead to the discovery of important and treatable underlying disease.
Finding the cause of small bowel obstructions can lead to the discovery of important and treatable underlying disease.

A 53-year-old male veteran with a history of heavy tobacco and alcohol use presented with abdominal pain, emesis, and no bowel movements for 2 days. He had no history of surgical procedures, malignancies, diverticulitis, inflammatory bowel disease, traveling abroad, parasitic infections, tuberculosis exposure, or hospital admissions for abdominal pain. He reported experiencing no flushing, diarrhea, or cardiac symptoms. His medical history included hypertension, depression, and osteoarthritis. His vital signs were within normal limits.

A physical examination revealed a distended abdomen with mild tenderness. He had no inguinal or ventral hernias. He also had no abnormal skin lesions. A rectal examination did not reveal any masses or blood. His laboratory values were normal. X-ray and computed tomography (CT) scan revealed dilated loops of proximal small bowel, mild wall thickening in a segment of the midileum, and narrowing of the distal small bowel suggestive of a partial small bowel obstruction (Figure 1). A 1-cm nonspecific omental nodule also was seen on the CT scan, but no enlarged lymph nodes or mesenteric calcifications were seen. There was no thickening of the terminal ileum.

The patient underwent an exploratory laparotomy, which revealed no adhesions. In the midileum there was an area of thickened bowel with some nodularity associated with the thickness, but no discrete mass. In the mesentery there were multiple hard, white, calcified nodules, with the majority clustered near the thickened ileal segment. There also was a 1-cm hard, peritoneal mass on the anterior abdominal wall. The segment of thickened ileum, the adjacent mesentery, and the peritoneal nodule were resected.

Pathologic examination of the resected tissue showed immunohistochemical stains that were positive for CD79a, CD10, and BCL-2 and negative for CD23, CD5, and CD3. Nineteen mesenteric lymph nodes were negative for malignancy. The postoperative staging positron emission tomography (PET) scan did not reveal any fluorodeoxyglucose avid masses anywhere else, and bone marrow biopsy showed no infiltration.

  • What is your diagnosis?
  • How would you treat this patient?
     

     

Diagnosis

Based on the pathologic examination of the resected tissue and immunohistochemical stains, this patient was diagnosed with malignant non-Hodgkin B-cell lymphoma, follicular type, grade 1. PET scan and bone marrow biopsy revealed no other lesions, making this a primary lymphoma of the small intestine. The resected tissue showed negative margins and negative lymph nodes, indicating the full extent of the patient’s tumor was removed. He then underwent nasogastric tube decompression and IV fluid resuscitation. Two days later, he had a large bowel movement, and his abdominal pain resolved. He was provided the treatment options of observation only, radiation therapy, or rituximab treatment. Based on the high risk of enteritis following radiation therapy, the patient elected for observation only, with a repeat scan in 6 months. He also was counseled on alcohol and tobacco cessation. At the 6-month oncology follow-up, the patient showed no evidence of disease recurrence.

Discussion

Small bowel obstruction accounts for about 350,000 hospitalizations annually in the US.1 The incidence is equal in men and women and can present at any age.2,3 Patients typically present nonspecifically, with intermittent, colicky abdominal pain, nausea, vomiting, and constipation.2 A physical examination may reveal abdominal distention, rigidity, and hypoactive or absent bowel sounds.1 The 2 most common etiologies of small bowel obstruction are adhesions from prior abdominal surgery (65%) and incarcerated inguinal hernias (10%).1 However, in a patient presenting with a small bowel obstruction in a surgically naïve abdomen with no hernias, a more detailed history covering current malignancies, past hospital admissions for abdominal pains, pelvic inflammatory disease, diverticulitis, inflammatory bowel disease, and risks for parasite infection must be taken. The differential should include intraluminal causes, including small bowel malignancy, which accounts for 5% of small bowel obstructions,1 as well as extraluminal causes, including adhesions from diverticulitis, Meckel diverticulum, Ladd bands, and undiagnosed prior appendicitis.

 

 

To provide a tissue diagnosis and definitive treatment, surgical exploration was needed for this patient. Exploratory laparotomy revealed an area of thickened ileum and calcified nodules in its mesentery. Pathologic examination of the resected tissue revealed large lymphoid nodules in a follicular pattern with coarse chromatin (Figure 2). Taken together with the immunohistochemical stains, this was consistent with malignant B-cell non-Hodgkin lymphoma, follicular type, grade 1.

Small bowel malignancy accounts for > 5% of all gastrointestinal tumors.4 Of these, small bowel neuroendocrine tumors are the most common, followed by adenocarcinomas, lymphomas, and stromal tumors.4 Primary follicular lymphoma (PFL) is a B-cell non-Hodgkin lymphoma, and comprises between 3.8% and 11% of gastrointestinal lymphomas, commonly in the duodenum and terminal ileum.5

PFL typically occurs in middle-aged females and can be difficult to diagnose, as most patients are asymptomatic or present with unspecified abdominal pain. Many are diagnosed incidentally when endoscopy biopsies are performed for other reasons.4,5 Histologically, PFL is composed of a mixed population of small (centrocytes) and large (centroblasts) lymphoid cells, with higher proportions of centroblasts corresponding to a higher grade lymphoma.6 The classic immunophenotype of PFL shows coexpression of CD79a (or CD20), CD10, and BCL-2; however, in rare cases, low-grade PFL may stain negative for BCL-2 and have diminished staining for CD10 in interfollicular areas.7

PFL generally carries a favorable prognosis. Most patients achieving complete disease regression or stable disease following treatment and a low recurrence rate. Treatment can include surgical resection, radiation, rituximab therapy, chemotherapy, or observation.8 Patient also should be counseled in alcohol and tobacco cessation to reduce recurrence risk.

Other small bowel malignancies may present as small bowel obstructions as well. Neuroendocrine tumors and adenocarcinomas are both more common than small bowel lymphomas and can present as small bowel obstruction. However, neuroendocrine tumors are derived from serotonin-expressing enterochromaffin cells of the midgut and often present with classic carcinoid syndrome symptoms, including diarrhea, flushing, and right heart fibrosis, which the patient lacked.9 Immunohistology of small bowel adenocarcinoma often shows expression of MUC1 or MUC5AC with tumor markers CEA and CA 19-9.10

Primary intestinal melanoma, another small bowel malignancy, is extremely rare. More commonly, the etiology of intestinal melanoma is cutaneous melanoma that metastasizes to the gastrointestinal tract.11 This patient had no skin lesions to suggest metastatic melanoma. With intestinal melanoma, immunohistochemical evaluation may show S-100, the most sensitive marker for melanoma, or HMB-45, MART-1/Melan-A, tyrosinase, and MITF.12

Conclusion

This case is notable because it highlights the importance of examining the cause of small bowel obstruction in a surgically naïve abdomen, as exploration led to the discovery and curative treatment of a primary intestinal malignancy. It also underscores the nonspecific presentation that PFLs of the small intestine can have and the importance of understanding the different histopathology and immunohistochemical profiles of small bowel malignancies.

A 53-year-old male veteran with a history of heavy tobacco and alcohol use presented with abdominal pain, emesis, and no bowel movements for 2 days. He had no history of surgical procedures, malignancies, diverticulitis, inflammatory bowel disease, traveling abroad, parasitic infections, tuberculosis exposure, or hospital admissions for abdominal pain. He reported experiencing no flushing, diarrhea, or cardiac symptoms. His medical history included hypertension, depression, and osteoarthritis. His vital signs were within normal limits.

A physical examination revealed a distended abdomen with mild tenderness. He had no inguinal or ventral hernias. He also had no abnormal skin lesions. A rectal examination did not reveal any masses or blood. His laboratory values were normal. X-ray and computed tomography (CT) scan revealed dilated loops of proximal small bowel, mild wall thickening in a segment of the midileum, and narrowing of the distal small bowel suggestive of a partial small bowel obstruction (Figure 1). A 1-cm nonspecific omental nodule also was seen on the CT scan, but no enlarged lymph nodes or mesenteric calcifications were seen. There was no thickening of the terminal ileum.

The patient underwent an exploratory laparotomy, which revealed no adhesions. In the midileum there was an area of thickened bowel with some nodularity associated with the thickness, but no discrete mass. In the mesentery there were multiple hard, white, calcified nodules, with the majority clustered near the thickened ileal segment. There also was a 1-cm hard, peritoneal mass on the anterior abdominal wall. The segment of thickened ileum, the adjacent mesentery, and the peritoneal nodule were resected.

Pathologic examination of the resected tissue showed immunohistochemical stains that were positive for CD79a, CD10, and BCL-2 and negative for CD23, CD5, and CD3. Nineteen mesenteric lymph nodes were negative for malignancy. The postoperative staging positron emission tomography (PET) scan did not reveal any fluorodeoxyglucose avid masses anywhere else, and bone marrow biopsy showed no infiltration.

  • What is your diagnosis?
  • How would you treat this patient?
     

     

Diagnosis

Based on the pathologic examination of the resected tissue and immunohistochemical stains, this patient was diagnosed with malignant non-Hodgkin B-cell lymphoma, follicular type, grade 1. PET scan and bone marrow biopsy revealed no other lesions, making this a primary lymphoma of the small intestine. The resected tissue showed negative margins and negative lymph nodes, indicating the full extent of the patient’s tumor was removed. He then underwent nasogastric tube decompression and IV fluid resuscitation. Two days later, he had a large bowel movement, and his abdominal pain resolved. He was provided the treatment options of observation only, radiation therapy, or rituximab treatment. Based on the high risk of enteritis following radiation therapy, the patient elected for observation only, with a repeat scan in 6 months. He also was counseled on alcohol and tobacco cessation. At the 6-month oncology follow-up, the patient showed no evidence of disease recurrence.

Discussion

Small bowel obstruction accounts for about 350,000 hospitalizations annually in the US.1 The incidence is equal in men and women and can present at any age.2,3 Patients typically present nonspecifically, with intermittent, colicky abdominal pain, nausea, vomiting, and constipation.2 A physical examination may reveal abdominal distention, rigidity, and hypoactive or absent bowel sounds.1 The 2 most common etiologies of small bowel obstruction are adhesions from prior abdominal surgery (65%) and incarcerated inguinal hernias (10%).1 However, in a patient presenting with a small bowel obstruction in a surgically naïve abdomen with no hernias, a more detailed history covering current malignancies, past hospital admissions for abdominal pains, pelvic inflammatory disease, diverticulitis, inflammatory bowel disease, and risks for parasite infection must be taken. The differential should include intraluminal causes, including small bowel malignancy, which accounts for 5% of small bowel obstructions,1 as well as extraluminal causes, including adhesions from diverticulitis, Meckel diverticulum, Ladd bands, and undiagnosed prior appendicitis.

 

 

To provide a tissue diagnosis and definitive treatment, surgical exploration was needed for this patient. Exploratory laparotomy revealed an area of thickened ileum and calcified nodules in its mesentery. Pathologic examination of the resected tissue revealed large lymphoid nodules in a follicular pattern with coarse chromatin (Figure 2). Taken together with the immunohistochemical stains, this was consistent with malignant B-cell non-Hodgkin lymphoma, follicular type, grade 1.

Small bowel malignancy accounts for > 5% of all gastrointestinal tumors.4 Of these, small bowel neuroendocrine tumors are the most common, followed by adenocarcinomas, lymphomas, and stromal tumors.4 Primary follicular lymphoma (PFL) is a B-cell non-Hodgkin lymphoma, and comprises between 3.8% and 11% of gastrointestinal lymphomas, commonly in the duodenum and terminal ileum.5

PFL typically occurs in middle-aged females and can be difficult to diagnose, as most patients are asymptomatic or present with unspecified abdominal pain. Many are diagnosed incidentally when endoscopy biopsies are performed for other reasons.4,5 Histologically, PFL is composed of a mixed population of small (centrocytes) and large (centroblasts) lymphoid cells, with higher proportions of centroblasts corresponding to a higher grade lymphoma.6 The classic immunophenotype of PFL shows coexpression of CD79a (or CD20), CD10, and BCL-2; however, in rare cases, low-grade PFL may stain negative for BCL-2 and have diminished staining for CD10 in interfollicular areas.7

PFL generally carries a favorable prognosis. Most patients achieving complete disease regression or stable disease following treatment and a low recurrence rate. Treatment can include surgical resection, radiation, rituximab therapy, chemotherapy, or observation.8 Patient also should be counseled in alcohol and tobacco cessation to reduce recurrence risk.

Other small bowel malignancies may present as small bowel obstructions as well. Neuroendocrine tumors and adenocarcinomas are both more common than small bowel lymphomas and can present as small bowel obstruction. However, neuroendocrine tumors are derived from serotonin-expressing enterochromaffin cells of the midgut and often present with classic carcinoid syndrome symptoms, including diarrhea, flushing, and right heart fibrosis, which the patient lacked.9 Immunohistology of small bowel adenocarcinoma often shows expression of MUC1 or MUC5AC with tumor markers CEA and CA 19-9.10

Primary intestinal melanoma, another small bowel malignancy, is extremely rare. More commonly, the etiology of intestinal melanoma is cutaneous melanoma that metastasizes to the gastrointestinal tract.11 This patient had no skin lesions to suggest metastatic melanoma. With intestinal melanoma, immunohistochemical evaluation may show S-100, the most sensitive marker for melanoma, or HMB-45, MART-1/Melan-A, tyrosinase, and MITF.12

Conclusion

This case is notable because it highlights the importance of examining the cause of small bowel obstruction in a surgically naïve abdomen, as exploration led to the discovery and curative treatment of a primary intestinal malignancy. It also underscores the nonspecific presentation that PFLs of the small intestine can have and the importance of understanding the different histopathology and immunohistochemical profiles of small bowel malignancies.

References

1. Rami Reddy SR, Cappell MS. A systematic review of the clinical presentation, diagnosis, and treatment of small bowel obstruction. Curr Gastroenterol Rep. 2017;19(6):28.

2. Smith DA, Nehring SM. Bowel obstruction. https://www.ncbi.nlm.nih.gov/books/NBK441975. Updated November 12, 2019. Accessed February 6, 2020.

3. Popoola D, Lou MA, Mansour AY, Sims EH. Small bowel obstruction: review of nine years of experience. J Natl Med Assoc. 1984;76(11):1089-1094.

4. Bilimoria KY, Bentrem DJ, Wayne JD, Ko CY, Bennett CL, Talamonti MS. Small bowel cancer in the United States: changes in epidemiology, treatment, and survival over the last 20 years. Ann Surg. 2009;249(1):63-71.

5. Freedman AS. Clinical presentation and diagnosis of primary gastrointestinal lymphomas. https://www.uptodate.com/contents/clinical-presentation-and-diagnosis-of-primary-gastrointestinal-lymphomas. Updated March 26, 2019. Accessed February 6, 2020.

6. Moy BT, Wilmot J, Ballesteros E, Forouhar F, Vaziri H. Primary follicular lymphoma of the gastrointestinal tract: casereport and review. J Gastrointest Cancer. 2016;47(3):255-263.

7. Choi SM, Betz BL, Perry AM. Follicular lymphoma diagnostic caveats and updates. Arch Pathol Lab Med. 2018;142(11):1330-1340.

8. Schmatz AI, Streubel B, Kretschmer-Chott E, et al. Primary follicular lymphoma of the duodenum is a distinct mucosal/submucosal variant of follicular lymphoma: a retrospective study of 63 cases. J Clin Oncol. 2011;29(11):1445-1451.

9. Grin A, Streutker CJ. Neuroendocrine tumors of the luminal gastrointestinal tract. Arch Pathol Lab Med. 2015;139(6):750-756.

10. Chang H-K, Yu E, Kim J, et al; Korean Small Intestinal Cancer Study Group. Adenocarcinoma of the small intestine: a multi-institutional study of 197 surgically resected cases. Hum Pathol. 2010;41(8):1087-1096.

11. Lens M, Bataille V, Krivokapic Z. Melanoma of the small intestine. Lancet Oncol. 2009;10(5):516-521.

12. Ohsie SJ, Sarantopoulos GP, Cochran AJ, Binder SW. Immunohistochemical characteristics of melanoma. J Cutan Pathol. 2008;35(5):433-444.

References

1. Rami Reddy SR, Cappell MS. A systematic review of the clinical presentation, diagnosis, and treatment of small bowel obstruction. Curr Gastroenterol Rep. 2017;19(6):28.

2. Smith DA, Nehring SM. Bowel obstruction. https://www.ncbi.nlm.nih.gov/books/NBK441975. Updated November 12, 2019. Accessed February 6, 2020.

3. Popoola D, Lou MA, Mansour AY, Sims EH. Small bowel obstruction: review of nine years of experience. J Natl Med Assoc. 1984;76(11):1089-1094.

4. Bilimoria KY, Bentrem DJ, Wayne JD, Ko CY, Bennett CL, Talamonti MS. Small bowel cancer in the United States: changes in epidemiology, treatment, and survival over the last 20 years. Ann Surg. 2009;249(1):63-71.

5. Freedman AS. Clinical presentation and diagnosis of primary gastrointestinal lymphomas. https://www.uptodate.com/contents/clinical-presentation-and-diagnosis-of-primary-gastrointestinal-lymphomas. Updated March 26, 2019. Accessed February 6, 2020.

6. Moy BT, Wilmot J, Ballesteros E, Forouhar F, Vaziri H. Primary follicular lymphoma of the gastrointestinal tract: casereport and review. J Gastrointest Cancer. 2016;47(3):255-263.

7. Choi SM, Betz BL, Perry AM. Follicular lymphoma diagnostic caveats and updates. Arch Pathol Lab Med. 2018;142(11):1330-1340.

8. Schmatz AI, Streubel B, Kretschmer-Chott E, et al. Primary follicular lymphoma of the duodenum is a distinct mucosal/submucosal variant of follicular lymphoma: a retrospective study of 63 cases. J Clin Oncol. 2011;29(11):1445-1451.

9. Grin A, Streutker CJ. Neuroendocrine tumors of the luminal gastrointestinal tract. Arch Pathol Lab Med. 2015;139(6):750-756.

10. Chang H-K, Yu E, Kim J, et al; Korean Small Intestinal Cancer Study Group. Adenocarcinoma of the small intestine: a multi-institutional study of 197 surgically resected cases. Hum Pathol. 2010;41(8):1087-1096.

11. Lens M, Bataille V, Krivokapic Z. Melanoma of the small intestine. Lancet Oncol. 2009;10(5):516-521.

12. Ohsie SJ, Sarantopoulos GP, Cochran AJ, Binder SW. Immunohistochemical characteristics of melanoma. J Cutan Pathol. 2008;35(5):433-444.

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Remote Temperature Monitoring of the Diabetic Foot: From Research to Practice

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Diabetic foot ulcers (DFUs) are devastating, common, and costly. This burden is borne disproportionately by veterans who have high prevalence of type 2 diabetes mellitus (T2DM) and other precipitating risk factors.1 The mortality of veterans following a DFU is sobering, and ulceration is recognized as a significant marker of disease severity.

A 2017 study by Brennan and colleagues reported a 19% mortality rate within 1 year, and only 29% survive past 5 years.2 DFUs are often complicated by peripheral arterial disease (PAD) and diabetic immune dysfunction, contributing to chronic wounds and infection.3,4 About 60% of all foot ulcers become infected, and > 20% of patients with a diabetic foot infection require amputation.5,6

A 2010 retrospective study reports that > 3,400 veterans have a diabetes-related lower extremity amputation annually, vastly surpassing the rate of amputation secondary to trauma in the Veterans Health Administration (VHA).7,8 The inpatient costs for each amputation exceeded $60,000 in fiscal year 2010, and these amputation-related costs represent only 1 component of the total expense to the VHA attributable to diabetic foot complications.7 A recent systematic review by Chan and colleagues estimated mean annual costs in the year following a foot ulcer to be $44,200 to the public payer.9 This implies that direct expenditures for treatment of DFUs within the VHA exceeds $3 billion annually.

 

 

Diabetic Foot Ulcer Prevention

Given the dramatic impact of diabetic foot complications to the veteran and the US health care system, the VHA has long recognized the importance of preventive care for those at risk. In 2017 US Department of Veterans Affairs (VA) and Department of Defense issued a clinical practice guideline for the management of T2DM that recommended prophylactic foot care for early identification of any deformity or skin breakdown.10 The guidelines note that a “person who has had a foot ulcer is at lifelong risk of further ulceration,” reflecting the high rate of recurrence among all patients, including veterans. Multiple studies suggest that as many as 40% of patients experience recidivism in the first year after healing from a wound.11-16

The VA is well equipped to deliver quality preventive care because of its innovative and long-standing PAVE (Prevention of Amputations for Veterans Everywhere) program.17 PAVE provides screening, education, appropriate footwear, and stratified care guidelines for veterans at risk for diabetes-related foot complications (Table 1). The practices encouraged by PAVE are evidence-based and synergistic with the objectives of the VA’s patient aligned care team (PACT) delivery approach.18 The granular data collected through PAVE are used to guide best practices and provide benchmarks for diabetic foot outcomes.

Unfortunately, despite PAVE guidelines requiring annual specialist foot care for at-risk veterans, a 2013 report by the VA Office of the Inspector General (OIG) found that one-third of all patients had no documentation of this minimal requirement of preventive foot care.19 Although the VA has worked to address this issue, the data hint at the missed opportunities for prevention of complications and the challenges of ensuring that a large at-risk veteran population has systematic and routine screening with access to specialist foot care.

Given the large proportion of veterans at high risk of chronic wound formation and the challenges of ensuring that this cohort receives good preventive foot care, expanding telemedicine has been suggested. Telemedicine solutions have the potential to reduce the impact of chronic wounds on overburdened clinic resources, schedules, and local and federal budgets.20 Interestingly, the only preventive practice for the diabetic foot that has been proven effective through multiple randomized controlled trials and national and international clinical guidance documents is once-daily foot temperature monitoring.21-26 Daily monitoring has the potential to reduce the burden of DFUs to veterans, improve veteran access to needed preventive care, and reduce costs incurred by the VHA treating diabetic foot complications. Yet despite a recent national guidance document detailing its appropriate use in PAVE 3 veterans, it remains underutilized.27

The purpose of this review is to: (1) discuss the evidence supporting once-daily remote temperature monitoring (RTM), a telemedicine approach critical to improving both veteran access to care and diabetic foot outcomes; (2) summarize a 2017 study that presented an advanced clinical understanding of RTM use among veterans; (3) provide previously unpublished data from this study comparing high-risk VA and non-VA cohorts, highlighting the opportunity for additional focus on foot ulcer prevention within the VA; and (4) report on recent VA utilization of a RTM technology based on this research, emphasizing lessons learned and best practices.

 

 

Remote Temperature Monitoring

The objective of daily foot temperature monitoring is to identify impending inflammatory foot conditions, such as DFUs, infection, and acute Charcot neuroarthropathy episodes. The patient and care team then act to resolve the cause of detected inflammation before clinical presentation (prevention) and begin treatment earlier than would otherwise be possible to avoid expensive complications, such as infection (early detection). Preventive therapies are low risk to the patient and inexpensive.

RTM is recommended by multiple clinical practice guidelines, including those of the International Working Group on the Diabetic Foot, the American College of Foot and Ankle Surgeons, and the Wound Healing Society.24-26 Its use is supported by evidence from 3 National Institutes of Health-funded and well-designed randomized controlled trials, 1 of which was additionally supported by a VA Health Services Research and Development Service Merit Award.21-23,28 Conducted between 2004 and 2007, these studies demonstrated the potential to reduce foot ulcer incidence by as much as 85% using a dermal thermometer to identify inflammation and prompt decreased ambulation. Investigators established a clinical monitoring protocol comparing the temperatures between 6 matched locations on the left and right feet. Persistent differences in contralateral temperatures exceeding 2.2°C (4.0°F) were used as a marker for elevated risk and to initiate preventive care. Based on the encouraging results from these studies, a 2017 effectiveness review prepared for the Agency for Healthcare Research and Quality concluded that “home monitoring of foot skin temperature is effective for reducing foot ulcer incidence and recurrence.”29

Accuracy of RTM

A 2017 longitudinal study (NCT02647346) has provided novel data to advance understanding of RTM for the prediction and prevention of DFUs.30 This study was the first to systematically analyze the accuracy of RTM over different monitoring thresholds. The results enable practitioners to deliver risk-stratified preventive care. Policy makers can use the data from this study to weigh the cost and benefits of RTM for population health.

The multicenter trials had 129 participants from 4 VA health care systems: VA Long Beach Healthcare System in California, Miami VA Healthcare System in Florida, Phoenix VA Healthcare System in Arizona, and VA West Los Angeles Healthcare System in California. Each participant was followed for 34 weeks under standard preventive foot care and was instructed to step on a telemedicine SmartMat (Podimetrics, Inc) RTM mat for 20 seconds daily. Participants and investigators were blinded to the temperature data so that the accuracy of temperature monitoring could be assessed. All participants had a history of T2DM and healed DFU. Principal exclusion criteria included unhealed plantar wound, history of proximal lower extremity amputation (ie, above ankle), active Charcot foot disease, and comorbidities that could potentially inhibit an inflammatory response, such as end-stage renal disease, active malignancy, and immunosuppressive diseases.

The investigators reported that RTM with the study mat detected 97% of nonacute plantar DFUs using the most commonly studied threshold (sustained 2.2°C temperature difference). The lead time averaged 37 days before clinical identification of the wound under standard care. Although the false-positive rate of 57% was high, corresponding to approximately 3.0 notifications per patient per year on average in the research setting, it is important to note that this study only considered the prediction of plantar DFUs. Thus, detection of foot inflammation secondary to other conditions, such as preulcerative lesion, dorsal wound, Charcot neuroarthropathy, or foot infection, were reported as a false positive per the study’s definitions. Further, Crisologo and Lavery noted in a translational medicine summary of this research, because the intervention is noninvasive and minimally impactful to the patient and the health care system, “the potential to arrest re-ulceration is worth the perceived inconvenience to the patient.”31

Secondary outcomes related to adherence and ease of use were encouraging. Eighty-eight percent of participants reported that the mat was “very easy to use,” the highest possible score, and 98% were able to set up the mat for home use without difficulty. At the end of the 34-week study, more than 74% of participants remained engaged in routine use of the mat under a per-protocol assessment of adherence. These results are especially impressive given the documented poor adherence of at-risk patients to routine use of therapeutic footwear, which has been reported to be as low as 15%.32

 

 

New Research

The data collected during this study has led to new research and advancements in RTM. A recent publication by Gordon and colleagues investigated whether RTM is less accurate in cohorts with perceived challenges.33 They include patients with recently healed wounds and those with a history of partial foot amputation. There was no difference in the accuracy or lead time for either cohort relative to the entire cohort, suggesting that RTM is appropriate for monitoring patients with recently healed DFUs or partial foot amputations.

In another recent study, the data were used to derive a novel approach to monitor a single at-risk foot.34 The practice of RTM has traditionally required comparing temperatures between contralaterally matched plantar locations on the feet, thus limiting its use in patients with a history of major lower extremity amputation and patients being treated for a wound, which may be bandaged or in an off-loading cast or boot. Because the risk factors for DFUs exist in both limbs, these patients are at high risk for developing complications to the contralateral foot and may benefit from preventive once-daily foot temperature monitoring. The investigators empirically derived a novel monitoring approach for patients without a contralateral control. This approach was found to predict 91% of impending plantar DFUs on average 41 days before clinical presentation with a false positive rate of 54%.

Additional Focus on Prevention

Table 2 shows previously unpublished data from a subgroup analysis between veteran and nonveteran participants in the study.25 These descriptive statistics reinforce some widely held assumptions regarding the high-risk veteran population and challenge others. For example, compared with the nonveteran participants, the veteran cohort unsurprisingly had a larger ratio of male participants (P < .01), had a higher rate of cigarette use (P < .01), and was more likely to live alone (although not at a statistically significant level). Veterans in the study had body mass index, rates of alcohol use, frequency of exercise, and glucose control comparable to that of nonveterans.

The potential impact of the PAVE program is clear in several of these comparisons. Although as few as 15% of patients use therapeutic shoes routinely, PAVE ensures that the majority of veterans receive them. Nearly 95% of veterans have therapeutic shoes compared with about 80% of nonveteran participants (P < .05). Veterans also had higher ankle-brachial index results (P < .05), although on average both cohorts were within normal clinical parameters. Veterans had a significantly longer duration since healing from the most recent wound, and fewer veteran participants had a wound that healed in the 3 months prior to the study. Despite this, during the study veterans had annualized DFU incidence equal to that of nonveterans. Furthermore, veterans also had significantly higher rates of amputation prior to participation. That these critical outcomes for veterans are no better than those observed in other care environments despite PAVE suggests that approaches recommended via PAVE alone are insufficient to significantly arrest DFU recurrence, and even more focus on prevention in the VA may be warranted.

 

 

From Research to Practice

Since the publication of the 2017 study, the VHA has been at the vanguard of translating the evidence and research underlying RTM into clinical practice. A clinical guidance document governing appropriate use of RTM with the study mat was recently published by the VA Prosthetic and Sensory Aids Service in collaboration with the National Podiatry Program office.27 This guidance document recommends once-daily RTM for at-risk veterans designated PAVE level 3. It defines roles and responsibilities required for the successful implementation of a RTM program with the study device. The document additionally presents various clinical monitoring protocols for veterans, although the protocol and thresholds used are at the discretion of the prescribing clinician and should reflect the risk profile of the veteran in question.

A staged response to inflammation has proven popular, whereby an initial high-sensitivity threshold is chosen for monitoring. The initial response is telephone outreach by a designee supplied by the clinic or device manufacturer, typically a trained registered nurse, to the veteran to collect subjective history and instruct off-loading and reduced ambulation, with a target of 50% baseline reduction in step count. Should the inflammation persist despite off-loading, an examination may be necessary to identify and resolve its cause. For recalcitrant inflammation, more targeted pressure off-loading of the affected area may be accomplished with custom orthotics, accommodative insoles, removable cast walkers, and total contact casting. After 2 to 4 weeks without signs of inflammation, the cause is deemed to have been resolved and lowered the acute risk for developing further diabetic foot complications.

More than 600 veterans have been monitored for > 1,000 patient-years—13 VA medical centers are practicing RTM with the study mat as of this writing. The monitoring program has been integrated into many veteran daily routines as evidenced by > 70% retaining full engagement after having been monitored for > 1 year. The total number of alerts/patient-years across these veterans has been 1.4, significantly lower than the 3.0 alerts/patient-year observed in the study. This is potentially due to successful interventions in response to detected inflammation, resolving inflammation, and avoiding unnecessary alerts occurring in the research setting, which did not employ interventions that resolved inflammation episodes. In the past 6 months, 68% of all inflammation detected resolved via off-loading alone without requiring further clinical intervention. In the cases that required an examination, 76% of patients reported clinically meaningful preventive care (eg, preulcerative callus was debrided, a subungual hemorrhage was treated, a foot ulcer was identified).

Organizational Best Practices

Several best practices have been cultivated related to initiating a RTM program at a new site, for promoting the success of a RTM program, and provisioning excellent preventive care to support the RTM program. Although we advise adhering to the recommendations in the VA guidance document,27 the authors have observed several additional organizational best practices that are not explicitly addressed.

Partnering with PACT. Collaboration between PAVE and PACT has the potential not only to improve outcomes for patients at risk for diabetic foot complications, but also can help identify appropriate high-risk veteran candidates for preventive care with RTM who may not be followed for routine care from a specialty provider, such as a podiatrist, as highlighted by the 2013 OIG report.

Prescreening eligible patients. Several programs have used PAVE data or appointment schedules to identify and target high-risk veterans proactively. This approach has several benefits. It simplifies clinical coordination and streamlines workflow for patient identification and onboarding. It also allows those veterans at highest risk to receive needed and recommended preventive care at their next scheduled appointment. Finally, if PAVE data are used to identify eligible patients, it has the added benefit of ensuring a baseline level of telemedicine preventive foot care for veterans who have become lost to follow-up and have not been seen recently for a routine foot examination.

Implementing foot monitoring during wound treatment. Recent research has expanded the reach of once-daily RTM with the mat to patients being treated for a wound to only 1 foot. This practice has 2 benefits: The patient is able to establish a preventive routine before healing, an important advantage because research strongly suggests that recurrence is most likely in the first months after healing. Second, 48% of patients with a history of DFUs will develop new wounds to the contralateral foot because risk factors, such as neuropathy and peripheral arterial disease, exist in both limbs.35 Furthermore, ongoing treatment for a wound to 1 foot may result in gait deviation and elevated pressure to the sound foot, additionally predisposing the veteran to complications, resulting in a high rate of wounds occurring to the unwounded foot during treatment (0.2 DFU/DFU-year).34 Thus, there is potential benefit in monitoring the sound foot while undergoing treatment for a wound; further, the patient will have immediate access to the device for prevention of recurrence once the wound has resolved.

Utilizing foot monitoring as an extension of telemedicine. Many VA facilities have large geographic catchment areas, making routine follow-up difficult for veterans living in rural areas. RTM serves as an extension of the patient’s daily self-examination and the clinician’s ability to monitor patients with objective information daily. The veterans using the system become more invested and feel as though they are taking an active role in their health care.

Investing in ongoing medical education. Multidisciplinary education sessions reviewing supporting clinical data and resultant clinical practice guidelines raise awareness for those providers and trainees unaware of preventive best practices for the diabetic foot, including those related to foot RTM. These sessions also are helpful for those familiar with foot temperature monitoring or who are responsible for administration of an ongoing program to remain current with contemporary best practices and to discuss improvements for patient care. Familiarity also can help address clinical inertia when benefits and evidence are clearly communicated with health care providers (HCPs).

 

 

Clinical Best Practices

Treating preulcerative lesions urgently and aggressively. Callus and other preulcerative lesions often cause progressive tissue damage and poor outcomes. When identified, these lesions should be promptly treated to ensure best outcomes.24

Recognizing the limits of patient self-examinations. Comorbidities such as visual impairment and reduced joint mobility often preclude patients from completing rigorous self-examinations of the foot, which is especially critical while collecting subjective history from the patient during triage of inflammation. A caregiver or spouse can help inspect the foot during outreach and provide additional context.36

Interpreting a benign foot on examination. Because RTM has been demonstrated to detect inflammation preceding a foot ulcer as many as 5 weeks before presentation to the clinic, some veterans may have few signs or symptoms of acute risk during examination. Often, the damage is to subcutaneous tissue resulting from repetitive microtrauma. Research suggests that clinical examination in these cases is often unreliable for identifying the earliest signs of risk, such as palpation to identify subtle temperature changes secondary to inflammation.37 If a patient has refractory inflammation requiring examination and presents with an otherwise unremarkable foot, it is an opportunity to evaluate whether the patient’s shoewear remains appropriate or has worn out, to communicate the veteran’s ongoing elevated risk, and to educate on the importance of diligence in daily foot self-examinations, daily use of the foot temperature monitoring, and continued off-loading until the inflammation resolves.

Communicating the distinction between healing and remission. Although healing is the goal of wound care, patients should be educated that the underlying disease remains after epithelialization. In some cases, tissue deep to the skin has not completed remodeling, and the patient is at acute risk of recurrence. Remission is a powerful metaphor that better describes the patient’s ongoing risk to encourage continued healthy routines and diligent self-care.38Considering the entirety of both feet for recurrence. Critical risk factors for diabetic foot complications, such as peripheral neuropathy and PAD, exist in both limbs, and patients with a history of wounds often develop new complications to different ipsilateral locations, or in as many as 48% of cases, to the contralateral foot.35 For best outcomes, detected inflammation should be treated aggressively independent of whether the location coincides with an area of previous concern.

Encouraging adherence, routine, and empowerment. Advanced diabetes mellitus and neuropathy may impact a patient’s executive function, and multiple studies have reported that patients at risk for inflammatory foot diseases exhibit fatalism toward their foot care and outcomes.39-41 Consistent education, encouragement, empowerment, and establishment of positive routines are needed to ensure high adherence with all preventive care regimens, including RTM.

Case Presentations

The following case series illustrates many of these clinical best practices and characterizes the potential benefits of RTM to veterans within the VA.

Case 1: Prevention After Healing

A veteran underwent a Chopart amputation and was recommended to use the mat after healing was perceived. Immediately on use of the study mat, the patient was found to have inflammation to the surgical incision (Figure 1). Clinical staff was alerted to the findings, and the patient was instructed to limit further walking and continue off-loading in his removable cast walker, per protocol. The inflammation of the operative foot quickly reduced, and the patient continued healing successfully, potentially avoiding incisional dehiscence and possible postoperative infection.

 

 

This case illustrates that patients’ wounds or surgical incisions may not be completely healed on epithelialization. In the immediate phase after closure, HCPs should consider additional protection to avoid complications. This case demonstrates that RTM can provide objective data to help guide care in that critical period.

Case 2: Identifying Preulcerative Lesions

An 88-year-old veteran had a chronic callus under the second metatarsal head. In addition to routine foot care and therapeutic shoes, he was followed with once-daily RTM. Inflammation was noted, and the veteran was seen in the podiatry clinic where debridement of the callus was performed. The difference in temperatures between feet detected by thermography prior to the clinic visits rapidly resolved after callus debridement, indicating that the underlying inflammation had subsided. RTM was used by the clinical staff to determine the appropriate time interval between clinic visits to avoid callus breakdown and subsequent ulceration.

Case 3: Extending the Clinic Into the Home

An 80-year-old veteran with T2DM and neuropathy was deemed a high-risk patient due to recurrent ulcerations to the left great toe. He was issued a RTM mat and was adherent with routine use. After nearly a year without hot-spot development, inflammation was noted (Figure 2).

Unfortunately, the patient had missed several routine foot care visits and likely that was the reason for the noted inflammation. The patient was called and became reengaged in regular visits for routine foot care. On debridement of his callus, a superficial, noninfected ulceration was discovered. Had remote monitoring not detected the inflammation and impending ulceration, the patient likely would not have been seen in the regular clinic and may have developed a wound infection, potentially resulting in a worse and more costly outcome.

Paradigm Shift to Prevention

Given the exceedingly high burden of diabetic foot complications in the VA, a paradigm shift is needed among HCPs from a culture of treatment to one of prevention. Bus and colleagues reported that in Europe, for every euro spent on ulcer prevention, 10 are spent on ulcer healing, and for every randomized clinical trial conducted on prevention, 10 are conducted on treatment.42-44 Hicks and colleagues showed that the cost of curative care for DFUs is 5 to 30 times greater than the cost of preventive care.45 For RTM in high-risk cohorts (ie, PAVE level 3), the number-needed-to-treat for DFU prevention may be as low as 6, assuming that a 70% reduction in incidence is possible, consistent with previous research. In the year following a DFU, costs exceed $44,000.9 Thus, it seems natural that future direction in diabetic foot care should emphasize prevention strategies.

Foot ulcers that become infected often lead to hospitalization and result in an increased burden to an already overburdened VA health care system. Research suggests that about two-thirds of all diabetic foot costs are attributable to inpatient management.46 The impact of diabetic foot complications on hospital resource utilization is staggering. A 2017 study by Skrepnik analyzed the risk of hospitalization for various diseases.47 The investigators found that the inpatient admission odds ratio (OR) for congestive heart failure was 2.6, surpassed only by DFUs (OR, 3.4) and diabetic foot infection (OR, 6.7). A 2019 point-prevalence study found that > 10% of hospital admissions have a foot-related condition as the primary or secondary reason, and the majority of these are due to foot diseases, such as ulcers, infections, and Charcot neuroarthropathy.48

It is therefore incumbent on VA HCPs to avert wound recurrence in the interest of avoiding veteran hospitalizations and for administrators to encourage and incentivize best practices for managing the diabetic foot, with an emphasis on prevention therapies. In evaluating the financial impact of prevention with foot RTM, administrators should consider that the cost benefit is likely to be realized across the medical center, with budgets related to inpatient management likely to receive the largest returns.

Prevention has the potential to rein in costs as well as reduce strain on the hospital and clinic by preventing outcomes that require frequent visits for treatment or hospitalization. Wound treatment is very burdensome to the clinic; patients require frequent (in many cases, weekly) examinations, and chronic wounds often require hospitalization, necessitating rounding and additional coordination in care. Thus, preventing wounds or reducing their severity at presentation substantially reduces burden on the clinic, even after accounting for the modest clinical resources needed to administer preventative care. For example, a brief examination may be necessary if the inflammation detected by the study mat is secondary to a callus that must be debrided. However, if the patient was not seen until the callus had progressed to a wound, weekly follow-up and substantial clinical and budgetary resources may be required to heal the wound. Preventive care allows for substantially better patient outcomes, and the minimal time invested prevents the clinical burden of extensive wound treatment.

The success of preventive efforts relies on multidisciplinary management of this high-risk patient cohort. Often, it is the responsibility of the primary care provider to follow diabetic foot clinical reminders and appropriately refer to specialty care. Successful, open communication between PACT, PAVE, and the Podiatry Service has been shown to reduce poor outcomes, including lower extremity amputations. Traditionally, the model of preventive care has included podiatrist-driven interventions, including integrated routine foot care and comprehensive diabetic foot education. Collaboration between routine evaluation and prompt referral of at-risk patients for specialist foot care, therapeutic footwear recommendations, daily self-foot examinations, and in-home temperature monitoring are critically effective when performed consistently.

When trying to translate research science to effective clinical practice for preventing lower extremity complication, there are several important concepts. First, given the frequency of examination for patients being treated for a wound, provision of good preventive care, such as RTM, can reduce overall burden to resource-constrained clinics and improve access for patients needing to be seen. Additionally, preventive efforts extend clinical practice into the home and may reduce the need for in-clinic examinations and routine follow-up visits. Finally, there may be a sense of trust established between the clinician and patient with a positive record of adherence with preventive practices. This may translate into more productive communication and less frequent routine visits to better accommodate urgent visits and ensure podiatric care is accessible to veterans.

 

 

Conclusions

There is a significant opportunity to shift diabetic foot care from treatment to prevention, improving veteran outcomes and reducing resource utilization. RTM is an evidence-based and recommended but underused telemedicine solution that can catalyze this needed paradigm shift. The VA has been at the forefront of preventive foot care through the PAVE program and more recently through research and clinical application of RTM for veterans. However, as the data presented suggest, more can be done to improve veteran outcomes. More widespread adoption of evidence-based preventive technologies for the diabetic foot, such as RTM, has the potential to dramatically improve the quality of and access to care and reduce costs and burden on resource-constrained clinics.

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45. Hicks CW, Selvarajah S, Mathioudakis N, et al. Burden of infected diabetic foot ulcers on hospital admissions and costs. Ann Vasc Surg. 2016;33:149-158.

46. Rice JB, Desai U, Cummings AKG, Birnbaum HG, Skornicki M, Parsons NB. Burden of diabetic foot ulcers for Medicare and private insurers. Diabetes Care. 2014;37(3):651-658.

47. Skrepnek GH, Mills JL Sr, Lavery LA, Armstrong DG. Health care service and outcomes among an estimated 6.7 million ambulatory care diabetic foot cases in the U.S. Diabetes Care. 2017;40(7):936-942.

48. Lazzarini PA, Hurn SE, Kuys SS, et al. Direct inpatient burden caused by foot-related conditions: a multisite point-prevalence study. BMJ Open. 2016;6(6):e010811.

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Gary Rothenberg is a Clinical Assistant Professor in the Department of Internal Medicine at the University of Michigan School of Medicine in Ann Arbor. He previously served as the Attending Podiatrist and Residency Director at the Miami VA Medical Center in Florida. Jeffrey Page is a Professor at the School of Podiatric Medicine at Midwestern University in Glendale, Arizona. At the time the article was written he was the Interim Chief and Residency Director of the Phoenix VA Medical Center. Rodney Stuck is Professor of Orthopaedic Surgery and Rehabilitation at Loyola University Medical Center and Hines VA Medical Center in Illinois. Charles Spencer is a Rehabilitation/Wound Care Physical Therapist at the Salt Lake City VA Medical Center in Utah. Lonnie Kaplan is a Staff Podiatrist at the Coatesville VA Medical Center in Pennsylvania. Ian Gordon is a Vascular Surgeon at the Long Beach VA Medical Center in California.
Correspondence: Gary Rothenberg ([email protected])

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Gary Rothenberg serves as a Consultant Medical Director for Podimetrics. All other authors report no actual or potential conflicts of interest with regard to this article.

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The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

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Gary Rothenberg is a Clinical Assistant Professor in the Department of Internal Medicine at the University of Michigan School of Medicine in Ann Arbor. He previously served as the Attending Podiatrist and Residency Director at the Miami VA Medical Center in Florida. Jeffrey Page is a Professor at the School of Podiatric Medicine at Midwestern University in Glendale, Arizona. At the time the article was written he was the Interim Chief and Residency Director of the Phoenix VA Medical Center. Rodney Stuck is Professor of Orthopaedic Surgery and Rehabilitation at Loyola University Medical Center and Hines VA Medical Center in Illinois. Charles Spencer is a Rehabilitation/Wound Care Physical Therapist at the Salt Lake City VA Medical Center in Utah. Lonnie Kaplan is a Staff Podiatrist at the Coatesville VA Medical Center in Pennsylvania. Ian Gordon is a Vascular Surgeon at the Long Beach VA Medical Center in California.
Correspondence: Gary Rothenberg ([email protected])

Author disclosures
Gary Rothenberg serves as a Consultant Medical Director for Podimetrics. All other authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Author and Disclosure Information

Gary Rothenberg is a Clinical Assistant Professor in the Department of Internal Medicine at the University of Michigan School of Medicine in Ann Arbor. He previously served as the Attending Podiatrist and Residency Director at the Miami VA Medical Center in Florida. Jeffrey Page is a Professor at the School of Podiatric Medicine at Midwestern University in Glendale, Arizona. At the time the article was written he was the Interim Chief and Residency Director of the Phoenix VA Medical Center. Rodney Stuck is Professor of Orthopaedic Surgery and Rehabilitation at Loyola University Medical Center and Hines VA Medical Center in Illinois. Charles Spencer is a Rehabilitation/Wound Care Physical Therapist at the Salt Lake City VA Medical Center in Utah. Lonnie Kaplan is a Staff Podiatrist at the Coatesville VA Medical Center in Pennsylvania. Ian Gordon is a Vascular Surgeon at the Long Beach VA Medical Center in California.
Correspondence: Gary Rothenberg ([email protected])

Author disclosures
Gary Rothenberg serves as a Consultant Medical Director for Podimetrics. All other authors report no actual or potential conflicts of interest with regard to this article.

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The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

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Related Articles

Diabetic foot ulcers (DFUs) are devastating, common, and costly. This burden is borne disproportionately by veterans who have high prevalence of type 2 diabetes mellitus (T2DM) and other precipitating risk factors.1 The mortality of veterans following a DFU is sobering, and ulceration is recognized as a significant marker of disease severity.

A 2017 study by Brennan and colleagues reported a 19% mortality rate within 1 year, and only 29% survive past 5 years.2 DFUs are often complicated by peripheral arterial disease (PAD) and diabetic immune dysfunction, contributing to chronic wounds and infection.3,4 About 60% of all foot ulcers become infected, and > 20% of patients with a diabetic foot infection require amputation.5,6

A 2010 retrospective study reports that > 3,400 veterans have a diabetes-related lower extremity amputation annually, vastly surpassing the rate of amputation secondary to trauma in the Veterans Health Administration (VHA).7,8 The inpatient costs for each amputation exceeded $60,000 in fiscal year 2010, and these amputation-related costs represent only 1 component of the total expense to the VHA attributable to diabetic foot complications.7 A recent systematic review by Chan and colleagues estimated mean annual costs in the year following a foot ulcer to be $44,200 to the public payer.9 This implies that direct expenditures for treatment of DFUs within the VHA exceeds $3 billion annually.

 

 

Diabetic Foot Ulcer Prevention

Given the dramatic impact of diabetic foot complications to the veteran and the US health care system, the VHA has long recognized the importance of preventive care for those at risk. In 2017 US Department of Veterans Affairs (VA) and Department of Defense issued a clinical practice guideline for the management of T2DM that recommended prophylactic foot care for early identification of any deformity or skin breakdown.10 The guidelines note that a “person who has had a foot ulcer is at lifelong risk of further ulceration,” reflecting the high rate of recurrence among all patients, including veterans. Multiple studies suggest that as many as 40% of patients experience recidivism in the first year after healing from a wound.11-16

The VA is well equipped to deliver quality preventive care because of its innovative and long-standing PAVE (Prevention of Amputations for Veterans Everywhere) program.17 PAVE provides screening, education, appropriate footwear, and stratified care guidelines for veterans at risk for diabetes-related foot complications (Table 1). The practices encouraged by PAVE are evidence-based and synergistic with the objectives of the VA’s patient aligned care team (PACT) delivery approach.18 The granular data collected through PAVE are used to guide best practices and provide benchmarks for diabetic foot outcomes.

Unfortunately, despite PAVE guidelines requiring annual specialist foot care for at-risk veterans, a 2013 report by the VA Office of the Inspector General (OIG) found that one-third of all patients had no documentation of this minimal requirement of preventive foot care.19 Although the VA has worked to address this issue, the data hint at the missed opportunities for prevention of complications and the challenges of ensuring that a large at-risk veteran population has systematic and routine screening with access to specialist foot care.

Given the large proportion of veterans at high risk of chronic wound formation and the challenges of ensuring that this cohort receives good preventive foot care, expanding telemedicine has been suggested. Telemedicine solutions have the potential to reduce the impact of chronic wounds on overburdened clinic resources, schedules, and local and federal budgets.20 Interestingly, the only preventive practice for the diabetic foot that has been proven effective through multiple randomized controlled trials and national and international clinical guidance documents is once-daily foot temperature monitoring.21-26 Daily monitoring has the potential to reduce the burden of DFUs to veterans, improve veteran access to needed preventive care, and reduce costs incurred by the VHA treating diabetic foot complications. Yet despite a recent national guidance document detailing its appropriate use in PAVE 3 veterans, it remains underutilized.27

The purpose of this review is to: (1) discuss the evidence supporting once-daily remote temperature monitoring (RTM), a telemedicine approach critical to improving both veteran access to care and diabetic foot outcomes; (2) summarize a 2017 study that presented an advanced clinical understanding of RTM use among veterans; (3) provide previously unpublished data from this study comparing high-risk VA and non-VA cohorts, highlighting the opportunity for additional focus on foot ulcer prevention within the VA; and (4) report on recent VA utilization of a RTM technology based on this research, emphasizing lessons learned and best practices.

 

 

Remote Temperature Monitoring

The objective of daily foot temperature monitoring is to identify impending inflammatory foot conditions, such as DFUs, infection, and acute Charcot neuroarthropathy episodes. The patient and care team then act to resolve the cause of detected inflammation before clinical presentation (prevention) and begin treatment earlier than would otherwise be possible to avoid expensive complications, such as infection (early detection). Preventive therapies are low risk to the patient and inexpensive.

RTM is recommended by multiple clinical practice guidelines, including those of the International Working Group on the Diabetic Foot, the American College of Foot and Ankle Surgeons, and the Wound Healing Society.24-26 Its use is supported by evidence from 3 National Institutes of Health-funded and well-designed randomized controlled trials, 1 of which was additionally supported by a VA Health Services Research and Development Service Merit Award.21-23,28 Conducted between 2004 and 2007, these studies demonstrated the potential to reduce foot ulcer incidence by as much as 85% using a dermal thermometer to identify inflammation and prompt decreased ambulation. Investigators established a clinical monitoring protocol comparing the temperatures between 6 matched locations on the left and right feet. Persistent differences in contralateral temperatures exceeding 2.2°C (4.0°F) were used as a marker for elevated risk and to initiate preventive care. Based on the encouraging results from these studies, a 2017 effectiveness review prepared for the Agency for Healthcare Research and Quality concluded that “home monitoring of foot skin temperature is effective for reducing foot ulcer incidence and recurrence.”29

Accuracy of RTM

A 2017 longitudinal study (NCT02647346) has provided novel data to advance understanding of RTM for the prediction and prevention of DFUs.30 This study was the first to systematically analyze the accuracy of RTM over different monitoring thresholds. The results enable practitioners to deliver risk-stratified preventive care. Policy makers can use the data from this study to weigh the cost and benefits of RTM for population health.

The multicenter trials had 129 participants from 4 VA health care systems: VA Long Beach Healthcare System in California, Miami VA Healthcare System in Florida, Phoenix VA Healthcare System in Arizona, and VA West Los Angeles Healthcare System in California. Each participant was followed for 34 weeks under standard preventive foot care and was instructed to step on a telemedicine SmartMat (Podimetrics, Inc) RTM mat for 20 seconds daily. Participants and investigators were blinded to the temperature data so that the accuracy of temperature monitoring could be assessed. All participants had a history of T2DM and healed DFU. Principal exclusion criteria included unhealed plantar wound, history of proximal lower extremity amputation (ie, above ankle), active Charcot foot disease, and comorbidities that could potentially inhibit an inflammatory response, such as end-stage renal disease, active malignancy, and immunosuppressive diseases.

The investigators reported that RTM with the study mat detected 97% of nonacute plantar DFUs using the most commonly studied threshold (sustained 2.2°C temperature difference). The lead time averaged 37 days before clinical identification of the wound under standard care. Although the false-positive rate of 57% was high, corresponding to approximately 3.0 notifications per patient per year on average in the research setting, it is important to note that this study only considered the prediction of plantar DFUs. Thus, detection of foot inflammation secondary to other conditions, such as preulcerative lesion, dorsal wound, Charcot neuroarthropathy, or foot infection, were reported as a false positive per the study’s definitions. Further, Crisologo and Lavery noted in a translational medicine summary of this research, because the intervention is noninvasive and minimally impactful to the patient and the health care system, “the potential to arrest re-ulceration is worth the perceived inconvenience to the patient.”31

Secondary outcomes related to adherence and ease of use were encouraging. Eighty-eight percent of participants reported that the mat was “very easy to use,” the highest possible score, and 98% were able to set up the mat for home use without difficulty. At the end of the 34-week study, more than 74% of participants remained engaged in routine use of the mat under a per-protocol assessment of adherence. These results are especially impressive given the documented poor adherence of at-risk patients to routine use of therapeutic footwear, which has been reported to be as low as 15%.32

 

 

New Research

The data collected during this study has led to new research and advancements in RTM. A recent publication by Gordon and colleagues investigated whether RTM is less accurate in cohorts with perceived challenges.33 They include patients with recently healed wounds and those with a history of partial foot amputation. There was no difference in the accuracy or lead time for either cohort relative to the entire cohort, suggesting that RTM is appropriate for monitoring patients with recently healed DFUs or partial foot amputations.

In another recent study, the data were used to derive a novel approach to monitor a single at-risk foot.34 The practice of RTM has traditionally required comparing temperatures between contralaterally matched plantar locations on the feet, thus limiting its use in patients with a history of major lower extremity amputation and patients being treated for a wound, which may be bandaged or in an off-loading cast or boot. Because the risk factors for DFUs exist in both limbs, these patients are at high risk for developing complications to the contralateral foot and may benefit from preventive once-daily foot temperature monitoring. The investigators empirically derived a novel monitoring approach for patients without a contralateral control. This approach was found to predict 91% of impending plantar DFUs on average 41 days before clinical presentation with a false positive rate of 54%.

Additional Focus on Prevention

Table 2 shows previously unpublished data from a subgroup analysis between veteran and nonveteran participants in the study.25 These descriptive statistics reinforce some widely held assumptions regarding the high-risk veteran population and challenge others. For example, compared with the nonveteran participants, the veteran cohort unsurprisingly had a larger ratio of male participants (P < .01), had a higher rate of cigarette use (P < .01), and was more likely to live alone (although not at a statistically significant level). Veterans in the study had body mass index, rates of alcohol use, frequency of exercise, and glucose control comparable to that of nonveterans.

The potential impact of the PAVE program is clear in several of these comparisons. Although as few as 15% of patients use therapeutic shoes routinely, PAVE ensures that the majority of veterans receive them. Nearly 95% of veterans have therapeutic shoes compared with about 80% of nonveteran participants (P < .05). Veterans also had higher ankle-brachial index results (P < .05), although on average both cohorts were within normal clinical parameters. Veterans had a significantly longer duration since healing from the most recent wound, and fewer veteran participants had a wound that healed in the 3 months prior to the study. Despite this, during the study veterans had annualized DFU incidence equal to that of nonveterans. Furthermore, veterans also had significantly higher rates of amputation prior to participation. That these critical outcomes for veterans are no better than those observed in other care environments despite PAVE suggests that approaches recommended via PAVE alone are insufficient to significantly arrest DFU recurrence, and even more focus on prevention in the VA may be warranted.

 

 

From Research to Practice

Since the publication of the 2017 study, the VHA has been at the vanguard of translating the evidence and research underlying RTM into clinical practice. A clinical guidance document governing appropriate use of RTM with the study mat was recently published by the VA Prosthetic and Sensory Aids Service in collaboration with the National Podiatry Program office.27 This guidance document recommends once-daily RTM for at-risk veterans designated PAVE level 3. It defines roles and responsibilities required for the successful implementation of a RTM program with the study device. The document additionally presents various clinical monitoring protocols for veterans, although the protocol and thresholds used are at the discretion of the prescribing clinician and should reflect the risk profile of the veteran in question.

A staged response to inflammation has proven popular, whereby an initial high-sensitivity threshold is chosen for monitoring. The initial response is telephone outreach by a designee supplied by the clinic or device manufacturer, typically a trained registered nurse, to the veteran to collect subjective history and instruct off-loading and reduced ambulation, with a target of 50% baseline reduction in step count. Should the inflammation persist despite off-loading, an examination may be necessary to identify and resolve its cause. For recalcitrant inflammation, more targeted pressure off-loading of the affected area may be accomplished with custom orthotics, accommodative insoles, removable cast walkers, and total contact casting. After 2 to 4 weeks without signs of inflammation, the cause is deemed to have been resolved and lowered the acute risk for developing further diabetic foot complications.

More than 600 veterans have been monitored for > 1,000 patient-years—13 VA medical centers are practicing RTM with the study mat as of this writing. The monitoring program has been integrated into many veteran daily routines as evidenced by > 70% retaining full engagement after having been monitored for > 1 year. The total number of alerts/patient-years across these veterans has been 1.4, significantly lower than the 3.0 alerts/patient-year observed in the study. This is potentially due to successful interventions in response to detected inflammation, resolving inflammation, and avoiding unnecessary alerts occurring in the research setting, which did not employ interventions that resolved inflammation episodes. In the past 6 months, 68% of all inflammation detected resolved via off-loading alone without requiring further clinical intervention. In the cases that required an examination, 76% of patients reported clinically meaningful preventive care (eg, preulcerative callus was debrided, a subungual hemorrhage was treated, a foot ulcer was identified).

Organizational Best Practices

Several best practices have been cultivated related to initiating a RTM program at a new site, for promoting the success of a RTM program, and provisioning excellent preventive care to support the RTM program. Although we advise adhering to the recommendations in the VA guidance document,27 the authors have observed several additional organizational best practices that are not explicitly addressed.

Partnering with PACT. Collaboration between PAVE and PACT has the potential not only to improve outcomes for patients at risk for diabetic foot complications, but also can help identify appropriate high-risk veteran candidates for preventive care with RTM who may not be followed for routine care from a specialty provider, such as a podiatrist, as highlighted by the 2013 OIG report.

Prescreening eligible patients. Several programs have used PAVE data or appointment schedules to identify and target high-risk veterans proactively. This approach has several benefits. It simplifies clinical coordination and streamlines workflow for patient identification and onboarding. It also allows those veterans at highest risk to receive needed and recommended preventive care at their next scheduled appointment. Finally, if PAVE data are used to identify eligible patients, it has the added benefit of ensuring a baseline level of telemedicine preventive foot care for veterans who have become lost to follow-up and have not been seen recently for a routine foot examination.

Implementing foot monitoring during wound treatment. Recent research has expanded the reach of once-daily RTM with the mat to patients being treated for a wound to only 1 foot. This practice has 2 benefits: The patient is able to establish a preventive routine before healing, an important advantage because research strongly suggests that recurrence is most likely in the first months after healing. Second, 48% of patients with a history of DFUs will develop new wounds to the contralateral foot because risk factors, such as neuropathy and peripheral arterial disease, exist in both limbs.35 Furthermore, ongoing treatment for a wound to 1 foot may result in gait deviation and elevated pressure to the sound foot, additionally predisposing the veteran to complications, resulting in a high rate of wounds occurring to the unwounded foot during treatment (0.2 DFU/DFU-year).34 Thus, there is potential benefit in monitoring the sound foot while undergoing treatment for a wound; further, the patient will have immediate access to the device for prevention of recurrence once the wound has resolved.

Utilizing foot monitoring as an extension of telemedicine. Many VA facilities have large geographic catchment areas, making routine follow-up difficult for veterans living in rural areas. RTM serves as an extension of the patient’s daily self-examination and the clinician’s ability to monitor patients with objective information daily. The veterans using the system become more invested and feel as though they are taking an active role in their health care.

Investing in ongoing medical education. Multidisciplinary education sessions reviewing supporting clinical data and resultant clinical practice guidelines raise awareness for those providers and trainees unaware of preventive best practices for the diabetic foot, including those related to foot RTM. These sessions also are helpful for those familiar with foot temperature monitoring or who are responsible for administration of an ongoing program to remain current with contemporary best practices and to discuss improvements for patient care. Familiarity also can help address clinical inertia when benefits and evidence are clearly communicated with health care providers (HCPs).

 

 

Clinical Best Practices

Treating preulcerative lesions urgently and aggressively. Callus and other preulcerative lesions often cause progressive tissue damage and poor outcomes. When identified, these lesions should be promptly treated to ensure best outcomes.24

Recognizing the limits of patient self-examinations. Comorbidities such as visual impairment and reduced joint mobility often preclude patients from completing rigorous self-examinations of the foot, which is especially critical while collecting subjective history from the patient during triage of inflammation. A caregiver or spouse can help inspect the foot during outreach and provide additional context.36

Interpreting a benign foot on examination. Because RTM has been demonstrated to detect inflammation preceding a foot ulcer as many as 5 weeks before presentation to the clinic, some veterans may have few signs or symptoms of acute risk during examination. Often, the damage is to subcutaneous tissue resulting from repetitive microtrauma. Research suggests that clinical examination in these cases is often unreliable for identifying the earliest signs of risk, such as palpation to identify subtle temperature changes secondary to inflammation.37 If a patient has refractory inflammation requiring examination and presents with an otherwise unremarkable foot, it is an opportunity to evaluate whether the patient’s shoewear remains appropriate or has worn out, to communicate the veteran’s ongoing elevated risk, and to educate on the importance of diligence in daily foot self-examinations, daily use of the foot temperature monitoring, and continued off-loading until the inflammation resolves.

Communicating the distinction between healing and remission. Although healing is the goal of wound care, patients should be educated that the underlying disease remains after epithelialization. In some cases, tissue deep to the skin has not completed remodeling, and the patient is at acute risk of recurrence. Remission is a powerful metaphor that better describes the patient’s ongoing risk to encourage continued healthy routines and diligent self-care.38Considering the entirety of both feet for recurrence. Critical risk factors for diabetic foot complications, such as peripheral neuropathy and PAD, exist in both limbs, and patients with a history of wounds often develop new complications to different ipsilateral locations, or in as many as 48% of cases, to the contralateral foot.35 For best outcomes, detected inflammation should be treated aggressively independent of whether the location coincides with an area of previous concern.

Encouraging adherence, routine, and empowerment. Advanced diabetes mellitus and neuropathy may impact a patient’s executive function, and multiple studies have reported that patients at risk for inflammatory foot diseases exhibit fatalism toward their foot care and outcomes.39-41 Consistent education, encouragement, empowerment, and establishment of positive routines are needed to ensure high adherence with all preventive care regimens, including RTM.

Case Presentations

The following case series illustrates many of these clinical best practices and characterizes the potential benefits of RTM to veterans within the VA.

Case 1: Prevention After Healing

A veteran underwent a Chopart amputation and was recommended to use the mat after healing was perceived. Immediately on use of the study mat, the patient was found to have inflammation to the surgical incision (Figure 1). Clinical staff was alerted to the findings, and the patient was instructed to limit further walking and continue off-loading in his removable cast walker, per protocol. The inflammation of the operative foot quickly reduced, and the patient continued healing successfully, potentially avoiding incisional dehiscence and possible postoperative infection.

 

 

This case illustrates that patients’ wounds or surgical incisions may not be completely healed on epithelialization. In the immediate phase after closure, HCPs should consider additional protection to avoid complications. This case demonstrates that RTM can provide objective data to help guide care in that critical period.

Case 2: Identifying Preulcerative Lesions

An 88-year-old veteran had a chronic callus under the second metatarsal head. In addition to routine foot care and therapeutic shoes, he was followed with once-daily RTM. Inflammation was noted, and the veteran was seen in the podiatry clinic where debridement of the callus was performed. The difference in temperatures between feet detected by thermography prior to the clinic visits rapidly resolved after callus debridement, indicating that the underlying inflammation had subsided. RTM was used by the clinical staff to determine the appropriate time interval between clinic visits to avoid callus breakdown and subsequent ulceration.

Case 3: Extending the Clinic Into the Home

An 80-year-old veteran with T2DM and neuropathy was deemed a high-risk patient due to recurrent ulcerations to the left great toe. He was issued a RTM mat and was adherent with routine use. After nearly a year without hot-spot development, inflammation was noted (Figure 2).

Unfortunately, the patient had missed several routine foot care visits and likely that was the reason for the noted inflammation. The patient was called and became reengaged in regular visits for routine foot care. On debridement of his callus, a superficial, noninfected ulceration was discovered. Had remote monitoring not detected the inflammation and impending ulceration, the patient likely would not have been seen in the regular clinic and may have developed a wound infection, potentially resulting in a worse and more costly outcome.

Paradigm Shift to Prevention

Given the exceedingly high burden of diabetic foot complications in the VA, a paradigm shift is needed among HCPs from a culture of treatment to one of prevention. Bus and colleagues reported that in Europe, for every euro spent on ulcer prevention, 10 are spent on ulcer healing, and for every randomized clinical trial conducted on prevention, 10 are conducted on treatment.42-44 Hicks and colleagues showed that the cost of curative care for DFUs is 5 to 30 times greater than the cost of preventive care.45 For RTM in high-risk cohorts (ie, PAVE level 3), the number-needed-to-treat for DFU prevention may be as low as 6, assuming that a 70% reduction in incidence is possible, consistent with previous research. In the year following a DFU, costs exceed $44,000.9 Thus, it seems natural that future direction in diabetic foot care should emphasize prevention strategies.

Foot ulcers that become infected often lead to hospitalization and result in an increased burden to an already overburdened VA health care system. Research suggests that about two-thirds of all diabetic foot costs are attributable to inpatient management.46 The impact of diabetic foot complications on hospital resource utilization is staggering. A 2017 study by Skrepnik analyzed the risk of hospitalization for various diseases.47 The investigators found that the inpatient admission odds ratio (OR) for congestive heart failure was 2.6, surpassed only by DFUs (OR, 3.4) and diabetic foot infection (OR, 6.7). A 2019 point-prevalence study found that > 10% of hospital admissions have a foot-related condition as the primary or secondary reason, and the majority of these are due to foot diseases, such as ulcers, infections, and Charcot neuroarthropathy.48

It is therefore incumbent on VA HCPs to avert wound recurrence in the interest of avoiding veteran hospitalizations and for administrators to encourage and incentivize best practices for managing the diabetic foot, with an emphasis on prevention therapies. In evaluating the financial impact of prevention with foot RTM, administrators should consider that the cost benefit is likely to be realized across the medical center, with budgets related to inpatient management likely to receive the largest returns.

Prevention has the potential to rein in costs as well as reduce strain on the hospital and clinic by preventing outcomes that require frequent visits for treatment or hospitalization. Wound treatment is very burdensome to the clinic; patients require frequent (in many cases, weekly) examinations, and chronic wounds often require hospitalization, necessitating rounding and additional coordination in care. Thus, preventing wounds or reducing their severity at presentation substantially reduces burden on the clinic, even after accounting for the modest clinical resources needed to administer preventative care. For example, a brief examination may be necessary if the inflammation detected by the study mat is secondary to a callus that must be debrided. However, if the patient was not seen until the callus had progressed to a wound, weekly follow-up and substantial clinical and budgetary resources may be required to heal the wound. Preventive care allows for substantially better patient outcomes, and the minimal time invested prevents the clinical burden of extensive wound treatment.

The success of preventive efforts relies on multidisciplinary management of this high-risk patient cohort. Often, it is the responsibility of the primary care provider to follow diabetic foot clinical reminders and appropriately refer to specialty care. Successful, open communication between PACT, PAVE, and the Podiatry Service has been shown to reduce poor outcomes, including lower extremity amputations. Traditionally, the model of preventive care has included podiatrist-driven interventions, including integrated routine foot care and comprehensive diabetic foot education. Collaboration between routine evaluation and prompt referral of at-risk patients for specialist foot care, therapeutic footwear recommendations, daily self-foot examinations, and in-home temperature monitoring are critically effective when performed consistently.

When trying to translate research science to effective clinical practice for preventing lower extremity complication, there are several important concepts. First, given the frequency of examination for patients being treated for a wound, provision of good preventive care, such as RTM, can reduce overall burden to resource-constrained clinics and improve access for patients needing to be seen. Additionally, preventive efforts extend clinical practice into the home and may reduce the need for in-clinic examinations and routine follow-up visits. Finally, there may be a sense of trust established between the clinician and patient with a positive record of adherence with preventive practices. This may translate into more productive communication and less frequent routine visits to better accommodate urgent visits and ensure podiatric care is accessible to veterans.

 

 

Conclusions

There is a significant opportunity to shift diabetic foot care from treatment to prevention, improving veteran outcomes and reducing resource utilization. RTM is an evidence-based and recommended but underused telemedicine solution that can catalyze this needed paradigm shift. The VA has been at the forefront of preventive foot care through the PAVE program and more recently through research and clinical application of RTM for veterans. However, as the data presented suggest, more can be done to improve veteran outcomes. More widespread adoption of evidence-based preventive technologies for the diabetic foot, such as RTM, has the potential to dramatically improve the quality of and access to care and reduce costs and burden on resource-constrained clinics.

Diabetic foot ulcers (DFUs) are devastating, common, and costly. This burden is borne disproportionately by veterans who have high prevalence of type 2 diabetes mellitus (T2DM) and other precipitating risk factors.1 The mortality of veterans following a DFU is sobering, and ulceration is recognized as a significant marker of disease severity.

A 2017 study by Brennan and colleagues reported a 19% mortality rate within 1 year, and only 29% survive past 5 years.2 DFUs are often complicated by peripheral arterial disease (PAD) and diabetic immune dysfunction, contributing to chronic wounds and infection.3,4 About 60% of all foot ulcers become infected, and > 20% of patients with a diabetic foot infection require amputation.5,6

A 2010 retrospective study reports that > 3,400 veterans have a diabetes-related lower extremity amputation annually, vastly surpassing the rate of amputation secondary to trauma in the Veterans Health Administration (VHA).7,8 The inpatient costs for each amputation exceeded $60,000 in fiscal year 2010, and these amputation-related costs represent only 1 component of the total expense to the VHA attributable to diabetic foot complications.7 A recent systematic review by Chan and colleagues estimated mean annual costs in the year following a foot ulcer to be $44,200 to the public payer.9 This implies that direct expenditures for treatment of DFUs within the VHA exceeds $3 billion annually.

 

 

Diabetic Foot Ulcer Prevention

Given the dramatic impact of diabetic foot complications to the veteran and the US health care system, the VHA has long recognized the importance of preventive care for those at risk. In 2017 US Department of Veterans Affairs (VA) and Department of Defense issued a clinical practice guideline for the management of T2DM that recommended prophylactic foot care for early identification of any deformity or skin breakdown.10 The guidelines note that a “person who has had a foot ulcer is at lifelong risk of further ulceration,” reflecting the high rate of recurrence among all patients, including veterans. Multiple studies suggest that as many as 40% of patients experience recidivism in the first year after healing from a wound.11-16

The VA is well equipped to deliver quality preventive care because of its innovative and long-standing PAVE (Prevention of Amputations for Veterans Everywhere) program.17 PAVE provides screening, education, appropriate footwear, and stratified care guidelines for veterans at risk for diabetes-related foot complications (Table 1). The practices encouraged by PAVE are evidence-based and synergistic with the objectives of the VA’s patient aligned care team (PACT) delivery approach.18 The granular data collected through PAVE are used to guide best practices and provide benchmarks for diabetic foot outcomes.

Unfortunately, despite PAVE guidelines requiring annual specialist foot care for at-risk veterans, a 2013 report by the VA Office of the Inspector General (OIG) found that one-third of all patients had no documentation of this minimal requirement of preventive foot care.19 Although the VA has worked to address this issue, the data hint at the missed opportunities for prevention of complications and the challenges of ensuring that a large at-risk veteran population has systematic and routine screening with access to specialist foot care.

Given the large proportion of veterans at high risk of chronic wound formation and the challenges of ensuring that this cohort receives good preventive foot care, expanding telemedicine has been suggested. Telemedicine solutions have the potential to reduce the impact of chronic wounds on overburdened clinic resources, schedules, and local and federal budgets.20 Interestingly, the only preventive practice for the diabetic foot that has been proven effective through multiple randomized controlled trials and national and international clinical guidance documents is once-daily foot temperature monitoring.21-26 Daily monitoring has the potential to reduce the burden of DFUs to veterans, improve veteran access to needed preventive care, and reduce costs incurred by the VHA treating diabetic foot complications. Yet despite a recent national guidance document detailing its appropriate use in PAVE 3 veterans, it remains underutilized.27

The purpose of this review is to: (1) discuss the evidence supporting once-daily remote temperature monitoring (RTM), a telemedicine approach critical to improving both veteran access to care and diabetic foot outcomes; (2) summarize a 2017 study that presented an advanced clinical understanding of RTM use among veterans; (3) provide previously unpublished data from this study comparing high-risk VA and non-VA cohorts, highlighting the opportunity for additional focus on foot ulcer prevention within the VA; and (4) report on recent VA utilization of a RTM technology based on this research, emphasizing lessons learned and best practices.

 

 

Remote Temperature Monitoring

The objective of daily foot temperature monitoring is to identify impending inflammatory foot conditions, such as DFUs, infection, and acute Charcot neuroarthropathy episodes. The patient and care team then act to resolve the cause of detected inflammation before clinical presentation (prevention) and begin treatment earlier than would otherwise be possible to avoid expensive complications, such as infection (early detection). Preventive therapies are low risk to the patient and inexpensive.

RTM is recommended by multiple clinical practice guidelines, including those of the International Working Group on the Diabetic Foot, the American College of Foot and Ankle Surgeons, and the Wound Healing Society.24-26 Its use is supported by evidence from 3 National Institutes of Health-funded and well-designed randomized controlled trials, 1 of which was additionally supported by a VA Health Services Research and Development Service Merit Award.21-23,28 Conducted between 2004 and 2007, these studies demonstrated the potential to reduce foot ulcer incidence by as much as 85% using a dermal thermometer to identify inflammation and prompt decreased ambulation. Investigators established a clinical monitoring protocol comparing the temperatures between 6 matched locations on the left and right feet. Persistent differences in contralateral temperatures exceeding 2.2°C (4.0°F) were used as a marker for elevated risk and to initiate preventive care. Based on the encouraging results from these studies, a 2017 effectiveness review prepared for the Agency for Healthcare Research and Quality concluded that “home monitoring of foot skin temperature is effective for reducing foot ulcer incidence and recurrence.”29

Accuracy of RTM

A 2017 longitudinal study (NCT02647346) has provided novel data to advance understanding of RTM for the prediction and prevention of DFUs.30 This study was the first to systematically analyze the accuracy of RTM over different monitoring thresholds. The results enable practitioners to deliver risk-stratified preventive care. Policy makers can use the data from this study to weigh the cost and benefits of RTM for population health.

The multicenter trials had 129 participants from 4 VA health care systems: VA Long Beach Healthcare System in California, Miami VA Healthcare System in Florida, Phoenix VA Healthcare System in Arizona, and VA West Los Angeles Healthcare System in California. Each participant was followed for 34 weeks under standard preventive foot care and was instructed to step on a telemedicine SmartMat (Podimetrics, Inc) RTM mat for 20 seconds daily. Participants and investigators were blinded to the temperature data so that the accuracy of temperature monitoring could be assessed. All participants had a history of T2DM and healed DFU. Principal exclusion criteria included unhealed plantar wound, history of proximal lower extremity amputation (ie, above ankle), active Charcot foot disease, and comorbidities that could potentially inhibit an inflammatory response, such as end-stage renal disease, active malignancy, and immunosuppressive diseases.

The investigators reported that RTM with the study mat detected 97% of nonacute plantar DFUs using the most commonly studied threshold (sustained 2.2°C temperature difference). The lead time averaged 37 days before clinical identification of the wound under standard care. Although the false-positive rate of 57% was high, corresponding to approximately 3.0 notifications per patient per year on average in the research setting, it is important to note that this study only considered the prediction of plantar DFUs. Thus, detection of foot inflammation secondary to other conditions, such as preulcerative lesion, dorsal wound, Charcot neuroarthropathy, or foot infection, were reported as a false positive per the study’s definitions. Further, Crisologo and Lavery noted in a translational medicine summary of this research, because the intervention is noninvasive and minimally impactful to the patient and the health care system, “the potential to arrest re-ulceration is worth the perceived inconvenience to the patient.”31

Secondary outcomes related to adherence and ease of use were encouraging. Eighty-eight percent of participants reported that the mat was “very easy to use,” the highest possible score, and 98% were able to set up the mat for home use without difficulty. At the end of the 34-week study, more than 74% of participants remained engaged in routine use of the mat under a per-protocol assessment of adherence. These results are especially impressive given the documented poor adherence of at-risk patients to routine use of therapeutic footwear, which has been reported to be as low as 15%.32

 

 

New Research

The data collected during this study has led to new research and advancements in RTM. A recent publication by Gordon and colleagues investigated whether RTM is less accurate in cohorts with perceived challenges.33 They include patients with recently healed wounds and those with a history of partial foot amputation. There was no difference in the accuracy or lead time for either cohort relative to the entire cohort, suggesting that RTM is appropriate for monitoring patients with recently healed DFUs or partial foot amputations.

In another recent study, the data were used to derive a novel approach to monitor a single at-risk foot.34 The practice of RTM has traditionally required comparing temperatures between contralaterally matched plantar locations on the feet, thus limiting its use in patients with a history of major lower extremity amputation and patients being treated for a wound, which may be bandaged or in an off-loading cast or boot. Because the risk factors for DFUs exist in both limbs, these patients are at high risk for developing complications to the contralateral foot and may benefit from preventive once-daily foot temperature monitoring. The investigators empirically derived a novel monitoring approach for patients without a contralateral control. This approach was found to predict 91% of impending plantar DFUs on average 41 days before clinical presentation with a false positive rate of 54%.

Additional Focus on Prevention

Table 2 shows previously unpublished data from a subgroup analysis between veteran and nonveteran participants in the study.25 These descriptive statistics reinforce some widely held assumptions regarding the high-risk veteran population and challenge others. For example, compared with the nonveteran participants, the veteran cohort unsurprisingly had a larger ratio of male participants (P < .01), had a higher rate of cigarette use (P < .01), and was more likely to live alone (although not at a statistically significant level). Veterans in the study had body mass index, rates of alcohol use, frequency of exercise, and glucose control comparable to that of nonveterans.

The potential impact of the PAVE program is clear in several of these comparisons. Although as few as 15% of patients use therapeutic shoes routinely, PAVE ensures that the majority of veterans receive them. Nearly 95% of veterans have therapeutic shoes compared with about 80% of nonveteran participants (P < .05). Veterans also had higher ankle-brachial index results (P < .05), although on average both cohorts were within normal clinical parameters. Veterans had a significantly longer duration since healing from the most recent wound, and fewer veteran participants had a wound that healed in the 3 months prior to the study. Despite this, during the study veterans had annualized DFU incidence equal to that of nonveterans. Furthermore, veterans also had significantly higher rates of amputation prior to participation. That these critical outcomes for veterans are no better than those observed in other care environments despite PAVE suggests that approaches recommended via PAVE alone are insufficient to significantly arrest DFU recurrence, and even more focus on prevention in the VA may be warranted.

 

 

From Research to Practice

Since the publication of the 2017 study, the VHA has been at the vanguard of translating the evidence and research underlying RTM into clinical practice. A clinical guidance document governing appropriate use of RTM with the study mat was recently published by the VA Prosthetic and Sensory Aids Service in collaboration with the National Podiatry Program office.27 This guidance document recommends once-daily RTM for at-risk veterans designated PAVE level 3. It defines roles and responsibilities required for the successful implementation of a RTM program with the study device. The document additionally presents various clinical monitoring protocols for veterans, although the protocol and thresholds used are at the discretion of the prescribing clinician and should reflect the risk profile of the veteran in question.

A staged response to inflammation has proven popular, whereby an initial high-sensitivity threshold is chosen for monitoring. The initial response is telephone outreach by a designee supplied by the clinic or device manufacturer, typically a trained registered nurse, to the veteran to collect subjective history and instruct off-loading and reduced ambulation, with a target of 50% baseline reduction in step count. Should the inflammation persist despite off-loading, an examination may be necessary to identify and resolve its cause. For recalcitrant inflammation, more targeted pressure off-loading of the affected area may be accomplished with custom orthotics, accommodative insoles, removable cast walkers, and total contact casting. After 2 to 4 weeks without signs of inflammation, the cause is deemed to have been resolved and lowered the acute risk for developing further diabetic foot complications.

More than 600 veterans have been monitored for > 1,000 patient-years—13 VA medical centers are practicing RTM with the study mat as of this writing. The monitoring program has been integrated into many veteran daily routines as evidenced by > 70% retaining full engagement after having been monitored for > 1 year. The total number of alerts/patient-years across these veterans has been 1.4, significantly lower than the 3.0 alerts/patient-year observed in the study. This is potentially due to successful interventions in response to detected inflammation, resolving inflammation, and avoiding unnecessary alerts occurring in the research setting, which did not employ interventions that resolved inflammation episodes. In the past 6 months, 68% of all inflammation detected resolved via off-loading alone without requiring further clinical intervention. In the cases that required an examination, 76% of patients reported clinically meaningful preventive care (eg, preulcerative callus was debrided, a subungual hemorrhage was treated, a foot ulcer was identified).

Organizational Best Practices

Several best practices have been cultivated related to initiating a RTM program at a new site, for promoting the success of a RTM program, and provisioning excellent preventive care to support the RTM program. Although we advise adhering to the recommendations in the VA guidance document,27 the authors have observed several additional organizational best practices that are not explicitly addressed.

Partnering with PACT. Collaboration between PAVE and PACT has the potential not only to improve outcomes for patients at risk for diabetic foot complications, but also can help identify appropriate high-risk veteran candidates for preventive care with RTM who may not be followed for routine care from a specialty provider, such as a podiatrist, as highlighted by the 2013 OIG report.

Prescreening eligible patients. Several programs have used PAVE data or appointment schedules to identify and target high-risk veterans proactively. This approach has several benefits. It simplifies clinical coordination and streamlines workflow for patient identification and onboarding. It also allows those veterans at highest risk to receive needed and recommended preventive care at their next scheduled appointment. Finally, if PAVE data are used to identify eligible patients, it has the added benefit of ensuring a baseline level of telemedicine preventive foot care for veterans who have become lost to follow-up and have not been seen recently for a routine foot examination.

Implementing foot monitoring during wound treatment. Recent research has expanded the reach of once-daily RTM with the mat to patients being treated for a wound to only 1 foot. This practice has 2 benefits: The patient is able to establish a preventive routine before healing, an important advantage because research strongly suggests that recurrence is most likely in the first months after healing. Second, 48% of patients with a history of DFUs will develop new wounds to the contralateral foot because risk factors, such as neuropathy and peripheral arterial disease, exist in both limbs.35 Furthermore, ongoing treatment for a wound to 1 foot may result in gait deviation and elevated pressure to the sound foot, additionally predisposing the veteran to complications, resulting in a high rate of wounds occurring to the unwounded foot during treatment (0.2 DFU/DFU-year).34 Thus, there is potential benefit in monitoring the sound foot while undergoing treatment for a wound; further, the patient will have immediate access to the device for prevention of recurrence once the wound has resolved.

Utilizing foot monitoring as an extension of telemedicine. Many VA facilities have large geographic catchment areas, making routine follow-up difficult for veterans living in rural areas. RTM serves as an extension of the patient’s daily self-examination and the clinician’s ability to monitor patients with objective information daily. The veterans using the system become more invested and feel as though they are taking an active role in their health care.

Investing in ongoing medical education. Multidisciplinary education sessions reviewing supporting clinical data and resultant clinical practice guidelines raise awareness for those providers and trainees unaware of preventive best practices for the diabetic foot, including those related to foot RTM. These sessions also are helpful for those familiar with foot temperature monitoring or who are responsible for administration of an ongoing program to remain current with contemporary best practices and to discuss improvements for patient care. Familiarity also can help address clinical inertia when benefits and evidence are clearly communicated with health care providers (HCPs).

 

 

Clinical Best Practices

Treating preulcerative lesions urgently and aggressively. Callus and other preulcerative lesions often cause progressive tissue damage and poor outcomes. When identified, these lesions should be promptly treated to ensure best outcomes.24

Recognizing the limits of patient self-examinations. Comorbidities such as visual impairment and reduced joint mobility often preclude patients from completing rigorous self-examinations of the foot, which is especially critical while collecting subjective history from the patient during triage of inflammation. A caregiver or spouse can help inspect the foot during outreach and provide additional context.36

Interpreting a benign foot on examination. Because RTM has been demonstrated to detect inflammation preceding a foot ulcer as many as 5 weeks before presentation to the clinic, some veterans may have few signs or symptoms of acute risk during examination. Often, the damage is to subcutaneous tissue resulting from repetitive microtrauma. Research suggests that clinical examination in these cases is often unreliable for identifying the earliest signs of risk, such as palpation to identify subtle temperature changes secondary to inflammation.37 If a patient has refractory inflammation requiring examination and presents with an otherwise unremarkable foot, it is an opportunity to evaluate whether the patient’s shoewear remains appropriate or has worn out, to communicate the veteran’s ongoing elevated risk, and to educate on the importance of diligence in daily foot self-examinations, daily use of the foot temperature monitoring, and continued off-loading until the inflammation resolves.

Communicating the distinction between healing and remission. Although healing is the goal of wound care, patients should be educated that the underlying disease remains after epithelialization. In some cases, tissue deep to the skin has not completed remodeling, and the patient is at acute risk of recurrence. Remission is a powerful metaphor that better describes the patient’s ongoing risk to encourage continued healthy routines and diligent self-care.38Considering the entirety of both feet for recurrence. Critical risk factors for diabetic foot complications, such as peripheral neuropathy and PAD, exist in both limbs, and patients with a history of wounds often develop new complications to different ipsilateral locations, or in as many as 48% of cases, to the contralateral foot.35 For best outcomes, detected inflammation should be treated aggressively independent of whether the location coincides with an area of previous concern.

Encouraging adherence, routine, and empowerment. Advanced diabetes mellitus and neuropathy may impact a patient’s executive function, and multiple studies have reported that patients at risk for inflammatory foot diseases exhibit fatalism toward their foot care and outcomes.39-41 Consistent education, encouragement, empowerment, and establishment of positive routines are needed to ensure high adherence with all preventive care regimens, including RTM.

Case Presentations

The following case series illustrates many of these clinical best practices and characterizes the potential benefits of RTM to veterans within the VA.

Case 1: Prevention After Healing

A veteran underwent a Chopart amputation and was recommended to use the mat after healing was perceived. Immediately on use of the study mat, the patient was found to have inflammation to the surgical incision (Figure 1). Clinical staff was alerted to the findings, and the patient was instructed to limit further walking and continue off-loading in his removable cast walker, per protocol. The inflammation of the operative foot quickly reduced, and the patient continued healing successfully, potentially avoiding incisional dehiscence and possible postoperative infection.

 

 

This case illustrates that patients’ wounds or surgical incisions may not be completely healed on epithelialization. In the immediate phase after closure, HCPs should consider additional protection to avoid complications. This case demonstrates that RTM can provide objective data to help guide care in that critical period.

Case 2: Identifying Preulcerative Lesions

An 88-year-old veteran had a chronic callus under the second metatarsal head. In addition to routine foot care and therapeutic shoes, he was followed with once-daily RTM. Inflammation was noted, and the veteran was seen in the podiatry clinic where debridement of the callus was performed. The difference in temperatures between feet detected by thermography prior to the clinic visits rapidly resolved after callus debridement, indicating that the underlying inflammation had subsided. RTM was used by the clinical staff to determine the appropriate time interval between clinic visits to avoid callus breakdown and subsequent ulceration.

Case 3: Extending the Clinic Into the Home

An 80-year-old veteran with T2DM and neuropathy was deemed a high-risk patient due to recurrent ulcerations to the left great toe. He was issued a RTM mat and was adherent with routine use. After nearly a year without hot-spot development, inflammation was noted (Figure 2).

Unfortunately, the patient had missed several routine foot care visits and likely that was the reason for the noted inflammation. The patient was called and became reengaged in regular visits for routine foot care. On debridement of his callus, a superficial, noninfected ulceration was discovered. Had remote monitoring not detected the inflammation and impending ulceration, the patient likely would not have been seen in the regular clinic and may have developed a wound infection, potentially resulting in a worse and more costly outcome.

Paradigm Shift to Prevention

Given the exceedingly high burden of diabetic foot complications in the VA, a paradigm shift is needed among HCPs from a culture of treatment to one of prevention. Bus and colleagues reported that in Europe, for every euro spent on ulcer prevention, 10 are spent on ulcer healing, and for every randomized clinical trial conducted on prevention, 10 are conducted on treatment.42-44 Hicks and colleagues showed that the cost of curative care for DFUs is 5 to 30 times greater than the cost of preventive care.45 For RTM in high-risk cohorts (ie, PAVE level 3), the number-needed-to-treat for DFU prevention may be as low as 6, assuming that a 70% reduction in incidence is possible, consistent with previous research. In the year following a DFU, costs exceed $44,000.9 Thus, it seems natural that future direction in diabetic foot care should emphasize prevention strategies.

Foot ulcers that become infected often lead to hospitalization and result in an increased burden to an already overburdened VA health care system. Research suggests that about two-thirds of all diabetic foot costs are attributable to inpatient management.46 The impact of diabetic foot complications on hospital resource utilization is staggering. A 2017 study by Skrepnik analyzed the risk of hospitalization for various diseases.47 The investigators found that the inpatient admission odds ratio (OR) for congestive heart failure was 2.6, surpassed only by DFUs (OR, 3.4) and diabetic foot infection (OR, 6.7). A 2019 point-prevalence study found that > 10% of hospital admissions have a foot-related condition as the primary or secondary reason, and the majority of these are due to foot diseases, such as ulcers, infections, and Charcot neuroarthropathy.48

It is therefore incumbent on VA HCPs to avert wound recurrence in the interest of avoiding veteran hospitalizations and for administrators to encourage and incentivize best practices for managing the diabetic foot, with an emphasis on prevention therapies. In evaluating the financial impact of prevention with foot RTM, administrators should consider that the cost benefit is likely to be realized across the medical center, with budgets related to inpatient management likely to receive the largest returns.

Prevention has the potential to rein in costs as well as reduce strain on the hospital and clinic by preventing outcomes that require frequent visits for treatment or hospitalization. Wound treatment is very burdensome to the clinic; patients require frequent (in many cases, weekly) examinations, and chronic wounds often require hospitalization, necessitating rounding and additional coordination in care. Thus, preventing wounds or reducing their severity at presentation substantially reduces burden on the clinic, even after accounting for the modest clinical resources needed to administer preventative care. For example, a brief examination may be necessary if the inflammation detected by the study mat is secondary to a callus that must be debrided. However, if the patient was not seen until the callus had progressed to a wound, weekly follow-up and substantial clinical and budgetary resources may be required to heal the wound. Preventive care allows for substantially better patient outcomes, and the minimal time invested prevents the clinical burden of extensive wound treatment.

The success of preventive efforts relies on multidisciplinary management of this high-risk patient cohort. Often, it is the responsibility of the primary care provider to follow diabetic foot clinical reminders and appropriately refer to specialty care. Successful, open communication between PACT, PAVE, and the Podiatry Service has been shown to reduce poor outcomes, including lower extremity amputations. Traditionally, the model of preventive care has included podiatrist-driven interventions, including integrated routine foot care and comprehensive diabetic foot education. Collaboration between routine evaluation and prompt referral of at-risk patients for specialist foot care, therapeutic footwear recommendations, daily self-foot examinations, and in-home temperature monitoring are critically effective when performed consistently.

When trying to translate research science to effective clinical practice for preventing lower extremity complication, there are several important concepts. First, given the frequency of examination for patients being treated for a wound, provision of good preventive care, such as RTM, can reduce overall burden to resource-constrained clinics and improve access for patients needing to be seen. Additionally, preventive efforts extend clinical practice into the home and may reduce the need for in-clinic examinations and routine follow-up visits. Finally, there may be a sense of trust established between the clinician and patient with a positive record of adherence with preventive practices. This may translate into more productive communication and less frequent routine visits to better accommodate urgent visits and ensure podiatric care is accessible to veterans.

 

 

Conclusions

There is a significant opportunity to shift diabetic foot care from treatment to prevention, improving veteran outcomes and reducing resource utilization. RTM is an evidence-based and recommended but underused telemedicine solution that can catalyze this needed paradigm shift. The VA has been at the forefront of preventive foot care through the PAVE program and more recently through research and clinical application of RTM for veterans. However, as the data presented suggest, more can be done to improve veteran outcomes. More widespread adoption of evidence-based preventive technologies for the diabetic foot, such as RTM, has the potential to dramatically improve the quality of and access to care and reduce costs and burden on resource-constrained clinics.

References

1. Liu Y, Sayam S, Shao X, et al. Prevalence of and trends in diabetes among veterans, United States, 2005-2014. Prev Chronic Dis. 2017;14:E135.

2. Brennan MB, Hess TM, Bartle B, et al. Diabetic foot ulcer severity predicts mortality among veterans with type 2 diabetes. J Diabetes Complications. 2017;31(3):556-561.

3. Prompers L, Schaper N, Apelqvist J, et al. Prediction of outcome in individuals with diabetic foot ulcers: focus on the differences between individuals with and without peripheral arterial disease. The EURODIALE Study. Diabetologia. 2008;51(5):747-755.

4. Geerlings SE, Hoepelman AIM. Immune dysfunction in patients with diabetes mellitus (DM). FEMS Immunol Med Microbiol. 1999;26(3-4):259-265.

5. Prompers L, Huijberts M, Apelqvist J, et al. High prevalence of ischaemia, infection and serious comorbidity in patients with diabetic foot disease in Europe. Baseline results from the Eurodiale study. Diabetologia. 2007;50(1):18-25.

6. Glover JL, Weingarten MS, Buchbinder DS, Poucher RL, Deitrick GA 3rd, Fylling CP. A 4-year outcome-based retrospective study of wound healing and limb salvage in patients with chronic wounds. Adv Wound Care. 1997;10(1):33-38.

7. Franklin H, Rajan M, Tseng C-L, Pogach L, Sinha A. Cost of lower-limb amputation in U.S. veterans with diabetes using health services data in fiscal years 2004 and 2010. J Rehabil Res Dev. 2014;51(8):1325-1330.

8. Melcer T, Sechriest VF, Walker J, Galarneau M. A comparison of health outcomes for combat amputee and limb salvage patients injured in Iraq and Afghanistan wars. J Trauma Acute Care Surg. 2013;75(2)(suppl 2):S247-S254.

9. Chan B, Cadarette S, Wodchis W, Wong J, Mittmann N, Krahn M. Cost-of-illness studies in chronic ulcers: a systematic review. J Wound Care. 2017;26(suppl 4):S4-S14.

10. US Department of Veterans Affairs. VA/DoD clinical practice guideline for the management of type 2 diabetes mellitus in Primary Care. Version 5.0. https://www.healthquality.va.gov/guidelines/CD/diabetes/VADoDDMCPGFinal508.pdf. Published April 2017. Accessed January 31, 2020.

11. Morbach S, Furchert H, Gröblinghoff U, et al. Long-term prognosis of diabetic foot patients and their limbs: amputation and death over the course of a decade. Diabetes Care. 2012;35(10):2021-2027.

12. Apelqvist J, Larsson J, Agardh CD. Long-term prognosis for diabetic patients with foot ulcers. J Intern Med. 1993;233(6):485-491.

13. Pound N, Chipchase S, Treece K, Game F, Jeffcoate W. Ulcer-free survival following management of foot ulcers in diabetes. Diabet Med. 2005;22(10):1306-1309.

14. Dubský M, Jirkovská A, Bem R, et al. Risk factors for recurrence of diabetic foot ulcers: prospective follow-up analysis in the Eurodiale subgroup. Int Wound J. 2013;10(5):555-561.

15. Ulbrecht JS, Hurley T, Mauger DT, Cavanagh PR. Prevention of recurrent foot ulcers with plantar pressure-based in-shoe orthoses: the CareFUL prevention multicenter randomized controlled trial. Diabetes Care. 2014;37(7):1982-1989.

16. Waaijman R, de Haart M, Arts MLJ, et al. Risk factors for plantar foot ulcer recurrence in neuropathic diabetic patients. Diabetes Care. 2014;37(6):1697-1705.

17. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1410: Prevention of Amputations in Veterans Everywhere (PAVE) Program. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=5364. Published March 31, 2017. Accessed February 10, 2020.

18. Robbins JM, Wrobel JS, Kirsh S, Pogach L. Characteristics of high-functioning collaborations between primary care and podiatry in VHA patient aligned care teams. Fed Pract. 2016;33(8):32-36.

19. US Department of Veterans Affairs. Office of Inspector General. Healthcare inspection: foot care for patients with diabetes and additional risk factors for amputation. https://www.va.gov/oig/pubs/VAOIG-11-00711-74.pdf. Published January 17, 2013. Accessed February 3, 2020.

20. Kehle SM, Greer N, Rutks I, Wilt T. Interventions to improve veterans’ access to care: a systematic review of the literature. J Gen Intern Med. 2011;26(suppl 2):689-696.

21. Lavery LA, Higgins KR, Lanctot DR, et al. Home monitoring of foot skin temperatures to prevent ulceration. Diabetes Care. 2004;27(11):2642-2647.

22. Lavery LA, Higgins KR, Lanctot DR, et al. Preventing diabetic foot ulcer recurrence in high-risk patients: use of temperature monitoring as a self-assessment tool. Diabetes Care. 2007;30(1):14-20.

23. Armstrong DG, Holtz-Neiderer K, Wendel C, Mohler MJ, Kimbriel HR, Lavery LA. Skin temperature monitoring reduces the risk for diabetic foot ulceration in high-risk patients. Am J Med. 2007;120(12):1042-1046.

24. Bakker K, Apelqvist J, Lipsky BA, Van Netten JJ; International Working Group on the Diabetic Foot. The 2015 IWGDF guidance documents on prevention and management of foot problems in diabetes: development of an evidence-based global consensus. Diabetes Metab Res Rev. 2016;32 (suppl 1):2-6.

25. Frykberg RG, Zgonis T, Armstrong DG, et al; American College of Foot Ankle Surgeons. Diabetic foot disorders: a clinical practice guideline (2006 revision). J Foot Ankle Surg. 2006;45(suppl 5):S1-S66.

26. Lavery LA, Davis KE, Berriman SJ, et al. WHS guidelines update: diabetic foot ulcer treatment guidelines. Wound Repair Regen. 2016;24(1):112-126.

27. US Department of Veterans Affairs, VA National Prosthetics and Sensory Aids Service and National Podiatry Program Office. Podimetrics – TMD temperature monitoring devices. [Source not verified.]

28. Arad Y, Fonseca V, Peters A, Vinik A. Beyond the monofilament for the insensate diabetic foot: a systematic review of randomized trials to prevent the occurrence of plantar foot ulcers in patients with diabetes. Diabetes Care. 2011;34(4):1041-1046.

29. Dy SM, Bennett WL, Sharma R, et al. Preventing Complications and Treating Symptoms of Diabetic Peripheral Neuropathy. Rockville, MD: Agency for Healthcare Research and Quality US; 2017.

30. Frykberg RG, Gordon IL, Reyzelman AM, et al. Feasibility and efficacy of a SmartMat technology to predict development of diabetic plantar ulcers. Diabetes Care. 2017;40(7):973-980.

31. Crisologo PA, Lavery LA. Remote home monitoring to identify and prevent diabetic foot ulceration. Ann Transl Med. 2017;5(21):430.

32. Armstrong DG, Abu-Rumman PL, Nixon BP, Boulton AJ. Continuous activity monitoring in persons at high risk for diabetes-related lower-extremity amputation. J Am Podiatr Med Assoc. 2001;91(9):451-455.

33. Gordon IL, Rothenberg GM, Lepow BD, et al. Accuracy of a foot temperature monitoring mat for predicting diabetic foot ulcers in patients with recent wounds or partial foot amputation. Diabetes Res Clin Pract. 2020. [Online ahead of print.]

34. Lavery LA, Petersen BJ, Linders DR, Bloom JD, Rothenberg GM, Armstrong DG. Unilateral remote temperature monitoring to predict future ulceration for the diabetic foot in remission. BMJ Open Diabetes Res Care. 2019;7(1):e000696.

35. Petersen BJ, Rothenberg GM, Lakhani PJ, et al. Ulcer metastasis? Anatomical locations of recurrence for patients in diabetic foot remission. J Foot Ankle Res. 2020;13:1.

36. Killeen AL, Brock KM, Dancho JF, Walters JL. Remote temperature monitoring in patients with visual impairment due to diabetes mellitus, a proposed improvement to curren standard of care for prevention of diabetic foot ulcers. J Diabetes Sci Technol. 2020;14(1):37-45.

37. Murff RT, Armstrong DG, Lanctot D, Lavery LA, Athanasiou KA. How effective is manual palpation in detecting subtle temperature differences? Clin Podiatr Med Surg. 1998;15(1):151-154.

38. Armstrong DG, Boulton AJM, Bus SA. Diabetic foot ulcers and their recurrence. N Engl J Med. 2017;376(24):2367-2375.

39. Natovich R, Kushnir T, Harman-Boehm I, et al. Cognitive dysfunction: part and parcel of the diabetic foot. Diabetes Care. 2016;39(7):1202-1207.

40. Zhong A, Li G, Wang D, Sun Y, Zou X, Li B. The risks and external effects of diabetic foot ulcer on diabetic patients: a hospital-based survey in Wuhan area, China. Wound Repair Regen. 2017;25(5):858-863.

41. Vileikyte L. Diabetic foot ulcers: a quality of life issue. Diabetes Metab Res Rev. 2001;17(4):246-249.

42. Van Acker K, Oleen-Burkey M, De Decker L, et al. Cost and resource utilization for prevention and treatment of foot lesions in a diabetic foot clinic in Belgium. Diabetes Res Clin Pract. 2000;50(2):87-95.

43. Kerr M, Rayman G, Jeffcoate WJ. Cost of diabetic foot disease to the National Health Service in England. Diabetes Med. 2014;31(12):1498-1504.

44. Bus SA, van Netten JJ. A shift in priority in diabetic foot care and research: 75% of foot ulcers are preventable. Diabetes Metab Res Rev. 2016;32(suppl 1):195-200.

45. Hicks CW, Selvarajah S, Mathioudakis N, et al. Burden of infected diabetic foot ulcers on hospital admissions and costs. Ann Vasc Surg. 2016;33:149-158.

46. Rice JB, Desai U, Cummings AKG, Birnbaum HG, Skornicki M, Parsons NB. Burden of diabetic foot ulcers for Medicare and private insurers. Diabetes Care. 2014;37(3):651-658.

47. Skrepnek GH, Mills JL Sr, Lavery LA, Armstrong DG. Health care service and outcomes among an estimated 6.7 million ambulatory care diabetic foot cases in the U.S. Diabetes Care. 2017;40(7):936-942.

48. Lazzarini PA, Hurn SE, Kuys SS, et al. Direct inpatient burden caused by foot-related conditions: a multisite point-prevalence study. BMJ Open. 2016;6(6):e010811.

References

1. Liu Y, Sayam S, Shao X, et al. Prevalence of and trends in diabetes among veterans, United States, 2005-2014. Prev Chronic Dis. 2017;14:E135.

2. Brennan MB, Hess TM, Bartle B, et al. Diabetic foot ulcer severity predicts mortality among veterans with type 2 diabetes. J Diabetes Complications. 2017;31(3):556-561.

3. Prompers L, Schaper N, Apelqvist J, et al. Prediction of outcome in individuals with diabetic foot ulcers: focus on the differences between individuals with and without peripheral arterial disease. The EURODIALE Study. Diabetologia. 2008;51(5):747-755.

4. Geerlings SE, Hoepelman AIM. Immune dysfunction in patients with diabetes mellitus (DM). FEMS Immunol Med Microbiol. 1999;26(3-4):259-265.

5. Prompers L, Huijberts M, Apelqvist J, et al. High prevalence of ischaemia, infection and serious comorbidity in patients with diabetic foot disease in Europe. Baseline results from the Eurodiale study. Diabetologia. 2007;50(1):18-25.

6. Glover JL, Weingarten MS, Buchbinder DS, Poucher RL, Deitrick GA 3rd, Fylling CP. A 4-year outcome-based retrospective study of wound healing and limb salvage in patients with chronic wounds. Adv Wound Care. 1997;10(1):33-38.

7. Franklin H, Rajan M, Tseng C-L, Pogach L, Sinha A. Cost of lower-limb amputation in U.S. veterans with diabetes using health services data in fiscal years 2004 and 2010. J Rehabil Res Dev. 2014;51(8):1325-1330.

8. Melcer T, Sechriest VF, Walker J, Galarneau M. A comparison of health outcomes for combat amputee and limb salvage patients injured in Iraq and Afghanistan wars. J Trauma Acute Care Surg. 2013;75(2)(suppl 2):S247-S254.

9. Chan B, Cadarette S, Wodchis W, Wong J, Mittmann N, Krahn M. Cost-of-illness studies in chronic ulcers: a systematic review. J Wound Care. 2017;26(suppl 4):S4-S14.

10. US Department of Veterans Affairs. VA/DoD clinical practice guideline for the management of type 2 diabetes mellitus in Primary Care. Version 5.0. https://www.healthquality.va.gov/guidelines/CD/diabetes/VADoDDMCPGFinal508.pdf. Published April 2017. Accessed January 31, 2020.

11. Morbach S, Furchert H, Gröblinghoff U, et al. Long-term prognosis of diabetic foot patients and their limbs: amputation and death over the course of a decade. Diabetes Care. 2012;35(10):2021-2027.

12. Apelqvist J, Larsson J, Agardh CD. Long-term prognosis for diabetic patients with foot ulcers. J Intern Med. 1993;233(6):485-491.

13. Pound N, Chipchase S, Treece K, Game F, Jeffcoate W. Ulcer-free survival following management of foot ulcers in diabetes. Diabet Med. 2005;22(10):1306-1309.

14. Dubský M, Jirkovská A, Bem R, et al. Risk factors for recurrence of diabetic foot ulcers: prospective follow-up analysis in the Eurodiale subgroup. Int Wound J. 2013;10(5):555-561.

15. Ulbrecht JS, Hurley T, Mauger DT, Cavanagh PR. Prevention of recurrent foot ulcers with plantar pressure-based in-shoe orthoses: the CareFUL prevention multicenter randomized controlled trial. Diabetes Care. 2014;37(7):1982-1989.

16. Waaijman R, de Haart M, Arts MLJ, et al. Risk factors for plantar foot ulcer recurrence in neuropathic diabetic patients. Diabetes Care. 2014;37(6):1697-1705.

17. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1410: Prevention of Amputations in Veterans Everywhere (PAVE) Program. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=5364. Published March 31, 2017. Accessed February 10, 2020.

18. Robbins JM, Wrobel JS, Kirsh S, Pogach L. Characteristics of high-functioning collaborations between primary care and podiatry in VHA patient aligned care teams. Fed Pract. 2016;33(8):32-36.

19. US Department of Veterans Affairs. Office of Inspector General. Healthcare inspection: foot care for patients with diabetes and additional risk factors for amputation. https://www.va.gov/oig/pubs/VAOIG-11-00711-74.pdf. Published January 17, 2013. Accessed February 3, 2020.

20. Kehle SM, Greer N, Rutks I, Wilt T. Interventions to improve veterans’ access to care: a systematic review of the literature. J Gen Intern Med. 2011;26(suppl 2):689-696.

21. Lavery LA, Higgins KR, Lanctot DR, et al. Home monitoring of foot skin temperatures to prevent ulceration. Diabetes Care. 2004;27(11):2642-2647.

22. Lavery LA, Higgins KR, Lanctot DR, et al. Preventing diabetic foot ulcer recurrence in high-risk patients: use of temperature monitoring as a self-assessment tool. Diabetes Care. 2007;30(1):14-20.

23. Armstrong DG, Holtz-Neiderer K, Wendel C, Mohler MJ, Kimbriel HR, Lavery LA. Skin temperature monitoring reduces the risk for diabetic foot ulceration in high-risk patients. Am J Med. 2007;120(12):1042-1046.

24. Bakker K, Apelqvist J, Lipsky BA, Van Netten JJ; International Working Group on the Diabetic Foot. The 2015 IWGDF guidance documents on prevention and management of foot problems in diabetes: development of an evidence-based global consensus. Diabetes Metab Res Rev. 2016;32 (suppl 1):2-6.

25. Frykberg RG, Zgonis T, Armstrong DG, et al; American College of Foot Ankle Surgeons. Diabetic foot disorders: a clinical practice guideline (2006 revision). J Foot Ankle Surg. 2006;45(suppl 5):S1-S66.

26. Lavery LA, Davis KE, Berriman SJ, et al. WHS guidelines update: diabetic foot ulcer treatment guidelines. Wound Repair Regen. 2016;24(1):112-126.

27. US Department of Veterans Affairs, VA National Prosthetics and Sensory Aids Service and National Podiatry Program Office. Podimetrics – TMD temperature monitoring devices. [Source not verified.]

28. Arad Y, Fonseca V, Peters A, Vinik A. Beyond the monofilament for the insensate diabetic foot: a systematic review of randomized trials to prevent the occurrence of plantar foot ulcers in patients with diabetes. Diabetes Care. 2011;34(4):1041-1046.

29. Dy SM, Bennett WL, Sharma R, et al. Preventing Complications and Treating Symptoms of Diabetic Peripheral Neuropathy. Rockville, MD: Agency for Healthcare Research and Quality US; 2017.

30. Frykberg RG, Gordon IL, Reyzelman AM, et al. Feasibility and efficacy of a SmartMat technology to predict development of diabetic plantar ulcers. Diabetes Care. 2017;40(7):973-980.

31. Crisologo PA, Lavery LA. Remote home monitoring to identify and prevent diabetic foot ulceration. Ann Transl Med. 2017;5(21):430.

32. Armstrong DG, Abu-Rumman PL, Nixon BP, Boulton AJ. Continuous activity monitoring in persons at high risk for diabetes-related lower-extremity amputation. J Am Podiatr Med Assoc. 2001;91(9):451-455.

33. Gordon IL, Rothenberg GM, Lepow BD, et al. Accuracy of a foot temperature monitoring mat for predicting diabetic foot ulcers in patients with recent wounds or partial foot amputation. Diabetes Res Clin Pract. 2020. [Online ahead of print.]

34. Lavery LA, Petersen BJ, Linders DR, Bloom JD, Rothenberg GM, Armstrong DG. Unilateral remote temperature monitoring to predict future ulceration for the diabetic foot in remission. BMJ Open Diabetes Res Care. 2019;7(1):e000696.

35. Petersen BJ, Rothenberg GM, Lakhani PJ, et al. Ulcer metastasis? Anatomical locations of recurrence for patients in diabetic foot remission. J Foot Ankle Res. 2020;13:1.

36. Killeen AL, Brock KM, Dancho JF, Walters JL. Remote temperature monitoring in patients with visual impairment due to diabetes mellitus, a proposed improvement to curren standard of care for prevention of diabetic foot ulcers. J Diabetes Sci Technol. 2020;14(1):37-45.

37. Murff RT, Armstrong DG, Lanctot D, Lavery LA, Athanasiou KA. How effective is manual palpation in detecting subtle temperature differences? Clin Podiatr Med Surg. 1998;15(1):151-154.

38. Armstrong DG, Boulton AJM, Bus SA. Diabetic foot ulcers and their recurrence. N Engl J Med. 2017;376(24):2367-2375.

39. Natovich R, Kushnir T, Harman-Boehm I, et al. Cognitive dysfunction: part and parcel of the diabetic foot. Diabetes Care. 2016;39(7):1202-1207.

40. Zhong A, Li G, Wang D, Sun Y, Zou X, Li B. The risks and external effects of diabetic foot ulcer on diabetic patients: a hospital-based survey in Wuhan area, China. Wound Repair Regen. 2017;25(5):858-863.

41. Vileikyte L. Diabetic foot ulcers: a quality of life issue. Diabetes Metab Res Rev. 2001;17(4):246-249.

42. Van Acker K, Oleen-Burkey M, De Decker L, et al. Cost and resource utilization for prevention and treatment of foot lesions in a diabetic foot clinic in Belgium. Diabetes Res Clin Pract. 2000;50(2):87-95.

43. Kerr M, Rayman G, Jeffcoate WJ. Cost of diabetic foot disease to the National Health Service in England. Diabetes Med. 2014;31(12):1498-1504.

44. Bus SA, van Netten JJ. A shift in priority in diabetic foot care and research: 75% of foot ulcers are preventable. Diabetes Metab Res Rev. 2016;32(suppl 1):195-200.

45. Hicks CW, Selvarajah S, Mathioudakis N, et al. Burden of infected diabetic foot ulcers on hospital admissions and costs. Ann Vasc Surg. 2016;33:149-158.

46. Rice JB, Desai U, Cummings AKG, Birnbaum HG, Skornicki M, Parsons NB. Burden of diabetic foot ulcers for Medicare and private insurers. Diabetes Care. 2014;37(3):651-658.

47. Skrepnek GH, Mills JL Sr, Lavery LA, Armstrong DG. Health care service and outcomes among an estimated 6.7 million ambulatory care diabetic foot cases in the U.S. Diabetes Care. 2017;40(7):936-942.

48. Lazzarini PA, Hurn SE, Kuys SS, et al. Direct inpatient burden caused by foot-related conditions: a multisite point-prevalence study. BMJ Open. 2016;6(6):e010811.

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To Prevent Pernicious Political Activities: The Hatch Act and Government Ethics

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The impeachment trial has concluded. By the time you read this editorial, Super Tuesday will be over. Then there will be the political party conventions, and finally the general election. Politics is everywhere and will be for the rest of 2020. As a preventive ethics measure, the legal arms of almost every federal agency will be sending cautionary e-mails to employees to remind us that any political activity undertaken must comply with the Hatch Act. Many of you who have worked in federal health care for some years may have heard a fellow employee say, “be careful you don’t violate the Hatch Act.”

Most readers probably had not heard of the statute before entering federal service. And you may have had an experience similar to mine in my early federal career when through osmosis I absorbed my peers fear and trembling when the Hatch Act was mentioned. This was the situation even though you were not at all sure you understood what the lawyers were warning you not to do. In my decades in federal service, I have heard that the Hatch Act dictates everything from you cannot vote to you can run for political office.

All this makes the timing right to review a piece of legislation that governs the political actions of every federal health and administrative professional. The Hatch Act sets apart federal employees from many, if not most, of our civilian counterparts, who, depending on your perspective, have more freedom to express their political views or are not held to such a high standard of ethical conduct.

In legalese, the Hatch Act is Political Activity Authorized; Prohibitions, 5 USC §7323 (1939). The title of this editorial, “To Prevent Pernicious Political Activities” is the formal title of the Hatch Act enacted at a time when government legislation was written in more ornamental rhetoric than the staid language of the current bureaucratic style. The alliterative title phrase of the act is an apt, if dated, encapsulation of the legislative intention of the act, which in modern parlance:

The law’s purpose is to ensure that federal programs are administered in a nonpartisan fashion, to protect federal employees from political coercion in the workplace, and to ensure that federal employees are advanced based on merit and not based on political affiliation. 2

For all its poetic turn of phrase, the title is historically accurate. The Hatch Act was passed in response to rampant partisan activity in public office. It was a key part of an effort to professionalize civil service, and as an essential aspect of that process, to protect federal employees from widespread political influence. The ethical principle behind the legislation is the one that still stands as the ideal for federal practitioners: to serve the people and act for the good of the public and republic.

The Hatch Act was intended to prevent unscrupulous politicians from intimidating federal employees and usurping the machinery of major government agencies to achieve their political ambitions. Imagine if your supervisor was running for office or supporting a particular candidate and ordered you to put a campaign sign in your yard, attend a political rally, and wear a campaign button on your lapel or you would be fired. All that and far worse happened in the good old USA before the Hatch Act.3

The Office of Special Counsel (OSC) is the authoritative guardian of the Hatch Act providing opinions on whether an activity is permitted under the act; investigating compliance with the provisions of the act; taking disciplinary action against the employee for serious violations; and prosecuting those violations before the Merit Systems Protection Board. Now I understand why the incantation “Hatch Act” casts a chill on our civil service souls. While there have been recent allegations against a high-profile political appointee, federal practitioners are not immune to prosecution.4 In 2017, Federal Times reported that the OSC sought disciplinary action against a VA physician for 15 violations of the Hatch Act after he ran for a state Senate seat in 2014.5

Fortunately, the OSC has produced a handy list of “Though Shalt Nots” and “You Cans” as a guide to the Hatch Act.6 Only the highpoints are mentioned here:

 

 

  • Thou shalt not be a candidate for nomination or election to a partisan public office;
  • Thou shalt not use a position of official public authority to influence or interfere with the result of an election;
  • Thou shalt not solicit or host, accept, or receive a donation or contribution to a partisan political party, candidate, or group; and
  • Thou shalt not engage in political activity on behalf of a partisan political party, candidate, or group while on duty, in a federal space, wearing a federal uniform, or driving a federal vehicle.

Covered under these daunting prohibitions is ordinary American politicking like hosting fundraisers or inviting your coworkers to a political rally, distributing campaign materials, and wearing a T-shirt with your favorite candidates smiling face at work. The new hotbed of concern for the Hatch Act is, you guessed it, social media—you cannot use your blog, Facebook, Instagram, or e-mail account to comment pro or con for a partisan candidate, party, office, or group.6

You may be asking at this point whether you can even watch the political debates? Yes, that is allowed under the Hatch Act along with running for nonpartisan election and participating in nonpartisan campaigns; voting, and registering others to vote; you can contribute money to political campaigns, parties, or partisan groups; attend political rallies, meetings and fundraisers; and even join a political party. Of course these activities must be on your own time and dime, not that of your federal employer. All of these “You Cans” enable a federal employee to engage in the bare minimum of democracy: voting in elections, but opponents argue they bar the civil servant from fully participating in the complex richness of the American political process.7

Nonetheless, since its inception the Hatch Act has been a matter of fierce debate among federal employees and other advocates of civil liberties. Those who feel it should be relaxed contend that the modern merit-based system of government service has rendered the provisions of the Hatch Act unnecessary, even obsolete. In addition, unlike in 1939, critics of the act claim there are now formidable whistleblower protections for employees who experience political coercion. Over the years there have been several efforts to weaken the conflict of interest safeguards that the act contains, leading many commentators to think that some of the amendments and reforms have blurred the tight boundaries between the professional and the political. Others such as the government unions and the American Civil Liberties Union (ACLU) believe that the tight line drawn between public and private binds the liberty of civil servants.8 Those who defend the Hatch Act believe that the wall it erects between professional and personal in the realm of political activities for federal employees must remain high and strong to protect the integrity of the administrative branch and the public trust.9

So, as political advertisements dominate television programming and the texts never stop asking for campaign donations, you can cast your own vote for or against the Hatch Act. As for me and my house, we will follow President Jefferson in preferring to be the property of the people rather than be indebted to the powerful. You need never encounter a true conflict of interest if you have no false conflict of obligation: history teaches us that serving 2 masters usually turns out badly for the slave. Many of you will completely disagree with my stance, holding that your constitutional rights as a citizen are being curtailed, if not outright denied, simply because you choose to serve your country. Our ability to freely hold and express our differences of opinions about the Hatch Act and so much else is what keeps democracy alive.

References

1. Rayner BL. Life of Thomas Jefferson With Selections From the Most Valuable Portions of his Voluminous and Unrivalled Private Correspondence. Boston, MA: Lilly, Wait, Colman, and Holden; 1834:356.

2. US Office of Special Counsel. Hatch Act overview. https://osc.gov/Services/Pages/HatchAct.aspx. Accessed February 24, 2020.

3. Brown AJ. Public employee participation: Hatch Acts in the federal and state governments. Public Integrity. 2000;2(2):105-120.

4. Phillips A. What is the Hatch Act, and why did Kellyanne Conway get accused of violating it so egregiously? Washington Post. June 13, 2019. https://www.washingtonpost.com/politics/2019/06/13/what-is-hatch-act-why-did-kellyanne-conway-get-accused-violating-it-so-egregiously. Accessed February 24, 2020.

5. Bur J. Special counsel: VA doctor violated Hatch Act while campaigning. https://www.federaltimes.com/federal-oversight/watchdogs/2017/11/22/special-counsel-va-doctor-violated-hatch-act-while-campaigning. Published November 22, 2017. Accessed February 24, 2020.

6. US Office of Special Counsel. A guide to the Hatch Act for the federal employee. https://osc.gov/Documents/Outreach%20and%20Training/Handouts/A%20Guide%20to%20the%20Hatch%20Act%20for%20Federal%20Employees.pdf. Published September 2014. Accessed February 24, 2020.

7. Brown C, Maskell J. Hatch Act restrictions on federal employee’s political activities in the digital age. https://fas.org/sgp/crs/misc/R44469.pdf. Published April 13, 2016. Accessed February 24, 2020.

8. Thurber KT Jr. Revising the Hatch Act: a practitioner’s perspective. Public Manag. 1993;22(1):43.

9. Pearson WM, Castle DS. Expanding the opportunity for partisan activity among government employees: potential effects of federal executive’s political involvement. Int J Public Adm. 2007;16(4):511-525.

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Related Articles

The impeachment trial has concluded. By the time you read this editorial, Super Tuesday will be over. Then there will be the political party conventions, and finally the general election. Politics is everywhere and will be for the rest of 2020. As a preventive ethics measure, the legal arms of almost every federal agency will be sending cautionary e-mails to employees to remind us that any political activity undertaken must comply with the Hatch Act. Many of you who have worked in federal health care for some years may have heard a fellow employee say, “be careful you don’t violate the Hatch Act.”

Most readers probably had not heard of the statute before entering federal service. And you may have had an experience similar to mine in my early federal career when through osmosis I absorbed my peers fear and trembling when the Hatch Act was mentioned. This was the situation even though you were not at all sure you understood what the lawyers were warning you not to do. In my decades in federal service, I have heard that the Hatch Act dictates everything from you cannot vote to you can run for political office.

All this makes the timing right to review a piece of legislation that governs the political actions of every federal health and administrative professional. The Hatch Act sets apart federal employees from many, if not most, of our civilian counterparts, who, depending on your perspective, have more freedom to express their political views or are not held to such a high standard of ethical conduct.

In legalese, the Hatch Act is Political Activity Authorized; Prohibitions, 5 USC §7323 (1939). The title of this editorial, “To Prevent Pernicious Political Activities” is the formal title of the Hatch Act enacted at a time when government legislation was written in more ornamental rhetoric than the staid language of the current bureaucratic style. The alliterative title phrase of the act is an apt, if dated, encapsulation of the legislative intention of the act, which in modern parlance:

The law’s purpose is to ensure that federal programs are administered in a nonpartisan fashion, to protect federal employees from political coercion in the workplace, and to ensure that federal employees are advanced based on merit and not based on political affiliation. 2

For all its poetic turn of phrase, the title is historically accurate. The Hatch Act was passed in response to rampant partisan activity in public office. It was a key part of an effort to professionalize civil service, and as an essential aspect of that process, to protect federal employees from widespread political influence. The ethical principle behind the legislation is the one that still stands as the ideal for federal practitioners: to serve the people and act for the good of the public and republic.

The Hatch Act was intended to prevent unscrupulous politicians from intimidating federal employees and usurping the machinery of major government agencies to achieve their political ambitions. Imagine if your supervisor was running for office or supporting a particular candidate and ordered you to put a campaign sign in your yard, attend a political rally, and wear a campaign button on your lapel or you would be fired. All that and far worse happened in the good old USA before the Hatch Act.3

The Office of Special Counsel (OSC) is the authoritative guardian of the Hatch Act providing opinions on whether an activity is permitted under the act; investigating compliance with the provisions of the act; taking disciplinary action against the employee for serious violations; and prosecuting those violations before the Merit Systems Protection Board. Now I understand why the incantation “Hatch Act” casts a chill on our civil service souls. While there have been recent allegations against a high-profile political appointee, federal practitioners are not immune to prosecution.4 In 2017, Federal Times reported that the OSC sought disciplinary action against a VA physician for 15 violations of the Hatch Act after he ran for a state Senate seat in 2014.5

Fortunately, the OSC has produced a handy list of “Though Shalt Nots” and “You Cans” as a guide to the Hatch Act.6 Only the highpoints are mentioned here:

 

 

  • Thou shalt not be a candidate for nomination or election to a partisan public office;
  • Thou shalt not use a position of official public authority to influence or interfere with the result of an election;
  • Thou shalt not solicit or host, accept, or receive a donation or contribution to a partisan political party, candidate, or group; and
  • Thou shalt not engage in political activity on behalf of a partisan political party, candidate, or group while on duty, in a federal space, wearing a federal uniform, or driving a federal vehicle.

Covered under these daunting prohibitions is ordinary American politicking like hosting fundraisers or inviting your coworkers to a political rally, distributing campaign materials, and wearing a T-shirt with your favorite candidates smiling face at work. The new hotbed of concern for the Hatch Act is, you guessed it, social media—you cannot use your blog, Facebook, Instagram, or e-mail account to comment pro or con for a partisan candidate, party, office, or group.6

You may be asking at this point whether you can even watch the political debates? Yes, that is allowed under the Hatch Act along with running for nonpartisan election and participating in nonpartisan campaigns; voting, and registering others to vote; you can contribute money to political campaigns, parties, or partisan groups; attend political rallies, meetings and fundraisers; and even join a political party. Of course these activities must be on your own time and dime, not that of your federal employer. All of these “You Cans” enable a federal employee to engage in the bare minimum of democracy: voting in elections, but opponents argue they bar the civil servant from fully participating in the complex richness of the American political process.7

Nonetheless, since its inception the Hatch Act has been a matter of fierce debate among federal employees and other advocates of civil liberties. Those who feel it should be relaxed contend that the modern merit-based system of government service has rendered the provisions of the Hatch Act unnecessary, even obsolete. In addition, unlike in 1939, critics of the act claim there are now formidable whistleblower protections for employees who experience political coercion. Over the years there have been several efforts to weaken the conflict of interest safeguards that the act contains, leading many commentators to think that some of the amendments and reforms have blurred the tight boundaries between the professional and the political. Others such as the government unions and the American Civil Liberties Union (ACLU) believe that the tight line drawn between public and private binds the liberty of civil servants.8 Those who defend the Hatch Act believe that the wall it erects between professional and personal in the realm of political activities for federal employees must remain high and strong to protect the integrity of the administrative branch and the public trust.9

So, as political advertisements dominate television programming and the texts never stop asking for campaign donations, you can cast your own vote for or against the Hatch Act. As for me and my house, we will follow President Jefferson in preferring to be the property of the people rather than be indebted to the powerful. You need never encounter a true conflict of interest if you have no false conflict of obligation: history teaches us that serving 2 masters usually turns out badly for the slave. Many of you will completely disagree with my stance, holding that your constitutional rights as a citizen are being curtailed, if not outright denied, simply because you choose to serve your country. Our ability to freely hold and express our differences of opinions about the Hatch Act and so much else is what keeps democracy alive.

The impeachment trial has concluded. By the time you read this editorial, Super Tuesday will be over. Then there will be the political party conventions, and finally the general election. Politics is everywhere and will be for the rest of 2020. As a preventive ethics measure, the legal arms of almost every federal agency will be sending cautionary e-mails to employees to remind us that any political activity undertaken must comply with the Hatch Act. Many of you who have worked in federal health care for some years may have heard a fellow employee say, “be careful you don’t violate the Hatch Act.”

Most readers probably had not heard of the statute before entering federal service. And you may have had an experience similar to mine in my early federal career when through osmosis I absorbed my peers fear and trembling when the Hatch Act was mentioned. This was the situation even though you were not at all sure you understood what the lawyers were warning you not to do. In my decades in federal service, I have heard that the Hatch Act dictates everything from you cannot vote to you can run for political office.

All this makes the timing right to review a piece of legislation that governs the political actions of every federal health and administrative professional. The Hatch Act sets apart federal employees from many, if not most, of our civilian counterparts, who, depending on your perspective, have more freedom to express their political views or are not held to such a high standard of ethical conduct.

In legalese, the Hatch Act is Political Activity Authorized; Prohibitions, 5 USC §7323 (1939). The title of this editorial, “To Prevent Pernicious Political Activities” is the formal title of the Hatch Act enacted at a time when government legislation was written in more ornamental rhetoric than the staid language of the current bureaucratic style. The alliterative title phrase of the act is an apt, if dated, encapsulation of the legislative intention of the act, which in modern parlance:

The law’s purpose is to ensure that federal programs are administered in a nonpartisan fashion, to protect federal employees from political coercion in the workplace, and to ensure that federal employees are advanced based on merit and not based on political affiliation. 2

For all its poetic turn of phrase, the title is historically accurate. The Hatch Act was passed in response to rampant partisan activity in public office. It was a key part of an effort to professionalize civil service, and as an essential aspect of that process, to protect federal employees from widespread political influence. The ethical principle behind the legislation is the one that still stands as the ideal for federal practitioners: to serve the people and act for the good of the public and republic.

The Hatch Act was intended to prevent unscrupulous politicians from intimidating federal employees and usurping the machinery of major government agencies to achieve their political ambitions. Imagine if your supervisor was running for office or supporting a particular candidate and ordered you to put a campaign sign in your yard, attend a political rally, and wear a campaign button on your lapel or you would be fired. All that and far worse happened in the good old USA before the Hatch Act.3

The Office of Special Counsel (OSC) is the authoritative guardian of the Hatch Act providing opinions on whether an activity is permitted under the act; investigating compliance with the provisions of the act; taking disciplinary action against the employee for serious violations; and prosecuting those violations before the Merit Systems Protection Board. Now I understand why the incantation “Hatch Act” casts a chill on our civil service souls. While there have been recent allegations against a high-profile political appointee, federal practitioners are not immune to prosecution.4 In 2017, Federal Times reported that the OSC sought disciplinary action against a VA physician for 15 violations of the Hatch Act after he ran for a state Senate seat in 2014.5

Fortunately, the OSC has produced a handy list of “Though Shalt Nots” and “You Cans” as a guide to the Hatch Act.6 Only the highpoints are mentioned here:

 

 

  • Thou shalt not be a candidate for nomination or election to a partisan public office;
  • Thou shalt not use a position of official public authority to influence or interfere with the result of an election;
  • Thou shalt not solicit or host, accept, or receive a donation or contribution to a partisan political party, candidate, or group; and
  • Thou shalt not engage in political activity on behalf of a partisan political party, candidate, or group while on duty, in a federal space, wearing a federal uniform, or driving a federal vehicle.

Covered under these daunting prohibitions is ordinary American politicking like hosting fundraisers or inviting your coworkers to a political rally, distributing campaign materials, and wearing a T-shirt with your favorite candidates smiling face at work. The new hotbed of concern for the Hatch Act is, you guessed it, social media—you cannot use your blog, Facebook, Instagram, or e-mail account to comment pro or con for a partisan candidate, party, office, or group.6

You may be asking at this point whether you can even watch the political debates? Yes, that is allowed under the Hatch Act along with running for nonpartisan election and participating in nonpartisan campaigns; voting, and registering others to vote; you can contribute money to political campaigns, parties, or partisan groups; attend political rallies, meetings and fundraisers; and even join a political party. Of course these activities must be on your own time and dime, not that of your federal employer. All of these “You Cans” enable a federal employee to engage in the bare minimum of democracy: voting in elections, but opponents argue they bar the civil servant from fully participating in the complex richness of the American political process.7

Nonetheless, since its inception the Hatch Act has been a matter of fierce debate among federal employees and other advocates of civil liberties. Those who feel it should be relaxed contend that the modern merit-based system of government service has rendered the provisions of the Hatch Act unnecessary, even obsolete. In addition, unlike in 1939, critics of the act claim there are now formidable whistleblower protections for employees who experience political coercion. Over the years there have been several efforts to weaken the conflict of interest safeguards that the act contains, leading many commentators to think that some of the amendments and reforms have blurred the tight boundaries between the professional and the political. Others such as the government unions and the American Civil Liberties Union (ACLU) believe that the tight line drawn between public and private binds the liberty of civil servants.8 Those who defend the Hatch Act believe that the wall it erects between professional and personal in the realm of political activities for federal employees must remain high and strong to protect the integrity of the administrative branch and the public trust.9

So, as political advertisements dominate television programming and the texts never stop asking for campaign donations, you can cast your own vote for or against the Hatch Act. As for me and my house, we will follow President Jefferson in preferring to be the property of the people rather than be indebted to the powerful. You need never encounter a true conflict of interest if you have no false conflict of obligation: history teaches us that serving 2 masters usually turns out badly for the slave. Many of you will completely disagree with my stance, holding that your constitutional rights as a citizen are being curtailed, if not outright denied, simply because you choose to serve your country. Our ability to freely hold and express our differences of opinions about the Hatch Act and so much else is what keeps democracy alive.

References

1. Rayner BL. Life of Thomas Jefferson With Selections From the Most Valuable Portions of his Voluminous and Unrivalled Private Correspondence. Boston, MA: Lilly, Wait, Colman, and Holden; 1834:356.

2. US Office of Special Counsel. Hatch Act overview. https://osc.gov/Services/Pages/HatchAct.aspx. Accessed February 24, 2020.

3. Brown AJ. Public employee participation: Hatch Acts in the federal and state governments. Public Integrity. 2000;2(2):105-120.

4. Phillips A. What is the Hatch Act, and why did Kellyanne Conway get accused of violating it so egregiously? Washington Post. June 13, 2019. https://www.washingtonpost.com/politics/2019/06/13/what-is-hatch-act-why-did-kellyanne-conway-get-accused-violating-it-so-egregiously. Accessed February 24, 2020.

5. Bur J. Special counsel: VA doctor violated Hatch Act while campaigning. https://www.federaltimes.com/federal-oversight/watchdogs/2017/11/22/special-counsel-va-doctor-violated-hatch-act-while-campaigning. Published November 22, 2017. Accessed February 24, 2020.

6. US Office of Special Counsel. A guide to the Hatch Act for the federal employee. https://osc.gov/Documents/Outreach%20and%20Training/Handouts/A%20Guide%20to%20the%20Hatch%20Act%20for%20Federal%20Employees.pdf. Published September 2014. Accessed February 24, 2020.

7. Brown C, Maskell J. Hatch Act restrictions on federal employee’s political activities in the digital age. https://fas.org/sgp/crs/misc/R44469.pdf. Published April 13, 2016. Accessed February 24, 2020.

8. Thurber KT Jr. Revising the Hatch Act: a practitioner’s perspective. Public Manag. 1993;22(1):43.

9. Pearson WM, Castle DS. Expanding the opportunity for partisan activity among government employees: potential effects of federal executive’s political involvement. Int J Public Adm. 2007;16(4):511-525.

References

1. Rayner BL. Life of Thomas Jefferson With Selections From the Most Valuable Portions of his Voluminous and Unrivalled Private Correspondence. Boston, MA: Lilly, Wait, Colman, and Holden; 1834:356.

2. US Office of Special Counsel. Hatch Act overview. https://osc.gov/Services/Pages/HatchAct.aspx. Accessed February 24, 2020.

3. Brown AJ. Public employee participation: Hatch Acts in the federal and state governments. Public Integrity. 2000;2(2):105-120.

4. Phillips A. What is the Hatch Act, and why did Kellyanne Conway get accused of violating it so egregiously? Washington Post. June 13, 2019. https://www.washingtonpost.com/politics/2019/06/13/what-is-hatch-act-why-did-kellyanne-conway-get-accused-violating-it-so-egregiously. Accessed February 24, 2020.

5. Bur J. Special counsel: VA doctor violated Hatch Act while campaigning. https://www.federaltimes.com/federal-oversight/watchdogs/2017/11/22/special-counsel-va-doctor-violated-hatch-act-while-campaigning. Published November 22, 2017. Accessed February 24, 2020.

6. US Office of Special Counsel. A guide to the Hatch Act for the federal employee. https://osc.gov/Documents/Outreach%20and%20Training/Handouts/A%20Guide%20to%20the%20Hatch%20Act%20for%20Federal%20Employees.pdf. Published September 2014. Accessed February 24, 2020.

7. Brown C, Maskell J. Hatch Act restrictions on federal employee’s political activities in the digital age. https://fas.org/sgp/crs/misc/R44469.pdf. Published April 13, 2016. Accessed February 24, 2020.

8. Thurber KT Jr. Revising the Hatch Act: a practitioner’s perspective. Public Manag. 1993;22(1):43.

9. Pearson WM, Castle DS. Expanding the opportunity for partisan activity among government employees: potential effects of federal executive’s political involvement. Int J Public Adm. 2007;16(4):511-525.

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Stored CD34 cells for multiple myeloma patients largely unused

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– Collecting and storing extra stem cells on the off chance that a patient with multiple myeloma will need a salvage autologous stem cell transplant may not be worth the money or effort, investigators say.

Neil Osterweil/MDedge News
Dr. Nausheen Ahmed

Among patients with multiple myeloma who had adequate collection of mobilized and stored cells, only 3 of 146 eligible patients were given the stored cells in a second autologous stem cell transplant (ASCT), reported Nausheen Ahmed, MD, from the Case Western Reserve Cancer Center and University Hospitals Seidman Cancer Center, both in Cleveland.

“We found overall low utilization of salvage transplants and storage stem cells at our institution, which may not justify the strategy of early collection for all patients fit for transplant,” she said at the Transplantation and Cellular Therapy Meetings.

But Sergio Giralt, MD, a transplant specialist from Memorial Sloan Kettering Cancer Center, New York, who was not involved in the study, warned against changing practice “for the wrong reason, because it’s just a financial reason.”
 

Get them while they’re fresh

The rationale for collecting and storing extra cells is the risk that mobilization will fail in the future following prolonged maintenance with immunomodulatory agents such as lenalidomide (Revlimid), and the risk for genetic or epigenetic damage to cells from high-dose melphalan used in transplant-conditioning regimens, Dr. Ahmed noted at the meeting held by the American Society for Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research.

“However, there are potential issues with early mobilization and storage, including cost, resources, apheresis scheduling, uncertainty of cell viability, and liability. There’s also risk of side effects with filgrastim and plerixafor use [for mobilization],” she said.

Dr. Ahmed and colleagues conducted a study to determine how stored stem cells for second ASCT were used, describe how second ASCTs are used in patients who meet the Mayo Consensus Stratification for Myeloma & Risk-Adapted Therapy (mSMART) criteria, and the costs of mobilizing and storing stem cells for a second ASCT.

They took a retrospective look at all adults aged 18 years and older with a diagnosis of multiple myeloma who received a first ASCT at their institution from 2009 to 2017. They excluded patients who had amyloidosis without myeloma or POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes) syndrome.

Patients were considered eligible for a second ASCT based on mSMART recommendations if they had a relapse either 18 or more months without maintenance therapy or after at least 36 months on maintenance. The investigators defined an extra day of collection as an additional day of apheresis to obtain 2 million or more CD34 cells/kg for storage only.

They estimated costs from the institution’s charge master as the sum of cell processing, leukapheresis costs, additional plerixafor costs, and storage costs, and calculated the total duration of storage as months from the date of collection until the last follow-up.

The median age of the total study population of 179 patients was 61 years, with a majority of male and white patients. Of this group, 98% had an Eastern Cooperative Oncology Group performance score of 0-1. In all, 63.7% of the patients had standard-risk cytogenetics, 22.4% had high-risk disease, and the remainder had unknown cytogenetic risk.

At a median follow-up of 56.5 months, 95 patients (53.1%) had experienced a relapse after transplant with a median time to progression of 47.5 months. The majority of patients (166; 92.7%) had received a single transplant, 10 (5.6%) had received tandem transplants, and only 3 (1.6%) had a second transplant at relapse.

Looking at the use of second transplant in patients who met the criteria for salvage transplant based on mSMART (excluding patients who had undergone tandem transplant) and whose maintenance status was known, they identified 61 patients on maintenance therapy and 24 with no maintenance. A total of 31 patients (18 in the maintenance group and 13 in the no-maintenance group) met mSMART criteria for salvage ASCT.

Dr. Ahmed and colleagues next looked at the 146 patients who had at least 2 million stored cells/kg, and found that the stored cells were used for only three patients. Of the 146 patients, 66 had 1 extra collection day, 17 had 2 extra days, and 4 had 3 extra days, for an average additional cost per patient of $16,859.
 

 

 

‘Woefully underutilized’

Discussing the study, Dr. Giralt asked: “How valid are the SMART criteria of 36 months? And the answer is there is no data to support it, and if we actually go back to our oncology, any patient who has had more than 18 months without exposure to a drug can continue to have sensitivity to that drug, and that’s why if we used the ASBMT criteria of greater than 18 months you’d have a larger population” of patients eligible for salvage transplant.

He stated that, “we know these patients exist, we know they have cells in the freezer, but we’re not using those cells. Second transplant is woefully underutilized in myeloma patients,” and he added that stored cells could also be used to support those patients who develop cytopenias following chimeric antigen receptor (CAR) T-cell therapy.

Yago Nieto, MD, from the University of Texas MD Anderson Cancer Center, Houston, who comoderated the session where the data were presented, agreed with Dr. Giralt that stored stem cells are underutilized in the treatment of patients with multiple myeloma.

“I don’t think that the experience from Case Western, where the percentage of patients who are eligible for salvage transplant and actually got it was less than 10%, can be extrapolated to many other centers. I think that in most centers the actual percentage is higher than that,” he said in an interview.

“There are going to be therapies like CAR T that will compete with salvage transplants, but I think more patients should be considered for this salvage procedure,” he added.

No funding source for the story was disclosed. Dr. Ahmed reported no financial disclosures. Dr. Giralt reported consulting/advisory activities and receiving research funding from multiple companies. Dr. Nieto disclosed research funding from, and consultancy for, several companies.

SOURCE: Ahmed N et al. TCT 2020, Abstract 28.

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– Collecting and storing extra stem cells on the off chance that a patient with multiple myeloma will need a salvage autologous stem cell transplant may not be worth the money or effort, investigators say.

Neil Osterweil/MDedge News
Dr. Nausheen Ahmed

Among patients with multiple myeloma who had adequate collection of mobilized and stored cells, only 3 of 146 eligible patients were given the stored cells in a second autologous stem cell transplant (ASCT), reported Nausheen Ahmed, MD, from the Case Western Reserve Cancer Center and University Hospitals Seidman Cancer Center, both in Cleveland.

“We found overall low utilization of salvage transplants and storage stem cells at our institution, which may not justify the strategy of early collection for all patients fit for transplant,” she said at the Transplantation and Cellular Therapy Meetings.

But Sergio Giralt, MD, a transplant specialist from Memorial Sloan Kettering Cancer Center, New York, who was not involved in the study, warned against changing practice “for the wrong reason, because it’s just a financial reason.”
 

Get them while they’re fresh

The rationale for collecting and storing extra cells is the risk that mobilization will fail in the future following prolonged maintenance with immunomodulatory agents such as lenalidomide (Revlimid), and the risk for genetic or epigenetic damage to cells from high-dose melphalan used in transplant-conditioning regimens, Dr. Ahmed noted at the meeting held by the American Society for Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research.

“However, there are potential issues with early mobilization and storage, including cost, resources, apheresis scheduling, uncertainty of cell viability, and liability. There’s also risk of side effects with filgrastim and plerixafor use [for mobilization],” she said.

Dr. Ahmed and colleagues conducted a study to determine how stored stem cells for second ASCT were used, describe how second ASCTs are used in patients who meet the Mayo Consensus Stratification for Myeloma & Risk-Adapted Therapy (mSMART) criteria, and the costs of mobilizing and storing stem cells for a second ASCT.

They took a retrospective look at all adults aged 18 years and older with a diagnosis of multiple myeloma who received a first ASCT at their institution from 2009 to 2017. They excluded patients who had amyloidosis without myeloma or POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes) syndrome.

Patients were considered eligible for a second ASCT based on mSMART recommendations if they had a relapse either 18 or more months without maintenance therapy or after at least 36 months on maintenance. The investigators defined an extra day of collection as an additional day of apheresis to obtain 2 million or more CD34 cells/kg for storage only.

They estimated costs from the institution’s charge master as the sum of cell processing, leukapheresis costs, additional plerixafor costs, and storage costs, and calculated the total duration of storage as months from the date of collection until the last follow-up.

The median age of the total study population of 179 patients was 61 years, with a majority of male and white patients. Of this group, 98% had an Eastern Cooperative Oncology Group performance score of 0-1. In all, 63.7% of the patients had standard-risk cytogenetics, 22.4% had high-risk disease, and the remainder had unknown cytogenetic risk.

At a median follow-up of 56.5 months, 95 patients (53.1%) had experienced a relapse after transplant with a median time to progression of 47.5 months. The majority of patients (166; 92.7%) had received a single transplant, 10 (5.6%) had received tandem transplants, and only 3 (1.6%) had a second transplant at relapse.

Looking at the use of second transplant in patients who met the criteria for salvage transplant based on mSMART (excluding patients who had undergone tandem transplant) and whose maintenance status was known, they identified 61 patients on maintenance therapy and 24 with no maintenance. A total of 31 patients (18 in the maintenance group and 13 in the no-maintenance group) met mSMART criteria for salvage ASCT.

Dr. Ahmed and colleagues next looked at the 146 patients who had at least 2 million stored cells/kg, and found that the stored cells were used for only three patients. Of the 146 patients, 66 had 1 extra collection day, 17 had 2 extra days, and 4 had 3 extra days, for an average additional cost per patient of $16,859.
 

 

 

‘Woefully underutilized’

Discussing the study, Dr. Giralt asked: “How valid are the SMART criteria of 36 months? And the answer is there is no data to support it, and if we actually go back to our oncology, any patient who has had more than 18 months without exposure to a drug can continue to have sensitivity to that drug, and that’s why if we used the ASBMT criteria of greater than 18 months you’d have a larger population” of patients eligible for salvage transplant.

He stated that, “we know these patients exist, we know they have cells in the freezer, but we’re not using those cells. Second transplant is woefully underutilized in myeloma patients,” and he added that stored cells could also be used to support those patients who develop cytopenias following chimeric antigen receptor (CAR) T-cell therapy.

Yago Nieto, MD, from the University of Texas MD Anderson Cancer Center, Houston, who comoderated the session where the data were presented, agreed with Dr. Giralt that stored stem cells are underutilized in the treatment of patients with multiple myeloma.

“I don’t think that the experience from Case Western, where the percentage of patients who are eligible for salvage transplant and actually got it was less than 10%, can be extrapolated to many other centers. I think that in most centers the actual percentage is higher than that,” he said in an interview.

“There are going to be therapies like CAR T that will compete with salvage transplants, but I think more patients should be considered for this salvage procedure,” he added.

No funding source for the story was disclosed. Dr. Ahmed reported no financial disclosures. Dr. Giralt reported consulting/advisory activities and receiving research funding from multiple companies. Dr. Nieto disclosed research funding from, and consultancy for, several companies.

SOURCE: Ahmed N et al. TCT 2020, Abstract 28.

– Collecting and storing extra stem cells on the off chance that a patient with multiple myeloma will need a salvage autologous stem cell transplant may not be worth the money or effort, investigators say.

Neil Osterweil/MDedge News
Dr. Nausheen Ahmed

Among patients with multiple myeloma who had adequate collection of mobilized and stored cells, only 3 of 146 eligible patients were given the stored cells in a second autologous stem cell transplant (ASCT), reported Nausheen Ahmed, MD, from the Case Western Reserve Cancer Center and University Hospitals Seidman Cancer Center, both in Cleveland.

“We found overall low utilization of salvage transplants and storage stem cells at our institution, which may not justify the strategy of early collection for all patients fit for transplant,” she said at the Transplantation and Cellular Therapy Meetings.

But Sergio Giralt, MD, a transplant specialist from Memorial Sloan Kettering Cancer Center, New York, who was not involved in the study, warned against changing practice “for the wrong reason, because it’s just a financial reason.”
 

Get them while they’re fresh

The rationale for collecting and storing extra cells is the risk that mobilization will fail in the future following prolonged maintenance with immunomodulatory agents such as lenalidomide (Revlimid), and the risk for genetic or epigenetic damage to cells from high-dose melphalan used in transplant-conditioning regimens, Dr. Ahmed noted at the meeting held by the American Society for Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research.

“However, there are potential issues with early mobilization and storage, including cost, resources, apheresis scheduling, uncertainty of cell viability, and liability. There’s also risk of side effects with filgrastim and plerixafor use [for mobilization],” she said.

Dr. Ahmed and colleagues conducted a study to determine how stored stem cells for second ASCT were used, describe how second ASCTs are used in patients who meet the Mayo Consensus Stratification for Myeloma & Risk-Adapted Therapy (mSMART) criteria, and the costs of mobilizing and storing stem cells for a second ASCT.

They took a retrospective look at all adults aged 18 years and older with a diagnosis of multiple myeloma who received a first ASCT at their institution from 2009 to 2017. They excluded patients who had amyloidosis without myeloma or POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes) syndrome.

Patients were considered eligible for a second ASCT based on mSMART recommendations if they had a relapse either 18 or more months without maintenance therapy or after at least 36 months on maintenance. The investigators defined an extra day of collection as an additional day of apheresis to obtain 2 million or more CD34 cells/kg for storage only.

They estimated costs from the institution’s charge master as the sum of cell processing, leukapheresis costs, additional plerixafor costs, and storage costs, and calculated the total duration of storage as months from the date of collection until the last follow-up.

The median age of the total study population of 179 patients was 61 years, with a majority of male and white patients. Of this group, 98% had an Eastern Cooperative Oncology Group performance score of 0-1. In all, 63.7% of the patients had standard-risk cytogenetics, 22.4% had high-risk disease, and the remainder had unknown cytogenetic risk.

At a median follow-up of 56.5 months, 95 patients (53.1%) had experienced a relapse after transplant with a median time to progression of 47.5 months. The majority of patients (166; 92.7%) had received a single transplant, 10 (5.6%) had received tandem transplants, and only 3 (1.6%) had a second transplant at relapse.

Looking at the use of second transplant in patients who met the criteria for salvage transplant based on mSMART (excluding patients who had undergone tandem transplant) and whose maintenance status was known, they identified 61 patients on maintenance therapy and 24 with no maintenance. A total of 31 patients (18 in the maintenance group and 13 in the no-maintenance group) met mSMART criteria for salvage ASCT.

Dr. Ahmed and colleagues next looked at the 146 patients who had at least 2 million stored cells/kg, and found that the stored cells were used for only three patients. Of the 146 patients, 66 had 1 extra collection day, 17 had 2 extra days, and 4 had 3 extra days, for an average additional cost per patient of $16,859.
 

 

 

‘Woefully underutilized’

Discussing the study, Dr. Giralt asked: “How valid are the SMART criteria of 36 months? And the answer is there is no data to support it, and if we actually go back to our oncology, any patient who has had more than 18 months without exposure to a drug can continue to have sensitivity to that drug, and that’s why if we used the ASBMT criteria of greater than 18 months you’d have a larger population” of patients eligible for salvage transplant.

He stated that, “we know these patients exist, we know they have cells in the freezer, but we’re not using those cells. Second transplant is woefully underutilized in myeloma patients,” and he added that stored cells could also be used to support those patients who develop cytopenias following chimeric antigen receptor (CAR) T-cell therapy.

Yago Nieto, MD, from the University of Texas MD Anderson Cancer Center, Houston, who comoderated the session where the data were presented, agreed with Dr. Giralt that stored stem cells are underutilized in the treatment of patients with multiple myeloma.

“I don’t think that the experience from Case Western, where the percentage of patients who are eligible for salvage transplant and actually got it was less than 10%, can be extrapolated to many other centers. I think that in most centers the actual percentage is higher than that,” he said in an interview.

“There are going to be therapies like CAR T that will compete with salvage transplants, but I think more patients should be considered for this salvage procedure,” he added.

No funding source for the story was disclosed. Dr. Ahmed reported no financial disclosures. Dr. Giralt reported consulting/advisory activities and receiving research funding from multiple companies. Dr. Nieto disclosed research funding from, and consultancy for, several companies.

SOURCE: Ahmed N et al. TCT 2020, Abstract 28.

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