Here’s a new direction for smartphones in healthcare. 

Researchers from the National Institute of Standards and Technology (NIST), Boulder, Colorado, say a smartphone compass could be used to analyze biomarkers in body fluids — blood, sweat, urine, or saliva — to monitor or diagnose disease.

“We’re just at this point demonstrating this new way of sensing that we hope [will be] very accessible and very portable,” said Gary Zabow, PhD, a group leader in the applied physics division at NIST who supervised the research. 

In a proof-of-concept study, the researchers measured glucose levels in sangria, pinot grigio, and champagne. The detection limit reached micromolar concentrations — on par with or better than some widely used glucose sensors, such as continuous glucose monitors. They also accurately measured the pH levels of coffee, orange juice, and root beer.

More tests are needed to confirm the method works in biological fluids, so it could be a while before it’s available for clinical or commercial use. 

Still, the prospect is “exciting,” said Aydogan Ozcan, PhD, a bioengineering professor at the University of California, Los Angeles, who was not involved in the study. “It might enable new capabilities for advanced sensing applications in field settings or even at home.”

The advance builds on growing research using smartphones to put powerful medical devices in patients’ hands. A new AI-powered app can use a smartphone camera to detect skin cancer, while other apps administer cognitive tests to detect dementia. Smartphone cameras can even be harnessed for “advanced optical microscopes and sensors to the level where we could even see and detect individual DNA molecules with inexpensive optical attachments,” Dr. Ozcan said. More than six billion people worldwide own a smartphone.

The compass inside smartphones is a magnetometer — it measures magnetic fields. Normally it detects the earth’s magnetic fields, but it can also detect small, nearby magnets and changes in those magnets’ positions. 

The researchers embedded a small magnet inside a strip of “smart hydrogel — a piece of material that expands or contracts” when immersed in a solution, said Dr. Zabow.

As the hydrogel gets bigger or smaller, it moves the magnet, Dr. Zabow explained. For example, if the hydrogel is designed to expand when the solution is acidic or contract when it’s basic, it can move the magnet closer or farther from the phone’s magnetometer, providing an indicator of pH. For glucose, the hydrogel expands or contracts depending on the concentration of sugar in the liquid.

With some calibration and coding to translate that reading into a number, “you can effectively read out glucose or pH,” Dr. Zabow said.

Only a small strip of hydrogel is needed, “like a pH test strip that you use for a pool,” said first study author Mark Ferris, PhD, a postdoctoral researcher at NIST. 

Like a pool pH test strip, this test is meant to be “easy to use, and at that kind of price,” Dr. Ferris said. “It’s supposed to be something that’s cheap and disposable.” Each pH hydrogel strip is about 3 cents, and glucose strips are 16 cents, Dr. Ferris estimated. In bulk, those prices could go down.

Next the team plans to test the strips with biological fluids. But complex fluids like blood could pose a challenge, as other molecules present could react with the strip and affect the results. “It may be that you need to tweak the chemistry of the hydrogel to make sure it is really specific to one biomolecule and there is no interference from other biomolecules,” Dr. Zabow said.

The technique could be adapted to detect other biomarkers or molecules, the researchers said. It could also be used to check for chemical contaminants in tap, lake, or stream water. 
 

A version of this article appeared on Medscape.com.

Here’s a new direction for smartphones in healthcare. 

Researchers from the National Institute of Standards and Technology (NIST), Boulder, Colorado, say a smartphone compass could be used to analyze biomarkers in body fluids — blood, sweat, urine, or saliva — to monitor or diagnose disease.

“We’re just at this point demonstrating this new way of sensing that we hope [will be] very accessible and very portable,” said Gary Zabow, PhD, a group leader in the applied physics division at NIST who supervised the research. 

In a proof-of-concept study, the researchers measured glucose levels in sangria, pinot grigio, and champagne. The detection limit reached micromolar concentrations — on par with or better than some widely used glucose sensors, such as continuous glucose monitors. They also accurately measured the pH levels of coffee, orange juice, and root beer.

More tests are needed to confirm the method works in biological fluids, so it could be a while before it’s available for clinical or commercial use. 

Still, the prospect is “exciting,” said Aydogan Ozcan, PhD, a bioengineering professor at the University of California, Los Angeles, who was not involved in the study. “It might enable new capabilities for advanced sensing applications in field settings or even at home.”

The advance builds on growing research using smartphones to put powerful medical devices in patients’ hands. A new AI-powered app can use a smartphone camera to detect skin cancer, while other apps administer cognitive tests to detect dementia. Smartphone cameras can even be harnessed for “advanced optical microscopes and sensors to the level where we could even see and detect individual DNA molecules with inexpensive optical attachments,” Dr. Ozcan said. More than six billion people worldwide own a smartphone.

The compass inside smartphones is a magnetometer — it measures magnetic fields. Normally it detects the earth’s magnetic fields, but it can also detect small, nearby magnets and changes in those magnets’ positions. 

The researchers embedded a small magnet inside a strip of “smart hydrogel — a piece of material that expands or contracts” when immersed in a solution, said Dr. Zabow.

As the hydrogel gets bigger or smaller, it moves the magnet, Dr. Zabow explained. For example, if the hydrogel is designed to expand when the solution is acidic or contract when it’s basic, it can move the magnet closer or farther from the phone’s magnetometer, providing an indicator of pH. For glucose, the hydrogel expands or contracts depending on the concentration of sugar in the liquid.

With some calibration and coding to translate that reading into a number, “you can effectively read out glucose or pH,” Dr. Zabow said.

Only a small strip of hydrogel is needed, “like a pH test strip that you use for a pool,” said first study author Mark Ferris, PhD, a postdoctoral researcher at NIST. 

Like a pool pH test strip, this test is meant to be “easy to use, and at that kind of price,” Dr. Ferris said. “It’s supposed to be something that’s cheap and disposable.” Each pH hydrogel strip is about 3 cents, and glucose strips are 16 cents, Dr. Ferris estimated. In bulk, those prices could go down.

Next the team plans to test the strips with biological fluids. But complex fluids like blood could pose a challenge, as other molecules present could react with the strip and affect the results. “It may be that you need to tweak the chemistry of the hydrogel to make sure it is really specific to one biomolecule and there is no interference from other biomolecules,” Dr. Zabow said.

The technique could be adapted to detect other biomarkers or molecules, the researchers said. It could also be used to check for chemical contaminants in tap, lake, or stream water. 
 

A version of this article appeared on Medscape.com.

Here’s a new direction for smartphones in healthcare. 

Researchers from the National Institute of Standards and Technology (NIST), Boulder, Colorado, say a smartphone compass could be used to analyze biomarkers in body fluids — blood, sweat, urine, or saliva — to monitor or diagnose disease.

“We’re just at this point demonstrating this new way of sensing that we hope [will be] very accessible and very portable,” said Gary Zabow, PhD, a group leader in the applied physics division at NIST who supervised the research. 

In a proof-of-concept study, the researchers measured glucose levels in sangria, pinot grigio, and champagne. The detection limit reached micromolar concentrations — on par with or better than some widely used glucose sensors, such as continuous glucose monitors. They also accurately measured the pH levels of coffee, orange juice, and root beer.

More tests are needed to confirm the method works in biological fluids, so it could be a while before it’s available for clinical or commercial use. 

Still, the prospect is “exciting,” said Aydogan Ozcan, PhD, a bioengineering professor at the University of California, Los Angeles, who was not involved in the study. “It might enable new capabilities for advanced sensing applications in field settings or even at home.”

The advance builds on growing research using smartphones to put powerful medical devices in patients’ hands. A new AI-powered app can use a smartphone camera to detect skin cancer, while other apps administer cognitive tests to detect dementia. Smartphone cameras can even be harnessed for “advanced optical microscopes and sensors to the level where we could even see and detect individual DNA molecules with inexpensive optical attachments,” Dr. Ozcan said. More than six billion people worldwide own a smartphone.

The compass inside smartphones is a magnetometer — it measures magnetic fields. Normally it detects the earth’s magnetic fields, but it can also detect small, nearby magnets and changes in those magnets’ positions. 

The researchers embedded a small magnet inside a strip of “smart hydrogel — a piece of material that expands or contracts” when immersed in a solution, said Dr. Zabow.

As the hydrogel gets bigger or smaller, it moves the magnet, Dr. Zabow explained. For example, if the hydrogel is designed to expand when the solution is acidic or contract when it’s basic, it can move the magnet closer or farther from the phone’s magnetometer, providing an indicator of pH. For glucose, the hydrogel expands or contracts depending on the concentration of sugar in the liquid.

With some calibration and coding to translate that reading into a number, “you can effectively read out glucose or pH,” Dr. Zabow said.

Only a small strip of hydrogel is needed, “like a pH test strip that you use for a pool,” said first study author Mark Ferris, PhD, a postdoctoral researcher at NIST. 

Like a pool pH test strip, this test is meant to be “easy to use, and at that kind of price,” Dr. Ferris said. “It’s supposed to be something that’s cheap and disposable.” Each pH hydrogel strip is about 3 cents, and glucose strips are 16 cents, Dr. Ferris estimated. In bulk, those prices could go down.

Next the team plans to test the strips with biological fluids. But complex fluids like blood could pose a challenge, as other molecules present could react with the strip and affect the results. “It may be that you need to tweak the chemistry of the hydrogel to make sure it is really specific to one biomolecule and there is no interference from other biomolecules,” Dr. Zabow said.

The technique could be adapted to detect other biomarkers or molecules, the researchers said. It could also be used to check for chemical contaminants in tap, lake, or stream water. 
 

A version of this article appeared on Medscape.com.

Even in large urban areas there aren’t enough rheumatologists to go around, and as a 2015 American College of Rheumatology workforce study projected, the number of rheumatology providers is expected to drop by 25% by the year 2030, while the demand for patient care in rheumatology is expected to increase by more than 100%.

The shortage of rheumatology care is even more acute in rural areas, but as a pilot project supported by the Arthritis Foundation shows, linking rheumatologists to health centers in remote and underserved locations via telehealth can help community providers improve care for patients with rheumatic diseases.

The novel collaborative model was described by Alfredo Rivadeneira, MD, professor of medicine in the division of rheumatology, allergy, and immunology at the University of North Carolina (UNC) School of Medicine in Chapel Hill, North Carolina.

UNC School of Medicine

“We found that this pilot, a unique partnership in North Carolina, improves access to rheumatology care to a rural population with high satisfaction scores. It underlines the importance of seeking collaboration with community providers when implementing these programs. It also allows timely specialty care and alleviates the barriers relating to transportation, insurance coverage, and telecommunication challenges,” he said at the 2024 Rheumatoid Arthritis Research Summit presented by the Arthritis Foundation and the Hospital for Special Surgery in New York City. 
 

Too Many Patients, Too Few Rheumatologists

Access to health is challenging for people from traditionally underserved racial and ethnic backgrounds, especially in states such as North Carolina, where 40% of the population lives in rural counties, which have higher age-adjusted mortality than more densely populated areas of the state, Dr. Rivadeneira said. 

In addition, 42% of the North Carolina residents seen at the state’s 42 Federally Qualified Health Centers (FQHCs) don’t have health insurance, which is higher than the average of 23% uninsured seen at FQHCs in other states.

There are currently approximately 250 rheumatology providers in North Carolina, the majority of whom work in the states’ three academic medical centers. Currently, North Carolina has an estimated population of 10 million people, which is projected to increase to 11.7 million by 2030. And by 2030, 20% of North Carolinians will be aged ≥ 65 years, Dr. Rivadeneira said, highlighting the need for expanded rheumatology care. 

Although telehealth services could be an option for expanding services to underserved communities, only 14 of the 42 FQHCs in the state use telehealth and only on a limited basis because it is not sufficiently reimbursed. 

Rivadeneira pointed to a 2022 study that showed how patients with rheumatic and musculoskeletal disease patients in North Carolina were less likely to use online patient portals if they lived in rural areas; came from racial or ethnic minority backgrounds; were older, men, had lower economic status (Medicaid enrollment or uninsured); or spoke a language other than English as their primary tongue. 
 

Pilot Project

To help smooth out some of the above-mentioned disparities, Dr. Rivadeneira and colleagues, in collaboration with the Arthritis Foundation, started a pilot project in 2022 designed to enhance access to rheumatology specialty care for rural residents through a shared telehealth model between the UNC rheumatology clinic and two separate Piedmont Health Services clinics in rural areas.

The project includes tailored educational sessions designed to empower Piedmont Health Services providers for evaluating and managing patients with rheumatic diseases.

Patients with prior diagnoses of rheumatologic diseases who were lost to rheumatology specialty care follow-up and those with new rheumatic symptoms who had transportation and/or financial barriers to receiving specialty care are triaged to the shared telemedicine visits.

Providers conduct monthly clinic sessions via shared visits between the on-site Piedmont Health Services provider and patients, with off-site UNC rheumatology fellows and attending physicians connected virtually. 

The educational component of the project includes monthly didactic sessions offered to all Piedmont Health Services providers across 12 locations. 

The topics that were chosen cover the most common rheumatologic conditions seen by community providers, including evaluating pain from a rheumatology perspective; using antinuclear antibodies and other serologies; evaluating and managing rheumatoid arthritis, lupus, gout, giant cell arteritis, polymyalgia rheumatica, and osteoarthritis; and methotrexate management and complications. 

“One of the aspects of this pilot that I want to emphasize is the importance of having the generalists with the patient, relaying the objective data, especially the physical exam, and that’s one of the great features of this model. It also provides a stable platform for telehealth to the individual patients, as many of these patients don’t have access to health technology,” Dr. Rivadeneira said. 
 

Thumbs Up

Both patients and general practitioners in the Piedmont Health system expressed high degrees of satisfaction with the shared telehealth program. Patients especially liked the time they saved not having to travel to see a specialist, and a large majority agreed that the visits were “as good as” in-person visits, felt that their concerns were addressed appropriately during the virtual visit, expressed overall satisfaction, and said they would like to continue virtual visits.

Physicians expressed a high degree of satisfaction with the rheumatology didactic sessions and said that the sessions enhanced their knowledge of evaluating and managing or co-managing rheumatologic diseases, as well as helping them to feel comfortable about applying this knowledge to patient care.

Dr. Rivadeneira noted that the pilot study was limited by low levels of Piedmont Health Services physician participation (two out of 45 total participated in shared visits), and only three or four providers typically took part in each didactic session. 
 

How to Improve?

In a follow-up study, the investigators asked Piedmont Health Services providers about barriers to rheumatology care, the most common and challenging diseases they encountered, how to improve the didactic components, and their perspectives on the pilot and how it may have affected referral patterns to rheumatology care.

The providers identified the cost of diagnostic evaluations and medications, transportation, long wait times, and language as the main barriers to patient access of rheumatology care.

“Additionally, over a third of them encountered patients on a weekly basis that were overdue for a visit with a rheumatologist,” Dr. Rivadeneira said. 

“Direct participation in the physical exam by the primary care provider enhances greatly, in my opinion, these telehealth visits. Focused didactic sessions, electronic handouts and/or quick access guides could empower more rural community providers to manage rheumatic diseases,” he concluded.

In the Q&A following the presentation, Laura Cappelli, MD, MHS, MS, associate professor of medicine in the division of rheumatology at Johns Hopkins School of Medicine in Baltimore, asked Dr. Rivadeneira how rheumatologists involved felt about the program and whether his team did any surveying or qualitative work with them.

“Just so you know, the rheumatologist was me,” he replied.

“I’m very picky about telemedicine,” he continued. “I don’t like it, I prefer, as most of us do, to have the patient there. But having the provider there, doing the exam, and you guiding them — I can ask, ‘Did you check their joints? Did you check their strength?’ — makes a huge difference and makes me feel comfortable with the sessions.”

Dr. Rivadeneira added that if a particular case was too complex or too vague to adequately assess via telehealth, he would arrange to see the patient in person.

The project was supported by the Arthritis Foundation. Dr. Rivadeneira and Dr. Cappelli reported no conflicts of interest.
 

A version of this article appeared on Medscape.com.

Even in large urban areas there aren’t enough rheumatologists to go around, and as a 2015 American College of Rheumatology workforce study projected, the number of rheumatology providers is expected to drop by 25% by the year 2030, while the demand for patient care in rheumatology is expected to increase by more than 100%.

The shortage of rheumatology care is even more acute in rural areas, but as a pilot project supported by the Arthritis Foundation shows, linking rheumatologists to health centers in remote and underserved locations via telehealth can help community providers improve care for patients with rheumatic diseases.

The novel collaborative model was described by Alfredo Rivadeneira, MD, professor of medicine in the division of rheumatology, allergy, and immunology at the University of North Carolina (UNC) School of Medicine in Chapel Hill, North Carolina.

UNC School of Medicine

“We found that this pilot, a unique partnership in North Carolina, improves access to rheumatology care to a rural population with high satisfaction scores. It underlines the importance of seeking collaboration with community providers when implementing these programs. It also allows timely specialty care and alleviates the barriers relating to transportation, insurance coverage, and telecommunication challenges,” he said at the 2024 Rheumatoid Arthritis Research Summit presented by the Arthritis Foundation and the Hospital for Special Surgery in New York City. 
 

Too Many Patients, Too Few Rheumatologists

Access to health is challenging for people from traditionally underserved racial and ethnic backgrounds, especially in states such as North Carolina, where 40% of the population lives in rural counties, which have higher age-adjusted mortality than more densely populated areas of the state, Dr. Rivadeneira said. 

In addition, 42% of the North Carolina residents seen at the state’s 42 Federally Qualified Health Centers (FQHCs) don’t have health insurance, which is higher than the average of 23% uninsured seen at FQHCs in other states.

There are currently approximately 250 rheumatology providers in North Carolina, the majority of whom work in the states’ three academic medical centers. Currently, North Carolina has an estimated population of 10 million people, which is projected to increase to 11.7 million by 2030. And by 2030, 20% of North Carolinians will be aged ≥ 65 years, Dr. Rivadeneira said, highlighting the need for expanded rheumatology care. 

Although telehealth services could be an option for expanding services to underserved communities, only 14 of the 42 FQHCs in the state use telehealth and only on a limited basis because it is not sufficiently reimbursed. 

Rivadeneira pointed to a 2022 study that showed how patients with rheumatic and musculoskeletal disease patients in North Carolina were less likely to use online patient portals if they lived in rural areas; came from racial or ethnic minority backgrounds; were older, men, had lower economic status (Medicaid enrollment or uninsured); or spoke a language other than English as their primary tongue. 
 

Pilot Project

To help smooth out some of the above-mentioned disparities, Dr. Rivadeneira and colleagues, in collaboration with the Arthritis Foundation, started a pilot project in 2022 designed to enhance access to rheumatology specialty care for rural residents through a shared telehealth model between the UNC rheumatology clinic and two separate Piedmont Health Services clinics in rural areas.

The project includes tailored educational sessions designed to empower Piedmont Health Services providers for evaluating and managing patients with rheumatic diseases.

Patients with prior diagnoses of rheumatologic diseases who were lost to rheumatology specialty care follow-up and those with new rheumatic symptoms who had transportation and/or financial barriers to receiving specialty care are triaged to the shared telemedicine visits.

Providers conduct monthly clinic sessions via shared visits between the on-site Piedmont Health Services provider and patients, with off-site UNC rheumatology fellows and attending physicians connected virtually. 

The educational component of the project includes monthly didactic sessions offered to all Piedmont Health Services providers across 12 locations. 

The topics that were chosen cover the most common rheumatologic conditions seen by community providers, including evaluating pain from a rheumatology perspective; using antinuclear antibodies and other serologies; evaluating and managing rheumatoid arthritis, lupus, gout, giant cell arteritis, polymyalgia rheumatica, and osteoarthritis; and methotrexate management and complications. 

“One of the aspects of this pilot that I want to emphasize is the importance of having the generalists with the patient, relaying the objective data, especially the physical exam, and that’s one of the great features of this model. It also provides a stable platform for telehealth to the individual patients, as many of these patients don’t have access to health technology,” Dr. Rivadeneira said. 
 

Thumbs Up

Both patients and general practitioners in the Piedmont Health system expressed high degrees of satisfaction with the shared telehealth program. Patients especially liked the time they saved not having to travel to see a specialist, and a large majority agreed that the visits were “as good as” in-person visits, felt that their concerns were addressed appropriately during the virtual visit, expressed overall satisfaction, and said they would like to continue virtual visits.

Physicians expressed a high degree of satisfaction with the rheumatology didactic sessions and said that the sessions enhanced their knowledge of evaluating and managing or co-managing rheumatologic diseases, as well as helping them to feel comfortable about applying this knowledge to patient care.

Dr. Rivadeneira noted that the pilot study was limited by low levels of Piedmont Health Services physician participation (two out of 45 total participated in shared visits), and only three or four providers typically took part in each didactic session. 
 

How to Improve?

In a follow-up study, the investigators asked Piedmont Health Services providers about barriers to rheumatology care, the most common and challenging diseases they encountered, how to improve the didactic components, and their perspectives on the pilot and how it may have affected referral patterns to rheumatology care.

The providers identified the cost of diagnostic evaluations and medications, transportation, long wait times, and language as the main barriers to patient access of rheumatology care.

“Additionally, over a third of them encountered patients on a weekly basis that were overdue for a visit with a rheumatologist,” Dr. Rivadeneira said. 

“Direct participation in the physical exam by the primary care provider enhances greatly, in my opinion, these telehealth visits. Focused didactic sessions, electronic handouts and/or quick access guides could empower more rural community providers to manage rheumatic diseases,” he concluded.

In the Q&A following the presentation, Laura Cappelli, MD, MHS, MS, associate professor of medicine in the division of rheumatology at Johns Hopkins School of Medicine in Baltimore, asked Dr. Rivadeneira how rheumatologists involved felt about the program and whether his team did any surveying or qualitative work with them.

“Just so you know, the rheumatologist was me,” he replied.

“I’m very picky about telemedicine,” he continued. “I don’t like it, I prefer, as most of us do, to have the patient there. But having the provider there, doing the exam, and you guiding them — I can ask, ‘Did you check their joints? Did you check their strength?’ — makes a huge difference and makes me feel comfortable with the sessions.”

Dr. Rivadeneira added that if a particular case was too complex or too vague to adequately assess via telehealth, he would arrange to see the patient in person.

The project was supported by the Arthritis Foundation. Dr. Rivadeneira and Dr. Cappelli reported no conflicts of interest.
 

A version of this article appeared on Medscape.com.

Even in large urban areas there aren’t enough rheumatologists to go around, and as a 2015 American College of Rheumatology workforce study projected, the number of rheumatology providers is expected to drop by 25% by the year 2030, while the demand for patient care in rheumatology is expected to increase by more than 100%.

The shortage of rheumatology care is even more acute in rural areas, but as a pilot project supported by the Arthritis Foundation shows, linking rheumatologists to health centers in remote and underserved locations via telehealth can help community providers improve care for patients with rheumatic diseases.

The novel collaborative model was described by Alfredo Rivadeneira, MD, professor of medicine in the division of rheumatology, allergy, and immunology at the University of North Carolina (UNC) School of Medicine in Chapel Hill, North Carolina.

UNC School of Medicine

“We found that this pilot, a unique partnership in North Carolina, improves access to rheumatology care to a rural population with high satisfaction scores. It underlines the importance of seeking collaboration with community providers when implementing these programs. It also allows timely specialty care and alleviates the barriers relating to transportation, insurance coverage, and telecommunication challenges,” he said at the 2024 Rheumatoid Arthritis Research Summit presented by the Arthritis Foundation and the Hospital for Special Surgery in New York City. 
 

Too Many Patients, Too Few Rheumatologists

Access to health is challenging for people from traditionally underserved racial and ethnic backgrounds, especially in states such as North Carolina, where 40% of the population lives in rural counties, which have higher age-adjusted mortality than more densely populated areas of the state, Dr. Rivadeneira said. 

In addition, 42% of the North Carolina residents seen at the state’s 42 Federally Qualified Health Centers (FQHCs) don’t have health insurance, which is higher than the average of 23% uninsured seen at FQHCs in other states.

There are currently approximately 250 rheumatology providers in North Carolina, the majority of whom work in the states’ three academic medical centers. Currently, North Carolina has an estimated population of 10 million people, which is projected to increase to 11.7 million by 2030. And by 2030, 20% of North Carolinians will be aged ≥ 65 years, Dr. Rivadeneira said, highlighting the need for expanded rheumatology care. 

Although telehealth services could be an option for expanding services to underserved communities, only 14 of the 42 FQHCs in the state use telehealth and only on a limited basis because it is not sufficiently reimbursed. 

Rivadeneira pointed to a 2022 study that showed how patients with rheumatic and musculoskeletal disease patients in North Carolina were less likely to use online patient portals if they lived in rural areas; came from racial or ethnic minority backgrounds; were older, men, had lower economic status (Medicaid enrollment or uninsured); or spoke a language other than English as their primary tongue. 
 

Pilot Project

To help smooth out some of the above-mentioned disparities, Dr. Rivadeneira and colleagues, in collaboration with the Arthritis Foundation, started a pilot project in 2022 designed to enhance access to rheumatology specialty care for rural residents through a shared telehealth model between the UNC rheumatology clinic and two separate Piedmont Health Services clinics in rural areas.

The project includes tailored educational sessions designed to empower Piedmont Health Services providers for evaluating and managing patients with rheumatic diseases.

Patients with prior diagnoses of rheumatologic diseases who were lost to rheumatology specialty care follow-up and those with new rheumatic symptoms who had transportation and/or financial barriers to receiving specialty care are triaged to the shared telemedicine visits.

Providers conduct monthly clinic sessions via shared visits between the on-site Piedmont Health Services provider and patients, with off-site UNC rheumatology fellows and attending physicians connected virtually. 

The educational component of the project includes monthly didactic sessions offered to all Piedmont Health Services providers across 12 locations. 

The topics that were chosen cover the most common rheumatologic conditions seen by community providers, including evaluating pain from a rheumatology perspective; using antinuclear antibodies and other serologies; evaluating and managing rheumatoid arthritis, lupus, gout, giant cell arteritis, polymyalgia rheumatica, and osteoarthritis; and methotrexate management and complications. 

“One of the aspects of this pilot that I want to emphasize is the importance of having the generalists with the patient, relaying the objective data, especially the physical exam, and that’s one of the great features of this model. It also provides a stable platform for telehealth to the individual patients, as many of these patients don’t have access to health technology,” Dr. Rivadeneira said. 
 

Thumbs Up

Both patients and general practitioners in the Piedmont Health system expressed high degrees of satisfaction with the shared telehealth program. Patients especially liked the time they saved not having to travel to see a specialist, and a large majority agreed that the visits were “as good as” in-person visits, felt that their concerns were addressed appropriately during the virtual visit, expressed overall satisfaction, and said they would like to continue virtual visits.

Physicians expressed a high degree of satisfaction with the rheumatology didactic sessions and said that the sessions enhanced their knowledge of evaluating and managing or co-managing rheumatologic diseases, as well as helping them to feel comfortable about applying this knowledge to patient care.

Dr. Rivadeneira noted that the pilot study was limited by low levels of Piedmont Health Services physician participation (two out of 45 total participated in shared visits), and only three or four providers typically took part in each didactic session. 
 

How to Improve?

In a follow-up study, the investigators asked Piedmont Health Services providers about barriers to rheumatology care, the most common and challenging diseases they encountered, how to improve the didactic components, and their perspectives on the pilot and how it may have affected referral patterns to rheumatology care.

The providers identified the cost of diagnostic evaluations and medications, transportation, long wait times, and language as the main barriers to patient access of rheumatology care.

“Additionally, over a third of them encountered patients on a weekly basis that were overdue for a visit with a rheumatologist,” Dr. Rivadeneira said. 

“Direct participation in the physical exam by the primary care provider enhances greatly, in my opinion, these telehealth visits. Focused didactic sessions, electronic handouts and/or quick access guides could empower more rural community providers to manage rheumatic diseases,” he concluded.

In the Q&A following the presentation, Laura Cappelli, MD, MHS, MS, associate professor of medicine in the division of rheumatology at Johns Hopkins School of Medicine in Baltimore, asked Dr. Rivadeneira how rheumatologists involved felt about the program and whether his team did any surveying or qualitative work with them.

“Just so you know, the rheumatologist was me,” he replied.

“I’m very picky about telemedicine,” he continued. “I don’t like it, I prefer, as most of us do, to have the patient there. But having the provider there, doing the exam, and you guiding them — I can ask, ‘Did you check their joints? Did you check their strength?’ — makes a huge difference and makes me feel comfortable with the sessions.”

Dr. Rivadeneira added that if a particular case was too complex or too vague to adequately assess via telehealth, he would arrange to see the patient in person.

The project was supported by the Arthritis Foundation. Dr. Rivadeneira and Dr. Cappelli reported no conflicts of interest.
 

A version of this article appeared on Medscape.com.

The current tetravalent dengue vaccine TAK-003, from the Japanese laboratory Takeda, is not likely to control the ongoing epidemic, according to the Pan American Health Organization (PAHO). The organization emphasized the need to better understand the vaccine’s effectiveness against different serotypes and its safety under real-world clinical conditions.

The Americas are experiencing a record increase in dengue cases. Three times as many cases have been identified during 2024 (3.5 million) than were reported for the same period in 2023. 

“The vaccine we have available will not curb the dengue epidemic; it should be used complementarily with other actions. The most important actions are field operations, vector control, prevention, and education,” said Daniel Salas, MD, executive manager of the PAHO Comprehensive Immunization Program, during a press conference on March 28.

“The vaccines we currently have are not the best response to reduce transmission and prevent deaths,” added Jarbas Barbosa, MD, PhD, PAHO’s director. The fatality rate remains below 0.05%, but this figure could be hard to maintain if the situation becomes more uncontrolled.

The TAK-003 regimen consists of two doses with a 3-month interval between applications, so “it is not a tool to control transmission at this moment. Studies have shown that only 8 years of [population-level] vaccination would have a significant impact on dengue transmission,” said Dr. Barbosa.

A new vaccine developed in Brazil in partnership with the company MSD, Butantan-DV, is in phase 3 trials and has the advantage of being a single-dose application, which could facilitate its use in situations with accelerated transmission. “But this vaccine will likely only be available in 2025,” said Dr. Barbosa.

PAHO officials also highlighted the need to better characterize the vaccine’s effectiveness and safety in the real world. They observed, for example, that when TAK-003 was investigated, the circulation of dengue serotype 3 was almost nonexistent, so the efficacy data against that serotype “are very limited.”

“The producer, Takeda, has very limited production capacity. Brazil is the country that uses this vaccine the most, followed by Argentina. Given that these countries have a good epidemiological surveillance system and adverse effect registration, they can conduct studies on how the vaccine performs in real life, which will greatly increase our knowledge about it. For example, we will see its effectiveness against serotype 3,” said Dr. Barbosa.

The PAHO Technical Advisory Group (TAG) on vaccine-preventable diseases recommended that any country using these vaccines have surveillance systems in place because it is important to promptly report and investigate any adverse events, said Dr. Salas. The organization also suggested that vaccination should ideally be administered in a “more controlled environment,” a phase 4 study, “to complete the safety and efficacy profile, especially in those who have not had dengue before and for dengue 3 and 4,” said Dr. Salas in response to a question from this news organization.

“People cannot expect that just because they were vaccinated, they will not get dengue. The vaccine has limited reach,” he emphasized.

Other research strategies for vector control, such as the use of the Wolbachia bacteria and mosquito sterilization, are future strategies and “not tools to control this outbreak,” noted Sylvain Aldighieri, MD, director of the Department of Prevention, Control, and Elimination of Transmissible Diseases at PAHO.

In his opening remarks, Dr. Barbosa urged the intensification of efforts with tools that are already available. These approaches include eliminating mosquito breeding sites (“80% are in or near homes”) and protecting against mosquito bites, preparing health services for early diagnosis and timely clinical management, and educating the population about dengue symptoms so they seek medical attention immediately.

Although dengue is increasing throughout Latin America and the Caribbean, the most affected countries are Brazil (83%), Paraguay (5.3%), and Argentina (3.7%), which account for 92% of the cases and 87% of the deaths, PAHO reported.

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

The current tetravalent dengue vaccine TAK-003, from the Japanese laboratory Takeda, is not likely to control the ongoing epidemic, according to the Pan American Health Organization (PAHO). The organization emphasized the need to better understand the vaccine’s effectiveness against different serotypes and its safety under real-world clinical conditions.

The Americas are experiencing a record increase in dengue cases. Three times as many cases have been identified during 2024 (3.5 million) than were reported for the same period in 2023. 

“The vaccine we have available will not curb the dengue epidemic; it should be used complementarily with other actions. The most important actions are field operations, vector control, prevention, and education,” said Daniel Salas, MD, executive manager of the PAHO Comprehensive Immunization Program, during a press conference on March 28.

“The vaccines we currently have are not the best response to reduce transmission and prevent deaths,” added Jarbas Barbosa, MD, PhD, PAHO’s director. The fatality rate remains below 0.05%, but this figure could be hard to maintain if the situation becomes more uncontrolled.

The TAK-003 regimen consists of two doses with a 3-month interval between applications, so “it is not a tool to control transmission at this moment. Studies have shown that only 8 years of [population-level] vaccination would have a significant impact on dengue transmission,” said Dr. Barbosa.

A new vaccine developed in Brazil in partnership with the company MSD, Butantan-DV, is in phase 3 trials and has the advantage of being a single-dose application, which could facilitate its use in situations with accelerated transmission. “But this vaccine will likely only be available in 2025,” said Dr. Barbosa.

PAHO officials also highlighted the need to better characterize the vaccine’s effectiveness and safety in the real world. They observed, for example, that when TAK-003 was investigated, the circulation of dengue serotype 3 was almost nonexistent, so the efficacy data against that serotype “are very limited.”

“The producer, Takeda, has very limited production capacity. Brazil is the country that uses this vaccine the most, followed by Argentina. Given that these countries have a good epidemiological surveillance system and adverse effect registration, they can conduct studies on how the vaccine performs in real life, which will greatly increase our knowledge about it. For example, we will see its effectiveness against serotype 3,” said Dr. Barbosa.

The PAHO Technical Advisory Group (TAG) on vaccine-preventable diseases recommended that any country using these vaccines have surveillance systems in place because it is important to promptly report and investigate any adverse events, said Dr. Salas. The organization also suggested that vaccination should ideally be administered in a “more controlled environment,” a phase 4 study, “to complete the safety and efficacy profile, especially in those who have not had dengue before and for dengue 3 and 4,” said Dr. Salas in response to a question from this news organization.

“People cannot expect that just because they were vaccinated, they will not get dengue. The vaccine has limited reach,” he emphasized.

Other research strategies for vector control, such as the use of the Wolbachia bacteria and mosquito sterilization, are future strategies and “not tools to control this outbreak,” noted Sylvain Aldighieri, MD, director of the Department of Prevention, Control, and Elimination of Transmissible Diseases at PAHO.

In his opening remarks, Dr. Barbosa urged the intensification of efforts with tools that are already available. These approaches include eliminating mosquito breeding sites (“80% are in or near homes”) and protecting against mosquito bites, preparing health services for early diagnosis and timely clinical management, and educating the population about dengue symptoms so they seek medical attention immediately.

Although dengue is increasing throughout Latin America and the Caribbean, the most affected countries are Brazil (83%), Paraguay (5.3%), and Argentina (3.7%), which account for 92% of the cases and 87% of the deaths, PAHO reported.

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

The current tetravalent dengue vaccine TAK-003, from the Japanese laboratory Takeda, is not likely to control the ongoing epidemic, according to the Pan American Health Organization (PAHO). The organization emphasized the need to better understand the vaccine’s effectiveness against different serotypes and its safety under real-world clinical conditions.

The Americas are experiencing a record increase in dengue cases. Three times as many cases have been identified during 2024 (3.5 million) than were reported for the same period in 2023. 

“The vaccine we have available will not curb the dengue epidemic; it should be used complementarily with other actions. The most important actions are field operations, vector control, prevention, and education,” said Daniel Salas, MD, executive manager of the PAHO Comprehensive Immunization Program, during a press conference on March 28.

“The vaccines we currently have are not the best response to reduce transmission and prevent deaths,” added Jarbas Barbosa, MD, PhD, PAHO’s director. The fatality rate remains below 0.05%, but this figure could be hard to maintain if the situation becomes more uncontrolled.

The TAK-003 regimen consists of two doses with a 3-month interval between applications, so “it is not a tool to control transmission at this moment. Studies have shown that only 8 years of [population-level] vaccination would have a significant impact on dengue transmission,” said Dr. Barbosa.

A new vaccine developed in Brazil in partnership with the company MSD, Butantan-DV, is in phase 3 trials and has the advantage of being a single-dose application, which could facilitate its use in situations with accelerated transmission. “But this vaccine will likely only be available in 2025,” said Dr. Barbosa.

PAHO officials also highlighted the need to better characterize the vaccine’s effectiveness and safety in the real world. They observed, for example, that when TAK-003 was investigated, the circulation of dengue serotype 3 was almost nonexistent, so the efficacy data against that serotype “are very limited.”

“The producer, Takeda, has very limited production capacity. Brazil is the country that uses this vaccine the most, followed by Argentina. Given that these countries have a good epidemiological surveillance system and adverse effect registration, they can conduct studies on how the vaccine performs in real life, which will greatly increase our knowledge about it. For example, we will see its effectiveness against serotype 3,” said Dr. Barbosa.

The PAHO Technical Advisory Group (TAG) on vaccine-preventable diseases recommended that any country using these vaccines have surveillance systems in place because it is important to promptly report and investigate any adverse events, said Dr. Salas. The organization also suggested that vaccination should ideally be administered in a “more controlled environment,” a phase 4 study, “to complete the safety and efficacy profile, especially in those who have not had dengue before and for dengue 3 and 4,” said Dr. Salas in response to a question from this news organization.

“People cannot expect that just because they were vaccinated, they will not get dengue. The vaccine has limited reach,” he emphasized.

Other research strategies for vector control, such as the use of the Wolbachia bacteria and mosquito sterilization, are future strategies and “not tools to control this outbreak,” noted Sylvain Aldighieri, MD, director of the Department of Prevention, Control, and Elimination of Transmissible Diseases at PAHO.

In his opening remarks, Dr. Barbosa urged the intensification of efforts with tools that are already available. These approaches include eliminating mosquito breeding sites (“80% are in or near homes”) and protecting against mosquito bites, preparing health services for early diagnosis and timely clinical management, and educating the population about dengue symptoms so they seek medical attention immediately.

Although dengue is increasing throughout Latin America and the Caribbean, the most affected countries are Brazil (83%), Paraguay (5.3%), and Argentina (3.7%), which account for 92% of the cases and 87% of the deaths, PAHO reported.

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

The US Food and Drug Administration (FDA) has approved the biosimilar ustekinumab-aekn (Selarsdi) for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in adults and pediatric patients aged 6 years or older.

This is the second ustekinumab biosimilar approved by the regulatory agency and is the second biosimilar approval in the United States for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals. 

Ustekinumab (Stelara) is a human monoclonal antibody targeting interleukin (IL)–12 and IL-23. The drug, manufactured by Johnson & Johnson, totaled nearly $7 billion in sales in 2023 alone, according a press release. 

“Bringing Selarsdi to market in the US early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs,” the chairman and CEO of Alvotech said in the release. 

The first ustekinumab biosimilar, ustekinumab-auub (Wezlana), was approved by the FDA in on October 31, 2023 and is interchangeable with the reference product. This allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Besides psoriasis and psoriatic arthritis, ustekinumab-auub was also approved for treating moderate to severely active Crohn’s disease and ulcerative colitis. Ustekinumab-aekn does not have an interchangeability designation and was not approved for Crohn’s disease or ulcerative colitis. 

The approval of ustekinumab-aekn was based on two clinical studies. A randomized, double blind, multicenter, 52-week study of 581 patients with moderate to severe plaque psoriasis demonstrated that the biosimilar was as effective as the reference product, with equivalent safety and immunogenicity profiles. A phase 1, randomized, double-blind, single-dose, parallel-group, three-arm study also compared the pharmacokinetic profile of the biosimilar to ustekinumab in 294 healthy adults.

Ustekinumab-aekn is expected to be marketed in the United States on or after February 21, 2025 per a settlement and license agreement with Johnson & Johnson. 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the biosimilar ustekinumab-aekn (Selarsdi) for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in adults and pediatric patients aged 6 years or older.

This is the second ustekinumab biosimilar approved by the regulatory agency and is the second biosimilar approval in the United States for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals. 

Ustekinumab (Stelara) is a human monoclonal antibody targeting interleukin (IL)–12 and IL-23. The drug, manufactured by Johnson & Johnson, totaled nearly $7 billion in sales in 2023 alone, according a press release. 

“Bringing Selarsdi to market in the US early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs,” the chairman and CEO of Alvotech said in the release. 

The first ustekinumab biosimilar, ustekinumab-auub (Wezlana), was approved by the FDA in on October 31, 2023 and is interchangeable with the reference product. This allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Besides psoriasis and psoriatic arthritis, ustekinumab-auub was also approved for treating moderate to severely active Crohn’s disease and ulcerative colitis. Ustekinumab-aekn does not have an interchangeability designation and was not approved for Crohn’s disease or ulcerative colitis. 

The approval of ustekinumab-aekn was based on two clinical studies. A randomized, double blind, multicenter, 52-week study of 581 patients with moderate to severe plaque psoriasis demonstrated that the biosimilar was as effective as the reference product, with equivalent safety and immunogenicity profiles. A phase 1, randomized, double-blind, single-dose, parallel-group, three-arm study also compared the pharmacokinetic profile of the biosimilar to ustekinumab in 294 healthy adults.

Ustekinumab-aekn is expected to be marketed in the United States on or after February 21, 2025 per a settlement and license agreement with Johnson & Johnson. 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the biosimilar ustekinumab-aekn (Selarsdi) for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in adults and pediatric patients aged 6 years or older.

This is the second ustekinumab biosimilar approved by the regulatory agency and is the second biosimilar approval in the United States for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals. 

Ustekinumab (Stelara) is a human monoclonal antibody targeting interleukin (IL)–12 and IL-23. The drug, manufactured by Johnson & Johnson, totaled nearly $7 billion in sales in 2023 alone, according a press release. 

“Bringing Selarsdi to market in the US early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs,” the chairman and CEO of Alvotech said in the release. 

The first ustekinumab biosimilar, ustekinumab-auub (Wezlana), was approved by the FDA in on October 31, 2023 and is interchangeable with the reference product. This allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Besides psoriasis and psoriatic arthritis, ustekinumab-auub was also approved for treating moderate to severely active Crohn’s disease and ulcerative colitis. Ustekinumab-aekn does not have an interchangeability designation and was not approved for Crohn’s disease or ulcerative colitis. 

The approval of ustekinumab-aekn was based on two clinical studies. A randomized, double blind, multicenter, 52-week study of 581 patients with moderate to severe plaque psoriasis demonstrated that the biosimilar was as effective as the reference product, with equivalent safety and immunogenicity profiles. A phase 1, randomized, double-blind, single-dose, parallel-group, three-arm study also compared the pharmacokinetic profile of the biosimilar to ustekinumab in 294 healthy adults.

Ustekinumab-aekn is expected to be marketed in the United States on or after February 21, 2025 per a settlement and license agreement with Johnson & Johnson. 

A version of this article appeared on Medscape.com.

More women today are surviving breast cancer if it’s caught early, largely because of better screening and more effective and targeted treatments.

However, not everyone has benefited equitably from this progress. Critical gaps in breast cancer outcomes and survival remain for women in racial and ethnic minority groups.

Black women for instance, have a 41% higher death rate from breast cancer compared with White patients. They also have a greater incidence of aggressive disease like triple-negative breast cancer. Native American and Hispanic women, meanwhile, are more likely to be diagnosed with breast cancer at an earlier age than White women and experience more aggressive breast cancers.

In 2023, Farhad Islami, MD, PhD, and his team published an updated analysis of racial/ethnic and socioeconomic disparities in cancer trends based on data from 2014 to 2020. The analysis found that Black women in particular, were the least likely to have an early-stage diagnosis of breast cancer. Localized‐stage breast cancer was diagnosed in 57% of Black women versus 68% of White women.

American Cancer Society

“Despite substantial progress in cancer prevention, early detection, and treatments, the burden of cancer remains greater among populations that have been historically marginalized, including people of color, people with lower socioeconomic status, and people living in nonmetropolitan areas,” said Dr. Islami, who is senior scientific director of cancer disparity research in the Surveillance & Health Equity Science Department at the American Cancer Society.

The reasons behind outcomes disparities in breast cancer are complex, making solutions challenging, say experts researching racial differences in cancer outcomes.

While social determinants of health (SDH) seem to be drivers of higher breast cancer mortality in Black women, biological differences between Black and White women are also linked to poorer outcomes in Black women with breast cancer, new studies suggest. Among the findings of this research is that breast cancer tests may be contributing to the disparities and misguiding care for some patients of color.
 

SDH and Screening Rates Differences By Race

A range of factors contribute to racial and ethnic disparities in breast cancer outcomes, said Pamela Ganschow, MD, an associate professor in the Department of Internal Medicine at the University of Illinois Cancer Center in Chicago and part of the university’s Cancer Prevention and Control research program. These include socioeconomic status, access to timely and high-quality care across the cancer control continuum, cultural beliefs, differences in genetic makeup and tumor biology, as well as system biases, such as implicit biases and systemic racism, Dr. Ganschow said.

Dr. Islami adds that gaps in access to cancer prevention, early detection, and treatment are largely rooted in fundamental inequities in social determinants of health (SDH), such as whether a patient has safe housing, transportation, education, job opportunities, income, access to nutritious foods, and language and literacy skills, among others.

Dr. Islami’s analysis, for example, shows that people of color are generally more likely to have lower educational attainment and to experience poverty, food insecurity, and housing insecurity compared with White people. Among people aged 18-64 years, the age-adjusted proportion of individuals with no health insurance in 2021 was also higher among Black (13.7%), American Indian/Alaskan Native (18.7%), and Hispanic (28.7%) patients than among White (7.8%) or Asian (5.9%) people, according to the report.

Competing needs can also get in the way of prioritizing cancer screenings, especially for patients in lower socio-economic populations, Dr. Ganschow said.

University of Illinois Cancer Center

Biological Differences, Bad Testing Recommendations May Contribute to Poor Outcomes

Differences in biology may be one overlooked internal driver of lower breast cancer survival in Black women.

Researchers at Sanford Burnham Prebys in La Jolla, California, recently analyzed the breast cells of White and Black women, finding significant molecular differences that may be contributing to higher breast cancer mortality rates in Black women.

Investigators analyzed both healthy tissue and tumor tissue from 185 Black women and compared the samples to that of White women. They discovered differences among Black and White women in the way their DNA repair genes are expressed, both in healthy breast tissue and in tumors positive for estrogen receptor breast cancer. Molecular differences were also present in the cellular signals that control how fast cells, including cancer cells, grow.

DNA repair is part of normal cellular function and helps cells recover from damage that can occur during DNA replication or in response to external factors, such as stress.

“One of the first lines of defense, to prevent the cell from becoming a tumor are DNA damage repair pathways,” said Svasti Haricharan, PhD, a coauthor of the study and an assistant professor at Sanford Burnham Prebys. “We know there are many different DNA damage repair pathways that respond to different types of DNA damage. What we didn’t know was that, even in our normal cells, based on your race and ethnicity, you have different levels of DNA repair proteins.”

Sanford Burnham Prebys

University of Illinois Cancer Center

How Neighborhood Impacts Breast Cancer, Death Rates

Living in a disadvantaged neighborhood also lowers breast cancer survival, according to new research. A disadvantaged neighborhood is generally defined as a location associated with higher concentrations of poverty, higher rates of unemployment, and less access to health care, quality housing, food, and community resources, according to the Centers for Disease Control and Prevention.

Authors of a study published in JAMA Network Open on April 18 identified 350,824 patients with breast cancer. Of these, 41,519 (11.8%) were Hispanic, 39,631 (11.3%) were non-Hispanic Black, and 234,698 (66.9%) were non-Hispanic White. Investigators divided the patients into five groups representing the lowest to highest neighborhood socioeconomic indices using the Yost Index. (The Yost Index is used by the National Cancer Institute for cancer surveillance and is based on variables such as household income, home value, median rent, percentage below 150% of the poverty line, education, and unemployment.)

Of the Black and Hispanic patients in the study, the highest proportions of both demographics lived in the most disadvantaged neighborhoods. (16,141 Black patients [30.9%]) and 10,168 Hispanic patients [19.5%]). Although 45% of White patients also fell into that same category, the highest proportion of White patients in the study lived in the most advantaged neighborhoods (66,529 patients [76.2%]).

Findings showed patients in the most disadvantaged neighborhoods had the highest proportion of triple-negative breast cancer. Patients in this group also had the lowest proportion of patients who completed surgery and radiation, and the highest proportion of patients who received chemotherapy, compared with all other neighborhood groups. The most advantaged neighborhoods group had higher proportions of localized-stage cancer, a higher proportion of patients who underwent surgery and radiation, and the lowest proportion of patients receiving chemotherapy treatment.

Patients in the most disadvantaged neighborhoods also had the highest risk of mortality (hazard ratio [HR,] 1.53; 95% CI, 1.48-1.59; P less than .001) compared with patients living in the most advantaged neighborhoods. Non-Hispanic Black patients in particular, had the highest risk of mortality, compared with non-Hispanic White patients (HR, 1.16; 95% CI, 1.13-1.20; P less than .001).

Authors wrote that the findings suggest neighborhood disadvantage is independently associated with shorter survival in patients with breast cancer, even after controlling for individual-level factors, tumor characteristics, and treatment.

“To address these residual disparities associated with neighborhood disadvantage, research must focus on which components of the built environment influence outcomes,” the authors said.

Another recent study also found correlations among where breast cancer patients lived and how they fared with the disease.

Jasmine M. Miller-Kleinhenz, PhD, an assistant professor at University of Mississippi Medical Center in Jackson, studied how historical redlining impacts breast cancer development and outcomes in her research published in JAMA Network Open, earlier this year. Redlining refers to the practice of denying people access to credit because of where they live. Historically, mortgage lenders widely redlined neighborhoods with predominantly Black residents. The 1968 Fair Housing Act outlawed racially motivated redlining, but consequences from historical redlining still exist.

University of Mississippi Medical Center

Hope for Improved Outcomes, Higher Survival Rates

Investigators hope the findings of all of this new research lead to better, more targeted treatments and, in turn, improved outcomes.

Dr. Haricharan is optimistic about the improvement of breast cancer outcomes as more is learned about the biology of Black patients and other non-White patients.

There is a growing effort to include more data from minoritized populations in breast cancer research studies, Dr. Haricharan said, and she foresees associated changes to clinical protocols in the future. Her own team is working on creating larger data sets that are more representative of non-White patients to further analyze the differences found in their prior study.

“I think there’s this understanding that, until we have data sets that are more representative, we really are catering to [only one] population in terms of our diagnostic and therapeutic technological advances,” she said.

The American Cancer Society meanwhile, is launching a new initiative in May that aims to collect more health data from Black women to ultimately develop more effective cancer interventions. VOICES of Black Women will focus on collecting and studying health data from Black women through online surveys. The society’s goal is to enroll at least 100,000 Black women in the United States between ages 25 and 55.

Dr. Miller-Kleinhenz called the initiative “an important step to starting to research and answer some of these lingering questions about why there continue to be breast cancer disparities.”

More women today are surviving breast cancer if it’s caught early, largely because of better screening and more effective and targeted treatments.

However, not everyone has benefited equitably from this progress. Critical gaps in breast cancer outcomes and survival remain for women in racial and ethnic minority groups.

Black women for instance, have a 41% higher death rate from breast cancer compared with White patients. They also have a greater incidence of aggressive disease like triple-negative breast cancer. Native American and Hispanic women, meanwhile, are more likely to be diagnosed with breast cancer at an earlier age than White women and experience more aggressive breast cancers.

In 2023, Farhad Islami, MD, PhD, and his team published an updated analysis of racial/ethnic and socioeconomic disparities in cancer trends based on data from 2014 to 2020. The analysis found that Black women in particular, were the least likely to have an early-stage diagnosis of breast cancer. Localized‐stage breast cancer was diagnosed in 57% of Black women versus 68% of White women.

American Cancer Society

“Despite substantial progress in cancer prevention, early detection, and treatments, the burden of cancer remains greater among populations that have been historically marginalized, including people of color, people with lower socioeconomic status, and people living in nonmetropolitan areas,” said Dr. Islami, who is senior scientific director of cancer disparity research in the Surveillance & Health Equity Science Department at the American Cancer Society.

The reasons behind outcomes disparities in breast cancer are complex, making solutions challenging, say experts researching racial differences in cancer outcomes.

While social determinants of health (SDH) seem to be drivers of higher breast cancer mortality in Black women, biological differences between Black and White women are also linked to poorer outcomes in Black women with breast cancer, new studies suggest. Among the findings of this research is that breast cancer tests may be contributing to the disparities and misguiding care for some patients of color.
 

SDH and Screening Rates Differences By Race

A range of factors contribute to racial and ethnic disparities in breast cancer outcomes, said Pamela Ganschow, MD, an associate professor in the Department of Internal Medicine at the University of Illinois Cancer Center in Chicago and part of the university’s Cancer Prevention and Control research program. These include socioeconomic status, access to timely and high-quality care across the cancer control continuum, cultural beliefs, differences in genetic makeup and tumor biology, as well as system biases, such as implicit biases and systemic racism, Dr. Ganschow said.

Dr. Islami adds that gaps in access to cancer prevention, early detection, and treatment are largely rooted in fundamental inequities in social determinants of health (SDH), such as whether a patient has safe housing, transportation, education, job opportunities, income, access to nutritious foods, and language and literacy skills, among others.

Dr. Islami’s analysis, for example, shows that people of color are generally more likely to have lower educational attainment and to experience poverty, food insecurity, and housing insecurity compared with White people. Among people aged 18-64 years, the age-adjusted proportion of individuals with no health insurance in 2021 was also higher among Black (13.7%), American Indian/Alaskan Native (18.7%), and Hispanic (28.7%) patients than among White (7.8%) or Asian (5.9%) people, according to the report.

Competing needs can also get in the way of prioritizing cancer screenings, especially for patients in lower socio-economic populations, Dr. Ganschow said.

University of Illinois Cancer Center

Biological Differences, Bad Testing Recommendations May Contribute to Poor Outcomes

Differences in biology may be one overlooked internal driver of lower breast cancer survival in Black women.

Researchers at Sanford Burnham Prebys in La Jolla, California, recently analyzed the breast cells of White and Black women, finding significant molecular differences that may be contributing to higher breast cancer mortality rates in Black women.

Investigators analyzed both healthy tissue and tumor tissue from 185 Black women and compared the samples to that of White women. They discovered differences among Black and White women in the way their DNA repair genes are expressed, both in healthy breast tissue and in tumors positive for estrogen receptor breast cancer. Molecular differences were also present in the cellular signals that control how fast cells, including cancer cells, grow.

DNA repair is part of normal cellular function and helps cells recover from damage that can occur during DNA replication or in response to external factors, such as stress.

“One of the first lines of defense, to prevent the cell from becoming a tumor are DNA damage repair pathways,” said Svasti Haricharan, PhD, a coauthor of the study and an assistant professor at Sanford Burnham Prebys. “We know there are many different DNA damage repair pathways that respond to different types of DNA damage. What we didn’t know was that, even in our normal cells, based on your race and ethnicity, you have different levels of DNA repair proteins.”

Sanford Burnham Prebys

University of Illinois Cancer Center

How Neighborhood Impacts Breast Cancer, Death Rates

Living in a disadvantaged neighborhood also lowers breast cancer survival, according to new research. A disadvantaged neighborhood is generally defined as a location associated with higher concentrations of poverty, higher rates of unemployment, and less access to health care, quality housing, food, and community resources, according to the Centers for Disease Control and Prevention.

Authors of a study published in JAMA Network Open on April 18 identified 350,824 patients with breast cancer. Of these, 41,519 (11.8%) were Hispanic, 39,631 (11.3%) were non-Hispanic Black, and 234,698 (66.9%) were non-Hispanic White. Investigators divided the patients into five groups representing the lowest to highest neighborhood socioeconomic indices using the Yost Index. (The Yost Index is used by the National Cancer Institute for cancer surveillance and is based on variables such as household income, home value, median rent, percentage below 150% of the poverty line, education, and unemployment.)

Of the Black and Hispanic patients in the study, the highest proportions of both demographics lived in the most disadvantaged neighborhoods. (16,141 Black patients [30.9%]) and 10,168 Hispanic patients [19.5%]). Although 45% of White patients also fell into that same category, the highest proportion of White patients in the study lived in the most advantaged neighborhoods (66,529 patients [76.2%]).

Findings showed patients in the most disadvantaged neighborhoods had the highest proportion of triple-negative breast cancer. Patients in this group also had the lowest proportion of patients who completed surgery and radiation, and the highest proportion of patients who received chemotherapy, compared with all other neighborhood groups. The most advantaged neighborhoods group had higher proportions of localized-stage cancer, a higher proportion of patients who underwent surgery and radiation, and the lowest proportion of patients receiving chemotherapy treatment.

Patients in the most disadvantaged neighborhoods also had the highest risk of mortality (hazard ratio [HR,] 1.53; 95% CI, 1.48-1.59; P less than .001) compared with patients living in the most advantaged neighborhoods. Non-Hispanic Black patients in particular, had the highest risk of mortality, compared with non-Hispanic White patients (HR, 1.16; 95% CI, 1.13-1.20; P less than .001).

Authors wrote that the findings suggest neighborhood disadvantage is independently associated with shorter survival in patients with breast cancer, even after controlling for individual-level factors, tumor characteristics, and treatment.

“To address these residual disparities associated with neighborhood disadvantage, research must focus on which components of the built environment influence outcomes,” the authors said.

Another recent study also found correlations among where breast cancer patients lived and how they fared with the disease.

Jasmine M. Miller-Kleinhenz, PhD, an assistant professor at University of Mississippi Medical Center in Jackson, studied how historical redlining impacts breast cancer development and outcomes in her research published in JAMA Network Open, earlier this year. Redlining refers to the practice of denying people access to credit because of where they live. Historically, mortgage lenders widely redlined neighborhoods with predominantly Black residents. The 1968 Fair Housing Act outlawed racially motivated redlining, but consequences from historical redlining still exist.

University of Mississippi Medical Center

Hope for Improved Outcomes, Higher Survival Rates

Investigators hope the findings of all of this new research lead to better, more targeted treatments and, in turn, improved outcomes.

Dr. Haricharan is optimistic about the improvement of breast cancer outcomes as more is learned about the biology of Black patients and other non-White patients.

There is a growing effort to include more data from minoritized populations in breast cancer research studies, Dr. Haricharan said, and she foresees associated changes to clinical protocols in the future. Her own team is working on creating larger data sets that are more representative of non-White patients to further analyze the differences found in their prior study.

“I think there’s this understanding that, until we have data sets that are more representative, we really are catering to [only one] population in terms of our diagnostic and therapeutic technological advances,” she said.

The American Cancer Society meanwhile, is launching a new initiative in May that aims to collect more health data from Black women to ultimately develop more effective cancer interventions. VOICES of Black Women will focus on collecting and studying health data from Black women through online surveys. The society’s goal is to enroll at least 100,000 Black women in the United States between ages 25 and 55.

Dr. Miller-Kleinhenz called the initiative “an important step to starting to research and answer some of these lingering questions about why there continue to be breast cancer disparities.”

More women today are surviving breast cancer if it’s caught early, largely because of better screening and more effective and targeted treatments.

However, not everyone has benefited equitably from this progress. Critical gaps in breast cancer outcomes and survival remain for women in racial and ethnic minority groups.

Black women for instance, have a 41% higher death rate from breast cancer compared with White patients. They also have a greater incidence of aggressive disease like triple-negative breast cancer. Native American and Hispanic women, meanwhile, are more likely to be diagnosed with breast cancer at an earlier age than White women and experience more aggressive breast cancers.

In 2023, Farhad Islami, MD, PhD, and his team published an updated analysis of racial/ethnic and socioeconomic disparities in cancer trends based on data from 2014 to 2020. The analysis found that Black women in particular, were the least likely to have an early-stage diagnosis of breast cancer. Localized‐stage breast cancer was diagnosed in 57% of Black women versus 68% of White women.

American Cancer Society

“Despite substantial progress in cancer prevention, early detection, and treatments, the burden of cancer remains greater among populations that have been historically marginalized, including people of color, people with lower socioeconomic status, and people living in nonmetropolitan areas,” said Dr. Islami, who is senior scientific director of cancer disparity research in the Surveillance & Health Equity Science Department at the American Cancer Society.

The reasons behind outcomes disparities in breast cancer are complex, making solutions challenging, say experts researching racial differences in cancer outcomes.

While social determinants of health (SDH) seem to be drivers of higher breast cancer mortality in Black women, biological differences between Black and White women are also linked to poorer outcomes in Black women with breast cancer, new studies suggest. Among the findings of this research is that breast cancer tests may be contributing to the disparities and misguiding care for some patients of color.
 

SDH and Screening Rates Differences By Race

A range of factors contribute to racial and ethnic disparities in breast cancer outcomes, said Pamela Ganschow, MD, an associate professor in the Department of Internal Medicine at the University of Illinois Cancer Center in Chicago and part of the university’s Cancer Prevention and Control research program. These include socioeconomic status, access to timely and high-quality care across the cancer control continuum, cultural beliefs, differences in genetic makeup and tumor biology, as well as system biases, such as implicit biases and systemic racism, Dr. Ganschow said.

Dr. Islami adds that gaps in access to cancer prevention, early detection, and treatment are largely rooted in fundamental inequities in social determinants of health (SDH), such as whether a patient has safe housing, transportation, education, job opportunities, income, access to nutritious foods, and language and literacy skills, among others.

Dr. Islami’s analysis, for example, shows that people of color are generally more likely to have lower educational attainment and to experience poverty, food insecurity, and housing insecurity compared with White people. Among people aged 18-64 years, the age-adjusted proportion of individuals with no health insurance in 2021 was also higher among Black (13.7%), American Indian/Alaskan Native (18.7%), and Hispanic (28.7%) patients than among White (7.8%) or Asian (5.9%) people, according to the report.

Competing needs can also get in the way of prioritizing cancer screenings, especially for patients in lower socio-economic populations, Dr. Ganschow said.

University of Illinois Cancer Center

Biological Differences, Bad Testing Recommendations May Contribute to Poor Outcomes

Differences in biology may be one overlooked internal driver of lower breast cancer survival in Black women.

Researchers at Sanford Burnham Prebys in La Jolla, California, recently analyzed the breast cells of White and Black women, finding significant molecular differences that may be contributing to higher breast cancer mortality rates in Black women.

Investigators analyzed both healthy tissue and tumor tissue from 185 Black women and compared the samples to that of White women. They discovered differences among Black and White women in the way their DNA repair genes are expressed, both in healthy breast tissue and in tumors positive for estrogen receptor breast cancer. Molecular differences were also present in the cellular signals that control how fast cells, including cancer cells, grow.

DNA repair is part of normal cellular function and helps cells recover from damage that can occur during DNA replication or in response to external factors, such as stress.

“One of the first lines of defense, to prevent the cell from becoming a tumor are DNA damage repair pathways,” said Svasti Haricharan, PhD, a coauthor of the study and an assistant professor at Sanford Burnham Prebys. “We know there are many different DNA damage repair pathways that respond to different types of DNA damage. What we didn’t know was that, even in our normal cells, based on your race and ethnicity, you have different levels of DNA repair proteins.”

Sanford Burnham Prebys

University of Illinois Cancer Center

How Neighborhood Impacts Breast Cancer, Death Rates

Living in a disadvantaged neighborhood also lowers breast cancer survival, according to new research. A disadvantaged neighborhood is generally defined as a location associated with higher concentrations of poverty, higher rates of unemployment, and less access to health care, quality housing, food, and community resources, according to the Centers for Disease Control and Prevention.

Authors of a study published in JAMA Network Open on April 18 identified 350,824 patients with breast cancer. Of these, 41,519 (11.8%) were Hispanic, 39,631 (11.3%) were non-Hispanic Black, and 234,698 (66.9%) were non-Hispanic White. Investigators divided the patients into five groups representing the lowest to highest neighborhood socioeconomic indices using the Yost Index. (The Yost Index is used by the National Cancer Institute for cancer surveillance and is based on variables such as household income, home value, median rent, percentage below 150% of the poverty line, education, and unemployment.)

Of the Black and Hispanic patients in the study, the highest proportions of both demographics lived in the most disadvantaged neighborhoods. (16,141 Black patients [30.9%]) and 10,168 Hispanic patients [19.5%]). Although 45% of White patients also fell into that same category, the highest proportion of White patients in the study lived in the most advantaged neighborhoods (66,529 patients [76.2%]).

Findings showed patients in the most disadvantaged neighborhoods had the highest proportion of triple-negative breast cancer. Patients in this group also had the lowest proportion of patients who completed surgery and radiation, and the highest proportion of patients who received chemotherapy, compared with all other neighborhood groups. The most advantaged neighborhoods group had higher proportions of localized-stage cancer, a higher proportion of patients who underwent surgery and radiation, and the lowest proportion of patients receiving chemotherapy treatment.

Patients in the most disadvantaged neighborhoods also had the highest risk of mortality (hazard ratio [HR,] 1.53; 95% CI, 1.48-1.59; P less than .001) compared with patients living in the most advantaged neighborhoods. Non-Hispanic Black patients in particular, had the highest risk of mortality, compared with non-Hispanic White patients (HR, 1.16; 95% CI, 1.13-1.20; P less than .001).

Authors wrote that the findings suggest neighborhood disadvantage is independently associated with shorter survival in patients with breast cancer, even after controlling for individual-level factors, tumor characteristics, and treatment.

“To address these residual disparities associated with neighborhood disadvantage, research must focus on which components of the built environment influence outcomes,” the authors said.

Another recent study also found correlations among where breast cancer patients lived and how they fared with the disease.

Jasmine M. Miller-Kleinhenz, PhD, an assistant professor at University of Mississippi Medical Center in Jackson, studied how historical redlining impacts breast cancer development and outcomes in her research published in JAMA Network Open, earlier this year. Redlining refers to the practice of denying people access to credit because of where they live. Historically, mortgage lenders widely redlined neighborhoods with predominantly Black residents. The 1968 Fair Housing Act outlawed racially motivated redlining, but consequences from historical redlining still exist.

University of Mississippi Medical Center

Hope for Improved Outcomes, Higher Survival Rates

Investigators hope the findings of all of this new research lead to better, more targeted treatments and, in turn, improved outcomes.

Dr. Haricharan is optimistic about the improvement of breast cancer outcomes as more is learned about the biology of Black patients and other non-White patients.

There is a growing effort to include more data from minoritized populations in breast cancer research studies, Dr. Haricharan said, and she foresees associated changes to clinical protocols in the future. Her own team is working on creating larger data sets that are more representative of non-White patients to further analyze the differences found in their prior study.

“I think there’s this understanding that, until we have data sets that are more representative, we really are catering to [only one] population in terms of our diagnostic and therapeutic technological advances,” she said.

The American Cancer Society meanwhile, is launching a new initiative in May that aims to collect more health data from Black women to ultimately develop more effective cancer interventions. VOICES of Black Women will focus on collecting and studying health data from Black women through online surveys. The society’s goal is to enroll at least 100,000 Black women in the United States between ages 25 and 55.

Dr. Miller-Kleinhenz called the initiative “an important step to starting to research and answer some of these lingering questions about why there continue to be breast cancer disparities.”

The US Food and Drug Administration (FDA) has approved a medical device named the Sepsis ImmunoScore, which is an artificial intelligence/machine learning software, to guide rapid diagnosis and prediction of sepsis. The authorization was granted through the FDA’s De Novo pathway.

Sepsis is a complex condition, so diagnosing it early is difficult and has been a decades-long challenge for the US healthcare system.

Using both biomarkers and clinical data with the assistance of AI, the Sepsis ImmunoScore helps assess the risk for the presence of or progression to sepsis within 24 hours of patient evaluation in the emergency department or hospital. By considering 22 diverse parameters, the AI-powered tool provides a comprehensive evaluation of the patient’s biological condition, resulting in a risk score and categorization into four distinct risk levels.

It’s important to note that this system is not an alert mechanism. These risk categories are correlated with the risk for patient deterioration, including length of hospital stay, in-hospital mortality, and the need for escalated care within 24 hours (such as intensive care unit admission, mechanical ventilation, or vasopressor use). The diagnostic software is integrated directly into hospital electronic medical records.

This is the first AI diagnostic tool for sepsis to receive marketing authorization from the FDA.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved a medical device named the Sepsis ImmunoScore, which is an artificial intelligence/machine learning software, to guide rapid diagnosis and prediction of sepsis. The authorization was granted through the FDA’s De Novo pathway.

Sepsis is a complex condition, so diagnosing it early is difficult and has been a decades-long challenge for the US healthcare system.

Using both biomarkers and clinical data with the assistance of AI, the Sepsis ImmunoScore helps assess the risk for the presence of or progression to sepsis within 24 hours of patient evaluation in the emergency department or hospital. By considering 22 diverse parameters, the AI-powered tool provides a comprehensive evaluation of the patient’s biological condition, resulting in a risk score and categorization into four distinct risk levels.

It’s important to note that this system is not an alert mechanism. These risk categories are correlated with the risk for patient deterioration, including length of hospital stay, in-hospital mortality, and the need for escalated care within 24 hours (such as intensive care unit admission, mechanical ventilation, or vasopressor use). The diagnostic software is integrated directly into hospital electronic medical records.

This is the first AI diagnostic tool for sepsis to receive marketing authorization from the FDA.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved a medical device named the Sepsis ImmunoScore, which is an artificial intelligence/machine learning software, to guide rapid diagnosis and prediction of sepsis. The authorization was granted through the FDA’s De Novo pathway.

Sepsis is a complex condition, so diagnosing it early is difficult and has been a decades-long challenge for the US healthcare system.

Using both biomarkers and clinical data with the assistance of AI, the Sepsis ImmunoScore helps assess the risk for the presence of or progression to sepsis within 24 hours of patient evaluation in the emergency department or hospital. By considering 22 diverse parameters, the AI-powered tool provides a comprehensive evaluation of the patient’s biological condition, resulting in a risk score and categorization into four distinct risk levels.

It’s important to note that this system is not an alert mechanism. These risk categories are correlated with the risk for patient deterioration, including length of hospital stay, in-hospital mortality, and the need for escalated care within 24 hours (such as intensive care unit admission, mechanical ventilation, or vasopressor use). The diagnostic software is integrated directly into hospital electronic medical records.

This is the first AI diagnostic tool for sepsis to receive marketing authorization from the FDA.

A version of this article appeared on Medscape.com.

For patients with relapsed/refractory follicular lymphoma (R/R FL), chimeric antigen responder (CAR) T-cell therapy offers the best chance of survival, despite its high rate of serious side effects and the need to travel to infusion centers. Alternatively, updated chemo+immunotherapy regimens and bispecific antibodies provide less rigorous but effective treatment options for low-risk patients who cannot tolerate or access CAR T.

“CAR T-cells offer patients with relapsed or refractory follicular lymphoma the most durable responses and improved chance of survival beyond all other available therapies. This holds true for a broad range of high-risk disease features in patients with relapsed or refractory FL. Furthermore, it accomplishes this with a single infusion, and a discrete toxicity that is predictable, reversible and manageable,” said Caron Jacobson, MD, MMSc, of the Dana-Farber Cancer Institute in Boston.

Presenting at the Great Debates & Updates Hematologic Malignancies conference, held April 5-6 in New York City, Dr. Jacobson argued that more patients with R/R FL should be treated with CAR T.

Dana-Farber Cancer Institute

NY Presbyterian Hospital, Weill Cornell Medicine

For patients with relapsed/refractory follicular lymphoma (R/R FL), chimeric antigen responder (CAR) T-cell therapy offers the best chance of survival, despite its high rate of serious side effects and the need to travel to infusion centers. Alternatively, updated chemo+immunotherapy regimens and bispecific antibodies provide less rigorous but effective treatment options for low-risk patients who cannot tolerate or access CAR T.

“CAR T-cells offer patients with relapsed or refractory follicular lymphoma the most durable responses and improved chance of survival beyond all other available therapies. This holds true for a broad range of high-risk disease features in patients with relapsed or refractory FL. Furthermore, it accomplishes this with a single infusion, and a discrete toxicity that is predictable, reversible and manageable,” said Caron Jacobson, MD, MMSc, of the Dana-Farber Cancer Institute in Boston.

Presenting at the Great Debates & Updates Hematologic Malignancies conference, held April 5-6 in New York City, Dr. Jacobson argued that more patients with R/R FL should be treated with CAR T.

Dana-Farber Cancer Institute

NY Presbyterian Hospital, Weill Cornell Medicine

For patients with relapsed/refractory follicular lymphoma (R/R FL), chimeric antigen responder (CAR) T-cell therapy offers the best chance of survival, despite its high rate of serious side effects and the need to travel to infusion centers. Alternatively, updated chemo+immunotherapy regimens and bispecific antibodies provide less rigorous but effective treatment options for low-risk patients who cannot tolerate or access CAR T.

“CAR T-cells offer patients with relapsed or refractory follicular lymphoma the most durable responses and improved chance of survival beyond all other available therapies. This holds true for a broad range of high-risk disease features in patients with relapsed or refractory FL. Furthermore, it accomplishes this with a single infusion, and a discrete toxicity that is predictable, reversible and manageable,” said Caron Jacobson, MD, MMSc, of the Dana-Farber Cancer Institute in Boston.

Presenting at the Great Debates & Updates Hematologic Malignancies conference, held April 5-6 in New York City, Dr. Jacobson argued that more patients with R/R FL should be treated with CAR T.

Dana-Farber Cancer Institute

NY Presbyterian Hospital, Weill Cornell Medicine

Primary care physicians who served marginalized communities had the highest proportion of patients who were unvaccinated against COVID-19, Canadian data suggested.

A study of more than 9000 family physicians in Ontario also found that the physicians with the largest proportion of unvaccinated patients were more likely to be male, to have trained outside Canada, to be older, and to work in an enhanced fee-for-service model than their counterparts who had lower proportions of unvaccinated patients.

“The family physicians with the most unvaccinated patients were also more likely to be solo practitioners and less likely to practice in team-based models, meaning they may have fewer support staff in their clinics,” lead author Jennifer Shuldiner, PhD, a scientist at Women’s College Hospital in Toronto, Ontario, Canada, told this news organization.

The findings were published in CMAJ.
 

Need vs Resources

Dr. Shuldiner and her team had been working on a project to provide additional support to family physicians with large numbers of patients who had not received their COVID-19 vaccinations. Their goal was to encourage family physicians to support these patients in getting vaccinated.

“As we were designing this project, we wondered how these physicians and their patients might differ. What characteristics might they have that would enable us to design and implement an intervention with high uptake and impact?” she said.

The researchers conducted a cross-sectional, population-based cohort study using linked administrative datasets in Ontario. They calculated the percentage of patients unvaccinated against SARS-CoV-2 who were enrolled with each comprehensive care family physician, ranked physicians according to the proportion of unvaccinated patients, and identified 906 physicians in the top 10% of unvaccinated patients. These physicians were compared with the remaining 90% of family physicians.

The physicians with the highest proportion of unvaccinated patients cared for 259,130 unvaccinated patients as of November 1, 2021. The proportion of patients who received two or more doses of the SARS-CoV-2 vaccine in this group was 74.2%. In comparison, the proportion of patients who received two or more doses of the vaccine was 87.0% in the remaining 90% of physicians.

Physicians with the largest proportion of unvaccinated patients were more likely to be male (64.6% vs 48.1%), to have trained outside Canada (46.9% vs 29.3%), to be older (mean age, 56 years vs 49 years), and to work in an enhanced fee-for-service model (49% vs 28%).

The study also found that patients enrolled with physicians in the most unvaccinated group tended to live in places with more ethnic diversity, higher material deprivation, and lower incomes. The proportion of recent immigrants was higher in this group.

“Clinics or practices with a large number of unvaccinated patients could be viable targets for efforts to coordinate public health and primary care,” said Dr. Shuldiner.

The findings indicate “the ongoing inverse relationship between the need for care and its accessibility and utilization. In other words, the practices with the highest need receive the fewest resources,” she noted.

“We know that relationships with trusted family physicians can positively influence patients’ decisions. Our study highlights the need to create equitable systems and processes that create opportunities for primary care teams to play a crucial role in influencing general and COVID-19-specific vaccine-related decision-making.”
 

Helping Primary Care Physicians

Commenting on the study for this news organization, Sabrina Wong, RN, PhD, professor of nursing at the University of British Columbia in Vancouver, British Columbia, Canada, said, “They did quite a nice analysis to show this using administrative data, and I think the information they’ve uncovered will be helpful in trying to fill the gaps and provide these practitioners with more support.”

Dr. Wong did not participate in the study. “The information they provide will be useful in helping us to move forward working with underserved, underresourced communities and also hopefully provide the clinicians, family physicians, and nurse practitioners working in these areas with more resources,” she said.

“The authors also point out that there needs to be more collaboration between public health and primary care to support these communities in their efforts to get the vaccines to the people in these communities who need them.”

The study was supported by a Canadian Institutes of Health Research grant. Dr. Shuldiner and Dr. Wong reported no relevant financial relationships.

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

Primary care physicians who served marginalized communities had the highest proportion of patients who were unvaccinated against COVID-19, Canadian data suggested.

A study of more than 9000 family physicians in Ontario also found that the physicians with the largest proportion of unvaccinated patients were more likely to be male, to have trained outside Canada, to be older, and to work in an enhanced fee-for-service model than their counterparts who had lower proportions of unvaccinated patients.

“The family physicians with the most unvaccinated patients were also more likely to be solo practitioners and less likely to practice in team-based models, meaning they may have fewer support staff in their clinics,” lead author Jennifer Shuldiner, PhD, a scientist at Women’s College Hospital in Toronto, Ontario, Canada, told this news organization.

The findings were published in CMAJ.
 

Need vs Resources

Dr. Shuldiner and her team had been working on a project to provide additional support to family physicians with large numbers of patients who had not received their COVID-19 vaccinations. Their goal was to encourage family physicians to support these patients in getting vaccinated.

“As we were designing this project, we wondered how these physicians and their patients might differ. What characteristics might they have that would enable us to design and implement an intervention with high uptake and impact?” she said.

The researchers conducted a cross-sectional, population-based cohort study using linked administrative datasets in Ontario. They calculated the percentage of patients unvaccinated against SARS-CoV-2 who were enrolled with each comprehensive care family physician, ranked physicians according to the proportion of unvaccinated patients, and identified 906 physicians in the top 10% of unvaccinated patients. These physicians were compared with the remaining 90% of family physicians.

The physicians with the highest proportion of unvaccinated patients cared for 259,130 unvaccinated patients as of November 1, 2021. The proportion of patients who received two or more doses of the SARS-CoV-2 vaccine in this group was 74.2%. In comparison, the proportion of patients who received two or more doses of the vaccine was 87.0% in the remaining 90% of physicians.

Physicians with the largest proportion of unvaccinated patients were more likely to be male (64.6% vs 48.1%), to have trained outside Canada (46.9% vs 29.3%), to be older (mean age, 56 years vs 49 years), and to work in an enhanced fee-for-service model (49% vs 28%).

The study also found that patients enrolled with physicians in the most unvaccinated group tended to live in places with more ethnic diversity, higher material deprivation, and lower incomes. The proportion of recent immigrants was higher in this group.

“Clinics or practices with a large number of unvaccinated patients could be viable targets for efforts to coordinate public health and primary care,” said Dr. Shuldiner.

The findings indicate “the ongoing inverse relationship between the need for care and its accessibility and utilization. In other words, the practices with the highest need receive the fewest resources,” she noted.

“We know that relationships with trusted family physicians can positively influence patients’ decisions. Our study highlights the need to create equitable systems and processes that create opportunities for primary care teams to play a crucial role in influencing general and COVID-19-specific vaccine-related decision-making.”
 

Helping Primary Care Physicians

Commenting on the study for this news organization, Sabrina Wong, RN, PhD, professor of nursing at the University of British Columbia in Vancouver, British Columbia, Canada, said, “They did quite a nice analysis to show this using administrative data, and I think the information they’ve uncovered will be helpful in trying to fill the gaps and provide these practitioners with more support.”

Dr. Wong did not participate in the study. “The information they provide will be useful in helping us to move forward working with underserved, underresourced communities and also hopefully provide the clinicians, family physicians, and nurse practitioners working in these areas with more resources,” she said.

“The authors also point out that there needs to be more collaboration between public health and primary care to support these communities in their efforts to get the vaccines to the people in these communities who need them.”

The study was supported by a Canadian Institutes of Health Research grant. Dr. Shuldiner and Dr. Wong reported no relevant financial relationships.

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

Primary care physicians who served marginalized communities had the highest proportion of patients who were unvaccinated against COVID-19, Canadian data suggested.

A study of more than 9000 family physicians in Ontario also found that the physicians with the largest proportion of unvaccinated patients were more likely to be male, to have trained outside Canada, to be older, and to work in an enhanced fee-for-service model than their counterparts who had lower proportions of unvaccinated patients.

“The family physicians with the most unvaccinated patients were also more likely to be solo practitioners and less likely to practice in team-based models, meaning they may have fewer support staff in their clinics,” lead author Jennifer Shuldiner, PhD, a scientist at Women’s College Hospital in Toronto, Ontario, Canada, told this news organization.

The findings were published in CMAJ.
 

Need vs Resources

Dr. Shuldiner and her team had been working on a project to provide additional support to family physicians with large numbers of patients who had not received their COVID-19 vaccinations. Their goal was to encourage family physicians to support these patients in getting vaccinated.

“As we were designing this project, we wondered how these physicians and their patients might differ. What characteristics might they have that would enable us to design and implement an intervention with high uptake and impact?” she said.

The researchers conducted a cross-sectional, population-based cohort study using linked administrative datasets in Ontario. They calculated the percentage of patients unvaccinated against SARS-CoV-2 who were enrolled with each comprehensive care family physician, ranked physicians according to the proportion of unvaccinated patients, and identified 906 physicians in the top 10% of unvaccinated patients. These physicians were compared with the remaining 90% of family physicians.

The physicians with the highest proportion of unvaccinated patients cared for 259,130 unvaccinated patients as of November 1, 2021. The proportion of patients who received two or more doses of the SARS-CoV-2 vaccine in this group was 74.2%. In comparison, the proportion of patients who received two or more doses of the vaccine was 87.0% in the remaining 90% of physicians.

Physicians with the largest proportion of unvaccinated patients were more likely to be male (64.6% vs 48.1%), to have trained outside Canada (46.9% vs 29.3%), to be older (mean age, 56 years vs 49 years), and to work in an enhanced fee-for-service model (49% vs 28%).

The study also found that patients enrolled with physicians in the most unvaccinated group tended to live in places with more ethnic diversity, higher material deprivation, and lower incomes. The proportion of recent immigrants was higher in this group.

“Clinics or practices with a large number of unvaccinated patients could be viable targets for efforts to coordinate public health and primary care,” said Dr. Shuldiner.

The findings indicate “the ongoing inverse relationship between the need for care and its accessibility and utilization. In other words, the practices with the highest need receive the fewest resources,” she noted.

“We know that relationships with trusted family physicians can positively influence patients’ decisions. Our study highlights the need to create equitable systems and processes that create opportunities for primary care teams to play a crucial role in influencing general and COVID-19-specific vaccine-related decision-making.”
 

Helping Primary Care Physicians

Commenting on the study for this news organization, Sabrina Wong, RN, PhD, professor of nursing at the University of British Columbia in Vancouver, British Columbia, Canada, said, “They did quite a nice analysis to show this using administrative data, and I think the information they’ve uncovered will be helpful in trying to fill the gaps and provide these practitioners with more support.”

Dr. Wong did not participate in the study. “The information they provide will be useful in helping us to move forward working with underserved, underresourced communities and also hopefully provide the clinicians, family physicians, and nurse practitioners working in these areas with more resources,” she said.

“The authors also point out that there needs to be more collaboration between public health and primary care to support these communities in their efforts to get the vaccines to the people in these communities who need them.”

The study was supported by a Canadian Institutes of Health Research grant. Dr. Shuldiner and Dr. Wong reported no relevant financial relationships.

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

The photo of the patient’s foot, sent from his campsite, included a cheeky note: “I remember you telling me that getting in trouble doing something was better than getting in trouble doing nothing. This lets me get out there and know that I have feedback.”

The “this” was the patient’s “foot selfie,” an approach that allows patients at a risk for diabetic foot ulcers (DFUs) to snap a picture and send it to their healthcare providers for evaluation.

This particular patient had an extensive history of previous wounds. Some had essentially kept him house-bound in the past, as he was afraid to get another one.

This time, however, he got an all-clear to keep on camping, “and we scheduled him in on the following Tuesday [for follow-up],” said the camper’s physician David G. Armstrong, DPM, MD, PhD, professor of surgery and neurological surgery, USC Keck School of Medicine, Los Angeles.

Dr. Armstrong is one of the researchers evaluating the concept of foot selfies. It’s a welcome advance, he and others said, and has been shown to help heal wounds and reverse pre-ulcer lesions. Research on foot selfies continues, but much more is needed to solve the issue of DFUs, diabetic foot infections (DFIs), and the high rates of reinfection, experts know.

Worldwide, about 18.6 million people have a DFU each year, including 1.6 million in the United States. About 50%-60% of ulcers become infected, with 20% of moderate to severe infections requiring amputation of the limb. The 5-year mortality rate for DFUs is 30%, but it climbs to 70% after amputation. While about 40% of ulcers heal within 12 weeks, 42% recur at the 1-year mark, setting up a vicious and costly cycle. Healthcare costs for patients with diabetes and DFUs are five times as high as costs for patients with diabetes but no DFUs. The per capita cost to treat a DFU in America is $17,500.

While the statistics paint a grim picture, progress is being made on several fronts:

• US Food and Drug Administration (FDA) guidance on the development of drugs for DFUs, under evaluation, is forthcoming.
• New treatments are under study.
• A multidisciplinary team approach is known to improve outcomes.

Anatomy of a DFU

When neuropathy develops in those with diabetes, they no longer have what Dr. Armstrong calls the “gift” of pain perception. “They can wear a hole in their foot like you and I wear a hole in our sock or shoe,” he said. “That hole is called a diabetic foot ulcer.”

A DFU is an open wound on the foot, often occurring when bleeding develops beneath a callus and then the callus wears away. Deeper tissues of the foot are then exposed.

About half of the DFUs get infected, hence the FDA guidance, said Dr. Armstrong, who is also founding president of the American Limb Preservation Society, which aims to eliminate preventable amputations within the next generation. Every 20 seconds, Dr. Armstrong said, someone in the world loses a leg due to diabetes.
 

FDA Guidance on Drug Development for DFIs

In October, the FDA issued draft guidance for industry to articulate the design of clinical trials for developing antibacterial drugs to treat DFIs without concomitant bone and joint involvement. Comments closed on December 18. Among the points in the guidance, which is nonbinding, are to include DFIs of varying depths and extent in phase 3 trials and ideally to include only those patients who have not had prior antibacterial treatment for the current DFI.

According to an FDA spokesperson, “The agency is working to finalize the guidance. However, a timeline for its release has not yet been established.”

The good news about the upcoming FDA guidance, Dr. Armstrong said, is that the agency has realized the importance of treating the infections. Fully one third of direct costs of care for diabetes are spent on the lower extremities, he said. Keeping patients out of the hospital, uninfected, and “keeping legs on bodies” are all important goals, he said.

Pharmaceutical firms need to understand that “you aren’t dealing with a normal ulcer,” said Andrew J.M. Boulton, MD, professor of medicine at the University of Manchester and physician consultant at the Manchester Royal Infirmary, Manchester, England, and a visiting professor at the University of Miami. For research, “the most important thing is to take account of off-loading the ulcers,” he said. “Most ulcers will heal if put in a boot.”

Dr. Boulton, like Dr. Armstrong, a long-time expert in the field, contended that pharma has not understood this concept and has wasted millions over the last three decades doing studies that were poorly designed and controlled.
 

Treatments: Current, Under Study

Currently, DFIs are treated with antimicrobial therapy, without or without debridement, along with a clinical assessment for ischemia. If ischemia is found, care progresses to wound care and off-loading devices, such as healing sandals. Clinicians then assess the likelihood of improved outcomes with revascularization based on operative risks and distribution of lower extremity artery disease and proceed depending on the likelihood. If osteomyelitis testing shows it is present, providers proceed to wound debridement, limb-sparing amputation, and prolonged antimicrobials, as needed.

More options are needed, Dr. Armstrong said.

Among the many approaches under study:

• DFUs can be accurately detected by applying artificial intelligence to the “foot selfie” images taken by patients on smartphones, research by Dr.  and  has found.
• After a phase 3 study of  for DFUs originally intending to enroll 300 subjects was discontinued because of slow patient recruitment, an interim analysis was conducted on 44 participants. It showed a positive trend toward wound closure in the group receiving the injected gene therapy, VM202 (ENGENSIS), in their calf muscles. VM202 is a plasmid DNA-encoding human hepatocyte growth factor. While those in both the intervention and placebo groups showed wound-closing effects at month 6, in 23 patients with neuro-ischemic ulcers, the percentage of those reaching complete closure of the DFU was significantly higher in the treated group at months 3, 4, and 5 (P = .0391, .0391, and .0361, respectively). After excluding two outliers, the difference in months 3-6 became more significant (P = .03).
• An closed more DFUs than standard care after 12 weeks — 70% vs 34% (P = .00032). Of the 100 participants randomized, 50 per group, 42% of the treatment group and 56% of the control group experienced adverse events, with eight withdrawn due to serious adverse events (such as osteomyelitis).
• A closed more refractory DFUs over a 16-week study than standard sharp debridement, with 65% of water-treated ulcers healed but just 42% of the standard care group (P = .021, unadjusted).
• Researchers from UC Davis and VA Northern California Healthcare are evaluating timolol, a beta adrenergic receptor blocker already approved for topical administration for glaucoma, as a way to heal chronic DFUs faster. After demonstrating that the medication worked in animal models, researchers then launched a study to use it off-label for DFUs. While data are still being analyzed, researcher Roslyn (Rivkah) Isseroff, MD, of UC Davis and VA, said that data so far demonstrate that the timolol reduced transepidermal water loss in the healed wounds, and that is linked with a decrease in re-ulceration.

The Power of a Team

Multidisciplinary approaches to treatment are effective in reducing amputation, with one review of 33 studies finding the approach worked to decrease amputation in 94% of them. “The American Limb Preservation Society (ALPS) lists 30 programs,” said Dr. Armstrong, the founding president of the organization. “There may be as many as 100.”

Team compositions vary but usually include at least one medical specialty clinician, such as infectious disease, primary care, or endocrinology, and two or more specialty clinicians, such as vascular, podiatric, orthopedic, or plastic surgery. A shoe specialist is needed to prescribe and manage footwear. Other important team members include nutrition experts and behavioral health professionals to deal with associated depression.

Johns Hopkins’ Multidisciplinary Diabetic Foot and Wound Service launched in 2012 and includes vascular surgeons, surgical podiatrists, endocrinologists, wound care nurses, advanced practice staff, board-certified wound care specialists, orthopedic surgeons, infection disease experts, physical therapists, and certified orthotists.

“This interdisciplinary care model has been repeatedly validated by research as superior for limb salvage and wound healing,” said Nestoras Mathioudakis, MD, codirector of the service. “For instance, endocrinologists and diabetes educators are crucial for managing uncontrolled diabetes — a key factor in infection and delayed wound healing. Similarly, vascular surgeons play a vital role in addressing peripheral arterial disease to improve blood flow to the affected area.”

“Diabetic foot ulcers might require prolonged periods of specialized care, including meticulous wound management and off-loading, overseen by surgical podiatrists and wound care experts,” he said. “In cases where infection is present, particularly with multidrug resistant organisms or when standard antibiotics are contraindicated, the insight of an infectious disease specialist is invaluable.”

While the makeup of teams varies from location to location, he said “the hallmark of effective teams is their ability to comprehensively manage glycemic control, foot wounds, vascular disease, and infections.”

The power of teams, Dr. Armstrong said, is very much evident after his weekly “foot selfie rounds” conducted Mondays at 7 AM, with an “all feet on deck” approach. “Not a week goes by when we don’t stop a hospitalization,” he said of the team evaluating the photos, due to detecting issues early, while still in the manageable state.

Teams can trump technology, Dr. Armstrong said. A team of just a primary care doctor and a podiatrist can make a significant reduction in amputations, he said, just by a “Knock your socks off” approach. He reminds primary care doctors that observing the feet of their patients with diabetes can go a long way to reducing DFUs and the hospitalizations and amputations that can result.

Dr. Mathioudakis and Dr. Isseroff reported no disclosures. Dr. Boulton consults for Urgo Medical, Nevro Corporation, and AOT, Inc. Dr. Armstrong reported receiving consulting fees from Podimetrics; Molnlycke; Cardiovascular Systems, Inc.; Endo Pharmaceuticals; and Averitas Pharma (GRT US).

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

The photo of the patient’s foot, sent from his campsite, included a cheeky note: “I remember you telling me that getting in trouble doing something was better than getting in trouble doing nothing. This lets me get out there and know that I have feedback.”

The “this” was the patient’s “foot selfie,” an approach that allows patients at a risk for diabetic foot ulcers (DFUs) to snap a picture and send it to their healthcare providers for evaluation.

This particular patient had an extensive history of previous wounds. Some had essentially kept him house-bound in the past, as he was afraid to get another one.

This time, however, he got an all-clear to keep on camping, “and we scheduled him in on the following Tuesday [for follow-up],” said the camper’s physician David G. Armstrong, DPM, MD, PhD, professor of surgery and neurological surgery, USC Keck School of Medicine, Los Angeles.

Dr. Armstrong is one of the researchers evaluating the concept of foot selfies. It’s a welcome advance, he and others said, and has been shown to help heal wounds and reverse pre-ulcer lesions. Research on foot selfies continues, but much more is needed to solve the issue of DFUs, diabetic foot infections (DFIs), and the high rates of reinfection, experts know.

Worldwide, about 18.6 million people have a DFU each year, including 1.6 million in the United States. About 50%-60% of ulcers become infected, with 20% of moderate to severe infections requiring amputation of the limb. The 5-year mortality rate for DFUs is 30%, but it climbs to 70% after amputation. While about 40% of ulcers heal within 12 weeks, 42% recur at the 1-year mark, setting up a vicious and costly cycle. Healthcare costs for patients with diabetes and DFUs are five times as high as costs for patients with diabetes but no DFUs. The per capita cost to treat a DFU in America is $17,500.

While the statistics paint a grim picture, progress is being made on several fronts:

• US Food and Drug Administration (FDA) guidance on the development of drugs for DFUs, under evaluation, is forthcoming.
• New treatments are under study.
• A multidisciplinary team approach is known to improve outcomes.

Anatomy of a DFU

When neuropathy develops in those with diabetes, they no longer have what Dr. Armstrong calls the “gift” of pain perception. “They can wear a hole in their foot like you and I wear a hole in our sock or shoe,” he said. “That hole is called a diabetic foot ulcer.”

A DFU is an open wound on the foot, often occurring when bleeding develops beneath a callus and then the callus wears away. Deeper tissues of the foot are then exposed.

About half of the DFUs get infected, hence the FDA guidance, said Dr. Armstrong, who is also founding president of the American Limb Preservation Society, which aims to eliminate preventable amputations within the next generation. Every 20 seconds, Dr. Armstrong said, someone in the world loses a leg due to diabetes.
 

FDA Guidance on Drug Development for DFIs

In October, the FDA issued draft guidance for industry to articulate the design of clinical trials for developing antibacterial drugs to treat DFIs without concomitant bone and joint involvement. Comments closed on December 18. Among the points in the guidance, which is nonbinding, are to include DFIs of varying depths and extent in phase 3 trials and ideally to include only those patients who have not had prior antibacterial treatment for the current DFI.

According to an FDA spokesperson, “The agency is working to finalize the guidance. However, a timeline for its release has not yet been established.”

The good news about the upcoming FDA guidance, Dr. Armstrong said, is that the agency has realized the importance of treating the infections. Fully one third of direct costs of care for diabetes are spent on the lower extremities, he said. Keeping patients out of the hospital, uninfected, and “keeping legs on bodies” are all important goals, he said.

Pharmaceutical firms need to understand that “you aren’t dealing with a normal ulcer,” said Andrew J.M. Boulton, MD, professor of medicine at the University of Manchester and physician consultant at the Manchester Royal Infirmary, Manchester, England, and a visiting professor at the University of Miami. For research, “the most important thing is to take account of off-loading the ulcers,” he said. “Most ulcers will heal if put in a boot.”

Dr. Boulton, like Dr. Armstrong, a long-time expert in the field, contended that pharma has not understood this concept and has wasted millions over the last three decades doing studies that were poorly designed and controlled.
 

Treatments: Current, Under Study

Currently, DFIs are treated with antimicrobial therapy, without or without debridement, along with a clinical assessment for ischemia. If ischemia is found, care progresses to wound care and off-loading devices, such as healing sandals. Clinicians then assess the likelihood of improved outcomes with revascularization based on operative risks and distribution of lower extremity artery disease and proceed depending on the likelihood. If osteomyelitis testing shows it is present, providers proceed to wound debridement, limb-sparing amputation, and prolonged antimicrobials, as needed.

More options are needed, Dr. Armstrong said.

Among the many approaches under study:

• DFUs can be accurately detected by applying artificial intelligence to the “foot selfie” images taken by patients on smartphones, research by Dr.  and  has found.
• After a phase 3 study of  for DFUs originally intending to enroll 300 subjects was discontinued because of slow patient recruitment, an interim analysis was conducted on 44 participants. It showed a positive trend toward wound closure in the group receiving the injected gene therapy, VM202 (ENGENSIS), in their calf muscles. VM202 is a plasmid DNA-encoding human hepatocyte growth factor. While those in both the intervention and placebo groups showed wound-closing effects at month 6, in 23 patients with neuro-ischemic ulcers, the percentage of those reaching complete closure of the DFU was significantly higher in the treated group at months 3, 4, and 5 (P = .0391, .0391, and .0361, respectively). After excluding two outliers, the difference in months 3-6 became more significant (P = .03).
• An closed more DFUs than standard care after 12 weeks — 70% vs 34% (P = .00032). Of the 100 participants randomized, 50 per group, 42% of the treatment group and 56% of the control group experienced adverse events, with eight withdrawn due to serious adverse events (such as osteomyelitis).
• A closed more refractory DFUs over a 16-week study than standard sharp debridement, with 65% of water-treated ulcers healed but just 42% of the standard care group (P = .021, unadjusted).
• Researchers from UC Davis and VA Northern California Healthcare are evaluating timolol, a beta adrenergic receptor blocker already approved for topical administration for glaucoma, as a way to heal chronic DFUs faster. After demonstrating that the medication worked in animal models, researchers then launched a study to use it off-label for DFUs. While data are still being analyzed, researcher Roslyn (Rivkah) Isseroff, MD, of UC Davis and VA, said that data so far demonstrate that the timolol reduced transepidermal water loss in the healed wounds, and that is linked with a decrease in re-ulceration.

The Power of a Team

Multidisciplinary approaches to treatment are effective in reducing amputation, with one review of 33 studies finding the approach worked to decrease amputation in 94% of them. “The American Limb Preservation Society (ALPS) lists 30 programs,” said Dr. Armstrong, the founding president of the organization. “There may be as many as 100.”

Team compositions vary but usually include at least one medical specialty clinician, such as infectious disease, primary care, or endocrinology, and two or more specialty clinicians, such as vascular, podiatric, orthopedic, or plastic surgery. A shoe specialist is needed to prescribe and manage footwear. Other important team members include nutrition experts and behavioral health professionals to deal with associated depression.

Johns Hopkins’ Multidisciplinary Diabetic Foot and Wound Service launched in 2012 and includes vascular surgeons, surgical podiatrists, endocrinologists, wound care nurses, advanced practice staff, board-certified wound care specialists, orthopedic surgeons, infection disease experts, physical therapists, and certified orthotists.

“This interdisciplinary care model has been repeatedly validated by research as superior for limb salvage and wound healing,” said Nestoras Mathioudakis, MD, codirector of the service. “For instance, endocrinologists and diabetes educators are crucial for managing uncontrolled diabetes — a key factor in infection and delayed wound healing. Similarly, vascular surgeons play a vital role in addressing peripheral arterial disease to improve blood flow to the affected area.”

“Diabetic foot ulcers might require prolonged periods of specialized care, including meticulous wound management and off-loading, overseen by surgical podiatrists and wound care experts,” he said. “In cases where infection is present, particularly with multidrug resistant organisms or when standard antibiotics are contraindicated, the insight of an infectious disease specialist is invaluable.”

While the makeup of teams varies from location to location, he said “the hallmark of effective teams is their ability to comprehensively manage glycemic control, foot wounds, vascular disease, and infections.”

The power of teams, Dr. Armstrong said, is very much evident after his weekly “foot selfie rounds” conducted Mondays at 7 AM, with an “all feet on deck” approach. “Not a week goes by when we don’t stop a hospitalization,” he said of the team evaluating the photos, due to detecting issues early, while still in the manageable state.

Teams can trump technology, Dr. Armstrong said. A team of just a primary care doctor and a podiatrist can make a significant reduction in amputations, he said, just by a “Knock your socks off” approach. He reminds primary care doctors that observing the feet of their patients with diabetes can go a long way to reducing DFUs and the hospitalizations and amputations that can result.

Dr. Mathioudakis and Dr. Isseroff reported no disclosures. Dr. Boulton consults for Urgo Medical, Nevro Corporation, and AOT, Inc. Dr. Armstrong reported receiving consulting fees from Podimetrics; Molnlycke; Cardiovascular Systems, Inc.; Endo Pharmaceuticals; and Averitas Pharma (GRT US).

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

The photo of the patient’s foot, sent from his campsite, included a cheeky note: “I remember you telling me that getting in trouble doing something was better than getting in trouble doing nothing. This lets me get out there and know that I have feedback.”

The “this” was the patient’s “foot selfie,” an approach that allows patients at a risk for diabetic foot ulcers (DFUs) to snap a picture and send it to their healthcare providers for evaluation.

This particular patient had an extensive history of previous wounds. Some had essentially kept him house-bound in the past, as he was afraid to get another one.

This time, however, he got an all-clear to keep on camping, “and we scheduled him in on the following Tuesday [for follow-up],” said the camper’s physician David G. Armstrong, DPM, MD, PhD, professor of surgery and neurological surgery, USC Keck School of Medicine, Los Angeles.

Dr. Armstrong is one of the researchers evaluating the concept of foot selfies. It’s a welcome advance, he and others said, and has been shown to help heal wounds and reverse pre-ulcer lesions. Research on foot selfies continues, but much more is needed to solve the issue of DFUs, diabetic foot infections (DFIs), and the high rates of reinfection, experts know.

Worldwide, about 18.6 million people have a DFU each year, including 1.6 million in the United States. About 50%-60% of ulcers become infected, with 20% of moderate to severe infections requiring amputation of the limb. The 5-year mortality rate for DFUs is 30%, but it climbs to 70% after amputation. While about 40% of ulcers heal within 12 weeks, 42% recur at the 1-year mark, setting up a vicious and costly cycle. Healthcare costs for patients with diabetes and DFUs are five times as high as costs for patients with diabetes but no DFUs. The per capita cost to treat a DFU in America is $17,500.

While the statistics paint a grim picture, progress is being made on several fronts:

• US Food and Drug Administration (FDA) guidance on the development of drugs for DFUs, under evaluation, is forthcoming.
• New treatments are under study.
• A multidisciplinary team approach is known to improve outcomes.

Anatomy of a DFU

When neuropathy develops in those with diabetes, they no longer have what Dr. Armstrong calls the “gift” of pain perception. “They can wear a hole in their foot like you and I wear a hole in our sock or shoe,” he said. “That hole is called a diabetic foot ulcer.”

A DFU is an open wound on the foot, often occurring when bleeding develops beneath a callus and then the callus wears away. Deeper tissues of the foot are then exposed.

About half of the DFUs get infected, hence the FDA guidance, said Dr. Armstrong, who is also founding president of the American Limb Preservation Society, which aims to eliminate preventable amputations within the next generation. Every 20 seconds, Dr. Armstrong said, someone in the world loses a leg due to diabetes.
 

FDA Guidance on Drug Development for DFIs

In October, the FDA issued draft guidance for industry to articulate the design of clinical trials for developing antibacterial drugs to treat DFIs without concomitant bone and joint involvement. Comments closed on December 18. Among the points in the guidance, which is nonbinding, are to include DFIs of varying depths and extent in phase 3 trials and ideally to include only those patients who have not had prior antibacterial treatment for the current DFI.

According to an FDA spokesperson, “The agency is working to finalize the guidance. However, a timeline for its release has not yet been established.”

The good news about the upcoming FDA guidance, Dr. Armstrong said, is that the agency has realized the importance of treating the infections. Fully one third of direct costs of care for diabetes are spent on the lower extremities, he said. Keeping patients out of the hospital, uninfected, and “keeping legs on bodies” are all important goals, he said.

Pharmaceutical firms need to understand that “you aren’t dealing with a normal ulcer,” said Andrew J.M. Boulton, MD, professor of medicine at the University of Manchester and physician consultant at the Manchester Royal Infirmary, Manchester, England, and a visiting professor at the University of Miami. For research, “the most important thing is to take account of off-loading the ulcers,” he said. “Most ulcers will heal if put in a boot.”

Dr. Boulton, like Dr. Armstrong, a long-time expert in the field, contended that pharma has not understood this concept and has wasted millions over the last three decades doing studies that were poorly designed and controlled.
 

Treatments: Current, Under Study

Currently, DFIs are treated with antimicrobial therapy, without or without debridement, along with a clinical assessment for ischemia. If ischemia is found, care progresses to wound care and off-loading devices, such as healing sandals. Clinicians then assess the likelihood of improved outcomes with revascularization based on operative risks and distribution of lower extremity artery disease and proceed depending on the likelihood. If osteomyelitis testing shows it is present, providers proceed to wound debridement, limb-sparing amputation, and prolonged antimicrobials, as needed.

More options are needed, Dr. Armstrong said.

Among the many approaches under study:

• DFUs can be accurately detected by applying artificial intelligence to the “foot selfie” images taken by patients on smartphones, research by Dr.  and  has found.
• After a phase 3 study of  for DFUs originally intending to enroll 300 subjects was discontinued because of slow patient recruitment, an interim analysis was conducted on 44 participants. It showed a positive trend toward wound closure in the group receiving the injected gene therapy, VM202 (ENGENSIS), in their calf muscles. VM202 is a plasmid DNA-encoding human hepatocyte growth factor. While those in both the intervention and placebo groups showed wound-closing effects at month 6, in 23 patients with neuro-ischemic ulcers, the percentage of those reaching complete closure of the DFU was significantly higher in the treated group at months 3, 4, and 5 (P = .0391, .0391, and .0361, respectively). After excluding two outliers, the difference in months 3-6 became more significant (P = .03).
• An closed more DFUs than standard care after 12 weeks — 70% vs 34% (P = .00032). Of the 100 participants randomized, 50 per group, 42% of the treatment group and 56% of the control group experienced adverse events, with eight withdrawn due to serious adverse events (such as osteomyelitis).
• A closed more refractory DFUs over a 16-week study than standard sharp debridement, with 65% of water-treated ulcers healed but just 42% of the standard care group (P = .021, unadjusted).
• Researchers from UC Davis and VA Northern California Healthcare are evaluating timolol, a beta adrenergic receptor blocker already approved for topical administration for glaucoma, as a way to heal chronic DFUs faster. After demonstrating that the medication worked in animal models, researchers then launched a study to use it off-label for DFUs. While data are still being analyzed, researcher Roslyn (Rivkah) Isseroff, MD, of UC Davis and VA, said that data so far demonstrate that the timolol reduced transepidermal water loss in the healed wounds, and that is linked with a decrease in re-ulceration.

The Power of a Team

Multidisciplinary approaches to treatment are effective in reducing amputation, with one review of 33 studies finding the approach worked to decrease amputation in 94% of them. “The American Limb Preservation Society (ALPS) lists 30 programs,” said Dr. Armstrong, the founding president of the organization. “There may be as many as 100.”

Team compositions vary but usually include at least one medical specialty clinician, such as infectious disease, primary care, or endocrinology, and two or more specialty clinicians, such as vascular, podiatric, orthopedic, or plastic surgery. A shoe specialist is needed to prescribe and manage footwear. Other important team members include nutrition experts and behavioral health professionals to deal with associated depression.

Johns Hopkins’ Multidisciplinary Diabetic Foot and Wound Service launched in 2012 and includes vascular surgeons, surgical podiatrists, endocrinologists, wound care nurses, advanced practice staff, board-certified wound care specialists, orthopedic surgeons, infection disease experts, physical therapists, and certified orthotists.

“This interdisciplinary care model has been repeatedly validated by research as superior for limb salvage and wound healing,” said Nestoras Mathioudakis, MD, codirector of the service. “For instance, endocrinologists and diabetes educators are crucial for managing uncontrolled diabetes — a key factor in infection and delayed wound healing. Similarly, vascular surgeons play a vital role in addressing peripheral arterial disease to improve blood flow to the affected area.”

“Diabetic foot ulcers might require prolonged periods of specialized care, including meticulous wound management and off-loading, overseen by surgical podiatrists and wound care experts,” he said. “In cases where infection is present, particularly with multidrug resistant organisms or when standard antibiotics are contraindicated, the insight of an infectious disease specialist is invaluable.”

While the makeup of teams varies from location to location, he said “the hallmark of effective teams is their ability to comprehensively manage glycemic control, foot wounds, vascular disease, and infections.”

The power of teams, Dr. Armstrong said, is very much evident after his weekly “foot selfie rounds” conducted Mondays at 7 AM, with an “all feet on deck” approach. “Not a week goes by when we don’t stop a hospitalization,” he said of the team evaluating the photos, due to detecting issues early, while still in the manageable state.

Teams can trump technology, Dr. Armstrong said. A team of just a primary care doctor and a podiatrist can make a significant reduction in amputations, he said, just by a “Knock your socks off” approach. He reminds primary care doctors that observing the feet of their patients with diabetes can go a long way to reducing DFUs and the hospitalizations and amputations that can result.

Dr. Mathioudakis and Dr. Isseroff reported no disclosures. Dr. Boulton consults for Urgo Medical, Nevro Corporation, and AOT, Inc. Dr. Armstrong reported receiving consulting fees from Podimetrics; Molnlycke; Cardiovascular Systems, Inc.; Endo Pharmaceuticals; and Averitas Pharma (GRT US).

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

DENVER — Intravenous (IV) ketamine is an effective and safe treatment option for children with severe refractory headache, new research suggests. In a retrospective chart review, IV ketamine led to in a 50% reduction in pain at discharge, with “nearly two-thirds” of patients having no recurrence within 30 days, noted lead investigator Scott Rosenthal, MD, from the University of Colorado Anschutz Medical Campus, Aurora.

Dr. Rosenthal reported the findings at the 2024 annual meeting of the American Academy of Neurology.
 

Statistically Significant Pain Relief

“IV ketamine has shown benefit in nonheadache chronic pain syndromes and refractory mood disorders. Patients with refractory status migraines are often left with ongoing pain and dysfunction after failing typical interventions,” Dr. Rosenthal said. 

“Ketamine has emerged as a potential treatment option in this population. However, there’s very little research on the efficacy and tolerability of it in general as well as the pediatric population,” he noted. 

Dr. Rosenthal and colleagues took a look back at patients admitted to Children’s Hospital Colorado between 2019 and 2022 for treatment of severe refractory headache who were treated with continuous IV ketamine. 

They analyzed 68 encounters of 41 unique patients aged 5-21 years (median age 16 years; 85% girls). Chronic migraine without aura made up 79% of cases. 

On presentation, most patients had an exacerbation or ongoing worsening of pain for about 10 days, and all but two were taking a preventive medication. Nearly 70% had a comorbid psychiatric diagnosis such as anxiety or depression, and 60% had a comorbid chronic pain diagnosis separate from their headache diagnosis. 

The primary outcome was percent pain reduction at discharge and headache recurrence within 72 hours, with headache recurrence defined as receipt of neurology care via phone, clinic, or hospital encounter. 

Patients received IV ketamine at a median dose of 0.25 mg/kg/hr for a median of 3 days.

Overall, the treatment was “safe and well tolerated,” Dr. Rosenthal said. 

There were no serious adverse events and no cardiac side effects; 7% (five out of 68) stopped treatment due to side effects. The most common side effects were dizziness (23%), nausea (16%), blurred vision (12%), hallucinations (19%), cognitive fog (7%), vomiting (6%) and dysphoria (4%), worsening headache (4%), and paresthesia and cramping (1.5%).
 

‘Exciting Starting Point’

At baseline, pain scores were 8 (on a scale of 0-10) and progressively fell (improved) during treatment. Pain scores were 6 on day 1 and were 5 on day 2, with a slight rebound to 5 at discharge, although the pain reduction at discharge (vs baseline) remained statistically significant (P < .001). 

“The median percent pain reduction after 3 days of ketamine was about 40%,” Dr. Rosenthal said. 

He noted that on the first day of treatment, 16% of patients responded to treatment (with a > 50% reduction in their initial pain); this doubled to 33% on day 2 and increased to 44% at discharge. 

In terms of recurrence, 38% had a recurrence within 1 month, “meaning two thirds did not,” Dr. Rosenthal noted. Median time to recurrence was 7 days. There were no recurrences within 72 hours. 

The researchers also tried to tease out which patients might respond best to ketamine.

“Surprisingly,” there wasn’t a strong effect of most demographic variables such as age, sex, gender identity, chronic pain, psychiatric comorbidities, duration of headache, or prior interventions, Dr. Rosenthal noted. 

“Interestingly,” he said, patients who were on two or more preventive medications had a 50% reduction in their pain at discharge compared with a 33% reduction in patients taking one or no preventive medication. It’s possible that more preventative medications may “prime” a patient’s response to ketamine, Dr. Rosenthal said. 

She added that future randomized studies are needed to further assess IV ketamine for refractory headache in children, but these results are “an exciting starting point.” 
 

‘Still an Unknown’

Seniha Nur Ozudogru, MD, assistant professor of clinical neurology at Penn Medicine in Philadelphia, echoed the need for further study.

The role of IV ketamine in refractory pediatric headache is “still an unknown,” said Dr. Ozudogru, who was not involved in the study. 

She noted that currently, there is “no standard protocol for ketamine infusion, even for adults. Every institution has their own protocols, which makes it difficult.” 

Dr. Ozudogru also wonders how “doable” in-hospital IV infusions over 3 days may be for children. 

“Especially for chronic migraine patients, it can be really tricky to manage expectations in that even if they don’t respond and the headache doesn’t go away, they still may have to be discharged. That requires a specific approach and discussion with the patients,” Dr. Ozudogru said. 

Intranasal ketamine is another potential option, she said, with a recent study suggesting that intranasal ketamine is an effective treatment for children hospitalized with refractory migraine. 

“However, there is some concern about the potential of addiction and the side effects of hallucinations and what the main protocol will be, so this not a standard treatment and has to be studied further,” she said. 

The study had no specific funding. Dr. Rosenthal and Dr. Ozudogru have no relevant disclosures.
 

A version of this article appeared on Medscape.com.

DENVER — Intravenous (IV) ketamine is an effective and safe treatment option for children with severe refractory headache, new research suggests. In a retrospective chart review, IV ketamine led to in a 50% reduction in pain at discharge, with “nearly two-thirds” of patients having no recurrence within 30 days, noted lead investigator Scott Rosenthal, MD, from the University of Colorado Anschutz Medical Campus, Aurora.

Dr. Rosenthal reported the findings at the 2024 annual meeting of the American Academy of Neurology.
 

Statistically Significant Pain Relief

“IV ketamine has shown benefit in nonheadache chronic pain syndromes and refractory mood disorders. Patients with refractory status migraines are often left with ongoing pain and dysfunction after failing typical interventions,” Dr. Rosenthal said. 

“Ketamine has emerged as a potential treatment option in this population. However, there’s very little research on the efficacy and tolerability of it in general as well as the pediatric population,” he noted. 

Dr. Rosenthal and colleagues took a look back at patients admitted to Children’s Hospital Colorado between 2019 and 2022 for treatment of severe refractory headache who were treated with continuous IV ketamine. 

They analyzed 68 encounters of 41 unique patients aged 5-21 years (median age 16 years; 85% girls). Chronic migraine without aura made up 79% of cases. 

On presentation, most patients had an exacerbation or ongoing worsening of pain for about 10 days, and all but two were taking a preventive medication. Nearly 70% had a comorbid psychiatric diagnosis such as anxiety or depression, and 60% had a comorbid chronic pain diagnosis separate from their headache diagnosis. 

The primary outcome was percent pain reduction at discharge and headache recurrence within 72 hours, with headache recurrence defined as receipt of neurology care via phone, clinic, or hospital encounter. 

Patients received IV ketamine at a median dose of 0.25 mg/kg/hr for a median of 3 days.

Overall, the treatment was “safe and well tolerated,” Dr. Rosenthal said. 

There were no serious adverse events and no cardiac side effects; 7% (five out of 68) stopped treatment due to side effects. The most common side effects were dizziness (23%), nausea (16%), blurred vision (12%), hallucinations (19%), cognitive fog (7%), vomiting (6%) and dysphoria (4%), worsening headache (4%), and paresthesia and cramping (1.5%).
 

‘Exciting Starting Point’

At baseline, pain scores were 8 (on a scale of 0-10) and progressively fell (improved) during treatment. Pain scores were 6 on day 1 and were 5 on day 2, with a slight rebound to 5 at discharge, although the pain reduction at discharge (vs baseline) remained statistically significant (P < .001). 

“The median percent pain reduction after 3 days of ketamine was about 40%,” Dr. Rosenthal said. 

He noted that on the first day of treatment, 16% of patients responded to treatment (with a > 50% reduction in their initial pain); this doubled to 33% on day 2 and increased to 44% at discharge. 

In terms of recurrence, 38% had a recurrence within 1 month, “meaning two thirds did not,” Dr. Rosenthal noted. Median time to recurrence was 7 days. There were no recurrences within 72 hours. 

The researchers also tried to tease out which patients might respond best to ketamine.

“Surprisingly,” there wasn’t a strong effect of most demographic variables such as age, sex, gender identity, chronic pain, psychiatric comorbidities, duration of headache, or prior interventions, Dr. Rosenthal noted. 

“Interestingly,” he said, patients who were on two or more preventive medications had a 50% reduction in their pain at discharge compared with a 33% reduction in patients taking one or no preventive medication. It’s possible that more preventative medications may “prime” a patient’s response to ketamine, Dr. Rosenthal said. 

She added that future randomized studies are needed to further assess IV ketamine for refractory headache in children, but these results are “an exciting starting point.” 
 

‘Still an Unknown’

Seniha Nur Ozudogru, MD, assistant professor of clinical neurology at Penn Medicine in Philadelphia, echoed the need for further study.

The role of IV ketamine in refractory pediatric headache is “still an unknown,” said Dr. Ozudogru, who was not involved in the study. 

She noted that currently, there is “no standard protocol for ketamine infusion, even for adults. Every institution has their own protocols, which makes it difficult.” 

Dr. Ozudogru also wonders how “doable” in-hospital IV infusions over 3 days may be for children. 

“Especially for chronic migraine patients, it can be really tricky to manage expectations in that even if they don’t respond and the headache doesn’t go away, they still may have to be discharged. That requires a specific approach and discussion with the patients,” Dr. Ozudogru said. 

Intranasal ketamine is another potential option, she said, with a recent study suggesting that intranasal ketamine is an effective treatment for children hospitalized with refractory migraine. 

“However, there is some concern about the potential of addiction and the side effects of hallucinations and what the main protocol will be, so this not a standard treatment and has to be studied further,” she said. 

The study had no specific funding. Dr. Rosenthal and Dr. Ozudogru have no relevant disclosures.
 

A version of this article appeared on Medscape.com.

DENVER — Intravenous (IV) ketamine is an effective and safe treatment option for children with severe refractory headache, new research suggests. In a retrospective chart review, IV ketamine led to in a 50% reduction in pain at discharge, with “nearly two-thirds” of patients having no recurrence within 30 days, noted lead investigator Scott Rosenthal, MD, from the University of Colorado Anschutz Medical Campus, Aurora.

Dr. Rosenthal reported the findings at the 2024 annual meeting of the American Academy of Neurology.
 

Statistically Significant Pain Relief

“IV ketamine has shown benefit in nonheadache chronic pain syndromes and refractory mood disorders. Patients with refractory status migraines are often left with ongoing pain and dysfunction after failing typical interventions,” Dr. Rosenthal said. 

“Ketamine has emerged as a potential treatment option in this population. However, there’s very little research on the efficacy and tolerability of it in general as well as the pediatric population,” he noted. 

Dr. Rosenthal and colleagues took a look back at patients admitted to Children’s Hospital Colorado between 2019 and 2022 for treatment of severe refractory headache who were treated with continuous IV ketamine. 

They analyzed 68 encounters of 41 unique patients aged 5-21 years (median age 16 years; 85% girls). Chronic migraine without aura made up 79% of cases. 

On presentation, most patients had an exacerbation or ongoing worsening of pain for about 10 days, and all but two were taking a preventive medication. Nearly 70% had a comorbid psychiatric diagnosis such as anxiety or depression, and 60% had a comorbid chronic pain diagnosis separate from their headache diagnosis. 

The primary outcome was percent pain reduction at discharge and headache recurrence within 72 hours, with headache recurrence defined as receipt of neurology care via phone, clinic, or hospital encounter. 

Patients received IV ketamine at a median dose of 0.25 mg/kg/hr for a median of 3 days.

Overall, the treatment was “safe and well tolerated,” Dr. Rosenthal said. 

There were no serious adverse events and no cardiac side effects; 7% (five out of 68) stopped treatment due to side effects. The most common side effects were dizziness (23%), nausea (16%), blurred vision (12%), hallucinations (19%), cognitive fog (7%), vomiting (6%) and dysphoria (4%), worsening headache (4%), and paresthesia and cramping (1.5%).
 

‘Exciting Starting Point’

At baseline, pain scores were 8 (on a scale of 0-10) and progressively fell (improved) during treatment. Pain scores were 6 on day 1 and were 5 on day 2, with a slight rebound to 5 at discharge, although the pain reduction at discharge (vs baseline) remained statistically significant (P < .001). 

“The median percent pain reduction after 3 days of ketamine was about 40%,” Dr. Rosenthal said. 

He noted that on the first day of treatment, 16% of patients responded to treatment (with a > 50% reduction in their initial pain); this doubled to 33% on day 2 and increased to 44% at discharge. 

In terms of recurrence, 38% had a recurrence within 1 month, “meaning two thirds did not,” Dr. Rosenthal noted. Median time to recurrence was 7 days. There were no recurrences within 72 hours. 

The researchers also tried to tease out which patients might respond best to ketamine.

“Surprisingly,” there wasn’t a strong effect of most demographic variables such as age, sex, gender identity, chronic pain, psychiatric comorbidities, duration of headache, or prior interventions, Dr. Rosenthal noted. 

“Interestingly,” he said, patients who were on two or more preventive medications had a 50% reduction in their pain at discharge compared with a 33% reduction in patients taking one or no preventive medication. It’s possible that more preventative medications may “prime” a patient’s response to ketamine, Dr. Rosenthal said. 

She added that future randomized studies are needed to further assess IV ketamine for refractory headache in children, but these results are “an exciting starting point.” 
 

‘Still an Unknown’

Seniha Nur Ozudogru, MD, assistant professor of clinical neurology at Penn Medicine in Philadelphia, echoed the need for further study.

The role of IV ketamine in refractory pediatric headache is “still an unknown,” said Dr. Ozudogru, who was not involved in the study. 

She noted that currently, there is “no standard protocol for ketamine infusion, even for adults. Every institution has their own protocols, which makes it difficult.” 

Dr. Ozudogru also wonders how “doable” in-hospital IV infusions over 3 days may be for children. 

“Especially for chronic migraine patients, it can be really tricky to manage expectations in that even if they don’t respond and the headache doesn’t go away, they still may have to be discharged. That requires a specific approach and discussion with the patients,” Dr. Ozudogru said. 

Intranasal ketamine is another potential option, she said, with a recent study suggesting that intranasal ketamine is an effective treatment for children hospitalized with refractory migraine. 

“However, there is some concern about the potential of addiction and the side effects of hallucinations and what the main protocol will be, so this not a standard treatment and has to be studied further,” she said. 

The study had no specific funding. Dr. Rosenthal and Dr. Ozudogru have no relevant disclosures.
 

A version of this article appeared on Medscape.com.